Why All Those Testosterone Ads Constitute Disease Mongering

Snippet from a much longer article on Forbes.com

Archived link here

Documenting part of the much bigger pattern of disease mongering on the part of Big Pharma.

[...]

Over the last 10 years, testosterone prescriptions have risen 10-fold in the U.S. and 40-fold in Canada, according to an editorial published today in the Journal of the American Geriatrics Society. It’s likely no coincidence that the U.S. and Canada are two of only three countries (the other being New Zealand) that allow direct-to-consumer advertising of prescription drugs, say the authors, Thomas Perls, a professor at Boston University and geriatrician at Boston Medical Center, and David Handelsman, a professor at the University of Sydney in Australia.

Testosterone makers and some doctors “market the idea that men go through something similar to menopause, where they have these marked declines in testosterone and all these symptoms that we normally attribute to aging,” Perls says. “They say ‘If we give you testosterone, it will reverse the problem.’ It was a wildly successful ad campaign. We consider it to be disease mongering.”

Perls and Handelsman’s critique of testosterone marketing comes just weeks after the U.S. Food & Drug Administration issued tough new rules for the companies that market the hormone treatment. The agency demanded labels be revised make it clear the drugs are only for patients with diseases like hypogonadism or injuries that cause severely low levels of testosterone, and that replacement therapy may raise the risk of cardiovascular problems. Furthermore, the agency ordered testosterone makers to conduct post-marketing research to better elucidate testosterone’s risks.

But Perls and Handelsman argue that’s not enough. They’re calling for the agency to team up with the Federal Trade Commission and ban testosterone advertising for “contrived” conditions such as Low T or “andropause,” the term commonly used for male menopause. And they’re urging the FDA and Health Canada to require physicians to demonstrate—with legitimate hormone testing and the like—that any patient handed a prescription for testosterone actually has a disease that needs to be treated.

[...]

Is your doctor is getting paid by a pharma company? Look It up here

Using the Open Payments website you can research if your doctor is receiving payments from various drug companies. You can also look up other data by company name and by teaching hospital. USA only.

Here's the link

https://openpaymentsdata.cms.gov

Obligatory disclaimer

This search tool only searches identified data. The datasets are large and the search tool searches millions of records. For some searches the results will take some time to load, please be patient.

Data is reported on this website in accordance with the statutory authority in Section 1128 G of the Social Security Act. CMS has an impartial role in the collection and reporting of data regarding payments or other transfers of value pursuant to Open Payments. The transparency display of transactions from applicable manufacturers and group purchasing organizations to physicians and teaching hospitals does not necessarily mean any of the reported financial relationships are improper.

See our earlier post on this topic

The Era of "Marketing-based Medicine"

From a much longer article by Melissa Sweet, published in Crikey Online

The tactics used by the pharma industry to entrench its influence – whether with politicians, health groups or prescribers – have been hitting the headlines lately.

A story on the cover of the SMHS’s Weekend Business section (beats me why it wasn’t on the paper’s main cover) examined how the industry buys influence in Canberra, and last week Sun Dunlevy splashed in The Daily Telegraph on pharma funding of patient and other health groups. (For more about this particular story, see the bottom of the post)

Meanwhile, Dr Peter Parry, a psychiatrist and senior lecturer at Flinders University, has been investigating internal pharma documents and has come to the conclusion that we live in a world of “marketing-based medicine”. He writes:

“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data…”  AstraZeneca publications manager in internal email 6 Dec 1999.

In recent years doctors and other health professionals have been exhorted to practice “Evidence-based Medicine” or “EBM”. We should prescribe to our patients the right medication based on the best available medical science. Similarly surgeons should select the right implantable prosthesis according to EBM.

However there has been a growing tide of voices claiming EBM is not what it seems, that given the multi-billions of dollars involved, the medical science system has been distorted. The big pharmaceutical companies spend around 11% to 15% on research and development, but they spend around 36% of their budgets on marketing. This influence means much of what passes as EBM, may in fact be “MBM” – “Marketing-based Medicine”.

Psychiatric diagnosis of schizophrenia is not compatible with the facts of modern science

A Few thoughts prompted by this article in Psychology Today

The Oct 16 issue of the Scientific American has a short piece on “Massive Study Reveals Schizophrenia’s Genetic Roots.” These roots are, we learn, incredibly complicated. A huge consortium involving more than 300 scientists from 35 countries found “128 gene variants associated with schizophrenia, in 108 distinct locations in the human genome.”

Wow, eh?

This “genome-wide association study” found so many mutations in the molecular pairs of the 113,000 people it studied that . . . I can’t tell you. The mind boggles at how complicated “schizophrenia” must be.

Unless there is no such thing as schizophrenia.

The obvious conclusion seems not to have occurred to the Scientific American commentators: It is not that schizophrenia is “incredibly complicated,” but that there are several different diseases buried under the term “schizophrenia,” each with a genetics of its own.

[...]

It is a sign of the diminished American interest in psychopathology that all of these symptoms, which are highly diverse, each pointing in a different direction, have all been lumped together as “schizophrenia,” which makes as much sense as lumping measles, syphilis, and gangrene together as “skin diseases.”

[...] it was all dumped together in the same cauldron. Catatonia, adolescent insanity, psychosis at midlife, paranoia, who cares? It was all “schizophrenia.”

And this is the inheritance we’re now living with, as the geneticists take the phenotypes they’ve inherited from psychiatry and try to make sense of the anomalies they find on the DNA – which up to now, after billions of dollars and decades of research – have been indecipherable.

So, hunting for schizophrenia’s “genetic roots,” are we? Good luck with that.

But it all gets worse. As seen in this blog article "Biology and Genetics are Irrelevant Once True Causes are Recognized"

As superbly reviewed by psychologist John Read in the 2013 second edition of Models of Madness: Psychological, Social and Biological Approaches to Psychosis, since the turn of the 21st century many studies have linked schizophrenia and other psychotic conditions to childhood adversities such as having experienced bullying, emotional abuse, incest, neglect, parental loss, physical abuse, or sexual abuse—findings that are well known to clinicians who work with people diagnosed with psychotic disorders.

Read reviewed research linking schizophrenia and other psychotic disorders to social environments such as poverty, racism, migratory stress, and urbanicity. He concluded, “There is ample evidence that inequality, deprivation and discrimination, filtered through their social and personal meanings, are key causal factors in psychosis.” Psychological processes identified by Read and his colleagues, through which childhood adversities may lead to symptoms of psychosis later in life, include attachment, dissociation, dysfunctional cognitive processes, psychodynamic defenses, problematic coping responses, impaired access to social support, behavioral sensitization, and revictimization. A biologically oriented commentator might object that even if these factors play a role in causing schizophrenia and psychosis, only people who are genetically predisposed will develop them, and it is therefore important to understand and study hereditary factors. Aside from the fact that the evidence in support of genetics is weak, a clear understanding of the environmental causes of a condition frequently renders potential genetic factors irrelevant.

For example, 33 miners were trapped underground for 69 days in a copper mine near Copiapó, Chile in 2010. Although the miners were finally rescued and were treated as heroes, and in some cases as celebrities, many subsequently developed severe psychological symptoms caused by their ordeal, such as depression, anxiety, nightmares, and avoidant behavior. Because the causes of these symptoms are obvious and recognized, no one to my knowledge has suggested that the miners have genetically based brain disorders or “chemical imbalances.” It is clear that the miners’ experiences caused their symptoms, and the symptoms of most psychiatric conditions can also be seen in this way.

