Posts Tagged 'FDA'

Psych Drugs, Shady Practices and One Fixer

In 2003, after taking Zoloft for six weeks to help him sleep, Woody Witczak, a vivacious, intelligent, energetic and happy man, hung himself — and died.

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Last evening I leafed through my December issue of Consumer Reports. There on page 65 was my friend and colleague Kim Witczak, Woody’s widow, and one of the most active fixers I know.

The article featured Kim’s work to clean up the rules by which drugs get approved by the FDA. Since Woody took his own life, and because it seemed so completely outside anything Woody ever would have done, Kim knew there must be some kind of dark force, some kind of shady coverup that contributed to the tragedy.

She learned several things. She learned that Zoloft is an antidepressant, not a sleep aid, and it had been prescribed to Woody “off-label.” Woody had just begun working at his dream job. His sleeping problems were related to his excitement and overwork — not depression problems. Kim questioned how Zoloft could have been prescribed for him.

Digging further, she learned a few things about Zoloft and even more about the FDA and its approval process for new drugs. Included were the following: pharmaceutical manufacturers could apply for approval to make drugs available to patients by showcasing only those clinical trials that show the drugs “work.” They were able to cover up any others that didn’t work out so favorably. Also, once a drug was approved, the FDA could request follow up studies, but had no way of enforcing those requests.

It also turns out that among the people who have the power to approve or disapprove any given drug, are people who may benefit financially from the sale of the drug. Think about that for a moment…. A panel of professionals is supposed to objectively determine whether a pharma company can make millions or billions of dollars on a drug — and some of those people will be the ones who make money when it’s sold.

Objective? I think not.

And here’s a big one, too — more than half the FDA’s budget for considering whether or not drugs should be approved comes from the fees paid to them by the pharma companies. So, when paired with the revelation above about who sits on the review panels?

Scary, isn’t it?

In September, the laws changed for how drugs will get approved, and what follow up will be required. The law goes into effect within 18 months. Kim was a large force in getting the changes made, as was Consumer’s Union, the publisher of Consumer Reports.

The changes affected were: All clinical trials used to prove a drug is — or isn’t — safe will be made public. There will be some new regulations on the drug ads we see. All print ads will have a toll free number and a web address to help consumers report problems. The numbers of reviewers on the approval panel with ties to drug companies will be reduced (but not eliminated). But no change has been made to how the FDA’s budget is put together — meaning — approvals will continue to be influenced by contributions made by the pharma companies seeking those approvals.

There’s not much of a message here for us as individual patients and consumers — except — to be thankful we have people like Kim Witczak who take their pain and suffering from the loss of a loved one and turn it away from blaming and into fixing. You can learn more at Kim’s website, WoodyMatters.org .

Healthcare will be safer because of Kim’s work, and that of Consumer’s Union, too. Fixers at their finest.

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Behind the Counter Drugs?

When the doctor wants us to take a certain drug, he provides us with a prescription, which we take to the pharmacist to fill.

When we decide on our own to take a drug, we go to the pharmacy to purchase it. It’s considered “over the counter” (OTC) because it’s sitting on a shelf, available to anyone who wants to purchase it. You may remember about a year ago finding fairly empty shelves in the cold and flu section…. it’s because there was an ingredient in those medicines that was being abused.

So now it looks like there may be a new, more formal designation for “behind the counter” (BTC) drugs — meaning — you won’t need a prescription, but you can’t just pick them up off a shelf either. If you want to purchase one of them, you’ll have to ask the pharmacist for permission. That’s what happened to those cold medicines last year. (And I think I remember in my youth (!) that condoms and pregnancy tests were kept there, too?)

The Food and Drug Administration is taking comments on this concept — they want to know what we think about the concept of behind the counter drugs. The drugs in question could range from some of the statins (cholesterol reducers like Lipitor), those cold medicines I mentioned above, insulin, even Viagra might end up BTC.

