October 30, 2009

NAMI Lies In NYT Letter To The Editor

Today, NAMI National's executive director Michael Fitzpatrick penned a letter to the editor of the New York Times and objected to how NAMI had been portrayed in a recent article which outlined how the group had gotten about $23 million in pharma funding in recent years. The paper had claimed that represented two-thirds of NAMI's budget and Fitzpatrick wrote to claim it only represented 50 percent.

Then he dropped this claim into the letter:

"NAMI maintains strict guidelines that govern all corporate relations and does not endorse or promote any specific medication, treatment, service or product."

That's a bald-faced lie. In December 2006, Fitzpatrick was quoted in a Janssen/J&J press release wherein he openly touted the company's new atypical antipsychotic Invega:

"'We are pleased that innovative delivery technologies are being applied to new treatments for schizophrenia,' said Michael J. Fitzpatrick, MSW, Executive Director, National Alliance on Mental Illness (NAMI). 'New and efficacious treatment options, like INVEGA, provide significant opportunities for more people with schizophrenia to manage their disease as they work with their treatment teams to live more fulfilling and productive lives.'"

Sadly, the press release itself is no longer online, but if Fitzpatrick wants to claim his group has been mischaracterized, then he needs to be more careful in what he states.

Posted by Philip Dawdy at 12:53 PM | Comments (11)

House Health Care Bill Pushes Mental Health Promotion, Nanny State In Workplace

There are many references to mental health in the House health care reform bill, 110 to be exact. Most of them use the term generically in reference to facilities and health care providers, but not so when it comes to "wellness program grants." (The language begins on page 62 of the bill, downloadable here.) These wellness grants appear to be--as best as I can understand the bill--aimed at smaller businesses and would allow for a 50 percent grant of wellness plan expenses (presumably from a private plan) but only if said wellness program and said businesses institute a Nanny State program that goes far beyond the usual "smoking is bad" provisions and rushes right into the stomachs and moods of working Americans.

If you think I am joking, it's clear that the federal government will be directing provisions of these plans, as the bill orders (on page 66) the secretaries of HHS and Labor to:

"compile and disseminate to employer health plans information on model health literacy curricula, instructional programs, and effective intervention strategies."

Employees will pretty much be forced to play along (pages 66-67):

"EMPLOYEE ENGAGEMENT COMPONENT. An employee engagement component which provides for the active engagement of employees in worksite wellness programs through worksite assessments and program planning, onsite delivery, evaluation, and improvement efforts."

Then it's time for behavioral change (page 67) for one and all!

"(3) BEHAVIORALCHANGECOMPONENT. A behavioral change component which encourages healthy living through counseling, seminars, on-line programs, self-help materials, or other programs which provide technical assistance and problem solving skills. Such component may include programs relating to (A) tobacco use; (B) obesity; (C) stress management; (D) physical fitness; (E) nutrition; (F) substance abuse; (G) depression; and (H) mental health promotion."

That's right, mental health promotion. That's exactly what government should be doing.

"(4) SUPPORTIVE ENVIRONMENT COMPONENT. A supportive environment component which includes the following: (A) ON-SITE POLICIES. Policies and services at the worksite which promote a healthy lifestyle, including policies relating to (i) tobacco use at the worksite; (ii) the nutrition of food available at the worksite through cafeterias and vending options; (iii) minimizing stress and promoting positive mental health in the workplace; and (iv) the encouragement of physical activity before, during, and after work hours."

Wow, going after smoking on breaks, food at work, stress, mental health promotion and pushing exercise. This set of provisions in the bill is simply...breathtaking. There's a Libertarian in me that just screams when I read that the feds want to get involved in creating positive moods at work and creating healthy lifestyles. That kind of thing is so far out of the purview of the feds--read the Constitution if you think I am kidding--that it makes my skin crawl that House Speaker Nancy Pelosi (D-Calif.) is pushing this kind of thing. But then she's always struck me as someone who has spiked her office water coolers with Zoloft.

So the Nanny State has arrived. Enjoy. When I was still at Seattle Weekly in January 2006 and wrote this lengthy piece on Seattle's Nanny State, I thought I was excessive in predicting what the Nanny Statists would come after. Looks like I understated things.

There is a provision on page 68 stating that employers cannot make participation mandatory, but if you've ever worked for a small employer (and I have for several), then you know how voluntary can become mandatory in two seconds. You like that paycheck, right? Well, go jogging with the boss!

Posted by Philip Dawdy at 12:05 AM | Comments (6)

House Health Care Bill Contains MOTHERS Act

The House health care reform bill rolled out yesterday contains most of the language and provisions of the long-stalled, much-controversial MOTHERS Act. Go to page 1418 of the bill, downloadable here, for the language. An earlier version of the MOTHERS act is here.

Minus the original bill's prologue about depression in new moms, much of the Act's provisions are in the House bill, but with slightly softened language. Postpartum depression screening is no longer, in essence, mandatory but is now something that "may" be included in a national education campaign for health professionals and the public. The bill also calls for research on the causes and treatments for PPD, studies of differences in PPD between different ethnicities, "[t]he development of improved screening and diagnostic techniques, Clinical research for the development and evaluation of new treatments."

So that ought to make Big Pharma and the Act's proponents happy.

As for the education program, the bill specifies:

"Information and education programs for health professionals and the public, which may include a coordinated national campaign that "(i) is designed to increase the awareness and knowledge of postpartum conditions; (ii) may include public service announcements through television, radio, and other means; and (iii) may focus on (I) raising awareness about screening; (II) educating new mothers and their families about postpartum conditions to promote earlier diagnosis and treatment; and (III) ensuring that such edu-cation includes complete information concerning postpartum conditions, including its symptoms, methods of coping with the illness, and treatment resources."

That sounds similar to what critics of the Act have objected to in the past (see Evelyn Pringle and Martha Rosenberg), seeing the Act as disease mongering by pharma companies, so it'll be interesting to see the reaction this time out.

I've learned through bitter experience that it's best for me not to have an opinion of the MOTHERS Act or to even ask fairly innocent questions about why we seem to have so much PPD these days. But I will point out that I find it odd that the House is using a bill that's supposed to reform health care access and delivery to fund various research studies which ought to be broken out into NIH's regular budget funding. These studies aren't going to affect health care delivery and access and just add to the cost of an already-costly bill. Just my opinion.

Posted by Philip Dawdy at 12:03 AM | Comments (9)

House Health Care Bill Contains End-Of-Life Counseling

The AP reported last night that the House health care reform bill indeed contains provisions for end-of-life counseling, which generated so much controversy over the summer when it was included in earlier version of the bill. Former Alaska Governor Sarah Palin dubbed this counseling "death panels"--a bit of an overstatement I think--and it was off to the races.

I figured the Democrats were smart enough to strip these provisions out of the House bill, but no. The reality is the counseling likely wouldn't make its way into an eventual combined House-Senate bill because over in the more adult chamber the Dems are struggling to land votes. You can read the language of the end-of-life counseling beginning on page 641 of the bill, downloadable here.

While the language does state that such counseling would be strictly voluntary, I can appreciate why some people object to the Congress legislating much of anything about end-of-life because it seems just as weird to me as the bill's many Nanny State provisions--yay, the government is going to tell me how many calories are in restaurant food because I'm too stupid to figure out that a Big Mac is fattening!--and its provision encouraging workplace wellness plans to create positive mental health in the workplace. Can't business owners work that kind of thing out for themselves? Or is the government to regulate our moods now, too? I feel roughly the same about the end-of-life counseling--it's something the government is best keeping its nose out of.

Interestingly, the prime backer of the counseling is Rep. Earl Blumenauer (D-Oregon) who I dealt with many times when I was a reporter in Portland. I found him to be very smart, very quirky (bow ties, biking everywhere, showing up for endorsement interviews in biking shorts) and very committed to whatever his particular position was, often to the point where you couldn't ask legitimate questions.

He told the AP:

"'There is nothing more basic than giving someone the option of speaking with their doctor about how they want to be treated in the case of an emergency,' said Rep. Earl Blumenauer, D-Ore. 'I think the outrageous and vindictive attacks may have backfired to help raise awareness about this problem, which is why it's been kept in the bill.'"

Blumenauer knows damn well that there's a lot more in this portion of the bill than emergency treatment. There's consulting on wills, living wills, and "[a]n explanation by the practitioner of physician orders regarding life sustaining treatment."

I bet you this blows up all over cable news and the blogosphere later today. Stay tuned.

Posted by Philip Dawdy at 12:01 AM | Comments (3)

October 29, 2009

House Health Care Bill Mandates Study Of Mental Health Outcomes of Abortion, Adoption

Just putting this out there in as non-confrontational a way as one can: Beginning on page 1420, the House health care reform bill rolled out earlier today requires NIMH to study the mental health outcomes for women who have abortions or otherwise "resolve" a pregnancy. The bill is downloadable here.

"It is the sense of the Congress that the Director of the National Institute of Mental Health may conduct a nationally representative longitudinal study (during the period of fiscal years 2011 through 2020) on the relative mental health consequences for women of resolving a pregnancy (intended and unintended) in various ways, including carrying the pregnancy to term and parenting the child, carrying the pregnancy to term and placing the child for adoption, miscarriage, and having an abortion. This study may assess the incidence, timing, magnitude, and duration of the immediate and long-term mental health consequences (positive or negative) of these pregnancy outcomes."

I have no idea why this is included in a bill that's supposed to reform our health care system--for good or ill. Maybe I'm missing something. The bill requires NIMH to report back to Congress on study progress and findings within three years.

Of course, the relative psychological impacts of abortion are some of the most heated aspects of the abortion debate. Pro-lifers often claim that women who undergo abortions often end up depressed while pro-choicers often claim that there's no psychological detriment. I've seen competing evidence in the medical literature on this point over the years. I'll leave it at that.

