[SSRI-Research] Pringle - Lawmakers Say FDA Better Clean Up Its Act

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Sat, 19 Aug 2006 20:45:50 -0400

[sSRI-Research] Pringle - Lawmakers Say FDA Better Clean Up

Its Act

 

 

 

 

http://www.lawyersandsettlements.com/articles/FDA_Pharma.html

 

 

 

 

Lawmakers Say FDA Better Clean Up Its Act

 

August 18, 2006.

 

By Evelyn Pringle

 

*For six years, the Bush administration has placed pharmaceutical

industry interests ahead of public interest by appointing persons with

strong ties to drug companies to high level positions at the FDA.*

 

As a result, Congressional investigations and a recent survey indicate

that the health and safety of all Americans is being compromised.

 

On July 20, 2006, the Union of Concerned Scientists published the

results of a survey that showed an insidious political influence of

science within the FDA. According to the UCS press release, the survey

was co-sponsored by Public Employees for Environmental Responsibility

(PEER), and was sent to 5,918 FDA scientists.

 

The survey found that 61% of the responding scientists knew of cases

where the " Department of Health and Human Services or FDA political

appointees have inappropriately injected themselves into FDA

determinations or actions. "

 

In responding to the survey, one scientist wrote: " Over the last several

years I have noticed a significant increase in the number of decisions

that have become politicized (e.g., increasing requests to review even

simple regulations and changes, both by Congress and the Commissioner's

office and to make apparently politically-motivated changes in language

and sometimes to alter bottom line results), and I think the integrity

of scientific work could be improved by minimising the 'politics' of the

process. "

 

Out of the nearly 1000 scientists who responded, close to one-fifth or

18.4%, said they had " been asked, for non-scientific reasons, to

inappropriately exclude or alter technical information or their

conclusions in a FDA scientific document. "

 

In addition, 40% of the scientists said they fear retaliation for

voicing safety concerns in public and more than one-third said they did

not feel they can express safety concerns even inside the agency.

 

The survey also found that only 47% think the " FDA routinely provides

complete and accurate information to the public, " and 81% agreed that

the " public would be better served if the independence and authority of

FDA post-market safety systems were strengthened. "

 

In a complaint aimed at the FDA's Office of Regulatory Affairs, one

scientist said it should " not ostracise scientists or black ball them

because their foresight sees a problem with a drug, device, food,

biologics, etc. that possess a potential hazard to health now or in the

future. "

 

In response to the concerns raised by FDA scientists, the UCS recommends:

 

- Accountability: FDA leadership must face consequences if they side

with commercial or political interests and not with the American people.

 

- Transparency: Scientific research and reviews should be open so any

undue manipulation is immediately apparent.

 

- Protection: Safeguards must be put in place for all government

scientists who speak out.

 

" These disturbing survey results make it clear that inappropriate

interference is putting people in harm's way, " said Dr Francesca Grifo,

Senior Scientist and Director of UCS's Scientific Integrity Program, in

the press release.

 

" All federal scientists, " he said, " need protections so they can speak

out when their science is manipulated, and all federal agencies need

fully functioning independent advisory committees. "

 

" FDA leaders, " Dr Grifo noted, " should act now to improve transparency

and accountability and renew respect for independent science at the

agency. "

 

" FDA leadership, " he stated, " must understand and support independent

science and it is up to Congress to hold them accountable. "

 

But nothing about this survey is news to FDA officials. By use of the

FOIA, the UCS and PEER, recently obtained a copy of a previously

unpublished survey by the Health and Human Services Office of Inspector

General from late 2002, that polled 846 FDA scientists, and with nearly

half responding determined that:

 

Nearly one in five said that they " have been pressured to approve or

recommend approval " for a drug " despite reservations about the safety,

efficacy or quality of the drug "

 

Two-thirds lacked confidence that the FDA " adequately monitors the

safety of prescription drugs once they are on the market "

 

Only 12% of the responding scientists were completely confident that FDA

" labeling decisions adequately address key safety concerns, " and 30%

were not at all or only somewhat confident

 

More than one-third were not at all or only somewhat confident that

" final decisions adequately assess the safety of a drug "

 

Despite the above results, the report published by the OIG in March

2003, included the conclusion that FDA scientific reviewers " have high

confidence in decisions FDA makes. "

 

On August 8, 2006, the UCS briefed acting FDA Commissioner, Andrew von

Eschenbach, on the latest survey and discussed the political inference

at the FDA. To restore integrity, UCS recommended that Dr von Eschenbach

adopt and enforce three basic commitments:

 

(1) to ensure that data or results are never softened for any audience.

