Disclosure

Harvard students demand pharma disclosures

Tracy Staton — Fri, 21 Nov 2008 11:40:59 -0500

While we're talking potential conflicts of interest, here's a story from the younger generation. Medical students from Harvard, Tufts and Boston universities rallied at Harvard Medical School in support of a comprehensive anti-conflict policy covering not only the classroom but also all affiliated teaching hospitals. The protestors delivered a 200-signature petition to the Dean's office, saying that students have been fighting for such a policy for six years.

"We really view this issue as something that is key to the integrity of medical education at Harvard," David C. Tian, a first-year student, told The Harvard Crimson. Tian recently pushed the administration to adopt a policy addition mandating that faculty and students disclose financial ties to pharmaceutical companies when discussing drugs developed by those companies in the classroom, the paper reported.

Administrators told the Crimson that they're taking the student demands seriously. One difficulty lies in the fact that Harvard doesn't own its teaching hospitals as many med schools do; instead, there are 15 affiliated institutions owned and operated by non-profits. Harvard can't force those hospitals to adopt specific policies, officials said. But Yale, which also does not own its affiliated hospitals, has a comprehensive conflict of interest policy. Harvard Medical School Dean Jeff Flier has promised that the issue will be part of a university-wide policy review this fall, so stay tuned.

- see the Crimson article

NPR doc didn't disclose pharma payments

Tracy Staton — Fri, 21 Nov 2008 11:25:53 -0500

We've heard about drugmaker's payments and grants to prescribing doctors, researchers, medical societies, teaching hospitals, CME companies... and now, a radio host. The psychiatrist and former NIMH director Dr. Frederick K. Goodwin (photo), whose radio program "The Infinite Mind" airs on NPR, collected some $1.3 million from drugmakers between 2000 and 2007. Goodwin never mentioned those payments to listeners, despite the fact that some of his programs dealt with subjects "important to the commercial interests of the companies for which he consults," the New York Times reports.

The payments have come to light as part of a Congressional investigation into drugmakers' potential influence on prescribing habits. For instance, Goodwin told listeners that children with untreated bipolar disorder could suffer brain damage (a view not universally shared in psychiatry). During the same program, Goodwin touted the safety and efficacy of treatments for the disease, particularly mood stabilizing drugs. And the same day, GlaxoSmithKline paid the psychiatrist $2,500 to give a promotional lecture for its mood stabilizer Lamictal, just part of the $329,000 he collected for promoting Lamictal that year, Congressional records show.

Goodwin told the NYT that the radio show's producer knew about his consulting with drugmakers, but that neither he nor the producer realized at the time that they should have disclosed the relationships. "In retrospect, that should have been disclosed," Goodwin told the paper. But the NPR producer told the paper that Goodwin had denied getting money from drugmakers. "The fact that he was out on the stump for pharmaceutical companies was not something we were aware of. It would have violated our agreements," producer Bill Lichtenstein said in an interview.

NPR now says it's pulling the program as soon as possible and that, had it been aware of Goodwin's financial relationships, it would not have aired "The Infinite Mind." A Glaxo spokesperson said that the responsibility for disclosing its payments to Goodwin lay with the doctor. "We continue to believe that healthcare professionals are responsible for making disclosures to their employers and other entities, in this case National Public Radio and its listeners."

- read the NYT story

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GSK will cap payments to docs

Tracy Staton — Thu, 23 Oct 2008 11:15:52 -0400

GlaxoSmithKline is joining the queue of drugmakers that will unveil payments to doctors. The drugmaker said it will report the fees it pays to doctors and medical researchers. Plus, the company plans to cap payments to U.S. physicians and academics at $150,000 annually. CEO Andrew Witty (photo) told the Financial Times that the cap will be "without exception" and that all fees that change hands will be published.

As you know, there's been a groundswell of concern about Big Pharma's financial relationships with doctors and researchers. Congressional reps and patient advocates alike have been pushing for greater transparency about the amount of money drugmakers are shelling out. Anticipating federal legislation that would mandate disclosure, companies such as Eli Lilly and Merck have pledged to cough up the information voluntarily.

"It's appropriate that we have a limit on what we pay," Witty told the FT. "In the past, whatever has happened has happened, but in the future there will be strict adherence to these caps, which will be clearer to everybody."

