FDA: Doctors don't disclose conflicts of interest? We don't really care

According to a NYTimes article, government investigators have reported that the FDA doesn’t seem to care much about the financial disclosure of doctors who participated in clinical trials of medication and diagnostic devices. Then get this:

Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort. (Despite the fact that the FDA’s rules require it.)

Doctor making moneyThe article goes on to say that in 42 percent of clinical trials, the FDA did not receive financial disclosure forms that might report conflicts of interest and never followed up on them. In 31 percent of the trials in which the forms were received, “agency reviewers did not document that they looked at the information.” And then, in 20 percent of the cases in which doctors disclosed significant financial conflicts—”neither the FDA nor the sponsoring companies took any action to deal with the conflicts.”

Apparently, the NIH has been investigated for the same thing and government investigators came to the same conclusion as in the FDA case.

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For No One

NOTE: This post heavily focuses on God, His impact on my life, and living according to the Bible.

When I talk to my husband about embarking on freelance writing, he often asks me: "What do you define success as?"

Hmm. Good question.

My responses vary:

"It’s educating others and making a difference in other people’s lives."
"Bringing in a decent income."
"Doing what I love to do every day."

But if I’m honest with myself, I define success as writing a brilliant piece, receiving recognition, being lavished with laud and praise over it, and winning a slew of writing and/or journalism awards. I’ve done it in the past. I’d like to do it all over again.

Back in my senior year of college, I won an award as the best student print journalism writer on Long Island. I beat out I-don’t-know-how-many other college students on an island that boasts a population of 2.8 million (as of the 2000 census). Sure, it was just college but it opened my eyes and made me feel as though I had the potential to do that on a bigger scale.

Then comes Epic Fail. (Link provided for your amusement.)

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The Act and Follow-through of Suicide: Part IV

Compilation of Statistics Regarding Suicide

Scott Anderson in his NYT article weaves the grim statistics of suicide in and out of his story. Here’s the morbid list:

General

  • mental illnessThe nation’s suicide rate (11 victims per 100,000 inhabitants) is almost precisely what it was in 1965.
  • In 2005, approximately 32,000 Americans committed suicide, or nearly twice the number of those killed by homicide.
  • The National Institute of Mental Health says that 90 percent of all suicide “completers” display some form of diagnosable mental disorder.

Demographics

  • Both elderly men living in Western states and white male adolescents from divorced families are at elevated risk.

Premeditation vs. Passion

  • [T]he person who best fits the classic definition of “being suicidal” might actually be safer than one acting in the heat of the moment — at least 40 times safer in the case of someone opting for an overdose of pills over shooting himself.
  • In a 2001 University of Houston study of 153 survivors of nearly lethal attempts between the ages of 13 and 34, only 13 percent reported having contemplated their act for eight hours or longer. To the contrary, 70 percent set the interval between deciding to kill themselves and acting at less than an hour, including an astonishing 24 percent who pegged the interval at less than five minutes.
  • “Sticking one’s head in the oven” became so common in Britain that by the late 1950s it accounted for some 2,500 suicides a year, almost half the nation’s total. By the early 1970s, the amount of carbon monoxide
    running through domestic gas lines had been reduced to nearly zero. During those same years, Britain’s national suicide rate dropped by nearly a third, and it has remained close to that reduced level ever since.

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The Act and Follow-through of Suicide: Part III

Premeditation vs. Passion

Author Scott Anderson in his NYT magazine article, "The Urge to End It All," notes:

Just as with homicide, researchers have long recognized a premeditation-versus-passion dichotomy in suicide.

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The Act and Follow-through of Suicide: Part II

The British Coal-Gas Story

According to Scott Anderson’s NYT article, the little-known British coal-gas story — even among mental health professionals — is a good example of how suicides can be prevented if one takes away the means:

Coal-gas ovenFor generations, the people of Britain heated their homes and fueled their stoves with coal gas. While plentiful and cheap, coal-derived gas could also be deadly; in its unburned form, it released very high levels of carbon monoxide, and an open valve or a leak in a closed space could induce asphyxiation in a matter of minutes. This extreme toxicity also made it a preferred method of suicide. “Sticking one’s head in the oven” became so common in Britain that by the late 1950s it accounted for some 2,500 suicides a year, almost half the nation’s total.

Those numbers began dropping over the next decade as the British government embarked on a program to phase out coal gas in favor of the much cleaner natural gas. By the early 1970s, the amount of carbon monoxide running through domestic gas lines had been reduced to nearly zero. During those same years, Britain’s national suicide rate dropped by nearly a third, and it has remained close to that reduced level ever since.

