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Bush Uses FDA To Shield Big Pharma From Lawsuits

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By Pringle*

May 12, 2006.

In January 2006, the FDA announced the Bush administration's

latest gift to

Big Pharma in a statement that said people who believe they have been

injured by drugs approved by the FDA should not be allowed to sue

drug

companies in state courts.

" We think that if your company complies with the FDA processes, if

you bring

forward the benefits and risks of your drug, and let your

information be

judged through a process with highly trained scientists, you should

not be

second-guessed by state courts that don't have the same scientific

knowledge, " said Gottlieb, the FDA's deputy commissioner for

medical

and scientific affairs.

To soften the blow, the agency's claim of federal preemption was

included as

a preamble to the long sought after new drug labeling guidelines. In

response to the FDA's statement, Senator Kennedy (D-MA)

issued a

statement of his own that said: " It's a typical abuse by the Bush

Administration -- take a regulation to improve the information that

doctors

and patients receive about prescription drugs and turn it into a

protection

against liability for the drug industry. "

The ploy was also readily recognized by state lawmakers and trial

lawyers as

another ploy to reduce the public's ability to hold Big Pharma

accountable.

" Eliminating the rights of individuals to hold negligent drug

companies

accountable puts patients in even more danger than they already are

in from

drug company executives that put profits before safety, " said Ken

Suggs,

president of the Association of Trial Lawyers of America.

" The fact that the drug industry can get the FDA to rewrite the

rules so

that CEOs can escape accountability for putting dangerous and deadly

drugs

on the market is the scariest example yet of how much control these

big

corporations have over our political process, " Mr Suggs told the

Washington

Post.

According to Attorney Mark Labaton, a partner at the firm Kreindler &

Kreindler, LLP, with offices in New York and LA, " the

Administration's

recent efforts to misuse federal rulemaking in the pharmaceutical

and other

areas to eviserate consumer rights is a big step backward. "

" The new FDA rules to limit consumers' rights, " he says, " are part

and

parcel of a larger effort to deny persons injured by unsafe

products -- be

they drugs, cigarettes or automobiles -- any form of redress. "

" Clearly, " Mr Labaton notes, " this Administration and its supporters

want to

slam the courthouse doors on working men and women injured by unsafe

products.

He says its ironic that " an Administrative that calls

itself " compassionate "

and " conservative " consistently turns its back on " limited

government " and

" states rights " when it comes to protecting the rights of seriously

injured

consumers. "

Upon learning of the FDA's power grab, the National Conference of

State

Legislatures, a bipartisan group that represents state lawmakers,

accused

the FDA of trying to seize authority that it did not have. The

organization

bases its opposition, in part on the following:

" FDA has usurped the authority of Congress, state legislatures and

state

courts. There is no statutory authority in the FDCA for FDA to

preempt state

product liability laws as they relate to prescription drugs.

" Instead of seeking valid congressional authority, unelected agency

officials are seeking to preempt state product liability laws by

writing

this preemption into a final rule, thereby undermining state policy

and

judicial decision made in this area.

" State tort laws and civil justice systems serve as an important

check on

federal standards. Our civil justice system establishes a duty of

care that

protects citizens when the federal government is too slow to act or

when

federal standards are insufficient. States have the ability to

achieve

greater protections for their citizens through successful product

liability

lawsuits. "

In an earlier gift delivered to Big Pharma in December 2005,

Republican

leaders, and specifically Senator Bill Frist (R-TN), attached

protective

provisions to a Department of Defense appropriations report that

gave the

industry " unprecedented immunity, " according to Democratic lawmakers

who

described the underhanded move as follows:

" Republican leaders added provisions to the conference report after

cutting

a back-room deal in the middle of the night. The conference report

grants

sweeping immunity to drug companies for injuries caused by vaccines

and

drugs and for the administration of those vaccines and drugs, even

if they

are made with flagrant disregard for basic safety precautions.

" Moreover, the compensation program is a sham, leaving people who

become

injured from a drug or vaccine without recourse. "

Since 2002, Senator Frist had tried numerous times to insert this

rider in

Homeland Security Bills after thousands of lawsuits were filed by

parents

who believe the mercury-based preservative thimerosal, contained in

childhood vaccines until recently, caused autism and other

neurological

disorders in their kids.

The rider could save Big Pharma hundreds of millions, if not

billions of

dollars.

The latest revelation on this little stunt came on May 8, 2006 when

the

Tennessean reported that vaccine industry officials helped shape

legislation

behind the scenes that Frist secretly amended into a bill, according

to

e-mails obtained by Pubic Citizen, a public advocacy group.

The industry group, called the Biotechnology Industry Organization,

wanted

the vaccine liability language in the bill, the e-mails proves.

" At Senator Frist's staff's request, this morning, BIO (Tom and I)

participated in a meeting with three other industry representatives

(Sanofi

and an outside counsel who works for both Pfizer and Roche, I

believe),

administration staff (HHS, DoJ and WH Leg Affairs), and Liz Hall to

further

discuss liability, " BIO official Dave Boyer wrote in a November e-

mail

obtained by Public Citizen.

Other E-mails and documents show that BIO met privately with Frist's

staff

and the White House to figure out ways to give drug makers

protection from

people injured by vaccines.

" The lack of any restriction on jury trial is problematic, " the BIO

analysis

said. " Where injured parties have no other avenue for relief, juries

are

likely to find ways to award damages. "

In another e-mail, Boyer described a meeting in which Karl Rove said

it was

" important to the President that a bill move this year, " and

said " they had

invited industry to discuss what they understood to be a few key

remaining

points " of contention.

Republicans members of Congress had tried to on several occasions to

enact

similar legislation of its own, but with voters already so angry over

soaring drug costs, they finally had to back off.

With less than 3 years left in office, and the Democrats positioned

to take

over Congress in the fall elections, Bush had to find a way to repay

Big

Pharma so he came up with the bright idea to utilize the FDA and

kill 2

birds with one stone.

This route would spare Republicans the task of trying to pass pro-

industry

legislation in an election year and still reward Big Pharma for the

more

than $80 million that Republicans received from drug makers over the

past

decade.

Since 2000, the top drug corporations, their trade group, and their

employees gave more than $10 million to 527 organizations, tax-exempt

political committees which operate in the grey area between federal

and

state campaign finance laws, according to Drug Lobby Second to None,

July 7,

2005, M. Asif Ismail.

Nearly $87 million of the contributions went to federal politicians,

with

almost 69% going to Republicans. Top recipients include Bush, with

upwards

of $1.5 million, and members who sit on committees that have

jurisdiction

over pharmaceutical issues, reports Drug Lobby Second to None.

During Bush's campaigns, 21 pharmaceutical industry executives and

lobbyists

achieved " Ranger " or " Pioneer " status, which means they raised at

least

$200,000 or $100,000, respectively, during the 2000 or 2004

campaigns.

According to Public Citizen, the group included 5 executives from

brand-name

drug companies, 6 officials from HMOs, the CEO of a pharmacy services

company that runs a PBM, the head of a direct-mail pharmacy, and 8

Washington lobbyists who represent drug companies and HMOs.

Frist is never shy when it comes to calling in markers from drug

companies.

In November 2004, when he wanted to take a victory tour celebrating

the

newly elected Republican senators, " A Gulfstream corporate jet owned

by drug

maker Schering-Plough was ready to zip the Senate majority leader to

stops

in Florida, Georgia and the Carolinas, " according to the April 25,

2005 USA

Today

Frist's PAC reimbursed Schering $10,809, the equivalent of a

commercial

first-class fare, but that was only a fraction of the cost of a

charter

flight, which would have cost 3 times that much. Besides, the cost

was

almost a wash because Schering had donated $10,000 to Frist's

committee in

2003-04, according to USA Today.

Its also worth pointing out that Big Pharma was the largest

contributor to

the National Republican Senatorial Campaign Committee while Frist

chaired

the Committee.

The ever-growing number of lawsuits in state courts has created a

nagging

fear in drug makers. Local juries and elected judges in state courts

are

much more likely to go against drug giants than juries and appointed

judges

in federal courts which is a one of the main reasons why Big Pharma

wants

all cases moved to federal courts.

Vioxx set off the industry's worst nightmare when users or their

heirs began

filing lawsuits all over the US. According to the January 24, 2006,

Associated Press, Merck currently faces 9,200 Vioxx lawsuits, with

about

4,050 in federal courts and the rest in state courts.

But Vioxx by far is not the only worry for Big Pharma. These days,

every

major drug company has litigation problems involving one or more

FDA-approved products and a few prominent law firms have taken up

the battle

for plaintiff's in state courts.

For instance, since 1990, the Los Angeles based Baum Hedlund Law

Firm has

been handling SSRI (selective serotonin reuptake inhibitor)

suicide/violence

cases and served on the Plaintiffs' Steering Committee in the first

SSRI-suicide litigation involving Prozac, the first SSRI approved by

the

FDA.

Baum Hedlund partner, Barth Menzies, has been litigating

claims

involving injuries stemming from SSRIs such as Prozac, Paxil, Zoloft

and,

more recently, Lexapro/Celexa, for over a decade.

She heads a team of attorneys, who have successfully defeated

Pfizer's and

the FDA's preemption arguments in a number of cases, including Motus

v

Pfizer and Witczak v Pfizer.

In addition to her court activities, Ms Menzies has testified about

the

dangers of SSRIs before the California State Assembly and the FDA's

Psychopharmacologic

Drugs Advisory Committees and met with members of Congress regarding

the

risk of antidepressant induced suicidality and preemption issues.

Ms Menzies wrote an article discussing the ill-effects of preemption

in

Mealey's Emerg. Drugs & Devices 27 (2006), titled,

" Preamble To FDA Final Rule: FDA's Latest Effort To Immunize Drug

Manufacturers From Tort Liability At The Expense of Consumer

Safety, " and

stated in part:

" Pharmaceutical industry lobbying efforts and zealot tort reformers

have

sired a new wave of brazen attempts to shield drug manufacturers

from tort

liability.

" The preemption language in the preamble to the Final Rule is but

the latest

attempt. Preemption has become the argument du jour and politically

appointed regulatory officials the mouthpieces. The crafty messages

sound of

consumer protection, but are just the opposite. Limiting the

liability of

drug companies will not improve public safety.

" The FDA s purported position on preemption assumes that the FDA is

infallible and that negligent misconduct by pharmaceutical companies

should

be the sole purview of FDA. Recent regulatory failures demonstrate

that FDA

is neither infallible nor does it have the capability of policing

drug

manufacturers negligent misconduct. "

The Bush administration went up against a tough opponent in Baum

Hedlund

when it turned to the courts, and had the FDA file amicus briefs

hoping the

courts would rule in favor of preemption, but those attempts also

failed.

Ms. Menzies explains some of the history of the FDA's intervention

into

lawsuits she was involved in stating: " Until his resignation in late

2004,

FDA Chief Counsel, Troy, was the pharmaceutical

industry's 'inside

man,' filing legal briefs on behalf of former clients such as Pfizer

(the

maker of Zoloft) and soliciting defense attorneys to submit their

cases for

government amicus brief consideration. "

" Although the newly appointed Chief Counsel, Sheldon Bradshaw, lacks

the

blatant pharmaceutical industry ties that Troy had, " she advises, " he

clearly was not selected to his position because of a sudden change-

of-heart

in the political leadership or direction of the FDA. "

" In fact, " Ms. Menzies says, " following in his predecessor's

footsteps,

Bradshaw submitted a legal brief in support of Pfizer's federal

preemption

arguments. "

The FDA filed its first brief in favor of a manufacturer of SSRIs in

September 2002 in Motus v Pfizer, one of Baum Hedlund's cases in

California,

which was pending in the 9th Circuit Court of Appeals.

Troy, who was the FDA's Chief Counsel at the time, was

contacted by

Pfizer's national counsel, Malcolm Wheeler, in the summer of 2002

requesting

that the government get involved in this private lawsuit to help

Pfizer with

its preemption argument related to Zoloft-induced suicidality.

