Drug And Device Makers To Disclose Grants
6 CommentsBy Ed Silverman // April 11th, 2008 // 9:48 am
File this under ‘Say Uncle.’ A dozen drug and device makers have told Chuck Grassley, the Iowa Republican, that they have plans or are working on plans to publicly disclose grants to outside groups, and the details will be provided on each company’s Web sites, the Associated Press reports. In particular, Grassley is interested in money spent on continuing medical education.
Recently, Grassley asked 15 companies whether they planned to do what Lilly does, which is disclose its grants to such programs. And the responses are in. They are wide-ranging and sometimes vague, but mostly what the senator wanted to hear - many say they will go beyond disclosing CME grants and will also disclose payments to patients advocacy groups such as the American Heart Association or the American Diabetes Association. Boston Scientific is developing a system that even discloses certain payments to docs. Here is the list of responses.
Watchdog groups, not surprisingly, say the companies are trying to head off legislation that would require public disclosure of their giving. “If they were doing this out of the goodness of their heart, they would have done so decades ago,” Peter Lurie of the consumer group Public Citizen tells the AP. “If your company does not yet have any efforts or plans in place, please explain why not,” Grassley wrote.
Shering-Plough, however, wins the Tin Ear award. The drugmaker, which has been harshly criticized for its handling of Vytorin clinical trial data, tells Grassley that “we do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us.”
The hip-and-knee industry was the subject of a recent Senate Aging Committee hearing titled “Surgeons for Sale,” the AP notes. Device makers often paid docs $5,000 every three months for providing info on market trends and operating-room activity. However, the reports typically offered only cursory descriptions and often were duplicated from one quarter to the next. Also, companies sponsored consultant meetings at resort locations. The meetings lasted just a few hours each day. The docs who presented information at the meetings spoke for as little as 10 minutes.
“Although the remainder of the day was available for recreational activities paid for by the company, the consultants were compensated $5,000 for a full day of work,” Greg Demske, an assistant inspector general, tells the AP.
Lilly began listing its grants last year and gave $18.9 million in the second quarter of 2007, according to the Prescription Policy Project, which promotes policies to reduce conflicts of interest, the AP explains
If all of the companies follow through with their commitments to Grassley, there also would be widespread disclosure of how much money they give patient advocacy groups. The groups rely on industry for much of their financing, the AP notes. For example, the American Heart Association said donations from drug and device makers comprise about 6 percent of its annual income, and totaled $48.3 million in the organization’s latest fiscal year.
“Donations from corporations, including the pharmaceutical and device industry, allow us to further enhance our programs and outreach, and to bring objective science and the highest quality of public education and information to more people,” Maggie Francis, the association’s communications manager, tells the AP.
Grassley and Herb Kohl, a Wisconsin Democrat, have introduced legislation that would require drug and device makers to disclose anything of value given to physicians, such as payments, gifts or travel. The disclosure of medical education grants is an extension of that concept. Last year, the staff for the Senate Finance Committee issued a report saying pharma may be using the “medical education industry to deliver favorable messages about off-label uses that the drug companies cannot legally deliver on their own.”
The committee report noted that Warner-Lambert, now owned by Pfizer, paid $430 million to settle claims that medical conferences it sponsored were used to illegally promote off-label uses of the anti-seizure drug Neurontin. Serono-Laboratories paid $704 million to settle a similar claim concerning the AIDS drug Serostim.
This is a summary of the responses filed by the drug and device makers:
- AstraZeneca will make available, beginning Aug. 1, the names of academic institutions, hospitals and medical education companies getting grants, the amounts and the purpose;
- Bristol-MyersSquibb will begin making “the information you refer to in your letter” available in the first quarter of 2009;
- Johnson & Johnson expects by the end of the first quarter of 2009 to disclose “financial relationships with medical professional societies and healthcare-related charities;”
- Medtronic, starting May 1, will post “donations to customers or organizations affiliated with customers (this will include patient groups and medical societies);”
- Pfizer intends, beginning in 2008, to report grants for medical education and to patient groups “under the condition that the recipient consents to public disclosure;”
- Abbott Labs “respects the principles of transparency that you outline.” Working on how data might be compiled and displayed;
- Amgen “is working diligently to determine exactly how to achieve this objective in the most timely and efficient manner;”
- Boston Scientific in mid-2007 commenced a project to “develop the systems necessary for disclosure of payments to physicians, institutions, patient organizations and medical societies;”
- Merck “will implement a system through which the public can learn about grants Merck makes to the type of health care organizations referenced in your letter;”
- Zimmer Holdings must already disclose under a deferred prosecution agreement detailed payments to certain health care professionals;
- Stryker, as part of a non-prosecution agreement, already has agreed to disclose “payments made to both physicians and medical organizations;”
- St. Jude Medical believes that each individual drug and device company designing its own reporting mechanism may not be the best approach to providing meaningful information to patients. Rather, it would support “uniform reporting guidelines covering what should be disclosed, how and when;”
- Wyeth is “open to the concept of releasing additional information, but we have some reservations about the potential unintended consequences for patients that might result if this initiative is implemented.” Would like to further discuss issues raised in letter;
- Baxter International “can support a comprehensive federal standard for disclosure.”
- Schering-Plough writes that “we do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us.”
Dan
Aren’t grants just one of the many methods of big pharma’s output financially, though?
BWP MD
In my experience, Big Pharma will never come clean on their activities in this area because they fear the PR nightmare that will occur. The heavy graft occurred between 2000-2006 and several companies have been backing off from their conflicted ways for the past two years after the governemnet started asking questions about grants.
Not surprisingly, it seems that Schering-Plough is the most reluctant to cooperate. Apparently, they have the most to hide and be concerned about. What a shocker given their recent history!
Casual Observer
It sounds like Schering-Plough is quite against this effort. I wonder what the implications for them might be? Are they tipping off the government that there may be a problem there by refusing to even entertain cooperation? They are the only ones to express such resistance. If they were smart, they could have faked a willingness to comply and delayed for a year. They seem to have mastered “delaying.”
Justice in Michigan
Lots of wiggle room suggested by several of the responses. I agree with Peter Lurie - it should either be mandated or forgotten about.
I found Pfizer response interesting re: the recipients and public disclosure. As I recall, this was one of the reasons it was hard to get particulars when the Women in Government/Gardasil/Merck links first came up. Based on my own review, most advocacy groups do not publicly disclose.
Bob Freeman
I agree with Justice that it would be preferable to mandate disclosure. In addition to any PR fall-out, voluntary disclosure and the different ways companies will report expenditures means, in effect, that companies which are open will suffer from a competitive disadvantage to those companies that do not. These types of spending are competitive strategies and, as such, companies are loathe to put themselves at a disadvantage.
Truth in 2008
Why do you think some have to wait until 1st Q. 2009 to disclose? It is because most of the grants will expire by that date? The information should have to include the last 5 years of grant making. They’ll scurry around and get grants off the books by the time they have to disclose. Any annual report of a reputable company lists the total dollar amounts given in grants. You can’t come up with a total without the individual grants so they HAVE the information. Thank God for Grassley. Do you think they’ll follow through with prosecuting some of these pharma moguls? When drug companies pay grants for laws that directly impact their bottom line, they should be prosecuted under the RICO act.