Payments

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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Vermont docs received more secret payments

Christe Bruderlin-Nelson — Wed, 05 Nov 2008 10:17:01 -0500

A March 2007 article in the Journal of the American Medical Association told the story of pharma companies paying physicians in Vermont over $2.7 million between July 2002 and June 2004, but the advocacy group that reported the original findings now says the amount is actually much higher.

According to the organization Public Citizen, the payments total nearly $5 million and "strongly suggest" violations of American Medical Association and PhRMA professional guidelines, which restrict said payments to $100 per doctor, per occassion.

In fact, the group found that more than $3.2 million worth of the payments were greater than $100 each, representing nearly 90 percent of the payments to physicians by drug companies. Twenty-one drugmakers were said to have kept the payments under wraps. The companies involved included Abbott Labs, AstraZeneca, Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Merck and Roche.

- see the full story at Pharmalot

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

Emory grant aid suspended over GSK payments

Christe Bruderlin-Nelson — Wed, 15 Oct 2008 06:20:12 -0400

Suspicions over physician payments means Emory University School of Medicine will not be touching its $9.3 million NIH grant for a while.

Senator Chuck Grassley said that faculty in the medical school's psychiatry department agreed to keep consulting payments from GlaxoSmithKline to less than $10,000 each year, but failed to do so. In fact, Charles Nemeroff received $70,000 from GSK, bringing the total in payments to upwards of a half million dollars, which Nemeroff failed to report.

The grant has three years remaining, but NIH will keep it on hold until the university resolves its conflicts of interest and ensures that it's researcher physicians report payments from drug companies accurately.

It will be interesting to see which universities, researchers and drug companies Grassley picks for his next examples.

- see the Wall Street Journal blog entry

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

Lawsuit: Medtronic perks wooed docs

Tracy Staton — Thu, 25 Sep 2008 11:12:05 -0400

What do a Memphis gentlemen's club, trips to Alaska and ill-gotten patent royalties have in common? They're all perks that Medtronic gave to doctors, according to a lawsuit brought by a former Medtronic lawyer. The incentives were handed out by the company's $3 billion spinal devices unit, which has already been under investigation for its physician relationships.

As you know, Sen. Charles Grassley has been probing off-label use of Medtronic's spine products, examining whether those unapproved uses were driven by incentives given to doctors. The FDA has warned that off-label use of a Medtronic bone graft has led to potentially life-threatening side effects in dozens of patients.

The allegations were made in a lawsuit, filed in 2002 but only recently--and partially--unsealed. A heavily redacted copy of the complaint is the only version publicly available. But the Wall Street Journal got an unredacted copy, which alleged that kickbacks were "pervasive" in the spinal unit.

Medtronic says that it's changed many business practices since that lawsuit was filed. The company says it's "committed to reform and transparency in the industry."

- read the Wall Street Journal story

Merck joins Lilly in disclosure pledge

Tracy Staton — Thu, 25 Sep 2008 10:03:57 -0400

It didn't take long for other drugmakers to follow Eli Lilly's lead in promising more transparency. Before the end of the day Wednesday, Merck had announced that it would pull the veil on physician payments beginning next year. Johnson & Johnson said it plans to start disclosing funding for professional educational grants, patient-advocacy groups and other healthcare charities, also early next year. And AstraZeneca says it's reviewing its transparency policies, considering recent steps toward disclosure of CME grants as "a floor, not a ceiling" in the openness arena.

Already, Pfizer has said it would disclose CME grants, and so has Lilly. And several drugmakers--namely Merck, AZ, J&J, and Lilly -- have pledged their support to the Physician Payment Sunshine Act, which would require pharma firms and device makers to disclose the amount of money they give to doctors.

As you know, the relationships between drugmakers and doctors have been getting lots of scrutiny of late. Congress has shone a spotlight on various extreme examples of financial ties between doctors and researchers and the pharma industry. It seems like it's just a matter of time before the government forces some form of disclosure. It makes sense for drugmakers to get out in front of the legal requirement, if only for PR reasons.

- see Merck's release
- check out the New York Times article

GSK to report organization grants

Tracy Staton — Thu, 21 Aug 2008 09:43:11 -0400

Full disclosure: Getting pharma to fess up on its payments to doctors is only part of the drive for that sort of data. Some have been pushing drugmakers to tell how much they're giving to health-related organizations, too. Now, GlaxoSmithKline has announced that it will report its grants to U.S. hospitals, CME companies, patient advocacy groups, professional associations and the like. The reports will come quarterly beginning in February 2009.

GSK's move comes at a time when payments of all sorts are coming under increased scrutiny. Everything from academic research support to doctor speaking fees is coming under the microscope, not only in the media, but in Congressional hearings and in some professional-association research. So drugmakers are taking steps--slowly but surely--toward increased transparency. Criticism of industry-funded CME prompted Pfizer, for instance, to stop paying for any courses offered by for-profit CME companies. Look for more pharma firms to make similar pledges as the year goes on.

--see GlaxoSmithKline's release
--Vote: Should drug and medical device makers be required to report payments made to doctors?

Americans want doc payments disclosed

Tracy Staton — Mon, 23 Jun 2008 11:03:12 -0400

Apparently, it's not just a few activist Congressional reps who want doctors to fess up to payments from pharmaceutical companies. A new poll found that Americans want to know whether their physicians are getting gifts or payments from drugmakers. The Prescription Project's survey showed that more than half of respondents thought they should know their doctors' relationships with pharma, but only a third said they'd be willing to ask directly.

Hence the move toward mandating disclosure, one version of which is making its way through the Senate as we speak. This survey showed that the public supports mandatory disclosure--by a margin of 2 to 1. That's not surprising, considering that half of the respondents believe doctors' prescribing habits are influenced by pharma gifts and payments.

- read the item at the Boston Globe
- check out the Pharmalot post

Feds probe Medtronic payments to docs

Wed, 05 Dec 2007 06:59:55 -0500

The feds are investigating payments Medtronic made to doctors, hospitals, and others that use its heart devices and stents. According to a filing with the Securities and Exchange Commission, a U.S. Attorney's Office in Pennsylvania has asked the company for details on both cash and in-kind payments. This particular U.S. Attorney, Patrick Meehan, has previously prosecuted healthcare fraud cases involving pharma companies and benefits managers.

Earlier this year, Sen. Charles Grassley asked for information on Medtronic's payments to orthopedic surgeons. Grassley has introduced a bill that would require device and drug makers to disclose payments they make to doctors.

The company has said it pays doctors for help developing new products and for training other doctors to use them. A spokeswoman wouldn't comment on this particular investigation.

- see Medtronic's SEC filing (information on this investigation is under Legal Proceedings)
- check out this report from the St. Paul Pioneer Press

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

ALSO: Should drug and medical device makers be made to to report payments made to doctors? Poll

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