FDA Grants Guinea Pig Status To US Citizens

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February 28, 2006FDA Grants Guinea Pig Status To US Citizens by Evelyn Pringlehttp://www.opednews.com"It is outrageous that, for all intents and purposes, the FDA allowed aclinical trial to proceed, which makes every citizen in the UnitedStates a potential "guinea pig," without providing a practical,informative warning to the public."The statement of outrage above was included in a letter to acting FDACommissioner, Dr von Eschenbach, from Senator Charles Grassley (R-Iowa)on February 24, 2006. Senator Grassley has been keeping a close eye onthe performance of the FDA in recent years. Evelyn PringleAs a Senator representing the State of Iowa and Chairman of theCommittee on Finance, which has jurisdiction over the Medicare andMedicaid programs, the Senator wrote, "I am responsible for oversight ofmatters that affect my constituents and the beneficiaries of thesefederal health care programs."In the letter, he advised Dr von Eschenbach that he found a recent WallStreet Journal article titled, "Amid Alarm Bells, A Blood SubstituteKeeps Pumping," alarming.According to Sen Grassley, the WSJ says the FDA is allowingIllinois-based Northfield Laboratories to test a blood substitute calledPolyHeme, in a clinical trial without the consent of patients, who maybe unconscious or otherwise incapable of providing informed consent,pursuant to a rarely used FDA regulation, which allows for waiver of theconsent required in clinical trials, if some type of community outreachprogram is put into practice."I understand the value of a viable blood substitute," Senator Grassleytold Dr von Eschenbach in the letter, "but I'm really disturbed by whatI'm hearing about the FDA's role here and I want to find out what'sgoing on."PolyHeme contains hemoglobin processed from expired blood donations andis designed to be given to trauma victims in place of blood or salinesolution. The product is supposed to be used as a temporary measure whenthere is a large blood loss and no readily available blood supply,according to Northfield.Under guidelines for emergency teams participating in the study, attrauma sites, they administer PolyHeme to half of the patients, andstandard saline solution to the other half. At the emergency room,patients who get PolyHeme at the trauma site continue to receive PolyHeme.The 1996 federal regulation in question allows trials of possiblelife-saving treatments without patient consent if participatingfacilities inform members of the community about the trial and gaugepublic sentiment."I am skeptical," Sen Grassley told the FDA, "that any participatingmedical centers managed to conduct effective, practical outreach to thecommunity and to provide a meaningful, informative warning to the publicabout the PolyHeme Study.""If you're in a car accident, of course you want emergency doctors tosave your life," Sen Grassley said in a press release. "But noreasonable person would expect to be treated as an experimental subjectwithout consent," he added.The trial is currently being conducted in 18 states that includeCalifornia, Colorado, Delaware, Georgia, Illinois, Indiana, Kansas,Kentucky, Michigan, Minnesota, New York, North Carolina, Ohio,Pennsylvania, Tennessee, Texas, Utah, and VirginiaSo if you travel in these states and suffer a traumatic injury or needemergency treatment at a participating trauma center, you could becomean unknowing research subject without your consent.That is, unless you happen to be wearing a lightblue wristband imprintedwith the statement: "I decline the Northfield PolyHeme Study."This silly provision has further angered the Senator. "The idea that theFDA would put the burden on the public to opt out of this massexperiment is outrageous," he said.An unknown number of community meetings were reportedly held inparticipating states and anyone who took time to attend a meeting couldopt out by wearing continuously for an undetermined period of time oneof these light-blue wristbands."Why should Americans have to wear a bracelet at all times to protectthemselves from a government-sanctioned medical experiment if theyhappen to get into a car accident?" he asked the FDA."I suspect many people, if they knew this," Senator Grassley noted,"might reasonably ask, "where do I get my wristband?"This question is not readily answerable according to the Senator, "it'snot apparent from any information on the FDA's website," he said.Researchers at Legacy Health System and Oregon Health & ScienceUniversity in Portland, Oregon suspended their plans to test the bloodsubstitute after attempts to get local approval for the experiment wereunsuccessful for 2 years.The WSJ reported that, in an earlier clinical trial of PolyHeme, 10 outof 81 patients suffered heart attacks within a week of receiving thesubstitute and that 2 of those people died.Besides the heart attacks and deaths, the trial suggested the PolyHemewas linked with other adverse events such as heart rhythm aberrationsand pneumonia. These events occurred in 