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FDA vs. WMD - breaking news
FDA Asks Pfizer To Remove Bextra From Market
POSTED: 6:22 am PDT April 7, 2005
UPDATED: 6:35 am PDT April 7, 2005

The government has asked Pfizer to withdraw the painkiller Bextra from the market because it increases the risk of heart attack and stroke.

Regulators also want all other anti-inflammatory drugs in the same class to carry the strongest safety warning possible.

The Food and Drug Administration has been studying the safety of the so-called Cox-2 inhibiters since Merck voluntarily pulled Vioxx from the market last year after heart problems were reported in some users.

Advisers to the FDA recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to continue to use them despite the health risks.

The FDA also is asking manufacturers of over-the-counter nonsteroidal anti-inflammatory drugs to revise their labels to include information about the risks of cardiovascular incident and gastrointestinal bleeding.

New Data Prompts Renewed Call For Celebrex Ban

POSTED: 7:33 am EST February 1, 2005

A consumer watchdog group is renewing its call that the arthritis drug Celebrex be pulled off the market.
The FDA is once again siding with a large pharmaceutical company, in this case Pfizer, in refusing to ban the two Pfizer COX-2 selective drugs Celebrex and Bextra.
Both Celebrex and Bextra are doomed drugs that are in the twilight of their existence. Breathing extra live into them is surely beneficial to Pfizer executives and stockholders but is a step backward for an agency that is supposed to be part of the Public Health Service.
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Pfizer's Tough Sell
Matthew Herper, 11.30.04, 5:45 PM ET

NEW YORK - At the end of Pfizer's annual analyst meeting, Chief Executive Hank McKinnell dropped a bombshell.

    More on Henry McKinnell     
    More on Pfizer 
Older, over-the-counter pain medicines may not be safe for the heart, McKinnell said, because there is no way of tracking the cardiovascular or stomach safety of older arthritis drugs. On the other hand, no heart risk has emerged with Celebrex, a Pfizer (nyse: PFE - news - people ) drug that has been under scrutiny because it is similar to Vioxx, after extensive studies.

Pfizer Chief Medical Officer Joe Feczko had already defended Pfizer's arthritis medicines, Celebrex and Bextra. Both drugs work by the same basic mechanism as Vioxx, the Merck (nyse: MRK - news - people ) drug that was pulled from the market because it doubled the increase of heart attack and stroke. Feczko emphasized that these drugs are different from Vioxx on a chemical level. Additionally, while other arthritis drugs can increase blood pressure, Celebrex seems not to.

With Celebrex, Pfizer is putting its money where its mouth is by testing the drug to prevent heart attacks. (Conflict over Celebrex's safety led the drug to be temporarily withdrawn in Turkey.) The situation for Bextra is grimmer. Pfizer says Bextra will have a serious warning that it can cause a potentially deadly skin reaction. The fact that Bextra, given with an injectable drug, increased the risk of heart attacks following open-heart surgery will also be included in the Bextra label.

McKinnell faced other investor concerns head-on, helping the stock close up 1.61%, or 44 cents, to $27.77 today. In three years, Pfizer drugs bringing in $14 billion in annual sales will be lost to patent expirations. "We recognize that patent [or PATIENT] expirations are certain," McKinnell said, "and that everything else is uncertain."

That's an eloquent statement of the reasons why investors are running from drug stocks. And McKinnell, from his seat at the drug industry's biggest battleship, was quick to point to rival Merck as an example of a company in decline. But he and other executives tried to make a case that Pfizer can avoid the pitfalls that have hit other big drug companies because of its research and marketing heft.

The most important drug in Pfizer's pipeline remains torcetrapib, a medicine to increase good cholesterol and, it's hoped, to clear plaque out of the arteries. Almost 1,200 patients have enrolled in imaging studies to test the drug, conducted by the Cleveland Clinic's Steven Nissen. Some 25,000 patients will be included in clinical trials for the medicine, at a cost of $800 million. The medicine may cause slight hypertension in some patients (see: "The Immortal Pill"). A problem on the horizon: Roche is not far behind with a competing drug, but McKinnell says he is not concerned. The imaging studies are expected to be the ones needed to get the drug approved.

Pfizer had promised to submit 20 new drugs by 2006; 12 of these will have been submitted by year's end. Pfizer also has a full slate of exciting medicines. One exciting area is Pfizer's burgeoning pipeline of cancer compounds, including SU-11248, one of the first targeted cancer pills and a treatment for melanoma (see: "Four Winning Cancer Drugs"). Also exciting: a stop-smoking pill, a long-delayed inhaled insulin, an osteoporosis medicine, a sleep drug and an antibiotic that can treat infections in a single dose.

