Off-Label Marketing and its Dangerous Side Effects: How Pharmaceutical Companies Sell Drugs for Unauthorized Purposes

by Laura Sophia Hauck

Probably none of us can avoid swallowing one or two pills in our lives and we rely on the prescription and recommendation of our treating physicians. However, that these physicians are courted and influenced by large pharmaceutical companies to prescribe certain medication that falls out of the official permission for the ailment and for which there is neither authorization nor empirical evidence of efficacy, is largely unknown to the public in this country. Such prescribing practices, under certain circumstances, may end fatally.

source: Martin Vorel


Despite the fact that drugs not only make life easier for countless people, but also save them, the pharmaceutical industry does not have a good reputation. Bribery and price fixing are just two examples, even profit seeking is put at the expense of companies – in stark contrast to other capital market-oriented organizations. In the US in particular, another aspect can be added to this list: off-label marketing, i.e. the promotion of a drug for purposes not authorized by drug regulators. This is a criminal offense both in the US and in Germany, as the inappropriate application of medicines essentially threatens patient safety. Unlike in Germany, the direct and unrestricted approach of potential consumers in the US is legal even for prescription drugs. It is thus possible for pharmaceutical companies to promote their products in TV commercials or via advertisements in print media. However, if, in the case of off-label marketing, the advertising promises refer to un-(officially)-authorized purposes, it is up to the pharmacologically uneducated client to either verify the actual approval or efficacy himself or to trust the promises of the companies. Their marketing budget for 2016 was $ 9.6 billion. However, much more is spent on wooing those who ultimately prescribe the drugs: the doctors. In 2016, spending on marketing to health care professionals was $ 20.3 billion.

The Bextra Case

Like in virtually all other industries, drug manufacturers compete with each other. Accordingly, the marketing departments have huge budgets to win customers. And illegal activities are not rare, as for example, in the case of the COX-2 inhibitor Bextra, a drug formerly sold by Pharmacia & Upjohn Company and later by Pfizer, that had an FDA (Food and Drug Administration) approval for the treatment of arthritis. It was marketed, however, as a painkiller for postoperative administration – which was explicitly prohibited because of cardiovascular and thrombosis risks. To increase sales of the drug, Pharmacia & Upjohn Company held events for doctors on the popular holiday island of Bahamas in the early 2000s. In contrast to off-label marketing, off-label use, i.e. the medical prescription of a drug outside the use permitted by the authorities, is legal and often a useful practice. In some cases, even after the official approval, there are other medically based and evidence-based types and / or areas of application of a drug – not so in the case of Bextra, whose use was associated with health risks beyond the authorization.

The improper marketing strategy did not change even after the takeover by Pfizer. In order to gain a market advantage over other drugs such as Vioxx from Merck and to differentiate itself from Celebrex, another drug from Pharmacia & Upjohn Company, Bextra was still being advertised „off label.“ When the US authorities finally notified Pfizer of the initiation of the investigation in 2004, the pharmaceutical company illegally began shredding and tampering with its files. A year later, Bextra was finally taken off the market completely.

The court records from US Attorney’s Office show that a marketing team that described itself as the „Highlanders“ was instrumental in the scandal. Two of them were convicted in separate proceedings: Thomas F. a district manager, and Mary H., a regional manager. However, in the relevant documents, it is already clear that the scandal is not just due to isolated individuals, the „black sheep“, but that the corporate culture tolerated, if not encouraged, deviant behavior. Thus, Mary H. describes that the company approved of the marketing strategy and that it was „part of the Pfizer culture“. She speaks clearly of having had the support of her superiors. In the meantime, there were no signs of personal enrichment on the part of the off-label marketing team, but internal incentive structures existed in the company itself to boost sales, such as „rewards“ for sales representatives and praise from colleagues: „Mary was awesome!“ From a sociological point of view in particular, it is the disintegration of a formal structure that prohibits illegal advertising and an informal structure in which individual teams with (silent) acquiescence from high-level executives to deliberately breach these rules that are interesting. For example, a code of conduct has been in place at Pfizer since the 1990s, and as of 2000, the company is a member of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and and its US equivalent Pharmaceutical Research and Manufacturers of America (PhRMA), both of which provided very detailed codes of conduct that clearly forbid off-label marketing: „Promotional material for pharmaceutical products should be accurate, fair and objective and presented in such a way as to conform not only to legal requirements but also to high ethical standards and to be in good taste. Claims should not be stronger than scientific evidence warrants, and every effort should be made to avoid ambiguity.“ Nevertheless, a whistleblower in connection with the Bextra case said: „At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives.“

