Bloomberg.com
By Margaret Cronin Fisk, Jef Feeley and David Voreacos
March 10, 2010

Johnson & Johnson made plans to reach $302 million in geriatric sales for its antipsychotic Risperdal just months after federal regulators said the company falsely claimed the drug was safe and effective with the elderly, according to internal documents.

The U.S. Food and Drug Administration told J&J in 1999 that its marketing materials for geriatric patients overstated Risperdal’s benefits and minimized risks. A J&J business plan for the next year called for increasing the drug’s market share for elderly dementia sales, an unapproved use, according to newly unsealed documents in a lawsuit by the state of Louisiana.

“The geriatric market represents Risperdal’s second wave of growth,” J&J officials wrote in the business plan. “The aging population will continue to drive market growth well into the next century.”

Louisiana officials cited the document and dozens of other internal J&J files in its lawsuit claiming the company marketed Risperdal to the elderly and children for unapproved uses. Professor Jerry Avorn of Harvard Medical School, who isn’t involved in the case, called the papers “one of the more egregious examples” of marketing drugs to vulnerable patients.

“By 2010, most grownups in medicine know that drug companies resort to unsavory practices to promote drugs, but seeing such clear evidence in black and white of the details of a campaign like this is still pretty upsetting,” Avorn said.

Read entire article:  http://www.bloomberg.com/apps/news?pid=20601109&sid=ag4Ya8UOIob0&pos=13

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Pharmalot
By Ed Silverman
March 4, 2010

The FDA plans to increase misdemeanor prosecutions of industry execs as it looks to refocus its Office of Criminal Investigations (see this letter to the Senate Finance committee). The move comes in response to a new report from the General Accountability Office that the OCI suffers from lax oversight, despite increased in funding and staffing over the past decade. In fact, the FDA hasn’t reviewed most OCI offices in more than three years. The OCI investigates counterfeit drugs and other bad stuff, as well as misconduct by FDA employees.

The GAO concluded the FDA “has relied largely on the OCI director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.” The GAO found assessments of six OCI field offices aren’t being done on a timely basis. Of 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office hadn’t been assessed in over 10 years.

In addition, the FDA lacks performance measures that could enhance oversight by allowing it to assess OCI’s overall success. A few more facts: the OCI has a 230-person operation with more than $41 million in funding. In 2008, the group’s investigations led to more than 400 convictions. The OCI budget rose 73 percent between 1999 and 2008 to $41 million, and the number of employees increased by about 40 percent.

The GAO study, which was first reported by The Wall Street Journal, was requested by Chuck Grassley, the ranking Republican on the US Senate Finance, who has been probing drug safety issues, among other things. A report on GlaxoSmithKline’s Avandia noted that several drugmakers – Pfizer, Lilly, Bristol-Myers Squibb – have recently paid large criminal fines totaling $7 billion. Among the infractions – off-label promotion.

Read entire article:  http://www.pharmalot.com/2010/03/fda-oversight-of-criminal-investigations-is-lax/

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AlterNet
By Martha Rosenberg
March 9, 2010

Sgt. Eric Layne’s death was not pretty.

A few months after starting a drug regimen combining the antidepressant Paxil, the mood stabilizer Klonopin and a controversial anti-psychotic drug manufactured by pharmaceutical giant AstraZeneca, Seroquel, the Iraq war veteran was “suffering from incontinence, severe depression [and] continuous headaches,” according to his widow, Janette Layne.

Soon he had tremors. ” … [H]is breathing was labored [and] he had developed sleep apnea,” Layne said.

Janette Layne, who served in the National Guard during Operation Iraqi Freedom along with her husband, told the story of his decline last year, at official FDA hearings on new approvals for Seroquel. On the last day of his life, she testified, Eric stayed in the bathroom nearly all night battling acute urinary retention (an inability to urinate). He died while his family slept.

Sgt. Layne had just returned from a seven-week inpatient program at the VA Medical Center in Cincinnati where he was being treated for post-traumatic stress disorder (PTSD). A video shot during that time, played by his wife at the FDA hearings, shows a dangerously sedated figure barely able to talk.

Sgt. Layne was not the first veteran to die after being prescribed medical cocktails including Seroquel for PTSD.

Read entire article:  http://www.alternet.org/world/145892/are_veterans_being_given_deadly_cocktails_to_treat_ptsd

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IndyStar.com
John Russell
March 8, 2010

Eli Lilly and Co. has agreed to add four new senior positions to “promote highly ethical and compliant behaviors” as part of a settlement of two lawsuits arising from the company’s illegal marketing and promotion of several drugs.

The Indianapolis drugmaker also has agreed to upgrade its policies and procedures to ensure that patient safety “shall be of paramount importance,” according to a government filing the company made today.