Experts seems to insist that committing suicide is proof of an underlying mental illness. Suicide that stems from impulsivity, among these experts, is also considered part of a mental illness. Anderson subtly argues against this, and I find myself agreeing with him:

How can this be? After all, if the impulse to suicide is primarily rooted in mental illness and that illness goes untreated, how does merely closing off one means of self-destruction have any lasting effect? At least a partial answer is that many of those Britons who asphyxiated themselves did so impulsively. In a moment of deep despair or rage or sadness, they turned to what was easy and quick and deadly — “the execution chamber in everyone’s kitchen,” as one psychologist described it — and that instrument allowed little time for second thoughts. Remove it, and the process slowed down; it allowed time for the dark passion to pass.

Would this mean that if people had less access to suicidal means that promoted “ease, speed, and certainty of death” (ESCOD), a number of suicides could be averted? It appears so. Anderson continues to make a case using the Ellington Bridge in Northwest Washington as an example:

Read the rest of this entry »

Great editorial in NYTimes

The New York Times published a great editorial supporting a ban on much of the lavish treatment that doctors get from drug reps. If adopted by medical schools, restrictions would include:

  • Ban on personal gifts, industry-supplied foods and meals, free travel (not reimbursed for services), and payment for attending industry-sponsored meetings
  • Ban on ghostwriting, the practice of drug companies drafting an article and then getting a doc to slap his or her name on it making it look at though the doc actually wrote it
  • Drug samples would have to be submitted to a central pharmacy not individual doctors

The restrictions, however, end there. The editorial says the proposal goes far but not far enough.

Patients need to be assured that their doctors are prescribing what’s best for them, not what’s best for companies.

Can someone get a doctor to read this?

NYTimes

“The drugs save lives, and we often have no choice but to use them — even if we have questions about their long-term use. But the questions are big ones, and we owe it to our patients to try to answer them.”

Richard FriedmanDr. Richard Friedman, a frequent mental health columnist for the New York Times, has written a piece that questions the use of antidepressants and how dependent patients have become on them. I’ve read Friedman’s previous columns and appreciate his realistic take on the psychiatric and psychological field. His most recent piece is worth reading.

Loose Screws Mental Health News

An article in the NYTimes addresses the issue of diagnosing mental health in developing countries. A startling fact:

Depression and anxiety have long been seen as Western afflictions, diseases of the affluent. But new studies find that they are just as common in poor countries, with rates up to 20 percent in a given year.

emoIn India, as in much of the developing world, depression and anxiety are rarely diagnosed or treated. With a population of more than one billion, India has fewer than 4,000 psychiatrists, one-tenth the United States total. Because most psychiatrists are clustered in a few urban areas, the problem is much worse elsewhere.

Looks like depression is really more than just a whiny rich American kid who chooses to be upset because he’s got nothing better to do. That’s “emo” for those who aren’t hip-to-the-jive. 😉


On The Elite Agenda, Dr. Fred Baughman mentions Swedish writer Janne Larson who asserts that “over 80 percent of persons killing themselves were treated with psychiatric drugs.” Thank God for FOIA that provides the docs to back this up:

According to data received via a Freedom of Information Act request, more than 80 percent of the 367 suicides had been receiving psychiatric medications. More than half of these were receiving antidepressants, while more than 60 percent were receiving either antidepressants or antipsychotics. There is no mention of this either in the NBHW paper or in major Swedish media reports about the health care suicides.

I guess Sweden isn’t the only country in the world that wants to sweep unfavorable mental health coverage under the rug. By the way, Sweden also is considered to be the seventh happiest country in the world.

While the FDA has recognized that antidepressants can cause an increase in suicidal behavior (as indicated by the “black box warning”), antipsychotics seem to have fallen under the radar. In fact in 2002, Clozaril was approved to combat suicidal behavior in schizophrenic patients. Since then, research has shown that antipsychotics can increase suicidal behavior in schizophrenic patients twenty-fold.

Akathisia – a serious side effect that has occurred for nearly all psych drugs in clinical trials – has been found to be linked to suicidal behavior with not only antidepressants but also in conjunction with antipsychotics.

Finally, Baughman closes with this:

It is important to note that nearly every school shooting that has happened in the United States over the last decade has been conducted by young males who were taking antidepressant drugs. The drugs not only cause suicidal behavior, they also seem to promote extreme violence towards other individuals. In most school shooting cases, the young men committing the violence also committed suicide after killing classmates and teachers. These are classic signs of antidepressant use.

