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A Bitter Pill for Black Hearts

By Margaret Kimberly, The Black Commentator. Posted June 28, 2005.


A drug recently approved to treat African-American heart disease seems to be just another case of the pharmaceutical industry's endless search for profits.

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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. 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," said B. 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 on another.

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 the dubious 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 Raymond 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 2007."

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.

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Margaret Kimberley is a freelance writer living in New York City. She also maintains the Freedom Rider blog.

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View:
arginine
Posted by: strydg on Jun 28, 2005 1:29 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
Some research indicates that the amino acid arginine, taken as a nutritional supplement, improves cardiovascular function by increasing nitric oxide production. Bidil mimics this action of arginine but with many unwanted side effects and costs much more. Details probably can be obtained from Thorne Research in Idaho.

[« Reply to this comment] [Post a new comment »] [Rate this comment: 1 - 2 - 3 - 4 - 5]

Shrewd capitalism, bloody greed
Posted by: fredo1012 on Jun 28, 2005 5:01 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
I'd dare say that for NitroMed it's shrewd capitalism fanned by sheer greed. Those who betray our people are equally complicit - the Congressional Black Caucus, the National Medical Association and the NAACP, etc. As the Good Book says, "Woe be unto the pastors [leaders] who lead my sheep astray; everyone shall have his pay..."

That said, I'm not big on drugs, but I'm sure there are existing non-racially biased medication that excel NitroMed's claim. Check with your doctor, and hope that he/she is not on NitroMed's virtual payroll. As Fela Anikulapo-Kuti, the late Nigerian pop icon and human rights activities once sang: those who follow blindly end up in a ditch.

Folks, let's not forget Tuskeegee. Besides, this one is about your heart!

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Nothing new
Posted by: jeffrey7 on Jun 28, 2005 6:08 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
Being a paraplegic I've made it a point to get to know folks in
the healthcare industry.Especially Convention attendees.All of them report back to me the same feedback so this senarieo so it must be true;
THE DRUG COMPANIES CAN CURE MOST EVERYTHING

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Who is black? Who is white?
Posted by: claw on Jun 28, 2005 12:07 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
So-called black people are not of one genetic group. So-called whites are not of one genetic group. The most highly genetically diverse people on the planet live in sub-Saharan Africa, people whom people in the race-obsessed USA would call "black." Watch again PBS' 3-part series "Race: the power of an illusion." You might find it at some public libraries or college libraries.
I would adivse every black person NOT to take any drug that's labeled race-specific. There is evidence that the WHO as well as the U.S. has specifically planted toxins and viruses in injections administered to Africans. Do your research. And, if you like, read my article on the topic of racism in medical research in the spring 2005 issue of "International Issues in Philosophy" now on its way to the printers. The notion of eugenics and the idea of "whites" as the master race are alive and well to this day.
Also read Edwin Black's thoroughly researched book "WAR AGAINST THE WEAK: Eugenics and America's campaign to create a master race." Get educated and informed on this topic. Your life depends on it.

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Call the Death Squads off
Posted by: pjrsullivan on Jun 28, 2005 1:34 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
The Wall Street War Criminals have a deep love and affection for mass murder and atrocity. The black community has been the recipient of crimes against it by this group.

Of course the WSWCs have a hardon against all of us, and make as much money as possible on us using their war machine and prison scene.

As any lawyer can tell you, Extrajudicial Executions are not legal in any recognized government. Of course the WSWCs feel that they live in the world of the "true law," and do not recognize anything but force and fraud.

Outing of our internal death squad activity could improve the health of not only black americans, but all americans.

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Does the Science Count ?
Posted by: AdamSelene40 on Jun 28, 2005 3:22 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
I'm no fan of Big Pharma or the way medications are tested and assigned their uses.

BUT ...

I' m also in the "Zipper Club" (-- 4x bypass after sudden onset angina, 95% blockage but with total cholesterol under 200-- ) so I sort of pay attention to medications and outcome studies, what doctors have to say, and what other patients in the waiting room have to say, also. The choices ain't always clear cut, and they ain't often simple.

So, Margaret Kimberly doesn't get much respect from me by lumping BiDil, fenfen, viox and statins in the same paragraph.

