Polyheme© and The Newest Plastic Bracelet

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Artificial Blood: The Lifesaving Promise

Idecline Northfield Laboratories has been developing its blood product Polyheme© for decades. Its latest clinical trial, one of many, has suddenly caught the attention of the nation for its peculiar structure: giving a blood substitute of questionable benefit to trauma patients who cannot and do not give informed consent.

Scientists have been trying to develop artificial blood for centuries and apparently have experimented with an array of substitutes including "wine, ale and opium". Artificial blood is one of the holy grails of medicine for obvious reasons; it could potentially eliminate the need for blood type matching, could be reconstituted from dried powder that would be far less perishable than fresh blood, and could be sold to developing countries where blood supplies are scarce and donor is blood deemed "less safe" then in western countries. It would be especially useful in wars, and in this bellicose age perhaps the impetus and funding for blood products has increased. For many reasons, scientists seem eternally motivated to continue their human experiments with blood "products"; and some of these experiments are seen as ethically sketchy, even barbaric.

What the Wall Street Journal Said

On Tuesday, February 22nd, the Wall Street Journal published an article by Thomas M. Burton: "Amid Alarm Bells, A Blood Substitute Keeps Pumping", about ongoing clinical trials of the blood sustitute PolyHeme© Northfield's product. The waiver of the the usual patient consents is particularly perturbing because Polyheme© was abandoned in prior trials due to adverse patient consequences. Burton wrote:

"The FDA is allowing Northfield to test its blood substitute without the consent of the trauma patients, who often are unconscious. In lieu of patient consent, the 31 medical centers testing the product are required to carry out community-awareness campaigns about the trials. Several hospitals have told community meetings that previous trials showed PolyHeme to be safe, failing to mention the [risk of] heart attacks, in their printed materials."

The clinical trials are done via a Food and Drug Administration *special* category of research that makes an exception for informed consent requirements under section CFR. 50.24, waiving consent rules for certain trauma patients so that scientists can gather, in their words: "valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, that is necessary to determine the safety and effectiveness of particular interventions.."

Media Coverage In the Past Three Years

The Wall Street Journal article attracted the attention of Senator Grassley, a Republican representing Iowa, who promptly demanded an inquiry into Northfield Laboratories and the FDA's approval of the trial, actions that Burton follows in the WSJ. However, what's more noteworthy than the sudden attention to these human experiments is the complete lack of public attention for the past three years. Why didn't the study set of "alarm bells" earlier? It's certainly not because of lack of media coverage and questioning, since there has been coverage of the trials since they started in 2003. Here are some articles published in major newspapers that question the ethics of the Polyheme© clinical trials:

  • May 20, 2003; "Synthetic-blood testing to begin at Denver Health". The Denver Post.
  • December 17,2003; "Artificial blood may get S.A. trial ; Many participants won't have given their consent." San Antonio Express-News.
  • February 21, 2004; "Substitute Blood Trial Worries Ethicists", the Boston Globe.
  • February 9, 2004; "Blood-substitute test skips consent" in the Chicago Sun-Times.
  • February 20, 2004; "Artificial blood tested without patients' consent: Similar tests halted in 1998 when deaths of 20 patients tied to different product". The Ottawa Citizen.
  • March 23, 2004 "An Experiment in Saving Lives. Emergency Patients Unwittingly Get Artificial Blood": The Washington Post.

Many newspapers also covered the company's previous trials. But the February 22, 2006 Wall Street Journal article is the only one that generated any sort of national response -- or a Northfield press release.

Is The Blood Substitute Safe?

The company vehemantly disputed the article in a flurry of "news". They specifically deny the Burtons's recounting of past clinical trials, that he described this way:

"Ten of 81 patients who received the fake blood suffered a heart attack within seven days, and two of those died. None of the 71 patients in the trial who received real blood were found to have had a heart attack. PolyHeme's maker, Northfield Laboratories Inc., quietly shut down the trial and didn't publicly disclose the results..."

