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.
Psych Drugs, Shady Practices and One Fixer
Published November 29, 2007 Blamers and Fixers , Death , Health , Health /Medical Consumerism , Healthcare Quality , Medical and Research Studies , Medical Commentary , Medical Errors and Mistakes / Misdiagnosis , Medical News , Patient Empowerment , Patient Safety , Patient Tools , Patients , Patientude , Pharmaceutical Drugs Leave a CommentTags: consumers union, drug advertising, FDA, Kim Witczak, Zoloft
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.
…………………..
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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