The State of Georgia yesterday settled its claims against Eli Lilly over accusations of off-label marketing of its antipsychotic Zyprexa for $15 million, according to the Atlanta Journal_Constitution. The feds will get $9 million of that to cover payouts from the federal portion of Medicaid while the state will get $6 million. (Neither Lilly of the Georgia AG's office have put out press releases.)
The AJC's reporter pointedly quotes trial lawyers who say that the state let Lilly off cheap. Keep in mind that last year the much smaller State of Alaska settled similar claims with Lilly for $15 million. It's especially surprising since Lilly has pleaded guilty to federal criminal charges concerning its marketing of Zyprexa. You'd think taking this case to a jury in Georgia would pretty much be a slam dunk for even an incompetent litigator.
Eleven more states are suing Lilly over Zyprexa. To date, Lilly has agreed to about $2.7 billion in settlements over Zyprexa. And, there's more to come.
Yesterday, I posted on the fact that 10 percent of people being treated for depression in the US are now being prescribed antipsychotics (Abilify, Seroquel, Risperdal, Zyprexa) and one reader had some thoughts on a Seroquel-related incident. Q is Seroquel (or Susie Q), AZ is AstraZeneca (the drug's maker) and 5oh is the police (as in "Hawaii 5-0").
"There's a certain hospital here in SE Connecticut (not many to chose between, so don't strain yourselves trying to sort it out...) that literally uses a shovel to dispense Q to its in-patients. I thought it rather odd until I saw the AZ clock on the wall and numerous other pharma paraphernalia about the nurse's station."I had a chance discussion with a young man who flipped out due to unplanned Q withdrawal. He had been unable to refill a prescription - 800 mg/day!!!! - became highly agitated and later corralled by 5oh. Basically, all he wanted was a refill, but he was kept under observation for quite some time and in the end was given a short supply and released. I often think of this young man and wonder what sort of life he can expect. What he really needed and wanted was dependable shelter and a job. Too bad none of the staff managed to capture this in his chart.
"I've really come to hate the field of mental health. I'm so fucking sick of the way fellow human beings are treated as chattel. It's shameful and embarrassing."
I know how the commenter feels. I've seen the mental health system on a street level on the West Coast for two decades and I've seen so many examples of the above kind of situation that I've at times gone numb to it all.
BTW, it's interesting that no one in the media has picked up on that 10 percent Rx rate, which strikes me as a watershed moment in depression treatment. I bet you the media would pay more attention if 10 percent of patients with depression were being given ECT.
Much of this will come as old news to most readers of this site, but an Institute of Medicine (part of the National Academy of Sciences) panel has issued a report wherein it found all sorts of conflicts of interest in relationships between docs (and doctor training) and pharma companies, and wherein it found such relationships unacceptable, and wherein it called upon docs (medical schools, etc.) to stop taking gifts (which run the gamut from pens to strippers), free samples and underwriting of continuing medical education courses. Or at least to publicly reveal those relationships.
The IOM panel was speaking to all of medicine, not just psychiatry.
Of course, such relationships strip away public trust in docs and their advice (much less their research findings) because any smart consumer will wonder whose team their doc is on when their doc gets speaking fees from AstraZeneca, say, and their CME courses are paid for by Eli Lilly and the like.
The IOM is a very influential body in the medical world, so it'll be interesting to see what effect this all has. On his blog, psychiatrist Danny Carlat calls the report a "knock out blow to greed in medicine." Bernard Carroll at Health Care Renewal offers his thoughts on some possible conflicts around the IOM.
A recent conference call with financial analysts by executives with Bristol-Myers Squibb, makers of Abilify--the antipsychotic that will cure your non-psychotic issues--is revealing. Over 10 percent of Americans now take an atypical antipsychotic for depression, according to the company. Much of that prescribing has got to be off-label as Abilify is the only approved antipsychotic for the condition, all of which makes me damn suspicious of how Seroquel's bipolar depression approval in 2006 may have been turned into a proxy approval for major depression.
Forget about Prozac Nation, this is Atypical Nation. Think I'm joking? Antipsychotics are now the top revenue producing class of drugs, topping even statins.
But I'll let Elliott Siga, BMS's chief scientific office, talk his talk:
"Obviously, we cannot comment on if and how Seroquel XR will be approved. What we can say is that what we’ve seen so far as far as Abilify in that indication is concerned is very positive and we’re very happy. Since we launched Abilify in that indication, and we’re the first and only atypical approved for that indication, we have seen the total market growing."Atypical penetration in MDD has grown more than a full percentage point since we launched, and it’s now 10.6%, and our share in that expanded market has gone up to 21.7%. This is the last data point I have, and it’s as of December 2008. Now, we’re speaking about a huge market. There are 10 million patients treated and diagnosed for depression in the US, and there are 6 million patients in second line and beyond [the total number is on the order of 20 million], so this is a huge market, and we believe that there is space also for a competitor in this market, especially given the different profiles that the two products have.
"Let me add that every time we launched a new indication for Abilify, we also see important halo affects on the other indications on that product, and this is why we have been aggressively and seriously working on a large clinical development plan for this product. Therefore, what we see is that since we launched the MDD indication, the growth in the other indications has continued to be significant and important, and as a reminder, there is a population of up to 2 million patients with bipolar disease with manic or mixed symptoms. This is the target of Ability, and there is an additional 1.5 million patients treated and diagnosed with schizophrenia. Our growth comes not only from MDD, but comes from all the indications."
Halo effects? Well isn't that special?
If there are about 20 million Americans taking some kind of medication for depression, the use of atypicals would work out to about 2 million Americans taking the drugs for depression--and the research on these drugs' use in depression isn't especially promising. That 2 million number would also work out to more people taking the drugs for depression than for schizophrenia, or something very close to that.
I think this trend of using atypicals like Abilify and Seroquel for depression (as opposed to psychotic depression) is scary and will result in numerous patients winding up with all manner of problems (weight gain, diabetes, akathisia, heart problems, etc.). Good luck to one and all who take these drugs for depression.
This trend also signifies just how weak a technology anti-depressants have proven to be in many cases (even the Abilify TV ad for depression states that two-thirds of people who take an anti-depressant don't see good results), how desperate some people are for relief and how willing they are to try out psychiatry's nuclear weapons. That says something about depression and America.
First quarter sales of Pfizer's stop smoking drug Chantix were down 36 percent from the same period last year to $177 million. Of course, this is being driven by reports that the drug caused suicidal ideation (and actual suicides) in some cases. It's interesting that the public paid so much attention to this in regards to a smoking drug but not nearly as much with anti-depressants. (All kinds of previous coverage of Chantix here.)
Two thoughts: one, Chantix sales had already gone down dramatically in the first quarter of 2008, so this further decline is strike. Two, even more striking, is that Pfizer advertised the hell out of Chantix in the first quarter of this year, primarily through the "my time to quit" advertising campaign and through some advertising for the pill itself. It's nice to see that on occasion Big Pharma's ad campaigns fail to pay off.
There was a fabulous and very telling op-ed in the Boston Globe yesterday. Authored by Claudia Meininger Gold, a Massachusetts pediatrician, it goes into how so many children--and adults, by implication--are being medicated for underlying psychological issues (as opposed to psychiatric ones) when the children (and adults) could benefit far more from addressing underlying grief and other issues. Seriously, a doctor wrote this in a major American newspaper.
And what Gold wrote is so illustrative of what I (and many others) have been pointing out about America's much-changed medical, educational and family systems that I'm going to let her say it.
"A 5-year-old girl was referred by her kindergarten teacher for evaluation of attention deficit hyperactivity disorder, with a strong recommendation that medication be considered. Her behavior had been disruptive since preschool, but was now affecting her ability to learn. There was concern that she might not be able to move on to first grade. Before I even saw the patient, armed with standardized forms and psychological testing, I was quite sure that she would meet diagnostic criteria for ADHD and that medication would be a reasonable consideration."I met with her parents, who described classic symptoms of ADHD, including prolonged battles at home around such simple tasks as getting dressed for school. About halfway through the visit, I began to ask, as I always do, about past history. "How was your pregnancy with her?" There was a pause, during which the parents exchanged looks. "Actually, I'm not her biological mother."
"Now it was my turn to pause, as I was quite shocked to receive this important piece of information so late in the evaluation process. With some reluctance, they went on to tell me that the girl's mother was seriously mentally ill, had been intermittently involved in her life, and had disappeared completely two years earlier. But, they assured me, she never talked about her mother and it wasn't an important issue.
"This story has a happy ending. I agreed that medication could be helpful, but, building on the trust they had developed with me as their pediatrician, I suggested that the loss of her mother was actually very important and needed to be addressed. They accepted my referral to a therapist. I am fortunate to have an excellent colleague across the street who accepts their insurance. He wisely explained to them that children do grieve, and now the whole family is engaged in working with him around this painful and difficult task. This child is now thriving in first grade.
"For this one positive outcome, there are hundreds that do not end this way. Children who have experienced terrible loss do not have the opportunity this girl had. They are aggressive and disruptive, and their symptoms are medicated away. They continue to struggle, often failing in school. Some of the reasons this path is chosen are lack of time, limited access to mental health services, and resistance to doing this hard work."
Gold sure covered the waterfront there.
She also noted that the Commonwealth of Massachusetts spends $190 million a year on psych meds. You've got to wonder how much of that is spend on papering over grief and the like and how much of it turns out quite badly for the children (and adults) involved. I'm not pretending that among some of these children (and adults) that there isn't something other than grief driving matters, but when you read this kind of talk from clinicians it makes you wonder about a lot of the assessments of researchers on child (and adult) disorders.
A new study is out in Pediatrics, asserting a positive association between kids taking ADHD meds and test scores. The study covered a five-year period and involved 594 children. What surprised me about the results is how small they are and how the New York Times characterized them on its Well blog.
Here are the study results:
"RESULTS. Medicated children had a mean mathematics score that was 2.9 points higher than the mean score of unmedicated peers with attention-deficit/hyperactivity disorder. Children who were medicated for a longer duration (at >2 waves) had a mean reading score that was 5.4 points higher than the mean score of unmedicated peers with attention-deficit/hyperactivity disorder. The medication-reading association was lower for children who had an individualized education program than for those without such educational accommodation."CONCLUSIONS. The finding of a positive association between medication use and standardized mathematics and reading test scores is important, given the high prevalence of attention-deficit/hyperactivity disorder and its association with low academic achievement. The 2.9-point mathematics and 5.4-point reading score differences are comparable with score gains of 0.19 and 0.29 school years, respectively, but these gains are insufficient to eliminate the test-score gap between children with attention-deficit/hyperactivity disorder and those without the disorder. Long-term trials are needed to better understand the relationship between medication use and academic achievement."
Those are pretty minimal gains. But the NYT cast them thus:
"Children with attention deficit problems make bigger academic gains if they are taking stimulant medications compared to similar kids who aren’t receiving drug therapy, a new study shows."
That's just silly, especially since the reporter didn't add findings of other recent ADHD meds studies showing no gains with stimulant use after about two years. Here's the recent MTA study, for example. Interestingly, the new study claims that 7.8 percent of American children (4.4 million people) have ADHD, one of the larger prevalence claims I've seen for the disorder.
I sure don't envy parents of young children these days.
I know some of you are aware of the case of Christian Hageseth, a Colorado psychiatrist, who was convicted earlier this year in California of prescribing without appropriate licensure to a Stanford student. The drug in question was Prozac, Hageseth prescribed it over the Net after the student filled out a questionnaire, and the student later killed himself.
Hageseth faces 9 months in jail.
Now Coloradoan.com has a fascinating article in which Hageseth defends Internet prescribing as serving the poor and underinsured with depression and basically says he knew what he was doing was illegal, but that his sense of mission in serving people with depression justified his actions. He's a true believer and has been on anti-depressants himself for many years. So has his wife--for 20 years. Hageseth says he wants to start a non-profit that will give vouchers for doctor visits to depressed people without insurance.
I think Hageseth is out of his mind. While there are obvious problems with health care access for the poor and underinsured (I know this so well personally) and while I'm all in favor people getting help for depression, prescribing anti-depressants, as Hageseth did, without a proper medical and psychiatric exam is a huge ethical breach and dangerous, regardless of prescribing laws in various states. Questionaires on web sites simply don't cut it. And Hageseth's voucher idea would be little more than a one-way ticket to SSRIs, not psychotherapy of any kind and likely not to a doctor who's going to press the patient to go through appropriate steps (watchful waiting, exercise, diet) prior to sticking them on a drug.
What's more, the Hageseth case also makes me wonder about the propriety of doctors who take anti-depressants prescribing anti-depressants to patients. I've encountered a few of these sorts over the years and they are so deeply biased in favor of anti-depressants at all times (and for long term chronic use) that they ought to come with a warning label or disclaimer of some kind.
It's not too often I note anything from a fashion mag, but Vogue has an article out detailing the rethink some moms (and doctors) are going through concerning the use of anti-depressants during and after pregnancy, particularly in light of reports of birth defects cropping up in some cases. The article is worth a read. It's certainly nice to see something like this cropping up in one of the most mainstream publications imaginable. (Via Beyond Meds.)
Beyond Meds posted a lengthy, searing indictment of NAMI and its "Family to Family" program recently. It's essentially the text of a booklet authored by a psychologist named Ty Colbert who, among other things, criticizes NAMI for offering families "false hope" when they grapple with a mentally ill child (or adult child) because the group pins almost all of its claims on weak theories of chemical imbalance driving mental illnesses. What's intriguing about Colbert's assertions is that he makes them as someone who has participated in many NAMI conferences and who observed an entire "Family to Family" course for 12 weeks.
NAMI is of course under investigation by Sen. Charles Grassley (R-Iowa) for the many millions it get from pharma companies.
A sample of Colbert's writing:
"Even though these members (parents) are dedicated to helping their children, because they have been falsely convinced that mental illness is a biological disorder, they are blindly helping to disable their children, many for life. This booklet has been written to expose this tragedy that has affected hundreds of thousands of young individuals and their families."
Colbert is pretty much from the anti-meds camp and has written a few books on psychiatry and psychology. It's interesting that he presents small case studies of one person for whom the NAMI approach (medication first, last and always) worked and someone for whom it didn't.
Anyhow, it's a long, interesting read and has certainly led to an epic comment thread over at Beyond Meds.
I hadn't known AstraZeneca was trialing its top-selling atypical antipsychotic Seroquel as a treatment for anorexia nervosa, but in fact it has two trials underway. A press account of the trial reveals that one patient's "weight is back in a healthy, normal range and her thoughts about food have improved."
That's nice, although it's a bit odd to be publicizing a clinical trial before it's complete. It'll be interesting to see if AZ pursues FDA approval of the drug for anorexia.
A small study last year found that Lilly's atypical Zyprexa was an awesome anorexia treatment.
