InfoMail for March 15a, 2002

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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

March 15a, 2002


Harm to Alzheimer ExperimentalPatients

FYI

ABC reports that Bob Helms, the self-described humanguinea pig, has written a book about his experience and observations about theconduct of research and those who become human subjects for cash or out ofdesperation.

The current system relies on self regulation: it lacksboth independent oversight and accountability. Drug trials pose serious risks ofharm, both to healthy test subjects like Helms, and even more so, to thosedesperately seeking treatment. In most instances, the odds of a test subjectbenefiting directly from a clinical trial are not favorable: many trials are notdesigned to benefit the test subjects but to gather data about their response.But those who are recruited aren’t informed about the odds.

ABC reports that the most recent report– about 15instances of brain inflammation in Alzheimer’s vaccine trials (conducted by theDublin-based Elan Corp)– has led bio-ethicists to revisit the drug testingsystem which is largely self-regulated. However, the human drug testing industryis unlikely to impose restrictions to ensure that vulnerable people who serve astest subjects are adequately protected. Not as long as those formulating publicpolicy in this area are themselves influenced by the pharmaceutical industrythat funds them directly and indirectly.

On March 14, 2002, The Associated Press reported, CDCSuspended Tuberculosis-HIV Study After 5 Patients Become Resistant toTuberculosis Drug http://abcnews.go.com/wire/US/ap20020314_1285.html

http://printerfriendly.abcnews.com/printerfriendly/Print?fetchFromGLUE=true&GLUEService=ABCNewsCom

For the Sake of Science: Weighing the Risks andBenefits of Human Guinea Pigs

By Amanda Onion

March 13 — For Bob Helms, a day at work can literally bea draining experience.

"I’ve gone home with ugly track marks on my arm thattake a week to heal. I’ve fainted, I’ve passed out for eight hoursafterward," said the 44-year-old Helms. "It can be dreary and veryboring." Helms is a self-described human guinea pig who, for seven years,has taken money in exchange for his time, blood, urine and sometimes feces as apaid volunteer in drug research trials.

Helms has written a book called Guinea Pig Zero about theexperiences of human guinea pigs in clinical trials to come out this May. He maysound like a hero of sorts — as someone who braves the uncertain effects ofnew medicines to help researchers ensure they’re safe for future patients.

But he’s clear his motives are not selfless.

"I do it because it’s a way to catch up on my billsand earn a little," said Helms, who earns $150-$400 a day for hiscontributions.

Drug Testing ‘Terribly Flawed’

The real heroes, and the ones most vulnerable to risk,Helms claims, are those who are already sick and undergo clinical trials attheir doctors’ advice, out of desperation, or even unknowingly.

Sometimes the trials help save lives — like TomChristerson, 70, who just became the longest living recipient of a totallyimplantable artificial heart after six months with the device. But occasionally,they jeopardize them, as what happened last month when 15 Alzheimer’s patientssuffered brain inflammation after taking an experimental vaccine.

The failed Alzheimer’s vaccine trials, conducted by theDublin-based Elan Corp., has caused bioethicists to revisit the drug testingsystem that past mishaps had already revealed as flawed. Despite some reforms,many conclude the system still poses serious risks to both healthy test subjectslike Helms and ones seeking treatment.

"It’s kind of like democracy," said Paul RootWolpe, a sociologist at the Center for Bioethics at the University ofPennsylvania. "It’s terribly flawed and problems fall through the cracks,but it’s still a better system than all the others."

A Long Road to Market

The process goes like this: Once a drug company hasformulated a new drug and tested it on animals, they must then test the drug ina series of human trials. Phase I trials test the safety of the new drug on asmall group of healthy volunteers (like Helms). Phase II tests the safety andeffectiveness on a small group of sick patients. And phase III trials test thedrug on a large group of patients.

Before conducting any drug trials all publicly funded andsome privately funded researchers must submit their projects to an InternalReview Board, or IRB. The IRB then evaluates the risks and protections forfuture trial subjects. Publicly funded projects must meet federal standardsenforced for clinical trials as outlined by the Food and Drug Administration in1991.

Some argue all clinical trials — public and private —should be held to these federal standards. In fact, a bioethics counseloperating under President Clinton’s administration recommended this step fiveyears ago but it hasn’t yet been taken.

"There’s a great deal of commercial research thatisn’t regulated at all," said Beverly Woodward, a medical ethicist atBrandeis University who has monitored the system.