Simply, psychiatric diagnoses are not compatible with the facts of modern science

Drugging our kids: RX alliance rewards doctors as drug companies get richer

An Investigative report by the Los Angeles Daily News

The following is from a much larger article well worth reading:

An investigation by this news organization has found that drugmakers, anxious to expand the market for some of their most profitable products, spent more than $14 million from 2010 to 2013 to woo the California doctors who treat this captive and fragile audience of patients at taxpayers’ expense.

Drugmakers distribute their cash to all manner of doctors, but the investigation found that they paid the state’s foster care prescribers on average more than double what they gave to the typical California physician.

The connection raises concerns that Hernandez and many other unsuspecting youth have been caught in the middle of a big-money alliance that could be helping to drive the rampant use of psychiatric medications in the state’s foster care system.

“It sucks that the people marketed it that way, but that’s not that shocking. I’m more mad at the doctors for just going along with it,” said Hernandez, 22, who was prescribed as many as four of the drugs at a time as a foster youth in Southern California.

Overall, drugmakers reported payments to 908 doctors — well over half of those who prescribed psych medications to the state’s foster children, according to this news organization’s analysis of prescribing data and four years of pharmaceutical company payments compiled by the public interest journalism nonprofit ProPublica. And those who prescribed the most typically received the most, the analysis found.

The results provide the most comprehensive look to date at the pharmaceutical industry’s influence on the doctors who treat the 60,000 kids in the country’s largest foster care system — a lucrative target because Medi-Cal pays the bill with little scrutiny.

One Sacramento doctor raked in more than $310,000 in four years to give promotional speeches and an extra $8,500 in meals, records show. Another 224 doctors each got more than $500 in meals, and two of them each received more than $20,000 for travel. The biggest payments went for research, with two Southern California doctors each receiving more than $2 million to conduct drug company-sponsored trials.

Doctors who accept the drug companies’ offerings say they aren’t influenced, and the pharmaceutical industry defends its partnerships as a necessity for developing the lifesaving drugs of tomorrow.

“The kind of medical innovation that we have in this country wouldn’t happen without a robust dialogue between industry and physicians,” said John Murphy, assistant general counsel for the Pharmaceutical Research and Manufacturers of America.

But critics say the drug companies are disguising investments in the name of science to reward doctors who in turn boost the industry’s bottom line.

“These figures suggest these doctors are not looking out primarily for the kids’ interests,” said UCLA social welfare professor David Cohen, who has studied medication use in the foster care system and drug company influence. “They suggest many doctors are looking out for their financial interests, and we should all be wary.”

The findings are especially disturbing because of the growing evidence that psychiatric drugs are being overprescribed to California’s foster children despite their significant side effects, the subject of this news organization’s yearlong investigation “Drugging Our Kids.” The news organization previously reported that almost 1 in every 4 adolescents in California foster care has been prescribed psychotropic medications, often to manage troublesome behavior rather than treat the severe mental illnesses for which they are approved.

While the federal government has cracked down in recent years on how drug companies market powerful antipsychotic drugs to the elderly and children, the industry’s investment in courting doctors appears to still be paying off: California taxpayers spend more on psychotropic drugs than on any other kind of medication prescribed to foster children, according to a decade of Medi-Cal spending data revealed by this news organization in August.

This is only the tip of the iceberg

Psychiatric Drugs Are More Dangerous than You Ever Imagined

A New Video By Doctor Peter Breggin,part of a series

Big Pharma's Newest Money-Making Scheme: Adult ADHD

Evelyn Pringle has brought us another expose of disease mongering by the psych drug industry. Here's a snippet. Please visit the original post for all of the details

By Evelyn Pringle and Martha Rosenberg

Who belongs to this “untapped” market? Just about anybody.

There is good news and bad news about attention deficit/hyperactivity disorder (ADHD) -- that is, if you’re a drug company. The bad news is the kid market has peaked out with 4.5 million U.S. children now carrying the label. The good news is adult ADHD is an emerging market. In fact, adult ADHD, with symptoms similar to pediatric ADHD such as impulsivity, distractibility and difficulty paying attention, following instructions and meeting deadlines, is the next big thing.

"Immature adult market continues to offer greatest commercial potential," read a 2008 press release to the pharmaceutical industry from the market research agency Datamonitor: "Estimated to be twice the size of the pediatric ADHD population, the highly prevalent, yet largely untapped, adult ADHD population continues to represent an attractive niche to target."

Also seen on Alternet here

The myth of the chemical cure - It only gets you stoned

A commentary publish on the BBC website It looks like the drugs merely get you stoned or something, and cost way too much as well.

---

Taking a pill to treat depression is widely believed to work by reversing a chemical imbalance.

Medication is a mainstay of mental health therapy

But in this week's Scrubbing Up health column, Dr Joanna Moncrieff, of the department of mental health sciences at University College London, says they actually put people into "drug-induced states".

If you've seen a doctor about emotional problems some time over the past 20 years, you may have been told that you had a chemical imbalance, and that you needed tablets to correct it.

It's not just doctors that think this way, either.

Magazines, newspapers, patients' organisations and internet sites have all publicised the idea that conditions like depression, anxiety, schizophrenia and bipolar disorder can be treated by drugs that help to rectify an underlying brain problem.

People with schizophrenia and other conditions are frequently told that they need to take psychiatric medication for the rest of their lives to stabilise their brain chemicals, just like a diabetic needs to take insulin.

The trouble is there is little justification for this view of psychiatric drugs.


Altered states

First, although ideas like the serotonin theory of depression have been widely publicised, scientific research has not detected any reliable abnormalities of the serotonin system in people who are depressed.

Second, it is often said the fact that drug treatment "works" proves there's an underlying biological deficiency.

Psychoactive drugs make people feel different

But there is another explanation for how psychiatric drugs affect people with emotional problems.

It is frequently overlooked that drugs used in psychiatry are psychoactive drugs, like alcohol and cannabis.

Psychoactive drugs make people feel different; they put people into an altered mental and physical state.

They affect everyone, regardless of whether they have a mental disorder or not.

Therefore, an alternative way of understanding how psychiatric drugs affect people is to look at the psychoactive effects they produce.

Drugs referred to as antipsychotics, for example, dampen down thoughts and emotions, which may be helpful in someone with psychosis.

Drugs like Valium produce a state of relaxation and a pleasant drowsiness, which may reduce anxiety and agitation.

Drugs labelled as "anti-depressants" come from many different chemical classes and produce a variety of effects.

Prior to the 1950s, the drugs that were used for mental health problems were thought of as psychoactive drugs, which produced mainly sedative effects.

'Informed choice'

Views about psychiatric drugs changed over the course of the 1950s and 1960s.

They gradually came to be seen as being specific treatments for specific diseases, or "magic bullets", and their psychoactive effects were forgotten.

However, this transformation was not based on any compelling evidence.

In my view it remains more plausible that they "work" by producing drug-induced states which suppress or mask emotional problems.

If we gave people a clearer picture drug treatment might not always be so appealing

This doesn't mean psychiatric drugs can't be useful, sometimes.

But, people need to be aware of what they do and the sorts of effects they produce.

At the moment people are being encouraged to believe that taking a pill will make them feel better by reversing some defective brain process.

That sounds good. If your brain is not functioning properly, and a drug can make it work better, then it makes sense to take the pill.

If, on the other hand, we gave people a clearer picture, drug treatment might not always be so appealing.

If you told people that we have no idea what is going on in their brain, but that they could take a drug that would make them feel different and might help to suppress their thoughts and feelings, then many people might choose to avoid taking drugs if they could.

On the other hand, people who are severely disturbed or distressed might welcome these effects, at least for a time.

People need to make up their own minds about whether taking psychoactive drugs is a useful way to manage emotional problems.

