Once in a while the veil is removed and much is revealed. Behold Eli Lilly - in clinical trials conducted SIXTEEN YEARS AGO the company learned that 38 percent of Prozac users had,”symptoms such as agitation, panic attacks, insomnia, and aggressiveness” attributable to Prozac. In other words, Prozac possibly made people MORE VIOLENT than they were to begin with … so they force the depressed patient to take Prozac, which makes him violent, which makes his diagnosis more serious, which calls for more serious forced medicine, etc. Very convenient, eh?

Here’s the article from the British Journal of Medicine:

FDA to review “missing” drug company documents

Jeanne Lenzer

The US Food and Drug Administration has agreed to review confidential drug company documents that went missing during a controversial product liability suit more than 10 years ago. The documents appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence.

The missing documents, which were sent to the BMJ by an anonymous source last month, include reviews and memos indicating that Eli Lilly officials were aware in the 1980s that fluoxetine had troubling side effects and sought to minimise their likely negative effect on prescribing.

The documents received by the BMJ reportedly went missing during the 1994 Wesbecker case that grew out of a lawsuit filed on behalf of victims of a work-place shooting in 1989. Joseph Wesbecker, armed with an AK-47, shot eight people dead and wounded another 12. He then shot and killed himself. Mr Wesbecker, who had a long history of depression, had been placed on fluoxetine one month before the shootings.

One of the internal company documents, a report of 8 November 1988, entitled “Activation and Sedation in Fluoxetine Clinical Trials,” found that in clinical trials “38% of fluoxetine-treated patients reported new activation but 19% of placebo-treated patients also reported new activation yielding a difference of 19% attributable to fluoxetine.”

The FDA recently issued a warning that antidepressants can cause a cluster of “activating” or stimulating symptoms such as agitation, panic attacks, insomnia, and aggressiveness. Dr Joseph Glenmullen, a Harvard psychiatrist and author of The Antidepressant Solution, published by Free Press, said it should come as little surprise that fluoxetine might cause serious behavioural disturbances, as it is similar to cocaine in its effects on serotonin.

Dr Richard Kapit, the FDA clinical reviewer who approved fluoxetine, said he was not given the Lilly data. “These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it.”

Congressman Maurice Hinchey’s office is currently reviewing the documents to determine whether Lilly withheld data from the public and the FDA. Mr Hinchey (Democrat, New York) said: “This is an alarming study that should have been shared with the public and the FDA from the get-go, not 16 years later.

“This case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks.”

BMJ 2005;330:7 (1 January), doi:10.1136/bmj.330.7481.7

Okay, this has to be the most confusing story ever. It’s a Reuter’s piece on mapping emotional responses in the brain - that part is clear. The study reveals the breakthrough fact that feeling very sad after the end of a romantic relationship is a lot like being clinically depressed. They both, “showed greater decreases in brain activity in brain regions associated with emotion, motivation and attention … factors that go awry in depression and now, it appears grief as well.” Yeah. You’ve got to be a genius to know that heartache is heartache. I suppose I should be grateful that they are talking about the role of human emotions in depression at all …

Breakups Can Be Mapped in the Brain

By Alison McCook

NEW YORK (Reuters Health) - Women who are distraught after breaking up with a romantic partner show brain changes that are not seen in women less upset by a romantic rift, researchers report.

Specifically, women who said they were particularly upset about the breakup showed greater decreases in brain activity in brain regions associated with emotion, motivation and attention while thinking sad thoughts about their former partners.

Emotion, motivation and attention are “all factors that go awry in depression and now, it appears grief as well,” Dr. Jeffrey P. Lorberbaum told Reuters Health.

“We speculate that brain regions involved in emotion, motivation and attention regions are impaired with severe grief,” said Lorberbaum, at the Medical University of South Carolina in Charleston.

These findings may provide clues to how the brain processes extreme sadness, and how that sadness can sometimes lead to depression, he added. “If we can first understand the brain basis of grief then we eventually might be able to help those who are disabled by grief, as well as understand how depression gets triggered.”

By JOHN SOLOMON, Associated Press Writer

WASHINGTON - Thousands of federal doctors and medical researchers who receive some of the highest salaries in government don’t enjoy the same protections to blow the whistle on wrongdoing as other civil servants, a judge has ruled.

