FYI

. . . And the band plays on and the body count continues to mount--

The New York Times reports that Eli Lilly is in negotiation talks with the

US Justice department to settle both civil and criminal investigations of

the company's marketing of its toxic diabetes-inducing antipsychotic,

Zyprexa. If the settlement is reached, the Times reports, Lilly would pay

the biggest fine in history.

In a recent study in The Lancet, compared Risperdal an antipsychotic in the

same class as Zyprexa, to placebo in calming aggression--which is the

primary reason that Zyprexa and Risperdal are prescribed. They found the

harmless placebo to be more effective:

http://www.thelancet.com/journals/lancet/article/PIIS0140673608600720/abstract

The authors concluded: "Antipsychotic drugs should no longer be regarded as

an acceptable routine treatment for aggressive challenging behaviour in

people with intellectual disability."

Underscoring the total failure by the US government to take meaningful

action to protect the public health as well as the public wealth, The Times

reports:

"But the company would be allowed to keep selling Zyprexa to Medicare and

Medicaid, the government programs that are the biggest customers of the

drug. Zyprexa is Lilly's most profitable product and among the worlds

best-selling medicines, with 2007 sales of $4.8 billion, about half in the

United States."

Indeed, Medicaid pays for about 70% go 80% of the antipsychotic drug

prescriptions.

All anyone involved cares about is money--as they lend their government seal

of approval that leads the lambs to slaughter

Contact: Vera Hassner Sharav

This email address is being protected from spambots. You need JavaScript enabled to view it.

212-595-8974

http://www.nytimes.com/2008/01/30/business/30cnd-drug.html?hp

THE NEW YORK TIMES

January 30, 2008

Lilly in Settlement Talks With U.S.

By ALEX BERENSON

Eli Lilly and federal prosecutors are discussing a settlement of a civil and

criminal investigation into the company's marketing of the antipsychotic

drug Zyprexa that could result in Lilly's paying more than

$1 billion to federal and state governments.

If a deal is reached, the fine would be the largest ever paid by a drug

company for breaking the federal laws that govern how drug makers can

promote their medicines.

Several people involved in the investigation confirmed the settlement

discussions. They insisted on anonymity because they have not been

authorized to talk about the negotiations.

Zyprexa has serious side effects and is approved only to treat people with

schizophrenia and severe bipolar disorder. But documents from Lilly show

that between 2000 and 2003, Lilly encouraged doctors to prescribe Zyprexa to

people with age-related dementia, as well as people with mild bipolar

disorder who had previously been diagnosed only as depressed.

Although doctors can prescribe drugs for any use once they are on the

market, it is illegal for drug makers to promote their medicines any uses

not formally approved by the Food and Drug Administration.

Lilly may also plead guilty to a misdemeanor criminal charge as part of the

agreement, the people involved with the investigation said. But the company

would be allowed to keep selling Zyprexa to Medicare and Medicaid, the

government programs that are the biggest customers for the drug. Zyprexa is

Lilly's most profitable product and among the world's best-selling

medicines, with 2007 sales of $4.8 billion, about half in the United States.

Lilly would neither confirm nor deny the settlement talks.

"We have been and are continuing to cooperate in state and federal

investigations related to Zyprexa, including providing a broad range of

documents and information," Lilly said in a statement Wednesday afternoon.

"As part of that cooperation we regularly have discussions with the

government. However, we have no intention of sharing those discussions with

the news media and it would be speculative and irresponsible for anyone to

do so."

Lilly also said that it had always followed state and federal laws when

promoting Zyprexa.

The Lilly fine would be distributed among federal and state governments,

which spend about $1.5 billion on Zyprexa each year through Medicare and

Medicaid.

The fine would be in addition to $1.2 billion that Lilly has already paid to

settle 30,000 lawsuits from people who claim that Zyprexa caused them to

suffer diabetes or other diseases. Zyprexa can cause severe weight gain in

many patients and has been linked to diabetes by the American Diabetes

Association.

Prescriptions for Zyprexa have skidded since 2003 over concerns about those

side effects. But the drug continues to be widely used, especially among

severely mentally ill patients. Many psychiatrists say that it works better

than other medicines at calming patients who are psychotic and

hallucinating. About four million Zyprexa prescriptions were written in the

United States last year.

