David Tarloff, who stands accused of murdering a therapist in NYC this past February and of wounding his former psychiatrist, has been found unfit to stand trial by two psychiatrists who recently examined him, according to WABC-TV. Tarloff is diagnosed with paranoid schizophrenia and has struck me as being very insane from what I've gleaned from various press accounts. It's not clear if the judge in the case will buy this new finding--Tarloff was previously found fit for trial--but there's a hearing in the case next week.
If found unfit, he'll likely be locked up for life in a state hospital, a move I agree with.
Only days after news came out of one Lilly-run trial where its anti-depressant/Swiss Army knife of drugs performed weakly in a study of its efficacy in treating low back pain comes news now that a separate Lilly-run trial of Cymbalta for back pain found the drug in a dead heat with placebo. The first study, Lilly trumpeted with a press release. The second, Lilly was silent about. But someone at MedPage Today caught wind of it:
"The study reported at the Glasgow meeting involved 400 patients with chronic low back pain, randomized to 20, 60, or 120 mg of duloxetine or matching placebo."The primary outcome was the change in weekly mean of the 24-hour average pain score at 13 weeks, as assessed by mixed-effects models repeated measures. At the end of the study, no significant differences were observed between any of the duloxetine groups and placebo for the primary endpoint."
A tie with placebo sure isn't good news for Lilly, which is trying to get its blockbuster anti-depressant approved for the treatment of chronic pain.
Well, this should be another nail in the coffin of antipsychotic use in the elderly: British researchers report in the BMJ that antipsychotic use in elderly patients increases the risk of stroke. What's more that risk increases even more with the use of the second generation antipsychotics (aka, the atypicals). This risk is even higher in people with dementia. You can go read the paper here and see the numbers for yourself.
But of course these drugs are still healthy for small children!
I've previously written about risks of using these drugs in the elderly many times.
According to the Pittsburgh Press-Gazette, five lawsuits were filed in federal court yesterday in Pittsburgh against AstraZeneca, makers of the atypical antipsychotic Seroquel.
"The lawsuits claim negligence, fraud and intentional misrepresentation. 'The marketing and promotion efforts of AstraZeneca, through its advertisers and sales force, overstated the benefits of Seroquel and minimized, downplayed and concealed the risks associated with this drug,' the lawsuits contend."
None of the various lawsuits against AZ over Seroquel have gone to trial yet and none have been settled. It'll sure be interesting to see how all of this plays out, given that Lilly, makers of Zyprexa, have already settled about $1.3 billion in suits and could be looking at several billion dollars more to settle remaining class action lawsuits, state lawsuits (such as Arkansas' and Montana's) and federal claims. One prior estimate pegged AZ's potential liability at about $10 billion.
And yet the FDA is on the verge of approving this drug for depression and anxiety. Nice.
I don't often write about autism on this site as it's a bit out of my wheelhouse, but I was intrigued by this press release by Bernard Rimland, founder of the Autism Research Institute in San Diego, wherein he identifies a few cases of extreme autism where violent behaviors have been quelled by giving the patients medical marijuana.
"In ARRI 16-2 (The American Journal for Autism Research) we published a letter from a mother in Florida whose very large autistic son changed from a sweet, loving boy to a teenager who flew into unpredictable rages which 'were usually associated with self injury, aggression and property damage.” She went on, “At times I had to lock myself in the bathroom; otherwise he would attack me. We gave him many medications, but nothing worked.'"A friend suggested a solution: a brownie with marijuana baked into it. 'Soon after he ate the brownie,' she said, 'my son’s anxiety disappeared, and his sweet, loving behavior returned. He shows no signs of being under the influence of a drug. He now receives one marijuana brownie and several doses of Marinol, which contains the active ingredient in marijuana [THC], each day. This has clearly saved my child’s life and my family’s life.'"
Rimland reports on a few other similar cases in which marijuana produced positive results in patients who were thought to be lost causes. Then he takes up the question of marijuana versus antipsychotics often used to treat autism:
"It seems to me if one is going to need to use drugs, one ought to consider a relatively safe drug, like marijuana, if research bears out the good results that a number of parents have reported. I use the term 'relatively safe' because marijuana and Marinol, the prescription drug that contains the active marijuana ingredient tetrahydrocannabinol (THC), do cause adverse effects-but these effects, evidence suggests, are generally much less harmful than those caused by psychotropic drugs."
I'm certainly not advocating for medical marijuana to be used in treating autism, but pot is generally a safe drug whereas Risperdal has killed over 1,000 Americans. As far as I know, autism is not an approved condition for medical marijuana in any of the 12 states that have medical marijuana laws. But with case reports such as these, you've got to wonder why someone isn't researching whether there are any positive benefits to be gained from using medical marijuana or Marinol in treating autism. Of course, the feds would do their best to block such research with marijuana but Marinol is a legal prescription drug in the US. Given just how desperate I know many families with autistic family members are, you'd think they'd be clamoring for research as well and that Marinol's maker, Solvay, would fund some level of initial research. The feds would have little choice but to stand back and watch what happens.
But perhaps I am simply being naive.
Nature Neuroscience is out with a late-to-the-party editorial decrying revelations that some child psychiatrists and pharma companies are pushing the hell out of antipsychotics and other drugs on children with alleged behavioral problems despite dodgy clinical trials, poor evidence of safety and efficacy and a regulatory system that doesn't regulate very well.
"The revelation of the extent of the undisclosed ties between psychiatrists and drug companies further erodes the credibility of this field."
I've been saying this for almost two years. Nice to see this journal playing catch up.
You can read the full editorial here.
Eli Lilly yesterday announced that its anti-depressant Cymbalta outperformed placebo in reducing low back pain. Cymbalta reduced pain by 50 percent or more in 31 percent of patients while placebo reduced it in 19 percent of patients, according to the company. That's a 12 percent effect size, a very small effect size for this $2 billion-plus a year drug in treating pain. The study was performed by a Lilly scientist.
Lilly recently filed an application for Cymbalta to be approved by the FDA to treat chronic pain.
But as I've previously reported, already released studies don't show that the drug is a particularly robust performer in treating knee pain (a 14 percent effect size here) and last year one academic paper found Lilly's claims of pain reduction in depression via Cymbalta treatment to be overstated and quite small in reality--an 11.5 percent effect size across several trials. As the New York Times' Well blog pointed out earlier this year, one out of four PCPs prescribe anti-depressants such as SSRIs for back pain, but there's no proof that these drugs work either.
But the FDA has already approved the drug for use in treating diabetic neuropathic pain and fibromyalgia. The latter approval came only in June. It's clear that Lilly very much wants to have the drug approved for at least one more pain indication so it can market the hell out of the drug--which is already being used off-label by pain management docs who are too scared of the DEA to treat pain with opiates and the Cymbalta results are not too grand from what patients tell me--but with a 12 percent effect size you've really got to wonder if the FDA would approve the drug because that is barely beating placebo in the real world. And, then, there are the drug's well known side effects--suicidality, nausea, fatigue, and withdrawal problems. One hopes that the FDA takes that sort of thing into consideration.
And if this new study is part of Lilly's application for chronic pain (and I bet it is), then I'd really like to see Lilly put Cymbalta up against medical marijuana, which is approved for chronic pain treatment (and reportedly works pretty well) in several states. Bet the feds never let that trial happen.
We ought to know before year's end.
Between 2002 and 2007, Canadian health regulators issued a slew of warnings on the use of antipsychotics in the elderly--so did American regulators between 2004 and this year--and yet the use of drugs like Zyprexa, Risperdal and Seroquel actually increased among the elderly, according to a new study in the Canadian Medical Association Journal.
"'The three warnings about serious adverse events associated with use of atypical antipsychotic agents in elderly people with dementia had a limited effect on the prescription rates of these agents,' [writes] Dr. Geoffrey Anderson of the department of health policy, management and evaluation at the University of Toronto."'We also found that the overall rates of use of these drugs actually increased between the first warning in 2002 and the end of our follow-up in 2007.
'This finding highlights the limited impact of warnings and suggests that more effective approaches are needed to protect vulnerable populations from potentially hazardous medications.'"
Keep in mind this was almost all off-label use as well and the use of these drugs exploded in the US despite warnings about dangers associated with their use. Makes you wonder what it takes to get a doctor's attention? Perhaps regulators ought to be hiring hot pharma rep types and send them off to doctors' office with Reese's Peanut Butter Cups.
Just a note to let you regulars know that I will be very light on posting this week unless something truly earth-shattering pops up. I am doing this in lieu of taking a formal vacation and because it's the last week of summer and many of you are off doing other things and because I could use some time away from the computer.
I'll be back to the regular routine right after Labor Day.
Have a nice week.
