Risperdal Researcher Promised Drug Maker Positive Results from Clinical Trials

A prominent Harvard psychiatrist promised positive results to Johnson & Johnson before the start of some clinical trials for Risperdal. According to The Wall Street Journal, the revelations regarding Dr. Joseph Biederman came to light in court documents that are part of a lawsuit involving Risperdal and other atypical antipsychotic drugs. While he is not a defendant in the case, Biederman was called as a witness to illustrate the questionable financial ties between drug makers and the research community.

Some of the 2,000 plaintiffs involved in the multi-state lawsuit are children. Risperdal wasn’t approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected “opinion leaders” - usually top experts in their field - to discuss their off-label prescribing experiences at “educational” talks or meetings.

As we reported last November, Biederman was one of those opinion leaders. Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder. The lawsuit has raised questions about Biederman’s role in convincing Johnson & Johnson’s to fund a center on pediatric bipolar disorder at Harvard’s Massachusetts General Hospital.

READ MORE @ NEWS INFERNO

Common Anticonvulsants May Raise Epileptics' Cardio Risk

Two widely prescribed anticonvulsants appear to increase cardiovascular risk in epileptics, researchers here found.

Patients who were switched from phenytoin or carbamazepine to newer medications had significant drops in cholesterol, C-reactive protein, and other markers of cardiovascular disease risk, Scott Mintzer, M.D., of Thomas Jefferson University here, and colleagues reported online in Annals of Neurology.

The researchers said it was unlikely the improvements resulted from treatment with the newer drugs.

"It's a consequence of being taken off the older ones, which were causing the cholesterol and other markers to be elevated in the first place," Dr. Mintzer said.

READ MORE @ MEDPAGE TODAY

Changing Rx Practices in the Treatment of Mental Illness: Impact on Forensic Evidence

"Off-label" prescription practices are increasingly used in the treatment of symptoms related to mental illness. In support of this conclusion, evidence is reviewed on the antidepressant treatment of numerous non-depressive disorders and on the antipsychotic drug treatment of non-psychotic disorders. The impact of this evidence is discussed in light of the Daubert decision rendered by the U.S. Supreme Court. It is concluded that such practices challenge the application of the decision and increase the potential for testimonial error. Finally, a promising trend of identifying drugs by their neurochemical action is briefly discussed.

One trend that has revolutionized the face of Clinical Psychopharmacology is a breakdown in the disorder-specific nature of drug treatment (i.e., the use of antidepressant drugs to treat depression, antipsychotic drugs to treat psychosis, etc.). This "off-label" prescription practice has resulted in a clear broadening of the range of possible psychological symptoms that can be positively influenced by a specific class of drugs. The purpose of this article is to present examples of this practice in the published literature and suggest how this trend has impacted forensic considerations in the area of Clinical Psychopharmacology. Although no attempt has been made to exhaust coverage of this trend, an attempt has been made to present examples representative of different classes of drugs.

READ MORE @ THE FORENSIC EXAMINER

Pitt Study Of Pregnant Women Shows Antidepressants, Depression May Raise Risk Of Premature Birth

Pregnant women who had untreated major depression in all three trimesters of pregnancy, as well as those who took certain antidepressants, had preterm birth rates exceeding 20 percent, according to a study by University of Pittsburgh School of Medicine researchers published in the March issue of American Journal of Psychiatry.

Approximately 10-to-20 percent of women struggle with symptoms of major depression during their pregnancies, but treating it can be complicated. Selective serotonin reuptake inhibitor (SSRI) antidepressants are usually the first line of depression treatment, but can lead to unwanted outcomes such as preterm births if used continuously throughout pregnancy, the findings suggest.

READ MORE @ MEDICAL NEWS TODAY

Antidepressants Linked to Sudden Cardiac Death in Women

A new study has concluded that women with no history of cardiac problems but who use antidepressants are at an increased risk for sudden cardiac death (SCD). HealthDay ,News reports that the reason for the link remains unknown, according to the researchers whose findings were published in the Journal of the American College of Cardiology.