To do this responsibly, however, doctors and patients need much more information about the nature of psychiatric drugs and the effects they produce.

Misuse of Psychological Tests in Forensic Settings: Some Horrible Examples

As seen on ParentingPlan.net We have not quoted the entire paper, but only the introductory section with a few of the smaller examples.

The original post has many fine examples, plenty of detailed references, and is oriented to situations where parents are separated. Unfortunately, given other news reports of recent years, this paper is still quite relevant

Misuse of Psychological Tests in Forensic Settings: Some Horrible Examples

Ralph Underwager and Hollida Wakefield

American Journal of Forensic Psychology, Volume 11, Issue 1

Psychological tests are often used inappropriately and are misinterpreted and overinterpreted in the forensic setting. This harms the person being evaluated and interferes with the cause of justice. It also does a disservice to the reputation of psychologists and the science of psychology. Actual examples of misuse of particular techniques and tests and misinterpretation illustrate what has been done in forensic settings.

A forensic evaluation is different from a clinical evaluation. When an evaluation is done in the clinical setting, the conclusions are used to develop a treatment plan. These conclusions form working hypotheses which can be confirmed or rejected during treatment. However, in the forensic setting, a one-time decision is made about the individual — a decision which can markedly affect the person's life.

If tests are misinterpreted in the clinical setting, the treatment plan developed from the evaluation may not be the most effective for the client. However, since treatment plans are generally modified and revised throughout the course of treatment, the mistaken conclusions can be corrected. But, an erroneous decision in the forensic setting can result in immediate and severe consequences, such as losing custody of a child or being jailed. If decisions and recommendations by the psychologist are not based on adequate data, the psychologist is acting both incompetently and unethically.

In addition, conclusions drawn by the psychologist are subject to cross-examination in the adversarial setting. If the conclusions are not based upon adequate data, the psychologist's testimony will be discredited or impeached by a skillful opposing attorney. Therefore, the psychologist should only present conclusions in reports and testimony which can be defended when challenged in cross-examination.

In the course of examining hundreds of reports, we have seen many examples of tests that are misadministered, misinterpreted, overinterpreted, or should never have been given in the particular setting. We are presenting a sample of these to illustrate what should be avoided by any psychologist who does forensic evaluations.

DRAWINGS

Tests such as the House-Tree-Person (HTP) and Kinetic Family Drawings are often overinterpreted and misinterpreted. There is a lack of validity and reliability in the use of drawings as projective assessment devices. In a review of the Draw-A-Person test in the Seventh Mental Measurements Yearbook, Harris (1) notes that there is very little evidence for the use of "signs" as valid indicators of personality characteristics. With children's drawings there is so much variability from drawing to drawing that particular features of any one drawing are too unreliable to say anything about them. The Tenth Mental Measurements Yearbook (2), in reviews by Cundick and Weinberg (p.422-425) continues the consistent finding since the first edition, 1938, that interpretations of drawings (as are often done in forensic evaluations) are unsupported by empirical evidence. Both reviewers note that there are no normative data establishing reliability and validity of the Kinetic Drawing System.

Here are some of the examples as given:

Example 2

A four-year-old girl was asked to draw a picture of herself and the family doing something. She instead, according to the school psychologist who was evaluating her, "seemed to be preoccupied with drawing circles within circles which she called 'caves.' Her second representation bore a significant resemblance to male genitalia (when asked what it represented, she reported that it was a ball rolling into a lion's cave)." This was interpreted as being suggestive of sexual abuse and the fact that the child has been subjected to some type of traumatic experience.

When we saw the child, now age five, we tested her and found borderline to low-average intelligence and no ability to draw anything other than scribbled circles. The child clearly had difficulties with visual motor perception and indeed, could not draw, a fact which was ignored by the other evaluator. This example, therefore, illustrates the importance of recognizing the child's developmental level.

Example 5

A four-year-old girl's drawing of a tree in the HTP was considered significant because the child, when asked to draw a tree, also drew a cactus. This was interpreted in terms of "unconscious expression of danger and fearfulness." However, the child was not asked if she had a cactus in her yard (this was in Texas).

The child also brought a drawing of a clown's face to the therapist which she had ostensibly drawn while in the waiting room with her parents. The clown was interpreted as being significant because "there is an element of sadness in the clown's eyes." This clown is of much greater sophistication and detail than the child's other drawings. When pressed about this in his deposition, the psychologist acknowledged that the parents probably drew it and she colored it. This example illustrates both problems in administration and in interpretation.

Example 20

A baby was returned to the foster mother following a visit with the parents and was described as having the "smell of sex." An emergency hearing was held in which social services attempted to cut off visits because this "smell of sex" triggered the suspicion that the parents were having sex with their baby. A psychologist agreed that the sex smell was significant and indicated probable abuse on the part of the parents. Fortunately, the parents had been at a church potluck dinner during the entire visit so they were able to disprove, the accusations.

We can just imagine the horror that happens when this gets involved with separation and divorce proceedings.

A Celebrity Patient's Backing Turns Sour for Drug Company

The Wall Street Journal has published a revealing story about one of the seamier sides of the drug industry's marketing campaigns: paying patients to offer testimonials about their drugs. Despite side effects one man had to continue because the money way so good. He is now writing a book about his experience. Here's the Video.




I note in the video that they show the complete original testimonial, which sort of defeats the purpose of the original news story. Way to go WSJ!

(the embedded player is a little funky, you might have to pause and push play an extra time or to to get past the intro)

Bitterness To Be Classified As a Mental Illness

Some psychiatrists are trying to get excessive bitterness identified as a mental illness named post-traumatic embitterment disorder. Of course this has some people who live perfect little lives, and always get what they want, questioning the new classification. The so called "disorder" is modeled after post-traumatic stress disorder because it too is a response to a trauma that endures. "They feel the world has treated them unfairly. It's one step more complex than anger. They're angry plus helpless," says Dr. Michael Linden, the psychiatrist who put a name to how the world works. Reported in the LA Times, via Slashdot

Why people should be concerned with the impending revision of the DSM

An excellent but long post from the fine folks at feministing.com, with only a portion quoted below

The Diagnostic and Statistical Manual of Mental Disorders (DSM) has been called the "bible of mental illness" because it lists and defines all of the "official" psychiatric diagnoses according to the American Psychiatric Association. The DSM is in the early stages of undergoing its 5th major revision; each previous revision has seen the total number of mental disorders recognized (some might say invented) by the APA greatly increase. Last year, trans activists were particularly concerned to learn that Ken Zucker and Ray Blanchard had been named to play critical lead roles in determining the language of the DSM sections focusing on gender and sexuality, especially given that these researchers are well known for forwarding theories and therapies that are especially pathologizing and stigmatizing to gender-variant people.

Blanchard has recently presented some of his suggestions to revise the "Paraphilia" section of the DSM. In the past, this section has generally received little attention from feminists, as it has been primarily limited to several sexual crimes (e.g., pedophilia, frotteurism and exhibitionism) and a handful of other generally consensual but unnecessarily stigmatized sexual acts (such as fetishism and BDSM) that are considered "atypical" by sex researchers. However, there are two aspects of the proposed Paraphilia section revision that should be of great concern to feminists, as well as anyone else who is interested in gender and sexual equality.

Expanding "Paraphilia"

First, Blanchard is proposing a significant expansion of the DSM's definition of "paraphilia" to include:

"any intense and persistent sexual interest other than sexual interest in genital stimulation or preparatory fondling with phenotypically normal, consenting adult human partners."

