Healthy Skepticism Library item: 13279

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Berenson A.
One Drug, Two Faces
New York Times 2008 Mar 24
http://www.nytimes.com/2008/03/25/business/25zyprexa.html?pagewanted=1&_r=2&ref=business

Full text:

ANCHORAGE – Two courtrooms, two floors of the Nesbett courthouse, two views of Zyprexa.

In courtroom 403, lawyers read corporate memos to the jury deciding the fate of a lawsuit brought by the state of Alaska, which was charging the drug maker Eli Lilly with hiding the dangers of Zyprexa, its best-selling schizophrenia medicine.

At the same time, in courtroom 301, William Bigley had his own opinions on Zyprexa and on the other drugs he has taken since 1980 to battle demons that only he can see. On March 14, a state court judge was to decide whether Bigley should be held for 30 days in a psychiatric hospital.

Bigley, 55, told the judge that the drugs were “poison” and that he did not need them. “I’m fine,” he said. His words were undercut, however, by regular claims to having seen flying saucers and to knowing that President George W. Bush owned a private jet.

Of all the facts at issue in the two courtrooms, one was beyond debate. Bigley was not fine.

Even so, the hearing in the Bigley case offered a textbook illustration of the agonizing choices mentally ill patients face as they consider whether to take Zyprexa or other antipsychotics.

By calming the hallucinations and delusions that plague people with schizophrenia, drugs like Zyprexa allow many patients to live outside psychiatric institutions. But the documents discussed in room 403 offered plenty of evidence that Bigley, whatever his delusions, had good reason to dislike the medicines.

All antipsychotics have side effects, and Zyprexa’s are among the worst, according to the American Diabetes Association and to independent scientists. In many patients, Zyprexa causes severe weight gain that can lead to diabetes, as well as sharply higher cholesterol and triglyceride levels in the blood. Those are all risk factors for heart disease.

Furthermore, the documents introduced in courtroom 403 showed that for much of the past decade, Lilly executives played down those risks. Among themselves, in internal e-mail messages and memos, they shared worries that sales of Zyprexa would fall if the drug were linked to weight gain or diabetes.

In 2002, for example, the Japanese government ordered Lilly to warn Japanese physicians against giving Zyprexa to people at high risk for diabetes. But Lilly did not add a similar warning to Zyprexa labels in the United States. Internally, Lilly executives acknowledged that the warning had hurt Zyprexa sales in Japan.

“The impact of the label change in Japan has been very profound,” two senior Lilly executives wrote in a memo on July 1, 2002. “There has been a 75% drop in new patients who are being put on the drug.”

Indeed, with U.S. doctors learning on their own about the connection between Zyprexa and diabetes, prescriptions for the drug have fallen 50 percent since 2003.

Yet Zyprexa, which sometimes works better than other antipsychotics on severely ill patients, remains widely used. In the United States, it is still prescribed almost 4 million times a year. Worldwide sales in 2007 were worth $4.8 billion, with half of them in the United States.

The Bigley case illustrates why psychiatrists and patients feel they have no alternative to Zyprexa, whatever its side effects. Bigley, a thin man with black hair and cloudy eyes, has been hospitalized more than 70 times since his first breakdown in 1980.

Psychiatrists say he has paranoid schizophrenia with symptoms of mania. Over the years, he has been medicated with Zyprexa, Risperdal, Haldol, Thorazine, and many other psychiatric drugs, despite his objections.

The records show that neither Zyprexa nor any other drug provided Bigley any lasting relief, and that he always stopped taking his medicines after being released from the hospital.

But Bigley has never been known to be violent or suicidal. Despite his psychosis, he has survived Alaska’s harsh winters. He bounces between apartments, group homes, and the Alaska Psychiatric Institute, the state-run mental hospital in Anchorage, mumbling about the Secret Service and other favorite topics to anyone who will listen.

But he made one point with absolute clarity: He does not want to be medicated or hospitalized.

So, on March 14, he said as much to Judge Jack Smith of Alaska state court, who was hearing the psychiatric institute’s request to confine him.

There was little reason to believe that Judge Smith would side with Bigley. Such hearings usually last only a few minutes. Psychiatrists and advocates for the mentally ill say that judges prefer not to second-guess doctors and typically rubber-stamp hospitals’ requests to confine and medicate patients.

As he sat before Smith, Bigley – who had asked that his hearing be open to the public – hardly seemed like a good candidate for release. He fidgeted and interrupted the proceedings as his lawyers tried to shush him. He had been brought to the Alaska Psychiatric Institute on Feb. 23, after squabbling with housemates at his group home, who called the police.

Dr. John Raasoch, a doctor at the hospital that treated Bigley, said that Bigley had irritated the staff and other patients. “He’s yelling, swearing on the unit, he hit the door,” Dr. Raasoch said. Antipsychotic medication would calm Bigley and make him more cooperative, the doctor said.

“There’s no point to have a psychotic individual in the hospital and not be able to treat him,” he said. “I think he’s suffering severe distress.”

But Smith appeared worried about both the side effects of antipsychotic medicines and the fact that Bigley’s history suggested he would not benefit from them.

“We’re getting a short-term fix that doesn’t change Mr. Bigley’s underlying condition,” he said.

Under Alaskan law, a person cannot be forced to take medicine against his will simply because a psychiatrist says he is unhappy or delusional. Bigley could be confined and medicated only if the judge found he was violent, suicidal, or a grave danger to himself because of his mental incompetence.

Bigley was not violent or suicidal, Dr. Raasoch said. But the doctor did say Bigley was in grave danger because he might irritate other people, including police officers, to the point where he might end up being hurt.

“He’s very inappropriate,” Dr. Raasoch said. “He gets up in people’s faces. I think the majority of people would just punch him.”

Elizabeth Brennan, the public defender representing Bigley, agreed that Bigley could be difficult. But that did not mean he was in grave danger, she said, and confining and medicating him would not help. “The hospital has not shown that treatment will improve him,” she said.

After nearly an hour of testimony, mainly from Dr. Raasoch, Judge Smith appeared troubled by the thought of confining or medicating Bigley against his will. “It sounds like aside from getting in and out of the hospital, he gets by,” the judge said. “That’s a choice that he should be allowed to make.”

Judge Smith ordered the hospital to release Bigley, though he acknowledged that Bigley was likely to be picked up again in a few weeks, or months at most. “I don’t find by clear and convincing evidence he’s gravely disabled,” the judge said.

Though the decision was unusual for such cases, Bigley did not seem particularly surprised, or even pleased.

Within a few seconds, Bigley asked his state-appointed guardian to get him a hotel suite. “He’s going to give me a dirty place,” he complained.

With that thought, Bigley headed for the street, his brain in chaos but his body free from the side effects of the medicines he will not take. One floor up, lawyers for Lilly and the state argued on, debating whether the benefits of Zyprexa outweighed its risks – a choice Bigley, sound mind or not, had already made.