2006: Fake Blood Experiments Without Consent: Is Your City Participating? FDA: Closed Door Meeting

An investigative report by ABC- 20/20 aired on Friday night (July 7). Viewers were informed that an unconscious trauma patient in the U.S. may become a human guinea pig in an experiment testing an artificial blood product without his / her informed consent.

“Artificial Blood Experiment Hits 27 U.S. Cities,” elicited a huge response from the public. The comments received by ABC over the week-end (almost 100 pp) –poured in from both the product’s stakeholders and the public. Read ABC News 

(AHRP received dozens of requests over the week-end for a list of those hospitals conducting the experiment so that they can avoid them).

ABC’s report focused on PolyHeme (manufactured by Northfield Laboratories) that is being tested on non-consenting trauma patients. In a previous trial conducted on surgery patients, 10 of 81 people who received PolyHeme suffered heart attacks, versus zero of 71 receiving donor blood.

FDA’s approval of the experiment with a waiver from consent requirements has stirred national controversy within the biomedical ethics community and Congress. The experiment violates the standards set forth by FDA’s emergency waiver of consent Rule.  See: http://www.ahrp.org/cms/content/view/91/80/

Since the controversy was reported by the press, nine of the original 31 hospitals that signed on to participate in the PolyHeme trials without patients’ informed consent have suspended the trial. Below is a list of those hospitals.

On the same day of the ABC broadcast, the Wall Street Journal reported (below) that the Navy and Biopure (the manufacturer of a competitor artificial blood product, Hemopure) were aggressively pushing the FDA to approve a proposed experiment on non-consenting trauma patients.

The WSJ reports that the FDA had rejected the Navy’s trial proposal: “based on its review of existing Biopure research on surgery patients. The results of that trial revealed “highly significant differences” showing more “serious adverse events” with Hemopure than with blood.  On July 8, 2005, the FDA told the Navy its study couldn’t proceed “because subjects would be exposed to an unreasonable and significant risk of injury.”

In all previous clinical studies conducted by 5 different manufacturers of artificial blood products the results have shown only harm without a benefit.

In four trials conducted by each of four drug substitute blood manufacturers–Biopure, Hemosol, Northfield, and Somatogen–in patients undergoing elective surgery, patients suffered “increased hypertension, heart attacks and other serious cardiac problems.”

In a trial conducted by Biopure there was a “42% higher incidence of serious adverse events in elective orthopedic surgery patients.” [1]

And in the disastrous trial conducted on non-consenting trauma patients, the artificial blood product increased death. Indeed, in the first non-consensual trial approved by the FDA, Baxter Healthcare tested the most promising of the blood substitute products, Bayer’s diaspirin cross-linked hemoglobin (DCLHb). The trial was suspended when the artificial blood caused a “three-fold higher mortality than conventional treatment (46.2 vs. 17.4%).” [2]

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.  The WSJ reports that FDA’s response to the controversy was to disinvite two independent expert consultants from the advisory panel and to hold a public hearing (scheduled for this week) behind closed doors.

How can we pretend to be an open society?

References:
1. Jahr JS, Steward LM, MacKenzie C, et al. Pivotal phase III study: safety of polymerized bovine hemoglobin (HBOC-201, Hemopure) as compared to RBC in patients undergoing orthopedic surgery, Poster presentation: American Society of Anesthesiology, 2002.

  1. Sloan EP, Koenigsberg M, Gens D et al. Diaspirin-cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock. , JAMA, 1998, 282:1857-1864.

See also: Lesley Kresie, MD, Artificial blood: an update on current red cell and platelet substitutes (Baylor University Medical Center)  Proc (Bayl Univ Med Cent). 2001 April; 14(2): 158–161. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1291332

Contact: Vera Hassner Sharav
veracare@ahrp.org


ABC
Artificial Blood Experiment Hits 27 U.S. Cities
July 07, 2006 10:10 AM
Brian Ross and Joseph Rhee Report:

In 27 cities across the United States, seriously injured accident victims could end up in a medical experiment, without their knowledge or consent.

The experiment involves an artificial blood called Polyheme.
The federal government has given the company that makes it approval to use badly bleeding accident victims as test subjects, without the subjects informed consent.

The only way out is to wear a blue bracelet provided by the company.
The company says it’s the only way to test such a product.
But others, including Pastor Paul Burleson of a Denver church alliance, say it turns Americans into human guinea pigs.

“If I’m in accident and I just don’t happen to have this particular wristband, that I’d be a guinea pig is unconscionable,” he said.