I don’t know if that’s wholly true but it’s a trend I’ve seen with Cho, Kazmierczak, and Eric Harris of Columbine. Since 1996, there have been 55 major school shootings all around the world; 43 of them occurred in the U.S. Makes you wonder how many of these gunmen were on a psychotropic drug – prescribed or not – of some kind.

(Image from Style Hair Magazine)

Pristiq receives approval from FDA

PristiqMore than a year ago, I promised to keep tabs on Wyeth’s new (renamed, rather) drug Pristiq. So I’m living up to it.

On February 29, 2008, the FDA granted Wyeth approval to move forward with putting the drug out on the market.

Wyeth said the company planned a big sales effort to introduce the product to psychiatrists and primary care doctors.

There’s a problem with that sentence. I’ll give you a second to figure out what’s wrong with it. Haven’t got it yet?

Primary care doctors. PCP should not be in the business of prescribing or providing psych meds. I’ve gone on and on about it at length before, but I’ll mention it again. PCPs are trained to treat overall conditions that have no need of referral to specialists. Think about it this way: If your psychiatrist prescribed anti-inflammatory medication because you mentioned that you’ve been having problems with your foot, you’d be taken aback, right? If a dermatologist prescribed heartburn medication after a patient mentioned he’d been having heartburn trouble, that would seem almost illogical, wouldn’t it?

(Pristiq logo from Pristiq.com)

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Loose Screws Mental Health News

"Can an antipsychotic drug from the 1950s be paired with a 1980s antibiotic to shrink 21st-century tumors?"

That's the first line from the NYT's recent article on biotech companies mixing two unrelated generic drugs to treat medical problems. Alexis Borisy, the executive of CombinatoRx, is spearheading the movement to mix and match two different generic drugs in the hopes that the combo will cure or effectively treat a disease that may be unrelated to the drugs' initial purposes.

"Orexigen, in creating its obesity drug Contrave, took a treatment used for drug and alcohol addiction and combined it with an antidepressant sometimes used to help people quit smoking." (My guess is that the antid was Zyban.)

It's a nice concept, but I'd hate to see risk of side effects doubled. One med can be a doozy; coupled with another could turn out to be problematic.


More from the NYT: Pharmaceutical companies pay psychiatrists (to push their products) more than doctors in any other specialty.

"For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved."

The bipolar child paradigm.

Vermont officials disclosed Tuesday that drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state’s Medicaid program.

Over all last year, drug makers spent $2.25 million on marketing payments, fees and travel expenses to Vermont doctors, hospitals and universities, a 2.3 percent increase over the prior year, the state said.

The number most likely represents a small fraction of drug makers’ total marketing expenditures to doctors since it does not include the costs of free drug samples or the salaries of sales representatives and their staff members. According to their income statements, drug makers generally spend twice as much to market drugs as they do to research them.

Doesn't the last sentence make you feel all warm and fuzzy inside? It's great to know that getting people to use drugs are more important to these companies than making sure these drugs are safe to use. Yeah, yeah, I know, it's a company and companies are only out to make profits. Whatever kind of optimist is in me wants to believe that maybe there's one doctor out there who is more motivated by helping others than by pharma-backing money. But I'm only a slight optimist.

Take two pills and call me if there's a birth defect

A recent article in the NYT reported that two studies released in The New England Journal of Medicine claim that an antidepressant could potentially increase the risk of a baby being born with a birth defect, but, uh,  it's unlikely and "confined to a few rare defects."

Benedict Carey, author of the article, points out that the studies didn't have a good sampling to really prove that assertion:

"In both studies, researchers interviewed mothers of more than 9,500 infants with birth defects, including cleft palate and heart valve problems. They found that mothers who remember being on antidepressants like Zoloft, Paxil, or Prozac while pregnant were at no higher risk for most defects than a control group of women who said they had not taken antidepressants."

So what's it's sounding like for me is that researchers got a group of expecting moms together, basically said, "Hey, have you taken an antidepressant?" and the ones who said yes were placed in one control group and the ones who said no were placed in another. How reliable.

Having been part of a clinical trial for bipolar disorder, I know it's likely these women got paid for their participation in this study. (Most people do, from what I understand.) So some could essentially have lied in the hopes they could snag $100. It doesn't sound like these women agreed to have their past medical history released to researchers that could prove they've been on antidepressant medication, they could have just been like:

"Uh, yeah. I took the antidepressant with the happy little egg sad face thingy."

Doctor: "Zoloft?"

