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Featured Regulatory News, Opinions, and Positions

American Medical Student Association PharmFree Scorecard 2008 [UPDATED]
The AMSA PharmFree Scorecard 2008 evaluates conflict-of-interest policies at the 150 medical colleges and colleges of osteopathic medicine in the United States. Using letter grades to assess schools’ performance in eleven potential areas of conflict, the Scorecard offers a comprehensive look at the landscape of conflict-of-interest policies across American medical education, as well as more in-depth assessment of individual policies that govern industry interaction with medical school faculty and trainees. The Scorecard assesses policies related to potential conflicts of interest created by industry marketing at the level of the individual physician and trainee.  The Association of American Medical Colleges, which recently proposed strong guidelines for many of these domains, has also addressed institutional and research conflicts of interest in earlier reports.

Commonwealth Of Massachusetts Senate No. 2526

A far-reaching healthcare reform bill that would, among other provisions, impose a ban on all gifts to healthcare providers and their immediate family members. Read and review S.2526 (PDF).

 
Pfizer Sacks Commercial Support Of CME
Medical Marketing & Media by Matthew Arnold July 02, 2008 
Pfizer will no longer fund continuing medical education through med ed firms. The company, until recently the leading supporter of CME, said it will continue to support CME programs provided by academic medical centers and teaching hospitals, associations, medical societies and community hospitals, but will no longer offer direct funding for programs provided by medical education and communication companies (MECCs).

The move is aimed at tempering concerns that industry support biases CME content. “We understand that even the appearance of conflicts in CME is damaging and we are determined to take actions that are in the best interests of patients and physicians,” said Pfizer Chief Medical Officer Dr. Joseph Feczko in a statement.

Pfizer's support of CME has dropped considerably in recent years. In 2005, the company spent $314 million on all forms of CME, including accredited and non-accredited programs, according to Verispan figures. In 2006, CME support dropped to $285 million, again according to Verispan. Last year, the manufacturer reported spending around $80 million on CME. In May, as part of a transparency push, Pfizer posted a list of $10 million in med ed grants for the first quarter of 2008.
 
Payola | Doctors and Drugs
Charleston Gazette July 1, 2008  [FULL EDITORIAL | LINKS ADDED BY PCMC WEBMASTER]
Three Harvard University psychiatrists accepted $4.2 million in consulting fees from drug companies while performing research that promoted pharmaceuticals made by those companies as the best way to treat bipolar and other disorders. Due in part to the influence of psychiatrist Joseph Biederman, who received at least $1.6 million in pharmaceutical consulting fees since 2000, diagnoses of pediatric bipolar disorders ballooned. Between 1994 and 2003, the number of small children and teenagers diagnosed with those disorders jumped by a factor of 40. Bloomberg News reported: "The expanded use of bipolar as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion U.S. market for anti-psychotic drugs."

Biederman and his Harvard colleagues failed to report most of their drug company income to university officials, according to an ongoing congressional investigation led by Sen. Charles Grassley, R-Iowa. Biederman "suddenly admitted to over $1.6 million from the drug companies," Grassley said during a June 4 hearing, but only after Harvard and Massachusetts General Hospital began to investigate how much money Biederman and his colleagues were getting from those companies.

The Harvard psychiatrists may also be facing another problem: The National Institutes of Health prohibits anyone receiving NIH research grants from accepting more than $20,000 from any company making drugs that are being studied by the NIH recipient. Grassley told his committee: "If a researcher is taking money from a drug company while also receiving federal dollars to research that company's product, then there is a conflict of interest."

Tranquilizing drugs do calm children down. But "youngsters appear to be especially susceptible to the weight gain and metabolic problems caused by drugs," a June 8 New York Times report stated. "And it is far from clear that the medications improve children's lives over time." Vera Sharav, founder of the Alliance for Human Research Protection, said Dr. Biederman and his colleagues "have given the Harvard imprimatur to this commercial experimentation on children." University and congressional investigations have already raised major questions about violations of federal regulations and academic research standards. The biggest victims, however, are hundreds of thousands of children who have taken drugs based on questionable academic research and questionable psychiatric diagnoses.

This disclosure about doctor payola adds a spotlight to West Virginia's ongoing problem with the state Pharmaceutical Cost Management Council, which voted to conceal the names of Mountain State physicians who take more than $10,000 each per year from drug firms.