Pfizer said that its Lyrica, a follow-up to the blockbuster epilepsy and nerve pain drug Neurontin, has been associated with a few cases of muscle weakness, but that the company is still expecting U.S. Food and Drug Administration approval for the long-delayed drug. Pfizer reaffirmed 2004 earnings estimates. But that's not the question weighing on investors' minds. The big question: Will all this research be enough?

 "Tough times don't last," McKinnell said. "Tough people do."


Grassley Defends Whistle-Blower Senator Asks FDA Not to Retaliate

By Marc Kaufman
Washington Post Staff Writer
Tuesday, November 30, 2004; Page A17

At a hearing, David Graham said the Food and Drug Administration is not protecting the public from unsafe drugs. (Gerald Herbert -- AP)

Food and Drug Administration whistle-blower David J. Graham believes he will soon be transferred or fired in retaliation for telling a congressional hearing that the agency is falling short on ensuring drug safety, but his Senate champion is trying to keep that from happening.

In a letter sent yesterday to acting FDA Commissioner Lester M. Crawford, Sen. Charles E. Grassley (R-Iowa) formally asked whether Graham was going to be moved, and made clear that he would regard any reassignment as punishment for Graham's public criticism of the agency.

"I understand that retaliatory action against dissident employees can come under many guises," Grassley wrote. "Therefore, I . . . request that you address allegations that administrative action may be taken against Dr. Graham, including that he may be terminated or transferred against his wishes to a job other than conducting scientific research. Please advise me whether there is any truth to these allegations."

An FDA spokesman said that he could not comment on personnel matters because of privacy considerations.

During his Nov. 18 testimony before Grassley's hearing into the withdrawal of the arthritis drug Vioxx, Graham said the FDA is incapable of protecting the public from similar harmful drugs in the future. Asked by another senator whether other unsafe drugs remained on the market, Graham named five that he considered to be problematic: the diet drug Meridia, the arthritis drug Bextra, the asthma medication Serevent, the acne treatment Accutane and the cholesterol-lowering drug Crestor.

His attorney, Tom Devine of the Government Accountability Project, a whistle-blower protection group, said Graham was offered a transfer to the FDA commissioner's office just before his Senate testimony. Devine said that Graham declined -- saying his life's work was to review the safety of drugs on the market -- but that efforts to move him have continued.

"The reason that Dr. Graham is surviving in his position now is solidarity beyond the call of duty from Senator Grassley and his being in the public spotlight," Devine said. "Without that, he'd be gone."

The federal whistle-blower protection law offers no help because of changes made since it was enacted, Devine said.

During the Vioxx hearing, Grassley told senior FDA officials that Graham should be allowed to continue doing his scientific work on drug safety. Last week, Grassley asked for an Office of the Inspector General inquiry into alleged agency efforts to smear Graham before his testimony.

Devine said that after Graham asked his whistle-blower group for help in October, he received a number of anonymous calls criticizing Graham as personally and professionally irresponsible and calling him a bully. Based on several indicators, Devine said he believes the anonymous callers were managers at the FDA.

In his letter yesterday, Grassley demanded full FDA cooperation with the inquiry into Devine's charges, and an FDA spokesman said the agency would cooperate fully.

Graham has worked in the FDA's Office of Drug Safety for 20 years. Ten drugs he questioned were ultimately withdrawn.

12/03/04 19:22 ET - Updated: 07:23 PM EST

Pfizer seeks approval of Viagra for lung disorder

NEW YORK, Dec 3 (Reuters) - Pfizer Inc. on Friday said it asked U.S. and European regulators for permission to sell the active ingredient of its Viagra impotence medicine to treat a rare but often-fatal lung condition.

The New York-based drugmaker said it asked regulators to clear sildenafil as a treatment for pulmonary arterial hypertension. For that use, it would be sold under the brand name Revatio.

Pfizer said about 100,000 people in the United States and Europe have the condition, which involves high blood pressure in arteries that connect the heart to the lungs. Patients often ultimately need heart and lung transplants to survive the disease.


Viagra was originally designed to treat chest pain caused by clogged arteries but did not prove successful for that use. Researchers then stumbled upon its effectiveness as a treatment for impotence.

As Viagra faced increasing competition in the erectile dysfunction arena, Pfizer stepped up its research into other potential uses for the drug.

If approved for PAH, Revatio would compete with Tracleer, a treatment sold by Swiss drugmaker Actelion which accounts for virtually all of the biotechnology company's revenue. Tracleer is currently the only approved oral treatment for PAH.

Encysive Pharmaceuticals is also developing an experimental PAH treatment, called Thelin.