Stan Cavers is likely known to some of you as someone who's commented here in the past. He lives in California and is diagnosed with bipolar disorder. Back in the spring, he took a job as a kind of peer mental health worker up in Humboldt County. Not long after, he was attacked by a patient whom he was checking on. Cavers suffered a serious concussion and other injuries.
Now, the County is trying to fire Cavers because he couldn't report to work in June due to the concussion and post-concussion syndrome (rather similar to the NY Mets outfielder who has only recently returned to the team), it is fighting his workers compensation claim and Cavers is without legal help of any kind. He's tried contacting numerous attorneys who won't touch his case (probably not much money in it for them) and mental health advocacy groups, which have ignored Cavers. There's much more on all of this here.
This is one of the most wicked examples I have seen in ages of a mental health bureaucracy run amok. It'd be great if any readers who may know of a lawyer in California who can help Cavers would reach out to him. It'd also be really cool if some of you went over to his blog and left him some comments.
Aurora Las Encinas Hospital, a Pasadena, Calif. psych hospital and chemical dependency unit, is in a big heap of trouble, according to the Los Angeles Times, over the deaths of three patients in recent months and the rape of a teenage girl by another patient while staffers slept nearby. The hospital is a well-known care facility for various LA-area celebs and offspring of the rich (rooms run to over $800 a day) and is famous because the co-medical director of its rehab unit is Drew Pinsky. Pinsky is better-known as Dr. Drew, a host of the radio show "Loveline" and anchor of of the VH1 reality TV show "Celebrity Rehab With Dr. Drew." He also frequently appears as an expert on CNN and other networks on mental health and addiction issues.
Details:
"The patients, who were being treated for drug abuse in the chemical dependency unit, both died of apparent drug overdoses, according to coroner's records and the report by inspectors for the state Department of Public Health."This month, a patient in the NASH House, which treats substance abusers on the hospital grounds, hanged himself from a wooden beam, the Los Angeles County coroner found.
"One day after his body was found a 14-year-old girl was raped by a 16-year-old patient as hospital staffers and the suspect's probation officer slept nearby, according to two sources familiar with the matter. 'Not a very good track record, especially at an expensive hospital like that,' said Taras Otus, the brother of Timur Otus, the 43-year-old bipolar patient who hanged himself. 'I don't understand what's going on there exactly.'"
The hospital declined comment, citing patient confidentiality. Pinsky himself issued a statement saying he'd not been involved in the care of any of the four patients and declining further comment.
It's not clear what the state is doing about any of this, but one insurance company has refused to cover patients at the hospital.
A few months ago, I rolled out Eli Lilly's grants to various advocacy groups, universities, continuing medical education companies and whatnot for the first quarter of 2008. Some of the big grantees were Harvard and the American Psychiatric Association. The numbers are now out for the second quarter, an ongoign effort by Lilly to blunt criticism of its donations to various groups--they can now claim they are all transparent--that work hand-in-glove with the pharma giant to get lots of Americans diagnosed with mental disorder and sell lots of psych meds. The grants are also for diabetes and cancer work, but we're mostly interested in mental health--or neuroscience, as Lilly calls it--here.
Once again, the APA raked in big dough from Lilly: $623,188. Add that to the $623,190 the group got from Lilly in the first quarter and that comes to a very cool $1,246,378 for the first six months of the year (and that doesn't count ads in the APA journals). The APA affiliated American Psychiatric Foundation took in $272,634. The APA is being investigated by Sen. Charles Grassley for its intimate relationship with Big Pharma.
The US Psychiatric and Mental Health Congress was no slouch either with $476,250 to show for its grantwriting efforts. The American Academy for Child and Adolescent Psychiatry didn't go away empty-handed either: it got $123,000, including $25,000 for a program called "Early Onset Bipolar Disorder: What Those in the Know, Know."
Among advocacy groups, NAMI and Mental Health America (the old NMHA) were big winners. NAMI National took in $490,000 while local and state affiliates took in so many individual contributions that I didn't even bother to add them up. MHA National got $635,000 from Lilly.
Johns Hopkins University School of Medicine was the leader amongst universities this time out, taking in $392,317. No money for Harvard this time, but there were lots of smaller contributions to other universities including the University of Washington's psychiatry department which got $5,000 to do a grand rounds on "Bipolar Depression: Controversies and Challenges." Nice to see Lilly's money at work right down the street from me.
And then there were the CME companies, taking in so much I couldn't make myself run the calculator that long. I will note that the controversial Medscape took in $87,500.
Word has it that pharma companies like Pfizer, AstraZeneca and such will soon be disclosing their own contributions to groups like these on a regular basis. I cannot wait.
Stories like these only seem to exist in government bureaucracy and especially in the corrupt state of New Jersey:
"The former chief executive at a New Jersey state psychiatric hospital troubled by escapes, a suicide and homicide has a different state job investigating those kinds of problems at all five state hospitals."This week, LaTanya Wood-El took charge of psychiatric hospital investigations for the state Human Services Department.
"She was removed last December from a job as chief executive officer at the Ancora Psychiatric Hospital, which officials said lacked routine procedures for tracking, reporting and preventing violence.
"State Assemblywoman Mary Pat Angelini, a Monmouth County Republican, told the Asbury Park Press that the new post is 'outrageous.'
"But Human Services officials said she's qualified for the job."
Qualified by dint of being a complete fuck-up? How the hell does someone get pulled from a responsibility they clearly couldn't handle at one hospital and then get put in charge of overseeing investigations of all the hospitals? This just boogles my pea brain. Hopefully, my NJ readers will write their local legislators.
As for Ancora, under Wood-El's "leadership" patients were dying at the hospital and being abused. Why she wasn't fired outright is beyond me.
Here we go again: the AP has news of a patient in a psych unit in North Carolina who, among other things, had barely eaten in days. The hospital staff left him unattended to for 22 hours and the man died. The hospital is in a heap of trouble with Medicaid and, one assumes, state regulators. One also assumes several employees will lose their licenses. This happened back in April and, yes, it sure does sound a lot like what happened with that poor woman in Brooklyn earlier this summer.
What the hell is wrong with some of the people who work in mental hospitals? It's not that difficult to tend to patients' basic needs, so you have to wonder what the work culture is like in some of these places and what level of day-to-day accountability exists. You also have to wonder if the docs in these units are asleep. A guy is in a hospital 22 hours and he doesn't even get a basic work-up from a doc much less a once-over? Something really weird happened in this case, but this kind of weirdness goes on far too much in this country.
Mental Health Notes has been reporting on her own experiences with Cymbalta withdrawal and published an interview with another patient who went through a hellish withdrawal from the drug. Even more, the patient's doc ignored her problem and tried to get her further onto the medication merry-goround.
"MHN: What kinds of symptoms did you experience when you stopped taking Cymbalta?"Dee: Abdominal pain. Severe nausea. Brain zaps. Flashing lights when I moved my eyes. Insomnia. Extreme agitation & nervousness. Wanting to cry over everything. Hot flashes, sweats. Brain fog. Hyper vigilance.
"MHN: Did you doctor offer any support? For example, did he or she suggest a different medication, offer any tips on how to alleviate the withdrawal symptoms, or even suggest that you stay on the medicine to avoid the withdrawal symptoms?
"Dee: No. Made an appointment to tell him I wanted to go off Cymbalta because of the nausea. He told me I more than likely had an ulcer and it would be best if I continued taking the medication, and add Prevacid to the lineup. Offered no other alternative to Cymbalta. This doctor led me to believe this was the best SSRI on the market. Left office no better off than when I went in."
Perhaps, the local Lilly sales rep hadn't told the doctor yet about the profound withdrawal problems some patients are experiencing with this drug. I'm only half-joking. A large number of docs rely upon pharma reps for their information about drugs and relevant journal articles for treating depression. When docs work that way, they are blind to the range of what's really going on with their patients. A doctor could spend about five minutes poking around the Internet and determine that, at a minimum, there are documented cases of Cymbalta withdrawal and, while he might not believe them outright, it might force him to take off the blinders when assessing patients complaining about anti-depressant withdrawal.
But, then, many docs do a poor job of listening to patients in general.
In all seriousness, it beats me why some docs completely discount what their patients are telling them, particularly since they are willing to believe patients when they report good experiences. Why wouldn't they disbelieve that bit of information as well? Or do they still think they are so special because they graduated from medical school?
Basically, the only ways to fight back that are available to patients are to take their money elsewhere (as in getting another doc) or putting their foot down and telling their doctor that they won't be taking drug X anymore and that that's final. That approach won't work with every doctor, but they do need to realize that its their patient's body at stake.
I've written about Cymbalta and its problems elsewhere on this site.
A few of you likely know of the Living With A Purple Dog blog on bipolar disorder, authored by Jon. Sadly, his 24-year-old son, who also had the disorder, died after a freak fall at home last week. Jon is pretty beaten-up, as you can imagine, and has an interesting post ruminating on things. Go read it and leave you condolences.