Administrative Judge Raphael Ben-Ami of the U.S. Merit Systems Protection Board ruled recently that Dr. Jonathan Fishbein, a National Institutes of Health

specialist, could not seek the board’s protection from firing under the Whistleblower Protection Act.

Fishbein was hired by NIH in 2003 to help improve AIDS research practices. He alleges he is being fired because he uncovered concerns about sloppy research practices that might endanger patient safety. NIH said he is being fired for poor performance and that the allegations come from a “disgruntled” employee who failed to make his two-year probation period.

…

The Associated Press reported last week that Fishbein was among several NIH employees who raised concerns in 2002 about a study in Africa involving the AIDS drug nevirapine.

Documents showed that the way the research was conducted violated federal patient safety rules and suffered from record-keeping and patient monitoring problems. But the study’s general conclusion that the drug could be used safely in single doses to protect babies from HIV (news - web sites) was upheld.

Attorney Steve Kohn, who represents Fishbein, said federal agencies like NIH have markedly increased their recruitment and hiring of employees under Title 42 in recent years, leaving an entire class of federal workers without whistleblower protections.

“It’s a game of cat and mouse, in which the real losers are the American people,” Kohn said.

link

This article is a very important read. These are the types of conditions that lead to tragedies like lobotomy. Everyone elses interests come before that of the patient.

—————–

The National Institutes of Health: Public Servant or Private Marketer?

By David Willman Times Staff Writer

For 15 million Americans, it is a daily ritual: gulping down a pill to reduce cholesterol.

They do it because their doctors tell them to. Their doctors, in turn, rely on recommendations from the National Institutes of Health (news - web sites) and its scientists, such as Dr. H. Bryan Brewer Jr.

Brewer, as a leader at the NIH, was part of a team that gave the nation new cholesterol guidelines that were expected to prompt millions more people to take the daily pill. He also has written favorably of a specific brand of cholesterol medication, Crestor, which recently proved controversial.

What doctors were not told for years is this: While making recommendations in the name of the NIH, Brewer was working for the companies that sell the drugs. Government and company records show that from 2001 to 2003, he accepted about $114,000 in consulting fees from four companies making or developing cholesterol medications, including $31,000 from the maker of Crestor.

…

But a July report by the U.S. Office of Government Ethics concluded that the NIH was beset by a “permissive culture.” The office found that 40% of the 155 outside payments to NIH employees it sampled randomly had not been approved in advance or accounted for within the agency.

Zerhouni proposed another compromise: a one-year “moratorium” on industry consulting. Details of the moratorium have not been completed.

Last month, nearly 200 NIH researchers said in a letter to Zerhouni that a permanent ban would make the scientific staff — who are paid between $130,000 and $200,000 a year by the government — “second-class citizens in the biomedical community.”

Dr. Raynard S. Kington, a deputy NIH director, said Tuesday that the agency had “moved actually quite fast” to carry out tougher restrictions. Yet he acknowledged that unless new rules were put into effect, perhaps in the new year, the scientists were free to continue collecting stock options and consulting fees from drug companies.

“Fundamentally,” Kington said, “we are operating under the same rules.”

link

This item from Reuters is particularly significant when you consider that in many cases psychiatric patients are forced to swallow medications that may be harming or even killing them:

Some FDA Staff Had Drug Safety Concerns-Survey

By Lisa Richwine

WASHINGTON (Reuters) - Nearly 20 percent of U.S. Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite their reservations about the drug’s risks or effectiveness, according to documents made public on Thursday.

Also, two-thirds of the scientists questioned by the Department of Health and Human Services’ inspector general said they lacked full confidence in the FDA’s ability to monitor side effects of prescription drugs after they hit the market.

The survey shows at least some government scientists backed accusations last month by FDA safety officer Dr. David Graham, who told a Senate hearing he was pressed to water down safety concerns about Merck & Co. Inc.’s painkiller Vioxx. The drug was pulled from the market Sept. 30 over links to heart attacks and strokes. Graham, associate director for science in the FDA’s Office of Drug Safety, also told Congress he felt the FDA was incapable of protecting the public from other dangerous drugs.