Just another "statistically insignificant tragedy"

12-04-04 15:55 EST - Updated: 06:49 PM EST

Teen Says Antidepressants Led to Slayings

COLUMBIA, S.C. (Dec. 4) - Authorities say 12-year-old Christopher Pittman shot his grandparents as they slept three years ago because they had scolded him for fighting. But Christopher's father, Joe Pittman, thinks his son killed because his sense of right and wrong was clouded by the anti-depressant Zoloft.

Joe Pittman spoke out against the drug in a Food and Drug Administration hearing early this year. The boy, who had threatened suicide, was put on the drug three weeks before the slayings, and his dose was doubled just two days earlier.

Joe Pittman's hands shook as he read his son's confession to a roomful of strangers during the hearing.

"I took everything out on my grandparents, who I loved so very much," wrote then-12-year-old Christopher Pittman. "When I was lying in my bed that night, I couldn't sleep because my voice in my head kept echoing through my mind, telling me to kill them."

But prosecutors and police say Christopher's actions during and after the November 2001 slayings show he clearly knew what he was doing was wrong.

The boy waited until his grandparents were sleeping and took a pump-action shotgun from a gun cabinet. He crept into the couple's dark bedroom, first shooting 66-year-old Joe Frank Pittman in his open mouth, then firing into the back of 62-year-old Joy Pittman's head.

Christopher then set the house on fire and drove off in the family car. When he got stuck on a dirt road 20 miles away, he told hunters he was kidnapped by a man who killed his grandparents, set the fire, drove him into the woods and ran away.

Christopher was living with his father's parents in hopes of turning his life around. He told defense experts he felt abandoned by his mother and his relationship with his father was rocky. No one answered phone calls to Joe Pittman's home.

A month before the slayings, Christopher was hospitalized in Florida, where his father lives, after he threatened to kill himself. The boy was prescribed the anti-depressant Paxil, but another doctor soon put him on Zoloft instead.

Pittman decided to send the boy to live with his grandparents in Chester County, a rural area between Columbia and Charlotte, N.C.

Christopher, who turns 16 in April, is being prosecuted as an adult and faces 30 years to life in prison if convicted at his trial, set to start next month. His lawyers argue that his case should be moved to Family Court, where if convicted, he could only be kept in custody until he turns 21.

Karen Menzies, one of Christopher's lawyers and an attorney specializing in lawsuits against anti-depressant makers, said medical research is available to support the Zoloft defense.

In the three years the teen has spent in jail awaiting trial, the FDA has become increasingly wary of doctors prescribing Zoloft and other antidepressants for children.

In October, the agency ordered the drugs to carry "black box" warnings - the government's strongest warning short of a ban - about increasing the risk of suicidal behavior in children.

"The science has been out there for a while. The prescription drug companies have been able to hide it," Menzies said.

On the other side is Pfizer Inc., the maker of Zoloft, which has aided the prosecution, according to Solicitor John Justice, who has since taken himself off the case for health reasons.

The company has vigorously fought cases claiming antidepressants cause violent or suicidal behavior.

A spokesman responded to inquiries by pointing out an October statement on the company's Web site addressing concerns of suicide attempts, saying studies show "no statistically significant difference" between children using Zoloft and nonusers. The statement, though, does not discuss any possible link between the drug and violent acts against others.

Trying to blame a drug for causing someone to commit a crime is an uphill fight, but it has been done successfully.

In April, a Santa Cruz, Calif., jury acquitted a man of attempted murder after he beat his friend, then blamed the episode on Zoloft.

National Association of Criminal Defense Lawyers spokesman Jack King said the "Zoloft-made-me-do-it" defense likely means that the Pittman case will come down to defense vs. prosecution experts.

"It's going to be a battle of whose experts the jury believes," King said. [it's not about the TRUTH - but who has the most "believable" experts - how SAD . . .]

Christopher's maternal grandmother, Delnora Duprey, of Wildwood, Fla., said her grandson is no longer on any medication and is the "sweet, quiet, laid-back" boy she knew growing up. "He's the old Christopher again."

Menzies said the teenager is getting good grades and behaving behind bars.

Duprey says the "whole entire family is behind Christopher 150 percent."

She thinks Zoloft had to have caused Christopher to kill his grandparents because he loved them both, especially the grandfather he called "Pop-Pop."

"We used to joke that he was his Pop-Pop's shadow," Duprey said.

However, those who dealt with the boy after the crime feel differently.

"Anybody who could kill his grandparents in the fashion he did shouldn't be let loose on the public at age 21. And that would have been the best-case scenario," said former prosecutor Justice, who pushed to move the case to adult court.

