How will you be affected by the latest FDA mix-up?

The FDA recommends consumers don't go outside of the US to buy less expensive prescriptions but............ Come on FDA, just do your job.


Even I've grown tired of hearing myself beat on the U.S. Food and Drug Administration (FDA). Believe me, I'd like to lay off these guys, but they keep making the gaffes that make me nuts. And I feel compelled to pass this info on to you because everyone should know that the government agency that's allegedly responsible for protecting is often, well … out to lunch.

And this time, it's a big screw up.

The good news is that FDA officials were in China to look into the safety of a Chinese- made drug that's found in heparin, a blood thinner made by Baxter International, that's been linked to four deaths due to allergic reactions. The bad news? They actually evaluated the wrong factory.

The next time you reach for your prescription bottle, remember that it's been approved by the Keystone Kops.

Instead of inspecting the suspect manufacturer, the FDA confused it with another company in the agency's database that has a similar name. Worse still, even though they THOUGHT they had the suspect company, the company that they were inspecting had a history of positive inspections … SO THEY DIDN'T RE-INSPECT IT. You can't make this stuff up, unfortunately.

After discovering the error a month after the fact, the FDA immediately dispatched investigators to the suspect company.

Keeping in mind that there are over 2,000 characters in written Chinese and who knows how many dialects of that language, I'm inclined to say that it was an honest mistake for Western bureaucrats to get a little mixed up with the name of a Chinese company. Given all the recent news stories about shoddy and potentially deadly products from China that have been finding their way into America, it's hard to believe that the FDA wouldn't check and triple check the DRUGS coming from the same place—ESPECIALLY when the ingredient in question could possibly be linked to DEATHS.

In my opinion, the U.S. government should have immediately banned ALL Chinese imports the second the first tube of poisoned toothpaste was discovered. But of course, that would cost big business too much money. And you know that Big Pharma has repeatedly assured their friends in the FDA that the Chinese companies who supply many ingredients to for Big Pharma's vastly lucrative drug brands (at cut-rate prices) are surely on the up-and-up.

So of course the FDA had no need or desire to do the most logical thing: RE-INSPECT EVERY SINGLE CHINESE DRUG PLANT THAT EXPORTS INGREDIENTS TO THE US. And to halt the sale of drugs containing those ingredients until, in the case of heparin, the source of the allergic reactions that caused the deaths could be determined.

Am I naïve to think that the government agency charged with the inspection of drugs sold in the U.S. should do their job? To be fair, the FDA did tell physicians across the country to immediately cease the use of the Baxter's brand of heparin, which has had as many as 350 reported cases of side effects in just 2008 (there were 100 reported cases last year). And Baxter has recalled nine lots of the injectable drug and stopped production while the source of the allergic reactions is investigated.

But like so much with the FDA and Big Pharma, the measures are just temporary and don't go far enough. I write so many negative things about the FDA and Big Pharma that you may get the impression that I think they're out to harm people. I know that's not the case. And I'm not at all surprised that both the FDA and Baxter International have done the right thing and brought an immediate halt to the distribution and manufacture of heparin while these lethal side effects are investigated. What bothers me is that, because of money, they won't take the logical next step which – to my mind – is to stop the use of Chinese drug imports as ingredients in drugs sold in the U.S.

I don't believe the Chinese can be trusted to follow safety regulations that are up to U.S. standards. Plain and simple. This country has exhibited a complete disregard for the safety of the drugs, food, and goods distributed within their own country – why should we expect them to have a higher standard for good meant for export?

The global economy is likely to be a dangerous economy. We need to hope and pray that our government is on its toes. If the FDA is going to allow the import of drugs from China, they need to watch both the Chinese and the U.S. drug manufacturers very, very closely. There's a great deal of money at stake, but patients within the American health care systems shouldn't become victims of a growing economy.

Unfortunately, this is the FDA we're talking about. I know that they don't always make the right decision. Now I'll always be wondering if they're even in the right place at the right time.

William Campbell Douglass II, M.D.