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Politics : Don't Blame Me, I Voted For Kerry -- Ignore unavailable to you. Want to Upgrade?


To: Richnorth who wrote (66143)9/1/2005 1:12:02 PM
From: paretRead Replies (1) | Respond to of 81568
 
Are you aware that one third of all psychiatrists commit suicide-ACCORDING TO THEIR OWN RECORDS?



To: Richnorth who wrote (66143)9/1/2005 1:27:27 PM
From: paretRespond to of 81568
 
Researcher admits fraud in grant data
Ex-Vermont scientist won nearly $3m from US
By Carey Goldberg and Scott Allen, Boston Globe Staff | March 18, 2005

In the worst case of scientific fakery to come to light in two decades, a top obesity researcher who long worked at the University of Vermont admitted yesterday that he fabricated data in 17 applications for federal grants to make his work seem more promising, helping him win nearly $3 million in Eric T. Poehlman, a leading specialist on metabolic changes during aging, acknowledged that he altered and made up research results from 1992 to 2002, including findings published in medical journals that overstated the effect of menopause on women's health.

Under a plea agreement with federal prosecutors, Poehlman, 49, will be barred for life from receiving federal funding, pay back $180,000, and plead guilty to a criminal charge of fraud that could bring jail time. He agreed to ask scientific journals to retract and correct 10 articles they published by him.

''Dr. Poehlman fraudulently diverted millions of dollars," said David V. Kirby, the US attorney for Vermont. ''This in turn siphoned millions of dollars from the pool of resources available for valid scientific research proposals. As this prosecution proves, such conduct will not be tolerated."

The fraud charge carries up to five years in prison, but lawyers involved in the case said Poehlman would ask for leniency and would probably get a lesser sentence or possibly no prison time at all.

Poehlman's misconduct was detected and exposed by a former University of Vermont lab technician, Walter F. DeNino, who once viewed Poehlman as his mentor.

Poehlman was a star among obesity researchers. For years at the Universities of Vermont and Maryland and, since 2001, at the Université de Montréal, he won millions in grant dollars, copious prizes, and accolades from the students he mentored.

Over two decades in which he published more than 200 journal articles, he built a reputation as a leading authority on the metabolic changes that come with aging, particularly during menopause. He also studied the genetics of obesity and the impact of exercise, often following human subjects over time to document how their physiology changed.

Now that stellar career has unraveled. Poehlman resigned from the Université de Montréal in January. He did not respond to requests left at his Montreal home and with his attorney to be interviewed.

Some colleagues speculated that Poehlman buckled to an exaggerated perception of the pressure to publish papers and win grants to keep his laboratory going. Or perhaps he was so sure he knew the right answers that he cut corners to get to them, they said.

DeNino, the lab technician, said in an interview that he does not know what Poehlman was thinking, but the benefits were clear: The fabricated data made his grant proposals more appealing and his papers more publishable, helping Poehlman become one of the better-funded researchers at the University of Vermont. Continued...




To: Richnorth who wrote (66143)9/1/2005 1:30:36 PM
From: paretRespond to of 81568
 
Panelists in FDA Drug Vote Tied to Makers
Yahoo (AP prss release) ^ | Feb 25, 4:03 PM

A study by the Center for Science in the Public Interest indicates that 10 of the 32 panel members had ties to either Pfizer Inc. or Merck & Co., ranging from consulting fees and speaking honoraria to research support.

The FDA issued a statement saying it screened members of the panel for conflicts of interest. "This transparent process requires the agency to carefully weigh any potential financial interest with the need for essential scientific expertise in order to protect and advance the public health," the agency said.

After three days of hearings on the drugs, known as Cox-2 inhibitors, the panel voted 31-1 to keep Pfizer's Celebrex on the market, 17-13 with 2 abstentions in favor of Pfizer's Bextra and 17-15 that Merck's Vioxx should be allowed back on sale.

Merck pulled Vioxx from the market Sept. 30 after heart problems were reported in some users. Similar questions were later raised about the other two drugs, prompting the FDA to call the advisory panel to look into the matter.

Since drug companies fund many studies it is not unusual for researchers to have ties to manufacturers, though some have questioned the practice.