Rigorous scientific debate must be valued at the FDA;

 

(2) to pledge to support scientists who speak out by taking adverse

employment action against any manager who retaliates against a reviewer;

and

 

(3) to commit to a culture that supports a collaborative process of

testing and challenging scientific hypotheses.

 

Along with the recommendations, the group's August 8, 2006, press

release said, " The FDA must allow an open scientific process and

recognize the need for scientists to pose and answer questions without

consequences related to their status at the FDA. "

 

Critics claim that a major issue that needs to be addressed involves the

rampant conflicts of interest among members of the FDA's advisory panels

who have financial ties to the pharmaceutical industry. In November

2005, a new law was passed that required members of the committees to

disclose all financial ties to drug companies.

 

The categories for disclosure were broken down into dollar amounts and

time frames, such as less than $10,000 a year or between $10,000 and

$50,000 a year. After reviewing the financial disclosure forms, the FDA

is permitted to grant waivers that allow experts to sit on panels even

if they have financial ties to a drug company.

 

However, on April 21, 2006, the Boston Globe discussed the practical

effects of the law since it was enacted and reported that FDA critics

" say the new transparency has changed little, and scientists who have

conflicts of interest can still guide FDA decision making. "

 

In less than 6 months after the law went into effect, the Globe

determined the FDA had granted close to 100 waivers.

 

One of the current investigations of the FDA involves allegations that

the agency approved the antibiotic, Ketek, despite serious questions

about the drug's safety and efficacy, and with full knowledge that the

clinical study submitted to support Ketek's approval was fraudulent.

 

Critics say Ketek's side effects of liver damage were known to its

maker, Sanofi-Aventis, early in clinical trials but were covered up. The

drug has been blamed for the death of four patients and the liver damage

or failure in 37 other patients since 2004.

 

Internal FDA emails that surfaced during the investigation show that at

least four FDA safety officials, Dr David Graham, Dr Charles Cooper, Dr

David Ross and Dr Rosemary Johann-Liang, had voiced serious concerns

about the safety of the drug.

 

" I tried to argue that given Aventis's track record in which they have

proven themselves to be nontrustworthy that we have to consider the

possibility that they are intentionally doing a poor job of collecting

the postmarketing data to protect their drug sales, " Dr Cooper said in

an email.

 

" It's as if every principle governing the review and approval of new

drugs was abandoned or suspended where telithromycin is concerned, " Dr

David Graham wrote in an email that recommended Ketek's " immediate

withdrawal. "

 

" We don't really know if the drug works; " he said, " no one is claiming

it works better than other, safer drugs; and we're flying blind as far

as safety goes, except for our own A.D.R. data that suggests

telithromycin is uniquely more toxic than most other drugs. "

 

In May 2006, Dr Johann-Liang called for a halt to tests of Ketek in

children with ear infections, arguing that cutting the duration of ear

pain by one day was hardly worth risking death.

 

The FDA's actions in regard to Ketek are being investigated by Senator

Charles Grassley's (R-Iowa), Senate Finance Committee, and by

Representatives, Edward Markey of Massachusetts, and Henry Waxman of

California, ranking Democrats on the House Government Reform Committee.

 

In May 2006, the lawmakers released a statement that said although " the

FDA has consistently assured the public of Ketek's safety and efficacy,

public documents obtained and examined by Representatives Markey and

Waxman's staff indicate that the approval process for this drug was

seriously flawed. "

 

As Chairman of the Senate Committee, Senate Grassley has called for a

" major overhaul and a culture change at the highest levels " of the FDA.

In a May 1, 2006, press release, he noted concerns over the FDA's

complicity with the drug maker and its subsequent failure to ensure the

integrity of a study on the benefits and risks of Ketek.

 

The Senator called it " mystifying " on May 16, 2006, that the FDA would

continued to provide information that it knew was fraudulent, and warned

that he planned to keep the pressure on the FDA to provide more

information about Ketek's approval and post-market surveillance.

