Shielding Big Pharma

[Guest guest]

Nice article today at tompaine.com:

http://tinyurl.com/b7vnj

Shielding Big Pharma

by Pizzo

It's an image that haunts pharmaceutical CEOs' private moments—Big

Tobacco CEOs swearing to tell the truth on live television. And later,

tobacco companies were ordered to pay billions of dollars in damages

to their product's victims.

Pharmaceutical CEOs can't wipe those images away, because they know

that they also knew. They too knowingly and purposely obfuscated,

obscured, fudged the facts and, when push came to shove, lied about

the known dangers of some of their most profitable products. Now they

are terrified that their crimes of commission and omission could reap

them the same whirlwind harvest of accountability.

That's really all you need to know to understand what W. Bush's

FDA was up to last week. Ostensibly, last week's news conference was

to unveil new rules—long demanded by consumer advocates and fiercely

fought by drug companies—requiring clearer labeling of prescription

drugs, particularly about possible harmful side effects.

Drug companies had successfully fought such a rule for more than two

decades. They convinced the incoming Reagan administration to nix a

similar administration rule that was about to go into effect.

Drug companies did not want to produce marketing materials that could

scare off customers—so they didn't. When the University of Wisconsin

conducted a study of industry-produced drug pamphlets, they concluded

that the information contained in the pamphlets contained only half

the story—the good half. Particularly lacking were clear, unambiguous

warnings about any given drug's potential negative attributes.

The new rules announced by the FDA last week requiring clearer

labeling and more detailed warnings represent a long overdue,

pro-consumer change for the FDA—which causes one to wonder what's

really up. Whenever the fiercely anti-regulation, pro-business Bush

administration sides with consumer advocates, there must be more to

the story. And there was.

Tacked onto that consumer-friendly drug labeling rule change was

another rule change, one that couldn't have been less

consumer-friendly if it had been written by Big Pharma itself—which it

likely was. It represents nothing less than a multibillion dollar gift

to the pharmaceutical industry.

The second rule change announced that day would bar state courts from

hearing individual or class-action liability suits against drug

companies. The reasoning behind this change was that, because a

federal agency—the FDA— approves drugs before they can be marketed to

the public, only federal courts should hear cases where someone claims

they were injured by those drugs. It's called " federal preemption, "

and, if upheld, it will require anyone wanting to sue a drug do so in

federal court.

Deputy FDA commissioner Gottlieb explained the logic behind

federal preemption.

We think that if your (drug) 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.

It may come as no surprise that not everyone agrees.

" This is a sneak attack on consumer rights, " responded Joan Claybrook,

president of Public Citizen. " Bush is once again abusing his executive

powers, this time in his attempt to protect the big pharmaceutical

companies from the consequences of their actions. Thousands of people

in this country have died or been seriously injured by drugs approved

by the FDA, and this administration is saying it doesn't think people

should have any recourse. "

Third Time's The Charm

Republicans tried to pass legislation to shield Big Pharma from

litigation. But with so much angst roiling voters over soaring drug

costs, it proved too hot a potato. So the Bush administration turned

to the courts, hoping they would rule in favor of federal preemption

in drug liability cases. But those attempts failed as well.

With only three more years left in Bush's tenure, time was running

out. That's why anti-regulation Bush administration officials decided

to go the regulatory route. By employing executive branch regulatory

authority, the administration was able to spare Republicans in

Congress from having to fight for such an explosive pro-industry

measure during an election year while still rewarding Big Pharma for

the generous support—roughly $84 million— for Republican candidates

over the past decade. It was a win/win situation.

Too Close For Comfort

You could almost hear the sighs of relief from drug company executives

last week when the FDA finally went public with its federal preemption

rule. It came not a second too soon for them. Tweedledee-Big Pharma

had just been rescued by its federal friends from the fate that befell

Tweedledum-Big Tobacco.

The rule change is timely because law firms—some the same firms who

took Big Tobacco to the cleaners a few years ago—now have Big Pharma

firmly in the crosshairs. It would be so easy. All those law firms

would have to do is white out the old defendants—from Brown and

on and — and type the names of drug makers like

Merck and Pfizer. After all, the causes of action were the same:

* Both Big Tobacco and Big Pharma produce and sell products that

often cause injury or death when used as directed.

* Both industries knew that some of their most profitable products

were injuring and killing people, and either hid such evidence, lied

about it or both.

* Both industries hired their own experts to produce often phony,

always misleading non-peer-reviewed, " research " designed solely to

cast doubt on any genuine research by outside experts that came to

conclusions that could hurt sales.

* Both industries attacked, slandered and punished those within or

associated with their industries who broke the company stonewall by

trying to sound a warning .

* Finally, both industries enjoyed overly cozy relationships with

government—relationships that enabled them to maximize profits for a

long as possible, regardless of the harm such products were known to

be causing. (In this regard, Big Pharma has gone even further, by

compromising the FDA, the very federal regulatory agency that is

supposed to protect consumers.)

The growing number of drug-liability lawsuits popping up in state

courts had worried drug companies for years. State court juries are

considered softies when it comes to these kind of v. Goliath

encounters. State juries tend to sympathize with consumers over big

corporations. The failure to get litigation protections for Big Pharma

through Congress left them exposed to the same kind of financial

trashing Big Tobacco suffered in state courts.

The Vioxx Nightmare

Then Vioxx happened. Big Pharma's worst nightmare was realized.

