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.
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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