“We suspect that their use is a marker for people with worse depression,” explained the study’s lead author Dr. William Whang, an assistant professor of clinical medicine at Columbia University Medical Center in Manhattan. “The elevated risk seems more specific for antidepressant use, but that use may well be a marker of more severe symptoms,” quoted HealthDay News. Whang noted that the link seemed to be physiological saying, “We found that women who had worse depressive symptoms had higher rates of risk factors such as hypertension, diabetes, and smoking.” As a matter-of-fact, the report indicated, said HealthDay News, women with clinical depression were at a two-fold risk of experiencing SCD.

READ MORE @ NEWS INFERNO

Aripiprazole Boosts Efficacy of Antidepressants in Older Patients With Major Depressive Disorder: Presented at AAGP

Adjunctive aripiprazole appears to be effective in relieving the symptoms of depression in patients aged 50 years or older, according to research presented at the American Association for Geriatric Psychiatry (AAGP) 22nd Annual Meeting.

J. Craig Nelson, MD, University of California San Francisco School of Medicine, San Francisco, California, and colleagues presented the findings here on March 6. According to the researchers, the treatment effect of selective serotonin-reuptake inhibitors is generally minimal in elderly patients with major depressive disorder. The current study sought to determine whether adjunctive aripiprazole might benefit this population when added to standard antidepressant treatment.

Aripiprazole is an atypical antipsychotic currently approved for use only as an adjunct to antidepressant medication.

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Crackdown on Doctors Who Take Kickbacks

Federal health officials and prosecutors, frustrated that they have been unable to stop illegal kickbacks to doctors from drug and device companies, are investigating doctors who take money for using these products.

For years, prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians. But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products.

“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,” said Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services. “We want to send the message to the physician community — particularly surgeons — that you can’t do this.”

The move against doctors is part of a diverse campaign to curb industry marketing tactics that enrich doctors but increase health care costs and sometimes endanger patients. Taken together, the new measures are likely to transform the relationship between medicine and industry.

READ MORE @ NY TIMES

Obama backing generic biologics

President Obama's budget would pave the way for government to approve generic versions of biologic drugs, an administration official said yesterday, a move that could save taxpayers, insurers, and patients billions on the world's most expensive drugs but could hurt profits of some Massachusetts biotechs.

The Food and Drug Administration currently has no process for approving biogenerics, also called "follow-on biologics" and "biosimilars." Such drugs are made from living organisms, not chemicals, and are extremely difficult to duplicate precisely. Congress in the last few years has haggled over how to create regulations to approve generic versions of biologics.

The generic industry has proposed letting companies copy biologics after three to five years, similar to rules set for conventional drugs under the 1984 Hatch-Waxman Act. The administration's proposal suggests the time frame would be consistent with Hatch-Waxman, though administration officials could not confirm that last night.

READ MORE @ BOSTON GLOBE

How to Get Off Psychiatric Drugs Safely

Taper off antidepressants, antipsychotics, benzodiazepines and ADHD Medication without withdrawal side. The new fourth edition book "How to Get Off Psychiatric Drugs Safely" by James Harper, researcher and founder of The Road Back Program, details a proven successful method for tapering off these medications with separate chapters covering each of several classes of drugs.

Millions suffering the myriad side effects caused by antidepressants, benzodiazepines, antipsychotics and ADHD medications - from extreme weight gain to a dulled life - want to stop taking the drugs, their doctors would like to have their patients off the drugs, but cannot endure the emotional and physical pain involved with withdrawal or by what is known as discontinuance syndrome. Drug companies now state in the drug descriptions the medications must be tapered off of slowly to help avoid this debilitating withdrawal syndrome. The common withdrawal side effects include; electric brain zaps, nausea, anxiety, strange behavior, insomnia even relapsing into conditions these drugs are supposed to address.

The new fourth edition book "How to Get Off Psychiatric Drugs Safely" by James Harper, researcher and founder of The Road Back Program, details a proven successful method for tapering off these medications with separate chapters covering each of several classes of drugs, from antidepressants, antipsychotics, anti-anxiety medications to ADHD drugs and benzodiazepines. Employing specific vitamins and nutritional supplements, this exact tapering method has been successfully used by more than 30,000 people and is endorsed by doctors across the US, as well as the UK and Europe.

READ MORE @ PR WEB

Mental illness 'link to parents'

Children of bipolar parents have a 13-fold increased chance of suffering the same problem or other psychiatric disorders themselves, a study has shown.

A team of psychiatrists assessed two groups of children aged six to 18 for signs of bipolar disorder - formally known as manic depression - or other problems such as mood or anxiety disorders.

