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.

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.)

Continue reading “For No One”

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.

Continue reading “The Act and Follow-through of Suicide: Part IV”

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:

Continue reading “The Act and Follow-through of Suicide: Part II”

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)

Continue reading “Pristiq receives approval from FDA”

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.