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Pharma Companies Agree to Sunshine Act: disclosing doctor payments, grants
 
 
  The Sunshine Act requires drug and device manufacturers to disclose to the Secretary of Health and Human Services (HHS), on a quarterly basis, anything of value given to physicians, such as payments, gifts, honoraria, or travel. It only applies to companies with annual revenues over $100 million. The Act was sponsored by Senators Charles Grassley (Republican-Iowa) and Herbert Kohl (Democrat-Wisconsin) to create a single, national system for the reporting of information.
 
Merck Joins Other Pharma Companies in Agreeing to Subscribe to Sunshine Act
 
http://www.pharmalot.com
 
Over the past few months, one drugmaker after another has promised - in varying degrees - to disclose info about payments to docs and campaign contributions, publish more clinical trial data or end support of third-party continuing medical education.
 
Two days ago, Lilly promised to reveal payments to docs and touted its clinical trial registry (back story here, here and here). Glaxo vowed to disclose educational and charitable grants, as did Pfizer, which is also ending support for third-party CME. And AstraZeneca is disclosing political donations, grants to medical education and contributions to non-profits.
 
Today, Merck has joined the party. The drugmaker issued a statement saying next month, grants to patient groups, professional medical societies and other organizations will be posted on its web site. Next year, payments to docs who serve as speakers will also be posted. Also next month, Merck will post study results on the ClinicalTrials.gov site.
 
Merck & Other Drug Makers to Report Fees to Doctors
 
The Sunshine Act requires drug and device manufacturers to disclose to the Secretary of Health and Human Services (HHS), on a quarterly basis, anything of value given to physicians, such as payments, gifts, honoraria, or travel. It only applies to companies with annual revenues over $100 million. The Act was sponsored by Senators Charles Grassley (Republican-Iowa) and Herbert Kohl (Democrat-Wisconsin) to create a single, national system for the reporting of information.
 
NY Times
By BENEDICT CAREY
Published: September 24, 2008
 
Amid a national debate over the influence of industry money on medical research and practice, two pharmaceutical giants say they will begin publicly reporting payments they make to outside doctors.
 
John C. Lechleiter, chief executive of Eli Lilly & Company, announced on Wednesday that starting next year it intended to post in an online database all its payments to doctors for speaking and consulting services. The postings will "likely include" the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments, the company said.
 
In the wake of Lilly's announcement, Merck & Company said later Wednesday that it would disclose speaking fees it pays to doctors, also beginning in 2009.
 
Members of Congress have been pushing for a national registry of such payments. In the last year and a half, Senate investigations have found that prominent researchers at several institutions, including Harvard and the University of Cincinnati, failed to report millions of dollars in outside income from drug makers, contrary to the institutions' reporting requirements.
 
University administrators and journal editors say they have no reliable way to verify doctors' private income from industry. Research has found that industry money can bias doctors' interpretation of study findings and may alter their prescribing habits.
 
A bipartisan bill called the Physician Payments Sunshine Act, expected to be taken up by Congress next year, would require such a registry. The Pharmaceutical Research and Manufacturers of America, the industry's principal trade group, supports the legislation, as do the American Medical Association and a number of major drug makers.
 
"Though we remain hopeful that the Sunshine Act will be passed by Congress at some point, Lilly is taking action independently," Dr. Lechleiter said Wednesday in a speech to the Economic Club of Indiana. "Being more transparent by opening up our business to the public is an important step to building trust and confidence."
 
A Lilly spokesman said the company hoped others would follow its lead, a wish voiced by some independent experts.
 
"This is a good step, and one that should be emulated by other companies, even in the absence of legislation requiring it," Dr. Paul S. Appelbaum, a professor of psychiatry, medicine and law at Columbia University and the New York State Psychiatric Institute, said in an e-mail message.
 
Dr. Appelbaum said the simplest way to achieve comprehensive disclosure was for the industry itself to maintain public records. "Any physician who believes that disclosure is likely to be embarrassing," he said, "should not be accepting the money in the first place."
 
As of late Wednesday, Merck was the only other drug company to have joined Lilly in announcing plans for disclosure of such payments.
 
