Showing posts with label Legislation. Show all posts
Showing posts with label Legislation. Show all posts

Monday, August 11, 2008

Getting the Massachusetts Rx Drug Marketing Reforms Bill Signed

MASSPIRG is an advocate for the public interest in the state of Massachusetts.

When consumers are cheated or the voices of ordinary citizens are drowned out by special interest lobbyists, MASSPIRG speaks up and takes action. They use the time-tested tools of investigative research, media exposés, grassroots organizing, advocacy and litigation.

Last week on August 1st, they released this press regarding the regulation of Drug Company Marketing Practices, etc in the state of Massachusetts.

Legislature Passes Rx Drug Marketing Reforms And Other Measures To Control Health Care Costs

The legislature enacted and sent to the Governor last night a Health Care Cost Control Bill that will begin to reign in aggressive and inappropriate marketing tactics by drug companies and medical device companies. Those excessive marketing tactics have resulted in excessive prescription drug costs and compromised care. Direct-to-physician industry marketing promotes the prescribing of expensive drugs in place of equally safe and effective lower-cost drugs and the prescribing of newer brand name drugs that have the least safety and efficacy information. The excessive marketing of Vioxx, for example, led to the prescribing of a new drug that ended up causing unforeseen heart problems that killed 40,000 people.

“While the bill does not include a complete ban on industry gifts to prescribers it does make a giant step forward in shining the light on this marketing practice through the disclosure of anything of more than $50 value, giving the DPH authority to ban some gifts, and including significant fines for violations of the new regulations,” said Deirdre Cummings, Legislative Director of MASSPIRG.

The final bill also included the following cost control reforms:

RX Drug Marketing Regulations: Requires pharmaceutical and medical device companies to disclose payments to health care providers of $50 or above to DPH which will make the disclosures publicly available. Directs DPH to establish regulations on pharmaceutical and medical device marketing, using the industry’s own Code as a minimum standard, and establishes a $5000 penalty for violation, enforceable by the Attorney General.

Creation of an Academic Detailing Program: A much needed counterweight to the industry’s commercial detailing and gift-giving marketing efforts. Academic detailing programs are cost-effective ways to improve physician prescribing behavior and so reduce health care costs: Based on other states’ experiences with academic detailing programs, Massachusetts can expect to save two to three dollars for every dollar we spend on academic detailing.

Use of Uniform Claim Codes: Currently, nearly one-third of all dollars spent on health care go toward administrative costs – and much of that is wasted on managing the tangle of bureaucratic claim codes created by different insurance plans. Conservative estimates project that the adoption of uniform claim codes will save Massachusetts hospitals over $50 million annually in administrative costs.

Public Reporting of Healthcare-Associated Infections and Serious Reportable Events: Requires facility-specific public reporting of infections, as already required in twenty-two other states and the reporting of, and allows for the nonpayment for, serious reportable events.

Taken together, these provisions will begin to contain the cost of health care in the commonwealth helping Massachusetts citizens continue to have access to affordable health care.


They also have this online petition encouraging Governor Patrick to sign the Bill

Tell Gov.Patrick to stand up to Big Pharma

Big Pharma is a big spender.

They spent $8.2 billion marketing their drugs last year.

And they don't exactly scrimp when it comes to hiring lobbyists to represent their interests on Beacon Hill, either.

Maybe that's why they're so upset that things didn't go their way last week, when the Legislature voted for the Health Care Cost Control Bill, which included reforms to curb drug companies' over-the-top marketing gimmicks.

But Big Pharma isn’t about to back down. They've already set their sights on the one person they think might overturn the decision: Gov. Deval Patrick.

Tell Gov. Patrick to stand up to the pressure and sign the Legislature's Health Care Cost Control Bill into law:

Follow these 3 easy steps to help out.
1. Look over the message below, and feel free to add your own comments. Using your own words makes the message more meaningful.
2. Sign the letter by filling in the form below. We will not share your information with anyone else.
3. Click the button to send your message.
We encourage citizens from the Sate of Massachusetts to sign the petition

Tuesday, August 05, 2008

Mentally retarded child beaten up by an angry caregiver at Denton State School in Texas

From a much longer article in the Houston Press

Every day she comes here to be with him — to wash his wiry hair and clip his yellowed nails and rub his calloused feet. The boy has no control over his body. His head rolls from side to side, his eyes dart from one thing to another and drool pools out of his mouth. His name is Haseeb, and he is 34.

He wasn't always like this. For most of his life, he has been profoundly mentally retarded, but there was a time when he could sing and dance and communicate with his mother, in broken English and Urdu. There was a time when he ate cheeseburgers with his family and bopped his head to his brother's hip-hop.

And then something happened.

Six years ago, not far from where Chishty sits, a nurse's aide found Haseeb in bed, soaking in his own blood and urine. No one at the school could explain what happened. For six months he lay in intensive care, suffering from massive internal injuries that triggered toxic shock and then paralysis. His mother insisted someone at the school was to blame — she had seen a bruise in the shape of a footprint near his groin on the morning they found him. But no one had reported any abuse, so her claims went ignored.

For two and a half years, she told this story to anyone who would listen, and then the unexpected happened. Kevin Miller, a former caregiver at the school, admitted he had abused Haseeb in a drug-induced rage, punching and kicking him more than a dozen times. He said his supervisors knew about the attack and helped him cover it up. Even more alarming, he said abuse at the school was rampant. He knew his confession, which he first offered at a drug rehab clinic in Houston, might send him to prison, but he felt it was worth the risk if it sparked reforms.

More than three years have passed since then, and none of the changes Miller envisioned have taken place. Yet largely thanks to Chishty's efforts, her son has become the face of a movement. For the first time in nearly a decade, advocacy groups for the mentally retarded are pushing for the closure of the 13 state schools in Texas. These facilities, which house nearly 5,000 people, represent the largest institutionalization of mentally retarded in the nation. The alternatives — smaller, community-based group homes — are cheaper, safer and more humane, mental health rights advocates say. The trend across the country is toward this model of care, and other states, including California and New York, have either shuttered their institutions or are in the process of doing so.

Jeff Garrison-Tate, who heads Community Now, an Austin-based advocacy group, cites the Chishty tragedy as a defining example of why Texas should close all its state schools. "Haseeb is the tip of the iceberg," he says. "By their very nature, these are places where abuse is rife to occur."

Wednesday, March 05, 2008

Practical Advice for Police, Fire Fighters, EMTs, and others taking Civil Service Psychiatric Exams.

This is a repost of an earlier article, with a new title to make it easier to find for police, fire fighters, and others taking civil service psychiatric exams. Oriented towards fire fighters, there is still good advice for other public servants. See also this commentary by Physicist Richard Feynman on his own government psychiatric exam back in the day when he was just starting out.



More municipalities are increasingly relying on psychological tests - not only in the hiring phase but also in the entry-level examination format. For example, numerous fire fighter candidates with stellar credentials (including degrees in fire science technology, EMT and Paramedic certifications) doing well on all other portions of the exam yet failing the psychological part.

As noted here:
The psychological test is changing the fire service. Sure there are some folks who have a lot of baggage and shouldn’t be hired. But most of the red-hot’s, the back bone of the fire service, can’t make it through the process. Surprisingly, the evaluations are based on the performance of those in already in the fire service.

More and more agencies are using the psychological test in their hiring process. Psychologists are competing for this lucrative business and agencies feel they need the service to hire the right candidates. In one large department forty-percent of candidates were eliminated from the hiring process through the psychological tests. Fire administrations feel theirs hands are tied and get frustrated when they see a high percentage of their superior candidates that were eliminated by their physiological test and then being hired by other agencies.

"Psychologists are given more power then they should," says Robert Thomas Flint, Ph.D., who sometimes does re-evaluations of potential peace officers and firefighters who have failed psychological tests. Although he tends to agree 40-50% of the original decisions were valid, he finds that another 30-50% of the rejected candidates are acceptable and can handle the job.
It sounds that they would do just about as well using a coin flip to screen the candidates, if you think about it. In the rush to protect themselves from liabilities, the use of psychological testing is interfering with public safety. So much so that a cottage industry is growing up telling people how to pass the psych test. Check this out
You Have to Pass The Psych Test First Time Out!

Most candidates are more than surprised when I tell them up to 40% fail the psychological test given by many departments.

I received one phone call and two e-mails from relatives of a firefighter/medic candidate who failed a psych test before the candidate called asking "What can I do now?" He had been testing for 5 years and this was the first job offer. I asked him if he knew who we were? Yes. Did you know we had a preparation program for the psych? Yes. Why didn't you get it? I wish I had a dollar for every time I've heard this, "Things were going so great I didn't think I needed it."

