We now know that
atypical antipsychotics are responsible for a high incidence of diabetes,
stroke, endocrine, cardiac problems and movement disorders.
In recent years,
drugmakers have been forced to admit to misleading the FDA, physicians, and
consumers about the deadly side effects of these drugs. But they are still
routinely prescribed to patients of all ages, including children and the
On April 12, The
New York Times reported that the FDA will now require black box warnings about
the increased risk of death on the labels of some of the most aggressively
marketed, hence widely prescribed drugs such as Zyprexa (Eli Lilly) Risperdal
(Johnson & Johnson) Abilify (Bristol-Myers Squibb), Clozril (Novartis),
On July 24, 2004,
the Miami Herald reported that the maker of Risperdal "has acknowledged
misleading doctors and other healthcare providers about the safety of the
product, minimizing potentially deadly side effects."
the leading drug used to combat schizophrenia and other types of psychotic
disorders, earning Janssen about $2.1 billion in annual sales," the Herald
wrote. "The drug was first marketed about eight years ago, and is
prescribed to more than 10 million people worldwide."
The worst part of
this tragedy is that atypicals are not even effective. One review of 52 studies
involving 12,649 patients published in the December 2000 British Journal of
Psychiatry reported: "There is no clear evidence that the atypical
antipsychotics are more effective or better tolerated than conventional
While the health
and drug control agencies of Japan and Great Britain issued warnings against
the drug Zyprexa in 2002, the FDA continued to allow its sale and distribution
until September 2003, before it finally required a warning label on the drug.
The FDA made all
atypicals carry the same warning label even though the risk of diabetes with
Zyprexa was 37 percent higher than with the other atypicals.
In February 2004,
the American Diabetes Association, the American Psychiatric Association, the
American Association of Clinical Endocrinologists and the North American
Association for the Study of Obesity published a joint statement confirming the
association between Zyprexa and diabetes.
researcher, Dr David Healy, studied FDA raw data on Zyprexa and concluded that
it was among �the deadliest drugs ever to gain FDA approval.�
Yet, despite all
the warnings of adverse affects and lack of effectiveness, atypicals are being
prescribed for patients in record numbers, including children. On April 25, the
Ohio Columbus Dispatch reported an investigation of state Medicaid records that
found 18 newborn to 3 year-old babies in Ohio had been prescribed antipsychotic
drugs in July 2004.
CBS.marketwatch.com on February 7, atypical Zyprexa, earned Eli Lilly $4.4
billion in 2004. A considerable amount when compared to Lilly's $13 billion
total net sales in 2004. The global giant also produces other psychiatric drugs
such as Prozac, Strattera, and Symbyax.
In 2003, Zyprexa
became Lilly's top seller with worldwide sales of over $4 billion. According to
The New York Times, 70 percent of the Zyprexa purchased in the US in 2003 was
paid for by government programs like Medicare and Medicaid.
The State of New
York's $4-billion-a-year bill for drugs covered by Medicaid is the biggest in
the nation. In the first 10 months of 2003, the state spent $205 million on
Zyprexa alone, far more than for any other one drug.
The state of
California spent over $500 million on the atypicals Risperdal, Zyprexa and
Seroqual in 2003.
In a New York Times
Article (Leading Drugs for Psychosis Come Under New Scrutiny), Erica Goode
reported a study by the Department of Veterans Affairs which found that Zyprexa
cost the VA $3,000 to $9,000 more per patient each year than conventional
drugs, with no benefit to symptoms, side effects or overall quality of life.
Today, a month's
supply of Zyprexa is 10�30 times more expensive than a month's supply of a
conventional antipsychotic, according to Leonard Roy Frank, author of Zyprexa:
A Prescription for Diabetes, Disease and Early Death in the August 2005
Edition of Street Spirit.
Its ironic, that in
the same year that the FDA got around to forcing the company to warn of the
drug's link to diabetes, Lilly�s second most profitable line of products was
drugs used to treat diabetes, which grossed $2.51 billion in 2003.
The profits from
the sale of these drugs are not being spent on research and development, they
in large part go for marketing and salaries for top executives. A report by the
non-profit group Families USA showed that in 2001, former CEO of Bristol-Myers
Squibb, Charles Heimbold Jr, received $74,890,918, not counting his $76,095,611
worth of unexercised stock options, and the chairman of Wyeth raked in
$40,521,011, plus $40,629,459 in stock options.
Eli Lilly is
currently under fire from the FDA, state attorneys general, doctors, and
consumers, with complaints about Zyprexa.