There was a big drug sweep of low level dealers in Lehigh County, Pennsylvania yesterday and along with popping people for allegedly dealing cocaine and pot, cops arrested two people for allegedly dealing Seroquel:
"Ashley Thomas Morgan, 21, with no known address, was charged with criminal use of a communication facility, sale of non-proprietary drug, possession with intent to deliver a controlled substance, possession of a controlled substance and two counts of criminal conspiracy. He was sent to county prison under $50,000 bail."He and another person allegedly twice sold Seroquel, a medication normally used to treat bipolar disorder and schizophrenia, to an undercover officer in February at Route 873 and Chestnut Street in Slatington. He and the other person also allegedly sold cocaine to the undercover officer in February at Main and Walnut streets."
Lovely.
You don't know whether to laugh or feel bad for all involved, but the "Dear Prudence" column on Slate.com has a letter from a man who's on anti-depressants and Ambien. He claims that he went out to do errands one night and ended up having sex with a woman he barely knew, and remembered none of it until she called him asking for more. I guess this could be called "sleep cheating."
Funny or not, that Ambien-induced amnesia sounds like hell.
There's apparently a real trend in our land toward excessive polypharmacy in our elders and this account from Peter Gott's "Family Doctor" syndicated column provides a spooky example of the trend and the overuse of psych meds to "calm" patients. The man was 79 and was diagnosed with multisystem atrophy and also has dementia.
"He fell last May, breaking his arm and hitting his head. Within one day, he was unable to feed himself, walk or do anything. He was hospitalized for eight days and then spent two months in a rehabilitation facility. During his hospitalization, he became extremely agitated and was given Ativan. A few days later, it was found that he had a urinary-tract infection. He had two more UTIs while in rehab, which would cause him to become agitated. Each time, he was given Ativan."After completing rehab, it was suggested that he go to a hospital ward where 'they would adjust his medications.' He spent a month there. Because of his orthostatic hypotension (low blood pressure from sitting or standing up too quickly) from the MSA, he was immediately restrained. During that month, he was given FazaClo, Haldol, Provigil, Lunesta, Lexapro, Seroquel, Cymbalta, Thorazine, Depakote sprinkles and eventually had four electroshock treatments. The drugs were given in various combinations and dosages, which sometimes changed daily. When he was discharged, he was sent to an assisted-living facility. He could no longer walk, was incontinent, couldn’t hold up his head, communicate, or feed or care for himself in any way. He had lost 35 pounds."
That's some nice medication adjusting going on there.
Seriously, though, I keep hearing similar stories from readers and you've got to wonder what the hell is going on out there and where this overuse of psych meds got started. As for ECT for agitation with dementia, I've never heard of the practice and am disgusted by it. You've got to wonder how all this was going down and if it happened behind the family's back. The case sure sounds like elder abuse to me.
As it happens, the above man was taken off all the psych meds and has reportedly improved over the last five months. Gott himself agreed with the move.
On a personal note, my father, 76, recently developed bronchitis and went to one of those Redi-Care sorts of clinics they have in Arizona. The doctor who saw my dad said he was stunned that my father was on no medication of any kind (there's no reason for any). Apparently, it's quite common for senior citizens to be on a slew of drugs for all kinds of ailments, but when you read stories like the above you just shake your head.
I ran into a transcript of the conference call held the other day between executives for Forest Labs, makers of Lexapro, and financial analysts. In it, Lawrence Olanoff, the company president and COO, stated:
"Further last month we announced that the FDA approved our supplemental NDA for Lexapro with the indication of acute and maintenance treatments of major depressive disorder adolescents of 12 to 17 years of age. This program included clinical studies in a patient population, which has in the past proven difficult to demonstrate positive results. We are enormously gratified that Lexapro now be available for the approximately 2 million depressed adolescents in the U.S. who can share the benefit which Lexapro has provided for depressed adult patients for the past seven years."We expect that this additional indication will further help to stabilize to position of Lexapro in the market as we begin to detail to psychiatrists who diagnose and treat adolescent patients with a depressive disorder."
I sure cannot wait to see the company's sales pitch to doctors, especially given that the drug had two failed clinical trials for adolescents and its positive trials had small effect sizes. But 2 million American teens and their parents remain to be confused about the drug's alleged benefits.
Even more interesting is that company officials also identified that they had set aside $170 million "in connection with the ongoing discussions with the U.S. Department of Justice investigations." Forest didn't say which specific investigations they meant, but it's a clear reference to the DOJ's current investigation of the company off-label marketing Lexapro for kids and of the company providing kickbacks to doctors. The drug was only recently approved for use in adolescents. Whether whatever deal the company reaches--or doesn't--with the feds works out to $170 million or not remains to be seen.
Stay tuned.
It's been an interesting last two weeks or so around here: I get interviewed by Psychology Today's website two weeks ago and last week none other than the great CL Psych noted:
"After a very interesting interview with Philip Dawdy, and now one with David Healy (and other interesting posts), I am really glad the Psychology Today has Christopher Lane on board. I'm sure some people are not pleased with Lane interviewing two of the more prominent critics of modern psychiatry."
Flattering to say the least. Last week, too, I wrote a post noting the controversy around the MOTHERS Act, expressed my view that post partum depression is real, that it's treatment (as with all "depressions") is fraught with problems and then offered a few skeptical observations about PPD now as compared with the past. As some of you know, I got knifed up very hard by some of the supports of the ACT, even ones who claimed I had denied the very existence of PPD. Among the critics was John Grohol, the founder of PsychCentral.com who emailed me to complain about one bloody graf in my post. We exchanged emails and the other day Grohol wrote a post attacking skeptics of the MOTHERS Act and singling me out in particular.
Sometimes I ignore criticism of my writing on the Net, but a lot of people read PsychCentral and its blogs, including some of my colleagues in the media, so a non-response on my part isn't possible.
"It is estimated that postpartum depression (PPD) affects from 10 to 20 percent of new mothers. In the United States, there may be as many as 800,000 new cases of postpartum conditions each year. The cause of PPD isn’t known but changes in hormone levels, a difficult pregnancy or birth, and a family history of depression are considered possible factors."Sounds good to me. But Philip Dawdy over at Furious Seasons remains skeptical:
"'Here’s the thing that makes my scratch my head, however: women have given birth for many thousands of years and many have experienced “baby blues,” until recently without mental health screenings or psych meds of any kind and without a bunch of arm waving about post-partum depression (the advocacy on this issue is a phenomenon of the last decade). Broadly speaking, the lack of such supposed benefits does not seem to have harmed society a bit, although there are obviously individual exceptions.'
"With that same logic, Philip could be scratching his head about a lot of disorders where, prior to their “invention,” people seemed to get along just fine in society — attention deficit disorder (ADHD), PTSD, panic attacks, autism, Asperger’s syndrome, etc. It’s no surprise to anyone who’s studied women’s history to understand how repressed their voices have been in society until the past few decades. So is it any wonder that history isn’t filled with their accounts of grappling with postpartum depression? A woman would be an outcast from their own family for admitting such a thing even 50 years ago. Even possibly disowned or institutionalized. It just wasn’t said or discussed much."
Where do you even start with this kind of shit? To begin with, the whole feminist line, which Grohol accepts, that all women were oppressed at all times in American history prior to say 1980 to the point where they couldn't speak about anything is excessive on its face and pretty much sexist propaganda. It's also a cheap shot considering that some women have publicly criticized the Act. And instead he goes after a guy? Nice.
But, anyway, yes, in 1946 approximately 4 million women gave birth (the same number as in recent years but with less than half the 300 million or so Americans that there are now), so if you believe Grohol about 800,000 women would have had PPD (note: Grohol and I aren't talking about postpartum psychosis or so-called baby blues). It is a big stretch to assume that that many women could be muzzled about having depression. But, in revisionist American social history, all men are rapists, wife beaters, neer-do-wells and raging alcoholics who silence their women folk for fun. Look, there are plenty of lousy men now and there were then, but for all of them to successfully silence the women is the kind of a claim that sets by bullshit detector off. I find it truly odd that before our age of medicalizing absolutely everything about our lives (for the profit of Big Pharma and doctors of course) that some kind of data, literature, cultural anecodotes or family histories from that time hasn't trickled through to ours on PPD.
More importantly, what I wrote in my original posting and what I tried to express in several emails to Grohol is that I was curious about what has changed about childbirth and being a new mom (indeed with being a woman) now as opposed to 1946 and if there might not be some clues there to help us address PPD (many things have changed about child birth and being a new mom over hte last 60 years). Because if 800,000 women a year are being laid low by PPD, then you'd want to leave no stone unturned in looking for answers and treatments, especially given the well-known problems with depression treatment. It'd pay to be a bit skeptical in such an environment and that's what I was trying to do as gingerly as possible. Besides, I didn't even deny the existence of PPD. In fact, I said it was real.
What's also cute is that Grohol ignores the fact that many of the critics of the MOTHERS Act are women (Evelyn Pringle is a good example) and that there are many, many examples of anti-depressants damaging new moms and causing birth defects. They want to be heard, they want a voice in all this, too. Would Grohol support an act of Congress for them? Or would the pharma ads on his website reduce his interest in assisting them?
But what really tears it for me is when Grohol asserts: "With that same logic, Philip could be scratching his head about a lot of disorders where, prior to their “invention,” people seemed to get along just fine in society — attention deficit disorder (ADHD), PTSD, panic attacks, autism, Asperger’s syndrome, etc."
Grohol knows quite well that I scratch my over ADHD, bipolar disorder 2, social anxiety disorder, depression and the like (in some cases their validity, but mostly about questions of prevalence, diagnosis and treatment), so it's not clear to me what he's saying here. But if he's going to bang on me for being skeptical about mental disorders, then he really ought to extend his attack to Healy himself who is deeply skeptical about what's gone on with bipolar disorder over the last two decades. I'd really, really, really like to see that. Maybe he can also go after CL Psych for his all skepticism over diagnostic criteria.
What really PO's me about some in the MOTHERS Act crew is that they support an act named after Melanie Blocker Stokes, who experienced post partum depression and committed suicide despite several psych hospitalizations, several different medications and several rounds of ECT. Do they not wonder--just a little--if her treatment weren't as detrimental as her depression?
Even more, Act supporters are pushing legislation that will create a federal government program that will seek to raise awareness of PPD in our culture. Fair enough. Unfortunately, federal government programs to address this or that mental health crisis do not exactly have a glorious record of success. In 1999, Healthy People 2010 set as one of its big goals the reduction of the suicide rate in America by 50 percent. Today we have roughly the same suicide rate as in 1999. In 2004, Congress passed the Garrett Lee Smith Memorial Act, which has clearly ended teen suicide as we know it in America (if only it had).
If passed, I hope the MOTHERS Act and the many moms with PPD fare far, far better.
As many of you know, there was an awful murder-suicide in Middletown, Maryland last week in which a father killed his three children and his wife before killing himself. Sadly, there have been a few of these incidents around the country lately, including a father in the Seattle area who killed his five children before killing himself.
There is now some indication that the Maryland father may have been on anti-depressants at the time of his act, or may have been on them recently, according to press reports. We'll know more when toxicology reports become available.
"[Christopher] Wood, 34, also suffered from depression and anxiety and had been prescribed four anti-depressant medications, Sheriff Chuck Jenkins said during a Tuesday afternoon press conference."Because toxicology reports will not be available for several weeks, detectives do not know if he was taking his medication at the time of his death. The drugs seized were Cymbalta (duloxetine), alprazolam, paroxetine, and buspirone, officials said."
Cymbalta is Lilly's newish blockbuster anti-depressant, alprazolam is better known as Xanax and is an anti-anxiety drug not an anti-depressant per se, paroxetine is Paxil's generic name, buspirone is the anti-depressant Buspar.
How connected anti-depressants may or may not have been to this crime may never be known with precision, but here's a big clue that they may have somehow influenced Wood's behavior:
"A reporter asked Jenkins if it was true that the three children's throats were slashed almost to the point of decapitation."Jenkins took a deep breath, looked down, then up and addressed the question.
"'Listen I, I really don't know what this purpose serves to the public,' Jenkins said. 'I will simply answer yes.'
"The reporter then asked if Billotti-Wood did not suffer the same fate as her children.
"'I cannot confirm that,' he said."
Murdering one's own children is a bizarre and irrational act to begin with, but to slash their throats after the children were dead from gunshots suggests a deeply unhinged man and certainly Paxil is well-known among patients (and clinicians who are honest) to cause deeply irrational behavior in some people who take the drug, particularly on induction, dose changes or during withdrawal from the drug. It's the worst of the SSRIs in this regard. Cymbalta, an SNRI, is also slowly gaining a reputation as creating similar problems in some people.
Wood left six notes at the family home.
"'The sixth and final note can be best characterized as a suicide note describing his day-to-day stresses, his day-to-day frustrations,' Jenkins said. 'Their financial problems and how he was going to raise his family. He also stated that he had tried a number of medications to control his depression and he had, in fact, felt it had gotten worse over time.'"
So much for the magic of anti-depressants. To be clear, I am not saying that anti-depressants caused Wood to kill his family, but they are without a doubt now linked and connected to this tragedy.
Suicide in the general population is rare and the tragic act is even rarer among children under the age of 14. It's to the point where reported suicides of kids that young come as a total shock, so prepare to be shocked: news is out that a 7-year-old boy in Florida named Gabriel Myers hanged himself at his foster home last week.
The boy had reportedly been on Vyvanase--a newish ADHD med--plus Lexapro and Zyprexa in the recent past, but that he'd recently been switched off the latter two drugs in favor of Symbyax, Eli Lilly's rarely-used Prozac, Zyprexa combo pill. The child psychiatrist who prescribed meds to Myers told reporters he couldn't remember the boy (nice touch) and defended using these drugs in little kids:
"Punjwani defended the use of psychiatric drugs on children, even if they are not approved for such use, saying the lack of approval stems from the reluctance of drug makers and the medical establishment to launch clinical trials on children."The anti-psychotic drugs, he added, are used routinely to treat mood instability and insomnia among children."
Look, these drugs are dangerous in adults and teens and are even more so in children. I'm so done with doctors and parents who defend their use in kids. If they cannot wake up and see that they are harming a generation of kids (especially foster children) with these drugs and that what they are doing can be interpreted as child abuse in some cases, then they are deluded, dangerously so.
Symbyax is not approved for use in children and carries a suicidality black box warning.
Some docs are a bit more on the ball on these issues:
"Dr. David L. Katz, professor of public health at Yale University's medical school, called the use of such drugs on youngsters 'extremely risky,' He questioned whether the boy needed to be taking such powerful medications absent a diagnosis of schizophrenia. 'These are medications that are potent and potentially dangerous,' Katz said. 'They certainly are powerful drugs for anybody, let alone a 7-year-old boy.'"
