Posts Tagged 'vioxx'

One-Third of Readers Will Shake Their Heads

I read news reports relating to health and medicine every day. Many of them are medical research study reports — usually interesting — but they also make me question how they are being interpreted.

Here’s what I mean: We are a nation of statistics, and statistics are the standard of proof. They are the foundation for evidence-based medicine, which is becoming the standard of care. In each of the medical research study reports I cite below, you’ll find statistics as findings:

Causes of Death are Linked to a Person’s Weight from the New York Times

America May Over Vaccinate from the Science Times

Heart Devices Zapped by Patient Studies from CNN

Sleepless? Maybe It’s Your Statin from Reuters

Here’s the problem I see: in each case, there is a percentage of patients the studied drug or device DID help, and a percentage of patients it did NOT. But the conclusions always seem to suggest that whatever the majority is, will rule. And once the majority rules, the drug or device may disappear for other’s use.

That’s a shame, because if you are the person that drug or device helped, but the majority were NOT helped, then it might be pulled from the market, and you may no longer have access to it. That doesn’t account for the fact that no two human bodies are exactly the same, and we can’t expect each person’s system to react the same way as someone else’s. (This doesn’t even begin to account for the studies that are not objective, or are flawed in their theories, to begin with.)

Medical research is finally beginning to recognize this on a big scale. Studies are showing that female bodies don’t react the same way as men (the symptoms of heart disease are a good example) and that children’s bodies don’t react as “smaller adults.” (the problems with children and adult antidepressants showcase this.)  Further, drugs are being prescribed “off label” meaning they were FDA approved for one medical problem but benefits for another medical problem were discovered.

So what’s the point? Evidence-based medicine should continue to be a scientific process with translatable results across the various segments of our population, as it is.  But the FDA and those who prescribe drugs need to remember that evidence based medicine is not intended to be a democratic process. We need to allow for individual differences.  So just because a drug or device doesn’t help the majority, it doesn’t mean it isn’t a viable answer.

I’ll even go so far as to say that if this recognition might have brought Vioxx to the market differently.  If Merck had admitted problems with Vioxx in some populations prior to sending it to the marketplace, those who found relief from the use of Vioxx might still have access to it today.

Here’s the article that illustrates this problem the best:

Study: A Third of Medical Studies are Wrong

It’s a little like the advertising truism, “Fifty percent of advertising works, I just don’t know which fifty percent it is.”

Point made.

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Patients: Report Problem Pharma Drugs

Were you a victim of the Vioxx deceptions? Did you ever take Phen Fen or Ketek or Avandia, only to find out you were at increased risk for heart attack or stroke or liver damage — or whatever medical horror may have been the true result of taking the drug?

I could write reams about how these drugs get through the approval process to begin with — but that’s not what will help patients today. Instead, I’m going to tell you about a new resource that involves patients and can benefit patients — one of my favorite kinds of resources!

You won’t find much promotion on this blog — and you never find it in my columns. I just don’t see enough products or services that I think are worth promoting on this website. But last week I heard from some folks who have launched a new website called www.iGuard.org. As near as I can tell, this one can be a winner.

Some background: the Food and Drug Administration (FDA) is the keeper of all pharm drug info. It is up to the FDA to review all drugs and approve or disapprove their ability to be prescribed and sold in the US. Patient-consumers can keep track of those processes on one part of the FDA’s website called MedWatch.

When patients are prescribed a drug that causes them side effects or “adverse reactions,” in particular those that are undocumented for that drug, patients can go to the MedWatch website and report those problems. What happens from there? Not much. The FDA may use the information, but patients aren’t notified, nor can they provide additional input. Eventually, if enough problems are reported by other patients or doctors or hospitals or whatever — then there may be some further research into potential problems with that drug.

That seems like a huge IF to me.

Along comes iGuard.org . A registered patient can upload a list of the drugs they are taking, and reports about those drugs will be sent to them. Included are any pharm drugs, over the counter, supplements, natural remedies, illegal drugs — even caffeine and other substances.

Further, if a patient experiences any problems in taking that drug, the patient can report them back to iGuard.

Yes — patients can participate, and see some results! Unlike MedWatch, there will be feedback as updates sent to the patient when problems are identified.

I tried it myself. I set up a profile — which is done by email address and did NOT ask me for personal information (very good). I got two reports back on each of the drugs I take daily. I was asked to input the name of my doctor so they could report to my doctor. I chose not to do that.

I’m told by the iGuard folks that they gather information from MedWatch, manufacturers and scientific literature.

I did have some pointed questions for them — always keeping that “healthcare is about money” mentality…. how is iGuard paid for? It’s a free service for patients, but of course they need to make their money somewhere.

Their reply, “iGuard received seed funding from Quintiles Transnational Corp and launched in 2007 as a wholly owned subsidiary. It will be funded through the provision of customized research and risk management services utilizing the de-identified data collected from iGuard users. iGuard was launched in 2007 as a wholly owned subsidiary of Quintiles Transnational Corp., the world’s leading clinical research organizations.”

So what does that mean? It means they will be selling the information they gather to certain organizations that are interested (probably health insurance companies) BUT that the information won’t be identified with any certain person (de-identified.)

If you are a patient who is concerned that you may be taking drugs that are causing you problems they shouldn’t cause, or if you have been prescribed a drug that is newly on the market and you are concerned that problems could be identified down the road, this can be a good service for you.

If you have more questions about iGuard, they are doing a webcast and you can participate this Thursday (10/4) at 2 PM eastern. Link here.

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