On August 3,
Reuter's reported that Lilly had received a subpoena from the Florida attorney
general's office seeking documents on Medicaid-related sales of Zyprexa and
Lilly's marketing of the drug.
In a regulatory
filing, the drugmaker said it had received the subpoena in June from the
Medicaid Fraud Control Unit and said it was possible that other Lilly products
could become subject to the investigation and that the investigation could lead
to criminal charges, fines or penalties against the company.
investigation comes amid a continuing investigation by the US attorney for the
Eastern District of Pennsylvania into the company's marketing and promotion of
Zyprexa and Prozac in that state. That investigation was initiated in March
In another turn of
events in June, Lilly agreed to pay $690 million to settle lawsuits filed by
approximately 8,000 Zyprexa patients who alleged they had not been warned the
drug might increase the risk of diabetes.
2,500 other claimants refused to participate in the settlement, presumably in
the belief that the amount received by each claimant, $62,500 on average, was
insufficient compensation for the pain and suffering Zyprexa caused them,"
according to Leonard Roy Frank, author of Zyprexa: A Prescription for
Diabetes, Disease and Early Death,
August 2005 edition of Street Spirit.
One of the
litigants, Ellen Liversridge, who's son died at age 39 allegedly due to the
adverse affects of Zyprexa, states, "both the FDA and Lilly fought putting
a warning on the label, but thorough articles on the front pages of the
Baltimore Sun, Wall Street Journal, and new York Times so embarrassed the FDA
that they finally gave in to warnings."
"Rob was a
peaceful, funny, brilliant man who battled manic depression with grace and
dignity," said his mother, "he deserved the best."
She tells how her
son "gained almost 100 pounds on Zyprexa, back before there was a warning
on the label."
"funny" one Sunday morning," Ellen relates, "but his
symptoms weren't psychiatric and, to my sorrow, I didn't take him to the
Tuesday," she said, "he had fallen into a coma from which he never
came out." Rob remained in a coma for four days and "died Saturday,
October 5, 2002, of profound hyperglycemia."
deserve to be killed by a drug carrying a lethal bomb that we knew nothing
about" Ellen said, "He didn't deserve to become another Eli Lilly
"And we, his
family, don't deserve to carry the pain that never goes away," she added.
Ellen will be the
August 24 Washington, DC, protest, "I have a strong sense of justice as
well as retribution," she said, "I plan to use these things in
whatever way I can, in his memory."
Marketing & Promotion
journalist Robert Whitaker, author of Mad in America, investigated the industry's marketing strategy of the atypicals
and found biased reviews and deceptive reporting to be prominent in the promotion
of the drugs. Via the Freedom of Information Act he gained access to FDA raw
data on the drug trials and learned that the FDA�s review of the trials did not
support industry claims that the atypicals were safer or more effective than
existing generic drugs.
Marcia Angell is a
senior lecturer in Social Medicine at Harvard Medical School. She is also a
physician, former editor in chief of The New England Journal of Medicine and
the author of the book, The Truth About the Drug Companies.
According to Marcia
the industry is "primarily a marketing machine" to sell drugs of
dubious benefit and uses its wealth and power to co-opt every institution that
might stand in its way, including Congress, the FDA, academic medical centers,
and the medical profession itself. Most of its marketing efforts are focused on
influencing doctors, since they must write the prescriptions. "
And its obviously
working. A study released in August 2004, noted that 41 percent of
prescriptions for 765,423 people over age 65 were for psychotropic medications.
(L Curtis et al, Archives of Internal Medicine, Vol 164, pp 1621�1625, 2004).
Even though a recent analysis by the FDA noted that elderly patients using
Zyprexa had �a higher chance for death than patients who did not take the
medicine," and older persons have suffered strokes when taking Risperdal.
A May 2004 report
by The New York Times explained how drug companies were using new strategies to
capture the Medicaid and Medicare markets that involved a "focus on a much
smaller group of customers: state officials who oversee treatment for many
people with serious mental illness. Those patients�in mental hospitals, at
mental health clinics and on Medicaid�make states among the largest buyers of
Prime examples of
this trend, include Ohio Mental Health Director Michael Hogan and California
Director Stephen Mayberg. Both control mental health services in their
respective states, and both are members of a Janssen advisory board.
