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A Perilous Prescription: The Dangers of Unregulated Drug Ads

Drug advertising policies need to be updated to protect public health.

Morgan Coulson

During the COVID-19 pandemic, as many stayed home, direct-to-consumer prescription drug advertising—already big business—boomed. Websites, social media, streaming services, and other on-demand platforms became ideal real estate for drug manufacturers, start up clinics, telemedicine practitioners, and others to market drugs, whether they were FDA-approved or not.

There are policies in place to police such ads’ legitimacy, but there’s a catch. The FDA’s prescription drug advertising regulations focus only on entities “that manufacture, distribute, or pack” prescription drugs—leaving a gaping loophole for any company that falls outside that jurisdiction to market their products—and putting vulnerable populations seeking cures at risk. Epidemiology professor Caleb Alexander, MD , and senior associate Thomas Moore recently answered some questions to identify, as Alexander puts it, exactly where “the [drug ad] train went off the rails.”

What is and isn’t allowed when it comes to direct-to-consumer advertising of prescription drugs in the U.S.?

TM: The FDA drug advertising regulations require that advertisements for prescription drugs only promote them for medical uses that have been evaluated and approved by the agency. In addition, the ads must present a fair balance between the benefits and risks. 

It is illegal to overstate a drug’s benefits, misrepresent data from studies, or make claims not supported by adequate evidence.

Why are some entities allowed to publish false or misleading information about drugs?

TM: The prescription drug advertising regulations and standards were formulated more than two decades ago when the only business entities that advertised were drug companies, and the main outlets were print and broadcast media. Today all kinds of new businesses promote drugs, online and in social media, and fall into a regulatory loophole.

Keep in mind the important qualification that the FDA regulates only “prescription drugs.” Advertising for over-the-counter drugs, dietary supplements, and other products is regulated by the FTC.

Why is that dangerous for consumers?

CA: While regulations governing drug advertising were designed to target drug manufacturers, we now live in an era where other parties—health care insurers, start-up clinics, telemedicine start-ups—are getting into the business of marketing prescription drugs. And quite a business it is.

The problem is that these entities are not being held to any standard regarding what they can say about the drugs in question—products like ketamine, testosterone, and stimulants for the treatment of ADHD, to name a few—and they are not only misconstruing the evidence, in many cases, they are making outlandish, pants-on-fire claims about these products.

What should consumers consider when encountering drug ads?

TM: Look to see how the risks of the prescription drug are portrayed. Lists of adverse effects should be detailed, complete and have equal prominence to any benefit claims.

CA: Any ad should be taken with a grain of salt; these ads are designed for one main purpose—to boost sales.

How do these ads differ from other prescription drug marketing?

CA: The ads we are talking about are not the typical drug ads seen on TV or drugs prescribed by physicians or nurse practitioners and dispensed by pharmacies. The ads we’re talking about represent a whole new frontier of prescription drug marketing and promotion, and are run not by pharmaceutical manufacturers, but by companies seeking to profit through linking their services to the provision of select prescription drugs.

If you feel you can benefit from a suggested medication, how should you confirm an ad’s credibility?

TM: Go to the FDA website and read the objective Medication Guide for the drug of interest. 

CA: Decisions about whether or not a treatment is worth pursuing should be based on careful consideration by patient and clinician. Full stop. 

Should you report false ads?

TM: It requires effort and some research to use, but the FDA provides “The Bad Ad Program” to help identify and report potentially false or misleading prescription drug advertising.  

Are certain groups more vulnerable to this type of marketing?

TM: People with serious diseases or a condition that impacts their daily life often embrace drugs seeking “hope” and are eager to try something. They are the most vulnerable to being misled.

CA: Some of the more egregious and concerning examples of this problem are reflected in the rapid growth of telemedicine start-ups offering simplified access to powerful drugs with non-trivial risks, such as prescription stimulants for the treatment of ADHD. Another prime example is ketamine. 

Unfortunately, the evidence to support the types of therapies we are talking about is often quite limited, and it's also complex.

What can be done to protect consumers? 

CA: It’s not fair, reasonable, nor practicable to expect consumers to be able to sort through these misrepresentations—and I don’t believe it’s the system that was intended. It’s time to close the loophole that is allowing this to happen.

Companies that are marketing and promoting these drugs should be held to the same standards as drug manufacturers, whether or not they are the ones actually producing the product. 

When it comes to the risks of false advertising, and the threat that it poses to public health, there is nothing fundamentally different between a telemedicine start-up making outlandish claims and such claims arising from the drug maker itself.

Morgan Coulson is an editorial specialist in the Office of External Affairs at the Johns Hopkins Bloomberg School of Public Health.

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A business journal from the Wharton School of the University of Pennsylvania

Cause and Effect: Do Prescription Drug Ads Really Work?

January 4, 2017 • 8 min read.

Drug ads increase the number of prescriptions for medications, Wharton research finds, but that doesn't necessarily translate into health benefits.

• Health Care Management

Wharton's Abby Alpert discusses her research on prescription drug ads.

Pharmaceutical advertising has exploded across print, digital and television media in the last decade, accounting for billions of dollars. But what is the effect of seeing a commercial for the latest diabetes medication or cholesterol drug? Wharton health care management professor Abby Alpert examined that question in her latest research, and she found some informative results that could reshape the market. The paper, “Prescription Drug Advertising and Drug Utilization: The Role of Medicare Part D,” was co-authored with University of Southern California professors Darius Lakdawalla and Neeraj Sood. Advertising does bring about an increase in the number of prescriptions, she says, but that doesn’t necessarily translate into health benefits. Alpert sat down with Knowledge at Wharton to explain her findings in greater detail.

An edited transcript of the conversation follows.

Knowledge at Wharton: Give us a brief summary of what you studied.

Abby Alpert: My research is on health economics and public finance, and my recent work has focused on the pharmaceutical market. In a recent project, I’ve studied the impacts of direct-to-consumer advertising for prescription drugs on drug utilization and drug adherence. We’ve seen a very dramatic increase in the number of pharmaceutical ads on TV in the last two decades. Pharmaceuticals are now one of the largest categories of advertising on TV, and over $4 billion is spent on this type of advertising.

Economists have been interested for a long time in understanding the extent to which advertising is informative versus persuasive, and pharmaceutical advertising is particularly controversial in this respect. There has been a lot of debate about its potential effects on patient welfare. On the one hand, advertising may have informational value if it educates patients about available treatments and encourages people to seek care, especially for under-diagnosed conditions, or it may even improve communication between patients and their doctors. For people who are already taking advertised medications, seeing an ad on TV for your drug could serve as a reminder to take your medication, or it may even enhance your perception of the benefits of treatment, potentially leading to better drug adherence. On the other hand, drug advertising may also lead to unnecessary overuse of prescription drugs and increased drug spending.

“Pharmaceuticals are now one of the largest categories of advertising on TV.”

In this project, we are trying to quantify the extent to which advertising impacts drug utilization, and we also explore some of the mechanisms underlying advertising’s impacts. This helps us to try to understand some of the health and welfare implications of advertising. To do this, we use a natural experiment design, which helps us get at the causal effects of advertising. Our natural experiment is the introduction of Medicare Part D in 2006. Using data from the Nielsen Corporation, we find that there was a sharp increase in pharmaceutical advertising immediately following the introduction of Part D. We also find that this advertising was targeted to markets with the highest concentration of elderly — places like West Palm Beach, Florida, for example.

We also find that this advertising spilled over onto younger consumers in these markets, even though it was targeted to the older consumers, and that they also experienced increased exposure to drug ads after Part D. This sets the stage for our research design, because what we do is compare drug advertising before and after Part D across geographic areas with a higher or lower concentration of elderly. Then we use this change in advertising exposure due to Part D to estimate its effects on drug utilization for the non-elderly — people who are under age 65 and not eligible for Medicare. We focus on the non-elderly population in order to isolate the effects of advertising on drug utilization from the direct effects of the Part D program.

To give a simple example, our strategy boils down to a comparison across areas such as West Palm Beach, Florida, with a large elderly population, and Denver, Colorado, with a much younger population. Young people living in West Palm Beach are going to be exposed to a larger increase in drug advertising after Part D relative to their peers living in Denver. We then test whether this also leads to a differential increase in drug use. Our data on drug utilization comes from a very large database of insurance claims, which covers a wide variety of geographic areas.

Knowledge at Wharton: After looking at this, what were some of your key takeaways?

“We find substantial effects of advertising on drug utilization.”

Alpert: We find substantial effects of advertising on drug utilization. We estimate that a 10% increase in advertising exposure increased the number of prescriptions purchased by about 5%. About 70% of this effect is driven by increased new initiation, and the other 30% is due to increased drug adherence among existing patients.

Specifically, we find that a 10% increase in advertising would increase the rate of drug adherence by about 1% to 2%. While advertising increases drug adherence among existing patients, we also find that among people who initiate treatment because of advertising, their compliance with treatment is actually lower on average. This is a concern if advertising is capturing people for whom treatment is marginally less appropriate or for people who are simply less attached to treatment. This is because initiating a treatment without complying with it will lead to increased drug spending without very many gains to health.

Another finding we have is that there was a large spillover effect of advertising on non-advertised drugs within the same drug classes. These non-advertised drugs are typically generics or off-patent brands. The idea is that someone sees an ad on TV for Lipitor, asks their doctor for Lipitor, but then gets prescribed another statin or a generic drug. What we’re finding is that advertising expands utilization for entire classes of drugs.

Knowledge at Wharton: Could you talk about the practical implications of this paper?

Alpert: Pharmaceutical advertising has been in the news a lot lately because the American Medical Association recently called for a ban on all direct-to-consumer advertising for prescription drugs. The United States is actually only one of two countries in the world that allows this type of advertising. The AMA argues that drug advertising leads people to substitute away from low-cost generic drugs towards more expensive brands, even when they’re not appropriate. Our research can help to inform this debate.

While our findings show that advertising does indeed increase drug spending, we also find that advertising may have health benefits because it increases drug adherence and the take-up of important drugs for treatments like high cholesterol, hypertension, depression and others. However, we can’t exactly fully tease out appropriate versus inappropriate use in our study.

More concerning, though, is that we find that people who initiate drug treatment because of advertising are, on average, less compliant with treatment. So, this could mitigate some of these health gains. We also find that a significant share of the increase in drug utilization driven by advertising is actually for non-advertised drugs, which tend to be lower-cost generics and off-patent brands.

Another implication of this research is that we find there were very large spillover effects of Medicare Part D on the non-elderly population outside of the Medicare program. These effects are large and important on their own and may warrant some consideration by policymakers.

“Initiating a treatment without complying with it will lead to increased drug spending without very many gains to health.”

Knowledge at Wharton: What implications does this have for how physicians should treat patients who have come to them because of an ad?

Alpert: We find that people who are initiating treatment because of advertising are less adherent. So, doctors should be potentially aware that people who are coming in and asking for a treatment may not be as eligible for that treatment or as likely to comply with it, and they may require more monitoring and assessment of whether the treatment is appropriate for them. This is compared to someone the doctor decides is in need of this treatment.

Knowledge at Wharton: What are you going to look at next?

Alpert: Our current findings show a very detailed picture of the utilization responses to advertising. The next thing that I would be interested in pursuing is to use our research design to analyze the effects of advertising on health more directly, as well as isolating appropriate versus inappropriate use. To do this requires detailed data and health outcomes, data on mortality and also data on more intermediate outcomes like hospitalizations or other clinical outcomes. But I think that the ultimate test of whether pharmaceutical advertising improves welfare is its effects on health directly. Currently, there’s very little evidence on advertising’s effect on health, and I think this is an important area for future research.

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• Introduction
• Article Information

eFigure. Identification of Advertised Drug-Indications

eReferences.

Data Sharing Statement

• Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising JAMA Original Investigation February 7, 2023 This pharmacoeconomic study estimates associations between drug characteristics and the proportion of manufacturer promotional spending allocated to direct-to-consumer advertising. Michael J. DiStefano, PhD; Jenny M. Markell, BA; Caroline C. Doherty, MHS; G. Caleb Alexander, MD; Gerard F. Anderson, PhD
• Added Therapeutic Benefit of Top-Selling Brand-name Drugs in Medicare JAMA Original Investigation April 18, 2023 This cross-sectional study assesses Medicare spending on 50 top-selling drugs with limited added clinical benefits using ratings from health technology assessment organizations in Canada, France, and Germany. Alexander C. Egilman, BA; Benjamin N. Rome, MD, MPH; Aaron S. Kesselheim, MD, JD, MPH

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Patel NG , Hwang TJ , Woloshin S , Kesselheim AS. Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021. JAMA Netw Open. 2023;6(1):e2250991. doi:10.1001/jamanetworkopen.2022.50991

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Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021

• 1 Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
• 2 Yale School of Medicine, New Haven, Connecticut
• 3 Center for Medicine in the Media, Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire
• 4 Lisa Schwartz Foundation for Truth in Medicine, Norwich, Vermont
• Original Investigation Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising Michael J. DiStefano, PhD; Jenny M. Markell, BA; Caroline C. Doherty, MHS; G. Caleb Alexander, MD; Gerard F. Anderson, PhD JAMA
• Original Investigation Added Therapeutic Benefit of Top-Selling Brand-name Drugs in Medicare Alexander C. Egilman, BA; Benjamin N. Rome, MD, MPH; Aaron S. Kesselheim, MD, JD, MPH JAMA

Direct-to-consumer drug advertising increased by nearly 5-fold from 1997 to 2016, with 663 000 television commercials reported in 2016. Television advertisements account for roughly two-thirds of total direct-to-consumer advertising spending. 1 Direct-to-consumer advertising is associated with use of higher-cost drugs over generics and less expensive alternatives. 2 Proponents have argued that such advertising improves public health by promoting clinically beneficial prescribing. We assessed the therapeutic value (ie, whether they represent advances over existing treatments) of drugs subject to most direct-to-consumer television advertising from 2015 to 2021.

We collected monthly lists of the US top-advertised drugs and advertisements by manufacturer spending in direct-to-consumer television advertising from an industry publication (September 2015 to August 2021) and extracted advertised indications from an online advertising database. 3 , 4 After excluding duplicates and advertisements without any mentioned products, we merged this list of advertised drug indications with television advertising spending data from Kantar Media AdSpender database and adjusted for inflation (2021 US dollars). The eMethods and eFigure in Supplement 1 describe this process and illustrate the inclusions and exclusions that arrived at our final cohort of 81 drugs.

For each drug indication, we obtained therapeutic value ratings from independent health technology assessment agencies of Canada, France, and Germany and defined ratings of moderate or greater therapeutic value as high therapeutic value, using methods described previously. 5 Ratings consider drugs’ added benefit, safety, and strength of evidence, as compared with existing therapies. We used the most favorable rating available in cases of reevaluations or multiple ratings for a single indication (eg, for different patient subgroups). The final cohort included drugs with at least 1 therapeutic value rating.

We first assessed the proportion of commonly advertised drugs rated as high therapeutic value by any agency. We then examined drugs that were rated by at least 2 agencies. Analyses were conducted using Excel version 16.67 (Microsoft Corp). The study was exempt from institutional review board review and the requirement for informed consent, as no patient data were used. We followed the STROBE reporting guideline.

Among the 81 top-advertised drugs, 26 (32.1%) were immunomodulating agents; 13 (16.0%), alimentary tract and metabolism drugs; and 11 (13.6%) neurologic drugs. Among these, 73 (90.1%) had at least 1 therapeutic value rating, and 55 (67.9%) had ratings from at least 2 health agencies. The 73 drugs with at least 1 therapeutic value rating were associated with advertising spending of $22.3 billion from 2015 to 2021 ( Table ). Twenty of these commonly marketed drugs (27.4%), representing $6.4 billion (28.7%) in advertising spending, were rated by any agency as having high therapeutic value. Results were similar in the subgroup of drugs with at least 2 ratings: 17 of 55 drugs (30.9%) were rated as having high therapeutic value, accounting for 32.7% of advertising spending.

Fewer than one-third of the most common drugs featured in direct-to-consumer television advertising were rated as having high therapeutic value, defined as providing at least moderate improvement in clinical outcomes compared with existing therapies. Manufacturers’ television advertising spending on included products rated as low therapeutic value was $15.9 billion from 2015 to 2021. A limitation of this study was that a small number of drugs lacked ratings, although these only accounted for 5% of advertising spending. We used the most favorable therapeutic value rating at any point since approval, which may overestimate the proportion of higher-benefit drugs.

The findings of this study are consistent with prior research that questioned the therapeutic value of drugs heavily promoted to clinicians. 6 One explanation might be that drugs with substantial therapeutic value are likely to be recognized and prescribed without advertising, so manufacturers have greater incentive to promote drugs of lesser value. The American Medical Association and public health advocates have called for restrictions on direct-to-consumer drug advertising, warning that it inflates demand for newer, more expensive drugs at the expense of less costly alternatives. Policy makers and regulators could consider limiting direct-to-consumer advertising to drugs with high therapeutic or public health value or requiring standardized disclosure of comparative effectiveness and safety data, but policy changes would likely require industry cooperation or face constitutional challenge.

Accepted for Publication: November 22, 2022.

Published: January 13, 2023. doi:10.1001/jamanetworkopen.2022.50991

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2023 Patel NG et al. JAMA Network Open .

Corresponding Author: Aaron S. Kesselheim, MD, JD, MPH, Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, 1620 Tremont St, Ste 3030, Boston MA 02120 ( [email protected] ).

Author Contributions: Dr Hwang had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Mr Patel and Dr Hwang shared first authorship.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Patel, Hwang, Woloshin.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Patel, Hwang.

Obtained funding: Kesselheim.

Administrative, technical, or material support: Hwang.

Supervision: Hwang, Kesselheim.

Conflict of Interest Disclosures: Dr Kesselheim reported having served as an expert witness for the state of West Virginia in litigation against opioid manufacturers relating to their marketing and use (2021-2022). Dr Woloshin reported serving as an expert witness for the state of New Mexico in litigation against the manufacturer of a testosterone gel relating to its marketing. No other disclosures were reported.

