Posts tagged ‘Seroquel’

Cross a Line, Pay a Toll

In another case of pharmaceutical giants taking part in what has become a convoluted pay-to-promote plan, AstraZeneca is set to pay a $520 million settlement as the result of a federal investigation revolving around their off label marketing of Seroquel. That sounds like a lot of money until you realize they made nearly 5 billion off of the drug in 2009 alone. That makes the settlement look a lot more like paying a toll than a hefty fine and still raises the question, When (if ever) will convictions start coming down?

From the NY Times:

“AstraZeneca paid kickbacks to doctors as part of an illegal scheme to market drugs for unapproved uses,”Kathleen Sebelius, secretary of health and human services, said at the event in Washington. She said the company promoted drugs for unapproved uses by children, the elderly, veterans and prisoners.

Glenn Engelmann, AstraZeneca’s U.S. general counsel, released a statement saying the company denies the allegations but settled the investigation with the payment.

“It is in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines — while avoiding the delay, uncertainty, and expense of protracted litigation,” Mr. Engelmann said.

If companies’ sidestepping safety measures and paying doctors to disregard patient safety is going to continue to be treated not as a crime but an indiscretion, there is little hope for a turnaround in any foreseeable future. It’s a bad step made worse by the fact that they’ve targeted some of the most at-risk and vulnerable among us. Children, elderly, veterans and prisoners are all  left with little choice but to take the drugs they’re given whether the perceived need is determined by medical inquiry or financial gain on the part of the doctor.

Of course it’s in the company’s best interests to deny the allegations and pay the toll. The alternative, in theory and on paper, is to go down the road of criminal litigation. Patient safety be damned, there’s money to be made and if a conviction resulting from “protracted litigation” can exclude companies from  government programs like Medicaid, then the best option for them will always be to pay these small settlements.

As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration. The drugs have caused rapid weight gain in children, and side effects including deaths have prompted warnings against giving the drugs to elderly patients for dementia.

According to company e-mail messages unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study that showed Seroquel users gained 11 pounds a year, while publicizing a study that asserted users lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on unfavorable studies.

Warnings and small fines are not going to save lives or turn the tide of corruption in marketing and medicine, they will only serve as a payment of a toll and an acknowledgement of roles without consequence. If their actions are criminal and dangerous — and they clearly are — then they should be treated as such. Maybe we can start with actually prosecuting for their off label marketing and doctor kickbacks — or better yet, a few hundred thousand counts of reckless endangerment.

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April 28, 2010 at 9:26 am 2 comments

Kifuji on the Defense

The controversial Dr. Kifuji, prescribing psychiatrist for Rebecca Riley, appears to have evaded any criminal responsibility by exchanging her testimony for immunity. She is, however, up against a malpractice suit and some of the things that have come up are startling in terms of just how Rebecca’s very early death transpired and the role Kifuji played in all of it. I know I’ve brought up the doctor’s role in this before but every new fact that comes out is more frightening and infuriating than the last.

The Patriot Ledger ran an article that covers many of the almost too-bad-to-be-true circumstances that point to the fact that if Rebecca and Dr. Kifuji had never met, Rebecca might still be here. Regardless of your opinions on children and drugs, this case was wrong all around and the result of at least three people’s indefensible actions. Kifuji was more a drug dealer than a psychiatrist and while that’s not particularly uncommon, the young ages of her patients makes her a standout, even among the over-drugging crowd and the predictable end result in Rebecca’s case shows her to be  both reckless and ill qualified.

From the Patriot Ledger article:

Years before she became a board-certified psychiatrist, Dr. Kayoko Kifuji was diagnosing children as young as 2 as bipolar and hyperactive – and prescribing powerful cocktails of mood-altering drugs to quiet them.

By the time Kifuji finally passed the psychiatric board exam – on her fourth try – one of her youngest patients, Rebecca Riley, had a little more than a year to live.

The lack of involvement on Kifuji’s part was shocking. She saw Rebecca primarily for twenty minute sessions to adjust doses. Often she just used these sessions to put on paper her approval for the adjustments her mother was already making, having increased doses on her own and experimented with drug cocktails using drugs prescribed (also by Kifuji) to Rebecca’s siblings.