"Yeah, yeah! That one. It maketed me alllll better."

Remember – it's mothers who "remembered" being on antidepressants while pregnant, not medical histories that proved that they've at least been prescribed the medication.

One doctor, not involved in the research, had reservations about the so-called findings:

"These are important papers, but they don't close the questions of whether there are major effects" of these drugs on developing babies, said Dr. Timothy Oberlander, a developmental pediatrician at the University of British Columbia, who was not involved in the studies.

Despite the seemingly positive outcomes that "support doctors' assurances that antidepressants are not a major cause of serious physical problems in newborns," both studies uncovered some pretty serious – but considered rare – conditions.

"One of the studies, led by Carol Louik of Boston University and financed in part by the drug makers GlaxoSmithKline and Sanofi-Aventis, found that use of Paxil was associated with an increased risk of a rare heart defect, which the company had previously reported.

The other study, led by Sura Alwan of the University of British Columbia, found that use of antidepressants increased the risk of craniosynostosis, a condition in which the bones in the skull fuse prematurely. Rare gastric and neural tube defects may also be more common in babies exposed to the medication, the studies suggested."

But don't worry, pregnant moms – the risks are low, "appear remote, and confined to a few rare defects." So, hey, even if your baby DID develop a rare defect, at least it's rare! [sarcasm]

I'd take the chance of depression if it meant my baby had a better chance of being born healthy. I'm lucky – I couldn't take Lamictal if I got pregnant. I wish antidepressants would have the same instruction.

Empathetic therapists

Read a good op-ed in New York Times on whether therapists need to have shared experiences with their patients to be a good therapist.

Loose Screws Mental Health News

In one of the scariest articles I’ve read in a while, Ms . Jane Brody in the NYT explains the symptoms and results of an illness called serotonin syndrome. And yes, too much of it can be fatal. Key symptoms to watch out for:

  • Cognitive-behavioral symptoms like confusion, disorientation, agitation, irritability, unresponsiveness and anxiety.
  • Neuromuscular symptoms like muscle spasms, exaggerated reflexes, muscular rigidity, tremors, loss of coordination and shivering.
  • Autonomic nervous system symptoms like fever, profuse sweating, rapid heart rate, raised blood pressure and dilated pupils.

(link attribution: Furious Seasons)

doggieIn another story that I find appalling, the FDA has approved a drug for carsick dogs. Yes, that’s right. Carsick dogs. soulful sepulcher first wrote about it and linked to the original story. How long before kids start taking this stuff to get high or something? You know something’s wrong when dogs can die from serotonin syndrome and feel better off of FDA-approved drugs. *shakes head* He’s cute, but he’ll just have to throw up.

Mean behavior isn't always mental illness

OK – I continue my streak of NYTimesing (lookee! A verb!) and post a link to an essay by Dr. Richard Friedman about how chronically "mean" people may not have a mental illness. They are just… well, mean.

Friedman raises an interesting point about how psychiatry and psychology try to explain away so much of people’s behaviors via diagnosis that people aren’t left any room to be "normal." Mean people don’t need to be lumped into a category of "anger disorder" or some crazy nonsense like that. Perhaps there are people who have extreme issues with anger and need to learn behavioral techniques to get it under control. But other people at their very core like to hurt, manipulate, and demean others. This is not a mental illness. This is a human, sinful nature.

Catching up: Furious Seasons

I’ve been out of it. Really out of it.

In my backlog of reading, Furious Seasons has posted the results of what he’s entitled, "The Zyprexa Chronicles."

The judge ruled in favor of Lilly.

Holy crap. I knew this would happen, but hoped it wouldn’t.

This all occurred on Feb. 13, so I’m really behind the times here. (Did Punxsawtawney Phil see his shadow yet?) But it’s a reminder to, not just the blogosphere, but also to the media that, well, pharma companies are more powerful and have more sway in court.

After reading a bit more on the situation (ok – I’m getting all my info from ONE blog), it seems that the judge hasn’t really ruled against blogs using or disseminating these documents (MindFreedom.org being the exception apparently) but these leaked documents could cause Lilly "irreparable harm." What? Documents that need to be made public would harm Lilly? It’s David against Goliath. Mainstream media — CBS, ABC, NBC, AP — haven’t picked up on this story. The majority of Americans – I’d venture to say the majority of Zyprexa consumers – don’t know about the proven side effects of this drug. I highly doubt it would cause "irreparable harm."

Classic quote:

"The way reporters work is a good deal for the public. We get paid like school teachers, think like lawyers and detectives, fight like Marines when necessary and write like… oh, nevermind."

