New Research Examines How Drug Promotion Rules Impact Physician Prescribing Practices

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Findings from a new study led by researchers at Dartmouth’s Geisel School of Medicine and Harvard Medical School and published in the journal Circulation: Cardiovascular Quality and Outcomes, show that the way in which pharmaceutical companies are permitted to share information about their drugs can influence physician prescribing practices.

In an effort to ensure safety and efficacy of new medications, the Food and Drug Administration (FDA) has, historically, only allowed manufacturers to promote their drugs for approved uses. But a few recent court rulings at the federal level have created some exceptions to that rule.

In one case, the pharmaceutical company Amarin won a decision which allowed it to promote its prescription fish oil Vascepa? to physicians as an effective add-on therapy to a statin for certain heart patients, even though no clinical benefit had been demonstrated at that time (in reducing patients’ cardiovascular risk).

Steven Woloshin, MD, MS

“Using the Vascepa? case as a model, we conducted a national randomized survey with cardiologists, internists, and endocrinologists to assess how providing different forms of information about a drug would affect their beliefs about its efficacy,” explains lead author Steven Woloshin, MD, MS, a general internist and a professor of medicine, community and family medicine, and of The Dartmouth Institute for Health Policy and Clinical Practice.

In the study, the researchers sent the physicians one of three information scenarios about a hypothetical prescription fish oil product (based on Vascepa?), asking them if they felt it would lower patients’ cardiovascular risk and if they would prescribe it.

The first scenario described the drug as FDA-approved to reduce very high triglyceride levels. The second scenario included an off-label (non-FDA approved) claim about reducing heart attack risk for patients with high triglyceride levels, despite taking a statin, along with disclaimers stating that the drug was not approved by the FDA for this purpose and that relevant evidence was “supportive but not conclusive.”

The third scenario included the off-label claim and disclaimers, but also included more extensive context, explaining that three clinical trials testing the effect of adding other drugs to statins to reduce high triglyceride levels did not show additional cardiovascular benefit.

The investigators found that standard disclaimers hardly changed perceptions about the hypothetical fish oil product, but that presenting more extensive context improved physician knowledge about the drug while reducing their enthusiasm for prescribing it. The proportion of physicians who endorsed the unproven, off-label claim that the drug reduced cardiovascular risk was similar for those randomized to the first two scenarios (35 percent versus 37 percent), but significantly lower among those randomized to the third scenario (21 percent).

The researchers also found that physicians who had received company-sponsored information about the off-label use of Vascepa? were more likely to report prescribing it as an off-label medication than those who did not (38 percent versus 7 percent).

Despite major concerns from physicians and the FDA, more off-label drug promotion may continue to expand due to actions by courts or legislatures.

“If it does, our study highlights the need for FDA to develop guidelines for creating evidence context, and the importance of allowing it to exert authority over the language and format used to ensure that the statements are explicit, clear, and prominently displayed,” says Woloshin. “Otherwise, the victory of commercial speech will come at the expense of public health.”

  1. Unfortunately the FDA really screwed this up in 2013 when they rescinded ANCHOR SPA; this rescindment went against diabetic treatment guidelines recommending treatment of high trigs 200-500. Instead the FDA lost the 2015 First Amendment case based on truthful speech and in 2018 it was proven that Vascepa did actually decrease cardiovascular events and DEATHS. Since 2013, hundreds of thousands of preventable cardiovascular deaths have occurred due to FDA ANCHOR SPA rescindmernt incompetence. We need legislation to protect us from FDA scientific ignorance, that’s scary.
    Jason Williams

  2. Vascepa is a bad example to support your premise because of the placebo like side effects and multiple benefits known to most cardiologist. I understand your point with drugs that would have negative effects. Vascepa should have been approved for the last 6 years. I prescribe regularly off label proudly.