Funding/Support: This work was supported by a grant from Arnold Ventures.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement : See Supplement 2 .

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Modern Drug Advertisements, Themes & FDA Regulations

Over $6 billion was spent on   direct-to-consumer prescription drug advertising  in 2016. This money produced 4.6 millio n advertisements  ( Schwartz, 2019) , including 663,000  television commercials .   Today, m odern pharmaceutical advertising campaigns spent  the majority of   their funds mark et ing dru g s  to treat  diabetes , skin  conditions ,  pain disorders, arthritis,  heart   disease , and cancer.      

In 2016, these  companies also  spent  close to $500 million dollars on  awareness campaigns   ( Schwartz, 2019) . Awareness campaigns ,  also referred to as   “help-seeking advertisements” by the FDA ,  do not mention  a particular drug by name, but rather discuss specific health conditions such as smoking cessation, insomnia,  migraine ,  depression, etc.  They may also work to raise awareness of conditions that are not typically considered pressing medical problems such as d ry eye, or low testosterone . The goal of these advertisements  is  to educate the public on various health concerns, but  of course they  also incentivize viewers to research medications  that can   treat these  conditions.       

Whether or not an advertisement specifically mentions a drug name, it is clear by the enormous sums of money spent by pharmaceutical companies   that  they find  connecting with the public through advertisements  to be a   financially  sound  investment .   In this section, we will  now  look more closely   at modern  print,  television , and online  advertising  and what current research in each of these areas has uncovered.   

Print Advertising   

A  wide variety of  p opular print magazines such as  Sports Illustrated  and  Good  Houskeeping   were examined  by researchers  interested  urological drug  advertisements  (Folso m , 2010) .     The majority of  the se   drug  advertisements   were   for the treatment of   common urological conditions such as erectile dysfunction  or  bladder incontinence . The ads   discovered were filled with  images  meant t o capture  the  reader’s eye   and  often appeared to have been created to  specifically  appeal to either male or female readers . When  looking at their messages, these ads  often  discussed  symptom control  and   effectiveness of   the  medication . The se advertisements  also mentioned how the medication  could increase reader’s satisfaction and enjoyment of life .   However, the research team noted that   no  evidence to support these claims such as  charts and/or graphs, or  citations of  peer-reviewed  journal articles ,  w as  presented  to help the   reader  further  evaluate the medication of interest .  Interestingly, none of the   advertisements  highlighted the safety of the advertised medication s .  

In a different study, a research team found that r eaders who encounter  drug ads in their magazines tended to  fall into one of four  categories : “ lay physician”, “informed shopper”, “voyeur” , or “evader”   (Arney, 2013) .  These  categories were developed by the research team to describe the  four unique ways readers interacted with  the   pharmaceutical ads printed in magazines.  For instance, the “lay physician”, “informed shopper”, and “voyeur” will each read drug ads while the  “ evader ”  will not.  Those in the  “ lay  physician ”  group  looked at drug advertisements to learn more about medical diagnoses and how the  drug of interest treat ed  these health issues.  They would also recommend potentially helpful medications to family and friends. The “informed shopper” looked at advertisements for their own  personal  use . If a medicatio n  could be  helpful to them,  this group  paid  special  attention to  listed benefits  AND   side effects , to see if it might be better than what they were currently taking. The “ voyeur ”  looked at  advertisements to learn more about diseases , but not necessarily to use or recommend the  medications advertised.  And finally, readers that flipped right past drug ad s  were  termed “evaders” , as they had no interest in these types of  advertisements .   

See  the t able  below for  more details on each of these groups.   Which  category  do you  fall into when  reading  drug advertisements?   

Television Pharmaceutical Advertising   

On television , t oday’s drug advertisments  often link the use of  their  m edication  with  increase d   physical  activity , showing people riding bikes, walking  with partners ,  and  playing sports   (Applequist, 2018) .   The se  ads  often  depict   medications   as able to   increa se   social interaction , friendships , and  enhance  overall  satisfaction .  To further convince viewers, these ads often use  language  that stress the  novelty  and importance  of these medication s . T he  medication advertised   is  often d escribed as  “revolutionary”,  or “ the first time ... ”  some important health benefit  can be provided  to  patients.   

While  the length of  television  drug advertisments  ha s  increased by 30% over the past decade, the educational content included in these segments ha s  de clined  (Applequist, 2018) . For example,  the importance of lifestyle changes (dietary  adjustments ,  increased exercise)  was discussed much less often in newer advertisements  which could leave viewers with the impression that these non-drug options were less effective .  

Online  Pharmaceutical   Advertising    

Online advertising is  a  rapidly  growing  segment of the pharmaceutical advertising industry .    D uring 2016 ,  $500  million   was  spent on internet and mobile  advertisements   alone  (Schwartz, 2019) .  When search ing  for health information, internet users often  first  turn to general internet  search  engines   such as Google , rather than navigating to specific health information websites, such as MedlinePlus .  Reliance on the results from a general internet search is problematic  when searching for health information  as  advertisers   can use search engine optimization techniques to ensure  their products  are some of the first among returned results (De Freitas, 2014).  Drug company websites for medications may also be problematic as  they can be created to draw the eye towards positive images and statements, and away from side-effects, or effective alternative treatments.  Likewise, pharmaceutical companies have  been  criticized   for  contribut ing  funding to  health information websites  such as WebM D ( De Freitas, 2014) . This  is  concerning  as  patients  may assume  these types of websites  are neutral sources of  health  informatio n, but instead they may contain biased drug-company sponsored information.    

When  searching for   online health information,  health  experts warn that  internet users are vulnerable to  being influenced by  misinformation from   pharmaceutical  companies  (De Freitas, 2013) .  This vulnerability  is due to several reasons:

• dependance on internet as a primary source of information;
• overwhelming   t rust   in the truthfulness of   online  information ;
• unawareness of internet-based information produced by pharmaceutical  companies;
• social isolation   of  more  severely ill   individuals;
• sick individuals  tend to  pay extra  attention to  details and   convince themselves as to  how they  could  apply to their  own  unique health situation .       

The Past and the Present of Medication Advertising:  Bringing  it All  Together    

Through print, television, and internet advertisements, pharmaceutical companies  work to convince  us to explore  their products.   While the method of delivering these ads has  certainly   evolved from the  turn-of-the-20 th   century and   pharmaceutical trade cards,  a  close  examination   reveals  strikingly similar  methods of connecting with a viewer .   

Activity Time!!!

Take some time to  consider and compare  the two advertisements  below .  On the left is a vintage advertisement for  Vegetine  from  our WCM/NYP Medical Archive’s Trade Card Collection .  On the right is a more modern  advertisement  f or Viagra from Pfizer.    

Look closely at the   images , colors ,  text,   and overall tone of these  two  advertisements .   W hat similarities are there between these two advertisements? What differences do you see?  Who  is  the indented audience for each of these ads?   H ow do they make you feel ?   If you  used   one word  to  summarize   each   advertisement's main message , what wo rd would you choose ?    

Although these advertisements were created a century  apart from one another, they have many similarities. Both feature a person looking directly at the viewer .  On the left, the  women in the  Vegetine  ad smiles  and relaxes against a fenc e, holding an empty bottle of the medication. Underneath a flowering tree, she appears youthful and healthy .  We are left with the impression that  Vegitine  will help us regain (or maintain) our youth .    On  the right, the man folds his hands in a  strong yet controlled  manner , thoughtfully looking at the viewer in a well-fitting suit.  The blue of his shirt and the background is a subtle visual reminder that this medication is often known as  the  “blue pill” . Viewers are left with the feeling that Viagra  w ill help one regain  (or maintain) authority and success .   

While the older  advertisement  depicts a young Caucasian woman, and the newer one depicts a middle-aged  African- American  man , both hint that their medications can restore what has been lost  and promote satisfaction . One does this through youthful smiles and flowers, while the other does this through  specific  color s  and  composed  strength.  While the modern Viagra advertisement has more text  visible , pharmaceutical trade cards  also contained quite a bit of text ,   however  these were  typically featured upon the  card’s  backside  ( which is  not included in the above image) .  

These examples illustrate several of the commonalities seen when looking broadly  at both modern and historical pharmaceutical  advertisements .   Regardless of when they were created, these advertisements tend to focus on reclaiming   what was lost . That might be  health, beauty, control,  or certain  daily activities . Whatever it is, advertisers look to convince viewers that a particular medication can help restore and rejuvenate .  Closely aligned with this are messages of hope. Many advertisements of both the past and the present  worked to instill hope in their viewers .  This hope however is usually linked to the  medication being advertised.  One other overarching theme must also be mentioned, that is a gener al lack of scientific data to support the claims made by these advertisements.  While the medications advertised may indeed  be effective and safe (particularly true with modern  pharmaceuticals ), the data to back up these claims is  often  excluded from  advertisements as chubby babies, cute animals, and smiling people tend to sell more products!  

The Food and Drug Administration and Oversight of Modern Pharmaceutical Advertising  

To help ensure that modern advertisements  include  important facts, the Food and Drug Administration  (FDA)  has developed several policies and programs .  Empowered by Congress to regulate  prescription-drug advertisements, the FDA also regulates prescription and over-the  c ounter   ( non- prescription )  medications . The Federal Trade Commission (FTC) oversees  over-the-counter drug  advertisements.        

When  advertising prescription medications, the FDA allows for three basic types of  advertisements :  “ Product  C laim  A dvertisements ” ,  “ R eminder  Advertisements ” , and  “ H elp- S eeking  Advertisements ” . Each of these types of advertisements  must follow certain rules developed by the FDA.  

Product Claim Advertisements  are the most typical drug ad. These are the only  advertisements   that can   refer to a medication by name . These ads   include discussions of  benefits and risks.   Th is information  must not be false or  misleading and must specifically mention both the brand and generic name of the medication,  at least  one FDA-approved use for the drug, and the most significant risks of the drug . 

If printed, a “brief summary”  detailing who should take the drug, when not to take the drug, as well as rare   but   serious and common  but less serious side effects  must be provided. When broadcasted on television or the radio,  the drug ’s most important risks and either ALL of the risks listed in the medication’s prescribing information, or sourc es where viewers/listeners can go to  learn more about the  prescribing information  ( health care provider,   toll-free number, website address,  etc )  must be  provided .     

Reminder Advertisements   provide  the name of a drug, but  do not discuss  the  drug's approved  uses .  These ads assume the viewer already knows the use of a particular drug. These ads do not have to discus s medication risks, but they also can’t say anything about how a drug works. Reminder advertisements cannot be used  for drugs with potentially serious risks, such as those with “black-box” warning s.   

Help-Seeking Advertisements   describe a health condition or  disease but  cannot recommend a specific medication or treatment.  As we have  seen earlier in this section,  conditions discussed might include  incontinence and erectile dysfunction,  or   the dangers of   high cholesterol, osteoporosis, etc.  These  advertisements   often direct the viewer to talk with their health care  provider, but   can  also  include a drug company’s name and number for patients to refer to should they be interested in learning more  information .    

Activity Time!

Now that we know the  basic  types   of  allowable pharmaceutical  advertisement ,  it’s  time for an activity!  T he FDA has developed  incorrect and correct   example ads f or each type of  pharmaceutical advertisement.  For each category of advertisement,  Product Claim ,  Reminder , and  Help-Seeking  you will see two examples .  Take a look  at each  example and  try to determine which  is  the most   CORRECT   and which is the most  PROBLEMATIC  according to the FDA requirments .  

Hint –  in each  advertisement ,  look for the number in the yellow circles .  Look closely at these numbered sections, does something seem missing or problematic? Or  do the numbered sections  look informative and make claims that seem reliable?   

Look  closely to figure out which  are  the correct and which  are  the incorrect examples!  After investigating each,  click on the ANSWERS link  below  to download  the answer sheet !   

Product Claim  Advertisements  

Remember - A product claim ad names a drug, the condition it treats, and talks about both its benefits and risks.  

Reminder Advertisements  

Remember - A reminder ad gives the drug's name but not the drug's use.  

Help-Seeking Advertisements  

Remember - Help-seeking ads describe a disease or condition but do not recommend or suggest specific drugs.   

FDA Warning Letters and the Bad Ad Program    

The FDA actively monitors television commercials, printed advertisements, and online media to ensure  pharmaceutical companies follow their guidelines  when advertising .  If   found to be in violation of these  regulations , the FDA  issues warning letters to the companies at fault. These letters describe in  detail  the  type of  violation /s ,   provide  specific  examples of  these violations, and  address  how the company can   comply with the  FDA’s  regulations  as they move forward.   

FDA warning letters sent to pharmaceutical companies are freely available  for you  to examine , and can be accessed  here:  https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters  

The FDA also oversees the   “ Bad Ad ” or  Truthful Prescription Drug Marketing and Promotion Program . This  project empowers  both the general public and health care providers to identify and report  potential  sources of drug misinformation.    

Remember, prescription drug promotion must:   

Not be  intentionally  false or  misleading  

Have balance between medication effectivness and risk  information  

Reveal material facts about the product being promoted, including facts about consequences that may result from use of the  drug  

  The  FDA provides the  following list of common  reasons  pharmaceutical   advertisements  may be reported and/or   receive  a  warning letter :  

Omitting  or downplaying of  risk  

Overstating the drug’s benefits  

Failing to present a “fair balance” of risk and benefit  information  

Omitting material facts about the drug  

Making claims that are not appropriately  supported  

Misrepresenting data f rom studies  

Misleading drug comparisons  

Misbranding an investigational drug  

If  you come across a   potentially false or misleading drug  advertisement , you  can report it anonymously using the following methods:   

Email:   [email protected]  

Call toll-free : 855-RX-BADAD or 855-792-2323  

Bad Ad Program   FDA/CDER/OPDP   5901-B  Ammendale  Road   Beltsville, MD 20705-1266  

More information about the Bad Ad program itself can be found here:     https://www.fda.gov/drugs/office-prescription-drug-promotion/bad-ad-program

And now, you are up to speed with modern drug advertisements, including their methods of misinformation! You are also now aware of the ways the FDA works to keep drug advertisements informative and transparent.

It's time to learn how you can more critically view the drug advertisements shown to us on a daily basis. In this next section, we will provide an overview of questions to ask yourself when viewing medication ads, as well as the reliable online resources you can turn to when interested in learning more about the medications you see advertised.

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Nih research matters.

May 23, 2017

How drug marketing may influence prescriptions

At a glance.

• After academic medical centers restricted marketing activities, doctors prescribed fewer promoted drugs and more of those that weren’t.
• Future studies will be needed to understand how marketing restrictions affect patient outcomes and costs.

Drug companies often promote products during events or sales visits to doctors. This type of marketing is known as detailing because doctors learn details about drug benefits and side effects. Doctors may also receive gifts such as meals and free samples. Some academic medical centers have begun to restrict detailing. But little is known about the impact of detailing on prescribing practices.

A team led by Dr. Ian Larkin at the University of California, Los Angeles, and Dr. George Loewenstein at Carnegie Mellon University examined whether policies to limit detailing affect prescription patterns. They examined prescriptions in 19 academic medical centers that restricted detailing from January 2006 to June 2012. More than 2,000 doctors were affiliated with the centers. For comparison, the team examined prescriptions by nearly 25,000 doctors who weren’t at the centers.

The analysis included more than 16 million prescriptions in eight major drug classes. These included drugs for acid reflux, attention deficit disorder, depression, diabetes, high blood pressure, lipid disorders, psychosis, and sleep disorders. The team compared detailed and nondetailed drugs, which included generics and brand-name drugs not promoted at the centers. The study was supported in part by NIH’s National Institute of Mental Health (NIMH). Results appeared in the May 2, 2017, issue of the Journal of the American Medical Association .

The mean market share—the share of prescriptions for each drug within its class—of detailed drugs in the centers prior to policy changes was 19.3%. That share declined by 1.67 percentage point after policy changes—an 8.7% relative decrease from before the policy changes. The mean market share of nondetailed drugs was 14.2% before policy changes. Their share increased by 0.84 percentage point after the changes—a 5.6% relative increase. Prescriptions of detailed drugs in the comparison group declined only slightly over the same period.

The changes in mean market share were statistically significant for six of the eight drug classes. Changes varied across academic medical centers, likely because their policies varied widely. Centers with the most stringent policies, such as salesperson registration and training requirements, had the greatest declines in detailed drug prescriptions.

“There has long been concern that drug marketing to physicians might influence their prescribing, including—and maybe especially—for psychiatric drugs,” says coauthor Dr. Michael Schoenbaum of NIMH. “Many medical schools have adopted policies to limit such marketing, and this study is one of the first to document what effect these policies actually have. Important next steps include assessing the economic impact of these policies and whether they affect patients’ clinical outcomes.”

Related Links

• Reducing Antibiotic Prescriptions
• End-of-Life Costs for Dementia Far Greater Than for Other Diseases
• Patient Outcomes Improved by Pay-For-Performance

References:  Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing . Larkin I, Ang D, Steinhart J, Chao M, Patterson M, Sah S, Wu T, Schoenbaum M, Hutchins D, Brennan T, Loewenstein G. JAMA . 2017 May 2;317(17):1785-1795. doi: 10.1001/jama.2017.4039. PMID: 28464141.

Funding:  NIH’s National Institute of Mental Health (NIMH); National Science Foundation; and CVS Caremark (data and assistance).

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Pharmaceutical Marketing: Balance in Prescription Drug Advertising

A study from 2021 stated the amount of money spent on direct to consumer prescription drug advertising increased 460% between 1997 and 2016 . An estimated $10 billon was spent in 2016 alone. According to consumer behavior researcher Brent Rollins, PhD, RPh , associate professor in the Department of Pharmacy Practice at PCOM Georgia, there are only two countries in the world that allow direct to consumer advertising (DTCA) of prescription medications: the United States and New Zealand.

• The rapid growth of direct to consumer prescription drug advertising in the United States requires a robust regulatory framework.
• Rollins’ research focuses on understanding how healthcare consumers behave in response to direct to consumer advertising.
• When the communication of risk and benefit is balanced, advertising prescription drugs can be advantageous for consumers.

