Diabetes Drugs and Safety: A New FDA Report
Reprinted with permission of Amy Tenderich of www.diabetesmine.com.
How safe are the medicines we're all taking? Who's to know? As good Americans, we tend to put our faith in the system and assume that the authorities have it covered. After all, they'd get sued or something if this stuff wasn't safe, wouldn't they?
A few recent headlines have shaken my blind faith in drug safety:
* A front page feature in the San Francisco Chronicle last week about online pharmacies selling imported medicines for cheap. And I don't mean ordering some no-label stuff from some cloaked online vendor listing no physical location. This story's about a 31-year-old entrepreneur out of SF who now fills 1,000 medicine orders a month through his site, ProgressiveRx. He started the site when his brother and aunt lost their jobs and health insurance, and a friend was diagnosed with Lou Gehrig's disease. The best of intentions...
But "the practice of importing (FDA) unapproved drugs from other countries is technically illegal" so he's had to use a number of legal loopholes, including purchasing his goods from Asia's largest health care provider, since he can't buy directly from Indian drug manufacturers. The article notes that while this web provider takes great pains to ensure product quality, "as much as 20 percent of the medicines sold in India is fake," and cites the Organization for Economic Cooperation and Development stating that 75 percent of the world's bogus drugs originate in India.
I'm not pointing fingers here, but just pointing out that in our quest for more affordable medicines, we're running a high risk of buying - and taking - a bunch of veritable snake oil. Not good.
* Possibly more disturbing is Scott Strumello's frustrated criticism of the ADA for their
"deafening silence" on a recent call for input on guiding diabetes treatments. First off, he calls attention to a new FDA report about that agency's internal problems and resulting inability to properly review the safety of food and medicines in this country. It looked it up.
Major findings No.s 1-3:
1) The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
2) The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability
3) The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate
As of this month, however, the FDA is taking steps to remedy itself with a "multi-year hiring scheme" and "wide sweeping plans to improve" its efforts.
OK, helpful. But in the meantime, Scott points out that the ADA has also failed to fulfill its mission by refraining from reacting or submitting any statements when the FDA recently solicited public comments on the Agency's Draft Guidance for Diabetes Treatments.
"How can an organization whose 501(C)3 status claims that its mission statement is ‘to prevent and cure diabetes and to improve the lives of all people affected by diabetes' have remained silent on this issue?" he asks.
My question is: If the FDA is bottoming out and the ADA isn't speaking out, who's looking out for our safety as all these new medicines hit market?!
* Finally, there's the issue of drug interactions. How does your Aunt Bessie know if her heart medication is incompatible with her various inhalers or that blood thinner she's taking?
According to this ABC News story, a new study shows that more than half of all insured Americans are taking prescription medicines regularly for chronic health problems. "Some of them are on 10 to 15 different medications. They could be going to different types of doctors, a lot of drug therapy," says Los Angeles Pharmacist Harold Capeloto.
Naturally, a number of new Health 2.0 websites have popped up to fill this market niche. Among them are DoubleCheckMD.com; the brand new site eHealthMe.com for both generic and brand name drugs; and a user-ratings site called HealthGrades.com.
I have two worries about this:
1) the people who need this information most are probably the least likely to find and use slick new Health 2.0 websites (think Aunt Bessie).
2) This doesn't account for so-called "off-label" use of drugs, meaning when doctors are encouraged to prescribe meds for additional conditions the drug wasn't really meant for.
For example, when my carpal tunnel was at its worst, the orthopedist suggested I try Nuerontin, which I looked up and was horrified to find was developed for the treatment of epilepsy. Later it turned out that Nuerontin was a classic off-label use drug scandal.
So what I'm saying is, you could easily end up experiencing some nasty side effects or drug interactions from a medicine you had no business taking in the first place.
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This is a rather depressing post for a Monday, sorry. But having looked into this, I just had to share; I'm feeling all jittery about this topic now. Oooh, maybe it's one or more of those prescription drugs I'm taking (Detrol, Diflucan, Zyrtec, Levoxyl, or Oxytrol, anyone?)