Man, ain’t it the truth. Especially the schoolteacher pay. Except in Brooklyn, NY where they’ll pay a starting teacher at $40K because they need teachers in the inner city. But I digress.

"So, Ms. [Marni] Lemons (Eli Lilly spokeswoman), what I reported on yesterday — that your company was talking about potentially downplaying glucose increases noted in studies used to approve Zyprexa for long-term use in bipolar disorder — was based on these documents and it sure looks to me like your employees were strategizing all over the Lilly email system. I contacted your press office on Monday and asked them to respond to several questions about that document. Your people never responded….

The same goes for you people at the FDA. Stop telling me to file FOIAs in order to get basic public information that affects millions of people that should already be freely available on your website."

For those who don’t know, FOIA stands for Freedom of Information Act, in which anyone can write to a governmental agency and appeal for documents that have been made public. The nice part about this? The agency can black out information that don’t want you to know. They can deny your request, block out some data, or block out so much that the document ends up being useless. Oh, and FOIAs take forever and freaking day to arrive because the gov’t sends them when it’s convenient for them.

Furious Seasons has also been following the NYT’s coverage about a child diagnosed with ADHD and bipolar, who was killed and supposedly overdosed on medication. Riiight. Unfortunately, from what I can see – perhaps I’ll find a bit more – the NYT is extensively covering mental health issues. Perhaps they’re getting a ton of hits on the Zyprexa series and have figured out that people actually care about mental health topics. Whatever the reasoning, I’m glad they’re doing it.

Astute observation from Furious Seasons:

"This whole diagnose-medicate-blame-the-"illness"-for-bad-outcomes nonsense has got to stop. It’s bad enough in adults and teens, but in kids it is a complete outrage. It is interesting to me, though, that when a child dies, the skeptical questions are asked. When an adult has awful results from taking Zyprexa, say, or Paxil, the media is largely silent."

More to come on other blogs…

Blogs vs. Mainstream Media

“Mr. [James B.] Gottstein, [a lawyer from Alaska, who was pursuing unrelated litigation for mentally ill patients in his state], sends [Dr. David Egilman, a consulting witness in ongoing litigation against Lilly] a subpoena for copies. Hell begins breaking loose.” – Tom Zeller, Jr. in The New York Times

I think Furious Seasons originally linked to this (I can’t remember the source of the post), but I read this on the NYT and had a few thoughts, regarding brick-and-mortar courts vs. “teh Internets.”

Warning: Rant ahead.

I can’t help but think back to the 2004 showdown between Dan Rather and CBS (endearingly named Rathergate) vs. political blogs regarding a memo about George W. Bush’s service in the Texas Air National Guard. From NewsMax:

“Added [Matthew] Sheffield [of RatherBiased.com]: A virtual think-tank was born… Forty-seven posts later, a person who called himself ‘Buckhead’ offered the proposition that he thought the documents were forgeries.’

Sheffield and his Web site jumped on the bandwagon, searching the Web for experts on 1970’s typewriters. Another blogger site, PowerlineBlog.com, raised the question of forgery. ‘Matt Drudge and his DrudgeReport.com then linked to the Powerline piece, and the story took off,’ recounted Sheffield.”

Someone please tell Drudge about Zyprexa, Risperdal, Cymbalta, Seroquel, Abilify, and blah blah blah, psych med, blah blah blah.

“Some media observers now contend the “Blogosphere” is rapidly replacing CBS and the rest of the mainstream media.

“You’ll note that several blogs rank higher than mid-size daily newspapers and some are pushing the sites of papers in the top 50 (by daily circulation). The data suggest that the question isn’t “When will blogs arrive?” but rather “Blogs HAVE arrived, what now?” [said Kevin Aylward of Wizbangblog.]”

I’ll probably have a string of quotes from the newsmax article, but I will eventually get to my point.

