The ethical practices of the pharmaceutical industry have recently come under scrutiny as never before. Here is a quick rundown of the main issues involved and what reforms have taken place, or may soon take place.
Background. Industry-funded ghostwriting refers to the practice whereby drug companies pay medical writers to write drafts or final versions of research articles and then seek out academics to become the identified authors. The ghostwriters are not listed as authors, though they are sometimes acknowledged at the end of the article for their “editorial support.”
Points of contention. Critics argue that ghostwritten articles always endorse the sponsor’s product, and that it is a deceptive marketing technique that undermines trust in the medical literature. Supporters say that the identified authors often play key roles in producing the articles, and that listing them as authors is not deceptive.
Proposed reforms. The International Committee of Medical Journal Editors has issued strict criteria governing what an academic must do in order to qualify as an author (see http://bit.ly/8CaC8a). Many journals have begun to require detailed “authorship disclosure” statements. Several academic medical centers now explicitly forbid faculty participation in ghostwriting.
Biased research results
Background. A systematic review found that studies funded by pharmaceutical companies were four times more likely to have outcomes favoring the sponsor than were studies with other sponsors (Lexchin J et al., Br Med J 2003;326: 1167).
Points of contention. Industry critics argue that drug companies ensure positive results by subtly biasing the research designs of their studies. Supporters counter that the methodological quality of industry-supported studies is unusually good, and that the trend of positive results may mean that companies choose to do research on drugs that they know are effective.
Proposed reforms. A recent piece in the New England Journal of Medicine suggested that the FDA require companies to include an active comparator drug in clinical trials, and that approval would be contingent on showing that new drugs are equivalent or superior to medications already in use. The current standard merely requires that a drug be superior to placebo; such studies are more likely to show a favorable result for the sponsor (Stafford R et al., NEJM 2009;361:13).
Background. Drug companies are under no obligation to publish the results of research they have funded. A recent analysis found that a third of antidepressant trials conducted for FDA approval were never published, and most of these were negative (ie, there was no difference between drug and placebo) (Turner E et al., NEJM 2008; 358:252–260).
Points of contention. Critics argue that publication bias deceives clinicians by cherry picking only the positive data, giving the appearance that a drug is more effective than it actually is. There are no prominent supporters of this practice.
Proposed reforms. In 2002, the drug industry trade group PhRMA adopted voluntary guidelines requiring that all new research studies be posted on a clinical trial website (such as www.clinicaltrials.gov) and that all results, positive or negative, be made available to the public.
Prescription data mining
Background. Drug companies purchase information from pharmacies about doctors’ prescribing habits. This information is used by drug reps to target particular doctors in their sales calls and other marketing efforts.
Points of contention. Critics argue that this is an exploitation of the patient-doctor relationship for marketing purposes. Supporters argue that this activity is benign and is protected by free speech laws.
Proposed reforms. At least two state legislatures have voted to ban prescription data mining, and many other states are considering such legislation. Efforts by data mining companies to overturn these bans based on the free speech argument have thus far been unsuccessful.
Gifts to doctors
Background. Drug companies have traditionally given doctors gifts, ranging from pens and sandwiches to trips to Carribean resorts. The more lavish gifts have been banned by the AMA’s ethics policy for some time. But gifts no more than $100 in value are still allowed by AMA guidelines.
Points of contention.Gift critics cite evidence that even small gifts create a feeling of obligation in the physician, who may be consciously or unconsciously influenced in prescribing habits (Wazana A JAMA 2000;283:373–380). Defenders scoff at the notion that a physician could be influenced by a small gift.
Proposed reforms. PhRMA issued new voluntary guidelines in 2009 forbidding drug reps from giving any gifts except for those with an educational value (such as textbooks) or lunches that can be brought to a doctor’s office. But the American Association of Medical Colleges issued stricter guidelines, recommending that academic medical centers ban any gifts, including lunches (see the press release at http://bit.ly/6BN69w). Several academic medical centers have instituted these guidelines.
Background. Doctors in almost all states are required to obtain Category 1 CME credits in order to maintain their medical licenses. Over the years, the pharmaceutical industry has funded an increasing proportion of accredited CME courses.
Points of contention. Critics of industry-funded CME argue that this is an inherent conflict of interest, and that it inevitably leads to education biased in favor of the sponsor’s products. Supporters believe that there are enough regulations in place to prevent promotional content from permeating CME, and they argue that there would be much less education available to doctors without industry support.
Proposed reforms. The Institute of Medicine proposes a phase out of all commercial support of CME. The Office of the Inspector General of the Department of Health and Human Services proposes either a phase out of industry support or a central CME fund to which companies would contribute; they would have no input over any aspect of the programs funded. The APA (American Psychiatric Association) has recently decided to phase out all industry-supported CME symposia at the annual meeting. However, the American Medical Association recently rejected an ethics report that recommended limits on industry funding.
Background. Drug companies hire prominent physicians to give promotional talks for other doctors.
Points of contention. Critics argue that such speakers are likely to bias their presentations in favor of the sponsor’s drugs. Supporters argue that most promotional speakers are honest in their talks and are not susceptible to such bias.
Proposed reforms. Several drug companies have been forced by legal settlements to post their payments to doctors on their websites. The current health care reform legislation contains a provision to require all drug companies to post this information (called the Physician Payments Sunshine Act). Several academic medical centers now ban faculty from giving promotional talks.
TCPR VERDICT: Restrictions on industry influence will lead to more evidence-based care.