One group of 388 children had mothers or fathers with bipolar disorder. The other group of 251 had parents with no mental health problems.

A total of 10.6% of children with bipolar parents were positively tested for bipolar disorder or mood and anxiety disorders. In comparison, just 0.8% of children of mentally healthy parents had psychiatric conditions.

READ MORE @ PRESS ASSOCIATION

AstraZeneca Seroquel Studies ‘Buried,’ Papers Show (Update3)

AstraZeneca Plc “buried” unfavorable studies on its antipsychotic drug Seroquel, according to an internal e-mail unsealed as part of litigation over the medicine.

The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in “cherry picking” of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients. The London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes and other health problems.

“The larger issue is how we face the outside world when they begin to criticize us for suppressing data,” John Tumas, an AstraZeneca publications manager, told colleagues in the e-mail.

READ MORE @ BLOOMBERG

Seroquel Case: Must AstraZeneca Tell All?

In more lawsuits, companies are being forced to reveal internal information during the pretrial discovery phase that otherwise would be kept private

A showdown is looming in a Florida courtroom over an issue that has long bedeviled business: How much internal information can a company be forced to make public simply because it has become a defendant in a lawsuit?

In federal court in Orlando, drugmaker AstraZeneca (AZN) is battling to keep confidential thousands of pages of correspondence, studies, and other material related to its blockbuster antipsychotic drug Seroquel. On Feb. 13, Bloomberg News, invoking "the public's right of access to judicial documents," asked the court to unseal selected filings. A hearing on the request is scheduled for Feb. 26.

The battle grows out of claims by consumers who allege that AstraZeneca didn't adequately disclose that Seroquel can trigger serious weight gain and diabetes. There is also an unusual allegation of sexual misconduct that AstraZeneca is trying to keep contained by arguing that it is irrelevant and should be kept from a jury. More than 6,000 Seroquel cases have been consolidated in the Florida case.

READ MORE @ BUSINESS WEEK

Diabetic pregnant women at risk for depression

Low-income pregnant women and new mothers with diabetes are nearly twice as likely as those without diabetes to be diagnosed with depression during and after pregnancy, new research indicates.

Depression during the last several months of pregnancy and the year following childbirth -- the so-called perinatal period -- affects at least 10 percent to 12 percent of new mothers, and approximately 2 percent to 9 percent of pregnancies are complicated by diabetes, the researchers note. Past research has established an association between diabetes and depression in the general adult population.

In the current study, Dr. Bernard L. Harlow, at the University of Minnesota, Minneapolis, and colleagues examined the association between diabetes and depression in the perinatal period among approximately 11,000 low-income women enrolled in Medicaid who gave birth between 2004 and 2006.

They found that women with diabetes had nearly double the odds of having a diagnosis of depression or taking an antidepressant during the perinatal period compared with women without diabetes (15.2 percent versus 8.5 percent).

READ MORE @ REUTERS

Agomelatine Approved in EU for Major Depressive Episodes

The European Commission has granted marketing authorisation for agomelatine (Valdoxan) for the treatment of adult patients with major depressive episodes.

The approval is based on both short-term and long-term results from a large, comprehensive, international development programme including almost 6,000 adult patients with depression.

The results demonstrated the superior efficacy of agomelatine as compared with placebo, selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitor (SNRI) treatments.

READ MORE @ DOCTOR'S GUIDE

Aging: Vitamin D Levels Tied to Dementia Risk

Low blood levels of vitamin D may be associated with an increased risk for dementia, a British study has found.

Scientists measured blood levels of the vitamin in a representative sample of 1,766 people over 65 and assessed their mental functioning with a widely used questionnaire. About 12 percent were cognitively impaired, and the lower their vitamin D level, the more likely they were to be in that group. Compared with those in the highest one-quarter for serum vitamin D, those in the lowest were 2.3 times as likely to be impaired, even after statistically adjusting for age, sex, education and ethnicity. Men showed the effect more strongly than women.

READ MORE @ NY TIMES

There's help to rein in drug costs Generics and mail order among the best ways to save

These days the price of prescription drugs can seem harder to swallow than the pills themselves. Operators of health-related hot lines say they've been swamped with calls from consumers looking for cheaper alternatives. For young families and seniors - two groups that tend to use more medications - the costs can be eye-popping. While there may not be a ready cure for the nation's soaring healthcare costs, there are a number of cost-cutting tips to ease the pain. Here are some favorites from pharmacists who help callers at MassMedLine, 866-633-1617 or www.massmedline.com, a free information service run by the Massachusetts College of Pharmacy and Health Sciences.

