E-drug: Bristol-Myers Squibb Fights Generics in Central America
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San Jos�, Costa Rica
14 September, 2000
For immediate release...
Bristol-Myers Squibb Fights Generics in Central America
By Richard Stern*
Bristol-Myers Squibb may have $100 million to share with Africans Living
with AIDS, but the company's new found good will apparently has not
spread to Central America. The company seems bent on doing every
thing it can to maintain its Central American price structure and
interfere with efforts by generic producers to enter the market.
The company, threatened by competition from a generic producer in Costa
Rica which recently won a government contract to produce the
anti-retroviral product stavudine (BMS "Zerit" or D4T), sent a
"Product Representative" to meet with People Living with AIDS here to
convince them that the generic products are untested and potentially
unsafe. Costa Rica has been providing anti-retroviral medications to
its AIDS affected population since 1997. But in the other six
Central American Countries, less than 10 percent of all People Living
with AIDS have access to ARV's.
Earlier this year, Bristol-Myers Squibb (BMS) also filed an administrative
appeal designed to prevent the Costa Rican government health care
provider (known as the CCSS) from buying the generic version of
stavudine which BMS sells as Zerit for $145 per month per patient.
However, Bristol-Myers appeal concerning the government's decision
to buy generic D4T was denied. Bristol-Myer Squibb's representative
acknowledged that BMS prefers that subsequent legal actions, such as
a Supreme Court appeal, come directly from the PWA population and
not from the company itself.
The generic producer, Gutis Laboratories, has offered to produce the
medication for just over half of Bristol-Myers' price, or $85 per month
per patient (based on an 80mg dosage daily). Gutis has now begun
delivery of generic DT4 to the CCSS.
The Bristol-Myers' Product Representative came to a meeting of the
Network of Non-Governmental AIDS organizations on Friday August 4th,
2000, about three weeks after the company lost the appeal. He
addressed the group, which included several People who are taking ARV
cocktails provided by the CCSS, and indicated that the CCSS was
purchasing potentially untested and unsafe generic versions of ddI,
AZT, 3TC and D4T.
The representative alleged that some patients have had negative
reactions to generic versions of AZT, and gave an example of a
patient who nearly died of thrombosis after taking a generic version
of a coagulant. He provided copies of a document indicating that
original versions of medications must meet 25 different requirements
to be approved by the government, but generic versions need only meet
five requirements.
PWA activist Guillermo Murillo pointed out to the Bristol Myers'
representative that members of various non-governmental
organizations working in the AIDS field, recently held a meeting
with CCSS pharmacology Director Albin Chavez who indicated that all
generic medications approved for use in Costa Rica undergo rigid
testing in the CCSS's own laboratory. Chavez also indicated that
this Laboratory was open to be visited by any qualified consultant,
in order to see records and confirm results of testing. Gutis
Laboratories, located in San Jos�, through its Director Anna Maria
Fallas, has also indicated that it will cooperate completely in
opening its doors for independent evaluation of the quality of its
generic version of stavudine, as well as any other generic
medications it produces. Fallas also has delivered samples of its
generic products to PWA groups for independent evaluation.
Bristol-Myers Squibb Regional Sales Director Jos� Avenda�o
acknowledged that the company is worried about generic production of
its product in Costa Rica and throughout the Central American region.
Interviewed from Guatemala by telephone on August 24th, Avenda�o
recognized that BMS had filed a legal action designed to prevent the
Costa Rica government from utilizing the generic product.
"But this appeal is only on administrative level and we will not go to the
Constitutional Courts without direct involvement from PWA's who would
be willing to sign a complaint. We believe we are acting in their best
interests," he stated, adding that "the tests used to assure the quality of
the generic products are inadequate."
Questioned about the Bristol-Myer Africa donation, Avenda�o replied that
this program was poorly understood outside of the African region. But the
full page BMS ad on the back cover of POZ magazine's July edition seems
clear enough:
"As a company dedicated to extending and enhancing human life,
Bristol-Myers Squibb is...committing $100 million to Secure the
Future: Care and support for Women and Children with HIV/AIDS, an
initiative in partnership with the countries of Botswana, Lesotho,
Namibia, South Africa, and Swaziland and HIV/AIDS organizations
across the globe."
Avenda�o indicated, in a meeting held on August 27th, that
Non-Governmental Organizations in Central America could make
applications to the Bristol-Myers Squibb Foundation in the United
States to apply for support for their programs.
According to figures published in the magazine "Chemical Marketing
Reporter," just the drug Zerit alone generated $315 million in revenues
in the United States during the year ending in February of 2000. There are
about 900 people with AIDS on ARV therapy in Costa Rica. If half of them
were taking Zerit, company revenue would be approximately $730,000
per year in this country. Dropping the price by 45%, as the generic
producer has done, would imply a drop of about $330,000 in the
company's revenues in Costa Rica.
As one PWA who attended the NGO meeting commented: "Bristol-Myers
seems to be trying to maintain its profits in Central America to pay
for their program in Africa...we know we have to be vigilant about
the quality of any medications we receive and we don't need anyone to
tell us this. The strategy of trying to scare us into filing
lawsuits against generic
producers isn't going to work."
Medecins Sans Frontieres (Doctors Without Borders), the Nobel Peace
Prize winning organization is beginning a campaign directed at
increasing access to medications for AIDS affected people in the
Central America Region. The group has indicated that it will offer
qualified technical support to assure the quality of any generic AIDS
medications used in the region.
*Richard Stern
Director of the Agua Buena Human Rights Association
San Jos�, Costa Rica, a non-profit organization promoting access to
treatment for People with AIDS in Central America.
Telephone and fax 506-234-2411
e-mail rastern@sol.racsa.co.cr
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