Biomedical engineering and bioengineering involve finding solutions to medical problems, often using technology, electronics, or mechanics. Research is dominated by Caucasians, Indians & Asians. Why?

This is a very serious issue never discussed in the black community.

Black scientists are significantly less likely than white, Indian & Asian researchers to win grants from the National Institutes of Health, according to an audit release. Is the NIH bias against black scientist seeking grants from the National?

NIH’s internal auditing had indicated that there is bias in its scientific review process. NIH Director Francis S. Collins said, "this data is deeply troubling.” The findings are troubling because they indicate that race remains a significant factor in who gets funding for research into diabetes, cancer, heart disease and other health problems from the premier founder of biomedical research.

Sure it's a difference in scientists education and training. Only 1.4% of applications came from black scientists, even though black folks account for about 13% of the U.S. population.
Moreover, the applications from black scientists tended to receive poorer scores than those from whites, resulting in bleaker chances of getting funded.

Donna K. Ginther, “I don’t think it’s overt racism. I’m not thinking someone is going through the applications and saying: ‘Black, do not fund,’ ” Ginther said. “But it could be a matter of networks — that these investigators are not as well connected as others. Or it could be the resources of their home institutions in preparing the applications.”

Although an applicant’s race is removed before reviewers see applications, evaluators might be able to figure it out through a scientist’s name, where they work or simply because they know who they are. NIH plans to conduct experiments in which all information that might indicate the race of the applicants, such as their names and where they work, are hidden to see whether that affects how applicants are evaluated. Another study might assess the ability of reviewers to infer the race of applicants. Reviewers might also receive sensitivity training.

 

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Few black folks win grants from the National Institutes of Health. When top black scientist research & hard work are able to contribute to humanity what happens?

Remember when Cecil Pickett was on the verge of a breakthrough in the treatment of hepatitis C — a virus that infects 5 million in the United States and 300 million worldwide? Of course u don't. So u want remember when a advocacy group accused Cecil Pickett & Schering-Plough laboratory of racism. What's strange about this is that Pickett is black in an industry where few African Americans reach the top. The Kenilworth company excluded blacks from early human testing to skew the data and accelerate regulatory approval. It was the first time a drugmaker was accused of racial bias for the design of a clinical trial.

The dispute highlights a collision of scientific research and social realities in the development of life-saving medicines. It also illustrates conflicting principles of risk vs. benefit in the ethical guidelines that have governed all human experimentation since the Nazi era Nuremberg Trials and the notorious Tuskegee Syphilis Study.

In the Schering-Plough case, the issue is not whether to experiment on people — but who to include. African Americans don’t respond well to existing hepatitis therapies, Pickett said. They were kept out of the early trial in case the drug wasn’t safe, he said. There were always plans to include blacks in the final Phase III trials, he said.
“The point is we didn’t want to expose a population we know are poor responders to existing therapies to an investigational new drug,” he said.

Arthur Caplan, chairman of the department of medical ethics at the University of Pennsylvania and director of its Center for Bioethics said, "What if, for example, pharmaceutical researchers discovered a promising cure for HIV2, the strain of the AIDS virus in Sub-Saharan Africa? Despite a legitimate scientific rationale." Chaplan also said, "the scientists could look like the world’s greatest racist for limiting human testing to poor African villagers. Schering-Plough faces a similar problem now." he said.

Hepatitis, an inflammation of the liver, infects about two of every five HIV sufferers in the United States, mainly because both viruses are transmitted by contact with blood. It is a leading cause of chronic liver disease. Infection typically happens during sex, childbirth or the sharing hypodermic needles by drug addicts.

About half of people infected with the most common strain of hepatitis C in the United States do not respond well to the existing treatment, a combination of the protein interferon and anti-viral agent ribavirin. The injections are so physically demanding that often patients qualify for temporary disability.

For reasons unknown to science, blacks have even a lower response rate to interferon-based drugs, if they work at all.

That’s why Schering-Plough’s hepatitis drug, designed specifically to treat “non-responders,” is being watched so closely by both the pharmaceutical industry and HIV/AIDS activists. It also has the eye of Wall Street as a potentially important source of revenue for the company. The worldwide market for hepatitis C drugs is expected to reach nearly $4 billion next year.

Schering-Plough’s drug is a protease inhibitor, a genetically engineered agent designed to switch off the hepatitis virus’s ability to copy itself and spread. Stop its ability to spread, the thinking goes, and halt the disease.

Code-named SCH 503034, the tablet has been granted fast track status by the FDA, which means the agency is closely monitoring Schering-Plough’s testing program. Phase III trials that involve thousands of patients could get under way next year.

Clinical trials occur in four phases that play out over several years. Generally, Phase I tests for toxicity and Phase II establishes efficacy over ranges of dosages. Phase III is the definitive assessment, double-blind randomized controlled trials with up to 5,000 patients. Phase IV involves surveillance for side effects after the drug receives FDA approval for sale.

Only one of 10 drug candidates win final FDA approval, so the stakes are high.

Science or Business?

Dr. William Gray, a family physician in Spokane, Wash., and an official of the Association of Clinical Research Professionals, said Schering-Plough must be guided by science.

“They don’t they have any obligation to fulfill any social obligation very early in the testing of a new drug,” he said. “The research team has to come up with a development plan that is purely scientific and does not have to follow social conscious.”

But Dr. Jacob Lalezari, an assistant clinical professor at University of California, San Francisco, denounced the hepatitis drug’s Phase II trial design as “bad science.” He said it was a missed opportunity to add to the medical literature about a little-documented new medicine.