READ MORE @ BOSTON GLOBE

It's the Cymbalta Stupid

Many are outraged that Eli Lilly gave nonprofits $3.9 million in grants last year for medical courses to "educate" doctors about the pain-and-fatigue ailment fibromyalgia--more than it spent for diabetes and Alzheimer's which people already know they have.

But finding new diseases to justify a drug's existence is the normal way pharma operates.

Especially Lilly who agreed to pay $1.42 billion for illegal marketing of its anti-psychotic Zyprexa last month--$615 million for criminally promoting it for dementia--another $62 million to 32 states for illegal pediatric marketing and agreed to resolve Medicaid fraud investigations into "rebates" at the same time. (And how was your year?)

And whose diabetes treatment Byetta is tanking since reports last summer of six deaths, at least two from pancreatitis.

But Lilly's fibromyalgia-fighting drug, Cymbalta (duloxetine)--its second best seller after Zyprexa--is anything but normal.

Starting with the death of 19-year-old Cymbalta test subject Traci Johnson in 2004--who hanged herself in the Lilly Clinic in Indianapolis and had no history of mental problems--it has been beset by reports of baffling, rapid, unprovoked, and out of character suicides and suicide attempts.

READ MORE @ COUNTERPUNCH

Listen without prejudice

People with mental health problems deal with bigotry daily. What training is being offered to public sector workers to address this?

At any one time, one in six of us will have a mental health problem. The majority of us will surely have had some contact with someone who has personal experience of mental ill health. Yet stigma and discrimination are widespread and stop many people from admitting to mental health problems and doing things that the rest of us take for granted: applying for jobs; going out and meeting new friends; going to clubs and the shops; and even using public services like buses and libraries.

Every year the Department of Health carries out a public attitudes survey to gauge beliefs and attitudes towards people with mental illness. The 2008 survey found that one in eight people would not want to live next door to someone with a mental health problem, while a third thought those with mental health problems should not have the same rights to a job as everyone else.

The new statutory disability equalities duty (part of the Disability Discrimination Act) and the government-led social inclusion agenda are spurring public services to ensure people with mental health problems have equal access to mainstream services, from housing and transport through to education, arts, health and sport.

READ MORE @ THE GUARDIAN

Bipolar disorder increases risk of disease

Bipolar disorder, like smoking, increases the risk of early death from medical illnesses, a U.S. review found.

The review of 17 studies, published in Psychiatric Services, involving more than 331,000 patients suggested that people with bipolar disorder have a higher mortality from natural causes compared with people in the general population of similar age and gender but without mental illness.

"The review of data gathered from large population studies suggests that having bipolar disorder is similar to being a smoker in terms of increasing a person's risk of early death," Dr. Wayne Katon of the University of Washington in Seattle, co-author of the review, said in a statement.

People with bipolar disorder tend to have both manic phases that can include sleepless periods and depressed phases that can even leave them immobilized. There are many possible factors that may account for the higher risk of premature death.

READ MORE @ UPI

Drug giant GlaxoSmithKline pledges cheap medicine for world's poor Head of GSK shocks industry with challenge to other 'big pharma' companies

The world's second biggest pharmaceutical company is to radically shift its attitude to providing cheap drugs to millions of people in the developing world.

In a major change of strategy, the new head of GlaxoSmithKline, Andrew Witty, has told the Guardian he will slash prices on all medicines in the poorest countries, give back profits to be spent on hospitals and clinics and – most ground-breaking of all – share knowledge about potential drugs that are currently protected by patents.

Witty says he believes drug companies have an obligation to help the poor get treatment. He challenges other pharmaceutical giants to follow his lead.

Pressure on the industry has been growing over the past decade, triggered by the Aids catastrophe.

Drug companies have been repeatedly criticised for failing to drop their prices for HIV drugs while millions died in Africa and Asia. Since then, campaigners have targeted them for defending the patents, which keep their prices high, while attempting to crush competition from generic manufacturers, who undercut them dramatically in countries where patents do not apply.
READ MORE @ THE GUARDIAN