Seroquel, Zyprexa and Geodon for Kids? You Bet Says FDA Panel

ADELPHI, MD — Even as a US District Court prepares 6,000 Seroquel lawsuits for trial, Eli Lilly pays $1.42 billion for illegal Zyrexa marketing and 30 states sue over heisted Medicaid funds for atypical antipsychotics, an FDA advisory panel has recommended approval of Seroquel, Zyrexa and Geodon for children.

After two days of hearings, the FDA Psychopharmacologic Drugs Advisory Committee voted to recommend approval of AstraZeneca’s Seroquel (quetiapine) for the acute treatment of schizophrenia in adolescents 13-17, acute treatment of bipolar mania in children 10-12 and adolescents 13-17; Pfizer’s Geodon (ziprasidone) for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages 10-17; and Eli Lilly’s Zyprexa (olanzapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder and acute treatment of schizophrenia in adolescents.

Most people know pharma’s blockbuster atypical antipsychotics Seroquel, Zyprexa and Geodon, off label marketed to kids, the elderly, the uncategorizable and the suggestible –are you sure you don’t have racing thoughts ask ads?–correlate with weight gain, diabetes and metabolic derangement.

But who knew until the hearings that Seroquel also causes an extra seven or eight heart beats a minute in children? Possibly for as long as they take it? With no studies to show the long term effect? Or the safety of drugs to treat the effect? And no theory as to why?

Who knew Seroquel could cause cataracts?

Who knew Geodon could cause a prolonged QT interval also known as “sudden death.”

Who knew the atypicals, along with tremor and muscle rigidity, could cause the permanent and stigmatizing tardive dyskinesia they were developed to prevent? Hello?

Of course AstraZeneca doctor Liza O’Dowd did her best during her presentation to sail through the negatives–assuring the panel that Seroquel’s blood pressure, weight, glucose and prolactin issues could be “controlled and monitored” and that they “didn’t lead to discontinuation of the study” (let’s hope not when the trial was three weeks.)

But she was less forthcoming when discussing the five child suicides seen during trials, a slide she only produced in response to panel questions.

AstraZeneca’s Ihor Rak, MD did his best to dismiss cataract problems as “poor hygiene, nutrition and accidents” seen with schizophrenics but had no ready answer when panelist member Benedetto Vitiello, MD asked why not, then, remove instructions to examine patient lenses from the prescribing information.

AstraZeneca presenter Lili Kopala, MD was certain the study suicides stemmed from patients who were “still on the recovery curve,” but when panelist Christopher Granger, MD challenged her, she changed her mind and said, “they may be random.”

And panelists had other questions.

Not being trained psychiatrists, how did you make the differential diagnosis of bipolar for your studies asked panelist Kenneth Towbin, MD? How do you know irritability, anxiety or aggression don’t denote other disorders? How could a Seroquel study in which children with mania are kept on stimulants be scientifically valid–or ethical?

Children are often on “cocktails of seven or eight medications,” agreed Rochelle Caplan, MD, and “once we get them off,” they might just have a learning disability.

Worse than problems diagnosing pediatric bipolar or schizophrenia–3,000 suspected childhood schizophrenia cases yielded only 110 actual cases in one study said panelist Nitin Gogtay, MD–and worse than the lack of “real world” and mixed medicine “cocktail” studies was the brevity of the studies themselves said panelists.

How can three and six week studies suggest safety for maintenance treatment of schizophrenia and bipolar disorders which lasts decades? “We know they won’t stop [using the medications] at the acute phase,” said Towbin.

Panelist Granger confessed to “real discomfort” approving drugs which “generat[e] metabolic syndrome in adolescents in a very short period of time” for “indefinite use” on the basis of three or six week trials. “Hopefully we’re not exposing someone for decades,” agreed fellow cardiologist Edward Pritchett, MD.

But Thomas Laughren, MD, FDA’s director of psychiatric drugs was more upbeat. Not only was he sure pediatric safety could be extrapolated from adult studies–promising to include the clinical leap on labels–he didn’t want to be derailed over the two children who perversely died from stroke and cardiopulmonary failure in Geodon studies either.

There’s “hazard in drawing too much from subsetting the data,” said Laughren. Phillip Chappell, MD of Pfizer thanked him.

Frank Greenway, MD, an endocrine specialist on the panel, was also upbeat, observing prolactin elevation from the atypicals was less than a “prolactin secreting tumor.” Whew.

Still the elephant in the room at the proceedings was why drugs that are already available off-label need FDA approval at all–and why it’s urgent that kids showing symptoms be Treated Now.

