Posts tagged ‘Zyprexa’
This morning, I stumbled upon an opinion piece for the Buffalo News pushing for Kendra’s Law to be made permanent. Kendra’s Law is an attempt to prevent violent crime by essentially treating people diagnosed as mentally ill like some sort of pre-criminals. On paper it’s also supposed to be for the safety of the “patient” too but when it’s time to push for support, it’s almost always about protecting “us” from “them.” (As I’ve said before, fear sells when facts fail.) Advocates of Kendra’s Law and similar attempts to criminalize extreme states of mind use phrases like assisted outpatient treatment (AOT) instead of the more truthful involuntary or forced outpatient treatment. These are the types of laws that allow for forced drugging, electroshock and hospital confinement — all based on the unfounded idea of biological mental illness but the idea is just the packaging. It’s essentially a way to keep people under control out of fear of what they might do. This thinking has no basis in fact regarding mental illness and certainly no place in the arena of human rights or a constitutional America. The article is a fine example of fearmongering but that’s the current state of media. Somehow factmongering never caught on.
As with most battles for thought and opinion, this one is very much centered on carefully crafted words and phrases — not unlike much of the current mental health industry. As with force being rephrased as assistance, drugs are renamed and recategorized, some officially and some in the minds and words of the public. (Neuroleptics have come to be called antipsychotics which are now being called antidepressants.) Sometimes words with no previous connection are paired and when spoken with some authority or when used to speak to people’s fear these words become inseparable, creating a false choice scenario. The latest I’ve seen, in the aforementioned article, is “violence prevention medication.” Of course, there is no such thing but it’s another step in grooming the vernacular.
Kendra’s Law—designed to keep people who really need it on their violence-prevention medication—was passed about 10 years ago. It’s up for renewal, again. Just make it permanent…
The law allows judges to order certain mentally ill people to remain on violence-prevention medication as a condition of release and, if that doesn’t work, to order involuntary committal to mental hospitals if shown to be a danger to themselves or others.
The author creates a connection between violence prevention and drugs. Simply by accepting the phrasing, you’d be accept the idea as truth. And if that’s the truth, you are either in favor of forced drugging or you don’t care if innocent children are slaughtered at the hands of madmen. Facts be damned, that’s your choice. Somehow, when I picture people being tackled to the ground, restrained by undue force, faces pressed against a cold hospital floor and forcibly injected with drugs — powerful mind and body altering drugs — it’s hard to see it as “violence prevention.” We are transferring violence at best and at worst and in truth, causing it.
Further on the topic of Zyprexa and diabetes, Alaska lawyer Jim Gottstein of the Law Project for Psychiatric Rights is heading to court today to face down the drug’s maker, Eli Lilly in a lawsuit they brought against him for “conspiring to steal” documents that show the company suppressed information regarding the dangers of their star drug.
For those who don’t recall, Gottstein…was accused along with two others by US District Court Judge Jack Weinstein of violating a court order by scheming to leak and publish sealed Zyprexa documents. The Zyprexa documents, which detailed hidden side-effect data and improper marketing, were published by The New York Times (Gottstein provides documents and related background here), setting off a feverish debate over the public’s right to know about concealed side effect data.
As a result of Jim going public with the information, Lilly agreed to plead guilty and pay a 1.415 billion dollar fine for promoting Zyprexa off label. $515 million of that was in the form of a criminal fine — the largest single corporate criminal fine in history. The rest was paid out as civil settlements to the states and the FDA. I don’t know how exactly anyone can pay out a record breaking fine and no one notices but then, the lack of media coverage regarding pharma’s indiscretions and outright deceit is always pretty puzzling. At least the important information was taken to the public and to a degree that has made people aware and force Eli Lilly to take some accountability.
As for Gottstein, he maintains innocence. ‘Ever since Judge Weinstein ruled against me on February 13, 2007, Lilly has threatened me with civil and criminal contempt sanctions and going after my license to practice law,’ Gottstein writes to supporters. “I believe I did nothing wrong – that when Lilly failed to object after being given a reasonable opportunity to do so and then Dr. Egilman sent the Zyprexa Papers to me, they had lost their secrecy protection. I hope the Second Circuit will agree.”
Forget for a moment that Gottstein is an outspoken advocate for informed choice in mental health. He’s a human being. If you know a company is suppressing the fact that its product is directly leading to thousands of deaths from children right up through our elderly and all stops between, don’t you have an obligation to let those people know? It takes people like Jim Gottstein to bring this level of systemic deceit to light because if recent history shows us anything, the corporate conscience isn’t going to do it and a judge who see this as a “trade secrets” issue and not a public safety issue isn’t going to do it.
In news of the not-so-surprising, The LA Times reports that the FDA has issued a warning to doctors concerning increased metabolic risks in adolescents taking the drug olanzapine (Zyprexa). Risks include rapid weight gain and an increased likelihood of weight related physical concerns like diabetes and high cholesterol — serious problems that, you may remember, most doctors can’t be bothered to watch for. While this particular warning is limited to young people, you’ll find that the same risks are present in adults though it appears that adolescents are at a higher comparative risk. Interestingly, the warning applies only to those ages 13-17 being treated for diagnoses of schizophrenia and bipolar disorder, leaving out the growing number of even younger people for whom the drug is not approved but administered off label.