The Wall Street Journal goes on to describe one randomized trial was "abruptly" shut down, and quotes a number of people knowledgeable of the experiments who say that results that went unpublished and that trial participants were uninformed. The company denies it all on its website:

"Every investigator and every IRB at every site involved in the current trauma trial was fully informed of the results of all of Northfield's prior trials....Northfield made no effort to dissuade centers from presenting previous trial information in any of their community outreach efforts."

However despite what the company and its president claim, Northfield has not been very frank about the results of its trials. In addition to the Wall Street Journal's extensive account, there are others. The Minneapolis Star Tribune said in its January 30, 2004 article on the Mayo Clinic participation in clinical trials: "The successes of earlier studies showing that some patients who lost all of their blood were kept alive when PolyHeme persuaded the U.S. Food and Drug Administration (FDA) to allow this study to go forward, said officials with Northfield Laboratories". The company's spokespeople have put some spin on the real story, which is that the Food and Drug administration denied the company's request for approval based on the flimsy structure of a previous trial in which Northfield compared their trial results to other, unaffiliated studies. Thus, the FDA requested a new trial. However a Boston Globe article (February 21, 2004), quoted Dr. Steven Gould, president of the company:

"In five clinical trials so far, he said PolyHeme has proven safe even when given rapidly in large volumes. Most recently, the death rate among 171 patients who received rapid PolyHeme infusions was less than half the rate of those who didn't receive blood, according to a study in the Journal of the American College of Surgeons."

One of the most damaging accounts was by The San Diego Reader. The paper published an extensive investigative report by Matt Potter on the Northfield's clinical trials contract with the University of San Diego last July called "Bad Blood". UCSD is one of two medical centers in San Diego that participated in the trials. The Reader quotes a doctor from the medical center who says "In a study of PolyHeme from the late 1990s, 75 percent of those treated with it survived, compared with 30 percent treated only with saline solution." (In many articles, the doctors running the trials, not company officials, gave misleading safety information to journalists).

Northfield's Restraining Order Against the San Diego Reader

According to the Reader, contrary to the requirements of the trials and Dr. Gould and Northfield's indignant defense, the city of San Diego produced scant information about the trials. What was publicized leaned more towards marketing and recruiting material, as opposed to than the balanced public information that was required in lieu of patient consent. Contrary to the company's claims to transparency, information was tightly controlled - if not censored - by Northfield Laboratories. In a memo sent from Gould to the principal investigator of the UCSD study, published by the Reader, he wrote:

"I urge you to remind your study coordinator and all others associated with the trial that information about patients and the details of the trial at your site are not to be shared with anyone outside the study team." UCSD sent the request on to the City of San Diego, who agreed, "not to disclose to any third party any Confidential information," defined as "all information, data, materials, in whatever form or medium, that [Northfield] treats as confidential and proprietary information."

But this may be just the tip of the ethical allegations iceberg. The Reader's thorough, interesting, and potentially damaging report investigated participant recruitment for the trials, hospital and doctor compensation for the study, as well as adverse events that occurred in the Polyheme© trial. The San Diego Reader found that only a few ambulances servicing only select areas of the city were participating: "...paramedic units in three of the city's poorest communities -- Oak Park, Nestor, and San Ysidro -- had been chosen for the trial because those areas generate the largest number of severe trauma patients..."

The San Diego Reader waited months to get documents they requested from UCSD. The documents they did get were blackened out, blank, or refused altogether. Some documents noted trivial communications between the stakeholders, for instance, the City had problems recruiting study participants so in one meeting Northfield suggested offering incentives; "inexpensive give-aways like pens, penlights, mugs with 'Polyheme study' on them...as a thank-you for participation". More troubling, Northfield paid the hospital and principals per patient who "completed" the study, which could financially motivate doctors to continue with Polyheme© even if the patient would have benefited from donor blood. One of the most ethically contentious aspects of the trial is that it requires patients to be treated with Polyheme© for 12 hours, longer than what would be medically necessary in a city hospital where donor blood is available.

