Big pharma often commits corporate crime, and this must be stopped
by Peter C Gøtzsche professor
Nordic Cochrane Centre, Copenhagen, Denmark
British Medical Journal 2012;345:e8462 doi: 10.1136/bmj.e8462.
When a drug company commits a serious crime, the standard response from the industry is that there are bad apples in any enterprise. Sure, but the interesting question is whether drug companies routinely break the law. I googled the names of the 10 largest drug companies in combination with the term “fraud” and looked for offences on the first page for each company. The most common recent crimes were illegal marketing by recommending drugs for non-approved [off label] uses, misrepresentation of research results, hiding data on harms, and Medicaid and Medicare fraud. All cases were related to the United States and involved huge settlements or fines, exceeding $1bn [£620.6m; €769m] each for four companies.It was easy to find additional crimes committed by these same companies and committed outside the US. As the crimes were widespread and repetitive, they are probably committed deliberately—because crime pays. Pfizer, for example, agreed in 2009 to pay $430m to resolve charges related to illegal marketing of gabapentin [Neurontin], but as sales were $2.7bn in 2003 alone, and as about 90% was for off label use, such fines are far too small to have any deterrent effect. When Pfizer was fined $2.3bn for off label use of four other drugs, also in 2009, the company entered into a corporate integrity agreement with the US Department of Health and Human Services to detect and avoid such problems in future. Pfizer had previously entered into three such agreements in the past decade. Of the top 10 drug companies, in July 2012 only Roche was not bound by such an agreement. However, over 10 years in the 1990s, high level executives in Roche had previously led a vitamin cartel that, according to the US Justice Department, was the most pervasive and harmful criminal antitrust conspiracy ever uncovered. Roche agreed to pay $500m to settle charges, equivalent to about one year’s revenue from its US vitamin business.
Doctors are often complicit in these crimes, as kickbacks and other forms of corruption were common; they were induced to use expensive drugs and paid to lend their names to ghostwritten articles purporting to show that a drug works for unapproved conditions.
The disconnect between the drug industry’s proclamations—of the “highest ethical standards,” of “following … all legal requirements,” and providing “most accurate information available regarding prescription medicines”—and the reality of the conduct of big pharma is vast. These proclamations are not shared by the companies’ employees or experienced by the public. An internal survey of Pfizer employees in 2001 showed that about 30% didn’t agree with the statement, “Senior management demonstrates honest, ethical behavior.” When 5000 Danes ranked 51 industries in terms of the confidence they had in them, the drug industry came second to bottom, beaten only by automobile repair companies. A US poll also ranked the drug industry at the bottom, together with oil and tobacco companies.
The consequences of these crimes are huge, including the unnecessary deaths of thousands of people and many billions in losses for our national economies every year. As doctors have access only to selected and manipulated information, they believe drugs are far more effective and safe than they really are. Thus, both legal and illegal marketing leads to massive overtreatment of the population. In the US, the most sold class of drugs in 2009 [in US dollars] was antipsychotics. Antidepressants came fourth, after lipid lowering drugs and proton pump inhibitors. It is hard to imagine that so many Americans can be so mentally disturbed that these sales reflect genuine needs.It is time to introduce tougher sanctions, as the number of crimes, not the detection rate, seems to be increasing. Fines need to be so large that companies risk going bankrupt. Top executives should be held personally accountable so that they would need to think of the risk of imprisonment when they consider performing or acquiescing in crimes. To bring the crimes to light also outside the US, we need laws that protect whistleblowers and ensure they get a fair proportion of the fines. We also need to avoid the situation that, by settling accusations of crimes, drug companies can pretend they are innocent, which they often do. We also need laws requiring firms to disclose all knowledge about their drugs and research data, and laws that not only allow but require drug agencies to publish what they know, without hiding under some absurd “proprietary nature of companies’ trial results” clause, as happened with rosiglitazone—with the consequence that the public was not informed that the drug causes myocardial infarction. Last but not least, doctors and their organisations should recognise that it is unethical to receive money that has been earned in part through crimes that have harmed those people whose interests doctors are expected to take care of. Many crimes would be impossible to carry out if doctors weren’t willing to participate in them.
Part of the reason is that psychiatry is poor. Departments are hard to maintain because there’s little revenue stream – institutional, governmental, or fee-for-service. So when KOLs show up that can raise pharmaceutical revenue, it’s hard to turn down. My own university tolerated the boss of bosses, Dr. Charles Nemeroff, for 19 years because he was a master at financing the department. And when that revenue becomes essential, it becomes "institutional." That happened in psychiatry more than in other specialties of medicine, and was the mechanism that supported a lot of the bad stuff some of us write about every day now. The same thing happened in the APA and other organizations in the field. So reform doesn’t just solve current problems, it unearths the forces that facilitated their development. That said, step one is still to stop being often complicit, and pretending that we were induced to allow the corruption of the last three decades. The fact that poverty breeds crime doesn’t justify it. Put the criminals [including accessories] in jail, and if they’re doctors, also pull their licenses.