54% of the PolyHeme patientsversus 28% in the control group, according to Northfield's internaldocuments.The previous study differs from the current study in that patients inthe first study were not trauma patients, they were undergoing surgeryto repair aneurysms in their aortas and consented to participating inthe study. In the first study, patients in one group received PolyHemeand patients in the control group received real blood.In the second half of 2001, "Northfield abruptly shut down the study,explaining in a Securities and Exchange Commission filing that it wastaking too long to complete," the WSJ reports. The paper says Northfieldfailed to make the results of the study public.Northfield's chief executive, Steven Gould, says it has not been proventhat the adverse events in the trial were caused by PolyHeme and claimsthe heart attacks may have been caused by doctors who pumped too muchfluid into patients, when adding PolyHeme and real blood.William Hoffman, chief of the cardiac-surgery intensive-care unit atMassachusetts General Hospital in Boston, told the WSJ that substitutesin a class that includes PolyHeme, are associated with heart attacks andstrokes. "It is self-serving and potentially misleading to associateharmful effects with something other than the test drug," he said.Doctors who took part in the first study have questions but saidNorthfield restricted access to the full data so they only knew whathappened to their own patients.At the University of Pennsylvania, Dr. Fairman told the WSJ that he anda colleague, Albert Cheung, repeatedly called Dr Gould at Northfield."We said, 'Let's sit down and write up the data,' " Dr. Fairman recalls."He wouldn't do it."Dr. Cheung proposed a meeting of doctors at the 21 hospitals that hadtaken part in the study and says Dr Gould agreed to the meeting, butthen canceled it at the last minute.T.J. Gan, a Duke University anesthesiologist involved in the study, toldthe WSJ he called Northfield three years ago to ask if results had beenpublished and Dr. Gould told him, "Someone's working on it."Northfield issued a statement saying company officials do not recall thespecifics of any discussion about a meeting with Dr Cheung or theconversation with Dr Gan. It denies that it "resisted publication" butsays: "We did not allocate resources to publication. In retrospect,reporting the full study results earlier would have been better.""Last year," according to the WSJ, "the FDA required Northfield tomention on its Web site "serious cardiovascular adverse experiences"with PolyHeme.""Five of the 31 hospitals in the trauma study followed suit, but wellafter many trauma patients had been treated," the paper noted.In his letter, Senator Grassley told the FDA to address the issue "byproviding the public with meaningful information related to what itshould already have known about the PolyHeme Study."In addition, by March 8, 2006, he instructed the agency to provide hisCommittee with a detailed briefing regarding the study."Over the next few days," Senator Grassley wrote, "my Committee staffwill contact your staff with more specific requests for information, butat the minimum your staff should be prepared to address the followingissues related to the PolyHeme Study:1. What oversight, if any, has FDA conducted related to the PolyHemeStudy?2. What consultation with representatives of the community was conducted?3. What public disclosure to communities was conducted prior toinitiation of the PolyHeme Study?4. Were known adverse events, including but not limited to thosereported in the WSJ, disclosed with the risks and expected benefitsinformation?5. Has Northfield Laboratories, Inc., met all regulatory reportingrequirements related to its PolyHeme product, including but not limitedto timely reporting of all adverse events?"He also asked the FDA to provide a detailed list and summary of allclinical trials conducted since January 1, 1996, under the FDAregulation governing exception from informed consent requirements.In regard to the current study, Northfield says an independent committeemonitoring the study reviewed reports of death and other seriousproblems four times, and each time recommended the trial continueunchanged, according to Reuters News on February 24, 2006.By Evelyn Pringleevelyn.pringle«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»MedicalConspiracies - PULSE ON WORLD HEALTH CONSPIRACIES!MedicalConspiraciesSubscribe: MedicalConspiracies- «¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§ - PULSE ON WORLD HEALTH CONSPIRACIES! §Subscribe:......... - «¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»New Sister Group: MedicalConspiracies (One Word)Google groups:http://groups.google.comMedicalConspiraciesPost message: MedicalConspiracies (AT) googl (DOT) comSubscribe: MedicalConspiracies- (AT) googl (DOT) com«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»Any information here in is for educational purpose only, it may be news related, purely speculation or someone's opinion. 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