I quoted this previously, but it’s worth requoting:

“It’s great that [Philip] Dawdy [of Furious Seasons] has stepped up for a huge, mainly voiceless population, but on the other hand, it’s weird to see citizen journalists so responsible for watchdogging our mental health industry. When we hear newspapers complain about declining readership, we can’t help but think it’s mainly because — gosh, this is awkward — the shit they’re reporting on isn’t newsworthy. And this shit is.” – Seattlest

Read the rest of this entry »

Bloggers are mental health watchdogs

Seattlest wrote a piece on Philip Dawdy and how he’s been tracking the story of a cop who was fired for being bipolar despite several years of stellar service on the force. I can’t investigate things to the depth that he can, but Seattlest has an awesome quote that I had to use here:

"It’s great that Dawdy has stepped up for a huge, mainly voiceless population, but on the other hand, it’s weird to see citizen journalists so responsible for watchdogging our mental health industry. When we hear newspapers complain about declining readership, we can’t help but think it’s mainly because — gosh, this is awkward — the shit they’re reporting on isn’t newsworthy. And this shit is." [emphasis all mine]

With the exception of the NYT, no one else IS monitoring the mental health industry for abuse of power. It’s pretty sad that organizations like NIH and NIMH, which are supposed to be helping patients, can be bought out. Can the mental health bloggers take down Big Pharma like the political bloggers took down, uh, well… Dan Rather?

Pessimists get heart disease while Lexapro's "better" than Cymbalta

If view the glass as half-empty, you may be at increased risk for heart disease. An essay, published via the NYT, explains the findings of a study.

"A study by researchers in the Netherlands has found that people who are temperamentally pessimistic are more likely to die of heart disease and other causes than those who are by nature optimistic."

While people with depression are at a higher risk for poor health, pessimists apparently are too.

"Dr. [Eric J.] Giltay and his colleagues found that subjects with the highest level of optimism were 45 percent less likely than those with the highest level of pessimism to die of all causes during the study.

For people who already have well-documented heart disease, depression increases the risk of death about threefold."

Dr. Richard A. Friedman, author of the essay, get to the heart (npi) of the matter: screen pessimists for depression.


CL Psych wrote about how Lexapro’s data beat Cymbalta’s data but in a semi-shady manner. My mind can’t comprehend all the scientific math and data behind this so feel free to read his post and ask him your questions.

Loose Screws Mental Health News

Yay for the New York Times! Alex Berenson, doggedly keeping up on the Zyprexa story, has written an article about how state prosecutors in Vermont and Illinois are now demanding that Eli Lilly submits documents to them about their marketing practices of Zyprexa. Something I didn’t know:

“Federal prosecutors in Philadelphia have also recently accelerated their own investigation into Lilly’s marketing of Zyprexa.”

My residence in the Philly area has prompted me to follow this closely now. More juicy information:

“In a statement yesterday, Lilly said it would cooperate with the investigations and had done nothing wrong. ‘We intend to cooperate with the Illinois attorney general’s civil investigative demand relating to Zyprexa,’ the company said.

While the investigation being led by Illinois is civil, other investigations into Lilly’s conduct are both civil and criminal. [emphasis mine] Attorneys general in California and Florida may seek to recover Medicaid payments that the states made for Zyprexa. Any fine or cost recovery could be sizable, because Zyprexa has been a commercial success.”

Because investigators need to search through more than 10,000 documents relating to Zyprexa and its marketing and talk to former and current employees about the matter, it could take years for anything to happen. Berenson’s last paragraph at the end brought my excitement to a quick halt:

“As long as drug makers comply with federal requirements to provide data about their products to the Food and Drug Administration, companies have a relatively strong defense against criminal prosecution, according to lawyers who are experts in drug marketing.”

Great. So as long as Lilly complies with the FDA and state and federal prosecutors, they can escape criminal prosecution. Please don’t tell families who have loved ones who died over this medication. Lilly’s settlements are nice and all, but money is never restitution for someone’s death. I’ll soon have a post up about how Pfizer had this issue with Neurontin from 2002-2004. They, too, had to pay more than $430 million to settle lawsuits on civil and criminal charges. Pfizer plead guilty; let’s see if Eli Lilly follow suit (no pun intended).

Andre WatersI’ve been a little late on the bus with this, but I’ve previously written about Andre Waters who killed himself in November. Despite theories of depression surrounding his suicide, a neurologist has claimed that Waters sustained brain damage from playing football which triggered his depression and led to his death. Dr. Bennet Omalu, an expert in forensic pathology, says that Water’s brain tissue “had degenerated into that of an 85-year-old man with similar characteristics as those of early-stage Alzheimer’s victims.” Omalu gets pretty grim though:

“If [Waters] had lived, within 10 or 15 years ‘Andre Waters would have been fully incapacitated.'”