The agency has not approved the marketing of olanzapine — sold under the commercial name Zyprexa by the drug maker Eli Lilly — for use in children under 13 who are diagnosed with schizophrenia or bipolar disorder. But the medication, one of a class of psychiatric medications called the “atypical antipsychotics,” is widely prescribed for young patients, despite growing evidence that call its safety profile into question for this population.
The warning comes in the wake of the October publication in the Journal of the American Medical Assn., in which a study showed that children and adolescents taking their first-ever course of Zyprexa gained, on average, more than 17 pounds over a 12-week period, as well as dramatic increases in triglycerides and cholesterol levels — all factors that put them at higher risk of developing cardiovascular disease. While two other antipsychotic drugs — Seroquel and Risperdal — were implicated in significant weight gain and metabolic changes, Zyprexa was found to carry the highest risks of all three.
More than 17 pounds in 12 weeks? Whether a parent or a doctor, you wouldn’t think you’d need clinical trials and an FDA warning to notice such rapid weight gain in a kid. A pair of eyes and even vague concern should do the trick and while the primary problem is not cosmetic, rest assured — if you don’t notice the weight gain, the other kids will. So in addition to battling the middle school years with a psychiatric label, they can now do it overweight and worrying about their heart health and diabetes. That should do wonders for their emotional well being in the formative years. Actually, the LA Times erred on the conservative side in reporting those numbers. From the JAMA study that prompted the warning:
Patients taking their first-ever course of drugs marketed as Abilify, Risperdal, Seroquel and Zyprexa experienced weight gains ranging from about 9.7 pounds for Abilify to 18.7 pounds for Zyprexa. (Seroquel users gained about 13.2 pounds and Risperdal users gained about 11.7 pounds over 12 weeks. A comparison group of children with a diagnosis of severe mental illness but who were not on the medications gained less than a half-pound in the course of the study.)
With the youth market for antipsychotics constantly expanding and these drugs being approved or used off label for a range of behaviors broadening well into the mildest end of the spectrum (attention deficit, irritability), we need to be taking these risks seriously. The shift from using drugs as a last resort to using drugs as a means of grooming children for desirable behavior can’t be ignored in a discussion about antipsychotics in children and little good can come from making a child’s physical health take a back seat to a theory on mental illness. Do we really want to expose young people to greater risks of cardiovascular disease, diabetes and high cholesterol to “correct” moods and behaviors?
With the influx in young people on antipsychotics you might think this is the time to be looking into these problems but I think the time was fifteen years ago when Zyprexa was poised to enter the market. Now here we are repeating an often seen pattern — downplay risks for the duration of a drug’s patented life and spill it all at the end when its exclusivity is about to sunset — making the older, cheaper drug poor competition for its maker’s new and exclusive replacement. I wonder what the kids think about all of this. Something tells me no one’s really asking.
Facing the impending expiration of its bestseller Zyprexa’s patent, Eli Lily has just introduced their newly approved Zyprexa Relprevv, a long acting injectable, for use in adults diagnosed with schizophrenia. While it may be good business, it may prove for many to be bad medicine.
From the Wall Street Journal:
If a classic pharma strategy holds true, the drug may also extend Lilly’s ability to make money from its Zyprexa franchise.
The company is likely to face generic competition on regular-selling Zyprexa in 2011. But a key patent on the extended release version of the drug is valid until 2018, a Lilly spokeswoman told the Health Blog.
Drug makers have long brought out extended-release versions of drugs (often branded XR or CR) as a way to fight generic competition. Antipsychotics were the top-selling class of drugsin the U.S. last year, and they’re losing patent protection left and right these days. Drug makers are bringing out extend-release versions of several drugs in the class, including AstraZeneca’sSeroquel XR and Johnson and Johnson’s Risperdal Consta.
Well, if “classic pharma strategy holds true,” we’ll see this drug touted off label for everything from dementia to depression and to suppress unruly conduct in children. The injectable is geared toward people who are deemed “non-compliant” and appears to have been introduced with more of an eye toward administration than patient health. From the Associated Press:
For the new version, patients will visit their doctors every two or four weeks — depending on their dosage — to receive the injection, spokeswoman Janell Smith said.
She said the longer-lasting version makes it easier for patients to stay on the medication, and it allows doctors to track whether they’re doing that since they have to make office visits for the injections.
Given the list of risks and side effects, I wouldn’t say it makes it easy for patients but it does make it easy for their doctors to monitor and carry out their drug regimen. This effectively clears the hurdle of a person’s choice to discontinue the drug if, for example, the side effects prove too brutal or they choose another path toward their own wellness. While force isn’t the only intended purpose for this drug, you’ll find it’s the perfect companion (from the pro-drug and pro-force perspective) to the growing national trend toward forced outpatient treatment, more kindly termed by its proponents in government and industry as “assisted” outpatient treatment. A term not unlike calling solitary confinement assisted “me time.” AOT laws are currently in place in most states and are in the works in many of the remaining few.