You've no doubt read or heard about Michael Phelps' 12,000 calorie breakfasts as the story is all over the media and now the latest Phelps storyline is how much money will he make in endorsements. Seriously, CNN spent five minutes on that nonsense yesterday. Or maybe it was Fox News.
But one Phelps bio bit that has been getting almost zero attention is that the epic swimmer was once diagnosed with ADHD and treated with stimulants. It's not clear if he still meets parameters for the disorder or if he is still on stimulants--I somehow doubt that swimming's sanctioning body would go for that--but here's his mother describing to Good Housekeeping what things were like when he was younger:
"Q. You’re a spokesperson for the newly launched ADHD Moms online community, sponsored by McNeil Pediatrics. Why did you get involved? A. Michael was diagnosed with ADHD when he was 9, so I wanted to share our story with moms across the country. It was quite exciting to be in Baltimore, and talk to a mom in California via podcast. This Facebook community is a great way for moms to connect with each other.Q. Every child with ADHD is different. Before Michael was diagnosed, what kind of behaviors did he show?
A. He was always full of energy. He’d talk constantly, and ask questions nonstop. He also had trouble focusing in school, and his teachers said they couldn’t get him to interact during learning time. He was always pushing, nudging, shoving, and fidgeting. It was hard for him to listen unless it was something that really captivated his attention, so you can imagine what bedtime was like!Q. What kind of treatment worked for him?
A. Michael’s doctor prescribed a stimulant medication. He only took it Monday through Friday, though — no weekends, no vacations, no holidays. I knew he’d benefit from the medication at school.Q. Do you have any tips for moms who have kids with ADHD?
A. Make a task list. With Michael, there were always certain things that he knew he needed to do before going to swim practice or playing outside with friends. I posted a task list on the refrigerator, and gave him stickers when he completed his responsibilities. It was a fun way to help him focus and get him out the door.Q. Did swimming help Michael cope with ADHD?
A. It did help. Swimmers have to develop good time management when they’re juggling school work and hours of practice. The pool itself helped Michael, too. ADHD children need parameters. There’s nothing better for that than two lane lines! Even if Michael’s mind was all over the place, he could focus on going up and down the pool. Plus, water itself has a calming, soothing effect. I think the pool became a safe haven where he could release his energy. But it’s not just swimming that helped Michael; it was finding his passion and channeling his energy in that direction."
McNeil, a division of J&J, makes Concerta. Gee, I wonder if he'll endorse the drug.
The interesting thing about Phelps' story and his obvious success is that it sure could drive a stake in the heart of the argument some doctors and advocates make that kids with ADHD never outgrow their ailment and are screwed for life. Hopefully, Phelps will one day pipe up on the issue. He could sure make ADHD as American as apple pie in about five minutes.
Or maybe some smart person in the media should ask him point blank and see what he says. It sure would make for a more interesting story than how many people have asked to be his friend on Facebook, another media fave lately.
(Thanks to a very attentive reader who caught an item on Phelps and ADHD on TV in Philadelphia.)
I'm not a big fan of playing journalism police on this site simply because it's pretty awkward for a journalist to criticize other journalists and because that stuff is for Howard Kurtz, one of the big media critics out there. But at times there are mental health pieces in the media that simply demand criticism because they are so poorly-executed and continue to spread all the old voodoo about people with mental illness. Such a piece appeared on A-1 of the Wall Street Journal on Saturday. You just read it for yourself and see if you felt it was filled with cheap shots as I did.
Anyway, after reading the article a few times, I decided to drop the reporters in question an email. P and A's refers to the various state protection and advocacy systems, designed to protect disabled people from the ravages of the health care system:
"liz/nathan:"interesting piece on william bruce, and interesting in that it's the very case that fuller torrey's treatment advocacy center has been using to argue to change laws in maine and attack the p and a's. interesting too since i suspect you found out about the case thru tac or someone connected with them. interesting too that he and tac aren't quoted. interesting too that you guys are wet enough behind the ears to not smell a load of bs: a p and a was tough enough to roll over a hospital? oh please. you don't even have evidence in your story that the hospital fought very hard to keep bruce--and they probably should've fought like um crazy given that bruce was into doing strange crap with guns. that's kind of one-sided reporting. or did your editor want that?
"simply put, in 10 years of reporting on social issues/mental health, i've never heard of a p and a rolling over a hospital like that. you guys have a very extreme case in your article, but you are acting as if this is common. please. it's not.
"what's more, you quote a doc calling advocates biased, but have you ever considered how deeply docs are biased? ever taken a look at the false positive rate of diagnosis around schizophrenia and bipolar disorder? bet you haven't. you probably should before you let a doc roll you that easily. bet you that same doc would've told you, if he's honest, that there's a large amount of false positives out there that docs refuse to acknowledge. so to paint all of this as fucked up violent schizophrenic refuses to acknowledge his mental illness and advocates help him beat the system and america is at risk due to these commies tending to the rights of the mentally ill is so wacky that perhaps i'll see if the makers of the dsm can come up with a new diagnosis: journalistic brain cramp disorder.
"can you point me to the published scientific evidence that outpatient treatment actually works? what about the published scientific evidence that antipsychotics always work? did you interview jeff swanson, who's done much of the published research on violence, schizophrenia and outpatient commitment?
"you are doing little in your article but operating from some deeply biased assumptions. i'm sure your editors are cool with that, but i'm not. you engaged in nothing but advocacy in your piece--a-1 no less. awesome!--and if you can't see that then i cannot help you out.
"sometimes, people are right when they challenge their diagnoses. maybe you ought to get off your duffs and interview some of them. other story ideas: why is it that meds do nothing for about 30 percent of seriously ill schizophrenics? what do we do as a culture: give them more meds or something else?
"obviously, i expect zero response from you all, but i thought i'd just pass along my thoughts on what strikes me as being one of the more ignorant, one-sided pieces on mental health i have seen in ages.
"cheers"
The reporters' emails are at the end of the article. To put this all in perspective, this is the first time in two years that I've reached out directly to reporters to savage a piece like this, principally because I have seen the Journal do far better work on these issues. The last time was the Washington Post.
Ah, the mainstream media.
The Daily Mail (UK) is reporting that as many as nine million Britons are addicted to anti-depressants, benzos, sleeping pills and pain killers. If it's nine million there, then it's likely to be at least three times higher in the US.
"However, the Seroxat [Paxil] patients are a tiny proportion of the growing number of people addicted to prescription drugs. It's thought that between three and seven million Britons are affected, with antidepressants, tranquillisers, sleeping pills and pain-killers the main culprits."A recent report by the United Nations' International Narcotics Control Board predicted that the scale of the problem of addiction to legal drugs will soon overtake addiction to banned substances."
The story is led by one of the people suing GlaxoSmithKline over allegations that the company hid the fact that Paxil (Seroxat in the UK) was addictive. I cannot wait to see the documents from that lawsuit.
Benzo, pain killer and sleeping pill addiction is a well-known phenomenon in the UK and US, but it was nice to see a major paper treat anti-depressant addiction as a serious issue, one that the media commonly ignores primarily because doctors regularly deny that anti-depressants are addictive. Which is a lie.
Of course, the tricky question is what does a doctor do for such patients. One suggestion: research on how to get people off anti-depressants should be a research objective of NIMH.
Several of the recently-released Zyprexa documents from the Alaska lawsuit against Eli Lilly, the drug's maker, are accounts of sales calls (or detailing, as it's known in the pharma biz) on PCPs in the state and what things sales reps aid to docs about the drug. These sales calls took place in the spring and summer of 2002 and the details offer further evidence of the lengths Lilly was going to in order to market its drug for use in "complex mood cases" which the company was out to convince doctors were in fact cases of bipolar disorder requiring the use of the diabetes-causing antipsychotic. In some instances, the documents further establish that Lilly reps were openly lying to doctors about the drug's safety profile.
Even more egregious in my opinion: Lilly was using cases of patients--apparently with bipolar disorder, likely type 2--who ran into problems on SSRIs such as agitation to create a scenario for selling doctors on using Zyprexa in these patients.
A bit of context, first. As I reported last year, in April 2002 Japanese regulators ordered Lilly to put warnings on Zyprexa in Japan.
"The label, according to a Lilly document, would instruct doctors not to use Zyprexa in patients with diabetes or in patients with a history of diabetes. The warning would also indicate that there was an increase in blood glucose for patients taking the drug. 'Strongly disagrees' is what Lilly's assessment was of the Japanese decision."'This does not change the status of Zyprexa as a safe, effective and cost effective agent in the US market,' the internal document also states."
It would be almost another two years before the FDA would order Lilly and other atypical antipsychotic makers in the US to slap black box warnings on these drugs. That left Lilly with an open door to market the heck out of its drug in the US while claiming it was safe and effective, despite the fact that the company acknowledged internally (and had also been informed by docs) since the late-1990s that the drug was causing explosive weight gain in some patients, diabetes and hyperglycemia.
