The Astonishing Zyprexa Cover-Up

Last week, I was interviewed by Jesse Ventura (with whom I’ve co-authored five books) for one of his upcoming weekly Podcasts, “We the People.”  When we began talking about my recently-published memoir, My Mysterious Son, we zeroed in on the health impacts of the big pharmaceutical companies and their antipsychotic medications – a story with which I was painfully familiar.

This week I will be interviewed on Ru-Tv’s news program “Breaking the Set” about this and other elements of “My Mysterious Son.” It is scheduled to air in the near future.

Back in 2006, when my son Franklin was in his late twenties and living in a group home in the Boston area, he refused to take Clozaril any more because of the required bi-weekly blood draws.  His doctor prescribed Zyprexa as a substitute, and Frank suddenly began to gain weight … a lot of weight.  The group home staff blamed this on inactivity, as it was winter and Frank began retreating more and more to his room.

Before long, a physical revealed that my son’s heart rate was more than twice what it should be.  Frank’s eyes began rolling back in his head, a sign of paranoia that hadn’t occurred in a few years, and which often seemed to arise out of nowhere but he said happens when he becomes fearful.

He agreed to stop by a YMCA and I got him a membership.  Frank began working out fairly regularly and, to my great relief, his heart rate soon fell dramatically.  But his cholesterol level was high – which meant yet another medication.  Though he continued to gain weight, the medication therapist didn’t seem inclined to change a thing!  He was simply eating too much, the “authorities” believed.

Within months he’d put on at least 75 pounds, ballooning up to almost 300.  And he was diagnosed with adult-onset diabetes.

That December, 2006, perusing an online edition of the New York Times, I came across a front-page article about Zyprexa.  It began: “The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.  The documents, given to the Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar – both known risk factors for diabetes.”

The company had told its sales representatives to play down such data with doctors, including the fact that some patients had reported gaining a hundred pounds or more.  The documents revealed that Eli Llly had been concerned about these side effects since 1999, which I recalled as the year Frank was first prescribed the drug.  Zyprexa was by far the pharmaceutical company’s top selling product, hitting some $4.2 billion in revenues in 2005, and being prescribed to about two million people worldwide.  Also in 2005, the company had agreed to pay $750 million to settle class action lawsuits by 8,000 people, and thousands more claims were still pending.¹

Later, I would learn that UCLA psychiatrist Dr. William Wirshing had said of Zyprexa prior to its 1996 approval by the FDA:  “It is just un-stinkin’-believable.  It is the best drug for gaining weight I’ve ever seen.”  The doctor indicated that taking ten milligrams of the medication was equivalent to ingesting 1,500 extra calories per day.²

My outrage knew no bounds.  They knew all along.  The bastards!  They had plenty of evidence!  Prescribing physicians had the wool pulled over their eyes, or had blinders on, or maybe something worse … I set out on an intense Internet search for a class action suit in which to involve Franklin.  Several U.S. law firms seemed to still be pursuing this.

It would be another six years before I learned more about the background of the Zyprexa story in a book called Pharmageddon.  Author David Healy recounted:  “The first generation of antipsychotics ran into problems in the 1970s with million-dollar legal settlements against their manufacturers for a disfiguring neurological side effect of treatment – tardive dyskinesia [a disorder resulting in involuntary, repetitive body movements].  This led to a period of almost twenty years when no new antipsychotic came on the market.  The only antipsychotic that did not cause this problem was clozapine [Clozaril was the brand name], but clozapine had been withdrawn in 1975 because it was associated with a higher rate of mortality than other antipsychotics.  The way forward seemed to lie in producing a safe clozapine.”

One way to do so was “to make minor adjustments to the clozapine molecule.  Tweaking a molecule risks producing a compound with all the hazards and none of the benefits of the parent.  This is what Lilly did:  in 1974 the company produced a series of compounds that were all abandoned because of toxicity.”  The company was in “serious financial trouble, facing potential takeover … On April 29, 1982, they opted to move forward with a compound from the original series that by definition was not novel – olanzapine, later branded as Zyprexa.  To make Zyprexa commercially viable, they needed a new patent, which meant demonstrating some benefit not found with other antipsychotics.  In 1991, the only novelty presented in the company’s new patent application, which was approved, was a study in dogs in which Zyprexa produced less elevation of blood cholesterol levels than another never-marketed drug.