Posted by Philip Dawdy at 03:17 PM | Comments (4)

House Health Care Bill Mandates Calorie Counts At Restaurants Nationally

House Speaker Nancy Pelosi earlier today rolled out the House's version of health care reform. The bill is a 1,990 page whopper, downloadable here. I've been able to poke through it a bit and, beginning at page 1,510, I encountered something that will embiggen the hearts of public health advocates (and frankly the whole bill is a gigantic wet kiss to the public health crowd) and make haters of the Nanny State say, "Told you so."

The House bill mandates for calorie counts of almost any item served at a restaurant (or similar food establishment) owned by a company with 20 or more restaurants in the US as well as on drive-thru menu boards. Currently, only a few cities and counties require such information in the US, notably New York City and King County (Seattle), Washington. So America is about to go from Nanny State cities to the Nanny State nation.

And the trouble with calorie counts is that they seem to have a fairly limited impact on what people eat, according to this New York Times account of a recent study of the calorie count law in NYC. (I have no idea how this is playing out in Seattle so far.) It perplexes me beyond belief that we have a government that doesn't get that people already know a Big Mac is fattening and people are going to order one anyway, calorie count information be damned, because they like Big Macs. This calorie count thing nationally is going to be expensive to implement and will likely not change human behavior much. I cannot wait to see how the food industry responds.

Beginning on page 1515, the bill also mandates calories counts for items in a vending machine operated by anyone who operates 20 or more vending machines. And the nutritional information that's already on the majority of food (chips, cookies, etc.) you can buy from a vending machine isn't sufficient under the House bill. Instead, vending machine operators would be required to post a prominent sign next to each item, readable before a consumer makes a purchase. That is going to be a very expensive hassle for vending machine operators across the country, especially smaller operators.

I'm a bit lost on what American over the age of 14, say, doesn't know that chips from a vending machine are high-calorie items, so why this provision exists in the bill is beyond me--except that I know it's there to serve the true believers in the Nanny State.

There's more in this bill that I'll post on in a bit.

Posted by Philip Dawdy at 02:50 PM | Comments (9)

AstraZeneca To Pay Feds $520 Million To Settle Seroquel Claims

Just out this morning in AZ's third quarter financial results is this little whopper:

"Agreement in principle reached with the US Attorney`s Office in Philadelphia to resolve its investigations related to Seroquel sales and marketing practices. This accounts for $520 million of the $538 million provisions taken in the first nine months, $108 million of which taken in third quarter."

I don't have any more details on this yet, so stay tuned.

Excepting J&J/Janssen, all the makers of atypicals have agreed to settlements with the feds over illegal marketing.

Posted by Philip Dawdy at 10:34 AM | Comments (5)

Pristiq Ad Runs During World Series As Adverse Events Reports Mount

Yes, that creepy ad for Pristiq with the woman staring at the wind-up doll has been running again during the ALCS and NLCS and now during game one of the World Series last night (won by the Phillies 6-1 over the Yanks with a big assist from former Mariner Raul Ibanez). It's bad enough having to sit through Cialis and Viagra ads during the Fall Classic, but anti-depressant ads, too? Hand me a beer instead. You see the ad here.

Meanwhile, adverse events for the Son of Effexor continue to mount and stand at 1,361 adverse events reports in the FDA's database. That's good going for a drug that's been on the market two-plus years and that still is used so little that Pfizer (Wyeth's new owner) doesn't list third quarter 2009 sales figures for the drug.

Posted by Philip Dawdy at 12:05 AM | Comments (2)

Congress To Go After Medicaid Fraud, Why Not Fraud Against Patients Too?

The Wall Street Journal noted yesterday that Congress is planning to take steps to wipe out the estimated $60 billion a year in Medicaid fraud.

"'The scale of health care fraud in America today is staggering,' Senate Judiciary Committee Chairman Patrick Leahy (D., Vt.) said at a hearing. 'Now, as health care reform moves through the Senate, I want to make sure we do all we can to tackle the fraud that could undermine efforts to reduce the skyrocketing cost of health care.'"

That's all well and good and I wish Congress luck. A good amount of the fraudulent behavior comes from our friends at America's Pharmaceutical Research Companies (see Lilly, Pfizer, BMS, etc.). All of the billions in awards the feds have gotten out of these companies for ripping off taxpayers has also come at the expense of individual Americans who, in many cases, never get compensated and never get the satisfaction of watching a Lilly exec, say, do a perp walk. Meanwhile, their bodies are ravaged.

Congress ought to be interested in beefing up consumer protections regarding pharmaceuticals and also in creating penalties that really matter instead of the situation we have now where pharma basically pays off the feds through its liability insurance. The system of laws and regulations in place now is apparently not sufficient to protect Americans against another Zyprexa or Byetta.

Posted by Philip Dawdy at 12:03 AM | Comments (2)

Yes, I Got Spoofed

JC, a reader from Back East somewhere, left a comment yesterday that I broke out as a post because he fooled me into thinking he really was one of the Biederman groupies, bipolar child defenders, etc. His comment was so perfect that it got by my BS detector, which may not have been fully on at 10.30 am. It's classic and you all should go read it here.

What I love is that JC says he took a lot of the language straight from the Child and Adolescent Bipolar Foundation website.

Posted by Philip Dawdy at 12:01 AM | Comments (4)

October 28, 2009

Weirdest Comment Ever On This Site

And thus well worth highlighting since it comes in response to the JAMA study which found that antipsychotics are putting tons of fat on youngsters.

"I think this report smells fishy. Smells like the work of anti-psychiatry Scientologists. Psychiatric medications are a healthy part of a balanced lifestyle for the majority of children with childhood bipolar disease, a serious but treatable medical condition.

"My child has bipolar disorder and I've come to learn that her rages have nothing to do with me and that this is a highly genetic biological brain-based disorder.

"We have her on eight meds prescribed by the director of our local university clinic and we've received extensive psychoeducation about the nature of her disease. Additionally, my husband and I attend a support group three times a week for parents of bipolar children at the hospital.

"I trust very much in the power of medicine and am very thankful for the big glitzy university hospital where we live. Her neuropsychopharm says that when taken as prescribed, her medicines including the atypicals are safe and effective. They're all FDA approved drugs anyway.

"Studies like this are done by stupid Scientologists that don't understand brain-based disorders."

Speaks for itself.

Posted by Philip Dawdy at 10:28 AM | Comments (22)

Harvard Psychiatrist Stabbed, Patient/Attacker Killed

Yesterday, a tragedy occurred at one of Massachusetts General's buildings. A patient attacked a psychiatrist named Astrid Desrosiers with a knife, reportedly inside the Massachusetts General Hospital Bipolar Clinic & Research Program. An off-duty security guard shot and killed her assailant, identified as Jay Carciero, after he refused to surrender and put down his knife. Desrosiers is reportedly is serious, but stable condition. I wish her a continued and speedy recovery.

I'm sure we'll learn more about this tragedy in the near future.

Posted by Philip Dawdy at 12:05 AM | Comments (12)

JAMA Study Slaughters Antipsychotics For Kids, Teens Paradigm

Late yesterday I got a copy of the JAMA study detailing how kids and teens on atypical antipsychotics are putting on lots of weight very quickly and suffering detriments on just about every metabolic measure researchers looked at (my initial post is here). I'll come to the study itself in a moment as well as the accompanying editorial, but first I wanted to note that I have been banging on the kids-on-meds issue (especially atypicals) for three years and have taken a ton of heat in the process. I feel vindicated by this new study and other recent studies tossing cold water on various treatment paradigms involving kids and many of you should feel vindicated as well. I remember how gingerly I first took on the subject in November 2006 and how many of you kicked me in the pants and told me to trust my instincts. Thanks.

The reason this new study feels so big to me is because it was in JAMA (so its readership will be wide amongst doctors), and because it got a ton of media attention (the wire services and the New York Times were all over it. Sadly, nothing has hit TV or NPR. Hmmmm, I wonder why), and because several psych researchers were quoted as saying how powerful the study results were, and because the editorial in JAMA was simply scorching.

Let me note one thing my colleagues in the media completely missed. The study's acronym is SATIETY, which means fed (or stuffed) to excess. It's got to be the most ironic and honest acronym in the history of psychiatry.

Authored by Jon McClellan (a well-known critic of the bipolar child paradigm) and Christopher Varley, both child psychiatrists at Children's Hospital here in Seattle, the editorial declared:

"These results challenge the widespread use of atypi- cal antipsychotic medications in youth...."

"[G]iven the risk for weight gain and long-term risk for cardiovascular and metabolic problems, the widespread and increasing use of atypical antipsychotic medications in children and adolescents should be reconsidered...."

"Pronounced weight gain early in life and significant changes in lipid profiles have ominous long-term health implications...."

"[C]onsideration of less risky treatment interventions and scrupulous attention to metabolic parameters in children and adolescents who receive atypical antipsychotic medications are essential."

Those are strong words, likely fighting words to researchers and mental health advocates who are totally down with the disordered kid and teens paradigm. I'm ready for that fight because, except in truly extreme cases (which sadly exist), kids and teens should not be slapped onto atypicals (much less any med), especially when they are not afforded access to psychosocial interventions.

As for the study itself, it involved 272 kids and teens (average age 13.9 years, although kids as young a 4 were in the study) who were treatment naive (meaning they'd never taken an antipsychotic before), had a mean weight of 117.7 pounds, a mean BMI of 21.3 (meaning normal weight for their body size), and a mean waist size of 30.4 inches. Thirty percent of the patients were diagnosed with schizophrenia spectrum disorders, 47.8 percent were diagnosed with a mood disorder (with depression, bipolar disorder and mood disorder NOS about equally represented) and 22.1 percent were diagnosed with "disruptive or aggressive behavior spectrum disorder" (including autism, ODD, etc.).

