October 26

Lilly to Add Suicide Warning to Strattera – Medicaid May shrink $5.5 Billion spending on Schizophrenia Drug

Lilly to Add Suicide Warning to Strattera – Medicaid May shrink $5.5 Billion spending on Schizophrenia Drug

Thu, 29 Sep 2005

Reuters reports that Eli Lilly is adding a Black Box suicide warning to the Strattera label. Strattera has been promoted as a “non stimulant” treatment for ADHD. Since ADHD is loosely defined as attention deficit disorder, which is NOT associated with suicide, one cannot blame anything other than the drug–an antidepressant of the selective norepinephrine reuptake inhibitor variety.

One by one, psychiatry’s magic bullets–the new gteneration of antidepressants and antipsychotics–are being unmasked for presenting both unfavorable risk/benefit and unfavorable cost/ benefit ratios for patients and the public purse. The pharmaceutical influence on doctors’ prescribing is harming patients and impeding rational public health spending policy:

Bloomberg News reports that in the wake of the CATIE study in which the four most prescribed, most expensive antipsychotic drugs were compared to an old cheap drug, failed to demonstrate a clinical difference, the US Medicaid program is considering reducinge the $5.5 billion it misspends annually for these aggressively marketed, high priced drugs.

The CATIE study, which is a major government-sponsored study, pulled the rug out from under the $9.7 billion atypical antipsychyotic drug market.

However, Robert Rosenheck, MD, professor of psychiatry at Yale University, said “Getting doctors to prescribe perphenazine won’t be easy.” Acknowledging, “We have a dilemma in that the rational policy would be to use the cheaper drug and use the savings to provide additional rehabilitation services. But there is no clear way of implementing that policy without impinging on the autonomy of doctors.”

But doctors’ autonomy is impinged by the prescribing guidelines of TMAP (the Texas Medication Algorithm Project ). TMAP requires doctors to prescribe the most expensive new antipsychotics and antidepressants. The TMAP prescribing guidelines are mandatory throughout the Texas mental health/ mental retardation system–including psychiatric hospitals and clinics- and also the Texas prison system, juvenile justice system and foster care system. As the use of these most expensive drugs expanded, the Texas health care budget was depleted.

TMAP was formulated by a consortium of Texas state officials and University of Texas psychiatrists who recommend the most expensive psychotropic drugs as first line treatment. TMAP and its panel of “experts” was financed by the manufacturers of the drugs recdommended by the TMAP guidelines–the recommendations have no scientific basis. TMAP, which passes itself off as an “evidence-based” treatment guideline is, in fact, the pharmaceutical industry’s most ambitious scheme for increasing the market for antipsychotic and antidepression drugs. It has been adopted in at least 9 states

Allen Jones, the Pennsylvania inspector in the Office of the Inspector General, who first blew the whistle on the TMAP spending scam in Pennsylvania, calls TMAP “a Trojan horse.”

“Through TMAP, the drug industry methodically compromised the decision making of elected and appointed public officials to gain access to captive populations of mentally ill individuals in prisons and state mental health hospitals. The pharmaceutical industry bypassed governmental safeguards and medical review by creating and marketing TMAP as a "treatment model" that was instituted in various states as an administrative decision by a select few politically appointed officials. The treatment model accepted by these state officials had a fundamental requirement rooted deep within it: Doctors must first treat their patients with the newest, most expensive drugs patented by the pharmaceutical companies. The state doctors treating mental illness could choose which patented drug to use, but effectively could not choose to use less expensive generic drugs unless and until the patented drugs failed.”

See: http://psychrights.org/Drugs/AllenJonesTMAPJanuary20.pdf

Indeed, by February 9, 2001, Nancy San Martin, in the Dallas Morning News, reported "Texas now spends more money on medication to treat mental illness for low-income residents than on any other type of prescription drug."  See: State Spending More on Mental Illness Drugs:

The manufacturers of the drugs endorsed by TMAP not only funded state agencies and officials, but funded key opinion leaders in psychiatry and patient “advocacy” groups:

According to the TMAP /TIMA PROCEDURAL MANUAL Schizophrenia Module:

“TMAP and TIMA represent a unique collaboration of public mental health, academia, and advocacy in attempting to address challenges and improve the care provided for people with severe mental illnesses. Collaborative partners include TDMHMR, University of Texas Southwestern Medical Center at Dallas, The University of Texas at Austin, University of Texas Health Science Center at San Antonio, and various consumer advocacy groups, including the Mental Health Association in Texas, NAMI ­ Texas, Texas Depressive and Manic Depressive Association and Texas Mental Health Consumers. This collaboration of different resources, expertise, and perspectives has been invaluable in enhancing acceptance of this initiative in professional and consumer communities. See: http://www.dshs.state.tx.us/mhprograms/timasczman.pdf

Of note, in a letter to The New York Times, the executive director of NAMI (National Alliance for the Mentally Ill) dismissed the CATIE study evidence showing that 3/4 of patients on both old and new antipsychotics could not tolerate the side effects of eitherclass of antipsychotic drugs. He blamed the patients by declaring “anosognosia may have been a factor.”