The transcript, including the votes by the individual members of the panel, has not yet been posted by the FDA. However, a copy obtained by The Associated Press indicated that the 10 panel members in question voted 10-0 in favor of keeping Celebrex and Bextra available and 9-1 in favor of allowing Vioxx to be brought back onto the market.

Without those ballots the vote would have been 13-7 in favor of withdrawing Bextra and 14-8 to keep Vioxx off sale.

The industry ties of the panel members were first reported Friday by The New York Times.




To: Richnorth who wrote (66143)9/1/2005 1:31:47 PM
From: paretRespond to of 81568
 
Documents Said to Show Prozac Risks
NY Times ^ | December 31, 2004 | REUTERS

LONDON, Friday, Dec. 31 (Reuters) - The British Medical Journal said on Friday it had sent documents to health regulators in the United States that it said appear to suggest a link between the antidepressant drug Prozac and suicidal behavior.

The journal said an anonymous source had provided "missing documents" relating to clinical trials of the drug, made by Eli Lilly & Company.

It said the documents had been lost during a product liability suit in 1994. They included reviews and memos that appeared to show Eli Lilly officials were aware in the 1980's that the drug, whose generic name is fluoxetine, had "troubling side effects," the journal said.

Officials at Eli Lilly, which is based in Indianapolis, could not immediately be reached for comment on the report.

In an article appearing in its Jan. 1 issue, which it posted on its Web site at www.bmj.com on Friday, the journal said it had sent the papers to the Food and Drug Administration.

It quoted Dr. Richard Kapit of the F.D.A., a clinical reviewer who approved fluoxetine, as saying that he had not been given the data highlighted in the documents, and that they were "very important."

The journal said Lilly officials declined to be interviewed but issued a statement saying the safety and usefulness of Prozac were well established.




To: Richnorth who wrote (66143)9/1/2005 1:35:51 PM
From: paretRead Replies (1) | Respond to of 81568
 
Traumatized Kerry supporters in Florida seek therapy: report

MIAMI (AFP) Nov. 9, 2004- Shocked supporters of defeated US presidential candidate John Kerry are seeking help from psychologists, who refer to their condition as "post-election selection trauma."

The Boca Raton News reported Tuesday that Palm Beach, Florida trauma specialist Douglas Schooler alone has already treated 15 clients and friends with intense hypnotherapy since the Democratic candidate conceded on November 3.

"I had one friend tell me he's never been so depressed and angry in his life," Schooler said. "I observed patients threatening to leave the country or staring listlessly into space. They were emotionally paralyzed, shocked and devastated," he told the daily.

"We're calling it 'post-election selection trauma' and we're working to develop a counseling program for it," said Rob Gordon, the Boca Raton-based executive director of the American Health Association.

"It's like post-traumatic stress syndrome, but it's a short-term shock rather than a childhood trauma," he told the daily.




To: Richnorth who wrote (66143)9/1/2005 1:40:05 PM
From: paretRespond to of 81568
 
Drug-Safety Reviewer Says F.D.A. Delayed Vioxx Study
By GARDINER HARRIS
NY TIMES November 4, 2004

n a series of testy e-mail exchanges with his bosses, a federal drug-safety reviewer contends that an effort to publish his study demonstrating the dangers of Vioxx was delayed and demeaned by top officials at the Food and Drug Administration.

The e-mail and meeting notes also show that Dr. David Graham, an official in the F.D.A.'s Office of Drug Safety, is seeking to launch a study of the safety of Bextra and Mobic, two arthritis pills that are similar to Vioxx. Merck withdrew Vioxx in September after finding that it caused an increase in the risk of heart attacks.





The proposed study of Bextra and Mobic would use data from the California Medicaid program, according to a note written Oct. 29 by Dr. Graham about a meeting held between Dr. Graham and his boss, Dr. Paul Seligman, director of the Office of Drug Safety.

The exchanges are part of a stream of e-mail suggesting a tense environment in the F.D.A. office. In one note, Dr. Graham reports that the atmosphere has gotten so bad that Dr. Seligman has said he was going to resign.

In the note from the meeting of Oct. 29, Dr. Graham wrote that Dr. Seligman said to him: "This only confirms what I suspected, that the staff don't trust me. You can't lead if the staff don't trust you. That's why I have a letter of resignation I am handing in next Tuesday.''

Dr. Seligman could not be reached for comment.

