Physicians and Pharmaceutical Marketing: Collaborators or Conscientious Objectors?

Of all the critical ethical issues in medicine today, the relationship between doctors and pharmaceutical companies is one of the most serious, because these relationships may be marked by significant conflicts of interest. Consider the following headlines penned by the investigative efforts of ProPublica(1) over the past five years:

• “Across the U.S., over 700 doctors were paid more than a million dollars by drug and medical-device companies since 2014” (https://www.inquirer.com/health/dollars-for-docs-propublica-doctors-drugmakers-devicemakers-20191021.html )

• “Now There’s Proof: Docs Who Get Company Cash Tend to Prescribe More Brand-Name Meds” (www.propublica.org/article/doctors-who-take-company-cash-tend-to-prescribe-more-brand-name-drugs )

• “Pharma Money Reaches Guideline Writers, Patient Groups, Even Doctors on Twitter” (www.propublica.org/article/pharma-money-reaches-guideline-writers-patient-groups-doctors-on-twitter )

• “Illinois Sues Controversial Drug Maker Over Deceptive Marketing Practices” (www.propublica.org/article/illinois-sues-controversial-drug-maker-over-deceptive-marketing-practices )

• “Drug and Device Makers Pay Thousands of Docs with Disciplinary Records” (www.propublica.org/article/drug-and-device-makers-pay-thousands-of-docs-with-disciplinary-records )

Dollars and Doctors

ProPublica’s exposés reveal that a small cadre of physicians have become millionaires speaking on behalf of drug companies, consulting for them, or helping companies promote new drugs and devices. Over the past five years, more than 2500 U.S. physicians—approximately one-quarter of 1% of roughly 950,000 actively licensed physicians(2)—have received at least half a million dollars apiece from drug makers and medical device companies. The more payments physicians receive from drug companies, the more likely they are to prescribe expensive brand-name drugs rather than cheaper generic versions. Payments of less than $20 may be influential—even a meal can sway a doctor’s prescribing decision!(3)

Doctors who receive gifts and payments from opioid manufacturers are more likely to prescribe higher amounts of opioid painkillers than their colleagues within a year.

Although one would expect pharmaceutical firms to hire only well-qualified individuals, there are speakers and advisers who have had licensing sanctions for serious misconduct—including harming patients, bilking federal insurance programs, and even sexual misconduct. At least 2300 doctors with records of discipline received payments from drug and medical device companies between August 2013 and December 2015. Some doctors were disciplined for unnecessarily prescribing opioid and other addictive drugs, further contributing to the opioid crisis. A recent study(4) found that doctors who receive gifts and payments from opioid manufacturers are more likely to prescribe higher amounts of opioid painkillers than their colleagues within a year.

Far-Reaching Effects

Doctors riding the pharmaceutical gravy train are relatively small in number, but intentionally or not, they have become “enablers” to industry. Money paid to physicians by pharmaceutical companies can have far-reaching effects. Many physician researchers double as clinicians and teachers, so their treatment choices and teaching content could reflect a bias toward a company’s product or its hypothesized mechanism of action. Biased physicians could ignore critical scientific evidence or, conversely, give it undue emphasis. Practice guidelines, which rely heavily on science, could become partisan to industry. The very science base for the practice of medicine could be jeopardized, given that some editors of medical journals have significant undeclared conflicts with industry.(5)

There’s already a problem regarding the reliability of medical science.(6) Many research studies cannot be replicated, and negative studies are not usually published. Yet, pharmaceutical companies persist in finding ways to “spin” the data into meaningful stories, exaggerating the capabilities of the product in the process. Flawed science undermines good medicine. Furthermore, it impairs the ability of basic research to inform the development of new and better drugs. In essence, pharmaceutical marketing confounds its own R&D, becoming “the enemy of innovation”(7) by changing the definition of value to a marketing proposition rather than a scientific one.

Inside Experience

All of this news is not really unexpected to those who are, or have been, industry insiders. I worked in the pharmaceutical industry in the United States from 2001 to 2014. Much of my time in industry was spent reviewing promotional material for medical accuracy and completeness. I wrote an article(8) about best practices to achieve high-performing promotional review committees—committees comprised of marketing managers and medical, regulatory, and legal personnel. Promotional review committees are charged with vetting all ideas and written copy destined for advertising and promotion, guaranteeing that the information is truthful and not misleading. I challenged marketing teams and stopped them from over-zealous promotion. However, my position was eliminated. I was told that physicians were not deemed essential to pharmaceutical promotion, even though I argued (and published(9)) otherwise.

