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 The products are artificial blood, | | | | unpublished data of trials done by Northfield |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