 

According to Dr Graham, Ketek is at least as toxic to the liver as three

other drugs that have been pulled off the market and the FDA's original

approval of the drug was based on a study that FDA officials knew was

fraudulent.

 

" It's no surprise to learn that the FDA didn't listen to Dr. Graham on

the dangers of Ketek, " Senator Grassley was quick to point out. " The FDA

has made it their business to discredit Dr. Graham and others who aren't

willing to cater to the drug companies, " he noted.

 

In October 2001, doctors began enrolling subjects for the Ketek clinical

trial known as Study 3014, and were paid $100 for each patient that

signed up. The participating doctors would also receive another $150

when the study results were submitted, and a final $150 when all

questions related to the study were resolved, according to the May 1,

2006, Wall Street Journal.

 

On July 24, 2002, drug maker Aventis submitted the results of the study

to the FDA, but when FDA officials submitted the study to the advisory

committee for review, they did not disclose that the Division of

Scientific Investigation and Office of Criminal Investigation was

investigating the integrity of the study.

 

The misconduct that took place during the clinical trials is so serious

that critics say it calls the validity of the entire study into

question. For instance, the doctor who signed up the 3rd highest number

of patients, was in a chronic state of cocaine addiction while

conducting the clinical trial, and was arrested and found to have

cocaine hidden in his underwear, while holding his wife hostage with a

gun, the same month the study results were submitted to the FDA.

 

Another doctor who participated in the study was totally disqualified as

an investigator and prohibited from conducting any clinical trials in

the future, and another who signed up 150 patients was cited for 20

violations of the study's instructions.

 

Dr Anne Campbell, the doctor with the highest number of subjects in the

study, was sentenced to nearly 5 years in prison in March 2004, after

being charged in a 21-count indictment over her misconduct.

 

Senator Grassley is demanding a face-to-face interview with the FDA

investigator who discovered the fraud and misconduct in the trials, who

he contends " is key to understanding what the FDA did when it became

clear that the safety study required by the FDA in order to approve the

drug was fraudulent and faulty. "

 

This investigator authored a March 25, 2004, memorandum from the

Division of Scientific Investigations titled, " DSI Recommendations on

Data Integrity, " that states in part, that Study 3014 involved " multiple

instances of fraud " and that " the integrity of data from all sites

involved in [the] study ... cannot be assured with any degree of

confidence. "

 

After months of trying unsuccessfully to get an interview, Senator

Grassley finally marched right over to the Department of Health and

Human Services headquarters and asserted a congressional right to speak

to the investigator.

 

After a brief conversation with senior officials, he left mad as a

hornet. " This is extraordinary to me, " he said outside HHS headquarters.

" I haven't had to go to an agency like this since 1983 to get

information I requested.

 

" I smell a cover-up, " he stated.

 

On June 22, 2006, Senator Grassley publicly announced a not too subtle

warning to officials at the agency. " Two years ago I called a

congressional hearing to probe the FDA's handling of the withdrawn

painkiller Vioxx, " he said in a statement.

 

" It might be time, " he warned, " to round up another oversight hearing

after the runaround I got recently at the FDA. "

 

" The FDA, " he wrote, " refused to allow me to question an internal

investigator who is leading an inquiry into alleged fraud involved with

clinical trials for the antibiotic Ketek. "

 

" So for only the second time in 23 years, " he said, " I resurrected in

June my unconventional means to fulfill my Constitutional oversight

responsibilities. "

 

He said, " I appeared at the FDA's doorstep, " and noted that agency

officials refused to let the investigator speak to him.

 

However, he warned, " Bureaucratic stonewalling won't deter this U.S.

Senator. "

 

" I won't rest, " Senator Grassley said, " until the light of day exposes

what ought to be available for public consumption. "

 

" It all boils down to keeping the government accountable, " he wrote, " to

the people and strengthening the public trust in government. "

 

In another statement released on June 29, 2006, he stated, " Ketek is

another example where the F.D.A. accommodated a drug maker and turned a

blind eye to serious safety concerns. "

 

Over the past couple of years, the suppression of the scientific process

and the muzzling of scientific dissent at the FDA became evident first

when officials forced Dr Andrew Mosholder to suppress a link he found

between SSRI antidepressants and suicide in children, and Dr Graham went

public with allegations about the FDA's mishandling of the Vioxx matter.