Despite the fact that Pfizer had been one of his clients and Troy

was paid

over $358,000 for work he had conducted for Pfizer in the year he

took

office, Troy acquiesced, arguing that there was no impropriety in

doing so

because he did not become involved until after the required 1-year

period in

which government employees may not participate in official activities

involving former clients.

From public accounts, it appears that the 1-year " grace period "

elapsed less

then a month before Troy entered the fray.

Troy argued in the FDA brief that, even though Pfizer never sought to

strengthen Zoloft's warning label concerning suicidality, any

warning, no

matter how worded, that suggested a link between Zoloft and

suicidality

would have been false and misleading, would have misbranded the

drug, and

the FDA would have rejected any effort by Pfizer to use such a

warning.

The 9th Circuit never decided the preemption issue, instead ruling on

another appellate issue, which concluded the case on unrelated

grounds.

Nevertheless, Menziess said that Pfizer has continued to use the

brief in

its battle against Zoloft-induced suicide cases, arguing that the

lawsuits

are federally preempted and should be dismissed.

But Judges across the US have been rejecting Pfizer's arguments, as

well as

the FDA brief itself. A federal judge in Texas pointed out that the

law

" allows, even encourages, manufacturers to be proactive when

learning of new

safety information related to their drug. "

" Manufacturers, not the FDA, are tasked with the responsibility of

taking

proactive steps once a manufacturer learns of 'reasonable evidence

of an

association of a serious hazard with a drug,' " the judge stated.

A state court judge in California ordered the FDA brief stricken

from the

record, calling it " hearsay and irrelevant. "

In an Illinois case, the judge said the brief " contains nothing more

than

legal argument by [FDA] counsel. "

In a Zoloft suicide case in Minnesota, the court rejected Pfizer's

arguments, stating that it " declines to treat statements from a

single FDA

legal brief as declarations afforded the preemptive force of law. "

The same

judge also called Pfizer's arguments " perverse " and a " public policy

argument gone awry. "

Ms Menzies notes that the FDA's legal stance on preemption

is " particularly

egregious in the wake of congressional investigations involving FDA

failures

to protect the public health, in particular related to

antidepressants. "

Without state liability laws, she says, drug companies will be able

to

escape liability for injuries and deaths caused by drugs like SSRIs

and

Vioxx.

Baum Hedlund currently represents approximately 50 victims and their

families in cases involving alleged antidepressant-induced suicide

and

suicide attempts, over one third of whom are children and

adolescents.

As with Vioxx, the risks associated with SSRIs were also kept

hidden. Ms.

Menzies's litigation has evidence from as far back as the 1980's

that people

taking SSRIs were at a heightened risk of suicidality, and not just

children, she notes.

In fact, in the early 1990s, it was the FDA safety officer Dr

Graham,

of recent Vioxx fame, who raised concerns about the risk between

antidepressants and suicidality, but no one listened, Ms Menzies

says.

Fourteen years later, the FDA finally ordered black box warnings

labels on

SSRIs alerting physicians about the increased risk of suicidality. Ms

Menziess describes the FDA during these years as " complacent,

ignoring its

own internal scientist when they raise concerns, and in the pocket of

industry. "

She believes that the FDA would never have confronted the issue had

it not

been for the public outcry from victims, consumer groups, courageous

experts

willing to place their careers on the line, investigative reporters

and

pressure from certain members of Congress; and yes, she

says, " lawyers

uncovering the drug industry's dirty little secrets through legal

discovery

and speaking out about the dangers. "

Ms. Menzies points out that " the antidepressant controversy and

resultant

congressional investigations, and later, the Vioxx public health

debacle,

have served to highlight deep-seeded problems within the FDA. "

Over the past couple of years, a growing number of lawmakers have

been

turning up the heat on both the FDA and the industry in response to

their

combined failure to reveal the problems found in studies conducted

on drugs

like SSRIs and Vioxx.

At one point, Senator Grassley (R-Iowa), Chairman of the

Senate

Finance Committee, came right out and accused the FDA of suppressing

studies

in order to protect industry profits and the careers of certain FDA

officials.

" The Vioxx example showed that the FDA and Merck were too close for

comfort, " Senator Grassely told Health News on March 12,

2005. " Testimony

and documents at our Finance Committee hearing showed that the FDA

allowed

itself to be manipulated by Merck, " he said.

The results of a trial that took place in 2000, surfaced that showed

that

the FDA and Merck were aware that heart attacks were 5 times more

likely in

patients taking Vioxx than among those taking a similar drug, Senator

Grassley pointed out, but the FDA did nothing to change the labeling

for

nearly 2 years, he said, while Merck marketed its product on nightly

TV.

On November 18, 2004, Senator Grassley drew enormous media attention

when he

held hearings on Vioxx, and FDA scientist, Dr. Graham, testified

that he

determined that Vioxx may have caused tens of thousands of heart

attacks and

strokes but that his superiors at the FDA pressured him to keep

quiet.

" The estimates range from 88,000 to 139,000 Americans, " Dr. Graham

told the

committee. " Of these, 30 to 40 percent probably died, " he

advised. " For the

survivors, " he added, " their lives were changed forever. "

To put the number of injuries into perspective, Dr. Graham told

members of

the committee that instead of side-effects from a drug, to think of

it as if

they were talking about jetliners.

" If there were an average of 150 to 200 people on an aircraft, " he

said,

" this range of 88,000 to 138,000 would be the rough equivalent of

500 to 900

aircraft dropping from the sky. "

" This translates to 2-4 aircraft every week, " he advised, " week in

and week

out, for the past 5 years. "

" If you were confronted by this situation, " Dr. Graham asked the

panel,

" what would be your reaction, what would you want to know and what

would you

do about it? "

He noted the problems with the FDA's reliance on a 95% paradigm. In

other

words, he said, a drug is considered safe " until you can show with

95% or

greater certainty that it is not safe. "

The scientist condemned the FDA's failure to acknowledge the Vioxx

risks

sooner. " I strongly believe that this should have been, and largely

could

have been, avoided, " Dr. Graham told the committee.

Ms. Menzies often cites his testimony to demonstrate that the FDA's

position

on preemption is wrong and states: " Dr. Graham's testimony

illustrates why

FDA approval and subsequent post-marketing acquiescence should have

no

preemptive effect. "

The Vioxx matter caught the attention of the Senate Finance Committee

basically because of the drug's cost to government programs like

Medicaid

and Medicare. The committee is responsible for oversight of the two

programs.

At the November 18, 2004 hearing, Senator Max Baucus discussed the

high-costs related to the drug: " In the 5 years that Vioxx was on the

market, Medicaid spent more than $1 billion on the drug, " he said.

In addition to the prescription costs, government programs are now

paying

for the damage caused by Vioxx. " Medicaid bears the cost of any

additional

medical care necessary when drugs cause injury, " Senator Baucus

pointed out.

By far, the Vioxx debacle is the most serious public health failure

to occur

since the FDA took on the authority for safety oversight of medical

products

in 1938.

On September 3, 2005, Shane Ellison, a former pharmaceutical chemist

turned

whistleblower and author of the book, " Health Myths Exposed, " gave an

interview to Crusador Magazine and discussed Vioxx and the problems

within

the FDA.

According to Mr. Ellison, the FDA and Merck knew about the dangers

of Vioxx

for at least 4 years before it was pulled off the market. " Instead of

removing the drug immediately, " he said, " they kept it on the drug

market

for matters of wealth not health. "

Mr. Ellison says compliant politicians have " democratized " the

industry.

" This means that drug approval is a matter of 51% telling the other

49% that

deadly drugs are safe and necessary, " he reports. " Science and

choice no

longer prevail at the FDA or at pharmaceutical companies, " he added.

" To go against the 51% means losing your career, " Mr. Ellison

explains.

" Therefore, the majority of scientists choose to please drug

companies, not

the general public. "

To substantiate this allegation, Dr. Ellison points to Dr. Curt

Furberg, a

member of the FDA's drug safety advisory committee. Dr. Furberg went

public

with findings that Bextra also caused heart attacks and strokes and

said

studies " showed that Bextra is no different than Vioxx, and Pfizer

is trying

to suppress that information, " in the British Medical Journal.

" Immediately thereafter, " Mr. Ellison said, " Dr. Furberg was barred

from

serving on the panel that was responsible for considering the safety

of

cyclo-oxygenase-2 (COX 2) inhibitors. "

" The end result being more votes in favor of COX 2 inhibitors, the

drug

company wins by votes - not science, " he told Crusador.

Another relevant, but little-mentioned fact, is that many FDA

officials end

up working for Big Pharma. " The old joke is that the FDA is sort of

like a

showcase for a future job in the drug industry, " Whitaker,

author of

Mad In America, said in an August 2005 interview with Street Spirit.

" You go there, you work awhile, then you go off into the drug

industry, " he

said, " the progression that people make, in essence they're making

good old

boy network connections, so they're not going to be so harsh on the

drug

companies. "

In addition, when leaving office many federal employees and members

of

Congress go to work for Big Pharma in one area or another. For

instance, of

the 1,274 people registered to lobby in Washington for drug

companies in

2003, according to an April 2005 report by the Center for Public

Integrity,

476 are former federal officials, including 40 former members of

Congress.

Critics say the Prescription Drug User Fee Act, is in large part to

blame,

for the current problems within the FDA. The Act allows the agency to

collect a fee from a drug company seeking approval for a new drug. In

return, the FDA is expected complete the review process within 12

months.

User fees now account for about 40% of the approval process, which

means the

FDA is dependent on drug companies for nearly half of its funding.

This

situation creates a major conflict of interest according to Dr

Graham: " This

culture views the pharmaceutical industry it is supposed to regulate

as its

client. It overvalues the benefits of the drugs it approves, and

seriously

undervalues, disregards and disrespects drug safety, " he told

members of

Congress.

Another problem he said is that even when the FDA does try to take

measures

to limit harm, the agency lacks the authority to force drug

companies to

comply. For example with Vioxx, he said, it took more than 2 years

to get

Merck to add the increased risk of heart attack and stroke on the

label.

Then there is the matter of the conflicts of interests involving the

FDA

panels that advise the agency on which drugs should be approved,

what their

warning labels should say, and how studies should be conducted.

The approximately 300 experts on the 18 committees make decisions

that

affect billions of dollars in sales and with very few exceptions the

FDA

follows their advice.

Members of the panels are supposed to be free of conflicts of

interest

relating to products they consider but they rarely are. For example,

in

February 2005, when the hearings were held to determine whether the

COX-2

inhibitors should be allowed to remain on the market, a panel mired

with

conflicts was exposed. Out of the 32 voting members, ten had served

as

consultants to Merck and Pfizer in recent years.

This revelation prompted Senator Mike Enzi, (R -WY), the chairman

of the

Health, Education, Labor and Pensions Committee, along with

Senators,

Kennedy (D-MA), and Durbin (D-IL), to ask the General

Accounting

Office to look into the FDA's practice of letting scientists serve

on panels

when they have conflicts of interest.

" We are concerned about the process that supports FDA's decisions to

waive

conflicts of interest rules for scientists with financial ties to the

manufacturers of the products under consideration, or their

competitors, "

said their letter to the GAO in September 2005.

" These practices appear to have undermined the public's faith in the

objectivity and fairness of FDA's advisory committees, " they wrote.

The

Senators specifically referred to the conflicts among the panels that

studied the -2 inhibitors like Vioxx.

According to Ms. Menzies, " The FDA's preemption argument, if

successful,

would take away the sole means by which American consumers may obtain

compensation for drug-induced injuries caused by a drug company's

failure to

warn. "

" Civil lawsuits uncover internal company documents to which not even

the FDA

has access, " she explains.

process

" The tort system provides an important check on the regulatory and

on drug

companies' compliance with law. "

" Preemption, " Ms Menzies warns, " would close off one of the few

avenues by

which we learn of safety and efficacy information that pharmaceutical

companies do not publish or hide from FDA. "

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Guest guest

By Pringle*

May 12, 2006.