Federal prosecutors in Philadelphia are leading the settlement talks for the

government, in consultation with the Department of Justice headquarters in

Washington. State attorneys general's offices are also involved. Lawyers at

Pepper Hamilton, a firm based in Philadelphia, and Sidley Austin, a firm

based in Chicago, are negotiating for Lilly.

Nina Gussack, who is representing Lilly at Pepper Hamilton, said she could

not comment on the case. Joseph Trautwein, an assistant United States

attorney in the Eastern District of Pennsylvania, also declined to comment.

While a settlement has not been concluded and the negotiations could

collapse, both sides want to reach an agreement, according to the people

involved in the investigation. Besides the escalating pressure of the

federal criminal inquiry, Lilly faces a civil trial scheduled for March in

Anchorage, Alaska, in a lawsuit brought by the state of Alaska to recover

money the state has spent on Zyprexa prescriptions. A loss in that lawsuit

would damage Lilly's bargaining position in the Philadelphia talks.

While expensive for Lilly, the settlement would end a four-year federal

investigation and remove a cloud over Zyprexa. While Zyprexa prescriptions

are falling, its overall dollar volume of sales is rising because Lilly has

raised Zyprexa's price about 40 percent since 2003.

Federal prosecutors have been investigating Lilly for its marketing of

Zyprexa since 2004, and state attorneys general since 2005. The people

involved in the investigations said the inquiries gained momentum after

December 2006, when The New York Times published articles describing Lilly's

multiyear efforts to play down Zyprexa's side effects and to promote the

drug for conditions other than schizophrenia and severe bipolar disorder - a

practice called off-label marketing.

Internal Lilly marketing documents and e-mail messages showed that Lilly

wanted to convince doctors to prescribe Zyprexa for patients with

age-related dementia or relatively mild bipolar disorder.

In one document, an unidentified Lilly marketing executive wrote that

primary care doctors "do treat dementia" but leave schizophrenia and bipolar

disorder to psychiatrists. As a result, "dementia should be first message"

to primary-care doctors, according to the document, which appears to be part

of a larger marketing presentation but is not marked more specifically.

Later, the same document says that some primary care doctors "might

prescribe outside of label."

In late 2000, Lilly began a marketing campaign called Viva Zyprexa and told

its sales representatives to suggest that doctors prescribe Zyprexa to older

patients with symptoms of dementia.

The documents were under federal court seal when The Times published the

articles, and Judge Jack B. Weinstein of Federal District Court in Brooklyn

rebuked The Times for publishing them.

The settlement negotiations in Philadelphia began several months ago,

according to the people involved in the investigation.

Last fall, the two sides were close to a deal in which Lilly would have paid

less than $1 billion to settle the case, which at the time consisted only of

a civil complaint.

Then Justice Department lawyers in Washington pressed for a grand jury

investigation to examine whether Lilly should be charged criminally for its

promotional activities, according to the people involved in the

negotiations. A few days ago, facing the possibility of both civil and

criminal charges, Lilly opened new discussions with the prosecutors in

Philadelphia.

Copyright 2008 The New York Times Company

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

The information herein shall not be considered an endorsement of anyone discontinuing psychiatric drugs. If you are stopping taking medication it is advisable to reduce the dose gradually WITH EXTREME CAUTION, as it is difficult to predict who will have problems withdrawing. It is worth getting as much information and support as you can, and involving your doctor whereve

http://www.latimes.com/business/printedition/la-fi-lilly31jan31,1,2496462.story?ctrack=1&cset=true