A spokesman for Johnson & Johnson said on Tuesday that the company supported a revised version of the Sunshine Act and had committed to disclosing payments for educational grants and to patient-advocacy organizations by early 2009.
 
A spokesman for AstraZeneca said that it already posted educational grants and contributions to nonprofits but that it had not made a decision "on other areas just yet."
 
A spokesman for Pfizer said it supported the Sunshine Act.
 
Lilly was the first drug maker to publish extensive clinical trial data online, beginning in 2004, and last year it began posting its educational grants and charitable contributions online. Its new database will record all payments it makes to doctors on or after next Jan. 1, and will be accessible online in June or July. If Congress passes a law requiring such reporting, the information will be brought into line with federal guidelines, the company said.
 
Through a spokeswoman, Senator Charles E. Grassley, Republican of Iowa, who has been leading the investigations into drug companies' payment practices, said: "Disclosing information about financial relationships between industry and doctors is a good thing, and this announcement contributes to transparency. My effort for broad-based transparency and accountability will continue because a uniform reporting requirement is needed to get the full picture."
 
Drug companies' payments to doctors generally fall into one of two broad categories: speaking fees, to doctors who give presentations about products to other doctors, very often while the group dines at the company's expense; and consulting fees, to experts who advise the company on new product development or help design clinical trials.
 
Commercial arrangements are common throughout medicine. In the last two decades, drug and device makers have made payments to tens of thousands of doctors and researchers in all specialties. Worried that this money could taint doctors' research plans or clinical judgment, government agencies, medical journals and universities have been looking more closely at the deals.
 
Minnesota and Vermont are among the few states that have been keeping a record of those payments. From 1997, when Minnesota began its database, to 2005, drug makers made payments to more than 5,500 doctors, nurses and other health care providers in the state, totaling at least $57 million, the state found. An additional $40 million went to clinics, research centers and other organizations. More than 20 percent of the state's licensed physicians received money.
 
Vermont reported last year that from July 2005 to June 2006, 81 drug manufacturers spent a total of $2.25 million on "fees, travel expenses and other direct payments to Vermont physicians, hospitals, universities and others for the purpose of marketing their products."
 
Merck Follows Lilly, Announces It Will Disclose Speaking Fees to Physicians [Sep 25, 2008] Kaiser
 
Merck on Wednesday afternoon followed up Eli Lilly's morning announcement that Merck would start disclosing all fees paid to physicians for consulting and speaking in an online database by announcing that it would disclose the speaking fees it pays to physicians, the New York Times reports.
 
According to the Times, the announcements come as lawmakers have begun pushing for the bipartisan Physician Payments Sunshine Act (HR 5605, S 2029), which would require such a registry. The Times reports that Senate investigations found prominent researchers at several institutions failed to report millions of dollars in outside income from pharmaceutical companies, contrary to the institutions' reporting policies.
 
Sen. Chuck Grassley (R-Iowa), who led the Senate investigations, through a spokesperson said, "Disclosing information about financial relationships between industry and doctors is a good thing, and this announcement contributes to transparency." He added, "My effort for broad-based transparency and accountability will continue because a uniform reporting requirement is needed to get the full picture."
 
Following the Leader
A Lilly spokesperson on Wednesday said the company hoped other drugmakers would follow its lead in disclosing payments to physicians. According to the Times, Merck was the only other company as of late Wednesday to do so.
 
A Johnson & Johnson spokesperson on Tuesday said that the company supports a revised version of the Sunshine Act and that it will begin by early 2009 disclosing payments for educational grants and to patient-advocacy organizations. An AstraZeneca spokesperson said that the company already has begun disclosing educational grants and payments to not-for-profit organizations but that it has not come to a decision "on other areas just yet." A Pfizer spokesperson said the company supports the Sunshine Act (Carey, New York Times, 9/25).
 
Sunshine Act
 
http://www.mmm-online.com
 
The Physician Payments Sunshine Act of 2008-or H. R. 5605-could require quarterly transparency reporting of product rebates, dividends, education, funded research, food, trips and travel, consulting fees, rebates, dividends and anything else over the value of $25, transferred to physicians by drug, device and medical supply companies, or by third parties acting on their behalf. That information-who got what from whom-would be made publicly available.
 