While working in industry, most of my speaking engagements were at industry conferences—not drug company dinners attended by practicing clinicians—explaining the application of well-established FDA guidelines for pharmaceutical promotion and advertising, and discussing instances where companies promoted products incorrectly and were fined for marketing transgressions (Table 1). You could say I was an insider policing the efforts of marketing individuals prone to taking liberties with the facts. Mark Twain popularized the phrase “lies, damned lies, and statistics” to describe the persuasive power of numbers when applied incorrectly to bolster weak arguments. Not on my watch!

Managing Conflicts

When it comes to pharmaceutical promotion and advertising, managing conflicts of interest is key. That is why significant transparency surrounds relationships between physicians and drug companies. Under the physician payment “sunshine” provisions in the Affordable Care Act, companies and medical device makers must report to the federal government all payments and gifts to doctors. Questionable marketing tactics and industry relationships with physicians are thus more easily codified and tracked.

The need for transparency was backed by a landmark study(10) that showed a significant escalation in medical marketing in the United States between 1997 and 2016—marketing to both health professionals and consumers. During this time, there were 103 financial settlements between pharmaceutical companies and federal and state governments, resulting in more than $11 billion in fines for marketing practices considered deceptive or “off-label”—that is, inconsistent with the product’s characteristics as outlined in the package insert approved by the FDA.

Putting the Brakes on Big Pharma

Putting the brakes on pharmaceutical marketing is difficult in light of the following scenario:

• Academic medical centers are home to “key opinion leaders” (influencers) who conduct important research;

• Some institutions turn a blind eye to these high-profile doctors as speakers and advisers to industry because they raise significant research dollars;

• The doctors claim they are not influenced by pharmaceutical companies, even though abundant research(11) has proved them wrong; and

• Meanwhile, Big Pharma continues to compensate doctors and seemingly anyone else who has skin in the game.

It’s a win for everyone except patients—they don’t appear to reap any of the gains. The notion that patients will benefit from novel and innovative therapies in the belief that drug companies will reinvest their profits in research is a myth.(12) Only about 1 in 10 newly approved medicines substantially benefits patients, with many others classified as “me-too” drugs (i.e., similar to existing ones yet with a new lease [patent] on life). Besides, insurance companies are reluctant to pay for expensive breakthrough and first-in-class drugs unless companies are under extreme outside pressure to change their formulary policies. The ultimate hypocrisy is that some academic medical centers allow doctors to make money from Big Pharma, but patients are not allowed to receive samples!

Erosion of Trust

It is important to note that although unscrupulous pharmaceutical marketing practices certainly do occur, many companies (and academic medical centers) are doing the right thing. Nevertheless, nationwide disclosure of industry payments to doctors has eroded trust in the medical profession.(14) Surprisingly, patients have not used the information to make decisions about their care, nor has the information led to substantive corrective actions against doctors and drug companies—only fines and, in rare instances, jail terms. Educational awareness programs and policies limiting physician–pharmaceutical company interactions have likewise been unsuccessful in curtailing marketing largesse.

Oversight of pharmaceutical marketing remains limited, in part, because the FDA Office of Prescription Drug Promotion is understaffed and inundated by promotional materials submitted for advisory comments and other reasons. Despite the best efforts of the FDA to protect the public, one study(14) found that only 18% of physician-directed print pharmaceutical advertisements adhered to all FDA guidelines; over half failed to quantify serious risks. Until recently, the FDA maintained a hidden database(15) chronicling over five million incidents of malfunctions and injuries linked to medical devices over two decades.

Furthermore, bypassing physicians and marketing directly to consumers (DTC)—legal only in the United States and New Zealand—has generated demand for new therapies that are only marginally indicated or effective compared to established medicines. Drugs and devices marketed directly to consumers also are potentially unsafe—the majority of DTC advertising contains information related to risks rather than benefits. In fact, one-third of 222 novel therapeutics approved by the FDA from 2001 through 2010 had a post-market safety event during a median 11.7 years after approval.(16)

The well-intended push for transparency has not had any meaningful effect in terms of curbing pharmaceutical marketing or resolving ethical conflicts between doctors and industry. Mere disclosure of a conflict does not necessarily resolve it. Moreover, the practice of medicine has become so complicated and corporatized that dealing effectively with major conflicts requires not only total transparency, but also reporting of conflicts to organizational compliance officers. Corporate compliance officers may not always possess the necessary neutrality to assist in delivering fair dispute conflict resolution outcomes,(17) but they can be a valuable resource for physicians plagued by ethical dilemmas.

Conclusion

In keeping with the notion that, at some level, all physicians are considered leaders,(18) doctors have the capacity to lead by “expert authority.”(19) They are in a position to leverage their unique and extensive knowledge of diseases, therapeutics, and human nature as the basis of their authority and platform for leading. Through leadership efforts, the vast majority of physicians have the potential to mitigate misleading or inaccurate marketing. Several conditions are prerequisite, however, for leaders to impact bad marketing practices:

1. First and foremost, physicians need to own up to their conflicts of interest with industry, whether real, perceived, potential, or otherwise. I used to inform audiences—tongue-in-cheek—that as a psychiatrist, I’m always conflicted, but at least I know how to manage my conflicts.

