November 18, 2004, Wonder Drugs That Make You Wonder
In some recent exchanges between yours truly and Granny, who, by profession, is a pharmacy technician, we learned from Granny that the recently-pulled-off-the-market arthritis drug Vioxx (from Merck... its stock price has suffered some...) was only the beginning.
We learn today from a respected scientist (and government drug reviewer), David Graham, that at least five more FDA-approved drugs pose imminent risks, and should be pulled off the market immediately. These drugs are Meridia (a weight-loss drug which creates risks of higher blood pressure and stroke among people taking it), Crestor (an anti-cholesterol drug that causes occurrence of renal failure and other serious side effects among people taking it, while two of three other statin competitors prevent heart attack and stroke and do not cause renal failure),
Accutane (an acne drug linked to birth defects; Graham said the drug represents a 20-year "regulatory failure" by the FDA and sales should be restricted immediately ), Bextra (a painkiller that Graham says poses the same heart attack and stroke risk as Vioxx) and Serevent (an asthma treatment that Graham says has shown, with 90 percent certainty in a long-term trial in England, to cause deaths due to asthma;"We've got case reports of people dying, clutching their Serevent inhaler," Graham said. "But Serevent is still on the market."). Drug makers defended the use and safety of their products, as did, of course, the pharmaceutical industry council, also known as the "Food and Drug Administration".
Graham contended the country is "virtually defenseless" against a repeat of the Vioxx debacle, because of hopeless conflicts within the FDA, and a defective mechanism to ensure drug safety. Naturally, Dr. Steven Galson of the FDA rejected that comment as having "no basis in fact." Merck & Co. previously pulled Vioxx from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.
Again, Granny believes this is the tip of the iceberg: no one (for example) is keeping track of the unbelievable number of possible adverse drug interactions, particularly from long term use, of the ever increasing and more complicated (and more profitable) group of wonder drugs.
To be fair, this has a number of factors driving it. Americans are always willing to reach for a magic pill to solve everything, even if prudence would dictate simply grinning and bearing the condition, or leading a simple, decent healthy lifestyle of reasonable diet, exercise, not smoking and so forth. Our perverse health care system will happily pay hundreds of dollars a month, forever, for the latest wonder drug, rather than far more reasonable costs of, say, a health club membership, or reasonable dietary counseling. And of course, we are obsessed with quick relief for everything... probably caused by our industrial-assembly-line public education system and hair-trigger attention spans caused by television (and the crap that's on it).
Well, the quick relief, it seems, presents far more problems than they solve, in many cases. As we obsess about this year's budget destroying gimmick, the Medicare "prescription drug benefit", perhaps we should consider whether this is "a benefit" at all to anyone... except pharmaceutical companies... at any level.
Anyway, since Americans clearly voted for a mandate against reality, there's no point in worrying about any of this for at least the next four years or so.
Comments
Tsk, tsk. Such sarcastic advice you give, young man.
If I were a) taking a Cox-2 inhibitor or b) a shareholder in Big Pharma I'd be looking to my hole card.
Posted by Linkmeister at November 19, 2004 1:02 AM
There're lots of things to dislike about both Big Pharma and the FDA, TD, but it's silly to suggest that "reasonable diet, exercise, not smoking and so forth" are a substitute for medication for such things as arthritis pain (Vioxx) and asthma (Serevent). Indeed, since you are a long-distance runner, I think there is a strong likelihood that in the next 15 years we'll have a chance to hear from you about whether "exercise," at least in its more extreme forms, was worth the severe pain of arthritis. Better start saving up for the knee surgery and hip replacements, Dude.
Drugs that work are truly wonderful things. Drugs that are rushed to market with inadequate testing or, worse, fraudulent research results, are a very bad thing. Just as with "reasonable diet, exercise," etc., there often are some trade-offs that need to be evaluated. Gosh, it's all so darned complicated.
Posted by mamayo at November 19, 2004 9:33 AM
Not saying that we need to go to an ascetic lifestyle, or Chinese herbs and Christian science reading rooms (unless you WANT to do those, of course, in which case, go for it!)
I AM saying that the United States ALONE (except for tiny New Zealand) is the only country that permits drug companies to legally advertise pharmaceuticals directly to the public; the public responds by DEMANDING that their doctors (who often have a waiting room full of patients!) prescribe the latest wonder drug they saw on t.v.
I am ALSO saying that a drug that causes more problems than it solves should be banned. Certainly people in severe pain should have relief available. No question. I certainly partake of pharmaceuticals, including prescription medicines, when I believe necessary (which is probably less often than most Americans).
