We've done many columns on the risks and dangers of new drugs, and here is another variation on that theme - off-label use of drugs. That refers to drugs approved for one reason, but used for another reason unapproved by the FDA. The off-label drugs may even be riskier than the new drugs, which at least have been approved by the FDA.
Off-label use is commonplace, but it is not based on scientific study and has not gone through the FDA-approval process involving clinical trials. But under the law, doctors can prescribe any drug for an unapproved use. That rule is based on the concept that the FDA does not regulate the practice of medicine, and can't tell doctors what to prescribe. In fact, at times, it seems no one regulates the practice of medicine.
The doctor may go to an off-label use based on his theories about the drug, based on his experience with the drug and also based on recommendations from those touting the drug, or on anything else.
Now, there's new proof that, whatever intuition or other powers doctors draw on when making off-label prescriptions, they sometimes miss the mark.
A common off-label use for three drugs in the class called atypical antipsychotics is to treat agitation and aggression of Alzheimer's patients. The new study finds that the drugs are no more effective than placebos, but in addition, they can cause serious and even fatal adverse effects. In other words, the three drugs are worse than nothing.
Here are the names of those three drugs: Zyprexa, Risperdal and Seroquel. Those drugs, for on-label and off-label uses, ring up about $2 billion in sales a year. This new study passed no judgment on these drugs when used for approved purposes.
According to one published report, the drugs are prescribed on this off-label basis because families are so desperate to try to help an Alzheimer's victim, because the drugs seem to help once in a while, because company-sponsored doctors are out pushing the off-label uses and perhaps because doctors often prescribe ineffective and/or unsafe drugs.
I found this great revelation from this study published in the New England Journal of Medicine so interesting because, for years, doctors have been indicating these drugs are of little value and, their benefits, if any, are so negligible as not to be worth the risk of adverse effects, which include increased risk of death (compared to a placebo), sedation and confusion causing increased risk of falls and, in the case of Zyprexa and Risperdal, tremors and other Parkinson-like symptoms.
Another interesting aspect of the study involves the sponsor. The sponsor that financed the study is the National Institute of Mental Health. If this agency did not finance the study, the virtually useless and sometimes dangerous use of these drugs would probably have continued for many years, if not decades. You can be sure the drug industry is not likely to finance any after-approval-of-the-drug study to see if one of its products works or doesn't work. Perhaps an outcome, like the one in question, would be too likely for its tastes.
Still another interesting aspect of the study relates to the prescribing information, which states that patients with Alzheimer's-related psychosis "are at increased risk of death compared to placebo." This suggests that doctors either don't read prescribing information or don't consider death such a big deal when dealing with Alzheimer's patients.
In a published report in The New York Times, Dr. Gary Kennedy, director of geriatric psychiatry at Montefiore Medical Center in the Bronx, observed that the drugs produce improvement that is modest at best, but that environment and behavior are more important in managing the combative behaviors of the patients (which the drugs are used to control). But the health delivery system is so obsessed with drugs that managing environment, behavior and other variables is not high on the priority list, even if such action would produce better outcomes. Prescribing and testing take the place of many things, including managing environment and behavior and talking to patients. It's much easier to write a prescription, especially when the prescribing pen is pushed by the marketing and legalized bribery of the drug industry, than to explore other more promising approaches.
Another expert, Dr. Jason Karlawish of the University of Pennsylvania, says the three drugs may be of use for "a subgroup of patients who can tolerate them, and in facilities that have the expertise to manage side effects." It would be reassuring to think that all facilities would have expertise to manage the side effects of drugs they give their patients, but apparently that is not the case.
Still another point of interest is that the study in question is the third in a series that finds this class of drugs, the atypical antipsychotics, is not as safe as are usually portrayed. When it comes to drugs, what else is new?
Finally, some observers say this study proves we need more research on how to handle the behavioral problems of Alzheimer's. My guess is this conclusion could have been reached by anyone of modest intelligence without the benefit of this study.

Labels: No Prescription, Online Pharmacy, Prescription Drugs