Imagine after all the education, experience and time preparing to get this job like the above candidate . . . and you're eliminated. Then no one will talk to you to find out what happened. I've talked to too many candidates who were devastated and didn't know what to do next. This is a critical part of the testing process you need to prepare for and pass the first time out.

You've jumped through all the flaming hoops and made it through the background check. Then, you're conditionally offered the job pending the medical, which includes a psychological test. You take the test, no big deal right? Then the phone stops ringing.

You are out of the hiring process. You are told that you didn't meet the profile. What profile?

What do you mean I didn't meet the profile? I've got training, experience, education, every degree, certificate, merit badge, and a paramedic certification. I've been a volunteer, paid member of another department for 10 years, and lived and breathed this job. And, I don't meet the profile?

What's included in the psych test? There is a written test that sets up a profile of you. Then, there is an evaluation by a psychologist.

Written Test: The most common written portion of the psychological evaluation is the Minnesota Multiphasic Personality Inventory interview test of up to 1000 questions. The aim here is not to pass the test but to go into the job fully prepared. Put your pride and natural defensiveness aside. They ask a few questions in several different ways. You want to answer questions "strongly for" or "strongly against" instead of being in the middle undecided. Answer questions to present yourself as a more social, interactive, team playing type of person, i.e., you would rather be in a conversation with others than reading a book alone.

[...]

The Evaluation: This is where the wheels start coming off the wagon for too many candidates.

Before the interview, the psychologist will often have you take a separate personality test, fill out a personal family history, a biography and additional information forms.

The biggest error candidates make during the psychological evaluation is thinking there is a patient/doctor confidentiality even when the doctor has them sign a release that there is not. This is not your family doctor. Guess who's paying the bill?

What gets candidates in trouble here is they want this job so bad that they will say and do almost anything to get it.

Although I don't encourage candidates to be less than truthful, those candidates who are honest to a fault diminish their chances of passing the psychological interview! That's right. You folks want this job so bad you will tell the psychologist anything they want to know. Even stuff they didn't ask you. Once you start down this road of total honesty, creating trails where you don't have to, tossing out more information than was asked for thinking this guy is your friend is where you get into big trouble. Especially when the psychologist says, "Everyone has skeletons in their closet, this interview is not designed to eliminate you from the process", or "you don't want to be too squeaky clean." So you open up. Then the phone stops ringing and no one will talk to you. You are out of the process Mcfly. And, you don't know why.

So what should you do?

Only answer the question you're being asked. Before you volunteer information, think before you speak. If they want to know more they will ask. Don't appear to be closed but warm and cordial. Present your ideas clearly. Don't ramble or chat. Be articulate. This is how you're going to be in the field. Believe it or not this is part of the job interview. You are making an impression of who you are going to be as a firefighter.

Make sure you dress up and don't slouch. Be prepared to audition for the part of being a firefighter. Know your strong points. Be prepared to demonstrate you are a team player.

A large city fire department called in twelve candidates for the psychological interview. Only three passed. They sent in six more, only two passed. Another six more were tested. Again, only two passed. All those who passed were our candidates. They prepared in advance with our special report that took us over a year to compile to let them know where the land mines were before they went in. Ask them if it was worth knowing what was a coming?

This from a new firefighter:

I want to comment on your psych test information and report. I had to take one for two departments. Well all I know is that I went into the test and followed your advice. I tried to answer the questions as honestly as I could, while presenting myself as a very positive social person. Some of the "experts" out there say that you should be brutally honest on the test. Well 3 good guys I know did just that, and they did not pass either test. We lost 10 out of 25 guys on one test! In all honesty I might not have passed either if I hadn't followed your advice. I feel that is a very dangerous test, and some of the advice these people are giving out is costing great candidates a job. I wanted to let you know that your advice worked, and I owe you much thanks! Steve.

This from an in service firefighter:

During the last hiring process 2 years ago the psychologist passed 10 people. Of those 10, 2 have quit, 2 have been fired, and 1 committed suicide. I wonder if he is worth what the city pays him to evaluate prospects? Have a nice weekend.
So obviously, the shrinks aren't worth the money they are charging. And they are not delivering the results needed to protect the public and the professionals whose lives depend on each other.

Sunday, February 10, 2008

Witnesses bash alleged inaction of Kansas board that regulates doctors

A storm is brewing in Kansas over the passive corruption in the State Medical Board. Obviously, somebody is not doing their job, and the people of Kansas are suffering for it. We highlight a psychiatric case on misconduct in the report, there are others mentioned at the link. As seen in this report.

Too slow to act when doctors misbehave, and far too lenient when it does impose discipline.

Those were complaints raised repeatedly in testimony last week before state lawmakers about the Kansas board that regulates doctors.

The Kansas State Board of Healing Arts has come under intense scrutiny since it came to light that the board did not suspend the license of Stephen Schneider, a Haysville doctor accused of running a “pill mill,” until more than a month after federal criminal charges had been filed against him.

Witnesses testifying before the state Senate’s Health Strategies Committee last week said the board also had reacted sluggishly to other alleged problems.

On Tuesday, board officials will present their side to lawmakers, said committee chairwoman Sen. Susan Wagle, a Wichita Republican.

Andrew Jacobs, a psychologist from Leawood, told the committee Wednesday that he had filed a complaint with the board in 2003 against Overland Park psychiatrist Douglas Geenens.

Jacobs said Geenens had a sexual relationship with his wife, who was Geenens’ patient at the time.

In 2004, the board publicly censured Geenens, suspended his medical license for a week and ordered him to submit to supervision of his practice for at least two years by another doctor.

Jacobs told lawmakers the punishment was inadequate, and that since then, he has alerted the board to other claims against Geenens — only to see nothing happen.

“They don’t share with you what is going on. … Once you file a case, you are left out in the cold,” Jacobs said.

Geenens’ former partner, Rory Murphy, told the committee that the board’s decision shocked him because it was so slight compared to the offense.

“I really couldn’t comprehend the decision of the board,” said Murphy, an Overland Park psychiatrist.

Jacobs and Murphy said it was unethical for a therapist to have a sexual relationship with a current or former patient because patients could be easily exploited. Jacobs said he would like to see a law that would make it illegal for doctors to have sex with their patients.


Sen. Phil Journey, a Haysville Republican, said he believes such a law would be a good idea, pointing out that it is illegal for teachers to have sex with students. Extending the law to medical professionals makes sense, he said.

The telephone was disconnected at Geenens’ most recent known office address, and The Star was unable to contact him for comment.

[...]

Wednesday, January 16, 2008

Massachusetts Investigating Electric Shock at the Rotenburg School

As Reported By the Boston Herald, who devotes entirely too little space to the story abou the Rotten-Burg School. Also covered by WBZ radio, who also have an audio report highlighting the activism at the Brandeis University against the practice.

A legislative committee will examine the use of electric shock treatments on students at a controversial special education school.

Today’s hearing follows a state investigation into an incident last summer at a group home in Stoughton run by the Judge Rotenberg Education Center. Two emotionally disturbed students were wrongly given dozens of shocks after a prank call from a person posing as a supervisor.

The Committee on Children, Families and Individuals with Disabilities is considering a bill that would prohibit aversive therapy and another that would restrict its use.

Psychologists and former Rotenberg employees are among those expected to testify in favor of the legislation. But some parents are scheduled to testify about what they say are the benefits of the therapy.

Thursday, January 10, 2008

Washington D.C. Bill Could Require Licenses for Drug Reps

As seen in the WSJ Health Blog. This not only looks promising, but it seems to be a reasonable solution for an area where their have been multiple problems. We'll need to see how this works out, but it might be useful in other jurisdictions.

Drug sales reps could soon join cosmetologists, plumbers and funeral directors in line to get licenses to practice their trade in Washington, D.C. The D.C. council passed a bill yesterday that would require licenses and compliance with a set of rules governing professional practices for reps.

The bill explicitly bars reps from “any deceptive or misleading marketing of a pharmaceutical product, including the knowing concealment, suppression, omission, misleading representation or misstatement of any material fact.” It also prohibits promoting drugs for unapproved uses. New reps would be required to have a college degree. And bill would allow the D.C. Board of Pharmacy to collect information from reps regarding their interactions with health care providers.

[...]

The bill would also create a so-called “academic detailing program” in D.C. Academic detailing is a sort of ‘unsales pitch‘ that uses drug reps’ techniques to teach doctors when a cheap generic drug is as good as a more expensive branded one.