What is direct to consumer advertising?

Direct to consumer advertising is the promotion of prescription drugs by pharmaceutical companies through various media channels such as TV, social media and print. 

The U.S. Food and Drug Administration (FDA) through the Office of Prescription Drug Promotion (OPDP) is responsible for regulating prescription drug ads. But the FDA does not typically get to review and approve drug ads before they are viewed by consumers. The FDA website states , “consumers should know that they may not necessarily be able to tell whether any specific DTC ad includes false or misleading information.”

Making an informed decision

Through his research, Dr. Rollins wants to understand how healthcare consumers behave and the best ways to communicate with them through direct to consumer advertising. “Since it's explosion in the late 90s, early 2000s, it's been a topic that's been vastly researched,” Rollins explained. The goal is finding “the balance of giving information to the general healthcare consumer, but then also having the best conversations with physicians, not altering utilization or creating other healthcare issues.”

One of the OPDP’s main objectives is to ensure advertisements portray an accurate representation of the product's benefits and risks. Downplaying potential side effects, overstating benefits and making unsubstantiated claims are all violations of the law .

Psychology of consumer behavior

Dr. Rollins’ interest in DTCA began in graduate school with a course on consumer behavior. During the course, Rollins worked on a project related to a specific ad campaign by Eli Lilly titled "Depression Hurts." The ad was aimed at raising awareness about depression as a health condition rather than promoting a specific product. “I looked at and started to look at those type of ads where the product itself was not mentioned, and then that eventually evolved itself into my dissertation,” Rollins said. His research looked at how consumers respond to ads that initially discuss a disease state and later transition to promoting a specific product, using Eli Lilly's Cymbalta ads as an example.

Pharmaceutical industry careers

Dr. Rollins has seen numerous pharmacy students transition from PCOM’s School of Pharmacy into the pharmaceutical industry through fellowships, rotations and internships. His goal is to further expand this pathway for students which allows pharmacy graduates to bring their drug-related knowledge and skills to diverse sectors, such as technology companies and healthcare entities. He hopes to facilitate internships and rotations to provide practical experience and, through the Doctor of Pharmacy curriculum , prepare students for successful careers in the pharmaceutical industry.

“The knowledge of the drugs and knowledge of the healthcare system and the skills they have are the valuable component,” Rollins said.

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Consumer Behavior

Are direct-to-consumer drug ads becoming fair and balanced, how a new fda rule may change pharmaceutical advertising..

Updated April 10, 2024 | Reviewed by Tyler Woods

• Advertisements use marketing strategies to create positive expectations about a drug’s efficacy.
• A new FDA rule requires ads to present the major risks of the drug in a more balanced and accessible way.
• How this rule may change the ads that we encounter on an everyday basis is yet to be seen.

This post was co-authored with Ms. Lily Johns, research coordinator at the University of Michigan.

As discussed in a previous post , direct-to-consumer pharmaceutical advertising (DTCPA) is designed to create positive expectations by minimizing the risks and emphasizing the benefits of a medication . In November 2023, the Food and Drug Administration (FDA) announced a new rule that calls for marketers to communicate drug information in a way that is easier for consumers to comprehend. This new rule may have widespread implications not only in the context of the placebo effect but also for the pharmaceutical industry and the ads you encounter every day.

What is the new FDA rule?

As of May 2024, when the rule will go into effect, the FDA will require TV/radio DTCPA to ensure that the major statement, the segment of the advertisement that lists the side effects or contraindications of the drug, “be presented in a clear, conspicuous, and neutral manner.”

But what does this mean when it comes to DTCPA? The FDA is requiring advertisements to:

• Use language and terminology that is consumer-friendly and readily understandable
• Use audio that is as understandable as audio information in the rest of the ad in terms of volume, articulation, and pacing
• Refrain from using audio or visual elements during the major statement that might interfere with a consumer’s understanding of the content
• Use text that is easy to read
• For TV ads, present the major statement simultaneously in audio and text for long enough to be read easily

This rule responds, in part, to the criticisms of DTCPA from researchers and advocates. In the rule, the FDA highlights that the purpose of the regulation is “[to] ensure that DTC TV/radio ads convey a truthful and non-misleading net impression about the advertised drug, including its risks.”

Current strategies used in direct-to-consumer drug advertising

DTCPA uses different marketing tactics (e.g., positive imagery, movement/action happening on screen) to inhibit understanding of the risks or drawbacks associated with the drug. Although there are certainly some ads that are more balanced in their presentation of risk information, in general, the way that these advertisements portray the risk and effectiveness of the drug is often misleading.

For example, take one of the most popular ads of last year. During the main message, the advertisement makes a claim in large, bold text, while also adding, in much smaller, lighter text, that the drug's efficacy has limitations. In the same frame, the ad states that the drug causes "rapid symptom relief," with a smaller footnote that this relief occurs after “eight weeks” of taking the drug. While symptom relief after eight weeks may be a short time in the world of clinical trials, it may also contrast with a viewer’s concept of "rapid." It’s also important to note that there is a lot of visual movement on the screen during the major statement (e.g., the actors hiking, skiing), which works to distract the audience from reading the fine print, so to speak.

Under the new FDA rule, this ad could look very different. For example, the text at the bottom of the screen listing the side effects or additional information about efficacy would be enlarged, making it easier for the viewer to pay attention to and interpret. Additionally, the amount of movement during the major statement would be lessened, making it easier for the consumer to understand the information. Most important, perhaps, is the introduction of "dual modality" to this commercial, which would require the major statement to be presented in both audio and text form simultaneously. While this commercial currently presents risk information in the smaller text, it does not directly correspond with the audio version. The net result is that ads today highlight select information about medications rather than presenting all information equally.

However, many questions remain about how these standards will actually affect the end product and how consumers engage with it. Foremost, how will this rule be implemented and enforced? Prior studies have found that existing DTCPA ads have poor regulatory compliance, even under the current FDA regime. Additionally, how may the rule affect public trust in pharmaceutical companies, the FDA, or other agents of the healthcare system? This is especially important since the COVID-19 pandemic, which surveys suggest has dynamically impacted the trust that the public has in the pharmaceutical industry and, in some cases, medical research.

Shifting from a form of advertising to a form of health communication?

As previously discussed , advertisements shape expectations of a drug’s efficacy in a way that can affect health behaviors (i.e., specific drug requests) and health outcomes (i.e., by enhancing a placebo response). While the FDA was unlikely considering consumer expectations vis-a-vis the placebo effect specifically, the new requirement for advertisements to provide a more accurate and less biased portrayal of medications may impact perceptions of medications in terms of efficacy (e.g., How much will this drug improve my symptoms?) and risk (e.g., How likely am I to experience side effects from this drug?). With the new rule, the FDA aims to “[help] consumers notice, attend to, and understand the major statement in DTC TV/radio ads” to improve their educational value to the consumer.

However, many might argue that this rule is not enough to shift these ads into a form of health communication. Notably, this rule doesn’t at all address other core issues related to DTCPA that could affect consumer understanding and decision-making . A recent study found that 68 percent of the most-advertised drugs in 2023 were those with low added benefit compared to similar drugs on the market. In other words, many of the ads you see on TV may be an attempt to boost the sales of drugs that have lesser proven benefits (based on the results of clinical trials) and, therefore, are less likely to be prescribed to patients by their doctor. Research has also shown that DTCPA disproportionately targets certain demographics, including women (particularly in ads for antidepressants ) and older adults. Therefore, concerns remain regarding tactics used in ads that may mislead consumers, even if information regarding risks and benefits is presented in a more balanced manner.

The FDA rule represents an effort to improve transparency and enhance the educational value of DTCPA. Whether this rule is enforced, and what, if any, impacts it has on consumer understanding of treatment options and subsequent decision-making, is yet to be seen.

Applequist, J., & Ball, J. G. (2018). An Updated Analysis of Direct-to-Consumer Television Advertisements for Prescription Drugs. Annals of Family Medicine , 16(3), 211–216. https://doi.org/10.1370/afm.2220

Asadi, L. K., & Shah, A. A. (2023). Gender bias in antidepressant direct-to-consumer pharmaceutical advertising. Comprehensive Psychiatry , 123, 152384. https://doi.org/10.1016/j.comppsych.2023.152384

Brownfield, E. D., Bernhardt, J. M., Phan, J. L., Williams, M. V., & Parker, R. M. (2004). Direct-to-Consumer Drug Advertisements on Network Television: An Exploration of Quantity, Frequency, and Placement. Journal of Health Communication , 9(6), 491–497. https://doi.org/10.1080/10810730490523115

DiStefano, M. J., Markell, J. M., Doherty, C. C., Alexander, G. C., & Anderson, G. F. (2023). Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising. JAMA , 329(5), 386. https://doi.org/10.1001/jama.2022.23968

Food and Drug Administration. (2023). Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format (Rule 2023–25428; p. 27). Food and Drug Administration, Department of Health and Human Services.

Johns Hopkins Bloomberg School of Public Health. (2023, February 7). Spending on Consumer Advertising for Top-Selling Prescription Drugs in U.S. Favors Those With Low Added Benefit. Johns Hopkins Bloomberg School of Public Health.

Klara, K., Kim, J. & Ross, J.S. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines. Journal of General Internal Medicine 33, 651–658 (2018). https://doi-org.proxy.lib.umich.edu/10.1007/s11606-017-4274-9

Lupia A et al. Trends in US public confidence in science and opportunities for progress. PNAS 2024, 121(11) e2319488121.

PhRMA. (2006). PhRMA Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines.

RINVOQ® (Director). (2023, August 4). RINVOQ UC: Tour & Skiing | See bit.ly/RinvoqPI | RINVOQ UC Commercial. https://www.youtube.com/watch?v=b4Ft-lHAsy0

Briana Mezuk, Ph.D. , is a Professor of Epidemiology and Director of the Center for Social Epidemiology and Population Health at the University of Michigan's School of Public Health.

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Historically speaking, it’s not a bad time to be the liver of a teenager. Or the lungs.

Regular use of alcohol, tobacco and drugs among high school students has been on a long downward trend.

In 2023, 46 percent of seniors said that they’d had a drink in the year before being interviewed; that is a precipitous drop from 88 percent in 1979, when the behavior peaked, according to the annual Monitoring the Future survey, a closely watched national poll of youth substance use. A similar downward trend was observed among eighth and 10th graders, and for those three age groups when it came to cigarette smoking. In 2023, just 15 percent of seniors said that they had smoked a cigarette in their life, down from a peak of 76 percent in 1977 .

Illicit drug use among teens has remained low and fairly steady for the past three decades, with some notable declines during the Covid-19 pandemic.

In 2023, 29 percent of high school seniors reported using marijuana in the previous year — down from 37 percent in 2017, and from a peak of 51 percent in 1979.

There are some sobering caveats to the good news. One is that teen overdose deaths have sharply risen, with fentanyl-involved deaths among adolescents doubling from 2019 to 2020 and remaining at that level in the subsequent years.

Dr. Nora Volkow has devoted her career to studying use of drugs and alcohol. She has been the director of the National Institute on Drug Abuse since 2003. She sat down with The New York Times to discuss changing patterns and the reasons behind shifting drug-use trends.

What’s the big picture on teens and drug use?

People don’t really realize that among young people, particularly teenagers, the rate of drug use is at the lowest risk that we have seen in decades. And that’s worth saying, too, for legal alcohol and tobacco.

What do you credit for the change?

One major factor is education and prevention campaigns. Certainly, the prevention campaign for cigarette smoking has been one of the most effective we’ve ever seen.

Some of the policies that were implemented also significantly helped, not just making the legal age for alcohol and tobacco 21 years, but enforcing those laws. Then you stop the progression from drugs that are more accessible, like tobacco and alcohol, to the illicit ones. And teenagers don’t get exposed to advertisements of legal drugs like they did in the past. All of these policies and interventions have had a downstream impact on the use of illicit drugs.

Does social media use among teens play a role?

Absolutely. Social media has shifted the opportunity of being in the physical space with other teenagers. That reduces the likelihood that they will take drugs. And this became dramatically evident when they closed schools because of Covid-19. You saw a big jump downward in the prevalence of use of many substances during the pandemic. That might be because teenagers could not be with one another.

The issue that’s interesting is that despite the fact schools are back, the prevalence of substance use has not gone up to the prepandemic period. It has remained stable or continued to go down. It was a big jump downward, a shift, and some drug use trends continue to slowly go down.

Is there any thought that the stimulation that comes from using a digital device may satisfy some of the same neurochemical experiences of drugs, or provide some of the escapism?

Yes, that’s possible. There has been a shift in the types of reinforcers available to teenagers. It’s not just social media, it’s video gaming, for example. Video gaming can be very reinforcing, and you can produce patterns of compulsive use. So, you are shifting one reinforcer, one way of escaping, with another one. That may be another factor.

Is it too simplistic to see the decline in drug use as a good news story?

If you look at it in an objective way, yes, it’s very good news. Why? Because we know that the earlier you are using these drugs, the greater the risk of becoming addicted to them. It lowers the risk these drugs will interfere with your mental health, your general health, your ability to complete an education and your future job opportunities. That is absolutely good news.

But we don’t want to become complacent.

The supply of drugs is more dangerous, leading to an increase in overdose deaths. We’re not exaggerating. I mean, taking one of these drugs can kill you.

What about vaping? It has been falling, but use is still considerably higher than for cigarettes: In 2021, about a quarter of high school seniors said that they had vaped nicotine in the preceding year . Why would teens resist cigarettes and flock to vaping?

Most of the toxicity associated with tobacco has been ascribed to the burning of the leaf. The burning of that tobacco was responsible for cancer and for most of the other adverse effects, even though nicotine is the addictive element.

What we’ve come to understand is that nicotine vaping has harms of its own, but this has not been as well understood as was the case with tobacco. The other aspect that made vaping so appealing to teenagers was that it was associated with all sorts of flavors — candy flavors. It was not until the F.D.A. made those flavors illegal that vaping became less accessible.

My argument would be there’s no reason we should be exposing teenagers to nicotine. Because nicotine is very, very addictive.

Anything else you want to add?

We also have all of this interest in cannabis and psychedelic drugs. And there’s a lot of interest in the idea that psychedelic drugs may have therapeutic benefits. To prevent these new trends in drug use among teens requires different strategies than those we’ve used for alcohol or nicotine.

For example, we can say that if you take drugs like alcohol or nicotine, that can lead to addiction. That’s supported by extensive research. But warning about addiction for drugs like cannabis and psychedelics may not be as effective.

While cannabis can also be addictive, it’s perhaps less so than nicotine or alcohol, and more research is needed in this area, especially on newer, higher-potency products. Psychedelics don’t usually lead to addiction, but they can produce adverse mental experiences that can put you at risk of psychosis.

Matt Richtel is a health and science reporter for The Times, based in Boulder, Colo. More about Matt Richtel

Office of Research Training, Diversity, and Disparities Newsletter, April 2024

What’s New at NIDA

Nih simplified review framework for research project grants (rpgs): implementation and impact on funding opportunities.

The NIH is simplifying peer review for most research project grants (RPGs) for application due dates of January 25, 2025 or later. The purpose of these changes is to address the complexity of the peer review process and the potential for reputational bias to affect peer review outcomes. 

This framework will facilitate the mission of scientific peer review, which is identifying the strongest, highest-impact research. This change will enable peer reviewers to better focus on answering the key questions necessary to assess the scientific and technical merit of proposed research projects.

The Simplified Framework for NIH Peer Review reorganizes the current five factors into three: 1) Importance of the research, 2) Rigor and Feasibility, and 3) Expertise and Resources. All three factors will be considered in arriving at the Overall Impact score. Simplified peer review will apply to the following activity codes: R01, R03, R15, R16, R21, R33, R34, R36, R61, RC1, RC2, RC4, RF1, RL1, RL2, U01, U34, U3R, UA5, UC1, UC2, UC4, UF1, UG3, UH2, UH3, UH5, (including the following phased awards: R21/R33, UH2/UH3, UG3/UH3, R61/R33). 

Read more about the Framework and register for the upcoming April 17th webinar to learn more about these changes. A Q&A with NIH experts will follow the presentation.

Looking to network at a scientific conference? NIDA can help you get there!

The Diversity Scholars Travel Award Program online application form is now open! The NIDA Diversity Scholars Travel Award Program helps to defray the costs of in-person attendance to national scientific conferences. Selected awardees receive $1500 for round trip meeting travel, lodging, and/or registration.  Over the past 6 months, NIDA has provided awards for scholars attending the Society for Neuroscience and the Society for Research on Nicotine and Tobacco meetings. 

If you are a budding investigator looking to present your NIDA-related research at a major national conference, and would benefit from assistance with travel expenses, consider applying for an award. To be eligible, you must have submitted an abstract for presentation at one of the following 2024 scientific conferences:

• The College on Problems of Drug Dependence (CPDD): June 15th –19th in Montreal, Quebec, Canada
• The American Psychological Association (APA): August 8-10th in Seattle, WA
• The National Hispanic Science Network International Conference (NHSN): October 3-5th in New Orleans, LA
• The Society for Neuroscience (SfN) Meeting: October 5-9th in Chicago, IL

Deadlines to apply for a NIDA Travel Award:

• CPDD – April 19, 2024, 11:59PM EST
• APA – May 31, 2024, 11:59 EST
• NHSN/SfN – July 12, 2024, 11:59PM EST

Stay tuned as we plan to offer travel awards for the 2025 SRNT meeting. To learn more about eligibility and the application process, please see the travel award website . Questions?  Contact Dr. Yohansa Fernández .

NIDA Diversity Scholars Travel Award Program Testimonials

ORTDD is thrilled to introduce two NIDA Diversity Scholars Travel Awardees, Emmanuel Alvarez, PhD candidate in Neuroscience and a NIDA F31-diversity fellow at Robert Wood Johnson Medical School and Troy Dildine, Postdoctoral Scholar at Stanford University. Both Emmanuel and Troy presented at the 2023 Society for Neuroscience (SfN) conference and share their experiences on the NIDA travel award website !   