That out of the way, on May 17, 2002, a Lilly rep named Margaret Williams visited a doctor named Kathyrn Flores in Soldotna, Alaska. This call is documented on page AK6930 of the new documents. (I have corrected typos and abbreviations in the document. The sales calls document can be found here. It is 15 MB in size, so please only download if you really, really need to read it or you'll kill my bandwidth.)
"[R]eminded doc that Zyprexa is a great mood stabilizer, especially for patients whose symptoms were aggravated by an SSRI...Dr. Anderson just stabilized a bipolar patient earlier this week on 15 mg."
Fifteen milligrams of Zyprexa would likely stabilize a horse much less anyone with a bad reaction to an SSRI such as Lilly's all-star agitator Prozac.
Williams visited another doc in town that same day and stressed the SSRI-agitation theme again:
"Really work Zyprexa via patient whose symptoms are aggravated by an SSRI, emphasize Zyprexa as a mood stabilizer."
Williams hit the same theme with a doctor in Palmer, Alaska a few weeks later.
In late June a Lilly rep named Kristen Clouthier visited a doctor in Anchorage and handled the weight gain issue (AK6931):
"Pam Engle [a doctor?] was concerned about weight gain for those Zyprexa patients but we discussed proper diet and the fact that if patients are feeling better perhaps they will be able to actually exercise. Also discussed the mechanism of Zyprexa and that the drug does not cause weight gain but it does increase patient's appetite."
As has been established since, the weight gain issue had nothing to do with patients feeling better and everything to do with the drug itself.
Soon after, this same rep and other Lilly reps were discussing patient types with doctors and had stepped up to recommend using the drug in elderly patients as well as in non-manic bipolar patients.
"[D]iscussed Zyprexa patient type--elderly and SSRI patient also angered or can't keep a job, marriage....He said he has seen many people come through the door like that."
Throughout sales call details in these Alaska documents, Lilly reps continue to dance around weight gain issues and press for the drug to be used in agitated patients as well as the elderly. These are all things we've known about previously, since details from the initial Zyprexa documents were reported by the New York Times and myself over 18 months ago, especially the company's "Martha" campaign for the elderly and its "Donna" campaign for the agitated and depressed (see here under Donna). But these new docs show that Lilly's campaign of deception had reached into deepest Alaska.
For example, this (AK6933) from another 2002 sales call:
"[S]cheulles [presumably a doctor] asked about Zyprexa and diabetes--was able to respond according and discus moa [method of action?] of Zyprexa--Increase in appetite which may lead to obesity but no causal relationship established between Zyprexa and diabetes. Also compared to other agents [other atypicals] there is no increased incidence with Zyprexa--high risk rate in this population any way."
That's Lilly: always blaming the patient. Cute.
Especially cute in this document (AK6937) is when in April 2002 sales rep Williams went to a hectic clinic:
"Took in Reese's Peanut Butter Cups so I got back OK [presumably back in to the inner office]. Gave Dr. Child a cupcake sized peanut butter cup. He was kind of tickled."
OK, so you are hocking a drug that causes weight gain and blood sugar problems and you are giving doctors Reese's? That's ballsy.
But then Lilly knew its audience. I continue to be amazed that doctors are stupid enough to fall for free food and Lilly's lying sales tactics as regards Zyprexa in 2002.
The Dallas Morning News reports that Texas state officials have suspended a program called the Children's Medication Algorithm Project over concerns of conflicts of interest between researchers and pharma companies pushing to have their drugs included on the influential list. CMAP is the kid brother of the infamous and deeply-conflicted Texas Medication Algorithm Project, aimed at adults with mental health issues and designed to determine what drugs should be used in state mental health programs and in what order. TMAP has been widely used across the country by other states' mental health programs. TMAP and its pharma sponsors are the subject of at least one lawsuit by state officials and there have been allegations of fraud. Looks like that may be happening on the kiddie program as well:
"At most, the suspension indicates that state investigators fear fraud has occurred. At the least, it reflects nationwide unease with potential conflicts of interest between leading medical researchers and the pharmaceutical firms that fund much of their work."Publicly, officials say it's because the state is suing a pharmaceutical company alleged to have used false advertising and improper influence to get its drugs on Texas' now-mandatory adult protocol, the Texas Medication Algorithm Project.
"Privately, individuals with knowledge of the case – who spoke only on condition of anonymity because of the pending litigation – say the attorney general's investigation of possible fraud in the adult protocol has spread to the children's version."
Read the rest of the article, which offers fascinating details of how pharma has intruded on medical decision making. (Via Pharmalot.)
Over the weekend, about 1,000 pages of documents recently unsealed by an Alaskan court--which had been overseeing the recent Alaska v. Lilly case up there--hit the Internet. The documents were unsealed because of the efforts of the Bloomberg wire service and have hit the Net thanks to the efforts of Psych Rights. I owe both parties a debt.
I was able to skim about 200 pages of the documents on Saturday and my sense of things is that these documents simply add more layers of detail to what is already known about how Lilly tried to cover up problems with Zyprexa and how the company played fast-and-loose with off-label marketing rules, among other things. In other words, the original set of Zyprexa documents on this site have already established the main allegations against Lilly.
If there are any smoking guns in the new documents, I'll let you know.
The documents are located here under "Unsealed Documents." I want to encourage readers to not go rushing to download these documents for a few reasons. One, I am not sure what Psych Right's bandwidth situation is and the collected documents run to about 400 megabytes and we don't want to overwhelm the group's resources. Second, the scans of the documents are of poor quality and you would find them difficult to read much less print out. Hopefully, they'll be in somewhat cleaner form in the near future.
More on this later today.
Yesterday, I reported that the FDA's psychiatry products chief, Thomas Laughren, and the FDA itself were refusing to answer questions about pediatric bipolar disorder which the agency had two weeks previously determined unilaterally was a valid diagnosis. The FDA's move came despite much controversy in psychiatry about the disorder.
Now, I can report that Laughren has a potentially huge conflict of interest and was deeply involved in helping "America's Pharmaceutical Research Companies" design clinical trials for the disorder. That would seem to be at-odds with his role as a federal regulator whom one would expect to be a disinterested, unconflicted reviewer of clinical trials submitted to the FDA. So far, the FDA has declined to comment on Laughren's role.
In 2002, Laughren participated in a conference entitled "Methodological Issues and Controversies in Clinical Trials with Child and Adolescent Patients with Bipolar Disorder." The conference was held in the DC area and its proceedings were later published in the Journal of Child and Adolescent Psychopharmacology in 2003 (the paper is here). In the paper, it is noted that "Dr. Laughren is with the Food and Drug Administration, Rockville, Maryland. However, Dr. Laughren’s contribution to this article was made in his private capacity. No official support or endorsement by the Food and Drug Administration is intended or should be inferred."
Why wouldn't it be inferred?
Laughren attended and spoke at this conference sponsored by pharmaceutical companies helping a slew of researchers determine what pediatric bipolar disorder is, how it might be measured scientifically and how researchers and pharmaceutical companies might design and run clinical trials in order to get various drugs approved to treat the condition. Laughren attended the conference as a private person instead of as an FDA official, although he heads the FDA division that would later be responsible for reviewing clinical trials submitted by drug companies seeking to treat this newly-minted disorder. In the last year, the FDA approved two drugs for use in the disorder, Risperdal and Abilify, which are both atypical antipsychotics. In 2008, Laughren would claim that pediatric bipolar disorder is a valid disorder and then decline to specify what the disorder actually is.
Laughren's participation in the conference strikes me as a conflict of interest and certainly is a telling indictation of how deeply entwined the relationship is between Big Pharma and the FDA when it comes both to drug approval and the creation of new disorders and new markets for the companies. John Grohol at Psych Central has already called this "diagnosis by government decree," since the disorder does not exist in the DSM and is not accepted as valid by many doctors as well as by private and public insurance programs.
To be fair, I should note that there may be a perfectly good reason for Laughren's attendance at the conference. I can't guess at what that reason might be and that's why I contacted the FDA and Laughren seeking clarification of the reasons for Laughren's participation at the conference, but so far neither has responded to my request for comment.
That said, it is difficult to imagine how it couldn't have been a conflict between Laughren's participation and his role as a federal regulator, especially once you take into account that the conference was underwritten by pharmaceutical companies. Listed as sponsors of the two-day event were Best Practice (a clinical trials consulting company) with financial support from the following companies: Abbott Pharmaceuticals, Bristol-Myers Squibb (makers of Abilify), GlaxoSmithKline, INC Research, Janssen Pharmaceutica, Johnson & Johnson Pharmaceutical Research and Development (J&J/Janssen makes Risperdal), Eli Lilly, Novartis, Pfizer, and Solvay Pharmaceuticals.
