An adverse drug reaction from Seroquel: This was a revelation

A story from Kaitlin Bell Barnett's book, Dosed:  The Medication Generation Grows Up:

This excerpt is about one of the book's main subjects, a fourteen-year-old boy named Paul who has been a ward of the Florida foster care system since being taken from his parents at age five because of abuse and neglect. At the time of this scene Paul has been taking the atypical antipsychotic drug Seroquel for several years after being diagnosed with bipolar disorder. He has recently been sent to the hospital with dangerously high blood sugar resulting from untreated diabetes. At the hospital, he was diagnosed with diabetes and told he must inject himself with insulin multiple times a day to keep his disease in check.

     [Paul was] not particularly stoic about the pain. The first time he had to give himself a shot, he nearly passed out - it hurt.  He couldn't do this three times a day for the rest of his life.  From then on, whenever he had to prick himself to check his blood sugar or inject himself with insulin, he felt a wave of sadness and defeat come over him.  So far, he'd been very good at manipulating his circumstances to suit his purposes, but diabetes seemed one thing he couldn't wiggle out of.  His alleged behavioral problems were finally under control, and at the residential psychiatric center at least he'd been able to spit out the Seroquel.  But failure to inject himself, everyone told him, would put his life in danger.  

     At some point, Paul's psychiatrist explained that his diabetes probably resulted from taking Seroquel.  Paul wondered why doctors would prescribe him a drug that caused another illness, but he figured at first that they knew what they were doing.  As he got a little older, he also made a connection between the diabetes and the other side effects of Seroquel that he disliked so much - the dry mouth, the cravings, the woozy, dizzy feeling.  Once when he had either forgotten to take his Seroquel the night before or his foster parents had forgotten to give it to him, he awoke without a dry mouth, and it occurred to him that maybe he could avoid that feeling if he didn't take the pills.  So he went a week without taking them.  He felt better, and saw that his blood sugar readings were more level.  Then, the morning after he'd gone back to taking the drug, he awoke with a dry, fat-feeling tongue and abnormal blood sugar again.  Finally, he understood the connection - and realized that maybe the diabetes was reversible if he stopped taking his medication.  This was a revelation.  As he'd understood it, he'd have to deal with the condition for the rest of his life.

     By the time Paul figured this out, he have moved away from the group home and was living in a different therapeutic foster-care placement, one chosen for him because the father was a nurse and could monitor his condition.  Both parents watched like hawks while Paul took his insulin and his Seroquel, nagged him to go out and get some exercise to lose weight and control his blood sugar, and monitored his whereabouts and his grades.  Later, he would see the discipline they imposed as beneficial, but for the moment he chafed at being stuck adhering to two different medical treatments he intensely disliked, one of which - the Seroquel - seemed to be maddeningly and needlessly causing the other.

     In time, with his diabetes under control, Paul was transferred to a more relaxed foster home where, now aged sixteen or so, he was put in charge of his own medication.   He stopped taking Seroquel altogether, and noticed himself shedding weight.  Eventually, his blood sugar problems disappeared, and his doctor told him he no longer needed insulin.  He felt vindicated.

     Read a story of a similar adverse drug reaction to the anti-psychotic drug Zyprexa on this blog.  Thanks to Kaitlin for this excerpt from her book, Dosed:  The Medication Generation Grows Up, and to Bethany Sales of Newman Communications for connecting us.

We may as well milk it while we can: Zyprexa and prescription drug reform

Here's a victim’s name and face for the prescription drug reform issue. It's a story of cherry-picked studies, aggressive marketing to doctors by pharma salesmen bearing gifts, and an ultimately fatal side effect of Zyprexa:

His prom photo showed he was a handsome teenager with a messy mop of dark brown hair. He went to college to study political science. But within the next year or two John Eric Kauffman developed mental illness--a severe form of bipolar disorder. In 1992, in his late twenties, he suffered his most severe psychotic breakdown. Over the next 8 years, he didn't suffer any psychotic breakdowns, thanks to lithium and Stelazine. After that, a psychiatrist changed his medications, John stopped taking them, his condition worsened, and he was hospitalized. In the hospital he was given Zyprexa in a relatively high dose. He then remained on Zyprexa for 6 years, and gained 100 pounds, developing heart disease. John's weight gain probably contributed to her son's death in his forties from an irregular heart beat, according to a forensic pathologist. (NY Times, 1/5/07). More of John's story can be found here.

Drug maker Eli Lilly had done studies. But tens of thousands of lawsuits contend that Lilly did not fully disclose risks it discovered during studies conducted to get FDA approval for Zyprexa, risks that became more apparent in the years after the drug hit the market.

