InfoMail for April 13, 2002

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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

April 14, 2002

Clinical Trials Given "At Your Own Risk"

FYI

TIME Magazine’s cover story, "At Your Own Risk,"(excerpts below) focuses on several high profile research scandals that led tothe shut down of clinical research at some of the nation’s most prestigiousresearch centers. The article begins by describing why Cherlynn Matthias, thenurse research administrator, blew the whistle on a worthless cancer vaccinetrial at Oklahoma University. The federal Office of Human Research Protectionconcluded that the research violated ethical and scientific standards ofresearch, and that it was making patients worse rather than better. The articledescribes two fatal experiments that resulted in the death of two youngsubjects. Ellen Roche died in the hexamethonium experiment conducted at JohnsHopkins University, and Jesse Gelsinger died in a gene transfer experimentconducted at the University of Pennsylvania.

Although the institutions whose research brought publiccondemnation have announced plans to revamp their research oversight andapproval process, the explosion of research involving humans and the lack of afederal law mandating independent oversight, leaves total control in the handsof the stakeholders who have inherent conflicts of interest. TIME reports,"the U.S. can’t afford to wait for every research institution to react toits own lapses. That’s the impetus for a sweeping overhaul of the OHRP, designedby director Greg Koski—with advice from a newly motivated Johns Hopkins—tomake the agency more aggressive in protecting human subjects."

Congress is finally waking to the need to protect humansubjects from illegitimate experiments, and to hold those who violate ethicalstandards and undermine subjects’ safety, liable. Because clinical research is(at best) poorly regulated, people–unlike animals–are being put at risk ofharm in needlessly duplicated experiments. As Marcia Angell, former editor ofthe New England Journal of Medicine confirms: "So much research is trivialduplication."

George Annas, a health law expert, and one of the fewbio-ethicists who is not beholden to the pharmaceutical industry says:"Researchers tend to approve research; they know this is how theinstitution makes its money. They rarely deny anything."

Senator Edward Kennedy is holding a hearing April 23 andis planning to submit legislation to protect human subjects. The Alliance forHuman Research Protection has been invited to submit testimony for inclusion inthe public record of the Subcommittee’s proceedings. Congress Woman DianneDeGette plans to introduce legislation in the House.

TIME magazine reporters and editors,however, don’t seem to recognize an apparent conflict of interest when theypromote CenterWatch as "a patient information group that monitorsclinical research." The implication that this commercial publishing companyserves patients’ interests is…quaint.

CenterWatch is a subsidiary of the ThomsonCorporation publication empire whose earnings last year were $7 billion. See: http://www.thomson.com/Businesses/index.jsp?Market=6

http://www.thomson.com/PressRelease/PRDetail.jsp?PRID=173"We hold leading positions in the information sectors of the legal andregulatory, financial services, scientific, healthcare, and learning markets ona global basis."

CenterWatch promotes the interests of the clinicaltrial industry serving as a human subject recruitment vehicle. See their websitewww.centerwatch.com.

The Alliance for Human Research Protection (AHRP)is anindependent national network of lay people and professionals dedicated toadvancing responsible and ethical medical research practices, to ensure that thehuman rights, dignity and welfare of human subjects are protected, and tominimize the risks associated with such endeavors. One way to accomplish thatmission is to inform people about their rights and how to elicit vitalinformation before they sign consent to research. AHRP has initiated a humansubject protection Informed Consent campaign to help ferret out informationrarely provided to people being sought as research subjects. We do not acceptmoney from the pharmaceutical or healthcare industry.

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http://www.time.com/time/health/article/0,8599,230358,00.html

Sunday, Apr. 14, 2002 
At Your Own Risk

Some patients join clinical trials out ofdesperation. 
Others to help medicine advance. 
Whom do you blame if they get sick—or even die? 
by Michael D. Lemonick and Andrew Goldstein/Tulsa

By the time Cherlynn Mathias was ready to blow the whistleon Dr. Michael McGee two years ago, it had been clear for quite a while thatsomething fishy was going on. For one thing, there were the hokey infomercialstouting his experimental vaccine for malignant melanoma, a particularly nastyform of cancer, as if it were a Veg-O-Matic. Thanks to the vaccine, a patientdeclared onscreen, my cancer is in total remission. Then there was the salespitch McGee delivered in person. When she and the doctor met with a prospectivepatient, says Mathias, who worked as his research nurse, he would come on like aused-car salesman: "’We have the best vaccine out there,’" sheremembers his saying. "’Two-thirds of my patients have responded to thetreatment.’" He was even giving the drug to his father-in-law, he wouldtell people; that’s how good it was.