Merck's miracle painkiller had become a record-breaking cash cow for

the company. The only trouble was, it was killing people in alarming

numbers— upward of 55,000 Americans before it was finally pulled from

the market. But this was known to both Merck and the FDA long before

that—and both had ignored, denied and even suppressed evidence of this

deadly side effect. )

But it's hard to just ignore that many dead customers, and it wasn't

long before state court dockets were filling with class-action suits

against Merck. Then Merck was slapped by a Texas jury with a

quarter-billion-dollar judgment in one of the first Vioxx cases to go

to trial.

But things got worse. Vioxx users—or their surviving heirs—began

elbowing their way into state courts across America. As of Nov. 30,

2005, Merck admits to being served or being named as a defendant in no

fewer than 9,200 lawsuits brought by 18,250 plaintiff groups, each

alleging personal injuries from the use of Vioxx. While most of those

cases are still in the courts or on appeal, stock analysts warn that

if Merck keeps losing Vioxx-related suits, it could cost the company

as much as $50 billion.

Tale Of Two Industries

Almost everywhere one looks, this tale of two industries intersect.

It's like watching the remake of an old movie: the faces change but

the characters are the same. It's another reason Big Pharma needed

this rule change, and needed it now.

Stop for a moment and try to imagine a state court jury of 12 ordinary

Americans, hearing that testimony as the widow of a Vioxx victim

softly sobs at the plaintiff table.

You can be quite sure lawyers for Merck have imagined it. And not just

Merck. There isn't a major drug company that doesn't have a similar

liability problem looming over one or more of its FDA-approved drug

products.

That was the driving motivation for last week's FDA rule change, which

claimed that only federal courts have jurisdiction to hear such

cases—federal courts now populated more than ever before by

conservative judges. Federal courts where, as in the case below,

defendant drug companies can count on the support from a " friend of

the court " with serious heft—the FDA.

Victor Motus killed himself with a shotgun six days after he began

taking Zoloft, an anti-depressant he complained was making him

" crazy. " His widow sued Pfizer, the drug's manufacturer, charging that

the company should have warned doctors that Zoloft could cause some

people to have suicidal thoughts. But Flora Motus soon discovered the

pharmaceutical giant wasn't her only adversary. The California woman

was also fighting the U.S. government.

The FDA filed a legal brief on Pfizer's behalf in the fall of 2002,

asserting that anti-depressants don't increase the risk of suicide.

" Had Pfizer given a warning as to a causal relation between Zoloft and

suicide, the FDA would have disapproved the warning, " the agency argued.

That court ended up dismissing Motus' case against Pfizer.

So there you have it—the FDA's rule changes last week, decoded. Better

labels on prescription drugs may or may not make consumers safer, but

drug companies hope they will make them safer from lawsuits. Remember

when Big Tobacco finally agreed to put warning labels on cigarette

packages? They, too, had opposed clear warning labels for decades. But

once the evidence of their product was killing millions of people

every year became undeniable, they embraced the idea. It had become

increasingly clear to Big Tobacco that the jig was up. Sooner or

later, juries would hear all the ugly evidence. So when that time

came, the tobacco company lawyers' defense would be: " The government

wanted us to put warning labels on our products. So we put warning

labels on them. Customers smoked anyway. So how can you hold us

liable? They were warned. "

But there was serious flaw in Big Tobacco's strategy: It had left home

plate—state courts—unguarded. That lapse cost Big Tobacco dearly, and

Big Pharma took note of that nearly fatal oversight. So last week,

besides requiring clearer warning labels, the FDA also strung

concertina wire around home plate for Big Pharma.

The Homeland Security Defense

The FDA's claim of federal preemption for drug liability cases will

certainly be challenged in court by consumer advocates. If they are

successful in overturning that rule, get ready for the

administration's last gambit—declaring Big Pharma part of our homeland

security/defense private sector infrastructure. That would put

pharmaceutical companies into the same category as Northrup, Boeing,

Halliburton and other large defense contractors that produce products

vital to the national defense and therefore deserve special, protected

relationship with the federal government.

The administration will argue that bioterrorists lurk, as do new, drug

resistant nation-crippling pandemics like avian flu, and that only

large drug companies can produce the new drugs and in large enough

amounts needed to defeat these new threats. It will argue that, sure,

a certain number of those vaccines and drugs will inevitably injure or

kill a certain number of people. But we are at war, after all, and

during war innocent people die. As sorry as we are to see such deaths

occur, they will say, allowing " greedy lawyers " to bleed drug

companies white in such cases would be like putting defense

contractors out of business in the weeks following the Japanese attack

on Pearl Harbor.

That will be the Bush administration's argument, an argument that is

already undergoing early market testing. In December, Republican

leaders attached many controversial provisions to the Department of

Defense appropriations conference report to include numerous

extraneous items for special interests that could not pass the Senate

and House on their own. One of them gave the drug industry

" unprecedented immunity, " according to Democrats:

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. "

There is one big difference between the Big Tobacco and Big Pharma

stories, though. Big Tobacco faced a hostile FDA under Bill Clinton,

while Big Pharma has a true friend in this FDA, and, for that matter,

this White House. The same administration is now trying its damnedest

to whittle those penalties against Big Tobacco down from $130 billion

to $10 billion.

Who knows, the administration may just pull Big Tobacco's chestnuts

out of that fire. But Big Pharma figured a stitch in time—a federal

preemption rule—was worth nine.