NIDA Scholar Spotlight: Amelia Cuarenta

The ORTDD would like to spotlight Dr. Amelia Cuarenta, postdoctoral research associate at the Center for Behavioral Neuroscience at the Georgia State University. Dr. Cuarenta was a 2023 NIDA Diversity Scholars Network program participant and recent MOSAIC K99/R00 awardee. 

Please share a little about yourself and your upbringing (if you're comfortable doing so), your educational background, and research focus.

My name is Amelia Cuarenta and I am from Milwaukee, WI. I was raised in a low-income single parent household. My interest in science and academia began when I was a child and watched my mother pursue a college education while working. Following this interest, I pursued a B.S. in Psychology and Human Development from the University of Wisconsin-Madison. I continued my education at the University of Wisconsin-Madison and earned my M.A. and Ph.D. in Biopsychology in the lab of Dr. Anthony Auger where we studied the impact of gene x environment interactions on later adolescent behavior. 

At what point in your life did you know you wanted to become a scientist? What drew you to the STEM field and particularly substance use/addiction research?

I realized I wanted to be a scientist my junior year of college. I had taken plenty of science courses by that time, but I still hadn’t found exactly what I wanted to do for my career. Then, junior year, I took a course called Behavioral Genetics, Genomics, and Epigenetics which completely changed my career trajectory. This course was my “lightbulb” moment and I wanted to continue research within this field. I approached one of the professors teaching the course to inquire about joining his lab, and was offered a position as an undergraduate research assistant. I continued in this lab for 2 years and applied to graduate schools across the country. I decided to stay at the University of Wisconsin because I was in a wonderful lab doing the research I always wanted to do. I was always interested in the impact of early life adversity on later development with a specific interest in adolescence and early adulthood. In graduate school I was particularly interested in the rewarding nature of juvenile social interactions. When looking for a postdoctoral position I knew I wanted to stay within the behavioral neuroscience field, but I was becoming increasingly interested in other types of reward. Thus, I took a position with Dr. Debra Bangasser to investigate the impact of psychosocial stress on opioid use patterns. 

Were there any events or individuals who inspired you throughout your professional journey?

My mom has always been my biggest inspiration. Watching her work ethic while I was growing up inspired me to also work hard. She was a single mom, worked as a waitress, and went to school to try and give us a better life. Her sacrifice and perseverance motivated me to do the best I am capable of with the intention of giving back to my family. 

How did you learn about the NDSN Program? Please share about your experience as an NDSN scholar and major takeaways from participating in the program.

I learned about the NDSN program through email communication on one of the listservs I’m part of. Participation in the NDSN scholar program was such a great experience. Being a postdoc, there are a lot of things I am still learning about the grant application process. The NDSN program broke down a lot of this information so I had a better understanding of the entire process and how to package my grant application. I have to say the mock review was an amazing experience and I learned so much! The program is great, but the mock review put it over the top for me. I learned so much that day!

What has been the most challenging obstacle you have had to face throughout your career journey to becoming a scientist and what have you done to push through?

One of the challenging obstacles I’ve faced in my career is lack of representation and having to continuously prove that I belong in spaces. As a biracial LGBTQIA+ neuroscientist, I have personally experienced the isolation that comes from limited outward facing representation within academia. Especially when I was a younger trainee, the need to continuously prove myself and prove I was smart enough, good enough, etc. to be in the academic space was tiring. Dealing with this facet of academia is ever evolving for me, but what has helped is finding allies and mentors that support me and my career goals. Having a mentors and peers that believe in you and boost your confidence can be a game changer. Being part of peer groups with diversity at the forefront can also be incredibly helpful. NDSN is one example of this, and throughout this program I got to meet other scholars and grow my network and community. 

Can you offer any advice to ESIs/scholars in earlier career stages who are navigating the NIH process for submitting grants and working towards the goal of being independently funded?

I am still in this process myself as a postdoc, so there’s still a lot I’m learning. What I have learned so far that has been helpful is identifying a network of mentors that can support your project. For my K99 I have a mentoring committee and each person on the committee has a specific expertise that fills certain gaps in my training. Identifying those mentors early and reaching out to them early is really important. The other thing that I think is incredibly important is writing and re-writing. I had so many people give me feedback before submitting and that was invaluable. The first draft to the last draft are very different in terms of how the information is presented. One other thing I just thought of that a mentor of mine told me: Don’t make the reviewers work for it. Give it to them on a platter. Make it easy for them to understand why your work is important, innovative, and technically sound.  

Congratulations 2024 NIDA Diversity Scholars Network (NDSN) Program Scholars!

NIDA received a record high number of NDSN scholar applications in 2024, and we are proud to announce that we will support 16 spectacular scholars this year. The scholars come from a variety of institutions all over the U.S., such as University of Mississippi, Tulane University, University of Vermont, Tennessee State University, University of Chicago. This year’s scholars are canvassing an exceptionally wide range of research areas, and NIDA’s ORTDD is eager to witness what this cohort will achieve. Learn more about the NDSN program and consider applying for the 2025 program in November, 2024.

Time is running out to apply for FY2024! 

Nida diversity supplement program .

NIDA participates in the NIH diversity supplement program, funding administrative supplements to active NIDA grants in order to provide research and professional development opportunities to trainees and early career scholars.  The goal of the program is to improve the diversity of the research workforce; graduate students, postdoctoral students, and eligible early career investigators from diverse backgrounds, including those from groups demonstrated to be underrepresented in the biomedical, behavioral, clinical and social sciences, are eligible to apply. All areas of NIDA-relevant research are eligible for diversity supplement support, including HIV/AIDS-related grants. 

There are multiple Diversity Supplement Programs to consider, depending on the NIH program that funds the “parent” (i.e., funded, eligible base grant award). For example, the parent grant may be funded by the NIH Helping End Addiction Long-term (HEAL) Initiative , the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative , or the NIH Tobacco Regulatory Science Program (TRSP) .  NIDA also provides funds for diversity supplements linked to other grant awards funded by the institute. All of these programs are designed to provide support that will help launch the careers of scientists, including underrepresented scientists, in addiction research. 

Please note: HEAL awardees must apply to PA-23-189 through NOT-NS-20-107 (receipt date: May 15th). BRAIN Initiative awardees must apply to PA-23-189 through NOT-NS-22-012 . TRSP awardees must apply to PA-23-189 through NOT-OD-24-074 (receipt date: May 15th). Be sure to follow all instructions for these announcements. 

If you are planning to apply for diversity supplement support through NIDA, but the parent award is not funded through HEAL, BRAIN or TRSP, the application must be submitted by May 9, 2024 to be considered for funding during the 2024 fiscal year .

Applicants interested in the Diversity Supplement programs are encouraged to carefully review PA-23-189 , relevant Notices (links above), and the NIDA Diversity Supplement Program webpage, FAQs , and How to Apply . Applicants are also encouraged to contact Dr. Angela Holmes with any questions well in advance of the submission deadline.

NIDA, NIMH, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)

NIDA is encouraging applications to PAR-22-181 . This funding opportunity solicits R01 grant applications from New Investigators and "At-Risk” Investigators from diverse backgrounds, including those from groups underrepresented in the health-related sciences (e.g., see NOT-OD-20-031, Notice of NIH’s Interest in Diversity). For more information about eligibility and how to apply, visit the link above and NIDA's Diversity R01 for New and "At-Risk" Investigators .

Due Dates for New Applications: May 06, 2024; September 06, 2024; January 08, 2025; May 05, 2025

Due Dates for Resubmission Applications: June 06, 2024; October 08, 2024; February 06, 2025; June 06, 2025

Happy 50th Anniversary NIDA!

On May 14, 1974, Congress established the National Institute on Drug Abuse (NIDA), and since then NIDA has led the world in funding and conducting research on substance use and addiction. Read more on Nora’s blog .

Did you know?

Nih has an “all about grants podcast”.

The NIH All About Grants Podcast is a helpful resource that The Office of Extramural Research (OER) talks to NIH staff members about the ins and outs of NIH funding. Designed for investigators, fellows, students, research administrators, and others just curious about the application and award process, they provide insights on grant topics from those who live and breathe the information.

The most recent episode on February 23 featured Dr. Kenneth Gibbs, Chief of the Undergraduate and Predoctoral Cross-Disciplinary Training Branch at the National Institute of General Medical Sciences and Dr. Maria Carranza, Senior Training Officer with the National Institute on Aging. Part 1 of this NIH All About Grants podcast mini-series dives into considerations for developing training grant applications and the review process, and part 2 focuses on post-award monitoring, mentorship, and provides insights for trainees. The discussion focuses on Kirschstein-National Research Service Awards (T32 and T34), but the advice is generally applicable to other training grant programs. Give this podcast a listen! 

Economic conditions outlook, March 2024

Executives’ latest views on the global economy and their countries’ economies lean much more positive than they did at the end of 2023.

In the latest McKinsey Global Survey on economic conditions, 1 The online survey was in the field from March 4 to March 8, 2024, and garnered responses from 957 participants representing the full range of regions, industries, company sizes, functional specialties, and tenures. To adjust for differences in response rates, the data are weighted by the contribution of each respondent’s nation to global GDP. the outlook on domestic conditions in most regions has become more hopeful, despite ongoing shared concerns about geopolitical instability and conflicts. In a year brimming with national elections, 2 Katharina Buchholz, “2024: The super election year,” Statista, January 19, 2024. respondents increasingly see transitions of political leadership as a primary hazard to the global economy, particularly in Asia–Pacific, Europe, and North America.

Furthermore, respondents now view policy and regulatory changes as a top threat to their companies’ performance, and they offer more muted optimism than in December about their companies’ prospects.

Optimism builds over global and domestic conditions

Respondents share much brighter assessments of the global economy and conditions in their countries than they did at the end of 2023, and views of the global economy are the most positive they’ve been since March 2022 (Exhibit 1). In the December survey, respondents were equally likely to say the global economy had improved and worsened. Today, respondents are twice as likely to report improving rather than deteriorating conditions. Looking ahead to the next six months, respondents are also more optimistic than they were last quarter. Forty-six percent expect the global economy to improve—nearly double the share expecting worsening conditions—while 37 percent expected improvement in the previous survey.

Likewise, respondents offer hopeful views when asked about the most likely near-term scenario for the global economy, suggesting confidence in central banks. They are more likely to expect a soft landing overall—with either slowing or accelerating growth compared with 2023—than a recession (Exhibit 2). The largest share of respondents expect a soft landing, with slowing growth relative to 2023.

Respondents’ views on their own economies have also become more upbeat. Nearly half of respondents say economic conditions at home are better now than they were six months ago, up from 41 percent in December, while just 22 percent say conditions have gotten worse. Respondents in Europe—who offered the most negative assessments of any respondents in September and December—are now nearly twice as likely as in December to say conditions have improved in the past six months, though it is unclear what has prompted that change and whether it is a durable finding.

McKinsey’s original survey research

More than half of respondents expect their economies to improve over the next six months. It’s the first time in two years that a majority of respondents have said that. In most regions, larger shares of respondents express optimism about economic conditions at home now than in December (Exhibit 3).

Geopolitical instability remains top of mind as concerns over political transitions rise

Geopolitical instability and conflict continues to be the most cited risk to global growth, selected by two-thirds of respondents for the second quarter in a row (Exhibit 4). Yet in this first quarterly survey of 2024—a year in which more than 60 countries will hold national elections 3 Katharina Buchholz, “2024: The super election year,” Statista, January 19, 2024. —transitions of political leadership have jumped from the fifth-most-cited to the second-most-cited threat to the world economy. The share of respondents in Europe reporting political transitions as a top threat is 2.4 times the share in December, while the shares in North America and Asia–Pacific have nearly doubled. 4 Prior to the latest survey, respondents in Mexico were included in Latin America in analyses but are now included in North America. We see a smaller uptick in concern about supply chain disruptions, which is cited as a threat by the largest share of respondents since December 2022.

Looking at risks to growth in respondents’ countries, geopolitical instability and conflict remains the top perceived threat, cited by a larger share than in any quarter since March 2022. Uneasiness about domestic political conflicts and transitions of political leadership, now the second- and third-most-cited risks, have overtaken concerns about inflation, which was the second-most-cited risk in December. Among respondents in North America, transitions of political leadership are cited nearly twice as often as in December (Exhibit 5). In Greater China, multiple risks now appear to carry equal weight, whereas in December, inflation was the top concern.

Policy and regulatory changes top the list of cited threats to companies’ growth

As respondents’ concerns about inflation as a domestic threat wane, the survey results suggest that companies are holding off on price increases. For the first time since we began asking about companies’ prices in September 2022, less than half of private-sector respondents in the latest survey—45 percent—say their companies increased the price of their goods or services over the past six months, down from 56 percent in December.

For five quarters, respondents’ most cited risk to their companies’ performance in the next 12 months was weak customer demand. Now, they most often point to policy and regulatory changes as a threat. In December 2023, policy and regulatory changes weren’t even one of the top five perceived risks. This increased wariness of policy changes cuts across most regions, though we see the largest increase in Europe.

Even though weak demand is no longer the most cited risk for companies, optimism over expected demand has tapered  since December. Fifty-one percent of respondents expect an increase in customer demand over the next six months, down from 57 percent in December. Yet expectations about profits remain upbeat: about six in ten respondents expect increasing profits in the months ahead, in line with expectations in much of 2023.

The survey content and analysis were developed by Jeffrey Condon , a senior knowledge expert in McKinsey’s Atlanta office; Krzysztof Kwiatkowski , a capabilities and insights expert in the Boston office; and Sven Smit , chair of insights and ecosystems, chair of the McKinsey Global Institute, and a senior partner in the Amsterdam office.

They wish to thank Jan Mischke for his contributions to this work.

This article was edited by Heather Hanselman, a senior editor in the Atlanta office.

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Global Economics Intelligence executive summary, February 2024

New insight into combating drug-resistant prostate cancer

New research from the University of Eastern Finland sheds light on the significance of the glucocorticoid receptor in drug-resistant prostate cancer, showing that the development of drug resistance could be prevented by limiting the activity of coregulator proteins.

Glucocorticoids regulate vital biological processes by affecting gene encoding through a DNA-binding transcription factor, namely the glucocorticoid receptor. The activity of the glucocorticoid receptor is made extensive use of in medicine because glucocorticoids have a strong anti-inflammatory effect. For this reason, synthetic glucocorticoids are one of the most prescribed drugs in the world. They are used to treat inflammatory diseases, such as rheumatoid arthritis, and as adjuvant therapy for cancer patients to alleviate the side effects of cancer therapy. In blood cancer, glucocorticoids are important drugs that limit the growth of cancer cells.

However, recent studies have shown that the glucocorticoid receptor also has an oncogenic, or cancer-promoting, effect in cancers like breast and prostate cancer. In prostate cancer, the glucocorticoid receptor can replace the activity of the androgen receptor, which is main oncogenic factor in this cancer, when its activity is inhibited by drug therapy. Thus, glucocorticoids help prostate cancer develop resistance to drug therapy.

"Due to these drug resistance and cancer-promoting effects, it is important to study how the glucocorticoid receptor functions on the cellular and molecular level in cancer," Academy Research Fellow, Docent Ville Paakinaho of the University of Eastern Finland notes.

The Paakinaho Lab has published two recent genome-wide deep sequencing studies on the subject. The first, published in Nucleic Acids Research , explored how the glucocorticoid receptor replaces the androgen receptor on the molecular level.

"This study showed that the glucocorticoid receptor can only use regulatory regions that are already active in prostate cancer cells," says Doctoral Researcher Laura Helminen of the University of Eastern Finland.

In other words, glucocorticoid receptor-mediated drug resistance emerges through these regulatory regions, and by affecting the activity of these areas, the harmful effects of glucocorticoids in prostate cancer could be prevented. Bioinformatics analyses indicated the pioneer transcription factor FOXA1 as one possible target. FOXA1 is known to have cancer-promoting properties, which is why the researchers assumed that inhibiting its activity would limit the development of glucocorticoid receptor-mediated drug-resistant prostate cancer. Surprisingly however, the effect was exactly the opposite: inhibiting the activity of FOXA1 further increased the activity of the glucocorticoid receptor -- and the development of drug resistance.

This is because FOXA1 was found to be involved in the silencing of the glucocorticoid receptor gene, and this is what increased its activity when FOXA1 was inhibited.

"Research often reveals the unexpected, and that's part of its charm," Paakinaho says.

The activity of the glucocorticoid receptor in regulatory regions can, however, be influenced in drug-resistant prostate cancer through an alternative pathway. Coregulator proteins were identified as an alternative target through which the glucocorticoid receptor affects the regulation of gene expression. These proteins include EP300 and CREBBP. Several pharmaceutical companies are developing small-molecule inhibitors targeting these proteins, and some are already being studied in patients.

In another study by the Paakinaho Lab, the researchers explored ways to inhibit glucocorticoid receptor-mediated effects by inhibiting coregulator proteins. These findings were reported in Cellular and Molecular Life Sciences.

"Silencing the EP300 and CREBBP proteins with a small-molecule inhibitor clearly prevented the activity of the glucocorticoid receptor in prostate cancer cells," Project Researcher Jasmin Huttunen of the University of Eastern Finland says.

This allowed the growth of drug-resistant prostate cancer cells to be inhibited. Furthermore, the researchers found that silencing EP300 and CREBBP also effectively inhibited the activity of the androgen receptor especially in prostate cancer cells that have an amplification of the androgen receptor gene. This amplification is found in up to half of patients with advanced prostate cancer.

Surprisingly, the EP300 and CREBBP inhibitor also inhibited the activity of FOXA1, while still preserving its ability to silence the expression of the glucocorticoid receptor gene. By using the EP300 and CREBBP inhibitor, it was possible to block the activity of FOXA1 without the development of glucocorticoid receptor-mediated drug resistance. Ultimately, inhibiting the activity of both the androgen and the glucocorticoid receptor was found to be primarily due to the limitation of FOXA1 activity. The study suggests that treatment targeting coregulator proteins could also be effective in untreated prostate cancer.