The bill would impose fines of $10,000 to $100,000 per violation, and if a company failed to report a single gift over $25, it would lose its tax deductions on all advertising-related expenses for that year.
 
A similar bill, S. 2029, is moving through the Senate.
 
Revised Physician Payments Sunshine Act Would Override State Laws
 
http://www.aafp.org/online
 
By James Arvantes
8/20/2008
 
Recent revisions in the Physician Payments Sunshine Act would override physician sunshine laws at the state level, establishing national rules and regulations requiring drug, biological product and medical device manufacturers with $100 million or more in annual gross revenues to disclose the names and office addresses of every physician who receives a gift valued at more than $25 from one of these companies.
 
The revised bill would establish a national registry of payments to physicians by large medical device, medical supply and pharmaceutical companies. A key change from the previous version of the bill is that this version would preempt physician sunshine laws passed by the states. Overriding state laws to establish uniform rules and regulations has made the legislation acceptable to the pharmaceutical and medical device industries, leading, in turn, to endorsements from Eli Lilly and Co., Merck, Astra Zeneca, and Johnson & Johnson, among others.
 
The Advanced Medical Technology Association, the trade association representing device manufacturers, also is backing the legislation, and the Pharmaceutical Research and Manufacturers of America issued a statement on Aug. 8 saying it supports the legislation as long as the bill continues to include a provision that preempts state law.
 
"We think a national type of registry where everyone is reporting the same thing within the same time frame is beneficial for everyone instead of various states doing this or doing that," said Edward Sagebiel, a spokesperson for Eli Lilly, in an interview with AAFP News Now.
 
The legislation, which is sponsored by Sens. Charles Grassley, R-Iowa, and Herb Kohl, D-Wis., would apply to payments, honoraria, travel and other rewards to physicians from pharmaceutical companies or medical device manufacturers. It would not apply to drug samples or funding for clinical trials.
 
According to the legislation, gifts to physicians would be listed in a national database created and maintained by HHS. It would impose fines of $10,000 to $100,000 on companies for each incidence of failing to report a gift to a physician.
 
The legislation's intent is to let patients decide whether physician prescribing patterns are influenced by perks from the pharmaceutical, biological product and medical device industries. The original bill, which was introduced last fall, attempted to augment rather than override similar initiatives in various states, including Minnesota, Vermont, Maine and West Virginia.
 
According to the AMA Council on Ethical and Judicial Affairs' Ethical Opinion 8.061, "Guidelines on Gifts to Physicians From Industry," which has been supported by the AAFP since its inception in 1991, physicians cannot accept gifts of substantial value or those with conditions attached. The AMA guidelines also stipulate that all gifts must primarily benefit patients or be related to a physician's work.
 
Support for S.2029, the Grassley-Kohl Physician Payments Sunshine Act
 
Introduction of the legislation in September 2007
 
June 10, 2008 New York Times editorial
 
April 16, 2008 Journal of the American Medical Association editorial
Impugning the Integrity of Medical Science: The Adverse Effects of Industry Influence
-Catherine D. DeAngelis; Phil B. Fontanarosa
-JAMA 2008; 299: 1833-1835.
 
Letter of support from the American Medical Association for the Grassley-Kohl Physician Payments Sunshine Act of 2007 Association of American Medical Colleges letter of endorsement AdvaMed Endorsement Letter
 
Pharma Endorsement Letter
Letter from Abbott Lab
Letter from Amgen
Letter from AstraZeneca
Letter from Baxter
Letter from Boston Scientific
Letter from Bristol Myers Squibb
Eli Lilly letter of endorsement
Letter from J&J
Letter of endorsement from Medtronic, Inc.
Letter from Medtronic
Merck Endorsement Letter
Letter from Merck
Letter from Pfizer
Letter from St. Jude Medical
Letter from Stryker
Letter from Wyeth
Letter from Zimmer Holdings
Letter from Abbott
 
 
 
 
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