Lilly subpoenaed on Zyprexa marketing

template_bas Probes center on doctor payments and communications, the drug maker says. From Times Wire Services January 31, 2008 Eli Lilly & Co. said Wednesday that it received a subpoena in November from a U.S. grand jury in Pennsylvania seeking documents involving the marketing of the company's bestselling drug, the antipsychotic Zyprexa. The Indianapolis drug maker is cooperating in state and U.S. investigations into its marketing practices, according to a statement from spokeswoman Marni Lemons. Her e-mail also cited "many speculative statements" in a New York Times article that said the company might pay more than $1 billion to settle the investigation. Connecticut Atty. Gen. Richard Blumenthal told the Reuters news service late Wednesday that his office was involved in the investigation and negotiations with the company over Zyprexa. "There are discussions," Blumenthal said. But he declined to confirm that those were settlement talks. The probe centers on marketing and promotional practices related to the pill's sales in the United States, including communication with doctors and the way the company paid consulting physicians and other advisors, Lemons said. Lilly has been accused of promoting the drug for nonapproved, so-called off-label, uses and of playing down side effects such as weight gain, which raises the risk of diabetes. Doctors are free to prescribe drugs in any way they see fit, but drug companies may promote them only for uses approved by U.S. regulators. Sales of Zyprexa tablets, also used to treat bipolar disorder, rose 9% to $4.76 billion last year, accounting for about a quarter of Lilly's revenue. The New York Times, citing "several people involved in the investigation," said in a story on its website that settlement discussions with states and the U.S. government were underway, led by the U.S. attorney's office in Philadelphia. A $1-billion payment could be the largest for breaking laws on how medications are promoted, the newspaper wrote. "We regularly have discussions with the government," Lemons said. She didn't comment further on the story. The U.S. attorney's office in Philadelphia is "not confirming anything in the New York Times article," spokeswoman Patty Hartman said. Joseph Trautwein, an assistant U.S. attorney, declined to comment. In March 2004, the U.S. attorney's office told Lilly that it had begun a civil investigation of the drug maker's marketing and promotional practices, according to a Nov. 5 regulatory filing. In 2005, the office told Lilly it was conducting an inquiry into rebate agreements involving Zyprexa and other drugs with an unnamed pharmacy benefits manager, the filing reported. Lilly has received subpoenas from California, Florida and Illinois on its marketing and promotional practices, according to the filing. Thirty states have joined in an effort coordinated by a committee of attorneys general "under various state consumer protection laws," the filing said. The company is cooperating in all of these investigations, Lilly said. In September, Lilly agreed to settle its claims against a doctor who leaked secret marketing documents on Zyprexa to the New York Times. David Egilman, an expert witness for patients suing Lilly in U.S. court in Brooklyn, N.Y., agreed to pay $100,000 to the drug maker. Lilly said Egilman violated an order to keep the documents secret. Note:  A correction here.  Alaska attorney Jim Gottstein subpoennaed these documents from Dr. Egilman and provided these documents to the Times.   Vince This month, Lilly settled 950 claims related to Zyprexa on allegations that it caused diabetes and other illnesses. The company has said it faces an additional 1,100 cases. Bloomberg News and Reuters were used in compiling this report.

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

The information herein shall not be considered an endorsement of anyone discontinuing psychiatric drugs. If you are stopping taking medication it is advisable to reduce the dose gradually WITH EXTREME CAUTION, as it is difficult to predict who will have problems withdrawing. It is worth getting as much information and support as you can, an

                                                   

 SAY NO TO ELECTROSHOCK -  PLEASE SIGN THIS PETITION?

 

 http://www.petitionspot.com/petitions/noeloctroshock/

 

Doctors of Deception: What They Don't Want You to Know about

 

 

 

 

 

 

How Teenage Rebellion Has Become a "Mental Illness"

by David W. Oaks — last modified 2008-01-28 22:15

Psychologist, author and MindFreedom member Bruce E. Levine has an article on Alternet exposing the way rebellion by young people is being diagnosed as a psychiatric "disease" to be drugged.

Bruce E. Levine, PhD is author and psychologist.

 