(One pharma doctor claimed gray matter shrinks ever time someone is “psychotic” but others admitted early treatment has no effect on the course of the diseases.)

The answer of course was in the other elephant in the room–the wall of 40 pharma funded doctors sitting at attention, outnumbering FDA representatives two to one and unabashed referred as “sponsors.” (Though their Medicaid streams imply that’s backwards.)

It’s the sponsors who exhort doctors–and parents–to subject kids to increased heart beat, sudden death, metabolic syndrome, tardive dyskinesia, cataracts, stroke and suicidal side effects for diseases they may not even have.

Certainly that’s how two mothers who testified during the open public hearings felt.

Liza Ortiz of Austin, TX lost her 13-year-old son to Seroquel toxicity earlier this year. “His hands twisted in ways I never thought possible in the I.C.U., ” she said.

Mary Kitchens of Bandera, TX said her son suffers from crossed eyes, nightmares, trembling, neutropenia, hypothyroidism, tachycardia, dyskinesia and cogwheeling since Seroquel treatment.

“AstraZeneca marketed this to my child in 2003,” she said holding the original Seroquel package for the panel to see. “And now they want your seal of approval.”

Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: Read other articles by Martha.

8 comments on this article so far ...

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  1. Daniel Haszard said on June 13th, 2009 at 11:26am #

    Eli Lilly Zyprexa can cause diabetes

    I took Zyprexa a powerful Lilly schizophrenic drug for 4 years it was prescribed to me off-label for post traumatic stress disorder was ineffective costly and gave me diabetes.
    This is a powerful drug that can damage a young person physiologically for life.

    Please take with caution and learn as much as you can about side effects.
    Eli Lilly’s #1 cash cow Zyprexa drug sale $38 billion dollars so far,has a ten times greater risk of causing type 2 diabetes over the non-user of Zyprexa.
    So,here we have a conflict of interest that this same company also is a big profiteer of diabetes treatment.

    Daniel Haszard

  2. kalidas said on June 13th, 2009 at 1:26pm #

    Eat more dirt!

  3. RH2 said on June 14th, 2009 at 5:24am #

    Daniel Haszard,

    It is a sad experience for you to get diabetes. I work as a clinical psychologist at a psychiatric hospital somewhere in Europe. We usually treat traumatic stress disorder (TSD) with psychotherapy, talking to people and guiding them through exercise to find a way out. In persistent cases an antidepressive drug could be helpful, if well-tolerated. In case of restlessness or suicidal thoughts it must be stopped and replaced by another drug. Individuals react differently to antidepressive medication. I cannot say that all antidepressive drugs were bad for all people. I know from clinical experience that these drugs are indispensable. You should know that depression is a serious psychic disorder with anxiety and loss of pleasure and joy. But one should not treat every upset or ill feeling as depression. The filth of Lilly which is not quite clear in daily psychiatry is the marketing of Zyprexa as a schizophrenic drug and mood stabilizer. This fraudulent marketing seduces inexperienced and also bribed psychiatrists into prescribing this stuff off label. Bribery varies from severe like paying pretty good sums of money to banal like inviting a doctor to continuation courses with overnight stay at a luxurious hotel. You correctly advise the persons concerned to learn as much as they can about side effects. Did your therapist not inform you of side effects of Zyprexa before taking it?

    Lilly is a corporate at imperial and capitalistic (corrupt) level. Its filth is comparable to that of Monsanto. There are no reliable long term control studies. I hope that people with psychic problems read the articles of Martha Rosenberg. It is a good idea to have her on DV.

  4. Frederique Flynn said on June 15th, 2009 at 5:48am #

    Is that the new Society of tomorrow?
    A bunch of youth & people drugged up to their ears with damaging drugs?
    Lilly is making billions on psychiatric drugs under false data of people & kids having mental problems!
    Pretty soon, they will invent a drug because someone is too happy to live. What will they call it? Acute happiness disorder? AHD? Extreme exhilaration disorder? EAD?
    All is total BS! This has to stop!
    This pharmaceutical racket of totally criminal drugs has to stop.
    This marketing of drugs do not cure anything but only cause the worst nightmares in the Life of families. Kids die from it, people become like zombies & the pharmaceutical industry rakes billions of tax payer money.
    Wow! What an industry! Turning individuals into victims.
    All these Drs should be sued for malpractice.
    If anyone really wants to know more about the effects of these drugs, I suggest to them to go on the CCHR.ORG web site & get your own opinion after learning what these drugs are really doing to you & your kids.
    Learn about it & decide for yourself.