The first concern here is the term "phenotypically normal" (meaning "normal" with regards to observable anatomical or behavioral traits). Thus, according to this definition, attraction to any person deemed by sex researchers to be "abnormal" or "atypical" could conceivably be diagnosed as paraphilic. So, do you happen to be attracted to, or in a relationship with, someone who is differently-abled or differently-sized? Or someone who is gender-variant in some way? Well congratulations, you may now be diagnosed with a paraphilia!

Seriously.

Blanchard and other like-minded sex researchers have coined words like Gynandromorphophilia (attraction to trans women), Andromimetophilia (attraction to trans men), Abasiophilia (attraction to people who are physically disabled), Acrotomophilia (attraction to amputees), Gerontophilia (attraction to elderly people), Fat Fetishism (attraction to fat people), etc., and have forwarded them in the medical literature to denote the presumed "paraphilic" nature of such attractions.

This tendency reinforces the cultural belief that young, thin, able-bodied cisgender women and men are the only legitimate objects of sexual desire, and that you must be mentally disordered in some way if you are attracted to someone who falls outside of this ideal. It's bad enough that such cultural norms exist in the first place, but to codify them in the DSM is a truly terrifying prospect.

Another frightening aspect of Blanchard's proposal is that any sexual interest other than "genital stimulation or preparatory fondling" is now, by definition, a paraphilia.

In his presentation, he claimed that paraphilias should include all "erotic interests that are not focused on copulatory or precopulatory behaviors, or the equivalent behaviors in same-sex adult partners." Copulatory is defined as related to coitus or sexual intercourse (i.e., penetration sex). So, essentially, all forms of sexual arousal and expression that are not centered around penetration sex may now be considered paraphilias.

So, do you and your partner occasionally role-play or talk dirty to one another over the phone? Or engage in arousing play that is not intended to necessarily lead to "doing the deed"? Do you masturbate? Do you get a sexual charge from wearing a particularly sexy outfit or performing any act that falls outside of "genital stimulation or preparatory fondling"? Well, then congratulations, you can be diagnosed with a paraphilia!

The Drugs, They Do Nothing!

Some selected snippets from this report

Short-term Intensive Treatment Not Likely to Improve Long-term Outcomes for Children with ADHD

Initial positive results gleaned from intensive treatment of childhood attention deficit hyperactivity disorder (ADHD) are unlikely to be sustained over the long term, according to a recent analysis of data from the NIMH-funded Multimodal Treatment Study of Children with ADHD (MTA). The study was published online ahead of print March 2009 in the Journal of the American Academy of Child and Adolescent Psychiatry.

Using reports from parents and teachers as well as self-reports from the children, now high school-aged, the researchers found that the youth’s functioning remained improved overall compared to their functioning at the beginning of the study, suggesting that available treatments can still be effective. However, they also found the following:

• The eight-year follow-up revealed no differences in symptoms or functioning among the youths assigned to the different treatment groups as children. This result suggests that the type or intensity of a one-year treatment for ADHD in childhood does not predict future functioning.
  
• A majority (61.5 percent) of the children who were medicated at the end of the 14-month trial had stopped taking medication by the eight-year follow-up, suggesting that medication treatment may lose appeal with families over time. The reasons for this decline are under investigation, but they nevertheless signal the need for alternative treatments.
  
• Children who were no longer taking medication at the eight-year follow-up were generally functioning as well as children who were still medicated, raising questions about whether medication treatment beyond two years continues to be beneficial or needed by all.

Basically, parents become disillusioned with the failed promise of the easy fix of drugs for the treatment of this "condition"

FDA Approves Depressant Drug For The Annoyingly Cheerful

A Satire from the Onion, although the way drug companies operate, it makes you wonder sometimes.


FDA Approves Depressant Drug For The Annoyingly Cheerful

SSRI Pushers under Fire

We now have another excellent story by Evelyn Pringle, as seen in the Scoop Independent News, and elsewhere.

SSRI Pushers under Fire

By Evelyn Pringle

Throughout the 1990's, most doctors who attended conferences, medical seminars and other events were not aware that the so-called "key opinion leaders" encouraging them to prescribe the new generation of antidepressants for everything under the sun, including to children as young as infants, were nothing more than highly paid drug pushers for Big Pharma.

For years, the research that showed SSRI antidepressants (selective serotonin reuptake inhibitors) were dangerous and practically useless was kept hidden, while the studies published and presented to potential prescribers painted a glowing picture of success. These days, a person would be hard pressed to find someone who does not have a family member or friend labeled mentally ill and taking drugs like Prozac, Paxil, Zoloft, Lexapro and Celexa, or their chemical cousins Effexor, Cymbalta and Wellbutrin.

About once a year, a new round of headlines about all the money made by the SSRI pushers comes and goes; but nothing really ever seemed to stick, until now.

The Senate Finance Committee, with the ranking Republican, Senator Charles Grassley, leading the charge, is investigating GlaxoSmithKline regarding new revelations in a report filed in litigation showing that the company manipulated the numbers on adverse events related to suicidality in clinical trials back in 1989, to make it appear that Paxil did not increase the risk of patients experiencing suicidal behavior when, in fact, trial subjects on Paxil were eight times more likely to attempt or commit suicide than patients taking placebos.

Quite a few of the top pushers are also under investigation by the Committee due to revelations that millions of dollars has changed hands between the SSRI makers and the academics who signed off on some of the most fraudulently reported research in the history of modern medicine. A full list of names is easy to compile by scanning the literature on SSRI studies conducted on children. The same names appear repeatedly.

In alphabetical order, the Fortune 500 team of pushers, at a minimum, includes Drs Joseph Biederman, David Brent, Jeffrey Bridge, Daniel Casey, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer, and Karen Wagner.


Truth Buried in Litigation Graveyard

On February 6, 2007, the world famous historian on psycho-pharmacology, Dr David Healy, published a commentary entitled, "Why you should never trust new wonder drugs," in the UK's Daily Mail stating:

"Ten years ago, I sat faced with boxes and boxes that contained a dirty secret. Inside were thousands of confidential internal company documents about Prozac."

"The secret they revealed was that public statements about the safety of the drug were a lie; that the company knew Prozac was responsible for a raised risk of suicide and was only slightly more effective than a placebo."

Several years later, Dr Healy recounts, he was faced with the secrets of Paxil. "No one outside the two companies, and few within them," he writes, "knew what those boxes contained; I saw them because I was an expert witness in a court case."

"Documents prised out of companies by American court cases," he says, "have become the main way we have of discovering the truth about some of our best-selling drugs."

"The scientific literature, the very place doctors would look for a warning," he writes, "contained barely a hint of problems.”

"What's more, no one seems likely ever to have to answer for what appears to be fraud," he points out.

"In other organizations when evidence of disregard for public safety emerges, heads roll," Dr Healy said. "But there have been no resignations following these drug disasters - barely a flicker of embarrassment."

The UK's medicines “watchdog,” the British Medicines and Healthcare Products Regulatory Agency, he reports, "has never taken any action against the academics who make fraudulent claims in ghostwritten articles, nor doctors working for the companies who repeat such claims, even when they have been shown to be untrue."

"And no one in Britain," he points out, "has any means of finding out why their husband or child might have died."

Seven years before Dr Healy wrote this commentary, in a Prozac case for which he served as an expert witness, the plaintiff's legal team learned that Eli Lilly had withheld evidence in a jury trial when the May 7, 2007 Boston Globe reported that Lilly had agreed to pay $20 million for the rights to a patent on a new version of Prozac that would reduce "akathisia," the very side effect long believed to increase the risk of suicidal behavior, three months before the trial began.