Congestive heart failure is the heart disease you really don't want to have. It's the one you really will be willing to take a few serious long term risks in return for significant immediate relief.

For all their profiteering and supply line rigging, Big Pharma comes up with some downright miraculous products: but ultimately the drug has to go into a patient and the results -- good and bad -- have to be monitored by a physician. Ultimately doctors and patients have to review the available information and see what drug does the most good with the least immediate harm and the least risk of future harm.

Is it possible that factors other than racial heredity explain why BiDil behaves as it does in S&E Studies? Of course
Is there a case that BiDil needs more race-specific large scale studies ? Sure. Is there an arguement that this research should be subsidized and expedited ? Right again!

If the BiDil seems better than other drugs in the identified population, but the two generic drugs are cheaper and just as effective are two generics the way to go ? Open question, but its a it's medical one, not political.

If Big Pharma is playing a race card to create a market share for a less than optimal drug -- shame on them -- and may the litigation be swift and deadly.

If Margaret Kimberly is playing a race card to create a saleable essay -- shame on her.

Who gets the last word who's spinning for dollars?

Fortunately: not me

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??
Posted by: achangeisgonnacome on Jun 29, 2005 4:58 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
Can no one see the real picture in this atrocity? There is no difference between a black persons heart than any other race. Skin pigment is external. The insides are exactly the same.

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divadiva
Posted by: divadiva on Jul 1, 2005 11:17 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
yes, the problem is "what is a black heart", will someone please tell me? And realizing that MOST so-called BLACK americans (carribeans, southamerican etc) are mixed, some highly and some not so highly, '(due to harsh activities in the cotton, field, and, just downright love), when does one acquire a 'Black' heart. What percentage do you have to be. Or is it that to be white means to be 'pure' and all others are black And does this mean that all medicine should be 'race' specific (whatever race means; if someone knows tell me, please, cause I ain't got a clue to what it refers). And sadly there are people, "white" and, unfortunately, (in terms of self-protection) "black" as well who buy into this rubbish. I need to know what black is. Is it anyone who is not 'purely' white. THEN MAYBE WE SHOULD CALL OURSELVES MONGRELS? WE SEEM TO BE A GROWING RACE!

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Editorial: Color Blind or Just Plain Blind
Posted by: alczap on Sep 2, 2005 3:21 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
From Alternative Medicine Review Vol 10, Number 2.



Let's review the respective scorecards.
For BiDil:
1. Will be an expensive pharmaceutical-
2. Increases nitric oxide to tissues, which can dramatically lower the
risk of heart failure-

Side efects that have been reported for BilDil and/or its two component ingredients include: allergic reaction, blood in
urine or stools, numbness, tingling, pain or weakness of arms or legs, irregular or very fast heartbeat, new or worsening chest pain,fainting, dizziness, dry mouth, low blood pressure,
skin rash, sweating,feeling of extreme pressure in the head, headache, nausea, vomiting, water retention, diarrhea, decreased appetite, and bluish discoloration of the lips, fingernails, or palms-

For time-release arginine:
1. Is an inexpensive dietary supplement -
2. Increases nitric oxide to tissues, which can dramatically lower risk of
heart failure -
Is available now, without prescription -
Has virtually no documented side effects: may increase herpes
flare-ups for those with active herpes,. lysine supplementation is recommended -

These results beg the question: What will it take to draw attention to the fact that pharmaceutically-oriented organizations... are not color blind when it comes to seeing the color green, but are completely blind when it comes to seeing beyond the drug model, especially when more effective, infinitely less harmful alternatives are available. All persons - not just African-Americans over the age of 45 - should insist on immediate studies, with the mandated cooperation of such organizations as the AHA and ABC, of every alternative to the drugs so casually prescribed on a daily basis. If the AHA experiences its own Vioxx debacle with its own Pandora's box, many people will have died unnecessarily.
Al Czap, Publisher
Alternative Medicine Review Volume 10, Number 2 Copyright @ 2005 Thorne Research, Inc. All Rights Reserved. No Reprints Without Written Permission

full text available at
http://www.thorne.com/index/mod/amr/a/amr

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