The boy's uncle, who cared for him at one point, said a previous doctor had taken Gabriel off all his meds and that the kid was getting A's and B's in school. Then, more recently:
"A week or two before Gabriel died, his grandfather in Ohio expressed concerns that the boy sounded overmedicated. 'My father said that the last conversation he had a couple of weeks ago Gabriel sounded like he was too drugged,' Myers [the uncle] said."'He sounded like he was doped up.'"
It's not clear why the kid was put into a different foster home and why he ended up back on meds, but whoever pressed to have Gabriel back on meds helped end his life.
USA Today had an interesting-ish article out last week, allegedly debunking many of the myths around the 1999 Columbine High School massacre. Eric Harris and Dylan Klebold were not goths, they weren't in the Trenchcoat Mafia, they didn't target jocks, and so on. But in one place, the paper made what appears to be a substantial error of fact:
"Contrary to early reports, Harris and Klebold weren't on antidepressant medication."
The paper cited police sources "citing the killers' journals and witness accounts." While it's been known for a long time that Klebold wasn't on anti-depressants, I've reviewed a copy of Harris' autopsy report wherein the toxicology report states:
"Only drug detected is Fluvoxamine--390 ng/Ml (therapeutic levels 50-900 ng/Ml"
Fluvoxamine is the generic name for Luvox, an SSRI anti-depressant.
I've written the paper's reader representative--or whomever reads those emails--but have not heard anything in return. I also wrote to Dave Cullen, author of the recently-released "Columbine," to try and clarify the matter, but have heard nothing.
At a minimum, I expect the paper to offer a clarification of some kind. But if they are anything like other news organizations to which I've brought errors to their attention (New York Times, AP, etc.), then they won't do a thing.
BTW, as I explained the other day, I don't blame anti-depressants for Harris' actions, but they are sure connected to the Columbine tragedy. Unless the paper can offer an authoritative source to overturn Harris' toxicology report, then I'd say its demythologization has gone a bit too far.
One well-known quality of anti-depressants is their tendency to induce akathisia in a large number of patients, causing the kind of internal racing or restlessness that makes the meds impossible for some to take and, in some cases, can drive people to the edge of suicide. There's now an emerging body of evidence that atypical antipsychotics--or second generation antipsychotics, if you prefer--cause akathisia in some cases and it's important to note this because the atypicals are now gaining a spooky vogue as anti-depressants. (The older antipsychotics have long been notorious for this as well.)
Now a new study is out in the Journal of Clinical Psychiatry, a meta analysis of 77 studies of the atypicals, asserting that there's akathisia all over the place with these alleged wonder drug:
"Seventy-seven trials were included in the comparative review. Akathisia was observed with the use of all the SGAs. The akathisia incidence reported in bipolar disorder trials was generally higher compared with schizophrenia trials. The incidence reported for FGAs was consistently higher than that reported for SGAs, regardless of the patient population studied."Conclusions: Akathisia remains a concern with the use of SGAs. More accurate and standardized evaluations are required for a better understanding of the nature and incidence of akathisia."
I've not seen the full study yet, so I cannot speak to the prevalence of akathisia in the underlying studies, but it sure doesn't sound good, especially when added to all the other known problems with these drugs. Keep in mind that the clinical trials of Abilify as an add-on treatment for depression showed akathisia cropping up in 26 percent of patients (versus 4 percent on placebo).
If that doesn't make doctors and patients worry about this class of drug, then very little will.
We're currently having the nicest weather in Seattle since last September--70+ and sunny yesterday and today--so I'm going to focus on shaking off the cobwebs of winter and will be back to regular posting tomorrow. Besides, it's supposed to rain tomorrow.
Have a nice day.
I learned yesterday that the Alliance for Human Research Protection last week sent a letter to the president of Harvard University, calling for the school to order a broad-based, independent review of the work of controversial Harvard child psychiatrist Joseph Biederman, who is one of the prime movers behind the rush to diagnose America's kids with ADHD and is the chief developer of the bipolar child paradigm. Biederman is already being investigated by the Harvard-owned Massachusetts General Hospital, where he works, over various questions surrounding his financial relationships with pharmaceutical companies. Biederman is also being investigated by Sen. Charles Grassley (R-Iowa).
While I've not seen researchers raise questions about the validity of Biederman's research (they've raised questions about his paradigms, however), AHRP's head Vera Sharvaz says there's much to question:
"The only way to remove the cloud of suspicion currently hovering over MGH and Harvard University with respect to its pediatric psychiatry faculty, and for these institutions to regain the public trust, is to undertake a fresh and unbiased review of Dr. Biederman's entire production of published (and unpublished) research conducted at MGH."The essence of empirical science is its verifiability. The Alliance for Human Research Protection (AHRP) proposes that a multi-disciplinary team of independent scientists with expertise in medical and drug research, biostatistics, epidemiology and medical ethics, be convened to review ALL of Dr. Biederman's publications and supporting documents, including: research protocols, consent forms, and the original (of course, anonymized) data sets with associated code books for all pediatric studies."
It'll be interesting to see what kind of response AHRP gets, if any.
I don't even have the space to summarize this very extensive investigation by the AP, so here are the lede grafs:
"U.S. manufacturers, including major drugmakers, have legally released at least 271 million pounds of pharmaceuticals into waterways that often provide drinking water - contamination the federal government has consistently overlooked, according to an Associated Press investigation."Hundreds of active pharmaceutical ingredients are used in a variety of manufacturing, including drugmaking: For example, lithium is used to make ceramics and treat bipolar disorder; nitroglycerin is a heart drug and also used in explosives; copper shows up in everything from pipes to contraceptives.
"Federal and industry officials say they don't know the extent to which pharmaceuticals are released by U.S. manufacturers because no one tracks them - as drugs. But a close analysis of 20 years of federal records found that, in fact, the government unintentionally keeps data on a few, allowing a glimpse of the pharmaceuticals coming from factories."
Suffice to say that tons and tons of this stuff ends up in America's waterways each year and that goodly amounts of it are connected with psych meds and other pharma products and governments federal and local don't seem too concerned about the phenomenon, even though there's research showing it's bad for fish. So it would be less worrisome for humans? Methinks not.
Today is the 10th anniversary of the massacre at Columbine High School in Littleton, Colo., which claimed 13 students plus the shooters. Two dozen others were injured. Committed by high school students Eric Harris and Dylan Klebold, the event is often cited by SSRI opponents as evidence of violence induction caused by the drugs. Harris had been on Zoloft in the months leading up to the shooting and not long before the shooting he was taken off that drug and put on Luvox, another SSRI. As far as I know, Klebold wasn't on an anti-depressant.
There's no question that Harris displayed a lot of the prototypical bad responses to SSRIs that are well-known in the patient world (and he'd had a recent med change and probably a fast taper off Zoloft), but the kid was a mess for a long, long time before he took Zoloft and may have even been a sociopath (opinions vary)--he and Klebold were building bombs, threatening other kids on the Net, they were (illegally) buying guns and modifying them (illegally), had been dragged into court and were showing other outward signs of nutiness and trouble. The parents of one of Klebold's friends reported their suspicions about Harris to the police, but were basically blown off.
How these ticking time bombs managed to slip through the cracks as they did remains a question that'll never be answered with the kind of precision you'd like.
While anti-depressants surely didn't help Harris and will forever be linked to Columbine, I don't think they were a precipitating cause of the event. Are they connected? Sure. Did they make Harris and Klebold go storming through their high school and shooting whomever they pleased? They are in the mix, but that's about it. There was something deeper and adark going on with the pair, especially with Harris, than mere teen depression and a bad SSRI.
But then a bunch of other things are connected to the event: goths, high school bullying, teenage isolation, easy gun availability for underage kids, the Internet, video games (especially "Doom," a great game BTW), parents who clearly had lost control of troubled teens and on and on it goes. Some officials have denied that bullying and video games, for example, played a role in the Harris/Klebold time bomb, but I'm not so sure of that since others insist the two (especially Klebold) had been bullied by other kids and that Harris was totally addicted to "Doom."
Of course, I'm willing to be proven wrong on the SSRI question, but from the long memory of a formerly-troubled teen and as someone who got freaked out on SSRIs as an adult, I just can't get there all the way with the "SSRIs made Harris do it" meme (Harris was the ringleader). But, then again, maybe it's because my level of teen trouble was normal and because Harris' was so much worse and, in that kind of teen, maybe anti-depressants uncork psychological force that I cannot even guess at.
Anyway, you're bound to encounter oodles of press accounts of the anniversary today along the lines of "Lessons of Columbine" and it'll be interesting to see how many of them even mention the anti-depressant connection. I bet few do.
Christopher Lane has an excellent interview on his Psychology Today blog with British psychiatrist David Healy, known to many of you as the author of Let Them Eat Prozac and oddles of journal articles and as one of the brave psychiatrists who stood up to Big Pharma and the SSRI machine.
I'll not attempt to recap Healy's interview except to note a few things. He had this to say about "mania" in 2009:
"How does our understanding of 'mania' differ today from earlier conceptions of the phenomenon?"Bipolar disorder itself is a somewhat mythical entity. As used now the term bears little relation to classic manic-depressive illness, which required people to be hospitalized with an episode of illness, either depression or mania. The problems that currently are grouped under the heading 'bipolar disorder' are akin to problems that, in the 1960s and 1970s, would have been called 'anxiety' and treated with tranquilizers or, during the 1990s, would have been labeled 'depression' and treated with antidepressants."
I point this out because when Lane interviewed me last week, I was roundly criticized by some for stating:
"BP2 isn't bipolar disorder, properly understood. There's no mania, there's no hospitalization for mania, and there's no one running naked down the street. The most prominent features of BP2 are depression (and that covers the vast majority of a person's time who is diagnosed with BP2) and bursts of energy, broadly understood. To me, that sounds a whole lot more like depression and agitation than it does manic-depression."
Sounds like I am in good company. Healy also makes reference to and uses the Donna document from the Zyprexa documents collection on this site.
Healy has plenty more to add, including the classic observation:
"Well, I think what Donna's story above illustrates is that pharmaceutical marketing departments are actually the postmodernists par excellence. They treat the human body (including its disorders and complaints) as texts to be interpreted one way this year and in just the opposite way a year or two later."In contrast, when it comes to the hazards of these drugs—just like the tobacco companies before them—the motto of Pharma has become 'doubt is our product'-—they simply refuse to concede that their drugs are linked to any hazard at all . . . until the drug goes off patent. You cannot get a better definition of postmodernism than "doubt is our product.'"
There's much more in the interview and I encourage you all to go read it and go comment over at the PT today website, so the editors there know people are interested in this kind of deep skepticism.
There's a highly discouraging study out in the New England Journal of Medicine in which researchers assert that the widely used anti-seizure drug Depakote (valproate in generic form) is leading to significantly lower IQ scores in children whose mothers took the drug while pregnant with the child. The drug is widely used as an epilepsy treatment and as a so-called mood stabilizer in bipolar disorder. Worldwide, Depakote generated $1.364 billion in sales in 2008 for its maker, Abbott Labs. It's not clear to me how much revenue the drug generates in generic form. (Full disclosure: I was once a sales rep for Abbott Critical Care Systems, the company's smallest division, in the late-1980s.)
The study was of offspring of moms who took the drug for epilepsy, but it's difficult to imagine anyone arguing that the same issues wouldn't be present in moms who took the drug for bipolar disorder (but I'm sure someone will try).
Offspring of moms who took Lamictal had IQ scores at age 3 of 101; 99 for phenytoin; 98 for carbamazepine; and, 92 for Depakote.
As one researcher told the AP:
"'We've known this drug is a bad actor for a long time,' said Dr. Lewis Holmes, director of the North American Antiepileptic Disease Pregnancy Registry, based at Massachusetts General Hospital in Boston."The new study is important because it's the largest to show a connection between valproate and diminished IQ. Its publication in the prestigious New England Journal of Medicine should alert physicians who until now have ignored the drug's potential dangers to fetuses, added Holmes, who was not involved with the study."
Depakote has also been tied to ovarian cysts and menstrual irregularities. A small British study last year linked use of the drug in utero to autism in offspring.
I'm sure some of you will get a chuckle out of this: in November, the International Forum on Mood and Anxiety Disorders (website) will hold its annual conference, this year in Monaco, and one of the conference topics will be "Making Sense of Media Attacks on Experts: Is this a Wanton Witch Hunt?"
This is little more than a coded reference to the hubub of press attention focused on such psych experts as Charles Nemeroff, John Rush, Melissa DelBello, the Joseph Biederman crew at Harvard, Fred Goodwin and Alan Schatzberg. Ironically, Schatzberg sits on the scientific advisory committee of IFMAD, which one source tells me is little more than a pharma-created astroturfing group, and has certainly been kicked about in the press. (Feel free to use the search function on this site to get more info on these researchers.) One source of mine in the psych world tells me that there is something of a low-level whispering campaign/blog commenting campaign going on that seeks to take attention off the Nemeroffs and Biedermans of the world by pointing the finger at the media. Yeah, like that will work.
I hope researchers discussing this alleged witch hunt will keep in mind that quite often the information about the above-named psychiatrists has been coming out of the mouth of Sen. Charles Grassley (R-Iowa). Would they suggest that the media ignore the investigations of a sitting US senator? Would they describe him as a witch hunter? Um, I think not.
Liz Spikol, executive editor of the Philadelphia Weekly and mental health blogger, has a very interesting post up today. In it, she describes being approached by a documentary maker to be part of a doc--presumably on a mental health issue--that's being funded by AstraZeneca and would include some kind of promotional imagery of Seroquel. Spikol wisely refused to play along.
"I just felt like I can’t be part of an effort that promotes Seroquel — funny, I know, coming from someone who A. relies on the drug, and B. used to speak for AZ on just that topic. But times — and Big Pharma — sure do change, don’t they?"
I've been approached a few different times by doc makers to appear on camera discussing this and that about mental health and each time I politely refuse. I suspect that many of the docs poking into the dark side of Pharma and psychiatry are funded by the Church of Scientology somehow (and some recent ones sure have been) and that the more positive, "let's educate the public about mental illness" ones are somehow connected to pharma money (like the one Spikol smartly shot down). Like Spikol, I just don't trust how whatever interview I might do would be used. Documentary makers are a slippery breed, in my experience. Not to be trusted.
Back in 2004, I wrote an article for Seattle Weekly on the problems around suicide and depression in American culture. It got a ton of attention. Soon after, I was contacted by a Canadian doc maker who claimed to have had his work shown on the CBC. I checked him out and sure enough he seemed to be legit. So I agreed to be interviewed on suicide, depression and the like and the next day trundled myself off to the Seattle Art Museum to be filmed.
