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New Schizophrenia Drugs No Better Than Cheaper Generics_Bloomberg_WashPost

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    ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org FYI The second phase of the
    Message 1 of 1 , Dec 1, 2006
      Promoting Openness, Full Disclosure, and Accountability


      The second phase of the government study, Clinical Antipsychotic Trials in
      Intervention Effectiveness (CATIE), was released and the incontrovertible
      evidence pulls the rug out from psychiatry's current prescription practice
      guidelines that mental health professionals have trained to follow.

      Antipsychotic drug manufacturers created a marketing blockbuster cash cow
      with the help of influential psychiatrists from the University of Texas.
      Together they manufactured an "evidence-based" consensus promoting
      psychotropic drug prescription guidelines that requires use of these drugs
      as first line treatment. The Texas Medication Algorithm Project (TMAP) is
      the secret behind the most toxic drugs in medicine whose approval was
      limited for schizophrenia and short-term bipolar disorder to become
      blockbuster sellers.

      As Rob Waters of Bloomberg News reports (below) "Newer drugs, such as
      Johnson & Johnson's Risperdal, Eli Lilly & Co.'s Zyprexa and AstraZeneca
      Plc's Seroquel, account for more than 90 percent of the $10.5 billion-a-year
      U.S. antipsychotic drug market, largely paid for by federal and state
      governments. " This is the biggest taxpayer rip-off.

      How was this accomplished? Rip offs in psychiatry are easy because NONE of
      psychiatry's assumptions or claims are backed by ANY scientific evidence-all
      diagnoses and treatment recommendations are based on subjective unproven

      Indeed, Dr. Jeffrey Lieberman, chairman of Columbia University's psychiatry
      department, who is the lead CATIE author, now acknowledges in Bloomberg News
      "The 10-year history of the newer antipsychotics and the results of the
      current study throw those assumptions into question: The assumption was
      these medications would have superior efficacy, greater safety and
      ultimately result in better long- term outcomes. The presumption when the
      public is paying $10 billion a year is that it is worth it.''

      These drugs' severe adverse effects are documented in patient poor outcomes
      during this decade of highest profit for antipsychotic manufacturers. The
      CATIE study merely corroborates what psychiatry has been loath to admit.
      Reality check: Neuroleptics-the old and the new so-called 'atypical" were
      NEVER proven "safe and effective." Each class has its own set of serious
      debilitating, life-shortening adverse drug induced effects. The older
      neuroleptics cause involuntary motor movements, cognitive dysfunction, and
      irreversible tardive dyskinesia. The new drugs disrupt normal metabolic
      function causing spikes in cholesterol and blood pressure levels; induce
      potentially lethal metabolic syndrome with its attendant increased risk of
      death from cardiovascular abnormalities, stroke, heart attack, hyperthermia,
      and diabetes mellitus. They too cause cognitive dysfunction.

      In an editorial accompanying the first published report, Dr. Carol Tamminga,
      a leading schizophrenia researcher and promoter of these second generation
      neuroleptics expressed her dismay at the evidence of terrible patient
      outcomes: "the side effect outcomes are staggering in their magnitude and
      extent and demonstrate the significant medication burden for persons with
      schizophrenia.. Sky-high drug discontinuation rates were seen, suggesting
      rampant drug dissatisfaction and inefficacy." [1]

      U.S. State Attorneys General should investigate the fraudulent marketing of
      the atypical neuroleptic drugs-and FDA's role in helping conceal the truth.
      They were marketed as "breakthrough" "wonder drugs"-even as the severe risks
      and poor efficacy were detected by FDA safety officers in the data submitted
      to the FDA when the drugs were approved. The risks were ignored by officials
      of FDA's Center for Drug Evaluation and Research (CDER)-the same officials
      who ignored the evidence of increase suicide risk of the new SSRI

      After obtaining FDA marketing license manufacturers proceeded to rip off the
      American taxpayers. The drugs' risks were concealed in ghostwritten journal
      reports and reviews signed by academic psychiatrists paid by drug
      manufacturers to promote TMAP formularies urging doctors to use these drugs
      as first line treatment. There is some evidence that government officials
      were bribed to put these expensive toxic drugs on state formularies as first
      line treatment. [2]

      These drugs are destroying lives not saving lives: ask Ellen Liversidge, one
      of 8,000 plaintiffs who filed lawsuits charging that Zyprexa caused
      hyperthermia and diabetes.
      Eli Lilly has so far signed a settlement in the amount of $690 million.

