[Pharm-policy] NYT on BMS action, also note NIH comment

[James Love]

This is the NYT report on the BMS decision.  Note that 
Melody Peterson is now also working on this issue for
the NYT.  Note that the NYT quotes an unamed person from
the NIH which says that the Bush Administration will not
let international organizations use the US government rights
in HIV drugs in poor countries.    Jamie

http://www.nytimes.com/2001/03/15/health/15AIDS.html

March 15, 2001 

Maker Yielding Patent in Africa for AIDS Drug

By MELODY PETERSEN and DONALD G. McNEIL Jr.
Bristol-Myers Squibb said yesterday that it would no longer try to stop
generic-drug makers from selling low-cost versions of one of its H.I.V.
drugs in Africa, making it the second drug company in a week to greatly
change its policies in the face of the AIDS epidemic. 
    
  [snip]

Bristol-Myers holds the patent on a drug known as d4T or stavudine,
which is sold under the brand name Zerit, and said it would not use its
legal rights to keep lower-cost generic versions of this drug out of
South Africa or any other African nation. 

Yale University, which owns the rights to the Zerit patent with
Bristol-Myers, said it would go along.

Bristol-Myers, based in Manhattan, also said it would sharply reduce the
price of Zerit and another AIDS drug, ddI or didanosine, which is sold
as Videx, in Africa, to a combined price of $1 a day. The company does
not own the patent to Videx.

  [Note.  Of course, BMS does claim patent rights in ddI in some
countries, such as its formulation patent in Thailand].

In the United States, by contrast, one day's dose of the two drugs costs
$18, the company said. 

   [snip]

"This is groundbreaking," said Kate Kraus, a member of Act-Up
Philadelphia, a group that has led protests around the world against the
big drug makers. "This is the first time that a U.S. drug company has
acknowledged that generic drugs are the key to saving lives."
 
But the activists questioned why Bristol-Myers was not dropping out of a
lawsuit it has filed with the other drug companies in South Africa to
keep generic-drug makers from making copycat medicines.

Bristol-Myers executives said yesterday that the lawsuit was still
important because it was aimed at protecting their rights to all
prescription drugs, not just AIDS drugs.

Whether any of the other makers of AIDS drugs will follow Bristol-
Myers's move on its drug prices or patents was not clear yesterday. A
spokeswoman for Hoffmann-LaRoche said that the company was reviewing
what Bristol-Myers had done and did not have a position yet.

But Nancy Pekarek, a spokeswoman for GlaxoSmithKline, the British drug
giant, said it was not planning a similar move. The company believes,
she said, that it has already reduced the prices of its drugs enough in
Africa that there is little need for generic-drug makers to make cheap
versions.

"Our position is that patents are not the issue," Ms. Pekarek said. "The
drugs are more affordable than they have ever been."

  [snip]

Bristol-Myers's move could put pressure on the United States government
to allow generic companies to make low-cost versions of essential
medicines on which the government holds the patent rights. It holds
rights to a myriad of drugs — including AIDS drugs like Videx and Hivid,
which is also known as ddC and which is sold by Hoffmann — because they
were discovered in government labs or by scientists financed by
government grants.

Some activists, including the Consumer Project on Technology, a group
founded by Ralph Nader, have asked the National Institutes of Health to
give the World Health Organization the right to use patents owned by the
United States government to provide cheap medicines for the world's
poor.

A spokesman for the National Institutes of Health said yesterday that
the government's position had not changed since 1999 when it responded
to the Consumer Project on Technology. Dr. Harold Varmus, the director
of the National Institutes of Health at the time, wrote then that the
government was worried that such a move would put the system of
developing medicines with government research dollars at risk. "It is
reasonable to assume that companies will not undertake the development
costs of these inventions if they believe the government will readily
allow third parties to practice the inventions," Dr. Varmus wrote.

Pressure has intensified companies to cut the prices of their AIDS drugs
in Africa, where 25 million people may be infected with H.I.V. Early
last week, protesters marched in South Africa as 39 companies went to
court to challenge a law that would allow the country to buy generic
substitutes of patented drugs. The protesters demanded that the
companies stop the suit and slash prices.

Then Cipla, a large Indian maker of generic medicines, asked the South
African government for permission to sell inexpensive copycat versions
of eight anti-H.I.V drugs, including Zerit and Videx.

Last Thursday, Merck said it would offer its two AIDS medicines, the
protease inhibitor Crixivan and another anti-retroviral, Sustiva, at
prices that the company said equalled its manufacturing cost.

Yesterday, Bristol-Myers said its new prices were below its cost. It
will cut the price of Zerit to 15 cents a day or 7.5 cents a pill, while
the price of Videx will be cut to 85 cents a day. 

But some activists questioned whether the new prices were truly below
cost, and noted that Indian generic companies have offered to make Zerit
for 5 cents a tablet. And James Love, of the Consumer Project on
Technology, said, "We had a quote from a generic company for 22 cents a
day for ddI."



-- 
James Love
Consumer Project on Technology
http://www.cptech.org
1.202.380.3080 fax 1.202.234.5176
mailto:love@cptech.org