AlterNet original story posted 28 January 2008: http://www.alternet.org/story/75081/By Bruce E. Levine, AlterNetFor a generation now, disruptive young Americans who rebel against authority figures have been increasingly diagnosed with mental illnesses and medicated with psychiatric (psychotropic) drugs.Disruptive young people who are medicated with Ritalin, Adderall and other amphetamines routinely report that these drugs make them "care less" about their boredom, resentments and other negative emotions, thus making them more compliant and manageable. And so-called atypical antipsychotics such as Risperdal and Zyprexa -- powerful tranquilizing drugs -- are increasingly prescribed to disruptive young Americans, even though in most cases they are not displaying any psychotic symptoms.Many talk show hosts think I'm kidding when I mention oppositional defiant disorder (ODD). After I assure them that ODD is in fact an official mental illness -- an increasingly popular diagnosis for children and teenagers -- they often guess that ODD is simply a new term for juvenile delinquency. But that is not the case.Young people diagnosed with ODD, by definition, are doing nothing illegal (illegal behaviors are a symptom of another mental illness called conduct disorder). In 1980, the American Psychiatric Association (APA) created oppositional defiant disorder, defining it as "a pattern of negativistic, hostile and defiant behavior." The official symptoms of ODD include "often actively defies or refuses to comply with adult requests or rules" and "often argues with adults." While ODD-diagnosed young people are obnoxious with adults they don't respect, these kids can be a delight with adults they do respect; yet many of them are medicated with psychotropic drugs.An even more common reaction to oppressive authorities than overt defiance is some type of passive defiance.John Holt, the late school critic, described passive-aggressive strategies employed by prisoners in concentration camps and slaves on plantations, as well as some children in classrooms. Holt pointed out that subjects may attempt to appease their rulers while still satisfying some part of their own desire for dignity "by putting on a mask, by acting much more stupid and incompetent than they really are, by denying their rulers the full use of their intelligence and ability, by declaring their minds and spirits free of their enslaved bodies."Holt observed that by "going stupid" in a classroom, children frustrate authorities through withdrawing the most intelligent and creative parts of their minds from the scene, thus achieving some sense of potency.Going stupid -- or passive aggression -- is one of many nondisease explanations for attention deficit hyperactivity disorder (ADHD). Studies show that virtually all ADHD-diagnosed children will pay attention to activities that they enjoy or that they have chosen. In other words, when ADHD-labeled kids are having a good time and in control, the "disease" goes away.There are other passive rebellions against authority that have been medicalized by mental health authorities. I have talked to many people who earlier in their lives had been diagnosed with substance abuse, depression and even schizophrenia but believe that their "symptoms" had in fact been a kind of resistance to the demands of an oppressive environment. Some of these people now call themselves psychiatric survivors.While there are several reasons for behavioral disruptiveness and emotional difficulties, rebellion against an oppressive environment is one common reason that is routinely not even considered by many mental health professionals. Why? It is my experience that many mental health professionals are unaware of how extremely obedient they are to authorities. Acceptance into medical school and graduate school and achieving a Ph.D. or M.D. means jumping through many meaningless hoops, all of which require much behavioral, attentional and emotional compliance to authorities -- even disrespected ones. When compliant M.D.s and Ph.D.s begin seeing noncompliant patients, many of these doctors become anxious, sometimes even ashamed of their own excessive compliance, and this anxiety and shame can be fuel for diseasing normal human reactions.Two ways of subduing defiance are to criminalize it and to pathologize it, and U.S. history is replete with examples of both. In the same era that John Adams' Sedition Act criminalized criticism of U.S. governmental policy, Dr. Benjamin Rush, the father of American psychiatry (his image adorns the APA seal), pathologized anti-authoritarianism. Rush diagnosed those rebelling against a centralized federal authority as having an "excess of the passion for liberty" that "constituted a form of insanity." He labeled this illness "anarchia."Throughout American history, both direct and indirect resistance to authority has been diseased. In an 1851 article in the New Orleans Medical and Surgical Journal, Louisiana physician Samuel Cartwright reported his discovery of "drapetomania," the disease that caused slaves to flee captivity. Cartwright also reported his discovery of "dysaesthesia aethiopis," the disease that caused slaves to pay insufficient attention to the master's needs. Early versions of ODD and ADHD?In Rush's lifetime, few Americans took anarchia seriously, nor was drapetomania or dysaesthesia aethiopis taken seriously in Cartwright's lifetime. But these were eras before the diseasing of defiance had a powerful financial ally in Big Pharma.In every generation there will be authoritarians. There will also be the "bohemian bourgeois" who may enjoy anti-authoritarian books, music, and movies but don't act on them. And there will be genuine anti-authoritarians, who are so pained by exploitive hierarchies that they take action. Only occasionally in American history do these genuine anti-authoritarians actually take effective direct action that inspires others to successfully revolt, but every once in a while a Tom Paine comes along. So authoritarians take no chances, and the state-corporate partnership criminalizes anti-authoritarianism, pathologizes it, markets drugs to "cure" it and financially intimidates those who might buck the system.It would certainly be a dream of Big Pharma and those who favor an authoritarian society if every would-be Tom Paine -- or Crazy Horse, Tecumseh, Emma Goldman or Malcolm X -- were diagnosed as a youngster with mental illness and quieted with a lifelong regimen of chill pills. The question is: Has this dream become reality?Bruce E. Levine, Ph.D., is a clinical psychologist and author of Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy (Chelsea Green, 2007).