The survey of nearly 400 FDA scientists was obtained through the Freedom of Information Act by the Union of Concerned Scientists and Public Employees for Environmental Responsibility, two environmental activist groups.

Is anyone surprised to see that Representative Billy Tauzin who was a major sponsor of the Medicare drug law (you know, the one where the government is expressly forbidden to negotiate drug prices with the drug companies) is becoming a drug company lobbyist? Oh the shock!

And in case you’d like to get partisan about it, he has been both a Democrat and Republican over the years. This country is broken - it’s bought and paid for by monied interests. The people caught in the middle are the sick or those who are trying not to get sick. Why are we so complaicent?

There are those who would have you believe that all mental illness has a biological cause. When you bring up post-traumatic stress disorder they tend to mutter and then say really stuipd things like, “Stress causes physical changes in the brain.” Yeah, right.

We have a crisis coming up - it is the soldiers returning from the Iraq War with scarred souls and broken hearts. There are many who will want to give them pills and make them go away, but we know that pills aren’t enough. They need to be as honored with actions as they are with words.

The VA has already announced that it is not ready to deal with the soldiers - all 100,000 that will need help according to one Pentagon estimate. Of course, helping them now will prevent other problems like unemployment and homelessness.

To their credit, the military fully acknowledges PTSD and the devestating effect it can have. It’s an excellent improvement from the times when they denied it existed. But how to convince soldiers that it’s not shameful or weak to need support - to need to be helped? We must believe it ourselves.

The Nobel Committee strikes again, this time celebrating peace and justice through a huge Peace Prize extravaganza featuring Tom Cruise and Oprah Winfrey. Of course, the fact that they will not acknowledge their guilt in the Lobotomy tragedy makes them hypocrites of the worst kind. If they won’t acknowledge their own complicity in this crime, how can we ever trust their word again? How can we ever trust their judgment in awarding prizes again?

We can’t.

When I posted about the awful nightclub killings yesterday it was unclear that the gunman had been killed. So much for my “he’ll claim to be crazy whether he is or not” theory.

There are conflicting reports about Nathan Gale, Some say he was annoying but relatively normal. Others resported that “he was off of his rocker”. It is interesting to hear that he was in the Marine Corp but left early. I think we’ll learn much more about Gale in the days to come. It will be interesting to watch the “crazy or not” debate. As far as I’m concerned, once Jeffrey Dahmer was declared sane, all bets were off as far as legal pronouncements and mental health.

Whenever a mentally ill person commits a violent crime, the cruel people of the world hold it up as an example of how they should ALL be locked away preemptively, or at least forced to take powerful medications even if it’s against their will. Usually this advice is accompanied by dire (and inaccurate) statistics about how dangerous mentally ill people are and how likely it is that they will shoot your family and eat your babies.

But when a non-mentally ill person does something horrible like, say, shooting a band onstage and then firing into the crowd, there are no calls for all disgruntled people to be drugged or locked away.

How many times have you heard people on the news comment on an accused criminal in the following way, “He was nice, quiet, never bothered anyone. Went to work every day. I don’t know why he did this.” Non-mentally ill people sometimes snap and kill, and we can’t really predict it. The same thing happens with mentally ill people. Schizophrenic does not equal killer. “Sane” does not equal kind and gentle.

Sadly, it’s nearly impossible to predict what will lead people to violence. It’s something we need to accept - as much as we’d like, we cannot keep everyone safe all the time. There are over 2 million people in American prisons, yet murders and muggings and rapes still happen every day. That’s reality. Consider this - inside prison, where civil rights like privacy and protection from search and seizure don’t exist, there are still murders and rapes every day. No matter how tightly you control people, they will find a way to be violent if that’s what they really want.

Of course, don’t be surprised if the “Damageplan gunman” starts talking about being mentally ill. It’s all part of the horrid mixing of mental illness and legal guilt … and it’s part of what makes people think that all mentally ill people are dangerous. They see all these killers claiming to be ill and assume that there really is a connection. Once in a while it’s really true that someone committed a crime because they are mentally ill, but so many guilty people have tried to use illness as an excuse for their crime that there is no compassion left when the real deal shows up in court.

Our deepest sympathy to the families of the victims of these vile shootings. No matter what the mental state of the killer, this is a heinous, heartbreaking crime.