The interview went along normally for about 20 minutes and I said all kinds of serious and sober things about depression and suicide. Then quite out of the blue, the doc maker asked me: "How do you think Americans should respond to the crimes of George Bush?"
"What do you mean?" I asked. It was early morning and I can be a bit slow in the morning and I hadn't quite figured out what this guy was up to.
"Don't you think Americans should want to shoot him?"
About this time, my brain did kick in and I realized that something odd was afoot. "I don't want to shoot anyone, especially the President. If people don't like him, then they can vote him out of office later this year. That's how our system works."
I asked him if he had anything else he wanted to discuss about depression and suicide. He did and so I spent a few more minutes saying serious and sober things. Then, he came back once again to the question of shooting President Bush--obviously he was trying to trick me into saying something weird on camera, for reasons I can only guess at--and I told him that the interview was over.
As far as I know, the guy never made a doc about suicide and depression and it's pretty obvious to me, in retrospect, that he was trying to cook up some weird doc that would wind up on TV or the Net in which he could get Americans on-camera calling for President Bush to be shot. The experience of it all was so surreal that I could hardly believe it had happened and I walked back to my office and dug into my work day and tried to forget the whole thing. In retrospect, I should've called the Secret Service on the guy and let them sort it out.
Ever since, I have been deeply suspicious of doc makers and rightly so I think.
I had so hoped that I'd heard the last of the flap over unreported conflicts on interest in a Lexapro study published in JAMA last year. I cannot even make myself type the back ground out once more, so read it here.
Anyway, now the primary author of the study, University of Iowa psychiatrist Robert Robinson, has written a letter to the BMJ, complaining about the role that journal's website had in all of this and then questioning the potential bias of the researchers (Jonathan Leo and Jeffrey Lacasse) who brought his conflict to the attention of JAMA's editors and then he bitches about bloggers who wrote about the JAMA fracas. Yes, it's a big old catfight now, complete with Robinson accusing Leo of having an "ideological agenda." Robinson points out that Leo is on the board of the International Center for the Study of Psychiatry and Psychology (ICSPP), which has been around since 1971 and is well-known as being a dissident group within mental health circles. Many people within the mental health industry perceive ICSPP as being against the use of medications, but that's not true.
The problem with Robinson's argument is that Leo hasn't been on the board of ICSPP for two years. While he might have identified in his and Lacasse's initial letter to JAMA that he was a past board member that hardly compares with the kinds of financial conflicts researchers often have. What's more, almost anyone who's read the medical literature in the psych world over the last decade or so knows who Leo is--along with Lacasse, he's become the most persistent critic of conflicts of interest, shabby scientific evidence and pharmaceutical advertising. But, then, maybe psychiatrists don't stay up on the medical literature as they should.
Robinson also notes:
"Bloggers, who knew nothing about the biases of the letter writers or about my relationship (or more accurately, lack of relationship) with Forest Laboratories, have publicly criticized me."
I'm not sure which bloggers Robinson means, but most of my criticism has been reserved for JAMA's editors. I was however aware of Leo and Lacasse's biases. I've been reading their journal articles for four years. Their biases seem to be ones of researchers interested in helping clean up a dirty evidence base, helping limit conflicts of interest with pharma companies and of preventing psychiatry from making false and exaggerated claims like asserting that a chemical imbalance causes depression (an alleged true "fact" that remains unproven). I can handle those biases. Besides, I've not known them to make false assertions about conflicts in the research world.
It'll be interesting to see how this all gets resolved once the AMA board president's call for an investigation of JAMA's editors is answered. (Via the Wall Street Journal's Health blog.)
I'm sure many of you are aware of the MOTHERS Act legislation currently before Congress. If passed by the Senate--it's already passed the House--it would kick start nationwide post-partum depression education and screening for new moms. Such screening is already mandatory in New Jersey, although the practice is so new that I don't know of any identifiable results from it yet.
The act has passionate supporters and passionate critics, both of them making legitimate points (you can get a sense for how wild things are by looking at this Google search). Before I lay that out, let me not that as a man I feel almost as if I don't have a right to an opinion--we're talking pregnancy and childbirth here, something guys should probably tip-toe around--unless I am partly responsible for a pregnancy in question.
Just to be clear, there is no post-partum depression denying going on here. I've seen the condition erupt in women I know and I know a widower in my neighborhood whose wife killed herself not long after having a baby (and about two days after being put on Prozac). I also have a friend who was put on Paxil for post-partum depression and went completely batty on the drug.
Anyway, the bill does sound non-controversial on its face. It would:
"(1) provide education to women who have recently given birth, and their families, concerning postpartum depression, postpartum mood and anxiety disorders, and postpartum psychosis (referred to in this chapter as `postpartum conditions') before such women leave their birthing centers and to screen new mothers for postpartum conditions during their first year of postnatal checkup visits, including the standard 6-week postnatal checkup visit; and"(2) provide for the delivery of essential services to individuals with postpartum conditions and their families."
Critics, many of them women, argue that this is little more than a land grab by pharma companies and their advocates and that we'd wind up with millions of women a year being slapped with anti-depressants and loads of kids would wind up with birth defects and loads of new moms would wind up suicidal as a result of the meds. Evelyn Pringle argues all of this in two recent pieces.
Proponents, many of them women, argue that not passing the bill would deny education and life-saving treatment to millions of moms and that their offspring will suffer all kinds of deficits as a result and moms will commit suicide and so on. Proponents claim that 80 percent of women will experience baby blues and that fully 20 percent of new moms will experience post-partum depression. The proponents seem to feel a bit embattled, since the bill has been floating around Congress for a decade or so, but it's not been passed due to an aggressive backlash. Here's one writer at PsychCentral's blog calling for action:
"Wake up, people who care about mental health. Wake up, people who work to prevent child abuse, people who work to prevent suicide, people who work to prevent preterm births, people who care about healthy families. Wake up, psychiatric professionals, nurses, gynecologists, pediatricians."
It's all very intense stuff on both sides and it's difficult to know where the truth resides.
Here's the thing that makes my scratch my head, however: women have given birth for many thousands of years and many have experienced "baby blues," until recently without mental health screenings or psych meds of any kind and without a bunch of arm waving about post-partum depression (the advocacy on this issue is a phenomenon of the last decade). Broadly speaking, the lack of such supposed benefits does not seem to have harmed society a bit, although there are obviously individual exceptions. I don't even have a guess as to what would result if, say, 1 million new moms (to pick a number) wound up taking anti-depressants and add-on antipsychotics while pregnant and/or breastfeeding.
What do you think?
Yesterday a self-identified NAMI volunteer offered the following comment in regards to an investigation by Sen. Charles Grassley (R-Iowa) of NAMI National's pharma funding. I'll let it speak for itself.
"I am a NAMI volunteer and all of this comment is solely my responsibility and opinion. I am present teaching a course called family to family which is partially sponsored by Squibb. After 8 weeks of teaching this course (for the forth time), I asked all 22 students, 'How many of you know the name of the pharmaceutical company that helps underwrite this course?' Answer, not one person knew. Then I asked the second question: 'Name drugs manufactured by Squibb?' No one knew of any with surety, although there were a few guesses."The bottom line is, from where I am where the rubber meets the road, there is no sign of drug companies trying to influence consumer buying habits. Trying to obtain funding for a non-profit like NAMI is a daunting task. Ever since the cutbacks in funding for hospitals and treatments for our loved ones, we have had to scramble for every nickel. From my perspective, I have seen no influences of any kind by drug companies at the grassroots level. I personally am grateful that we received funding from such companies."
Squibb is Bristol-Myers Squibb. NAMI family-to-family courses are not for patients, but for family members. You can learn more about the course here. The course would be but one example of the many ways pharma money is used by NAMI.
I'm sure many readers will object to his views. Given that it took some guts to come here and comment thus, please be respectful in comments. Thanks.
I've been holding off writing much about the efficacy and safety data that emerged in connection with last week's FDA psychopharmacology advisory committee hearing as to whether the committee would recommend to the FDA approval of Seroquel XR for a range of indications. The committee said "No" to approval for Seroquel as a treatment for generalized anxiety and as a treatment for depression as a monotherapy and as a maintenance therapy. The committee did recommend approval of AstraZeneca's atypical antipsychotic as an add-on, or adjunctive, treatment for depression. I've held off writing until now because Seroquel is a drug that harmed me and I wanted others to take the lead in examining safety and efficacy data.
Now Tufts University psychiatrist Danny Carlat casts a cold eye on the add-on treatment data submitted to the FDA at his blog.
"While I agree with the committee's rejection of two indications, I'm concerned that they were inappropriately impressed by the Seroquel augmentation data. As far as I know, the augmentation studies have not been published, but a summary can be found on page 27 of AZ's briefing document [found here]. It looks like they used the same research design as BMS did in their Abilify augmentation studies, and that the Seroquel results were equally unimpressive (see this article at Clin Psych for a slam of the Abilify data). Seroquel reduced the MADRS depression score by about 15 points, while placebo decreased it by about 12 points. This 3 point advantage is tiny, considering that the MADRS is a 60 point scale. Personally, I don't think that this 5% advantage (3 divided by 60 possible points) is worth Seroquel's side effects."
That's pretty damn indicting and absolutely limited efficacy--a 5 percent advantage? Oh, boy--although it's not possible to calculate the effect size of the drug yet, as the full dat sets have not been published. But I bet it's small.
The two add-on studies of Seroquel are called Study 6 and Study 7, respectively, and were six-week trials.
A summary of Study 6, conducted in the US, can be found in this FDA briefing document, given to members of the committee and also made publicly available (starts on page 29). In it, the FDA lays out clinical improvement in patients in AZ's study who took an anti-depressant plus placebo, an anti-depressant plus 150 mgs. a day of Seroquel or an anti-depressant plus 300 mgs. a day of Seroquel.
On the Montgomery-Åsberg Depression Rating Scale (the primary outcome measure) in Study 6, patients in the placebo/anti-depressant group saw an average reduction (meaning improvement) in their MADRS score of 11.70 points, the anti-depressant/Seroquel 150 mgs. group saw a reduction of 13.60 points while the anti-depressant/Seroquel 300 mgs. group saw a reduction of 14.70 points. So that's a 3.16 percent advantage over placebo for the 150 mgs. group and a 5 percent advantage for the 300 mgs a day group.
Study 7 begins on page 33 of the same document and was a similarly constructed six-week trial of patients in South Africa, Europe, North America and Australia.
On the Montgomery-Åsberg Depression Rating Scale in Study 7, patients in the placebo/anti-depressant group saw an average reduction in their MADRS score of 12.21 points, the anti-depressant/Seroquel 150 mgs. group saw a reduction of 15.26 points while the anti-depressant/Seroquel 300 mgs. group saw a reduction of 14.94 points. So that's a 5.08 percent advantage over placebo for the 150 mgs. group and a 4.55 percent advantage over placebo for the 300 mgs. group.
I'm not even sure how the advisory committee arrived at a determination that Seroquel XR had demonstrated efficacy in these six weeks studies, since the drug is barely efficacious. It literally must have just squeaked by the committee.
Carlat also delivers a bit of a coup de grace by noting that in a:
"[R]ecently published randomized trial showed that when Seroquel was added to Prozac, it yielded no advantages over placebo, aside from helping patients sleep better over the first few weeks. This was not a study of treatment-resistant patients (unlike the FDA data) but it nonetheless shakes my confidence in the potency of the medication."
That study is right here. Read the abstract for yourself.
Like Carlat, I worry that FDA approval of Seroquel XR as an add-on depression treatment will lead to a huge direct-to-consumer marketing campaign and plenty of patients gaining weight and developing diabetes. The FDA should not follow the advisory committee's recommendation. The agency may just be doing millions of Americans a favor.
The Los Angeles Times had an interesting package of articles yesterday on the wide use of atypical antipsychotics in the US (one of which I've already addressed). In one, the paper reported about the lack of efficacy in Abilify used as an add-on treatment for depression:
"[T]he clinical trials cited as evidence of Abilify's power to vanquish depression have been met with skepticism. In the most-cited company-funded study, published in the April 2008 Journal of Psychopharmacology, researchers found that among depressed subjects who supplemented their antidepressant with Abilify, rather than with a placebo, 25.4% reported some relief of their symptoms. Among those taking a dummy pill with their antidepressant, 15.2% reported some improvement in their mental health."
This won't be news to readers of this site, as I reported on the very slim efficacy (and teensy effect size) of Abilify used in such a manner last November. Among other things, I noted that patients had more than twice the chance of experiencing akathisia on Abilify than they did in improving their depression symptoms. This issue was first raised by Emory University psychiatrist Douglas Bremner on his website. Interestingly, the paper's report cites CL Psych's blog on issues around Abilify (good for him or her) and quotes Danny Carlat, a Tufts University psychiatrist:
"'The results are extremely unimpressive; they just squeak by,' says Massachusetts psychiatrist Daniel Carlat, editor of the respected Carlat Psychiatry Report. For a clinician or a patient's family, the difference between those on Abilify and those who took a placebo 'would be hard to actually see,' he adds."
I'm glad to see the LAT putting this information out in the mainstream world, but I kind of giggle at the fact that I've been raising a ruckus around Abilify's use as an anti-depressant for some time now. Just saying.
Interestingly, Bristol-Myers Squibb, the drug's maker, had this to say to the paper:
"Sonia Choi, a spokeswoman for Bristol-Myers Squibb, said the company does not comment on its promotional efforts for Abilify and that it continues to monitor the safety and effectiveness of Abilify for depression in the wake of the FDA's approval for that use. In the meantime, she noted, the company is committed to making public the results of studies involving all of its drugs, including Abilify."
While the company may well monitor the safety and effectiveness of the drug, they sure aren't being forthcoming with the public. As I noted last December when I contacted Choi with, among other things, an inquiry on akathisia I got no answer:
"I also asked Choi what the company knew about akathisia on Abilify and what percentage of patients experienced the condition when taking Abilify."'I don't know,' she said, an interesting response from the company's spokeswoman for Abilify."
What makes me think she'd be no more forthcoming now.
In a shocking (pun fully intended) bit of news, the FDA yesterday announced (federal Register announcement here) that it would require makers of 26 classes of medical devices to submit safety and effectiveness data for their products, listed under Class III (most risky) of the FDA's device classification system. The list of devices that fall into a group of devices that have been exempted from the FDA's standard requirements for clinical trials is stunning: ECT devices, intra-aortic balloon pumps, the female condom, external cardiac defibrillators, pedicle spinal screws, hip joints and so on.
It's stunning to me that such devices have not been run through some kind of clinical trial before, especially given their widespread use (balloon pumps have been used in ICUs since the late-1980s), although there are some of these devices it'd be impossible to run a null control group for. You'd compare a heart defibrillator to what? Certain death? And an intra-aortic balloon pump (it assists weak hearts in an ICU setting and I've seen them in use many moons ago) would compare to what? Kind of hard to run a proper randomized trial there.
