Activists
Take on Eli Lilly Over
Off-Label Sale Of Zyprexa
By Evelyn Pringle
27 February, 2007
Countercurrents.org
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
[email protected]
(Evelyn Pringle is a columnist
for OpEd News and an investigative journalist focused on exposing corruption
in government and corporate America)