The studies were funded by the Research Council of Finland, the Sigrid Jusélius Foundation, and the Cancer Foundation Finland.

• Prostate Cancer
• Men's Health
• Breast Cancer
• Lung Cancer
• Personalized Medicine
• Diseases and Conditions
• Prostate cancer
• Drug discovery
• Personalized medicine
• Pharmaceutical company
• Drug addiction
• Antibiotic resistance

Story Source:

Materials provided by University of Eastern Finland . Note: Content may be edited for style and length.

Journal References :

• Jasmin Huttunen, Niina Aaltonen, Laura Helminen, Kirsi Rilla, Ville Paakinaho. EP300/CREBBP acetyltransferase inhibition limits steroid receptor and FOXA1 signaling in prostate cancer cells . Cellular and Molecular Life Sciences , 2024; 81 (1) DOI: 10.1007/s00018-024-05209-z
• Laura Helminen, Jasmin Huttunen, Melina Tulonen, Niina Aaltonen, Einari A Niskanen, Jorma J Palvimo, Ville Paakinaho. Chromatin accessibility and pioneer factor FOXA1 restrict glucocorticoid receptor action in prostate cancer . Nucleic Acids Research , 2024; 52 (2): 625 DOI: 10.1093/nar/gkad1126

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A History of Drug Advertising: The Evolving Roles of Consumers and Consumer Protection

Direct-to-consumer advertising (DTCA) of prescription drugs in the United States is controversial. Underlying the debate are disagreements over the role of consumers in medical decision making, the appropriateness of consumers engaging in self-diagnosis, and the ethics of an industry promoting potentially dangerous drugs. Drug advertising and federal policy governing drug advertising have both responded to and reinforced changes in the consumer's role in health care and in the doctor-patient relationship over time. This article discusses the history of DTCA in the context of social movements to secure rights for health care patients and consumers, the modern trend toward consumer-oriented medicine, and the implications of DTCA and consumer-oriented medicine for contemporary health policy debates about improving the health care system.

American consumers are bombarded daily with advertisements for prescription drugs that treat high cholesterol, diabetes, depression, pain, erectile dysfunction, and a host of other conditions. While the majority of pharmaceutical promotional expenditures is still aimed at physicians, spending on direct-to-consumer advertising of prescription drugs increased dramatically from $166 million in 1993 to $4.2 billion in 2005 and now makes up nearly 40 percent of total pharmaceutical promotional spending ( IMS Health 2006 ). Moreover, for some drugs, direct-to-consumer advertising (DTCA) makes up the bulk of promotional spending ( Ma et al. 2003 ).

The increased use of mass media advertising for prescription drugs has been controversial. Opponents of DTCA argue that it misleads consumers into taking costly prescription drugs that they do not need and that in seeking to sell products, pharmaceutical marketers turn normal human experiences with things like hair loss or shyness into diseases ( Angell 2004 , 123–26; Mintzes 2002 ). Then, after the September 2004 withdrawal of Vioxx due to evidence of increased cardiovascular risk, critics called for at least a partial ban on DTCA ( Saul 2005 ). In contrast, advocates of DTCA argue that prescription drug ads are an appropriate and highly valued source of information for empowering health care consumers ( Bonaccorso and Sturchio 2002 ; Holmer 1999 , 2002 ).

Underlying this policy debate are profound disagreements over the role of consumers in medical decision making, the appropriateness of consumers engaging in self-diagnosis, and the ethics of an industry promoting potentially dangerous drugs. Over the last three decades, important reforms of the health care system have secured patients' rights to information about treatment options (informed consent) and purchasing decisions. Some bioethicists and historians of the patients' and consumers' rights movements in health care have suggested that the pharmaceutical industry co-opted these movements by means of DTCA, disingenuously using the language of individual rights to support commercial activities ( Halpern 2004 ; Rothman 2001 ). But these commentaries do not provide a historical perspective on how DTCA came about or what makes it so controversial despite recent expansions of the consumer's role in health care. Similarly, even though histories of DTCA and the regulation of drug advertising have been published ( Palumbo and Mullins 2002 ; Pines 1999 ), they do not trace the changes in pharmaceutical advertising along with the evolution of the health care consumer. Bringing together the history of the patients' and consumers' rights movements in health care with the history of drug advertising and its regulation should further our understanding of (1) why the pharmaceutical industry, which for decades had focused its promotional efforts solely on physicians, began investing heavily in influencing consumers; (2) why the Food and Drug Administration (FDA) allowed DTCA to expand as it did; and (3) why some stakeholders see DTCA as threatening the doctor-patient relationship. While the evolution in the consumers' roles in health care was certainly not the only factor influencing the pharmaceutical industry or the FDA, I argue that it was nonetheless a necessary condition.

In the first section of this article, I define the terms patient and consumer and discuss the movements to bolster the rights of patients and consumers in medical care. Second, I trace the key points in the history of federal drug regulation. Over time, federal regulators have responded to and reinforced changes in the roles of patients and consumers, most notably in how they regulate drug labeling and advertising. The third section of the article follows DTCA from the early 1980s to the present and provides evidence of shifts in the views of consumer groups, physicians' organizations, pharmaceutical manufacturers, and the Food and Drug Administration during this period. These changing views reflect advances made by the patients' and consumers' rights movements as well as the current challenges facing them. I conclude by exploring the wider implications of DTCA and consumer movements for contemporary health policy debates over how to improve the quality of and access to health care.

Patients and Consumers and Their “Rights” to Information

The central thesis of this article is that the pharmaceutical promotion of prescription drugs to consumers was made possible by the rise of consumer-oriented medicine following the social movements for patients' and consumers' rights. The term consumer-oriented has been used to describe everything from efforts to give individuals more responsibility for their health care expenditures (e.g., consumer-directed health plans) to initiatives to promote shared decision making between doctors and patients. Accordingly, I should explain what I mean by the terms patient , consumer , and consumer-oriented medicine (or consumerism ).

My point of departure is Wendy Mariner's legal definition of consumers and patients (1998). According to her, consumers are buyers of goods and services. Although historically patients have also been buyers in that they have paid for some if not all of their health care, they were not considered consumers until recently. A patient is a recipient of a health care service ( Mariner 1998 ). Some people use the term consumer to refer to the buying role (e.g., educating consumers about their health plan choices). Other people use the term as a substitute for patient because the latter term implies subservience to health care professionals, although no economic role is attached to the consumer in this usage.

Whereas the distinction between the terms patient and consumer is often blurred, the differences between the legal rights of patients and consumers are clearer. Furthermore, although entitlement to information is central to both the patients' and consumers' rights movements, the goals of providing this information are different. Mariner (1998) contends that the main tool of consumer protection laws is the disclosure of information in order to level the playing field between buyers and sellers ( Mariner 1998 ). The rights of patients , she points out, developed outside the context of commercial markets, independently of health insurance, and without regard to the existence or source of payment for health care. Ordinarily a patient is in a relationship with a physician or other health care professional. Mariner (1998, 4) states that

the law of patients' rights does not seek to give patients and physicians equal medical knowledge. Instead the law accepts inequality and protects patients by imposing on physicians a fiduciary duty to use their skills only in the patients' best interest and provide services that meet professionally accepted standards. In contrast, businesses do not have fiduciary obligations to their consumers.

The goal of the patients' rights movement in the 1970s was to require health professionals to provide information to patients about their treatment options. In contrast, the goal of the consumers' rights movement in the 1990s was to require health insurance companies to provide information about benefits and policies. The first DTCA campaigns were launched in the early 1980s after the patients' rights movement had taken hold but before the era of consumer rights had begun. In effect, DTCA blends elements of both the patients' and consumers' rights movements, although I argue that it is partly an unintended consequence of these social movements; that is, it is a vehicle for pharmaceutical manufacturers to tell end users about their products. This seems to parallel efforts to secure consumers' rights, which ultimately aim to improve the functioning of markets. 1 For DTCA to be effective (from the pharmaceutical industry's perspective), these ads must expand patients' knowledge and influence over medical decision making, which is ostensibly a major goal of patients' rights movements. However, as Mariner notes, patients' rights movements have focused on requiring health professionals to give patients information, not to help businesses market their products. Because of the unique history of prescription drugs and physicians' important role as intermediaries between drug manufacturers and patients for more than a half century, DTCA represents a challenge to physicians' roles as agents for their patients. Next I discuss how this physician agency relationship was created during the twentieth century through federal drug regulation.

Federal Drug Regulation

I begin my account of federal drug regulation in the early twentieth century for two reasons. First, DTCA and other forms of pharmaceutical promotion are heavily regulated by the Food and Drug Administration, as its authority to regulate advertising is closely related to its authority to approve prescription drugs, the primary means through which the FDA ensures public health and safety in the use of pharmaceuticals. The federal regulation of drugs began in 1906 and was expanded with three major pieces of legislation between 1938 and 1962. Because changes in the way that companies promoted drugs are closely tied to these expansions in regulatory authority, they warrant a brief explanation. Second, criticism of DTCA is related to the fact that the promoted products are available only by a doctor's prescription. Advertising for over-the-counter medicines, though prevalent, has not engendered the same level of controversy because they are considered safe for consumers' self-directed use. The modern distinction between over-the-counter and prescription medicines, which stems from legislation passed in the 1950s, is, therefore, a crucial part of the story.

The Context of Early Drug Regulation

The federal regulation of drugs began when only a few effective drugs were on the market, and patients usually chose the medication themselves ( Shorter 1991 ). Then, in the early twentieth century, the clear roles of physicians as prescribers and pharmacists as dispensers were not as clearly distinct as they are today. At that time, consumers could obtain drugs by seeking a prescription from a doctor and filling it at a pharmacy, as they do now. State medical licensing laws, which were passed in the mid- to late nineteenth century, gave physicians the authority to write prescriptions. It is important to note, however, that a prescription was not required, so almost any drug that could be obtained with a prescription could also be obtained without one. 2 Prescriptions, in other words, “were a convenience to be used or not as the situation indicated” ( Temin 1980 , 23). Furthermore, consumers could obtain a drug compounded by a pharmacist but did not need a doctor's prescription. Physicians were also in the business of dispensing drugs during this time, and thus a third and final way that consumers could obtain drugs was directly from a doctor. Thus doctors did not play the same gatekeeping role in drug consumption that they do today.

In the early twentieth century there were two classes of drugs. Those in the first group, which were later dubbed “ethical” drugs by the American Medical Association, were listed in the United States Pharmacopoeia (USP). The USP is a compendium of standard drugs first established in 1820 by eleven physicians who met in Washington, D.C. Of the many drugs originally listed in the USP, only a few are still considered today to be “effective” and include digitalis, morphine, quinine, diphtheria antitoxin, aspirin, and ether ( Temin 1980 ). The other class of drugs in the early twentieth century was patent or proprietary medicines, which were made of unknown ingredients under trademarked names (e.g., Lydia Pinkham's Vegetable Compound, Hamlin's Wizard Oil, Kick-a-poo Indian Sagwa, Warner's Safe Cure for Diabetes). The main ingredient of many of these tonics, salves, and bitters was water, plus in some products addictive substances such as alcohol or opium ( Young 1961 ).

Manufacturers promoted these two classes of drugs very differently. Patent medicine makers were prolific advertisers, and at the turn of the century, ads for their products accounted for roughly half of newspapers' entire advertising income ( Young 1961 ). These advertisements routinely made exaggerated claims about the effectiveness of their products and seldom disclosed their ingredients or risks. For instance, an advertisement for Lydia E. Pinkham's Vegetable Compound claimed “to cure entirely the worst form of female complaints, all ovarian troubles, Inflammation and Ulceration, Falling and Displacements. And the consequent spinal weakness, and it is particularly adapted to the change of life.” 3

Although many of these advertising messages invoked positive images of doctors and the promise of new medical science, most pharmaceutical advertising still emphasized self-treatment. James Harvey Young (1961, 169) provides examples of how patent medicine advertisers differentiated their treatments from those of doctors:

Wherever regular physicians were weak, lo, there the nostrum maker was strong. Their therapy was brutal, his was mild. Their treatment was costly, his was cheap. Their procedures were mysterious, his were open. Their prescriptions were in Latin, his label could be read by all. Their attack on illness was temporizing, his was quick.

Ethical pharmaceuticals, in contrast, were not advertised to consumers in part because of the efforts of organized medicine. In 1905, the American Medical Association (AMA) established the Council on Pharmacy and Chemistry, which set standards for drugs and then evaluated them ( Young 1961 ). The council's goal was to steer patients toward using effective pharmaceutical preparations prescribed by physicians and to discourage their using ineffective, self-administered patent medicines. The AMA urged physicians not to prescribe, and medical journals not to run advertisements for, drugs that were “advertised directly to the laity” ( Journal of the American Medical Association 1900 ). The AMA regarded self-medication as a threat to the medical profession. Therefore, by categorizing drugs advertised solely to physicians as “ethical,” the AMA created an incentive for pharmaceutical companies to focus their promotional efforts on physicians. At the heart of these efforts were the goals of reducing self-treatment and encouraging deference to professional medical judgment ( Starr 1982 ).

The 1906 Pure Food and Drugs Act

Federal drug regulation began in the Progressive Era, during which a new faith in the scientific enterprise and a belief in active, informed consumers reigned ( Pescosolido and Martin 2004 ). The objective of the first federal drug legislation was not to discourage self-medication, as organized medicine wished to do, but to give consumers more information so that they could identify effective medicines ( Temin 1980 ; Young 1981 ). The 1906 Pure Food and Drugs Act also prohibited the interstate transport of unlawful food and drugs. The basis of this law rested on the regulation of product labeling rather than premarket approval, as would later be the case. Drugs, defined in accordance with the USP's standards of strength, quality, and purity, could not be sold in any other condition unless the specific variations from the standards were stated on the label. Also, no detail of a drug label could be false or misleading, and it had to list the presence and amount of eleven dangerous substances, including alcohol, heroin, and cocaine. But in 1911, the U.S. Supreme Court ruled in U.S. v. Johnson that the 1906 act did not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug. The Sherley Amendment, which was passed by Congress in 1912, overruled the Supreme Court's ruling by prohibiting labeling medicines with false therapeutic claims intended to defraud the purchaser. It was difficult, however, for the federal government to prove intent to defraud, and so the advertising provisions of the 1906 act had little effect on the behavior of the patent medicine industry.

The 1938 Food, Drug, and Cosmetic Act

By the 1930s, federal drug regulators had abandoned the belief that consumers, armed solely with information about a drug's ingredients, could safely self-medicate. Throughout the decade, FDA officials, supported by New Deal activists including newly founded consumer groups (e.g., the National Consumers League), tried to expand federal authority over drugs. After more than one hundred people died after taking a drug called elixir sulfanilamide, Congress passed the 1938 Food, Drug, and Cosmetic Act (FDCA) which required, for the first time, that drugs had to be proven safe and to receive the FDA's approval before they could be marketed. Opponents of the legislation claimed the act would abridge the sacred right of consumers to self-medicate ( Jackson 1970 ). The FDCA also expanded the concept of drug “labeling” to include more than the drug's name and a list of ingredients. It stated that drug labeling must include adequate directions for use and that these directions had to appear on the package with “conspicuousness and in terms such as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” These requirements for labeling are similar to those for what we would now refer to as “over-the-counter” (OTC) products more than to prescription drugs ( Juhl 1998 ). However, the FDCA gave the FDA the authority to publish regulations exempting certain drugs from the labeling requirement, and in 1938 the FDA issued regulations stating that exempted drugs must include the warning “Caution: to be used only by or on the prescription of a physician, dentist, or veterinarian,” and the directions for use had to employ medical terminology that would not likely be understood by an ordinary person ( Swann 1994 ). Neither the FDCA nor its accompanying regulations, however, define what drugs were to be available by prescription, nor do they clarify the distinction between prescription and OTC drugs.

Requiring Prescriptions: Durham Humphrey Amendments

Before 1951, the categorization of a drug as available by either prescription or OTC was left up to the manufacturers, although the FDA did require some drugs to be sold by prescription only (e.g., sulfa drugs in the 1930s) ( Goodrich 1986 ; Juhl 1998 ). The lack of a clear distinction between prescription and OTC drugs led to confusion by both consumers and pharmacists and also variations in how drugs were categorized ( Goodrich 1986 ). By 1941, FDA officials had identified more than twenty drugs or groups of drugs they considered too dangerous to sell except with a physician's prescription ( Swann 1994 ). In 1951, Congress passed the Durham Humphrey Amendments to the FDCA, which created a statutory definition of prescription drugs to include those that “because of [their] toxicity or other potentiality for harmful effect, or the method of [their] use, or the collateral measures necessary to [their] use, [they are] not safe for use except under the supervision of a practitioner licensed by law to administer such drug[s]” (Public Law 82-215, 65 stat 648).

After the Durham Humphrey Amendments became law, more drugs were sold by prescription but did not carry the full product labeling that OTC drugs did. Instead, the primary purpose of the amendments was to avoid patient self-diagnosis and self-administration of complex and potentially harmful drugs ( Kendellen 1985 ). Indeed, FDA officials viewed some drugs as potentially so dangerous that no amount of information provided to consumers would make self-medication safe. The labeling instead would be directed to pharmacists and physicians who in turn would provide information to the patient. Thus, a paradoxical situation developed in which potentially dangerous prescription drugs were dispensed to consumers with less accompanying information than OTC drugs carried ( IOM 1979 ). The view of federal drug regulators that requiring prescriptions was an important means of protecting consumers coincided with the AMA's long-held objective of securing more control by physicians over the use of pharmaceuticals ( Starr 1982 ; Temin 1980 ).