2. Doctors should consult proactively with their corporate compliance officers or legal counsel and seek their advice about thorny ethical issues. Institutional compliance officers are unable to mediate conflicts if they are unaware of them or, worse yet, if doctors purposely hide conflicts from them. Eventually, someone (usually the feds) will say “gotcha,” and reputations will be sullied.

3. Physicians, including those in industry, need to dial up their moral compasses. It’s imperative that they be up-front about who they’re taking money from, and why. Doctors have the right to make as much money (legally) as they can, but they must be true to themselves and ask whether these payments and business relationships are affecting their teaching methods, selection of drugs or devices, and the care they give their patients.

4. When questioned by patients about their relationships with industry, doctors should engage and answer honestly without becoming defensive. Let patients decide whether payments pose a threat to their care.

5. Doctors can report questionable marketing practices to the FDA by emailing BadAd@fda.gov or calling 855-RX-BADAD—the so-called “Bad Ad Program.” This program helps healthcare professionals recognize misleading prescription drug promotion and provides them an avenue to report this activity to the FDA.

6. Finally, doctors should think twice about attending or speaking at that next industry-sponsored steak dinner. They should not view drug promotion as the equivalent of medical education. A healthy relationship with industry hinges on doctors knowing when to collaborate and when to conscientiously object.

References

1. Tigas M, Jones RG, Ornstein C, Groeger LV. Dollars for docs: how industry money reaches physicians. ProPublica. www.propublica.org/series/dollars-for-docs .

2. Young A, Chaudhry HJ, Pei X, et al. A census of actively licensed physicians in the United States, 2016. Journal of Medical Regulation. 2017;103(2):7-21.

3. DeJong C, Aguilar T, Tseng CW, Boscardin WJ, Dudley RA. Pharmaceutical industry-sponsored meals and physician prescribing patterns for Medicare. JAMA Intern Med. 2016;176:1114-1112.

4. Hollander M, Donohue JM, Krans E, Stein BD. Opioid-related gifts from pharma companies linked to physician prescribing by specialty. J Gen Intern Med. https://eurekalert.org/pub_releases/2019-10/uop-ogf102919.php

5. Haque W, Minhajuddin A, Gupta A, Agrawal D. Conflicts of interest of editors of medical journals. PLoS One. 2018;13(5):e0197141. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0197141 .

6. Harris RF. Rigor Mortis: How Sloppy Science Creates Worthless Cures, Crushes Hope, and Wastes Billions. New York: Basic Books; 2017.

7. Applbaum K. Is marketing the enemy of pharmaceutical innovation? Hastings Center Report. 2009;39:13-17.

8. Lazarus A. Promotional review committees: how to achieve high performing teams. Pharmaceutical Executive. 2013;33(9):30-33.

9. Lazarus A. Ensuring accurate product advertising: a moral imperative for industry physicians. The Monitor. 2007;21(6):49-52.

10. Schwartz LM, Woloshin S. Medical marketing in the United States, 1997-2016. JAMA. 2019;321:80-96.

11. Fickweiler F, Fickweiler W, Urbach E. Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians’ attitudes and prescribing habits: a systematic review. BMJ Open. 2017;7(9):e016408. https://bmjopen.bmj.com/content/7/9/e016408 .

12. Light DW, Lexchin JR. Pharmaceutical R&D: what do we get for all that money? BMJ. 2012;345:22-24.

13. Kanter GP, Carpenter D, Lehmann LS. US nationwide disclosure of industry payments and public trust in physicians. JAMANetw Open. 2019;2(4):e191947. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2730473 .

14. Korenstein D, Keyhani S, Mendelson A, Ross JS. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing. PLoS ONE. 2011;6(8):1-7. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0023336 .

15. Jewett C. Hidden harm. Kaiser Health News. https://khn.org/news/tag/hidden-harm/ .

16. Downing NS, Shah ND, Aminawung JA, et al. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017;317:1854-1863.

17. Van Gramberg B, Teicher J. Managing neutrality and impartiality in workplace conflict resolution: the dilemma of the HR manager. Asia Pacific Journal of Human Resources. 2006;44:197-210.

18. Angood P. All Physicians are Leaders: Reflections on Inspiring Change Together for Better Healthcare. Tampa, Florida: American Association for Physician Leadership; 2020.

19. Sederer LI. Leadership. Psychiatric Services. 2012;63(2):103.