Inventor of ADHD confesses “ADHD is a prime example of a ficticious disease”. The APA turns the hoax Ïnternet Addiction Disorder” into a DSM billing bible diagnosis!
Following the email on November 23 from Peggy O’Mara which stated:
We have not recommended Zyprexa in any of our articles.
I wrote Peggy a reply the same day. Her reply to me follows that on December 20. Since she has asked that I share it with everyone I am posting both here for your benefit so that her reply will be in context. I apologize for the delay – I have been extremely busy the past three weeks and out of town, etc. Our letter to the editor (a revised version) is being considered for the March/April edition of Mothering magazine.
Dear Peggy,Thank you for responding to this letter to the editor from another activist. Did you receive the letter that John Breeding and I sent you several weeks ago? After we received no response we published it as an open letter. I did see the letter published in this month’s issue which refers readers to Katherine Stone’s Postpartum Progress and claims that nothing short of medication can help PPD. Perhaps you are still considering publishing further, more accurate information for your readers.
I could have misremembered the use of the term Zyprexa from your article and inserted it in my mind into the excerpt which tells moms to use antipsychotic drugs and continue breastfeeding in 2007. If that is the case I apologize. I recently gave away my copy of that month’s issue before seeing your September / October article which promotes antidepressants to breastfeeding mothers, so if I am mistaken then that is my fault for getting rid of your magazine before your September edition came out, which necessitated another letter.
I would be happy to clarify the Zyprexa issue in our letter to the editor and modify it to say simply that your magazine recommended the use of “antipsychotic drugs” if it’s true that the word Zyprexa or Olanzapine has not been mentioned in any Mothering articles / posts as a choice that moms should consider.
I do remember after reading your 2007 article, going to Thomas Hale’s website and looking for any studies relating to antipsychotics and discovering that he was recommending Zyprexa on the basis of a study of the blood of six babies.
I gave my copy of your May 2007 article to a friend at a speech I gave in April so I don’t have the hard copy. However this is what I found online regarding the information that you forwarded on antipsychotics.
These quotes below are from the excerpt that was included with the “Losing It” article from 2007 (I guess you may have had another title like “Overcoming Postpartum Psychosis” or “Victory Over Postpartum Psychosis” or something to that effect on the cover.)
Here is the Losing It article where Sarah Fields from Postpartum Support International writes about how she was on antipsychotics while breastfeeding and refers readers to Thomas Hale.http://mothering.com/health/losing-it
“Self-Care: According to Kathleen Kendall-Tackett, PhD, IBCLC, postpartum depression can be eased by use of an “adjunct treatment to help the body heal itself, but not necessarily as primary treatment. With psychosis, medications are necessary to stabilize symptoms. After that, adjunct treatments can help prevent another episode. That would be the safest course.”8
Kendall-Tackett encourages mothers who want to continue breastfeeding to do so, even through a psychotic episode. To facilitate breastfeeding, she advises: “Mothers need a supportive environment, where mom and the baby can stay together but the baby is safe. Mothers and their care providers also need to know about which medications are compatible with breastfeeding.” The best resource for that is Dr. Thomas W. Hale’s book, Medications and Mothers’ Milk.9”
On October 1, 2010, John Kelly reported on an investigation by Youth Today that found atypical antipsychotics were prescribed to many incarcerated youths in juvenile facilities in the US without a diagnosis of schizophrenia or bipolar disorder, the only FDA-approved indications for use with juveniles.
A wide variety of diagnoses were listed for the prescribing of the drugs including general mood disorders, intermittent explosive disorder, oppositional defiant disorder, PSTD and ADHD.
However, Kelly reports that critics believe most of these diagnoses are simply a cover for the fact that prisons now use drugs as a substitute for the banned physical restraints that were once used on juveniles who aggressively acted out.
“Fifty years ago, we were tying kids up with leather straps, but now that offends people, so instead we drug them,” Robert Jacobs, a former Florida psychologist and lawyer who now practices psychology in Australia, told Kelly.
“We cover it up with some justification that there is some medical reason, which there is not,” he said.
The atypical drugs include Bristol-Myer Squibb’s Abilify, Pfizer’s Geodon, Seroquel from AstraZeneca, Eli Lilly’s Zyprexa, and Risperdal and Invega from Johnson & Johnson.
Youth Today has been working for over a year to find out how much money individual states have been spending on the drugs for incarcerated youth, and for what reason. Medicaid records would not contain the relevant information because federal Medicaid money cannot be used to fund medical care for anyone incarcerated for a crime, whether adult or juvenile, Kelly reports.