Regulatory Action or Proposed Action

Commonwealth of Massachusetts Senate 2526
An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care

Senate Bill 2526 (PDF)

Opinions and Positions

Testimony of the Massachusetts Prescription Reform Coalition Before the Joint Committee on Health Care Financing March 12, 2008 
AARP Online Community
The Massachusetts Prescription Reform Coalition appreciates this opportunity to offer testimony in strong support of section 7 and section 22 of S. 2526, An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care, which seek to create an academic detailing program and ban the provision of gifts from pharmaceutical and medical device companies to physicians...

Massachusetts Bill Would Ban All Gifts to Physicians
MX: Business Strategies for Medical Technology Executives
Last month, the Massachusetts State Senate unveiled a far-reaching healthcare reform bill that would, among other provisions, impose a ban on all gifts to healthcare providers and their immediate family members. The gift ban provision of the bill—titled An Act to Promote Cost Containment, Transparency, and Efficiency in the Delivery of Quality Healthcare (S 2526)—would apply to medical device manufacturers as well as pharmaceutical and biotechnology companies...
 
Testimony of MASSPRIG Before the Joint Committee on Health Care Financing March 12, 2008
Safe And Affordable Drugs
MASSPRIG - Massachusetts Public Interest Research Group
Despite fierce opposition from drug company lobbyists, the senate voted 36-0 to curb rx company marketing practices by adopting a bill which includes a pharmaceutical gift ban, licensing requirement, and the adoption of an academic detailing program...
 
NAPSRx® to work with PhRMA to engage reps to oppose (Federal) Physician Payment Sunshine Act and the (Massachusetts) State Senate Bill
National Association of Pharmaceutical Sales Representatives
State of Massachusetts: Senate No. 2526 Talking Points Regarding Gift Ban. An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality HealthCare. We would like to engage MA employees to reach out to their Representative and Senator opposing the gift ban in Senate Bill 2526. Attached are talking points on the bill. In addition, below are two links...

Related News

froyo_art_200v_20080601174932.jpg

WARNING: May cause regulatory harm if given to Minnesota doctors.

Where Eli Lilly is giving away frozen yogurt, for example, a plain white sign (the only plain thing in Lilly’s elaborate booth) says:

Food, beverages and/or meals will not be provided by Eli Lilly and Company for the following parties:

* Physicians and individuals with prescribing authority in Minnesota in order to comply with Minnesota statutes

* Government employees in New York (both city and state) in order to comply with New York statutes

Drug company gifts to physicians have come under scrutiny nationwide in recent years, with arguments in some quarters that the freebies encourage docs to prescribe expensive, brand-name drugs when cheaper generics would be equally effective. A Minnesota law prohibits companies from giving gifts worth over $50 a year to docs.

Health Blog colleague Peter Loftus, in town to cover the American Society of Clinical Oncology for Dow Jones Newswires, saw the sign and talked to Eli Lilly to learn more. “We want to make sure we’re doing all the right things according to state regulations,” spokeswoman Amy Sousa told him, adding that she wasn’t aware of any doctors Minnesotans actually being turned away.

No, a small cup of yogurt isn’t worth $51. But it’s simpler for Lilly sales reps to keep track of gifts to doctors they call on, rather than trying to keep tabs on all the docs coming through for a treat between meetings, Sousa suggested.

Nearby, where Novartis was giving away soapstone bowls carved in Kenya, a sign noted that Minnesotans, members of a Medicare committee, and state and federal employees “may be subjected to restrictions on acceptance of food, beverages or items.”

Still, we’re not too worried about the Minnesota docs going without. There seemed to be plenty of booths giving away treats to all comers.

Photo by the Health Blog. Camera courtesy of Yuki Minagawa of Nikkei Business Publications.

What The Doctor Ordered
Sally Satel, M.D. May 7, 2008
In proposing a gift ban, the AAMC is accelerating a trend already well underway. For several years, the American Medical Student Association has held annual PharmFree Days. In 2004, it celebrated the occasion by dumping thousands of branded paraphernalia outside Pfizer headquarters. Last month, politicians weighed in; the Massachusetts state senate passed unprecedented legislation that would impose a fine of up to $5,000 on physicians accepting so much as a mouse pad from a drug company.

Unanimous Vote Bans Gifts to Doctors in Massachusetts
By MedHeadlines • Apr 21st, 2008 • Category: Drugs, Editor's Picks, Medicare
A unanimous vote, 36-0, in the Massachusetts Senate passes legislation pertaining to healthcare reforms within the state. The bill is the first of its kind in the nation although Minnesota and Vermont both have similar laws but without the full scope of the Massachusetts act...