The kids and teens were given one of four study medications (Zyprexa, Seroquel, Risperdal or Abilify) for 12 weeks. Then the metabolic changes began.

On Zyprexa, patients put on an average of 18.78 pounds (in 12 weeks!), their BMIs went up three points and their waists expanded an average of three inches (in 12 weeks!). On Seroquel, they put on an average of 13.3 pounds (so much for that weigh neutral claim, eh, AZ?), their BMIs went up an average of 2.12 points and their waists expanded an average of two inches. On Risperdal, they put on an average of 11.7 pounds, their BMIs increased an average of 1.92 points and their waists expanded an average of two inches. On Abilify, weight went up an average of 9.7 pounds, their BMIs went up an average of 1.67 points and their waists expanded an average of two inches. Patients in an untreated comparison group had almost zero changes in any of those parameters.

Zyprexa and Seroquel were the worst performers on blood glucose increases with an average increase of 3.14 mgs/dl and 2.64 mgs/dl, respectively (Risperdal and Abilify were much better). Total cholesterol exploded on Zyprexa, going up an average of 15.585 mgs/dl, and went up an average of 9.05 mgs/dl on Seroquel (Risperdal and Abilify were better).

So there you have it: The atypicals, especially Zyprexa and Seroquel, absolutely stink for kids and teens (they aren't any kinder to adults and the infamous 2006 PRIME study found similar metabolic problems in teens on Zyprexa)). That they had such profound effects in such a short period of time really calls their use into question, particularly because there is limited data on their efficacy and because only two of them are FDA-approved for treating kids and teens. Risperdal is approved for treating autism-related agitation in kids and teens and is approved for so-called pediatric bipolar disorder in kids and teens aged 10 to 17. Abilify is approved for PBD, as I guess I'll abbreviate it now, in kids and teens aged 10 to 17 and for treating schizophrenia in teens aged 13 to 17.

This study puts the FDA in a tricky spot. In June, an FDA advisory panel reluctantly recommended that the agency approve Geodon, Zyprexa and Seroquel for PBD in ages 10 to 17 and schizophrenia in ages 13 to 17. Over four months later, the agency still has not announced what it will do, but it is not bound by the panel's recommendation. I would hope that the agency takes this new study into consideration somehow as it does echo many of the concerns the panel had while making its lukewarm recommendation.

At this point, it's pretty clear to me that atypicals are harmful to young patients (they are to adults too) and their use should be drastically curtailed outside of psychotic disorders. The New York Times reported a couple of years ago that over 2.5 million American kids were getting atypicals, so there's a lot of curtailing and reassessing to do.

As for psychotic disorders, the documented damage caused by atypicals could argue for a careful return to older antipsychotics (presumably at very low doses) on a pragmatic level. On a more progressive level, I think the problems these drugs cause argue for new approaches to treating psychosis in youths. I know there's very little traction for a Soteria type of approach among mental health advocates for adults diagnosed with psychotic disorders, but perhaps we ought to be trying this--at least on a pilot study level--with kids.

They are kids after all and deserve a whole lot better than what they are getting now. Considering the damage these meds cause kids so quickly, it hardly seems radical to try--just try--something else.

Posted by Philip Dawdy at 12:03 AM | Comments (38)

October 27, 2009

JAMA Study Finds Explosive Weight Gain In Kids On Antipsychotics

A study to be published in JAMA tomorrow finds staggering weight gain in kids given antipsychotics. According to the AP:

"Children on widely used psychiatric drugs can quickly gain an alarming amount of weight; many pack on nearly 20 pounds and become obese within just 11 weeks, a study found.

"'Sometimes this stuff just happens like an explosion. You can actually see them grow between appointments,' said Dr. Christopher Varley, a psychiatrist with Seattle Children's Hospital who called the study 'sobering.'

"Weight gain is a known possible side effect of the anti-psychotic drugs which are prescribed for bipolar disorder and schizophrenia, but also increasingly for autism, attention deficit disorders and other behavior problems. The new study in mostly older children and teens suggests they may be more vulnerable to weight gain than adults."

That is very rapid and very significant weight gain. The drugs involved were Risperdal, Seroquel, Zyprexa and Abilify. Since I've not seen the study, which involved 205 New York-area kids aged 4 to 17, I don't know what range of diagnoses kids were getting these drugs for, but it'll likely be the usual muddle of schizophrenia, pediatric bipolar disorder, autism, ADHD and so on.

If this study does not give pause to those who wish to medicate kids, then nothing will.

Posted by Philip Dawdy at 11:51 AM | Comments (5)

Study, BBC Claim Anti-Depressants Work Instantly, 6 Reasons To Be Skeptical

That's right: A study in this month's American Journal of Psychiatry was written up by the BBC yesterday--not sure if there was a report on the radio or TV--and framed as establishing that anti-depressants work "instantly" to quote the BBC's headline. That would run counter to what most researchers and patients believe to be true (and plenty of studies have shown to be true) that anti-depressants take as long as several weeks to deliver a measurable effect. What Oxford researchers found was that depressed patients had a quick response to an anti-depressant called Reboxetine. They established this by measuring how patients' negative thoughts improved (using emotional recall kinds of tests) and found that negative thoughts improved within a few hours and even did so in healthy, non-depressed volunteers taking the drug.

"Dr Harmer said: 'We found the antidepressants target the negative thoughts before the patient is aware of any change in feeling subjectively.'

"'Over time, this will affect our mood and how we feel because we are receiving more positive information.'"

Michael Thase, a psychiatry professor at the University of Pennsylvania, called the finding possibly "paradigm changing."

We live in interesting times when researchers can claim an anti-depressant is "working" when a patient has no sign of depression symptom improvement. As usual, several skeptical thoughts come to mind.

1. You don't know you are feeling better but you are is one of the study's main conclusions. That strikes me as a dubious claim, especially absent any knowledge of how the patients and healthy volunteers fared over time. I mean, isn't the point of treating depression to treat depression and not get all wound up about emotional recall tests? To the degree that it might predict later response to depression treatment, the response might be interesting.

2. The choice of Reboxetine (brand name Vestra) is an odd one. A recent study found it the least effective of all the modern anti-depressants and the FDA has not approved it for use in the US (which tells you something) and it's not widely-used in Europe. Why the researchers didn't choose a more commonly used medication is beyond me. It really doesn't tell doctors and patients much in a clinically useful way.

3. The study is of a small enough sample size--31 depressed patients, 30 healthy volunteers; half of each group on active medication--to make its findings little more than suggestive and not the paradigm changer Thase claims. It's research that needs to be replicated several times.

4. I'm not buying that someone on Reboxetine identifying more faces (two more on average) on a facial recognition test than someone not on Reboxetine means that much in a real world way. Maybe I'm being too skeptical here, but it doesn't quite add up.

5. The study's two primary authors (Guy Goodwin and Catherine Harmer--interesting name for a doc) have oddles of pharma funding in their past from the likes of AstraZeneca, BMS, Lilly and so on.

6. For the BBC to generalize from results of a Reboxetine study that its findings apply to all anti-depressants is complete bunk and lazy reporting and editing. And that's pretty much what the article and its headline claim.

Posted by Philip Dawdy at 12:05 AM | Comments (16)

AP Reports Health Insurance Company Profits Not Very High

I'm sure most of you are aware that health insurance companies have been just about every Democrats favorite whipping boy in the ongoing health care reform debate. Their profits are obscene and so on goes the rhetorical line out there and the companies are allegedly the cause of the explosion in health care costs in America. Well, a reporter at the AP went and did some checking and it turns out, according to the AP that across the health insurance industry profit margins are nowhere near the 25 percent some people claim.

"Health insurance profit margins typically run about 6 percent, give or take a point or two. That's anemic compared with other forms of insurance and a broad array of industries, even some beleaguered ones.

"Profits barely exceeded 2 percent of revenues in the latest annual measure. This partly explains why the credit ratings of some of the largest insurers were downgraded to negative from stable heading into this year, as investors were warned of a stagnant if not shrinking market for private plans...."

"Health insurers posted a 2.2 percent profit margin last year, placing them 35th on the Fortune 500 list of top industries. As is typical, other health sectors did much better - drugs and medical products and services were both in the top 10.

"The railroads brought in a 12.6 percent profit margin. Leading the list: network and other communications equipment, at 20.4 percent."

Interesting stuff, but it doesn't make me sympathize with health insurance companies because they are a gigantic pain to deal with.

Posted by Philip Dawdy at 12:03 AM | Comments (7)

October 26, 2009

NPR Does It Again

NPR's "Morning Edition" today had yet another installment on what it's essentially declaring a mental health crisis on college campuses. Based on what I know not. Today's show again focuses on Stanford University. I really cannot force myself to summarize the piece's contents. Listen to it or read it here and let me know what you think in comments.

Posted by Philip Dawdy at 02:10 PM | Comments (4)

Animal Study Finds Psych Meds Given To Young Create Psychiatric Disorders In Later Life

That is the conclusion of a study by a neuroscience graduate student at Georgetown University, but let me add some caveats: the applicability of animal studies to humans isn't 100 percent and this study has not been published yet. It's scheduled to be presented this week at a neuroscience meeting. Nonetheless, its conclusion is bound to be controversial.

"Using behavioral tests to detect characteristics of autism and schizophrenia, the researchers found that when given to infant rats, the drugs caused behavioral abnormalities later in life. What's more, the abnormalities were not limited to the drugs known to cause neuronal cell death.

"'That is of particular concern because some of the drugs may predispose to psychiatric disorders later in life,' says lead author Patrick Forcelli, a graduate student in the Interdisciplinary Program in Neuroscience at GUMC. 'At the same time, our studies identify specific drugs that cause little or no long-term behavioral impairment.'"

The drugs given the rats were described as ones for epilepsy, mood disorders and pain (meaning mostly likely they used anti-convulsants, anti-depressants and hydrocodone or similar drugs). I don't have any specificity beyond that, so I sure look forward to this study's presentation.