Healy went on: “Zyprexa has since turned out to be one of the drugs most likely in all of medicine to increase cholesterol levels in man … There was arguably a better case to be made for patenting it to raise cholesterol than to treat psychosis … There was no basis to think this drug was any more effective than dozens of others and a lot of reasons to think it was more problematic for patients, but the marketing power that came with its patented status enabled Lily to hype its benefits and conceal its hazards and steer doctors to write enough Zyprexa prescriptions to save the company.”³

From Franklin’s journal:

“The Mental Health System in the U.S. in this time, in this era, this 2000 period of time, people seem to assume that they know reality and others do not.  Doctors believe they are fully knowledgeable of the scientific area.  These doctors go around diagnosing people of this disease and that.  Many times they steal lives and get paid for it.  I resisted treatment in my young years.”

Franklin got off Zyprexa and agreed to resume a lesser amount of Clozaril, prior to spending more than a year at an alternative treatment facility for young adults called Earth House in rural New Jersey.  During that period, remarkably he dropped almost a hundred pounds and regained his health (the diabetes diagnosis disappeared), through a sound organic diet and seeing an orthomolecular specialist.  The class-action suit against Eli Lilly and Zyprexa in which I enrolled him did eventually result in some compensation for all that he had been through

“The time has now come to call an end to the psychopharmacological revolution … [it] now has to meld into a quiet world where drug therapy … will be joined by other approaches as equal partners, preferably working together in harness rather than in conflict.”

– Peter Tyrer, Editor of the British Journal of Psychiatry, August 2012.⁴

In a bookstore, I found myself drawn to a paperback by Robert Whitaker called Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Metal Illness in America.  The author wasn’t an advocate, but a former Boston Globe reporter whose series on the pharmaceutical industry led him to write Mad In America and now this book.  And what I read was appalling, and terrifying, though by this time not unexpected.

The figures boggled the mind: since 1987, a fifty-fold increase in sales of psychiatric drugs, from $800 million to more than $40 billion.  This coincided with a vast increase in people receiving government-funded psychiatric disability payments (with all medication costs covered by insurance), from 1.2 million adults twenty years earlier to four million adults in 2007.  And now the reach has extended to children – from 16,000 diagnosed with mental ills necessitating psychotropic medication in 1987, to more than 600,000 today.⁵

Perhaps the biggest revelation for me was that, while anti-psychotic drugs may prove effective for short periods, their long-term use often causes deterioration of brain function.  Schizophrenic-diagnosed patients who’ve been on medication for years, and then stop taking it, generally relapse in worse condition than before.  Yet studies by the World Health Organization, comparing schizophrenia outcomes in developed countries like the U.S. versus nations like Nigeria where the drugs weren’t generally available, found a much higher rate of recovery without them within two years in the poorer countries.⁶

Since Robert Whitaker lived in the Boston area, I arranged a get-together where I spoke to him about Franklin.  And I learned a great deal from this impassioned man who’d started a Foundation for Excellence in Mental Health.  Whitaker told me frankly that the Clozaril my son takes is the most effective antipsychotic, but also especially difficult in terms of withdrawal once you’ve been on it for a long time.  Also, epigenetic changes that it can cause in the brain may prove irreversible.  No easy answers; it’s a real Catch-22.  But support is crucial, Whitaker adds encouragingly.

Whitaker was to give the opening speech at a two-day conference in Maine toward the end of September, called “Innovative Solutions to Building Recovery with Alternatives to Psychotropic Medications.”  I made the two-hour drive up from Boston.  The most striking part of Whitaker’s Powerpoint presentation was that medical experts have doubted the long-term effectiveness of antipsychotic medications for a very long time.  Since hyperactivity of the brain’s dopamine system had been theorized as the root cause of schizophrenia, most of the newer drugs (interestingly, not Clozaril) were aimed at blocking dopamine receptors by as much as 70 percent.  The brain tries to compensate by becoming “supersensitive” to dopamine, with the drugs triggering an increase in the density of dopamine receptors.  Which, over the long haul, makes patients more biologically prone to psychosis, and as well as causing worse relapses upon withdrawal of the drugs.