In e-mail dated Oct. 25, 2004, Dr. Graham said one of his bosses, Dr. Anne Trontell, referred to his Vioxx study's conclusions "as nothing more than a scientific rumor."

Dr. Graham defended his study and chided Drs. Trontell and Seligman for taking weeks to decide whether they would approve the study's publication in the Lancet, a leading medical journal. Dr. Trontell is the office's deputy director. Dr. Graham's study concluded that Vioxx, also known as rofecoxib, had a dangerous effect on the heart. The study has been submitted to the Lancet for peer review and possible publication. Meanwhile, the F.D.A. posted a version of the study on its Web site on Tuesday, after certain parts of the study were first published in The Wall Street Journal.

"For all the center claims in its operating principles that respect for others is a core value, my experience with rofecoxib was just the opposite from management, once the results from this study and their potential implications came to light in August," Dr. Graham wrote in e-mail dated Oct. 26.

The e-mail and notes, which were made available to The New York Times, come in the midst of a Congressional inquiry into whether the agency has been slow to respond to findings that antidepressants may cause children to become suicidal and that Vioxx may be harmful to the heart in some cases. Senator Charles E. Grassley, Republican of Iowa, who is chairman of the Senate Finance Committee, has criticized the agency for failing to respond more quickly to these findings and for suppressing the findings of its own drug safety reviewers that concluded that the drugs were risky.

In the case of antidepressants, Dr. Andrew Mosholder, another reviewer at the Office of Drug Safety, concluded last fall that depressed children should not be prescribed most antidepressants because they have failed to show any benefit against depression and may cause some to become suicidal.

Top agency officials refused to allow Dr. Mosholder to testify about his findings at a public meeting in February because they disagreed with his conclusions. A second study conducted by researchers at Columbia University confirmed Dr. Mosholder's conclusions in August, and the agency has since decided to place a "black-box" warning on the labels of antidepressants warning of the suicide risk.

In his notes on an Oct. 29 meeting with Dr. Seligman, Dr. Graham writes that he, Dr. Mosholder and others in the Office of Drug Safety feel that "the review and clearance process had been turned into a battleground, full of contention and intimidation because our managers, the people who fill out our performance evaluations, had created a system where it was taking a great risk to stand firm in our scientific beliefs."





To: Richnorth who wrote (66143)9/1/2005 1:44:11 PM
From: paretRespond to of 81568
 
Psychiatric Association to investigate Brown University

10/6/99 PROVIDENCE, R.I. (AP) - The American Psychiatric Association plans to investigate a report that the head of Brown University's psychiatric department failed to disclose more than $500,000 in consulting fees, most from pharmaceutical companies whose health benefits he praised in journals and at conferences.

Dr. Martin Keller, a noted researcher on depression, could be banned from APA-sponsored conferences if he did not follow the group's policies for financial disclosures, association spokeswoman Lynn Writsel said Wednesday.

The Boston Globe reported this week that Keller failed to disclose that he was paid more than $500,000 in consulting fees in 1998.

Most of the money came from pharmaceutical companies whose drugs he praised in medical journals and at the APA's annual meeting this year and last, the newspaper reported.

Keller, of Newton, Mass. could not be reached at his home or office for comment, and did not return messages left at both places.

The Globe reported that Keller received consulting fees from companies such as Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly - all of which market antidepressants he praised in a series of medical research reports.

The school said Keller followed the school's rules to the letter. It requires annual conflict-of-interest reports for researchers who make more than $10,000 or 10 percent in equity. The reports are reviewed by a misconduct committee and the dean of the graduate school.

But the school does not require disclosure of specific dollar amounts earned.

Writsel said an association committee will review Keller's case later this month. If the committee determines punishment is necessary, it could range from a warning to a ban from making any presentations at future meetings.

Larry Sasich, a health-research analyst for Public Citizen, a Washington watchdog organization, said it is important for researchers to disclose the full extent of their financial ties with the maker of a drug they are researching.

``The fundamental basis of scientific research is that there is an open and honest presentation of the data that is not cooked, not slanted,'' Sasich said.

--------------------------------------------------------------------------------

.

The Globe reported that Keller received consulting fees from companies such as

Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly -

all of which market antidepressants he praised in a series of medical research reports.