With the FDA’s approval, Northfield Lab has recruited hospitals to participate in the trial study with exemption from informed consent requirements on study participants. Although Northfield Lab claims that extensive information on the study has been made public, a vast majority of the general public has never heard of the trial.

Below is a list of the cities and hospitals that are currently participating in the Polyheme trials. Copyright © 2006 ABC News Internet Ventures

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<strong><a href="http://online.wsj.com/article/SB115214086567098898.html ">http://online.wsj.com/article/SB115214086567098898.html </a>
THE WALL STREET JOURNAL</strong>

FDA to Weigh Using Fake Blood in Trauma Trial
By Thomas M. Burthon
July 6, 2006; Page B1

If the U.S. Navy gets its way, hundreds of civilian trauma patients could–without their consent–be given a blood substitute that has been linked in other large clinical studies to increases in hypertension, heart attacks and other serious cardiac problems.

The Food and Drug Administration has blocked the new Navy trial three times in the past year, but now is reconsidering after months of jockeying among the Navy, the agency and Biopure Corp., the Cambridge, Mass., maker of the blood substitute.

The agency has scheduled a closed-door hearing for next week on whether the Navy-designed trial can proceed.  More than 900 badly hemorrhaging civilian accident victims around the country would be involved, with paramedics giving some the blood substitute, called Hemopure, and others saline solution en route to hospitals.

Such non-consent studies are rare but legal where federal regulators determine there's no practical way to obtain consent, such as when patients are in shock or unconscious.  There also must be a reasonable likelihood that individual patients would benefit from the treatment under scrutiny.

Scientists have been hunting for a safe, workable blood substitute for decades.  Artificial blood, with oxygen-carrying ability, could eliminate  the need to match blood types or donor and recipient in some settings, and enjoy a far longer shelf life than donor blood.  It could also reduce the risk of hepatitis or HIV infection, although donor blood has become very safe over the past two decades.

The Navy, which provides all medical care for injured U.S. marines and sailors, has been particularly eager for a workable blood substitute.  Donor blood lasts only about 42 days before its oxygen-carrying capacity is diminished, while artificial blood could be stored aboard ships for an estimated three years.

But efforts to develop blood substitutes have encountered safety problems over the years.  some companies have gone out of business or exited blood-substitute research when past efforts failed.

Northfield Laboratories of Evanston, Ill., is nearing completion of a civilian non-consent study involving its own blood substitute, PolyHeme, and 720 trauma patients around the country.  In a previous trial of surgery patients, 10 of 81 people who received PolyHeme suffered heart attacks, versus zero of 71 receiving donor blood.

Northfield says it doesn't believe its product caused the heart attacks, but the Securities and Exchange Commission and Senator Charles Grassley, chairman of the Senate Finance Committee, are investigating whether the company properly disclosed those results in federal filings and community meetings.  Norhtfiled says it is cooperating with the investigations but declined to comment further.

Nine of the original 31 medical centers that agreed to participate in the trials are no longer testing patients with PolyHeme.

Past studies have raised questions about Biopure's Hemopure as well.  In 1998, the company began a clinical study comparing its substitute with donor blood in consenting orthopedic-surgery patients.  William G. Hoffman, then Biopure's medical director and now director of cardiac-surgery critical care at Massachusetts General Hospital, says he concluded during the study that the blood substitute wasn't working well and was "harmful," and urged Biopure to stop the trial.  Edward Jacobs, a Biopure founder and then senior vice president, says the company consulted outside cardiologists and "their opinion was to go ahead."

Evidence from that study, along with a separate study in general surgery patients, linked Hemopure to more complications such as strokes and mini-strokes than donor blood, FDA documents show.  Biopure acknowledges that there were more cases of cardiac arrest, more fluid in the lungs and more hypertension among patients who go Hemopure than those who received donor blood.

Navy officials declined to comment on why they want to conduct a trial with a product that has shown such negative side-effects.  But in documents submitted to the FDA, the Navy has maintained that a study of trauma patients would be significantly different from the trial with surgery patients.  The Navy also argues that the oxygen-carrying capacity of Biopure's product could lower the death rate in trauma patients by 25% versus patients getting gsaline.  "If we could replace salien with the thing that we need most, oxygen-carrying capacity, that would be the best," says the Navy's Surgeon General Vice Admiral Donald Arthur. "Our interest is in the field conditions where there is no blood."

