Society, Treatment

Good Old Days of Meds Not So Good

Longing for the days of safe, reliable medications? A drug discovery researcher says those days never existed. The health risks of drugs like aspirin, penicillin and acetaminophen, he claims, are great enough that many older meds wouldn’t have received FDA approval. Some wouldn’t have even made it to FDA review.

He concludes with, “What are we to make of all this? It’s possible to be both glad and worried. We can be relieved that we’ve learned so much more about pharmacology, ensuring that the drugs that manage to gain approval today are the safer than ever. Or we can think about how people seem to use aspirin and the other legacy drugs anyway, safety problems and all, and wonder how many more useful medicines we’re losing by insisting on a higher bar.”

I lament how how often drugs are approved on on the market before serious health risks are found (or revealed). But before any product is marketed a company (and the FDA in this case) considers the known risks and benefits. If a drug or medical procedure potentially helps significantly more people than it might harm, the benefits may outweigh the costs. It’s the same approach that insurance companies use.

If someone accepts that’s medications can’t be totally harmless and chooses to take a drug anyway, shouldn’t he or she know all of the risks beforehand? Truly it wouldn’t be difficult for drug companies to hide information about a drug’s harmful effects in plain sight. Isn’t that what’s been done with aspirin?

via Kevin, MD and Medpundit

News & Research, Society

Conflicts of Interest & Drug Approval

Friday’s FDA approval of a new diabetes drug made by Bristol-Myers Squib raised questions about panel members’ conflicts of interest, writes the New York Times. The panel decided that the benefits of the drug outweighed the possible risks, which include potentially serious heart problems. They did this even though the only cardiologist on the panel wasn’t present because he has served as a consultant for the drug company.

There’s a similar story behind a Pfizer drug that was approved by the same panel on Wednesday.

In the article, the director of the Center for Science in the Public Interest’s Integrity in Science project is quoted as saying, “The public’s faith in the integrity of the process is undermined when one-third of an advisory committee’s membership has significant financial ties to the company seeking the product’s approval.”

Panel Backs Drugs Amid Conflict Concerns