 

On March 10, 2005, Senator Grassley gave a speech to the Consumer

Federation of America and said these two whistleblowers had done more to

shake up a complacent FDA than probably anybody in recent history and

relayed parts of the story saying:

 

" Early last year I heard that the FDA was muzzling one of its own

scientists. In February 2004 the FDA held a meeting to decide whether

there was a link between some antidepressant drugs and suicidal behavior

in kids.

 

" Dr. Andrew Mosholder - the FDA's expert in this area -- concluded there

was a link. However, FDA management disagreed. So, when Dr. Mosholder

stuck by his findings, his supervisors canceled his presentation to an

advisory committee.

 

" Instead of allowing Dr. Mosholder to present his findings publicly and

subject them to committee scrutiny, the scientific process and his

peers, the FDA effectively muzzled him. "

 

But despite the FDA's best efforts, Senator Grassley said, Dr Mosholder

wouldn't be silenced and months later he was proven right.

 

Citing information from the Department of Justice, he told the audience

that there are currently under seal in the neighborhood of 100

whistleblower cases involving allegations against over 200 drug companies.

 

" During the past four years, " he stated, " the department recovered

nearly 2 and a half billion dollars from whistleblower cases against

drug companies. "

 

Senator Grassley called Dr Mosholder and Dr Graham great patriots.

" Think about the guts it takes to undermine your career, and to go

against your supervisors at a huge federal agency, " he said, " and in

this case, the multi-billion-dollar drug companies. "

 

In an August 30, 2005, interview with Manette Loudon, the lead

investigator for Dr Gary Null, Dr Graham discussed how FDA officials

attempted to suppress the results of his study on Vioxx a year earlier.

According to Dr Graham, prior to his Senate testimony in mid-November of

2004, there was an orchestrated campaign by senior FDA managers to

intimidate him so that he would not testify about the adverse affects of

Vioxx to Congress.

 

One attack he says, came when the acting FDA Commissioner, Lester

Crawford, contacted the editor of the Lancet, a UK medical journal, and

told him that Dr Graham had committed scientific misconduct and that the

journal should not publish the paper that he had written showing that

Vioxx increased the risks of heart attack.

 

The second attack came from other high level officials, he said, who

contacted Senator Grassley's office in attempt to prevent Senator

Grassley from calling him as a witness.

 

And the third he says came from senior FDA officials who contacted Tom

Devine, Dr Graham's attorney at the Government Accountability Project,

and attempted to convince him that the GAP should not represent Dr

Graham because he was guilty of scientific misconduct.

 

According to Dr Graham, these officials posed as whistleblowers

themselves, and told Mr Devine that Dr Graham was a " bully, " a

" demigod, " and a " terrible person " that could not be trusted.

 

In one more last ditch effort to thwart Dr Graham's testimony the week

before he testified, he says, the acting Commissioner offered him a job

in the Commissioner's Office to oversee the revitalization of drug

safety if he would just leave the Office of Drug Safety.

 

" Obviously he had been tipped off, " Dr Graham said in the interview, " by

people in the Senate Finance Committee who are sympathetic to the FDA's

status quo that I was going to be called as a witness. "

 

To preempt his testimony, he told Ms Loudon, he was offered a job " which

basically would have been exile to a fancy title with no real ability to

have an impact. "

 

According to Dr Graham, by allowing Vioxx to stay on the market, the FDA

is responsible for 140,000 heart attacks and 60,000 dead Americans.

" That's as many people as were killed in the Vietnam War, " he points out.

 

He says the FDA could have prevented many of the heart attacks and

deaths simply by banning the high dose Vioxx back in 2000 when the

agency learned about the results of the VIGOR Study. " But the FDA did

nothing for almost two years, " he states. " They were " negotiating " with

the company over a label. "

 

" The FDA made bad decisions, " Dr Graham said, " based of its culture and

its institutionalized biases that favor industry, and as a result

thousands of Americans died. "

 

During a July 18, 2005, speech on the Senate floor, Senator Grassley

proclaimed, " this country's confidence in the FDA has been shaken. "

 

It has not been shaken, he said, by one isolated incident or

whistleblower. " It has been shaken because multiple drug safety concerns

have been exposed by more than one courageous whistleblower. "

 

" Dr. Graham's testimony before the Finance Committee, " he told members

of Congress, " suggests that the problems are systemic. "

