InjuryBoard.com
By Jim Lewis
March 12, 2010

The multi-billion dollar drug company, Johnson & Johnson (J&J), has come under fire for allegedly violating the rules in their marketing of Risperdal, an antipsychotic drug. Back in 1999, the Food and Drug Administration (FDA) told J&J that their marketing materials for geriatric patients overstated Risperdals benefits and minimized risks, according to Bloomberg.com. In 2000, an internal business plan strategized a way to increase Risperdals market share by marketing the benefits for elderly dementia, an unapproved use.

This was described as one of the more egregious examples of marketing drugs to vulnerable patients by Jerry Avorn, who works at the Harvard Medical School. He went on to say, seeing such clear evidence in black and white of the details of a campaign like this is still pretty upsetting.

J&Js marketing of Risperdal could be illegal since current law states that drug companies cannot promote a drug for uses other than those approved by the FDA. At the time this marketing and business plan was crafted, Risperdal was only approved for psychotic disorders like schizophrenia, not for dementia.

Read entire article:  http://virginiabeach.injuryboard.com/fda-and-prescription-drugs/johnson-johnson-internal-documents-reveal-unsavory-and-potentially-illegal-marketing-of-risperdal.aspx?googleid=279316

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Bounty
March 12, 2010

Women expecting a baby have been warned over taking Prozac while they are pregnant, after a new study found it could be harmful to an unborn child.

According to a study from the Medicines and Healthcare Products Regulatory Agency there is a “small risk” of babies developing heart problems should their mother take the drug early on in their pregnancy.

The researchers behind the study said that pregnant mothers who use Prozac could be twice as likely to have children with a congenital heart problem, such as a murmur, or a hole in the heart.

Read entire article:  http://www.bounty.com/node/2191

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Fierce Pharma
By Tracy Staton
March 11, 2010

The Massachusetts attorney general joined that federal lawsuit accusing Johnson & Johnson of paying kickbacks to push the antipsychotic Risperdal and other drugs into nursing homes. AG Martha Coakley didn’t stop there; however, her office is also investigating other companies that market antipsychotics to nursing homes in the state.

At issue is whether drug companies are touting antipsychotic drugs for unapproved uses, such as dementia. The FDA has warned that use of the atypical antipsychotics in elderly dementia patients can increase the risk of death. “The inappropriate off-label marketing of antipsychotic drugs to nursing homes is a significant health and safety issue for our seniors,” Coakley says in a statement released by her office (as quoted by the Boston Globe). “We have taken strong action on this issue in the past and are continuing to monitor it very closely moving forward.”

Read entire article:  http://www.fiercepharma.com/story/massachusetts-joins-kickback-suit-against-j-j/2010-03-11

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Total Health Breakthroughs
By Jon Herring
March 10, 2010

“Hey, Phillip… do you mind if I sit here and eat with you?” I asked.

“Sure, whatever…”

“How’s school going? Are you doing well?”

“Not really. I just want it to be summer.”

“Yeah, I remember how that used to feel,” I told him.

Phillip is eleven years old. He’s the son of some family friends and I was at a small party when I saw him sitting by himself. I hadn’t seen him for a few years, so I wanted to remind him who I was and get to know him a little better.

As he became comfortable, he opened up a bit more. He told me his plans for the summer. He told me about his friends and the girl he likes at school. And he also told me that he didn’t care for school all that much.

“It’s hard,” he said. “Plus, I have ADHD, so I don’t pay attention very well.”

“Really? How do you know you have ADHD?” I asked.

“That’s what my doctor said. He said I’ve had it since I was born. That’s why I have to take medicine.”

“Well, I think you’re just fine. How does that medicine make you feel?”

“It used to make me kinda nervous,” he said. “And I couldn’t go to sleep when I took it. Now, it just makes me not want to eat.”

After complimenting Phillip on his manners and intelligence, I changed the subject back to his plans for the summer. But what he said bothered me. Here was a bright young boy who was bored and frustrated in school… who probably had a few behavioral problems… and who had now been labeled as having a “disease” and put on medication.

And, unfortunately, Phillip is just one of millions…

Read entire article:  http://www.totalhealthbreakthroughs.com/2010/03/adhd-is-not-a-disease/

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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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