Posted by Philip Dawdy at 12:05 AM | Comments (3)

Kansas Jury Accepts Prozac-Made-Me-Do-It Defense

According to hutchnews.com in Hutchinson, Kansas, a jury has acquitted a prisoner of beating a corrections officer because it bought the accused's defense that high doses of Prozac drove him batty.

"Andrew Housworth, 31, was found not guilty Friday of five counts of battery against a correctional officer and two counts of aggravated battery of a correctional officer and a fellow inmate....

"Housworth also admitted during trial his criminal history included aggravated assault, criminal threat and attempted robbery. However, he testified he believed high dosages of Prozac, an anti-depressant prescribed to him at the prison and jail, influenced his behavior.

"It made him feel like he wanted jump out of his skin, he said. Housworth told jurors he never intended to hurt anyone.

"During the time he's spent in youth shelters, jails and prisons, Housworth said he had nothing but "minor write-ups" until he began taking Prozac in 40-milligram to 90-milligram dosages at the local prison and jail.

"He said he never stopped taking the drug because he was 70 days shy of parole in June 2007, and then he signed a parole agreement specifying he would take his prescribed medications.

"Housworth said his concerns about Prozac's effects on him were ignored by local prison and jail staff."

Generally, meds-made-me-do-it defenses aren't too successful in court, so Housworth's case must've been quite compelling.

I can certainly sympathize a bit: I wound up in 1993 on 40, 60 and then 80 mgs. of Prozac and it made me utterly wacky and gave me that "want to jump out of my skin" feeling of akathisia.

Posted by Philip Dawdy at 12:03 AM | Comments (12)

October 23, 2009

Interesting Article On Mental Illness, Psychosis

And it's in the New York Times' "Fashion & Style" section, for reasons that escape my pea brain. It's quite well-written and begins:

"There are two kinds of madness: the kind that strikes suddenly, like a startled bird, and the kind that stalks silently for years, circling round and round until you are fully gathered in its dark wings. Mine was the latter."

Some of you will like the article, some will hate it, so I'm pretty much just passing it along.

Posted by Philip Dawdy at 01:48 PM | Comments (17)

Lilly Settles South Carolina Zyprexa Claims For $45 Million

News is out that the State of South Carolina nad Eli Lilly have reached a $45 million settlement over the state's lawsuit against Lilly over its handling of Zyprexa.

"South Carolina and other states argued Eli Lilly:

"Did not properly warn of the drug’s side effects, including heart problems, diabetes, hyperglycemia and an increased risk of death in patients with dementia.

"Falsely marketed the drug to treat other illnesses, including depression and attention deficit disorder."

Oh yes.

Posted by Philip Dawdy at 01:14 PM | Comments (3)

Bloomberg Dubs Abilify A "Mood Stabilizer"

In writing up BMS's third-quarter financials yesterday, two reporters at ordinarily-hyper-accurate Bloomberg described BMS's Abilify as a "mood stabilizer" twice in one article. Um, the drug is an antipsychotic and absolutely no one calls it a mood stabilizer, least of all BMS itself. Why Bloomberg is helping them rebrand the drug with a softer image is beyond me.

Abilify sales were up 16 percent in the quarter at $653 million in sales. That's a pretty hefty boost.

Posted by Philip Dawdy at 12:05 AM | Comments (15)

Public Option Headed For Senate Floor?

The New York Times reported last night that Senate Majority Leader Harry Reid (D-Nevada) was on the verge of deciding to include the so-called public option in the final Senate health care reform bill and send it to the floor for a vote. I'm pretty much neutral on the public option itself since the Congressional Budget Office hasn't scored it in the Reid bill (I think the Kennedy-Dodd bill which included the public option was estimated by the CBO to run $1.2 trillion over 10 years), but one thing I do know is that if Reid includes it, then all hell will break loose in the Senate. Republicans oppose the option and so do a good number of Democrats and if that puts Dems in the position of needing to invoke reconciliation--the so-called nuclear option--to get it passed with less than 60 votes, then it will come back to haunt the Dems somewhere down the road.

Obviously, what Reid is up to is risky political business.

Posted by Philip Dawdy at 12:03 AM | Comments (1)

A Katie Update

A bunch of you have asked how my cat Katie is doing since her dance with death of almost two weeks ago. She's fine and is eating well and has put weight back on. She's been fighting with KC, who's jealous of all the attention Katie got, and she's been playing with the laser pointer. So it all seems pretty good, but I'll feel much better when she gets back up to 12 pounds or so.

Thanks to all of you for your concern and kind thoughts.

Posted by Philip Dawdy at 12:01 AM | Comments (1)

October 22, 2009

NAMI Board Member Was Paid Consultant To AstraZeneca On Seroquel

Very big props to Jim Edwards at bnet.com and to whomever handed off some documents to him which reveal that Jim Dailey, then policy director of NAMI Kentucky and a NAMI National Board member, received $600 from AstraZeneca (at the time fighting to get market share for its antipsychotic Seroquel) in return for acting as a consultant for the company for one day in December 2003. You can obtain the document--essentially a contract between AZ and Dailey plus an itinerary of his meeting with AZ--at bnet.com.

Also attending the meeting were NAMI National's executive director Michael Fitzpatrick and Chuck Harmon, NAMI's director of corporate relations. To be discussed at the meeting, according to the document, was a presentation by AZ officials of what it saw as the role of advocacy groups in helping the company achieve its "Seroquel Vision." Also to be discussed were the "increasing role" of state Medicaid programs and "MAP initiatives" as well as "ensuring access for patients." MAP would of course be a reference to a medication algorithm project such as the infamous TMAP.

The NAMI officials were slated to lay out their views on "Partnering Opportunities" and the Mind of America program. Dailey was scheduled to discuss access issues in Kentucky while Harmon would address "current activities within industry."

Why would a NAMI official who was receiving a salary from NAMI Kentucky suddenly get a $500 honorarium from AZ? ($100 was the reimburse travel expenses.) That makes no sense to me.

In March 2004, NAMI Kentucky announced the launch of the Mind of America program:

"'Every day, our communities witness evidence of the consequences to our communities of the neglect of services for people with mental illness,' said Jim Dailey, Policy Director, NAMI Kentucky, and NAMI National board member.

"Advocates and experts will present report findings to legislators and other policymakers on the scope of the mental health crisis in Kentucky, and recommend solutions that are evidence-based, cost-effective, and safe.

"The report chronicles the results of an ineffective, insufficient mental health system and foreshadows the consequences that would result if Governor Fletcher’s plans to restrict access for Kentucky’s citizens even further are implemented.

"The report serves to launch the Campaign for the Mind of America in Kentucky, promoting smart choices with the broadest benefits-—the greater awareness of the cost of untreated mental illness."

All of this on the heels of today's revelation in the New York Times that NAMI has gotten almost $23 million from pharma companies in recent years.

It's time for a house cleaning at NAMI.

Posted by Philip Dawdy at 03:17 PM | Comments (2)

NAMI Got $23 Million From Pharma Companies

The New York Times is out today with an article on just how much money NAMI has been getting from Big Pharma in recent years--a ton, three-fourths of its total fundraising.

"The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private.

"But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.

"Even the group’s executive director, Michael Fitzpatrick, said in an interview that the drug companies’ donations were excessive and that things would change.

"'For at least the years of ’07, ’08 and ’09, the percentage of money from pharma has been higher than we have wanted it to be,' Mr. Fitzpatrick said.

"He promised that the industry’s share of the organization’s fund-raising would drop “significantly” next year.

"'I understand that NAMI gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals,' Mr. Fitzpatrick said. 'It’s simply not true.'"

"Mr. Fitzpatrick said Mr. Grassley’s scrutiny, which he described as understandable given the attention paid to potential conflicts of interest in medicine, had led his organization to begin posting on its Web site the names of companies that donate $5,000 or more. And he predicted that other patient and disease advocacy groups would be prodded by Mr. Grassley’s investigation to do the same."

Gee, I remember the old days when only half of NAMI's contributions came from pharma. What cheeses me off about all of this is that in 2005 Michael Fitzpatrick met with me and told me he was taking steps to make NAMI less pharma-dependent while, at the same time, the group was becoming more pharma-dependent.

As for making contributions available on NAMI's website, they are indeed there now, but you've got to poke around the site pretty hard to find NAMI's newfound transparency. Here are the Q1 and Q2 reports for this year.

Posted by Philip Dawdy at 01:10 PM | Comments (12)

Child Psychiatrist Says Kids Overmedicated, Wrongly Diagnosed

A child psychiatrist at Alta Bates Medical Center in Berkeley, California named Edmund Levin has thrown before his colleagues a major gauntlet, aimed in particular at the bio-psychiatry, bipolar child proponents at Harvard. In a paper in the Journal of The American Academy of Psychoanalysis and Dynamic Psychiatry (something the Biederman crowd likely doesn't read), he asserts that child psychiatrists are over-medicating their young patients, diagnosing them with pediatric bipolar disorder when a diagnosis of developmental trauma disorder is more appropriate, and that dramatically reducing medications actually improved children he's observed.

His conclusions come from four decades of working with children in residential treatment programs. From the paper's conclusion:

"Residential treatment programs can serve children well by reconsidering their diagnoses and by re-evaluating medication use. This study argues from an individual clinician’s experience that the overwhelming majority of children do no worse and most do considerably better entirely off or at doses of psychotropic medication significantly lower than that prescribed in the mainstream of contemporary child psychiatric care. It seems reasonable to attribute the clinical improvement of these children to diminished efforts to control thinking, affect, and behavior by pharmacologic interventions, while simultaneously increasing the amount and quality of analytically informed treatment. Success in effecting dramatic reductions in prescribed medications suggests that in mainstream child psychiatric care there is excessive overdiagnosing and overmedicating of affectively labile and rageful, aggressive children. Very likely, these children are responding to trauma and warrant the diagnosis of DTD rather BD/PBD/SMD and comorbid ADHD."