 

" Oversight of the FDA, " Senator Grassley advised, " exposed the cozy

relationship that exists between the FDA and the drug industry. "

 

" It revealed that the FDA negotiated for almost two years with Merck, "

he said, " about how to change the Vioxx label so people would know about

the risk of heart attacks. "

 

According to Dr Graham, the Vioxx disaster would not have been as severe

in the absence of direct-to-consumer advertising. " I submit, " he told Ms

Loudon, " that the numbers would have been far lower than what they were. "

 

Due to heavy marketing of new drugs, Dr Graham says, lots of patients

and doctors will use a new drug that is no better than another drug

already on the market, even though the FDA does not require that new

drugs be at least equivalent to, or better than, the drugs that are

already there. All the drug maker has to prove is that a drug works

better than a sugar pill, he says.

 

Silencing scientists to protect the industry has become habitual under

the current politically appointed rulers of the FDA. According to Shane

Ellison, author of " Health Myths Exposed, " 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, " he warns, " no longer prevail at the FDA or at

pharmaceutical companies. "

 

Mr Ellison is a former pharmaceutical industry chemist who says he felt

a responsibility to reveal the truth about the industry's sordid tactics

after he witnessed first-hand how they deceive the public, according to

a September 3, 2005, interview with Crusador Editor, Greg Ciola.

 

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

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

not the general public. "

 

As an example, Mr Ellison discussed Dr Curt Furberg, a member of the

FDA's drug safety advisory committee. Dr Furberg, he says, came forward

to reveal that Bextra also caused heart attack and stroke. In the

British Medical Journal, Dr Furberg said that his studies showed Bextra

to be no different than Vioxx, and warned that Pfizer was trying to

suppress that information.

 

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

serving on the panel that is 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, " Mr Ellison told Crusador.

 

In the case of the pain relieving Cox-2 inhibitors, the FDA's advisory

committee was stacked with experts with ties to the drug makers. Of the

32 advisers who would vote on the drugs, it has since become known that

10 of panel members had consulted in recent years for Vioxx maker,

Merck, or Pfizer who made Celebrex and Bextra.

 

While the committee voted unanimously that all of the drugs

significantly increased the risk of heart attack and stroke, in a 17-15

vote the panel said the FDA should allow Vioxx to remain on the market.

A tally of the votes showed that without the 9 votes of the 10 members

who consulted for the drug makers, the committee would have voted 14 to

8 to ban Vioxx.

 

However, the panel's recommendation was met with scorn and outrage by

medical experts and researchers alike in the media, and in a rare

occurrence, the FDA went against the recommendation of its advisory

panel and refused to allow Vioxx to remain on the market.

 

Critics also accuse the FDA of not properly monitoring the marketing

activities of the pharmaceutical industry. An investigation by the House

Committee on Government Reform found that since December 2001, there has

been a sharp decline in enforcement actions taken against drug companies

for illegally promoting their products.

 

The investigation determined that from 1999 to 2001, the FDA sent out

250 " Notice of Violation " or " Warning " letters to drug companies; but

for the time period of 2002 through 2004, the agency sent out only 70

letters, which amounts to a reduction of more than two-thirds.

 

Since the Vioxx and SSRI debacles, Senator Grassley has jumped on the

FDA every time there has been any indication that officials might be

putting the industry's interest over public safety. Earlier this year,

he wrote a letter to the FDA saying he was concerned that it might be

" dropping the regulatory ball " on stimulant drugs, prescribed to treat

ADHD.

 

Specifically, he wrote, " I'm concerned FDA's regulatory responsibilities

haven't kept pace with the explosion of prescriptions written to treat

2.5 million children with these drugs. "

 

Despite psychiatric and cardiovascular risk signals associated with the

drugs, he noted, it appears the FDA has failed to promptly respond to

their possible adverse effects. " Such events, " he wrote, " may include

sudden unexplained deaths, strokes, cardiovascular irregularities or

aggression, anxiety and depression. "

 

Sales of drugs, he said, " have zoomed to the moon, jumping from $759

million to $3.1 billion between 2000 and 2004. "

 

" And yet, " he wrote, " the FDA seems to have adopted a wait-and-see

approach before charting a course of action to study these risks. "

 

In early February 2006, he noted, that an advisory panel had recommended

adding the strongest black box warning to ADHD drugs to alert patients

about the possible cardiovascular side effects.