In January 2006, the FDA announced the Bush administration's

latest gift to

Big Pharma in a statement that said people who believe they have been

injured by drugs approved by the FDA should not be allowed to sue

drug

companies in state courts.

" We think that if your company complies with the FDA processes, if

you bring

forward the benefits and risks of your drug, and let your

information be

judged through a process with highly trained scientists, you should

not be

second-guessed by state courts that don't have the same scientific

knowledge, " said Gottlieb, the FDA's deputy commissioner for

medical

and scientific affairs.

To soften the blow, the agency's claim of federal preemption was

included as

a preamble to the long sought after new drug labeling guidelines. In

response to the FDA's statement, Senator Kennedy (D-MA)

issued a

statement of his own that said: " It's a typical abuse by the Bush

Administration -- take a regulation to improve the information that

doctors

and patients receive about prescription drugs and turn it into a

protection

against liability for the drug industry. "

The ploy was also readily recognized by state lawmakers and trial

lawyers as

another ploy to reduce the public's ability to hold Big Pharma

accountable.

" Eliminating the rights of individuals to hold negligent drug

companies

accountable puts patients in even more danger than they already are

in from

drug company executives that put profits before safety, " said Ken

Suggs,

president of the Association of Trial Lawyers of America.

" The fact that the drug industry can get the FDA to rewrite the

rules so

that CEOs can escape accountability for putting dangerous and deadly

drugs

on the market is the scariest example yet of how much control these

big

corporations have over our political process, " Mr Suggs told the

Washington

Post.

According to Attorney Mark Labaton, a partner at the firm Kreindler &

Kreindler, LLP, with offices in New York and LA, " the

Administration's

recent efforts to misuse federal rulemaking in the pharmaceutical

and other

areas to eviserate consumer rights is a big step backward. "

" The new FDA rules to limit consumers' rights, " he says, " are part

and

parcel of a larger effort to deny persons injured by unsafe

products -- be

they drugs, cigarettes or automobiles -- any form of redress. "

" Clearly, " Mr Labaton notes, " this Administration and its supporters

want to

slam the courthouse doors on working men and women injured by unsafe

products.

He says its ironic that " an Administrative that calls

itself " compassionate "

and " conservative " consistently turns its back on " limited

government " and

" states rights " when it comes to protecting the rights of seriously

injured

consumers. "

Upon learning of the FDA's power grab, the National Conference of

State

Legislatures, a bipartisan group that represents state lawmakers,

accused

the FDA of trying to seize authority that it did not have. The

organization

bases its opposition, in part on the following:

" FDA has usurped the authority of Congress, state legislatures and

state

courts. There is no statutory authority in the FDCA for FDA to

preempt state

product liability laws as they relate to prescription drugs.

" Instead of seeking valid congressional authority, unelected agency

officials are seeking to preempt state product liability laws by

writing

this preemption into a final rule, thereby undermining state policy

and

judicial decision made in this area.

" State tort laws and civil justice systems serve as an important

check on

federal standards. Our civil justice system establishes a duty of

care that

protects citizens when the federal government is too slow to act or

when

federal standards are insufficient. States have the ability to

achieve

greater protections for their citizens through successful product

liability

lawsuits. "

In an earlier gift delivered to Big Pharma in December 2005,

Republican

leaders, and specifically Senator Bill Frist (R-TN), attached

protective

provisions to a Department of Defense appropriations report that

gave the

industry " unprecedented immunity, " according to Democratic lawmakers

who

described the underhanded move as follows:

" Republican leaders added provisions to the conference report after

cutting

a back-room deal in the middle of the night. The conference report

grants

sweeping immunity to drug companies for injuries caused by vaccines

and

drugs and for the administration of those vaccines and drugs, even

if they

are made with flagrant disregard for basic safety precautions.

" Moreover, the compensation program is a sham, leaving people who

become

injured from a drug or vaccine without recourse. "

Since 2002, Senator Frist had tried numerous times to insert this

rider in

Homeland Security Bills after thousands of lawsuits were filed by

parents

who believe the mercury-based preservative thimerosal, contained in

childhood vaccines until recently, caused autism and other

neurological

disorders in their kids.

The rider could save Big Pharma hundreds of millions, if not

billions of

dollars.

The latest revelation on this little stunt came on May 8, 2006 when

the

Tennessean reported that vaccine industry officials helped shape

legislation

behind the scenes that Frist secretly amended into a bill, according

to

e-mails obtained by Pubic Citizen, a public advocacy group.

The industry group, called the Biotechnology Industry Organization,

wanted

the vaccine liability language in the bill, the e-mails proves.

" At Senator Frist's staff's request, this morning, BIO (Tom and I)

participated in a meeting with three other industry representatives

(Sanofi

and an outside counsel who works for both Pfizer and Roche, I

believe),

administration staff (HHS, DoJ and WH Leg Affairs), and Liz Hall to

further

discuss liability, " BIO official Dave Boyer wrote in a November e-

mail

obtained by Public Citizen.

Other E-mails and documents show that BIO met privately with Frist's

staff

and the White House to figure out ways to give drug makers

protection from

people injured by vaccines.

" The lack of any restriction on jury trial is problematic, " the BIO

analysis

said. " Where injured parties have no other avenue for relief, juries

are

likely to find ways to award damages. "

In another e-mail, Boyer described a meeting in which Karl Rove said

it was

" important to the President that a bill move this year, " and

said " they had

invited industry to discuss what they understood to be a few key

remaining

points " of contention.

Republicans members of Congress had tried to on several occasions to

enact

similar legislation of its own, but with voters already so angry over

soaring drug costs, they finally had to back off.

With less than 3 years left in office, and the Democrats positioned

to take

over Congress in the fall elections, Bush had to find a way to repay

Big

Pharma so he came up with the bright idea to utilize the FDA and

kill 2

birds with one stone.

This route would spare Republicans the task of trying to pass pro-

industry

legislation in an election year and still reward Big Pharma for the

more

than $80 million that Republicans received from drug makers over the

past

decade.

Since 2000, the top drug corporations, their trade group, and their

employees gave more than $10 million to 527 organizations, tax-exempt

political committees which operate in the grey area between federal

and

state campaign finance laws, according to Drug Lobby Second to None,

July 7,

2005, M. Asif Ismail.

Nearly $87 million of the contributions went to federal politicians,

with

almost 69% going to Republicans. Top recipients include Bush, with

upwards

of $1.5 million, and members who sit on committees that have

jurisdiction

over pharmaceutical issues, reports Drug Lobby Second to None.

During Bush's campaigns, 21 pharmaceutical industry executives and

lobbyists

achieved " Ranger " or " Pioneer " status, which means they raised at

least

$200,000 or $100,000, respectively, during the 2000 or 2004

campaigns.

According to Public Citizen, the group included 5 executives from

brand-name

drug companies, 6 officials from HMOs, the CEO of a pharmacy services

company that runs a PBM, the head of a direct-mail pharmacy, and 8

Washington lobbyists who represent drug companies and HMOs.

Frist is never shy when it comes to calling in markers from drug

companies.

In November 2004, when he wanted to take a victory tour celebrating

the

newly elected Republican senators, " A Gulfstream corporate jet owned

by drug

maker Schering-Plough was ready to zip the Senate majority leader to

stops

in Florida, Georgia and the Carolinas, " according to the April 25,

2005 USA

Today

Frist's PAC reimbursed Schering $10,809, the equivalent of a

commercial

first-class fare, but that was only a fraction of the cost of a

charter

flight, which would have cost 3 times that much. Besides, the cost

was

almost a wash because Schering had donated $10,000 to Frist's

committee in

2003-04, according to USA Today.

Its also worth pointing out that Big Pharma was the largest

contributor to

the National Republican Senatorial Campaign Committee while Frist

chaired

the Committee.

The ever-growing number of lawsuits in state courts has created a

nagging

fear in drug makers. Local juries and elected judges in state courts

are

much more likely to go against drug giants than juries and appointed

judges

in federal courts which is a one of the main reasons why Big Pharma

wants

all cases moved to federal courts.

Vioxx set off the industry's worst nightmare when users or their

heirs began

filing lawsuits all over the US. According to the January 24, 2006,

Associated Press, Merck currently faces 9,200 Vioxx lawsuits, with

about

4,050 in federal courts and the rest in state courts.

But Vioxx by far is not the only worry for Big Pharma. These days,

every

major drug company has litigation problems involving one or more

FDA-approved products and a few prominent law firms have taken up

the battle

for plaintiff's in state courts.

For instance, since 1990, the Los Angeles based Baum Hedlund Law

Firm has

been handling SSRI (selective serotonin reuptake inhibitor)

suicide/violence

cases and served on the Plaintiffs' Steering Committee in the first

SSRI-suicide litigation involving Prozac, the first SSRI approved by

the

FDA.

Baum Hedlund partner, Barth Menzies, has been litigating

claims

involving injuries stemming from SSRIs such as Prozac, Paxil, Zoloft

and,

more recently, Lexapro/Celexa, for over a decade.

She heads a team of attorneys, who have successfully defeated

Pfizer's and

the FDA's preemption arguments in a number of cases, including Motus

v

Pfizer and Witczak v Pfizer.

In addition to her court activities, Ms Menzies has testified about

the

dangers of SSRIs before the California State Assembly and the FDA's

Psychopharmacologic

Drugs Advisory Committees and met with members of Congress regarding

the

risk of antidepressant induced suicidality and preemption issues.

Ms Menzies wrote an article discussing the ill-effects of preemption

in

Mealey's Emerg. Drugs & Devices 27 (2006), titled,

" Preamble To FDA Final Rule: FDA's Latest Effort To Immunize Drug

Manufacturers From Tort Liability At The Expense of Consumer

Safety, " and

stated in part:

" Pharmaceutical industry lobbying efforts and zealot tort reformers

have

sired a new wave of brazen attempts to shield drug manufacturers

from tort

liability.

" The preemption language in the preamble to the Final Rule is but

the latest

attempt. Preemption has become the argument du jour and politically

appointed regulatory officials the mouthpieces. The crafty messages

sound of

consumer protection, but are just the opposite. Limiting the

liability of

drug companies will not improve public safety.

" The FDA s purported position on preemption assumes that the FDA is

infallible and that negligent misconduct by pharmaceutical companies

should

be the sole purview of FDA. Recent regulatory failures demonstrate

that FDA

is neither infallible nor does it have the capability of policing

drug

manufacturers negligent misconduct. "

The Bush administration went up against a tough opponent in Baum

Hedlund

when it turned to the courts, and had the FDA file amicus briefs

hoping the

courts would rule in favor of preemption, but those attempts also

failed.

Ms. Menzies explains some of the history of the FDA's intervention

into

lawsuits she was involved in stating: " Until his resignation in late

2004,

FDA Chief Counsel, Troy, was the pharmaceutical

industry's 'inside

man,' filing legal briefs on behalf of former clients such as Pfizer

(the

maker of Zoloft) and soliciting defense attorneys to submit their

cases for

government amicus brief consideration. "

" Although the newly appointed Chief Counsel, Sheldon Bradshaw, lacks

the

blatant pharmaceutical industry ties that Troy had, " she advises, " he

clearly was not selected to his position because of a sudden change-

of-heart

in the political leadership or direction of the FDA. "

" In fact, " Ms. Menzies says, " following in his predecessor's

footsteps,

Bradshaw submitted a legal brief in support of Pfizer's federal

preemption

arguments. "

The FDA filed its first brief in favor of a manufacturer of SSRIs in

September 2002 in Motus v Pfizer, one of Baum Hedlund's cases in

California,

which was pending in the 9th Circuit Court of Appeals.

Troy, who was the FDA's Chief Counsel at the time, was

contacted by

Pfizer's national counsel, Malcolm Wheeler, in the summer of 2002

requesting

that the government get involved in this private lawsuit to help

Pfizer with

its preemption argument related to Zoloft-induced suicidality.

Despite the fact that Pfizer had been one of his clients and Troy

was paid

over $358,000 for work he had conducted for Pfizer in the year he

took

office, Troy acquiesced, arguing that there was no impropriety in

doing so

because he did not become involved until after the required 1-year

period in

which government employees may not participate in official activities

involving former clients.