But look at the list: accutane IS AN ACNE DRUG. ACNE for Christ's sake. If it caused, oh, itching or skin rash as a side effect, well... small price to pay. IT CAUSES BIRTH DEFECTS. FOR A COSMETIC, NO LESS! BIRTH DEFECTS-- when there are other remedies available without that side effect. And we have an asthma drug that either doesn't work, or worse, kills people with a side effect of... sEVERE ASTHMA.
That is my point.
We seem not to be doing a cost-benefit analysis of our national pharmaceutical addiction. Prescribe first ask questions later is problematic. I submit that as more and more of our GDP is siphoned directly to Big Pharma, and big Pharma in turn is making us sicker than healthier (or in any event, no healthier), and as side effects and interactions and all prove to become major health problems in their own right, these questions will have to be asked.
Posted by the talking dog at November 19, 2004 10:39 AM
In India, I once saw a single dose of Tetracycline save the life of a man who was severely ill and dying of fever. There are times when meds can save lives, just as surgery can.
Then there are unnecessary meds and unnecessary surgeries. And variations, more or less, in between.
Given that, I, like you, look to the larger picture. The demand for instant relief from pain, the cry for young beautiful skin, the fear of an injury that may take a few days to heal --all are part and parcel of our American personality. I want it, I want it perfect, I want it youthful and painless and I want it NOW. Adolescent.
The ultimate solution, then, is a general maturation of our American character. Which may or may not happen.
Posted by Sarah at November 19, 2004 11:07 AM
Well, TD,
I see that, like most dogs, you have the unique ability to kiss your own ass. Yes, you are wonderful, and will soon break the Two Hour Marathon. But some people do need drugs (ask my buddy, Rush), some drugs do work, and mom & pop are eating up both the product, and the shares of drug companies. We must shine a light on the FDA, and the lobbyists.
However, how do you manage to throw in the ubiquitous MANDATE, so that this, too, is Bush's fault?
The Accutane debacle has been going on for twenty years. Most of these questionable drugs were tested and/or approved prior to W. The bio-tech investment industry emerged and fluorished under Clinton in the 90s.
To lay this all on Bush's non-prescription drug addled head is, once again, overreaching and unfair.
Posted by They Call Me Mr. Crabcake at November 19, 2004 12:25 PM
Didn't you get the memo, Mr. C?
EVERYTHING is Bush's fault. From bad hair days, to foul weather, to my personal inadequacies as a human being... ALL BUSH'S FAULT... All of it.
He has a mandate, you know.
Posted by the talking dog at November 19, 2004 12:28 PM
heard u on the webcast wednesday night, great job!!! the host used to work on the clinton national steering com. great back and forth conversation and not the yelling and screaming on other talk shows. GO DOG GO!!!!!!!!!!!
Posted by Kristen at November 20, 2004 2:57 AM
I've taken Serevent. The effects of regular albuterol-type inhalers didn't last long enough. Serevent is long-acting. It seemed to me like a mircle drug at the time.
But it is also _not_ for treating acute ashthma attacks so the "We've got case reports of people dying, clutching their Serevent inhaler" scenario is someone's medication mistake, not evidence of a lethal side-effect as such.
This may well not undermine studies showing the danger of the medication. But the image you describe gives the wrong impression of what it is supposed to be for.
I was taken off Serevent when I discovered I was preganant, so I was only on it for a total of about 4 months.
Posted by Kathryn Cramer at December 1, 2004 7:43 AM
Kathryn--
Dr. Graham's observations re: Serevent, not my own (having never taken it myself); also-- Dr. Graham's opinion as to what the indications are for taking it, and not my own (again, I purport to be an expert on far too many things for which I have no qualification, but practicing medicine is not one of them).
For my own very occasional asthma, I use primatene tablets, or when necessary, a very hot cup of coffee (it actually works, as long as I don't need to get to sleep anytime soon).
BUT-- you raise the key point: the fact that there are specific indications for these medications that patients and/or their doctors feel free to willy/nilly ignore, and overprescribe strong drugs for mild conditions, or more common "milder" drugs for more chronic conditions. We have a problem. And it almost doesn't matter if the problem is that patients are demanding drugs they shouldn't (because of the ill-advised legalized prescription drug advertising), or if doctors don't understand all of the limits of the lates wonder drug the drug company detail man (or woman) has sold them that month.
The result is the same: drugs meant to cure or alleviate end up causing more harm than good. Right now, the insurance company cost driven priorities (and the Big Pharma advertising and American mentality) of get a pill for a quick fix, rather than potentially better treatment that might be a better fit for the patient and the condition, is only going to get worse, as I see it.
Posted by the talking dog at December 1, 2004 11:13 AM