Because funds for medications prescribed to juvenile inmates must come from state sources, each state’s juvenile justice agency was asked how much was spent, in the most recent year available, on five drugs – Abilify, Geodon, Risperdal, Seroquel, and Zyprexa – and to provide the diagnosis listed for the prescriptions.
Only 14 states provided some information on the amount spent in either 2008 or 2009, with wide variations. For instance, New Jersey and Minnesota reported spending less than $100,000 a year, while Texas, Florida and Virginia each spent over $1 million.
Only five states were able to provide a comprehensive list of diagnoses along with the amounts. The total number of prescriptions for those five states combined was 5,299, with an off-label condition listed as the diagnosis for 3,709, or 70 percent.
In Texas, nearly 4,000 atypical prescriptions were written in 2008, for a total juvenile population in state facilities of between 1,600 and 1,900, with only 29 percent diagnosed with schizophrenia or bipolar disorder and no diagnosis listed for nearly 25 percent of the prescriptions.
Because Seroquel accounted for so many prescriptions with no diagnosis, Texas officials feared that it had become the “sleeping pill of choice” for agency clinicians, Kelly reports. Seroquel was prescribed 2,553 times in 2008, almost twice as often as the other four atypicals combined.
Please see updates to this letter on the following blog posts:
- My Bad – Mothering Magazine Promotes “Antipsychotics” Not Just Zyprexa
- Mothering Magazine Publishes Letter Reaming Them for Being So “Anti-drug”
To The Editor:
In May 2007 Mothering magazine published an article titled “Overcoming Postpartum Psychosis.” It featured the story of a woman who nursed while taking antipsychotic drugs but eventually found recovery through alternative means. The article also featured an excerpt from Kathleen Kendall-Tackett stating that Zyprexa was a good antipsychotic to use for breastfeeding moms who go psychotic.
This month (Sept/Oct 2010 edition of Mothering) the same article promoting Zyprexa to breastfeeding mothers is referenced at the end of the Kathleen Kendall-Tackett article on breastfeeding helping moms to “Beat the Baby Blues.” Adding insult to injury, you chose to publish a graphic encouraging the use of Wellbutrin, Paxil, and Zoloft for breastfeeding as though they are “compatible.” Based on what definition of compatible?
That breastfeeding helps alleviate depression, and co-sleeping helps prevent depression, is a wonderful topic for an article. We are very deeply concerned, however, about the misinformation regarding breastfeeding on psychotropic drugs! With all due respect to the admirable premise of the article, helping to encourage breastfeeding, it is a tragic mistake to encourage the notion that mothers can safely breastfeed while taking the antipsychotic drug Zyprexa—a drug that is well-documented to cause excessive sedation, diabetes, permanent neurological damage and high rates of death. Zyprexa is an extremely toxic and dangerous drug, and decidedly unsafe for babies.
After examining the literature critically we are sure that in 2007, the existing data, including one study cited by Thomas Hale as evidence of supposed safety which examined blood samples from only six babies, did not warrant a statement by anyone that Zyprexa is fine for nursing. As just one example of why it is still the case that Zyprexa cannot be considered safe for babies, consider a 2008 article by S. Gentile (J Clin Psychiatry, 2008; 69(4): 666-73.), “Infant safety with antipsychotic therapy in breast-feeding: a systematic review,” which specifically warns against using Zyprexa in breastfeeding mothers, stating, “The drug seems to be associated with an increased risk of inducing extrapyramidal reactions in the breast-fed babies.”
A vital omission for a magazine with such a critical eye on research is to forward any information based on studies, without mentioning that the research was conducted by people under Senate investigation for financial conflicts of interest with pharmaceutical companies.
Kathleen Kendall-Tackett has published other misleading statements in the past regarding antidepressant effectiveness. One example was a statement in an article on PPD alternatives in Leaven magazine, which claimed that antidepressants and exercise worked at relieving depression equally, when the actual study showed that by the end of the experiment, the medication groups relapsed while the exercise groups improved.
Presumably the editors of Mothering assume that mothers must be told to use antidepressants or antipsychotics because they cannot possibly be expected to get through the horrors of depression or psychosis without taking psychiatric drugs. The assumption is that babies will miss out if their mothers wean them. We think it is a regrettable mistake to ignore the immediate risk of death to the infant in favor of a hypothetical benefit from taking psychiatric drugs.
