Zyprexa: A Prescription for Diabetes, Disease and Early Death
by Leonard Roy Frank
were 20 deaths, including 12 suicides, in the Zyprexa group.
Shockingly, these deaths went unreported in the scientific literature.
The death cover-ups also took place in reporting trial results of
several other atypical antipsychotics. These deaths occurred during
very short trial periods, so the FDA's approval of these drugs is
On June 8, 2005, Eli Lilly & Co.
announced that it had agreed to pay $690 million to settle some 8,000
lawsuits filed by people who reported that taking the antipsychotic
drug Zyprexa resulted in unwanted weight gain, diabetes, other
metabolic diseases, and death.
top-selling drug, is used in the treatment of schizophrenia and in the
short-term treatment of manic episodes associated with bipolar
disorder. More than 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.
On July 21,
Eli Lilly came out with its second-quarter financial report showing
that $1.07 billion was allocated to cover its liabilities in these
lawsuits. That amount exceeded the $690 million settlement by $380
million. The additional sum was the company's estimate of its liability
and defense costs for the unsettled claims [reported in Forbes.com,
July 21, 2005]. News of the settlement may generate more damage claims,
in which event the cost to Eli Lilly may be greater than the $1.07
billion already set aside.
According to Eli Lilly,
about 17 million people in 86 countries have taken Zyprexa since its
introduction in 1996. Although there is no way of accurately estimating
the number of Zyprexa's victims, it's safe to say that this drug has
caused diabetes and other diseases in millions of people, and that tens
of thousands of people have died or will die prematurely.
these facts, the media has paid scant attention to the settlement.
Despite these facts, there hasn't been a single voice of outrage or
protest heard in the halls of Congress or on the evening news. And
despite these facts, Eli Lilly has made no special effort to warn the
public of the potentially disastrous consequences of taking Zyprexa as
it continues to rake in profits from the sale of this drug.
whose generic name is olanzapine, belongs to a class of psychiatric
drugs known as atypical antipsychotics. Others in this class are
Novartis' Clozaril (clozapine), Janssen's Risperdal (risperidone),
AstraZeneca's Seroquel (quetiapine), Bristol-Myers Squibb's Abilify
(aripiprazole), and Pfizer's Geodon (ziprasidone).
first atypical antipsychotic, Clozaril, came on the market in 1990. The
manufacturers hailed these drugs as more effective and safer than the
conventional antipsychotics such as Thorazine (chlorpromazine), Haldol
(haloperidol), and Navane (thiothixene), which have been available
since the 1950s.
Following expensive marketing and
promotional campaigns by the manufacturers of the atypicals, belief in
their unsubstantiated claims became widespread, with the result that
the companies were able to charge much more for the newer drugs than
were being charged for the older ones. Today, a month's supply of
Zyprexa costs about $380, 10-30 times more expensive than a month's
supply of a conventional antipsychotic.
worldwide sales for the antipsychotics have grown from less than $500
million in 1993 (almost all conventional antipsychotics) to more than
$14 billion in 2004 (all but $1 billion of which came from atypical
For more than 10 years, the drug
companies have consistently downplayed some of the serious risks
associated with taking atypical antipsychotic drugs. Psychiatrist E.
Fuller Torrey, a leading proponent of drug therapy for schizophrenics,
has written about one of the techniques used to mislead physicians and
the public: "Psychiatrists trying to evaluate schizophrenia drugs are
not told that the expert who minimizes the side effects of Zyprexa
receives a $10,000 retainer from Eli Lilly and also owns substantial
company stock." [American Prospect, July 15, 2002]
with mounting evidence of their harmfulness, the Food and Drug
Administration (FDA) finally required, in 2003, all manufacturers of
the atypicals to place on their labels a warning about the increased
risk of diabetes for users of these drugs.
Hersh, a San Francisco law firm representing some 400 of the claimants
in the recent settlement, charged that Eli Lilly "fraudulently withheld
relevant information from potential users of Zyprexa" before 2003. Eli
Lilly, went the charge, failed to warn doctors and patients that
Zyprexa carried terrible and potentially lethal risks from weight gain
and diabetes, which the company knew or should have known.
warnings might have led doctors to lower dosage levels in prescribing
Zyprexa and to regularly test the blood-sugar levels of their Zyprexa
patients. They might even have caused some doctors to stop prescribing
With these precautions, there undoubtedly
would have been fewer cases of diabetes and fewer deaths from taking
Zyprexa. But truthfulness is not one of Eli Lilly's strong suits when
profits are at stake. Telling the truth about Zyprexa would undoubtedly
have cut into sales for its blockbuster drug (the fifth best-selling
prescription drug in the world), which, in 2004, produced revenues of
$4.4 billion, almost a third of the company's total revenues and more
than a third of its profits.
