Drug Safety Jitters

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

OMG!

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.