Johns Hopkins University settles Lawsuit for overbilling pychiatric research

The Johns Hopkins University and one of its teaching hospitals have agreed to pay more than $2.6 million to settle a federal lawsuit alleging that they overbilled the National Institutes of Health for addiction research and other projects.

The settlement, announced yesterday by the U.S. attorney's office, came six years after an employee told federal authorities that researchers at Hopkins Bayview Medical Center had inflated the amount of time required to carry out studies on therapies for drug dependence.

"The United States must maintain the integrity of the grant application and funding process for research," U.S. Attorney Thomas M. DiBiagio said in a prepared statement. The university and Bayview agreed to pay $2.1 million in addition to $587,000 already refunded, but they did not admit any wrongdoing.

Drug Makers Face an angry Public

Pharmaceutical companies would be sufficiently challenged just dealing with the many internal pressures facing them today. Plagued by patent expirations on key drugs and late-stage disappointments for products in the development pipeline, major drugmakers are struggling to deliver the kind of earnings growth that was typical in the 1990s.

But at the same time, they are being buffeted by a number of external pressures on the public, political, and regulatory fronts. Taken together, these strains are increasing costs, holding down pricing, and creating additional barriers to profitability. Under growing pressure from patient groups and public officials, U.S. pharmaceutical producers must invent new ways to address these antagonistic outside forces.

Many of these problems stem from the public's deteriorating opinion of big drug companies.

Meaning that folks aren't trusting them like they used to. I wonder why?

New Jersey Superior Court OKs Psychiatrist's License Revocation

A panel of state Superior Court judges ruled that the license of accused sexual predator and Princeton-area psychiatrist Dr. Don Henry Wijaya should be revoked. Wijaya had been accused of having sex with a female patient identified only as F.B. from shortly after he began treating the divorced mother of two in 1981 until 1984, and again from July 1993 to August 1994. Wijaya disputed that, but an administrative law judge who heard the case "determined that the charges were supported by credible evidence and recommended revocation" of his license.

The ruling by a three-judge panel in the Superior Court appellate division affirms the decision of the New Jersey State Board of Medical Examiners, the body that regulates doctors. The board revoked to Wijaya's license in March 2002, but the appellate division issued a stay allowing Wijaya to continue practicing while his appeal proceeded.

The doctor's lawyer said he will appeal.

Psychiatric patient tells of ordeal in treatment

When Elizabeth Gale sought psychiatric treatment in 1986, she suffered from depression, the most common of psychiatric illnesses.

But Dr. Bennett Braun and his colleagues convinced her that her family indoctrinated her as a child so she would make babies for sacrifice in a satanic cult, Gale charged in a malpractice suit she settled Wednesday for $7.5 million. The therapists, she alleged, told her she needed their help to recover memories hidden beneath layers of rare multiple personalities that she had developed as a psychic guard against her childhood trauma.

Gale's attorney Todd Smith said that under the settlement, entered Wednesday in Cook County Circuit Court, Rush North Shore Medical Center, where Braun was director of the dissociative disorders program, will pay $3.6 million. Psychologist Roberta Sachs will pay $3.1 million, and a corporation affiliated with Braun will pay $500,000. Dr. Corydon Hammond will pay $175,000, and Rush University Medical Center must pay $150,000. No wrongdoing was admitted by the hospitals, the doctors or the psychologist.

In 1997, west suburban resident Patricia Burgus received a $10.5 million settlement in a suit filed against the hospital, then known as Rush-Presbyterian-St. Luke's, and two therapists, including Braun. Burgus and her sons were hospitalized at Rush in the late 1980s. Braun later sued his insurance company for allegedly settling the case without his consent.

Burgus, under Braun's care, said she came to believe she had more than 300 personalities and had cannibalized children as part of a satanic cult.

Full Details here

Unauthorized state bank account for mental health officials draws ethics scrutiny

Two pharmaceutical companies paid nearly $14,000 into an unauthorized state bank account that was used by state mental health officials for travel, meals and other expenses at a time when the drugmakers were courting state business, records show.

Janssen Pharmaceutica and Pfizer Inc., also paid at least $10,000 to two state officials who helped win approval for a mental-health treatment plan that uses drugs manufactured by the companies, according to interviews and a review of documents from the state Office of Inspector General. Those payments - some of which went to charity and the general state fund - were for speaking engagements and attendance at company meetings.

