THE NEW YORK TIMES

May 31, 2005

Despite Vow, Drug Makers Still Withhold Data

By ALEX BERENSON

When the drug industry came under fire last summer for failing to disclose

poor results from studies of antidepressants, major drug makers promised to

provide more information about their research on new medicines. But nearly a

year later, crucial facts about many clinical trials remain hidden,

scientists independent of the companies say.

Within the drug industry, companies are sharply divided about how much

information to reveal, both about new studies and completed studies for

drugs already being sold. The split is unusual in the industry, where

companies generally take similar stands on regulatory issues.

Eli Lilly and some other companies have posted hundreds of trial results on

the Web and pledged to disclose all results for all drugs they sell. But

other drug makers, including Merck and Pfizer, release less information and

are reluctant to add more, citing competitive pressures.

As a result, doctors and patients lack critical information about important

drugs, academic researchers say, and the companies can hide negative trial

results by refusing to publish studies, or by cherry-picking and

highlighting the most favorable data from studies they do publish.

"There are a lot of public statements from drug companies saying that they

support the registration of clinical trials or the dissemination of trial

results, but the devil is in the details," said Dr. Deborah Zarin, director

of clinicaltrials.gov, a Web site financed by the National Institutes of

Health that tracks many studies.

Journal editors and academic scientists have pressed big drug makers to

release more information about their studies for years. But the calls for

more disclosure grew stronger after reports last year that several companies

had failed to publish studies that showed their antidepressants worked no

better than placebos.

In August, GlaxoSmithKline agreed to pay $2.5 million to settle a suit by

Eliot Spitzer, the New York attorney general, alleging that Glaxo had hidden

results from trials showing that its antidepressant Paxil might increase

suicidal thoughts in children and teenagers. At a House hearing in

September, Republican and Democratic lawmakers excoriated executives from

several top companies, including Pfizer and Wyeth, for hiding study results.

In response, many companies promised to do better.

At the same time, Merck and Pfizer have been criticized for failing to

disclose until this year clinical trial results that indicated that cox-2

painkillers like Vioxx might be dangerous to the heart.

Drug makers test their medicines in thousands of trials each year, and

federal laws require the disclosure of all trials and trial results to the

F.D.A. While too complex for many patients to understand, the trial results

are useful to doctors and academic scientists, who use them to compare drugs

and look for clues to possible side effects. But companies are not required

to disclose trial results to scientists or the public.

Some scientists and lawmakers say new rules are needed, and a bill that

would require the companies to provide more data was introduced in the

Senate in February. So far no hearings have been scheduled on the

legislation. The bill's prospects are uncertain, said a co-sponsor, Senator

Christopher J. Dodd, Democrat of Connecticut.

The drug makers have been criticized both for failing to provide advance

notice of clinical trials before they begin and for refusing to publish

completed trial results for medicines that are already being sold.

The two issues are related, because companies cannot easily hide the results

of trials that have been disclosed in advance, said Dr. Alan Breier, chief

medical officer of Lilly, the company that has gone furthest in disclosing

results.

"You're registering a trial - at some point, the results have got to show

up," Dr. Breier said. He added that disclosing trial results was important

both to give doctors and patients as much information as possible and to

improve the industry's reputation, which has been damaged by several recent

withdrawals of high-profile drugs.

"Fundamentally, what we're doing is in the interest of patients, and I think

that that is the winning model, for academia, for industry and for the

future," he said.

In September, Pharmaceutical Research and Manufacturers of America, an

industry lobbying group known as PhRMA, said it would create a site for

companies to post the results of completed trials. Then, under pressure from

the editors of medical journals, the major drug companies in January agreed

to expand the number of trials registered on clinicaltrials.gov, the N.I.H.

site, which was originally created so patients with life-threatening

diseases could find out about clinical trials.

But Merck, Pfizer and GlaxoSmithKline, three of the six largest drug

companies, have met the letter but not the spirit of that agreement, Dr.

Zarin said.

The three companies have filed only vague descriptions of many studies,

often failing even to name the drugs under investigation, Dr. Zarin said.

For example, Merck describes one trial as a "one-year study of an

investigational drug in obese patients."

Drug names are crucial, because the clinicaltrials.gov registry is designed

in part to prevent companies from conducting several trials of a drug, then

publicizing the trials with positive results while hiding the negative ones.

If the descriptions do not include drug names, it is hard to tell how many

times a drug has been studied.

"If you're a systematic reviewer trying to understand all the results for a

particular drug, you might never know," Dr. Zarin said. "You don't know

whether you're seeing the one positive result and not the four negative

results - you don't have context."

Pfizer, Merck and GlaxoSmithKline say that they disclose their largest

trials, which determine whether a drug will be approved. Though they would

not discuss their policies in detail, executives and press representatives

at the companies said generally that disclosing too much information about

early-stage trials might reveal business or scientific secrets.