source: Flickr

In 2009, the Department of Justice and Pfizer agreed on a $ 2.3 billion payment – the second largest off-label marketing settlement – surpassed only by GlaxoSmithKline with a settlement of over $ 3 billion in 2012. What looks like a large sum at the first glance quickly turns out to be a kind of „speeding ticket“ to the world’s largest pharmaceutical company measured by revenue, as $ 2 billion is roughly equivalent to the proceeds of two weeks’ sale. In addition, Pfizer is already well acquainted with legal disputes: legal proceedings in the years of 2004, 2011 and most recently 2018 ended in settlements.

Off-Label Marketing as Common Practice

Pfizer isn’t the only pharmaceutical company with legal disputes: deviant behavior is a widespread, institutionalized practice in the organizational field of the pharmaceutical industry. On average, the pharmaceutical industry has three times as many legal violations compared to other industries (Clinard et al., 1979). The case presented here is an example of a systematic problem in the pharmaceutical industry: Almost all known drug manufacturers such as Eli Lily, Novartis, Johnson & Johnson and Boehringer Ingelheim have entered into at least one settlement agreement with the US Department of Justice for off-label marketing in the past. The salience of the topic is also shown by its own Wikipedia list with an (incomplete) overview of the court agreements. And this is just the bright field of the cases revealed. As so often, the dark field is probably much larger. Anyone in the US who is unsure about how the treating physician is financially supported by the pharmaceutical industry can find out about it on a search engine provided by the government (https://openpaymentsdata.cms.gov/). In Germany, a corresponding information portal is still pending, so it remains unclear to whom the approximately 600 million euros that the pharmaceutical industry paid to German doctors and clinics in 2017 exactly went.

source: table based on Wikipedia: „List of off-label promotion pharmaceutical settlements“

References

Braithwaite, John (1984), Corporate Crime in the Pharmaceutical Industry, London: Routledge.

Clinard, Marshall B.; Yaeger, Peter C., Brissette, Jeanne; Petrashek, Davis; Harris, Elizabeth (1979), Illegal Corporate Behaviour, Law Enforcement Assistance Administration, Washington, D.C.

Edwards, Jim (2009), 10 Amazing Facts About Pfizer’s $2.3B Bextra Settlement, CBSnews.

Griffin, Drew; Segal, Andy (2010), Feds found Pfizer too big to nail, CNN.

Keuchel, Jan (2018), Pharmakonzerne zahlen über 600 Millionen Euro an deutsche Ärzte, Handelsblatt.

Last Week Tonight with John Oliver (2015), Marketing to Doctors.

Schwartz, Lisa; Woloshin, Steven (2019), Medical Marketing in the United States, 1997-2016, JAMA.


Ein Gedanke zu „Off-Label Marketing and its Dangerous Side Effects: How Pharmaceutical Companies Sell Drugs for Unauthorized Purposes“

Schreibe einen Kommentar

Deine E-Mail-Adresse wird nicht veröffentlicht. Erforderliche Felder sind mit * markiert.

Diese Website verwendet Akismet, um Spam zu reduzieren. Erfahre mehr darüber, wie deine Kommentardaten verarbeitet werden.