Healthy Skepticism Library item: 18382

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Wokasch M
Commercially Successful Off-label Promotion Should be an Embarrassment to the Medical Profession
Pharma Reform 2010 July 7
http://www.pharmareform.com/2010/07/07/commercially-successful-off-label-promotion-should-be-an-embarrassment-to-the-medical-profession/

Full text:

While there are legitimate cases of last resort off-label prescribing (especially in oncology), many examples that have been brought to the attention of the courts that are not desperate attempts to find a viable treatment where nothing else has worked. To the contrary, the commercial success of off-label prescribing that has led to billions of dollars of incremental revenue for pharmaceutical companies should be an embarrassment for academics, healthcare providers, professional medical societies, and medical education providers. Why should they be embarrassed?

They should be embarrassed because many of these cases demonstrate that the medical profession has no effective way to educate physicians about prescription drugs. More importantly, it demonstrates that the evaluation process used by physicians to select treatments for their patients is less than rigorous and not necessarily based on package insert information, a critical evaluation of clinical data, or the literature. Simple “show me the data” requests with a diligent comparative evaluation should have revealed the data gaps and more importantly, exposed the marketing hype and sales slight of hand for many of these campaigns. How embarrassing for the medical establishment to have to face suggestions from litigation that pharmaceutical sale representatives and paid physician advocates have the skill and ability to influence prescribing practice without even having legitimate clinical proof of efficacy.

Rather than reveling in the success of winning billions of dollars in fines and settlements levied against the pharmaceutical industry, the plaintiffs and the medical profession should see this as a disturbing scorecard of medical education ineffectiveness and the inability of practicing physicians to critically evaluate prescription drugs for use in their practice.

It is also ironic and very disconcerting that states, private insurance companies, and even the federal government (CMS), all of whom espouse rigorous expert formulary evaluation processes, willingly encourage this prescribing by paying for these off-label uses without approved label claims or even supportive clinical data. These very same organizations however, find it lucrative to sue pharmaceutical companies for what is actually their own lack of due diligence (no clinical proof of efficacy or safety required), ineffective medical education processes, and lax prescribing oversight (more than just a few cases needing this product off-label might have raise concerns).

There are five simple solutions for preventing pharmaceutical companies from enhancing their sales from off-label promotion. These five actions would make it less attractive, less tempting, and less profitable for pharmaceutical companies to even consider off-label promotion.

If the government, insurers, or plan mangers don’t approve of off-label prescribing, they shouldn’t pay for off-label uses. If they decide to pay, they should not be allowed to sue the pharmaceutical companies for their own negligence in product assessments, inability to control prescribing, or ineffectiveness of their medical education processes.
Physicians should be required by law to inform patients that they are being prescribed a product off-label for their condition. If the patient agrees to the treatment, they should not be allowed to sue the pharmaceutical company for any reason related to the use of that product.
Physicians merely have to be more demanding for data and rigorous in their evaluation of off-label claims made by sales people and paid physician advocates. If they agree to use the product off-label, they should assume all liabilities related to its use.
Academia and medical education providers should be doing a much better job of teaching physicians about treatment options and challenging, even debunking off-label claims being made by pharmaceutical companies.
Academics and practicing physicians should be writing articles in medical journals that challenge the off-label claims being promoted by pharmaceutical companies.
If the market feels it is inappropriate to use prescription drugs off-label, that it results in the inappropriate overuse of higher priced prescription products, and therefore contributes to inflated healthcare costs, then the market should do its part and take responsibility for better educating the physician population and better manage the off-label use of prescription drugs.