Ban on generic AIDS drugs will prove to be fatal mistake
May 5, 2004
The Chicago Sun-Times
BY DR. MARDGE COHEN AND DR. GORDON SCHIFF
Poor people dying from HIV/AIDS face yet another obstacle in getting
life-saving drugs. In March at an international AIDS summit in Botswana,
U.S. officials defended a policy that, in effect, indefinitely bans the
most cost-effective medication regimens to treat people: generic drugs.
While the rationale is alleged concerns about safety of unapproved
generic drug combinations, we know that the end result could be lethal
to many of the 26 million people living with HIV/AIDS in sub-Saharan
At issue is the use of so-called fixed dose combination generic drugs.
These pills contain several medicines combined into one pill so that
people with AIDS simply have to take one in the morning and one in the
evening. They can cost as little as $140 dollars per year per patient.
They are easy for health professionals to administer and easy for
patients to take.
As we all know, generic drugs are less expensive but equivalent versions
of brand-name products developed by the major pharmaceutical
manufacturers. Because one of the major obstacles in the fight against
AIDS has been the affordability of medications in poor countries, the
search for less expensive regimens has led to the use of generics. While
the individual agents already have been approved by the FDA as safe and
effective, and their use in combination with each other has been widely
endorsed in the United States and internationally, the lack of official
FDA approval is being used to derail the effort to deliver these
medications to patients.
Some of the safety issues being raised include difficulty
individualizing dosing adjustments and the sanctioning of a ''lower
standard of care'' for those in developing countries. What a cruel irony
that these putative concerns about the welfare of these patients are
being used to hold up their only chance of life-saving therapy. Just as
the smokescreen of unsafe drugs being imported from Canada is being used
to justify lack of access to more affordable drugs for U.S. patients,
one has to view with skepticism claims of protecting African patients by
denying them drugs.
In fact, the world is already placing its trust in generic medications.
The World Health Organization already approved these fixed-combination
drugs through a process that involves representatives of national drug
regulatory authorities of countries including France, Germany, Sweden
and Switzerland. Medecins Sans Fronteires (Doctors Without Borders) and
Catholic Relief Services have been using generics, successfully treating
thousands of people with AIDS throughout Africa. The fixed combinations
may actually minimize resistance by improving patient compliance and
ensuring continued availability. Efforts to deliver the simplest,
first-line regimens are our current best offense against the effects and
spread of HIV worldwide.
The Bush administration has stepped forward, pledging $15 billion -- an
unprecedented amount -- to battle AIDS, in the President's Emergency
Plan for AIDS Relief. The plan, however, is vague on the question of
generics, leaving the door open for U.S. officials to now delay or even
prevent their use.
''This is a big issue and it could undermine all the good work we are
doing,'' said Richard Holbrooke, former ambassador to the United
Nations. ''Fairly or not, it is going to become a symbol that the United
States is protecting'' pharmaceutical companies.
Right now in Africa, only 400,000 people with HIV/AIDS are being
treated. The president's goal is to treat 2 million by 2005, but that
will be possible only if the plan relies on the least expensive
Dr. Mardge H. Cohen founded the Women and Children with HIV Program at
Cook County Hospital in 1988. Dr. Gordon Schiff is director of clinical
quality, research and improvement at Cook County. Both are associate
professors of medicine at Rush Medical College and members of the Health
Action AIDS campaign of Physicians for Human Rights.
Health Action AIDS Media Coordinator
Physicians for Human Rights
(617)695-0041, ext. 240
100 Boylston Street, Suite 702
Boston, Mass. 02116
Founded in 1986, Physicians for Human Rights (PHR), based in Boston, MA,
mobilizes the health professions to promote health by protecting human
rights. Health Action AIDS is a project of Physicians for Human Rights
in coordination with Partners In Health. As a founding member of the
International Campaign to Ban Landmines, PHR shared the 1997 Nobel Peace
From: MFleshman@AOL.COM [mailto:MFleshman@AOL.COM]
Sent: Wednesday, May 05, 2004 2:06 PM
To: HEALTHGAP@LISTSERV.CRITPATH.ORG Subject: [HEALTHGAP] Nigeria: 2 million AIDS deaths
Aids 'has killed 2m Nigerians'
Nigeria has one of the world's highest numbers of people living with the
Aids virus, the health minister has said. Eyitayo Lambo said that some
2.3m Nigerians have already died from Aids, while 3.8m were
Only South Africa and India have more people infected with HIV.
The rate of Aids infection is much lower in West Africa than in southern
Africa, where 30% of the population of some countries is HIV positive.
Nigeria - Africa's most populous country, with some 130m people - has
been criticised for not doing enough to fight Aids.
"HIV/Aids has now become the most nagging health problem affecting
individuals, families and communities," Mr Lambo said.
In 1997, one of Nigeria's best-known musicians Fela Ransome Kuti died
and his family said it was Aids-related in a bid to raise awareness of
The BBC's Jamila Tangaza in Abuja says that the government is now
undertaking extensive Aids awareness campaigns.
"But they could still do a lot more, especially in rural areas," our
She says that ordinary Nigerians are now taking the issue seriously but
nevertheless "there is still a lot of ignorance."