DTD is not in the DSM currently and I don't know enough about it to offer any wisdom. That said, Levin's assertion that many children with pediatric bipolar disorder diagnoses are in fact responding to a trauma of some kind is bound to be controversial among the bio-psych crowd because it would tend to point the finger for a childhood mental disorder squarely at a child's environment, to put it gingerly.

Posted by Philip Dawdy at 12:05 AM | Comments (13)

Forest Labs Bullish On Experimental Antipsychotic

In an earnings call with investment analysts on Tuesday, Larry Olanoff, Forest Labs' COO, spoke of the company's new atypical antipsychotic Cariprazine, which is currently in phase 2 clinical trials.

"Going further back into the question on Cariprazine, I would say that at this present time, we have very positive data in bipolar mania disorder, which potentially as a pivotal trial and clearly is justification going on with Phase III. That indication by itself is probably not commercially feasible, but it’s a nice add-on.

"We’re waiting on either the schizophrenia results or if the schizophrenia results are gray and perhaps are not definitive to move on, then we would consider perhaps then waiting for some of the additional trials we have ongoing in both bipolar depression, as well as in treatment resistant depression which would form a sufficient commercial core with bipolar mania to go forward in that way.

"As far as differentiation, it’s still early days. I can tell you based on the Phase II data we generated thus far, which is still fairly short term data, that we’re not seeing any major safety concerns, we’re not seeing anything substantial in the way of weight gain, we haven’t seen any major cardiovascular problems, and we see the kind of adverse event profile you’ve seen with the atypicals with regards to exter-parametal symptoms. That’s pretty much what I can say. I think the schizophrenia data coming out will further add to that initial assessment."

The drug has been trialed or is being trialed for acute mania, schizophrenia, major depression and bipolar depression. Interestingly, Olanoff's assertion that the company had a trial for mania isn't matched by what's in the clinicaltrials.gov database, so I wonder if we've got an unregistered study going on there. Anyway, I know very little about the new compound, but would expect the company to chase FDA approval in 2011 or 2012 if studies continue to pan out as they claim. Lexapro goes off-patent in early-2013, so you just know that Forest would love to have a depression indication for Cariprazine.

Posted by Philip Dawdy at 12:03 AM | Comments (3)

Lexapro Sales Stabilized By Lexapro Sales To Teens

In a conference call with analysts on Tuesday, Forest Labs' COO Larry Olanoff noted slightly decreased Lexapro sales and credited the drug's recent FDA approval for use in adolescents as helping to stabilize Lexapro's sales.

"Lexapro sales in the quarter totaled $566 million, a decline of 3.1% year-over-year. In March, we announced the FDA approval of our supplemental NDA for Lexapro, for the indication of acute and maintenance treatment of major depressive disorder in adolescence, 12 to 17 years of age. This additional indication is helping to stabilize the position of Lexapro in the market, and we have observed an increase in share for this patient population."

I've got no guess as to how many kids are on Lexapro, but it's well-known that the company has been charged by the feds with illegal off-label marketing of the drug for use in adolescents and with paying kickbacks to doctors, that a Harvard psychiatrist got $750,000 for helping them push Lexapro for kids and that the drug's FDA approval studies include two failed clinical trials (no advantage over placebo) and very limited efficacy in the two positive trials (one of which was actually done using Celexa, Lexapro's molecular big brother). Earlier this year, Forest set aside $170 million in expectation of a looming fine by the feds.

None of which came up during the conference call.

Posted by Philip Dawdy at 12:01 AM | Comments (1)

October 21, 2009

Cymbalta Sales Way Up

Eli Lilly announced its third quarter results today. Cymbalta sales are way up:

"Lilly's biggest drug, Zyprexa, posted sales of $1.2 billion, up 2.8%. Higher selling prices offset lower demand in the U.S. Demand increased outside the U.S. Sales of antidepressant Cymbalta rose 10% to $790 million."

A 10 percent increase over the same quarter last year is pretty significant. While I'm not clear on whether Lilly upped Cymbalta prices in the last year (which would account for a portion of the revenue increase if they had), it looks as though more scrips for this tricky anti-depressant are being written. Whether they are for depression or for pain indications isn't clear to me at all.

It looks like Cymbalta could top $3 billion in sales this year.

Posted by Philip Dawdy at 01:57 PM | Comments (4)

NPR's Biased Reporting On Mental Health

I was very discouraged by a piece that aired on National Public Radio's "Morning Edition" on Monday. It was another example of lazy, unquestioning reporting of mental health issues by a mainstream media outlet. The fact that it aired on "Morning Edition" is important because the show is one of the most popular on all of radio with an estimated 13 million listeners a week (that puts it just behind Limbaugh and Hannity, although Arbitron recently changed how it measures ratings so some of this may have changed).

The news hook for the story was the mental disorder diagnoses are way up among college students and that a group at Stanford University is using theatre monologues to "come out" about living with mental disorders. I'm all for people being upfront with the world about themselves and so on, but all I heard were a bunch of young people who were deeply-married to their diagnoses--practically boasting about them--and their meds. If that's what gets them through life as a college student at a tough school, then fine. I just hope they'll be in a position to someday be a bit more questioning as adults about diagnoses, medications and their futures as people with mental illnesses.

Of course, that would be something that NPR's reporter, Deborah Franklin, was not. In an 8-plus-minute piece, her reporting was almost completely flavored with bio-psychiatry biases (diagnoses are unquestioned, meds and treatment always work, etc.) and there was no information about, for example, the FDA's black box warning on anti-depressants which are specifically aimed at the under-25 set. There was nothing about recent research showing diagnoses of bipolar disorder are wrong almost 50 percent of the time and that in a large percentage of cases the disorder resolves by a human's mid-30s. That would've been useful context to have in such a piece and its absence makes me wonder what kind of game NPR thinks it's playing (I should note that NPR has long been heavily-underwritten, in part, by the Robert Wood Johnson Foundation, the big public health foundation begun by one of J&J's founders) and who is editing its science and health reporting. If NPR is not interested in contrary points of view, then it really needs to get back in touch with its journalistic values. It would've been an easy thing for the reporter to pick up the phone and interview someone from The Icarus Project, which is quite active on some college campuses, but instead Franklin settled for a wildly unbalanced piece.

As a reporter myself, I find that sad and embarrassing. In a piece on "Morning Edition" last year, an NPR reporter described bipolar disorder as "bipolar disease." I would so like someone at NPR to explain to me the disease process of bipolar "disease."

Here's the Franklin piece itself:

Here's one of the student monologues, read by an actor, involving OCD:

And another, also read by an actor, involving anxiety:

A web version of the piece is here. A transcript of the aired piece is here.

Posted by Philip Dawdy at 12:05 AM | Comments (13)

Pill Crazy, Mike Royko's Son Gets 30 Months For Bank Robbery

Rob Royko, son of the famous late Chicago columnist Mike Royko, was sentenced to 30 months in federal prison for an attempted bank robbery in 2005. What's significant about this case (other than the son of a famous father gone wrong theme) is that Rob had problems with drugs and drink for years, was diagnosed with depression and bipolar disorder, suddenly began taking a ton of pills (including Zyprexa, Depakote, Valium and Vicodin) and, in his 50s, committed his first crime--trying to rob a bank. He claims he was taking over 600 pills a month right before he attempted to knock over a bank, an amount that would surely drive anyone crazy if it didn't kill them first. Rob also apparently went off the Zyprexa a week before his crime after feeling suicidal (there are reports of suicidality connected with Zyprexa use, although with so many pills in his system it could've been any of them). The stunning thing is that the pills, he claims, were all prescribed to him. Royko showed alleged records of his scrips to a TV reporter.

Anyway, a federal court found that Royko's defense of diminished capacity could not be used in a federal case (I'm not sure why since it's allowed on a state level) and Royko was found guilty. He'll get to spend 30 months in a federal prison, although by federal standards his sentence is pretty light.

I don't often find myself sympathizing with criminals, but in Royko's case it sure does sound as if he was pill crazy. Why a federal court cannot allow a diminished capacity defense is beyond me.

Posted by Philip Dawdy at 12:01 AM | Comments (8)

October 20, 2009

Utne Names David Oaks A Visionary

Utne Reader has put out its list of "50 Visionaries Who Are Changing Your World" and MindFreedom founder David Oaks is one of the 50. Congratulations to David and MindFreedom.

Posted by Philip Dawdy at 02:39 PM | Comments (2)

6 Reasons To Be Skeptical Of Feds' New Medical Marijuana Policy

Yesterday, Attorney General Eric Holder sent a letter to US Attorneys in the 14 states with medical marijuana laws laying out a new policy--that the feds will no longer seek to prosecute medical marijuana patients and medical marijuana suppliers, as long as they are in compliance with their state's medical marijuana laws. Under the Bush Administration, the feds had ignored states' rights to declare marijuana legal for certain medical purposes and had set about busting medical marijuana suppliers and patients, especially in California where that state's above-ground dispensary system was seen as an affront to federal authority.

I'll come to why this is important in the mental health world in a second.

Holder's move is certainly a small victory for states' rights, but from the perspective of someone who's reported on medical marijuana in the Pacific Northwest--Oregon and Washington both have medical marijuana laws--over the last decade there are still reasons to be skeptical of what the outcome will be over time. Although anything that ends raids where the feds win up arresting people in wheelchairs is welcome.


1. Each of the 14 medical marijuana states has laws different enough that it will prove confusing to patients and law enforcement to sort out, especially where a patient might be crossing state lines.