She relied almost exclusively on what Carolyn told her about the kids when diagnosing them and ordering increasing amounts of drugs for them.

Kifuji also trusted the mother to keep tabs on Rebecca’s heart rate and blood pressure for signs of problems with the four drugs she was on. Kifuji, a pediatrician who later became a psychiatrist, told Novotny during the deposition that she didn’t realize she had a blood pressure cuff in her office and could check the girl’s vital signs herself until after Rebecca was dead. She said she didn’t take Rebecca’s pulse with her fingers because Carolyn Riley told her the child’s pulse “was within normal range.”

Even a well intentioned mother shouldn’t be solely in charge of monitoring a child’s heart rate and blood pressure let alone a woman hell bent on gaining access to more and stronger drugs at the expense of her daughter’s health. Also, any pediatrician turned psychiatrist should think of performing such simple tasks as second nature. If not that, then what is a doctor for? How do you not even know you have basic medical equipment in your office? How does a doctor fail to check a child’s pulse? Oh, that’s right — her mother said. If that’s all there is to doctoring, it’s no wonder some might see her as just a drug dispenser. They can do the rest at home, it’s a mere technicality that you must be licensed to prescribe.

  • Asked why she didn’t report Carolyn Riley to child welfare authorities after learning that the mother had increased the children’s doses at least twice without checking with her first, Kifuji said: “I just can’t report to the DSS. I need to … my role is to work with the parent and not judging them.”
  • Asked if she ever told Carolyn not to give Rebecca cold medicine on top of all the drugs the child was on, Kifuji says no, “but it’s because Rebecca didn’t get sick, and I was never asked ”

Right — let a mother chemically abuse and experiment on a child but whatever you do, don’t judge and certainly don’t  give them any more information than they asked for. The article goes on to point out other times that Kifuji refilled prescriptions before they should have run out, never asking for an explanation, just dishing out more and more drugs.

She prescribed clonidine – the drug that killed Rebecca – during the child’s first visit to control the “impulsivity” that Carolyn Riley described. Rebecca was 2 at the time.

Impulsivity at two hardly makes a child a psychiatric oddity but when you look at some of her notes regarding Rebecca’s apparently troubling behavior it’s easy to get the notion that Kifuji sees childhood as a disorder unto itself.

“Then consistently hyper all the time. Climbs up to top of jungle gym without any fears and thinking. Gets into everything. Just walk up to someone and smack them. Never gets aggressive. Hits kicks and spits when she’s being disciplined and laughs. Started to say things scared her. Whines and fusses a lot.”

Kifuji described the toddler as dysarthric, meaning she could not properly pronounce some words.

“A bit tired since yesterday. Coming down on flu. Fine as long as she takes clonidine. Sleeps throughout. Without clonidine gets very hyper and impulsive.”

“Climbs up on top of bureau. Tantrums or sobbing when she was told to clean up her toys” and “she wasn’t listening to her mother.”

This child was drugged for one reason — she was stricken with a case of toddlerhood. Dr. Kifuji seems to see no distinction between behavior and disease. Now that psychiatry has largely gotten away from talk therapy, we’re supposed to see psychiatrists as doctors of the brain — linking behavior to dysfunction in the brain. If that’s the case, Kifuji doesn’t make it very well. She’s like a mad scientist but without the science.

She explained that some researchers believe the area of the brain called the amygdala is different in people with bipolar disease. But she admitted she didn’t know where the amygdala is in the brain.

Of course you don’t need to know the brain at all to dispense drugs in the manner that Kifuji had begun making a career of (there is a timeline of Rebecca’s “treatment” at the bottom of the article). You only need to know that if you sedate a child enough, you can drug the behavior out of them. Sure, that child may be a “floppy doll” sitting in the corner but a quiet floppy doll and certainly not disruptive and if enough people will pay you to drug the childhood out of their children to one extent or another, then you’re in business.

Yes, the parents physically gave the drugs to Rebecca but they were used as a weapon and that weapon was provided by Dr. Kifuji. If she had given them a blackjack instead and told them how many times you have to hit a kid for effective behavioral treatment, this would be a different case entirely. Our view of prescribed medicine as care makes us resistant to the notion that drugs can be poison but they clearly can be and often are, particularly with psych drugs. When this happens, we need to respond accordingly.

