[NVIC] Vaccine Bill Guts Informed Consent

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" Protecting the health and informed consent rights of children since 1982. "

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But Barbara Loe Fisher, president of the National Vaccine Information

Center, a patients' advocacy organization, said that the FOIA exemption

could prove fatal.

If federal authorities declare an emergency in case of

biological attack, she said, people would be asked to take medication

about which they have no knowledge.

Fisher said she fears that without the oversight, public hearings on drug

effects would cease and there would be no one to hold accountable for

problems that arise because there would be no record. Furthermore, people

who eventually take the medication will be doing so without informed

consent, she said.

http://www.journalnow.com/servlet/Satellite?pagename=WSJ%2FMGArticle%2FWSJ_B

asicArticle & c=MGArticle & cid=1128768159466 & path=!localnews & s=1037645509099

Winston-Salem Journal, NC

Tuesday, November 15, 2005

Secrecy worries are raised over plan

Burr's antiterrorism agency would have disclosure exemption

By M. Shaffrey

JOURNAL WASHINGTON BUREAU

WASHINGTON

Sen. Burr, R-N.C., has been getting a lot of attention for his work

on a bill proposing the creation of a single federal agency responsible for

developing potential vaccines and countermeasures for use in case of a

bioterrorist attack.

But BARDA - the Biomedical Advanced Research and Development Agency - would

be allowed to operate shrouded in secrecy.

That troubles many public-health and open-government advocates.

" I am not aware of any agency that has the full FOIA (Freedom of Information

Act) exemption, even the CIA, " said Mark Tapscott, the director of the

Center for Media and Public Policy at the Heritage Foundation.

" What do they think they will be doing that will not be covered by the

exemptions that the CIA has in place? " he said. " There needs to be a

detailed explanation for why. "

The agency would report directly to the Secretary of Health and Human

Services, would receive a full exemption from the Freedom of Information

Act, and would offer limited liability to companies that manufacture drugs

that could be used in the event of an attack.

Drug companies say they need to be free of public scrutiny to protect their

research.

" The confidentiality is not meant to hide untoward results, " said

Painter, the president and CEO of Chimerix Inc., a biotechnology company,

based in Research Triangle Park, that is working on a smallpox vaccine,

among others.

" To immediately have that information available would be harmful to a

company because their competition could immediately get ahold of the work

that's been done, " he said.

Painter added that investors would be reluctant to pay for the work if they

were not assured it would be protected from other companies usurping the

results for free.

But Barbara Loe Fisher, president of the National Vaccine Information

Center, a patients' advocacy organization, said that the FOIA exemption

could prove fatal.

If federal authorities declare an emergency in case of biological attack,

she said, people would be asked to take medication about which they have no

knowledge.

Fisher said she fears that without the oversight, public hearings on drug

effects would cease and there would be no one to hold accountable for

problems that arise because there would be no record. Furthermore, people

who eventually take the medication will be doing so without informed

consent, she said.

Doug Heye, a spokesman for Burr, said that the FOIA exemption was not

automatic. It would only be used in limited circumstances, and the people

making the decision would all be public officials.

" The exemption is for limited situations for proprietary use or

national-security concerns that would make it necessary, " Heye said.

" The purpose of BARDA is to provide information, not shield it. "

But even some who have been consulted on the bill are worried. Dr. Tara

O'Toole, who is otherwise very supportive of the bill, said that the secrecy

issue gives her pause.

" I think it sort of frightens people, " said O'Toole, the director of the

Center for Biosecurity at the University of Pittsburgh Medical Center.

Public-interest groups are almost equally concerned about the

limited-liability protections in the bill.

As written now, the bill says companies that manufacture products to combat

a bioterror attack - or massive flu outbreak - would be shielded from

lawsuits if the product was made following Food and Drug Administration

guidelines, and was made in good faith.

Under the bill, if a company was determined to have defrauded the government

or was a so-called " bad actor, " they would not be shielded from protection.

" If there is no protection, the industry will view (manufacturing these

types of drugs) as too risky, " said Young, chairman of NC Bio and

president of AlphaVax, a vaccine company based in Research Triangle Park.

AlphaVax is currently working on several different biodefense vaccines, and

Young said that the legislation is needed for the work to continue.

O'Toole said that the flu vaccine shortage of 2004 is proof of why this

coverage is needed.

" This is why we did not have enough flu vaccine last year. We only had two

manufacturers, and when one had a problem, we were in trouble, " she said.

There is no money in making these types of drugs, O'Toole and others said.

Companies are not interested in investing millions of dollars in research

and development for medications that would be taken for only a few weeks.

M. Shaffrey can be reached in Washington at (202) 662-7672 or at

mshaffrey@...

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