While testifying under oath, Lilly researcher, Gary Tollefson, had told the jury, "there is absolutely no medically sound evidence of an association between any antidepressant medicine, including Prozac, and the induction of suicidal ideation or violence."

When in fact, the wording in the patent for the new formula stated "fluoxetine (Prozac) produces a state of inner restlessness (akathisia), which is one of its more significant side effects," and the "adverse effects which are decreased by administering the R(-) isomer of fluoxetine include but are not limited to headaches, nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal thoughts and self mutilation."

Patients who lived to talk about a failed suicide attempt have described the SSRI-induced akathisia, as being so unbearable that their only option for relief seemed to be death.


America’s Most Wanted

Dr Daniel Casey was a major player in the SSRI drug-push and useful in many ways to the companies promoting the drugs. He was the chairman of the very first FDA advisory committee that met in 1991, to decide whether a warning about the increased risk of suicide should be added to the label of Prozac, the first SSRI approved in the US, and voted it down. He was also the chairman of the advisory panel that voted to approve Zoloft for Pfizer later that same year.

Bob Sorenson was a sales representative for Pfizer for 21 years. He moved to Oregon shortly before Zoloft was approved. During the first week at his new location, Pfizer’s chief of marketing at the time told him he needed to start calling on a doctor by the name of Dr Daniel Casey at the V.A. in Portland because he was very important to the company.

Dr Casey worked at the V.A., but never treated patients for depression, Mr Sorenson says. "His expertise [was] psychotropic drugs and experimentation."

The chief of marketing said he was interested in finding out what Dr Casey thought of the company's new drug, Zoloft. The company tried to call on him that day, but Dr Casey was not in. Mr Sorenson called on him later in the week and learned that Dr Casey was the lead investigator on Zoloft, which was up for approval by the FDA advisory committee Dr Casey chaired.

"He said I shouldn't be there, but I did ask how it looks for the drug and he said very well," Mr Sorenson recalls.

Dr Casey ended up making a ton of money from Zoloft. "He told me personally one time that he made enough from Pfizer in one year to purchase two cars," Mr Sorenson reports.

Dr Casey became a member of Pfizer's Advisory Board for Zoloft, which meant "all expense paid trips," including honorariums, to anywhere Pfizer wanted him to advise, at any location in the world, Mr Sorenson explains.

"Many speakers were sought out that would only give lectures that put Zoloft in a positive light," he notes, "there was no room for a balanced lecture."

"Dr Casey later became one of the most sought after speakers for the Pfizer promotion of Zoloft," he says, "the reps loved him because of his positioning of Zoloft."

Mr Sorenson was often told to take information to speakers, "including Dr Casey, to have them add the information to their lectures," he reports. "I look back at it now and see how wrong it was," he states.

"As far as the suicide issue," Mr Sorenson says, "the standard company line was that parents and doctors should be monitoring these kids because after being on Zoloft they finally feel good enough that they can carry out their suicide tendencies."

"Another tactic was to blame Paxil and Effexor," he recalls, "it was those drugs that caused suicidal tendencies, not Zoloft."

"Finally," he notes, "the statement was made that if they didn't take Zoloft, they probably would have committed suicide anyway."

Sales reps would practice and rehearse these statements at sales meetings to be able to respond to concerns or objections raised by Doctors about Zoloft’s relationship to suicidality, he says. "There would be contests as to who could detail the drug the best with objections," he recalls.

Pfizer was able to get rid of employees and still keep them quiet, he says, by offering severance packages of up to a year's salary, while forcing them to sign a confidentiality agreement, in which they promised not to sue, or speak adversely about Pfizer, as part of the deal.

Many people were so surprised at being terminated that they felt forced to sign because Pfizer kept the pressure on, he explains. They feared they wouldn’t find another job before financial problems set in, but regretted signing the agreement later, he says.

Mr Sorenson did not sign an agreement when he was fired. His young son had developed cancer, but Pfizer expected him to continue to attend out-of-town meetings and refused to believe that his son was terminally ill, he recalls. After 20 years with the company, Mr Sorenson was let go when he insisted that he needed to remain near his dying son and distraught wife. The Sorenson's son passed away on April 1, 2005.


Going rate for Legal Drug Pushers

SEC filings for Cypress Bioscience provide a good source for estimating how much money legal drug pushers can make each year, from each company, because the names of several appear in these filings. According to its website, “Cypress Bioscience is committed to developing and commercializing pharmaceutical products and personalized medicine laboratory services that allow physicians to serve unmet medical needs.”

Drs Martin Keller and Charles Nemeroff, two of the most prolific depression-mongers, have served on the company’s board of directors, on its scientific advisory board and as consultants for this company. Under their 2004 Consulting Agreements, Cypress was required to pay them $50,000 per year for services rendered up to and including “two days per fiscal quarter.” In addition, the company could request additional services at a rate of $5,000 per day.

During 2003, Dr Nemeroff was paid $19,000 for additional services under his agreement, and Dr Keller was paid an extra $18,000. But they were only making $2,000 per day that year. As members of the Psychopharmacology Advisory Board, Dr Nemeroff earned $19,000 and Dr Keller $18,000 in 2003.

For their service as directors of the company in 2002, they each received $24,000. They were also offered stock options regularly. Cypress is only company. A bio on Dr Keller in a July 25, 2002 agenda for an annual meeting states that he is also a consultant to, "Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Janssen, Merck, Inc, Organon, Otsuka Pharmacia/Upjohn, Pharmastar, Pfizer, Inc. and Wyeth-Ayerst Laboratories."

It also shows he serves on the scientific advisory boards of, "Bristol-Myers Squibb, Cephalon, Cyberonics, Inc., Eli Lilly, Forest Laboratories, Merck, Inc, Mitsubishi, Organon, Pfizer, Sepracor, Scirex, SmithKline Beecham, Somerse, Vela Pharmaceuticals and Wyeth-Ayerst."

Dr David Dunner and a few more of the usual suspects appear in the Cypress SEC filings as advisory board members as well.

Dr Nemeroff's role in the prostitution of research is legendary. In April 2004, Shannon Brownlee, author of, "Overtreated," wrote an article in the Washington Monthly entitled, "Doctors Without Borders," after he was caught failing to disclose his financial ties to the companies whose treatments he promoted in a paper in Nature Neuroscience, and noted:

"With financial ties to nearly two dozen drug and biotech companies, Dr. Charles B. Nemeroff may hold some sort of record among academic clinicians for the most conflicts of interest.

"A psychiatrist, a prominent researcher, and chairman of the department of psychiatry and behavioral science at Emory University in Atlanta, Nemeroff receives funding for his academic research from Eli Lilly, AstraZeneca, Pfizer, Wyeth-Ayerst--indeed from virtually every pharmaceutical house that manufactures a drug to treat mental illness.

"He also serves as a consultant to drug and biotech companies, owns their stocks, and is a member of several speakers' bureaus, delivering talks--for a fee--to other physicians on behalf of the companies' products."

Dr Nemeroff stood to "reap as much as $1 million in stock" from just one company that manufactured one of the products in his Nature Neuroscience paper, she noted.

"But the drug industry's most powerful means of boosting the bottom line is funding research," Ms Brownlee writes, "which allows companies to control, or at least influence, a great deal of what gets published in the medical journals, effectively turning supposedly objective science into a marketing tool."

She notes how companies are able to routinely delay or prevent the publication of data and specifically how the majority of studies which found antidepressants to be no better than placebos, "never saw print in medical journals."

In conclusion, she states, "I'm struck more than anything by the apparent lack of shame among clinicians when it comes to this issue."