The bill must be signed by the mayor, who the Washington Post says supports the measure. Congress also has veto power over D.C.’s local ordinances — though given the skepticism toward pharma in Congress these days, it seems unlikely that a veto will come into play here.

[...]

Tuesday, November 20, 2007

More Fallout From ADHD Study - British Peer calls for ADHD care review

From the BBC - While this is a positive step, the Baroness might be shocked if she were to ever learn the actual truth. When disease is profitable, you get more disease.

A peer and neuroscientist will call on ministers to examine how attention deficit hyperactivity disorder (ADHD) is diagnosed and treated in the UK.

Independent peer Baroness Susan Greenfield will raise the issue in the House of Lords on Wednesday.

Her intervention follows a BBC Panorama programme which highlighted US research suggesting drugs are no better than therapy for ADHD in the long-term.

There was also evidence that their use may stunt child growth.

The Multimodal Treatment Study of Children with ADHD by the University of Buffalo has been monitoring the treatment of 600 children across the US since the 1990s.

Most of the estimated 500,000 children in Britain with ADHD receive no treatment at all.

But of those that do, most - about 55,000 last year - are prescribed stimulants like Ritalin and Concerta.

Baroness Greenfield will call for a wide-ranging inquiry into the huge increase in ADHD diagnoses.

She said: "As well as assessing ADHD drugs themselves, we also need to find out urgently why there has been such a remarkable increase in the numbers of children being diagnosed with ADHD in the last 20 years or so.

"Could the changes to our ways of living be contributing to this increase?

"The time is ripe for an inquiry exploring the actual causes of ADHD that goes beyond merely evaluating the pros and cons of Ritalin.

"Such an inquiry could consider diverse factors ranging from diet through to screen-based activity and how they may be changing the way both children and adults interact socially.

"Children live a fast-paced, highly interactive, response mode type of existence, and maybe as a result when they go to school they find it harder to sit still."

A Department of Health spokesperson said the National Institute for Health and Clinical Excellence (NICE) had advised that drugs should only be used to treat ADHD as part of a comprehensive treatment programme, including behavioural therapy.

"Careful, informed clinical decision-making, involving the parents and child should involve discussion of the benefits versus the risks of all interventions.

"We have also asked NICE to develop a clinical guideline on both the pharmacological and psychological interventions to treat ADHD."

Sunday, November 11, 2007

The 'Gilbert Affair' - notes on the decline and fall of Swedish Psychiatry

The following discusses some medical research by Christopher Gillberg, and what has come to be known as the “Gillberg affair”. As seen here, which also has references to many original sources. The whole matter gets worse the more one looks into it, and supports many speculations as to the probability of fraudulent research (especially ADHD) and fictional diseases.

This follows a number of scandals diminishing the reputation of Swedish psychiatry, which now seems to be in tatters and ruins.

The Swedish Parliamentary Ombudsman published its English Summary for the fiscal year ending June 2006. The Summary is 26 pages long; 18 pages are about the Gillberg case. [Available here in PDF Form] It is very critical of both Gillberg and Gothenburg University.

Christopher Gillberg is a professor of Child and Adolescent Psychiatry at Gothenburg University, in Sweden. He is internationally known for his research, and he has been a professor or visiting professor at the universities of Bergen, London, New York, Odense, San Fransisco, and Strathclyde. He is also author or editor of several scientific books, and he has authored or co-authored more than 300 research articles.

A significant portion of Gillberg's research has been about a psychiatric concept known as “DAMP” (Deficits in Attention, Motor control, and Perception). DAMP is related to Attention-Deficit Hyperactivity Disorder (ADHD). The concept of DAMP was conceived by Gillberg, but DAMP has been ignored or strongly criticized by other researchers.

Much of Gillberg's research on DAMP has involved children in the city of Gothenburg, Sweden. Gillberg undertook a study of children in Gothenburg who had been born in 1971. The study began when the children were 6–7 years old (in 1978), and lasted until the children were adults. Some of the children were diagnosed as having DAMP; others were not.

By following the children through to adulthood, the study was able to draw conclusions about how having DAMP affects peoples lives. For example, the study concluded that children with DAMP had more problems with the law, drugs, interpersonal relations, etc. when they reached adulthood than people who did not have DAMP.

Gillberg's study is one of very few studies to follow a group of people from childhood to adulthood (such a study is known as “longitudinal”). The study is thus important evidence for the hypothesis that having DAMP (or ADHD) as a child adversely affects the person's life in adulthood.

In the study, Gillberg asserted that one out of ten Swedish children have either DAMP or a similar neuropsychiatric problem. (A neuropsychiatric problem is a mental illness which is almost always inherited or otherwise congenital.) The optimal treatment for such problems generally involves the use of psychiatric drugs, e.g. Ritalin. Such drugs are typically prescribed for many years.

Eva Kärfve, a professor of sociology at Lund University, in Sweden, and Leif Elinder, a Swedish pediatrician, were highly skeptical of Gillberg's conclusion that about 10% of Swedish children had a congenital mental illness. They were also concerned because the safety of the psychiatric drugs on the developing brains of children is questionable, and because good-quality evidence for the drugs' long-term effectiveness is lacking.

Allegations of misconduct

In 2000, Gillberg and his colleague Peder Rasmussen published a major article describing an investigation of the Gothenburg study participants. (Most of the data for the investigation was actually gathered in 1993, when the participants were 22 years old.)

Kärfve and Elinder claimed to find serious discrepancies in the article. In 2002, Elinder petitioned Gothenburg University to investigate Gillberg's research for fraud. His petition was handled by the Ethics Committee, which dismissed it, after receiving a response from Gillberg. Kärfve then petitioned the university for an investigation. Her petition was considered more carefully. Ultimately, the Ethics Committee voted on whether or not to refer the matter to the Swedish Research Council for investigation. The vote was 3–1 against.

The main issues in the allegations made by Kärfve and Elinder seem clear. For example, Gillberg would not supply the names of the various specialists who examined the study subjects (for psychiatric disorders, etc.); even more, Gillberg repeatedly claimed that he had supplied the names—but he would not say what the names were.

Acts such as this obviously support suspicion of misconduct. Moreover—and importantly—they do not require specialist training in neuropsychiatry to understand. The decision of the Ethics Committee seems to have been based at least partially on the belief that a researcher with a reputation as great as Gillberg's could not have committed fraud.

Data requested

Kärfve and Elinder also requested access to the data used in the Gothenburg study, so as to investigate for themselves. They were denied this, on the grounds that the study participants had been promised confidentiality. They asked for the data to be anonymized (i.e. obfuscated so that individuals cannot be identified: this is a standard practice). They were told, however, that this could not be done.

Kärfve and Elinder took the matter to court, under the Swedish law of the Principle of Public Access. The court decided that they would be allowed access to some of the data. Gillberg refused to respect the court's decision. Instead, Gillberg asked to have the research material scrutinized by outside experts. A panel of appropriate experts was promptly constituted by the Swedish Research Council.

Before the panel could begin work, however, the Gillberg group asked Ove Lundgren, who was the Chairman of the Ethics Committee (and a Professor Emeritus of Physiology at the university) to examine the data. Lundgren was asked to do this as a private person, i.e. not representing the Committee. There was 22 meters of material, including about 100,000 pages. Lundgren was given four hours to scrutinize all this. He found nothing that seemed seriously wrong.

Gillberg then told the rector of the university that the Chairman of the Ethics Committee had done an investigation and that as a result “the accusations about scientific fraud … definitely could be dismissed”.
(The head of the faculty of health sciences—the Sahlgrenska Academy—at the university supported Gillberg in this.) Gillberg then withdrew his prior agreement to have the research material scrutinized by outside experts. His justification was that such scrutiny was no longer needed, because Lundgren had now acquitted him of fraud.

The members of the Ethics Committee later responded to all this by publishing a letter stating that the Committee “never acquitted Gillberg of the allegations” and that “the question about scientific fraud never has been investigated”. Lundgren said on Swedish TV that he thought he had been used/exploited by Gillberg.

Gillberg gave an additional reason for refusing to make the data available: he said that the study participants had been asked what they thought of this, and all but one was strongly opposed. That is true, but the Swedish journalist MarieLouise Samuelsson discovered that there is more to the story. Her report is referenced below; briefly, the story is as follows.

Among the study participants, there was a widespread belief that an investigation (by Kärfve and Elinder) would mean that virtually everyone would be allowed to see the research data. For example, a man who was a participant made a comment on Swedish television where he warned that “your worst enemy would get access to this sensitive information”. Gillberg also analogized an investigation thusly: “What would you say if you had AIDS and your doctor threw your medical records out on the street?”.

