• Bad legislation, perilous precedent
    March 14,2014
     

    A bill that is without precedent in Vermont’s legislative history is headed for the Senate Health and Welfare Committee, after having received a stamp of approval from the Vermont House. The bill, H.123, prevents the Vermont Board of Medical Practice from censuring physicians who prescribe long-term antibiotic medications for individuals with “chronic Lyme disease” and requires all of Vermont’s health insurers to pay for the treatment.

    After appropriate treatment, the vast majority of individuals who’ve been treated for the various forms of Lyme disease proceed with their lives without residual symptoms. If the illness was not detected in the earliest phase, then patients require two to four weeks of antibiotics, and their blood will reveal evidence of exposure to the illness for years to come.

    A segment of the U.S. population experiences distressing long-term symptoms that doctors have difficulty understanding and for which there may not be effective treatment. Often a great array of testing is done with entirely normal results. Commonly, these symptoms include some combination of muscle and joint pain, headache, relentless fatigue, cognitive dysfunction and dizziness.

    Currently, such patients are classified most commonly as suffering from fibromyalgia or chronic fatigue syndrome. Some show improvement in their physical symptoms when they’re treated for depression.

    Some of these individuals believe that their long-term symptoms are caused by past exposure to Lyme disease. Some believe that they experience improvement if they are treated with additional courses of antibiotics. But typically, perceived benefit from this treatment is transient.

    Consequently, many of these patients — and a few doctors — believe they should then be treated over and over with courses of broad spectrum antibiotics, or simply take them chronically. The bill making its way through Vermont’s Legislature incorrectly states that there is a diversity of opinion among physicians regarding the treatment of these individuals. There is not.

    If anything more than a minuscule percentage of physicians were comfortable ignoring the standard of care for this illness, then these advocates would not have found it necessary to attempt to persuade politicians in the Legislature to forbid the Board of Medical Practice from insisting that Vermont’s physicians adhere to practice guidelines based on scientific research.

    This approach to treatment of these individuals has been researched. Results of these studies demonstrate that patients who receive the placebo (sugar pill) do as well as those who receive the antibiotic medication. In other words, the treatment doesn’t work. So after the treatment of the initial infection, the standard of care for doctors treating these individuals with chronic symptoms is not to prescribe antibiotics, since they don’t work and have important side effects.

    There is a widespread perception that antibiotic therapy is completely safe. This is not true. Four types of side effects can and do occur.

    Allergic/sensitivity reactions are quite common with antibiotic therapy and are occasionally quite serious. Second, the mode of delivery can cause trouble: Some antibiotics are delivered only via the intravenous route, and infections of IV catheters are common. There is already a report in the medical literature of a “chronic Lyme disease” patient who died of a catheter-related complication.

    Two microbiologic consequences can be expected: As the bacteria in your body are exposed to an antibiotic, bacteria sensitive to the antibiotic will die off, leaving bacteria to survive that are able to resist the effect of the antibiotic. Unfortunately, the bacterial genes providing resistance to one antibiotic are often transmitted along with genes leading to resistance to other antibiotics. If at some point along the way such individuals develop a bacterial infection, the infection will likely be resistant to that antibiotic and possibly others, making the illness much more difficult to treat. This is not an occasional occurrence. It occurs regularly. Other individuals in the household will also come to harbor more of these antibiotic-resistant bacteria.

    The majority of bacteria that reside in or around the human body live in the intestinal tract. A great variety of bacterial species live in a balanced relationship, allowing for intestinal health. Antibiotic therapy disrupts this balance, frequently leading to diarrhea. Some of these antibiotic-treated individuals’ intestinal tracts can become infected by an antibiotic-resistant organism called Clostridium difficile, or C diff. This infection can cause profuse, bloody diarrhea that is very difficult to treat and is not uncommonly fatal.

    In Vermont, a well-organized group of individuals with fatigue, chronic pain and the other symptoms described above has proposed a bill exempting doctors who prescribe long-term antibiotic therapy for individuals felt to have this entity from any censure from the Vermont medical board.

    Not once in Vermont’s history has Vermont’s Legislature provided this type of directive to the Board of Medical Practice. And it shouldn’t be done now.

    — Legislators who support this law are ignoring the compelling research demonstrating that the treatment works no better than a placebo.

    — Legislators appear to be assuming that antibiotic therapy is much safer than is actually the case. Antibiotics — especially when given repeatedly or chronically — can have major side effects. Furthermore, overuse of antibiotics leads to the dissemination of antibiotic-resistant bacteria — including C diff— in the entire community, a problem that is of immense importance.

    — Vermont’s Legislature is in the process of significantly restructuring the health insurance and health care delivery system with the goal of clearing away obstacles to proper medical treatment.

    They will hopefully eliminate arcane insurance company approval processes and high deductibles that prevent patients from receiving needed medical care. Legislators and other leaders in the reform effort have reassured doctors that they were clearing away obstacles in the way of good medical care but had no intention of intruding into the practice of medicine.

    Telling the key organization charged with the responsibility of maintaining professional standards of care how to handle treatment of a specific medical problem can only be viewed as a major, unprecedented intrusion.

    The Legislature could hardly do more to undermine the confidence of Vermont’s physicians and other medical professionals in the Legislature — and the promises made surrounding the reform effort — than to intrude into medical practice in this manner.

    When listening to testimony in support of this bill, several legislators commented on how devastating these symptoms are to the individuals who testified, and heard these individuals describe their frustration with the lack of effective treatment. Unfortunately, facing illnesses with only modestly effective treatment available — or no effective treatment at all — is painfully common. Every day, patients suffering from degenerative arthritis, dementia, Lou Gehrig’s disease, many forms of cancer and many, many other diseases seek medical care.

    For these patients, everyone involved — patients, family members and the doctors treating them all wish that highly effective treatment were available. But lacking that, we try to help patients as best we can to contend with the medical issues they’re facing. But it is dishonest and unhelpful to prescribe medications that offer more harm than benefit — even if they have become trendy or have been advocated by support groups.

    Is the next step for the legislators to intervene in medical treatment, taking on one disease after the next, mandating what the Board of Medical Practice may or may not do in each case?

    The “chronic Lyme disease” advocacy group is seeking the Legislature’s approval for an ineffective and often harmful treatment with no scientific foundation. Vermont’s legislators should not allow the State House to become a battleground where health-related advocacy groups attempt to persuade the Legislature to directly intervene into medical practice. In so doing, neither the public health nor the well-being of medical practice in the state of Vermont is well-served.



    Dr. Marvin Malek is an internist working in Berlin.

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