[OT] When Drug Trials Go Wrong, Patients Have Little Recourse

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When Drug Trials Go Wrong, Patients Have Little Recourse

Lawsuits Push Liability Despite Consent Forms; Ms. Davenport's Decline

By SARAH RUBENSTEIN

January 31, 2008; Page A1

COUPEVILLE, Wash. -- Before Suzanne Davenport entered a clinical trial testing a

drug for Parkinson's disease, she could drive, cook and care for herself. Within

months, she was wheelchair-bound and living in a nursing home.

Ms. Davenport's family says the trial caused her precipitous decline. It is

suing the two drug makers that ran the trial and the university that enrolled

her in it for compensation to cover her mounting medical bills.

The case highlights one aspect of the legal and regulatory void surrounding

clinical trials. Federal law does not require researchers to compensate

participants harmed in such trials. It merely requires that their consent forms

spell out whether compensation will be available for research-related injuries

in trials that involve more than minimal risk.

The prospect of compensation for injuries, of course, encourages volunteers who

might otherwise be reluctant. But the wording in these consent forms is often

confusing and vague. It can be unclear which research entity is responsible for

the cost of subsequent care, how much that entity will pay and under what

circumstances it is obligated to pay. One big problem is that it can be

difficult to separate what was caused directly by a trial from the natural

progression of the participant's disease.

Companies " do not want to end up paying for all of somebody's care when that

care may simply be the product of the fact that that person had a grave

illness, " says Haavi Morreim, a University of Tennessee bioethics professor who

has studied clinical-trials lawsuits.

The issue has come into heavier focus as drug companies, under increasing

financial pressure to bring drugs to market, have stepped up the pace of

clinical trials. World-wide, the number of industry trials rose to 59,000 in

2006 from 40,000 in 2000, according to an estimate from CenterWatch, a

clinical-trial listing service. The growth has come in part from a jump in small

early-stage trials meant to help drug companies weed out duds quickly. Makers

say it is also increasingly common to test a single drug multiple times to see

if it can treat different conditions.

There is little definitive data on the number of injuries from clinical trials,

partly because there is no one government body that regulates all of them. But

the issue is getting more attention following several widely publicized

lawsuits, including a suit over the 1999 death of Gelsinger, an

18-year-old who participated in a gene-therapy trial at the University of

Pennsylvania.

Many lawyers had long been reluctant to pursue clinical-trial injury cases

because they worried the consent forms protected drug companies and universities

from liability, says Alan Milstein, the attorney for Mr. Gelsinger's family. The

Gelsinger case, which settled for an undisclosed sum, helped raised public

awareness of safety issues with trials. The lawsuits also showed that it was

possible to find flaws in the informed-consent process and sufficient

maneuvering room in the wording to be successful. Mr. Milstein says he has filed

13 cases involving clinical-trial injuries since then, with 11 involving full or

partial settlements.

A Gradual Decline

Suzanne Davenport, a 71-year-old retired kindergarten teacher, was diagnosed

with Parkinson's in 1989 after her husband noticed she was inadvertently

knocking her hand against posts as they walked their dog.

Her decline was very gradual, her family says. For years, she continued to

quilt, an activity that required the sorts of fine motor skills that Parkinson's

can ravage. But by 2003, the disease had advanced. Among other things, Ms.

Davenport had to keep redoing her stitches to get them right, says her husband,

Jim Davenport. She gave up the hobby.

In early 2004, neurologists at the University of California, Los Angeles, where

Ms. Davenport was receiving some of her care, discussed with her the idea of

participating in a clinical trial. It involved surgically implanting an

experimental drug called Spheramine into the brains of Parkinson's patients with

the aim of improving their motor skills.

The drug was in mid-stage development. An early-stage study in 2000 involving

six trial participants with Parkinson's found that it was " well tolerated

without serious adverse events related to the treatment, " and patients' motor

symptoms improved, according to a 2005 article in the Archives of Neurology.

Spheramine was originally developed by Titan Pharmaceuticals Inc. of South San

Francisco, Calif. Titan entered into a partnership to develop the drug with

another company, Berlex Inc., which was the U.S. arm of the German drug maker

Schering AG. Berlex sponsored the trial and UCLA enrolled patients and evaluated

them before and after receiving the treatment.

On June 10, 2004, Ms. Davenport signed a UCLA consent form stating: " If you are

injured as a direct result of research procedures, you will receive treatment at

no cost. The University of California does not provide any other form of

compensation for injury. "

Decoding 'Injury Statements'

Consent forms and compensation plans vary by institution. There have been

sporadic calls to standardize these programs, but none have been widely adopted.

The Institute of Medicine, a nonprofit group that advises the government on

health policy, recommended in 2002 the creation of a " no fault " compensation

system for injured subjects. The goal was to help trial participants resolve

their claims quickly, without having to resort to lawsuits.

Throughout the second half of 2004, Ms. Davenport went through periodic

pre-operative tests at UCLA. Shortly before the scheduled operation, the venue

for the procedure was switched from Stanford University's medical center to

Tampa General Hospital in Florida.

Ms. Davenport signed another consent document, this one from the University of

South Florida, which employed the surgeon who would operate on her. The form

contained three " injury statements. "

The first statement, from USF, said financial damages would be available to her

in the event of an injury " to the extent that negligent conduct of a University

employee caused your injuries, " but such damages could be " limited by law. " The

second statement, from Tampa General Hospital, said the cost of treatment for

any injury " may be the responsibility of you or your insurance company. " The

third statement, from Berlex, said: " If because of your participation in the

study you require additional care that would not ordinarily be necessary for

your condition, this will be provided at no additional cost to you. "

On Jan. 14, 2005, Ms. Davenport walked into Tampa General Hospital. When she

came out of the surgery, she was no longer the same person.

She could no longer stay upright in a chair and could not walk, her husband

says. She also needed a diaper and her mouth hung open. On the flight home, Mr.

Davenport says he spent about four hours propping his wife's upper body against

the back of her seat so she wouldn't fall forward. In the following weeks, Ms.

Davenport hallucinated frequently and her cognitive skills had diminished

considerably, says her daughter, Languille.

By September 2005, eight months after the surgery, Ms. Davenport required

constant monitoring. The family decided to put her in a nursing home outside

Seattle, near Ms. Languille's home. There, Ms. Davenport lost her balance and

fell a few times. The nurses put her in lap restraints to keep her from getting

out of her wheelchair.

Ms. Davenport's neurologist, of Virginia Mason Medical Center in

Seattle, says he believes Spheramine caused her sudden decline. Dr. was

not involved in the trial, but learned from a UCLA neurologist in early 2006

that Ms. Davenport was among the patients who had received the drug. As is the

case in many clinical trials, some patients who were part of a control group had

not received the drug.

Dr. , who had been treating Ms. Davenport for almost a year before she

entered the trial, says before the trial, she was able to walk and conduct basic

living activities independently. Based on her age and her overall health, he

estimates she could have gone another 10 years before needing to move into a

nursing home had she not taken part in the trial.

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