Tuesday, September 11, 2007

News Roundup

Antidepressant as Good as Antipsychotics for Dementia
Study finds fewer side effects for Alzheimer's patients prone to hallucinations, delusions


Doctor Ends Dilemma - Lilly, Doctor Reach Agreement Over Zyprexa Documents Leak
Zyprexa - Lilly's antipsychotic drug was approved by the FDA in 1996, only for the extremely limited use of treating schizophrenia and bipolar disorder in adults. However, Lilly promoted the drug for off-label, unapproved uses in treating anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia in patients of all ages, as can be seen from Medicaid records. Lilly has been accused of virtually concealing the risks of side effects from doctors and from the patients themselves.

The documents reveal that Lilly was well aware that 30% of patients taking Zyprexa, gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. An email written by vice president and chief medical officer Dr. Alan Breier to Lilly employees in Nov. 1999, reveals that the company was worried that Zyprexa's sales would suffer due to its side effects. The documents also have clinching evidence to prove that Lilly encouraged its sales representatives to play down the “side effects” of Zyprexa whose generic name is olanzapine, when talking to doctors. Zyprexa, which remains Lilly's top-selling drug, garnered worldwide sales of $4.36 billion in 2006. A study, which reviewed the adverse side effects of Zyprexa in 2002, found that of the 289 cases of diabetes reported, 225 of the patients were newly diagnosed. The same year, 100 cases of ketosis, a serious complication of diabetes, 22 cases of pancreatitis, a life-threatening inflammation of the pancreas, and 23 deaths associated with Zyprexa were reported. The results of the study were published in the July 2002 issue of Pharmacotherapy, by P Murali Doraiswamy, the chief of biological psychiatry at Duke University.

The link between diabetes and Zyprexa was again confirmed in February 2004, by the American Diabetes Association, the American Psychiatric Association, the American Association of Clinical Endocrinologists and the North American Association for the Study of Obesity.

Eli Lilly's tale took a tawdry turn as Zyprexa's lethal side effects continued to make headlines. Class action lawsuits as well as separate individual actions began to be filed against Eli Lilly, the makers of Zyprexa, by people who developed severe side effects after taking the drug. Including earlier settlements over Zyprexa, Lilly has thus far agreed to pay about $1.2 billion to settle cases out of court with about 28,500 victims.

After it was established in 2004, that there was an increased risk of hyperglycemia and diabetes associated with Zyprexa, Eli Lilly was asked by the FDA to change language on Zyprexa label describing the health risks for patients taking the medication. In addition, in April 2005, the FDA slapped a black box warning on Zyprexa's label indicating that the drug was not approved for older patients with dementia-related disorders after the drug was found to be associated with increased mortality in elderly patients with dementia.

As soon as the ‘New York Times' began running articles, describing the side effects of Zyprexa and Lilly's off-label marketing campaign called, “ Viva Zyprexa”, in which the drug was prescribed to older patients with symptoms of dementia, Lilly succeeded in getting a judge to issue a permanent injunction in Dec.2006, against Gottstein, and other persons who obtained the documents from Gottstein, ordering them to return the documents to the court. By then, copies of the documents ended up on various Web servers. The New York Times reporter, Alex Berenson, the only journalist who actually quoted from the documents in the press was not included in any injunction.
Psychotropic Drug Makers Bankroll Prescribing Shrinks Part II

The fact that drug makers were bribing state policy makers and members of advisory panels with the ultimate goal of capturing the lucrative Medicaid customer base to increase the sale of psychiatric drugs was first discovered several years ago by Allen Jones, while he was a federal fraud investigator in the Pennsylvania Office of Inspector General Bureau of Special Investigations, and Dr Stefan Kruszewski, a pediatric psychiatrist by trade, who was hired by the Pennsylvania Department of Public Welfare to review the quality of care provided to persons covered by state programs.
During his investigation in Pennsylvania, Mr Jones found a drug money trail to key policy officials who controlled the Medicaid preferred drug list in that state, which eventually led him to Texas and an elaborate scheme that involved influential psychiatrists, including many who served as professors at Texas universities, and state policy officials who developed the preferred drug list known as the "Texas Medication Algorithm Project (TMAP)".