Last year, Lilly paid $1.4 billion, the largest criminal fine ever imposed on a U.S. corporation, over the illegal marketing of Zyprexa. The company also pleaded guilty to a misdemeanor and agreed to additional oversight to resolve a 5-year-old federal investigation.

Federal prosecutors had said Lilly unlawfully promoted Zyprexa for agitation, aggression, hostility, dementia, depression and generalized sleep disorder, although the drug was approved only for schizophrenia and bipolar disorder.

The company had also improperly marketed Evista, its osteoporosis drug, and Prozac, its antidepressant.

In response, several shareholders sued the company, claiming it breached fiduciary duty in connection with the illegal marketing, exposing Lilly to substantial risk of damage. The suits are known as “derivative claims” as they were brought by shareholders on behalf of the company, rather than on behalf of shareholders, seeking to force the company to take corrective steps.

Read entire article:  http://www.indystar.com/article/20100308/BUSINESS/3080383/Eli-Lilly-adding-four-ethics-watchdogs

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Fox News
March 8, 2010

Federal officials say nearly 2,500 Massachusetts nursing home residents were given powerful antipsychotic drugs last year that were not intended or recommended for their medical condition.

The Boston Globe reports that data collected by the Centers for Medicare and Medicaid Services show that 28 percent of Massachusetts nursing home residents were given antipsychotics in 2009. Of that group, more than one out of every five did not have a medical condition that called for such treatment.

Federal officials say the drugs are often given to patients with dementia, which puts them at risk for serious side effects, even death.

An official with the organization that represents the state’s nursing homes acknowledges that the number is too high and says better training is needed.

Read article:  http://www.foxnews.com/story/0,2933,588391,00.html

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TransWorldNews
By Janne Larsson
March 5, 2010

The companies producing methylphenidate products (like Ritalin and Concerta) are normally competitors, marketing ADHD as a disease and the narcotic drugs as its solution. But when they are threatened with marketing restrictions they have a common interest.

If more scientific long-term studies would be done showing the harmful effects of the drugs it could lead to withdrawal from the market of this class of drugs. Therefore Big Pharma has to stop all such studies not written and controlled by themselves. The only studies they support are those conducted by paid researchers like psychiatry professors Joseph Biederman, Timothy Wilens and Thomas Spencer, where the outcome is known already from the beginning.

The European Commission has 27 May 2009, after a long review by the European Medicines Agency (EMEA), decided to issue warnings about methylphenidate drugs. The Commission has also decided that a number of long-term studies of good quality should be done to investigate different harmful effects of these drugs.

So for example the manufacturers were ordered to submit data how they could do long-term studies of psychiatric adverse effects (e.g. depression, hostility and psychotic reactions) and of cognitive effects (effects on learning, intellectual function) of the drugs. The answer from the pharmaceutical companies was a confidential report Feasibility Assessment of a Study of Long-term Effects of Methylphenidate on Cognition and Psychiatric Outcomes written 30 October 2009 – now made public by a Swedish court.

Read entire article:  http://www.transworldnews.com/NewsStory.aspx?StoryID=244733

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By Allen Jones
Former Investigator,
Pennsylvania Office of the Inspector General

On March 4, 2010, The Washington Times posted a scathing op-ed by Dr. Gilbert Ross in which Ross slammed Senator Grassley, Senator Baucus and FDA Whistleblower David Graham.   In a rambling tirade Ross accuses the trio of tinkering with the practice of medicine by unfairly criticizing pharmaceutical companies and defends GlaxoSmithKline (GSK) and their discredited drug Avandia.

Ross fails to disclose that he has a personal reason for being angry with the Federal Government. In June of 1993, Ross was found guilty in Federal Court of 13 counts of fraud in a scheme to operate medical clinics for the purpose of obtaining payments directly and indirectly from the Medicaid system. He served 2 years in Federal Prison. http://w3.health.state.ny.us/opmc/factions.nsf/0522fed2dd2160ff852568c0004e894a/85b1e5abf211b2a585256a4a0047eb10/$FILE/ATTH2LGV/lc116347.pdf

Ross is identified as “medical director of the American Council on Science and Health,” but Ross discloses no financial ties to GSK.  The ACSH website however acknowledges that 40% of ACSH’s budget comes from “corporations.”  Does this include Pharma funding? http://www.acsh.org/about/pageID.85/default.asp

It is disgraceful that The Washington Times would post Ross’ criticism of great men and their worthy cause without disclosing very relevant facts relating to Ross’ credibility.

Allen Jones worked as an investigator in the Pennsylvania Office of the Inspector General (OIG), and gained widespread national and international attention as a whistleblower after uncovering pharmaceutical industry payments to government officials for the purpose of implementing a national mental health screening/psychotropic drug treatment plan based on the controversial Texas Medication Algorithm Project (TMAP). In May 2004, the British Medical Journal reported Jones had uncovered evidence major drug companies sought to influence government officials.