That said, the fact that ECT devices haven't been through randomized clinical trials versus groups of patients on placebo or on an anti-depressant of known efficacy or against psychotherapy, etc. and the fact that such trial data hasn't been submitted to the agency represents a serious oversight on the part of the FDA, in my opinion. Even deeply treatment resistant depression treatments deserve this level of safety and efficacy review. You can read how Somatics, LLC, maker of the Thymatron ECT device, describes its product here. (Yes, I know there are trials of ECT devices versus other treatments, but they've not passed muster with the FDA, as far as I know. And, yes, I know device approval differs from drug approval, but likely shouldn't in the case of ECT.)
The Wall Street Journal explains what the deal is here:
"The agency's request comes in response to a 1990 order from Congress that directed the FDA to gather rigorous evidence before a manufacturer can sell medical devices considered to be in the most risky category, known as Class 3."But despite several attempts during the 1990s, the FDA hasn't finished implementing the law. In the past five years, it allowed hundreds of new Class 3 devices to be sold based on a less rigorous showing -- called a 510(k), after a section of federal law -- that they are "substantially equivalent" to combinations of other products marketed before 1976. Such evidence often is collected in a laboratory, not with a clinical trial in patients."
An even more in-depth explanation of this very complex set of regulations for Class III devices can be found at the FDA Law Blog. Part of the FDA review of submitted data will result in the agency deciding if the previously-exempted devices will remain as Class III device or be placed in the less-risky Class I or Class II.
This is going to set device makers scrambling because they have 120 days to respond. Then the agency will have to sort out what constitutes appropriate evidence of safety and effectiveness, which ought to be interesting.
As for ECT, I believe that the agency should require proper randomized clinical trials of ECT devices currently on the US market (unless their pulse wave technologies are substantially similar, then I guess trialing one of the devices alone would be acceptable). There are two makers of ECT devices in the US, the aforementioned Somatics and MECTA. It's unclear to me how many people a year undergo ECT in the US, but estimates range from about 30,000 people a year to as many as 200,000 a year.
Either way, there's mixed evidence on ECT efficacy. A 2001 JAMA study examining what meds (compared to placebo) to use to prevent relapse following ECT treatment reported that "virtually all remitted patients relapse[d] within six months of stopping ECT."
A 2004 study in Biological Psychiatry found:
"RESULTS: The sites differed markedly in patient features and ECT administration but did not differ in clinical outcomes. In contrast to the 70%-90% remission rates expected with ECT, remission rates, depending on criteria, were 30.3%-46.7%. Longer episode duration, comorbid personality disorder, and schizoaffective disorder were associated with poorer outcome. Among remitters, the relapse rate during follow-up was 64.3%. Relapse was more frequent in patients with psychotic depression or comorbid Axis I or Axis II disorders. Only 23.4% of ECT nonremitters had sustained remission during follow-up. CONCLUSIONS: The remission rate with ECT in community settings is substantially less than that in clinical trials. Providers frequently end the ECT course with the view that patients have benefited fully, yet formal assessment shows significant residual symptoms. Patients who do not remit with ECT have a poor prognosis; this underscores the need to achieve maximal improvement with this modality."
The 1999 Surgeon General's report on mental health claimed 60 percent to 70 percent remission rates for ECT.
It'll be interesting to see if the FDA requires formal clinical trials and formal approval submissions to the agency for ECT devices or whether it let's matters continue as is. It'll also be interesting to see if the agency moves ECT devices into lower risks classes of medical devices.
BTW, I know that when I post on ECT that fights often erupt in comments due to the emotional nature of the subject. Please don't go there this time out.
News is out in the UK of a US-made microchip (in capsule or pill form, swallowed) that would monitor (from one's stomach) whether or not a patient has complied with a prescribed drug therapy and, then, report back to the patient's doctor in real time (via a transmitter on the patient's back and, then, by cell phone). Yes, you read all this right and, yes, this technology, developed by Proteus Biomedical, will undergo two clinical trials in the UK later this year.
On one level, this kind of technology is fascinating and interesting for all the usual dorky techie reasons (wow, telemetry has gotten that advanced and so have transmission technologies--it's all so very sci-fi and high tech triumphant), but on another more important level it's downright frightening. That's because I see this "intelligent medicine" technology as a potentially massive intrusion on individual freedom and privacy.
In the above news article, look at the range of prescribed meds that's discussed as being monitoring-worthy (and in an unquestioning way): psychotropics, heart meds (statins, etc.) and even birth control pills.
Do any women really want their docs monitoring what they put in their bodies in such a fashion? Is there anyone who takes anti-depressants who wants his or her doc probing their medication compliance so intimately? I doubt it. What would the doctor even say if a woman missed taking the Pill for a week? "Hi, we've noticed a disturbing pattern in your estrogen intake. Oh, you are trying to get pregnant? Come into my office for mandatory counseling and depression screening? I need to sell you pills of some kind."
OK, so I'm being flippant, but if anyone thinks that such a scenario isn't somewhat realistic, then they are naive.
Now, if someone does voluntarily wish to be monitored and consents to being monitored, so be it. But just about the only scenario were I could see such monitoring being acceptable--assuming it even works--is in cases where psych patients have a proven track record of violence (as determined by a court, not a social worker) and there's a court order in place to allow such monitoring. Other than that, the mandatory use of such technology would violate individual liberties.
Even more worrisome to me is that such chip-in-a-capsule technologies could be used to monitor what people eat and drink and be used to report back to some central authority who could then determine if you've had too much soda (beer, wine, etc.) and send the public health department over to "counsel" you.
But there's another worry I have over the potential misuse of this technology:
"Professor Nick Peters, a cardiologist at Imperial College London, who is co-ordinating trials, said the technology was ‘transformative’."'This is all about empowering patients and their families because it measures wellness, and people can actually be tracked getting better,' he said."
"'Psychologically speaking, that’s hugely helpful for patients and enormously reassuring for carers.'"
This kind of thinking relies on two assumptions: One, that medicine always provide wellness and, two, that all people respond to medicines the same way.
Apply that to statins, which are very widely-used in the US. They are presumed to be benign meds and while I'm not questioning their cholesterol lowering powers, let me point you to the FDA's adverse events database on Lipitor, which has just under 50,000 reports through the third quarter of 2008.
Just as with anti-depressants, not everyone responds to allegedly benign meds the same way. For some people, statins are clearly awful drugs and I know of multiple cases from my personal orbit where people have been put on Lipitor and had powerful muscle cramps, liver problems, lost their memory and so on. When they went to their prescriber, they were told in each case that Lipitor couldn't be the cause and that they had to stay on the drug or they would die (cadiologists may approach psychiatrists for their religious attachment to their specialties' meds). In case, the people blew their docs off and away went the cramps and nerve problems and back came their memories. Interestingly, none of them re-developed problems with high cholesterol.
Think of that kind of thing when you think of "intelligent medicine."
I'm sure most of you know that Abilify is an atypical antipsychotic that's been repurposed as an add-on treatment for depression. As I noted earlier this year, since that FDA approval Abilify's sales exploded by 30 percent in 2008. The company has massively advertised the drug for depression in print media and on TV and here's the dynamic that has led to, according to the Los Angeles Times.
"About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify 'might be right for them.' Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery."Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.
"What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an 'add-on' treatment for depression."
I've been criticizing these ads since they first began appearing last Fall, so it's nice to see the LAT walking in my footsteps, so to speak. I've asked the FDA questions about the drug being advertised as an anti-depressant when it's clearly an antipsychotic and has all of the health risks associated with those very, very powerful drugs. Of course, the FDA has had little to say.
Fortunately, there are some critics within medicine of this very strange trend:
"In the process, the spreading use of these costly drugs is raising -- for the nation as well as individual patients -- the rates and the risks of weight gain, diabetes, strokes, fatal heart attacks, an array of movement disorders and potentially, suicide, according to a wide range of critics."'This is very worrisome; frankly I have serious concerns about these drugs,' says Dr. Steven Nissen, who is chairman of the Cleveland Clinic's cardiovascular medicine department and serves as an ad hoc advisor for FDA panels. Studies point to a 'very questionable balance between efficacy and safety' for the class, he said. But that message, he said, has been lost in an apparent 'marketing bonanza' for the companies that make the medications. A recent report by the consulting firm Decision Resources found the makers of the atypicals spent $993 million in 2006 to promote the drugs to doctors and patients."
And here's another critic:
"'The story's pretty clear, and pretty embarrassing for the profession of psychiatry, which has allowed itself to be led by marketing,' says Robert Rosenheck, a psychiatrist at Yale University who has studied the effectiveness and expanded use of the atypical antipsychotics. 'We know now what these companies' strategies are: The number of people with schizophrenia is limited, so the road to profitability goes through soccer moms. They need to market these drugs to ordinary people who have dissatisfactions in life.'"
Yes, let's medicate the soccer moms.
I've written loads about Abilify and you can read my back catalog here.
I'll let this news from the Boston Globe's health blog speak for itself:
"Dr. Robert B. Fogel, who taught at Harvard Medical School and practiced at Brigham and Women's Hospital until 2004, said he altered numbers and invented anatomic details reported in an article about obesity and sleep apnea. The journal Sleep retracted the article in February and the federal Office of Research Integrity concluded its investigation last month."'What I did was obviously horrendously wrong,' Fogel told The Scientist magazine. 'I never really thought through the consequences, and once I did this I got myself into a loop that I found I couldn't get out of....'
"The falsified paper concluded that the shape and volume of a person's airway combines with obesity to make those patients more likely to suffer sleep apnea, a breathing disorder."
Why the hell do some doctors feel the need to do this kind of thing? Why aren't they driven from the field when they get caught? Fogel is now a director of clinical research at Merck's respiratory and allergy division.
In journalism, if someone plagarizes, makes up facts or quotes and gets caught, they almost always get fired and are driven out of the field for life. In medicine, you get a job with Big Pharma. It all makes so much sense.
A very interesting and sad account of the April 8 FDA psychopharmacology advisory committee hearing comes from Merrill Goozner's GoozNews:
"I was rather shocked as the patient representative -- Margy Lawrence of Potomac, Md. -- on the panel announced her vote against approving the drug. 'My son died of sudden cardiac arrest,' she said. 'Seroquel was part of his cocktail.'"One has to wonder if the company knew in advance that someone with an obvious bias had been included on the committee. One has to wonder what the FDA, whose practices on advisory committees has been under scrutiny for years, was thinking when it decided to appoint someone who would appear on the surface to be incapable of offering a dispassionate analysis of the data.
"The 2007 reform law required the FDA to reduce the number of scientists with conflicts of interest who serve on advisory committees, and the agency appears to be making real progress. The law was silent on bias, however. In my view, when the agency appoints people with obvious biases, especially to the consumer and patient slots on these committees, it runs the risk of discrediting the entire effort to improve the advisory commitee process."
That's terribly sad.
One has to wonder, however, if Goozner has lost his sense of reality. It would be virtually impossible to have patient and consumer reps on FDA advisory panels who do not have some kind of experience or exposure (through themselves, family members or friends) to the very meds they are being asked to review. Or would it only be acceptable if their experiences were positive? So anyone with a negative experience with a drug would have to recuse themselves? I'm not sure how to sort that kind of thing out, but I should note that doctors on these panels have plenty of bias themselves. Even if they don't have direct ties to a drug under review, they would quite possibly have experiences with prescribing said drug (at least once the drug is past its initial approval) to patients and would have already formed an opinion of the drug.
My point is that this sort of thing cuts in both directions.
Goozner is director of the Integrity in Science program at the Center for Science in the Public Interest.
Hi readers. This is one of my occasional pieces on this site dealing with matters political. I'll get back to my usual stuff tomorrow.
As most of you know, there's been an awful spate of mass shootings in America over the last few weeks. Eight dead in Alabama, 13 dead in New York, four cops dead in California, three cops dead in Pennsylvania, five kids murdered by their own father about an hour south of Seattle. I've been waiting for the round of inevitable newspaper editorials and op-eds on all of this, the ones written by gun control advocates and their mouthpieces on various newspaper staffs that use such shootings to call for bans on gun ownership and so on.
Well, one of those sorts of pieces is on the New York Times' website today (not sure if it ran in the paper as well), authored by Tim Egan. I don't know if Egan is still on staff at the paper anymore, as he's a big shot book author now (and winner of a National Book Award), but he does pump out a once-a-week blog for the paper's website. as a rule, I generally admire Egan's work, but this piece shows just how out of control some otherwise-fine writers get when writing about guns. His piece is filled with usual pro forma hand-wringing over guns ("the cancer at the core of our democracy"), especially so-called assault rifles, and as usual with such pieces, it's filled with errors, omissions and exaggerations, all in an attempt to get guns of some kind, any kind, banned. You know where Egan is headed--right to a so-called ban on so-called assault rifles.
"In the aftermath of one of these atrocities, nothing is more chilling than a gun advocate racing before a camera to embrace a lunatic’s right to carry and kill."
And nothing is more frightening and embarrassing to me as a journalist than a knee-jerk liberal writing a column, going through the usual stations of the argumentative cross and calling for a ban on weapons while lecturing other Americans on what they should and shouldn't be allowed to own. That's because there's not a single gun advocate I know of who defends a lunatic's right to own a gun. That's why the gun laws in most, if not all, states have a provision banning convicted felons and "mental defectives"--meaning people with mental retardation or serious mental illnesses that required hospitalization--from owning a gun of any kind. Gun groups I know of (the Second Amendment Foundation for one) have worked with law enforcement and legislators to get such provisions in place.
"All a citizen can do is ask for some common sense around the Second Amendment. The assault weapons ban, outlawing 19 military style guns that no hunter with sense of fair play would ever use, should be reinstated. President Bush and Congress let it expire in 2004, even though it was a godsend for police officers and supported by a majority of gun owners."To the senators who back assault rifles while speaking of the 'sacred part of being a Montanan,' you don’t want this kind of heritage. It demeans you as Westerners to allow easy access to weapons that kill innocents, and it does a disservice to history."
You just have to sigh when reading something like this because what Egan and gun ban backers don't understand is that the 1994 assault weapons ban didn't outlaw AR-15s. What it did was limit their configuration and magazine capacity. It was a complicated law but the basic thrust of it was, in the case of AR-15s and AK-47s, that the guns couldn't have magazines containing more than 10 rounds and couldn't have flash suppressors, barrel shrouds and pistol grips (plus a bunch of other technical things). All of those came back onto the market in 2004 when the 1994 law expired, except in California, New York, New Jersey, Massachusetts and Connecticut where it's effectively still in place (due to those states' weak Constitutions on gun rights).