2. The new federal policy cannot address problems within medical marijuana states with local police and local governments, often with their own creative interpretations of of their state's medical marijuana laws. There are cops in Washington State who've busted patients and raided their homes, all the while telling said patients that there is no medical marijuana law in this state when their clearly is. Patients aren't exaclty in a position to argue with cops who pretty much take the law into their own hands this way with Glocks drawn and AR-15s locked and loaded.

3. The new policy will do nothing to address or undo the Bush Administration's policy of having the DEA block almost all medical research of marijuana. At this time, there are enough cases reports in the medical literature of marijuana's therapeutic properties for a host of ailments (and enough anecdotal evidence of the same) to where it ought to be researched formally (as in clinical trials). After all, NIMH has already researched the depression-fighting properties of Ketamine (it's apparently pretty useful), which isn't exactly the most benign drug on the planet. What's more, I've heard that in California--where doctors can recommend medical marijuana for anything they choose, unlike most other medical marijuana states--a good 30 percent of all medical marijuana use is for depression and anxiety. That would seem to indicate something worth researching, but it's certainly nothing the feds' new policy does anything to address.

4. No research means certain branches of the federal government will still be able to claim that marijuana has no medical value. A bogus claim, but one such agencies will still be able to make with a straight face.

5. I don't trust the DEA to pay much attention to Holder. During the first few weeks of the Obama Administration, the DEA was still running around raiding clinics in California even though Holder made it clear from the get-go that he (and President Obama) didn't want any more use of federal resources to arrest and prosecute people following state laws. The DEA was, in effect, a rogue agency for a few weeks. Even though the DEA doesn't have prosecutorial powers, it's staffed by the most ardent drug warriors in the federal government and they can easily still go around and arrest people and seize property and whatnot and, then, submit the evidence to the local US Attorney, who won't prosecute under the new federal policy. The DEA will be able to say it was just enforcing the law, its agents will have fun ripping peoples' homes apart and the big charade will continue. Sure, the AG will shut down such activity sooner or later, but in the meantime it'd be a big problem for all concerned.

6. Holder's new policy would allow federal prosecution of people in medical marijuana states who use medical marijuana laws as a cover for growing pot for commercial purposes. I agree with this aspect of the policy. But it's been a dirty little secret in the medical marijuana world for a long time that some medical marijuana growers do divert a fair amount of product to the underground commercial market out of sheer greed. Depending on the state and the "system" there, a grower could get as much as a 100 percent more per ounce of pot by selling it commercially than by selling it to patient dispensaries (which try to keep costs down, at least in Washington, for often low-income patients). I fear enough diversion will continue to go on and enough busts will be made that Holder can revert to the old way of doing things.

Posted by Philip Dawdy at 12:03 AM | Comments (6)

October 19, 2009

AstraZeneca Offers Buyouts To Entire Sales Force

I don't often comment on the ebb and flow of pharma corporate news, but via Pharmalot comes news that AstraZeneca is asking its entire US sales force--some 5,000 to 6,000 people--to "self identify" whether or not they want to accept a buyout from the pharma giant. Don't think that AZ is getting out of the drug business, but like a lot of pharma companies it faces several products going off-patent over the next few years (Seroquel, Crestor, etc.), so it's cutting costs where it can. Quite a few pharma companies (lilly, BMS, AZ) are facing a serious "pipeline problem" of not having new drugs forthcoming to market to the public.

As a longtime critic of Big Pharma, I find it rather odd that there have been no new product introductions of "breakthrough" drugs in recent years after decades of seeming innovation. In the mental health world, it sure does strike me that pharma has stopped trying to churn out new anti-depressants (aside from the Effexor-knockoff Pristiq), perhaps because there is no more commerical advantage to be wrung out of the chemical imbalance hypothesis of depression. At least in a patented product sense of things.

But, who knows? Perhaps pharma will surprise me some day soon.

Posted by Philip Dawdy at 10:16 AM | Comments (9)

Glaxo Negligent, Not Outrageous

An article in yesterday's Philadelphia Inquirer is the first mainstream media piece to try and grapple with the implications of last week's court award of $2.5 million to the family of Lyam Kilker. His mother took Paxil while she was pregnant with him and he was born with several heart defects. The jury verdict was in some ways mixed.

"Jurors linked Lyam's problems to Paxil and said Glaxo had been negligent in not properly warning David's doctor of the drug's risk, but they did not find the London company's behavior outrageous, which would have been necessary to award punitive damages....

"Kline said last week's jury verdict was a strong win because birth defects were fairly common whether or not a pregnant woman takes a drug. That can make it hard to convince a jury that a product caused a birth defect, he said.

"'The real hurdle is proving causation,' said Kline, who has represented plaintiffs at trial in many cases involving birth defects."

If you can prove it to one jury, I'd imagine you can prove it to others. There are about 600 pending similar Paxil birth defects cases awaiting trial. GlaxoSmithKline will fight them all.

It's striking to consider that only one other Paxil-related case in the US has gone to a jury and had a plaintiff's verdict--a 2001 Wyoming case where a jury ordered GSK to pay $6.4 million relating to a murder-suicide where a man had taken Paxil. In 2004, GSK also paid $2.5 million and made a bunch of concessions with the State of New York concerning GSK's covering up all manner of problems with Paxil (that case is the subject of Alison Bass' book "Side Effects").

There's also a large class action lawsuit concerning Paxil in the UK.

Posted by Philip Dawdy at 12:05 AM | Comments (1)

Pharm Parties, Proof Of America's Pharma-Dependent Culture

I suspect some of you have heard of the faddish "pharm parties" amongst some of today's teens. The basic idea is kids get their hands on whatever prescription medication they can--statins, anti-depressants, painkillers, antipsychotics and so on--and dump them into a bowl at a party. Then they go around taking them willy-nilly without a clue as to what they are taking or to dangerous interactions. The Flint Journal has an interesting account of the phenomenon in Michigan. Suffice to say, that teens have ended up in the hospital because of the practice, which appears to be a direct result of their parents having way too many prescription meds around and not under lock and key. Dumb.

The teens strike me as being pretty dumb, too. When I was a teen during the late-70s, the most radical thing I ever heard of my peers taking was an inhalant called Locker Room. It struck me as a one-way trip to brain damage and I never tried it. I felt the same way about LSD.

Things have gotten so wild around the abuse of prescription meds that federal officials seem to be more concerned about the misuse of drugs like OxyContin than they are cocaine and marijuana. That tells you something.

Posted by Philip Dawdy at 12:03 AM | Comments (10)

October 16, 2009

Court Rules AstraZeneca Overcharged KY Medicaid Program

AstraZeneca yesterday was found liable by a Kentucky court of ripping off that state's Medicaid program.

"AstraZeneca, maker of popular drugs such as Crestor, Nexium and Seroquel, must reimburse Kentucky $14.72 million after overcharging its Medicaid program between November 1999 and March 2005.

"AstraZeneca lied when reporting its average wholesale price on a number of drugs, said George Galland, representing Kentucky in the civil fraud trial that ended Thursday.

"AstraZeneca inflated its prices between 20 and 30 percent depending on the drug, Galland told the jury in his summation.

"The average wholesale price is calculated by adding a percentage to the price wholesalers pay for the drug. The percentage, usually between 1 and 3 percent, represents a profit that the wholesalers get after selling the drugs to pharmacies."

These pharma companies sure are bottomless where it comes to deceit.

Posted by Philip Dawdy at 12:00 PM | Comments (3)

By Popular Demand

I'm generally not a fan of spats in the blogosphere, but for some reason blogger John McManamy went after me on his Knowledge Is Necessity blog the other day and has continued to pound on me in the comments to his posting. He's accused me of having no sense of humor and of saying patently false things about bipolar disorder (interestingly, the well-known, widely-published psychiatrist David Healy happens to agree with me--or is it I with him?--on what McManamy attacks me upon. So, John, please go pick a fight with Healy since you're such a tough guy). Then McManamy went and began quoting from an email exchange he and I had back in April. Of course, he only reproduced it in part. McManamy is basically going around trying to re-brand me as an anti-psychiatrist.

Here is the email in its entirety:

On Apr 23, 2009, at 10:59 AM, Philip Dawdy wrote:

John:

On your blog "Knowledge is Necessity" today you wrote in the following post:

http://knowledgeisnecessity.blogspot.com/2009/04/growing-up-bipolar-recognition-at-last.html

"the story did not go down well with the antipsychiatry contingent. Phillip Dawdy of Furious Seasons had this to say:"

On your blog you are now attempting to link me to the anti-psychiatry movement. As I clearly note on my site (link below my signature), I am not anti-psychiatry so your reference above is potentially libel and defamation and puts me in a false light. Please kindly redact any reference in the post to me being connected with anti-psychiatry and cease and desist from describing me as such in the future.

In addition, you've misspelled my first name, which has only one "L."

Thanks for your attention to this matter.

Sincerely,

Philip Dawdy

http://www.furiousseasons.com/about.html

On Thu, Apr 23, 2009 at 11:21 AM, John McManamy wrote:

Why? Or you will tell readers that I beat my wife?

The misspelling has been corrected.

John McManamy

On Apr 23, 2009, at 12:56 PM, Philip Dawdy wrote:

redact the anti-psychiatry accusation. it's libel.

thanks.

On Thu, Apr 23, 2009 at 1:27 PM, John McManamy wrote:

Redact? You better look it up.

On Apr 23, 2009, at 1:32 PM, Philip Dawdy wrote:

remove it john. now.

On Thu, Apr 23, 2009 at 1:37 PM, John McManamy wrote:

And replace it with what?

John McManamy

On Apr 23, 2009, at 1:44 PM, Philip Dawdy wrote:

i'm not your editor, but cl psych recently dubbed me one of "more prominent critics of modern psychiatry."

i'm fine with being called a critic of psychiatry.

On Thu, Apr 23, 2009 at 1:49 PM, John McManamy wrote:

I'm thinking more along the lines of fake journalist and unprincipled idiot.