Rick Koenig, a spokesman for Glaxo, said the company understood the concerns

about disclosure and planned to add more information to clinicaltrials.gov.

He declined to be more specific, saying Glaxo and other companies were

discussing the issue with regulators and medical journal editors.

In contrast, Lilly has registered all but its smallest trials at

clinicaltrials.gov. Dr. Breier of Lilly said the company believed that it

could protect its intellectual property and still increase the amount of

information it released.

Lilly has also posted the results of many completed studies to

clinicalstudyresults.org, the Web site created last September by PhRMA. That

site now contains some information on nearly 80 drugs that are already on

the market. Both Lilly and Glaxo have posted detailed summaries of hundreds

of studies.

Pfizer, on the other hand, has posted only a few, and Merck has posted none.

All the companies were meeting the group's guidelines for the site, said Dr.

Alan Goldhammer, associate vice president for regulatory affairs at PhRMA.

The lobbying group requires only that its members post a notice that a trial

has been completed and a link to a published study or a summary of an

unpublished study, he said. Studies completed before October 2002 are exempt

from the requirements, and PhRMA has not set penalties for companies that do

not comply.

"We're seeing pretty regular posting on a weekly basis, and as best we can

assess right now, things are on track for meeting the goal we and our

members set for ourselves," Dr. Goldhammer said.

The continued gaps in disclosure have caused some lawmakers to call for new

federal laws. The bill introduced in February by Mr. Dodd and Senator

Charles E. Grassley, Republican of Iowa, would convert clinicaltrials.gov

into a national registry for both new trials and results and impose civil

penalties of up to $10,000 a day for companies that hide trial data. But Mr.

Dodd said that the chances the bill would pass in this Congress were even at

best.

"I haven't had that pat on the back saying, 'This is a great idea, let's get

going on this as fast as we can,' " Mr. Dodd said.

Dr. David Fassler, a psychiatry professor at the University of Vermont and a

longtime proponent of more disclosure, said that trial reporting had

improved in the last two years. But he said that a central federally run

site, as opposed to the current mix of government and industry efforts, was

the only long-term solution.

http://www.nytimes.com/2005/05/31/business/31trials.html?pagewanted=print

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Editorial

Hiding the Data on Drug Trials

Published: June 1, 2005

Any Americans gullible enough to believe that the drug industry can be

trusted to report fully on what clinical trials it is sponsoring or what

results were found must be sorely disappointed by recent developments. A

government survey determined that three of the largest drug companies have

effectively reneged on their pledges to list trials in a federal database. A

report in yesterday's Times by Alex Berenson reveals that this intransigence

also extends to a voluntary industry database. It looks as if demands from

researchers and the medical profession for full access to clinical trial

data will continue to be frustrated.

Companies already provide the data to the Food and Drug Administration,

which is required to keep much of it confidential. A public listing of

trials is important to prevent drug makers from hiding results that reflect

badly on their drugs while publishing only results that make their drugs

look good. By law, the companies are supposed to register important trials

with a government Web site. Most manufacturers are complying, but the three

big obfuscators - Merck, GlaxoSmithKline and Pfizer - are often getting

around the requirement by not naming the drugs they are testing, instead

using phrases like "an investigational drug." Merck was the worst offender,

failing to provide a drug's name some 90 percent of the time. Glaxo withheld

a name 53 percent of the time, and Pfizer 36 percent of the time.

Merck and Pfizer are also the most prominent withholders of trial results

from the industry's voluntary database. As Mr. Berenson reported, Pfizer has

posted only a few results of clinical trials, and Merck has posted none.

That meager contribution appears to satisfy the weak guidelines set by the

industry, but it offers a sorry contrast with the record of Eli Lilly. Lilly

appears to have been quite scrupulous in listing its current trials with the

government site and has posted the results of hundreds of completed clinical

trials on the industry site. Surely if one big company can make its trials

transparent, other drug makers can do the same.

A coalition of medical editors has just stiffened its announcement that

leading journals will soon refuse to publish the results of any clinical

trial that has not complied with tough international standards for

transparency. That should apply useful pressure to recalcitrant companies.

But the best hammer would be federal legislation to compel all companies to

provide critical information when a trial is begun and full results when a

trial is completed, with stiff penalties for noncompliance.

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COME TO MAINE and join Rushworth Kidder from July 11-13 for an interactive, small-group immersion course tackling the toughest challenges we face in communicating about ethics. For more information about the Camden Ethics Symposium(tm) call 800-729-2615 or email ethics@globalethics.org.