State and federal officials are examining the connection between the payments and the state's program.

Detailed article. Any appearance of corruption is merely a coincidence. yeh, right.

The Torture of Auckland's Behavioural Management Regime

From the ongoing trial for psychiatric abuse in New Zealand

Prison bosses invented a new "super maximum" security class in a hidden system that avoided normal rules for prisoners, a New Zealand High Court judge has been told.

Nine past and present prisoners say they were subject to psychological torture while being held on the "behavioural management regime" (BMR) at Auckland's Paremoremo prison, or while in solitary confinement.

Lawyer Tony Ellis began closing his case for the prisoners in Wellington yesterday.

During more than a month of evidence, prisoners said they were held in solitary for up to two years without regular review of their classification, or medical assessment, without access to natural light, or the chance to associate with other prisoners.

BMR amounted to a higher than maximum security classification, a kind of "super-maximum", Mr Ellis said.

"It is essentially a security classification that was not approved and was invented by the department."

Psychiatric evidence showed one prisoner developed post traumatic stress disorder within weeks of being put on the programme.

Mr Ellis said alleging torture was one of the most serious allegations it was possible to make, and he was trying to be responsible and not overstate the position.

The system was an experiment in behaviour modification when it began in April 1998, he said. It breached the prisoners' rights not to be subject to scientific or medical experimentation without consent.

More than 50,000 Australian children are being hand-fed antidepressant drugs that have been banned overseas.

More than 50,000 Australian children are being hand-fed antidepressant drugs that have been banned overseas. A British medical authority, The Medicines and Healthcare Products Regulatory Agency, told doctors in December not to prescribe the drugs to patients under 18 because they can increase the risk of suicide.

The warning covers five of the six drugs called selective serotonin reuptake inhibitors.

The US Food and Drug Administration has warned doctors to proceed with extreme caution in prescribing any SSRI other than Prozac to children. However, the Australian federal health department has done nothing to warn patients and doctors of the dangers, or moved to ban the five varieties of SSRI.

More than 90 per cent of American Women use prescription medication

New research shows that women could be running unnecessary risks by not fully disclosing to their doctors which medications they use, even when repeatedly prompted.

The study, published Tuesday in the United States, shows that women they examined are heavily medicated, relying on a potpourri of prescription and over-the-counter medications, topped up with herbal supplements.

The researchers said that they were surprised at the rates of medication use they found. Among the 567 women studied, more than 90 per cent used prescription medication and more than half used herbal supplements. A whopping 96.5 per cent used over-the-counter medications, almost two-thirds of them using four or more regularly.

Is the condition of being Female becoming a medical condition?

Antidepressants hazardous to health care coverage

As reported in the San Francisco Chronicle

With nearly 19 million Americans under a diagnosis of depression, antidepressant use is skyrocketing in the United States. The newer antidepressants are the second most commonly prescribed class of drugs in the country, according IMS Health, a firm that tracks the pharmaceutical industry.

However, people with individual insurance are vulnerable to rejection or higher rates due to any number of pre-existing conditions because, unlike group plans, they must answer detailed questions about their medical history to qualify.

Those with pre-existing conditions such as serious heart problems or a history of cancer may not be surprised to be rejected, but millions of Americans taking antidepressants for a variety of reasons -- from anxiety to a bout of minor depression following a divorce or even to smoking cessation -- may be shocked to have that prescription come back to haunt them.

The Insurance Companies remain skeptial of the wisdom of such wide spread prescriptions of such expensive medications, as well they should, and this is back firing of people who have been prescribed the drugs

Hospitals say chief psychiatrist 'out of touch'

Victorian hospital administrators in Australia have publicly accused the state's chief psychiatrist, Amgad Tanaghow, of failing to grasp the extent of the crisis in the mental health system.

The accusations, dating back to October last year, came to light yesterday amid warnings that large numbers of mentally ill patients are committing suicide after receiving inadequate care in the state's hospitals.

Psychoanalysis Is Dead ... So How Does That Make You Feel?

As seen in an article published in the LA Times

We now know that Freud compulsively fudged the historical record. This tendency is evident in Freud's backsliding statements on his advocacy of cocaine, his opportunism concerning the case of Anna O., his flip-flops on the seduction theory, and in almost every instance where he mentions a patient.

