Senate, House Democrats Push Legislation to Reduce
Drug Company Influence on Prescribing
New England Journal of Medicine, Journal of
American Medical Association point to need for physicians of
unbiased research on drugs
April 2, 2009 – A group of Democratic Senators and
House members are renewing their efforts to lower drug prices and
improve health care with legislation to provide doctors with unbiased
information on prescription drugs. This federal academic detailing
program will be based on “independent, scientific research,” the
sponsors say.
Drug detailing is a
process by which drug experts, often representing drug companies, inform
prescribers about the cost and efficacy of particular products, either
for educational or sales purposes. Academic detailing is
“university-based educational outreach.” The process usually involves
face-to-face education of prescribers by trained health professionals.
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. When doctors are better informed about the
full range of drugs available on the market, they are more likely to
prescribe the most effective treatment, as opposed to the latest
brand-name blockbuster drug. The result is also lower health care
costs, as generic drugs are more likely to be prescribed.
Last year, the Journal of the American Medical
Association (JAMA)
published an editorial underscoring the need for physician access to
unbiased research about the drugs available on the market.
“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,” said Senate Special Committee on Aging Chairman
Herb Kohl (D-WI), a bill sponsor.
Bill Supporters
“Patients are safer when doctors receive good,
unbiased drug information,” said Allan Coukell, director of the Pew
Prescription Project, one of the groups signed on as supporters of the
bill. “Programs like this already exist in other countries and in
several states, and they’ve been shown to improve care and generate
savings.”
Full List of Supporters
● The Prescription Project / Community Catalyst
HealthPartners Health Plan, MN
●
HealthPartners Medical Group, MN
●
Gray Panthers
●
American Medical Student Association (AMSA)
●
Consumers Union
●
Health Care for All (Massachusetts)
●
Medicare Rights Center
●
Mississippi Human Services Coalition
●
Minnesota Senior Federation
●
National Physicians Alliance
●
No Free Lunch
●
Tennessee Health Care Campaign
●
National Legislative Association on Prescription Drug Prices (NLARX)
●
American Association of Colleges of Pharmacy
●
UMass Memorial Medical Center
●
US PIRG
●
The Harvard Interfaculty Initiative on Medications and Society
●
The Division of Pharmacoepidemiology and Pharmacoeconomics, Department
of Medicine, Brigham and Women's Hospital / Harvard Medical School
●
The Leapfrog Group
BlueCross BlueShield Association
●
The Marshfield Clinic
●
Prescription Policy Choices
“By providing physicians with thorough, independent
research on all the drugs available to them, we believe we can improve
the quality of health care and reduce the cost of prescription drugs in
America.”
The academic detailing legislation is part of a
larger effort to change the way the pharmaceutical industry interacts
with doctors.
In January, Kohl and Finance Committee Ranking
Member Charles Grassley (R-IA) reintroduced the
Physician Payment Sunshine Act (S. 301) to require manufacturers of
pharmaceutical drugs, medical devices, and biologics to disclose the
amount of money they give to doctors through payments, gifts, honoraria,
travel and other means.
Other sponsors of the legislation filed yesterday
include Senate Majority Whip Dick Durbin (D-IL), Senate Committee on
Health, Education, Labor, and Pensions (HELP) Committee Chairman Ted
Kennedy (D-MA), and Senator Bob Casey (D-PA) were joined by House
Committee on Energy and Commerce Chairman Henry A. Waxman (D-CA), House
Energy and Commerce Subcommittee on Health Chairman Frank Pallone
(D-NJ), House Committee on Ways and Means Chairman Charles Rangel
(D-NY), and House Ways and Means Subcommittee on Health Chairman Pete
Stark (D-CA)
The Independent Drug Education and Outreach Act of
2009 would provide grants to produce educational materials for doctors
on the safety, efficacy, and cost of prescription drugs, including
generic and over-the-counter drugs.
A second set of up to ten grants would be made
available in order to dispatch trained medical staff (such as
pharmacists, nurses, and other health care professionals) into
physicians’ offices to distribute and discuss the independent
information.