For a magazine such as Mothering to condone the use of drugs during breastfeeding that cause infants to develop serotonin syndrome, or vomit, aspirate, suffer seizures, slip into comas and die from various toxic reactions, and to ignore the other serious nonfatal risks of these drugs is unconscionable. The wide readership of breastfeeding advocates gives your magazine added responsibilities, and we urge you to reconsider your position.
Mothering has taken seriously the topics of the risks of medicated births, vaccines, circumcision, and even chemicals in toys. In almost every respect Mothering is satisfied with nothing less than perfection in the information conveyed which can affect the way that we raise our children. But we see a blind spot when it comes to the so-called experts that Mothering endorses on the topics of postpartum depression and psychosis.
We encourage the magazine to spend some time investigating the deaths of babies linked to psychiatric drugs and breastfeeding. If you refuse to address the issue honestly you will lose not only the trust of your readers, but credibility in the much larger community of critics and informed consent advocates.
John Breeding, PhD
by John Breeding, PhD and Amy Philo
Working with others, we strive to alleviate distress and to support and enhance the personal growth, transformation, individuation, self-determination, and clear and expanded awareness of individuals. Necessity dictates that we also spend a lot of time challenging aspects of the mental health profession that do the opposite—creating more distress, suppressing growth and transformation, violating self-determination, and dulling and blinding awareness. We call it psychiatric oppression, the systematic, institutionalized mistreatment of those judged as “mentally ill.” This essay focuses especially on the ever expanding encroachment of psychiatric oppression to more and more of the population, and to individuals who are less and less in need of actual help. This encroachment takes the form of mass marketing for psychiatry and the pharmaceutical industry. One key aspect of oppression theory is the claim to virtue. For psychiatric oppression that claim is the notion that mentally ill people need their treatment; its growing extension is the concept of prevention, that potentially mentally ill people need treatment as well!
The Regressive Progression: Treatment to Prevention
“An ounce of prevention is a pound of cure.” Like all great aphorisms, this one, often associated with Ben Franklin, holds wisdom and is partly true, based on assumption. In this case, one must assume the role of victim of unnecessary malady that necessitates a cure…and that there is a felt connection or empathic relatedness to the one who suffers malady. Where these assumptions are not met, the aphorism is false. To wit, for the giant corporation of Halliburton and its government and military operations group, or for the mercenary army of Blackwater, going to war is worth a great deal more than diplomacy.
Evelyn Pringle November 7, 2007
Since August 2006, as part of an on-going, multistate investigative effort by approximately 30 states, Eli Lilly has received civil investigative demands or subpoenas seeking a broad range of documents relating to the company’s marketing and promotion of the antipsychotic drug
Zyprexa, and more states are expected to join the effort.
In addition, a total of ten states are now suing Lilly for Medicaid fraud to recover the cost of Zyprexa purchases for persons covered by the program, along with the past and future costs of treating Zyprexa-related illnesses. Alaska, Arkansas, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, Utah and West Virginia have filed cases thus far.
Zyprexa belongs to a new generation of antipsychotic drugs known as “atypicals” which arrived on the US market in 1994, beginning with Risperdal, marketed by Johnson and Johnson subsidiary Janssen. Other drugs in this class include Seroquel, sold by AstraZeneca; Geodon, by Pfizer; Abilify, from Bristol-Myers Squibb and Clozaril, marketed by Novartis.
For the first four years that Zyprexa was on the market in the US, it was only approved to treat adults with schizophrenia, and it was not until 2000 that the FDA approved the drug for adults in the manic phase of bipolar disorder.
However, in a matter of a few short years, Lilly turned Zyprexa into its best-selling product, despite the drug’s extremely limited approved uses, by influencing doctors to prescribe the drug off-label.
In addition to prescribing a drug for unapproved uses, off-label can mean treating an approved condition for a longer duration of time, or prescribing a drug in combination with other drugs, or at a different dosage, or to a different patient population such children or the elderly, other than those specified on the FDA-approved label.
According to Lilly’s SEC filings, the Office of the US Attorney for the Eastern District of Pennsylvania has also advised Lilly that it has commenced a civil investigation related to the company’s marketing and promotion of Zyprexa, and a “number of State Medicaid Fraud Control Units are coordinating with the EDPA in its investigation of any Medicaid-related claims relating to Lilly’s marketing and promotion of Zyprexa.”