The drug is of
paramount importance to Eli Lilly's bottom line. The company seems to
have developed a Zyprexa addiction, from which withdrawal will be
difficult. Eli Lilly has also realized indirect profits from Zyprexa
sales. It's a cruel irony that while the company is filling its coffers
by selling a drug that can cause diabetes, four of its top-selling
drugs are treatments for diabetes, with Humulin and Humalog each
expected to top $1 billion in annual revenues. Eli Lilly gets the
customer coming and going.
and current users of the drug, doctors, and the public are still almost
totally in the dark about Zyprexa's shameful history. Based on the
results of a six-week clinical trial sponsored by Eli Lilly, the FDA
granted the company permission to manufacture and distribute Zyprexa on
September 27, 1996. The trial involved 2,500 subjects, and two-thirds
of them didn't even successfully complete the trial. 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.
FDA reviewers found there was an average weight gain of almost one
pound a week during the six-week trial period and 26 pounds over a
year-long period for the Zyprexa subjects who remained for the
extension trial. Other drug effects included shaking, spasms, sedation,
diabetic complications, rapid heartbeat, restlessness, constipation,
seizures, liver problems, white blood cell disorders, and decreased
In addition, there were 20 deaths,
including 12 suicides, in the Zyprexa group. Shockingly, these deaths
went unreported in the scientific literature. The death cover-ups also
took place in reporting trial results of several other atypicals during
Information concerning these deaths was
obtained from FDA documents through the Freedom of Information Act by
science writer Robert Whitaker, who wrote that one in every 145
subjects who entered the trials for Zyprexa, Risperdal, Seroquel, and
Serdolect had died. [See Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill, by Robert Whitaker.]
Bearing in mind these deaths, which occurred during very short trial
periods, the FDA's approval of three of the four atypicals cited above
(Serdolect was unapproved) is appalling. It not only condemns the
agency's approval process but also raises doubts about the agency's
the case of Zyprexa, Eli Lilly's ties to the two Bush administrations
are a matter of public record. President George H. W. Bush is a former
member of Eli Lilly's board of directors. In 2000, Eli Lilly made
campaign contributions of $1.6 million, 82 percent of which went to
President George W. Bush and other Republicans. In 2001, President Bush
appointed Mitch Daniel, a former Eli Lilly vice president, to be White
House director of the Office of Management and Budget. And in 2002,
President Bush appointed Sidney Taurel, Eli Lilly's current chairman
and CEO, to the Homeland Security Council.
to report the deaths in the reviews of FDA atypical trials published in
the professional literature, which psychiatrists and other doctors rely
on for guidance in their prescription practices, unmasks the duplicity
of the companies involved, the psychiatrists who collaborated with them
by writing the articles, and the journal editors who accepted their
articles for publication.
In recent years, some reports
of death from the atypicals have appeared in the media, most often
one-shot affairs in a few newspapers with little or no follow-up. These
deaths were usually associated with weight gain and/or diabetes.
example, in February 2001, Frank Olenick, a Winterville, Ohio, truck
driver, died after going into a diabetic coma at age 40. His widow
Christine Olenick's lawsuit against Eli Lilly said that he began taking
Zyprexa to treat depression and withdrawal symptoms from a painkiller
prescribed for a job-related injury. Two months later, she rushed her
sick husband to a hospital, where a nurse told her his blood-sugar
level was 15 times higher than normal, although he hadn't had diabetes.
Mrs. Olenick said he went into a coma an hour later and died. [Indianapolis Star, March 16, 2003]
another case, Rob Liversidge, 39, of Silver Spring, Maryland, gained
more than 100 pounds while taking Zyprexa for manic-depression. Health
problems related to this weight gain ended his government career. A
week before he was to start a new job following a long layoff,
Liversidge collapsed and was taken to a hospital where, despite
emergency treatment, he went into a coma and died four days later. [Baltimore Sun, March 19, 2003]
two cases made it to the newspapers. But the large majority of
complications and deaths from Zyprexa are hidden from public view and
may not even be recognized as such. An exception was P. Murali
Doraiswamy's review of complications among Zyprexa users voluntarily
reported to the FDA over a six-year period.
the chief of biological psychiatry at Duke University, wrote: "Of the
289 cases of diabetes linked to the use of [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, a condition where the pancreas breaks
down and dies. Most cases (71 percent) occurred within six months of
starting the drug and many cases were associated with moderate weight
gain." [Pharmacotherapy, July 2002]
also an added risk of death for elderly people with dementia taking
Zyprexa and other atypicals. In early 2005, the FDA analyzed the
results of 17 placebo-controlled trials involving the atypicals,
including Zyprexa. The agency found that older patients with dementia
who were given the pills were 1.6 to 1.7 times more likely to die,
mostly from heart-related problems like heart failure or infections
like pneumonia, as those given placebos.
this review, the FDA now requires the makers of these drugs to place
black-box warnings for elderly patients with dementia on labels for the
atypicals. Black-box warnings are reserved for drugs posing the
greatest health risks. [New York Times, April 12, 2005]
there is no black-box warning for children and adolescents being
prescribed Zyprexa, and doctors apparently are prescribing the drug to
growing numbers of youngsters. The drug has not been FDA-approved for
any childhood condition; but doctors have been prescribing Zyprexa and
other atypicals for autism, attention deficit disorder, hyperactivity,
withdrawal, and aggression. Children in foster homes are especially
vulnerable to this kind of abuse.