The preapproval studies lasted six weeks, not nearly time for diabetes to manifest itself, plaintiffs' attorney Joseph Saunders says, but there were red flags. Some 29% of participants gained significant amounts of weight. Rapid weight gain puts people at higher risk of developing diabetes.

Lilly paid $1.2 billion to settle 30,000 claims. And Lilly has more than private attorneys to worry about. Nine states have sued, claiming the company illegally promoted unapproved uses of Zyprexa and downplayed its side effects. The states want to be reimbursed hundreds of millions for Medicaid dollars they paid for Zyprexa.

In 2003, the FDA directed that not only Zyprexa, but all atypical antipsychotics carry a warning about increased risk of hyperglycemia and diabetes.

Lilly continued to market its drug as more effective but no more dangerous than its competitors. Only in Fall, 2007 did the company agree to change Zyprexa's label to state that its tendency to increase blood sugar levels, another diabetes risk factor, is higher than its competitors.

Asked Saunders: "Why did it take 10 years to warn people about something they knew from their clinical trials?"

In the meantime, Eli Lilly marketed Zyprexa aggressively to doctors. Here's a confessional story of one Zyprexa salesman, Shahram Ahari:

Salesmen wooed doctors with free samples, treated them to expensive dinners and paid them to give speeches at seminars.

"It practically sold itself," said Ahari, who sold Zyprexa in New York from 1998 to 2000.

The gravy train hit some bumps. Reps started hearing from doctors concerned about patients "blimping up." Competitors hammered them on it, derisively twisting Zyprexa's generic name, olanzapine, into "olanza-pig."

The Zyprexa sales reps eagerly awaited word from Lilly's brand team on how they should deal with the weight/diabetes issue. Ahari says this is what they came up with: Tell doctors to instruct patients to drink a glass of water before and after they eat, to suppress appetite.

"We'd have to do it with a straight face," Ahari said, "and after a while, it just became uncomfortable."

With doctors he knew well, he said his pitch was blunt: "Would you rather have a skinny, unwell patient or a fat, stable one?"

Doctors started reporting patients developing diabetes. "That was a big, scary thing," Ahari said. If the FDA required that Zyprexa carry a black box warning about diabetes, "it would have been death, market-wise."

He says sales reps were instructed to deflect the issues of weight gain and diabetes. "We were taught to downplay it and negate it, or to change the topic."

Lemons, the Lilly spokeswoman, says the company can't be certain what every sales manager told their sales reps, but "that has never been our corporate policy." She questioned Ahari's objectivity because she said he is now a paid witness for trial attorneys taking on pharmaceutical companies. Ahari says he was a paid witness in just one case, which was about preserving the confidentiality of physicians' prescribing patterns.

Like many critics, Ahari came to feel Zyprexa was effective, appropriate for many people. But he believed that the brass at Lilly downplayed the weight and diabetes problems because the clock on the patents was ticking. The thinking was, "we may as well milk it while we can." (St. Petersburg Times, 12/16/07)

Advice: Urge your government health watchdog agencies to require doctors to disclose their research funding, and require pharma companies to allow doctors to publish whatever results they see fit.

Thanks to Helen Haskell, NY Times reporter Alex Berenson, and St. Petersburg Times reporter Robert Farley.

Thousands of patients won't take it: Online drug studies using PatientsLikeMe

Karen Felzer's father has ALS (amytotrophic lateral sclerosis), or Lou Gehrig's Disease, so she read with special interest an article about the results of a new drug. Italian researchers had published a small study in February saying that lithium, a drug used to treat bipolar disorder, seemed to slow the progress of ALS.

A scientist herself – she's a seismologist - Karen helped to launch an online study by patients of the effects of the drug. Participating patients use the web site PatientsLikeMe.com. Karen says, "We want to keep track of how people are doing on [lithium]. It's important for the whole community."

Lithium didn't seem to help her father, and he experienced some side effects, so he stopped taking the drug. That is consistent with the reports of other patients, which indicate that lithium seems much less effective than reported in the Italian study in the Proceedings of the National Academy of Sciences.

As a result, says James Heywood, the co-founder of PatientsLikeMe, less than a year after the Italian study was published, "we now have data on over 100 patients who have been on a drug long enough to demonstrate the hope of that drug was not what was originally assumed – and that means thousands of patients won't take it."

Advice to patients interested in clinical drug trials: Look into PatientsLikeMe.

Read another ALS story.

Thanks to Carolyn Johnson for the source article in the Nov. 17 issue of the Boston Globe.

Coming from several blocks away to gawk: Privacy and neighbors

Dear Amy,
I have a sensitive issue and nosy neighbors. Three weeks ago, I was taken to the hospital because I suffered from major depression and was suicidal. I was in the hospital for eight days.