To ensure their neutrality, grant recipients may
not receive financial support from any drug manufacturers whose products
they are reviewing.
The recently-passed stimulus package designates
$400 million dollars to the Department of Health and Human Services to
accelerate the development and dissemination of comparative
effectiveness research, which could be used to fund grants like those
included in the Independent Drug Education and Outreach Act.
Currently, pharmaceutical sales representatives are
one of the most common ways doctors learn about new drugs on the market,
and evidence has shown that interaction with them can impact doctors’
prescribing patterns.
At an
Aging Committee hearing on academic detailing in March 2008, a
former sales representative for the pharmaceutical company Eli Lilly
shared with the committee his experiences as a drug detailer and
discussed the techniques sales representatives employ when marketing
drugs to doctors.
Other witnesses, including Dr. Jerry Avorn from
Harvard’s School of Medicine, outlined the concept of academic
detailing, shared success stories from state and international programs
already underway, and discussed both the documented cost savings of
academic detailing programs and how patients stand to benefit when
doctors have access to unbiased information.
Statements from sponsors
“Many doctors learn about new drugs from drug
company salespersons who may not be objective,” Durbin said. “Studies
confirm 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.”
“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,” said Kennedy.
“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,”
said Casey. “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.”
Sen. Kohl Issues Statement on JAMA
Article Suggesting Professional Medical Associations Reject Drug
and Device Industry Funding
April 2, 2009 –Senator Herb Kohl, Chairman
of the Senate Special Committee on Aging, released the following
statement yesterday in reaction to an article in the April
edition of the Journal of the American Medical Association (JAMA),
in which leading medical professionals called on professional
medical associations (PMAs) to cut financial ties with the drug
and medical device industries:
“Professional medical associations were created to
set standards of medical practice for their field, however the
funding of PMAs by drug and device companies raises questions
concerning their impartiality. The public should know where
these organizations get their money, so that Americans can have
confidence in the health recommendations of their physicians.”
Senator Kohl has joined with Senator Chuck
Grassley (R-IA) in conducting oversight of the financial
relationships between doctors and industry. Kohl has chaired
hearings of the Senate Special Committee on Aging and continues
to pursue an ongoing investigation of such relationships.
In January, Kohl and Grassley
reintroduced the Physician Payments Sunshine Act, which
would require companies that make pharmaceuticals, medical
device and biologics to disclose payments they make to
physicians.
“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,” said Waxman. “This
important legislation will help provide doctors with the best objective
information to help them make better clinical decisions in partnership
with their patients.”
“Quality health care includes the best use of all
available medications,” said Pallone. “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. This bill is good for health
care in America, good for the medical profession and, most importantly,
good for consumers and patients.”
“Providing doctors and patients with direct access
to objective, comprehensive information on prescription drugs can help
save lives and money,” said Stark. “This legislation will test ways to
help doctors and patients make medication decisions based on facts, not
manufacturer propaganda.”
Bill Summary
● Fund grants or contracts through the HHS
Agency for Health Care Research and Quality (AHRQ) to develop
educational materials.
> 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.
● Fund ten grants or contracts through AHRQ to
dispatch trained medical professionals into physicians’ offices to
discuss and disseminate the unbiased educational materials.
> Public entities and nonprofit groups are
eligible to apply for the grant or contract, as are other entities that
can demonstrate the capacity to train and deploy the medical
professionals to disseminate and discuss the materials.
> Applicants may not receive financial
support from any manufacturer of the products being discussed.
> The grant or contract recipients will
hire and train appropriate staff, identify health care providers who
will be the recipients of the outreach, and evaluate the effectiveness
of the program on both cost and prescribing behavior.
> Regulations will also be in place to
ensure the accuracy and timeliness of the information being distributed,
to prevent conflicts of interest, and to promote the effectiveness of
the program.
April 2, 2009 – A group of Democratic Senators and
House members are renewing their efforts to lower drug prices and
improve health care with legislation to provide doctors with unbiased
information on prescription drugs. This federal academic detailing
program will be based on “independent, scientific research,” the
sponsors say.