- read the scoop in the FT
- see the Health Blog post

NIH slaps Emory with new grant rules

Tracy Staton — Tue, 14 Oct 2008 10:09:01 -0400

Sen. Chuck Grassley will be glad to hear NIH cracking down on Emory University's research funding. Last week, Grassley dropped the bombshell that Emory's psychiatry department head had failed to report more than $1 million in payments from drugmakers, including money from GlaxoSmithKline that Charles Nemeroff received while researching Glaxo meds. Grassley's committee is investigating those payments--and alleges that Emory failed to take action even after an internal probe into Nemeroff's payments.

Well, Emory is certainly taking action now. As you know, Nemeroff stepped down as department chair last week, after the funding news hit. The university also notified professors to let the sun shine on every aspect of their research projects, funding, and potential conflicts of interest. Unfortunately, the latter wasn't Emory's idea: In a memo sent to research faculty, and obtained by Pharmalot, an Emory VP outlined "special award conditions" that now apply to every application for funding from the NIH.

"The NIH Institute or Center from whom funding has been sought will not issue an award until the institutional assurance and relevant information has been received," the memo states. What's more, the university won't even submit the applications "until disclosures have been received for every Investigator participating in the study." Sounds a bit like closing the barn door after the horse has escaped, but we suppose it's better late than never.

- read the news at Pharmalot

Emory doc hid $1.2M in pharma payments

Tracy Staton — Mon, 06 Oct 2008 11:22:14 -0400

Here's yet another exhibit in the ongoing case for public disclosure of drugmakers' payments to doctors. One of the top psychiatrists in the U.S. failed to report $1.2 million in pharma consulting payments to his university, a Congressional investigation found. Dr. Charles B. Nemeroff of Emory University made some $2.8 million from drug company work from 2000 to 2007, the New York Times reports, and hid almost half of that income from administrators.

In one telling example, Nemeroff signed a promise to Emory that he would earn less than $10,000 a year from GlaxoSmithKline, to comply with federal research-funding rules. But that very day, he was at Four Seasons in Jackson Hole, earning $3,000 of the $170,000 he'd end up collecting from GSK that year.

The revelations come in an investigation spearheaded by Sen. Charles Grassley, whose Senate committee has been probing pharma-slash-physician financial relationships. “After questioning about 20 doctors and research institutions, it looks like problems with transparency are everywhere,” Grassley told the New York Times. “The current system for tracking financial relationships isn’t working.”

The Nemeroff case apparently adds ammo to Grassley's push for federally mandated disclosure of pharma's payments to doctors. And Grassley's revelations about the Emory doc have prompted immediate university action: Nemeroff has stepped down as chairman of the psych department, "pending resolution" of the allegations. For his part, Nemeroff says he thought he was in compliance with the rules and pledges to work with investigators.

- see the story in the New York Times
- read the item at Nature's blog

Eli Lilly makes transparency vow

Christe Bruderlin-Nelson — Wed, 24 Sep 2008 04:11:53 -0400

With all the talk about big pharma paying physicians for this or that, Eli Lilly is taking on the role of industry forerunner. In a proactive move, the pharma giant says it will start to become transparent about just how much cash it doles out to physicians and for what purpose.

Perhaps with more and more members of Congress setting a disclosure bill in motion, Lilly decided to come face to face with what might be inevitable. Regardless of what happens, it's a decent PR move and pharma companies definitely need good PR these days.

Specifically, Lilly will disclose how much it pays individual physicals for advisory roles, speeches and other services, as long as the payments are more than $500. The listing will be on a public database. However, Lilly will not be disclosing payments to physicians for travel, gifts and entertainment at this time.

- here's Lilly's release
- read the Associated Press story

Sen. Grassley: No disclosure, no NIH money

Tracy Staton — Thu, 11 Sep 2008 10:55:12 -0400

Sen. Charles Grassley is at it again. The perennial pharma critic has been knocking university researchers who don't fully disclose their ties to the drug industry--and pushing the National Institutes of Health to police that disclosure. Now Grassley is spurring universities themselves to hand over the info. The Senate Finance Committee sent letters to 20 institutions asking for potential conflicts of interest with drugmakers.

Adding urgency to that call for information was Grassley's own disclosure that a University of Texas researcher hadn't reported $150,000 in speaking fees from GlaxoSmithKline. That researcher, Karen Wagner, had worked on NIH-funded studies of GSK's antidepressant Paxil.

Meanwhile, NIH director Dr. Elias Zerhouni met yesterday with Grassley's committee staff; presumably they hashed over Grassley's calls for NIH to yank funding from universities that don't disclose all payments from pharma. "Starting today, the NIH could send a signal that business as usual is over," Grassley told the Wall Street Journal. "The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure."

