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Tuesday, November 26, 2002Even though the Food and Drug Administration has approved it only as an add-on drug for epilepsy and for shingles pain, more than 80 percent of prescriptions for it are written for bipolar illness, anxiety, posttraumatic stress disorder, all kinds of pain, insomnia, restless leg syndrome, hot flashes, migraines, and tension headaches. Using a drug for unapproved conditions isn’t necessarily a bad thing, as the article points out: This freedom to prescribe drugs for unapproved uses is a cornerstone of medicine, physicians said, a form of experimentation that has led to many important discoveries. And in the end, that could be true in the case of Neurontin, where evidence is building that the drug helps ease some patients' excruciating neuropathic pain, physicians said. Henry Esterman of West Roxbury, who took it for nerve pain in his lower back related to diabetes, said he was ''very grateful for it. The pain was unbearable, and nothing else touched it.'' I’ve used the drug with success for diabetic nerve damage, too, and would hate to lose the opportunity to use other drugs in similar ways. But, the use for diabetic pain is based on the theory that the nerve problem is similar to the process involved in shingles, so it’s really an expansion of an already approved use, and based on sound theory, if not on evidence. The danger comes when the companies abuse the system and hype their drugs for uses that don’t have any basis beyond wild speculation: Beginning in August 1994, the company recruited hundreds of physicians, particularly those who prescribed competing drugs to patients, to participate in teleconferences about Neurontin. The company also targeted continuing medical education courses for doctors and hired Medical Education Systems in Philadelphia in 1997 to draft a series of 12 scientific articles on anticonvulsant therapy, including expanded uses, monotherapy, bipolar disorder, and migraine. Why should drug companies have access to the prescribing habits of physicians? They shouldn't. And the sad fact is that a lot of doctors don't realize they've been targeted in this way. If they did, they wouldn't be as receptive to those sales pitches. Medical Education Systems contacted faculty members considered authorities in their field and chosen by Parke-Davis, and paid them $1,000 each to author the articles. The Globe could not determine whether all 12 articles were published, but some were, including articles on gabapentin's role in the treatment of pain, mania, and mood and anxiety disorders. At least three of the articles gave no hint to readers that Parke-Davis had paid for them, and even had a hand in reviewing drafts - the sort of disclosure many scholarly journals routinely require. On June 20, 1997, Medical Education Systems senior editor Mary Anderson wrote to Allen Crook, Parke-Davis product segment manager, about one of these articles, a discussion of the role of gabapentin and another drug in the treatment of mood and anxiety disorders. ''Please make any comments directly on the manuscript and return it to me,'' she directed. The company is obviously holding way too much sway in these supposedly objective reviews. With this sort of system, only the positives get accentuated, to the benefit of the company and the detriment of everyone else: ''Its share of the market, its sales, really exceed its efficacy,'' said Dr. Jerrold Rosenbaum, Mass. General's chief of psychiatry. ''The question is, was the company denying investigators access to negative data when they asked for it?'' We’ll never know. posted by Sydney on 11/26/2002 07:48:00 AM 0 comments 0 Comments: |
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