What's more, several controversial child psychiatrists were part of the conference, including Melissa DelBello (who's been sharply criticized by Sen. Charles Grassley), Janet Wozniak (of the much maligned Biederman group at Harvard), David Shaffer (of Columbia University and the creator of the controversial Teen Screen) and others with deep ties to Big Pharma including Fred Goodwin ("The Infinite Mind" radio host and also a partner in conference sponsor Best Practice) and Joseph Calabrese (who's done many clinical trials of Seroquel in adults).
In addition, representatives of three key advocacy groups also participated and one of them was credited as a co-author of the subsequent paper of the conference proceedings. That person was Martha Hellander, the then-executive director of the Child and Adolescent Bipolar Foundation. Also helping were Lydia Lewis, the then-executive director of the Depression and Bipolar Support Alliance and Darcy Gruttadaro, a lawyer identified as representing NAMI. All of these groups receive major funding from pharmaceutical companies and CABF in particular has been instrumental in helping the Biederman group at Harvard get the child bipolar business recognized in American medical circles.
What precise contribution Laughren made to the conference is unclear, but it is apparent that he participated in a part of the conference devoted to identifying what types of persons should run clinical studies of treatments for child bipolar disorder, what measurement instruments should be used and what types of medical facilities should run the trials. Beyond that, his contribution is unclear except in one respect.
There was some debate at the conference about how young patients should be who were to be included into the trials and how young a group it should be that pharma companies were seeking to get an FDA indication for. There was some discussion of this at the conference. "Representatives of regulatory agencies suggested that lowering the age limit to 7 or 8 years of age would oblige the sponsor to draw 40 percent of the sample from children 8 to 12 years of age."
Translation: Some at the conference wanted to run clinical trials in kids under 10, but backed off once the FDA pointed out that they'd have to round up many kids 8 and 9 years old in order to have enough statistical power to create valid findings.
So it's apparent that even though the FDA has now approved two drugs for pediatric bipolar disorder in children and teens aged 10 to 17 years old that pediatric bipolar disorder is essentially a proxy for much younger children.
I want to be clear that a definition of mania and depression in young children was not hammered out at this conference, especially as relates to episode duration. Yet the FDA has now approved drugs for use in treating what it calls pediatric bipolar disorder, so the agency must have determined some kind of standard delineating what length of episodes count as mania and depression in kids. But the FDA has declined to answer questions about pediatric bipolar disorder and I can find no specific information on the FDA's website.
What's more, the agency has not posted the approval packages for Risperdal and Abilify on its website, as required by law within 30 days of a drug's approval, so there isn't even a way to tell what the FDA considers the disorder to be from examining that data either.
So we have a mystery diagnosis out there in America, folks. And, the FDA official in charge of passing judgment on the very drugs that youngsters will be given for the disorder was involved in telling pharmaceutical companies how to conduct their clinical trials for the disorder and later approved these drugs for use in children.
Whose side is the FDA on?
Two weeks ago, the FDA announced that pediatric bipolar disorder--aka, child bipolar disorder, juvenile bipolar disorder, etc.--was a valid diagnosis, despite the fact that it doesn't exist in the DSM and child psychiatrists cannot even agree amongst themselves whether the disorder exists, whether it's a proxy term for something else, and what its exact symptomology might be much less its supposed pathology. The announcement occurred in an odd way--one of the inventors of child bipolar disorder, Harvard's Janet Wozniak, asserted in a letter to the editor of the Boston Globe that the FDA considered "pediatric bipolar disorder"--her term--a valid diagnosis. That was news to me, so I queried the FDA and was told that, why yes indeedy, the agency considered the diagnosis real. Despite approving two drugs (Risperdal and Abilify, both atypical antipsychotics) for the treatment of pediatric bipolar disorder in kids aged 10 to 17 in the last year, the agency had not taken any sort of public stance on the existence of the disorder in kids and teens. Now it has.
So, for the last two weeks, I've made repeated requests of the FDA to interview Thomas Laughren, director of the FDA's psychiatry products division. He was the official in whose name Sandy Walsh, an FDA spokeswoman, said the diagnosis was valid and I felt it was important for Laughren to come to the phone and answer some questions about the diangosis, what scientific criteria the FDA had used to determine the validity of same or was this just the opinion of some doctors at Harvard, and why Laughren had made this determination in the face of heated opposition from some credible figures in child psychiatry. In other words, my request was pretty straightforward journalism. Walsh and I traded some emails, but yesterday she told me by email--does the FDA not use phones?--that my request was being denied.
You see, according to an earlier email from Walsh, the FDA doesn't seen a controversy at all:
"It is the FDA's position that there may be some debate in the psychiatric community about the prevalence of pediatric bipolar disorder, but not about its validity as a diagnosis. As noted in our recent email exchange, the FDA does accept the validity of pediatric bipolar disorder."
This is simply crazy talk, as there is more than a little debate and disagreement within the psych world about the validity of the diagnosis. Last year, Jon McClellan of the University of Washington, said, they "can do the same diagnostic interview on 100 children and come up with five or 20 bipolar disorders, and I might do the same thing and find only one or none." Last year, McClellan also told KUOW-FM:
"Many kids have periods where they are quite irritable and they don't want to go to bed at night and they brag....[Classically,] they never would've been called manic. That changed in the last decade. Those kids are now being called manic."Why?
"Well, that's a good question. Probably because some fairly influential research centers nationally decided that was the proper way to apply the diagnosis."
More pointedly, McClellan told me earlier this year that the kids and teens he was seeing (he sees some very intense kids and teens at two Seattle-area hospitals) who had been diagnosed with bipolar were in fact kids with oppositional defiance disorder and conduct disorder who were largely the product of extreme, and extremely dysfunctional, environments. The leader of the Harvard group, Joe Biederman, has said kids are born this way.
McClellan is far from the only one flying red flags around the bipolar child business. Steven Hyman, a Harvard psychiatrist and former NIMH head, has publicly expressed his concerns about the meds these kids are given: "We don't know the first thing about safety and efficacy of these drugs even by themselves in these young ages, let alone when they are mixed together."
In 2006, Thomas Insel, NIMH director, also pointed to the meds being given bipolar kiddos as being a concern, telling the New York Times, "There are not any good scientific data to support the widespread use of these medicines in children, particularly in young children where the scientific data are even more scarce."
In an op-ed, Larry Diller of UCSF noted: "Biederman shocked the child psychiatric world in 1996 by announcing that nearly a quarter of the children he was treating for attention deficit hyperactivity disorder also met his criteria for bipolar disorder. Up until then bipolar disorder was rarely diagnosed in teenagers and unheard of in prepubertal children. Biederman could justify his findings by simply broadening the semantic definitions of a previously more circumscribed condition contained within American psychiatry's bible -- the 'Diagnostic and Statistical Manual of Mental Disorders'."
So, yes, there would seem to be some controversy around the diagnosis and huge concerns around the meds kids are being given. In fact, I recently detailed just how dangerous some of these drugs have proven in real world, off-label use in children and teens. I certainly wanted to ask Laughren how he could approve meds to be used in children when there was such an uproar over the diagnosis--which adult psychiatrists I know shake their heads at--and when there was evidence that the meds aren't as safe as the approval trials for Risperdal and Abilify might suggest. Not that any of us can examine the pediatric bipolar disorder approval data for the two drugs since the FDA is currently in violation of federal public records disclosure laws because it hasn't posted the approval packages for these drugs in allegedly bipolar kids online. (In fact, the FDA's public database for various psych med approvals is rife with holes, ones I've already asked the FDA to fix.)
But more than the controversy itself, I wanted to ask Laughren what exactly pediatric bipolar disorder is and how it is defined. Does it start at 10? Or two? The term pediatric is so loose that it can apply--as if often does in medicine--to anyone over the age of a baby and under 18 (BTW, there is some consensus that bipolar disorder does exist in teens). What studies had Laughren used to determine the validity of the diagnosis? Why would the FDA have the power to unilaterally create a diagnosis that hasn't even passed muster with the makers of the DSM, that isn't even accepted by state insurance programs (bipolar kids are commonly coded as ADHD) much less private insurance providers. I wanted to ask him how much influence the Biederman/Harvard group had had on the FDA's finding and whether he had taken into account the views of others within child psychiatry on the issue.
I wanted to ask why the FDA has stayed mum on the validity of the disorder, because, if it truly exists, then wouldn't the FDA want to flag its existence for public health authorities so they can screen every kid in America? Wouldn't the FDA want to media to know so they could inform the public? Wouldn't the FDA want to contact NIMH and let them know? NIMH does consider bipolar disorder as a disorder that occurs in children, but ironically its web page listing symptoms of the disorder doesn't include any length of time for the persistence of symptoms the way the DSM does for adults. Since Laughren considers pediatric bipolar disorder the real deal, then he must have it all worked out whether the symptoms of "childhood mania" need to persist for 30 minutes or one week (as with adults) and whether signs of depression need to exist for, say, a day or two weeks (as with adults), and it would probably make sense for him to tell the world precisely what the hell he's talking about.
