Posts Tagged FDA

FDA Tells Merck “NO” — Twice Burned, Twice Shy?

A few weeks ago, the FDA refused Merck Pharmaceuticals permission to sell a newly developed drug called MK-0524A  that combines niacin and a cholesterol drug . Today we learn that Merck has now stopped trials of the drug.

As you know if you read this blog or my other blogs regularly, Merck has been caught with its pants down twice in the past years — first with Vioxx, a pain-reducing drug that the FDA approved, not knowing that Merck had already learned that patients with pre-existing heart problems were dying after taking it. Merck is now paying out billions of dollars to the families of those who died, or people who got sicker from taking Vioxx.

Then earlier this year, Merck, in cohoots with Shering Plough’s eager marketers, finally released study results that showed Vytorin — a very EXPENSIVE cholesterol reducing drug — didn’t work the way they anticipated, and no better than far less expensive cholesterol reducing drugs. At least Vytorin (so far) isn’t considered dangerous. It just doesn’t work like it should.

You know — once burned, twice shy. But now the FDA, and Americans who took those Merck drugs have been burned twice (that we know about!)…. I wonder if this most recent denial of approval doesn’t reflect that?

Thank heavens the FDA is finally putting its foot down and not bowing to the big bucks of big pharma.

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Posted in: Health /Medical Consumerism, Healthcare Quality, Medical and Research Studies, Patient Advocacy, Patient Empowerment, Patient Safety

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Is the Federal Government Taking Away Your Patient Rights?

Kim Witczak, a fixer supreme, who has worked hard to protect others after losing her husband to prescription drug-induced suicide, has posted the second Every Patient’s Advocate Guest Blog Post — see it here.

Kim’s husband Woody was having trouble sleeping. His doctor prescribed Zoloft. Woody took his own life, and only later after doing some investigative work, did Kim learn that Pfizer, the manufacturer of Zoloft, knew that suicide was an adverse side effect of Zoloft. In order to get FDA approval to sell the drug, Pfizer covered up the studies that showed the suicide risk. Kim sued Pfizer and won the lawsuit.

Now it seems that drug companies are using FDA approval to stand between them and law suits. A recent ruling says patients who suffer from adverse events, even when they could not have known about possibilities because the drug companies withheld that information, cannot sue if the FDA gave approval.

So let’s think this through a minute…. the drug manufacturer lies by covering up patient deaths. The FDA approves the drug, because it doesn’t know the drug causes deaths. A patient takes the drug — and dies. And when a lawsuit ensues, the ruling is “sorry — since the FDA approved the drug, the patient has no case.”

Does this make sense to you? Read what Kim has to say about it. Then be outraged.

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Posted in: Health /Medical Consumerism, Healthcare Quality, Patient Advocacy, Patient Empowerment, Patient Safety, Pharmaceutical Drugs

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Prescription Drug Ads – Your Help Needed

What do you think of those prescription ads you see on TV, in magazines, newspapers and other places? Do you think they are helpful? Do you get frustrated because you know you can’t purchase those drugs directly anyway? Did you go to your doctor to ask about one of them? Do you think they are dangerous?

Prescription drug ads will be on TV for a long time. People may be objecting, but pharma is making a lot of money from them. I expect we’ll see many more of them, not fewer.

Truth is — if viewed in the right way, they can be useful. Unlike the dozens of anti-pharma folks who call for the demise of those ads, I say — if you can’t beat ’em, then learn about ’em.

And now, my friend Kim Witczak, founder of Woody Matters, has teamed with Consumer’s Union (non-profit publishers of Consumers Report) to petition the FDA to make these ads more helpful to consumers. It’s an idea borne of Kim’s wish to make drugs safer for Americans, based on the death of her husband, Woody, whose side effects from Zoloft caused him to take his own life.

The idea is that many side effects are unreported by drug companies, and the FDA can’t know about them unless those who take the drugs report them. (Don’t EVEN get me started on how that happens!) The proposal / petition asks for all pharma drug ads to include an 800 number and web address to report these problems as a part of the ad or commercial. Kinda like the warning on cigarette packaging — but even more useful because it’s a way we patients can really take action.

MedWatch is the FDA’s process for consumers to use to report their negative side effects and outcomes, but most consumers don’t know about it. The toll free number and web addresses already exist for reporting. (See below for that info.)

Consumer’s Union is hoping to garner 50,000 signatures — and you can easily sign right here online. You can take 30 seconds to say YES! to the idea of adding these two ways to report problems with drugs. Just follow this link to have your say.

……………………………………………..

Do you want to report side effects, problems or adverse events for a drug you take to the FDA?

Link here to MedWatch.

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Posted in: Health /Medical Consumerism, Healthcare Quality, Media, Medical Errors / Mistakes / Misdiagnosis, Patient Empowerment, Patient Safety, Patient Tools, Pharmaceutical Drugs, Politics and Medicine

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Disapprove of Drug Ads? Suffered Adverse Events? Do Something About Them!

I’ve told you before about one of my patient advocacy colleagues, Kim Witzcak. Kim’s husband, Woody, a vibrant, successful, energetic young man, committed suicide after being prescribed a drug to help him sleep. Since figuring out the basis for Woody’s complete change of personality — Zoloft — Kim has since campaigned to make the world more aware of problems in the American system of getting drugs approved — problems which have resulted in deaths and debilitations, like Woody’s.

One of Kim’s first successes was to get federal legislation passed that would require pharmaceutical companies to divulge ALL tests on drugs before they are approved by the FDA. In other words, companies like Merck, which covered up problems with Vioxx, and Glaxo Smith Kline, which it seems may have (this is not proven yet) covered up trial results for Paxil, will no longer be able to keep those cuprescription.gifresults from being public.

Now for round #2. This time Kim is working with Consumer’s Union on a new project — and you can help. This time she is taking on those ads you see on TV, in magazines, on the radio, and in other media for drugs that you can’t purchase without a prescription anyway. Those ads are never going to go away — because they work. BUT, they can carry with them a toll-free phone number and a link to a website to make it easier to report adverse events, meaning problems, for patients who experience bad outcomes from any of those drugs.

You can participate! And it won’t take you more than a minute. Consumer’s Union — the folks that bring you Consumer Reports — has set up an online petition. They hope for 50,000 signatures…. so log on right now and sign it.

Thanks to Kim for her diligence — AND the lives she may be saving. Another example of fixing.

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Posted in: Health /Medical Consumerism, Healthcare Quality, Media, Patient Empowerment, Pharmaceutical Drugs

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