The current prosecutor, Barney Giese of Columbia, said through his office that he doesn't talk about cases before they go to trial.

Chester County Sheriff Robbie Benson said interviews with Christopher left him shaken because he could not believe the lack of remorse. "This was cold-blooded."

Menzies said those observations might help her case.

"The boy was still suffering from the side-effects of this medication after the incident," she said. "I think we see a different Christopher now."


Date: 9/04/04
Drug Companies Still Make Bundle Even When They Admit They Lie

Even when the mega-billion drug companies admit to federal wrongdoings, they often get away a light slap on the wrist and, if they're lucky, can still make an obscene amount of money on the open market besides.

A great example is Warner-Lambert, a one-time independent now owned by Pfizer that recently pled guilty to illegally marketing Neurontin for treating ailments it wasn't approved to cover before August 1996. Warner-Lambert paid a sizeable fine ($430 million) and its parent agreed to stricter rules to compliance laws tighter than existing marketing rules. In addition, it also agreed to fund a multi-million program to educate doctors about Neurontin.

Think the publicity made Neurontin a pariah? Guess again. For one, the Warner-Lambert executives who executed the marketing plan were never prosecuted for their shenanigans. Lastly, and most importantly, Neurontin sales in 2004 are projected to exceed last year's totals: $2.7 billion. Federal law prohibits drug firms from marketing their products for treatments that aren't FDA-approved. Neurontin's expressed use was as an anti-seizure drug for epileptics early on and later for shingle-related nerve pain.

From 1994-2000, the Justice Department claims Warner-Lambert marketed Neurontin illegally in a number of ways:

  • Lied to doctors about the drug's effectiveness

  • Paid doctors to allow a sales representative to sit in on sessions with patients

  • Paid doctors, some up to $250,000, to unethically talk up Neurontin to other physicians

The list of diseases the company claimed Neurontin could cure was so ridiculously long, some employees called it the "snake oil" list. Nevertheless, Warner-Lambert's plan worked to perfection. The government estimates off-label uses for Neurontin increased from 40 to 94 percent from 1995-2002. Today, the estimated percentage of off-label use stands at 90 percent. Some 12 million people have taken Neurontin over the past decade and 60 countries have approved it to treat pain.

Still, government prosecutors believed the actions of Warner-Lambert forced Medicare to pay for an excessive number of prescriptions the agency didn't need to fill. So much so that one official believes directly increased medical costs to consumer, states and insurers.

One U.S. attorney who prosecuted the Neurontin case hopes drug industry practices will change due to the ruling, but doubts it will have any effect on the drug's popularity. Why?

Additional Quoting from the above site:

"Conventional healthcare slowly but surely progressed into a nasty disease . . . which now is at a rapid progression towards death. This "disease" is caused by:

"When morality comes up against profit, it is seldom profit that loses."
Shirley Chisolm, Former Member of Congress

December 6, 2004

Rachel Beck is the national business columnist for The Associated Press. Write to her at

Questions loom over Merck’s severance plan
NEW YORK (AP) — What does it take to stop executives from lining their own pockets? Not much, at least when you look at the recent decision by Merck & Co. to give fat severance packages to 230 of its top managers if there is a buyout or a merger.

These are tough times for Merck, the struggling pharmaceutical giant that recently pulled its blockbuster Vioxx painkiller from the market after concerns were raised over its safety. It now faces billions of dollars in potential liabilities as a result.

Still, Merck, which has a plant in Riverside, Pa., has been trying to spin the issuance of those "golden parachutes" in its favor, saying the promise of generous severance would help retain employees. And while that very well might be true, the devil of this compensation plan comes in its details.

It is understandable that Merck wants to prevent a mass employee exodus. The last thing it needs is crucial workers especially in areas of research and marketing to flee for better opportunities at companies with deeper pockets and without such looming uncertainties.

Vioxx was withdrawn two months ago after a study showed patients taking it for 18 months had double the risk of heart attacks and strokes than those taking a placebo. Vioxx had contributed $2.5 billion, or 11 percent, to Merck’s total annual revenues.

Merck must now contend with hundreds of lawsuits that threaten to further damage the company’s finances and reputation. Some estimates put the potential legal costs as high as $18 billion.

With so much to weigh, Merck investors have bailed out. The company’s stock has fallen by more than a third since the recall announcement, from about $45 to the high $20s. And that’s raised speculation the company could be an acquisition target.

Given all this, the company disclosed earlier this week in a filing with the Securities and Exchange Commission that it had adopted a new compensation plan for top executives. It offers one-time severance payments of up to triple their salary and bonus as well as other perks like health benefits if Merck was acquired and they lost their jobs.