The Impact of Federal Policy on Pharmaceutical Marketing

Between 1938 and 1951, federal drug legislation and regulation had a significant impact on the market for drugs, and between 1929 and 1949, the amount of money that consumers spent on drugs prescribed by doctors rose from 32 to 57 percent. By 1969, prescription drugs made up 83 percent of consumer spending on pharmaceuticals ( Temin 1980 , 4). Finally, between 1939 and 1959, drug sales rose from $300 million to $2.3 billion, with prescription drugs accounting for all but approximately $4 million of the increase ( Rehder 1965 ). Self-medication, which in the early twentieth century was widespread and viewed as a “sacred right,” now took a backseat to the pharmacological treatments guided by physicians after World War II.

Once drugs were made available only through a physician's prescription, the pharmaceutical companies stopped advertising directly to patients and instead channeled all their promotions to health professionals. By the 1960s, more than 90 percent of the pharmaceutical companies' spending on marketing was aimed at doctors (with the rest targeting pharmacists and hospitals), a complete reversal of the pattern thirty years earlier ( Hilts 2003 ). Now the bulk of pharmaceutical promotional spending was on sales representatives called “detail men,” pharmaceutical sales representatives who visited physicians' offices, and on advertising in medical journals. Thus, federal regulation granted physicians authority not only over access to prescription drugs but over the dissemination of commercial drug information as well.

American physicians were deluged with pharmaceutical promotional materials. In 1958 the industry estimated that it had turned out 3,790,809,000 pages of paid advertising in medical journals, sent out 741,213,700 pieces of direct mail, and made up to 20 million calls by detail men to physicians and pharmacists ( Harris 1964 ). The following passage from a study of detailing conducted in the early 1960s reveals physicians' reliance on detail men for information and the importance of personal relationships to the promotion of prescription drugs:

With growing competition from similar or virtually identical products manufactured by different companies, the importance of favorable interpersonal relationships has become increasingly important. … This inference was underscored by the study's finding that 45 percent of the physicians indicated that a “good” detail man was more like a friend than a salesman. ( Rehder 1965 , 287–88)

The requirement that consumers obtain a prescription for most drugs came at a time when the medical profession was rising to a level of unprecedented autonomy and respect in American society ( Starr 1982 ). Changes in medical education (e.g., establishing medical schools within universities, inserting a rigorous science base into the curriculum, and linking knowledge from laboratories to clinical practice) and scientific advances in the diagnosis and treatment of diseases increased the authority of medical professionals ( Pescosolido and Martin 2004 ; Starr 1982 ). Physicians were given total control over medical training, medical decisions, and the ethical conduct of medical professionals ( Pescosolido and Martin 2004 ).

The fact that pharmaceutical companies did not advertise prescription drugs to the public was consistent with the prevailing perception that patients were unable to make medical decisions on their own. After World War II, laypersons deferred to professional judgment to treat conditions that they previously would have treated by themselves. Social scientists writing about health care in the 1950s and 1960s portrayed medical consumers (referred to at the time solely as patients) as having little involvement in their health care, with sociologists describing them as “dependent: needing and expecting to be taken care of by stronger, more ‘adequate’ persons” ( Parsons and Fox 1952 , 32). Economist Kenneth Arrow (1963) portrayed the consumer of health care as uninformed and reliant on physicians to act as agents on his or her behalf. A major premise of Arrow's work was that health care markets were different primarily because of the asymmetry of information between physicians and their patients. Indeed, during this period, it was a common and accepted practice for physicians to withhold basic information from patients about their diagnosis and treatment ( Rothman 1991 ).

Expanded Federal Regulation of Prescription Drugs

When Congress expanded the federal government's regulatory authority over drugs in 1938 and 1951, it did not give the FDA authority over either over-the-counter or prescription drug advertising, because when it passed the Wheeler Lea Act in 1938, it gave jurisdiction over drug advertising to the Federal Trade Commission (FTC). Moreover, because physicians were deemed capable of evaluating the accuracy of drug advertising, ads in medical journals were specifically exempted from the FTC's regulatory authority ( Chadduck 1972 ). So even though the FDA tried to regulate advertising through the FDCA's labeling provisions, its authority was limited. For example, the FDA regulated direct mail ads to doctors but not advertising in medical journals.

In 1959 pharmaceutical marketing practices became the focus of congressional hearings, in response to prescription drug advertisements aimed at physicians that made efficacy claims for which no evidence existed and rarely mentioned side effects. For example, ads for diabinese (chlorpropamide), an oral antidiabetic introduced by Chas. Pfizer & Co., Inc., in 1958, claimed an “almost complete absence of unfavorable side effects,” despite a report prepared for the company showing a 27 percent incidence of serious side effects, including jaundice ( Ruge 1969 ). In addition, many observers argued that physicians were incapable of deciphering truth from fiction in drug advertisements ( May 1961 ).

In the early 1960s, the serious birth defects resulting from the use of thalidomide in Europe hastened Congress's efforts to overhaul federal drug regulation. In 1962, it passed the Kefauver-Harris Amendments to the FDCA, which dramatically expanded the FDA's authority over prescription drugs by requiring that they be proved not only safe but also effective before being marketed. In order to receive FDA approval, the amendments also required drugs to meet a high standard of scientific evidence and transferred jurisdiction over the advertising of prescription drugs from the FTC to the FDA. In response to concerns for patients' safety and the misleading marketing practices of the 1950s, the FDA took a more proactive approach to regulating the advertising of prescription drugs than the FTC had ( Terzian 1999 ). The FDCA's prescription drug–advertising provisions are relatively uncomplicated: they require prescription drug advertisements to contain the drug's established (or generic) name, the formula showing each ingredient, and a brief summary of the side effects, contraindications, and effectiveness. The detailed requirements for this summary were to be spelled out in regulations. In 1969 the FDA promulgated its final advertising regulations, which required advertisements to present a “true statement of information in brief summary relating to side effects, contraindications, and effectiveness” ( FDA/DHHS 1969 ). Prescription drug advertisements also must present a “fair balance” between information about the drug's side effects and contraindications and information about its effectiveness. The regulations also describe how an advertisement could be considered false, unbalanced, or otherwise misleading.

Although the 1969 regulations did not mention prescription drug ads to the public, they contained two important provisions that later became relevant to DTCA. First, the regulations stated that advertisements broadcast through media such as radio, television, or telephone communications systems

shall include information relating to the major side effects and contraindications of the advertised drugs in the audio or audio and visual parts of the presentation, and unless adequate provision is made for dissemination of the approved or permitted package labeling in connection with the broadcast presentation, shall contain a brief summary of all necessary information related to side effects and contraindications. (italics added) ( FDA/DHHS 1969 )

The meaning of “adequate provision” was unclear until 1997, when the FDA suggested ways in which pharmaceutical advertisements could meet the regulatory requirements, thus opening the door to broadcast DTCA. Second, the advertising regulations exempted some types of advertisements from the requirements. “Reminder advertisements,” which were designed for medical journals, contained only the name of the drug, and made “no claims for the therapeutic safety or effectiveness of the drug,” were specifically exempted from the FDA's requirements regarding the brief summary and fair balance of risks and benefits. Ads lacking a proprietary drug name also were exempted from the regulations. In the early 1990s, in order to circumvent the brief summary requirement, pharmaceutical manufacturers ran reminder ads and help-seeking ads that mentioned a disease or the name of a drug, but not both.

Informing the Patient

The FDA's authority over prescription drug advertising expanded during a time in which physicians had nearly complete control over medical practice and in which prescription drug advertising directed at the public did not exist. Rather, the advertising regulations were passed at a time when FDA officials were worried about patients' self-medication ( Merrill 1973 ). But when the FDA tried to give consumers more information about prescription drugs by requiring special labeling for patients, they touched off a debate about the extent to which patients should be informed of the risks of taking a drug. In 1968, the FDA required the manufacturers of isoproterenol inhalers to provide a two-sentence warning on the package regarding a potential effect from excessive use of the inhalers (33 Federal Register 8812 [1968] codified at 21 C.F.R. § 201.305). In the 1970s the FDA also mandated a brief information leaflet for oral contraceptives (35 Federal Register [1970] codified at 21 C.F.R. § 310.501) and a few other drugs and devices.

The FDA also considered requiring patient package inserts (PPIs) on a widespread basis, owing in part to demands from the growing number of consumer groups ( IOM 1979 ). Newly organized consumer groups such as the Health Research Group, formed under the auspices of Ralph Nader's Public Citizen, urged the FDA to make available to consumers more information about the risks of prescription drugs. In 1975 several consumer organizations filed a petition with the FDA requesting that the agency require patient labeling for prescription drugs because of their concern that doctor-patient communication about drugs was inadequate ( IOM 1979 ). After conducting its own research in the 1970s, the FDA likewise determined that physicians were not adequately informing consumers of the risks of prescription drugs and hoped that through the patient package inserts dispensed with the drugs, consumers would be better equipped to use prescription drugs more safely ( Kendellen 1985 ; Morris 1977 ). The broadening of the PPI initiative from a limited requirement for a few classes of drugs between 1968 and 1970 to a broader consumer education initiative in the late 1970s reflected the change in the FDA's views regarding the need to inform patients about prescription drugs ( IOM 1979 ).

In 1976 and in 1978, the FDA sponsored two symposia to solicit feedback on the PPI concept from consumer groups, professional societies, pharmaceutical manufacturers, pharmacist organizations, and other groups. Two argument s were offered in support of the PPI concept. The first pertained to making the use of drugs safer and more effective. The argument was that PPIs would help improve patients' compliance and reduce drug interactions and adverse drug events by ensuring that they used prescription drugs properly. The second argument justified PPIs on the basis of patients' rights to information relevant to decisions about their medical care. This idea, rooted in the values of egalitarianism and patients' autonomy, assumed that PPIs would enable patients to assume a greater role in medical decision making ( IOM 1979 ). Some observers of the debate over PPIs viewed these two lines of argument as conflicting, because the purpose of educating patients was better communication and cooperation, whereas the notion of patients' rights created confrontation (Albert Jonsen, cited in IOM 1979 ).

In the late 1970s the FDA proposed a regulation that would eventually require PPIs for all prescription drugs, an action that was resisted by the pharmaceutical industry because of the PPI program's cost ( Schmidt 1985 ). In 1979 the agency issued regulations requiring the inserts for ten classes of prescription drugs. In 1982, after the Reagan administration appointed a new commissioner to the FDA, it rescinded the 1979 regulation in favor of a plan under which pharmaceutical companies would voluntarily disseminate information on prescription drugs to consumers ( Pines 1999 ).

The FDA's policy on patient package inserts during the 1970s provides an important backdrop for subsequent debates over DTCA and the role of consumers in prescription drug markets ( Pines 1999 ). Some physicians' groups and the pharmaceutical industry vehemently opposed the mandatory PPIs and echoed a familiar theme of health reform debates: that PPIs interfered with the doctor-patient relationship and represented the government's intrusion into the practice of medicine ( Kendellen 1985 ). But the effort to require PPIs, albeit unsuccessful, showed that consumer groups' efforts to improve product safety in other areas of the economy could be applied to health care as well. Indeed, the Health Research Group became one of the most vocal critics of the pharmaceutical industry, its marketing practices, and DTCA.

The juxtaposition of the debates over PPIs and DTCA reveals that the stakeholders in the FDA's regulation of prescription drugs had somewhat nuanced views regarding patient information and education. On the one hand, pharmaceutical manufacturers objected to patients' rights to information regarding mandatory PPIs but supported them regarding looser restrictions on DTCA. On the other hand, consumer groups like the Health Research Group supported PPIs as a way to give consumers a greater role in decisions about their treatment, although this same group later opposed efforts to loosen restrictions on DTCA.

Dawn of the Patients' Rights Movement

The 1970s also marked the beginning of the patients' rights movement, which sought certain legal protections for patients, in response to cases of abuse of human biomedical research subjects publicized in the 1960s ( Katz 1972 ). In the 1970s, this movement expanded from research subjects to patients. In 1975, Karen Ann Quinlan, age twenty-one, fell into an unexplained coma and remained in a persistent vegetative state and on a respirator for several months. When Quinlan's father signed a release to permit her doctors to turn off the respirator, they refused. The medical consensus at the time of the Quinlan decision was that the traditional relationship among the physician, patient, and family should prevail over a detailed legal standard ( Clark and Agrest 1975 ). But this case and others that followed imposed a formality on medical decisions ( Rothman 1991 ). Ethics committees, a feature of most hospitals today, were first recommended after the New Jersey Supreme Court handed down the Quinlan decision ( Stevens 1996 ).

The Quinlan case helped spur the “right to die” movement that emphasized patients' autonomy in medical decision making. A review of public opinion surveys on death and dying conducted between 1950 and 1995 found a dramatic change in the public's attitudes toward personal control over the quality of life and death. In 1950, only 34 percent of Americans thought physicians should be allowed to end the lives of patients with incurable diseases if they and their families requested it, but by 1977, this figure had risen to 60 percent and has remained stable since then ( Blendon, Szalay, and Knox 1992 ). While physicians still maintained a great deal of control over medical care, the patients' rights movement led the public to question medical authority and created intermediaries to oversee doctors' actions (e.g., ethics committees).

Early DTC Campaigns

The debate over PPIs during the late 1970s raised the issue of consumers' awareness of prescription drugs, their uses, and their risks. In the early 1980s, some pharmaceutical marketers began rethinking the traditional models of promotion that relied solely on advertising to physicians. They began first with public relations techniques rather than paid advertising ( Pines 1999 ). For example, soon after Syntex, an analgesic, was introduced in the United Kingdom in 1978, it became a topic of discussion on talk shows and its use quickly accelerated. As a result, some pharmaceutical companies began considering the risks and benefits of communicating directly with the public about their products ( Smeeding 1990 ). Pfizer launched a public relations campaign in the early 1980s called Partners in Health Care, to increase awareness of underdiagnosed conditions such as diabetes, angina, arthritis, and hypertension. Although the ads did not mention any drugs by name, they prominently displayed Pfizer's name in the hope that consumers who visited their doctors might ask for one of the manufacturer's products for those conditions.

From the 1950s to the early 1980s, no pharmaceutical companies were running product-specific ads in the mass media. Then, two product-marketing campaigns broke with tradition and pursued a marketing strategy that depended on consumers' taking a more active role in prescribing decisions. In 1981, Boots pharmaceuticals used print and television ads to promote Rufen, a prescription pain reliever. The marketing strategy was to position Rufen as a cheaper alternative to the leading brand. In 1982, Merck and Dohme advertised its pneumonia vaccine, Pneumovax, to people over the age of sixty-five, after market research showed that only a small percentage of the patients who could benefit from the vaccine were receiving it ( U.S. House of Representatives 1984 ).

Early DTC campaigns demonstrated the role that consumers could play in health care, acting as price-conscious consumers or talking with their physicians about a condition that might otherwise not be detected. These early campaigns also demonstrated the potential harm associated with consumer-directed promotion. When it launched a new antiarthritic drug called Oraflex in 1982, Eli Lilly and Company distributed 6,500 press kits, including file films and videotapes, to television networks and radio stations ( Kolata 1983 ). Although they dispensed some cautionary information, the media emphasized that Oraflex might prevent the progression of arthritis, a claim that went beyond the approved product label. The use of this drug, which may have been more widespread because of the public relations campaign, resulted in a number of adverse drug events, and it was pulled from the market voluntarily by Eli Lilly only five months after it was introduced ( Basara 1992 ).

FDA Calls for Voluntary Moratorium on DTCA, 1983–1985

The FDA did not have an explicit policy regarding DTCA at the time of these early campaigns because there had been no mass media advertisements for prescription drugs when the 1969 regulations were promulgated. Initially, agency officials supported the concept of DTCA and had faith that the existing regulations for promotion to physicians would prevent any misleading advertisements directed at consumers ( Altman 1982 ). But in 1983, the agency began to voice serious concerns about advertising prescription drugs to consumers. Commissioner Arthur Hull Hayes asked the pharmaceutical industry to stop advertising drugs to the public. Concerns raised at the time were that DTCA would

lead patients to pressure physicians to prescribe unnecessary or un-indicated drugs, increase the price of drugs, confuse patients by leading them to believe that some minor difference represents a major therapeutic advance, potentiate the use of brand name products rather than cheaper, but equivalent generic drugs and foster increased drug taking in an already overmedicated society. ( Morris et al. 1986b , 82)

Furthermore, FDA Commissioner Hayes also voiced concern about the public's ability to evaluate “the risk/benefit ratio of a drug” ( Kolata 1983 ). The FDA undertook a study of consumer perceptions of and behavior related to prescription drug advertising and found that consumers wanted more drug information but that it was difficult to communicate risk information through short television ads ( FDA 1983 ; Morris et al. 1986a , 1986b ).

In September 1985, the FDA rescinded the moratorium on DTCA advertising and required the advertisements to meet the same legal requirements as those directed at physicians ( FDA/DHHS 1985 ). Public comments by the FDA commissioner suggested that agency officials did not believe that a widespread use of DTCA would result ( U.S. House of Representatives 1984 ). These advertising provisions of the 1969 regulations created a de facto barrier to the broadcast advertising of prescription drugs that included both the name of the drug and its indication, because it was not feasible to air the entire brief summary in a short television commercial, so the few DTCA campaigns initiated in the 1980s used print media. The brief summary of the product label had become something that was “neither brief nor a summary” but a densely worded compilation of every risk carried by the drug written in highly technical terms ( Feather 1997 ).

Critical Views of DTCA

An analysis of interest-group positions on DTCA in the early 1980s shows significant resistance to greater consumer control over prescription drug use, by physicians' organizations, consumer groups, and even many in the pharmaceutical industry. One of the recurrent themes in the early debates over DTCA was its potential to undermine physician authority ( Lanier 1982 ). Surveys by the AMA found that an overwhelming majority of physicians were opposed to DTCA on television (84 percent in 1984 and 81 percent in 1988 opposed DTCA on television) ( Harvey and Shubat 1989 ). In the early 1980s, the AMA, the American Society of Internal Medicine, the American Academy of Ophthalmology, the American Academy of Family Physicians, the American Society of Internal Medicine, and the American College of Physicians and other groups took positions against the DTCA of prescription drugs ( AMA 1989 ; Cohen 1988 ; U.S. House of Representatives 1984 ). A letter published in the New England Journal of Medicine said that DTCA “may tend to undermine physician control over prescribing” and that “most lay people are ill equipped to evaluate the efficacy or toxicity of drugs” ( O'Brien 1982 , 181).