One week to the day of my release, I had four police cars, eight officers and two paramedics at my home to take me back to the hospital. Literally, every one of my neighbors was outside wondering what was happening, and they saw me being carried away on a stretcher. I was gone for three days and was diagnosed with bipolar disorder.

That weekend I had the police at my house four times because of my son running away, becoming violent and threatening suicide. The last incident ended with five police cars, 10 officers and the obligatory ambulance and paramedics. They blocked the roadway in both directions. Everyone was outside and watching, some coming from several blocks away to gawk.

What do I say to these people? Do I tell them I was suicidal, depressed and now diagnosed as bipolar? Do I tell them my son has a drug and alcohol problem along with also being bipolar?

Or do I just ask them why they're so interested in something so personal?

I need a subtle way to tell them that it's none of their business without revealing the true reasons. Any suggestions?

Amy's Advice to Wondering:
First of all, I hope your situation has stabilized. I can imagine that you feel very exposed because of the public drama brought on by these crises.

You don't have to reveal anything to your neighbors, but if you choose to, you can say, "I realize that things have been very dramatic at our house lately I've had some health issues that brought on a crisis for me and my son, but we're hoping things are better now."

Browse for related stories in the index at the very bottom of this page, or read another privacy story.

Thanks to Amy Dickinson for the source letter in her column, published in the June 16 issue of the Philadelphia Inquirer.

Rats and mice get better protection: FDA and informed consent for human subjects

The case of Audine Graybill demonstrates the flaws in the system. According to the U.S. Food and Drug Administration, in the spring of 2005, she decided to try an experimental drug to treat mania associated with bipolar disorder. The consent form that she signed on May 29 said she could change her mind at any point in the study.

She checked into High Pointe healthcare in Oklahoma City, a psychiatric center owned by a psychiatrist, Dr. David Linden. On June 3, she changed her mind and asked to leave.

Dr. Linden refused to let her go.

On June 6, she was given the experimental medicine. Her lawyer, Anthony Sykes, presented a writ of habeas corpus to High Pointe to obtain her release. But the hospital staff neither obeyed it nor gave it as requested to Dr. Linden.

More than nine months later the FDA discovered many other problems there, but only this summer finally wrote a warning letter. Meanwhile, the Oklahoma Board of Medical Licensure and Supervision suspended the doctor's license.

Dr. Linden has conducted clinical trials for most major pharmaceutical companies and continues to do research, according to his website.

According to today's front-pagestory in the New York Times, Audine's experience is quite common because of lax management by the FDA.

"Rats and mice get greater protection as research subjects in the United States than do humans," said Dr. Arthur Caplan, Chairman of the Department of Medical Ethics at the University of Pennsylvania.


Advice to human subjects in clinical trials: Talk through your rights with a patient advocate or lawyer.

Read another of our informed consent stories, or read Gardiner Harris’ source story in today’s New York Times.

She Didn't Sue: A medication error

His prom photo showed he was a handsome teenager with a messy mop of dark brown hair. He went to college to study political science. But within the next year or two John Eric Kauffman developed mental illness--a severe form of bipolar disorder. In 1992, in his late twenties, he suffered his most severe psychotic breakdown. Over the next 8 years, he didn't suffer any psychotic breakdowns, thanks to lithium and Stelazine. After that, a psychiatrist changed his medications, John stopped taking them, his condition worsened, and he was hospitalized. In the hospital he was given Zyprexa in a relatively high dose. He then remained on Zyprexa for 6 years, and gained 100 pounds, developing heart disease. John's weight gain probably contributed to her son's death in his forties from an irregular heart beat, according to a forensic pathologist.

Such weight gain was not unusual for Zyprexa patients; the drug maker's internal records show one out of six patients gain more than 66 pounds! The drug maker, Eli Lilly, which received $4 billion in Zyprexa sales last year, had long played down data on these side effects.

Lilly has agreed to pay more than $1 billion in settlements to patients. But John's mother is not suing Lilly. She simply wants her son's case to be known as a cautionary story about Zyprexa's tendency to cause weight gain. "I don't think that price should be paid," she said. She added that the company should have been more honest with doctors, as well as the milions of people who take Zyprexa.

Advice for family members: If a member of your family is taking Zyprexa but is not acutely psychotic, discuss the side effects with their doctor. Some leading psychiatrists say that you and your doctor might consider other drugs for long-term treatment.

Source: New York Times articles by Alex Berenson, January 4 & 5: "Mother Wonders if Psychosis Drug Helped Kill Son," and "Lilly Settles with 18,000 over Zyprexa."