But past trials have shown even enforced governmentstandards can’t prevent tragedy.

In 1998, 24 critically ill patients died after being givena blood substitute without their informed consent. The FDA had recently grantedapproval for companies to conduct clinical trials without informed consent forcertain emergency room products. Baxter Healthcare Association was trying toglean data for their product, HemAssist, but when results showed more patientsdied in the HemAssist group than in the group receiving donated blood, thecompany stopped the trial.

In September 1999, 18-year-old Jesse Gelsinger died afterundergoing experimental gene therapy treatment at the University ofPennsylvania. Gelsinger had suffered from a rare liver disorder, but had beenrelatively healthy before undergoing the test trial. His father claimed theresearchers failed to reveal all the risks involved in the procedure.

"I encouraged my son to do this," Paul Gelsingertold a Senate Subcommittee on Feb. 2., 2000. "But I wasn’t given all theinformation."

And last June, Ellen Roche, a healthy 24-year-old woman,died after inhaling a drug known as hexamethonium for a drug trial at JohnsHopkins University. An investigation later revealed the consent form Roche hadsigned didn’t mention that the drug had never been approved for inhalation.

Children and Trials

Wolpe explains doctors on IRB’s are often underpaid andunder qualified to make sound judgments. Since drug trials often involve veryspecialized fields of medicine, risks can be overlooked during assessment.

Woodward is particularly concerned about children in drugtrials. She points out a 1997 FDA mandate encourages drug companies to testtheir products on children. The mandate rewards companies that do so byextending their patent on a drug by another six months — a term that can behighly profitable for companies selling a popular product.

"It’s a very dicey issue because you’re dealing withpeople who cannot really give their informed consent," said Woodward.

But researchers counter that parents are very capable ofmaking such delicate decisions for their children and that review boards payextra attention to safety when considering tests on children.

"The parents are made sure they understand all thepossible benefits and risks and are encouraged to ask questions," saidLaurence Greenhill of the New York Psychiatric Institute. Greenhill is principalinvestigator for a clinical trial testing the use of the psychiatric drug,Ritalin, in pre-schoolers.

Greenhill adds that if clinical trials do not includechildren, then doctors will never have access to research to guide theirtreatment of juveniles.

Money and Judgment

One skewing factor in the clinical trial system, Wolpeargues, is money. He’s concerned that healthy people like Roche might overlookthe risks involved in a particular experiment if the pay is high enough.

"The IRBs determine at what point are you using moneyto defeat people’s better judgment," said Wolpe.

Money might also compromise doctors’ judgments, he says.Drug companies often pay doctors for every new patient they recruit to undergodrug trials.

But John Plachetka, president and CEO of Pozen, aPharmaceutical Development Company based in Durham, N.C., claims this pay isonly designed to cover the costs a doctor adopts when entering a patient in atrial.

"The money is for their giving up time they could beusing for running their practice," said Plachetka. "If they don’tspend the time discussing all the risks with their patients, we’re notinterested."

When Trials Work

Recently patients have begun bypassing doctors and seekingclinical trials on their own through Web sites such as CenterWatch.com andClinicalTrials.gov. These sites serve to connect prospective patients directlyto drug companies seeking subjects. Once patients find drug trials they thinkcould help, they then seek advice from doctors and researchers about whetherthey qualify and might benefit.

The method worked for Ted Wiles, who used the Internet tofind a clinical trial for his stepdaughter, Taylor Nicholson, last year.Nicholson was suffering from a rare childhood brain stem glioma cancer.Nicholson’s mother explained the choice to enter her 6-year-old daughter in thedrug trial was easy.

"We were willing to try everything," said TinaWiles, Taylor’s mother. "We had taken her to faith healers, we had triednatural herb medicines. Even if this treatment only prolonged her life by sixmonths, we decided it was worth it."

Today Nicholson is back at school and her current testsshow no signs of the cancer.

It’s hopeful stories like Nicholson’s that drive the drugtrial process to begin with. As Plachetka says, "It’s absolutely tragicwhen mishaps occur, but somebody somewhere has to be among the first to take adrug. Otherwise we’ll never know what works and we’ll never get new drugs."

But Helms, who recently lost touch with a friend who hesays became mentally unstable after volunteering for a series of psychiatricdrug trials, argues the risks don’t need to be so high.

"We’re offering ourselves to science, even though noone ever hears about our contributions when the papers are published," saidHelms. "We deserve better protection."

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