Mr Jones calls the Texas panel the "most transparent example" of industry influence, because all of the project directors had financial ties to the drug makers. It was put into effect, he says, by buying off doctors who were considered "opinion leaders" in the psychiatric field, along with state policy makers in positions of authority with control over the preferred drug lists.

While reviewing the medical care provided to patients under state care in the summer of 2002, Dr Kruszewski immediately recognized that a mass drugging-for-profit scheme involving Medicaid patients, especially children, was taking place in Pennsylvania, and that several patients had died.

In one case, where the child fortunately survived, Dr Kruszewski found that the girl had been placed on 11 psychiatric drugs at the same time, including 5 antipsychotics, without ever being diagnosed with a psychiatric disorder. She exhibited impulsive behaviors and was mentally disabled, but there was nothing in the records to justify the use of all these drugs, he says.

According Dr Kruszewski, the atypicals are associated with an increased the risk of obesity which can lead to diabetes type II, hypertension, heart attacks and stroke. The weight of the girl who was on 11 drugs had ballooned from 106 pounds to 194, Dr Kruszewski found.

In reviewing patient records, he found a state-wide pattern where patients who were not mentally ill were placed on cocktails of 3 or more expensive psychiatric drugs at the same time and kept on the cocktails indefinitely and if patients experienced side effects from the original medications, more drugs were added to the mix.

The sheer greed evidenced by the mass drugging of patients on Medicaid all over the US, similar to that discovered by Dr Kruszewski in Pennsylvania, has forced state Medicaid programs to either put a stop to the drug maker's encouragement of the rampant prescribing of atypicals or go broke.

For instance, Texas Medicaid was charged nearly $15 million for antipsychotics for foster children in 2004, according to the December 2006 Special Report, "Foster Children - Texas Health Care Claims Study." In fact, Texas spent more money on antipsychotics for foster kids than any other class of drugs, and the report said, Zyprexa, Seroquel and Risperdal typically cost an average of $229 per prescription.


A USA TODAY study of FDA data from 2000 to 2004 found 45 pediatric deaths in which atypicals were the primary suspect, with at least six related to diabetes and other causes ranged from heart and pulmonary problems to suicide, choking and liver failure.


A July 29, 2007, report by Robert Farley in the St Petersburg Times revealed that in the last 7 years, the cost to Florida tax payers for atypicals prescribed to children jumped nearly 500%, from $4.7 million to $27.5 million, and on average in 2006, it cost the state nearly $1,800 for each child on atypicals.

Mr Farley reported that last year, more than 18,000 kids on Medicaid were prescribed antipsychotics including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration say children younger than 6 should generally not be given psychotropic drugs and they should "only be considered under the most extraordinary of circumstances."

Psychotropic Drug Makers Bankroll Prescribing Shrinks Part I

According to the August 27, 2007, Pioneer Press, since 2002, Dr Simon has received more than $570,000 from six drug makers, with most of the money coming from Eli Lilly, "whose antipsychotic drug Zyprexa is the most costly each year for Minnesota's fee-for-service health program for the poor and disabled," the article states.

In fact, Lilly's disclosure records for 2004 show payments to Dr Simon totaling a whopping $91,854.95 in that one year, and he also received another couple grand from Seroquel maker AstraZeneca.

Dr Simon told the Pioneer Press that companies pay him to speak about their drugs at conferences and clinics or about the conditions that are treated with the drugs. "Most of the psychiatrists who are really good," he said, "have ties to industry."

Whether Dr Simon is a "really good" psychiatrist is certainly open to debate. In 1997, the state medical board made him complete a clinical training program and issued a report which said that Dr Simon, "frequently makes abrupt and drastic changes in type and dosage of medication which seem erratic, not well considered and poorly integrated with nonmedication strategies."

The board also noted that Dr Simon prescribed addictive drugs to addicts and failed to stop giving medicines to patients when they were suffering severe drug side effects. He said in an interview with the Times that the board's action was a learning experience and that drug makers continued to hire him to speak because he was respected by his peers.

