[Ip-health] Bush Signed Texas Drug Law benefiting DuPont Merck Pharmaceutical

[James Love]

Tuesday, October 17, 2000

Bush Signed Texas Drug Law 
By LAURA MECKLER, Associated Press Writer

     WASHINGTON--Gov. George W. Bush, who promises to make prescription
drugs more affordable, signed legislation making it more difficult for
Texas doctors to prescribe a cheaper generic version of a popular
blood-thinning drug. 
     The legislation was sought by DuPont Merck Pharmaceutical, the drug
giant that manufactures the name-brand drug and tried to persuade states
to
block the new, generic competition. Just three states, including Texas,
adopted laws. 

     Texas has since reversed course, now agreeing with the Food and
Drug
Administration that generic warfarin is just as safe and effective as
name-brand Coumadin. A spokesman for Bush defended the law, saying the
governor was protecting patients when he signed the legislation in 1997. 
     "When we're talking about drugs that have the potential of life or
death, we ought to have an extra safety measure for patients," said Dan
Bartlett, spokesman for the Republican presidential nominee. 
     Many health experts say that risk was greatly exaggerated. 
     "It's pretty clear the FDA has gone to extensive lengths to verify
the
quality and standards necessary for generic drugs," said one heart
specialist, Dr. Raymond Woosley, chairman of pharmacology department at
Georgetown University School of Medicine. 
     And one of Bush's own top health advisers argues that it should be
up
to doctors and patients -not state drug boards -to choose among
FDA-approved drugs. 
     "Generics offer lower cost alternatives in most cases. They ought
to
be used as an option," Gail Wilensky, who helped craft Bush's Medicare
prescription drug plan, said Tuesday. 

    [snip]


     The controversy surrounds Coumadin, a blood thinner taken by some
2
million people, mostly heart disease sufferers, to prevent blood clots.
DuPont had been the exclusive manufacturer of the drug for decades,
although its patent expired in 1962. 
     In 1996, the FDA approved a generic substitute, known as warfarin,
concluding that it is identical to Coumadin and safe and effective for
patients to use. 
     DuPont mounted a campaign to convince state legislatures that the
two
are not the same. Coumadin is part of a class of pharmaceuticals known
as
"narrow therapeutic index" drugs. That means the dosages must be tightly
controlled. Slightly too little, and the medicine is ineffective;
slightly
too much, and it can be toxic. 
     The generic, DuPont told legislators, may not get the dosage just
right. Barr Laboratories, manufacturer of the generic version, made the
opposite case in a lobbying campaign of its own. 
     Overwhelmed with questions, in 1998 the FDA took the unusual step
of
writing a letter to doctors and state pharmacy boards stressing its
conclusion that the generic warfarin is just as good as Coumadin. 
     DuPont was motivated partly by profit and partly by concern for
patients, argued Stuart Haines, an expert on drug therapy at the
University
of Maryland who gets some of his research money from DuPont. 
     "Clearly they wanted to protect their market share," he said. "It
may
have been the primary motive. It may have been secondary." 
     A dollar's worth of Coumadin costs DuPont less than 10 cents to
make,
and the generic version is sold for 40 to 50 percent less than the name
brand. 

        [snip]

     In Texas, the legislation directed the pharmacy board to draw up a
list of drugs that would be subject to the law, which required
pharmacists
to double check with doctors who prescribed them. The board adopted a
list
of nine drugs including Coumadin, by far the most popular among them. 
     Barr labs sued the board on procedural grounds, saying it had not
issued its regulations properly. The board lost the case and reissued
the
rules in 1999. But after public hearings it concluded that opponents of
the
legislation were right and there was no reason to require extra
scrutiny,
said Gay Dodson, the board's executive director. 
     Together, Coumadin and its generic version sell some $540 million
per
year. Three years ago, DuPont had nearly 99 percent of the market. The
generic version now has 20 percent. 

-- 
James Love  mailto:love@cptech.org http://www.cptech.org
Consumer Project on Technology, P.O. Box 19367, Washington, DC 20036
voice 1.202.387.8030  fax  1.202.234.5176