In reality, only Kärfve and Elinder would have been able to see the data, and they had to sign statements agreeing to maintain confidentiality. (Moreover, they had asked for the data to be anonymized: even if Gillberg's claim that anonymization could not be done completely was valid, this could have been done at least partially.)

As well, the study participants were not simply asked if they were for or against making the data available. Rather, each participant was telephoned by someone representing the Gillberg group, and afterwards received a strongly-worded letter of protest against making the data available.

It is clear from all of this that the study participants were pressured and misled into opposing an investigation. It is worth considering what motives Gillberg could have had for doing that.

Gillberg, with assistance from the university, asked the court to reconsider its prior decision to require that the data be made available. The court dismissed this. The rector of the university, Gunnar Svedberg, then wrote a letter to Elinder and Kärfve, saying that although the university was required to comply with the judgement of the Swedish court, it would not be doing so in this instance. The reason he gave was that doing so would cause mental stress to Gillberg and colleagues.

Data destroyed

The question about access to the research material went to court several times, each time with the court ruling that some access should be allowed. On 4 May 2004, the Swedish court ruled for the fifth and final time that the research material had to be made available to Elinder and Kärfve.

The following weekend, three of Gillberg's coworkers, one of whom was his wife, deliberately destroyed almost all of the material. They argued that to obey the court order to make the material available would violate the promises of confidentiality that had been made to the study's participants. Gillberg claimed in an interview with the British Medical Journal that he was “completely unaware” of the destruction until after it was over.

Afterwards

In June 2005, Gillberg and the rector of Gothenburg University, Svedberg, were convicted (by a criminal court) for not making the data available to Kärfve and Elinder. Gillberg received a suspended sentence and a fine; Svedberg received a fine. Gillberg appealed his conviction up to the Supreme Court, and had his last appeal rejected in April 2006. Separately, the three coworkers were convicted for destroying the data. Each of the three received a suspended sentence and a fine.

The rector resigned his position at the university. Gillberg and his colleagues, though, continue with their work. In November 2006, Gillberg was awarded a substantial research grant by the Swedish Research Council. Gillberg also continues his research and his clinical practice in Britain (at the University of Strathclyde and the National Centre for Young People with Epilepsy).

The Swedish Parliamentary Ombudsman published its English Summary for the fiscal year ending June 2006. The Summary is 26 pages long; 18 pages are about the Gillberg case. It is very critical of both Gillberg and Gothenburg University.

The Swedish government decreed a new regulation for the handling of research misconduct allegations. The decree states, “A university that, by a petition from someone or in any other way, receives information about possible scientific misconduct in research, artistic reseach, or any other research at the university, will investigate the allegations”.

The whole affair has been the topic of much discussion in the media in Sweden, where it is known as the “Gillberg affair”. To date, there has been little media coverage outside Sweden, with the exception of Norway.

In Norway, the newspaper Dagsavisen ran a series of stories about the Gillberg affair. This led to a loss of confidence in Gillberg, who was head advisor of the Children in Bergen project (a project involving close to 10,000 children). Consequently, in February 2006, Gillberg resigned his position there.

Other criticisms


In 2005, Per-Anders Rydelius, Professor of Child Psychiatry at the Karolinska Institute, and Rolf Zetterström, past chief editor of Acta Paediatrica, published a report on the Gothenburg study. The report pointed out that the Gillberg group, in order to prove their hypothesis, repeatedly changed diagnoses and information in their material: “Accessible articles [from the Gillberg group] reveal that those studied have been managed in an unscientific way, a conclusion that does not need strengthening by what could have been found in the destroyed research material”. (Another problem is the boy:girl ratios in the study; the ratio in the control group is 1:1, whereas the ratio in the index groups is 4:1.)

Supplements

Petitions to the Ethics Committee

Timeline for the Gillberg affair

External discussions

Scientific Misconduct blog on the Gillberg affair

Thursday, November 08, 2007

Prozac nation: alarm at huge rise in anti-depressants’ use

From the Herald, in Scotland

Government efforts to cut the number of anti-depressants prescribed by GPs were thrown into doubt yesterday after new figures showed they had increased four-fold over the past decade.

A report by NHS Quality Improvement Scotland (QIS) found that the number of prescribed daily doses of the drugs had gone up from 19 per thousand to 85 between 1992 and 2006.


Medical experts at QIS, a health board established to oversee improvements in the NHS, said the record level of prescriptions may be due to the popularity of newer anti-depressants such as Prozac, which had fewer side effects, and patients being given more drugs over a longer period. But it was not clear whether there had been any increase in the number of people diagnosed as depressed.

Mental health charities expressed alarm at the latest figures, saying they showed an overdependence on medication to treat mental illnesses and highlighted a lack of available alternative treatments such as psychological therapy.

Faced with a rise in prescriptions, the previous Scottish Executive imposed a target of reducing the increase in anti-depressants being prescribed to zero by 2009. But while there were some signs that prescription rates were levelling out, there was scepticism over the SNP's manifesto commitment to cut them by 10% over the same period.

Dr Dorothy Muir, chair of the QIS clinical outcomes group, said that, though there were signs prescription rates were levelling, it was "probably unlikely" they could be reduced.

Dr Geraldine Bienkowski, lead clinician for psychology at NHS Education for Scotland, said there was "limited" evidence that providing alternative therapies led to a cut in prescription rates. But there was also evidence that, in some situations, increasing the provision of psychological therapies had a knock-on effect of increasing the rate of prescriptions, as it increased awareness of depression among GPs, she said.

Prescription rates for anti-depressants are strongly linked to deprivation, with Greater Glasgow having the highest rate in the country, according to QIS's figures.

Women are more likely to be diagnosed with depression and the condition was most common in the 25 to 44 age group, its figures show.

However, research undertaken by Glasgow University has found wide variations in prescribing levels between GP surgeries and that factors such as deprivation, gender, and age only account for 50% of these.

Dr Philip Wilson, a Glasgow GP involved in the research, said that different prescribing cultures within GPs surgeries may account for some of the variation. He also questioned whether simply cutting levels of prescriptions was in patients' best interests.

"There's a lot of evidence that people's depression relapses if they stop them too soon. In the case of a second or subsequent episode of depression the guidelines are now telling us we should be prescribing for a period of two years," he said.

Shona Neil, chief executive of the Scottish Association for Mental Health, said the figures betrayed a medical culture in which there was a "pill for every ill". She said: "People are being prescribed these pills for problems which are far beyond mental health issues. If you're living in poverty, are unemployed and without a good social support network, a pill isn't going to improve any of that. We have pathologised suffering to a level that isn't helpful."

Dr David Steel, chief executive of NHS QIS, defended the use of a target but conceded it was unlikely the new goal could be met. He said: "One of the great advantages of a target like that is it gets us talking about it, even if we don't meet it."

Shona Robison, Health Minister, said the Scottish Government was committed to the previous administration's goal of "levelling off" the prescription of anti-depressants and had invested £4.5m in developing alternative treatments for people with depression.

But she made no mention of the SNP's previous manifesto commitment. "We are striving to drive down the prescribing of antidepressants by offering a range of other effective interventions," she said.

Last night a Scottish Government spokeswoman denied that the manifesto commitment had been dropped saying it was "still committed to the reduction over the next two years".

Friday, October 19, 2007

Frankenstein's Children: Modern Torture's Scientific Bible

Of course our interest is in the criminality and lack of morality displayed by these experts on the mind when working for a government (not just the US government)

A frightening and detailed review of a book that is best described by this quote:

What if there was a book that dispassionately looked at the history and methodology of torture? What if this book looked at human physiology and psychology and tried to scientifically establish how to best break another human being and bend him or her to your will? What if this book were written by top behavioral scientists and published in the United States? And, finally, what if the studies published in this book were financed by the U.S. government?

Look no farther, there is, or rather was, such a book. Published in 1961 by John Wiley & Sons, The Manipulation of Human Behavior was edited by psychologists Albert D. Biderman and Herbert Zimmer. This book, unfortunately, cannot be found online, nor was a second edition or printing ever made (not surprisingly). But I will provide a review here, and an introduction into the nightmare world of science, torture, and politics that helped shape our modern world and today's news.
In recent months, it went on-line and and can be viewed at Internet Archive:

The Manipulation of Human Behavior - The text is copyright 1961, but not renewed (and therefore expired in the US). HTML formatting from unknown source.

We include this summary of the text:

The titles of the book's essays are bone-chilling in their scientific bland exactitude. Here they are, with authors, for the record:

1. The Physiological State of the Interrogation Subject as it Affects Brain Function, by Lawrence E. Hinkle, Jr., Assoc. Professor of Clinical Medicine in Psychiatry, New York Hospital

[I have come to see over the past months of research that this essay by Hinkle is often referenced, and is key in understanding later methods of psychological and modern torture.]