View this story online at: http://www.alternet.org/story/75081/

Related content Youth & Mental Health System

FOR THOSE WHO ARE INTERESTED IN THE LATEST ON ECT YOU WILL FIND IT AT THE BELOW BLOGSPOT

                                                                                                   Vera Sharav

http://www.ahrp.org and http://ahrp.blogspot.com

FYI

A front page article in The Wall Street Journal provides a glimpse into the

nature of the true risks involved in participation in clinical trials. The

documented findings confirm our long-held view that current laws,

regulations, government or institutional oversight bodies fail utterly to

ensure the safety of human subjects.

"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."

Informed consent documents are crafted to provide liability protection to

corporations, universities, ethics review boards, and clinicians who conduct

the trials. Patients are deliberately deceived by legal linguistic hyperbole:

"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."

The WSJ reports that before Suzanne Davenport, aged 71, 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.

Before entering the trial she signed a UCLA consent form (in 2004) 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."

She then signed another consent document 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.

The true nature of the potential risks of harm from experimental treatments

remain mostly concealed today--just as they had been concealed in 2000, when

18 -year old Jesse Gelsinger had unwittingly signed, what turned out to be

his death certificate, by volunteering for a fatally flawed gene therapy

(adenovirus) experiment.

Bioethicists with hidden financial ties to pharmaceutical companies-- then

as now--readily lend their rubber stamp of approval for whatever companies

do.

Contact: Vera Hassner Sharav

This email address is being protected from spambots. You need JavaScript enabled to view it.

212-595-8974

http://online.wsj.com/article/SB120173515260330205.html

THE WALL STREET JOURNAL

CLINICAL DECISION

When Drug Trials Go Wrong, Patients Have Little Recourse

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 Jesse

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, Julie 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, John Roberts of Virginia Mason Medical Center

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

Roberts 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. Roberts, 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.

Ms. Languille says Medicaid, the government health-insurance program for the

poor, has paid for most of Ms. Davenport's care since the surgery, more than

$100,000 to date. Mr. Davenport, a retired aerospace engineer, is required

to contribute $700 a month. So far, the family says it has spent more than

$28,000 on her care.

In March 2006, Ms. Languille decided to seek compensation. She started with

Jeff Bronstein, the neurologist who was the lead investigator at UCLA. Based

on conversations with clinicians at other trial sites where patients

received Spheramine, Dr. Bronstein says Ms. Davenport's condition after the

trial was unusual. He says it was also not typical of Parkinson's patients,

which indicated to him that the drug was likely a contributing factor.

Dr. Bronstein referred Ms. Languille to an official at Titan who was his

main contact for the trial. He says he thought the companies were

responsible for compensation. "I thought it was going to be the best way to

help the family, and the fastest way," he says.

A contract between Berlex and the Regents of the University of California,

obtained by The Wall Street Journal through a public-records request, says

Berlex would reimburse the university for "reasonable" costs for treatment

needed as a result of the trial, assuming the study was conducted according

to its rules and the university wasn't negligent.

Ms. Languille spoke with Dmitri Lissin, a clinical-development director at

Titan. He asked her to send him the nursing-home bills so he could submit

them for payment. In a subsequent letter, Dr. Lissin wrote that Titan had

initiated a legal review of her mother's case. Ms. Davenport's decline "can

possibly be attributed to the natural course [of her disease] or

experimental treatment, or both," he wrote.

In an interview, Dr. Lissin, who no longer works for Titan, said

responsibility ultimately rested with Berlex, and he was helping them to

review the case.

