Hundreds of years ago, people with mental illness might be burned at the stake or locked away in a dungeon. In the early 20th century, some patients with schizophrenia were lobotomized with an ice pick to blunt emotions and reduce agitation.
Other treatments included padded cells, straitjackets, cold wet sheets and electroshock therapy. Mental institutions in the first part of the 20th century were sometimes referred to as "snake pits."
It was in this barbaric context that the first antipsychotic drugs were developed. In 1952, when Thorazine (chlorpromazine) was first introduced, it was hailed as a breakthrough.
Other drugs such as Stelazine (trifluoperazine), Mellaril (thioridazine) and Haldol (haloperidol) followed. Although these antipsychotic medications were popular with psychiatrists, patients often thought of them as chemical straitjackets.
Such drugs helped reduce hallucinations and agitation. But there was a high price to pay for the apparent benefits. The drugs made people feel sedated and slowed them down, resulting in a zombielike shuffle.
Other side effects included dizziness, slurred speech, seizures and a variety of movement disorders such as severe neck muscle spasms causing head twitches or uncontrollable rhythmic movements such as sticking out the tongue. Urinary retention, constipation and sexual difficulties also contributed to the drugs' unpopularity with patients, who often discontinued their medicines as soon as they were discharged.
A newer generation of schizophrenia drugs was introduced in the early 1990s with great fanfare. Drugs like Clozaril (clozapine), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), Geodon (ziprasidone) and Abilify (aripiprazole) are known as atypical antipsychotics.
Psychiatrists hoped that these medications would be better tolerated and much more effective than older antipsychotics. Some even believed the new drugs would help schizophrenic patients return to normal.
More than $13 billion is spent on antipsychotic medications each year. They are prescribed for a range of conditions beyond schizophrenia, including Alzheimer's and dementia, bipolar disorder, insomnia, autism, obsessive-compulsive disorder, ADHD and major depression.
Despite the initial enthusiasm, there is growing consternation about the safety and effectiveness of these powerful mind medicines. A few years ago, a study found that the newer and far pricier drugs were no more effective or less likely to cause troublesome side effects than an older antipsychotic (New England Journal of Medicine, Sept. 22, 2005). A new study in the same journal (Jan. 15, 2009) reported an alarming rate of sudden cardiac death linked to the newer drugs.
It's no wonder that patients and families are nervous about these medicines, especially when you consider that they can cause other complications such as dramatic weight gain, diabetes, strokes and irregular heart rhythms. Children and older people may be particularly vulnerable.
People with mental illness deserve much better treatment than they have received to date. Although lobotomies and straitjackets are no longer used, modern medications leave a lot to be desired.
Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert.
Jan. 28 (Bloomberg) -- Eli Lilly & Co., after agreeing to spend more than $2.6 billion to settle government and individual claims over its antipsychotic Zyprexa, still faces lawsuits over the drug that might cost the company another $2 billion.
Lilly, based in Indianapolis, said Jan. 15 it had settled state and federal accusations of illegal sales practices for $1.42 billion, taking a charge of $1.29 a share. The company previously agreed to pay $1.2 billion to settle about 31,000 patients’ lawsuits.
Not part of the settlements were suits by 12 states and a class-action case brought by pension funds, insurance companies and labor unions seeking as much as $6.8 billion. Two state trials are set for this year. Settling all 12 might cost the company another $2 billion, and going to trial would cost more, said Patrick Burns, a spokesman for Taxpayers Against Fraud.
“The total nut on this could be four or five billion” if the company settles, Burns, who tracks the suits, said in an interview. “Their cheapest way of clearing the decks is to settle.”
Burns’s Washington-based group promotes lawsuits to fight fraud against the U.S. government.
The states claim Lilly withheld information about the side effects of Zyprexa, such as diabetes, and encouraged sales of the drug for unapproved, or off-label, purposes. The states asked for damages and fines for violation of laws against deceptive practices and false claims.
Company: Claims Meritless
“We believe their claims are without merit, and that’s why we’re prepared to go to court,” Marni Lemons, a spokeswoman for Lilly, said. She wouldn’t comment on how much more Lilly may spend to settle suits.
The non-settling states are continuing to litigate because the company’s offers are too low, said attorney David Stallard, who represents Utah.
“If Utah settled, the amount we would have gotten would be about $1.3 million,” Stallard said. “The damages we actually had are more like $150 million.”
The states are seeking reimbursement for the costs of prescriptions and alleged costs to Medicaid programs for patients who developed diabetes or other injuries from using Zyprexa.
Utah would be entitled by law to three times damages plus penalties of as much as $10,000 for each Zyprexa prescription written, Stallard said.
Lilly’s guilty plea to a criminal charge of improper marketing strengthens the remaining cases, said Tommy Fibich, a lawyer for six states including Pennsylvania and South Carolina.
“How does a company defend itself after pleading guilty?” Fibich asked in an interview. “It doesn’t get much better than a guilty plea.”
The plea “was related to a very narrow time frame,” Lemons, the company spokeswoman, said in a telephone interview.
The first trial on a state’s Zyprexa claim ended in March with Lilly agreeing to pay Alaska $15 million. Two trials are scheduled for this year, in the Connecticut case in June and South Carolina in August. The Connecticut trial probably will be postponed because of delays in evidence-gathering, Fibich said.
Additional costs probably wouldn’t affect the company’s shares, said analyst Jon Fisher, a portfolio manager for Fifth Third Bank who doesn’t own Lilly stock.
A $2 billion bill would be the equivalent of $1.76 a share, or 38 percent of third-quarter revenue. Shares fell 25 percent in the past year through yesterday. They fell 15 cents to $38.46 at 12:03 p.m. in New York Stock Exchange composite trading.
“Based on what people know now, I’d say the risk is priced into the stock,” Fisher said. “This is going to go on for a long time.”
Research and development might be “hurt by a big settlement,” he said. “Money spent on litigation is money not spent on R&D, and if it does strain resources, that’s obviously a negative.”
The Jan. 15 settlement concluded investigations by the U.S. Attorney’s Office in Philadelphia and Medicaid fraud units in more than 30 states.
About $362 million will go to states to end Medicaid investigations, including about $30 million to Texas, $44 million to Illinois and $26.4 million to Michigan. These states didn’t sue.
“I don’t know why these states settled for what I consider a modest amount,” Fibich said. “Lilly’s plea was to improper marketing, and that’s exactly what we’re talking about. The amount of the settlement certainly indicates great culpability and great damages.”
Lilly also faces a class action brought by insurance companies, pension funds and labor unions claiming it overpriced Zyprexa by making excessive claims about the drug’s usefulness. The plaintiffs are seeking damages up to $6.8 billion.
U.S. District Judge Jack Weinstein in Brooklyn, New York, in September allowed the plaintiffs to sue Lilly as a group and found there was “sufficient evidence of fraud” by Lilly to justify a trial.
Lilly has appealed Weinstein’s decisions granting class certification and denying the company’s motion to end the case without a trial. Lilly denies any fraud and contends the claims by the plaintiffs are too disparate to be combined. A New York appeals court has agreed to hear the appeal.
The Connecticut case is State of Connecticut v. Eli Lilly Co., 2:08-cv-00955, U.S. District court, Eastern District of New York (Central Islip). The criminal case is U.S. v. Eli Lilly Co., 2:09-00020, U.S. District Court, Eastern District of Pennsylvania (Philadelphia). The insurance case and most state lawsuits are part of In Re: Zyprexa Products Liability Litigation, 1:04-01596, U.S. District Court, Eastern District of New York (Brooklyn).