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Scoop Independent News
By Evelyn Pringle
March 4, 2010

A month before the first Paxil birth defect trial against GlaxoSmithKline was set to begin, the Associated Press ran the headline, “Glaxo Used Ghostwriting Program to Promote Paxil,” in reporting on a program called “CASPPER,” which allowed doctors to “take credit for medical journal articles mainly written by company consultants.”

“Drug companies frequently hire outside firms to draft a manuscript touting a company’s drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work,” the Associated Press said on August 19, 2009. “Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.”

Between 2000 and 2002, articles from the CASPPER program appeared in five medical journals. On August 21, 2009, Jim Edwards on BNET, described the CASSPER ghostwriting brochure. The document shows that the intent of CASSPER was to flood the market with ghostwritten information, he said. It stated: “Paxil Product Management has budgeted for 50 articles for 2000.”

The trial in Kilker v Glaxo ended on October 13, 2009, with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The family was award $2.5 million.

Read entire article:  http://www.scoop.co.nz/stories/HL1003/S00045.htm

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The Huffington Post
By Peter Breggin
March 3, 2010

On February 24, 2010 the Veterans’ Affairs Committee of the U. S. House of Representatives chaired by Bob Filner (D-CA) held hearings on “Exploring the Relationship Between Medication and Veteran Suicide.” Military suicides have risen rapidly in recent years at the same time that the prescription of antidepressants and other psychiatric drugs has escalated. The hearing focused on the dangers of the newer antidepressants like Prozac, Paxil, Zoloft, Celexa, Lexapro, Cymbalta, and Effexor.

Starting in the early 1990s, I was the first psychiatrist to write and speak extensively about the newer antidepressants causing suicide, violence, and mania. It was gratifying when Rep. Filner decided to hold the hearings after reading my new book, Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime (2008) and called me as his lead witness. I presented scientific evidence that antidepressants cause suicide, violence and mania. I also emphasized the profound danger of prescribing drugs that cause impulsivity, hostility and suicidality to heavily armed young men and women under stress on active military duty. I recommended that the armed services curtail the use of these drugs and rely instead on psychotherapeutic and educational processes that have already proved effective. I also called for additional research in the military and the VA concerning suicide and violence caused by antidepressants.

There is scant evidence for the effectiveness of antidepressants, and overwhelming evidence for their harmfulness. The military is already moving toward the implementation of better educational programs to help active duty soldiers handle stress. These educational programs, and counseling, need to replace the use of psychiatric drugs.

Read entire article:  http://www.huffingtonpost.com/dr-peter-breggin/congressional-hearings-on_b_480613.html

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The New Yorker
By Louis Menand
March 3, 2010

You arrive for work and someone informs you that you have until five o’clock to clean out your office. You have been laid off. At first, your family is brave and supportive, and although you’re in shock, you convince yourself that you were ready for something new. Then you start waking up at 3 A.M., apparently in order to stare at the ceiling. You can’t stop picturing the face of the employee who was deputized to give you the bad news. He does not look like George Clooney. You have fantasies of terrible things happening to him, to your boss, to George Clooney. You find—a novel recognition—not only that you have no sex drive but that you don’t care. You react irritably when friends advise you to let go and move on. After a week, you have a hard time getting out of bed in the morning. After two weeks, you have a hard time getting out of the house. You go see a doctor. The doctor hears your story and prescribes an antidepressant. Do you take it?

However you go about making this decision, do not read the psychiatric literature. Everything in it, from the science (do the meds really work?) to the metaphysics (is depression really a disease?), will confuse you. There is little agreement about what causes depression and no consensus about what cures it. Virtually no scientist subscribes to the man-in-the-waiting-room theory, which is that depression is caused by a lack of serotonin, but many people report that they feel better when they take drugs that affect serotonin and other brain chemicals.

There is suspicion that the pharmaceutical industry is cooking the studies that prove that antidepressant drugs are safe and effective, and that the industry’s direct-to-consumer advertising is encouraging people to demand pills to cure conditions that are not diseases (like shyness) or to get through ordinary life problems (like being laid off). The Food and Drug Administration has been accused of setting the bar too low for the approval of brand-name drugs. Critics claim that health-care organizations are corrupted by industry largesse, and that conflict-of-interest rules are lax or nonexistent. Within the profession, the manual that prescribes the criteria for official diagnoses, the Diagnostic and Statistical Manual of Mental Disorders, known as the D.S.M., has been under criticism for decades. And doctors prescribe antidepressants for patients who are not suffering from depression. People take antidepressants for eating disorders, panic attacks, premature ejaculation, and alcoholism.

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