From public accounts, it appears that the 1-year " grace period "

elapsed less

then a month before Troy entered the fray.

Troy argued in the FDA brief that, even though Pfizer never sought to

strengthen Zoloft's warning label concerning suicidality, any

warning, no

matter how worded, that suggested a link between Zoloft and

suicidality

would have been false and misleading, would have misbranded the

drug, and

the FDA would have rejected any effort by Pfizer to use such a

warning.

The 9th Circuit never decided the preemption issue, instead ruling on

another appellate issue, which concluded the case on unrelated

grounds.

Nevertheless, Menziess said that Pfizer has continued to use the

brief in

its battle against Zoloft-induced suicide cases, arguing that the

lawsuits

are federally preempted and should be dismissed.

But Judges across the US have been rejecting Pfizer's arguments, as

well as

the FDA brief itself. A federal judge in Texas pointed out that the

law

" allows, even encourages, manufacturers to be proactive when

learning of new

safety information related to their drug. "

" Manufacturers, not the FDA, are tasked with the responsibility of

taking

proactive steps once a manufacturer learns of 'reasonable evidence

of an

association of a serious hazard with a drug,' " the judge stated.

A state court judge in California ordered the FDA brief stricken

from the

record, calling it " hearsay and irrelevant. "

In an Illinois case, the judge said the brief " contains nothing more

than

legal argument by [FDA] counsel. "

In a Zoloft suicide case in Minnesota, the court rejected Pfizer's

arguments, stating that it " declines to treat statements from a

single FDA

legal brief as declarations afforded the preemptive force of law. "

The same

judge also called Pfizer's arguments " perverse " and a " public policy

argument gone awry. "

Ms Menzies notes that the FDA's legal stance on preemption

is " particularly

egregious in the wake of congressional investigations involving FDA

failures

to protect the public health, in particular related to

antidepressants. "

Without state liability laws, she says, drug companies will be able

to

escape liability for injuries and deaths caused by drugs like SSRIs

and

Vioxx.

Baum Hedlund currently represents approximately 50 victims and their

families in cases involving alleged antidepressant-induced suicide

and

suicide attempts, over one third of whom are children and

adolescents.

As with Vioxx, the risks associated with SSRIs were also kept

hidden. Ms.

Menzies's litigation has evidence from as far back as the 1980's

that people

taking SSRIs were at a heightened risk of suicidality, and not just

children, she notes.

In fact, in the early 1990s, it was the FDA safety officer Dr

Graham,

of recent Vioxx fame, who raised concerns about the risk between

antidepressants and suicidality, but no one listened, Ms Menzies

says.

Fourteen years later, the FDA finally ordered black box warnings

labels on

SSRIs alerting physicians about the increased risk of suicidality. Ms

Menziess describes the FDA during these years as " complacent,

ignoring its

own internal scientist when they raise concerns, and in the pocket of

industry. "

She believes that the FDA would never have confronted the issue had

it not

been for the public outcry from victims, consumer groups, courageous

experts

willing to place their careers on the line, investigative reporters

and

pressure from certain members of Congress; and yes, she

says, " lawyers

uncovering the drug industry's dirty little secrets through legal

discovery

and speaking out about the dangers. "

Ms. Menzies points out that " the antidepressant controversy and

resultant

congressional investigations, and later, the Vioxx public health

debacle,

have served to highlight deep-seeded problems within the FDA. "

Over the past couple of years, a growing number of lawmakers have

been

turning up the heat on both the FDA and the industry in response to

their

combined failure to reveal the problems found in studies conducted

on drugs

like SSRIs and Vioxx.

At one point, Senator Grassley (R-Iowa), Chairman of the

Senate

Finance Committee, came right out and accused the FDA of suppressing

studies

in order to protect industry profits and the careers of certain FDA

officials.

" The Vioxx example showed that the FDA and Merck were too close for

comfort, " Senator Grassely told Health News on March 12,

2005. " Testimony

and documents at our Finance Committee hearing showed that the FDA

allowed

itself to be manipulated by Merck, " he said.

The results of a trial that took place in 2000, surfaced that showed

that

the FDA and Merck were aware that heart attacks were 5 times more

likely in

patients taking Vioxx than among those taking a similar drug, Senator

Grassley pointed out, but the FDA did nothing to change the labeling

for

nearly 2 years, he said, while Merck marketed its product on nightly

TV.

On November 18, 2004, Senator Grassley drew enormous media attention

when he

held hearings on Vioxx, and FDA scientist, Dr. Graham, testified

that he

determined that Vioxx may have caused tens of thousands of heart

attacks and

strokes but that his superiors at the FDA pressured him to keep

quiet.

" The estimates range from 88,000 to 139,000 Americans, " Dr. Graham

told the

committee. " Of these, 30 to 40 percent probably died, " he

advised. " For the

survivors, " he added, " their lives were changed forever. "

To put the number of injuries into perspective, Dr. Graham told

members of

the committee that instead of side-effects from a drug, to think of

it as if

they were talking about jetliners.

" If there were an average of 150 to 200 people on an aircraft, " he

said,

" this range of 88,000 to 138,000 would be the rough equivalent of

500 to 900

aircraft dropping from the sky. "

" This translates to 2-4 aircraft every week, " he advised, " week in

and week

out, for the past 5 years. "

" If you were confronted by this situation, " Dr. Graham asked the

panel,

" what would be your reaction, what would you want to know and what

would you

do about it? "

He noted the problems with the FDA's reliance on a 95% paradigm. In

other

words, he said, a drug is considered safe " until you can show with

95% or

greater certainty that it is not safe. "

The scientist condemned the FDA's failure to acknowledge the Vioxx

risks

sooner. " I strongly believe that this should have been, and largely

could

have been, avoided, " Dr. Graham told the committee.

Ms. Menzies often cites his testimony to demonstrate that the FDA's

position

on preemption is wrong and states: " Dr. Graham's testimony

illustrates why

FDA approval and subsequent post-marketing acquiescence should have

no

preemptive effect. "

The Vioxx matter caught the attention of the Senate Finance Committee

basically because of the drug's cost to government programs like

Medicaid

and Medicare. The committee is responsible for oversight of the two

programs.

At the November 18, 2004 hearing, Senator Max Baucus discussed the

high-costs related to the drug: " In the 5 years that Vioxx was on the

market, Medicaid spent more than $1 billion on the drug, " he said.

In addition to the prescription costs, government programs are now

paying

for the damage caused by Vioxx. " Medicaid bears the cost of any

additional

medical care necessary when drugs cause injury, " Senator Baucus

pointed out.

By far, the Vioxx debacle is the most serious public health failure

to occur

since the FDA took on the authority for safety oversight of medical

products

in 1938.

On September 3, 2005, Shane Ellison, a former pharmaceutical chemist

turned

whistleblower and author of the book, " Health Myths Exposed, " gave an

interview to Crusador Magazine and discussed Vioxx and the problems

within

the FDA.

According to Mr. Ellison, the FDA and Merck knew about the dangers

of Vioxx

for at least 4 years before it was pulled off the market. " Instead of

removing the drug immediately, " he said, " they kept it on the drug

market

for matters of wealth not health. "

Mr. Ellison says compliant politicians have " democratized " the

industry.

" This means that drug approval is a matter of 51% telling the other

49% that

deadly drugs are safe and necessary, " he reports. " Science and

choice no

longer prevail at the FDA or at pharmaceutical companies, " he added.

" To go against the 51% means losing your career, " Mr. Ellison

explains.

" Therefore, the majority of scientists choose to please drug

companies, not

the general public. "

To substantiate this allegation, Dr. Ellison points to Dr. Curt

Furberg, a

member of the FDA's drug safety advisory committee. Dr. Furberg went

public

with findings that Bextra also caused heart attacks and strokes and

said

studies " showed that Bextra is no different than Vioxx, and Pfizer

is trying

to suppress that information, " in the British Medical Journal.

" Immediately thereafter, " Mr. Ellison said, " Dr. Furberg was barred

from

serving on the panel that was responsible for considering the safety

of

cyclo-oxygenase-2 (COX 2) inhibitors. "

" The end result being more votes in favor of COX 2 inhibitors, the

drug

company wins by votes - not science, " he told Crusador.

Another relevant, but little-mentioned fact, is that many FDA

officials end

up working for Big Pharma. " The old joke is that the FDA is sort of

like a

showcase for a future job in the drug industry, " Whitaker,

author of

Mad In America, said in an August 2005 interview with Street Spirit.

" You go there, you work awhile, then you go off into the drug

industry, " he

said, " the progression that people make, in essence they're making

good old

boy network connections, so they're not going to be so harsh on the

drug

companies. "

In addition, when leaving office many federal employees and members

of

Congress go to work for Big Pharma in one area or another. For

instance, of

the 1,274 people registered to lobby in Washington for drug

companies in

2003, according to an April 2005 report by the Center for Public

Integrity,

476 are former federal officials, including 40 former members of

Congress.

Critics say the Prescription Drug User Fee Act, is in large part to

blame,

for the current problems within the FDA. The Act allows the agency to

collect a fee from a drug company seeking approval for a new drug. In

return, the FDA is expected complete the review process within 12

months.

User fees now account for about 40% of the approval process, which

means the

FDA is dependent on drug companies for nearly half of its funding.

This

situation creates a major conflict of interest according to Dr

Graham: " This

culture views the pharmaceutical industry it is supposed to regulate

as its

client. It overvalues the benefits of the drugs it approves, and

seriously

undervalues, disregards and disrespects drug safety, " he told

members of

Congress.

Another problem he said is that even when the FDA does try to take

measures

to limit harm, the agency lacks the authority to force drug

companies to

comply. For example with Vioxx, he said, it took more than 2 years

to get

Merck to add the increased risk of heart attack and stroke on the

label.

Then there is the matter of the conflicts of interests involving the

FDA

panels that advise the agency on which drugs should be approved,

what their

warning labels should say, and how studies should be conducted.

The approximately 300 experts on the 18 committees make decisions

that

affect billions of dollars in sales and with very few exceptions the

FDA

follows their advice.

Members of the panels are supposed to be free of conflicts of

interest

relating to products they consider but they rarely are. For example,

in

February 2005, when the hearings were held to determine whether the

COX-2

inhibitors should be allowed to remain on the market, a panel mired

with

conflicts was exposed. Out of the 32 voting members, ten had served

as

consultants to Merck and Pfizer in recent years.

This revelation prompted Senator Mike Enzi, (R -WY), the chairman

of the

Health, Education, Labor and Pensions Committee, along with

Senators,

Kennedy (D-MA), and Durbin (D-IL), to ask the General

Accounting

Office to look into the FDA's practice of letting scientists serve

on panels

when they have conflicts of interest.

" We are concerned about the process that supports FDA's decisions to

waive

conflicts of interest rules for scientists with financial ties to the

manufacturers of the products under consideration, or their

competitors, "

said their letter to the GAO in September 2005.

" These practices appear to have undermined the public's faith in the

objectivity and fairness of FDA's advisory committees, " they wrote.

The

Senators specifically referred to the conflicts among the panels that

studied the -2 inhibitors like Vioxx.

According to Ms. Menzies, " The FDA's preemption argument, if

successful,

would take away the sole means by which American consumers may obtain

compensation for drug-induced injuries caused by a drug company's

failure to

warn. "

" Civil lawsuits uncover internal company documents to which not even

the FDA

has access, " she explains.

process

" The tort system provides an important check on the regulatory and

on drug

companies' compliance with law. "

" Preemption, " Ms Menzies warns, " would close off one of the few

avenues by

which we learn of safety and efficacy information that pharmaceutical

companies do not publish or hide from FDA. "

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Guest guest

By Pringle*

May 12, 2006.

In January 2006, the FDA announced the Bush administration's

latest gift to

Big Pharma in a statement that said people who believe they have been

injured by drugs approved by the FDA should not be allowed to sue

drug

companies in state courts.