Hogan has proven to
be so useful that Eli Lilly has given him a "Lifetime Achievement
Award." In granting the award it was noted that Hogan had given over 75
presentations at conferences and according to ace records researcher Sue
Weibert, every conference she tracked down that featured Hogan, was sponsored
by drug companies, and the group that organized the conference solicited money
from pharma to pay the keynote speaker.
particular scheme has become so blatant, that it is finally being investigated.
On June 10, Senators Chuck Grassley and Max Baucus issued a press release that
said they have asked a number of large drugmakers to explain a marketing
practice where the companies give money to state governments and other
organizations in the form of grants.
A request was sent
to the following drugmakers: Pfizer, GlaxoSmithKline, Johnson & Johnson,
Merck & Co, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, Novartis
Pharmaceuticals, Amgen, Wyeth Pharmaceuticals, Eli Lilly, Sanofi Aventis,
Eisai, Boehringer Ingelheim Pharmaceuticals, Schering-Plough Corporation,
Hoffman-LaRoche, Forest Pharmaceuticals, Abbott Laboratories, Genentech, Biogen
Idec, Genzyme Corporation, Chiron Corporation, Serono, and TAP Pharmaceutical
The senators said
their inquiry is based on reports that some companies have awarded these grants
to health care providers as inducements to prescribe medications the companies
produce. In other cases, such grants to state agencies may have prompted those
agencies to develop programs leading to overmedication of patients at the
expense of patient health or to unnecessary expense for taxpayers.
need to know how this behind-the-scenes funneling of money is influencing
decision makers," Grassley said, "The decisions result in the
government spending billions of dollars on drugs. The tactics look aggressive,
and the response on behalf of the public needs to be just as vigorous."
In addition to
influencing and corrupting state officials, drugmakers have infiltrated the
nation's health care facilities and gained influence over prescribing
physicians who engage in the practice of overmedicating patients.
For instance, they
have set up schemes to funnel profits through senior citizens in nursing homes.
Researcher have found that 75 percent of long-term care elderly residents
receive psychotropic medications. (D Fisk et al) Archives of Internal Medicine,
Vol 163, pp 2716�2724, 2003).
Child advocates say
kids are being overmedicated in state run foster care systems. The children go
into the system neurologically normal but leave neurologically damaged. Austin
psychologist and author, John Breeding said, "Children are not just placed
on one drug. Typically, they're placed on two or three or we've seen literally
up to 17 different drugs for the same child in foster care."
In 2001, the Miami
Herald published a series of stories about the common use of Risperdal among
children in state care. Child-welfare advocates said the drug routinely was
being used by foster care providers.
In April 2001,
Broward lawyer and child advocate Andrea Moore told the Florida Department of
Children & Families administrators that a large number of children in
foster care were being given Risperdal�an antipsychotic drug a UCLA child
psychiatrist describes as among the ``big guns'' of psychiatric medications.
At that time,
Florida officials confirmed that thousands of children, including toddlers,
were being prescribed psychiatric drugs, from Ritalin to powerful drugs like
Risperdal and Haldol.
''I had clients who
were displaying severe side effects, and I tried to alert the Department of
Children & Families both as to the local problem and the growing national
concern about a range of psychotropic medications, Risperdal and other
antipsychotics in particular,'' said Coral Springs attorney and children's
A prime example of
bribing doctors in state institutions was unearthed in Massachusetts, where
doctors were found to have changed the medication of four patients for
non-medical reasons. A Boston Globe article published on November 10, 2003,
reported that the patients were switched to the atypical Risperdal, without
consent or medical necessity, to make them eligible for a drug trial sponsored
by drug company Janssen, maker of Risperdal.
When other staff
members complained, a state agency investigated the matter and the drug trial
was stopped. All state hospital doctors were required to undergo
recertification in the ethics of medical research and the facility's director,
Dr Douglas Hughes, resigned after it was revealed that he had received $30,000
in speaker�s fees from Janssen in 2003.
The current prices
for a month's supply of the top three antipsychotics are: Risperdal $342;
Seroquel $414; and Zyprexa $572
Because these drugs
are the most expensive on the market, and are so often paid for by the
government, the rampant overprescribing of these medications is bankrupting
state Medicaid programs all over the country. (for reports on Massachusetts,
Florida, Texas, Illinois, and more information go to www.ahrp.org)
According to the
May 8, issue of Lab Business Week, a new analysis by the US Substance Abuse and
Mental Health Services Administration reveals that Medicaid is now the largest
single payer of mental health services, exceeding private insurance, Medicare,
or other state and local spending. The report notes that one out of every $5
spent on mental health care now goes for psychotropic drugs.
