Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

6.13.2007

"Diagnosis: Conflict of Interest"

Perhaps another reason to see Michael Moore's "Sicko"? Or just another indication of how much the FDA is in the pocket of pharmaceutical companies who decide what your doctor knows about treating you with what drug?

THE revelation that the diabetes drug Avandia can potentially cause heart disease is the latest in a string of pharmaceutical disappointments. Vioxx was pulled from the market in 2004 because it doubled the risks for heart attacks and strokes. Eli Lilly recently paid $750 million to settle lawsuits alleging that Zyprexa causes diabetes. Many have criticized the Food and Drug Administration as being too lax about monitoring drug safety.

While those criticisms have merit, there is another culprit: the transformation of continuing medical education into an enterprise for drug marketing. The chore of teaching doctors how to practice medicine has been handed to the pharmaceutical industry. As a result, dangerous side effects are rarely on the curriculum.

Most states require that doctors obtain a minimum number of credit hours of continuing medical education each year to maintain their medical licenses. Not so long ago, most of these courses were produced and paid for by universities and medical associations. But this has changed drastically over the past decade.

According to the most recent data available from the national organization in charge of accrediting the courses, drug-industry financing of continuing medical education has nearly quadrupled since 1998, from $302 million to $1.12 billion. Half of all continuing medical education courses in the United States are now paid for by drug companies, up from a third a decade ago. Because pharmaceutical companies now set much of the agenda for what doctors learn about drugs, crucial information about potential drug dangers is played down, to the detriment of patient care.

5.14.2007

"The Danger in Drug Kickbacks"

This op/ed in The Times' today confirms what I've heard and read:

The explosion in the use of three anti-anemia drugs to treat cancer and kidney patients illustrates much that is wrong in the American pharmaceutical marketplace.

Thanks to big payoffs to doctors, and reckless promotional ads permitted by lax regulators, the drugs have reached blockbuster status. Now we learn that the dosage levels routinely injected or given intravenously in doctors’ offices and dialysis centers may be harmful to patients.
As Alex Berenson and Andrew Pollack laid bare in The Times on May 9, wide use of the medicines — Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson — has been propelled by the two companies paying out hundreds of millions of dollars in so-called rebates. Doctors typically buy the drugs from the companies, get reimbursed for much of the cost by Medicare and private insurers, and on top of that get these rebates based on the amount they have purchased.

Although many doctors complain that they barely break even or even lose money on the costly drugs, for high-volume providers the profits can be substantial. One group of six cancer doctors in the Pacific Northwest earned a profit of about $1.8 million last year thanks to rebates from Amgen, while a large chain of dialysis centers gets an estimated 25 percent of its revenue, and a higher percentage of its profits, from the anemia drugs.

It seems likely that these financial incentives have led to wider use and the prescribing of higher doses than medically desirable.

Although the drugs are deemed valuable in fighting severe anemia, there is scant evidence they help much in moderate cases and some evidence that high doses can be dangerous. Half of the dialysis patients in this country are now receiving enough of the drugs to raise their red blood cell counts to levels deemed risky by the Food and Drug Administration. And last week a panel of cancer experts urged the F.D.A. to impose additional restrictions on use of the drugs in patients receiving cancer chemotherapy, based on studies that the drugs might make some cancers worse or hasten the deaths of patients.

3.21.2007

Why Don't We Know That Tainted Pet (Dog and Cat) Food Is Nothing New?

[Ed. note: As Ole Blue the Heretic, whose blog is here, notes in comments quite accurately: "The FDA protects large corporations esp. the pharmaceutical companies." Anyone who fails to recognize and accept this truth does so at their own peril.]

I happened to notice that I was getting hits here on the blog from various news sites about the massive pet food recall. Going backward, I noticed something rather interesting and extremely disturbing.

While currently the focus is on potentially contaminated pet food that was manufactured for and distributed by Menu Food Item Fund (check their recall list here) between January and March, there were pet deaths for other labels back LAST year. Many of them, in fact.

Here's a CBS story from December about Diamond Pet Food, for example, and here's the (ever useless *&#&(@#) FDA notice about it for containing something called aflatoxin.

A few things have struck me since I first learned of the recall last Saturday:

  1. Don't EVER believe the FDA is there to protect any of us (goes without saying, right?)
  2. How could these deaths go on so long with still no idea WHAT is in the tainted food that shuts down renal function (most pets are dying of kidney failure/shutdown)?
  3. If a terrorist group wanted to do an excellent "dry run" of how to scare the bejesus out of the American population AND how to contaminate the human food supply, they'd do it first through pet food (and, of course, the Bush Administration would not be interested because these aren't the terrorists that help the energy companies get sweetheart deals - notice they did nothing about the Anthrax Avenger)
  4. Why is the media not paying attention? And they aren't; not much. Now they report 100 dogs dead, for example, when I've heard anecdotal estimates of that many dogs dead in Vermont alonel