The Independent Drug Education and Outreach Act of 2009

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“This legislation will test ways to help doctors and patients make medication decisions based on facts, not manufacturer propaganda.”  Co-Sponsor Congressman Pete Stark (D-CA)

U.S. Senate Special Committee on Aging Chairman, Herb Kohl (D-WI), and House Committee on Energy and Commerce Chairman, Henry A. Waxman (D-CA), introduced the Independent Drug Education and Outreach Act of 2009. 

The bill, if adopted, would provide for government prescription drug detailers to span the country teaching physicians about “unbiased” medicine (the benefits of generic prescription drugs). 

The program will fund ten grants or contracts through the Health and Human Services (HHS) Agency for Health Care Research and Quality (AHRQ) to develop educational materials and dispatch trained medical professionals into physicians’ offices to discuss and disseminate the unbiased educational materials grants or contracts.

·    The grantee or contractor would develop educational materials showing the relative safety, effectiveness, and cost of prescription drugs, including generic and over–the-counter alternatives and non-drug treatments for selected conditions.  These materials would include brochures, handouts, and electronic information accessible to both patients and doctors.

·     Entities that can demonstrate clinical expertise in pharmaceutical research, such as medical and pharmacy schools and academic medical centers, would be eligible to apply.

·     Applicants may not receive financial support from any manufacturer of the drugs being reviewed.

·     AHRQ will review and approve the accuracy and effectiveness of the materials on a bi-yearly basis.

Senator Kohl stated that “A study in the New England Journal of Medicine projected that for every dollar spent on academic detailing, two dollars can be saved in drug costs.” 

On the surface, that sounds like it makes sense, except that the study was: Improving drug-therapy decisions through educational outreach, a randomized controlled trial of academically based "detailing Volume 308:1457-1463, June 16, 1983.   

Senator Kohl also stated “This bill will provide an important alternative to the way doctors currently get their information about drugs—from the drug companies themselves—a practice that seems to be fraught with conflicts of interest.”

“By providing physicians with thorough, independent research on all the drugs available to them, we believe we can improve the quality of healthcare and reduce the cost of prescription drugs in America.”

Some Key quotes from other sponsors include:

Senator Richard Durban (D-IL)

“Many doctors learn about new drugs from drug company salespersons who may not be objective.”  “Studies confirm (the 1983 study again) that when unbiased health professionals, armed with educational materials, provide guidance to doctors, they are more likely to purchase the best drug for the patient instead of the best deal for the pharmaceutical company.” 

Senator Edward Kennedy (D-MA)

“This bill will provide for objective, scientific reviews of the available evidence on the safety and effectiveness of drugs, and will get this information to the physicians who need it, so they and their patients can make more informed decisions about what is best for their care.”

Senator Robert Casey (D-PA)

“This legislation is a cost-effective, common sense, and practical solution to a serious problem – it is exactly the kind of support the federal government should be providing the states.”  “I’m proud to note that

Pennsylvania

has one of the best and most innovative academic detailing programs in the country, with documented and measurable cost savings.”

Congressman Henry Waxman (D-CA)

“For far too long, most of the information physicians receive to make prescribing decisions has come from the drug companies marketing reps, not independent experts.”

Congressman Frank Pallone (D-NJ)

“Pharmaceutical companies have produced medicines that save lives and improve the quality of life but doctors need the best, objective information about prescriptions if they are to be used properly and effectively.”

Congressman Pete Stark (D-CA)

“Providing doctors and patients with direct access to objective, comprehensive information on prescription drugs can help save lives and money.”  This legislation will test ways to help doctors and patients make medication decisions based on facts, not manufacturer propaganda.”

This is the exact same language of a bill with the same title introduced last year.  Both versions include a provision that only medical schools and medical societies can apply for grants and only those who have not received any funds from industry for one year.

That provision is what should be called the “keep in business provision” says Jerry Avorn, M.D. (author of the 1983 NEJM paper).  Jerry is the proprietor of the Independent Drug Information Service.

The Independent Drug Information Service is a private company to provide academic detailing services.  What is interesting to note is that almost all the staff of IDIS are actually moonlighting from his Harvard Division of Pharmacoepidemiology & Pharmacoeconomics.

The House Energy and Commerce Committee issued testimony from Dr. Avorn on April 2, 2009, in which he failed to disclose his ownership interest in the Independent Drug Information Service, but perhaps he doesn’t believe in disclosure of COI as he has stated he does not think that is enough.

Pharmaceutical companies go through rigorous processes to develop sales aids and product presentations, they then have to go through regulatory and legal review to ensure that the information they are providing matches the FDA approved product label.  The current academic detailing programs don’t come anywhere near that standard.

The idea that the government would pay for one-on-one education for physicians with the goal to get the providers to prescribe generic drugs may not at this time be the most efficient use of government resources. 

Perhaps this can be pitched as a stimulus package to get laid-off pharmaceutical reps jobs working for the government.

Congress

H.R. 1859 U.S. House Version

S 767 U.S. Senate Version

List of Congressional Sponsors

Organizational Endorsements

Bill Summary 08 (Same Bill Same Sponsors)

Staff Testimony April 2, 2009 (Jerry Avorn, MD)  (He fails to disclose in his testimony that he has ownership interest in the Independent Drug Information Services)

Policy and Medicine

Senator Kohl: IDEA Act – Government Sales Reps Coming Soon

Government Drug Reps — What will they think of Next

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