- read the Wall Street Journal story
- check out the article in the Washington Post

Pharma fights Mass. disclosure bill

Tracy Staton — Fri, 08 Aug 2008 10:09:48 -0400

Drugmakers are kicking back at a Massachusetts marketing-and-disclosure bill that we reported on a few days ago. The outright ban on gifts to docs didn't make it into the compromise measure, but pharma isn't happy nonetheless. The bill would require disclosure of any payment or gift of $50 or more--and companies are saying that handing over that info would have a "chilling effect" on life sciences in the state.

How so? Well, PhRMA is pointing to language in the bill requiring disclosure of the "nature and purpose" of every doc payment. The industry association says that could be construed to mean that clinical trial data would have to be an open book if docs were paid to be part of those trials. We think that's stretching a bit--maybe to scare the governor into vetoing the bill?--but then again, we aren't lawyers.

- read the post at Pharmalot

FDA advisors face conflict cap

Tracy Staton — Tue, 05 Aug 2008 10:04:08 -0400

The FDA is tightening up its conflict-of-interest rules for those expert advisory panels that often get involved in the most contentious drug safety decisions (and approvals, too). For years, consumer advocates and others have argued that panel members shouldn't have any financial conflicts. Arguing back, the agency would say that limiting committees to experts without conflicts would exclude many if not most top docs and researchers.

But now FDA has given in--at least a little. If an expert or anyone else in his immediate family has financial conflicts of more than $50,000, he can't participate in that meeting. Also, four specific kinds of conflicts won't be allowed, period. And any conflict waivers--required for people with less than $50,000 at stake and without those four disqualifiers--would have to be absolutely necessary for the committee to have "essential expertise."

Already some are saying that $50,000 is too high a threshold--but FDA types said they're pushing to find advisers with "minimal or no conflicts." We'll see how that effort plays out.

- see the FDA release
- read the post at Pharmalot
- check out the Wall Street Journal Health Blog's item

Harvard docs fail to report drug money

Tracy Staton — Mon, 09 Jun 2008 10:28:24 -0400

More proof that the cover-up causes more damage than the deed itself: Three Harvard researchers are under fire today for failing to disclose thousands in payments from drug companies. One of the three, Dr. Joseph Biederman, is a world-renowned child psychiatrist whose work helped touch off an explosion in the use of antipsychotics in children. He collected at least $1.6 million in consulting fees from drugmakers from 2000 to 2007, but didn't report much of his income to university officials as required by the school and by the National Institutes of Health, according to documents given to Congressional investigators.

Two reasons why this isn't just another story about doctors messing up their paperwork: One, if the NIH's newly launched investigation of the matter shows that Biederman and his colleagues ran afoul of disclosure rules, that could put millions in grants at risk. Two, because the non-disclosure was uncovered by Sen. Charles Grassley--and publicized by the same--it could further fuel Congress's attempts to regulate doc disclosure. And there's no guarantee that the sunshine legislation will end up in the pharma-approved form it's now taken.

- read the article in the New York Times

Doc disclosure gets boost from AZ, Merck

Tracy Staton — Fri, 23 May 2008 09:58:51 -0400

Drugmakers are climbing on the disclosure bandwagon. AstraZeneca and Merck have come out in favor of a bill requiring pharma and device-makers to report their payments to doctors, joining Eli Lilly, which gave the legislation a thumbs-up last week. Trade associations PhRMA (drugs) and Advamed (devices) have also expressed support.

The outpouring of support began after the bill's sponsors--Sen. Chuck Grassley and Sen. Herb Kohl--bumped up the minimum disclosure amount to $500 from $25. It also helped that they added language specifically preempting state disclosure rules--now in force in Vermont and Minnesota, and on the drawing board elsewhere.

Interestingly, Schering-Plough isn't among those backing the bill. In fact, the company expressly denied its support in a letter to the sponsors. The reason? That information might undermine the relationship between patients and doctors, the company says. We'll see if it changes its tune: The letter said execs "remain open to new information or points of view."

- check out the release from the Senate Special Committee on Aging
- read the item at the WSJ Health Blog
- see Pharmalot's take

U.K. pharma intensifies self-policing rules

Fri, 09 May 2008 06:59:55 -0400

U.S. lawmakers aren't the only ones toughening up on pharma. In the U.K., the industry itself is strengthening its code. The Association of the British Pharmaceutical Industry is adding rules on disclosure--of support for patient organizations, of sponsorships, of donations and grants to institutions that support healthcare and research--and on reporting side effects. Promo materials must "prominently" state that "adverse events should be reported" and offer contact information for those reports. And all clinical trials have to be made public; hiding data would be a violation of the rules. The new code will come into effect July 1.