2. The Effects of Reduced Environmental Stimulation on Human Behavior: A Review, by Phillip E. Kubazansky, Chief Psychologist, Boston City Hospital

3. The Use of Drugs in Interrogation, by Louis A. Gottschalk, Assoc. Professor of Psychiatry and Research Coordinator, Cincinnati General Hospital


And because you probably can't wait, and to juice up this account, I'll admit, yes, this is the chapter that goes into LSD, mescaline use and all that. Gottschalk found enough data in the research literature to find that LSD-25 might have "possible applications... to interrogation techniques".
The conclusions reached on mescaline hold equally for the possible applications of this drug to interrogation. As a tool in the advancement of knowledge of psychopharmacology, LSD-25 is a drug on which clinical and experimental research is likely to continue. (pp. 123-124)
Likely to continue..." An ironic understatement?

4. Physiological Responses as a Means of Evaluating Information, by R. C. Davis, Professor of Psychology, Indiana University

5. The Potential Uses of Hypnosis in Interrogation, by Martin T. Orne, Teaching Fellow, Department of Psychiatry, Harvard University Medical School

An aside: Some of you may recognize Martin Orne as the psychiatrist of the famous poet Anne Sexton, who in the early 1990s released the tapes of her psychotherapy sessions with him to a biographer, precipitating a storm of controversy.

6. The Experimental Investigation of Interpersonal Influence, by Robert R. Blake and Jane S. Mouton, Professor of Psychology, University of Texas, and Social Science Research Associate, University of Texas, respectively

7. Countermanipulation Through Malingering, by Malcolm L. Meltzer, Staff Psychologist, District of Columbia General Hospital

Six of the essay contributors were psychologists; two were psychiatrists.

Thursday, October 18, 2007

British Social Workers Use Discredited Psychiatric Disease as an Excuse to Confiscate a Woman's Future First Born Child.

Munchausen's syndrome by proxy was identified in the 1970s by the now discredited paediatrician Sir Roy Meadow. It was alleged to take the form of fabricated illness where a parent claims a child is ill by making up symptoms.

The theory became increasingly influential and in 1993 the professor's evidence helped convict British nurse Beverley Allitt of the murders of four children.

But the Angela Cannings and Sally Clark miscarriages of justice wrecked Professor Meadow's reputation because he had been an expert witness. Some now question whether Munchausen's exists.

Now we have a case where British social workers are threatening to take a woman's first born child because of the mere imagined possibility on their part that she would harm her child, based on her troubled teenage years.

From the Daily Mail:

A mother-to-be faces losing her baby within minutes of its birth because social workers fear she will harm the child.

Fran Lyon, 22, has been told she cannot be trusted with a newborn because she is likely to suffer from Munchausen's syndrome by proxy.

The condition is said to lead mothers to seek attention by harming their child or claiming it is ill.

Miss Lyon insisted yesterday that the mental health problems she had as a teenager were behind her. She also appealed for a place in a mother and baby unit so that she could look after her child under supervision.

"I would be happy to stay for as long as it takes," she said. "At the end of the day I have nothing to hide so why would I have a problem going? I know there is nothing wrong.

"I'm not depressed, although I have every right to be. I'm not struggling to cope."

Miss Lyon's child - a girl to be called Molly - is due in January.

"I know I wouldn't hurt her," she said. "I would quite happily have 24-hour supervision with a perfect stranger sat with me watching my every move.

"All I want is a chance to be Molly's mum."

Social workers told Miss Lyon last week that her child will be taken from her within 30 minutes of birth.

Munchausen's has been at the heart of a series of miscarriages of justice.

Sir Roy Meadow, a discredited paediatrician who helped develop theories about the condition, was responsible for evidence that led to the wrongful convictions of Angela Cannings and Sally Clark for murdering their children. Miss Clark died earlier this year, after, friends said, turning to alcohol following her release from prison.

Miss Lyon, from Hexham in Northumberland, started self-harming at the age of 15 and has been treated at psychiatric hospitals for borderline personality disorder.

She said a domestic incident in July led to the involvement of social services who became concerned by her pregnancy.

"I told them that I had mental health problems when I was a lot younger and that I had since moved on and now had a normal life," said Miss Lyon.

"I assumed that would be the end of it but the next thing I know they were going to a child protection conference.

"I am living with this constant notion that someone might walk into the delivery suite and take my baby away."

Her case has been taken up by Lib-Democrat MP John Hemming who has been campaigning against adoption of babies.

"The whole family court system, because of the secrecy which surrounds it, is vulnerable to bad practice," he said.

"Social workers are under pressure not to lose cases."

Family courts set up adoption orders and make decisions about children thought to be at risk. The evidence and the reasoning behind rulings are rarely made public.

A spokesman for Northumberland County Council said: "Legally we are unable to comment on the detail of individual cases.

"We can say that such cases can be very complex and involve a lot of information and various concerns relating to the safety of a child."

Dr Stella Newrith, a psychiatrist who has treated Miss Lyon, said she had made a significant recovery.

In a letter to Northumberland Council, she stated: "There has never been any clinical evidence to suggest Fran would put herself or others at risk and there is certainly no evidence to suggest she would put a child at risk of emotional, physical or sexual harm."

Wednesday, October 10, 2007

Congress Holds First Hearing on Abuse in Unregulated 'Troubled Teen' Industry, Exposing Quackery and Torture Across America

While not directly related to psychiatrists or psychiatry, you have to wonder where these jokers got their theory of mental health from. Just the name of "Attack Therapy" is enough to give me the chills. That said:

FIRST, we have this press release from a Statistics Watchdog Group in advance of a hearing held today on Capitol Hill. You have to know that when the statisticians are after you, you have really screwed up. We include it here because it speaks so well to the issue:

Deaths from medical neglect and other severe child abuse in teen "wilderness programs" "boot camps" "emotional growth boarding schools" and other residential facilities will be the subject of a first ever Congressional hearing this week. On Oct. 10, the House Education and Labor Committee, chaired by Representative George Miller (D-CA), will hold a full committee investigative hearing.

Parents of adolescents who have died in these programs will testify and the Government Accountability Office will present its findings from a recent investigation of the industry. Seven boot camp guards and a nurse are currently on trial for manslaughter in the death of one boy in Florida.

Statistical Assessment Service Senior Fellow Maia Szalavitz helped spur this investigation with the first book-length expose of this billion-dollar industry, "Help at Any Cost: How the Troubled-Teen Industry Cons Parents and Hurts Kids" (Riverhead Books, 2006), which detailed the horrifying abuse, medical ignorance, and neglect that caused thousands of injuries and dozens of deaths. It is the only book to comprehensively cover this subject. She will attend the hearing and be available to the media.

Your dog has more protection than your child

A federal law protects mule deer from harassment -- but teens held in these programs do not even have the right to contact their parents or law enforcement or be free from food deprivation, sleep deprivation, isolation, restraint and other severe punishments.

Most parents are unaware that in many states, dog kennels and nail salons are more highly regulated than the health and safety of children in these institutions.

Where state regulation exists, enforcement is lax. Anyone -- including convicts -- can open a program; no qualifications are required.

Szalavitz has continued to investigate this highly profitable industry, exposing the spurious treatment practices and abuses for STATS and other publications including the New York Times, the Washington Post, Reason, and the American Prospect.

[...]

About STATS: Since its founding in 1994, the non-profit, non-partisan Statistical Assessment Service (STATS) has become a much-valued resource on the use and abuse of science and statistics in the media. Our goals are to correct scientific misinformation in the media resulting from bad science, politics, or a simple lack of information or knowledge; and to act as a resource for journalists and policy makers on major scientific issues and controversies. For more information, contact Trevor Butterworth at 202-841-2868 or visit http://www.stats.org.
Second, we have this link to an earlier story regarding the political links between one political party and the 'Troubled Teen' industry, which would explain why investigations were not conducted earlier. It also includes a history of the weird origin of the Attack Therapy used throughout these prison camps for kids.

Thirdly: There are other reports (USA Today, Huffington Post) on these hearings as well. The complete video of the hearings can be seen online here

Finally, we have the Committee's press release, complete with direct links to the report and to transcripts of the testimony of several witnesses. :
A new government report released today found thousands of allegations of child abuse at private residential treatment programs between 1990 and 2007. The report also examined in detail ten cases of child abuse and neglect that resulted in death between 1990 and 2004.