" We think that if your company complies with the FDA processes, if

you bring

forward the benefits and risks of your drug, and let your

information be

judged through a process with highly trained scientists, you should

not be

second-guessed by state courts that don't have the same scientific

knowledge, " said Gottlieb, the FDA's deputy commissioner for

medical

and scientific affairs.

To soften the blow, the agency's claim of federal preemption was

included as

a preamble to the long sought after new drug labeling guidelines. In

response to the FDA's statement, Senator Kennedy (D-MA)

issued a

statement of his own that said: " It's a typical abuse by the Bush

Administration -- take a regulation to improve the information that

doctors

and patients receive about prescription drugs and turn it into a

protection

against liability for the drug industry. "

The ploy was also readily recognized by state lawmakers and trial

lawyers as

another ploy to reduce the public's ability to hold Big Pharma

accountable.

" Eliminating the rights of individuals to hold negligent drug

companies

accountable puts patients in even more danger than they already are

in from

drug company executives that put profits before safety, " said Ken

Suggs,

president of the Association of Trial Lawyers of America.

" The fact that the drug industry can get the FDA to rewrite the

rules so

that CEOs can escape accountability for putting dangerous and deadly

drugs

on the market is the scariest example yet of how much control these

big

corporations have over our political process, " Mr Suggs told the

Washington

Post.

According to Attorney Mark Labaton, a partner at the firm Kreindler &

Kreindler, LLP, with offices in New York and LA, " the

Administration's

recent efforts to misuse federal rulemaking in the pharmaceutical

and other

areas to eviserate consumer rights is a big step backward. "

" The new FDA rules to limit consumers' rights, " he says, " are part

and

parcel of a larger effort to deny persons injured by unsafe

products -- be

they drugs, cigarettes or automobiles -- any form of redress. "

" Clearly, " Mr Labaton notes, " this Administration and its supporters

want to

slam the courthouse doors on working men and women injured by unsafe

products.

He says its ironic that " an Administrative that calls

itself " compassionate "

and " conservative " consistently turns its back on " limited

government " and

" states rights " when it comes to protecting the rights of seriously

injured

consumers. "

Upon learning of the FDA's power grab, the National Conference of

State

Legislatures, a bipartisan group that represents state lawmakers,

accused

the FDA of trying to seize authority that it did not have. The

organization

bases its opposition, in part on the following:

" FDA has usurped the authority of Congress, state legislatures and

state

courts. There is no statutory authority in the FDCA for FDA to

preempt state

product liability laws as they relate to prescription drugs.

" Instead of seeking valid congressional authority, unelected agency

officials are seeking to preempt state product liability laws by

writing

this preemption into a final rule, thereby undermining state policy

and

judicial decision made in this area.

" State tort laws and civil justice systems serve as an important

check on

federal standards. Our civil justice system establishes a duty of

care that

protects citizens when the federal government is too slow to act or

when

federal standards are insufficient. States have the ability to

achieve

greater protections for their citizens through successful product

liability

lawsuits. "

In an earlier gift delivered to Big Pharma in December 2005,

Republican

leaders, and specifically Senator Bill Frist (R-TN), attached

protective

provisions to a Department of Defense appropriations report that

gave the

industry " unprecedented immunity, " according to Democratic lawmakers

who

described the underhanded move as follows:

" Republican leaders added provisions to the conference report after

cutting

a back-room deal in the middle of the night. The conference report

grants

sweeping immunity to drug companies for injuries caused by vaccines

and

drugs and for the administration of those vaccines and drugs, even

if they

are made with flagrant disregard for basic safety precautions.

" Moreover, the compensation program is a sham, leaving people who

become

injured from a drug or vaccine without recourse. "

Since 2002, Senator Frist had tried numerous times to insert this

rider in

Homeland Security Bills after thousands of lawsuits were filed by

parents

who believe the mercury-based preservative thimerosal, contained in

childhood vaccines until recently, caused autism and other

neurological

disorders in their kids.

The rider could save Big Pharma hundreds of millions, if not

billions of

dollars.

The latest revelation on this little stunt came on May 8, 2006 when

the

Tennessean reported that vaccine industry officials helped shape

legislation

behind the scenes that Frist secretly amended into a bill, according

to

e-mails obtained by Pubic Citizen, a public advocacy group.

The industry group, called the Biotechnology Industry Organization,

wanted

the vaccine liability language in the bill, the e-mails proves.

" At Senator Frist's staff's request, this morning, BIO (Tom and I)

participated in a meeting with three other industry representatives

(Sanofi

and an outside counsel who works for both Pfizer and Roche, I

believe),

administration staff (HHS, DoJ and WH Leg Affairs), and Liz Hall to

further

discuss liability, " BIO official Dave Boyer wrote in a November e-

mail

obtained by Public Citizen.

Other E-mails and documents show that BIO met privately with Frist's

staff

and the White House to figure out ways to give drug makers

protection from

people injured by vaccines.

" The lack of any restriction on jury trial is problematic, " the BIO

analysis

said. " Where injured parties have no other avenue for relief, juries

are

likely to find ways to award damages. "

In another e-mail, Boyer described a meeting in which Karl Rove said

it was

" important to the President that a bill move this year, " and

said " they had

invited industry to discuss what they understood to be a few key

remaining

points " of contention.

Republicans members of Congress had tried to on several occasions to

enact

similar legislation of its own, but with voters already so angry over

soaring drug costs, they finally had to back off.

With less than 3 years left in office, and the Democrats positioned

to take

over Congress in the fall elections, Bush had to find a way to repay

Big

Pharma so he came up with the bright idea to utilize the FDA and

kill 2

birds with one stone.

This route would spare Republicans the task of trying to pass pro-

industry

legislation in an election year and still reward Big Pharma for the

more

than $80 million that Republicans received from drug makers over the

past

decade.

Since 2000, the top drug corporations, their trade group, and their

employees gave more than $10 million to 527 organizations, tax-exempt

political committees which operate in the grey area between federal

and

state campaign finance laws, according to Drug Lobby Second to None,

July 7,

2005, M. Asif Ismail.

Nearly $87 million of the contributions went to federal politicians,

with

almost 69% going to Republicans. Top recipients include Bush, with

upwards

of $1.5 million, and members who sit on committees that have

jurisdiction

over pharmaceutical issues, reports Drug Lobby Second to None.

During Bush's campaigns, 21 pharmaceutical industry executives and

lobbyists

achieved " Ranger " or " Pioneer " status, which means they raised at

least

$200,000 or $100,000, respectively, during the 2000 or 2004

campaigns.

According to Public Citizen, the group included 5 executives from

brand-name

drug companies, 6 officials from HMOs, the CEO of a pharmacy services

company that runs a PBM, the head of a direct-mail pharmacy, and 8

Washington lobbyists who represent drug companies and HMOs.

Frist is never shy when it comes to calling in markers from drug

companies.

In November 2004, when he wanted to take a victory tour celebrating

the

newly elected Republican senators, " A Gulfstream corporate jet owned

by drug

maker Schering-Plough was ready to zip the Senate majority leader to

stops

in Florida, Georgia and the Carolinas, " according to the April 25,

2005 USA

Today

Frist's PAC reimbursed Schering $10,809, the equivalent of a

commercial

first-class fare, but that was only a fraction of the cost of a

charter

flight, which would have cost 3 times that much. Besides, the cost

was

almost a wash because Schering had donated $10,000 to Frist's

committee in

2003-04, according to USA Today.

Its also worth pointing out that Big Pharma was the largest

contributor to

the National Republican Senatorial Campaign Committee while Frist

chaired

the Committee.

The ever-growing number of lawsuits in state courts has created a

nagging

fear in drug makers. Local juries and elected judges in state courts

are

much more likely to go against drug giants than juries and appointed

judges

in federal courts which is a one of the main reasons why Big Pharma

wants

all cases moved to federal courts.

Vioxx set off the industry's worst nightmare when users or their

heirs began

filing lawsuits all over the US. According to the January 24, 2006,

Associated Press, Merck currently faces 9,200 Vioxx lawsuits, with

about

4,050 in federal courts and the rest in state courts.

But Vioxx by far is not the only worry for Big Pharma. These days,

every

major drug company has litigation problems involving one or more

FDA-approved products and a few prominent law firms have taken up

the battle

for plaintiff's in state courts.

For instance, since 1990, the Los Angeles based Baum Hedlund Law

Firm has

been handling SSRI (selective serotonin reuptake inhibitor)

suicide/violence

cases and served on the Plaintiffs' Steering Committee in the first

SSRI-suicide litigation involving Prozac, the first SSRI approved by

the

FDA.

Baum Hedlund partner, Barth Menzies, has been litigating

claims

involving injuries stemming from SSRIs such as Prozac, Paxil, Zoloft

and,

more recently, Lexapro/Celexa, for over a decade.

She heads a team of attorneys, who have successfully defeated

Pfizer's and

the FDA's preemption arguments in a number of cases, including Motus

v

Pfizer and Witczak v Pfizer.

In addition to her court activities, Ms Menzies has testified about

the

dangers of SSRIs before the California State Assembly and the FDA's

Psychopharmacologic

Drugs Advisory Committees and met with members of Congress regarding

the

risk of antidepressant induced suicidality and preemption issues.

Ms Menzies wrote an article discussing the ill-effects of preemption

in

Mealey's Emerg. Drugs & Devices 27 (2006), titled,

" Preamble To FDA Final Rule: FDA's Latest Effort To Immunize Drug

Manufacturers From Tort Liability At The Expense of Consumer

Safety, " and

stated in part:

" Pharmaceutical industry lobbying efforts and zealot tort reformers

have

sired a new wave of brazen attempts to shield drug manufacturers

from tort

liability.

" The preemption language in the preamble to the Final Rule is but

the latest

attempt. Preemption has become the argument du jour and politically

appointed regulatory officials the mouthpieces. The crafty messages

sound of

consumer protection, but are just the opposite. Limiting the

liability of

drug companies will not improve public safety.

" The FDA s purported position on preemption assumes that the FDA is

infallible and that negligent misconduct by pharmaceutical companies

should

be the sole purview of FDA. Recent regulatory failures demonstrate

that FDA

is neither infallible nor does it have the capability of policing

drug

manufacturers negligent misconduct. "

The Bush administration went up against a tough opponent in Baum

Hedlund

when it turned to the courts, and had the FDA file amicus briefs

hoping the

courts would rule in favor of preemption, but those attempts also

failed.

Ms. Menzies explains some of the history of the FDA's intervention

into

lawsuits she was involved in stating: " Until his resignation in late

2004,

FDA Chief Counsel, Troy, was the pharmaceutical

industry's 'inside

man,' filing legal briefs on behalf of former clients such as Pfizer

(the

maker of Zoloft) and soliciting defense attorneys to submit their

cases for

government amicus brief consideration. "

" Although the newly appointed Chief Counsel, Sheldon Bradshaw, lacks

the

blatant pharmaceutical industry ties that Troy had, " she advises, " he

clearly was not selected to his position because of a sudden change-

of-heart

in the political leadership or direction of the FDA. "

" In fact, " Ms. Menzies says, " following in his predecessor's

footsteps,

Bradshaw submitted a legal brief in support of Pfizer's federal

preemption

arguments. "

The FDA filed its first brief in favor of a manufacturer of SSRIs in

September 2002 in Motus v Pfizer, one of Baum Hedlund's cases in

California,

which was pending in the 9th Circuit Court of Appeals.

Troy, who was the FDA's Chief Counsel at the time, was

contacted by

Pfizer's national counsel, Malcolm Wheeler, in the summer of 2002

requesting

that the government get involved in this private lawsuit to help

Pfizer with

its preemption argument related to Zoloft-induced suicidality.

Despite the fact that Pfizer had been one of his clients and Troy

was paid

over $358,000 for work he had conducted for Pfizer in the year he

took

office, Troy acquiesced, arguing that there was no impropriety in

doing so

because he did not become involved until after the required 1-year

period in

which government employees may not participate in official activities

involving former clients.

From public accounts, it appears that the 1-year " grace period "

elapsed less

then a month before Troy entered the fray.