These are serious questions and they merit a serious response from the FDA. So far, that response is absent.
Well, there's got to be a reason the FDA is avoiding questions. Maybe a major media outlet hasn't called them yet (bureaucrats always get back to the New York Times. Freelancers? Not so much). Maybe the FDA is scared of bad publicity, although after the salmonella scandal I'm sure its skin is fairly thick.
But maybe there's a different reason. I think there is. I'll get into it in a subsequent post, possibly later today or tomorrow.
Stay tuned.
An interesting item popped up on Paxil Progress today, an account of a young man in Canada, who's been on Paxil since he was 15 and is going through a very lengthy and difficult withdrawal from the most addictive of all SSRIs. The basic story is that his doc is fighting him every step of the way, just like any street drug dealer would. The doc offers his patient, now 29, these reassuring words:
"'[Y]ou may just be one of those people that have to stay on Paxil the remainder of your life. It is like insulin for diabetics. Many people take SSRIs for their whole life. Plus, because of the length that you have been on Paxil, you may never be able to get off it.'"
I won't even begin to get into all the falsehoods in this doctor's statement, but why in God's name would a doc get a patient on a drug to allegedly help treat depression and, then, when the patient wants off the drug tell them something like that? It reminds me of the way drug pushers in old TV shows talk to heroin users trying to get clean.
Well, today is my birthday. Number 46. I'd planned on writing a long, reflective post today on some things I am truly bitter about as regards my experiences with being dubbed bipolar and going through psychiatry's big old meat grinder for 18 years when it possibly wasn't even justified. Despite the fact that some of you have written me directly to wonder why I don't fit the usual profile of the angry patient--ie, alleging that psychiatry is criminal and arguing for criminal trials for all pharma execs--there are indeed some things that piss me off mightily about my experiences and I was going to get into all of that and embiggen the hearts of one and all.
But, as I was settling down to write this evening, I was hit with yet another round of bad career news. I am simply too frustrated to write this evening.
I hope you all have a more enjoyable day than I am going to have.
BTW, comments are closed on this post and please don't send me email. While I appreciate your kind thoughts in advance, this is simply one day in my life when I need to be left alone.
In what I've already heard described as a scandal, the CEO of the infamous Western State Hospital near Tacoma, Wash. resigned suddenly last Friday. From yesterday's Tacoma News Tribune:
"Andy Phillips, the chief executive officer of Western State Hospital, resigned Friday, effective immediately."Thomas Shapley, a spokesman for the state Department of Social and Health Services, said agency officials would not answer questions about the reasons for Phillips’ resignation, why it was effective immediately or whether the departure was voluntary.
"Phillips has run the state mental hospital in Lakewood since 2004. The facility has about 1,000 patients and 2,000 employees. The hospital will be run by Richard Kellogg, the state mental health division director, until Sept. 2. Then Connie Wilmot, chief operating officer at Eastern State Hospital in Spokane County, will become acting CEO at Western State, Shapley said. The Washington Federation of State Employees, the union that represents many of the hospital’s workers, declined to comment."
Soulful Sepulcher has already written about it here. It's very interesting to me that neither the state nor the union had a thing to say about what happened. That must mean this is a tricky personnel matter as opposed to a tricky performance issue. What might make it a scandal, I cannot say.
Back when I was a working reporter, I interviewed Phillips a few times. He seemed OK as these things go and I've certainly heard from some families of patients that he treated them well. How the patients themselves fared is less well known to me (it was probably far better than say WSH circa 1995), but Western has been the object of one lawsuit--that I believe is settled--over the hospital discharging patients to the streets. According to a story I wrote back when, this was going on largely before Phillips' tenure.
If anyone has any information about this situation, I'd like to hear from you.
Some of you may recall that a few months ago a study established that there was fair amount of rapid cycling being induced in people with bipolar disorder who were taking anti-depressants. That study led Nassir Ghaemi, a leading researcher in the field, to pronounce that it was "one more nail in the coffin of antidepressant use in bipolar disorder." I expected that these twin assessments would generate some controversy and backlash in the field. I was right.
This month's American Journal of Psychiatry contains two letters to the editor that somewhat defend anti-depressant use in bipolar disorder, or at least question the above study. Neither said anything particularly remarkable or damning, but I note them to keep you all aware of the debate out there among docs. It's kind of amazing, given that we 20 years into the Age of Prozac, that there's still this kind of flux in the field. And thank God for flux, I always say.
In one letter, Joseph Goldberg, a psychiatrist at the Mount Sinai School of Medicine, argues:
"It is likely that antidepressants are neither all good nor all bad. STEP-BD has taught us that broad generalizations regarding the use of antidepressants are relatively uninformative. Much as antibiotics or antineoplastics exert different effects in different subgroups, so too are antidepressants likely to be safe and effective in a definable bipolar subtype—most likely bipolar II depressed patients with no mixed features, no recent mania, no prior antidepressant-associated mania, and no comorbid substance abuse. Far from being the nail in any coffin, the heterogeneity of antidepressant outcomes demands further controlled trials to discern more sophisticated profiles for guiding treatment decisions."
Given Goldberg's disclosure at the end of letter, it's easy to speculate who might fund those studies. "Dr. Goldberg has served on the scientific advisory boards of Eli Lilly and GlaxoSmithKline and has served on the speakers bureaus of AstraZeneca, Eli Lilly, GlaxoSmithKline, Pfizer, and Abbott Laboratories," notes the journal.
He does have a point that anti-depressants probably still have some function with some types of bipolar disorder, but I think your average psych doc or PCP and especially your average psychopharmacologist isn't a good enough diagnostician to tease out whether or not a patient might benefit from, or be harmed by, an anti-depressant. Therefore, patients should be damn careful who they trust.
Either way, I wonder if Goldberg's point isn't somewhat moot since the NIMH-funded STEP-BD study established that placebo outperforms anti-depressants in treating depression in bipolar disorder.
The second letter by Italian psych doc Franco Benazzi I really can't tell what his point is. Maybe you can.
Evelyn Pringle has a piece out today slamming and otherwise ripping apart former FDA official Peter Pitts and Robert Goldberg who author the drugwonks.com blog, a pro-pharma site if there ever was one. In fact, Pringle has dug up so much on these guys that she's written about them in two parts, here and here.
For the uninitiated, the site is one that always rises to the defense of, for example, anti-depressants and makes wild claims such as that a decrease in anti-depressant use in America has driven up the suicide rate, when the evidence is that anti-depressant use has increased despite black box warnings on the drugs and despite the fact that there's pretty solid evidence in the clinical literature that suicide rates and anti-depressant use are statistically independent phenomena, at least on a culture-wide level.
I'm not sure why Pitts and Goldberg are worthy of so much time and space as their influence on the Net is small and their traffic isn't particularly robust (I highly doubt claims Pitts has made on the site about the number of readers it has), but it's always fun to watch some pharma whores get smacked around. One concern I do have is that in neither piece is it clear to me that Pringle contacted either Pitts or Goldberg to ask them to answer questions. Journalistically, that's lame. Even pharma whores should be allowed to explain themselves.
Some people have been chipping me up in comments the last week or so over my choice of words on this site. When I noted that someone "mans" a phone, I wasn't being PC enough. When I used the term sociopath, I was told the term is meaningless (would you prefer I use evil, remorseless motherfucker? Is that any more specific?). And, there have been all manner of gripes lately over my use of the terms bipolar disorder and schizophrenia. And, that's not to forget the protests that erupt if I use the terms borderline or PTSD.
Look, I don't control language in our culture. I recognize there are all sorts of problems with a term like bipolar disorder--what does it really mean? How is it measured? Isn't it just oppressive psych docs fucking up powerless humans and using the labels of language as their M-16?--because there are all sorts of problems with defining human behavior when you cannot chase it back to a simple, testable physical cause and when bipolar disorder plays out much differently with different people.
I use the stock phrases of current-day psychiatry because I have nothing else to work with that a wide group of people can understand easily and because all those conversations about "Ooooh, let's change the terminology and fight the oppressive system" talk are only amusing in grad school when a prof will approve of your linguistic trickery and give you a good grade. In the real world, an editor will tell you stop sucking your thumb and get to your point.
Over the last three decades that I've been a serious reader and writer, I've noticed that the writers who spend their time railing against terminology in this or that field are generally terrible writers and take far too long to get simple ideas across to their audience. I don't want to to be one of those writers. I hope I'm not.
That said, I respect the point some of you are making, but I am already doing far too much with this site--and spending far too much time doing it--to get into language wars in a universe that really doesn't care very much. Besides, finding some nice new PC terms to use in place of various disorders really would do zero to change the social and clinical reality many of us face. I average about 30,000 words a month on this site--go find me another blogger or reporter who does--and I've simply got other concerns.
