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Subject(s): Corporations Pharmaceuticals; Drugs Prescription; FDA; Health Policy Failures; Health Psychology; Lawsuits; Lawsuits Litigation; OpEdNews; Press Release
Local Area(s): Australia; Canada; New Zealand; United Kingdom; United Kingdom England; US Midwest; US northeast; US Northwest; US South; Washington D.C.
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On February 23, 2007, a
new grass roots advocacy group issued a press release to rally support
for attorney, Jim Gottstein, in his legal battle with Eli Lilly over
his role in providing secret company documents obtained in litigation
to the media to alert the public about the health risks associated with
Zyprexa that were kept hidden since the mid-90s.
In turning the
document over to the press, Mr Gottstein's goal was also to alert the
public about Lilly's illegal off-label marketing schemes aimed at
getting doctors to prescribe Zyprexa, a drug FDA approved only for
adult patients with schizophrenia or bipolar disorder, to patients of
all ages for uses that were not approved as safe and effective.
Although a doctor may prescribe a drug for an unapproved
use, it is illegal for Lilly to promote Zyprexa for an off-label use.
The illegal marketing in this case includes influencing doctors to
prescribe the drug to millions of consumers for conditions not listed
on the label, prescribing Zyprexa in combination with other drugs or
for a longer duration than recommended, and prescribing a drug for
children that was only approved for adults.
Activists say most
consumers are not even aware that it is legal for a doctor to prescribe
a drug for an off-label use and take for granted that a prescribed drug
picked up at a pharmacy is approved to treat their condition and their
children.
The recent overdose death of 4-year-old, Rebecca
Riley, in Massachusetts, demonstrates the dire need to educate the
public about the practice of prescribing drugs for unapproved uses and
the dangers of prescribing drugs like Zyprexa to children.
At
2-and-a-half-years-old, Rebecca was diagnosed with attention deficit
disorder and bipolar disorder and was prescribed Zyprexa's atypical
cousin, Seroquel, along with Clonidine, an adult high blood pressure
drug, and Depakote, a drug approved to treat adults with epilepsy. None
of these drugs were approved for children and they were prescribed in a
combination that has never been tested even with adults.
From
age 2 on, Rebecca remained on this daily drug off-label concoction
until she was found dead on the floor in her parent's home on December
13, 2006. The autopsy report stated that she died of the "combined
effects" of the drugs and that her lungs and heart were damaged by
"prolonged abuse of these prescription drugs, rather than one
incident."
Experts say, this case reinforces the assertion
that judges have got to quit allowing drug makers to seal documents
with court orders that show the side effects of drugs and the illegal
conduct of promoting the sale of drugs for unapproved uses.
With
the Zyprexa documents, as soon as the New York Times began running
articles about Lilly's off-label marketing scheme and the side effects
of Zyprexa, Lilly went to court and got the judge in the underlying
litigation to issue a permanent injunction against Mr Gottstein, and
other persons who obtained the documents from Mr Gottstein, ordering
them to return the documents to the court.
However, after a
couple months of legal wrangling, the court recognized that it could
not restrain the world because the documents were all over the internet
and lifted the part of the injunction that enjoined certain web sites
from revealing the documents.
One of the documents that Lilly
fought to keep secret, is a November 12, 1999, letter from a
psychiatrist at the Ventura County Behavioral Health Department, Dr
Albert Marrero, to Lilly's medical director, and describes the blood
sugar problems occurring specifically with Zyprexa patients stating:
"We have had eight patients out of possibly thirty-five patients on
Zyprexa show up with high blood sugars."
Dr Marrero further
informed Lilly that, "Two patients had to be hospitalized due to out of
control diabetes....We have certainly never seen this with Haldol,
Navane, Risperdal and others to this extent."
And yet, despite
this clearly stated notification of these serious adverse events in
1999, Lilly did not revise the labeling on Zyprexa to include a warning
about high blood sugar and diabetes until the fall of 2003, and then it
was only because the FDA said do it.
With the health risks of
Zyprexa concealed for all that time, doctors were led to believe Lilly
sales representatives who said they could safely prescribe Zyprexa and
Lilly gained millions of new customers.