There are no less than three guilty parties here in a case of chemical assault that ended in a child’s death. It’s bad enough that Dr. Kifuji was granted immunity making it impossible to hold her criminally accountable, even as more facts come to light pointing to her role not in anything resembling care but in a death. If she is not held civilly and professionally accountable, we’re saying her actions are acceptable, even desirable and we’re signing off on a prescription for some seriously detrimental treatment. I’m relieved to see she’s at least going to be made to answer for her actions. She’s certainly got a lot to answer for in this suit. Now we’ll have to wait and see what passes as accountability these days.

April 14, 2010 at 10:47 am 4 comments

Calling Mom? Take Drugs.

Now that we’re getting all too comfortable taking antipsychotics for almost every perceived illness under the sun, from ADHD to depression and bipolar disorder, what does pharma offer for everyday concerns like…calling your mother? This ad for AstraZeneca’s Seroquel represents a new low in irresponsible attempts at positioning antipsychotics as a happy pill for every problem, feared problem and now even non-problem.

Oh and in case you missed it, the word schizophrenia is in muted type in the corner — snuck in just so they’re not technically marketing off label. That’s what it’s come to, just tack the name of the approved indication on the ad somewhere and sell a drug as the cure for daily life. If this is the shape of pharma marketing to come, what’s next?

As if it’s not bad enough to push the idea of using some of the most dangerous drugs on the market to cope with daily tasks and concerns, they’ve abandoned the idea of even pretending to condone judicious dosing and chosen instead to encourage buyers to take it to the limit. There is a reason the boldest type on the ad says “Up to 800 mg” and the arrow on the chart is maxed out. Even beer commercials tell you to drink responsibly, while this ad just tells you to take more. But hey, when it comes to Seroquel dosing, their slogan says it all, Aim High. If there was ever a line regarding responsible drug marketing, they’ve crossed it.

I was clued into this little gem by a BNET article via Beyond Meds.

March 24, 2010 at 8:01 pm 6 comments

A Senseless Passing, Reckless Drugging and a Strongly Worded Letter

I don’t have the time or energy to really delve into these intertwining stories so I’m just touching on them and providing links but I do think we should be paying attention to what is allowed to pass for care in this country and what is allowed to pass for accountability.

Florida has a terrible track record, pumping its youth and especially its children in foster care, full of pyschotropic drugs. Foster children in Florida are drugged about three times as much as children outside of the system. These drugs have  serious negative effects on developing minds and bodies and one of those effects is suicidal ideation. With that many kids drugged down and such extreme responses, it’s painfully obvious that many of those children are going to suffer terrible outcomes.

This was never more true than in the heart breaking story of Gabriel Myers, a child just seven years old who committed suicide by hanging while on a cocktail of psychotropic drugs including Seroquel. Seven years old. Suicide at that age is unnatural. A child that age taking his own life has been failed by somebody — maybe everybody. It took a long time in my mind to get to even thinking about what this says about broken systems, medication, responsibility and social failure — all I could think about was what a terribly sad, troubled and short life Gabriel had.

Florida’s response? From a CBS News article that does go on to present some critical views of the use of psych drugs in children:

The apparent suicide of 7-year-old boy Gabriel Myers, who was taking several psychiatric medications, has led to the introduction of a bill in the Florida legislature, which would assure that powerful mental health drugs dispensed to Florida foster care children would be more closely monitored…

The bill requires caregivers and doctors to report any adverse side effects, which DCF must document.

The bill also requires children to have a mental health treatment plan that includes counseling for children prescribed such drugs.

Monitoring? We need more than paperwork. Keeping track of your failures and an immediate reversal of your direction are two different things. Gabriel’s prescribing psychiatrist, Sohail Punjwani, is tied to a string of kids drugged down on powerful psychotropics and having horrible negative effects — facing everything from sedation and dizziness to hallucinations, suicidal urges and death either at their own hands or from the drugs directly and while he’s not the only one, he’s certainly at the center of the situation. It’s okay though. He got a strongly worded letter: From the Miami Herald:

A South Florida psychiatrist who was treating a 7-year-old foster child before the boy committed suicide last year has received a warning from federal drug regulators who say he failed “to protect the rights, safety and welfare” of children enrolled in clinical drug trials.