Troy argued in the FDA brief that, even though Pfizer never sought to

strengthen Zoloft's warning label concerning suicidality, any

warning, no

matter how worded, that suggested a link between Zoloft and

suicidality

would have been false and misleading, would have misbranded the

drug, and

the FDA would have rejected any effort by Pfizer to use such a

warning.

The 9th Circuit never decided the preemption issue, instead ruling on

another appellate issue, which concluded the case on unrelated

grounds.

Nevertheless, Menziess said that Pfizer has continued to use the

brief in

its battle against Zoloft-induced suicide cases, arguing that the

lawsuits

are federally preempted and should be dismissed.

But Judges across the US have been rejecting Pfizer's arguments, as

well as

the FDA brief itself. A federal judge in Texas pointed out that the

law

" allows, even encourages, manufacturers to be proactive when

learning of new

safety information related to their drug. "

" Manufacturers, not the FDA, are tasked with the responsibility of

taking

proactive steps once a manufacturer learns of 'reasonable evidence

of an

association of a serious hazard with a drug,' " the judge stated.

A state court judge in California ordered the FDA brief stricken

from the

record, calling it " hearsay and irrelevant. "

In an Illinois case, the judge said the brief " contains nothing more

than

legal argument by [FDA] counsel. "

In a Zoloft suicide case in Minnesota, the court rejected Pfizer's

arguments, stating that it " declines to treat statements from a

single FDA

legal brief as declarations afforded the preemptive force of law. "

The same

judge also called Pfizer's arguments " perverse " and a " public policy

argument gone awry. "

Ms Menzies notes that the FDA's legal stance on preemption

is " particularly

egregious in the wake of congressional investigations involving FDA

failures

to protect the public health, in particular related to

antidepressants. "

Without state liability laws, she says, drug companies will be able

to

escape liability for injuries and deaths caused by drugs like SSRIs

and

Vioxx.

Baum Hedlund currently represents approximately 50 victims and their

families in cases involving alleged antidepressant-induced suicide

and

suicide attempts, over one third of whom are children and

adolescents.

As with Vioxx, the risks associated with SSRIs were also kept

hidden. Ms.

Menzies's litigation has evidence from as far back as the 1980's

that people

taking SSRIs were at a heightened risk of suicidality, and not just

children, she notes.

In fact, in the early 1990s, it was the FDA safety officer Dr

Graham,

of recent Vioxx fame, who raised concerns about the risk between

antidepressants and suicidality, but no one listened, Ms Menzies

says.

Fourteen years later, the FDA finally ordered black box warnings

labels on

SSRIs alerting physicians about the increased risk of suicidality. Ms

Menziess describes the FDA during these years as " complacent,

ignoring its

own internal scientist when they raise concerns, and in the pocket of

industry. "

She believes that the FDA would never have confronted the issue had

it not

been for the public outcry from victims, consumer groups, courageous

experts

willing to place their careers on the line, investigative reporters

and

pressure from certain members of Congress; and yes, she

says, " lawyers

uncovering the drug industry's dirty little secrets through legal

discovery

and speaking out about the dangers. "

Ms. Menzies points out that " the antidepressant controversy and

resultant

congressional investigations, and later, the Vioxx public health

debacle,

have served to highlight deep-seeded problems within the FDA. "

Over the past couple of years, a growing number of lawmakers have

been

turning up the heat on both the FDA and the industry in response to

their

combined failure to reveal the problems found in studies conducted

on drugs

like SSRIs and Vioxx.

At one point, Senator Grassley (R-Iowa), Chairman of the

Senate

Finance Committee, came right out and accused the FDA of suppressing

studies

in order to protect industry profits and the careers of certain FDA

officials.

" The Vioxx example showed that the FDA and Merck were too close for

comfort, " Senator Grassely told Health News on March 12,

2005. " Testimony

and documents at our Finance Committee hearing showed that the FDA

allowed

itself to be manipulated by Merck, " he said.

The results of a trial that took place in 2000, surfaced that showed

that

the FDA and Merck were aware that heart attacks were 5 times more

likely in

patients taking Vioxx than among those taking a similar drug, Senator

Grassley pointed out, but the FDA did nothing to change the labeling

for

nearly 2 years, he said, while Merck marketed its product on nightly

TV.

On November 18, 2004, Senator Grassley drew enormous media attention

when he

held hearings on Vioxx, and FDA scientist, Dr. Graham, testified

that he

determined that Vioxx may have caused tens of thousands of heart

attacks and

strokes but that his superiors at the FDA pressured him to keep

quiet.

" The estimates range from 88,000 to 139,000 Americans, " Dr. Graham

told the

committee. " Of these, 30 to 40 percent probably died, " he

advised. " For the

survivors, " he added, " their lives were changed forever. "

To put the number of injuries into perspective, Dr. Graham told

members of

the committee that instead of side-effects from a drug, to think of

it as if

they were talking about jetliners.

" If there were an average of 150 to 200 people on an aircraft, " he

said,

" this range of 88,000 to 138,000 would be the rough equivalent of

500 to 900

aircraft dropping from the sky. "

" This translates to 2-4 aircraft every week, " he advised, " week in

and week

out, for the past 5 years. "

" If you were confronted by this situation, " Dr. Graham asked the

panel,

" what would be your reaction, what would you want to know and what

would you

do about it? "

He noted the problems with the FDA's reliance on a 95% paradigm. In

other

words, he said, a drug is considered safe " until you can show with

95% or

greater certainty that it is not safe. "

The scientist condemned the FDA's failure to acknowledge the Vioxx

risks

sooner. " I strongly believe that this should have been, and largely

could

have been, avoided, " Dr. Graham told the committee.

Ms. Menzies often cites his testimony to demonstrate that the FDA's

position

on preemption is wrong and states: " Dr. Graham's testimony

illustrates why

FDA approval and subsequent post-marketing acquiescence should have

no

preemptive effect. "

The Vioxx matter caught the attention of the Senate Finance Committee

basically because of the drug's cost to government programs like

Medicaid

and Medicare. The committee is responsible for oversight of the two

programs.

At the November 18, 2004 hearing, Senator Max Baucus discussed the

high-costs related to the drug: " In the 5 years that Vioxx was on the

market, Medicaid spent more than $1 billion on the drug, " he said.

In addition to the prescription costs, government programs are now

paying

for the damage caused by Vioxx. " Medicaid bears the cost of any

additional

medical care necessary when drugs cause injury, " Senator Baucus

pointed out.

By far, the Vioxx debacle is the most serious public health failure

to occur

since the FDA took on the authority for safety oversight of medical

products

in 1938.

On September 3, 2005, Shane Ellison, a former pharmaceutical chemist

turned

whistleblower and author of the book, " Health Myths Exposed, " gave an

interview to Crusador Magazine and discussed Vioxx and the problems

within

the FDA.

According to Mr. Ellison, the FDA and Merck knew about the dangers

of Vioxx

for at least 4 years before it was pulled off the market. " Instead of

removing the drug immediately, " he said, " they kept it on the drug

market

for matters of wealth not health. "

Mr. Ellison says compliant politicians have " democratized " the

industry.

" This means that drug approval is a matter of 51% telling the other

49% that

deadly drugs are safe and necessary, " he reports. " Science and

choice no

longer prevail at the FDA or at pharmaceutical companies, " he added.

" To go against the 51% means losing your career, " Mr. Ellison

explains.

" Therefore, the majority of scientists choose to please drug

companies, not

the general public. "

To substantiate this allegation, Dr. Ellison points to Dr. Curt

Furberg, a

member of the FDA's drug safety advisory committee. Dr. Furberg went

public

with findings that Bextra also caused heart attacks and strokes and

said

studies " showed that Bextra is no different than Vioxx, and Pfizer

is trying

to suppress that information, " in the British Medical Journal.

" Immediately thereafter, " Mr. Ellison said, " Dr. Furberg was barred

from

serving on the panel that was responsible for considering the safety

of

cyclo-oxygenase-2 (COX 2) inhibitors. "

" The end result being more votes in favor of COX 2 inhibitors, the

drug

company wins by votes - not science, " he told Crusador.

Another relevant, but little-mentioned fact, is that many FDA

officials end

up working for Big Pharma. " The old joke is that the FDA is sort of

like a

showcase for a future job in the drug industry, " Whitaker,

author of

Mad In America, said in an August 2005 interview with Street Spirit.

" You go there, you work awhile, then you go off into the drug

industry, " he

said, " the progression that people make, in essence they're making

good old

boy network connections, so they're not going to be so harsh on the

drug

companies. "

In addition, when leaving office many federal employees and members

of

Congress go to work for Big Pharma in one area or another. For

instance, of

the 1,274 people registered to lobby in Washington for drug

companies in

2003, according to an April 2005 report by the Center for Public

Integrity,

476 are former federal officials, including 40 former members of

Congress.

Critics say the Prescription Drug User Fee Act, is in large part to

blame,

for the current problems within the FDA. The Act allows the agency to

collect a fee from a drug company seeking approval for a new drug. In

return, the FDA is expected complete the review process within 12

months.

User fees now account for about 40% of the approval process, which

means the

FDA is dependent on drug companies for nearly half of its funding.

This

situation creates a major conflict of interest according to Dr

Graham: " This

culture views the pharmaceutical industry it is supposed to regulate

as its

client. It overvalues the benefits of the drugs it approves, and

seriously

undervalues, disregards and disrespects drug safety, " he told

members of

Congress.

Another problem he said is that even when the FDA does try to take

measures

to limit harm, the agency lacks the authority to force drug

companies to

comply. For example with Vioxx, he said, it took more than 2 years

to get

Merck to add the increased risk of heart attack and stroke on the

label.

Then there is the matter of the conflicts of interests involving the

FDA

panels that advise the agency on which drugs should be approved,

what their

warning labels should say, and how studies should be conducted.

The approximately 300 experts on the 18 committees make decisions

that

affect billions of dollars in sales and with very few exceptions the

FDA

follows their advice.

Members of the panels are supposed to be free of conflicts of

interest

relating to products they consider but they rarely are. For example,

in

February 2005, when the hearings were held to determine whether the

COX-2

inhibitors should be allowed to remain on the market, a panel mired

with

conflicts was exposed. Out of the 32 voting members, ten had served

as

consultants to Merck and Pfizer in recent years.

This revelation prompted Senator Mike Enzi, (R -WY), the chairman

of the

Health, Education, Labor and Pensions Committee, along with

Senators,

Kennedy (D-MA), and Durbin (D-IL), to ask the General

Accounting

Office to look into the FDA's practice of letting scientists serve

on panels

when they have conflicts of interest.

" We are concerned about the process that supports FDA's decisions to

waive

conflicts of interest rules for scientists with financial ties to the

manufacturers of the products under consideration, or their

competitors, "

said their letter to the GAO in September 2005.

" These practices appear to have undermined the public's faith in the

objectivity and fairness of FDA's advisory committees, " they wrote.

The

Senators specifically referred to the conflicts among the panels that

studied the -2 inhibitors like Vioxx.

According to Ms. Menzies, " The FDA's preemption argument, if

successful,

would take away the sole means by which American consumers may obtain

compensation for drug-induced injuries caused by a drug company's

failure to

warn. "

" Civil lawsuits uncover internal company documents to which not even

the FDA

has access, " she explains.

process

" The tort system provides an important check on the regulatory and

on drug

companies' compliance with law. "

" Preemption, " Ms Menzies warns, " would close off one of the few

avenues by

which we learn of safety and efficacy information that pharmaceutical

companies do not publish or hide from FDA. "

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Guest guest

By Pringle*

May 12, 2006.

In January 2006, the FDA announced the Bush administration's

latest gift to

Big Pharma in a statement that said people who believe they have been

injured by drugs approved by the FDA should not be allowed to sue

drug

companies in state courts.

" We think that if your company complies with the FDA processes, if

you bring

forward the benefits and risks of your drug, and let your

information be

judged through a process with highly trained scientists, you should

not be

second-guessed by state courts that don't have the same scientific

knowledge, " said Gottlieb, the FDA's deputy commissioner for

medical

and scientific affairs.

