Pharmalot….Pharmalittle….
1 CommentBy Ed Silverman // March 2nd, 2007 // 5:55 pm
Yet another eventful week draws to a close. Now, a day of rest is in order and a chance to enjoy a favorite Pharmalot food. Hopefully, this will provide enough energy for next week, without having to reach for that latest diet pill…..
On Friday morning, families who suffered drug side effects join Consumer Union and FDA whistleblowers, including Susan Wood and David Ross, to hold a safety pow-wow at the Longburn House building in Washington, DC.
Melody
In his book “Too Profitable to Cure, Hoadley says:
When a drug manufacturer covers up the flaws in a drug and submits information to government that is artfully skewed to diminish the flaws; when the FDA—that arm of the government meant to afford protection to the citizenry against unscrupulous behavior and dangerous drugs—refuses to give credence to the outcry of adverse events being reported to them; and when the politicians and reporters fail to do their jobs, whether from ignorance, self-aggrandizement or ennui, what is left of the government of the people, by the people, and for the people?
And he further states:
David Kessler (former head of FDA), in the Journal of the American Medical Association, noted the ADR system is entirely voluntary, with 90-99% of all ADRs never reported.
The ADR reports are usually not filled out completely and. . . there are thousands of highly-delineated classifications. Because of the large number of classifications, the likelihood that a single category will be impacted by numerous reports is minimized. For example, there are 160 terms for central nervous system reports. By dividing a large group of symptoms into many smaller categories, the pharmaceutical companies have been provided with a generous amount of “wiggle” room.
This system is so broken, I don’t know that even a first-rate computer system could provide a solution.