On February 23, a new grassroots 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 the 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.
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�s.
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 the age of 2�, 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 on 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 giving drug makers court orders allowing the sealing of
documents 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 him, 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
websites 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, which
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, �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 mandated 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 1
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 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 two siblings, ages 6 and 11, were also
fed the same three-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 percent of the costs for doctor�s visits and prescriptions
paid for by public health care programs.
Psychotropic drug expert Dr. Ann Blake Tracy, director of
the 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 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.�
Testing a 2-year old for these mental disorders, he says,
cannot 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 three 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 psychoactive 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 them. �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 affects entire families.
The off-label drugging of the Riley children is not an
isolated incident. None of the atypical 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 percent 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
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 the age of
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 is a columnist for
OpEd News and an investigative journalist focusing on exposing corruption in
government and corporate America.. She can be reached at: firstname.lastname@example.org.