corner
Healthy Skepticism
Join us to help reduce harm from misleading health information.
Increase font size   Decrease font size   Print-friendly view   Print
Register Log in

Healthy Skepticism Library item: 1469

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Extensive records analyzed for series
The Miami Herald 2003 Nov 2


Full text:

Knight Ridder’s investigative series is based on dozens of interviews with patients, doctors, researchers and drug companies, and a review of thousands of records from lawsuits, government hearings and regulatory actions, medical records and scientific studies.

To calculate how often drugs are prescribed off-label, Knight Ridder — The Herald’s parent company — purchased and reviewed prescribing data routinely used by the pharmaceutical industry. Verispan of Yardley, Pa., collects the data from a monthly survey of 3,400 doctors with office-based practices.

Knight Ridder analyzed the three top-selling drugs in 15 classes of medications, comparing what doctors said they prescribed them for with the FDA’s approval for each.

The analysis looked at 900 million prescriptions written in 1998 and 2003 for more than 1,000 different ailments. Its estimate of the prevalence of off-label prescribing excluded cancer treatments and pediatric off-label uses, because they already are known to have a large percentage of off-label use.

When calculating whether off-label prescribing had grown over the last five years, the study considered only the 31 drugs that had been on the market the entire time.

Prescribing data are for the 12 months ending July 31; sales figures are for the 12 months ending Aug. 31.

The analysis is perhaps the most comprehensive ever done on off-label prescribing.

While various reports have quoted the American Medical Association as estimating that 50 percent of drugs are prescribed off-label, an association representative said that the figure was a misinterpretation of a remark an official made years ago and that the AMA has no good estimate.

Knight Ridder’s analysis found that 21 percent of the prescriptions examined were for off-label uses, and that some of the drugs had off-label uses as high as 90 percent.

To estimate how often patients are harmed by this practice, Knight Ridder reviewed the FDA’s database of adverse drug reactions. The FDA estimates that only 1 percent to 10 percent of reactions are reported. Knight Ridder identified more than 800 reports filed during 2002 of serious reactions involving off-label prescriptions for its sample of 45 drugs. Experts say that means anywhere from 8,000 to 80,000 people probably were affected.

For detailed information about the prescription drugs in the Knight Ridder analysis, go to www.krwashington.com.

 

  Healthy Skepticism on RSS   Healthy Skepticism on Facebook   Healthy Skepticism on Twitter

Please
Click to Register

(read more)

then
Click to Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts


If there is something you don't like, please tell us. If you like our work, please tell others.

Email a Friend








Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909