Consumer groups also were firmly opposed to DTCA. Dr. Sidney Wolfe of the Health Research Group called for a ban on DTCA and renewed calls for patient package inserts ( Consumer Reports 1984 ). Representatives from the Consumer Federation of America and the American Association for Retired Persons (AARP) also spoke out against DTCA in the 1980s ( Kolata 1983 ). Survey research conducted at this time showed that consumers considered physicians the primary decision makers with regard to prescription drugs and viewed the patient's role in drug utilization and as an evaluator of prescription drug advertising as quite limited. More than three-quarters of consumers disagreed with the statement that they could decide about using a drug, and 63 percent disagreed with the statement that patients could tell whether a prescription drug ad was misleading ( Morris and Millstein 1984 ). But surveys conducted by the FDA in the early 1980s also revealed that consumers wanted more information about prescription drugs ( Morris et al. 1986b ).

In the early 1980s most pharmaceutical companies avoided DTCA of prescription drugs, according to a survey conducted in 1984 of pharmaceutical marketing executives ( Cutrer and Pleil 1991 ). When Representative John Dingell, chairman of a subcommittee of the House Energy and Commerce Committee, sent a letter to several pharmaceutical company executives in 1984 asking for their views on DTCA, most of the responses were deeply critical of DTCA (see the excerpts of letters in Figure 1 ). Pharmaceutical executives argued that DTCA would hurt the doctor-patient relationship, confuse an unsophisticated public, and lead to higher drug costs. They thus recommended strict limits, if not an outright ban, on prescription drug advertising to the public. Their views indicate that in the early 1980s, the pharmaceutical industry wanted to work with rather than challenge the traditional doctor-patient relationship.

Source: U.S. House of Representatives 1984 .

Excerpts from Letters from Pharmaceutical Executives to Committee Chairman John Dingell, 1984

Challenges to Physicians' Autonomy and the Increased Appeal of DTCA to the Pharmaceutical Industry

Around 1990, changes in the health care system and in the pharmaceutical industry itself led the pharmaceutical industry's opinion of DTCA to change as well. In the late 1980s and early 1990s, employers assumed more aggressive roles in reining in health care costs ( Schlesinger 2002 ). Escalating health insurance premiums combined with an economic recession in the early 1990s forced employers to begin reconsidering the merits of traditional fee-for-service insurance reimbursement ( Reinhardt 1999 ). Evidence revealed a substantial variation in health care utilization and spending and confirmed that high spending was not correlated with better treatment outcomes. Employers thus turned to managed care plans, which controlled health care spending through supply-side mechanisms such as requiring utilization reviews, capitating provider payments, and engaging in selective contracting with providers, all of which challenged physicians' autonomy ( Schlesinger 2002 ).

At the same time, the American public had been losing trust in physicians since the 1960s, mirroring the general weakening of trust in authority figures and institutions ( Blendon and Benson 2001 ; Pescosolido, Tuch, and Martin 2001 ). In 1966, three-quarters of the American public had a great deal of confidence in leaders in medicine, but in 1990, less than one-quarter did. Using survey data from policy elites and the general public, Schlesinger (2002) argued that the decline in trust was driven by doubts about the efficacy of medical care and questions about whether physicians were acting as good agents for their patients, particularly when a physician's economic interests and the patient's interest conflicted.

New Financial Imperatives

From the 1950s until the 1980s, pharmaceutical firms promoted their products by influencing a learned intermediary—the physician. Accordingly, when the autonomy of physicians over the practice of medicine was threatened by consumers' distrust and the growth of new institutions like managed care plans and hospital formulary committees, new forms of promotion emerged ( Kessler and Pines 1990 ). In the late 1980s, some pharmaceutical manufacturers, wary a few years earlier of upsetting doctors by advertising directly to consumers, began to view DTCA as an integral part of their marketing strategy. In the early 1980s, a handful of drug marketers employed indirect public relations tools to get the word out to the public about new drugs. By the end of the decade, several pharmaceutical manufacturers used paid advertising in its most visible and direct form to promote prescription drugs to consumers. Between 1985 and 1990, pharmaceutical marketers launched DTCA campaigns to promote at least twenty-four products directly to consumers ( Scott-Levin 1992 ). DTCA thus became part of a broader trend in the pharmaceutical industry toward more spending on all forms of promotion and more aggressive marketing techniques ( Feather 1997 ; Smeeding 1990 ).

Another trend that may have accelerated the trend toward DTC promotion is that many of the top-selling drugs switched from prescription to over-the-counter (OTC) status. Prescription drugs that advertised to consumers would therefore have the advantage of established brand recognition before being converted to OTC status ( Ling, Berndt, and Kyle 2003 ). In addition, the increased use of DTCA in the early 1990s may have been related to the introduction of “lifestyle” drugs for which no market yet existed. For example, it would have been difficult for Upjohn to convince physicians to talk with their male patients about the prescription drug Rogaine, a hair restoration product, through traditional forms of promotion such as detailing ( Ruby and Montagne 1991 ). The very existence of products like Rogaine—products that focused more on improving the quality of life than on treating disease—illustrates the consumer's growing importance in medical care at the time. Indeed, drugs advertised to consumers continue to be those requiring consumers to self-identify, either because physicians feel uncomfortable discussing the product (e.g., drugs that treat erectile dysfunction) or because a need for the product might not be detected in a primary care setting (e.g., drugs that treat depression) ( Iizuka 2004 ).

Consumerism in Health Care

In addition to reacting to changes within the industry, pharmaceutical firms capitalized on a significant cultural change in the health care system that accelerated in the late 1980s, one that emphasized the consumer's role in medical decision making. Efforts in the 1970s to secure legal rights for patients to be informed about their treatment options set the stage for efforts in the mid-1990s to secure consumer rights in managed care ( Rothman 2001 ). By the late 1990s a more diffuse change made possible by advances in information technology allowed patients and consumers to inform themselves and, as a consequence, become more involved in medical decision making, what I call consumerism .

By the late 1990s, several reforms of the health care system had been implemented, including changes in involuntary commitment laws, consent forms for surgery and other medical procedures, and stricter controls over human experimentation ( Tomes 2001 ). The Patient Self-Determination Act, passed in 1989, required health care institutions to advise patients upon admission of their right to accept or refuse medical care and to execute an advance directive ( Laine and Davidoff 1996 ). And in 1996, the Health Insurance Portability and Accountability Act (HIPAA) ensured patients' rights to privacy over their medical records.

Consumerism in health care did not end with the establishment of legal rights for patients, however. This new consumer power also was evident in the increasing number and political influence of disease-specific advocacy groups. In 2000, there were more than 3,100 disease-specific advocacy groups with at least some political involvement, many of which had been founded in the 1980s ( Baumgartner and Jones 1993 ; Carpenter 2004 ). In 1996, citizen groups and not-for-profit advocacy organizations outnumbered hospitals and clinics by a factor of two to one in terms of the number of groups lobbying federal policymakers on health care issues ( Baumgartner and Leech 1996 ). Health activism coalesced around stigmatized social groups (e.g., the mentally ill), and were created from existing constituencies (e.g., women, gays, consumer advocates) ( Halpern 2004 ). These groups were successful in lobbying for increased research funding for diseases like HIV/AIDS, breast cancer, and other conditions ( Epstein 1996 ).

Consumer advocates also played an important role in the backlash against managed care ( Peterson 1999 ). By the mid-1990s, managed care plans had gained a majority share in the private insurance market. In fact, state legislatures passed more than one thousand bills in the 1990s “regulating” managed care. The first wave of such legislation, led by providers, focused on removing plans' ability to use restrictive provider networks through “any willing provider” laws ( Sorian and Feder 1999 ). But the emphasis soon shifted to consumers. Managed care regulation passed at the state level and debated at the federal level blended patient protections (e.g., length of stay requirements, benefit mandates) with consumer protections (e.g., insurance plan information disclosure and due process requirements) ( Mariner 1998 ).

Important changes also were under way in the doctor-patient relationship through efforts to make medical care more “patient centered.” The editor of the New England Journal of Medicine wrote as early as 1983 that “physicians must set aside their image of themselves as making life and death decisions alone and undertake instead the less glamorous and more time-consuming process of exploring optimal outcomes with the patient” ( Kassirer 1983 , 900). Research on the impact of patients' adherence on clinical outcomes encouraged clinicians to abandon paternalistic approaches to patient care and adopt practice styles emphasizing the patient's participation in clinical decisions ( Roter and Hall 1992 ).

A related trend was the greater use of complementary and alternative medicines (e.g., herbal medicine, vitamins and dietary supplements, chiropractics) in the 1990s. For example, the percentage of adults in the United States who used alternative medicine increased from 33.8 percent in 1990 to 42.1 percent in 1997 ( Eisenberg et al. 1998 ) and remained stable between 1997 and 2002 ( Tindle et al. 2005 ). Since the establishment of the AMA's first code of ethics, organized medicine had actively opposed alternative medicine ( Kaptchuk and Miller 2005 ). But recently this opposition has given way to efforts to integrate alternative medicine into institutions of biomedicine, partly because of patients' demands for it. But in 1990 and 1997, less than 40 percent of the alternative therapies used were disclosed to a physician ( Eisenberg et al. 1998 ), indicating that most consumers still viewed alternative medicine as self-treatment rather than a recommendation by their doctor.

Technological change also spurred an increase in health information seeking and self-treatment. In the mid-1990s, American society was at the start of a revolution in information technology that significantly expanded the number of consumers seeking health information and support from sources other than their physicians. By 2000, more than 26,000 websites were related to health, and roughly one-quarter of individuals using the Internet did so primarily to find information about health and health care ( Haas-Wilson 2001 ). By March 2003, 66 percent of Internet users said they went online to look for health or other medical information ( Fox and Fallows 2003 ). Surveys conducted in conjunction with the Pew Internet and American Life Project found that (1) people used the Internet to inform themselves about their health and carried that information with them to their doctors and that (2) when they presented this information to their doctors, they sometimes encountered resistance ( Fox and Fallows 2003 ). As one consumer who responded to the survey summarized, “Knowledge is power. It also helps me to feel prepared to talk with doctors and nurses. I know the terminology and the options” ( Fox and Fallows 2003 , 16).

The convergence of these trends increased the amount of information available to consumers and their level of involvement in medical decision making. The expanding rights of patients, along with the more diffuse trend toward consumerism in health care, thereby made less salient any criticism of DTCA, often couched in terms of traditional norms of medical practice that emphasized physicians' authority.

Pressure on the FDA to Loosen Restrictions on Advertising

Pharmaceutical industry spending on DTCA rose from $55 million in 1991 to $363 million in 1995, reflecting the industry's calculation that the profits earned from pitching products directly to patients outweighed any loss of goodwill from a profession that for decades it had relied on to promote its products. This greater use of DTCA came at a time when the FDA was more actively enforcing advertising regulations and restricting new forms of promotion like video news releases, discussions of drug development with the investment community, and DTCA ( Kessler and Pines 1990 ).

In November 1990, President George H.W. Bush appointed David Kessler (both a physician and an attorney) as the head of the FDA. Kessler became one of the most active FDA commissioners in modern times. He tried to expand the FDA's authority to regulate the health claims made for dietary supplements and to regulate tobacco as a drug, but both efforts met with substantial political resistance and ultimately failed ( Hilts 2003 ). Kessler was particularly interested in reining in prescription drug marketing, and he increased the resources devoted to the FDA division that oversees drug advertising ( Kessler et al. 1994 ; Kessler and Pines 1990 ).

Significant counterregulatory pressures during the mid-1990s moderated the efforts to restrict drug promotion ( Epstein 1996 ; Hilts 2003 ). In 1994, with the Republican Party's takeover of Congress, the FDA encountered conservative opposition on many fronts. House Speaker Newt Gingrich called the FDA the “no. 1 job killer,” charging that it discouraged innovation and prevented profitable products from coming to market ( Hilts 2003 , 196). Conservatives also charged that the FDA's new drug approval process placed so much emphasis on keeping potentially bad drugs off the market that it unnecessarily delayed the introduction of important therapeutic advances. This criticism was echoed by a new and vocal breed of consumer advocacy organization that urged the FDA to reconsider its standards for approving drugs to combat HIV/AIDS ( Epstein 1996 ). A parallel criticism was leveled against the FDA's approach to regulating drug advertising. Some argued that the FDA was so heavily focused on prohibiting misleading advertising that it prevented valuable information about prescription drugs from reaching consumers and physicians ( Keith 1992 ).

In this environment of greater consumer involvement in health care, increased spending on consumer-directed promotion of prescription drugs, and scrutiny of the FDA's regulation of advertising, the agency held hearings on DTCA ( FDA/DHHS 1995b ). Officials heard testimony from pharmaceutical and advertising industry representatives, consumer organizations, medical societies, and academics. The pharmaceutical industry sought clarification of the provision in the 1969 advertising regulations that obviated the need for broadcast advertisements to contain the brief summary of the approved product label when “adequate provision” was made for dissemination of the product labeling in conjunction with the advertisement ( FDA/DHHS 1969 ). In 1995, roughly 15 percent of DTCA spending was for television advertising ( Kreling, Mott, and Wiederholt 2001 ). In order to circumvent the brief summary requirement, pharmaceutical companies ran reminder or help-seeking advertisements, which either included the name of the drug or discussed a particular condition, but not both. Reminder ads, which were originally designed for physicians and medical journals, led to some confusion among consumers who did not know what condition the drug was supposed to treat.

Some people who testified at the hearings noted that consumers' involvement in health care had expanded dramatically since the first DTC ads were aired in the early 1980s ( FDA/DHHS 1995a ). Participants in the hearings pointed to two divergent approaches to communicating risk information to consumers. Advocates of the first model proposed by critics of DTCA believed that the best method of educating consumers about prescription drugs was through something akin to patient package inserts. This model assumed that consumers needed to be educated after the prescribing decision had been made and that the package insert would help make the product safer. Consumer groups like the Health Research Group, which focused on product safety, adhered to this view.

The other model of information dissemination, supported by representatives of the advertising and pharmaceutical industries, proposed replacing the brief summary with a general risk statement like “prescription drugs could be harmful to your health and should not be taken without consulting a physician.” Advocates of this view considered advertising as a way to get the consumer—not the physician—to initiate the conversation about a prescription drug and so wanted to give consumers information about a drug well before the prescribing and purchasing decisions were made. The brief summary requirement was therefore seen as a barrier to direct communication between the pharmaceutical manufacturer and the consumer.

By 1997, those FDA officials who were reluctant to open the floodgates to prescription drug advertising on television felt increased pressure from a variety of sources to ease the regulations and permit broadcast advertising ( Feather 1997 ). In August, a few months after David Kessler left the FDA, the agency released the Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements. It outlined the ways in which pharmaceutical manufacturers could meet the brief summary requirement in broadcast ads by clarifying the ways in which the product labeling could be adequately provided ( FDA/DHHS 1997 , 1999 ). Instead of airing the entire brief summary, the ads could refer consumers to (1) a toll-free telephone number, (2) print ads, (3) a website, and/or (4) their pharmacists or physicians, from whom they could obtain complete information about the product's risks and benefits. Consumers' confusion over the reminder ads for prescription drugs on television was a major factor behind the policy change ( Woodcock 2003 ). Although whether the guidance was intended to loosen restrictions or to clarify existing provisions of advertising regulation has been debated, it nonetheless made broadcast advertisements of prescription drugs more feasible.

Contemporary Views of DTCA

The pharmaceutical industry quickly seized on the policy change, more than doubling its spending on television advertising from $310 million to $664 million between 1997 and 1998, with the total spending on DTCA advertising rising from $1.3 billion in 1998 to $3.3 billion in 2005 ( Figure 2 ). Pharmaceutical firms, which a little more than a decade earlier had feared the impact of DTCA on the doctor-patient relationship, now argued that prescription drug advertising empowered consumers. The president of the Pharmaceutical Research and Manufacturers of America stated, “Direct-to-consumer advertising is an excellent way to meet the growing demand for medical information, empowering consumers by educating them about health conditions and possible treatments” ( Holmer 1999 , 380). The majority of spending on DTCA since the policy change has been for television advertising, and more than 80 percent of prescription drug ads in the 1990s promoted specific products rather than raising awareness of medical conditions.

Total U.S. Pharmaceutical Industry Spending on DTCA 1996–2005

In 1992, the AMA recognized consumers' more assertive role in their health care and altered its policy to support DTCA on a limited basis when such ads were in the patient's best interest and conformed to guidelines established by the FDA and the AMA ( Borow 1993 ). But following the release of the draft guidance in 1997, the AMA sent a letter to the FDA expressing its concern about the potentially adverse impact of DTCA on the physician-patient relationship and the potentially negative public health and economic outcomes ( Neilsen 2003 ). In 1999, the AMA established standards for appropriate consumer-directed advertisements. They state that DTC advertisements should focus on diseases rather than specific products and also that physicians should be concerned about advertisements, which “do not refer patients to their physicians for more information, and do not identify the consumer population at risk by implying self-diagnosis and self-treatment” ( AMA 2000 , 122). The AMA's rather ambivalent policy on DTCA highlights the difficult balance between supporting consumers' involvement in health care and maintaining control over medical decision making.

Recent surveys of physicians indicate that even though many still oppose the practice of DTCA in general, they also point to some positive effects. A survey of family physicians in 1997 found that 80 percent of physicians believed DTCA was not a good idea ( Lipsky and Taylor 1997 ). More recently, however, in a 2002 survey of physicians conducted by the FDA, only 18 percent believed that DTC created problems with their interaction with a patient, and 41 percent said that DTC had beneficial effects on the interaction ( Swasy 2003 ). These findings contrast with the nearly universal opposition to DTCA expressed in surveys of physicians in the 1980s.