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In the May 31, 2005, edition of Ethics Newsline:

For the complete issue, click here: http://www.globalethics.org/newsline/members/currentissue2.tmpl

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1. Statline:

Public Rates Professions' Ethics

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=0531051817000

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2. Commentary by Rushworth Kidder:

Days of Remembrance

Memorial Day, the late-May U.S. holiday, coincides with school graduations and the change of seasons, blending commencement and summertime and remembrance. In one intense season of ceremony and start-of-summer storewide sales, we send forth the young, salute the dead, and celebrate the coming solstice. Is this right? In this particularly American blend of the commercial, the educational, and the military, are we dishonoring those who went before us? Are we at risk of discounting the sacrifices that helped defend the physical, mental, and moral infrastructure we've inherited?....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518184666

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3. What They're Saying:

Come to Terms

"I despised what he had done to me.... [But] you can't throw a human being away. When you see someone you have lived with, and you are so angry with them, you have to come to terms with yourself and get rid of the bitterness. Not for their sake, but for your own."

-- Millie Hayes, 67, a Louisiana antiques shop owner, talking with the "New York Times" about her decision to serve as caregiver for her ex-husband, a man described as cruel and controlling, as his health deteriorated due to Alzheimer's. As the U.S. population ages, the "Times" says healthcare workers are seeing a growing trend: "In scenes exhibiting a vivid range of feelings -- acrimony, compassion, rekindled love, abiding friendship -- sick and dying Americans are being cared for by former spouses."....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518191212

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4. U.S. Supplying Arms to Undemocratic, Oppressive Nations, Study Claims

NEW YORK

Seeking to secure military bases abroad and reward U.S. allies in the "war on terror," the United States is supplying weapons to nations deemed undemocratic and oppressive by its own State Department, a group studying arms sales warned last week....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518194765

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5. Amnesty International Slams U.S. for Human Rights Violations

WASHINGTON

Amnesty International last week lashed out at the United States over its treatment of terrorism detainees and prisoners, saying U.S. efforts to subvert international treaties against torture have made the world a more dangerous place....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518202477

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6. Treasurer of Powerful Texas PAC Fined Nearly $200,000

AUSTIN, Texas

A Texas political action committee (PAC) established by House Majority Leader Tom Delay violated campaign finance laws by failing to report nearly $700,000 in donations used to elect Republican candidates, a state judge ruled last week....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518210717

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7. Teachers Quit after Colleague is Fired for Challenging Principal

KANSAS CITY, Missouri

Seven of 10 teachers in a small Missouri school district quit their jobs last week to show support for a colleague who was fired after protesting the punishment of a fourth-grader as unsafe....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518213593

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8. Drug Firms Faulted for Continued Lack of Disclosure

NEW YORK

Citing a federal review of disclosure data, the "New England Journal of Medicine" last week accused three of the country's leading drug companies of not providing enough information about their clinical trials....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518220582

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9. Guidant Did Not Disclose Defibrillator Flaw for 3 Years

INDIANAPOLIS

Medical equipment maker Guidant Corp. last week disclosed that one of its surgically implanted defibrillators contained a flaw that could cause the device to malfunction -- news the company had known about for three years....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518223497

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10. Kenya Prosecutor Fired after Dropping Charges against Aristocrat

NAROK, Kenya

Kenya's president last week sacked a senior prosecutor for dismissing murder charges against a British aristocrat accused of killing a Maasai game warden investigating poaching....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518225899

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11. Geologist Behind Canada's Bre-X Scandal May Have Faked Death

TORONTO

A geologist at the center of one of Canada's biggest financial scandals, the fraudulent massive gold find by the former Canadian mining company Bre-X, may have faked his own death, according to press reports....

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518232471

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12. Research Report:

'Public and Press Differ about Partisan Bias, Accuracy, and Press Freedom'

From the Annenberg Public Policy Center at the University of Pennsylvania:

"The American public disapproves only narrowly of partisan journalism, splits about evenly on whether news organizations usually get their facts straight, and narrowly accepts the idea that the government can limit the right of the press to report a story, according to a national survey conducted for the University of Pennsylvania's Annenberg Public Policy Center...."

Full story: http://www.globalethics.org/redir/nl.html?d=5/31/2005&;id=05310518241024

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13. Quote from the Ethics File:

My Religion

"The world is my country, all mankind are my brethren, and to do good is my religion."

-- Thomas Paine (U.S. political philosopher and author, 1737-1809)

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Full issue available here: http://www.globalethics.org/newsline/members/currentissue2.tmpl

Ethics Newsline is a trademark of the:

Institute for Global Ethics

P.O. Box 563

Camden, Maine 04843

U.S.A.

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www.globalethics.org

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Recently I came across some research which encourage students to

participate as research subjects and gain course credit points.

On one hand it would be educational and beneficial to the students to

understand the role of a research subject and the process of a research

being conducted. On the other hand, the researchers now have a participant

pool where recruitment can be easily conducted.

A few questions came to my mind:

How can the researchers and the REB prevent coercion to participate;

How can the rights of the student be protected;

How can a student withdraws from the research if he still need to face the

researcher as a teacher; etc?

Some very good questions to ponder under our ethics rubric.