“This is a business decision,” said Lalezari, who is a supporter of the hepatitis activist movement and director of Quest Clinical Research, which develops antiviral treatments. “If black patients responded well or better they would want them in their study.”

Schering-Plough said Phase II trials will attempt to find the compound’s optimal doses and determine if it makes interferon and ribavirin treatments work better. All the Phase II volunteers had failed to respond to existing treatments.

Patients who defined themselves as African Americans, Pickett said, were excluded for fear the low dosage of interferon in combination with the new drug could “generate mutations in the virus” that made them resistant to future treatments. Black patients, he said, were enrolled in another branch of the Phase II trial that uses a high dosage of the new drug researchers believed had a better chance of working.

“If they develop resistance to this therapy,” he said, “there is no other therapy available.”

Defining Race

Schering-Plough’s clinical trial design caught the attention of Karama Neal, who has a doctorate in genetics from Emory University and has written extensively about the use of race in biomedical research.

She took part in a conference call this month with Pickett and other Schering-Plough scientists. Neal voiced opposition to volunteers “self-definition” of their race “because it’s not possible to define this concept and group at a biological level.” The University of Pennsylvania’s Caplan also panned “the crude characterization” of race in the trial design.

James Learned of the national Hepatitis C Action & Advocacy Coalition said the group wrote a letter to the FDA protesting the clinical trial design. He called Schering-Plough’s claim of safety concerns “a smoke screen” and that “we would have had the same reaction if women were excluded or any race were excluded, where we found no safety issue.”

Felix Khin-Maung-Gyi, a bioethicist at Chesapeake Research Review, which evaluates clinical trials, said the controversy is an example of the tough choices between ethical principles in the Belmont Report, which guides human medical research in the United States.

According to Khin-Maung-Gyi, the hepatitis advocates are calling for justice — the inclusion of African Americans to ensure they are afforded the benefits of the research.

The drugmaker, he said, is exercising beneficence — a risk-benefit analysis to minimize possible harm to clinical trail volunteers.

“If people died because they were not responding and we entered them in the study anyway, you could appreciate the conflict,” he said. “We should not just be all inclusive and disregard all the other principles in Belmont.”

Schering-Plough’s Pickett and Learned, the activist, meanwhile, both concede the controversy could have been defused with more extensive disclosure of the clinical trial’s goals.

“It would have made a difference,” Learned said.

Even so, Pickett was stung by the suggestion the company was biased against the very people who stand to benefit most of its new drug.

“It can have an impact on people of color who are infected by these diseases. Yeah, I’m interested,” he said. “Yeah, I was irritated. There are very few political things that catch my attention. This one caught my attention.”

I posted this on another website, this is a response. Maybe if they were really good at it, then this shouldn't even be a problem. Whites, Asians, and Indians are the leading best of the best. So just because blacks are not in the top list is because they're not the best and never will be. I hate when blacks use the race card for everything that doesn't go their way. It's called COMPETITION! You're not entitled to be with the best, they need to earn it and you have many many years to even have a chance to compete.

My response:
I don't think the National Institutes of Health is playing the race card. NIH Director Francis S. Collins said, "this data is deeply troubling.” She's not black. NIH’s internal auditing had indicated that there is bias in its scientific review process.

Sebrena Mollay responded to Onefre Gutierrez:
Race card is simply a term that means in translation: Black people be quiet. There-fore, white ppl should stop using the very race card they created. At any rate. A few months back, I read an article dedicated to two young Black scientist and that was a very positive read. Certainly, there are more young Black scientist to follow in those foot-steps and we should show our support.


My response:
I don't think not being able to compete is the reason why black scientist have not shared in the power structure such as department chairs, research award winners, study section reviewers, editorial board members & members of the National Academy of Sciences. That power structure rely on established knowledge that they are more comfortable with. They are more comfortable with proposals from scientists they are familiar with, scientists they either know personally or know of. Black researchers ideas in the biomedical sciences are at many times unfamiliar to reviewers. Some health conditions effect black folks different than Caucasians, Asians, Indians & Middle Easterns so Black scientist may propose studies involving a different set of diseases & that could be unfamiliar to reviewers. Mollay, Caucasian aren't the only ones saying black folks are playing the race card here. Asians, Indians & Middle Eastern professors & students are also saying the same. Gutierrez is merely stating what many Caucasian & a few minority groups are saying at dinner parties, cookouts & other gatherings. Sure, they will all agree that finding a cure or better treatment for HIV/AIDS, hepatitis, diabetes, cancer, heart disease and other health problems is not about COMPETITION! it's a unified effort. But very quietly they are saying black folks can't compete in their fields & that we contribute nothing. The NIH plans to conduct experiments in which all information that might indicate the race of the applicants, such as their names and where they work, are hidden to see whether that affects how applicants are evaluated. Why are NIH still concerned? Because applications, evaluators might be able to figure out through a scientist’s name, where they work or because they know who they are.

I think the misconceptions about discussing white privilege & one reason some Caucasians are uncomfortable with the issue is because certain whites think certain black folks want whites to accept some kind of guilt for feeling white & that's not the case. I don't give it much thought & I know most black folks that I know don't resent white folks. In fact, there are a large number of middle class blacks in the suburbs, inner cities & especially black scientist that will bend over backgrounds to fit in with Caucasians & many black folks will cater to Caucasians before they cater to another black person. I'm privilege to be an American, I don't fully understand that privilege because I & other black folks don't travel abroad, but I do understand that I have life better than most people living in other countries. That's why government & corporations & charities set-up relief ad & billionaires set-up foundations because we are more privileged. There are certain blacks that feel they're entitled to certain privileges because their lighter complexion or have Caucasians in their family.

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