Just ask the "Wolf Man," Sergius Pankejeff, whom Freud supposedly cured but who was, in truth, consigned to psychoanalysis for an additional 60 years. Not surprising, Pankejeff considered Freud's effect on his life a "catastrophe."

We also know that Freud never seriously dealt with the problem of "suggestion," which totally compromised his clinical findings and, by extension, his theories. Already, by the 1890s, few believed in Freud's convenient claim that suggestion — the undue influence of the psychoanalyst over the patient — was possible only in the biologically predisposed and was thus of no consequence to his findings. Amazingly, these critical insights were buried under Freud's rhetoric of denial and by his growing fame. Now we've come full circle.

Austin Psychiatrist On Trial For Sexual Assault

An Austin psychiatrist is on trial for sexually assaulting seven of his male patients. Doctor Gregory Vagshenian is charged with seven counts of sexual assault.

Assistant District Attorney Joe Maida argues Vagshenian, a psychiatrist, was performing physical exams, which turned out to be sexual acts on a number of men at a South Austin Veterans Affair Outpatient Clinic said. A former patient says the doctor sexually exploited him on this table. But he did tell somebody: an Austin police detective and an Austin attorney. Defense argues what he told the police only proves that this is all about money.

It's a crime many of Vagshenian's patients says happened to them, but they felt powerless against the doctor, and many prosecutors say had the power to send them to the psychiatric ward.

A video report is currently available

Legislator claims Mental Illness cased his ethical lapses

A 23-year-old New Hampshire state representative facing possible expulsion from the Legislature says he will sue to stop ethics proceedings against him. Bedford Rep. John Kerns failed to show up at a hearing Monday on three ethics charges against him: passing a bad check with “State of New Hampshire” written on it; using his title to get a parking spot reserved for school officials; and threatening them when told to stop parking there. He also faces four criminal charges of passing bad checks.

Kerns claims he has a medical condition that caused his behavior.

Kerns said private e-mails he sent to the chairman of the committee, state Rep. Shawn Jasper, R-Hudson, were improperly disclosed. The ethics committee’s own rules say its proceedings must be suspended if certain violations of confidentiality have occurred, he said.

Jasper recommended that Kerns be expelled from the Legislature. If he is, it would be the first expulsion of a state lawmaker since 1913. The committee meets again next week to resume its debate.

“He claims to have a mental illness. Before that it was a physical illness,” Jasper said. “He won’t tell anyone what it is. He led people to believe at one point he was diabetic.”

Woman participating in Lilly trial hangs self

A toxicology test will determine whether narcotics played a role in the suicide of a 19-year-old woman who was participating in clinical trials for a new drug that Eli Lilly and Co. hopes to launch this year. Traci Johnson, Bensalem, Pa., hanged herself Saturday night in the Lilly Laboratory for Clinical Research by tying a scarf to a bathroom shower rod, according to the Indianapolis Police Department.

While the toxicology test is standard procedure in the investigation of suicides by the Marion County coroner, it could have huge implications for Lilly if it is determined that the trial drug -- or removal from it -- played a role in the woman's suicide. Lilly said Monday it does not believe the drug, duloxetine, was related to the death of Johnson, who was a former student at Indiana Bible College. Toxicology test results are expected in about a month.

Duloxetine is key to future business prospects of Lilly. It is the main ingredient in Cymbalta, an anti-depressant drug, and in a stress urinary incontinence treatment, both of which are moving toward final approval by the U.S. Food and Drug Administration. However, incidents such as the suicide of a clinical trial participant often draw questions from the FDA and can delay the federal approval needed to bring a drug to market.

In earlier statements, Lilly has said it expects the FDA to approve duloxetine to treat both depression and incontinence in 2004. Analysts have predicted sales of each could near $200 million this year. They bill Cymbalta as a potential blockbuster that could top $2 billion in sales by 2008.

Lilly spokesman Rob Smith would not say which use of the drug was the subject of Johnson's trials. However, the trial cycled the participants between doses of duloxetine and a placebo. At the time of her death, Smith said, Johnson was taking placebo.

Lilly Claims that "there's nothing to suggest that this is anything but an isolated incident."

right. Much more to the story at the link