One of my purposes here is news interpretation. It's also a lot of fun. Filling in the blanks, that is, that conventional stories cannot.
Like this morning’s New York Times story on the seizure, by the Food & Drug Administration, of millions of tablets of two medicines from GlaxoSmithKline plants in Tennessee and Puerto Rico.
The FDA said it’s been trying to get Glaxo to solve quality-control problems for two years without success.
Here are two paragraphs from the story:
"The FDA said that neither pill was medically necessary and that many
alternatives existed for both. It added that it knew of no patients
harmed by the poorly made pills and said patients could safely take any
pills they had left.
Despite the absence of evidence that the pills had harmed anyone, the
agency said, a drug maker must be able to assure the public that its
products are properly made."
And one more that begins with a quote from the FDA:
"’FDA and the Department of Justice will not allow drug manufacturers
to ignore our high public health standards for drug manufacturing,’ said
John M. Taylor, the agency's associate commissioner for regulatory affairs."
OK. You have the picture. The FDA is clamping down on the industry.
Based on what I know about the relationship between FDA and Big Pharma, that picture has been doctored. (Pun intended.)
I see the FDA’s action as a cover intended to persuade the ill informed that FDA really regulates the pharmaceutical industry.
First, look at the FDA’s own information: The FDA said that neither pill was medically necessary…" So why is it on the market?
"…and that many alternatives existed for both." Forgive me, but why is it on the market?
Another point – the FDA opposes re-importation of drugs from Canada on the grounds that it cannot guarantee their safety. But Glaxo has been manufacturing these pills badly, according to the FDA, for two years. In Tennessee and Puerto Rico! Why single out Canada? Hmm. Might that have something to do with the price differential? Yeah, Big Pharma’s pills are so much less expensive north of the border that an American consumer can have them sent back here and still save money.
Incidentally, the Times says the drugs are "the antidepressant Paxil CR, which had $725 million in sales last year and is used by some 450,000 patients in the United States each month; and Avandamet, a diabetes medicine, whose sales are undisclosed but are far smaller."
Paxil CR is a controlled release version of plain old Paxil; Glaxo marketed it to blunt generic competition for plain old Paxil.
Now add to this what you already know about how the FDA researches drugs (mostly, it lets manufacturers do that job). Season with the fact that many FDA officials and consultants get freebies and/or big consultant fees from Big Pharma. Stir in what you remember about FDA approval of drugs that kill people who take them. And the FDA’s after-the-fact decisions to take drugs off the market that they’d previously approved.
I rest my case.
PS Critics have long noted that regulatory agencies set up to play watchdog play lapdog instead, thereby protecting those industries from the public’s scrutiny and wrath.
Plus ça change, plus c’est la meme chose.