Merck was quick to say the severance plan was first considered months before the Vioxx withdrawal, and it pointed out that 90 percent of large companies and most of its competitors have similar change-of-control protections in place.

The Whitehouse Station, N.J.-based company also said the plan was adopted by Merck’s board to avoid "the distraction and loss of key management personnel that may occur in connection with rumored or actual" corporate changes. Merck has denied it is in merger talks.

But using a change-of-control provision for employee retention isn’t something often seen, said Paul Hodgson, senior research associate at governance watchdog group The Corporate Library. The company instead could have used incentives such as bonuses for retention.

In addition, Merck’s compensation plan is richer than most. Only about 50 percent of companies with such plans promise executives three times their cash compensation, down from 80 percent three years ago as pressure from shareholder groups has spurred companies to rein in such payouts, according to The Corporate Library.

And just because other companies have similar plans, that doesn’t mean Merck should do the same.

"They say they were thinking about this for some time, which means they had the benefit of seeing where the trend was going," Hodgson said. "This was Merck’s chance to lead the way with best practices rather than through typical practices."

Also problematic is how the company defines what would trigger such payments. It doesn’t require another company to complete a full takeover, but instead allows executives to be entitled to such payments if another company buys 20 percent of Merck’s stock — not an extraordinary amount by most measures.

It is also worth noting that those getting such cushy incentives to stick around happen to be the same people who were the decision-makers when the company’s troubles emerged in the first place.

"This is just another nail in the coffin, another way to drag down Merck’s reputation rather than build it up," said Paul Argenti, professor of corporate communication at the Tuck School of Business at Dartmouth. "Companies need to understand how damaging risk to reputation can be."

So while Merck might want you to think this is all about employee retention, there seems to be more to this plan that just that.


FDA Resource page to check out drugs:

2004 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements

WHOM do YOU think "blew the whistle"?

[December 8, 2004 - Talk Paper - FDA]

Carbolith (lithium carbonate)
Audience: Neuropsychiatric healthcare professionals and consumers
The FDA advised consumers about a Canadian recall of Carbolith (lithium carbonate) 150 mg capsules distributed in Canada by Valeant Canada Limited. Although Carbolith is not an FDA-approved product, FDA is investigating several Internet websites advertising Carbolith for sale to U.S. consumers. Carbolith 150 mg capsules are used in the treatment of manic-depressive illness. The company's recent testing led to the conclusion that the product may not deliver adequate amounts of the drug to ensure effective treatment. U.S. consumers who have taken it for the treatment of manic-depressive illness could experience adverse events associated with lowered blood lithium levels.

date: 12/16/04
Finkelstein, Thompson & Loughran Files Shareholder Class Action Lawsuit Against Pfizer, Inc. and Henry A. McKinnel
WASHINGTON, Dec. 16 /PRNewswire/ -- Finkelstein, Thompson & Loughran has filed a securities fraud class action lawsuit in the United States District Court for the Southern District of New York, on behalf of investors who purchased or otherwise acquired the publicly-traded common stock of Pfizer, Inc. ("Pfizer" or the "Company") between November 1, 2000 and November 10,
2004, inclusive (the "Class Period").
The complaint alleges that, throughout the Class Period, defendants misrepresented and omitted material facts concerning the safety and marketability of Pfizer's Celebrex and Bextra products.  Specifically, Plaintiff alleges that at all times during the Class Period, Defendants were aware of strong indicators that Celebrex and Bextra, drugs known as "Cox-2 Inhibitors," posed serious undisclosed health risks to consumers, that these
undisclosed health risks would limit their marketability, and that the potential financial liability Pfizer faced from the harms these drugs caused posed a serious threat to the Company's finances.  Nevertheless, Defendants concealed these facts from the investing public.
Toward the close of the Class Period, a series of factual revelations from several sources caused the market to gradually perceive the truth about Pfizer's Bextra and Celebrex products.  For example, on November 4, 2004, the Calgary Herald reported that "Celebrex, a popular pain drug touted as the safe
alternative after Vioxx was pulled from drugstore shelves, is suspected of causing at least 14 deaths and numerous heart and brain side effects."  Then, on November 10, 2004, the New York Times further shocked the market by reporting on a study finding that "[t]he incidence of heart attacks and strokes among patients given Pfizer's painkiller Bextra was more than double that of those given placebos."
As a result of these and other revelations, Pfizer's share price dropped from a closing price of $29.45 on November 3, 2004 to $27.15 on November 11, 2004 -- a drop of 8%.
Plaintiff seeks to recover damages on behalf of all those who purchased or otherwise acquired Pfizer common stock during the Class Period, and is represented by the law firm of Finkelstein, Thompson & Loughran.  With offices in Washington, D.C. and San Francisco, CA, Finkelstein, Thompson & Loughran has spent almost three decades delivering outstanding representation to
institutional and individual clients in connection with securities and other finance-related litigation, and has been appointed as lead or co-lead counsel in dozens of federal securities fraud class actions.  