To soften the blow, the agency's claim of federal preemption was

included as

a preamble to the long sought after new drug labeling guidelines. In

response to the FDA's statement, Senator Kennedy (D-MA)

issued a

statement of his own that said: " It's a typical abuse by the Bush

Administration -- take a regulation to improve the information that

doctors

and patients receive about prescription drugs and turn it into a

protection

against liability for the drug industry. "

The ploy was also readily recognized by state lawmakers and trial

lawyers as

another ploy to reduce the public's ability to hold Big Pharma

accountable.

" Eliminating the rights of individuals to hold negligent drug

companies

accountable puts patients in even more danger than they already are

in from

drug company executives that put profits before safety, " said Ken

Suggs,

president of the Association of Trial Lawyers of America.

" The fact that the drug industry can get the FDA to rewrite the

rules so

that CEOs can escape accountability for putting dangerous and deadly

drugs

on the market is the scariest example yet of how much control these

big

corporations have over our political process, " Mr Suggs told the

Washington

Post.

According to Attorney Mark Labaton, a partner at the firm Kreindler &

Kreindler, LLP, with offices in New York and LA, " the

Administration's

recent efforts to misuse federal rulemaking in the pharmaceutical

and other

areas to eviserate consumer rights is a big step backward. "

" The new FDA rules to limit consumers' rights, " he says, " are part

and

parcel of a larger effort to deny persons injured by unsafe

products -- be

they drugs, cigarettes or automobiles -- any form of redress. "

" Clearly, " Mr Labaton notes, " this Administration and its supporters

want to

slam the courthouse doors on working men and women injured by unsafe

products.

He says its ironic that " an Administrative that calls

itself " compassionate "

and " conservative " consistently turns its back on " limited

government " and

" states rights " when it comes to protecting the rights of seriously

injured

consumers. "

Upon learning of the FDA's power grab, the National Conference of

State

Legislatures, a bipartisan group that represents state lawmakers,

accused

the FDA of trying to seize authority that it did not have. The

organization

bases its opposition, in part on the following:

" FDA has usurped the authority of Congress, state legislatures and

state

courts. There is no statutory authority in the FDCA for FDA to

preempt state

product liability laws as they relate to prescription drugs.

" Instead of seeking valid congressional authority, unelected agency

officials are seeking to preempt state product liability laws by

writing

this preemption into a final rule, thereby undermining state policy

and

judicial decision made in this area.

" State tort laws and civil justice systems serve as an important

check on

federal standards. Our civil justice system establishes a duty of

care that

protects citizens when the federal government is too slow to act or

when

federal standards are insufficient. States have the ability to

achieve

greater protections for their citizens through successful product

liability

lawsuits. "

In an earlier gift delivered to Big Pharma in December 2005,

Republican

leaders, and specifically Senator Bill Frist (R-TN), attached

protective

provisions to a Department of Defense appropriations report that

gave the

industry " unprecedented immunity, " according to Democratic lawmakers

who

described the underhanded move as follows:

" Republican leaders added provisions to the conference report after

cutting

a back-room deal in the middle of the night. The conference report

grants

sweeping immunity to drug companies for injuries caused by vaccines

and

drugs and for the administration of those vaccines and drugs, even

if they

are made with flagrant disregard for basic safety precautions.

" Moreover, the compensation program is a sham, leaving people who

become

injured from a drug or vaccine without recourse. "

Since 2002, Senator Frist had tried numerous times to insert this

rider in

Homeland Security Bills after thousands of lawsuits were filed by

parents

who believe the mercury-based preservative thimerosal, contained in

childhood vaccines until recently, caused autism and other

neurological

disorders in their kids.

The rider could save Big Pharma hundreds of millions, if not

billions of

dollars.

The latest revelation on this little stunt came on May 8, 2006 when

the

Tennessean reported that vaccine industry officials helped shape

legislation

behind the scenes that Frist secretly amended into a bill, according

to

e-mails obtained by Pubic Citizen, a public advocacy group.

The industry group, called the Biotechnology Industry Organization,

wanted

the vaccine liability language in the bill, the e-mails proves.

" At Senator Frist's staff's request, this morning, BIO (Tom and I)

participated in a meeting with three other industry representatives

(Sanofi

and an outside counsel who works for both Pfizer and Roche, I

believe),

administration staff (HHS, DoJ and WH Leg Affairs), and Liz Hall to

further

discuss liability, " BIO official Dave Boyer wrote in a November e-

mail

obtained by Public Citizen.

Other E-mails and documents show that BIO met privately with Frist's

staff

and the White House to figure out ways to give drug makers

protection from

people injured by vaccines.

" The lack of any restriction on jury trial is problematic, " the BIO

analysis

said. " Where injured parties have no other avenue for relief, juries

are

likely to find ways to award damages. "

In another e-mail, Boyer described a meeting in which Karl Rove said

it was

" important to the President that a bill move this year, " and

said " they had

invited industry to discuss what they understood to be a few key

remaining

points " of contention.

Republicans members of Congress had tried to on several occasions to

enact

similar legislation of its own, but with voters already so angry over

soaring drug costs, they finally had to back off.

With less than 3 years left in office, and the Democrats positioned

to take

over Congress in the fall elections, Bush had to find a way to repay

Big

Pharma so he came up with the bright idea to utilize the FDA and

kill 2

birds with one stone.

This route would spare Republicans the task of trying to pass pro-

industry

legislation in an election year and still reward Big Pharma for the

more

than $80 million that Republicans received from drug makers over the

past

decade.

Since 2000, the top drug corporations, their trade group, and their

employees gave more than $10 million to 527 organizations, tax-exempt

political committees which operate in the grey area between federal

and

state campaign finance laws, according to Drug Lobby Second to None,

July 7,

2005, M. Asif Ismail.

Nearly $87 million of the contributions went to federal politicians,

with

almost 69% going to Republicans. Top recipients include Bush, with

upwards

of $1.5 million, and members who sit on committees that have

jurisdiction

over pharmaceutical issues, reports Drug Lobby Second to None.

During Bush's campaigns, 21 pharmaceutical industry executives and

lobbyists

achieved " Ranger " or " Pioneer " status, which means they raised at

least

$200,000 or $100,000, respectively, during the 2000 or 2004

campaigns.

According to Public Citizen, the group included 5 executives from

brand-name

drug companies, 6 officials from HMOs, the CEO of a pharmacy services

company that runs a PBM, the head of a direct-mail pharmacy, and 8

Washington lobbyists who represent drug companies and HMOs.

Frist is never shy when it comes to calling in markers from drug

companies.

In November 2004, when he wanted to take a victory tour celebrating

the

newly elected Republican senators, " A Gulfstream corporate jet owned

by drug

maker Schering-Plough was ready to zip the Senate majority leader to

stops

in Florida, Georgia and the Carolinas, " according to the April 25,

2005 USA

Today

Frist's PAC reimbursed Schering $10,809, the equivalent of a

commercial

first-class fare, but that was only a fraction of the cost of a

charter

flight, which would have cost 3 times that much. Besides, the cost

was

almost a wash because Schering had donated $10,000 to Frist's

committee in

2003-04, according to USA Today.

Its also worth pointing out that Big Pharma was the largest

contributor to

the National Republican Senatorial Campaign Committee while Frist

chaired

the Committee.

The ever-growing number of lawsuits in state courts has created a

nagging

fear in drug makers. Local juries and elected judges in state courts

are

much more likely to go against drug giants than juries and appointed

judges

in federal courts which is a one of the main reasons why Big Pharma

wants

all cases moved to federal courts.

Vioxx set off the industry's worst nightmare when users or their

heirs began

filing lawsuits all over the US. According to the January 24, 2006,

Associated Press, Merck currently faces 9,200 Vioxx lawsuits, with

about

4,050 in federal courts and the rest in state courts.

But Vioxx by far is not the only worry for Big Pharma. These days,

every

major drug company has litigation problems involving one or more

FDA-approved products and a few prominent law firms have taken up

the battle

for plaintiff's in state courts.

For instance, since 1990, the Los Angeles based Baum Hedlund Law

Firm has

been handling SSRI (selective serotonin reuptake inhibitor)

suicide/violence

cases and served on the Plaintiffs' Steering Committee in the first

SSRI-suicide litigation involving Prozac, the first SSRI approved by

the

FDA.

Baum Hedlund partner, Barth Menzies, has been litigating

claims

involving injuries stemming from SSRIs such as Prozac, Paxil, Zoloft

and,

more recently, Lexapro/Celexa, for over a decade.

She heads a team of attorneys, who have successfully defeated

Pfizer's and

the FDA's preemption arguments in a number of cases, including Motus

v

Pfizer and Witczak v Pfizer.

In addition to her court activities, Ms Menzies has testified about

the

dangers of SSRIs before the California State Assembly and the FDA's

Psychopharmacologic

Drugs Advisory Committees and met with members of Congress regarding

the

risk of antidepressant induced suicidality and preemption issues.

Ms Menzies wrote an article discussing the ill-effects of preemption

in

Mealey's Emerg. Drugs & Devices 27 (2006), titled,

" Preamble To FDA Final Rule: FDA's Latest Effort To Immunize Drug

Manufacturers From Tort Liability At The Expense of Consumer

Safety, " and

stated in part:

" Pharmaceutical industry lobbying efforts and zealot tort reformers

have

sired a new wave of brazen attempts to shield drug manufacturers

from tort

liability.

" The preemption language in the preamble to the Final Rule is but

the latest

attempt. Preemption has become the argument du jour and politically

appointed regulatory officials the mouthpieces. The crafty messages

sound of

consumer protection, but are just the opposite. Limiting the

liability of

drug companies will not improve public safety.

" The FDA s purported position on preemption assumes that the FDA is

infallible and that negligent misconduct by pharmaceutical companies

should

be the sole purview of FDA. Recent regulatory failures demonstrate

that FDA

is neither infallible nor does it have the capability of policing

drug

manufacturers negligent misconduct. "

The Bush administration went up against a tough opponent in Baum

Hedlund

when it turned to the courts, and had the FDA file amicus briefs

hoping the

courts would rule in favor of preemption, but those attempts also

failed.

Ms. Menzies explains some of the history of the FDA's intervention

into

lawsuits she was involved in stating: " Until his resignation in late

2004,

FDA Chief Counsel, Troy, was the pharmaceutical

industry's 'inside

man,' filing legal briefs on behalf of former clients such as Pfizer

(the

maker of Zoloft) and soliciting defense attorneys to submit their

cases for

government amicus brief consideration. "

" Although the newly appointed Chief Counsel, Sheldon Bradshaw, lacks

the

blatant pharmaceutical industry ties that Troy had, " she advises, " he

clearly was not selected to his position because of a sudden change-

of-heart

in the political leadership or direction of the FDA. "

" In fact, " Ms. Menzies says, " following in his predecessor's

footsteps,

Bradshaw submitted a legal brief in support of Pfizer's federal

preemption

arguments. "

The FDA filed its first brief in favor of a manufacturer of SSRIs in

September 2002 in Motus v Pfizer, one of Baum Hedlund's cases in

California,

which was pending in the 9th Circuit Court of Appeals.

Troy, who was the FDA's Chief Counsel at the time, was

contacted by

Pfizer's national counsel, Malcolm Wheeler, in the summer of 2002

requesting

that the government get involved in this private lawsuit to help

Pfizer with

its preemption argument related to Zoloft-induced suicidality.

Despite the fact that Pfizer had been one of his clients and Troy

was paid

over $358,000 for work he had conducted for Pfizer in the year he

took

office, Troy acquiesced, arguing that there was no impropriety in

doing so

because he did not become involved until after the required 1-year

period in

which government employees may not participate in official activities

involving former clients.

From public accounts, it appears that the 1-year " grace period "

elapsed less

then a month before Troy entered the fray.

Troy argued in the FDA brief that, even though Pfizer never sought to

strengthen Zoloft's warning label concerning suicidality, any

warning, no

matter how worded, that suggested a link between Zoloft and

suicidality

would have been false and misleading, would have misbranded the

drug, and

the FDA would have rejected any effort by Pfizer to use such a

warning.