Two years later, on July 19, 2006, the Wall Street Journal reported that the journal, Neuropsychopharmacology, published by the American College of Neuropsychopharmacology (ACNP), planned to publish a correction of a favorable review of a new depression treatment device because it failed to list the ties of the eight academic authors to the device maker, Cyberonics, including lead author Dr Nemeroff, the editor of Neuropsychopharmacology at that time. The FDA had approved the VNS device in July 2005 over the objections of "more than 20" FDA scientists, Bloomberg reported a day earlier on July 18, 2006.

"This is about as classic an example as you'll ever find of conflict of interest and manipulation by thought leaders who are beholden to corporations," Dr Bernard Carroll, a member of the ACNP, told Bloomberg. "This article is a piece of a slick, skillfully coordinated PR campaign directed by the corporation," he said.

Ten days before the Wall Street Journal article, Cyberonics had sponsored a little noticed symposium on treatment-resistant depression at the annual Collegium Internationale Neuro-Psychopharmacologicum Meeting. The main presenters at the July 9, 2006 event were Drs Nemeroff, Dunner, and Keller (the lead author of the infamous Paxil “Study 329” on adolescents).

"In recent years, new treatment modalities have emerged, among them, the only FDA-approved treatment option specifically designed for this patient population, VNS Therapy," Dr Dunner stated in a press release for the event.

Dr Dunner was one of the authors vouching for the new device in the Neuropsychopharmacology paper. However, a “stamp of approval” from this guy should be taken with a grain of salt. Back in March 1995, he also vouched for Paxil as lead author of a study titled, "Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo," in the journal of European Neuropsychopharmacology. However, he later admitted that he never reviewed any of the actual data from that study.

Dr Nemeroff apparently learned nothing from the public embarrassment of the previous scandals. Last week, he was forced to step down as Chair of Emory’s psychiatry department. According to a December 23, 2008 posting by Ed Silverman, on the popular blog, Pharmalot:

"Under pressure from a US Senate Finance Committee investigation, renowned psychiatrist Charles Nemeroff is giving up the post he held for 17 years and must follow new restrictions on his outside activities, according to an Emory University statement.”

“Emory’s own investigation found Nemeroff received more than $800,000 from Glaxo, which paid Nemeroff more than any other drugmaker, but he never reported the fees. There were more than 250 speaking engagements between 2000 and 2006.”

"Moreover, Emory will not submit any National Institutes of Health grant or other sponsored grant or contract requests in which Nemeroff is listed as an investigator or has any other role for a period of at least two years,” Pharmalot reports.

All total, Dr Nemeroff earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory, according to the Senator.

Dr Keller’s disclosure records are under investigation as well He also appears center stage in a new book by former Boston Globe reporter, Alison Bass, called, "Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial," The book contains a treasure trove of insider revelations with specifics on Dr Keller's endless conflicts of interest, along with other academics on the take. However, Ms Bass first broke the Keller story back on October 4, 1999, in the Globe, when she reported that he was forced to forfeit "hundreds of thousands of dollars" in state grant money in 1998.

She explained how in the same year that Dr Keller authored a review article in "Biological Psychiatry," and concluded that the newer antidepressants Zoloft, Bristol-Meyer’s Serzone, and Wyeth’s Effexor were more effective, he received $77,400 in personal income and $1.2 million in research funding from Bristol-Myers, as well as $8,785 in personal income from Wyeth.

In "Side Effects," she notes that Dr Keller did not report any income to the IRS from Glaxo for 1998, but says he did receive money from the Paxil maker, and also earned $62,500 from Celexa maker Forest Labs that year.

Dr Keller published 3 studies, "with colleagues," in the Journal of the American Medical Association and the Journal of Clinical Psychiatry, touting the efficacy of Zoloft in 1998, and received $218,000 in personal income and more than $3 million in research funding from Pfizer the same year, Ms Bass reports.

The "colleagues," referred to include the all-time champion of child drugging, Dr Joseph Biederman, the main promoter of the bogus epidemic of childhood bipolar disorder. He too is under investigation for taking $1.6 million from drug companies between 2000 and 2007, and only disclosing a fraction of that amount to Harvard. On December 30, 2008, Harvard’s teaching hospital, Massachusetts General announced that Dr Biederman was no longer participating in several industry-funded trials and had agreed to “not to participate in any outside activities that are paid for or sponsored by industry, such as consulting activities or speaking engagements.”

In most of the SSRI trials conducted on children, "colleagues," will also include Dr Graham Emslie of Prozac fame, and the Zoloft Czar, Dr Karen Wagner, both from the University of Texas.

Back in April 2004, the British Medical Journal published a paper by a research team led by Dr Jon Jureidini, head of the department of psychological medicine at Women's and Children's Hospital in Australia, after a review of the clinical trial data on the safety and efficacy of antidepressant use with children. The review included the published trials, along with some unpublished data made public by the Committee on Safety of Medicines in the UK.

The Australian team was extremely critical of the published papers on the major trials of Prozac, Paxil and Zoloft, with Emslie, Wagner and Keller listed as lead authors. "In discussing their own data," the team wrote, "the authors of all of the four larger studies have exaggerated the benefits, downplayed the harms, or both."

"It is vital," they wrote, "that authors, reviewers, and editors ensure that published interpretations of data are more reasonable and balanced than is the case in the industry-dominated literature on childhood antidepressants."

Seven months later, the New York Times ran a report by Barry Meier on November 29, 2004, throwing another spotlight on the trail of corruption within the SSRI research factories, and zeroed in on Dr Wagner. He noted that, from 1998 to 2001, she was one of several researchers participating in more than a dozen industry-funded pediatric trials of antidepressants and other drugs, and that some of the results were published, but many were not.

In her Zoloft study, Dr Wagner acknowledged that she had received "research support" from several drug makers including Pfizer, which paid $80,000 to the center in connection with the test, Mr Meier reports. But she did not state that she received “sizable payments” from Pfizer for work related to the study, he says.

The same month that patients were first recruited for the Zoloft trial, in a financial filing with the school in December 1992, Dr Wagner reported that she received more than $10,000 from Pfizer, with no further details. A lawyer for the school told Meier that Dr Wagner said Pfizer had paid her $20,500 during the course of the Zoloft trial. But records for payments she received in speaking and consulting fees could not be located.

In September, Dr Wagner’s name was added to the Senator Grassley’s investigative roster, along with Dr John Rush. Between 2000 and 2005, Glaxo alone paid Dr Wagner $160,404, but only $600 was disclosed to the University, according to the Senator. She was also paid over $11,000 in 2002, by Eli Lilly, and that money was not disclosed either. Lilly paid Dr Rush $17,802 in 2001, but he only reported $3,000, Senator Grassley said.

Dr Emslie’s financial trail to the drug makers gained media attention last summer due to his prominent role in the “Texas Children's Medication Algorithm Project,” and the creation of a drug formularies for children. He was chairman of the panel that wrote guidelines instructing doctors to prescribe SSRIs off-label to kids for depression in 1998. On August 18, 2008, the Dallas Morning News ran the headline: “Conflict of interest fears halt children's mental health project.”

“A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list,” the News reported. University disclosure forms indicate that Dr Emslie “has made at least $130,000 in drug company speakers fees and consulting contracts since 2002,” the paper noted.

In discussing the investigation of Dr Wagner on the Senate floor, Dr Grassley pointed out that she was a co-author on Paxil Study 329. In 2001, when the study was published, Glaxo “reported paying her $18,255,” he said. “Study 329 was cited in a New York case where GlaxoSmithKline was charged with ‘repeated and persistent fraud,’” the Senator added.