If you don't like the terms I use, feel free to bitch in comments. Or better yet: go start your own blog, write 30,000 words a month, do it for three years and then get back to me on where you are at.
Keep something else in mind about language as well.
Back in 1994, the nice folks who make the DSM changed manic depression to bipolar disorder. The thinking was that a new term would clear the decks for patients and reduce social stigma and the general public wouldn't react with fear upon hearing the term bipolar disorder the way they did when they heard manic depression. We know how that worked out right?
NOTE: I am taking today off--part of an August slowdown that I've frankly earned--and will be on the road to Portland. I have no idea what my computer access will be like in Puddletown, so comment moderation will likely be erratic until I am back late Saturday.
Have a nice weekend.
Well this is simply classic: via Pharmalot, we learn that trade groups pimping for pharma companies are freaking out and have bought a full page ad in today's Boston Globe. This comes in response to legislation passed in Massachusetts last week that would require pharma companies to publicly disclose any docs they gave payments of more than $50 to. The pharma companies are interpreting this to mean that they would have to disclose information about ongoing, proprietary clinical trials, thereby tipping off competitors about what they are up to and who's in bed with them. Ironically, this info is already somewhat publicly available through the clinicaltrials.gov website.
Anyhow, the pharma companies are using this issue as their moment to threaten pulling clinical trials from the state. What with three major medical schools in the Boston area and a whole infrastructure of biotech and pharma companies and clinical trials shops in the state, that strikes me as an empty threat. Where are they going to move their trials? Maine?
Read the rest at Pharmalot.
As gingerly as possible, I want to note that the Los Angeles Times is reporting that Bruce Ivins, the Army anthrax scientist who killed himself last week and is believed to be the man responsible for killing five and sickening others by mailing out anthrax in 2001, was indeed on psych meds. Currently, the paper is reporting that he was on Celexa, an anti-depressants, and I've seen other indications that he may have been on antipsychotics as well. It's also known that he'd been seeing a therapist.
I don't draw any conclusions at this point about any SSRI/violence connection. Ivins, to judge by press coverage, was a seriously messed-up man who was a sociopath, likely well in advance of ever touching an anti-depressant. I seriously doubt any of us could ever build a defensible case that "Celexa made him do it."
I am simply noting his psych med use in order to document the many ways psych meds have crept into our culture and become tangled up in all manner of human tragedies.
Feel free to disagree with me in comments.
From Liz Spikol yesterday (while I was slacking on a hot Seattle day) comes news that MSNBC.com, one of my least favorite news sites on the planet, ran a big piece on electro convulsive therapy, or ECT. Spikol sees the piece as part of a dark trend in health journalism--an attempt to repopularize the brain zapping procedure which has fallen out of favor since the 1960s and 1970s. While I am in a bit of journalistic wonderment about what prompted the article--the news hook was where? NAMI is a legitimate data source for how many times ECT is used each year?--and am similarly amused as Spikol is by the "ECT is making a comeback" string of stories that have been in the media the last few years, I think the reporter did a fine job of capturing the views of proponents and opponents of the procedure and noting that there is evidence of ECT's lasting bad effects on patients. Ernest Hemingway--famous for, among other things, saying ECT "put me out of business"--is absent from her copy however.
One creepy bit is that she quotes a doctor administering ECT at Swedish Medical Center in Seattle, about a mile from my apartment and a place I won't be able to drive by again without pondering what's going on upstairs.
I'm officially neutral on ECT (except for myself and people I know), as long as the patient has actively consented and the treatment is not forced or state-mandated. If someone wants the procedure and is aware of its risks, then good luck. It's their brain. I don't know anyone personally who has ever had the procedure who has fared well, Spikol included, but I know there are a few readers of this site who say they benefitted from ECT. To each, their own.
Anyway, from a proponent:
"'It's the definitive treatment for depression,' says Dr. Kenneth Melman, a psychiatrist at Swedish Medical Center in Seattle who practices ECT. 'There aren't any other treatments for depression that have been found to be superior to ECT.'"
Definitive? Oh that's a bit much and if ECT is so definitive, then why aren't docs like Melman recommending it to patients as a first-line treatment?
Such talk does make me wonder that if ECT is still legal and somewhat encouraged by the psych industry despite the procedure's well-known risks (short-term memory loss, rebound depression, brain damage), then why don't we simply legalize the use of every possible depression treatment? If ECT strikes psychiatrists as safe and efficacious, then they ought to be able to accept the use of pot (a la California), MDMA, ketamine and so on as depression treatments. And while we're at it, why isn't the mental health industry encouraging people with chronic depression, who've generally flunked numerous anti-depressant trials already, to undergo an off-meds trial before recommending ECT? ECT is an any-port-in-a-storm procedure, so we may as well be consistent and try everything short of ECT first.
From opponents of ECT:
"Some former electroshock patients say that the treatment's side effects don't end with short-term memory loss. Juli Lawrence, who had 12 ECT treatments in 1994, says it caused long-term cognitive damage. She says she now has trouble learning new things, and she still has problems with her memory."'My family and I were told it would cure the depression and it did not,' says Lawrence, who's 46 and lives in Long Island, N.Y. 'After holding out all this hope that it would be the final answer, it didn't happen. I was completely devastated. On top of that, I had memory loss, and on top of that, I had cognitive damage.'
"Lawrence runs a Web site called ect.org, which has a message board filled with hundreds of former ECT patients who call themselves 'electroshock survivors.'"
Interestingly, one reader of this site occasionally mans a suicide hotline for a state government. She tells me that after the MSNBC.com article came out, she fielded two calls last night from patients wanting to know where they could get the procedure.
As I've been noting on this site for over 18 months, the blockbuster antipsychotic Seroquel is doing double-duty as a street drug. It's a downer-ish drug, snorted or injected, and is gaining some popularity as a replacement for OxyContin, which is apparently getting somewhat harder to get on the black market. So one of the top selling psych meds on the market is now becoming a new "hillbilly heroin."
From July's American Journal of Psychiatry, we learn that some doctors in the LA area have encountered some people so desperate to get their hands on Seroquel that they'll feign symptoms of schizophrenia.
"We present a case report of an individual who demonstrated classic drug seeking behavior, compulsive drug use, and diversion for resale of the atypical antipsychotic compound quetiapine.
"'Mr. A' was a 29-year-old divorced, unemployed, Caucasian man, with an unclear medical history, who presented himself as a walk-in to our acute psychiatric treatment unit with a medication refill request. He reported that he had been diagnosed with schizophrenia (for which he was being treated with quetiapine [600 mg nightly]) and the local police were disturbing his sleep by "electronically monitoring" his testicles. He received his "usual" dose of quetiapine and then slept soundly. On examination the following morning, Mr. A had become cagey about the details of his somatic preoccupation and, although still somnolent, he lacked evidence for either a thought or mood disturbance. His urine toxicology screen was negative. The profundity of his sedation prompted a pharmacy review, which revealed that he had been receiving different and excessive amounts of quetiapine from several sources during the past few months. Upon confrontation, he admitted to both the excessive use and sale ($3.00 per 100 mg tablet) of quetiapine."
Three bucks a pill? The black market is cheaper than drugstore.com, which sells Seroquel in 100 mg. slugs for almost $4 a pop.
The docs go on to comment:
"Quetiapine has come to dominate the atypical antipsychotic market, primarily through its use in the technically 'off label' circumstances described previously [anxiety and other mild mood disorders a la benzos in the 1960s and 70s and Miltown in the 50s]. The modestly sedating toxic profile and perceived absence of abuse liability of the drug have prompted many clinicians to use it in place of traditional benzodiazepines for anxiety and insomnia. There is currently an accumulating body of anecdotal evidence regarding the type of patient described in our case report, which questions both the accuracy of perceptions about the use of quetiapine and the wisdom of treatment practices. If the current misuse of the compound continues or expands, then the abuse 'signal' will predictably become more evident and could ultimately prompt federal regulators to declare quetiapine a controlled substance. Should such an unfortunate eventuality come to pass, we will be able to confidently lay the blame at the feet of our collective prescriptive imprudence."
In other words, they are saying that docs are a bit too free in prescribing Seroquel for whatever ails the American mood and that it's possible a fair number of people will end up addicted to the drug.
And, if someone is willing to fake symptoms of schizophrenia in order to get their dose, then that tells you something about the drug's addictive potential.
A recent Canadian study in the Journal of Clinical Psychiatry suddenly popped up on Reuters yesterday. In it, researchers assert that 20 mgs. of Paxil taken for two weeks, as opposed to all the time, will help alleviate symptoms of severe PMS--or premenstrual dysphoric disorder, to use its pathologized name--and improve social functioning among women. There's no limit to what these magic anti-depressants can do. What's next, Paxil for migranes?
