Tag Archives: COI

Most EU patient groups get industry money

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Over at Pharmalot, Covering Health veteran Ed Silverman reports on one European activist group’s survey of corporate sponsorship and disclosure in patient and consumer groups across that continent. The report focuses on the 23 groups eligible to work with the European Medicines Agency, an agency responsible for the scientific evaluation of medicines developed for use in the European Union. The EMA has clear transparency guidelines, but this report gives a strong indication that they’re often neither followed nor enforced.

euPhoto by dimnikolov via Flickr

HAI [the advocacy group] notes the EMA introduced transparency guidelines in 2005, but by March 2010, 20 of the 23 eligible groups that were surveyed had not yet reported 2006 income online. “Despite the lack of compliance, all organizations were invited to participate in the EMA annual meeting in December 2009,” HAI adds. One problem cited: EMA guidelines do not stipulate a reporting deadline or cycle, and so some groups have not yet met requirements established five years ago.

Here’s a summary of the data:

  • Fifteen organizations were either partly or almost entirely funded by industry-related groups, only seven had fully independent funding. One was unknown.
  • Contributions went up over the three years examined in the study. From Silverman: “The average donation rose from 185,500 EUR (about $235,500) per sponsored organization in 2006, to 282,090 EUR (about $358,00) in 2007, and to 321,230 EUR in 2008 (about $407,800). In percentage terms, the increases amounted to 47 percent, 51 percent and 57 percent, respectively (please note the dollar figures are expressed in today’s values).”
  • Most groups didn’t follow EMA transparency guidelines. Only six seem to have complied with the full letter and spirit of the rules.

The full report is available here (20-page PDF). If you’re just looking for the juicy stuff, scroll to the results table on page 10.

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AAMC gives recommendations for clinical COI

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

After taking on continuing medical education and medical research, the Association of American Medical Colleges is now tackling conflicts of interest related to clinical care with its latest report, “In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making” (46-page PDF). If you’re just looking for the Big Recommendations, the most salient of which are paraphrased below, fast forward to pages 24 and 25. Warning: They’re vague.

  • Medical centers should compensate doctors in a way that promotes the patients’ best interests.
  • Professional medical societies and medical institutions (such as teaching hospitals) need to take a long, hard look at their own relationships with the industry.
  • Institutions should identify their physicians’ industry relationships, set thresholds for their disclosure, and identify situations in which disclosures should be made directly to the patient. These regulations should all have teeth.
  • Centers and physicians should work with patients to figure out how best to disclose industry ties.

The AAMC committee that produced the report wrote that, while they focused on academic medicine, their recommendations could (and should) be applied to all of clinical medicine.

J-S settles records suit; docs rebel against COI rules

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

As a result of the Milwaukee Journal Sentinel‘s now-settled lawsuit against the University of Wisconsin, John Fauber was able to review newly public e-mails which show just how angry a segment of the faculty became when faced with the university’s new, stricter conflict of interest regulations. The regulations came, of course, in the wake of Fauber’s investigative reporting on the subject.

The newspaper’s lawsuit argued that the faculty comments were public records under Wisconsin law and sought a court order to obtain them. To settle the lawsuit, the newspaper agreed to accept the 41 e-mails with the names of the doctors blacked out. The foundation also provided a separate list with the names of the 28 doctors who wrote the e-mails.

The (UW Medical Foundation) also agreed to pay the newspaper’s attorneys’ fees of about $12,400.

The e-mails make for good reading, and Fauber wastes no time in deploying the liveliest phrases in his story.

For example, some physicians complained about the 18-month exemption for orthopedic surgeons and other implanters of medical devices, including one who said “Allowing our docs to shill for device companies is a complete perversion.” An orthopedic surgeon responded with a different take, saying it was “clearly ridiculous” to limit his hourly take from device makers to just $500.

For an explanation from Fauber on how he has been able to consistently produce groundbreaking stories on the conflict-of-interest beat, see the article he wrote for AHCJ.

APA’s new policy seeks collaboration with pharma

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The Wall Street Journal‘s Shirley Wang looked beyond the American Psychiatric Association’s new conflict of interest guidelines to explore what the APA’s loosening of ties with major pharmaceutical manufacturers meant for their business model and future. The APA has lost 10 percent of its revenue – about $7.5 million – over the past year as pharma is spending less on advertising in their journals and sponsored symposia have been phased out of the APA annual meeting. That last move, Wang found, cost the organization about $2 million.

In an interesting twist, Wang says that while some of the decline in pharma advertising can be attributed to the recession and APA’s attention to COI, some of it comes “because the industry faces its own pressures to avoid potential conflicts of interest.” Overall, pharma’s ad spending in health care publications has slipped from $865 million in 2005 to $626 million in 2009.

