FDA Approval: Good, Bad, or Just Ugly?

Hold on a moment: I’m donning my kid gloves to touch this one –- perhaps the most contentious issue in American medicine right now. The battle rages in the Senate as I write.

Is the FDA too fast or too slow to approve new drugs? Is their approval meaningful, or just a result of the strong arm of big pharma business and pork-barrel politics? Most importantly, how do I know the drugs my endocrinologist is prescribing are really safe?

One of the best articles I’ve read on this issue appeared last week in the San Francisco Chronicle. They explain the trade-offs between benefits and risks: Drug approval is an act of deciding whether the curative powers of a medicine are valuable enough to justify exposing a specific class of patients to the possible side effects… A drug with fairly severe side effects might be considered safe enough for patients with life-threatening conditions like cancer. But such risks would be unacceptable for a drug to treat the flu, for example.”

OK, I get that. What’s really scary is the recently exposed practice by drug manufacturers of “encouraging” doctors to prescribe drugs for additional, “non-approved” uses –- a way of maximizing profit before the drug is pulled from the market or falls out of favor. Neurontin (an epilepsy drug promoted for everything from migraines to hormone therapy) was the classic example. One can only hope that the $430 million settlement against Pfizer on Neurontin has scared other drug manufacturers off this practice!

I was also shocked to learn that the FDA announced creation of an independent drug safety board for the first time just a few weeks ago (!) –- with the operative word here being independent. That is, the new board will include both FDA officials and “medical oversight experts” from other government agencies like the Veterans Affairs Department, and it will –- in an innovative move –- actually consult with patient and consumer groups. There is also talk of a new consumer-friendly “Drug Watch” Web site offering easy access to new drug information.

The Web site sounds good. But let me get this straight… The FDA has been around for nearly 100 years, and is just now taking steps to create a safety review process that includes outside input? Talk about your old boys’ club! Fact is, the new board is only being established in reaction to the public outcry over the Vioxx fiasco.

Hard to believe, but the FDA’s existing Office of Drug Safety apparently monitors drugs only after they are licensed, and learns about adverse effects only through voluntary reports that come directly from drug manufacturers or patients and doctors willing to come forward with special appeals. This Office is currently under attack for lacking objectivity and resources, hence the new board, a pretense at opening up the previously closed-door drug evaluation process.

I say “pretense” because citizens’ groups are branding the move a “cruel hoax” –- a cosmetic fix without any fundamental change behind it. For one thing, the new board doesn’t include input from any outside advisory committees actually empowered to ask the tough questions. And who knows how this new board is going to effect speed?

The speed issue is actually quite the conundrum. Naturally, all the players are anxious for swift approval of drugs that promise relief to suffering people, but the fact is that the true long-term effects of new drugs can and will not be known for at least a decade or two. (DES is one good example.)

After years of complaints that the FDA was working too slowly, the Prescription Drug User Fee Act was introduced in 1992 to accelerate the process. Some groups, like the World Health Organization, are pushing for still-faster approval of “urgent” drugs such as generic AIDs medicines that can help infected people in poor countries to prolong their lives. This makes clear sense in terms of trade-offs.

But after the catastrophe with home-based drugs like Vioxx, Celebrex and Bextra –- proven to increase heart attack risk –- the FDA is now prolonging the evaluation process for numerous drugs, and manufacturers and many doctors are now decrying the “safety lag.”

When the FDA suspends drugs over safety concerns, as in the case of recent gene therapy experiments, such moves are often branded a “knee-jerk reaction” –- despite the Vioxx debacle. Go figure…

Upshot: I could go on for days about the complexities and fundamental faults of the FDA approvals process. Yes, big drug manufacturers are all-powerful, but they are slowly beginning to be called to the mat for their over-hyped products and dirty dealings. It’s going to be a long, painful road to an improved drug approvals process in this country (got Vioxx?). In the interim, nobody’s happy.

I suppose the best you can do as a patient right now is to take as few medications as humanly possible, and trust your instincts. This means picking doctors carefully, and doing some of your own research on the advice they give you. Or getting a second opinion if you suspect that recommended medicine might not be essential for you.

Meanwhile, the Senate Health, Education, Labor and Pensions Committee hearings about FDA effectiveness thunder on. You can watch the drama unfold in the headlines, or read up on “Five Ways to Fix the FDA” at Forbes.com. (Not as boring as it sounds; the articles are pretty concise).

Me? I’m keeping a close eye on Pfizer, seeking FDA approval of new inhalable insulin as of March 2. The FDA officials better darn well be removing their kid gloves in dealing with Pfizer on this one!

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One Response

  1. Jolene
    Jolene March 9, 2005 at 4:32 pm | | Reply

    I believe the FDA takes too long on some drugs, and not long enough on others. I also believe that there are too many drug companies with their hands in the pie so to speak.

    Outside of Type 2 diabetes, I have a thyroid condition. The main drug prescribed for people is Synthroid. Well –turns out that it had some serious problems, but the FDA didn’t do anything until the makers of Synthyroid were sued.

    I am too looking at this inhaled insulin issue. I hope it works – BUT I hope the FDA is sure when releases it, but doesn’t hold it back for 10 to 15 years when it could be used.

    As for the Vioxx issue — that I think had some dirty pool going on in a back room. Too many people don’t take medications as prescribed, and I think that’s what has happened here.

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