Guidelines: Guides to Profit
By John Fauber, Milwaukee Journal Sentinel/Medpage Today and
Ellen Gabler, Milwaukee Journal Sentinel
Published: December 19, 2012
But that intent may not be universally reflected in
published guidelines and the disconnect is all about money.The stated intent of treatment guidelines is to
"guide" clinicians' treatment of patients with a series of
recommendations based on evidence.
Money Talks
Doctors with financial ties to drug companies have heavily
influenced treatment guidelines ,an analysis by the Milwaukee Journal
Sentinel and MedPage Today has found.
Critics say those financial relationships have corrupted the
guideline process so that the end products, make dangerous or ineffective
recommendations.
Industry and some doctors counter that those with conflicts
are often top experts in their field.
The Journal Sentinel/MedPage Today examined 20
clinical practice guidelines for conditions treated by the 25 top-selling drugs
in the U.S.
These drugs sit in the medicine cabinets of millions of
Americans -- Nexium (esomeprazole magnesium) for acid reflux, Lipitor
(atorvastatin) for high cholesterol, Cymbalta (duloxetine) for depression, and
OxyContin (oxycodone) for pain. Their collective sales topped $94 billion in
2011, accounting for 30% of drug revenue in the U.S.
An analysis of the guideline panels, which involved 293
doctors, found:
Nine guidelines were written by panels where more than 80%
of doctors had financial ties to drug companies.
Four panels did not require members to disclose any
conflicts of interest.
Of the 16 guideline committees that required disclosure,
two-thirds of the panel members had ties to drug companies.
Some guidelines written by conflicted panels recommend drugs
that have not been scientifically proven to safely treat conditions, leading to
inappropriate or over prescribing, specifically guidelines for anemia, chronic
pain, and asthma.
In this analysis, research funded by drug companies was not
counted as a conflict in the Journal Sentinel/MedPage Today analysis
because there is disagreement about whether research funding poses as much of a
conflict as speaking, consulting and advising.
The findings offer the latest glimpse into how
pharmaceutical companies, with billions in sales at stake, exert a powerful but
often unrecognised influence over the practice of American medicine.
Past Journal Sentinel/MedPage Today reports have revealed articles in medical journals that were ghostwritten by drug company marketers; instructional videos for doctors that made misleading claims about drugs; payments to medical organizations that advocated for more use of drugs; and drug companies paying for continuing medical education courses that, in essence, market their products.
"At the end of the day, the drug companies own
medicine," said Eric Campbell, PhD an associate professor at Harvard
Medical School who has researched conflicts of interest in treatment
guidelines. "We've created a system that allows this."
In March 2011, the Institute of Medicine issued a report
that said fewer than 50% of members of a guideline-writing committee should
have financial relationships with drug companies. No committee chairman should
have a financial conflict of interest, the IOM said.
In this Journal Sentinel/MedPage Today analysis just
two guideline committees met the IOM criteria. Of the 16 panels that disclosed
conflicts of interest, at least 10 had chairmen with financial ties to drug
companies. Payment amounts were not disclosed in the guidelines, which were
issued between 2001 and 2012.
Some medical societies have agreed to adopt the IOM
recommendation, but many others complain the IOM set the bar too high, making
it is too difficult, costly and contentious for societies, said Sheldon
Greenfield, MD, chairman of the group that issued the report titled,
"Clinical Practice Guidelines We Can Trust."
"By and large, most of the societies have ignored
it," said Greenfield, a professor of medicine and executive co-director of
the Health Policy Research Institute at University of California, Irvine.
Extensive time, research and expertise are poured into
developing most guidelines, a process that can take years. The documents are
complicated, dense and extremely technical.
At their best, rigorously-developed, unbiased guidelines can
help synthesize new research and improve the quality of treatment that patients
receive.
Even critics who want to minimize or eliminate conflicts
acknowledge that guidelines written by doctors with financial ties to drug
companies can offer solid, scientifically-backed recommendations.
But protecting the integrity of clinical guidelines is essential to the practice of medicine, said Steven Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic.
"If those guidelines are produced in a way that is not
completely free of bias, then we are guiding physicians and patients toward
therapies based on opinions that may have been influenced by peoples' financial
relationships," Nissen said. "That is a huge problem."
Some doctors and pharmaceutical industry representatives say
physicians who consult for drug companies are among the most well-informed
experts in their field and should help write guidelines.
Experienced doctors are trained to evaluate and base their
decisions on complicated medical and scientific information, without being
influenced by their ties with drug companies, said Marjorie Powell, senior
assistant general counsel for PhRMA, a trade group that represents drug and
biotechnology companies doing research to develop new medicine.
Other doctors and researchers say there are countless
experts to call upon who do not have relationships with drug companies.
In fact, doctors are often willing to cut ties with drug
companies in order to sit on guideline writing panels, said Daniel Ouellette,
MD, vice chairman of the guidelines oversight committee for the American
College of Chest Physicians and a senior staff physician at Henry Ford Hospital
in Detroit. Ouellette said he looks at excluding potential bias as part
of the scientific process.
"We would rather have our panel be completely non-conflicted,"
he said.
People with industry ties may be allowed to give insight if
their expertise is so unique no one else can provide it, Ouellette said. But they
can only add comments and participate in discussions, not vote on or draft
guidelines.
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