The NFL has no comment.

doggieAs I’ve been trying to tell my husband recently, pets can relieve symptoms of depression. Come on, who can be sad when you’ve got an happy little dog wagging its tail at you with bundles of love? (I’m thinking cute little Yorkies or friendly Golden Retrievers.) Owning a pet can have great mental health benefits:

  • Can reduce anxiety
  • Induce social contact
  • Promote a better quality of life
  • Help kids develop higher self-esteem and lower levels of fear

The only downside: animals can cause stress. But it seems like the stressors can be addressed, i.e. animal training, neutering. (source: The Trouble With Spikol)

Also linked to by Liz Spikol, another interesting mental illness combatant: sports therapy. It seems that it can help those suffering from PTSD, abuse, amnesia, and shyness. Italian doctors, however, a testing to see if soccer can treat illnesses like depression and schizophrenia. This should be interesting.

Oh, and NOTHING to do with mental illness, but I found this NYT article on weight loss and maintaining it quite interesting.

More on Zyprexa

More on Zyprexa, folks. It just isn't going to go away.

NYT reporter Alex Berenson, continuing his stellar coverage of Zyprexa's risks and exposing Eli Lilly's deceitfulness, has uncovered a recent case of a man who died using Zyprexa. John Eric Kauffman has a complicated medical, which might have led to his death. However, he was a mentally ill patient on Zyprexa and as a result of his death, Eli Lilly must report his death to "federal regulators," which it is required to do under law. However, despite his heavy smoking, he gained 80 lbs. on Zyprexa – which possibly led him to develop heart disease and become sedentary after being active most of his life. His mother says that Zyprexa did help him stave off the psychosis of his bipolar disorder, but his mother wonders if the risk was worth the early death of her son. Kauffman at 41 years old weighed 259 lbs. at the time of his death. He was 5' 10".

Which leads to the question of whether mentally ill patients should choose between taking Zyprexa – which CAN help mentally ill people – and dealing with its significant side effects or risk not taking Zyprexa when other medications won't work. In light of all this, should a doctor even continue to prescribe Zyprexa after seeing its awful side effects but left with no other choice (given that a patient is treatment-resistant to most medications)?

Eli Lilly's response to this continues to be appalling:

"Zyprexa is a lifesaving drug and it has helped millions of people worldwide with schizophrenia and bipolar disorder regain control of their lives."

It may be true that it helps people "regain control of their lives," but as for being a lifesaving drug – that's unlikely. Zyprexa has been shown to induce diabetes, obesity, hyperglycemia, and now, heart disease and death. I commend Australian regulators for looking into the details of Lilly downplaying the risk of Zyprexa and hope that they will make the information public – a different course than what the U.S. federal government seems to be taking. Lilly's 2006 settlement with patients who developed diabetes and other health problems is pure evidence that despite their constant denials, Lilly's hiding something in an effort to make profits.

My prediction: The FDA will eventually slap a black-box warning on Zyprexa, warning patients that it makes them more prone to diabetes and its other ill health effects.

Loose Screws Mental Health News

Surprise, surprise — the likelihood of suicide attempts increases with antidepressants.

     “Suicidal patients taking antidepressants have a ‘markedly increased’ risk of additional suicide attempts but a "markedly decreased" risk of dying from suicide, a large Finnish study has found.
     “The research into nearly 15,400 patients hospitalized for suicide attempts between 1997 and 2003 showed that ‘current antidepressant use was associated with a 39 percent increase in risk of attempted suicide, but a 32 percent decrease in risk of completed suicide and a 49 percent reduced risk of death from any cause,’ the authors wrote in a report published in the Dec. 4 issue of Archives of General Psychiatry.
      “The Finnish study analyzed 15,390 suicidal patients of all ages for an average of 3.4 years. The authors said they did this ‘because previous suicide attempts are the most important risk factor for predicting suicide.’”

I think 15,390 patients is a sizeable, significant study that could probably yield semi-accurate statistics.

      “Among the 7,466 males and 7,924 females examined, there were 602 suicides, 7,136 suicide attempts requiring hospitalization and 1,583 deaths recorded during follow-up. The risk of completed suicide was 9 percent lower among those taking any antidepressants than among those not taking antidepressants.
     “But the picture was not so bright for all those who took SSRIs. It was for those taking fluoxetine (Prozac), who had a 48 percent lower risk of suicide than those not taking medication. But the study found that those taking another SSRI, venlafaxine hydrochloride (Effexor XR), had a 61 percent increased risk.”

So Prozac is better than Effexor XR in terms of suicidal risk. Nice, considering that I've had a 10-year history of suicidal attempts and this study seems to show that venlafaxine increases the risk of suicide attempts. Perhaps Effexor should be prescribed to those who aren't/have never been suicidal?