Indeed, in the past ten years, the firm has served in leadership roles in cases that have recovered almost $1 billion for investors and consumers.  
If you bought or otherwise acquired Pfizer common stock between November 1, 2000 and November 10, 2004, inclusive, you may request that the Court appoint you as lead plaintiff.  A lead plaintiff is a person who acts on behalf of other class members in directing the litigation.  Any member of the proposed class who wishes to move the Court to serve as lead plaintiff must do
so no later than February 14, 2005.  In order to serve as lead plaintiff, you must meet certain legal requirements. If you have any questions concerning this notice or your rights or interests, please contact Donald J. Enright or Michael G. McLellan with Finkelstein, Thompson & Loughran's Washington, DC office, at (866)592-1960, or by email at or
SOURCE Finkelstein, Thompson & Loughran
Web Site: 

Editorial comment [by Ginger Sanchez]: Personally, I'm having some difficulty working up very much sympathy for folks who've chosen to "make money" by investing in the drug industry and then complaining and/or suing when their "profits" don't match their expectations of riches because they've been lied to.  I DO have a LOT of sympathy and compassion for the REAL "victims" of the lies told by the drug industry and covered up by the FDA who have died and/or were damaged by the lies/cover-ups surrounding deadly drugs and risky side-effects.


Date: 12/07/04

Pfizer Says Celebrex Increases Heart Risk


NEW YORK (Dec. 17) -- Pfizer Inc. said it has found an increased risk of heart attacks with patients taking its top-selling painkiller Celebrex, a drug that is in the same class as Vioxx, but has no plans to remove it from the market.

[full article at above listed website]


date: 12/16/04

New Worries About Drug Safety
Matthew Herper, 12.16.04, 4:45 PM ET

NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.

The survey, which was obtained by two non-profit advocacy groups, the Union of Concerned Scientists and Public Employees for Environmental Responsibility, under the Freedom of Information Act, has some severe limitations--most notably, that only 47% of the 846 FDA staff who were queried responded to the late-2002 survey. Still, it would seem to boost the case of FDA whistleblower David Graham, who has warned about the current system for insuring drug safety. (See: Face of the Year: David Graham)

The survey can be found here, and an internal report regarding the results from the Department of Health and Human Services, the U.S. government agency under which the FDA falls, can be found here.

FDA officials were not immediately available for comment.

Graham, a proponent of drug safety, said in testimony before a Senate committee, that the current drug safety monitoring system could not prevent another case like the withdrawal of Vioxx, the Merck (nyse: MRK - news - people ) arthritis drug, that was pulled from the market because it raised the risk of heart attack and stroke with long-term use. The drug had been on the market for five years.

"Vioxx is a terrible tragedy and a profound regulatory failure," Graham told the Senate Finance Committee last month. "I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless."

Graham has been involved in the decision to pull ten drugs from the market, including Abbott Laboratories' (nyse: ABT - news - people ) Omniflox, Wyeth's (nyse: WYE - news - people ) Fen-Phen and Redux, and Pfizer's (nyse: PFE - news - people ) Rezulin. [See: Five Withdrawn Drugs]

In previous interviews, Graham has outlined the problems with the system. Doctors report side effect voluntarily, and the FDA only finds out about a small fraction--at most one-tenth--of these side-effect cases. This makes it incredibly difficult to figure out how often a problem is occurring. With Vioxx, there was an added problem, because heart attacks and strokes are common in the same arthritis patients who took the drug for pain. Therefore, it's possible they could slip under the radar entirely.

The issue of drug safety is becoming increasingly prominent. In a recent call, Sanford C. Bernstein analyst Gbola Amusa, analyzed the FDA's safety reporting data for Crestor, a cholesterol drug made by AstraZeneca (nyse: AZN - news - people ). This, he wrote, boosted the concerns of Graham and of public advocacy organizations and medical journals that called into question Crestor's safety. "Even if not withdrawn," Amusa wrote, "Crestor's commercial prospects are markedly diminished after the decision of European regulators to re-label Crestor, scrutiny from Lancet, scrutiny from Public Citizen and Dr. Graham's recent commentary."

Post-Vioxx, the debate on drug safety seems to only be getting hotter. 

