Public Citizen Report on Government/Pharma Collusion

[Guest guest]

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

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UNITED WAY/COMBINED FEDERAL CAMPAIGN

#8122

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

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BL Fisher Note:

The Public Citizen's May 4, 2006 report details how top drug company and

U.S. public health and justice officials colluded with each other and a few

members of Congress to to shield the pharmaceutical industry from liability.

The report confirms the October 19 and Nov. 15 public warning of the

National Vaccine Information Center (Go to www.nvic.org and click on

" Liability Shield Given to Pharma " under News & Features and under Press

Releases click on " Oct. 19-Congress Set to Pass Law Eliminating Liability

for Vaccine Injuries " and " Nov. 15 - Congress Set To Bail Out Big Pharma " ).

NVIC's early alarm stimulated national press coverage of the upcoming

dirty deal but was not enough to stop the deal from being done. The winners?

Drug company executives, their stockholders and politicians who take drug

money to stay in office. The losers? The American people, who will suffer

the consequences when the unelected Secretary of the Department of Health

and Human Services declares an " emergency " and the state militia is called

out to force experimental vaccines and drugs upon citizen, who will have no

legal recourse when they are harmed.

http://www.citizen.org/pressroom/release.cfm?ID=2197

Public Citizen

May 4, 2006

New Report: Drug Industry Conspired With Top Federal Officials

for Vast Liability Shield

A copy of the report titled

'Willful Misconduct:

How Bill Frist and the Drug Lobby Covertly

Bagged a Liability Shield'

is available here.

http://www.citizen.org/documents/050406PandemicFinal_1.pdf

Public Citizen Report Reveals Behind-the-Scenes Lobbying; Language Inserted

Into Bill Without Lawmakers’ Knowledge

WASHINGTON, D.C. – Drug industry lobbyists conspired with the White House

and Senate Majority Leader Bill Frist (R-Tenn.) last year to craft a

sweeping liability provision that shields the industry from lawsuits over

products used to treat pandemic illnesses, even in cases of gross negligence

or gross recklessness, according to a report issued today by Public Citizen.

The report, Willful Misconduct: How Bill Frist and the Drug Lobby Covertly

Bagged a Liability Shield, relies on internal documents and e-mails of the

Biotechnology Industry Organization (BIO) to illustrate the degree to which

Frist’s office deferred to drug industry demands and describes Frist’s

sleight of hand in securing passage of the provision. It underscores the

enormous power of the drug industry and its lobbyists to steer a highly

controversial provision into law.

Frist inserted the shield provision into an already-completed conference

report for the defense appropriations bill in the dead of night, with the

aid of House Majority Leader Dennis Hastert (R-Ill.). Many of the members of

the conference committee had never seen the language, let alone approved it.

Committee leaders explicitly assured Democrats, made wary by rumors

circulating in the preceding days, that no attempt would be made to insert

the liability measure into the spending bill.

The shield is unnecessary because the government now can – and does –

indemnify drug companies in contracts, using provisions saying that the

government will cover costs in excess of the companies’ insurance.

The pharmaceutical industry used legions of influence-peddlers to push for

the measure. The industry deployed at least 158 lobbyists to influence

policies relating to vaccines and pandemic preparedness in 2004 and 2005,

including 84 who were previously employed by the federal government. Of

those, seven were former members of Congress, two were former top health

care aides to Frist and another was the son of the speaker of the House.

“This is a case in which the drug industry used clout, stealth and cunning

to put one over on Congress and the American public,” said Joan Claybrook,

president of Public Citizen. “The industry crafted a liability shield that

is unprecedented in its scope and will literally allow it to harm innocent

people and get off scot-free.”

Claybrook called for Congress to revoke the provision.

The liability shield is extremely broad, applying to far more than just

avian flu vaccines and going well beyond the liability protections initially

proposed by the Bush administration. It bars all state and federal claims

arising from the use of a drug, vaccine or medical device related to any

government-declared health emergency. It extends to all companies, state

officials, healthcare workers and others involved in combating an actual or

potential health emergency.

It even encompasses all aspects of drug, vaccine and medical device

production and delivery, including design, development, testing,

manufacture, labeling, distribution, formulation, packaging, marketing,

dispensing and prescribing. What’s more, it shields pharmaceutical companies

from liability for long-used drugs, even those causing death or injury due

to a manufacturing error, so long as the drug is used to treat a condition

related to an officially declared health emergency.

The only exception is if an injured party can show by “clear and convincing

evidence” – a heightened standard of proof – that a defendant’s “willful

misconduct” caused serious injury or death. According to the law, “willful

misconduct” does not encompass “gross negligence” or “gross recklessness,”

but only “intentional, voluntary and conscious actions, or failures to act,

undertaken to achieve a wrongful purpose.”

The BIO documents obtained by Public Citizen and detailed in the report show

the extraordinary access to White House and congressional officials that

industry lobbyists enjoyed. On Nov. 15, 2005, for example, Dave Boyer,

director of federal relations for BIO, sent an e-mail message to an

undisclosed list announcing that BIO had been summoned to a White House

meeting to discuss the liability shield proposal.

Several days later, Boyer and lobbyists for three drug companies met with

Frist’s staff – along with representatives from the Justice Department, the

Department of Health and Human Services and the White House – for further

discussions.

The drug industry has long been among the most generous contributors to

congressional campaigns. The three lawmakers who were most responsible for

the waiver’s passage were Sen. Burr (R-N.C.), who drafted the

liability shield that served as a template for the text Frist inserted into

the defense bill; Hastert, who enabled Frist to make his move; and Frist.

Each of the three ranks in the top 10 in campaign contributions from the

pharmaceutical and biotechnology industries since the 2000 election cycle;

together they have collected more than $1.2 million in total receipts.

“This midnight assault on consumer safety puts a new and dangerous spin on

the notion of public-private partnership,” said Jillian Aldebron,

legislative counsel for Public Citizen’s Congress Watch division. “If

Congress doesn’t repeal this law, people are going to be hit with the

double-whammy of paying for injuries and deaths caused by the drugs meant to

keep them safe on top of whatever damage is caused by the pandemic diseases

themselves.”

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