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Furious Updates

Furious Seasons linked to this article about an internist who forgot about an incident with an Eli Lilly rep — until recently. Great excerpts:

     "I was reminded of the incident last week when news reports emerged that Eli Lilly had reportedly urged primary care doctors to use the drug for elderly patients with symptoms of dementia. The company has denied promoting the drug for off-label uses.
     The reports highlighted for me the crucial role that internists and other primary care doctors play in screening for psychiatric illnesses but also in knowing when to refer these patients for proper treatment. Although psychiatrists are not always available and not all patients are willing to see them, doctors must carve out our areas of expertise in keeping with our training and experience, and depression and psychosis are simply not my areas as an internist.
     I tell [patients] that this cost-benefit decision [of prescribing medicines] should be made in conjunction with the patient's psychiatrist, not solely by an internist placed under pressure by a salesperson."

To read this article, you must register with the LA Times' Web site. If you don't want to do that, just type in the following to get to the article:
          E-mail: bugmenot@bmn.com
          Password: dontbugme

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NYT video on age-related health

The NYT video on health includes a story about how health programs are aimed at baby boomers who are intent on staving off age-related problems such as dementia. (Related to Zyprexa being used off-label for dementia and all…)

NYT report

ADDENDUM: Eli Lilly wins Round 1 in court. According to the NYT, a federal appeals court has ruled in favor of Lilly in a challenge to its patent on Zyprexa. Ivax (affiliated with Teva Pharmaceutical Industries) and Dr. Reddy’s Laboratories filed a suit saying that a lower court ruling in Lilly’s favor was wrong. Lilly’s patent on Zyprexa expires in 2011. And random Zyprexa data because Seroquel actually looks better in this instance:

“Sales of Zyprexa dropped 16 percent and fell behind AstraZeneca’s Seroquel as America’s best-selling antipsychotic in 2005, according to IMS Health, which provides data on drug sales.”

Women in the Sciences

Not directly related to mental illness but a good article by the NYT on women in the sciences and why they are sorely lacking:

"Yet studies show that women in science still routinely receive less research support than their male colleagues, and they have not reached the top academic ranks in numbers anything like their growing presence would suggest."

And something that can’t help but remind me of my former employer:

"’Women in science are in a double bind,’ Dr. [Madeline] Heilman, [psychologist at New York University], said. ‘When not clearly successful, they are presumed to be incompetent. When they are successful, they are not liked.’"

It makes me wonder why the mental health industry is so effed. Is it because we don’t have women (who are more emotional and sensitive creatures) in biochem, biophysics, and neuro? The withering feminist in me can’t help but wonder.

Either way, women just can’t win.

ADDENDUM: Okay, I waited too long to post this and now, it’s apparently only available through TimesSelect. Bummer. Regardless, it was a good article. One of these days, I’ll anonymously type up the article, disseminate it all over the Internet and THEN link to it.

Catching up…

After a hectic week between work and excessive blogging, I've finally caught up to the latest NYTimes articles on Eli Lilly's troubles with Zyprexa.  I also read the NYT's editorial on the issue. The last paragraph caught my eye:

"Lilly contends that it has never promoted Zyprexa for unapproved uses and has always shown its marketing materials to the Food and Drug Administration, as required by law. Both claims ought to be tested in Congressional hearings that should focus on how well the industry complies with existing laws and how effectively the F.D.A. regulates the industry’s marketing materials."

Furious Seasons and CL Psych beat me to the punch on the skepticism. Congressional hearings would do nothing and I am even more skeptical of the FDA. Pharma companies like Lilly probably slip Dr. Andrew C. von Eschenbach some money to get their stuff approved. But I'm merely speculating because I'm tired and haven't done more research on this at the moment.

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Parenting instead of Ritalin

My husband's nephew is an overly active kid. I'm sure that if he went to public school teachers would classify him as suffering from ADHD and recommend that he take Ritalin. This article from the New York Times (the last in their series of covering mental illness in children) gives me hope that most children with ADD/ADHD can be helped without the assistance of a drug.

NYT plunges ahead with Eli Lilly story; Furious Seasons on the case

While the court is ordering the lawyer who released internal Eli Lilly docuemnts to hand them back, the New York Times is plunging ahead with more shocking revelations concerning the documents. God bless The New York Times and Alex Berenson for taking this story, running with it, and making it public. Even if the company documents become confidential, the story is out and people WILL sue in an attempt to make it public. Patients have a right to know what is affecting their bodies and why Zyprexa causes more medical complications than it helps overcome mental illness.

And God bless Furious Seasons. I don't have time to blog on it, but he does. Head over there to read his critical analysis on the whole situation.