      Isn't it about time for the Washington Post to include those directly
      affected by these toxic drugs? How long before the victims of unsound,
      self-interest policies are given space-rather than the "experts" ALL of who
      have vested interests to protect?

      By limiting news coverage to the voice of the "experts" the magnitude of the
      harm and the rip off remains mostly shrouded.

      1. Carol Tamminga, "Practical Treatment Information fore Schizophrenia"
      Editorial. American J of Psychiatry, April, 2006, vol 163:563-565

      2. Peter Jackson. Former State Pharmacist Charged, Business Week, Nov. 22,
      2006: www.ahrp.org/cms/content/view/392/29

      Contact: Vera Hassner Sharav

      New Schizophrenia Drugs No Better Than Older, Cheaper Generics
      By Rob Waters

      Dec. 1 (Bloomberg) -- Newer antipsychotic medications used to treat
      schizophrenia are no more effective than the older drugs they have largely
      replaced though they cost 10 to 20 times more, according to a large new U.S.
      government-funded study.

      Newer drugs, such as Johnson & Johnson's Risperdal, Eli Lilly & Co.'s
      Zyprexa and AstraZeneca Plc's Seroquel, account for more than 90 percent of
      the $10.5 billion-a-year U.S. antipsychotic drug market, largely paid for by
      federal and state governments.

      The drugs were billed in the mid-1990s as causing fewer of the side effects
      known as tardive dyskinesia that made users of earlier medications like
      Haldol and Thorazine tremble, doze off and jerk involuntarily. Today's study
      backed up earlier research suggesting the much-costlier new drugs are
      neither safer nor more effective than the older medications.

      ``The assumption was these medications would have superior efficacy, greater
      safety and ultimately result in better long- term outcomes,'' said study
      co-author Jeffrey Lieberman, chairman of Columbia University's psychiatry
      department. ``The presumption when the public is paying $10 billion a year
      is that it is worth it.''

      The 10-year history of the newer antipsychotics and the results of the
      current study throw those assumptions into question, Lieberman said in a
      phone interview yesterday. The new research was published in the American
      Journal of Psychiatry.

      ``The original understandings and expectations have not been met,''
      Lieberman said. ``We're paying more than the incremental value justifies and
      could probably use older medications that are less expensive.''


      Thomas Insel, director of the National Institute of Mental Health, which
      funded the $42.6 million research, said the study helped answer a key
      question: Is it cost-effective to use these second-generation drugs instead
      of the less-expensive older ones?
      ``The answer from this paper is that the older drugs may be a better buy,''
      Insel said.

      In an earlier analysis from the same clinical trial, known by the acronym
      CATIE, Lieberman and his colleagues reported last year that among four of
      the newer schizophrenia drugs, only Zyprexa was slightly more effective than
      a 40-year-old medicine, perphenazine. Today's report compared the cost
      effectiveness of the same antipsychotics.

      In the trial, almost 1,500 schizophrenia patients were randomly assigned to
      take perphenazine or one of four newer drugs: Seroquel, Zyprexa, Risperdal
      and Pfizer Inc.'s Geodon. The researchers evaluated the patients' progress
      in various ways throughout the 18-month study and calculated the total

      More Costly

      The researchers concluded that caring for patients taking the newer
      antipsychotics cost $300 to $600 more each month than for those on
      perphenazine, depending on which of the new drugs they took. The analysis
      included the cost of the drugs as well as medical care, hospitalization,
      social services and other treatment related to the patients' mental illness.

      The cost difference was almost entirely attributable to the higher prices of
      the new drugs. The average cost to treat a patient on perphenazine was $960
      a month -- just $50 of that for the drug. Treating a patient with Zyprexa,
      the most expensive of the newer antipsychotics, cost $1,404 a month, and
      more than a third of that, $545, was for the drug.

      The second-generation drugs that compete with Zyprexa cost less per pill,
      but the patients taking them incurred higher costs for care. Seroquel, which
      last year overtook Zyprexa as the top- selling antipsychotic, with $2.6
      million in sales, costs $412 a month, while the total cost of care for
      patients taking it in the study was $1,478.

