E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER
Vienna, Virginia http://www.nvic.org

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UNITED WAY/COMBINED FEDERAL CAMPAIGN
#9119
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"Protecting the health and informed consent rights of children since 1982."

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BL Fisher Note:

Pharmaceutical companies and the doctors performing research for them are
violating this federal law because there are no punishments attached to
violating it. Most doctors routinely violate federal law by refusing to
report hospitalizations, injuries and deaths following vaccination to the
federal Vaccine Adverse Event Reporting System (VAERS) as mandated under
the
1986 National Childhood Vaccine Injury Act. Because there are no sanctions
for doctors who refuse to report serious health problems following
vaccination, it is estimated that less than 5 percent of doctors bother to
make reports. Children are mandated to be injected with vaccines carrying
significant risks for some and yet those who adminster vaccines are both
protected from liability as well as given a free pass when it comes to
reporting vaccine-associated health problems. No wonder a growing number of
educated parents have a lack of trust and respect for doctors when they are
behaving this badly.


http://www.washingtonpost.com/wp-dyn/articles/A29576-2004Jul5.html
The Washington Post
Tuesday, July 6, 2004; Page A01

Drugmakers Prefer Silence On Test Data
Firms Violate U.S. Law By Not Registering Trials

By Shankar Vedantam
Washington Post Staff Writer



The pharmaceutical industry has repeatedly violated federal law by failing
to disclose the existence of large numbers of its clinical trials to a
government database, according to the Food and Drug Administration.

Doctors and patients say that compliance with the law would go a long way
toward addressing their growing concerns that they are not being given the
full picture about the effectiveness of many drugs because they are not
told
about drug trials that fail. The issue has gained urgency with recent
disclosures that the publicly available research on treating children with
antidepressants obscured the fact that in most studies, the drugs were no
better than sugar pills. Drugmakers chose not to publish those studies.

The 1997 law is so little known that scientific journal editors and
professional medical associations have recently debated whether to create a
system of private incentives for disclosure of trials. When she was told
the
law already requires companies to register trials, Catherine DeAngelis,
editor in chief of the Journal of the American Medical Association, said,
"That's a surprise to me. Tell me why it's not enforced."

Although the law was primarily passed for other reasons, DeAngelis said it
could very well address her concerns.

The FDA acknowledges it has not enforced the law -- officials said the
statute did not spell out penalties or explicitly give the agency authority
to crack down on violators.

An FDA analysis found that in 2002 only 48 percent of trials of cancer
drugs
had been registered, and a preliminary review now indicates the listing
rate
for drugs for some other serious diseases is in the single digits. Some
companies have listed no studies; some trials are listed without
identifying
the sponsoring company or the drug being tested.

As of Friday, the database, ClinicalTrials.gov, listed 5,754 ongoing
studies, but only 13 percent were industry sponsored. The federal
government, mainly the National Institutes of Health, accounted for 55
percent. Those proportions are in stark contrast to the true picture,
DeAngelis said. "Over 80 percent of trials are funded by for-profit
companies, not by the government," she said.

FDA officials said they are re-examining whether they have the power to
step
in. Members of Congress are also considering adding enforcement provisions
to the law, which was part of the FDA Modernization Act of 1997.

The registry was begun in 1998 and the ClinicalTrials.gov site went online
in February 2000, said Alexa McCray, director of biomedical communications
at the National Library of Medicine, which hosts the registry. Since then,
nearly 11,000 trials have been registered from all 50 states and 90
countries. Virtually all studies sponsored by the National Institutes of
Health are listed, and industry trials started coming in after March 2002,
when the FDA issued a formal "guidance" on implementing the law.

Although some companies say they are amenable to wider disclosure, the
patient advocacy group that fought the hardest to create the requirement
predicted it would never be enforced.

"Obviously it needs an enforcement mechanism attached to it," said Abbey S.
Meyers, president of the National Organization for Rare Disorders. "I can
guarantee you, however, that the full force of the drug industry will stop
it. They don't want you to know about clinical trials that fail. They are
afraid what it will do to their stock price. A lot of trials are for drugs
already on the market, and it would ruin their sales if the news got out."

