May 27, 2007

My Agenda: Why I Crusade against Dangerous Drugs

As a result of my postings about Avandia and Actos I've been accused by the moderator of the American Diabetes Association discussion board (in a private email) of having an "agenda." Well, I do have one-- it is keeping people healthy. And as long as the American Diabetes Association continues to give patients advice that damages their health, my "agenda" will annoy them.

The ADA's latest move was this: As soon as the news of Avandia's possible lethal side effects was broken by the far-from-hot-headed New England Journal of Medicine, the ADA immediately announced to the major media that patients should keep taking Avandia. This response was so swift that it is not possible that anyone at the ADA had actually analyzed the findings published by the NEJM--findings, which were, as it turned out, found to have been confirmed by independent studies run by the FDA. Clearly, the interests of the ADA's Big Pharma contributors, once again, trumped those of us poor schnooks with diabetes.

But because I do write about dangerous drugs a lot and ask a lot of questions, publicly, about new drugs, so that it is understandable that people might think that I do have an "attitude," I would like to explain why I have spent the last couple years collecting research data about the drugs prescribed to people with diabetes and posting warning about the drugs that can be dangerous.

Contrary to what you might think, I do not categorically think all drugs are bad. What I do think is that most drugs approved in the last decade are poorly understood, and that many of them do have serious and even lethal side effects that people ought to know about before they take them.

A serious side effect may only affect .01% of all the people who take a drug, but when a million people take a drug, that is 1,000 people, and if you are one of those unlucky 1,000, you are going to wish that someone had prevented it from ruining your life. At a minimum, you are going to wish that someone had told you that the side effect could happen and which people were more likely to experience it, so that it wasn't, as is so often the case, a complete and ugly surprise. But our current system of drug regulation ensures that you are very unlikely to know anything about any drug side effect no matter how serious that only affects a couple thousand people.

I learned this the hard way. I suffered a permanent side effect--loud and permanent ringing in my ears--after being given a prescription NSAID, Clinoril/Sulindac, 10 years ago by a doctor who wasn't aware that this side effect was possible. Even worse, I had a warning sign--an early episode of ringing in the ears which went away when I stopped the drug--which I reported to my doctor, who nevertheless assured me that I should just take a lower dose of the drug. I did, and 1/2 of one more pill was all it took to leave me with a lifetime of shrill squealing ears.

When my tinnitus struck, I was told by my doctor that my reaction to this drug was "extremely rare." But when I researched it, I discovered this wasn't true. There were other people all over the web who had undergone the same experience as I did, and even some in my local area. The problem was that each of their doctors thought that their experience was "rare" and did not report it to the FDA. So while hundreds of people around the country developing permanent tinnitus as a result of the drug I took and those closely related to it, doctors continue to prescribe it and ignore any early warning signs their patients might report. And people continue to develop permanent tinnitus from it.

That's why my mission now is to make sure that people can learn what the latest information is about dangerous side effects of the drugs they take, so that if they do experience an early warning sign, they'll be able to stop the drug before it goes on to cause permanent harm.

This should be what doctors do, but since doctors are too overwhelmed to be able to take the time to keep up with the research on the hundreds of conditions they treat and rely almost entirely on the drug companies to "educate" them about the dozens of new drugs that come on the market, those of us in the patient community must step in and do it ourselves.

The truth is that the information about the side effects of any drug less than a decade old is very incomplete. The drugs most people take now are approved after being tested for only two or three years in clinical trials in human populations. But if we judged the safety of cigarette smoking using 2 years of data, we'd conclude that cigarettes were a perfect diet aid which improved mood. It's only when you look at the results of 10 years of smoking data that you start seeing the cancer, lung disease and heart attacks.

The new drugs on the market are also in many cases more complex than those of the past. Like Avandia, they have been engineered to work on enzymes and receptors found throughout the body whose functions outside of their impact on blood sugar are often not well understood. To get a new drug approved, a drug company only has to submit data that shows that the new drug is effective for a single purpose. They do not have to investigate its effect on the many other organs throughout the body that use the same receptors and enzymes. They have to report on side effects found in more than 1% of people taking the drug, they must check how the drug interacts with a couple well known drugs that affect specific liver enzymes , and they must run some basic, but by no means comprehensive, tests for carcinogenicity. That's it.

Once a drug is on the market it will take a long time until even the most dangerous long term side effects are discovered, because the drug companies have ensured that there are no effective system in place to track after-market experience. A person with diabetes who dies of a heart attack, well, that's not likely to be reported as a side effect because people with diabetes are expected to die of heart attacks. You need to look at carefully screened data covering many thousands of people to detect "excess" deaths attributable to a diabetes drug. Not so surprisingly, after the experience with Vioxx and now Avandia, once they have gotten a new drug through the approval process, it is likely the big drug companies are never again going to fund the large expensive studies that might reveal the hidden cost of their profitable drugs.

So that's my "agenda." Getting the word out about stuff that can really hurt you. I don't earn a penny from any of my diabetes activities. You'll find no drug company ads on my site, unlike those of many better known diabetes bloggers. But I do hope that if you visit What They Don't Tell You About Diabetes you might just find a nugget of information that will help you live a longer, healthier life.


Anonymous said...

Keep up the important work!

Anonymous said...

From time to time I comment on the forum of 'though I more than often read daily (I'm RamonaNotthePest). I really appreciate your dedication to truth in setting the record straight on "drugs" and the stats folks put out trying to obscure the "real deal."

Thank you


Anonymous said...

You go, girl!

I feel like going out and buying one of your books, even though I have zero interest in the computer business.

Anonymous said...

I'm grateful you have your "agenda."

Please tell me the drug that gave you tinnitus was not Altace!

Jenny said...


The drug that gave me tinnitus was Clinoril (Sulindac) which is a prescription strength NSAID.

Anonymous said...

Thanks for revealing the name of the drug. Tinnitus is listed as a side effect of Altace, which so far seems to be the only antihypertensive that I can tolerate, that actually works for me. Needless to say, I'm a little nervous about it!

Anonymous said...

The ADA did not say that patients should keep taking Avandia. Here is what they said (along with the AHA etc.)

"In the meantime, patients using this drug should talk to their health care provider to determine the most appropriate course of action. Patients should not stop taking any prescribed medications without first discussing the issue with their health care provider. Further research will be needed in this area to provide conclusive evidence."

As for your agenda, it seems like you want clinical tests lasting 10 years, and even a side effect that impacts .01% of people (and in that range, there is bound to be lots of statistical noise). If all drugs were tested like that, there would be no new drugs on the market or each drug would cost $10K a dose. WHo's going to pay for that ? YOu ?

Anonymous said...

"If all drugs were tested like that, there would be no new drugs on the market or each drug would cost $10K a dose. WHo's going to pay for that ? YOu ?"

Is it better to pay with your life or your health? We might be better off with fewer drugs prescribed freely when they aren't more clearly needed or the risks outweigh the benefits.

sandradalton said...

I love what you're doing, getting the word out about dangerous medications.

"Anonymous" brings up an important point about slowing down the approval process, as well.

Both problems could be addressed by giving the patient more information, and letting individuals decide how much risk they are willing to take.

People who are dying should not be denied the chance to get well or live longer, simply because a drug may not be safe.

Everyone deserves to know the truth and the risks associated with the drugs that they choose to take, even if the risk can only be described as, "this is so new, we don't know what kind of side effects it may have."

It's really about full disclosure and the right to choose. Currently we take a blind gamble every time we accept a so-called safe medication, and people in need of groundbreaking drugs are dying while they wait for approval. Neither is necessary.