In an FBI press release today, the federal government announced that pharmaceutical giant Pfizer will pay $2.3 billion in civil and criminal fines for promoting "off label" uses of three of its big selling drugs by doctors treating patients in the Defense Department and Postal Service health plans. Even the FBI admits in its release that the "fraud" charges result not from injury or illness suffered by any of these patients, but rather from government payment of health insurance claims for "off label" prescriptions to federal employees.
This sort of cost control is just the kind of thing we can expect under President Obama's proposed federalization of our health care system. While it is legal for doctors to prescribe, and patients to take, legal drugs for purposes not included in the FDA approved labeling for the product in question, federal employee health benefits do not cover such "off label" uses of the drugs, and the federal health plans consider a claim for off label prescriptions as a fraudulent claim. Of course, the FBI did not go after federal employees to get back the billions paid out for uncovered prescriptions, it went after the drug maker instead. Why file a hundred thousand lawsuits when just one will do the same work?
Many patients across the country take prescriptions for off label conditions, including certain so called "orphan drugs" which are labeled for only one obscure use, but which have proven vital in treating other conditions. Blue Cross/Blue Shield and other private health plans will pay patient claims for such prescriptions, but the government employee health plans will not. Just as one example, patients with end stage liver disease have been treated for a long time with a drug called Rifaxamin, an antibiotic labeled for treatment of traveler's diarrhea caused by E. coli. The antibiotic is effective for this use since it stays inside the intestinal tract, instead of passing into the patient's bloodstream. Because Rifaxamin kills the intestinal bacteria which produce ammonia in the gut, it has proven effective to treat ammonia induced brain swelling in patients with end stage liver disease, but it was not until 1998 that FDA granted Rifaxamin orphan drug status for this use. Under the federal health plan's approach to drug coverage, all claims from end stage liver disease patients for buying Rifaxamin prescribed by their doctors before 1998 would have been denied, condemning the patients to perpetual confusion and loss of the ability to recognize their friends and family members, or to know what is going on around them, much like an Alzheimer's disease sufferer.
Obama says his health care plan won't interfere with your treatment if you like the doctor you have, but how can this be true when the government intends to stop the payment for "off label" drug prescriptions, even in cases where both the patient and the doctor believe the off label use is in fact helping the patient improve his or her condition?