"The findings, Steiner and colleagues add, support recently published expert guidelines for the treatment of PMDD, which state that an intermittent dosing schedule is an appropriate choice for women who wish to limit the amount of medication they take, can adhere to the on/off dosing regimen, have no mood symptoms at other times during the menstrual cycle, or are concerned about long-term side effects of antidepressant medication."
The study was fairly short term, tracking the women over four different two-week periods and relying upon the subjects to answer surveys, so you've got to wonder how effective and safe such a treatment paradigm would be long term. But then we live in a culture where doctors often assume that short-term studies augur long-term success.
As much of a problem as I know extreme PMS is, there are reasons to be dubious of this treatment as a way to manage PMS. Going on and off anti-depressants--hell, any meds--is flat out risky and can easily induce mania (there are docs who diagnose people with bipolar disorder based upon responses to Paxil) in some along with suicidality, hence the black box warning on the drug. Second, I've got wonder exactly how the drug is producing its PMS-dousing effect: I know the researchers claim that the effect is fairly small and I know that Paxil has a very short half-life for an SSRI, but it generally takes two to four weeks to get what researchers consider the full therapeutic effect of the drug and so you've got wonder if the Paxil is effecting things much at all or if something else is at work.
I'm sure researchers will not be looking for that answer.
A 14-year-old boy in the fancy Nashville suburb of Belle Mead--yep, it's where Al Gore lives--reportedly stabbed his parents in their sleep and was being treated with anti-depressants prior to the attack. The parents are OK.
Man, what is it with anti-depressants always hovering in the background of these weird, tragic events?
We'll see if there's further details on this later. Anyone want to place bets on what anti-depressant this kid was on?
I've opined before that the meds, meds, meds, bio, bio, bio paradigm of mental health treatment in our culture has damn near destroyed psychological treatments--and maybe innovations--over the last 20 years or so and that psychiatry, which used to be more about therapy than meds per se, has lost its soul in the process. A new study out in the Archives of General Psychiatry puts some numbers on my wild assertion.
In 1996, according to the study, 44 percent of psychiatrist visits involved psychotherapy while in 2004 only 29 percent of visits did. Keep in mind that that decrease took place over only eight years and that prior to the advent of SSRIs and mood stabilizing anti-seizure drugs and the kinder gentler, use-them-for-everything atypical antipsychotics in the late-80s/early-90s, the prevalence of therapy in psych doc visits was well over 50 percent.
The cliche of the couch has been replaced by the cliche of the 15-minute med management appointment with a psychiatrist who's, if you want to be really cynical, a drug dealer. Are we any better off as a culture as a result? I think not and don't know of any evidence to argue that we are.
You can round up the usual group of suspects to explain why this has gone down--corrupt pharma companies, corrupt researchers, a ginned-up DSM, lazy doctors, DTC advertising claiming the omnipotence of meds, insurance companies paying docs less for therapy than med prescribing, authors like Kay Jamison and Peter Kramer and their homies turning into very convincing shills for psychopharmacology, astroturfing patient groups spreading their voodoo around, a media that helped them spread their message and patients foolish enough to believe in the paradigm shift.
I count myself as once being among the latter group. Not anymore.
And let's not forget about all the problems meds have caused in our culture, aside from their propagandists leading us down a blind alley.
All of this has gone on despite decent evidence that psychotherapy is at least as effective in meds in treating depression and other psychological ills. From the AP:
"[S]aid Dr. Eric Plakun, who leads an American Psychiatric Association committee working to restore interest in psychotherapy by psychiatrists."'The couch is far from dead,' Plakun said. 'The couch turns out to be an effective 21st century treatment.'"
It'd be interesting to know how therapists and psychologists have fared during this shift in how America treats its mood. Probably as well as America's patients have.
Just as I was posting this, an ad came on my local TV station, touting a research study for a depression medication. Faceyourdepression.com was given as the site. This is a huge study--run by something called The Patient Recruiting Agency--with sites in 22 states and the District of Columbia. I went through the site and couldn't figure out what med or pharma company is involved, so if anyone does figure it out let me know.
When was the last time anyone saw a similar TV ad for an investigational psychotherapy?
A new Australian study in the Archives of General Psychiatry is out, bolstering earlier research showing a therapeutic benefit--ie, less psychosis--for women diagnosed with schizophrenia. It's an add-on treatment and, of course, not super helpful for men with schizophrenia (who generally are diagnosed with schizophrenia more than women are) and it's not entirely clear to me how great the benefit is for the women in terms of symptom improvement (I've not seen the full paper), but this is the first decent bit of news I've seen on the schizophrenia front in like forever. This relatively thin Reuters piece also covers the study.
The research on this is still in its infancy, but I have no doubt that some docs will start experimenting on their own. Of course, estrogen treatment essentially amounts to what's known as hormone replacement therapy and HRT has turned out to have all sorts of problems of its own, so it will be interesting to see where all of this goes. Maybe the day will come when Fuller Torrey will write op-eds demanding that women take their estrogen and be forced to do so.
Just wondering aloud: would testosterone replacement therapy have any benefit for men with schizophrenia?
There's a good, lengthy article in yesterday's News Journal (Wilmington, Del.) on just how big a drug the atypical antipsychotic Seroquel has become ($4 billion in sales), how central it is to AstraZeneca's profits, how the drug has been widely (and wildly) used for off-label conditions (insomnia, anxiety, agitation, etc.), how come people have ended up with diabetes and other problems on the drug, and how the lawsuits are now flying. There's even a fairly well known bipolar--Liz Spikol--quoted as saying the drug was a miracle for her. The company denies the lawsuit' allegations and so on.
I'm quoted at the end as saying much more unfriendly things about Seroquel, which among other things gave me tardive dyskenisia.
As for the drug's prominent off-label use and continued use for schizophrenia, despite CATIE and other studies showing its no better than older, cheaper drugs, one of the CATIE investigators said:
"'You had 10 to 15 years of marketing in which the companies controlled the journal publications, controlled the speakers bureaus, controlled the dinners, controlled the patient advocacy groups, all of which communicated these drugs were a breakthrough,' [Yale psychiatrist Robert] Rosenheck said. 'But there was little independent research.'"
All points I've been making on this site for almost three years. Seroquel is one drug upon which I have lavished a ton of attention on this site and you can browse through the collection here.
I was happy to see the reporter do a small sidebar on reported addiction problems with this drug, although the focus was mostly on its use as a drug of abuse in America's prisons as opposed to by America's teens, who apparently like to crush up the pills and snort them.
All in all, good work on a very tricky drug that is soon to be approved by the FDA for depression and anxiety. After that, things will get even trickier I bet.
There was a fascinating and disturbing piece in the New York Times magazine yesterday, profiling one of the world's most prolific and malicious Internet trolls. The young man profiled lives about 10 miles from me and is the guy behind the flashing screens that messed up some people with epilepsy in a forum and he also publicly revealed the identities of men who had answered a phony Craigslist sex ad he posted and so on. His mom must be very proud of her son, who strikes me as someone who is crazy like a serial rapist. And there are many other guys like him on the Net. One wonder why it is always guys.
It tells you a lot about where we are in America these days that such a creep merits 6,000 words in a major magazine. No doubt he will get a book deal and job offers as a result of the article. After all, the prostitute involved in former New York Governor Eliott Spitzer's downfall got a $2 million book advance last week. What a country.
I bring this up also as a way to point out to some readers who keep nudging me to ban certain commenters because they think their rhetoric is too heated that the heated comment threads on this site are nothing compared to what you encounter on popular political websites and the like. If you don't believe me, head over to Daily Kos and look through the old online war between Obama and Clinton supporters, which eventually drove the Hillary voters away from the site. Ugly isn't even the word for it for what went down between all those diversity-embracing progressives.
So welcome to the Internet. I've had trolls come through here a few times and I do what I can to chase them off when they are out of line. It mostly works, but it sure is tiring.
Well some gifts at any rate, as we learn from the Carlat Psychiatry Blog after the Massachusetts Legislature last night passed strict limits on pharma companies giving gifts to doctors. Any gift to a doctor--and this includes speaking fees--of over $50 must be disclosed and will be available in a public database.
The new gift code will be regulated by the state department of public health--one group I always hate to see get more power--but pharma companies will still be allowed to give doctors free lunches. No mugs but free food? Talking about your compromise bills.
As Carlat notes, the new law will not cover payments to docs by third party payers and that means the door will be wide open for continuing medical education companies to pay docs whatever to present CMEs and this will go undisclosed. Plus you've got to know that the CME companies will find a way to turn into a conduit to provide all manner of gifts to docs under their umbrella. Or some smart pharma rep will quit working for Lilly, say, and go off and start a third party, gift giving company that will go around and give docs all the free mugs and pens (and clocks and...) emblazoned with various drug logos.
And so America marches on.