Titan declined to comment on its role in Ms. Davenport's case but said in

written a statement that all trials of Spheramine have been monitored for

patient safety. It added that it is "committed to the...continued

development of Spheramine as a potential new treatment option for patients

suffering with Parkinson's disease."

Ms. Languille says she was next contacted by Berlex. In an email, Walter

Hong, a Berlex medical-development director who was following up on her

case, asked whether Ms. Davenport received any state aid, whether she would

qualify for Medicaid, and whether the family had "a plan in place for

spending down" its income and savings. The company says it was trying to

determine whether any settlement would damage Ms. Davenport's eligibility

for insurance from the government or another provider.

She was contacted next by a Berlex attorney, Eric Threadgold. She says he

told her over the phone that if the company were to pay, it would prefer to

do so in one lump sum rather than in monthly payments as bills arose. He

also said since Ms. Davenport would have required nursing-home care at some

point anyway, Berlex would only be accountable for the extra care required

as a direct result of the trial. He asked for an estimate of those costs.

Mr. Threadgold would not comment on the case.

Ms. Languille wanted to move her mother back home and hire live-in aids to

help take care of her. She calculated the cost over 20 years, including

equipping the house and providing 24-hour nursing care. Her calculation,

which also included reimbursement for prior costs, came to $3,429,248.

According to court documents, Mr. Threadgold wrote in an email to Ms.

Languille a month later that the company was willing to try to resolve her

mother's situation in a "mutually acceptable manner." He cited "Medicare,

tax and projected nursing-home expenses" as some issues that needed to be

addressed.

Fearing that the company was dragging its feet, Ms. Languille hired a

lawyer, Stephen Pappas. Mr. Pappas took over conversations with Berlex in

the fall of 2006.

In 2007, the family decided to sue Titan, Berlex and the regents of the

University of California, seeking more than $5 million for damages, medical

expenses and attorney's fees. Mr. Pappas says he sued the California regents

rather than Tampa General Hospital or the University of South Florida in

part because the UCLA consent form offered the broadest description of

compensation for medical care.

The University of California declined to comment on the substance of Ms.

Davenport's case because of the pending litigation. A spokeswoman for the

university said in a written statement that the university "takes these

matters very seriously" and that the parties "are working to determine a

satisfactory resolution."

[Testing, Testing]

<file:///C:/DOCUME~1/Vera/LOCALS~1/Temp/msohtml1/01/clip_image003.gif>

In a response to the Davenports' complaint filed in Alameda County Superior

Court in California, the regents said, among other things, that the

university had fulfilled its informed-consent obligation to Ms. Davenport.

It added that the university wasn't liable for an alleged "defectively

manufactured medical product."

Since testing of Spheramine began, Schering AG was acquired by Bayer AG, and

Berlex was renamed Bayer HealthCare Pharmaceuticals Inc. A spokeswoman for

Bayer said in a written statement that the company "has undertaken efforts

to try to agree on some type of compensation for Ms. Davenport's care" even

though "it has not been established" that her "current symptoms" were

related to the trial. She also said, "We sympathize with Ms. Davenport and

her family, and remain committed to resolving this matter as soon as

possible," adding that the parties are close to a legal settlement.

'Great Promise'

Bayer says Ms. Davenport was one of 71 patients enrolled in this stage of

the drug trial. It says the study is being monitored by an independent board

which has not reported a safety concern. Because the research is ongoing,

Bayer says results from the trial are not yet available, but says "early

research has shown great promise." It expects late-stage testing of

Spheramine will begin in the second half of 2009.

During a visit to her nursing home this past fall, Ms. Davenport rambled

mostly incoherently. At one point, she said she had been in the nursing home

"almost three years," prompting Ms. Languille to correct her. She had been

there two years, Ms. Languille reminded her. "But I bet it feels like

three," she added.

"Yes, it does," her mother responded.

Write to Sarah Rubenstein at This email address is being protected from spambots. You need JavaScript enabled to view it.

This email address is being protected from spambots. You need JavaScript enabled to view it. 8

KEY DOCUMENTS[pdf] <file:///C:/DOCUME~1/Vera/LOCALS~1/Temp/msohtml1/01/clip_image004.gif>. The consent form Ms. Davenport signed<http://online.wsj.com/public/resources/documents/trial-uclacons-01312008.pd