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Someone wrote in re HMO drug reimbursements in Massachusetts:

> .. I have a suggestion: use generics.

The American Council on Science and Health published a report "Are
Generic Drugs Appropriate Substitutes for Brand-name Drugs? -- No"
(see www.acsh.org, click on publcations) citing research by Susan
Horn, Senior Scientist at the Institute for Clinical Outcomes
Research, University of Utah School of Medicine, who found that HMO
patients fared worse under generic drugs.  They had significantly
more emergency-room visits and hospitalizations.

Here's why.  The usual test of generic equivalence is this:

" ... typically the innovator drug and its generic counterpart are
given in a highly structured setting to a small number of healthy
subjects--almost always fasting young male adults--and blood
concentrations of the drug are measured over time after just one
dosage. If it is found that the blood levels for each product are
similar (usually within 20 percent of each other), the FDA will
declare the generic product equivalent to the innovator product."

"In the "real world," however, these drugs will be administered
--usually inmultiple doses--to both young and old patients, male and
female, bedridden and active, on diverse dietary and medication
regimens. Each of these factors--age, sex, etc.--can affect drug
absorption. Moreover, the generic drugs that undergo bioequivalence
tests are almost always in experimental form. The form in which
generics are marketed usually differs somewhat from the form in which
they are tested. In contrast, virtually all innovator companies use
bioequivalence tests to compare the experimental and final forms of
their trademarked drugs before marketing them.

"Duplicator companies can repeatedly alter formulations to cut costs,
and such alteration can affect drug absorption. Yet the FDA requires
only "test tube" tests to determine whether absorption of the
variation in human patients will be the same as that of the unaltered
generic. There is no appropriate documentation that such tests
correlate with clinical experience.

"Thousands of studies published in the scientific literature have
cited substantial absorption differences between different versions
of the same drug. Differences much greater than 50 percent have been
observed among some formulations."

Such differences in strength may be very significant for PWPs in whom
there is a narrow window between PD symptoms and dyskinesia.

Phil Tompkins
Hoboken NJ
age 60/dx 1990