July 26, 2009
Conflicts Of Interest In Treatment Guidelines
By Richard Blumenthal
The Day newspaper, New London, CT
Published on 7/19/2009 in Home >> Editorial >> Perspective
Summer's start signals another season of struggling with Lyme disease. This scourge can be best fought with preventive vigilance - proper clothing, proper tick removal, close inspection of children after outdoor play. Also important are early diagnosis and prompt treatment.
For some, symptoms continue after treatment, suggesting that a more chronic form of the disease may exist and, if it does, raising questions about how it should be treated. Doctors and researchers disagree. Some say recurring symptoms reflect continuing infection and prescribe long-term antibiotics. Many patients say this regimen has relieved their suffering. Other experts dismiss the notion that the infection persists, and condemn the use of long-term antibiotics as useless and potentially harmful.
As a lawyer and not a doctor, I am unqualified to know the right medical answer, or even take sides in this often bitter professional disagreement. But as the state's law enforcement officer vested with authority to enforce Connecticut's antitrust laws, my duty is to assure full and fair access to medical products and treatment without anticompetitive interference or illegal restraint.
Laws protecting competition apply to medical society treatment guidelines, which often determine insurance coverage of Lyme disease and other illnesses. The process producing those guidelines must be fair, inclusive and scientific - untainted, for example, by improper and potentially illegal anticompetitive influence from health insurers and pharmaceutical companies seeking to maximize profits. An open and accountable process is more likely to yield guidelines and medical decisions based on science and fact.
In 2007, my office began an investigation of serious and credible allegations about exclusion of dissenting views and undisclosed, widespread conflicts of interest among panelists who wrote the Infectious Diseases Society of America's 2006 Lyme disease guidelines.
Our investigation revealed critical flaws in IDSA's guideline process. It lacked any meaningful conflict of interest screening. It was undermined by persistent refusal to consider dissenting views. And it excluded meaningful criticism.
Skewing medical guidelines to benefit health insurers and HMOs, drug makers and self-interested panelists is a serious and growing problem. Press reports abound of medical companies using financial incentives - speaking and consulting fees, research support, potentially lucrative patents - to improperly influence medical professionals. Using such tactics to skew guidelines can have potentially devastating impacts on patients, because insurers use them to determine what treatments they will fund.
In 2005, a Nature magazine article reported that one third of 200 medical experts serving on practice guideline writing panels admitted to having some financial interest in drugs they considered. A year earlier, the New York Times reported that eight of nine members of the National Cholesterol Education Program panel that recommended sharply decreasing so-called "bad" cholesterol levels had financial ties to the makers of cholesterol-lowering drugs.
Similar conflicts of interest and undisclosed financial interests in other areas are under investigation by congressional committees and other federal authorities. Responsible members of the medical profession are seeking to address such issues.
When confronted with our powerful evidence, the IDSA effectively admitted the flaws by agreeing to a review and reassessment of its 2006 guidelines by a conflicts-free panel. The settlement included an independent ombudsman to screen the panelists and disqualify any with conflicts of interest, and a public hearing to be broadcast live on the Internet.
The Lyme disease guideline review mandated by my office's settlement with the IDSA is under way, with the novel public hearing scheduled for July 30. The review may result in many, few or no changes. It is not my place or intention to determine what those changes may or may not be, nor am I seeking to shape the guidelines so they recognize or favor a particular treatment method. My purpose is to assure that the guidelines are developed through a fair, transparent and accountable scientific process, free from improper financial and anticompetitive influences.
My investigation and the resulting agreement have always been about the process, not specific results. Whether chronic Lyme exists and, if so, how it should be treated - are issues for scientists, researchers and doctors to determine, not lawyers.
My office has long fought for Connecticut consumers seeking much needed coverage for treatments their doctors recommend, but their insurers reject - reflecting my strong belief that physicians and patients should make medical decisions, not insurers or bureaucrats. This effort has included helping victims of Lyme disease obtain coverage for doctor-prescribed treatments. I never advocate or endorse a specific treatment or diagnosis, but make sure physicians can administer the treatments and drugs they believe necessary for their patients.
I will continue the fight against anticompetitive, anti-patient practices in this area and others.
Connecticut Attorney General
Richard Blumnthal