  3. Doc – so are you pushing dietary supplements then that are barely unregulated? You are using dietary supplement allowed FDA label claim language and comparing that to a FDA approved pharmaceutical label following FDA approved RCTs? Dietary supplements *may* self-police in their own voluntary monograph (specifications) – there’s no FDA oversight of those specifications or audits of their products. What’s next – some ephedra with your Dartmouth doctor recommended supplement because it may boost energy? The supplement fox is guarding the consumer hen house and you don’t have a problem with that?

    Come on. Fake news.

    Dietary supplements aren’t held to the same regulatory scrutiny as prescription drug ingredients. I hope my own doc is smart enough to recognize the difference and preference proven product safety and efficacy over vague free speech concerns.

  4. Vascepa should be in more medicine cabinets than Flinstone Gummies. Bad example. Your point is well taken, just the wrong example.

  5. I would take the opposite argument. How many patients have had preventable CVEs by NOT prescribing Vascepa? I didn’t need to wait for Reduce-it to understand the benefits. Are you familiar with Julis, Cherry, Anchor? I would hope most other clinicians are independent thinkers and not rely on KOL guidance. I practiced for 20 years and left ‘western medicine’ for these exact reasons. I have had more success with EPA, Oyster-mushrooms, and bitter gourd than any statin I ever prescribed. The supplement industry is full of false claims and impure manufacturing. Vascepa is natural and regulated. Would you rather send patients to isle 5 at CVS for a oxidized, heavy metal supplement? That is malpractice and that is what medicine has become. Until the FDA eliminates supplements, I am not convinced they are acting in the best interests of patients. How many labels contain suicidal thought? How many prescriptions are given to counter the side effects of other prescriptions? Your liver cannot keep up with the amount of chemicals we ingest. Guess what flushes the liver of these chemicals? I have researched EPA for over 10 years. I am 100% Positive in our lifetime we will see 100s of benefits of EPA including liver cleansing.

  6. As far as I know…Amarin wasn’t telling docs Vascepa would reduce CVD (R-it Trial) it said it would be beneficial for patients with high TGs. When it was only approved for Very High TGs. They promoted this to health care professionals base on the ANCHOR Trial results…which indeed did prove what they were saying to the docs. You should update your write up to reflect this. Instead of saying this in your write up:

    “In one case, the pharmaceutical company Amarin won a decision which allowed it to promote its prescription fish oil Vascepa? to physicians as an effective add-on therapy to a statin for certain heart patients, even though no clinical benefit had been demonstrated at that time (in reducing patients’ cardiovascular risk).”

  7. You do realize, Dr,. that in the First Amendment victory of Amarin over the FDA, Judge Englemeyer ruled that Amarin can communicate information to doctors and to the health care community as long as it was truthful and non-misleading?
    In light of that, do you feel that more, or less, information is beneficial to doctors and their patients?
    Did you also know that the FDA broke their SPA (Special Protocol Assessment) with Amarin that would have allowed Amarin to market Vascepa to a much larger patient population?
    Did you know that Medstar recently did a cost/benefit analysis showing that Vascepa was the rare drug that actually has the potential to LOWER health care costs?
    Are you aware of the REDUCE-IT study results? (let alone the JELIS study) Not to worry. An FDA Advisory Committee that reviewed that study voted 16-0 that Vascepa is safe and efficacious which will shortly lead to much broader labeling and patient access. Unfortunately it’s about six years later than it should have been.

  8. strange your choice of drugs to chose. It is almost as if you wanted to plant a negative seed. I believe we should be fighting for Vascepa. The medical community has never seen this sort of safety and results. The FDA screwed this up so badly years ago. The corruption is thicker that a pamphlet with the side effects of approved drugs it seems you would rather have doctors prescribe. Vascepa is safer than aspirin. Lets repeat that again, Vascepa is safer than aspirin. Is this really something you want to stand on the other side of?
    I understand the point of your article, but do you think the choice of using Vascepa as your example landed the results you were looking for?

  9. Please list the drug, the efficacy of that drug, and the side effects of that drug that you would want doctors prescribing in place of Vascepa? i 10000000% (more zeros than the Pvalue of Reduce-it) that you cant think of one. I guarantee it.

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