The 1994 "ban" effectively made the AR-15 a less-easy-to-handle weapon with a smaller capacity. That was about it. (It also banned or limited a bunch of other guns and you can read about the 1994 AWB, as it's known, here.) Other than their assault rifle moniker and semi-auto capabilities, they weren't much different from more common rifles which handle six to 10 rounds, in some configurations, and fire a round at a time. I can assure you from personal experience that you can blast off those six to 10 rounds pretty quickly one shot at a time, as did Lee Harvey Oswald.
You have to sigh, too, when urbanistas such as Egan tell folks in rural areas what heritage they ought to want. It's the kind of arrogance that may play out nicely in the Times and among prog-libs in Seattle, but it bespeaks the kind of liberalism that gives liberalism a bad name. What's next? Is Egan going to suggest how many horses and of what breed folks in Montana should own in order to keep with a heritage Egan thinks he understands sitting at his desk in a big city? Egan lives in Seattle and Seattle has about as much to do with the heritage of the rural West as I do with communism. Egan ought to keep his mouth shut about Western heritage. Doubly so, because the vast majority of murders in this country happen Back East not out West. And Egan has got to know that about half of the murders in Seattle each year (we have about 30 a year, give or take) involve gang members offing rivals. In addition, I cannot think of a single murder I've read of or covered in my seven years in this city (or state) that involved a semi-auto assault rifle. Handguns are the weapon of choice. (I used to cover cops and crime back when, and still read just about every news account of just about every murder in my area. Oh, and for the record, my family roots are pioneer rancher-farmer stuff from Arizona in the 1860s.)
What's more, the vast majority of shootings in this country do not involve so-called assault rifles. Go ahead and scan your local paper. What you'll find are folks shooting other people with handguns and single-shot rifles. Even more to the point, the sorts of mass killings that have gone on the last few weeks are statistically rare and, in my experience, don't typically involve semi-auto rifles. Kyle Huff, who murdered six people at a party in my neighborhood in 2006, used a pistol and a shotgun. The recent Binghamtom, New York killings: handguns. North Carolina: rifle. Alabama: rifle.
"Still, nearly 17,000 Americans are murdered each year — about 70 percent by guns — and 594,276 lost their lives betweens 1976 and 2005."
Does Egan say what percentage of these homicides by gun are committed by criminals offing other criminals (my loose guess is that about half of all murders are criminal on criminal), folks who legally can't even own guns? Does he explain that a huge number of these murders have come as a direct result of the drug trade in this country? Does he offer a guess as to how much of this can be tied to semi-auto rifles? No, of course not. It's his mission and the mission of the New York Times to create a certain level of hysteria in the public's mind that innocent people are going to be gunned down the moment they walk off to the market in Seattle (and NYC) with their earth-friendly canvas bags to buy organic produce.
To be clear, under the Second Amendment you cannot ban weapons of any kind and under last year's US Supreme Court ruling in the Heller case, you cannot ban handguns, rifles and shotguns. The ruling is, going by memory here (and, yes, I've read the case), open to the idea of restrictions on certain super weapons, a reference to what I'm not sure since the court didn't specify what super weapons it meant.
So at the end of the day, you've got Egan calling for a ban that wouldn't much change things and would likely have very little impact on the murder rate in the US. But like a lot of opinionistas, he wants something to show for all his hand-wringing, a scalp of some kind, and there seems to be some sentiment for a gun ban, or restriction of some kind, in Congress and Attorney General Eric Holder has called for re-enactment of the 1994 AWB (it's not clear to me where President Obama is on the matter). Yet the reality is that the Democrats in Congress simply don't want the political fight that will erupt, even inside their own party, should they seek to reimpose the 1994 AWB. They'll spend so much political capital and piss off so many centrist voters like myself that November 2010 will be a very rocky month for them.
And just to make it clear again, their ban would do very little to effect the murder rate in this country. I can't think of a single piece of evidence pointing to a sudden and dramatic drop in the murder rate in the US following enactment of the 1994 AWB.
Anyway, Egan also commits some serious errors in his piece where he writes:
"The recent twists involve Mexican drug cartels, who get their firepower from American retailers, and the mass killings this spring by shooters who appear to have acquired their weapons legally. Assault rifles figured prominently in the murders of seven police officers."
The Mexican cartel line of reasoning is a load of BS or a complete exaggeration or liberal mythologizing (take your pick), because it's a false claim, as Fox News found out when they recently poked around the claim that's been made all over the media that 90 percent of the cartel's weapons are coming from the US. Their reporting found that only 17 percent of the Mexican cartel's weaponry could be traced to the US, so presumably the rest is coming from somewhere else (um, like the deeply-corrupt Mexican Army).
Yes, assault rifles did figure in the deaths of cops in California and Pennsylvania, but Egan is wrong when he says it was seven cops. The three police officers in Pittsburgh, Penn. were indeed killed by an idiot shooting off an assault rifle. But in Oakland, Calif. two of the four cops murdered there by a wanted felon (who flat out shouldn't have had even an air pistol as he was on parole) were killed by said felon shooting a pistol. So when Egan writes "their lives ended by a convict with an assault rifle," he's being inaccurate. Two of the four were, but not all four. Egan doesn't even point out that the Oakland cop killer was a convicted felon and on parole, facts that raise more questions about California's parole system and how parolees are monitored than they do about anything to do with assault rifles.
BTW, it's worth noting that the Oakland murderer would likely have been using a semi-auto rifle that was either manufactured under the 1994 AWB or is a California-legal gun (meaning a 10 round only clip), so, as odd as it sounds, the felon killed two cops with probably the same exact type of gun which gun control advocates have found an acceptable compromise in the past. (Unless it was a pre-94 gun or something he'd gotten from a state without restrictions on semi-autos after 2004.)
I hope Egan corrects his errors and distortions.
Full disclosure: I've actually shot so-called assault rifles several times in my life, all of them AR-15s, the civilian semi-automatic riff on the military's M-16.
As many of you know already, an FDA advisory panel yesterday recommended against approval of Seroquel as a monotherapy and as a maintenance treatment for depression and recommended against approval for anxiety. In each case, it found the drug not sufficiently safe. The panel did recommend approval as an adjunctive treatment for depression. It's not clear to me how long people in trials for that particular indication were taking the drug.
Anyway, here's how AstraZeneca spun things in a press release:
"Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: 'We are pleased that the committee found SEROQUEL XR to be effective and acceptably safe for use as adjunctive therapy for the treatment of MDD. Although the committee recognized the effectiveness of SEROQUEL XR as monotherapy for MDD and GAD, they had concerns around the long-term safety profile in these new populations. We look forward to having further discussions with the FDA regarding both sNDAs.'"
So AZ is going to badger the FDA on the safety data in the two unapproved depression indications and try to get them to ignore the panel's recommendation. Nice. Good luck to you, AZ.
Meanwhile take a look at how strong the vote was against Seroquel's alleged safety in some of the reviewed indications way at the bottom of the above press release:
Questions to the Advisory Committee:1. Has SEROQUEL XR been shown to be effective as a treatment of:
* MDD as an adjunct therapy? Yes (9) | No (1) | Abstain (0)
* MDD as a monotherapy? Yes (8) | No (1) | Abstain (1)
* GAD as a monotherapy? Yes (7) | No (2) | Abstain (1)2. Has SEROQUEL XR been shown to be acceptably safe as an adjunctive treatment for MDD? Yes (6) | No (3) | Abstain (0)
3. Has SEROQUEL XR been shown to be acceptably safe as a treatment for:
* MDD as a monotherapy? Yes (0) | No (9) | Abstain (0)
* GAD as a monotherapy? Yes (0) | No (9) | Abstain (0)4. Has SEROQUEL XR been shown to be acceptably safe in certain instances as a treatment:
* MDD as a monotherapy? Yes (4) | No (4) | Abstain (1)
* GAD as a monotherapy? Yes (2) | No (6) | Abstain (1)
Those are very strong no votes and I hope the FDA keeps them in mind.
Certainly, I've been seeing all kinds of anxiety and depression here in Seattle in recent months, but according to this New York Times article it's a growing national trend (the paper loves nothing as much as it loves "trend" stories).
"'The economy and fear of what’s going to happen is having a huge effect,' said Sarah Bullard Steck, a Washington therapist who also directs the Commerce Department’s employee assistance program. 'People are coming in more' with 'severe anxiety' or 'more marital strife, some domestic violence, some substance abuse.'"Alan A. Axelson, a Pittsburgh psychiatrist, said he is seeing first-time patients, and infrequent patients experiencing “relapse and needing more therapy and medication; and Pittsburgh’s actually doing pretty good economically.'"
OK, that's all anecdotal and while I think it's likely true that people are more anxious and whatnot during this very odd recession we're experiencing, one of the most telling numbers from last year is that anti-depressant prescriptions were only up 2.4 percent last year, according to IMS Health. Keep in mind that we were in recession all of last year and the stock market crash occurred in mid-September, so I'm a bit surprised that anti-depressant Rxs weren't up much more (unless people are suddenly turning to other alternatives).
It will be interesting to see what sales are like in the first quarter of this year for Lexapro and Effexor (the remaining "modern" anti-depressants that are on-patent and are easy to track sales for). If they are up dramatically over last year, then that'll ell us something. Another bellweather drug might be Abilify, now approved for and advertised like crazy for add-on drug status for depression.
There was one stat in the story that blew my mind, however:
"National Suicide Prevention Lifeline calls jumped from 39,465 a month in January 2008 to 50,158 in January 2009, and economic stress more frequently 'played a central role,' said Richard McKeon, the Lifeline’s federal project officer."
That's of concern, no doubt about it.
News is just out that the FDA's psychopharmacology advisory panel has recommended that the agency approve Seroquel, an atypical antipsychotic, as an add-on or adjunctive treatment for depression, meaning to be taken in addition to anti-depressants. It recommended against approval as a monotherapy for depression and as a maintenance treatment for depression and as a treatment for anxiety. The recommendations now go to the full agency, which is not bound by them, for a final determination, likely in the near future.
"Several panel members stressed that doctors should try other medicines for depression first before deciding to add Seroquel XR."'I think this represents a second-line therapy,' said panel member Frank Greenway, an endocrinologist at Pennington Biomedical Research Center in Louisiana.
"The FDA asked the panel to weigh wider use of the drugs versus known side effects including weight gain and tardive dyskinesia, a movement disorder that causes jerking. A recent study also raised concern about sudden deaths of patients taking atypical antipsychotic drugs including Seroquel."
I hope the agency grows a pair and declines to approve the drug for any new indications.
A reader sent along an email from NAMI National to its many supporters yesterday and I thought I'd share it with you all. The initial Grassley query of NAMI is here.
From: Mike Fitzpatrick Sent: Tue 4/7/2009 3:05 PM To: boardg; edgroup; statepres; ccgroup; veterans Subject: Update on Senator Grassley's letter to NAMINAMI received a letter from Senator Charles Grassley on April 6, 2009 requesting information about the support it receives from the pharmaceutical industry. Senator Grassley has for the last three years been investigating various aspects of the pharmaceutical industry. NAMI shares Senator Grassley's interest in transparency and is cooperating fully with this request.
NAMI accepts charitable contributions from corporations, including the pharmaceutical industry, for one purpose - to improve the lives of people with mental illness and their families. These relationships are governed by NAMI's Guidelines for Business Support Relationships, a NAMI policy that was approved by the board of directors. This policy ensures that at all times NAMI will maintain an independent position on issues affecting the welfare of people with mental illness. NAMI does not engage in product promotion, endorsement, licensure or certification of any product, service or program owned by a corporate sponsor.
I want to note that, contrary to early reporting, NAMI did in fact respond to a media inquiry from Bloomberg.com regarding the Senator's letter to NAMI late yesterday. Unfortunately, the initial story published yesterday on the Bloomberg website contained inaccuracies. We are working to correct these errors.
NAMI looks forward to working with the Senator to provide all the information he has requested and supporting efforts aimed at creating greater transparency and accountability in our health care system. If you have questions regarding this information, please contact me.
Thanks. Mike Fitzpatrick
Michael J. Fitzpatrick, MSW
Executive Director
NAMI (National Alliance on Mental Illness)
Three thoughts: One, I cannot wait to see how detailed a response NAMI makes to Sen. Grassley and just how much money is involved. Two, Fitzpatrick has cretainly engaged in product pimpery for J&J/Janssen. Three, if there are errors in Bloomberg's reporting, I'd love to know what NAMI thinks they are because reporters at Bloomberg are pretty careful in my experience.
Yesterday, Bnet.com reported that 14 pharma companies had gotten warning letters from the FDA, which noted that the companies were misrepresenting their drugs' indications and were hiding side effect and risk information in various text ads that popped up during Google searches.
Among the companies were Eli Lilly and Pfizer, both of whom allegedly aren't giving the public proper risk information in those little text ads and sponsored links thingys that pop up all over the Net. You can read the letetr to Lilly here and the one to Pfizer here.
I'm glad the agency is now policing various aspects of pharma advertising on the Net. The agency might also want to take a look at what I ran into when I did a Google search of the term "depression." Up popped the following "sponsored links":
"1. Major Depression Symptoms www.MoreForDepression.com Find Out About a Treatment Plan To Help Manage Depression Symptoms.2. Depression
KnowMyDepression.com Learn About the Causes, Symptoms And a Proven Treatment Option.3. About Bipolar Disorder
BipolarTreatmentInfo.com Find Out About Signs, Symptoms, and a Treatment Option."
MoreForDepression.com takes you to a web page for Abilify.
KnowMyDepression.com takes you to a web page for Pristiq and that particular page has no risk information on it that I could see at all.
BipolarTreatmentInfo.com takes you to a web page for Seroquel XR and while that page does have risk information on it, the information is so far down the page that you've got to wonder if the average consumer would ever see it.
I hope the agency takes a look at those sponsored links as well.
I knew I would catch some heat when Christopher Lane's interview with me went live on Psychology Today's website yesterday, but have mostly been gratified by the response so far (thanks, Liz Spikol). That said, someone decided to slaughter me in comments on the PT website:
"PsychTodayReader"This interview was a disgrace. The interviewer, who is a Literature Professor, did not ask anything but softball questions, and let Dawdy viciously attack the work of some of the leading clinicians in the world with nothing to back it up except his opinion. This anti-psychiatry parade, which started with Scientologists and continues with people like Dawdy is destructive to all who are concerned about people with mental illness. 20 years ago they told people with depression to 'pull themselves up by their bootstraps'; today Dawdy tells parents with ill kids, 'let boys be boys.'
"Have too many kids been medicated? Yes. Did the pharma industry act like any other for profit industry? Yes. Is there a need for more regulation? Yes.
"Here's where the rubber meets the road: I was diagnosed with manic depression at age 40, after my life was wrecked for decades. I can only wish that someone had picked it up when I was younger, and had treated it. Sorry Mr. Dawdy; the least you could have done was to acknowledge your own reported manic depression, and your self-hatred and denial over it.