Weight gain may be
the most troubling effect of Zyprexa because it, in turn, causes many
other problems. The weight-gain issue should not be minimized as was
done by Dr. Alan Breier, Eli Lilly's vice president of pharmaceutical
sales and head of the Zyprexa product team, who told the Indianapolis Star on
April 16, 2003, that Zyprexa, like some of the other antipsychotic
drugs, causes weight gain in about half of all users. Excessive weight
gain would have been a more accurate way of putting it.
everyone taking Zyprexa gains at least some weight attributable to the
drug. Breier also said that while weight gain is a risk factor for
diabetes, it doesn't of itself necessarily lead to diabetes. Sure, and
smoking doesn't of itself necessarily lead to lung cancer. Extreme
weight gain can result in obesity, which in recent years has reached
near-epidemic proportions in the United States. Obesity further
increases the risk of diabetes. There are now 18 million diabetics in
this country. With more than half a million current users, Zyprexa is
worsening an already critical situation.
The obesity problem is illustrated in the following excerpt from Sharon Begley's Newsweek
article on March 11, 2002, in some ways favorable to Zyprexa, which
broadly describes the drug's effects: "Although the voices and visions
don't always disappear, the new drugs [i.e., the atypicals] can allow
people with schizophrenia to hold jobs and have families. Still, they
increase appetite, and may alter metabolism, resulting in what [Richard
Wyatt, chief of neuropsychiatry at the National Institute of Mental
Health] calls 'the enormous problem' of huge weight gain. [Donna
Willey, a patient interviewed for the article] gains 20 pounds a year
on Zyprexa, and has ballooned from 120 pounds to her current 280. That
makes some reluctant to take the drugs. Another side effect is foggy
thinking, the feeling that brain signals are trying to push through
caramel. Patients may also lose their libido. For all the power of the
new drugs, they are treatment and not cure."
diminished, lives shortened, lives destroyed! All this misery and
suffering, and for what advantage? One review of 52 studies involving
12,649 patients concluded, "There is no clear evidence that the
atypical antipsychotics are more effective or better tolerated than
conventional antipsychotics." [John Geddes et al., British Journal of Psychiatry, December, 2000]
Lilly executives, however, take no responsibility for the harm they've
caused. They've made no apology. There's been no contrition. There's
only been denial. Eli Lilly CEO Sidney Taurel has said of the legal
settlement: "While we believe the claims are without merit, we took
this difficult step because we believe it is in the best interest of
the company, the patients who depend on this medication, and their
doctors. We wanted to reduce significant uncertainties involved in
litigating such complex cases."
These were not
off-the-cuff remarks; they were included in Eli Lilly's press release
on the settlement. Such a response would be laughable were the issues
less serious for the public and for Eli Lilly shareholders. One can
only imagine what these shareholders think about a chief executive who
authorized the payment of $690 million in damages for claims that were,
in his opinion, "without merit."
But given Zyprexa's
profitability, Eli Lilly shareholders may have little to complain
about. The expense is just a cost of doing business. Besides, what's a
charge of $690 million, or even $1.07 billion, against profits of many
billions that Lilly has made from Zyprexa since its introduction nine
years ago, to say nothing of the future profits it can be expected to
How have recent developments in the legal arena
affected Zyprexa sales and the price of Eli Lilly's stock? Worldwide
Zyprexa sales fell 10 percent in the second quarter of 2005 compared
with the same period in 2004; while in the United States, Zyprexa sales
for like periods dropped 21 percent. More important, at least in terms
of the shareholders' immediate interests, Eli Lilly's stock has
declined roughly 16 percent from a high of $67.30 during the last 12
months to its current price at the end of July, of $56.32.
of Enron's fraudulent accounting practices, many people lost their
savings. Because of fraudulent drug-information from Eli Lilly, many
more people lost their health or their lives. But unlike the Enron
scandal, none of the responsible parties at Eli Lilly has been sent to
prison or even been charged with a crime. Bringing Eli Lilly executives
to justice is not likely to happen anytime soon.
what is to be done? Call it a crime; call it a tragedy; it's surely a
public-safety problem of vast proportions, one demanding government
intervention. Warning people who take or might take Zyprexa about its
grave risks is not a sufficient safeguard.
the early 1960s, the drug thalidomide was shown to cause horrible
deformities in the newborns of thousands of women, the FDA banned it.
Is death a less disastrous drug effect than deformity? How many more
people will have to die before the government steps in to protect
citizens by prohibiting the sale of Zyprexa?
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