Lilly has also received subpoenas from the Office of the Attorney General of the State of Illinois, and the Florida Office of the Attorney General, Medicaid Fraud Control Unit, asking for documents relating to sales, marketing and promotion of Zyprexa.
Lilly’s SEC filings also report that the company has received requests for information related to the company’s marketing and promotion of Zyprexa from the offices of Representative Henry Waxman, Chairman of the House Committee on Oversight and Government Reform, and Senator Charles Grassley, the ranking Republican on the Senate Finance Committee.
Collectively, the Medicaid fraud lawsuits allege that Lilly illegally influenced doctors to prescribe Zyprexa off-label to patients, including children, for conditions such as behavior and mood disorders, eating disorders, anxiety, post traumatic stress disorder, insomnia, PMS, Alzheimer’s, Tourette’s syndrome, dementia and other unapproved indications.
The lawsuits also allege that Lilly concealed the adverse effects associated with Zyprexa, including drastic weight gain, high blood sugar levels, diabetes and pancreatitis.
Other serious adverse effects known to be associated with Zyprexa include Parkinson-like symptoms, akathisia, tardive dyskinesia, dystonia, hypotension, constipation, tachycardia, seizures, liver abnormalities, white blood cell disorders and death.
The Mississippi lawsuit alleges that about 10% of Zyprexa patients have developed diabetes, some of whom are children, even though Zyprexa “has never been approved for, nor found to be effective, in the treatment of children.”
An estimated 1,500 Utah Medicaid patients who took Zyprexa have developed diabetes, according to the lawsuit filed on May 29, 2007, by state attorney general David Stallard.
Utah is seeking damages including $5,000-$10,000 for each prescription that was “not medically necessary.”
Lilly recently attempted to get the Utah case dismissed, in part by arguing that the allegations of off-label promotion and failure to warn were preempted by FDA regulations under a new rule put in place by the Bush Administration, largely viewed as a gift to the pharmaceutical industry.
In 2006, the FDA published a preamble to new prescription drug labeling rules in which it asserted that its approval of the labeling would prevent the filing of lawsuits in state courts premised on a theory that a drug company should have provided additional warnings on a drug’s label.
However, the Utah court ruled against Lilly on this issue and stated, in part: “In fields traditionally occupied by the states, such as health and safety regulation, there is a strong presumption against federal preemption,” and Lilly “has not overcome this strong presumption.”
Pennsylvania alleges that the state spent millions of dollars “for non-medically accepted indications and non-medically necessary uses of Zyprexa,” as well as “significant sums of money for the care and treatment” of patients injured by the drug.
Montana’s complaint charges that, “Lilly management participated, encouraged and authorized the unlawful payment of illegal kickbacks to physicians in order to continue generating sales of Zyprexa.”
The Montana lawsuit is asking for reimbursement on behalf of all citizens who purchased Zyprexa, and not only patients covered by public health care programs, because under the law in that state, the attorney general can request treble damages and attorneys’ fees on behalf of all consumers.
There are also several RICO class actions filed against Lilly on behalf of union insurance plans, pension funds, and other private health insurers, which accuse Lilly of violating racketeering laws and allege the drug maker engaged in illegal marketing schemes to promote the sale of Zyprexa for off-label uses and seek to recover the cost of purchasing the drug, as well as treble damages, punitive damages and attorneys’ fees.
On June 28, 2007, Lilly lost a motion for a summary judgment dismissal of the RICO claims, based on the preemption argument, when District Court Judge Jack Weinstein for the Eastern District of New York ruled against the company, In re Zyprexa Products Liability Litigation, 2007 WL 1851161.
In a written ruling rejecting Lilly’s argument that state law failure-to-warn claims are preempted, Judge Weinstein wrote that “the regulation of public health is an area traditionally occupied by the states, supporting a presumption against preemption.”
“Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs’ bar,” he stated, “the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs.”
The Judge also noted that Congress had not stated an intent to preempt these claims. “The FDA cannot be allowed to usher in such a sweeping change in substantive law through the back door,” he wrote.
The Medicaid fraud lawsuits allege that many children have been turned into customers for the off-label prescribing of Zyprexa. A recent October 7, 2007, report from the Florida Agency for Health Care Administration entitled, “The Use of Antipsychotic Medications with Children,” found that pediatric use of antipsychotics increased in the late 1990’s and early 2000’s, largely due to the arrival of the atypicals on the market.