"Psychology Today did a terrible disservice by running this interview."
What is it about (some) people diagnosed with bipolar disorder in their 40s? So often (but not always), they are some of the most aggressive in defending their dx to the point of lashing out at anyone who even mildly disagrees with them. It's an odd phenomenon.
For the umpteenth time, let me be clear: I am not a Scientologist, I am not an anti-psychiatrist. People who want to toss those slurs around are both childish and had better watch their mouths.
"Reported manic-depression?" Earth to commenter, as I've made my readers aware in short before, I don't have manic-depression or bipolar disorder any longer. I was either a bad diagnosis or I'm evidence that the disorder burns out over time or I am a medical freak. Take your pick. I still do experience depressiveness, however. One of these days, I'll get around to writing a long formal piece about all of this.
"Self-hatred and denial?" Um, wow. You sound just like the semi-well-known writer whom I won't identify who told me in an email that I'd either be back on-meds or dead within six months of being taken off-meds in July 2007. It's been 21 months. I'm thriving.
An anonymous commenter added:
"I am concerned at the implication that folks who have been diagnosed with Bipolar I or any other psychotic disorder deserve the stigma and prejudice they get and only people with Bipolar 2 diagnoses or depression do not. No one deserves stigma and prejudice. And running naked down the street is not a typical behavior of people with psychotic episodes and furthers stigma and prejudice."
I'm not quite sure where this reader got that I was laying stigma at the feet of others. But just so we are clear: no one deserves it.
The commenter should also review the DSM as bipolar disorder 1 is not a psychotic disorder, it's a mood disorder. There can be psychotic features in some cases, but psychosis is not a predominant feature of the disorder. Depression and mania on the other hand are far more prevalent.
As for running naked down the street, you might want to check in with the crisis team on just about any big city police force. It's not as uncommon as you'd think or wish to think that the cops do encounter someone with mania running around naked or half-naked. Or so they tell me. Interestingly enough, it's usually men doing the naked running thing. Either way, it's just one behavior among many. I wonder what cleansed, PC-'d-to-death real world behavior he or she would have preferred I use.
Over the last few days, I've wrestled with some very tough questions posed by Christopher Lane, whom most of you know as the author of Shyness: How Normal Behavior Became A Sickness and who is a professor literature at Northwestern University, who's now doing a blog for Psychology Today.
Among other things, I criticize the bipolar disorder 2 diagnosis and point out that the bipolar child phenomenon is a purely American one, "as big a metaphor of our times as credit swaps, subprime loans, and government bailouts." The interview is here.
I also kick ADHD around as well, and get into some of the problems with antipsychotics and kids.
I have a hunch I'll get kicked around fairly hard by some for what I've said, but someone's got to say these things or nothing ever changes and I'm glad Lane gave me the chance.
Happy reading.
As I've reported before, Seroquel is often used by prisoners--and some civilians in the outside world--to get stoned in prison and apparently so too is Wellbutrin, the well-known anti-depressant. The Wellbutrin bit is news to me.
Things have gotten so out of hand in Santa Clara County, California that prison officials there have almost completely halted giving them to inmates and the state prison system in the state has followed suit.
Seriously, two of the top-selling psych meds in the world can be crushed and snorted to produce a high, or more of a low in Seroquel's case.
"Corrections officials throughout the country have long suspected that some inmates were either using the pills to get loaded, or "cheeking" them in order to later sell them to other prisoners to chop up and snort. Seroquel is an anti-psychotic that produces a hypnotic effect, and Wellbutrin is an antidepressant some liken to speed....""'It definitely goes on,' said John Madsen, secretary of the California Association of Alcoholism and Drug Abuse Counselors. 'Say someone is addicted to cocaine but can't get it. They'll try the next best thing. When it comes to drugs, addicts will find themselves doing just about anything.'"
Keep in mind that Seroquel is on the verge of gaining FDA approval for depression and anxiety, indications that would make the drug even more widely available than it already is and would inevitably lead to even more abuse in America.
As I noted last year, America's uber mental health advocacy group the National Alliance on Mental Illness (NAMI) was getting oodles from pharma companies, including $490,000 from Eli Lilly. What NAMI uses that money for isn't clear to me, but the group does a ton of lobbying on Capitol Hill and of state legislatures throughout the country. NAMI National's annual budget once ran around $12 million and roughly half of that came from pharma companies. Is it any wonder that NAMI never uttered a word of caution or alarm while scandals rolled out around Zyprexa and other atypical antipsychotics?
Anyway, Bloomberg is out now with news that Sen. Charles Grassley (R-Iowa) has sent a letter to NAMI National and asked the group to disclose its pharma funding.
"'I have come to understand that money from the pharmaceutical industry shapes the practices of nonprofit organizations which purport to be independent in their viewpoints and actions,' Grassley wrote in his letter."
According to Bloomberg, a NAMI report shows that the group took in $10.5 million in contributions in 2007, but the donors aren't broken out.
I cannot wait to see how the group responds to Sen. Grassley's query. I wonder if Sen. Grassley would also be interested in the fact that in 2006 NAMI's executive director, Michael Fitzpatrick, openly touted Johnson & Johnson's new drug Invega? Perhaps he'd also be interested in the fact that in 2003 an Eli Lilly executive hatched plans to use NAMI to help it blunt criticism of its dangerous drug Zyprexa. It was called "Operation Restore Confidence."
And, to be fair, the slightly-smaller advocacy group Mental Health America (the old NMHA) gets oodles of money from pharma too and also lobbies Congress and state legislatures (see the first link above), but is a bit more tasteful in its advocacy. I wonder if the Senator will be sending them a letter too.
Thanks to Beyond Meds for making me aware of the letter to NAMI.
Via Alison Bass, news is out that Martin Keller, the chair of psychiatry at Brown University, will step down from his post in June. It's not clear if he was forced out or if this a "to spend more time with his family" situation, but Keller had to have become a major embarrassment for the school what with Bass' book Side Effects detailing how scuzzy he was in running clinical trials for Paxil in kids (the infamous Study 329), plus an investigation by Sen. Charles Grassley and websites like this one banging on Keller's ties to Big Pharma and his wacky research.
Read Bass' site for more on this.
For some reason, it's been warm and sunny the last two days, a brief respite for a rotten, gray Spring, so I'm going to go enjoy the sun and warmth. Have a nice day.
Some of you are aware that on Saturday the Philadelphia Inquirer had an excellent article which established that the chair of the FDA's Psychopharmacologic Drugs Advisory Committee, Florida child psychiatrist Jorge Armenteros, who was set to chair this week's committee hearing on Seroquel's potential aproval for depression and anxiety was forced to recuse himself. He's gotten funding from AstraZeneca in the past to talk to doctors about using Seroquel and with an AZ drug coming before the committee, he either opted out of the hearing or someone at the FDA forced him out. The FDA won't tell me which it was. (Soulful Sepulcher has also written about Armenteros.)
Four other permanent voting members of the committee are not listed as participating in this week's hearing, according to the paper, which is downright odd.
"FDA spokeswoman Sandy Walsh said that temporary members sometimes replace standing committee members but that the agency does not say why such substitutions occur. Armenteros remains the chair of the standing committee until his term expires in June, she said."
Well, with a hearing scheduled for June on Seroquel's approval for use in kids, I'd say Armenteros' days as committee chair are over.
Meanwhile the agency has had to do a bunch of scrambling to round up temporary committee members to add to the two (yes, only two) standing committee members who'll be hearing testimony this week. After doing some poking around, I'd have to say that both the consumer member of the committee and the temporary patient member of the committee have potential conflicts of their own that make me question their ability to be thorough and impartial and actually represent consumers and patients.
The recently-added psychiatric researcher members of the committee appear to have mostly received monies from pharma companies, but none from AZ as near as I can tell.
The consumer member is Gail Griffith. She's a Washington, D.C. based writer, who authored the book Will's Choice about her then-teen son's suicide attempt. In a disclosure made to the FDA, she reveals that she owns stock in pharmaceutical companies amounting to less than $25,000. Griffith has also made numerous appearances at various NAMI state level conventions and meetings, some as far away as New Mexico. I hope she has revealed to the FDA whether she received any honoraria and travel reimbursement for these appearances, as even state and local level NAMI affiliates receive a portion of their funding from pharmaceutical companies--especially for conferences--and it's possible that some of that could have somehow trickled through to Griffith. It's of course well-known that NAMI National receives about half of its annual $12 million budget from pharma companies.
She's also presented to a Mental Health America affiliate and to the American Psychiatric Nurse's Association. So I hope the FDA has pressed her on this matter for any potential pharma dough that may have found its way to her, directly of indirectly.
In addition, Griffith was first appointed to the committee in 2004 as patient member and voted in favor of the black box warning on suicidality on anti-depressants in 2004 (good for her). She again had to wrestle with a suicidality warning on anti-depressants, this time to potentially expand the warning to 18 to 24 year olds in 2006. She voted against the expanded warning. Here's how she explains this on her website:
"Gail is quoted in this Newsweek article which suggests that the black box warning on antidepressants for teens and young adults may have had an adverse effect on prescribing practices. Griffith says, 'If I had known how much the label would rattle parents, I wouldn't have voted for it [the black box warning].' In December 2006, the FDA's psychopharmacological committee voted 6 to 2 to extend the black box labelling to young persons up to twenty-four years of age. Griffith voted against extending the label to include this larger constituency, (sic) siting the extraordinary vulnerability of this population and the disastrous consequences of failing to treat depression."
She was later made a consumer member of the committee in 2007. Thankfully, the committee voted to expand the warning, but did not expand it beyond 24 year olds to other adults.
While Griffith is welcome to her private opinions, I am troubled that a voting member of an FDA advisory committee would worry about rattling parents with a black box warning. She should be vastly more interested in dealing with the facts as they are before her and vote accordingly.
This leads me to question her ability to deal appropriately with the alarming metabolic injury data cropping up around Seroquel's use in just about every condition under the sun, including in depression and anxiety. How could she effectively sort through potentially recommending approval or rejection of the drug or how could she evaluate possible recommendations for strong warnings on the drug if she's worried about such information, truthful as it may be, rattling patients?
I have my doubts.
The very purpose of a black box warning is to properly warn health care providers and patients of the very real potential of life threatening risks associated with use of the black-boxed drug. If that rattles anyone, then so be it.
Next, let's turn to Margy Lawrence. She's listed as being a temporary patient member of the committee. In 2007, she's listed on the NAMI of Montgomery County (MD) 990 as being the vice-president of the board (the form actually cover the period until June 30, 2008) and is currently listed on the organization's website as being the contact person for those wishing to volunteer for the group. She is not listed on either the 2007 990 or on the group's website as being paid any monies. But there's still something that made my eyebrows arch.
According the NAMI of Montgomery County's website, 20 percent of the group's revenue came from the following:
"Montgomery County Government, the Maryland Home and Community Care Foundation, the United Way Foundation, the Holland Foundation, the Gannett Corporation, Vanguard, the Montgomery County Community Foundation and Astra-Zeneca supported Family to Family, Latino Outreach, Child & Adolescent and general programs and provided funds for capital expenses."
While it's not clear how much AZ money was given to the group, it appears that the committee's patient representative for the upcoming hearing on AstraZeneca's drug Seroquel is someone who has potentially participated in AZ-sponsored activities or may have, as volunteer coordinator, helped put together activities and outreach that were sponsored in part by AZ.
Then, of course, there's what could be the biggest conflict of all for both Griffith and Lawrence. Both are deeply embedded in the NAMI worldview, which in its extreme forms amounts to little more than the complete acceptance of the line that all mental illnesses must be medicated for life and that all medications are always good.
I hope that the FDA queries the pair about their potential conflicts.
Dumb question for you all, especially those of you who are MDs: on Sunday, I had spasms--visible ones--running in the fleshy area between my right thumb and forefinger. I've never experienced this before in my life and wasn't able to find any sensible information on the Net. I assume the spasms were either in a muscle or tendon there.
So if any of you have any ideas as to possible causes or treatment (or if this just might be weirdly episodic), I'd love to hear them. Thanks.
The spasms eventually subsided, but they sure have me scratching my head.
Today the FDA released briefing documents for next week's psychopharmacology advisory committee hearing on whether to approve Seroquel for three depression indications and generalized anxiety. In the documents, the FDA psychiatry products chief stated:
"'There remains a concern about longer-term risks with this drug, in particular risks related to metabolic changes,' said FDA drug reviewer Thomas Laughren, in documents posted online. Laughren also pointed to a recent New England Journal of Medicine article that suggests antipsychotic drugs like Seroquel can increase the risk of sudden cardiac death."Specifically, the FDA will ask its panel to vote on whether the drug has 'been shown to be acceptably safe for the treatment' of depression and anxiety.
"The agency is not required to follow the advice of its panel, though it usually does."
According to the AP, the FDA found the drug efficacious for treating depression, but made no mention of any FDA finding on anxiety. AstraZeneca has kindly posted the briefing documents online here. They are very extensive, so only download them if you want all the technical details.
I encourage the committee to not recommend approval of Seroquel for any of the proposed depression and anxiety indications. It's a nasty drug and shouldn't be put into even wider use in the US.
It's difficult to properly headline this post because the underlying study I'm addressing here is one of the most annoying I've run across in ages. Perhaps I am being uncharitable in my assessment and if someone wants to slap me about for being excessive, have at it. But, yes, here we have a study (pdf here) examining suicidal behavior and suicidality and self-harm in teens who are on anti-depressants or anti-depressants and CBT and the researchers canot even make themselves state the obvious. I'll get to the obvious in a minute.
The study was just published in the American Journal of Psychiatry and its authors include many of the usual suspects of child psychiatry, including Boris Birmaher (Paxil Study 329), Benedetto Vitiello, Graham Emslie and, drum roll, the controversial Martin Keller of Brown University and Paxil Study 329 fame. Here they were trying to examine suicidal behavior in teens with treatment resistant depression and establish what were some of the predictors of such behavior.
To do so, 334 patients aged 12 to 18 had to have already been on an SSRI for two months and had to still be experiencing depression. So treatment resistant depression for these researchers was failing on a trial of one anti-depressant. Hell, even the loosey-goosey FDA requires failing two anti-depressant trials to get to that stage.
The teens were then put through a very rapid taper of their failed SSRI over--brace yourselves--two weeks. Unless they were on Prozac. Then they were simply taken directly off the drug even though they were taking it at 40 mgs. a day. I have no idea how such experienced researchers could justify such a quick taper and why their review boards would approve such a protocol. Such rapid tapers of SSRIs can induce suicidal behavior and otherwise mess people up. An accompanying editorial describes the study design as "elegant." I guess elegance ain't what it used to be.