The Reader has been unsuccessful in trying to get information about two "adverse events", the details of which were completely blotted out of the documents the paper recieved. One of the "events" was reported to have occurred before the study's official start date.

The San Diego Reader resorted to suing UCSD for the complete records under the "California Public Records Act." In January Northfield filed a restraining order against the San Diego Reader to prevent the company from publishing documents, alleging that they contained "trade secrets", and was granted the restraining order. That order was overturned by another judge a few weeks later.

Opt Out?

You or I or anyone we know or don't, could meet with some trauma, need blood and end up at a medical centers where the studies are being run, then become a participant in the trial, unbeknownst to any of us. There is an opt out. You can order a light blue plastic bracelet from Northfield Laboratories. The bracelet advises first responders and emergency room staff: "I Decline The Northfield Polyheme Study". They're quite fashionable -- in that plastic, hospital kind of way; snap handily around the wrist or ankle, and moreover could prove to be a lifesaver. They take about two weeks to arrive via U.S. mail and were wrapped in an apology from the post office for running them through some sort of envelope shredder -- the company spared only $.39 to send them letter rate. According to the WSJ article, Northfield says that if you "fail" to get the bracelet and find yourself in a trauma unit, you can then "withdraw from the study, without prejudice, at any time". That is, if you are conscious, have the wherewithal to speak up, and have lived through the initial "clinical trial" vetting.

The trials are winding down, which also means there's actually not much chance that *you* will be picked to participate. Because of this, the company is probably breathing a sigh of relief, since the article that received national attention was published once the study was mostly completed. True, Northfield Laboratories's stock has dipped, and the current national attention is not positive. Many questions remain. The potential uses for such a product are easy to recognize and highly valued (not only in monetary terms). Will the demand for the product, especially by the U.S. military -- create enough momentum for the product to continue development? Or will Northfield and the FDA be forced to face (and publicize) the results of the trial -- whatever they are? If the trials fail to show a benefit, will the company manage to push Polyheme© along anyway, as they have in the past? And finally, will details of adverse events continue to be redacted, with inevitable explanation that the "event" was "unrelated" to the product?

The Polyheme© story will continue to evolve. Importantly, trials conducted under the FDA waiver of informed consent will also continue. These trials will no doubt be risky (research on competing blood products for instance), and involve research that might be *off-putting* to potential volunteers. Perhaps, like Polyheme©, there will be concerns about litigation and public response so the details of the research will be obscured. Is this something we find acceptable in order to develop this type of product? There are obvious alternatives -- are they more acceptable?

UPDATE July 8th:

The the lastest Wall Street Journal article by Thomas M. Burton discusses possible FDA approval of the Navy's request to expand the trials of Northfield Laboratories Polyheme© product. Also, 20/20 ran a story on on Polyheme yesterday. Here are two short videos that are available on their site today: "Can You Bank on Artificial Blood?" and "Can Artificial Blood Save Lives?" (these links will launch video player from the ABC site). In the wake of this coverage, many people have written wanting to know where to get the bracelet. The 20/20 site has a list of 27 cities that are running the clinical trials -- you might want to check that out.

We orderd our bracelets by contacting Northfield Laboratory via their contact information on their website, though the site doesn't promote the bracelet heavily.

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Acronym Required recently wrote another article on Biopure, a company that is also pursuing clearance with the FDA to run Stage III clinical trials in conjunction with the Navy.

Update August 7th: According to the clincal trials site information on Polyheme at www.clinicaltrials.gov, Northfield has completed recruiting patients for this trial.

21 Comments

That would be great if they create it. But why would they use wine for it?

How can you get that bracelet?