For years, Dr Simon reportedly shared an office with another "really good" psychiatrist by the name of Dr Faruk Abuzzahab. On June 3, 2007, Gardiner Harris and Janet Roberts published a story in the New York Times with the headline: "After Sanctions, Doctors Get Drug Company Pay," and stated:

A decade ago, the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a "reckless, if not willful, disregard" for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that.

Over the past 20 years, this "really good" psychiatrist has repeatedly prescribed narcotics and other controlled substances to addicts and prescribed narcotics to pregnant women, one of whom delivered a baby prematurely that died, the board found.

The Times reports that separately, in 1979 and 1984, the FDA concluded that Dr Abuzzahab had violated the protocols of every study that the agency audited and that he reported inaccurate data to drug makers.

The FDA said he routinely oversaw 4 to 8 trials at the same time, moved patients from one study to another, gave experimental drugs to patients at their first consultation and once hospitalized a patient for the sole purpose of enrolling him in a study.

As recently as June 2006, the medical board criticized Dr Abuzzahab once again for writing prescriptions for narcotics and this time to patients he knew were using false names, according to the Times.

All that said, Dr Abuzzahab told the Times that he has helped study many popular psychiatric drugs, including Lilly's Zyprexa and Prozac, Janssen's Risperdal, AstraZeneca's Seroquel, Glaxo's Paxil and Pfizer's Zoloft.

A review of the Minnesota disclosure records for 2004 show that the drug makers apparently thought it was beneficial to keep paying big bucks to Dr Abuzzahab. Glaxo paid him $1,000, Pfizer gave him $750, and Wyeth forked over $18,084, in that year alone.

In 2003, psychiatrist Dr Ronald Hardrict pleaded guilty to Medicaid fraud. But a little charge like fraud apparently did not effect this Minnesota psychiatrist's earning power either. The very next year, disclosure records for 2004 show Risperdal maker Janssen paid him $10,000; Seroquel maker AstraZeneca gave $1,250; Abbott Labs paid him over $7500; Glaxo paid $1,500, and Wyeth forked over $8,846.

In reviewing the Minnesota disclosure records for 2004, the name Dr Dean Knudson kept popping up. A September 2004 Newsletter from the Ada Canyon Medical Education Consortium listed Dr Knudson as an associate professor of psychiatry at the University of Minnesota Medical School.

He must be a "really good" psychiatrist, too, because in 2004 alone, Lilly paid him close to $37,000; he earned nearly $2,750 from Pfizer; Seroquel maker AstraZeneca paid him $6,700; Janssen forked over $3750; Wyeth paid him $11,632, and he received $2,082 from Abbott. Lilly's 2003 forms also show another $8,740 paid to Dr Knudson.

The newsletter showed that Dr Knudson was paid to give educational presentations on dementia. On October 18, 2005, the Associated Press reported a study that showed atypicals used to treat elderly patients with dementia raised their risk of death.

For the study, the researchers pooled the results of 15 studies on the atypicals Zyprexa, Risperdal, Seroquel and Abilify and among more than 5,000 dementia patients, those taking any of the four drugs faced a 54% increased risk of dying within 12 weeks of starting the drugs, compared to patients taking placebos.

Another name that jumps out in the 2004 disclosure records is Dr David Adson. According to the August 20, 2007, Pioneer Press, Dr Adson, of the University of Minnesota, also has a state advisory role as the clinical leader of a program funded by Lilly and provided free of charge to Minnesota, which notifies doctors when their prescriptions for psychiatric drugs are out of line with clinical standards.

Although the program is funded by Lilly, it is supposedly run by an independent company called Comprehensive NeuroScience, Inc. All totaled, 20 states have contracts with CNS to identify doctors "who are prescribing psychiatric drugs outside of recommended guidelines for safety and effectiveness," according to the Press.

Critics say the program is actually a scam set up with state policy makers to make sure the expensive psychiatric drugs remain on the Medicaid covered drug lists instead of being placed on the lists that require prior authorization.

1 Comments:

At 3:40 PM, Anonymous Anonymous said...

I have Dr. Knudson as my Psychiatrist and feel comfortable with him .I am a 48 yr. old female who he put on seroquel after several hospital stays.
Should I be concerned about this drug or Dr. Knudson?

 

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