Hearing: Americans Denied Human Right to Say NO to Experimental Research Under FDA Rule

Tomorrow, October 11 the FDA is holding a hearing about its controversial Emergency Research Rule (21 CFR 50.24)  http://www.fda.gov/bbs/topics/NEWS/2006/NEW01439.html after 10 years of its existence. That rule breaches the Nuremberg Code and the fundamental principles of medical research within a civilized society. The Rule sacrifices the inalienable right of every human being NOT to be used in a medical experiment without voluntary, informed consent for commercial expediency. http://ohsr.od.nih.gov/guidelines/nuremberg.html

From its inception in 1996, FDA’s waiver of consent Rule posed a threat to undermine the safety of temporarily incapacitated patients who could under this rule be enrolled without their consent in experiments that increased the risk of death. As written, the rule is applicable only if:  “the human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory…randomized placebo-controlled investigations [are] necessary to determine the safety and effectiveness of particular interventions.” [21 CFR 50.24]

However, FDA has approved at least one experiment (that we are aware of) in which the Emergency Research Rule was violated. This highly controversial experiment was recently conducted by Northfield Laboratories (manufacturer of PolyHeme, an artificial blood product) on non-consenting trauma patients in urban centers across the country. FDA’s approval of the experiment has stirred national controversy—as it should.  See: [1] www.ahrp.org/cms/content/views/108/55

FDA approved the PolyHeme experiment despite unanimous agreement that human blood is proven safe, effective, and satisfactory—and hemoglobin solutions are not equivalent to real blood. Trauma patients in the experiment were denied the best proven treatment available and were subjected to an experimental product whose safety does not approximate real blood. They were used in a commercially driven experiment on the basis of so-called “community consent.”

But as the Wall Street Journal revealed, [3] communities were not informed that in a previous trial conducted on surgery patients, 10 of 81 people who received PolyHeme suffered heart attacks and died, compared to zero heart attacks of 71 receiving donor blood. Instead, Northfield Labs provided false and misleading information to the communities about the safety of their product.  http://online.wsj.com/article/SB115214086567098898.html www.ahrp.org/cms/content/view/285/80

Public confidence in the FDA and its pronouncements has plummeted from 58% two years ago, to 37% today. [2]  That loss of public trust by the American people is reasonable in light of  FDA’s abysmal record in its failure to protect public safety.

FDA has set its priorities on accommodating industry’s commercial intersts–even when the evidence revealed hazardous risks of harm for consumers. Senator Charles Grassley’s letter (March 2006) to the Secretary of Health and Human Services lays bare the duplicity of FDA officials who would not even discuss safety hazards of the PolyHeme blood substitute experiment with officials of the federal Office of Human Research Protections (OHRP) See: www.ahrp.org/cms/content/view/108/55

In a similar displays of arrogance that lost the agency public trust: FDA officials insisted that antidepressants were safe and effective when the evidence showed the contrary; FDA officials insisted that  Vioxx was safe less than two weeks before Merck withdrew the drug from the market because even the company had to acknowledge the tens of thousands of  casualties due to preventable heart attacks and strokes.

Tomorrow evening at 8:00 P.M , CNN News—with Paula Zahn—will inform the public about how the FDA’s Emergency Research Rule impacts on American citizens who happen to be incapacitated from an accident can be put at increased risk to test an experimental treatment without their knowledge or consent.

Scientists and entrepreneurs have tried for years to develop a safe and universal blood substitute that did not spoil after 42 days. However, all such efforts have encountered serious safety problems. Nothing has come close to human blood.

Indeed, in all previous clinical studies conducted by 5 different manufacturers of artificial blood products the results have shown only harm without a benefit. In patients undergoing elective surgery, patients suffered “increased hypertension, heart attacks and other serious cardiac problems.”

Given the poor results of all previous trials, it is reasonable to suspect that Northfield’s failure to report the results of its trial on non-consenting patients—even though the trial was completed several months ago—is an indication that the results were not what the company had hoped.

Other companies are clamoring for similar waivers from informed consent to test their products. For example, Biopure (manufacturer of a competitor artificial blood product, Hemopure) has aggressively pushed the FDA to approve a similar experiment on non-consenting trauma patients—despite its poor showing when tested in surgical patients who gave their consent: the results of that trial revealed “highly significant differences” showing more “serious adverse events” with Hemopure than with blood.

With a track record showing no benefit and overwhelming evidence of serious harm to patients exposed to every blood substitute tested—how can anyone justify testing such risk-laden experimental products in people, much less in patients who cannot exercise their right to informed consent?

These experiments are clearly commercially driven.  In 2005, FDA rejected Biopure’s bid to test Hempure “because subjects would be exposed to an unreasonable and significant risk of injury.” [3] But FDA’s accommodation to industry has evidently increased in one year. When controversy swirled around the Biopure trial, FDA planned to hold a public hearing  behind closed doors. But public disclosure led to the cancellation of that hearing.  How can we pretend to be an open society?

Until now, most Americans have been unaware of the risk of becoming a human guinea pig if they happen to be in an accident. A trauma patient is at risk of being subjected to experimentation by even non-physicians—as is the case when ambulance staff test an experimental artificial blood product on trauma patients without their knowledge or consent.

Tune in tomorrow evening at 8:00 P.M  to CNN—with Paula Zahn—at which time the public will learn about how the FDA’s Waiver of Informed Consent in Emergency Research puts American citizens at risk.  If you happen to have the bad luck of being in an accident in an urban center where biomedical companies want to test their hazardous products—you may be recruited without your knowledge or consent.


  1. Curt D. Furberg, MD, PhD; Arthur A. Levin, MPH; Peter A. Gross, MD; Robyn S. Shapiro, JD; Brian L. Strom, MD, MPH The FDA and Drug Safety: A Proposal for Sweeping Changes, Archives of Internal Medicine, (AMA) VOL 166, OCT 9, 2006

  2. Senator Charles Grassley letter to Secretary of Health & Human Services, March 13, 2006.  www.ahrp.org/cms/content/view/108/55

  3. Thomas Burthon. FDA to Weigh Using Fake Blood in Trauma Trial, Wall Street Journal, July 6, 2006, p. B-1:  http://online.wsj.com/article/SB115214086567098898.html

See also: Brian Ross and Joseph Rhee Report: Artificial Blood Experiment Hits 27 U.S. Cities  July 07, 2006, ABC News  http://blogs.abcnews.com/theblotter/2006/07/artifical_blood.html   See: www.ahrp.org/cms/content/view/285/80

Contact: Vera Hassner Sharav