Some consumer groups reacted negatively to the 1997 draft guidance for broadcast advertising ( Sasich and Wolfe 1997 ). For example, the Health Research Group (HRG) argued that a sixty-second television commercial would not be adequate to convey risk information to consumers and that the FDA's policy left “consumers naked in the viciously competitive marketplace for prescription drugs” ( Sasich and Wolfe 1997 , 1). The group called for a moratorium on DTCA until the FDA could issue regulations specifically governing consumer-directed advertisements. In an editorial, HRG's director acknowledged consumers' desire for more information but differentiated between drug information provided for educational purposes and advertising:

During the past two decades, there has been an irreversible change in the nature of the doctor-patient relationship. Patients are seeking much more medical information and are actively participating in decisions affecting their health. Intruding into this trend has been the rise of direct-to-consumer promotion, which in its initial thrust, bypasses primary care doctors and other physicians. Although increased access by patients to accurate, objective information about tests to diagnose and drugs to treat illnesses is an important advance, confusion arises when commercially driven promotional information is represented as educational. ( Wolfe 2002 , 524)

Other consumer groups, however, expressed more positive views about DTCA. After it held a roundtable on DTCA, the National Consumers League concluded that it was “an effective vehicle that motivates consumers to seek information, especially from health care professionals” ( National Consumers League 1998 ). Its 2003 press release noted that “critics attack such ads for provoking patients to ask their doctors for expensive drugs for which they may not have a medical need. But if these ads are encouraging dialogue of any nature between doctors and their patients, this can hardly be a bad thing” ( National Consumers League 2003 ).

Surveys suggest that DTCA affects consumers' behavior ( Slaughter 2002/2003 ). In 2002, 98 percent of Americans reported that they had seen or heard an ad for prescription drugs. Of those who had seen an ad, 33 percent talked to their physician about the medicine. Thirty percent (or about 8 percent of total) of those who talked to their doctor asked for a prescription, and 79 percent of those who asked for a prescription (or about 5 percent of all Americans) had their request honored. Another survey found that roughly half of consumers who talked to their physician after seeing a DTCA ad were seeking treatment for the condition for the first time ( Weissman et al. 2003 ). Moreover, surveys show that most consumers view DTC ads positively. Only one-quarter of consumers surveyed in 2002 believed that prescription drug ads should be limited to medical journals read by physicians ( National Consumers League 2003 ).

A few years after the draft guidance FDA Commissioner Jane Henney, citing a survey conducted by the FDA, wrote that “DTC prescription drug promotion offers public health benefits that may outweigh potential costs” ( Henney 2000 , 2242). In a few short years, the agency changed its view of DTCA from being wary of “opening the floodgates” to television advertising to seeing a public health benefit from this form of promotion. This marks a dramatic shift in the view of DTCA among regulators trying to balance the traditional emphasis on preventing misleading advertising with the goal of providing consumers with more information about possible treatments. Even former FDA Commissioner David Kessler, who had opposed loosening the regulations to allow broadcast advertising throughout his term in office, recently recanted ( Mishra 2002 ). Moreover, the director of the FDA Center for Drug Evaluation and Research spoke at a public meeting on DTCA sponsored by the FDA on the relationship between DTCA and consumerism ( Woodcock 2003 , 18–19):

It was not until the time of HIV and cancer activism in the late 1980s that the concept of patient empowerment really took hold. And I think it is no coincidence that around that time we began to see, again, reemergence in the interest … in direct-to-consumer advertising. Several other forces were also active at that time. First, outcomes researchers had shown that patient values and preferences could drive the choice of appropriate treatment. … Second, the rise of managed care in many forms led patients to believe that the health care system could not always be completely relied upon to act in their best interest at all times. These forces have resulted in a shift in the general societal perception of who needs what information. And of the dynamics of medical decision making in general.

The last few decades have seen a dramatic transformation of the consumer's role in health care, and DTCA and the policy debate surrounding it relate directly to this transformation. The current period of consumer involvement in health care harkens back to the drug market in the early twentieth century when self-treatment was highly valued and most drug advertising was aimed directly at consumers. Physicians' authority over the prescribing of drugs has been directly challenged by DTC advertising campaigns urging consumers both to self-diagnose and to demand specific medications from their provider. We therefore are not likely to return to the days when consumers were effectively cut off from commercial information about prescription drugs, nor are pharmaceutical companies likely to abandon their focus on physicians, who still control access to prescription drugs.

By 2004, DTCA seemed to have weathered the deluge of criticism it encountered in the late 1990s. But Merck's withdrawal of Vioxx from the market renewed criticism of DTCA, and in 2005 the U.S. Senate majority leader, William Frist (a physician), called for a two-year voluntary moratorium on the use of DTCA for newly approved drugs ( Saul 2005 ). In June 2005, Bristol Myers Squibb announced a one-year moratorium on DTCA for new product launches, and in 2004, Pfizer announced a voluntary moratorium on DTCA for Celebrex, its COX-2 inhibitor. In addition, the FDA is continuing its decades-long effort to improve the communication of drug risks and benefits to consumers. Because the FDA's authority is limited to approving drugs and it cannot decide the price purchasers will pay (as similar agencies in other countries can), the policy debate over DTCA is mostly limited to its effect on drugs' safety and effectiveness. The impact of DTCA, and related trends in medical consumerism, on health care costs receives less attention.

The history of consumerism and DTCA has important implications for other contemporary health policy debates. The first is that as bioethics historian David Rothman (2001, 261) wrote, “When commerce joins with ideology, we have a powerful engine for promoting change.” The pharmaceutical industry not only reacted to the trend toward consumer-oriented medicine but also reinforced this cultural shift with an onslaught of mass media advertising. The industry defined DTCA as a tool to enhance consumer choice and autonomy. Similarly, the industry has argued for consumer choice in prescription drug coverage policy in public insurance programs. Some state Medicaid policymakers have been reluctant to restrict access to costly psychotropic medications, in part because of vocal opposition from mental health consumer advocacy organizations. Borrowing the language of consumer empowerment and choice, pharmaceutical manufacturers, which have a clear financial incentive to remove any restrictions on the use of their products, have supported mental health consumer groups in opposing cost-control mechanisms ( Harris 2003 ). But the industries' funding of consumer groups' advocacy efforts have called into question the authenticity of the consumers' perspective ( Tomes 2006 ). Long-standing skepticism of medical research financed by the pharmaceutical industry has been joined by concerns about alliances between the pharmaceutical industry and consumer advocacy groups. Ethical issues surrounding these alliances have received less attention in the literature.

The image of consumers as highly educated, technology savvy, and assertive strongly influences the current reshaping of health insurance arrangements in the public and private sectors. In the last few years, the health insurance industry has adopted new benefit, network, medical management, and pricing policies in response to the demand from employers. These contemporary policies highlight the insurers' shift away from cost containment through supply-side mechanisms that try to influence physicians' behavior in favor of policies that focus on the consumer side of the health care market ( Robinson 2004 ). Arguments in favor of shifting entitlement programs and employment-based health insurance away from defined benefit plans toward the use of medical savings account models will be more salient when accompanied by descriptions of informed consumers. Indeed, the term defined contribution health plan has been replaced with consumer-driven health care plan , implying that consumers exert considerable control over their insurance arrangements ( Shearer 2004 ). Health plans and purchasers are relying less on supply-side cost control mechanisms like restrictive provider networks and are focusing more on altering consumers' behavior, arming them with information (at least in theory) and stronger financial incentives to make prudent purchasing decisions. The rhetoric of consumerism no doubt contributed to this transformation of the health insurance market.

Legal and cultural changes in health care brought about by the patients' and consumers' rights movements laid the groundwork for the DTCA of prescription drugs. DTCA was surely an unintended consequence of these social movements and may, paradoxically, serve to frustrate future efforts to protect patients and consumers. That is, by shifting the rights and responsibilities for financing health care from government and private purchasers toward individual consumers, we are reducing the opportunities for public discourse on what health services should be covered and for whom ( Robinson 2005 ). Collective decisions about health care priority setting are being replaced by private health care choices. Interestingly, countries with national health systems that delegate technology assessment and priority setting to governments have chosen not to allow the DTCA of prescription drugs. In 2002, the European Parliament voted 494 to 42 to reject a proposal to allow DTCA. European consumer groups contended that allowing DTCA would “lead to a US-style spiral of unsustainable health care spending” ( HAI/EPHA 2002 ). By arming consumers with more information about newer, more expensive treatments, the DTCA of prescription drugs and similar marketing efforts will likely foster continued resistance to centralized cost containment methods that explicitly limit the choices of consumers.

Acknowledgments

The author is grateful to Allan Brandt and Patricia Keenan for their insightful comments on earlier drafts of this article. In addition, I would like to thank Bradford Gray and the three anonymous reviewers for their constructive comments. All errors are my own.

1 The economic literature does not agree on whether advertising serves to inform consumers, thereby improving the performance of the market, or to persuade consumers by altering their preferences, thereby undermining competition. For a discussion of these issues, see Hurwitz and Caves 1988 .

2 Narcotic drugs were a notable exception. Before federal drug regulation, some states required consumers to obtain prescriptions for narcotics or poisons. In 1914, Congress passed the Harrison Narcotics Act, which required consumers to obtain a prescription for narcotic drugs, but most other classes of drugs did not require a prescription until after 1951.

3 Advertisement in an 1881 Salt Lake City newspaper obtained from Museum of Menstruation and Women's Health. See http://www.mum.org/MrsPink1.htm .

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The Impact of Direct-to-Consumer Advertising

When it comes to advertising prescription drugs on radio and television and in magazines, doctors say that, for the most part, the ads have both positive and negative effects on their patients and practices. Results of a Food and Drug Administration survey, released in 2004, also indicate that most physicians view direct-to-consumer (DTC) ads as one of many factors that affect their medical practices and their interactions with patients.

For decades, prescription drug makers promoted their products exclusively to health care professionals, who were expected to interpret drug information for their patients. Beginning in the early 1990s, some drug manufacturers began targeting consumers due, in part, to the aging baby boomers and to an increase in the number of patients participating in their own health care decisions. Since then, DTC advertising has become a popular promotional tool.

The FDA oversees the advertising of prescription drug products under the Federal Food, Drug, and Cosmetic Act and related regulations. That means the agency must ensure that prescription drug information provided by drug firms is truthful, balanced, and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both health professionals and consumers. The 500-physician survey, released in November 2004, is the third in a series of evaluations that the FDA is using to understand better how DTC prescription drug promotion affects the patient-doctor relationship.

The physician survey and two previous consumer surveys indicate that awareness of DTC ads is increasing. For example, 81 percent of consumer respondents in 2002 reported seeing or hearing an ad for a prescription drug. This figure is up from 72 percent in 1999. But 58 percent agreed strongly that DTC ads make the drugs seem better than they really are.

The results of all three surveys will help the agency decide whether advertising rules need to be changed to ensure better consumer understanding of a prescription drug's risks and benefits.

"Much of our compliance and enforcement activity is spent trying to ensure that companies don't low-ball risks in the ad and provide inflated expectations of benefit," says Janet Woodcock, M.D., deputy FDA commissioner for operations.

Other highlights of the surveys include:

Most physicians agreed that because their patient saw a DTC ad, he or she asked thoughtful questions during the visit. About the same percentage of physicians thought the ad made their patients more aware of possible treatments.

Many physicians thought that DTC ads made their patients more involved in their health care.

Physicians thought the ads did not convey information about risks and benefits equally well. Seventy-eight percent of physicians believe their patients understand the possible benefits of the drug very well or somewhat, compared to 40 percent who believe their patients understand the possible risks, and 65 percent believe DTC ads confuse patients about the relative risks and benefits of prescription drugs. In addition, about 75 percent of physicians surveyed believed that DTC ads cause patients to think that the drug works better than it does, and many physicians felt some pressure to prescribe something when patients mentioned DTC ads.

Eight percent of physicians said they felt very pressured to prescribe the specific brand-name drug when asked.

DTC ads help patients have better discussions with their physicians and provide greater awareness of treatments. The study demonstrated that when a patient asked about a specific drug, 88 percent of the time they had the condition that the drug treated. And 80 percent of physicians believed their patients understood what condition the advertised drug treats.

Doctors believe that patients understand that they need to consult a health care professional about appropriate treatment. Eighty-two percent responded either "very well" or "somewhat" when asked whether they believe that their patients understand that only a doctor can decide whether a drug is right for them. 

For More Information View the final report summarizing the three direct-to-consumer advertising surveys at Prescription Drug Promotion Research .

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• Protecting America's Health Through Human Drugs

An Ozempic baby boom? Some GLP-1 users report unexpected pregnancies.

Across social media, women who have used Ozempic or similar medications for diabetes or weight loss are reporting an unexpected side effect — surprise pregnancies.

The Facebook group “I got pregnant on Ozempic,” has more than 500 members. Numerous posts on Reddit and TikTok discuss unplanned pregnancies while on Ozempic and similar drugs which can spur significant weight loss by curbing appetite and slowing the digestive process. The drugs are known as “Glucagon-like peptide 1” or GLP-1 drugs.

The reports of an Ozempic baby boom are anecdotal, and it’s not known how widespread the phenomenon is. Experts say significant weight loss can affect fertility. Others speculate that the GLP-1 drugs could interfere with the absorption of oral contraceptives, causing birth control failures.

“I got pregnant on a GLP-1,” posted Deb Oliviara, 32, on her @Dkalsolive TikTok account, which has 36,000 followers. She had noted in another video that she’d previously suffered two miscarriages and a stillbirth.

Oliviara, who lives in Michigan, said in a direct message that she had been using Ozempic for three months before getting pregnant. “I was three weeks along when I found out,” Oliviara said. “I am now 3 months pregnant, and baby is doing amazing.”

“My little Mounjaro baby is almost 6 months old after trying for over 10 years with PCOS!” another woman commented on the post, referring to polycystic ovary syndrome , a hormonal health condition that is a leading cause of infertility.

Paige Burnham, 29, who lives in Louisville, had lost about 80 pounds while using Ozempic, also known as semaglutide, for Type 2 diabetes when she began feeling nauseous on a trip to Disney World. She assumed the symptom was due to the drug. “My most typical Ozempic side effect was nausea,” she said.

But she learned the symptom was actually morning sickness due to pregnancy — a surprise since she and her partner had tried for four years to conceive. She stopped taking Ozempic and gave birth to a healthy baby boy, Creed, in March 2023.

A lack of research on pregnancy and GLP-1 drugs

Little is known about the effects of Ozempic and similar drugs on women who want to get pregnant or who become pregnant while taking the drugs because they were specifically excluded from early clinical trials of the drug.

A spokesman for Novo Nordisk, which makes Ozempic and Wegovy, said the company is collecting data to evaluate the safety of becoming pregnant while using Wegovy, the version of semaglutide approved for weight loss.

“Pregnancy or intention to become pregnant were exclusion criteria in our trials with semaglutide in both obesity and type 2 diabetes,” the company said in a statement.

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Eli Lilly, maker of the GLP-1 drugs Mounjaro and Zepbound, did not respond to requests for comment.

The biggest concern among women who become pregnant using a GLP-1 is whether the drug poses a risk to the fetus. While women like Burnham and Oliviara have posted reassuring stories of delivering healthy babies, doctors say it’s important to use backup birth control and stop the drug immediately if you become pregnant.

A Novo Nordisk spokesman said in a statement that there isn’t enough available data to know if the drug poses a risk for birth defects, miscarriage or other adverse events related to pregnancy. Based on animal reproduction studies for Wegovy, the company said there “may be potential risks to the fetus from exposure to semaglutide during pregnancy.”

The company recommends stopping Wegovy at least two months before a planned pregnancy.

According to Ozempic’s prescribing information , pregnant rats administered Ozempic showed fetal structural abnormalities, fetal growth problems and embryonic mortality. In rabbits and cynomolgus monkeys, there were early pregnancy losses or structural abnormalities as well as marked maternal body weight loss.

Controlling diabetes is important for a healthy pregnancy, and experts say patients taking Ozempic for diabetes should discuss the risks and benefits with their doctor.

Why drugs like Ozempic might affect pregnancy risk

While it’s unclear whether women taking a GLP-1 have a higher risk of unplanned pregnancies, doctors say there are a few explanations why some women are getting pregnant while using the drugs.

Weight loss can have an effect on ovulation and fertility, said Lora Shahine , a reproductive endocrinologist with a fertility practice in Seattle and Bellevue, Wash.

“I think that with weight loss and balancing of hormones and improved insulin resistance, the hormonal access clicks back in, and all of a sudden they start ovulating again — they might not have been ovulating for years,” said Shahine, who is also an associate clinical professor at the University of Washington.

Stephanie Fein , an internist in Los Angeles who specializes in helping women lose weight for their fertility, said that losing just 5 to 10 percent of body weight can help someone conceive. “No one knows exactly the reason,” she said. “Fat is hormonally active. We know it has effects on estrogen, and it will impact ovulation and possibly egg development.”

The drugs also may interfere with oral contraceptives in some patients, doctors say. The GLP-1 drugs help people lose weight by slowing gastric emptying, curbing hunger and leaving people feel full sooner. It may be that the GLP-1 drugs also affect the absorption of oral contraceptives, said William Dietz, physician and chair of the STOP Obesity Alliance at the Milken Institute School of Public Health at George Washington University. “This may mean that birth control medications are metabolized or ineffective,” he said.

Dietz said most experts recommend discontinuing GLP-1 medications when pregnancy is detected. “I don’t think we know the impact of these drugs on fetal development,” he added.

Shahine recommends that women using oral contraceptives who are taking a GLP-1 drug use a second form of birth control. The drugs also aren’t recommended for mothers who are breastfeeding. Animal studies have shown semaglutide is present in the milk of lactating rats treated with the drug.

After Burnham stopped breastfeeding, she resumed taking Ozempic. Because of her past struggles with infertility, she doesn’t want to take birth control, although she said she is concerned about getting pregnant too soon. “I’m not ready yet,” she said.

Amy Klein is the author of “The Trying Game: Get Through Fertility Treatment and Get Pregnant without Losing Your Mind.”

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