The report noted that one study documented a 75% increase with commercially insured children aged 0 to 17 from 1997 to 2001, and another study of the managed care population from 1996 to 2001 found a 127% increase among children aged 0 to 18.
The study also reported that antipsychotic use in the Medicaid populations was three to four times higher than commercial populations in the late 1990’s, and in one program in the Midwest, the rate of prescriptions grew 304% between 1996 and 2001.
The authors said the analysis showed that the drugs are being used to treat a broad spectrum of disorders, and some of the disorders, such as attention deficit hyperactivity disorder and major depression, “clearly do not call for antipsychotic treatment.”
In the 0 to 5 age group, the study found that more than 53% of the drugs were prescribed for ADHD, even though antipsychotic use with children under 6 “should be considered only in very rare circumstances.”
A report in the May 10, 2007, New York Times revealed some of the known adverse events that occurred in children who were prescribed antipychotics in 2006 alone. The FDA received reports of 29 children dying, and at least 165 other serious side effects in children, where an antipsychotic was listed as the primary suspect, according to the Times.
The FDA acknowledges that its reporting system only picks up between one and ten percent of the adverse events that take place, which means the number of deaths and injuries above must be multiplied many times over to obtain an accurate estimation of how many children have been harmed by the drugs.
Evelyn Pringle November 10, 2007
Several Zyprexa-related class actions have been filed against Eli Lilly on behalf of the company’s shareholders charging Lilly, and certain of its officers and directors, with violations of the Securities Exchange Act.
On April 2, 2007, the Schiffrin Barroway Topaz & Kessler law firm issued a press release to announce a class action filed on behalf of all purchasers of Lilly stock between March 28, 2002, and December 22, 2006, alleging that Lilly disseminated false and misleading statements regarding Zyprexa.
More specifically, it alleges that Lilly was aware of a “clear link” between Zyprexa and diabetes, failed to warn the public and engaged in an illicit scheme to offset a drop in sales that was certain to occur when reports of side effects emerged, by creating a marketing plan which included the evaluation and pursuit of sales for Zyprexa based on “off-label” uses, in direct violation of Lilly’s own code of conduct.
The complaint further alleges that concealing the side effects and engaging in an illegal marketing campaign subjected Lilly to substantial regulatory fines, penalties and other legal action, compromising the company’s overall financial condition and prospects.
According to the complaint, between 2002 and 2004, sales of Zyprexa grew from $3.69 billion to $4.42 billion, and between July 18, 2002, and May 7, 2004, Lilly’s stock value increased from $43.75 per share to $76.95.
But when public warnings were issued about the safety of Zyprexa, the lawsuit alleges, sales slowed and share prices dropped from $76.95 to $50.34 between May 7, 2004, and October 25, 2004, representing a loss of market capitalization of over $30 billion.
Another shareholder’s complaint claims that Lilly had knowledge of a link between Zyprexa and extreme weight gain and diabetes and when sued by private individuals who developed these adverse effects, “the Company adamantly refused to acknowledge any wrongdoing.”
Still another lawsuit alleges that Zyprexa does cause such side effects, and to a greater extent than its competitors, and the “revelations sharply curtailed the sales growth of Zyprexa and resulted in thousands of product liability lawsuits against Lilly and hundreds of millions of dollars in settlements.”
A number of Zyprexa cases have been filed against Lilly in other countries as well.
In private litigation, almost all of the federal lawsuits are part of a Multi-District Litigation proceeding before Judge Jack Weinstein in the Federal District Court for the Eastern District of New York.
Since June 2005, Lilly has entered into out-of-court settlements with approximately 30,200 claimants in the US for about $1.2 billion, and there were still about 350 lawsuits covering about 540 claims pending at the time of the company’s August 7, 2007, SEC filing.
However, on June 29, 2007, Rob Waters and Margaret Cronin Fisk reported in Bloomberg News that Lilly “may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from US regulators.”
They report that Lilly was told in March that the FDA would delay the approval of Symbyax, which contains both Zyprexa and Prozac, for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the prescribing label. Symbyax was already approved for bipolar disorder.
In a letter obtained by Bloomberg, the FDA stated: “We are concerned that the proposed labeling is deficient with regard to information about weight gain and high levels of sugar and fat in the blood of patients who took the drug.”
“We do not feel that current labeling for either Symbyax or Zyprexa provides sufficient information on these risks,” the agency wrote.
According to Bloomberg, the FDA said Lilly’s proposed prescribing information for Symbyax failed to disclose that almost half of the patients who had high or borderline blood sugar levels when they started taking the drug ended up with levels high enough to be considered diabetic and that was over nine times the number of patients on placebos.