Another "Pinocchio" Award
date: 12/22/04


$508,050 From Pfizer, but No 'Outside Positions to Note'

By David Willman
Times Staff Writer

December 22, 2004

BETHESDA, Md. — While reviewing financial disclosure reports from scientists at the National Institutes of Health, ethics officer Olga Boikess noticed that Dr. P. Trey Sunderland III had not declared any jobs with industry.

In an e-mail sent in March 2000, Boikess told Sunderland: "You did not list any outside positions."

Sunderland, a leading NIH psychiatric researcher, replied: "I do not have any outside positions to note."

In fact, Sunderland had been paid $77,000 in consulting and speaking fees the previous year by Pfizer Inc., now the world's biggest drug company, according to company documents. Between 1998 and 2003, Pfizer paid him $508,050. He did not seek approval to work for Pfizer, and he did not report any of the income to the NIH, as required by agency rules.

Pfizer's payments to Sunderland and his failure to follow the NIH's reporting requirements were described at a congressional subcommittee hearing in June.

Subsequent interviews and government and company documents examined by the Los Angeles Times — including the e-mail exchange with the ethics officer — show that Sunderland's paid efforts for Pfizer often overlapped with his NIH role.

Sunderland took the fees from Pfizer at the same time that he led an NIH study of Alzheimer's patients in which the company collaborated.

He also endorsed use of Aricept, Pfizer's drug for Alzheimer's, during a televised presentation at the NIH in 2003. Sunderland did not tell the audience about his affiliation with the company.

Sunderland, 53, is one of the nation's leading researchers on Alzheimer's, the malady that causes dementia in approximately 10% of people over age 65.

He joined the NIH in 1982 after earning an undergraduate degree at Harvard University and a medical degree at George Washington University. As chief of the geriatric psychiatry branch at the agency's National Institute of Mental Health, he has focused on finding ways to detect the disease before a patient develops pronounced symptoms.

Pfizer, along with a corporate partner, Eisai Inc. of Japan, stands to gain billions of dollars in sales from early stage treatment of Alzheimer's. The companies jointly market Aricept, which is approved for treating the symptoms of mild to moderate Alzheimer's. The once-a-day pill generated worldwide sales of $1.6 billion last year, making it the top-selling Alzheimer's drug.

Sunderland also consulted for Eisai from 1999 to 2003, according to information newly provided to the NIH by Sunderland's attorney. Sunderland's income from Eisai was not reflected in documents that the NIH turned over to Congress this year.

Government and company documents show that Sunderland teamed up with Pfizer in both his government and his private roles beginning in 1998. He worked for the company as a paid consultant — and at the same time led his NIH laboratory in an official research collaboration with Pfizer.

While the NIH allows many forms of moonlighting, the agency forbids its scientists from accepting income from a company that is collaborating with their government laboratory.

The policy seeks to protect the independence of the labs and is consistent with federal law, which prohibits employees from being paid by an outside party for performing government work.

The results of the NIH-Pfizer collaboration, announced in April 2003, underscored the promise of early detection of Alzheimer's. An NIH news release quoted Sunderland, who said such diagnoses "could point to new possibilities for preventive" drugs.

The news release did not mention that Sunderland was a paid consultant to Pfizer.

Investigators at the NIH director's office are assessing whether to refer Sunderland's conduct to the inspector general at the Department of Health and Human Services, documents show.

Sunderland declined to answer questions submitted to him for this article.

Sunderland's attorney, Robert F. Muse, said in recent letters to the NIH that his client had not intentionally ignored any rules.

"Dr. Sunderland deeply regrets that he did not pay more attention to the forms that are now the subject of this review," Muse wrote. "But this lack of attention to outside activity reporting does not justify an inference that he was hiding his outside activities or that a conflict of interest existed."

Sunderland began his research of Alzheimer's in the early 1980s by studying elderly patients who were recruited to the NIH Clinical Center, the world's largest facility for experimental medical treatment.

Several times a year, the patients returned to have their spinal columns tapped for samples of fluid. Sunderland and his staff would examine the samples for biological "markers" that might provide clues for selecting new treatments. By the late 1990s, Sunderland had collected samples from about 600 spinal taps.

In spring 1998, Pfizer joined the NIH in a formal research collaboration. The "material transfer agreement" called for Sunderland's staff to provide samples of the spinal fluid to Pfizer. The company in turn would share its analyses of the materials with the NIH.

Sunderland already was on Pfizer's payroll as a consultant, according to company and government records.

Within months, the company assigned Sunderland research that even more directly overlapped his government responsibilities. He was "to assist Pfizer in its program to study known markers of Alzheimer's disease," the records show.

Sunderland has repeatedly encouraged the use of Aricept and other drugs in its chemical class. At a number of points, he did not acknowledge his role with Pfizer, records show.