This new injectable appears to be the first of its class approved for “acute agitation” a point laid out in this little fear-blurb from The Medical News.
Acute agitation is a well-recognized behavioral syndrome with a range of symptoms, including hostility, extreme excitement, poor impulse control, tension and uncooperativeness. The syndrome can occur with a number of conditions, including schizophrenia and bipolar disorder. Patients suffering from agitation in its severe forms are usually in an emergency situation and require immediate treatment to alleviate personal distress and to prevent harm to themselves and others.
“Well-recognized” just means “medically baseless but agreed upon” and their idea of agitation is a clear case of pathologizing human behavior. The “symptoms” of acute agitation are just a list of how any person might respond to forced treatment and incarceration. Unfortunately, our system is so tilted in the medical establishment’s favor that once it’s called a disease, a disorder or a syndrome, all bets are off and it can be treated with drugs and your consent is irrelevant. Disease debate aside, approving a long acting injectable for episodic behavior is a bold step toward an increasingly blatant use of drugs as control. No one should be on a month’s worth of drugs for a day’s worth of being hostile and uncooperative, regardless of the cause.
Interestingly but not surprisingly — US News directs readers not to Eli Lily for more information on the drug but to NAMI. That’s some clever positioning for a “grassroots” patients’ advocacy group. They are looking more like a drug makers’ advocacy group every day.
…and what a shady upswing it is (thus my previous post) — due mostly to a lax FDA, slick marketing and drug companies’ stripping powerful psychotropics of their “mental illness” (read: psycho killer) trappings to soften their image, making them easier to sell as antidepressants, mood stabilizers, now an irritability drug and who knows what’s next? It’s not a new viewpoint to anyone who’s paying attention but it’s not often covered by mainstream media either. I was pointed to the article by poking my head in at Beyond Meds, one of a handful of truly informative blogs. It is well worth your time.
According to an LA Times article, research in Finland confirms what many already know too well–that the second generation of antipsychotic medications touted as a new, improved and safer option are killing people at alarming rates, significantly higher than their predecessors. This study was limited to clozapine (Clorazil), a drug largely phased out of use in America as the newer round came into prominence. Researchers found that compared to patients using clozapine, those using the newer drugs, known as atypical antipsychotics, were more likely to die an early death.
Patients taking Seroquel (also known as quetiapine) were 41% more likely to die prematurely; those taking Risperdal (risperidone) were 34% more likely to die early; those taking Zyprexa (olanzapine) were 13% more likely to die early.
Those are some startling statistics considering how widely used those particular drugs are, especially in America. Atypical antipsychotics were developed and introduced for use with people diagnosed with schizophrenia but many have been approved for everything from bipolar disorder and the newly invented pediatric bipolar disorder and as an add-on treatment for depression.
In 2008, 50 million prescriptions for antipsychotic drugs — overwhelmingly the newer ones — were filled. The FDA is now considering whether to allow Seroquel to be prescribed for treatment-resistant depression, and to older children diagnosed with schizophrenia or bipolar disorder.
Britol-Myers Sqibb’s standout atypical Abilify, for which you may have seen direct-to-consumer ads, is experiencing dramatically improved sales since it’s FDA approval for “treatment resistant depression” and that’s what it really comes down to–sales. There is only one reason a host of new drugs are being pushed despite these studies while older drugs are being swept aside or abandoned as dangerous in comparison–money. By law, when a drug is around long enough it’s opened up for production by other companies as a generic substitute. When that happens the formerly singular producer and marketing machine for a drug needs a new and again exclusive product. A drug is often deemed unsafe or ineffective only when it fails to increase profits.
This is not to say any of the atypicals are safe. They are all very powerful and commonly harmful but we should be questioning how matters of marketing are allowed to supersede matters of safety and efficacy. The FDA does little to stem the tide of companies making billions of dollars from increasingly deadly drugs. While it is bad enough that there is an under-informed or blatantly misinformed public we must also be aware that it is no small number of people that are being forced to take these drugs. Many in this country are given a diagnosis and a prescription without a choice in either. There are toddlers in this country on Risperdal thanks to the new pediatric bipolar diagnosis and reports continue to come in regarding their off-label use in other areas of mental health concern.
The one thing Americans love to buy more than anything is an idea and corporations love to sell them. Big pharma makes billions of dollars selling us the idea that new equals improved, effective and safe. We want the name brand for everything. That’s how we know it works, right? They also make big money because you don’t normally see these studies and as pharma money continues to sponsor your favorite tv shows, don’t expect an expose´ on the tv news magazines. If you are willing to buy into the unproven idea that a drug can fix a troubled mind, at least don’t buy into the disproved idea that a new one can do it better. For those of you who are fortunate enough to choose whether to take drugs and which, inform yourself and choose wisely. For those who are not afforded that choice, help is on the way. There are people fighting hard for your survival.