The 9th Circuit never decided the preemption issue, instead ruling on

another appellate issue, which concluded the case on unrelated

grounds.

Nevertheless, Menziess said that Pfizer has continued to use the

brief in

its battle against Zoloft-induced suicide cases, arguing that the

lawsuits

are federally preempted and should be dismissed.

But Judges across the US have been rejecting Pfizer's arguments, as

well as

the FDA brief itself. A federal judge in Texas pointed out that the

law

" allows, even encourages, manufacturers to be proactive when

learning of new

safety information related to their drug. "

" Manufacturers, not the FDA, are tasked with the responsibility of

taking

proactive steps once a manufacturer learns of 'reasonable evidence

of an

association of a serious hazard with a drug,' " the judge stated.

A state court judge in California ordered the FDA brief stricken

from the

record, calling it " hearsay and irrelevant. "

In an Illinois case, the judge said the brief " contains nothing more

than

legal argument by [FDA] counsel. "

In a Zoloft suicide case in Minnesota, the court rejected Pfizer's

arguments, stating that it " declines to treat statements from a

single FDA

legal brief as declarations afforded the preemptive force of law. "

The same

judge also called Pfizer's arguments " perverse " and a " public policy

argument gone awry. "

Ms Menzies notes that the FDA's legal stance on preemption

is " particularly

egregious in the wake of congressional investigations involving FDA

failures

to protect the public health, in particular related to

antidepressants. "

Without state liability laws, she says, drug companies will be able

to

escape liability for injuries and deaths caused by drugs like SSRIs

and

Vioxx.

Baum Hedlund currently represents approximately 50 victims and their

families in cases involving alleged antidepressant-induced suicide

and

suicide attempts, over one third of whom are children and

adolescents.

As with Vioxx, the risks associated with SSRIs were also kept

hidden. Ms.

Menzies's litigation has evidence from as far back as the 1980's

that people

taking SSRIs were at a heightened risk of suicidality, and not just

children, she notes.

In fact, in the early 1990s, it was the FDA safety officer Dr

Graham,

of recent Vioxx fame, who raised concerns about the risk between

antidepressants and suicidality, but no one listened, Ms Menzies

says.

Fourteen years later, the FDA finally ordered black box warnings

labels on

SSRIs alerting physicians about the increased risk of suicidality. Ms

Menziess describes the FDA during these years as " complacent,

ignoring its

own internal scientist when they raise concerns, and in the pocket of

industry. "

She believes that the FDA would never have confronted the issue had

it not

been for the public outcry from victims, consumer groups, courageous

experts

willing to place their careers on the line, investigative reporters

and

pressure from certain members of Congress; and yes, she

says, " lawyers

uncovering the drug industry's dirty little secrets through legal

discovery

and speaking out about the dangers. "

Ms. Menzies points out that " the antidepressant controversy and

resultant

congressional investigations, and later, the Vioxx public health

debacle,

have served to highlight deep-seeded problems within the FDA. "

Over the past couple of years, a growing number of lawmakers have

been

turning up the heat on both the FDA and the industry in response to

their

combined failure to reveal the problems found in studies conducted

on drugs

like SSRIs and Vioxx.

At one point, Senator Grassley (R-Iowa), Chairman of the

Senate

Finance Committee, came right out and accused the FDA of suppressing

studies

in order to protect industry profits and the careers of certain FDA

officials.

" The Vioxx example showed that the FDA and Merck were too close for

comfort, " Senator Grassely told Health News on March 12,

2005. " Testimony

and documents at our Finance Committee hearing showed that the FDA

allowed

itself to be manipulated by Merck, " he said.

The results of a trial that took place in 2000, surfaced that showed

that

the FDA and Merck were aware that heart attacks were 5 times more

likely in

patients taking Vioxx than among those taking a similar drug, Senator

Grassley pointed out, but the FDA did nothing to change the labeling

for

nearly 2 years, he said, while Merck marketed its product on nightly

TV.

On November 18, 2004, Senator Grassley drew enormous media attention

when he

held hearings on Vioxx, and FDA scientist, Dr. Graham, testified

that he

determined that Vioxx may have caused tens of thousands of heart

attacks and

strokes but that his superiors at the FDA pressured him to keep

quiet.

" The estimates range from 88,000 to 139,000 Americans, " Dr. Graham

told the

committee. " Of these, 30 to 40 percent probably died, " he

advised. " For the

survivors, " he added, " their lives were changed forever. "

To put the number of injuries into perspective, Dr. Graham told

members of

the committee that instead of side-effects from a drug, to think of

it as if

they were talking about jetliners.

" If there were an average of 150 to 200 people on an aircraft, " he

said,

" this range of 88,000 to 138,000 would be the rough equivalent of

500 to 900

aircraft dropping from the sky. "

" This translates to 2-4 aircraft every week, " he advised, " week in

and week

out, for the past 5 years. "

" If you were confronted by this situation, " Dr. Graham asked the

panel,

" what would be your reaction, what would you want to know and what

would you

do about it? "

He noted the problems with the FDA's reliance on a 95% paradigm. In

other

words, he said, a drug is considered safe " until you can show with

95% or

greater certainty that it is not safe. "

The scientist condemned the FDA's failure to acknowledge the Vioxx

risks

sooner. " I strongly believe that this should have been, and largely

could

have been, avoided, " Dr. Graham told the committee.

Ms. Menzies often cites his testimony to demonstrate that the FDA's

position

on preemption is wrong and states: " Dr. Graham's testimony

illustrates why

FDA approval and subsequent post-marketing acquiescence should have

no

preemptive effect. "

The Vioxx matter caught the attention of the Senate Finance Committee

basically because of the drug's cost to government programs like

Medicaid

and Medicare. The committee is responsible for oversight of the two

programs.

At the November 18, 2004 hearing, Senator Max Baucus discussed the

high-costs related to the drug: " In the 5 years that Vioxx was on the

market, Medicaid spent more than $1 billion on the drug, " he said.

In addition to the prescription costs, government programs are now

paying

for the damage caused by Vioxx. " Medicaid bears the cost of any

additional

medical care necessary when drugs cause injury, " Senator Baucus

pointed out.

By far, the Vioxx debacle is the most serious public health failure

to occur

since the FDA took on the authority for safety oversight of medical

products

in 1938.

On September 3, 2005, Shane Ellison, a former pharmaceutical chemist

turned

whistleblower and author of the book, " Health Myths Exposed, " gave an

interview to Crusador Magazine and discussed Vioxx and the problems

within

the FDA.

According to Mr. Ellison, the FDA and Merck knew about the dangers

of Vioxx

for at least 4 years before it was pulled off the market. " Instead of

removing the drug immediately, " he said, " they kept it on the drug

market

for matters of wealth not health. "

Mr. Ellison says compliant politicians have " democratized " the

industry.

" This means that drug approval is a matter of 51% telling the other

49% that

deadly drugs are safe and necessary, " he reports. " Science and

choice no

longer prevail at the FDA or at pharmaceutical companies, " he added.

" To go against the 51% means losing your career, " Mr. Ellison

explains.

" Therefore, the majority of scientists choose to please drug

companies, not

the general public. "

To substantiate this allegation, Dr. Ellison points to Dr. Curt

Furberg, a

member of the FDA's drug safety advisory committee. Dr. Furberg went

public

with findings that Bextra also caused heart attacks and strokes and

said

studies " showed that Bextra is no different than Vioxx, and Pfizer

is trying

to suppress that information, " in the British Medical Journal.

" Immediately thereafter, " Mr. Ellison said, " Dr. Furberg was barred

from

serving on the panel that was responsible for considering the safety

of

cyclo-oxygenase-2 (COX 2) inhibitors. "

" The end result being more votes in favor of COX 2 inhibitors, the

drug

company wins by votes - not science, " he told Crusador.

Another relevant, but little-mentioned fact, is that many FDA

officials end

up working for Big Pharma. " The old joke is that the FDA is sort of

like a

showcase for a future job in the drug industry, " Whitaker,

author of

Mad In America, said in an August 2005 interview with Street Spirit.

" You go there, you work awhile, then you go off into the drug

industry, " he

said, " the progression that people make, in essence they're making

good old

boy network connections, so they're not going to be so harsh on the

drug

companies. "

In addition, when leaving office many federal employees and members

of

Congress go to work for Big Pharma in one area or another. For

instance, of

the 1,274 people registered to lobby in Washington for drug

companies in

2003, according to an April 2005 report by the Center for Public

Integrity,

476 are former federal officials, including 40 former members of

Congress.

Critics say the Prescription Drug User Fee Act, is in large part to

blame,

for the current problems within the FDA. The Act allows the agency to

collect a fee from a drug company seeking approval for a new drug. In

return, the FDA is expected complete the review process within 12

months.

User fees now account for about 40% of the approval process, which

means the

FDA is dependent on drug companies for nearly half of its funding.

This

situation creates a major conflict of interest according to Dr

Graham: " This

culture views the pharmaceutical industry it is supposed to regulate

as its

client. It overvalues the benefits of the drugs it approves, and

seriously

undervalues, disregards and disrespects drug safety, " he told

members of

Congress.

Another problem he said is that even when the FDA does try to take

measures

to limit harm, the agency lacks the authority to force drug

companies to

comply. For example with Vioxx, he said, it took more than 2 years

to get

Merck to add the increased risk of heart attack and stroke on the

label.

Then there is the matter of the conflicts of interests involving the

FDA

panels that advise the agency on which drugs should be approved,

what their

warning labels should say, and how studies should be conducted.

The approximately 300 experts on the 18 committees make decisions

that

affect billions of dollars in sales and with very few exceptions the

FDA

follows their advice.

Members of the panels are supposed to be free of conflicts of

interest

relating to products they consider but they rarely are. For example,

in

February 2005, when the hearings were held to determine whether the

COX-2

inhibitors should be allowed to remain on the market, a panel mired

with

conflicts was exposed. Out of the 32 voting members, ten had served

as

consultants to Merck and Pfizer in recent years.

This revelation prompted Senator Mike Enzi, (R -WY), the chairman

of the

Health, Education, Labor and Pensions Committee, along with

Senators,

Kennedy (D-MA), and Durbin (D-IL), to ask the General

Accounting

Office to look into the FDA's practice of letting scientists serve

on panels

when they have conflicts of interest.

" We are concerned about the process that supports FDA's decisions to

waive

conflicts of interest rules for scientists with financial ties to the

manufacturers of the products under consideration, or their

competitors, "

said their letter to the GAO in September 2005.

" These practices appear to have undermined the public's faith in the

objectivity and fairness of FDA's advisory committees, " they wrote.

The

Senators specifically referred to the conflicts among the panels that

studied the -2 inhibitors like Vioxx.

According to Ms. Menzies, " The FDA's preemption argument, if

successful,

would take away the sole means by which American consumers may obtain

compensation for drug-induced injuries caused by a drug company's

failure to

warn. "

" Civil lawsuits uncover internal company documents to which not even

the FDA

has access, " she explains.

process

" The tort system provides an important check on the regulatory and

on drug

companies' compliance with law. "

" Preemption, " Ms Menzies warns, " would close off one of the few

avenues by

which we learn of safety and efficacy information that pharmaceutical

companies do not publish or hide from FDA. "

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Very nasty. Thanks for this information.

Rolf M.

At 20:37 2006-05-13 +0100, you Sheri Nakken <snakken@...> wrote:

><http://www.opednews.com/articles/genera_evelyn_p_060513_bush_uses_fda_to_shi>h\

ttp://www.opednews.com/articles/genera_evelyn_p_060513_bush_uses_fda_to_shi

>.htm

>

>May 13, 2006

>Bush Uses FDA To Shield Big Pharma From Lawsuits

>By Pringle

>In January 2006, the FDA announced the Bush administration's latest gift to

>Big Pharma in a statement that said people who believe they have been

>injured by drugs approved by the FDA should not be allowed to sue drug

>companies in state courts.

....

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