      ``When you look at total health-care costs, Zyprexa was the most
      cost-effective among the atypicals,'' said Carole Puls, a spokeswoman for
      Lilly, in a phone interview yesterday. The chief reason was the patients
      avoided hospitalization, she said.

      Side Effects Less Likely

      The advantage of Seroquel is that patients taking it are less likely to
      experience the neurological side effects that used to plague users of the
      older drugs, according to Arthur Lazarus, senior director of clinical
      research for AstraZeneca.

      ``Seroqeul has the best side-effect profile of all,'' Lazarus said in a
      phone interview yesterday. ``As a practicing psychiatrist, I would never
      subject a patient to the risks of tardive dyskinesia.''

      The newer drugs were marketed in the mid-1990s almost as ``miracle drugs,''
      said Joseph Glenmullen, a clinical instructor of psychiatry at Harvard
      Medical School and a critic of the overuse of psychiatric medications.

      ``The companies exaggerated their safety and promoted these drugs as not
      causing tardive dyskinesia,'' he said. ``It's not true.''

      New Side Effects

      There is mounting evidence that the newer drugs can also cause tardive
      dyskinesia, though the relative rates are not yet clear. What is clear is
      that the newer drugs also cause another set of troubling side effects:
      weight gain and metabolic changes that can lead to diabetes. Patients taking
      Zyprexa gained an average of 2 pounds a month, the study found.

      With pharmaceutical companies funding so many drug studies, the National
      Institute of Mental Health should stop devoting most of its resources to
      funding them as well, said Vera Sharav, a critic of psychiatric medications
      and president of the Alliance of Human Research Protection, an advocacy

      ``NIMH has abandoned its mission by only funding drug studies,'' she said in
      a phone interview yesterday. ``There's been no funding for alternative
      modalities of treatment.''

      Not so, says NIMH director Insel.

      ``We spend a lot on psychosocial treatments,'' he said. ``No one would argue
      that medication should be the sum total. The worst thing that could happen
      is if we got into an either-or mindset.''

      To contact the reporter on this story: Rob Waters in San Francisco at
      rwaters5@... .

      Last Updated: December 1, 2006 00:16 EST

      The Washington Post
      Cost Benefits of New Schizophrenia Drugs Doubted
      Older Medication, Considered Equally Effective, Can Be as Much as $600 a
      Month Cheaper, Study Finds
      By Shankar Vedantam
      Friday, December 1, 2006; Page A09

      Treating schizophrenia with an older, cheaper drug, rather than with heavily
      promoted newer medications, reduces the cost by as much as 30 percent with
      no apparent difference in safety and effectiveness, according to the first
      study to examine the economic implications of antipsychotic drug prescribing
      practices in the United States.
      The newer drugs, such as Zyprexa, Seroquel and Risperdal, have cornered the
      lucrative U.S. market for antipsychotic drugs at a cost of $10 billion a
      year -- or around $100 for every family.

      The findings have roiled the field of psychiatry in a fierce debate over the
      study's implications and have triggered concerns it could lead public and
      private insurers to limit drastically which drugs they will pay for.

      Earlier research had shown that the older drug was as safe and effective as
      the newer medications. But experts cautioned against assuming that the
      cheaper drug would be as cost-effective once hospitalizations, side effects
      and quality-of-life issues were taken into account.

      The new study, published today in the American Journal of Psychiatry,
      concluded that when those factors were included, monthly costs per patient
      were $300 to $600 lower with the drug perphenazine, which is no longer under
      patent. The finding is the latest result from the $42 million Clinical
      Antipsychotic Trials in Intervention Effectiveness (CATIE), a federal study
      into the treatment of schizophrenia.

