With the proliferation of Big Pharma ads flooding mainstream media these days, it might get a wee bit harder for all of us to sift through the "facts" about various medications and their intended use. And now, the FDA has drafted new guidelines that could make the decision for doctors -- on what pill to give when -- all that more difficult...
You see, back in 2003, a New York Times report came out that detailed a criminal and civil investigation of a drug company.
Court documents showed that company officials hired a marketing firm to write medical journal articles that placed their drug in a positive light. The company paid $12,000 for each article and an additional $1,000 to various doctors who agreed to allow their names to be listed as "authors." Salespeople then distributed the phony articles to doctors to persuade them that the drug was safe and effective for off-label use.
If you're into detail, here's an interesting read.
Just so you know, back in the late 90s a law was passed allowing drug reps to share peer-reviewed articles with doctors.
But back then there were two conditions:
- Copies of the articles had to be submitted to the FDA, and
- A drug company that submitted an article had to promise to begin the process of seeking FDA approval for the off-label use of the drug.
In other words, before the drug company could send the article out to doctors, they would also have to "prove" their drug could meet the "new use" implied in the peer-reviewed articles by conducting their own efficacy tests for the new use.
That previous law lapsed a couple of years ago, and since then the issue about sharing articles has been in limbo.
But a new draft guidance seeks to establish clear guidelines, AND those two annoying (for Big Pharma) requirements have been dropped. No more bothering with sending copies of articles to the FDA, and no more promises to mount studies to examine little details like efficacy and safety.
According to a New York Times report, one FDA representative confides that "the agency did not really enforce those requirements anyway."
If you read our "Drugs in our Water" article the other day and checked out the AP news release, you might have read this quote:
Over the past five years, the number of U.S. prescriptions rose 12 percent to a record 3.7 billion, while nonprescription drug purchases held steady around 3.3 billion, according to IMS Health and The Nielsen Co.
With this new "guideline" I'm guessing the sales for presecription drugs are going to skyrocket to new and much higher heights.