John McManamy

On Apr 23, 2009, at 1:53 PM, Philip Dawdy wrote:

well let's see fake journalist would be a false claim as would unprincipled. call me an idiot if you like.

and for the good of one and all get over your anger with people who disagree with you.

On Thu, Apr 23, 2009 at 2:02 PM, John McManamy wrote:

I'm not the angry one. You're the one who threatened me. You're the one who publicly melts down. Really? Where were you coming from when you claimed I left my wife who supported me?

Dude, you need to get a grip on yourself.

John McManamy

On Apr 23, 2009, at 2:06 PM, Philip Dawdy wrote:

look, this is my final request for you to change the descriptor you used on me. i strongly recommend that you follow through.

there are no meltdowns on my site, passion yes.

On Thu, Apr 23, 2009 at 2:21 PM, John McManamy wrote:

No meltdowns? Your passion is not an excuse for making things up about my personal life. Or for not checking your facts when you characterize yourself as a critic of psychiatry.

As you said, you're not my editor. Moreover, you are not worth my valuable time. This conversation is over.

John McManamy

On Thu, Apr 23, 2009 at 2:30 PM, Philip Dawdy wrote:

just make sure you fix your false accusation.

As far as I know, McManamy never fixed his error.

Posted by Philip Dawdy at 11:39 AM | Comments (35)

More Paxil Birth Defects Case Documents Available

Bob Fiddaman of Seroxat (Paxil) Sufferers had done a fine job of getting his hands on various transcripts and depositions from the recently-completed Paxil birth defects case in Pennsylvania. He's now got up the deposition of Jane Nieman, a former GlaxoSmithKline employee. Go to his site to download the document.

Although there have been a few smallish articles in the US press, news of the $2.5 million jury award sure hasn't shown up in the New York Times, Washington Post or LA Times. That's kind of weird, especially in light of the fact that GSK faces about another 600 birth defects lawsuits and also because it's very uncommon for a pharma company to lose a case involving an anti-depressant.

GSK has announced that it will appeal the verdict. I look forward to seeing what legal argument the company's attorneys try to advance to undo the ruling.

Posted by Philip Dawdy at 12:05 AM | Comments (9)

McManamy Tries Criticizing Me Again

Can I just say that John McManamy, author the Knowledge Is Necessity blog and the book "Living Well with Depression and Bipolar Disorder," is an out-of-touch fool? Back in February, he alleged that I engaged in "dumb anti-psychiatry" for daring to criticize the possibility of a new type 3 of bipolar disorder and now he's gone and re-posted that entry for reasons that escape me, but establish once again that he's a malicious toad. Here's my response to him earlier this year, wherein I noted that he's a huge defender of the child bipolar paradigm, Fred Goodwin and pretty much anything mainstream psychiatry tells him is true.

Meanwhile, he's completely missed writing about how bipolar disorder is wrongly diagnosed almost 50 percent of the time, how there's evidence that the disorder resolves over human lifespans in a large percentage of cases and he totally ignored the Paxil birth defects verdict. But of course it's dumb anti-psychiatry for me to have written about these things. Right, John?

Earlier this year, McManamy again called me an anti-psychiatrist and I wrote to him asking him to correct the assertion, which is false, and he went batty on me. I decided against publicizing our exchange out of good taste. But maybe if enough people ask me to post it, I'll get over my standards and let you guys see what a goofball he can be.

Posted by Philip Dawdy at 12:03 AM | Comments (15)

October 14, 2009

Katie Is Fine

About an hour ago, I got the cytology results on Katie's liver. She does not have cancer. She does have feline hepatic lipidosis--fatty liver syndrome--which is fairly unique to cats. It can be fatal if not caught in time. The treatment is to get her weight back up and not let her get anorexic. She's been putting on weight the last few days and there's more to go.

I'm so relieved that I cannot get into it.

Posted by Philip Dawdy at 07:03 PM | Comments (12)

Lilly Settles Zyprexa Claims With Idaho

The Idaho State Attorney General Lawrence Wasden yesterday announced that the state and Eli Lilly have reached a settlement of claims the state had made of illegal off-label marketing of Zyprexa by the company. The settlement is for $13 million, which brings Lilly's total payouts for Zyprexa claims to about $2.8 billion. Lilly has now settled claims with almost three dozen states.

According to a statement from Wasden's office, Lilly admits no wrongdoing in the settlement.

Posted by Philip Dawdy at 12:03 AM | Comments (1)

October 13, 2009

Glaxo Must Pay $2.5 Million In Paxil Birth Defects Case

A Pennsylvania jury earlier today found GlaxoSmithKline liable for heart defects caused to a young boy whose mother was taking the company's anti-depressant Paxil while pregnant. The jury awarded the boy's family $2.5 million. Plaintiff's attorneys had argued that Paxil had caused the defects and had failed to properly test the drug and, while knowing of its ability to cause defects, had failed to warn consumers properly.

This is a significant ruling because it's the first time GSK has been found liable in a birth defects case and because there are abut 600 more similar cases awaiting trial.

GSK's lawyers said they would appeal the verdict. The company issued a statement:

"'While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy,' the company's statement said."

Good luck with that appeal.

Posted by Philip Dawdy at 11:47 AM | Comments (6)

Katie Is Improving

I'm pleased to report that my sweet cat Katie has made much progress over the past 24 hours. She's eating and drinking water and has put on more weight, all a major improvement over where she was on Friday and Saturday. I can't say she's out of the woods yet, but she's on the right path and, hopefully, her pathology report shows nothing freaky when I get it on Wednesday.

I'm still recovering from being a full-time cat nurse the last few days and will catch up with posts later today.

Thanks to all of you who left so many kind comments. Katie appreciates it and so do I.

Posted by Philip Dawdy at 12:03 AM | Comments (13)

October 12, 2009

Novartis To Market Fanapt

Novartis today announced that it's entered into an agreement to market Vanda Pharmaceuticals' recently approved antipsychotic Fanapt. It'll be interesting to see what kind of efficacy and side effect data the company offers to doctors and the public because, to date, I cannot get an answer out of Vanda. The drug is approved for schizophrenia. Novarti is paying Vanda $200 million up front for American and Canadian marketing rights to the drug.

In a press release the company noted:

"In the 1970s, Novartis pioneered the first atypical antipsychotic medication which was considered a breakthrough for patients with treatment-resistant schizophrenia."

That drug was Clozaril and we know how that worked out.

In the same press release, the company offers information on Fanapt-associated weight gain and QT interval prolongation.

"Based on the pooled data from the four placebo-controlled, 4- or 6-week, fixed- or flexible-dose studies, the proportions of patients having a weight gain of greater than or equal to 7% body weight was 12% for Fanapt 10-16 mg/day, 18% for Fanapt 20-24 mg/day, and 13% for Fanapt (combined doses) versus 4% for placebo."

Well, at least they admit to some weight gain issues.

Posted by Philip Dawdy at 03:44 PM | Comments (8)

Pharmalot Is Back

Many of you know that the wonderful blog Pharmalot went dark early this year after its author, Ed Silverman, took a buyout from the Newark Star-Ledger and went off to write for Elsevier. Ed got the rights to Pharmalot from his old employer and began posting again the other day. He's still working for Elsevier so don't expect anything like the volume of posts he used to do, but it's great that he's back.

Posted by Philip Dawdy at 02:37 PM | Comments (0)

President Obama Described As "Global Prozac"

One thing did lift my mood briefly while struggling with my sick cat over the weekend and that was the new-to-me blog Crooked Timber's take on President Barack Obama winning the Nobel Peace Prize on Friday:

"I am sure many Americans (and others) will be thinking 'It’s too soon. He hasn’t done anything yet!' Or even 'Dude can’t even pass health care already, but he’s been elevated to international sainthood?'

"But this isn’t about domestic politics, or about what he’s done yet. President Obama has changed how the world feels about America. He’s lifted the planet’s mood. This guy is global Prozac.

"There’s more to it than just the Bush presidency being a total downer for everyone in the world who cares about multi-lateralism or just wants to do business with the US. The tidal wave of bad faith Bush’s presidency created washed away any chance of progress in so many international initiatives.

"Obama’s not a game changer per se, but he’s changed how people feel about playing the game, or whether they even want to."

I am endlessly fascinated by how Prozac has become a metaphor for feeling blissful in our culture. Way to go Eli Lilly.

Posted by Philip Dawdy at 12:03 AM | Comments (11)

October 11, 2009

My Sick Cat, My Rollercoaster

My wonderful cat Katie took ill last Wednesday evening, drooling all of a sudden and rapidly losing several pounds of body weight. She's been to the vet three times in the last few days, the last time for an inconclusive (and expensive) ultrasound that narrowed things down to either feline hepatic lipidosis or lymphoma. The vet also took some fluid from her liver and sent it out for cytology. I won't get the results until Wednesday (the vet's initial reading before sending it to pathology was that there were no obviously cancerous cells, but as she told, "I'm not a pathologist"). If it's cancer, I will put Katie down the next time she relapses (she's currently comfortable and eating and drinking although not as much as I'd like. She put three-fourths of a pound back on between Saturday evening and Sunday morning). If it's lipidosis, I'll do what I can to get her past it.

When I was much younger, my family had a 14-year-old cat who we got through a near-fatal bladder condition. She improved and lived to be 22.

I've already drained my bank account getting to now, so I have no idea what the future holds or what treatment I'll be able to offer Katie.

This all came on very suddenly. Katie was literally chasing the laser pointer toy on Tuesday evening. I am crushed emotionally and have been on a huge emotional rollercoaster because I thought my cat was almost 10 years old with plenty of life left. Three vets in the last few days have told me she is 14-years-old and that I was lied to by the shelter where I got her in January 2003--something they do all the time, one of the vets told me. Nice. I haven't slept much either.

