OpEd News - [Pringle] FDA Shields Drug Companies From Lawsuits

[Guest guest]

SSRI-Research@

Wed, 01 Mar 2006 18:52:45 -0500

[sSRI-Research] OpEd News - [Pringle] FDA Shields Drug

Companies From Lawsuits

 

 

Evelyn Pringle has become a superstar among our gang member

journalists. She is in desperate need of your input for a series of

articles in preparation for the upcoming FDA hearings, March 22-23.

 

One hearing concerns stimulants used for treatment of ADHD The FDA is

looking at /_heart problems, liver problems, and suicide issues_/ of

these substances (Ritalin, and the like).

 

The other is concerned with a product called Provigil (Modafinil).

_/T//his is the most off-label prescribed drug/_ that I know of. If

approved, it will be marketed as Sparlon for ADHD

 

If you, or anyone you know of, has had experience with either of these

drugs, please contact Evelyn at evelyn.pringle. If you

are a professional concerned about either of these drugs, contact her

also.

 

*Thanks,*

 

V

*

 

 

 

Oped News

http://www.opednews.com/articles/genera_evelyn_p_060301_fda_shields_drug_com.htm

 

FDA Shields Drug Companies From Lawsuits

 

 

by Evelyn Pringle

 

http://www.opednews.com

 

evieLast month, the FDA revealed its latest protective policy for drug

companies 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 Scott Gottlieb, the FDA's deputy

commissioner for medical and scientific affairs.

 

The agency's assertion of " federal preemption " was included as a

preamble to its new drug labeling guidelines.

 

 

** Evelyn Pringle *

 

*The claim of preemption was quickly attacked by trial lawyers and

members of Congress as another effort by the Bush administration to

limit the public's ability to bring and win lawsuits, according to the

January 19, 2006 Washington Post.

 

" 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 Post.

 

In response to the FDA's announcement, Senator Kennedy issued a

statement 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 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.

 

Over the past several years, lawmakers have been turning up the heat on

both the FDA and the pharmaceutical industry in response to their

combined failure to reveal problems found during studies conducted on

top selling drugs like Vioxx.

 

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

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

studies in order to protect pharmaceutical 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.

 

Based on a trial that took place in 2000, both the FDA and Merck were

aware that heart attacks were five times more likely in patients taking

Vioxx than among those taking a similar drug, Sen Grassley pointed out,

but the FDA did nothing to change the labeling on the drug for nearly

two years, while Merck aggressively marketed its product on nightly TV.

 

Back on November 18, 2004, he generated enormous media attention when he

held hearings on Vioxx, and FDA scientist, Dr David Graham, who works in

the FDA Office of Drug Safety, testified that Vioxx may have been

responsible for tens of thousands of heart attacks and strokes but that

his superiors had pressured him to keep silent about his findings.

 

" 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 this large number of injuries into perspective, Dr Graham told

members of the committee that instead of a serious side-effect of a

prescription 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 noted, " week in and

week out, for the past 5 years. "

 

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

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

what would you do about it? "

 

He condemned the FDA's failure to acknowledge the risks that Vioxx posed

to millions of people in the 5 years it was allowed to remain on the

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

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

 

The Vioxx matter caught the attention of the Senate Finance Committee

basically because of the Vioxx related costs 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 said:

 

" In the 5 years that Vioxx was on the market, Medicaid spent more than

$1 billion on the drug. "

 

" And Medicaid bears the cost of any additional medical care necessary

when drugs cause injury, " he pointed out.

 

The hearings followed a study that estimated between 28,000 and 160,000

deaths may have been caused by the Vioxx since it gained FDA approval in

1999.

 

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, M.Sc, a former pharmaceutical

chemist turned whistleblower and author of the book, " Health Myths

Exposed, " gave an interview to Crusador Magazine and discussed Vioxx and

some of the problems within the FDA.

 

His book which was published before Vioxx began making headlines,

referred to Vioxx as the " silent killer. "

 

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

associated with Vioxx for at least 4 years before it was taken 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 pharmaceutically compliant politicians have

" democratized " the drug 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 said.

" Therefore, the majority of scientists choose to please drug companies,

not the general public. "

 

To substantiate this claim, Dr Ellison pointed to Dr Curt Furberg, a

member of the FDA's drug safety advisory committee.

 

In the wake of the Vioxx revelations, Dr Furberg went public with

findings that Pfizer's drug 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.

 

A little-mentioned fact is that many FDA employees end up working for

the pharmaceutical industry. " The old joke is that the FDA is sort of

like a showcase for a future job in the drug industry, " Robert 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. "

 

Critic say the passage of the Prescription Drug User Fee Act in 1992

contributed to 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 is the root of a major conflict of interest according to

Dr Graham: " This culture (at the FDA) 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 cited is that even when the FDA does try to take

measures to limit harm, the agency lacks the enforcement authority to

force drug companies to comply. In the case of Vioxx, Dr Graham said it

took more than 2 years to get Merck to add the increased risk of heart

attack and stroke to its label.

 

Then there are the conflicts of interests involving the FDA panels that

advise the agency on matters such as which drugs should be approved,

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

 

The 300 experts on the 18 committees make decisions that affect billions

of dollars in sales and with few exceptions the FDA follows their

recommendations.

 

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

relating to products they consider. But the FDA can grant a waiver if a

member's expertise is deemed to outweigh the risk of a conflict or if

the financial interest is minimal. Waivers are liberally granted all the

time.

 

For instance, in February 2005, when the highly publicized hearings were

held to determine whether the COX-2 inhibitors, manufactured by Merck

and Pfizer, should be permitted to remain on the market, an advisory

committee that was mired with conflicts of interest was exposed. Out of

the 32 advisers voting on the issue, 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,

Edward Kennedy (D-MA), and Richard 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 a letter to the GAO, signed by Senators 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 noted the conflicts among the panels that studied

the Cox-2 inhibitors like Vioxx.

 

According to the Associated Press on January 24, 2006, Merck currently

faces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and the

rest in state courts. Without state product liability laws, drug

companies like Merck will be able to escape liability for injuries and

deaths caused by drugs like Vioxx.

 

*