Minding The Pharm

With so many instructions and warnings on a bottle of prescription pills, one would think that the last person to disregard the intended use of a drug would be the doctor prescribing it. “Off-label” prescriptions are exactly that, and a number of legal cases are coming to trial because of the growing trend in pharmaceutical marketing of encouraging this practice.

Off-label prescriptions exist in a gray area of medicine. Birth control is regularly prescribed for minimizing menstrual cramps and clearing up acne. Rogaine’s use for baldness was prescribed off-label for years before the FDA approved it. So that while the practice is not in keeping with FDA regulations, some advocates claim that the practice is not necessarily illegal either.

James Beck, a defense attorney and co-author of the Drug and Device Law blog, claims that most off-label use is beneficial and it is only the few disasters that get noticed. In fact, in 2008 the FDA rules for the promotion of off-label drug use became lax, but the Obama administration has yet to review these new regulations.

However the cases that have come to trial have not been about doctors finding creative ways to treat patients; they are about corporate marketing systems designed to create new outlets for sales.

For example, in March, Johnson & Johnson was ordered to pay the state of West Virginia $3.95 million for misleading doctors about the risks and benefits of Risperdal, an antipsychotic. The pharmaceutical giant is facing an even larger case in Texas. (http://industry.bnet.com/pharma/10001223/jj-fined-5000-per-sales-rep-visit-for-risperdal-mismarketing/).

Currently, in this country, if a person or groups of people, are injured as a result of a drug (pharmaceutical) our tort system allows the injured party to sue the company for damages. As with any lawsuit for personal injury, there are several requirements that prevent the act of “suing” the company from becoming “frivolous”. The injury has to have caused damages and has to be as a result of the drug. (causation) Furthermore, it will have to be proved that the company knew of the problem and did nothing about it.

Until the lawsuit is filed, the pharmacuetical companies do not have to share any of what they knew or did not know about the problem with anyone. Problems with drugs in developement are supposed to be reported to the FDA but it has been shown time and again that is not always the case.

Now, there is a case in the Supreme Court, that has the potential to make pharmacuetical companies immune to lawsuits if a particular drug has already recieved FDA approval. The purpose of this blog is to discuss some of the problems in the current system and explain why this is a bad idea for comsumers. Read more at

In today’s prescription-drug marketplace competition is stiff for essentially the same population of patients. Only a fraction of the drugs seeking new drug approval offer a clear advantage of what is already on the market. Many of the other drugs are considered “me too” drugs because they are similar to those already on the market.

Examples of these drugs occur in many therapeutic classes- antidepressants, nonsteroidal antiimflammatory drugs, antiulcers drugs, osteoporosis drugs, etc.

Victory in these therapeutic- class wars can mean millions of dollars for a drug company. But for patients and providers it can mean misleading promotions, conflict of interests and increased cost for healthcare and sometime inappropriate prescribing. Read more about this in the New England Journal of Medicine.