I think that it is a brilliant idea, but they should advertise the study more for those of us who wish to opt out.

I think it is terrible that a person can be a participant in a test and not have the right to opt out. I see that even if you say no they can still give it to you and that is wrong. What is going on with this government. Do we have NO rights.

How do I get the opt out braclet?

How disgraceful that the government is helping
pharmaceutical companies make money at the
expense of people. Are we now just lab rats or
mice, we should become much more aware of the
antics of our government.

Outrageous. No company should be allowed to experiment with human lives without the consent of the individual or his/her family. Hospitals are a crap shoot (I know an ER was responsible for the death of my husband)anyway and the unsuspecting patient should not be experimented on just so some company can get rich.

The FDA is fast becoming an agency that seems to be selling out to the highest bidder, an agency that the US citizens should be able to trust and respect.

What they are doing is wrong we shouldnt have to wear a braclet not to an experiment and are lives risked even more because someone wants to be god

Sounds like something that could save thousands of lives especially those of our men and women fighting overseas. I hope it works.

T

What is your position on Mr. Burton's story about
another company wanting to expand this trial?

Thanks.

Go to the following website to see what hospitals are doing the testing. Call your local hopsital and ask that the bracelet be mailed to you. You can also contact Northridge and ask for one.

Remember, even if your area is not being served by one of these hospitals that is participating, you may be traveling through one of these areas and heaven forbid have an accident and be transported by/to a participating hospital.

http://abcnews.go.com/WNT/story?id=2166058&page=1&WNT=true

How do I get the opt. out braclet ??

To all the people who are commenting, asking where to get the bracelet:

At the bottom of the post above there is link to Northfield Laboratories, contact them, they will send you information. Alternatively search in Google for Northfield Laboratories.

Acronym Required cannot verify any information about getting the bracelet from any source other than the company, where we got ours. This was fairly efficient, as we explain in the post.

I cannot believe that America has come to this ...yet another secret!!! The home of the FREE????? I want my bracelet sent to me and they should send it to anyone or everyone who has any medical records and let them decide if they want to wear it. Wonder what else we dont know?

My opinion... you should have to wear the bracelets if you WANT TO participate. Not wear one if you dont. I would also know if anyone is aware or the cities that are taking part in the program?

I ordered my bracelets while the 20/20 story was still playing last week. I got them today. Hand addressed and marked "Hand Cancel".

[A.R.E. so they don't get run through the machines now- thanks for the update]

I am in a participating city and i knew NOTHING about it. I have been wearing my opt out bracelet for 2 weeks now and will continue until the study is complete.

I for one want no part of the experimental blood. It is horrible that our military is using it, those boys are not guinea pigs nor am I. How do I get the bracelet? Any company or medical facility doing such experimentation without written consent by its patients should lose its license to practice medicine.

I want to know who thinks that drugs and fake substances can keep us alive. The only thing they do is destroy more systems and cause more health problems. Our bodies were made to work, adapt and deal with problems, or natural selection would take over and you would die. Now, we are instead, killing ourselves by pumping man-made substances into it. I requsted 20 braclets. One for all of my family members.

[a.r.e.: many drugs are lifesaving, we would not be where we are without them]

Just called Northfield at the phone number provided on their website to order a bracelet. I was told that the bracelets were no longer needed. I asked if the study was still being conducted and the individual that answered the phone could not give me an answer. She kept repeatedly telling me that I would have to contact my local hospital to determine how to NOT be a part of this study. My question, how do I know what hospitals in this country are still conducting the study and how to avoid all of them??


[a.r.e.: Northfield Laboratories reports that they completed Phase III clinical trials. This clinical trials site notes that the trial ended, it looks like they finished recruiting patients at the end of July. The notice is posted online here.
Although this trial is ended, keep your eyes open for other trials like this, they are becoming more common. Thanks for your message. ]

This study really is arrogant. So who does the FDA protect? From M.Mazzola

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