- read the release from ABPI
- see the Financial Times article
- check out the item at PharmaGossip

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Congress probes med device payments

Wed, 27 Feb 2008 06:59:54 -0500

Should device makers retain surgeons as consultants? That's what the Senate Special Committee on Aging plans to discuss today at a hearing over some $221 million in payments five companies made to docs in 2007.

The companies--Zimmer Holdings, Biomet, Stryker, Smith & Nephew, and Johnson & Johnson's DePuy Orthopaedics--agreed to disclose those payments in September to settle government allegations that they violated anti-kickback laws. Four of the companies agreed to pay $310 million to settle kickback claims.

Sen. Herb Kohl, chair of the Senate committee, has proposed legislation that would mandate disclosure of the consulting payments.

- read the story in the Wall Street Journal

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Device makers divulge doc payments

Thu, 01 Nov 2007 07:59:57 -0400

Ever wonder how much orthopedic device makers are shelling out to so-called consultants? You're in luck. The five big implant companies have posted the figures to their websites. And the big news is that 47 docs or hospitals netted more than $1 million each. Almost half of them--21 to be exact--got their big checks from Zimmer Holdings. Massachusetts General Hospital netted a whopping $8.67 million.

The other companies that disclosed the info are Stryker, Johnson & Johnson subsidiary DePuy, Smith & Nephew, and Biomet. They did so under a deal with the U.S. Justice Department, which had been investigating financial relationships between the companies and surgeons. And these four handed out some big bucks, too; J&J's largest payment was around $6.75 million, and Stryker's was about $3.05 million.

- read Stryker's payment disclosure here
- read Smith & Nephew's disclosure here
- see Biomet's list
- read the report from CNN Money

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No freebies? No entry for pharma reps

Fri, 12 Oct 2007 06:59:58 -0400

Is this the shape of things to come? Two years after the state of Minnesota prohibited doctors from accepting more than $50 worth of food or gifts per year, pharma sales reps are having a tough time reaching them. Hospitals and clinics are banning routine visits, and doctors are turning away sales reps at twice the rate as doctors in other states.

The $50 limit doesn't apply to consulting fees, but drug makers do have to report those payments. Several other states also require disclosure of those fees, but none limits free food and tchotchkes--yet. New Jersey's attorney general has said she's considering it, and with so much attention on links between drug makers and physicians these days, other states may not be far behind.

- read the report from the New York Times

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Pharma faces payment disclosure law

Fri, 07 Sep 2007 06:59:58 -0400

Senator Charles Grassley said he would, and now he has: The Republican introduced a bill Thursday that would require drug and medical device makers to report almost every cent they pay to doctors. Each payment of more than $25 would have to be disclosed quarterly, and the data would be posted on a government website.

For several months now, news reports and Congressional hearings have been questioning the flow of dollars from drug makers to doctors--everything from free meals to speaking fees to consulting payments. Some doctors have reaped hundreds of thousands a year in such gifts or fees-for-services. The natural follow-up question--does it change doctors' behavior when they pick up their prescription pads?--has prompted much defensive denial, but it's also inspired fears of unnecessarily costly scrips and even patient harm.

Anticipating the outcry from pharma, Sen. Herb Kohl, the bill's co-sponsor, said that if companies have nothing to hide, then disclosure will only vindicate them. "Either way, patients win," he said.

- check out the release
- read the New York Times article

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MN panel mulls conflict-of-interest policy

Wed, 22 Aug 2007 06:59:55 -0400

What does Minnesota have that practically no other state does? A law that requires drug companies to report payments to doctors for lectures, consulting, research, and the like. What does Minnesota have that many other states might? A problem with drug makers paying members of state advisory panels that select the meds used by Medicaid patients. A doctor and a pharmacist on the state's eight-member committee each received thousands--more than $350,000 in the doctor's case--from pharmaceuticals firms for lecturing about their products.

Now, it's tough to prove a direct link between the money and the panel members' official decisions. But the state of Minnesota says it will begin screening these committee members for financial ties to the drug industry. Some other states, such as Nevada, bar panel members who have been paid by pharma companies. If the drive for disclosure of drug-doctor ties continues to grow, more states may decide to do the same.

- read the report from the Washington Post

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