    Hope this site will help you get a better understanding on psychiatry & their false pretenses.

  5. William Ortiz, Jr., said on August 14th, 2009 at 6:55pm #

    Parents/Caregivers we need to advocate for our children and say no to ANTIPSYCHOTIC DRUGS! We cannot allow our children to become strung out adults who cannot function later on in life. It is better to love them, to reassure them that we will always stand by to help them when they feel distress, and show compassion. It is not easy, but we must take a strong stance against the FDA and the mental health profession. Our children are a blessing and we will not allow antipsychotic drug to take away the genuine feelings our children have. Antipsychotic drug transforms our children into robots. Our children suffer from diseases that cause them to feel self-conscious and self-loathing because they cannot be “kids” anymore. We must love them. NO ZYPREXA! NO ABILIFY! NO SEROQUOEL! NO RISPERDAL! NO DEPAKOTE! NO LUVOX! NO INVEGA! NO CONGENTIN! NO NOTHING! I DON”T WANT IT! Parkinsonian-symptoms out the window! My 13-year old has tardive dyskenesia. He has no arm swing, walks with a stoop, and shuffles his feet. He cannot speak coherent anymore. It’s like he’s strung out all the time! Forget it. I WANT MY REAL SON BACK! I WILL ADVOCATE FOR MY SON UNTIL HE IS ANTIPSYCHOTIC DRUG-FREE! WHY PREACH ABOUT A DRUG-FREE AMERICA, WE ARE A COUNTRY WHICH BACKS UP THE GREEDY, DRUG PUSHING PHARMACEUTICAL COMPANIES! DOWN WITH ANTI-PSYCHOTIC DRUGS! IN WITH CLEAN AND SOBER! HAVE A CLEAR-FOCUSED MIND INSTEAD! LET’S PREACH HEALTHY BRAIN, A STRONG-MINDED CHILD!

  6. JC said on September 3rd, 2009 at 9:04pm #

    I am disheartened to read this article, as I am currently searching for a way that my sister – a true schizophrenic – can obtain this drug affordably. She responds incredibly well to these drugs. If you’ve even gone through the agony of your sister going in and and out of mental hospitals, being homeless, and in jail – because when she’s off these drugs, she’s always paranoid that the cops are raping her or the invisible lady is telling her to go to hell – you would understand how invaluable these drugs are. It’s tough to make a choice – do I want to have severe side effects and live a somewhat normal life, or do I want to struggle with hallucinations and end up homeless or worse yet, killing someone who I think is “out to get” me? Of course, for children, I think they’re too young to be diagnosed. But when children grow up, and there were signs of it early on – like my sister- we should readily accept the value of these drugs. Yes, they may be “kid like” and you pass over it as a parent, but the difficult truth is that child was likely going to have more delusions once he/she gets to 18, and then they are out of the house and a very real danger not just to themselves but to others. My sister is now 32, and she was diagnosed at age 18. It took my family about 5-10 years to accept she rally had hallucinations, and it wasn’t just something we could wish or pray away.

  7. Catherine said on October 18th, 2009 at 3:38am #

    Was on Zyprexa for 5 months. Gained 30 kilos. My body is destroyed in stretch marks. 2 years on I am still 5 kilos more than what I always was- 65 kilos. Thats six stone I gained in such a short time. I am now worried about diabetes. and there is no diabetes in my family. If I am diagnosed with it, I will be dealing with things in court. The world is so greedy it doesn’t care what these drugs are doing to us and our children. Consultant psychiatrists do whatever they want with no-one to answer to. Its a disgrace. I know doctors that prescribe seroquel to anybody they can, just to get free holidays! now that cant be right no way. I was prescribed seroquel when I was fourteen by a g.p because I was havin trouble sleeping. He said, and I quote ” you are probably bi-polar like the rest of your family” and started me on 60ml seroquel. I couldn’t even open my eyes the next morning. I also felt suicidal, when I didnt before the drugs. Needless to say, I stopped taking them and was fine. No bi-polar, just a brief maternal illness that I was treated for with zyprexa and effexor……drugs of choice these days for doctors.

  8. Debby said on December 4th, 2009 at 12:26pm #

    Catherine …. my son has anorexia and volunteered to hospital for treatment. Locked in with rights revoked and forced on zyprexa 20mg for 2 months. Finally able to get him out after having government check up on doctor. 5 days off zyprexa. I am worried about rebound meds. How much were you on? Did you decrease dose? Any withdrawal effects?