In addition to an
investigation by the US attorney for the Eastern District of Pennsylvania into
Eil Lilly's marketing and promotion of Zyprexa and Prozac in that state, two
former state investigators are diligently working to expose the industry's
corruption of state institutions.
According to former
investigator turned whistleblower, Allan Jones, Pennsylvania taxpayers are
saddled with an expensive drug treatment model known as PennMap, for the
treatment of mentally ill persons in state care.
"This model is
part of a large pharmaceutical marketing scheme designed to infiltrate public
institutions and influence treatment practices," he explained.
"Pennsylvania is paying tens of millions of dollars for patented drugs
that have no proven advantage over cheaper generic drugs."
As part of the
overall scheme, on July 27, 2001, Tom Ridge appointed Gerald Radke, an Eli
Lilly marketing director, to head the Pennsylvania Office of Mental Health and
Substance Abuse. With Radke at the helm, Pennsylvania Medicaid-funded sales of
Lilly�s Zyprexa rose from approximately $26.5 million in 2000 to $34.2 million
in 2001, and reached $39.2 million in 2003. In state hospitals, hundreds of
patients had their medications switched in the absence of medical need or
indication, to comply with administrative decisions.
In 2003, there was
a total of $139 million in public spending on just two classes of drugs, SSRI (selective serotonin reuptake inhibitor) antidepressants and atypical antipsychotics.
"A large portion of these dollars were spent to maintain children on these
drugs," Allen reports, "despite the fact that they have not been
proven effective in children and the FDA has not approved them for use in
effort at correlating dollars spent with deaths from drug side effects suggests
that people may be dying from side effects from the schizophrenia drugs alone
at the rate of at least one death for each one million dollars spent on these
drugs," Allen said. "The actual numbers may reflect a much higher
death rate," he added.
On July 1, 2004,
another former Pennsylvania investigator, Dr Stefan Kruszewski, a Harvard
psychiatrist/screenwriter-turned-activist, from Harrisburg, Pennsylvania, filed
suit against six major pharmaceutical companies after discovering that
commonwealth's children and adults were being abused and defiled by excessive
psychiatric drugs and hazardous psychiatric inpatient environments.
People are being
drugged for profit in Pennsylvania state institutions. While PennMap was being
implemented, Stefan was a psychiatric consultant for the Department of Health
and Human Services, in charge of the mental health programs, and found that
some patients were on as many as five neuroleptic psychiatric drugs at the same
discovered corrupt financial relationships between Pennsylvania politicians and
pharmaceutical representatives, fraudulent medication billings to the
government, and that four children and one adult died while under the state's
care, after they were prescribed lethal combinations of anti-psychotic drugs
under the PennMap model.
Stefan, the new generation of antipsychotics substantially increase the risk of
obesity, diabetes type II, hypertension, cardiovascular complications, heart
attacks and stroke. The drugmakers had this information and "simply
ignored the problem," he said.
"So, what we
have now is a drug, Zyprexa, whose massive revenues and promotion are based
upon faulty disclosures by the manufacturer, Eli Lilly," Stefan said.
"The drug causes both a severe metabolic syndrome and cardiovascular
problems at the same time that it continues to cause neurological side effects
like its older �typical� antipsychotics."
It does have a
decided advantage for Lilly, Stefan contends, "It is far more expensive,
dose per dose, than a comparable �generic� antipsychotic." A dose of
haloperidol might sell for 6 pennies while Zyprexa might sell for over $6 per
pill, he said.
Stefan, is also
board certified in adult, adolescent, geriatric and addiction psychiatry, and
he and Allen Jones will both be attending the Washington protest.
Trials and Studies
Based on the
results of a six-week clinical trial sponsored by Lilly, the FDA granted the
company approval to manufacture and distribute Zyprexa in September of 1996 for
the treatment of adult schizophrenics. The trial leading up to approval
involved 2,500 people, and two-thirds of the participants didn't even complete
Among those who
stuck it out, 22 percent of the Zyprexa subjects suffered a "serious"
adverse effect, compared to 18 percent in the group taking Haldol, according to
Leonard Roy Frank, author of Zyprexa: A Prescription for Diabetes, Disease
and Early Death, August 2005
Edition of Street Spirit.
That same year, FDA
data obtained by Robert Whitaker, under the Freedom of Information Act,
revealed Zyprexa's adverse effects to include: cardiac abnormalities and
hypotension, 10 percent to 15 percent; Parkinson-like motor impairment, 11.7
percent; unbearable restlessness (akathisia), 7.3 percent; and acute weight
gain, 50 percent, increasing the risk of diabetes.