The U.S. Government Accountability Office, which prepared the report at the request of House Education and Labor Committee Chairman George Miller (D-CA), testified about its findings at a committee hearing today. Three parents whose children died in private residential programs also testified at the hearing.

There are estimated to be tens of thousands of children enrolled in private residential treatment programs – often called “boot camps,” “wilderness camps,” and “behavior modification facilities” – around the country. A weak patchwork of state regulations governs the operation of these programs.

The GAO report found that the 10 programs it examined were marked by ineffective management, untrained staff; reckless or negligent operating practices; and misleading marketing practices.

Cynthia Harvey
’s daughter, Erica, was 15 years old when she died of dehydration and heat stroke at a wilderness program in Nevada. “When Erica’s eyes rolled into the back of her head and she fell off the trail, head first, into rocks and scrub brush, she was left to lie where she fell for 45 minutes, while two [program] staffers, still unwilling or unable to recognize what was happening, watched Erica die a slow, painful death,” testified Harvey.

Paul Lewis’ son Ryan committed suicide at a residential school and wilderness program in West Virginia in 2001. “Our family was duped into believing that caring people would help Ryan, who was struggling with a learning disability and clinical depression. We thought these were professionals who knew what they were doing. We had no idea that their interest was profit, not healing.”

Bob Bacon’s son Aaron died at a wilderness program in Utah in 2004. According to the GAO, Aaron showed signs of physical distress for three weeks that were ignored by program staff, including a company-employed Emergency Medical Technician. In those three weeks, Aaron lost 20 percent of his body weight.

“This company-employed EMT . . . dismissed [Aaron’s] final desperate plea to see a doctor who could prove he wasn’t faking and made a conscious decision to prove a point rather than render aid, thus effectively killing our son rather than saving him.”

Miller said today that Congress must act to regulate the industry to prevent abuse from happening.

“This nightmare has remained an open secret for years. Sporadic news accounts of specific incidents have built a record that should never have been ignored, but shamefully was,” said Miller. “Without regulations, the industry as a whole will continue to present unacceptable risks to the children it serves.”

Miller requested the GAO investigation in December 2005. The GAO is expected to release a comprehensive report in early 2008. To see a copy of Miller’s 2005 request, click here.

To see Miller’s opening statement from the hearing, click here.
See also this Video report

North Carolina Medical Board forced to give up secret proceedings due to psychiatric drug death.

A group of men protecting their own through secret proceedings is forced to tell the truth. But for one widow, it is far too late.

My own reaction to this story is to describe the North Carolina Medical Board in the most vile and disturbing terms. This is probably not appropriate for civilized society. And is probably would be too much of an understatement anyhow.

As seen in the News Observer.

A week ago Monday, a state law was changed thanks to Maggy Lewis of Durham.

She has been choking back tears, however, not sipping champagne.

The law she helped rewrite opens up the complaint process at the N.C. Medical Board. But the handling of her own husband's death will remain under wraps.

It was about four years ago that Lewis' husband, Mark, grew depressed after being laid off from a job he truly loved.

He had survived other job losses over the years, the deaths of both his parents and the dissolution of his previous marriage.

But this layoff threw him for a loop.

He went to a psychiatrist for help.

The doctor prescribed an antidepressant. And then, another, and another, and another.

After about a year and a half, Lewis' husband was on seven drugs simultaneously, five of which increase the amount of serotonin in the brain.

He shook, sweated, grew confused and slept poorly. His mood became erratic.

Finally, Mark took his own life.

Maggy Lewis was crushed. She blamed her husband's psychiatrist for prescribing so many drugs and changing the doses abruptly.

Lewis briefly looked into suing but decided against it.

During the research, however, she had four medical experts review her husband's files. Each independently found that his prescribed medications had induced serotonin syndrome, a well-documented syndrome caused by an overload of drugs that increase serotonin.

Lewis filed a complaint with the state medical board.

She was curious to see what the doctor's response was. Turns out she will never know.


Lewis came up against the hard fact that North Carolina law allows the doctor's response to a complaint to remain secret. Ditto the board's response -- unless direct action such as suspension of a doctor's license is involved.

Incredulous, Lewis contacted her state representative, Paul Luebke, to see about getting the law changed.

The medical board's openness was already under review, and to the board's credit, it supported opening up the complaint process.

When the bill passed in August, it seemed like a true victory. Under the rewritten law, patients have the right to know how the board handled their complaints and how it reached its decisions. The complaining patient or loved one also can request and receive a copy of the doctor's official response.

It was a few weeks later in August that Lewis received a letter from the medical board noting that her complaint had been "handled appropriately." Had the doctor been chastised? Had the doctor told the whole truth to the board?

Lewis appealed to the board for more information.

"I appealed to their basic decency," she said.

The week before the rewritten law went into effect, however, she got a final answer from the board: "No."

"I have no way of knowing what the doctor said in response, what she said about my husband," Lewis said. "The board members sat in a room and discussed my husband for hours, and I have no way of knowing what was said."

So, no, Lewis isn't celebrating -- though, for her legislative "victory," all of us owe her a debt of thanks.

Tuesday, October 02, 2007

New Federal Drug Safety Bill Signed Into Law

Some details not noted below - Among the many reforms, this new law gives the FDA the authority and money to monitor, investigate, report (and take action) on adverse side effects of drugs once they are on the market. It also requires all PRINT ads (Magazines, newspapers etc) to say: "You are encouraged to report side effects of prescription medication to the FDA's medwatch call 800# or log onto www.fda....." In six months the Secretary of Health and Human Services must make a report to Congress on how they can implement this in TV ads.

As seen in this report

The Food and Drug Administration on Thursday gained broad new powers to ensure the safety of prescription drugs used by millions of Americans under a bill President Bush signed into law.

At its core, the new law renews for five years programs to collect fees from drug and medical device manufacturers. The industry money accounts for about one-quarter of the FDA's overall budget, defraying the cost of reviewing products that need agency approval.

Members of Congress, acting in the wake of the withdrawal of the painkiller Vioxx three years ago, seized on the bipartisan legislation as a vehicle to reform the FDA's handling of drug safety.

In part, the legislation shifts more of the FDA's attention from experimental drugs pending approval to those already are on the market, and gives the agency more power to act when worrisome problems emerge.

"It really represents an important addition to the FDA's authority," said FDA commissioner Dr. Andrew von Eschenbach.

It gives the FDA the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems do appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities. The legislation further requires companies to publicly release results of all clinical trials that show how well their approved drugs performed. Not yet approved drugs could be subject to the requirement later.

Still, how the Food and Drug Administration Amendments Act of 2007 will change the agency remained unclear, beyond the expected hiring of several hundred new employees.

The FDA was still reviewing the 156-page law and its roughly 200 specific provisions, many with timelines, before deciding how to implement them. The fine-print list of actions the FDA must take runs more than 10 pages, said Randall Lutter, the agency's deputy commissioner for policy. The FDA may have to draft new regulations or guidelines - a process that can take years - to implement some of those provisions, Lutter said.

The legislation does spell out that the FDA will be able to fine drug companies for not completing follow-up studies on their drugs after they've won government approval. Those studies frequently remain undone, often leaving important safety questions unanswered.

The bill calls for drug companies to pay $393 million, and medical device makers $48 million, in various fees next year.

"The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for post-market surveillance, and modernize its information technology systems," said Billy Tauzin, head of the Pharmaceutical Research and Manufacturers of America.

It also requires the FDA to step up its active surveillance for new safety issues with drugs. That system traditionally has been largely passive.


"We welcome the ability to really engage in how those products perform once they are out on the market," said Dr. Janet Woodcock, the FDA's deputy commissioner and chief medical officer, citing the use of data-mining techniques to sift through electronic medical databases for hints of problems.

The manufacturers of certain new drugs will have to draft for each one a so-called "Risk Evaluation and Mitigation Strategy" that can include medication guides distributed with each prescription to ensure the medicine's safe use.

Under the legislation, the FDA will set up a registry to log incidents where adulterated food could pose a health risk. The agency also will have to establish pet food ingredient and processing standards - a provision born of the massive dog and cat food recalls earlier this year.

"It strengthens safety rules for the wave of new miracle drugs coming on the market that Americans count on to protect their health. It brings needed reassurance to families that the food they feed their pets is safe," said Sen. Edward Kennedy, D-Mass.

Monday, October 01, 2007

Shifting the Blame for the Effects of Combat Fatigue

As seen in this report

Thousands of U.S. soldiers in Iraq — as many as 10 a day — are being discharged by the military for mental health reasons. But the Pentagon isn't blaming the war. It says the soldiers had "pre-existing" conditions that disqualify them for treatment by the government.