A bit of background research tells me that locally based pharmacies think it’s a great idea — no doubt it’s the trust factor. Patients, in particular those without health insurance, think it’s a good idea. Big box pharmacies are afraid of the logistics. OTC manufacturers whose drugs would end up BTC aren’t happy at all. Doctors don’t like the idea because it takes some prescribing out of their control.

Learn more about the pros and cons and other’s opinions at Pharmalot.

What do you think? Let the FDA know: http://www.fda.gov/oc/op/btc/

This is your chance to be heard!

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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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Kids, Colds and Bad Assumptions

Sometimes my best contribution to the topic of the dysfunction of the American health care system has more to do with asking questions that can’t be answered than providing answers. Remember — I’m not a medical professional. I’m simply an empowered patient who reflects on this dysfunction daily.

This week there was a sudden flurry of concern about cold medicines for children. These are medicines that have existed for years and years — I gave them to my daughters when they were young children, and they are adults now! However, now parents are being told these drugs may be dangerous, and some drugmakers are withdrawing cold medicines for infants from store shelves.

This week I interviewed Dr. Thomas Welch, a pediatrician from University Hospital in Syracuse for my radio show. He talked about the evidence which seems to show no benefit to these medicines for children, and even suggested they may not be effective for adults. I inquired about my own experience — when one of my children would begin a coughing spasm in the middle of the night, I could give her some medicine and she would stop coughing and eventually go back to sleep. Dr. Welch suggested it worked because I was interrupting her sleep, giving her hugs and kisses, perhaps a glass of water to go along with the medicine; in short, because it was an interruption in the coughing pattern, her coughing stopped. It wasn’t the medicine, according the Dr. Welch.

The fact that these medicines have been sold for so long begins to raise some questions about all kinds of assumptions we, as patients, need to be concerned with.

1. Why have we continued to assume that drugs tested and approved for adults would be just as good for kids? Dr. Welch explained that because childrens’ physiology is different, then the drugs’ effects would be different, too. that makes perfect sense — so why hasn’t anyone questioned this before?

2. So doesn’t this mean, then, that cold medicines are just the beginning? What other drugs are we giving to children, not really knowing how children will be affected, and in what different kinds of ways from adults? I know that there are big questions about drugs related to mental health. It seems like this will be the tip of the iceberg.

3. Doesn’t this also bring to mind the question of what drugs and other treatments (and symptoms and everything else) that have been studied and followed in men, do not affect women in the same ways? I wonder if we should now be looking at cold medicine that has been tested on men — should it now be tested separately on women?

4. And then, too, whether girl children react differently from boy children?

5. What about people from different cultures? Do they react differently from each other?

6. So now we’re learning not only that these cold drugs may be ineffectual, but in some cases they may be harmful, too. Isn’t it interesting that as long as they were simply harmless, the drug companies were more than willing to let us keep spending those billions of dollars for their profits — but now that they may be considered harmful (as in — now that they fear a lawsuit over some of the deaths that have occurred) — NOW they want to back them off the shelves?

And for heaven’s sake — why is it that a patient is asking these questions? Why isn’t the FDA asking these questions? I’m not the scientist, and I’m not the manufacturer — but now I wonder just what drugs I can trust!

What does all this mean for patients?

It means we must begin to examine the drugs we decide to take, whether they are prescription or over the counter. If you are female, and are prescribed a drug that can be given to either gender, you should be asking the gender of the people it was tested on. If all the tests were run on men? Well then — don’t let your doctor suggest to you that it will work on you, too — because your doctor can’t know that for sure. That may be true for heart drugs — we’ve read quite a bit in recent years about the assumptions for women being based on testing for men, and that they are not the same.

And men — same thing. Many osteoporosis drugs, for example, have been tested extensively on women. Do you know if the drug you’re taking for bone loss was also tested on men? What makes you think it will work?

And for all of us — if you need to give your child a drug, find out if it has been tested and approved specifically for children (and perhaps, if necessary for children who match your child’s gender.)

You know what they say about assuming things, right? Well guess what. We’ve all been caught in this one.

I’ve said it before: Trust, but verify.

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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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