      In an indication of the widespread unease in the psychiatric establishment
      over the results , one senior doctor who helped conduct the study but not
      the cost-effectiveness assessment said the new finding faced stiff headwinds
      before it was published, and was subjected to an extraordinary level of

      "You are saying perphenazine is $500 cheaper," said the doctor, who spoke on
      condition of anonymity because of the sensitivity of the issue , to explain
      why many psychiatrists weighing the study seemed aghast. "Now the physicians
      feel defensive, because people will ask, 'Why are you charging the patient
      and insurance company $500 more when the drugs don't give you anything
      more?' "

      This doctor, the study's authors and several leading psychiatric experts,
      including Thomas R. Insel, director of the National Institute of Mental
      Health, emphasized that the study does not mean that patients doing well on
      more expensive drugs should be switched to cheaper medication. Switching
      drugs involves potential problems, and patients doing well on a drug should
      be kept on it, they said .

      But because many patients with schizophrenia need to change medications
      frequently -- an earlier part of the study found that three-quarters of
      patients discontinue whatever drug they are on within 18 months -- many
      could become candidates for treatment with the less expensive drug in a
      short period of time.

      "If they are chronically ill and are not on medication or want to switch, it
      is certainly a rational choice and would save money, and for the most part
      we can't detect effectiveness differences," said Robert Freedman, editor in
      chief of the journal, who co-wrote an editorial accompanying the study.

      Freedman and several experts said they were very worried, however, that the
      choice of medications would be taken from physicians and would be decreed by
      insurers. That would ignore the complexities of treating schizophrenia and
      the need for flexibility, the experts said.

      Patients who have tried perphenazine unsuccessfully, for example, may not be
      good candidates to go back on it. The federal study looked only at people
      who had had schizophrenia for a long time, not newly diagnosed patients. And
      overall, the fact that patients are dissatisfied so often with medications,
      including perphenazine, means that flexibility remains key.

      In statements, drugmakers AstraZeneca, which makes Seroquel, and Eli Lilly
      and Co., which makes Zyprexa, said patients benefit from having
      individualized treatment. The federal Centers for Medicare and Medicaid
      Services -- Medicaid picks up three-quarters of the $10 billion tab for
      antipsychotic drugs -- also believes that physician discretion is essential,
      a spokesman said.

      Drug-industry critic Jerry Avorn, author of the book "Powerful Medicine: the
      Benefits, Risks, and Costs of Prescription Drugs" and a professor of
      medicine at Harvard Medical School, said this is not a case of difficult
      trade-offs between cost and quality.
      "The cheapest drug produced an effect that was as good as the more expensive
      drugs," he said. "The resistance to this kind of finding comes from . . .
      the very legitimate worry that boneheaded cost containers will read this
      study and then try to get every schizophrenic on every other medication to
      be switched to the cheapest available product. I am a proponent of educating
      doctors first rather than tying our hands."

      Both Insel and Robert Rosenheck, the Yale University psychiatrist who led
      the cost-effectiveness study, said the message was not that the half-dozen
      expensive new drugs should be replaced by perphenazine. Rather, they said,
      the message of the CATIE study is that once a range of side effects is taken
      into account, many older antipsychotic drugs may have risks and benefits
      that are similar to those of the newer drugs.

      "It triples the size of the antipsychotic armamentarium available to
      psychiatrists," Rosenheck said. "Before CATIE, we had five to six drugs and
      we had tremendous pressure to not use the other 15.

      What CATIE has said is doctors should feel free to use whatever medicine is
      right for their patient, and there are 19 or 20 choices, not five or six."

      Although both old and new classes of drugs have similar effectiveness in
      controlling symptoms such as delusions and hallucinations, the advent of the
      newer drugs was hailed because they seemed less likely to cause side effects
      involving involuntary muscle movements.

      But evidence has gradually accumulated that the newer drugs do cause weight
      gain and serious metabolic problems. Essentially, the editorial noted, the
      new medications have resulted in a change in side effects, rather than
      eliminating them.

      Rosenheck said the study means that patients paying for expensive new drugs
      out of pocket who wanted to switch could try perphenazine without the
      concern that they are getting inferior treatment. The magazine Consumer
      Reports recently listed perphenazine, which is sold as a generic drug, as a
      "best buy" among antipsychotics.

      While Rosenheck and CATIE lead scientist Jeffrey Lieberman of Columbia
      University disagreed with the authors of the editorial on how to interpret
      several aspects of the study, everyone agreed that the trial provides the
      best window in the country to date on the treatment of schizophrenia. The
      editorial said the study highlighted the need for new and better treatments
      -- and perhaps a new and better mechanism of financial rewards to spur their

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