The data also
disclosed a participant drop-out rate during six-week clinical trials of 65
percent. In a one year trial, the drop out rate rose to 83 percent.
FDA reviewers found
an average weight gain of almost one pound a week for subjects during the
six-week trial, and a 26-pound increase for Zyprexa patients who remained in
the trial for a year. Other side effects included shaking, spasms, sedation,
diabetic complications, rapid heartbeat, restlessness, constipation, seizures,
liver problems, white blood cell disorders, decreased blood pressure; and
neuroleptic malignant syndrome, which is potentially fatal.
There were also 20
deaths, including 12 suicides, in the Zyprexa group. "Shockingly, these
deaths went unreported in the scientific literature," Leonard Frank said.
"The death cover-ups also took place in reporting trial results of several
other atypicals during the 1990s."
In his book, Mad
In America, Robert Whitaker,
reported that one in every 145 subjects who entered the trials for Zyprexa,
Risperdal, Seroquel, and Serdolect had died.
severe known side effects, children between the ages of 6 to 11 were recruited
for a clinical trial conducted at the University of California Los Angeles soon
after Zyprexa was approved for adults. The children were not schizophrenic, but
were diagnosed with other disorders. According to the published report on the
research, all of the children experienced adverse effects and none were helped.
The study was terminated less than six weeks after it began. Yet to this day,
doctors continue to regularly prescribe atypicals to children, even though they
have never been FDA approved for treatment of any illness in children.
In 2002, P Murali
Doraiswamy, the chief of biological psychiatry at Duke University, conducted a
review of adverse events reported to the FDA by Zyprexa patients and found:
Of the 289 cases of
diabetes linked to Zyprexa, 225 were newly diagnosed cases. One hundred
patients developed ketosis (a serious complication of diabetes), and 22 people
developed pancreatitis, or inflammation of the pancreas, which is a
life-threatening condition. There were 23 deaths, including that of a
15-year-old adolescent who died of necrotizing pancreatitis (Pharmacotherapy,
Persons on atypicals
have been found to commit suicide at rates two to five times more frequently
than schizophrenics in general. According to Bob Whitaker, "researchers in
Ireland reported in 2003 that since the introduction of the atypical
antipsychotics, the death rate among people with schizophrenia has
In an interview
this month with Street Spirit, he said, "They have done death rates of
people treated with standard neuroleptics and then they compare that with death
rates of people treated with atypical antipsychotics, and it doubles. It
doubles! It didn't reduce harm. In fact, in their seven-year study, 25 of the
72 patients died."
routinely hides negative results of studies. "We do not know the results
of the clinical trials they sponsor�only those they choose to make public,
which tend to be the most favorable findings," Marcia Angell advises.
The problem with
the FDA is the fact that it is practically owned by the industry that it is
supposed to regulate. In recent years, nearly half of the agency's $400 million
annual budget has been paid for by drug companies. This arrangement stems from
a 1992 agreement, made partly at the urging of AIDS activists, that the FDA
would speed up approvals in exchange for "user fees" from industry,
according to the May-June 2005 issue of Mother Jones Magazine.
According to the
September 9, 2004, Washington Post, because of the industry's pattern of hiding
research that shows adverse affects, medical journals are taking matters into
their own hands. The Post reported that a dozen editors of prestigious medical
journals jointly announced they will refuse to publish drug research sponsored
by pharmaceutical companies unless the studies are registered in a public
database from the outset�a step designed to ferret out unpublished studies that
find medications to be ineffective or dangerous.
creates a potent incentive for companies to register their drug trials and is
expected to give physicians and the public a window on unfavorable studies that
companies routinely suppress, the Post wrote. The new requirement calls on
companies to register their trials well before anyone knows whether a study
will turn out positive.
The Journal of the
American Medical Association, the Annals of Internal Medicine, the Lancet, the
New England Journal of Medicine and several other international publications
have signed on to the initiative, and their editors hope that more will join
in, the Wall Street Journal reported.
Activists who will be attending a three-day protest in
Washington this month, beginning August 24, have one thing in common. They want
to raise awareness of the fact that the pharmaceutical industry has allegedly
injured Americans with dangerous products to increase profits and the nation's
regulatory agencies have aided and abetted them.
Evelyn Pringle is a columnist for Independent
Media TV and an investigative journalist focused on exposing corruption.