The Pharmaceutical Research and Manufacturers of America countered that the
registry had initially been slow to list industry-sponsored trials, and
that
companies started supplying the information after the FDA issued its
guidance. Alan Goldhammer, PhRMA's associate vice president for regulatory
affairs, said he had heard anecdotally that companies are now fully
complying with the law.

But Theresa Toigo, director of the FDA's Office of Special Health Issues,
painted a different picture. "Many pharmaceutical trials are not
participating in ClinicalTrials.gov or are not fully participating," she
wrote in a recent report in the Journal of Biolaw and Business. Responding
to assertions by PhRMA that the 2002 data do not reflect the current
situation, she said, "It's not like we've seen a big increase in the
monthly
submissions of privately sponsored protocols."

Sen. Edward M. Kennedy (D-Mass.), who helped create the registry in 1997,
plans to seek revisions to enforce the registration requirement and to find
a way to report study results.

Meyers and Paul Kim, a former Kennedy staff member who now works for the
law
firm Foley Hoag LLP, said the original purpose of the registry was to link
patients who wanted to join clinical trials with the researchers.

The law required companies to register all effectiveness trials, known as
Phase 2, 3 or 4 studies, for serious and life-threatening diseases. In 2002
, the FDA defined "serious" diseases broadly, including everything from
AIDS
and cancer to arthritis, depression and diabetes.

Some companies have boasted to stockholders of having many ongoing studies
in the pipeline but not listed any with the registry. Forest Laboratories
Inc., which recently touted results for an Alzheimer's disease drug called
memantine and last month published a children's depression study showing
positive results for its antidepressant Celexa, has no trials registered.
Company spokesman Charles Triano said the law does not require companies to
register trials if other drugs are available for the same disease.

Triano said the company did not need to list its trials of memantine, a new
class of Alzheimer's drug, because the FDA had not given it the
"fast-track"
status reserved for breakthrough medicines and deadly diseases with limited
treatments.

The FDA's Toigo said the law required companies to register trials whether
or not medicines exist for the disease. "It doesn't say anything about
existing drugs on the market," she said.

Although 246 pharmaceutical and biotech companies had ongoing trials in the
database Friday, about half listed just one. GlaxoSmithKline had five, but
spokesman Rick Koenig said many of the company's trials are not listed
under
the company's name. "We didn't understand that to be a requirement or the
sort of information that is of use to a patient looking into where that
patient might enroll in a trial," he said.

Toigo said the FDA's 2002 guidelines called for companies to include their
names.

Journal editor DeAngelis, who is helping spearhead an editors'
initiative to
get all trials registered, said a government-enforced registry would be
vastly superior to any system of private incentives. "It will come as a
surprise to the vast majority of your readers," she said about the law's
requirements. "I had personally assumed it was only for federally funded
clinical trials."

Toigo said her analysis of industry compliance, which she hopes to complete
by the end of the year, will examine whether more than 2,000 trials
submitted to the FDA by companies seeking approval for medicines in 2002
had
been properly listed.

Companies are hesitant to register trials because they want to control
data,
said Kay Dickersin, a professor at Brown University who has sought such
data
for two decades. Some are worried that trade secrets will leak out, or that
a competitor will poach on patient networks. Others don't want patients to
petition them for medicines on "compassionate grounds."

One way to increase registration, said Dickersin, is for patients to insist
trials be registered before participating. Drummond Rennie, a professor at
the University of California in San Francisco, added that physicians who
conduct trials for companies "should examine their consciences" before
agreeing to let trials be kept secret.

"If I buy a camera and the thing falls apart, it's a lemon, I shrug and say
I'm never going back to that firm," said Rennie, who is also deputy editor
at JAMA. "But if I get a drug and it makes me worse, it can kill me or maim
me.

"We give pharmaceutical companies a lot of tax advantages and a whole
lot of
support in the Congress and a good business environment and patent
protection," he said. "They owe us more information."





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