Life Science Compliance Update

December 13, 2013

CME Coalition Questions Pew Taskforce on COI Recommendations as “Irresponsible” and Potentially Dangerous to America’s Health

This week, the Pew Charitable Trust Prescription Project released a small task force report for academic medical centers which included recommendations around continuing medical education (CME) that, if followed, could eliminate one out of every three dollars that are invested in accredited medical instruction for America's doctors today. On the basis of three studies, from 1988, 1992, and 2001, the Pew recommendations merely restate their longstanding condemnation of accredited CME: that any financial support from commercial interests—no matter how stringent the restrictions on its use—renders the curriculum irrevocably tainted.

Unfortunately, Pew's attempt to point out a problem creates more harm than good. Andrew Rosenberg, Senior Advisor to the CME Coalition stated, "Once again, the absolutists at the Pew Trust have staked an utterly irresponsible position that, if taken seriously, would literally jeopardize the health of every American due to an undocumented belief that a doctor's judgment can be bought for the price of a sandwich."

What is missing from Pew's report is an analysis of the benefits of physician-industry collaboration, or a middle-ground at all. The vast majority of collaborations between physicians and industry have added considerably to improved patient care. Industry has the resources and expertise to:
Discover new therapies and devise medical procedures;

  • Take these discoveries through the painstaking processes of basic research, clinical development and eventual production;
  • Deal with the related scientific, regulatory, legal, financial and manufacturing issues; and
  • Complement the skills and contributions of its academic and clinical partners. 

Criticism over collaboration has stemmed from several high profile cases, usually involving physicians who were conducting research for companies, but failed to disclose the financial relationships either in a medical journal or to their institution. Bias is certainly a legitimate concern. A successful collaboration proposal would recognize those potential harms, but not at the expense of physician education.

As it stands, Pew's report is an unbalanced set of recommendations that would severely limit physicians' exposure to new diagnoses, technologies, and procedures. Patients deserve physicians who are as up-to-date as possible on the best medical technologies. Cancer patients in particular want physicians who understand all aspects of therapeutics, and have received ongoing advanced medical education rather than potentially obsolete generic treatments.

Today, approximately one-third of the support for accredited continuing medical education is borne by commercial benefactors, and the projected need for CME is expected to rise considerably in the coming years along with expanding patient needs. Although the Pew Trust fails to cite meaningful evidence that commercial support for CME results in inaccurate physician instruction, or manifests any negative impact on patient outcomes, Pew does prescribe a "remedy" that would eviscerate funding for physician education.

Pew recommends that "In general, continuing medical education should not be supported by industry." It is worthy of note that the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support ensure that CME programs carefully avoid explicit commercial interests concerning specific products and observe strict balance when products are discussed.

 ACCME stresses financial disclosure, confirmation that supporting companies have no influence over the content and choice of speakers, and a procedure for resolving conflicts of interest should they arise. Despite the fact that Pew references no data on conflicts of interest in the ten years since ACCME adopted its Standards for Commercial Support: Standards to Ensure Independence in CME Activities, they argue that "where industry funding is nonetheless being considered, academic medical centers should implement additional safeguards beyond compliance with the ACCME." This includes:

  • Creating an undesignated, or blinded, pool of money contributed by multiple companies for the purpose of supporting an institution's CME program.
  • Requiring that commercially funded courses be supported by at least two companies and that no single company contribute more than 50 percent for a given program.
  • Requiring that physicians personally contribute some money toward industry-supported courses.
  • Requiring that industry-supported courses take place in non-resort locations.

_________

The Pew report concludes by stating that "strong policies will maintain the quality of medical education and support patient trust in the medical profession." Pew has made a painful step in the direction away from patient trust by ignoring the opportunities for improved health outcomes through discovery and innovative solutions that collaboration offers. The Pew taskforce was funded by the a grant from the Oregon Attorney General Consumer and Prescriber Education Grant Program, which is part of the Pfizer Neurontin settlement from 2004. It is notable that that grant also supports the AMSA scorecard of academic medical centers.

"It is astounding that a respected institution such as Pew could continue to promote such an irresponsible approach to CME," Rosenberg said, "and that these so-called experts are so willing to sacrifice the ability of doctors to avail themselves of the latest science out of a groundless distrust of physicians and their ability to put patients' interest first. These recommendations should come with a Surgeon General's warning; they are nothing short of dangerous to America's health."

December 11, 2013

ProPublica Criticizes Prescribing Brand-Name Drugs with Little Consideration to the Benefit

 

A recent ProPublica article and prescriber checkup database are designed to attack physicians for prescribing brand name drugs, and criticizing Medicare for failing to consider this prescribing practice. "Medicare is wasting hundreds of millions of dollars a year by failing to rein in doctors who routinely give patients pricey name-brand drugs when cheaper generic alternatives are available," ProPublica states.

ProPublica takes issue with Medicare's low income subsidy, which they argue encourages "wasteful name-brand prescribing" by keeping co-pays cheap for qualifying low-income patients. By merely stating the fact that generic drugs cost less than name-brand drugs, the article simplifies three issues: (1) Medicare patient's choice in the prescriptions, (2) the actual medical effect of brand-name drugs, and (3) the overall economic effect of name-brand prescription if lost wages and expensive hospitalizations are factored in.

In a somewhat more balanced article, ProPublica interviewed several doctors about the reasons for prescribing name-brand drugs. Several stated that patients often request or demand name-brand products. Others commented on the actual efficacy of the name-brand drugs. Dr. Alexander Gershman, a Los Angeles urologist stated that "[i]t would be wrong to say to physicians, 'You have to all prescribe generics' because I think this will tremendously limit the quality of the drugs to the patients." 

ProPublica's article hiding behind Medicare savings is overlooking the potential benefits of brand name drugs. One only has to look at the patient communities in areas such as HIV, Heart Disease and Cancer to see the overall benefit from brand name drugs overtime and that eventually all drugs become generic.

Doctors should feel comfortable advising patients about brand and generic medication options, and, they should prescribe the more effective choice if the patient can afford it.

However, the article's broad scope skirts the issue that each Medicare patient has a unique set of needs. Jumping to the conclusion that physician-industry collaboration is the root of the problem, as ProPublica often does, is, once again, not the answer.

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