In a strongly worded letter dated Feb. 4, regulators at the U.S. Food and Drug Administration said Dr. Sohail Punjwani over-medicated children who were enrolled in clinical trials for undisclosed drugs. One girl, the letter said, slashed her wrists while hallucinating.

A strongly worded letter? Strongly worded letters are written in response to bad stays in hotels not children dying at the hands of their reckless doctor. Surely, showing a complete disregard for the safety of your youngest patients warrants more than a letter. But then, it seems disregard for patient safety is just the tip of a particularly damaging iceberg. It would appear as though Punjwani, so far without interference from any overseeing agency, may have been using foster children in clinical trials. If that’s the case, the problem is systemic.

If experimenting on kids is the lowest of the low, I don’t even know what to say about hand selecting discarded or displaced children for a pseudo-science project. It is a clear use of a person’s social viability to define them as candidates for clinical trials.  You will never see a news report of senators’ children being hand picked for psychiatric experiments. With or without the pretense of clinical trials, children in this country have become the little white mice in psychiatry’s living lab and all too often their real lives are the mazes we watch them stagger through. That’s not good enough.

March 20, 2010 at 10:22 am

Violence Prevention Medication?

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.

March 17, 2010 at 7:42 pm

FDA Warns Docs about Zyprexa

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.

February 1, 2010 at 10:53 pm 5 comments

Seroquel XR’s New Ad

You may have seen the relatively new direct-to-consumer ad from Astra Zeneca for its long acting atypical antipsychotic, Seroquel XR. Creepy and pandering to say the least. I’ve heard a few people say that if you’re not depressed before watching it, you will be after — and isn’t that the point?  Like a carefully and corporately crafted emo/indie/whatever hit song, it’s made to strike a chord and sometimes it takes a panel of well payed analysts and some market research to find out how best to strike that chord in a way that shows that the company truly understands how you feel. Look at any one of the current pharmaceutical ads. The focus isn’t so much on selling you the drug as the disease. Once you’ve bought the idea of the disease, you’ll find the drug.

Here, they are positioning their Seroquel XR as a fix for “bipolar depression.” They show scene after dreary scene of miserable looking people who have half faded into the grays and browns of their equally dreary  environments, all while an instrumental from Badly Drawn Boy plays in the background. Oddly, one thing that separates this ad from a lot of the others is that it doesn’t switch to bright scenes of people laughing with friends at parties or rolling around in green, sun bathed fields. It stays pretty gray, though one woman does find the strength to get up off the couch. At least in that respect it’s a little closer to reality, considering a lot of people’s experience with this drug and others like it.

Another thing you can’t miss is that the health risk disclaimers take twice as much time as the first part of the ad telling you how great the drug is for treating “bipolar depression.” I’ll be the first to admit that a risk vs benefit scenario can’t be weighed out in seconds of air time but with such a vague diagnosis, based not on objective medical evidence but a nebulous cluster of feelings and behaviors laid out in a questionnaire, one has to wonder when the perceived benefits justify the very real risks. The question may now be more important than ever as we see these drugs being used in increasingly mild situations and in an ever broadening range of indications and demographics. Even with twice the time dedicated to the risks, the likelihood of those risks hasn’t fully been put forth and while they touch on metabolic symptoms and state the need for cholesterol and triglycerides to be checked, the reality is that only about ten percent of doctors prescribing these drugs are looking into metabolic responses by running those tests. With these companies downplaying, often even lying outright about the risks of these drugs to the FDA, prescribing doctors and now — via direct-to-consumer ads — the public, even with their FDA mandated obligations fulfilled, truth in advertising remains questionable at best.

Just as with the ad marketing Abilify as an add-on for “treatment resistent depression,” a viewer who sees this ad would have no reason to see Seroquel as anything but an antidepressant. It’s not an antidepressant though — far from it. It’s an antipsychotic designed to combat the cluster of “symptoms” associated with a diagnosis of schizophrenia — but then, when your product was designed for a perceived illness that affects only 1.1 percent of the population, you have to expand your market somehow.

January 28, 2010 at 10:40 am 2 comments

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