Even the study’s lead investigator, Dr. Jeffrey Lieberman, who has been an enthusiastic advocate of the new atypicals, conceded to the Times: “three-quarters of the people in our study voted with their feet and discontinued the drugs.”

Contrary to what key opinion leaders in psychiaty have been telling patients, policy makers and the public, the fact is, antipsychotic drugs–the old and the new–are among the most hazardous, toxic drugs in medicine. The drugs cause (iatrogenic) damage to neurological functions, the liver, the heart, kidneys, blood and cholesterol levels, and they damage frontal lobe function (which is the seat of human higher brain function).

Among the documented adverse effects suffered by patients on antipsychotics (many of who are forced to take the drugs) are cardiac arrest, stroke, blood clots, and diabetes. Patients on Zyprexa, for example, gain as much as 100–150 lbs. The debate is no longer on whether Zyprexa and Clozaril cause diabetes, but rather at what rate and after how long a period of exposure? In June, Eli Lilly settled a cluster of 8,000 Zyprexa-diabetes lawsuits for $690 million. If the evidence did not confirm that the drug caused diabetes, why would Lilly agree to pay close to $700 million?

The FDA, the NIMH, the professional psychiatric associations–APA, ACNP, AACAP–and the compromised self-serving advocacy groups–MHA, NAMI–have all coolaborated in the irresponsible marketing of atypicals and antidepressants. They have encouraged doctors to prescribe these toxic drugs widely–mostly off-label–that constitutes an unapproved human experiment. The mostly illegitimate prescribing of drugs approved for a very small population–schizophrenia and short term bi-polar disorder–have resulted in the companies raking in $9.7 billion annually–TMAP is a corporate enrichment scheme for transfering public funds to pharmaceutical companies.

TMAP was initiated in Texas when George W Bush was governor, and he endorsed it. As President his New Freedom Commission for Mental Health endorsed TMAP as a model for national policy.

Contact: Vera Hassner Sharav
veracare ahrp org

Lilly adds suicide risk to Strattera

Eli Lilly and Co. on Thursday said it will add strong warnings to its label for Strattera, used to treat attention-deficit/hyperactivity disorder, including the risk of suicidal thoughts among children and adolescents.

Strattera will now carry a “black box” warning, the strongest required by U.S. regulators.

Lilly said there were no suicides among children, adolescents or adults taking the medication during Strattera clinical trials, but there was one suicide attempt in a patient taking the drug.

The warning came after the U.S. Food and Drug Administration requested Lilly to submit an analysis of adverse event data from its Strattera clinical trials data base, which identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents.

Lilly said it is working with the FDA to finalize the product label. It also is working with regulators outside the United States.

Lilly backed its prior sales and earnings outlook for the year and said it expects to report full-year 2005 earnings per share of $1.90 to $1.96.

ADHD affects 3 to 7 percent of school-age children and manifests itself in inappropriate levels of attention, concentration, activity, distractibility and impulsivity.

Shares of Lilly closed at $53.47 on Wednesday on the New York Stock Exchange.

Copyright © 2005 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Bloomberg News
Medicaid May Shrink $5.5 Bln Spending on Schizophrenia Drugs

Sept. 28 (Bloomberg) — The U.S. Medicaid program may reduce the $5.5 billion it spends annually on schizophrenia drugs for the poor after a study found a cheaper generic about as effective as new pills, including Eli Lilly & Co.’s Zyprexa.

The 40-year-old drug perphenazine costs less than $1.50 a day while the newer medicines can cost 10 times as much. Only Zyprexa, the world’s fifth-biggest selling drug, was found slightly more effective in a U.S government-funded study of four schizophrenia pills with combined annual sales of $9.6 billion.

“A lot of Medicaid programs will use this study” to review the medications, said Devon Herrick, a health economist and senior fellow at the National Center for Policy Analysis in Dallas. “It’s probably wise to start with a cheaper drug and move your way up from there.”

Medicaid, the state-run health plan for the poor, is the biggest buyer of drugs for schizophrenia. Less than $9 million of those purchases were of perphenazine. The study published last week may lead the state programs to discourage use of Zyprexa and products made by Pfizer Inc., AstraZeneca Plc and Johnson & Johnson, Herrick said.