Many soldiers and Marines being discharged on this basis actually suffer from combat-related problems, experts say. But by classifying them as having a condition unrelated to the war, the Defense Department is able to quickly get rid of troops having trouble doing their work while also saving the expense of caring for them.

The result appears to be that many actually suffering from combat-related problems such as post-traumatic stress disorder or traumatic brain injuries don't get the help they need.

Working behind the scenes, Sens. Christopher "Kit" Bond, R-Mo., and Barack Obama, D-Ill., have written and inserted into the defense authorization bill a provision that would make it harder for the Pentagon to discharge thousands of troops. The Post-Dispatch has learned that the measure has been accepted into the Senate defense bill and will probably become part of the Senate-House bill to be voted on this week.

The legislation sets a higher bar for the Pentagon to use the personality-disorder discharge, and also mandates a review of the policies by the Government Accountability Office. Bond said it also would "force the Pentagon to stop using this discharge until we can fix the problem."

Bond said he learned of the practice from returning Iraq veterans. He called it an "abuse" of the system and "inexcusable."

"They've kicked out about 22,000 troops who they say have pre-existing personality disorders. I don't believe that," Bond said in an interview Friday. "And when you kick them out, they don't get the assistance they need, they aren't entitled to DOD or Veterans Administration care for those problems."

Obama said the practice is "deeply disturbing" because "it means that those who have served this country aren't getting the care they need.
…"

Pentagon spokesman Lt. Col. Todd Vician declined Friday to discuss the matter because it was related to current legislation.

Defense Department records show that 22,500 cases of personality-disorder discharges have been processed over the last six years.

Jon Soltz, an Iraq war combat veteran who founded the group VoteVets.org, said untreated psychological problems were contributing to the highest military suicide rate in a quarter-century and to growing homelessness among veterans, he said.

If such widespread mental problems really existed before people joined the military and saw combat, they would have been uncovered when the recruits were enlisting, Soltz said.

STRESS FACTORS

The issue of personality-disorder discharges is a window into the broader problem of psychological damage to Iraq veterans, which experts say has three main causes:

— Multiple and longer deployments.

— The stress of fighting an insurgency with no breaks and everyone always on the front line.

— Better and faster medical care that helps troops survive horrific physical injuries that often leave psychological scars.

"You land in Iraq, and you're on the battlefield, whether you're a quartermaster or a medic or a cook," said David Segal, director of the Center for Research on Military Organizations at the University of Maryland. "All you have to do is get on the highway to go somewhere from the airport."

The military and lawmakers are only slowly coming to grips with the consequences, Segal said.

"I think we have failed to recognize the extent of the problem," he said. "We've produced a problem that's going to be plaguing us for generations."

Past wars, through the Persian Gulf war, produced three casualties for every fatality, while now in Iraq "we're up to about 16-to-1," Segal said. Those killed are "really the tip of the iceberg" as far as the toll on soldiers, he added.

One Republican congressional staff member who works on military issues said the rationale behind the Pentagon's practice was: "We didn't break you, you were already broken. You're not our responsibility."

"One soldier I know received a diagnosis for a personality disorder after a 45-minute talk," said the staffer, who spoke on condition of anonymity. "He'd been in the military 10 years, had made it his career, and then he was told he was being shuffled out in a couple of weeks. We keep getting these stories."

In the House, Rep. Phil Hare, D-Ill., is leading the effort to get similar legislation approved.

"It defies logic to think that tens of thousands of our servicemen and women slipped through the cracks during the pre-screening process," Hare said. "We have a moral obligation to review the discharge process and ensure we are getting it right."

Sunday, September 23, 2007

Psychologists Shot Down Nine Times in 2007

Seen in this report

The National Psychologist reported in its Sept/Oct 2007 issue that prescription privileges bills to give psychologists prescription privileges in nine different U.S. states failed in each and every case. Most never left committee, reflecting the leadership’s unease of granting prescription rights to non-medical professionals.

The bills failed in Hawaii, California, Georgia, Illinois, Mississippi, Missouri, Montana, Tennessee and Oregon. It came closest to passing in Hawaii, but was vetoed by the governor when it reached her desk.

What’s at stake here?

Two powerful professional organizations — the American Psychological Association and the American Medical Association — butting heads over whether it is safe to allow psychologists, with additional medical training, to prescribe psychiatric medications.

Psychologists receive little or no formal training in medicine in their graduate studies today (as most physicians who are not psychiatrists receive little or no formal training in psychological theory and practices). If psychologists gained greater prescribing authority, they could rely less on medical doctors, such as psychiatrists, to prescribe common psychiatric medications.

Psychologists argue that there is a demand for such services in rural and areas throughout the country that currently do not have coverage by psychiatrists.

Doctors argue such privileges are already available to professionals who want them by undergoing medical school or similar training.

Psychologists believe they don’t need such intensive training because psychiatric medications are largely limited to affecting the mood, and don’t interact as much with other body systems.
As anyone who has looked into the side effects of psycho-active drugs knows, this last point is a woefully naive take on the situation. I can only imagine what additional horror stories await us if this were to go through.

Friday, September 21, 2007

Advertising Allies Turn Tide for Pharma

As seen in the WSJ Health Blog

A provision to empower FDA to yank consumer drug ads was stripped from the final version of an FDA bill, which was passed yesterday.

But it wasn’t Big Pharma that carried the day on the revision; it was the Gucci-loafered lobbyists for media and advertising firms.

[...]

Some in the advertising industry were concerned that giving FDA broad powers to block ads would lead to other government ad restrictions. “People just looked and they were incredulous,” says Harry Sweeney, chairman of Dorland Global Corp., a health marketing and communications firm that is a unit of Huntsworth PLC. “You’re getting into a very slippery-slope area.”
But of course, they were really just protecting their profits all along.

Monday, September 17, 2007

How British Columbia laws leave patients in the dark

A problem in public policy not specifically related to psychiatrists, but relevant to health providers of all specialties. Of course, statistics in many locales indicate that psychiatrists offend at a rate surpassing other medical specialties, and so they are covered by this discussion. From the Times Colonist

If you needed help for a sore back, you might want to know if your chiropractor was facing multiple sex-assault charges.

You might want to know, too, if your physical therapist had ever been reprimanded for alleged sexual misconduct, or why the registered nurse treating you had been suspended for three months.

But, if you live in British Columbia, there's no easy way to get that information -- if you can get it at all.

Despite moves to greater transparency in other jurisdictions, the B.C. laws that grant health professions the privilege to set up colleges and regulate themselves in the public interest place few obligations on those same colleges to tell patients about the records of their health care providers.

The Health Professions Act, which governs most and will soon cover all 24 regulated professions, permits the public to inspect college records during regular office hours to find out whether nurses, psychologists or other professionals have had their registrations suspended or revoked, or whether they're working under certain conditions.

But the law puts no onus on colleges to publish disciplinary decisions, tell the public about fines or reprimands, post notices of cases where people resign in the face of an investigation, or provide details of the vast majority of complaints resolved behind closed doors.

The Times Colonist examined complaint statistics from a dozen colleges over five years and found that less than one per cent of files ever make it to a disciplinary hearing -- the one point at which a college is required by law to make findings public.

The rest are dismissed or resolved in secret, so a patient might never know whether the person treating them has a history of complaints.

In essence, if you don't ask, they don't have to tell. And that means a lot of things that a patient might like to know slip through the cracks.


Among the TC's findings:
  • A B.C. psychologist was suspended pending a disciplinary hearing last year because his college feared he was a risk to the public. The college then waited more than four months before telling the public about the suspension.

  • A pair of Vancouver Island chiropractors, each facing multiple counts of sexual assault, continue to practice under the condition they see female patients in the presence of a chaperone. The presence of the chaperone must be documented, and those records are checked by the college on a regular basis. But the chiropractors are under no obligation to notify patients why they are practising under these conditions.

  • The majority of colleges have no online registry like that of the College of Physicians and Surgeons, which allows the public to search by doctor's name to check his or her disciplinary record. Ontario now requires colleges to post their entire registries online "in a manner that is accessible to the public." But there is debate in B.C. over whether colleges can release limited information even over the telephone.

  • If they do post disciplinary decisions online, few colleges make it easy for the public to find them. The doctors' college, which is not yet governed by the Health Professions Act, is the most transparent, posting disciplinary decisions -- including fines, reprimands and consent agreements -- in a prominent place on its website for a 10-year period. But most colleges put the onus on the public to sift through annual reports or newsletters, though usually there is nothing on the website telling the public where to look.

