It is hard to oppose an effort that purports to improve health
care for African Americans. Black people suffer more from everything
bad, including ill health (see Rockeymoore, BC,
9, 2005). When a drug company announced that it would market
a heart failure treatment specifically for use by blacks, the silence
from otherwise thoughtful persons and organizations was noticeable
but not very surprising.
In 1997 the federal Food and Drug Administration declined to approve
Bidil, a treatment for heart failure. Bidil is actually a combination
of two generic drugs used to treat chest pain and hypertension.
The FDA concluded that there was no proof of Bidil’s effectiveness.
That should have been the end of Bidil, until good old-fashioned
capitalism and marketing turned its fortunes around.
Bidil has now been approved
for use in black heart failure patients. It is the first drug in
America that has been approved specifically for the use of one racial
or ethnic group. NitroMed, the pharmaceutical company that will
produce Bidil, acted very shrewdly. The drug maker achieved this
success by giving the heads up to black leadership, lest it be accused
of recreating the infamous Tuskegee experiment.
NitroMed first went to the Congressional Black Caucus, the National
Medical Association and the NAACP. The drug company was “aware
of the political fallout if they did not have African American participation,”
Waine Kong, executive director of the Association of Black Cardiologists.
Too bad the participants didn’t ask a question or two in the process.
We are told that Bidil showed great success in black patients.
That doesn’t mean very much because it was only tested on black
patients. There is literally no
evidence that the drug works better on one racial group than
Nitromed did what other pharmaceutical companies have always done.
It gave money to people who later gave its medication the thumbs
up. The Association of Black Cardiologists co-sponsored the clinical
trials for Bidil, received $200,000 from Nitromed, and enthusiastically
supported the drug’s approval.
That arrangement wasn’t unusual. In July 2004 the National Institutes
of Health published a study urging millions of Americans to take
statin drugs in order to lower their risk of heart disease. It was
later revealed that eight of nine authors of the study had financial
ties to makers of statin drugs. The ties were not made public when
findings were first announced.
No one knows if Bidil is very effective or safe. If it isn’t it
will not be different from other drugs given FDA approval that were
later discovered to be dangerous. Fenfluramine was marketed as Redux,
a drug used to treat obesity. It was taken off the market after
causing cases of heart valve damage and pulmonary hypertension.
How many commercials exhorted consumes to ask their doctors about
vioxx and celebrex? We now see commercials from law firms exhorting
us to pursue malpractice suits against the makers of those drugs.
Past experience indicates that Bidil shouldn’t be greeted as a
health care panacea for anyone. It should be treated like all newly
approved pharmaceuticals, with great caution if not suspicion. As
Woosley, vice president for Health Sciences at the University
of Arizona, advised Public Television, “Americans need to recognize
that every time they put a pill in their mouth, especially a new
pill that they've never taken before, it's an experiment. How big
an experiment depends on the pill and how well it's been studied.”
NitroMed is using black people to get a drug approved that it couldn’t
get approved otherwise and in the process maintaining a patent that
keeps cheaper generics off the market until the year 2020. “[I]f
BiDil is approved for African Americans only, the drug will have
patent protection to 2020,” wrote Motley
Fool biotechnology industry analyst Karl Thiel. “That's because
patents based on this demographic were filed after studies showed
the drug was ineffective in a broader population. If the drug is
approved for a general heart failure audience, older use patents
will apply and the drug would appear to have exclusivity only to
Bidil isn’t the 21st Century equivalent of the Tuskegee experiment.
It is an example of what the pharmaceutical industry now does best,
which is to produce drugs with dubious effectiveness that guarantee
them large profits. Nitromed shares have risen
from $6 last July to more than $19 when approval was imminent.
There should be an outcry over Bidil. A system that allows millions
of people to go without health insurance, and consequently creates
conditions such as heart failure, is now using those same people
to repackage two generic drugs as a sort of medical magic bullet.
Surely many of the African American heart failure patients would
have been better off with universal health care, not a profit making
gimmick that does them little good.
Bidil is more than just another example of the market place run
amuck. It also gives justification to beliefs about biological differences
between races. These beliefs are never expressed for the benefit
of black people. Bidil makes it more difficult to argue against
theories of racial superiority and inferiority. Bidil’s supporters,
regardless of their race, should not be let off the hook when this
drug becomes the latest justification for the dogma of white superiority.
It doesn’t matter that African American physicians or other leaders
vouch for Bidil. The health care system in this country serves the
profit motive more than it serves up good health. Bidil is just
the latest example. The market place is definitely not the place
to cure broken hearts.
Margaret Kimberley’s Freedom Rider column appears weekly
Ms. Kimberley is a freelance writer living in New York
City. She can be reached via e-Mail at [email protected].
You can read more of Ms. Kimberley's writings at http://freedomrider.blogspot.com/