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Editor: Katharine Van Tassel
Akron Univ. School of Law

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Thursday, July 12, 2012

What will it take for Pharmaceutical Companies to Stop Offering Doctors Illegal Inducements to Prescribe Dangerous and Expensive Drugs—and for Doctors to Stop Accepting Them?

With all the excitement about the Supreme Court’s ruling on the Affordable Care Act, another remarkable event related to the rising cost of health care has gotten less attention than it deserves.  On July 2, 2012, GlaxoSmithKline (GSK) pled guilty to three counts of a criminal information and agreed to pay $3 Billion to settle its criminal and civil liability for persuading physicians to prescribe powerful drugs to patients and for diseases not approved by the FDA.   The Justice Department described the event as “the resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.”

 Specifically, GSK has pled guilty to allegations of persuading doctors to prescribe dangerous, unproven drugs to their most vulnerable patients.  This included promoting “Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”    The government also alleges that “GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.’  Worse than that, the government alleges that GSK “did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18.”  

GSK’s actions were illegal and they have been caught.  Whether or not the penalty is sufficient to discourage other companies from engaging in similar activities remains to be seen.   But the more interesting issue, to me, is why any doctor still thinks it’s OK to take any gift from a drug company?  After all, the only reason why a drug company’s shareholders would tolerate the expenditure is if it made it more likely for the physician to use her medical license in a way that would benefit the company.  According to the Justice Department GSK, “used a wide variety of gifts, payments and other forms of remuneration to induce physicians to prescribe GSK's drugs, including trips to Bermuda and Jamaica, spa treatments and hunting trips, and sham consulting fees.”  How did it ever seem OK to a physician who accepted tax payer money in exchange for treating patients through the Medicaid and Medicare programs to accept a trip to Jamaica from a drug company?

Have we, I wondered, gotten past the point of being able to rely on either criminal penalties against the drug companies or common sense on the part of physicians in order to protect the safety of patients?   Is it time to stop these attempts to evade FDA regulation by ending the era of the unregulated prescription pad?

 I have written before about the dangers posed by the out-date practice of allowing any physician to prescribe any drug approved by the FDA for any purpose and to any patient.  This ability to prescribe drugs “off-label” is in direct contrast to legal prohibition against a drug company’s marketing a drug for uses other than that approved by the FDA.  In other words, although a drug company has to provide the FDA with proof that its drug is safe and effective for specific uses, at specific doses, for specific populations, one a drug gets FDA approval a doctor can prescribe it in any dose to anyone for any purpose.   This asymmetrical legislative system invites exactly the kind of behavior that GlaxoSmithKline is only the latest company to be caught engaging in.

The current system invites pharmaceutical companies to do the least testing possible in order to get its products approved for use and then engage in a back-door effort to persuade doctors to prescribe it far beyond any proven use.   The campaign launched by GSK to promote the use of Paxil in children and adolescents included, according to the Justice Department,  sponsoring “dinner programs, lunch programs, spa programs and similar activities.” 

 In the face of the information brought forward in the Justice Department’s case against GSK, it is hard to imagine why physicians still agree to participate in these events.  According to the organization “No Free Lunch” which is an organization devoted to ending the influence of pharmaceutical companies. It describes itself as “health care providers who believe that pharmaceutical promotion should not guide clinical practice. Our mission is to encourage health care providers to practice medicine on the basis of scientific evidence rather than on the basis of pharmaceutical promotion. We discourage the acceptance of all gifts from industry by health care providers, trainees, and students. Our goal is improved patient care.”

 

No Free Lunch further explains that “We believe that there is ample evidence in the literature--contrary to the beliefs of most heath care providers--that drug companies, by means of samples, gifts, and food, exert significant influence on provider behavior.  There is also ample evidence in the literature that promotional materials and presentations are often biased and non-informative. We believe that health care professionals, precisely because they are professionals ,should not allow themselves to be bought by the pharmaceutical industry: It is time to Just say no to drug reps and their pens, pads, calendars, coffee mugs, and of course, lunch.”

 

No Free Lunch’s website contains extensive references to literature showing the effectiveness of drug company efforts to change doctors’ prescribing practices.  One of the many studies No Free Lunch cites is one in JAMA from 2000 that reviewed 563 studies and that found “There was an independent association between meetings with pharmaceutical representatives and formulary addition requests for the drug of the representative's company, both with respect to control physicians who did not meet representatives and with respect to requests for other companies' drugs.”  The article directly counters the argument sometimes made by physicians that the information they receive from drug companies actually helps their patients.  Rather, “most of the requested drugs presented little or no therapeutic advantage over existing formulary drugs, but the merit of the requests was not related to interactions with the pharmaceutical industry. This, as well as the strength, consistency, specificity, and independence of the results, make it unlikely that the interaction occurred because the physician was already convinced of that drug's influence.”

 

It’s hard to imagine what more evidence is necessary for physicians to separate themselves from the illegal efforts of drug companies to influence them in ways that can cause direct harm to their patients.  Maybe it’s time to take a more direct approach by providing direct oversight of physician prescribing privileges.

JSB

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