In 1998, he wrote two medical journal articles praising Aricept, which Pfizer and Eisai had just begun marketing to doctors in the U.S.

In one article, Sunderland wrote that Pfizer's drug "appears to be less toxic and better tolerated" than a competing medication. Using either Aricept or tacrine, he wrote, "provides modest significant symptomatic improvement in patients with mild to moderate Alzheimer's disease."

Neither article disclosed to its physician readers that Sunderland was a paid consultant to Pfizer. Sunderland's attorney has told the NIH that his client often acknowledged his affiliation with Pfizer when addressing physicians.

On April 15, 1999, Sunderland and one of Pfizer's chief researchers spoke together at an NIH conference, where an array of researchers, industry executives and federal regulators came to discuss new ways to develop drugs.

Sunderland's counterpart from Pfizer underscored the special value to the company of gaining access to the extensive spinal samples drawn at the NIH.

"I want to emphasize," said B. Michael Silber, Pfizer's director of genetics research, "that the beauty of what we're able to do as a partnership has really evolved because of Dr. Sunderland's ability to attract the kinds of patients to be followed in [long-term] studies … and who are granting us the permission to be able to take samples from them."

Silber called the then-ongoing project with the NIH "a very exciting collaboration" that, if successful, would help Pfizer to decide which drugs to push toward "expedited review and approval."

Sunderland did not tell the crowd that he was a paid consultant to Pfizer.

From 2001 to February of this year, Pfizer also paid consulting fees totaling about $64,500 to one of Sunderland's NIH staff, biostatistician Karen T. Putnam. Her attorney, David Schertler, said that based on a conversation with Sunderland, Putnam chose not to seek approval from the NIH to consult for Pfizer.

During recent questioning by NIH investigators, Sunderland said that he did not recall advising Putnam, according to a summary of the interview.

Sunderland was often on the road for Pfizer. From 1999 to June of this year, he appeared as a speaker for Pfizer at more than 80 domestic and international gatherings of doctors, documents show.

In July 2003, Sunderland also was coauthor of a report that urged the government and insurers to pay for more prescriptions for seniors with mood disorders, including Alzheimer's. Three coauthors of the report, published in Archives of General Psychiatry, listed their financial ties to Pfizer. Sunderland did not.

Pfizer and nine other drug companies helped pay for preparation of the report.

On Sept. 16, 2003, Sunderland delivered a public lecture at the NIH, "Alzheimer's Disease: Advances and Hope," during which he summarized his long-term work with the spinal fluids. The session was broadcast several times by C-SPAN.

A member of the audience asked Sunderland if he would object to a patient taking Aricept in combination with vitamin E "as an attempt at preventing or delaying possible onset of Alzheimer's."

Sunderland replied: "The quick answer is no. I have no problem with it." In fact, he said, "we're advocating" use of multiple medications simultaneously.

Again, Sunderland did not tell the audience about his paid role with Pfizer.

Sunderland also did not note that his comment on using Aricept for prevention exceeded the purpose for which the Food and Drug Administration approved the drug: treating symptoms of mild to moderate Alzheimer's.

Aricept and other drugs in its chemical class increase levels in the brain of a chemical that nerves use to communicate with one another. The drugs have not been proven to prevent or slow or halt the advance of Alzheimer's. On the other hand, doctors are permitted to prescribe drugs for any medical purpose they deem appropriate.

Dr. Russell Katz, who supervises the FDA's reviews of drugs for Alzheimer's, said in an agency newsletter last year that the compounds in Aricept's chemical class had "an effect on symptoms." But Katz added that the FDA had "no evidence that they have any effect on the underlying progression of the disease. During treatment, as far as we know, the nerve cells are still dying."

And there are side effects: At least 10% of patients who took Aricept in clinical trials suffered nausea or diarrhea — about double the rates of those given a placebo pill, according to Pfizer's data.

Muse, Sunderland's attorney, told the NIH in a letter this month that his client had not encouraged use of any Pfizer product "in an unbalanced way." Muse also has presented materials to NIH investigators showing times when his client acknowledged his ties to Pfizer and other drug companies at formal presentations to physicians.

"Several NIH administrators," Muse said in a letter to the agency on Aug. 31, also had known about Sunderland's role with Pfizer.

"Trey Sunderland has brought honor and distinction to the National Institutes of Health," Muse wrote. "His reputation with colleagues throughout the profession has been sterling. His leading role in the effort to tackle Alzheimer's disease is well recognized both nationally and internationally. His groundbreaking scientific work — and his effective communication of that work in a language that nonscientists can understand — represent the best that the NIH has to offer."


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