“We were troubled that this important information was not included in your proposed label,” the agency said.
“The FDA’s request,” Bloomberg points out, “may bolster plaintiffs’ suits against the Indianapolis company over side effects tied to Zyprexa,” attorneys told the reporters.
“When the FDA says something damning about the warnings of a drug, it’s admissible as evidence on the reasonableness of the manufacturer’s decisions,” said David Logan, dean of the Roger Williams University School of Law, in an interview with Bloomberg.
“It would likely carry some weight with juries,” he stated.
Experts say, in light of all the studies which have shown that the older cheaper antipsychotics work as well or better than atypicals for schizophrenia patients, it’s difficult to understand why Zyprexa is still being prescribed for those patients.
An October 2006 study in the Archives of General Psychiatry, funded by the British government and lead by Dr Peter Jones, a psychiatrist at the University of Cambridge, compared treatment outcomes for schizophrenia patients with the older antipsychotics with treatment results from the new atypicals and found the quality of life of patients was slightly better with the older drugs.
The study was conducted on behalf of Britain’s National Health Service to determine whether the increased cost of the new atypicals was justified and involved 227 patients who were assigned to two groups and evaluated by researchers who did not know which medication the patients were taking for over a year.
In the October 3, 2006, Washington Post, Dr Jones said a conservative interpretation of the data suggests that there is no difference, “so the notion you would pay 10 times as much would be difficult to justify.”
“Why were we so convinced?” he asked, referring to the widespread belief that the new drugs were worth the cost. “I think pharmaceutical companies did a great job in selling their products,” he said.
Experts are quick to point out that earlier studies in the US had produced the same results. In 2003, the Department of Veterans Affairs found there was no difference in compliance, symptoms or overall quality of life in patients treated with the older drug Haldol compared with Zyprexa, and a September 2005 government-funded study in the New England Journal reported that patients taking the older drug perphenazine did as well as patients on the new drugs and patients on atypicals experienced more side effects.
“The story of these newer antipsychotic drugs is a story that reveals an institutional gap,” according to Dr Robert Rosenheck, who was involved in both US studies, in the Post on October 3, 2006.
“It should not have needed 10 years to get three government studies,” he noted.
The fact is, Lilly promoted Zyprexa as being more effective than the older drugs with less side effects right from the start. On November 14, 1996, the FDA’s Division of Drug Marketing, Advertising and Communications sent a letter to Lilly addressing the company’s misrepresentations of the risks and benefits of Zyprexa in an October 2, 1996, promotional teleconference conducted by Dr Gary Tollefson, Vice President of Lilly Research Laboratories.
During the conference, the FDA said, Dr Tollefson made the false claim that Zyprexa did not cause the Parkinsons-like side effects observed in patients who received Haldol, and even though the FDA labeling for Zyprexa included weight gain as an adverse effect, during the conference Dr Tollefson claimed that it usually occurred in patients who were underweight to begin with, making it sound like weight gain was actually a benefit of the drug, according to the FDA letter.
In addition to the many serious health problems found to be associated with Zyprexa in recent years, experts say the suicide rate amongst Zyprexa patients is also high. According to an analysis of the FDA’s adverse event reports by Dr Gregory Warren, an independent researcher and statistician, since Zyprexa came on the market in 1996, there have been 532 suicide reports on the drug filed by health care professionals.
UK psychiatrist and professor Dr David Healy, one of the world’s leading authorities on pharmacology, says there has been a ten- to twenty-fold increase in the rate of suicide among patients diagnosed with schizophrenia since antipsychotics were first introduced.
All that said, apparently no amount of litigation will slow the off-label prescribing of Zyprexa. In 2006, sales were $4.3 billion, and for the second quarter and first half of 2007, US sales of Zyprexa increased 4% and 5%, respectively, and international sales increased 14% during both periods, according to the SEC filings.
Critics say going after the drug makers is not enough, that it’s time to sue the doctors who prescribe drugs off-label. Alaska human rights attorney Jim Gottstein says psychiatrists are seldom held legally responsible for their failure to adequately inform patients about the true efficacy and harms of the drugs they prescribe.
“This has likely lulled them into a false sense of security,” he notes, “because there are various factors at work which could loosen a tidal wave of legal cases against doctors who do not adequately inform their patients about the benefits and harms, including the efficacy of other approaches and of nontreatment.”