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.

July 03, 2013

Physician Payment Sunshine: ProPublica Matches Medicare Part D Data with Physician Manufacturer Payment Data in an Attempt to Discredit Physicians

With less than a month to go before applicable manufacturers must begin reporting payments to physicians and teaching hospitals as required by the Physician Payments Sunshine Act, ProPublica last week launched another series of articles using its Dollars for Docs website and its new Prescriber Checkup database of Medicare Part D claims to publish two stories about improper payments or relationships.

As a reminder to all physicians, Ardis Hoven, MD, president of the American Medical Association (AMA), recently noted that the association had made efforts to ensure that physicians would be able to challenge inaccurate or false information. "We strongly urge physicians to make sure all of their financial and conflict of interest disclosures, as well as their information in the national provider identifier database, are current and regularly updated," Hoven said in a statement. We also urge physicians to ask industry representatives with whom they interact to provide an opportunity to review and, if necessary, correct all information they will report before it is submitted."

In the first article, ProPublica reports on "Top Medicare Prescribers Rake In Speaking Fees From Drugmakers." The article, co-published with NPR, focused on the blood pressure drug Bystolic, which hit the market in 2008 with a "crowded field of cheap generics." The maker, Forest Laboratories, launched the normal promotional efforts that any brand-name company does to educate physicians and prescribers about a new FDA-approved treatment.

For ProPublica, this translates to "flooding" doctor's offices with drug reps, and hiring doctors to "persuade their peers to choose Bystolic." Their concern appears to be that the drug had not "proved more effective than competitors—thus suggesting it was as effective, but likely more expensive—always a concern for ProPublica and the government: costs, not outcomes.

By 2012, sales of Bystolic reached $348 million, almost double its total from two years earlier, the company reported. Using ProPublica's Prescriber Checkup, the authors were able to show that at least 17 of the top 20 Bystolic prescribers in Medicare's prescription drug program in 2010 have been paid by Forest to deliver promotional talks. In 2012, they together received $283,450 for speeches and more than $20,000 in meals—that's less than $1,700 a speaker on average, and less than $1,200 on meals. While the article does not detail how many speaking arrangements per physician, these values appear consistent with fair market value.

To support their assertion that these payments were influencing the speakers, who were thus influencing other prescribers, ProPublica cites industry critic Dr. Bernard Lo, who chaired an IOM panel on conflicts of interest. He told ProPublica that he believed these findings were not a coincidence and that the financial relationships were thus problematic. ProPublica maintains that its project and article are the "first time anyone has matched payment data made public by drug companies with physician prescribing records from the Medicare drug program"—something that is sure to increase once all payments are made public through the Sunshine Act.

The article appears to be criticizing physicians who are being paid fair market value for their services to educate other physicians about new drugs and treatments. In fact, the first physician the article singles out, Dr. Gary Reznik, from Los Angeles.  In 2012, he was paid $3,750 for giving talks about the drug.  In the two prior years, evidently the most recent for which Part D data exists, he wrote 2,500 (2010) and 2,900 (2011) prescriptions.

Reznik told ProPublica that if patients have blood pressure under control with another beta blocker, he doesn't switch them. But he believes Bystolic is more effective at lowering blood pressure and doesn't cause the slower heart rate and erectile dysfunction of other drugs in the class. He asserted that he "never felt that there were any expectations or pressure on the part of the company that [he] would prescribe it more or at all."

ProPublica cites several other drugs and prescribers, claiming the relationships with industry are problematic because the drugs were new or had new uses, "were expensive and often showed little benefit over existing medications or generics."

However, they do not cite any evidence as to why such drugs had little benefit over generics. Instead, they cite other industry critics, such as Dr. Steve Nissen and another cardiologist who merely use conjecture and anecdotal comments to suggest the drug has little benefits. Further, ProPublica cites a warning letter to Forest for an ad claiming the drug was "novel", but this is not the same as saying the drug does not have benefits over generics.

ProPublica maintains, "If financial relationships influence physicians to choose pricier brand-name drugs that have little benefit over generics, everyone pays the cost – particularly taxpayers, who spent $62 billion last year subsidizing Medicare Part D."

Another top prescriber, internist Mark Barats, of West Hollywood, Calif., said he uses smaller doses of Bystolic to achieve the same effects as higher doses of generic medications. "It has much less side effects, particularly much less side effects on the respiratory system," he said. "I've never seen anything that contradicts what Forest said about Bystolic," said Barats, who was paid $3,750 to speak for Forest in 2012.

Dr. Henry Yee, who was paid $5,000 by Forest, said he chooses the drug for many of the same reasons as Reznik and Barats. The cardiologist, whose office is in the Los Angeles suburb of Alhambra, said he learned about the drug from company sales reps and from reading studies. He started prescribing it "even before I started speaking for the company," he added.

Nevertheless, ProPublica digs on to cite several recent settlements with pharmaceutical companies, citing various disclosures from the unsealed cases about speaker programs. For example, they note that internal documents from such settlements, as well as government analysis show that speaker programs have a high return "on investment in terms of the additional prescriptions for its drugs written by the doctors who participated in the programs, both as speakers and attendees, with the highest return arising from payments to doctors as 'honoraria' for speaking."

However, companies like Pfizer "explicitly prohibit the selection of speakers based on their prescribing behavior ... any inference to the contrary is misleading," a spokesman wrote to ProPublica. Glaxo and Johnson & Johnson also said they do not choose speakers based on prescribing.

ProPublica also cited Boehringer Ingelheim Pharmaceuticals, which makes the blood thinner Pradaxa. The company, which began reporting its payments just last month, spent more on speakers for Pradaxa than any other drug in 2011, according to Cegedim. Of the top 20 prescribers in 2011, only six received speaking fees in the first quarter of this year. Boehringer told ProPublica that it does not pay speakers based on prescribing.


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