 

" The recommendation, " Senator Grassley wrote, " brings even more urgency

to the controversy surrounding the explosion of prescriptions being

filled with these medicines. "

 

" As the debate unfolds, " he warned agency officials, " I will continue to

closely track the FDA and urge its timely, thorough review of these

drugs. "

 

" With millions of Americans, mostly children, regularly taking these

medications, " he added, " it is essential the FDA leaves no stone

unturned to investigate and review this class of drugs. "

 

No doubt in response to all the intense scrutiny from members of

Congress, in late July 2006, the FDA outlined a series of changes it

plans to make in the methods used to evaluate clinical trials. One of

the proposed changes would require a drug company to notify the FDA

immediately if it believes a researcher has committed fraud during a

clinical trial.

 

As it is now, drugs companies are trusted to remove unreliable data and

are not required to report any fraudulent activity to the FDA until they

actually submit the application.

 

The agency also says it plans to clarify which adverse events in

clinical trials must be reported to the review boards that monitor the

studies. Other proposed change includes the standardization of forms

used to collect information and a revision of the rules on how patients

may qualify to participate in clinical trials.

 

However, people who are tempted to think that the FDA is capable of

changing under the agency's current team of politically appointed

officials, had better think again.

 

According to an article by Russell Mokhiber and Robert Weissman, for

Common Dreams on August 2, 2006, Dr Steven Nissen, chairman of the

Department of Cardiovascular Medicine at the Cleveland Clinic, was

recently a member of a panel debating the topic of: " Government Science

Panels: Fair and Balanced? " which was moderated by National Public

Radio's Snigdha Prakash, and sponsored the Center for Science in the

Public Interest.

 

Dr Nissen spoke about the conflict-of-interest problems " evident at the

highest levels of the FDA, " the article says.

 

" For years, " Dr Nissen said in describing FDA leadership, " we had an

interim FDA Commissioner, Lester Crawford, who shortly after

confirmation, abruptly resigns, apparently because he and his wife owned

stock in regulated companies. "

 

" Then the administration appointed Andrew Von Eschenbach as interim

commissioner, creating another conflict, " he noted.

 

" In his role as director of the National Cancer Institute, " Dr Nissen

said, " Von Eschenbach must seek FDA approval for human testing or

approval of new cancer drugs, an obvious conflict. "

 

But even worse, he said, " the administration appointed Scott Gottlieb as

deputy commissioner. "

 

" He came to this job with no regulatory experience, directly from Wall

Street, where he served as a biotech analyst and stock promoter, " Dr

Nissen stated.

 

" Between them, " he said, " Drs. Von Eschenbach and Gottlieb have whined

incessantly about the need to speed drug development. "

 

" So while the American people worry about the safety of drugs, " he

continued, " the top FDA leadership tells us we need faster drug approval. "

 

On November 12, 2005, the Boston Globe reported that prior to his job at

the FDA, Dr Gottlieb worked for the PR firm of Manning Selvage & Lee and

that his clients included Roche, the manufacturer of Tamiflu, and

Sanofi-Aventis, the maker of Ketek, and the parent company to the

nation's sole flu vaccine maker.

 

According to the Globe, the Manning PR firm paid Dr Gottlieb a monthly

retainer of $12,500 for nine months, for working on projects that

involved eight companies. Other firms regulated by the FDA that he was

involved with include Inamed Corp, a company seeking the return of

silicone gel implants to the market.

 

Between May and July 2005, Dr Gottlieb also was paid $9,000 for

consultant work performed for VaxGen, a company that won an $878 million

government contract to supply the US with 75 million doses of anthrax

vaccine.

 

In any event, no matter who's in charge, the Senator from Iowa is

keeping the heat on. In July 2006, he wrote a letter to the Daniel

Levinson, the Inspector General at the Department of Health and Human

Services, asking for an investigation into whether Dr Brian Harvey of

the FDA, conspired against Dr Graham by providing Merck with details

about Dr Graham's presentation on Vioxx, prior to the hearing in 2004 to

help the company refute his testimony.

 

" It is no secret that Dr. Graham was and is a critic of the FDA, " he

wrote to Inspector. " However, " he said, " that does not mean the FDA

should scheme with drug sponsors to discredit its own employees. "