  • Even when they do publish decisions, there is little consistency among colleges about how much detail they give the public. Some publish case summaries without names. Some publish names without case summaries. And a number of colleges do not even post annual reports, newsletters or complaint statistics on the Internet. For example, despite repeated telephone calls and e-mails, the College of Chiropractors took more than three months to provide the TC with complaint statistics, which are unavailable on its website.

  • The colleges are under no obligation to post malpractice or negligence findings by the courts, now required by law in Ontario.
Despite the gaps, the colleges insist the public is well protected by the current system.

"When we need to take action quickly, absolutely we do," says Cynthia Johansen, director of regulatory services at the College of Registered Nurses. "Our number 1 reason for being here is public protection."

But patients' rights advocates say the lack of transparency poses a risk. The TC found that only 75 of more than 8,300 complaints to 12 colleges went to a public hearing from 2001 to 2006.

"Clearly, there isn't enough information out there now," says Ann Van Regan, co-ordinator of the Zero Tolerance Network, a group dedicated to stopping abuse of patients by health professionals.

A victim of sexual abuse by an Ottawa-area physician in 1989, Van Regan says the obvious danger when the public doesn't have ready access to the discipline history of offending professionals is "that it happens again."

Sunday, August 26, 2007

Pharmageddon: the prescription pill epidemic

From the Independent

Our increasing reliance on pills has resulted in a 27 per cent rise in prescriptions written by doctors in just five years. It's costing the NHS £10bn a year, £200m of which is wasted on drugs that are never used. Nina Lakhani reports on a dangerous addiction

Britain is in the grip of a prescription drug-taking epidemic, with unprecedented numbers of medicines being handed out by GPs, costing billions of pounds and stretching already tight NHS resources to breaking point.

Prescription drug use has increased by 27 per cent in the past the five years and the NHS drug bill topped £10bn in 2006. GPs prescribed 918 million medicines last year compared with 721 million five years ago, according to figures obtained by The Independent on Sunday.

Health experts put rocketing prescription numbers down to medical advances, but also point to poor prescribing by GPs, growing public demand for a "pill for every ill" and aggressive marketing tactics by the pharmaceutical industry, which prompted one MP to warn that the UK is heading towards what he called "pharmageddon".

Paul Flynn, the Labour MP, warned that a failure to change attitudes would be disastrous. He said: "We are heading towards pharmageddon. The medicalising of society is convincing people they need a pill for everything. Drug companies recruit patients, particularly good-looking and articulate ones, to help promote new drugs in the media. Life and death decisions should not be taken by tabloids."

Doctors now write an average of 81 prescriptions a day compared with 64 five years ago. More than 730,000 prescriptions for antidepressants are being handed out each week, to the point where they almost match those for antibiotics at 870,000 a week.

More than £1bn has been wasted in the past five years on buying and disposing of drugs that were never used by patients, according to new research by the Conservative Party. GPs prescribe thousands of drugs patients don't want or take, according to this survey. The money wasted would pay for a year's worth of the breast cancer drug Herceptin for more than 10,000 women or 100,000 cycles of IVF.

Andrew Lansley, the shadow Health Secretary, said: "Every penny wasted is a penny lost to the improvement of NHS treatment. In an NHS that has a postcode lottery on access to NHS drug treatments, surely we must ensure that only those drugs that are really needed and will be used are prescribed."

News of the wastage comes at a time of growing disquiet at stories of patients being denied access to potentially life-changing drugs on the grounds of cost. Earlier this month, the High Court rejected an appeal by Alzheimer's sufferers for early treatment with a drug they claim helps to slow down the progress of the disease.

The increase in prescriptions will add pressure on GPs to improve their performance. Sir John Bourne, head of the National Audit Office, told the IoS: "If GPs more often followed official guidelines and prescribed generic and other cheaper drugs where suitable, there would be more money to treat patients and pay for expensive or innovative treatments."

GPs aren't 'tuned in' to mental health issues

Doctors are being criticised for overprescribing. Leading psychiatrist Professor Gordon Parker claims that too many people are being wrongly diagnosed with depression and prescribed drugs for perfectly "normal" emotions. Ninety per cent of GPs have said they prescribe antidepressants because there are not enough counselling alternatives, but voluntary organisations that provide such services rarely receive GP referrals. Paul Farmer, chief executive of Mind, said: "Many GPs are not tuned into mental health issues or support services that are available outside the NHS, and what is missing are the mechanisms to make that happen smoothly and effectively. It should be as easy to prescribe a course of counselling as it is to write a prescription."

Defending GPs, however, Professor Mayur Lakhani, chair of the Royal College of GPs, said that the increase should be celebrated as a sign of medical advances. He said: "The argument that society has become medicalised and there is a 'pill for every ill' is an exaggerated one, with no evidence. It is a great time to be a doctor. So much more can be done now. The challenge is for the Government to respond to the aspirations of doctors and patients in saving lives."

But some doctors argue that pressure from growing patient expectations is also behind the increase in prescriptions. Dr Chris Steele, GP and resident doctor on ITV's This Morning, said: "People expect to leave their GP appointment with a prescription in their hand, so if they don't, they are very disappointed. If you tell a patient that you are not prescribing something but want them to do 30 minutes' exercise every day and reduce the fat, sugar and salt content in their diet, a glazed look comes over their eyes and it is like to talking to a brick wall."

Evidence that patients want a "pill for every ill" is supported by the fact that more than 900 million non-prescription or over-the-counter items were also sold last year, and there is growing alarm at the number of people buying drugs from unregulated online pharmacies. Dr Richard Taylor, GP and independent MP for Kidderminster, said: "People now think it is better to take a pill than do something themselves about their own health; for example people want obesity drugs, when the basic thing about obesity is to take exercise and eat only what you need.

"We should be emphasising prevention for every kind of illness, for example, most skin cancers are preventable and a 'statins for all' approach is not helpful at all. Taking money out of treatment to put it into prevention is impossible at the moment; it would need a big change in the current climate. But what needs to be publicised is better self-control."

With 950 drugs currently being developed and no signs of diminishing public expectations, the costs look set to spiral further. Last month Roger Boyle, the Government's heart disease tsar, advocated cholesterol-lowering drugs for every man over 50, arguing that this would save the NHS money in the long term.

Dr Boyle faced criticism for his advice. Critics claimed that his proposal would "medicalise" millions of healthy people and that it failed to recognise that there is no such thing as a risk-free drug. The NHS is not a bottomless pit, they argue, and it has reached a tipping point. The British Medical Association has said for the first time that many health treatments will have to be rationed in the future because the NHS cannot cope with escalating patient demands.

Professor Karol Sikora, a leading cancer specialist, argued that a two-tier system is inevitable. He said: "The NHS is not a bottomless pit. To be fair, it should provide a good core package of cost-effective drugs and the others people should pay for themselves with health insurance. This is an unpopular stance that will not win me any votes, but there is no other solution. The NHS can't provide everything and we need to address this properly."

Some GPs argue that some clinical decisions come down to who shouts the loudest. "It is not possible for the NHS to keep paying for everything. Herceptin makes the front pages, so people with breast cancer get Herceptin, whereas people with Alzheimer's and age-related macular degeneration don't attract the attention, so they miss out," said Dr Taylor.

[...]

Friday, August 24, 2007

Backlash Grows on Psychologist Torture Resolution

from the Daily Kos, with lots of extended quotes from the relevant links

My thanks to the ever-energetic Stephen Soldz (whose blog "Science, Psyche, and Society" is must reading) for bringing attention to some major fallout over the American Psychological Association's scandalous so-called anti-torture resolution. This resolution formally condemned torture and cruel, unusual, inhumane and degrading forms of behavior inflicted on detainees in Bush's phony "war on terror". But its fine print gave the stamp of approval to certain forms of torture, including sensory deprivation, sleep deprivation, isolation, and even the use of psychotropic drugs on prisoners if not used for the immediate purpose of eliciting information. And the APA put its stamp of approval on psychologists working in settings where basic human rights, like habeas corpus, are not respected.

Soldz has written to colleagues to publicize the editorial in the Houston Chronicle yesterday, "Human wrongs: Psychologists have no place assisting interrogations at places such as Guantanamo Bay"



In addition to newspaper condemnations of APA's pathetic resolution, prominent psychologists are responding as well. Well-known psychologist and author Mary Pipher, of Reviving Ophelia fame, has taken up the cause. She has chosen to return an APA Presidential Citation she received in 2006 from then-APA president Gerald Koocher. Koocher has been a big supporter of the current APA position on allowing psychologists to work in Bush's coercive and inhumane detention camps.