Biopure's vice president for medical affairs, A. Gerson Greenburg, says the company's product "has an acceptable safety profile" and that a blood substitute can serve "a societal good whereby you're saving [donor] blood for other people."  He says many adverse events in past studies weren't necessarily linked to Hemopure.

The Navy proposed the new study of civilian trauma patients in 2004, saying that conducting such a study in combat wouldn't be practical.  Documents show the FDA concluded, based on its review of existing Biopure research on surgery patients, that there were "highly significan differences" showing more "serious adverse events" with Hemopure than with blood.  On July 8, 2005, the FDA told the Navy its study couldn't proceed "because subjects would be exposed to an unreasonable and significant risk of injury."

Dnaiel Frielich, who heads Navy blood substitute research , responded with a series of letters criticizing the FDA, writing in one that the agency's stance "is not scientifically and clinically rigorous."  The Navy also argued that the FDA had permitted Biopure's competitor, Northfield, to pursue its own study with a similar product.

On Oct. 13, Biopure CEO Zafris G. Zafrelis wrote to Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, suggesting that an FDA reviewer wasn't objective and had a possible conflict of interest.  In March, the FDA's Dr. Goodman wrote to Mr. Zafirelis that he had assigned three other high-ranking officials to preside over Biopure decisions, according to the people familiar with the matter.

Earlier this year, the FDA scheduled the advisory panel meeting for next week.  In an unusual step, the Navy, the sponsor of the proposed research, was able to recommend some doctors to be on the panel.  Additionally, two well-known skeptics of substitutes who initially had been named as advisory consultants to the panel–Charles Natanson, a critical care specialist with the National Institutes of Health and John Hess, director of the University of Maryland's blood bank–have in recent weeks been dismissed.

Neither FDA officials, Dr. Natanson, Dr. Hesll nor Dr. Goodman would comment for this article.

Write to Thomas M. Burton at tom.burton@wsj.com
copyright c. 2006  Dow Jones & Company

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

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Check the list to see if you live an area where you could become a trial participant without your informed consent.

To opt out of the study, contact Northfield Labs (http://www.northfieldlabs.com/contact.html) or a participating hospital and request a blue bracelet. If worn, you will be exempt from the trial.

California: UC San Diego Medical Center, San Diego, Calif.; No longer recruiting
Scripps Mercy, San Diego, Calif.; No longer recruiting

Colorado: Denver Health Medical Center, Denver, Colo.

Delaware: Christiana Hospital, Newark, Del.

Georgia: Medical Center of Central Georgia, Macon, Ga.

Illinois: Loyola University Medical Center, Maywood, Ill.

Indiana: Wishard Memorial Hospital, Indianapolis, Ind.
Methodist Hospital of Indiana, Indianapolis, Ind.

Kansas: University of Kansas Medical Center, Kansas City, Kan.

Kentucky: University of Kentucky Medical Center, Lexington, Ky.

Michigan: Detroit Receiving Hospital, Detroit, Mich.
Sinai Grace Hospital, Detroit, Mich.

Minnesota: The Mayo Clinic, Rochester, Minn.

New York: Albany Medical Center, Albany, N.Y.; Suspended

North Carolina: Duke University Medical Center, Durham, N.C.

Ohio: MetroHealth Medical Center, Cleveland, Ohio; Suspended
University of Cincinnati Medical Center, Cincinnati, Ohio
Miami Valley Hospital, Dayton, Ohio

Pennsylvania: Lehigh Valley Hospital, Allentown, Penn.; No longer recruiting
St. Luke’s Regional Resource Trauma Center, Bethlehem, Penn.
Penn State Milton S. Hershey Medical Center, Hershey, Penn.

Tennessee: University of Tennessee-Memphis, Memphis, Tenn.
Johnson City Medical Center, Johnson City, Tenn.; Suspended

Texas: Memorial-Hermann Hospital, Houston, Texas; No longer recruiting
University of Texas Health Science Center, San Antonio, Texas
Brooke Army Medical Center, Fort Sam, Houston, Texas

Utah: University of Utah Health Sciences Center, Salt Lake City, Utah
LDS Hospital, Salt Lake City, Utah

Virginia: Sentara Norfolk Hospital, Norfolk, Va.; No longer recruiting
Virginia Commonwealth University Medical Center, Richmond, Va.
Inova Fairfax Hospital, Falls Church, Va.; Suspended

West Virginia: West Virginia University/Jon Michael Moore Trauma Center, Morgantown, West Va.
(source: www.clinicaltrials.gov where it says “Verified by Northfield Laboratories June 2006)  (http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1)