This week’s HND piece explores a phenomenon that is more widespread than most people think. For starters, some estimates peg the extent of this practice at around 20 percent of all prescriptions written.
Not to make too fine a point of it, but since the use is off-label, by definition, there is little if any conventional scientific validation of these drug indications. Of course, given the state of science these days, as well as the politics of drug approvals, some of the best-selling FDA-approved drugs don’t have much science behind them, either.
For the most part, off-label use is based on plenty of anecdotal evidence that such practices are safe and effective—unless the off-label use is strictly driven by cost. Sadly, that is definitely the case regarding the off-label use of Avastin®—a cancer drug—instead of Lucentis®, for the treatment of neovascular (wet) age-related macular degeneration. Lucentis carries an FDA approval for this indication, and Avastin does not.
Be careful how you pick your fights. The FDA is in general a competent, rigorous, science-based agency. Even so, it’s clearly a version of government-managed health care — the government saying what patient gets what medication for what set of symptoms. It’s easily arguable that a doctor will necessarily know more about his patient’s condition than the government does. This suggests, at least, that prescribing off-label is not *automatically* a bad thing.
Eric–
Going off-label is definitely a bad thing if it is done only to save money. And, right back at you with “Be careful how you pick your fights.” You might be aware that to get a drug approved requires only the successful completion of two Phase III clinical trials. There is generally no limit on how many unsuccessful ones can be done, as long as the data is reported to the FDA.
That is the main reason that getting a drug approved is so expensive. It’s because most drugs are not terribly effective, and dozens of trials must be done to show any effect.
Also, while statins are approved because they do lower cholesterol, they do not lower the risk of heart disease except in a few narrow cases. Is that science?
The FDA is far too political and PC to do much good at this point—sad to say.
Get the government out of the doctor’s office.
Ban FDA and DEA. Let the pharmaceutical companies setup their own trade board for testing and certification.
I have a friend who was involved in a government suit over off-label use of his company’s drug. People’s lives were literally being saved, and the government wanted it stopped.