With this in mind, the
new advocacy group has launched, "The Just Say "Know" to Prescription
Drugs Campaign," with a goal of getting one million people to stop and
reevaluate the medications they are taking. It is also supporting Mr
Gottstein in his battle with Eli Lilly over the release of the Zyprexa
documents.
"If there is a case that dramatically highlights
the need to stop blindly taking prescriptions drugs, this is it," says
Dr Greg Tefft, co-founder of the Just Say "Know" Campaign. "We're
talking 20 million people potentially at risk and more being added
daily," he says.
But instead of focusing on Lilly or the judge
who suppressed the documents, the Campaign says, it will educate the
public about off-label prescribing and what consumers can do to protect
themselves against unwittingly taking Zyprexa, or other drugs, without
knowledge of the side effects or that the drugs are not approved for
their condition.
"We are convinced that the way to solve this
problem is to work the demand side of the market," Dr Tefft said. "We
are going directly to consumers and encouraging them to know what they
are taking."
To that end, a Zyprexa radio series, hosted by Dr
Dominick Riccio, Chairman of the Campaign, and Dr Laurence Simon,
provides information to consumers about the drug. The official web site
for the Campaign is http://justsayknow.kpncradio.com
This
group has a lofty goal because the off-label sale of Zyprexa has
literally been unstoppable so far. Throughout years of litigation,
while settling out of court with an estimated 26,000 Zyprexa victims,
Lilly has been successful in keeping the company's off-label marketing
schemes sealed under the ruse that they contain trade secrets and
confidential information.
Mr Gottstein obtained the documents
from Dr David Egilman, who had discovered that Lilly had failed to
disclose Zyprexa's link to rapid weight gain, high blood sugar levels,
and diabetes, while he was serving as an expert witness in the
underlying litigation.
It's likely that Dr Egilman also knew
that by settling the second batch of Zyprexa lawsuits out of court,
that Lilly planned to go right on concealing the information.
The
men had every reason to believe that the off-label prescribing would
continue because even after paying over $1 billion in settlements,
Zyprexa was still Lilly's top-selling product with sales of more than
$4 billion in 2006.
The story behind Rebecca Riley's death,
gives a clear picture of how blatant the off-label marketing scams have
become. After she died, investigators discovered that her 2 siblings,
ages 6 and 11, were also fed the same 3 drug cocktail every day and
that the parents were on psychiatric medications as well.
Which
means, if not for the disruption by Rebecca's untimely death, this
family represented five steady customers for the "mental health
industry," with 100% of the costs for doctor's visits and prescriptions
paid for by public health care programs.
Psychotropic drug
expert, Dr Ann Blake Tracy, Director, International Coalition for Drug
Awareness, and author of "Prozac: Panacea or Pandora?," says, "this is
what is referred to as the "Family Discount," when everyone in the
family is drugged."
And this is the type of tragedy she worries
about, Dr Tracy says. "The parents unable to function, the children
acting up and unable to function - all due to the effects of the drugs."
She
states that she would not be surprised to learn that the mother was on
psychiatric drugs while she carried Rebecca which also may have caused
problems for the child.
One of the world's leading experts
pharmacology experts, former Secretary of the British Association for
Psychopharmacology, Dr David Healy, also maintains that there is no
justification for giving these drugs a 2-year-old and "certainly not
for the combinations mentioned here," he states.
Testing a 2-year-old for these mental disorders, he says, can not be done.
Rebecca's
parents have been charged with first-degree murder for the overdose
death of a child, but many legal experts and advocacy groups say the
main perpetrator is still on the loose. That being the psychiatrist
with the prescription pad, Dr Kayoko Kifuji of Tufts-New England
Medical Center, who diagnosed these kids with bipolar disorder and
ADHD, and prescribed the drugs for all 3 children.
Attorney, Ted
Chabasinski, who works on cases involving psychiatric drugs, says he is
shocked that the parents are charged with the death, "while the
psychiatrist who prescribed the drugs that killed her will probably
never be held accountable."
"The prosecutor makes much of the
fact that the parents gave drugs to their daughter that were not
approved for use in children," he points out, "but it is the doctor,
not the parents, who is responsible for that."
Mr Chabasinski
says the drug company executives, and the psychiatrists who collude
with them, are criminally responsible for Rebecca's death. "This is an
example," he states, "of how the drug industry and the psychiatric
profession are out of control."