Reactions to these tightening regulations and budgets among APA membership has been mixed, as Wang illustrates:

At the annual conference in 2008 in Washington, D.C., Dr. Scully recalled meeting a group of young residents and medical students at the bottom of an escalator who wanted to “express their outrage” at the industry influence at the meeting. At the top of the escalator ride, he encountered another group of doctors upset that there weren’t enough seats in the industry-sponsored symposia. “A number of members liked those [symposia] and they liked that they got fed,” said Dr. Scully.

In an accompanying blog post, Wang writes that the APA hopes its new guidelines will increase transparency, decrease conflict and still maintain a good, cooperative relationship with the pharmaceutical industry.

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COI policy change has medical associations talking

COI policy change has medical associations talking

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

A policy intended to reduce conflicts of interest in continuing medical education will take effect at the American Heart Association’s annual Scientific Sessions in November: Pharmaceutical industry employees will not be allowed to make medical education presentations at the event.

John Fauber of the Milwaukee Journal Sentinel reports the change comes as the result of  “a relatively new interpretation on a policy of the Accreditation Council for Continuing Medical Education, the national body that accredits medical education courses.” Such presentations can be used to boost the marketing of new drugs, according to James Stein, a cardiologist and professor at the University of Wisconsin School of Medicine and Public Health.

Clyde W. Yancy, president of the American Heart Association, explains the new policy.

Clyde W. Yancy, president of the American Heart Association, explains the new policy.

The policy came up at a meeting at the National Institutes of Health last week, where Keith Yamamoto, executive vice dean of the University of California, San Francisco, School of Medicine, called it “bloodcurdling.”

Fauber quotes people on both sides of the issue, including a former editors of JAMA and NEJM, as well as critics of industry funding of medical education.

Clyde W. Yancy, M.D., president of the AHA, was at the NIH meeting and expressed “consternation” about the policy and was hoping to get support from others in the room to appeal the ACCME’s decision. He points out that the AHA’s event is the first major medical meeting at which these policies will be in place but that other organizations will have to deal with the changes to remain accredited by the ACCME.

Video of the meeting is online and the relevant proceedings start at about the 108 minute mark. It’s well worth watching to see the reactions in the room.

Reports: Clinical trial oversight lacking

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

ProPublica’s Alexandra Andrews reviewed two recent reports on conflicts of interest in the institutional review boards tasked with overseeing clinical trials and found that these boards may not be as independent as the public might like.

Board members “frequently” had connections with drug companies that can cause conflicts of interest, and while IRB chairs said they’d never presided over a session in which a conflicted member had voted, only 65 percent of surveyed members said they recused themselves every time a conflict came up. One third of surveyed IRB’s don’t even require members to disclose conflicts of interest, Andrews reported.

Sen. Chuck Grassley (R-IA), who has been a prominent advocate for the disclosure of doctor-industry ties, told ProPublica, “People have to trust that decisions about clinical trials are unbiased, and this study calls that into question. Lack of disclosure of financial ties can damage confidence in important medical research. Disclosure policies ought to be established and enforced to safeguard the integrity of that research because of its tremendous influence on the practice of medicine and public health.”

Even more alarming was a recent GAO release detailing the lack of barriers to the creation of for-profit IRBs.

GAO investigators created phony IRBs [7] (PDF), which they were successfully able to register with HHS using no more than an online registration form. One such company listed its address as “1234 Phulovit Lane” in “Chetesville, AZ” with employees named “April Phuls, Timothy Wittless, (and) Alan Ruse.” (You can still find its deactivated listing [8] on HHS’s Web site.)

Subsequent oversight wasn’t any better.

HHS then approved an assurance [9] for a bogus medical device company, also created by GAO, which listed one of GAO’s fake IRBs on its application. An assurance basically promises that the company will adhere to federal standards and, once approved, paves the way for that company to request federal research funds. According to GAO, “By approving our assurance application, HHS essentially deemed our bogus IRB as adequate to oversee human subjects research.”

And it almost sounds like some actual IRB’s weren’t much better than the one run by April Phuls and Alan Ruse.

GAO’s pièce de résistance was a sting operation involving real IRBs. GAO’s medical device company sent out plans for a fake trial to three real IRBs. Two of them responded with cries of “awful,” “a piece of junk” and the “riskiest thing I’ve ever seen on this board.” But the third IRB, now identified as Colorado-based Coast IRB, found it “probably pretty safe” and voted unanimously to approve it.

In HHS’ defense, at a hearing, Jerry Menikoff, director of the Office for Human Research Protections, which oversees IRBs along with the Food and Drug Administration, said “by registering an IRB, the government, the federal government is in no way endorsing that IRB or in any way saying that that IRB meets any standards.”