But since the early 1980s, studies had generally been geared toward finding favorable outcomes; indeed, the drug companies themselves often wrote the articles for medical journals.  It’s as though the drug companies have designed their products to ensure a lifetime of dependency.

And virtually no long-term research existed into the results of tapering slowly off of these medications.

In 2003, a fourteen-year-long study of more than 500 schizophrenia patients, overseen by Nancy Andreasen (editor in chief of the American Journal of Psychiatry) reported that MRI imaging tests showed a decline in brain volumes related to the antipsychotic drugs, including decreases in both white and grey matter.  “The prefrontal cortex doesn’t get the input it needs” and gradually atrophies, Andreasen said in 2008, because the medications “block basal ganglia activity.”⁷

Yet the drug model has become so ingrained in our culture that I couldn’t recall a whit of doubt ever being raised by Franklin’s doctors about whether he should stay on his medication.  No one talked about alternatives.  No one mentioned that Loren Mosher, in charge of schizophrenia studies at the National Institute of Mental Health in the 1970s, had conducted an experiment comparing conventional treatment in a hospital setting to the Soteria Project that he’d initiated.  This was a group home environment with minimal use of antipsychotics.  At the end of two years, the Soteria patients had “lower psychopathology scores, fewer (hospital) readmissions, and better global adjustment” than those treated with antipsychotics.  And only 31 percent who remained off these neuroleptics after leaving the program ever relapsed.⁸

Hearing all this – hearing an older woman ask, “were we human beings before we became a diagnosis?” – on Franklin’s behalf I felt cheated, even conspired against.  “We are surrounded by sudden genetic epidemics,” said Dr. Miles Simmons, “and Big Pharma is laughing all the way to the bank.”  He and other speakers discuss the value of nutritional supplements, such as the orthomolecular approach that had proven so beneficial for Franklin at Earth House.  But would he be willing to do this again, having abandoned the vitamin regimen (with no argument from his Boston therapist) soon after leaving their program.

Then, during one of the audience participation periods, I heard a woman’s voice in the back of the room raise something about … shamanism.  The speaker onstage offered no response.  But my curiosity was piqued.  I was in the middle of reading The Horse Boy, a father-son story recounting how author Rupert Issacson’s little boy, a victim of severe autism, begins to improve after learning to ride a neighbor’s horse.  As a travel writer, Isaacson was then struck by a wild idea – to take his son to Mongolia, the one place on the planet where horses and shamanic healing intersect.

Taking a break from the proceedings, I found myself in the outer hallway standing near a young woman.  We were the only people there.  Although I hadn’t been able to see the face of the questioner, I had a curious feeling that she was the one who tried to bring up shamanism.  I guessed right.  She was a psychiatric registered nurse in Maine who did some shamanic study part-time.  And for me, that moment marked the beginning of a quest that would dramatically improve Franklin’s life.

* * * * *

References:

1. The New York Times series by Alex Berenson began appearing on December 17, 2006.

2. Dr. William Wirshing is quoted in “Bitter Pill,” by Ben Wallace-Wells, in Rolling Stone’s article on Zyprexa, February 5, 2009.

3. Zyprexa and Clozaril:  Pharmageddon, pp. 31-32.

4. “From the Editor’s Desk,” by Peter Tyrer, BJP 2012, 201:168.

5. Statistics on psychiatric drugs:  Robert Whitaker, Anatomy of an Epidemic, Broadway paperback, 2010

6. World Health Organization study:  Anatomy of an Epidemic, pp. 110-11.

7. Nancy Andreasen: quoted in Robert Whitaker, Mad in America, Basic Books, 2010, pp. 297-8.

8. Soteria Project: www.madinamerica.com, March 8, 2012.