"Medication taper: Subjects were tapered to discontinuation from their initial medication by decreasing dosages over a period of 2 weeks, except for those who entered the study on fluoxetine, for whom the medication was simply discontinued, due to fluoxetine’s long half-life."
Then the teens were put right onto either an SSRI (Prozac or Paxil) or were put on Effexor. The teens were subdivided further into groups getting an SSRI-only, Effexor-only, SSRI plus CBT or Effexor plus CBT. They were then evaluated for three months for suicidal behavior.
Guess what? There was plenty of suicidal behavior and several actual suicide attempts in the study. What's more, at some point in this lengthy, multi-center study, researchers decided to stop using Paxil for one of the SSRIs and switched to Celexa "owing to concerns about the efficacy and safety of paroxetine." How nice. (Paroxetine is Paxil's generic name.)
"Higher rates of suicidal (20.8% vs. 8.8%) and nonsuicidal self-injury (17.6% vs. 2.2%), but not serious adverse events (8.4% vs. 7.3%) were detected with systematic monitoring [the lower numbers are for spontaneous self-reporting methods as opposed to doctor monitoring]. Median time to a suicidal event was 3 weeks, predicted by high baseline suicidal ideation, family conflict, and drug and alcohol use."
While I can appreciate the role that baseline suicidal ideation, family conflict and drug/alcohol use could potentially play in suicidal behavior, for the researchers to insist in the study, as they do, that that's all there was to it amounts to intellectual dishonesty.
Why's that? Well, the patients were on an SSRI which failed them and which they were taken off of quite rapidly (far more rapidly than most docs I know would approve of) and that could certainly account for at least some of the baseline ideation. Then they were put onto a subsequent anti-depressant before properly washing out of their previous anti-depressant and, then, at an average of three weeks, the ones who had a suicidal event had a suicidal event. And they are blaming this on outside factors when just about anyone who knows anything about anti-depressants knows it is the first month or so on a new drug (especially after a fast taper of something else) where tons of agitation and suicidality occur.
But the only mention the researchers make of potential issues with anti-depressants is where they note:
"In those participants with high suicidal ideation, treatment with venlafaxine, compared to treatment with an SSRI, was associated with a higher rate of either a suicidal or nonsuicidal self-injury event."
OK, so Effexor is associated with a higher rate of suicidality in the studied teens. Other than that, the anti-depressants aren't implicated at all--even though each and every one of the teens in the study who experienced suicidality issues or engaged in self-injury was on an anti-depressant and had just basically been put on the anti-depressant in question.
As I said before, elegance ain't what it used to be. Neither is honesty.
BTW, the authors are careful to hold CBT harmless here, noting that due to the rather prompt occurrence of suicidality and self-injury that patients who were in a CBT arm of the study hadn't had a full "dose" of CBT.
I began this site in September 2005 and until August 2007 I didn't have Sitemeter on it and didn't track statistics. I simply didn't want to know how many people were reading when I was still trying to figure out how to run a blog and while I was mostly still working as a reporter elsewhere. Anyway, I installed Sitemeter in August 2007 and last evening I hit a milestone as this site recorded its 500,000th visit since installing Sitemeter. Yee haw.
Thanks to all of you who read this site and especially to those of you who've been around the longest and who support it financially. You know who you are.
Oh, yes, yesterday was the third busiest day in this site's history as the post on the 1811 Eastlake housing for homeless alcoholics was quite popular and I ended up with something on the order of 7,000 visits. People were also reading my critique of President Obama's cigarette tax, including my father who for the first time in my 15 years of journalism wrote me and slammed me.
An article in today's Boston Globe details a new study in Psychotherapy and Psychosomatics (it's not online yet) wherein researchers went through the American Psychiatric Association's treatment guidelines for depression, bipolar disorder and schizophrenia and found that 18 of the 20 authors had ties to pharmaceutical companies. Medications for the three diagnoses are a $25 billion a year market for Big Pharma.
"'Most patients assume that when they're prescribed a drug, the decision is made on the basis of an objective review of the scientific evidence,' said the paper's lead author, Lisa Cosgrove of the University of Massachusetts at Boston. 'However, our study raises the question: Is that decision based in science, or is there a financial incentive behind it? This is an important question because the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence.'"
The APA insists that it works to screen out pharma bias from its guidelines--and maybe they do--but isn't it interesting how treatment guidelines almost always comprise a big arrow pointing directly to the goods and services of pharma companies. (You can view the guidelines here.)
"Dr. Roy Perlis, listed as a consultant on the bipolar guidelines, works in psychiatric genetics at Massachusetts General Hospital. In published papers - including one that examined financial conflicts of interest in clinical trials of psychiatric medications - he disclosed having received consultant or speaker's fees from five major drug companies: AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmith Kline, and Pfizer."But Perlis noted that the guidelines for bipolar disorder make two main points, neither of which benefit drug companies: that lithium, which has long been available as an inexpensive generic drug, is still the 'gold-standard treatment' and 'that certain kinds of talk therapy are a very important part of treatment.'"
Lithium, in its various coated-pill forms, isn't exactly cheap and it sure isn't a benign treatment, but what's classic is this gem from Perlis:
"'My job is to find better treatments for my patients. These are awful illnesses. People really suffer,' he said. 'And the people who are most responsible for developing new treatments right now are the pharmaceutical companies. What is being lost in all this is that if I didn't work with them, I couldn't do my job as a scientist - the part of my job that says we have people who are suffering that need new treatments.'"
New treatments? Please. Almost every psych med currently being written about, researched and so on these days has been on the market for 10 to 20 years (and longer) and quite often researchers like Perlis are simply conducting research that repurposes the drugs for diagnoses other than their original targets or seeks to repeat already-published research for the billionth time because the pharma companies and their academic partners didn't like the results of earlier studies, especially the federally-funded ones (like STAR-D, CATIE and STEP-BD) which show that pharma's psych meds don't work well at all and are side effect machines in a capsule.
Anyway, feel free to be bothered or not bothered by these ridiculous conflicts.
Three years ago, an experiment known as 1811 Eastlake opened in Seattle. It's a large apartment complex just off downtown and it houses about 100 chronic inebriates, as the term goes, all of them formerly homeless. The experiment part is that for eons America has attempted to grapple with the problem of urban street drunks by either sticking them in jail (very expensive and a practice that largely stopped in the 1970s), forcing them into housing where they couldn't drink (and inevitably relapsed and got the boot) or leaving them on the streets where they cycled from street to jail to ER to sobering center to homeless shelter to the liquor store to the streets. Commonly, such people (and it's usually guys) run up a $50,000 a year or so tab on the public purse and harm reduction advocate got to think that maybe it made more sense to stick such folks in long-term publicly supported housing and let them drink their brains (and livers) out and it'd wind up being cheaper.
This harm reduction bit got a lot of play in an interesting piece in the New Yorker in 2006, concerning a homeless man in Reno, Nev. known as "Million Dollar Murray."
The Seattle facility garnered tons of press--local and national--when it opened in late 2005 because it was the first big facility of its kind in the US, and many commentators were scornful of the place and the idea that the public would, in effect, be paying these guys to get drunk. I wrote my own piece on 1811 in Seattle Weekly and I'd written earlier of a lawsuit brought in attempt to keep the place from opening at all. My own sense of things--based on a decade or so of reporting on social issues--was that no approach whatsoever seemed to work with chronic street drunks, they were running up tons of expenses on the public dime, so why not try something new?
The 1811 facility wasn't a mats on the floor homeless shelter, but an actual apartment building with units along the lines of a college dorm room.
A new study came out in JAMA this week detailing whether the concept of "Housing First," as it's known, had any impact (here's an AP piece on the study). The 98 street drunks whom the study tracked had cost the public $4,066 a month prior to entering 1811 and afterwards they cost $1,492 a month after six months in the facility and $958 a month after 12 months. That's a pretty big savings and, oddly enough, some of the residents began to drink less. Some even got sober. (Some also died.)
My own interviews with residents there in 2006 turned up several who drank upwards of two fifths of hooch a day and had been for 20 years. Yes, it is amazing what the human body can endure.
While this sort of program would have to replicated elsewhere to see if these savings hold, it sure is a vastly more humane way to deal with a chronic urban problem than in the past. It also has all sorts of implications for addressing homelessness among the mentally ill, chronic crackheads and junkies of every stripe. My own guess is that, for example, housing the mentally ill who are homeless instead of herding them into very stressful homeless shelters or leaving them to the streets would improve their mental health issues dramatically, with or without medications. There is something magical about having a roof over one's head, even a modest one.
On a side note, I sure hope Robert Jamison (formerly a columnist at the now defunct Seattle Post-Intelligencer) and Ken Schram (a commentator at KOMO-TV in Seattle) plus a few other reporters in Seattle paid attention to this study. Because they were wrong, very wrong, about this place. (For some reason, I cannot find Jamison's attack on the place on the new seattlepi.com's website. Weird.)
1811 Eastlake is operated by the Downtown Emergency Service Center, a large social service agency in Seattle.
Full disclosure: I worked 15 shifts as a shelter counselor at DESC's main homeless shelter downtown as a relief, on-call, temporary employee from mid-December 2007 to mid-January 2008. I made $10 an hour. I doubt that it influenced anything I wrote in this post, but I thought I'd let you know.
I don't stick my nose into politics on this site much, but I'm sick and tired of the slick smoke-and-mirrors game being played by President Barack Obama (oh, yes, he's sure increased America's hope). Throughout his campaign last year and through his administration to date, President Obama pledged not to raise taxes on any person or family making under $250,000 a year. Yesterday, a bill he signed became law--a 62 cent federal tax increase on a pack of cigarettes and a huge increase on a bag of loose tobacco (at my local store, the price of a pound of tobacco doubled. So much for the roll-your-own solution).
I make under $250,000 a year and I smoke and yesterday my taxes went up, contrary to President Obama's earlier pledge. One pack of smokes will now run me over $8 in Seattle (we also have some of the highest state tobacco taxes in the US, something our smoking nazi governor prides herself on). Roughly 40 million to 50 million American adults smoke and their taxes just went up as well. Straight up: President Obama lied about taxes to one-quarter of the adult population of the US. That's a pretty big audience to piss off, especially considering that President Obama himself still smokes. That just makes it weird and unreflective for a former community organizer and alleged policy wonk. That is unless the President has a self-loathing streak.
But there are other things that bug me about this tax increase--it was a tax increase targeting the poor and millions of American diagnosed with a mental disorder. There are about 3 million Americans diagnosed with schizophrenia, for example, and some researchers claim that 90 percent of them smoke (it's one of the few things that makes them feel good) and, well, President Obama increased their taxes. What's more, the alleged representatives in Congress who passed this tax knew exactly who would end up paying this tax and there was not a moment of representation on their behalf.
I know all the public health "incentivizing" that's going on here and here's some news for you public health wonks out there and for those of you who are true believers in the pronouncements of health "authorities": folks with schizophrenia are not going to stop smoking (I checked in with two of them this evening), and neither are folks with bipolar disorder and depression. Smoking makes them feel good and sure takes the edge off the ridiculous medications your colleagues in the mental health end of the public health industry demand that they take. Meanwhile, many of these same public health sorts are on the take from Big Pharma.
I think there are plenty of other things that President Obama and the Congress are up to that are just as discriminatory and weird (whatever you make of financial executives, using the power of the federal government to break legal contracts is a bad, bad precedent, but I expect the same sort of thuggery to emerge when they try and enforce cap-and-trade) and I expect it to get weirder still.
I didn't vote for President Obama, principally because he struck me as an out-of-touch elitist (remember the guns and God business from last year?) with very little experience who was a smooth pitchman for the vague concepts of hope and change. I wrestled with myself and tried to find a reason to vote for him, but I kept coming back to something: My own experience in life has told me that people like him aren't to be trusted. They are marketers and players and little more. So I didn't vote for him. (I didn't vote for Sen. John McCain either, as his running mate was not my cup of tea.)
I'm beginning to think my hunch about President Obama was correct, but in truth I hope I was wrong and that I am wrong and that everything turns out just marvelously for one and all. But if anyone isn't bugged by the increase in federal tobacco taxes, keep in mind that you will be paying huge increases in taxes in the coming years to cover the federal stimulus program and the various bail outs that Congress is passing at President Obama's urging. That ought to stress you out enough for a Marlboro.
What's afoot in our political culture is all very frustrating to me and I'll be writing about it more in coming months, partly because it surely affects the mood of our country and our common psychology, partly because we are allegedly on the verge of health care reform and partly because I've got nowhere else to write and I've written little about politics and government since leaving Seattle Weekly in late-2006. Newspapers are dying, magazines are seeing their news holes decrease dramatically (and self important editors Back East don't pay attention to West Coast journalists) and it's kind of tough for a moderate to find a place to write when most publications seem to be so resolutely partisan (and extreme).
But, first, a cigarette.
It's snowing in Seattle today and it's clear we've got a winter this year that just won't quit. But it's not just that. The American economy is in total meltdown, we've got a new President who makes me very uneasy, a Congress that seems to have OD'd on SSRIs, a government that's invading private businesses, conservatives going utterly batshit and liberals going utterly batshit in return defending the whole thing. It's an ugly time to be a moderate. Hell, it's an ugly time to be an American. Meanwhile protesters are going batshit in London.
Pass the Prozac. Or the bourbon.
Word has it that Seattle is on the verge of becoming the first major US city without a daily newspaper (good news for our mayor though), my career as a journalist is pretty much toast (at least in print form) and I simply cannot get past the sense that there is a lot of crazy, dramatic change afoot in our culture and that it doesn't strike me as being for the good. Hell, I've got friends who are giving up on Seattle and moving to California--just picking up and moving like that--just because they feel like their lives here are played out and they've got to chase their dreams somewhere else. Yesterday, a young woman I know told me that some guy she didn't know tried to grab her by the hand in a park (she was walking her dog) with God only knows what in mind (she's OK). My part of town is reasonably safe, so that's really unusual and deeply troubling.
I'd like the world to make sense again. Really soon.
Also, news is out in PsychRights' case versus the State of Alaska over its drugging of foster kids and others in its care...and the state admitted in a legal filing that it cannot care for the kids allegedly in its care and that it has no influence or control over how doctors treat these kids for behavioral issues. That should put your jaw on the floor. There's more on this over at Beyond Meds and you can even write Gov. Sarah Palin to let her know what you think of the whole thing.
I don't even have words for that kind of bullshit. I think if you unspool the entire rise of the psychopharmacological paradigm, you will see the hand of our lovely government in each frame of the story.
But even more fun is news that AstraZeneca is seeking approval of Seroquel for for--drum roll--pediatric bipolar disorder. I didn't even know about this until the FDA announced that they are going to put the whole thing before an advisory committee in June.
I just want to vomit.
I was out at a book reading last evening and got home much later than I'd thought I would. As a result, posts will be late today, so see you then.