Dr Emslie was also a co-author on the Paxil study and a check of the full list for 329, reveals that 5 of the co-authors appear with Dr Emslie on the guidelines for the “Children's Medication Algorithm Project,” including Karen Wagner, Boris Birmaher, Barbara Geller, Neil Ryan and Michael Strober. Dr Rush’s name is also on the Texas guidelines but he moved to Singapore last August.

********

Evelyn Pringle

epringle05@yahoo.com

(Written as part of the SSRI Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department at http://www.baumhedlundlaw.com)

(Evelyn Pringle is a columnist for Scoop Independent News and an investigative journalist focused on exposing corruption in government and corporate America)

The Diagnostic and Statistical Manual of Mental Disorders is being revised under a cloak of secrecy

As seen in the LA Times

[...] An update is underway for the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, known as the DSM, which defines the emotional problems for which doctors prescribe drugs and insurance companies pay the treatment bills. Psychiatrists working on the new edition were required to sign a strict confidentiality agreement.

Critics contend that the American Psychiatric Assn. should allow outside observers to review the scientific debate behind new and revised diagnoses.

Among the most prominent to speak out is the editor of the manual's third edition, Dr. Robert Spitzer, hailed by peers as the most influential psychiatrist of his generation. If the DSM is often called the profession's bible, then the DSM-III is the King James Version. Released in 1980, it set the standard by which others are measured.

Recently, Spitzer broke ranks by publishing an open letter to the profession protesting the confidentiality mandate.

"If you don't know what goes on at someone's meetings, they're suspect of having a conflict of interest," the Columbia University professor said in an interview.

The profession is already confronting that issue through revelations that academics in the field are earning tens of thousands of dollars in consulting fees from drug companies. The financial links between the drug industry and the psychiatric community have sparked a congressional investigation headed by Sen. Charles E. Grassley (R-Iowa).

Officials with the APA counter that the psychiatrists working on the DSM revision are limited to $10,000 annually in fees from drug companies. The association says "transparency" is the byword of those overseeing the process.

Darrel Regier, who heads the APA's research arm, said the critics are failing to recognize progress in the field. "The field of psychiatry has gone from an ideology to a scientific pursuit," he said. The DSM grew out of a guidebook used by the military during World War II. Afterward, it was revised for general use and subsequently enlarged.

When it first appeared in the 1950s, psychiatry was dominated by Freud's model of psychological suffering, one that was resolvable by talking out the conflict with a therapist. Yet even then, drugs were appearing for relief of psychotic symptoms, and leadership in the profession has since passed to psychiatrists with an alternative model: biology and genetics as the source of emotional problems.

As the field has changed, the number of disorders in the DSM has tripled to 300, an increase paralleled by the rise in sales of drugs that pharmaceutical companies and psychiatrists tout as remedies for emotional suffering.

Some critics suspect that a quest for profits has encouraged the field to create mental illnesses out of personality quirks.

In his recent book, "Shyness: How Normal Behavior Became a Sickness," Christopher Lane traces how shyness morphed from a character trait into a pathological condition called "social phobia," which the DSM defines as "fears that he or she may do something or act in a way that will be humiliating or embarrassing." With disorders so broadly drawn, Lane wonders, who among us is sane?

It's an apt criticism, says David Kupfer, who is shepherding the DSM's revision.

"One of the raps against psychiatry is that you and I are the only two people in the U.S. without a psychiatric diagnosis," said Kupfer, head of the psychiatry department at the University of Pittsburgh.

Kupfer said he hopes to reduce the number of diagnostic categories in the forthcoming edition of the DSM, scheduled to appear in 2012.

He argues that scientific progress comes from formulating ideas, then seeing if others can shoot them down. If currently listed maladies fail that test, they'll be dropped, Kupfer said.

Meanwhile, Lane -- who has become something of a thorn in the side of the psychiatric community -- has irked some by obtaining the working papers of psychiatrists who produced the DSM-III and making plans to post them on his website.

Some of his finds read less like scientific discourse than like shtick from a Catskills comedian.

One syndrome under discussion at the time was "chronic complaint disorder."

Its supposed sufferers were largely "of Eastern European ancestry" and revealed their malady when asked how things are going.

"In those cases," the psychiatrists wrote, "the pathognomonic expression becomes, 'Oy vey, don't ask.' "

Big Pharma Spends More On Advertising Than Research

Seen on the ZME Science Blog, via a link to the story recently on Reddit, in reference to this paper

A drug company is a commercial business whose focus is to research, develop, market and/or distribute drugs, most commonly in the context of healthcare; from wikipedia. But according to a study by two York University researchers estimates the U.S. pharmaceutical industry spends almost twice as much on promotion as it does on research and development, contrary to the industry’s claim.

But how could this be you might ask yourself. Well the answer is fairly easy; regardless of its purpose of helping people it is a bussiness and thus it has to make money and the way of making money is by advertising more and researching less. The researchers’ estimate is based on the systematic collection of data directly from the industry and doctors during 2004, which shows the U.S. pharmaceutical industry spent 24.4% of the sales dollar on promotion, versus 13.4% for research and development, as a percentage of US domestic sales of US$235.4 billion.

In case you are wondering who made this study well the research is co-authored by PhD candidate Marc-André Gagnon, who led the study and Joel Lexchin, a long-time researcher of pharmaceutical promotion, Toronto physician, and Associate Chair of York’s School of Health Policy & Management in the Faculty of Health.

“In our paper, we make the case for the need for a new estimate of promotional expenditures by the U.S. pharmaceutical industry,” says Gagnon. “We then explain how we used proprietary databases to construct a revised estimate and finally, we compare our results with those from other data sources to argue in favor of changing the priorities of the industry.”

This study is very important as it shows the most accurate image yet of the promotional workings of the pharmaceutical industry, says Lexchin. But even this could be wrong a bit because there are other advertising campaigns which could not be taken into consideration such as ghost-writing and off-label promotion so in fact these companies are probably spending more than twice advertising rather then researching. As well, note the authors, the number of meetings for promotional purposes has dramatically increased in the U.S. pharmaceutical industry, jumping from 120,000 in 1998 to 371,000 in 2004, further supporting their findings that the U.S. pharmaceutical industry is marketing-driven.

Lapses at Psychiatric Solutions Inc., a major hospital chain with high earnings, have put patients at risk, regulators find. Some have even died.

Highlights from a MUCH longer article in the LA Times

Lapses at Psychiatric Solutions Inc., a major hospital chain with high earnings, have put patients at risk, regulators find. Some have even died.

[...]

Since 2005, the 10 hospitals PSI has owned longest have compiled almost twice as many patient-care deficiencies as 10 similar hospitals owned by its closest competitor, Universal Health Services Inc.

The PSI hospitals were cited in three patient deaths and for placing patients in immediate jeopardy four times, the inspection records show. The UHS hospitals received no equivalent citations.

Among private psychiatric hospitals in California, Sierra Vista had the single highest rate of state and federal deficiencies -- about eight times the statewide average.

It has twice been fined $25,000 for endangering patients -- accounting for the only such penalties levied against psychiatric hospitals under a 2006 state law establishing the sanctions. PSI executives declined to be interviewed for this article and, citing privacy law, would not discuss individual patients.

In written responses, they rejected the analysis showing the company's hospitals compared poorly to others, saying: "Your assumptions, calculations and apparent conclusions are invalid."

A spokesman, John Van Mol, said that PSI arguably has improved psychiatric care in the country overall. He cited the comparatively poor performance of state psychiatric facilities around the country in recent years.

PSI officials apologized for incidents resulting in harm to patients, saying they acted immediately to correct any problems. "Any incident involving patient care is one too many in our view, and everyone involved from the hospital level to the corporate level works very hard to prevent them," they wrote.

