If you have been in an accident during the last ten years, you could have been a guinea pig for a medical product without even being told-and the FDA approved it. The products are artificial blood, several types produced by different pharmaceutical corporations. Perfectly good human blood could have been available, but you would have been given the artificial stuff.
Making matters worse, the results of the studies were abysmal. The number of deaths increased by 30% and heart attacks nearly tripled. According to Charles Natanson, a researcher with the National Institutes of Health and the lead author of the study, “There have been no meaningful beneficial effects reported in any trial. "
So what is the FDA's response to these results? They plan to do more trials! They're saying that the studies were “too broad" and that new studies should focus only on patients who are expected to die.
That means that the weakest, most severely injured patients will be the only ones placed at increased risk of death and heart attack.
A product that kills 30% more people and causes three times more heart attacks than the natural alternative, blood, has produced no benefit. And the response of the FDA is to do more trials! The only difference is that the guinea pigs are expected to die, rather than simply being in great need of a blood transfusion, as in the first sixteen trials.
The sloppiness of the FDA and its penchant for hiding information from the public is also demonstrated in these studies. There doesn't seem to have been any coordination of these studies and no comparisons between them were made.
The organization Public Citizen became concerned and sued to get data. As a result, National Institutes of Health (NIH) researcher Charles Natanson, MD, and others took a look at information from the studies, which were done between 1998 and 2007, a span of ten years. That's ten years during which more and more people were placed at risk after each preceding study had shown no benefit and increased risk of death.
According to Natanson, the FDA should have been aware of the risks by 2000. Instead, they did another five trials. Another 714 patients were subjected to risks.
Findings from previous studies were not disclosed to hospitals considering doing trials. Jay S. Epstein, who is the director of the Office of Blood Research and Review, a division of the FDA, said that studies were approved only when the potential benefits outweighed the risks. On what basis the potential benefits were determined was unstated.
The FDA Trials
The Journal of the American Medical Association printed Natanson's study in April 2008. It documents the deaths and heart attacks caused by artificial blood in these FDA-approved tests. It states the likely reason for these products’ toxicity. They contain hemoglobin molecules that reside outside red cell membranes. Normally, hemoglobin exists only inside the red cells. As a result, they bind with nitric acid quickly, resulting in systemic vasoconstriction and platelets being made inactive. Vasoconstriction, decreased blood flow, and other effects lead to thrombosis - heart attacks.
Artificial blood products tested:
- PolyHeme, manufactured by Northfield Laboratories, Inc.
- HemAssist, manufactured by Baxter Healthcare Corporation
- Hemolink, manufactured by Hemosol BioPharma, Inc.
- Hemopure, manufactured by Biopure Corporation
- Hemospan, Sangart Inc.
The authors noted that requests for more detailed unpublished data of trials done by Northfield Laboratories, Baxter Healthcare Corporation, and BioPharma were refused. They were referred to press releases. Though other data was available for Northfield's PolyHeme, the authors were unable to locate results from trials by Baxter, which produced Optro, or BioPharma, which produced Hemolink. (Another trial's results were available, which is why Hemolink is included in the list above. )
These companies’ hiding of their results, along with the FDA's tacit agreement of this practice-indeed, the FDA's own hiding of such information - is indicative of a culture of deceit in the entire pharmaceutical and so-called regulation business.
The number of deaths in patients who received artificial blood was 164, compared with 123 in those who didn't receive it. Among those who were given artificial blood, there were 59 myocardial infarctions, as opposed to 16 among those who didn't get it.
In a finding that conflicts with the FDA's intent to continue testing on people at extreme risk of death, the report states that there was no difference in results for any subgroup. In other words, there is no reason to suspect that people who are expected to die will respond any better to artificial blood than those who stand a reasonable chance of living. Thus, the FDA's plans to do more tests are entirely unjustifiable.
The authors also point out that the results of the tests were not made available to anyone who might have been able to use them. They was not provided to scientists, doctors, institutional review boards, competing manufacturers, or the public.
A statement particularly incriminating of the FDA is:
"The most recent PolyHeme trial requires special mention for 2 reasons. First, the FDA gave approval for this trial in trauma patients even though the FDA presumably had unpublished data showing a significant increase in MIs [myocardial infarctions] in the prior PolyHeme trial in vascular surgery patients; the FDA had the results from trials involving other HBBS products also showing harm; and the FDA had placed a clinical hold on a Hemopure trauma trial because of serious adverse events in previous, mostly unpublished, trials of this HBBS [hemoglobin-based blood substitutes, that is, artificial blood]. "
The FDA allowed a second trial of a product, PolyHeme, in spite of the fact that the first trial had shown an increase in heart attacks and they knew that other similar products had the same results. Further, the FDA had previously stopped a trial of another equivalent product because of adverse outcomes.
FDA's Lack of Oversight
Clearly, blind trust in pharmaceutical companies is dangerously misplaced. After all, the purpose of a corporation is profit. Anything else is merely a means for achieving that end. Thus, it isn't surprising that, given the opportunity, pharmaceutical manufacturers misrepresent and hide the results of drug trials.
However, the agency that is supposed to be the watchdog over pharmaceutical corporations is now nothing more than a shill for them. As seen in artificial blood trials, the FDA now actively promotes trials for products that have already been shown to have no benefit and cause death. They hide the results of those trials. They allow testing without informed consent of the victims.
In short, the FDA acts as shields and shills for pharmaceutical firms.
Heidi Stevenson, BSc, DIHom, FBIH
Fellow, British Institute of Homeopathy
Gaia Therapy (http://www.gaia-therapy.com )
Heidi Stevenson sees many of today's concerns as belonging to one major issue, which can be thought of as the inherent flaws in our modern civilization. When a single issue is considered without considering its relation to the whole, then that issue must stand alone.
The story of the man who shows his feuding sons how easy it is to break a bundle of sticks by separating and snapping them individually, though they are unbreakable when banded together stands as a metaphor for our civilization and times. Truly, united we stand and divided we fall.
Heidi's calling as a writer is to bring a variety of issues that reflect society's woes to the attention of a broad audience, in the hope of arousing a bit of righteous indignation and ignite a spark to incite action.