Since 1961, Consumers Digest has devoted the time and effort to evaluate dozens of products in myriad categories to whittle down to the very best values that are on the market at various price points. Our editors also have applied the same energy and resources to the investigation of consumer services. These include personal finance, travel and health issues. Solid examples of the latter are our special report on providers of drug/alcohol rehab; the identification of the good and bad of online medical advice and medical mobile applications; our dissection of the Obama administration’s health-care-reform initiatives; and the revelations from our investigation of how doctors are courted by drugmakers. In this issue, we press on in the vein of the latter by pursuing the truth about so-called off-label prescriptions. We’re certain that you’ll find what we uncovered to be troubling.
In “A Dangerous Practice: How Drug Companies Bend FDA Rules,” we expose how makers of bona fide medications that are approved for use to treat a disease or condition take advantage of regulatory shortcomings to expand the use to ailments other than those which were approved by FDA. This isn’t to say that off-label prescription of medications is patently wrong. In fact, it can be indispensable. Unfortunately, we worry that the cases of inappropriate—dare we say negligent, at times—behavior outnumber the examples of legitimate expanded use. This includes deceptive research practices in which data are manipulated to produce positive findings for the off-label use.
Equally infuriating is Food and Drug Administration’s lack of a sense of urgency in regard to addressing off-label prescription abuse. An FDA spokesperson was told of our concerns and was asked whether the agency would bolster its drug-approval process to close loopholes that permit deception. The FDA representative answered only by stating that FDA would continue to enforce existing provisions—the same provisions that drugmakers are skirting.
What’s worse: If the Supreme Court decides to look into drugmakers’ free-speech rights to make claims in regard to off-label prescriptions, it very well might rule in favor of drugmakers. If it does rule on behalf of drugmakers, watch out. FDA’s system, which is designed to protect consumers against unscrupulous medication sales, might be put on life-support. An expert whom we interviewed told us that consumers would face “a perfect storm” when it comes to off-label medication use. That would increase the importance of what we urge you to do right now: Ask your doctor whether the medication that he/she prescribes to you is for on-label or off-label use. If your doctor prescribes off-label, ask why. If your doctor’s response leaves you unconvinced, don’t hesitate to ask your pharmacist. Finally, don’t hesitate to tell your doctor that you’d prefer an on-label prescription.
Maintaining your health and well-being is challenging enough. The prospect that your doctor will prescribe a medication for any reason other than because it’s the best option only exacerbates things.
If you want to read the reports that we note above, go to ConsumersDigest.com to find them and more.