Recent state and federal inspections show the company's efforts have fallen short:

* Poor patient supervision, understaffing and inadequate worker training have led to instances of chaos and brutality.

A 19-year-old alleged he was raped twice within 24 hours by a fellow patient at an Illinois hospital even after he reported the first assault, federal records show.

Staffers at a Texas facility had to barricade themselves in an office and call in a SWAT team to bring unruly residents under control.

In North Carolina, inspectors found, a 12-year-old boy with a history of sexual aggression was put in a room with a 5-year-old and attempted to force the younger boy to perform oral sex.

* Medical neglect and errors have resulted in grave harm. A nurse at another North Carolina facility gave a 7-year-old boy anti-seizure medication prescribed for an older patient, leaving him so drowsy that a doctor wrote in his chart that "he refuses to wake up."

Workers in Virginia waited almost an hour to call an ambulance for a 17-year-old girl who had suffered a seizure and was bleeding profusely, inspection records show. The girl died later that day.

* In several instances, PSI employees have sought to hide their failings from regulators. A hospital in Texas was cited by state inspectors for concealing key facts about a patient abduction and a suicide. Regulators in Virginia uncovered what they called an organized scheme to cover up violence, suicide attempts and medication errors at a Charlottesville facility for juveniles.

* Some of the PSI hospitals most under fire from authorities are those the chain has owned longest. The Justice Department has opened an investigation into alleged patient-care problems at one of PSI's first acquisitions, Riveredge Hospital near Chicago, issuing subpoenas for records earlier this year.

Nationwide since 2006, health officials have pulled children out of one PSI facility and have moved five times to revoke the state licenses of others. They have withheld or ordered the company to repay more than $2 million in government funding for providing substandard care.

In addition to thousands of pages of inspection reports by individual states and the U.S. Centers for Medicare and Medicaid Services, ProPublica's investigation was based on hospital and court records and interviews with about two dozen former employees.

PSI executives say they are filling a desperate need in a tough business.

"Everyone at Psychiatric Solutions works hard every day to achieve excellence in patient care, often under extremely difficult circumstances to serve a patient population that includes extremely acute and complex diagnoses," Chief Executive Joey Jacobs said in a written statement.

Chad Thompson, who worked in the admissions office at Sierra Vista when PSI took over, has a different view. He felt the chain put intense pressure on him to keep every bed full, with less emphasis on assuring that each patient got high-quality care.

"It's a pattern of behavior driven totally by the almighty dollar," said Thompson, now the director of a nonprofit that provides therapy to the uninsured and chairman of Sacramento County's Mental Health Board, which advises the county Board of Supervisors.

"It's not a client-centered approach. It's a money-centered approach."

Psychiatric Radio Host Had Undisclosed Drug Company Ties, Conflict of Interest Means His Show to Be Pulled From Air

From a Report in the NY Times

An influential psychiatrist who was the host of the popular NPR program “The Infinite Mind” earned at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers, income not mentioned on the program.

The psychiatrist and radio host, Dr. Frederick K. Goodwin, is the latest in a series of doctors and researchers whose ties to drugmakers have been uncovered by Senator Charles E. Grassley, Republican of Iowa. Dr. Goodwin, a former director of the National Institute of Mental Health, is the first news media figure to be investigated.

Dr. Goodwin’s weekly radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, he warned that children with bipolar disorder who were left untreated could suffer brain damage, a controversial view.

“But as we’ll be hearing today,” Dr. Goodwin told his audience, “modern treatments — mood stabilizers in particular — have been proven both safe and effective in bipolar children.”

That same day, GlaxoSmithKline paid Dr. Goodwin $2,500 to give a promotional lecture for its mood stabilizer drug, Lamictal, at the Ritz Carlton Golf Resort in Naples, Fla. In all, GlaxoSmithKline paid him more than $329,000 that year for promoting Lamictal, records given to Congressional investigators show.

In an interview, Dr. Goodwin said that Bill Lichtenstein, the program’s producer, knew of his consulting but that neither thought “getting money from drug companies could be an issue.”

“In retrospect, that should have been disclosed,” he said.

But Mr. Lichtenstein said that he was unaware of Dr. Goodwin’s financial ties to drugmakers and that, after an article in the online magazine Slate this year pointed out that guests on his program had undisclosed affiliations with drugmakers, he called Dr. Goodwin “and asked him point-blank if he was receiving funding from pharmaceutical companies, directly or indirectly, and the answer was, ‘No.’ ”

Asked about the contradiction, Dr. Goodwin and Mr. Lichtenstein each stood by their versions of events.

“The fact that he was out on the stump for pharmaceutical companies was not something we were aware of,” Mr. Lichtenstein said in an interview. “It would have violated our agreements.”

Margaret Low Smith, vice president of National Public Radio, said NPR would remove “The Infinite Mind” from its satellite radio service next week, the earliest date possible. Ms. Smith said that had NPR been aware of Dr. Goodwin’s financial interests, it would not have broadcast the program.

Sarah Alspach, a spokeswoman for GlaxoSmithKline, said, “We continue to believe that healthcare professionals are responsible for making disclosures to their employers and other entities, in this case National Public Radio and its listeners.”

[...]

Mr. Grassley is systematically asking some of the nation’s leading researchers and doctors to provide their conflict-of-interest disclosures, and he is comparing those documents with records of actual payments from drug companies. The records often conflict, sometimes starkly.

In October, Mr. Grassley revealed that Dr. Charles B. Nemeroff of Emory University, an influential psychiatric researcher, earned more than $2.8 million in consulting arrangements with drugmakers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules. As a result, the National Institutes of Health suspended a $9.3 million research grant to Emory, and Dr. Nemeroff gave up his chairmanship of Emory’s psychiatry department.

In June, the senator revealed that Dr. Joseph Biederman of Harvard, whose work has fueled an explosion in the use of powerful antipsychotic medicines in children, had earned at least $1.6 million from drugmakers from 2000 to 2007, and failed to report most of this income to Harvard.

Mr. Grassley’s investigation demonstrates how deeply pharmaceutical commercial interests reach into academic medicine, and it has shown that universities are all but incapable of policing these arrangements. As a result, almost every major medical school and medical society is reassessing its relationships with makers of drugs and devices.

“We know the drug companies are throwing huge amounts of money at medical researchers, and there’s no clear-cut way to know how much and exactly where,” Mr. Grassley said. “Now it looks like the same thing is happening in journalism.”

Mr. Grassley has proposed legislation that would require drugmakers to disclose all payments of $500 or more to doctors. Eli Lilly and Merck have promised to begin doing so next year.

[...]

Boston Legal: TV Drama Or Reality Show?

The Website PharmaLot has an item noting the intrusion of recent scandals involving Harvard Psychiatrist Joseph Biederman into primetime TV in the form the TV show Boston Legal

There is little time to watch TV on the Pharmalot corporate campus, but we were directed to a recent episode of ‘Boston Legal,’ that compelling drama about - what else? - a bunch of emotionally challenged lawyers, because there was mention of a recent pharma issue being investigated by the US Senate Finance Committee.

To wit, the committee is looking at alleged instances of undisclosed conflicts of interests involving academics who receive National Institutes of Health grants to research certain drugs and payments from drugmakers for consulting, research or speaking (back story). This is prominently noted by actress Candace Bergen, along with other matters such as pharma ties to the FDA, Congress and doctors, in a speech to a jury about a woman who suffered a heart attack after taking a drug…

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(To watch, please go to this link and click on season 5, episode 6, and skip to about 27 minutes into the program, although it can take awhile to load and you may need to install a plug-in).