But what they got, once they joined McGee’s clinicaltrial, many patients say, was a different story. According to Mathias, more thana third developed severe side effects, including uncontrollable nausea, fevers,rashes, swelling and terrible headaches. Some thought the doctor’s behavior wasodd. While on the vaccine, one patient, Dawanna Robertson, discovered she waspregnant; she panicked when she recalled the warning on the consent form she hadsigned: "The potential effects of these drugs on the growing fetus … mayinclude serious birth defects." Yet when she voiced her fears, Robertsonsays, McGee assured her that the vaccine couldn’t pass through the placenta. Shereceived another injection that day.

Still, Mathias says, most of McGee’s patients believedthat this vaccine was their best chance for recovery from what is usually afatal disease. That’s why they were so shocked when McGee sent them a letterthat read, in part, "Patients have enrolled in this study more rapidly thanoriginally expected … Due to this interest, the sponsor has exceeded itscapacity to supply the experimental Melanoma Vaccine and is unable to providematerial for further injections at this time."

The letter was devastating enough, but Mathias knew it wasa lie. The truth was that the trial had been suspended out of a growing concernamong McGee’s supervisors that it may have been doing more harm than good. Soafter agonizing for days about what to do, she wrote a long, detailed letter towhat is now called the federal Office for Human Research Protections (ohrp),describing McGee’s multiple lapses. Her letter reported that McGee had, amongother things, stored the vaccine improperly, exposing it to potentialcontamination; failed to maintain adequate records and track its consistencyfrom batch to batch; mislabeled vials of the stuff; and, worst of all, kept mostof the data on adverse side effects secret. An investigation by the Food andDrug Administration confirmed her suspicions and ultimately revealed more than20 separate deficiencies. "We were doing nothing right," says Mathias."It was a perfect lesson in how not to run a clinical trial."

Where the balance lies is a matter of serious, even bitterdebate. At one extreme are those who believe that most trials are taintedbecause they play on the fears of desperately ill patients, involve some sort ofsubtle coercion like money or free medicine or fail to warn patients of the veryreal dangers they face. Some critics argue as well that there are simply toomany trials, as pharmaceutical companies looking for a share of the blockbusterdrug market pump out copycat medicines that no one really needs. On the otherside are clinicians who feel they are already burdened with too much regulatorypaperwork. Tighter rules will just take time and energy away from what theyshould be doing—developing and testing desperately needed medications. A fewmishaps today, they say, may be the price we pay to save thousands of livestomorrow.

Still, something is clearly wrong with the system as itnow operates. Over the past three years, more than 60 institutions, includingseveral of the world’s most prestigious research centers, have been criticizedby the U.S. government for failing to protect human subjects adequately. McGee’spatients were very sick, so in a sense they couldn’t be made much worse by histreatments. But federal records show that since 1999 at least four people whoentered clinical trials in reasonably good health wound up dead—including twoinfamous cases, at Johns Hopkins Medical Center and the University ofPennsylvania.

The actual number of such deaths may be considerablyhigher, but nobody really knows. The monitoring of clinical research in the U.S.is so piecemeal, and the reporting of problems so haphazard, that it’s almostimpossible to find out what is really happening. Thanks to a patchworkregulatory system, perhaps a quarter of all clinical research—including somestudies on reconstructive surgery, dietary supplements, stem cells andinfertility treatments, for example—gets no federal oversight whatsoever. Andeven where oversight is mandated, it’s often applied loosely, if at all.

And it can only get worse as the number of trialsincreases. According to CenterWatch, a patient information group thatmonitors clinical research, 80,000 clinical trials were conducted in the U.S.last year alone….

Some experts favor tighter enforcement of existing rulesand greater resources for the understaffed, overworked review boards that toooften let shoddy research proceed. Others think patients need to be told moreclearly and forcefully what the dangers and limitations of clinical trialsreally are. Still others are convinced that financial conflicts of interest—drugcompanies sponsoring trials and paying doctors—are the root of all evil. Billsare being introduced in both houses of Congress in the next few weeks that aredesigned to better protect research subjects, and ohrp, the main researchregulatory agency, is rewriting its rules. What’s clear to nearly everyone,though, is that without uniform, federally mandated regulations, the situationwill only get worse.
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