Houston Attorney, Andy Vickery,
has been representing persons harmed by psychiatric drugs for many
years and he also finds this story "appalling."
He states that
the father seems to be a bad actor and he may have purposely overdosed
the child, but says, "he isn't the one that started her on the
psychoative medications and someone needs to do something to hold the
prescribing physician accountable."
David Oaks, director of
MindFreedom, an international human rights organization, also believes
the psychiatrist should be charged with criminal negligence. "It's
revealing," he notes, "that the criminal justice system has so far
targeted the parents and not the psychiatrist."
MindFreedom is
calling for criminal penalties against physicians for this level of
abuse, Mr Oaks says, because it may be the only way to change their
behavior.
Vera Sharav, the Director of the Alliance for Human
Research Protections, also believes that the only way to stop the
prescribing assault on children is to put the professionals who
prescribe the toxic drug cocktails on trial in open court. "Let the
public bear witness," she states, "to the proceedings that will
demonstrate the absence of scientific-medical evidence to support the
widespread misprescribing of harmful drugs for children."
Kelly
Patricia O'Meara, author of, "Psyched Out: How Psychiatry Sells Mental
Illness and Pushes Pills That Kill," says the most important issue
raised in the media is the response by the psychiatrist who prescribed
the drugs. "Given the known adverse reactions to many of these drugs,
and that they are not approved for children," she also says, "the
psychiatrist needs to be held responsible."
As for the behaviors
of family members described in the media, Ms O'Meara says, the
prescription drugs they were taking could have caused many of the same.
"Hostile, violent behavior," she says, "is a possible side effect of
many of the mind-altering drugs."
Dr Healy also notes that it
is at least possible that some of the alleged behaviors of the parents
could be caused by the drugs they were on. As far as drugging the whole
Riley family, he says, there is no mental illness that effects an
entire families.
The off-label drugging of the Riley children
is not an isolated incident. None of the atypicals drugs are approved
for children, yet on May 11, 2006, the Associated Press reported that
the number of prescriptions written for children had increased 73% over
a four year period, according to Medco Health Solutions, a pharmacy
benefits manager.
In addition to Zyprexa, the other atypicals in
the same class include Seroquel (AstraZeneca) the drug given to the
Riley children, Abilify (Bristol-Myers Squibb); Risperdal (Johnson
& Johnson); Geodon (Pfizer); and Clozril (Novartis).
Dr
Timothy Scott, author of, "America Fooled: The Truth about
Antidepressants, Antipsychotics and How We've Been Deceived, reports a
2005 study that found there are approximately 30,000 children under 5
on these drugs.
Overall, child neurologist, Dr Fred Baughman,
author of "The ADHD Fraud: How Psychiatry Makes "Patients" of Normal
Children," reports that 10 million of the 50 million school children in
the nation are on one or more psychiatric drugs and states: "This is
death by psychiatry."
Along with Lilly, many of the above drug
makers are currently under investigation by Federal and state law
enforcement agencies for promoting the atypicals for off-label use.
Lawsuits have also been filed to recover the money paid by public
health care programs for the actual purchase of the drugs, as well as
the cost of medical treatment for patients who developed diabetes and
other health problems as a result of taking them.
While Mr
Gottstein and Dr Egilman may have set themselves up for big trouble by
releasing the Zyprexa documents to the press; in light of the harm to
the public from off-label prescribing, evidenced well by the Riley
case, drastic measures were called for and they obviously believed the
risks were worth taking.
According to Dr Lawrence Diller, a
behavioral-developmental pediatrician, and author of "The Last Normal
Child," and A Prescription for Disaster: "The extensive prescription of
these medications for children, without adequate testing for safety and
effectiveness in children constitutes a hidden time bomb that could
explode with still more casualties."
"Catastrophic side
effects," he says, "may be rare, but they become predictable when we
treat so many children with so many drugs."
As for Lilly, the
company has billions of reasons to keep the documents buried because
they prove beyond any doubt that the company knew about the health
problems caused by Zyprexa and intentionally kept the information
hidden while it influenced doctors to write off-label prescriptions for
million of consumers in the name of the almighty dollar.
Evelyn Pringle
evelyn-pringle@sbcglobal.net
Evelyn Pringle is a columnist for OpEd
News and investigative journalist focused on exposing corruption in
government and corporate America.
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