Schizophrenia drugs account for the biggest share of the $39 billion that states spend each year on prescription medication. The disease affects about 3.2 million Americans, who experience hallucinations and delusions, have problems paying attention and can’t properly care for themselves.

U.S. sales of all anti-psychotic drugs doubled between 2001 and 2004, largely because of growing purchases by Medicaid. Indianapolis-based Lilly, whose Zyprexa is the top-selling product in the class at a $4.4 billion last year, may be hurt the most by a coverage change.

Study Findings

The new study, published last week in the New England Journal of Medicine, found Zyprexa was better than perphenazine by a slim margin, reducing hospital stays and keeping people on treatment. Patients reported more side effects on Zyprexa than those taking the generic or the other drugs, J&J’s Risperdal, AstraZeneca’s Seroquel and Pfizer’s Geodon.

Almost 60 percent of total U.S. spending for the newer drugs was for Medicaid patients, according to research by Mark Duggan, an economist at the University of Maryland in College Park.

“My gut is the new study could tar the whole class” of drugs, Michael Krensavage, an analyst at Raymond James & Associates, said in a Sept. 20 telephone interview from New York.

Because people with schizophrenia react differently to each drug, a wholesale move to the older generic product isn’t likely, doctors said. That’s because what works well for one patient isn’t as effective for others, said officials at Lilly in Indianapolis, Indiana, and at New Brunswick, New Jersey-based Johnson & Johnson.

‘Absolute Tragedy’

“I would hope as state formularies are looking at this, they would read the paper and think carefully about any superficial conclusion that the drugs work the same,” Robert Baker, director of U.S. neuroscience for Lilly, said in a Sept. 23 telephone interview. “Their wisest decision would be to let doctors have access to the widest possible range of medication.”

Pfizer’s Anthony Loebel, a marketing official, said the older drugs have side effects, such as muscle spasms, not associated with Geodon. “It would be an absolute tragedy” to force Medicaid patients back onto the older drugs, Loebel said in a Sept. 23 interview

AstraZeneca of London didn’t return phone calls and New York- based Bristol-Myers declined to comment.

Oregon Plan

“It seems that doctors were prescribing only the new drugs,” Marian McDonough, an assistant professor at Oregon Health and Science University in Portland, said in a Sept. 20 telephone interview. The new study “may very much change” that, said McDonough, who produces research that helps state and private insurer decide which drugs to encourage doctors to use.

The schizophrenia study will be used by a program at Oregon that reviews drugs for 14 state Medicaid plans, said its medical director, John Santa in a Sept. 20 interview. Washington state plans to use Oregon’s information to decide next year which pills doctors should consider first for low-income patients, Siri Childs, pharmacy policy chief for the state’s Medicaid program, said in a Sept. 20 telephone interview.

Washington already requires doctors to try less expensive generic drugs first for treating depression, Childs said. The state is one of several that allow Medicaid to restrict the use of mental-health drugs.

Florida left Zyprexa off its list in July after Lilly refused to give the state a price break, spokesman Jonathan Burns said in a Sept. 23 interview. The drug was added back on Sept. 12 after Lilly relented, he said, declining to cite the discount.

Drug Prices

States can negotiate for lower drug prices from companies or accept a rebate on Medicaid sales. Neither the companies nor the states discloses prices Medicaid pays for drugs.

The three-month retail price on http://www.drustore.com for Zyprexa is $1,500; for AstraZeneca’s Seroquel, $1,300; for Pfizer’s Geodon, $875; and for Johnson & Johnson’s Risperdal, $750. Bristol-Myers’s Abilify, a fifth treatment that wasn’t in the government study, costs $1,200 for the same period. Perphenazine’s comparable price is $135.

Getting doctors to prescribe perphenazine won’t be easy, said Robert Rosenheck, professor of psychiatry at Yale University Medical School in New Haven, Connecticut.

Policy Dilemma

“We have a dilemma in that the rational policy would be to use the cheaper drug and use the savings to provide additional rehabilitation services,” Rosenheck said in a telephone interview Sept. 21. “But there is no clear way of implementing that policy without impinging on the autonomy of doctors.”

He and other public health experts said they expect the new study to at least spur efforts to encourage greater use of the cheaper pill.

‘It’s a fascinating policy dilemma,” Rosenheck said. “I, like everyone else, am looking to see how agencies like VA and Medicaid deal with it.”

In New York Stock Exchange composite trading yesterday, Lilly shares rose 28 cents to close at $53.57, Bristol-Myers rose 2 cents to $24.15, J&J dropped 42 cents to $63.45, and Pfizer, based in New York, declined 39 cents to $24.80. AstraZeneca’s American depositary receipts, representing one ordinary share, fell 19 cents to $47.31.

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