I'm not sure how much I'll be writing the next few days. It'll depend on how my cat is doing and how rattled I am. I'm plenty rattled already. So is my other cat, KC, who is also pissed at all the attention I'm giving Katie.

Posted by Philip Dawdy at 06:29 PM | Comments (23)

October 09, 2009

Shire Trialing ADHD Drug As Add-On Depression Treatment

There has been a flurry of TV ads in Seattle for a research study of an investigational drug plus an anti-depressant for people not getting enough relief from anti-depressants alone. The ads are being run by Summit Research, a clinical trials shop here in Seattle. I thought to myself that there couldn't possibly be another atypical antipsychotic being tested this way (since most are almost off-patent), so I went to poking through clinicaltrials.gov and found that Summit is one of a number of places trialing Shire's Vyvanase, a methamphetamine-based ADHD stimulant, as an add-on treatment for depression in a six-week study expected to be complete next year. It will involve 150 patients and includes a placebo arm so this isn't likely to be an approval trial, but an initial trial to see if a larger trial and FDA approval is worth pursuing.

An ADHD drug as a depression treatment? Sounds pretty dubious to me.

Shire also makes Adderall.

Posted by Philip Dawdy at 12:05 AM | Comments (19)

AstraZeneca Defends Seroquel Weight Gain Warnings

It's always flattering in a weird way to know that various pharma companies follow this website--AZ, Lilly, BMS, J&J, Wyeth and so on all pop in from time to time--and yesterday I got an email from Tony Jewell, a spokesman for AstraZeneca. He was responding to a post I wrote yesterday regarding AZ casting Seroquel as a "weight neutral" drug in the early years of this decade when the company had knowledge that some patients were packing on the pounds.

"Re the post below, it is important to remember that since 1997, when Seroquel was first approved, labeling has alerted physicians that 'diabetes mellitus,' 'hyperglycemia' and 'weight gain' had been observed in clinical trials. We have continued to update the label on these topics as the science has developed."

I don't know what the 2001 package insert or the 2004 insert (the year I began taking the drug) said on the matter of weight gain, but weight gain is pretty prominently featured in the current PI under "warnings and precautions" and the percent of people gaining more than 7 percent of body weight (indicator of diabetes risk) is outlined from various clinical trials.

I'm pretty damn certain that such information wasn't in the PI in 2004 or my doctor would have alerted me about weight gain issues or I would've found the information myself. I doubt that the weight gain warnings were as prominent in 2004. I wish AZ had been more upfront at the time, as it would've saved me much trouble (not to mention tardive dyskinesia, nightmares and muscle tightening. Yes, Tony, I experienced neuroleptic malignant syndrome on Seroquel).

More to the point, however, AZ was clearly telling its sales force to tell doctors that Seroquel was weight neutral, so the fact that there was a stray notice of some kind in the PI circa 2004 about weight gain is almost meaningless.

Jim Edwards at bnet.com had some fun with AZ's weight neutral claims yesterday.

Posted by Philip Dawdy at 12:03 AM | Comments (4)

October 08, 2009

Cymbalta Being Trialed In Kids As Young As 7

Last evening one of little header text ads appeared at the top of my gmail account, something to the effect of "Learn about MDD in kids." MDD being major depressive disorder. So of course I clicked on the link. I was sent to a website called kidswithdepression.com. It read "Pediatric Major Depressive Disorder: Clinical Research Study" and included statements like:

"Childhood and teenage depression is often in hiding.

"Did you know that depression affects approximately 5% of children and teenagers? However, there are currently very limited treatment options for children with depression, also called Major Depressive Disorder (MDD). Research is being done that may bring alternative treatment options out into the open for children in the future.

"If your child or teenager is depressed, consider joining our research study."

The site is a recruiting tool for a 700-person study of Cymbalta as a treatment for major depression in kids aged 7 to 17 years. The study will include a placebo arm and also use Prozac as a known comparator (interestingly, Prozac is not approved for use in 7 to 17 year olds). The study is broken out into two separate clinical trials, one of 448 kiddos and the other of 336 kids. The studies are expected to be completed in early 2012 and each runs for 36 weeks, so this is no short-term clinical trial.

The two trials come on the heels of a smaller trial of Cymbalta in 72 kids aged 7 to 17 that was completed late in 2008. I cannot find its results published anywhere. It did not have a placebo or comparator arm.

So it's obvious that Lilly has its sights set on getting Cymbalta approved for use in kids. I cannot think of anything useful to say about that except to point out that since its introduction in 2004 Cymbalta has racked up 130 adverse events reports in the FDA's database among kid aged 0 to 17 (so the drug hasn't been used much off label in kids) and an astounding 14378 reports among all age groups.

Posted by Philip Dawdy at 12:05 AM | Comments (17)

Seroquel Promoted As Weight Neutral When Company Knew It Produced Large Weight Gain

According to court documents released to Bloomberg yesterday, AstraZeneca pushed its sales reps to claim that Seroquel, the company's atypical antipsychotic, was "weight neutral" four years after the company had determined that there were "clinically significant" weight gains among users of the drug (and increased risk of diabetes).

"AstraZeneca’s 'global strategy is to demonstrate to consumers that Seroquel has a weight-neutral profile,' Debbie Holdsworth, a marketing official, wrote in a 'dear colleague' letter dated May 14, 2001."

Here's the BS explanation of the weight neutral claim by John Patterson, a former AZ executive:

"'If you look at the population as a whole, some are below weight, some are average weight and some are above weight, so that taken together the effect of Seroquel is weight neutral,' Patterson said. Some underweight patients may even be helped in gaining weight by using the drug, he said."

Please. I wish AZ good luck with that line of argument should one of the cases against it ever go to trial.

Here's what pisses me off on a personal level: In April 2004, I began seeing a new psychiatrist and was upfront with him that I was dissatisfied with the meds I was on at the time (Depakote and Wellbutrin, and had gone off Risperdal a few months before) and that I was tired of all the weight I had gained on them. I'd managed to get my weight back down to about 220 pounds after going off Risperdal and I told me doctor that I wouldn't consider any new medication that caused weight gain. He suggested that I get off the Depakote and Wellbutrin and go on Lamictal and a low dose of Seroquel. He assured me that he knew of no weight gain issues with Seroquel. One year later, I had put on 25 pounds and it sure wasn't due to Lamictal. If my doctor had known the truth and told me, I would've never consented to take Seroquel.

So thanks for misleading doctors and patients everywhere, AstraZeneca.

Posted by Philip Dawdy at 12:03 AM | Comments (1)

Many Interested In Jani, Schizophrenia

Something like 4,000 people have swung through this site the last couple of days in the wake of Oprah's show on Jani Schofield, the 7-year-old girl who is claimed to have schizophrenia (I don't have an opinion of whether she has the very, very rare disorder in kids. I'm just very, very skeptical). There's obviously a lot of interest in her case and apparently just as much interest in the fact that her dad claimed he'd hit and starved the girl at different times (he's since removed the claim from his website, well in advance of the Oprah show).

Just thought I'd let you know.

Posted by Philip Dawdy at 12:01 AM | Comments (21)

October 07, 2009

Lilly Settles Zyprexa Claims With South Carolina

Bloomberg is reporting this morning that Eli Lilly has reached a tentative settlement with the State of South Carolina over allegations that the company illegally marketed Zyprexa, the company's atypical antipsychotic, for unapproved uses. The state's lawsuit against Lilly had been set to go to trial this week, but Lilly won a delay and then hammered out an agreement with the state. Financial details of the settlement are not yet available.

Posted by Philip Dawdy at 09:50 AM | Comments (2)

Study: Large Percentage Of Bipolar Disorder Cases "Resolve Spontaneously" By Mid-30s

A fascinating and possibly very important study came out in August in the Journal of Abnormal Psychology (one of the American Psychological Association's journals). It concerns bipolar disorder and its course across human lifespans and the study's conclusion that many cases of bipolar disorder "resolve spontaneously"--the authors' term, not mine--by the latter half of the third decade of life is both startling and not surprising to me because I've been making a similar argument about the disorder's natural course for a long time. It's also not surprising to me that this study has gotten almost zero press attention--its primary finding goes so against the grain of what health reporters think they know about mental disorders and so against the grain of what psychiatry claims about bipolar disorder that it's almost an untouchable subject.

But not for me.

1. The study was NIH-funded and its lead author is Kenneth Sher, a professor of psychology at the University of Missouri-Columbia, and two colleagues. The researchers took the data from two large and very detailed national health surveys (read the paper for more on the surveys and their diagnostic methodology) and examined it for what they call an age gradient (ie, more prevalence of bipolar disorder in one age group versus another age group). They found a significant age gradient with high prevalences of bipolar disorder among late-teens and early to mid-20somethings and much less by the time of the mid-30s--as much as 30 percent less prevalence in the 30s, about 50 percent less in the 40s and 50s and even less in 60s and older (see the graph on page 435 of the study or page 5 of the pdf). This sort of resolving as one gets older holds across both bipolar 1 and bipolar 2 diagnoses.

2. The authors use the term developmentally limited bipolar disorder to describe the phenomenon and argue that it may represent a subtype of bipolar disorder. They also note that some bipolar disorders are still present in 30 and older age groups.

3. This finding is not supposed to be happening, as the authors themselves note:

"This is contradictory to DSM–IV bipolar disorder, which is characterized as chronic, in which a history of mania is sufficient for a bipolar diagnosis. However, we remain cautious in drawing strong conclusions here, because a single follow-up after 3 years [as the underlying surveys have] does not resolve the question of reoccurrence over the life course, and the lack of noncriterial symptoms included in the interview precludes more fine-grained analysis of residual symptomatology.

4. This study is not proof that bipolar disorder fades with time. The authors call for more studies and longitudinal analyses and so on. It's a study just begging for replication and I hope NIH and others in psychiatry get serious about its finding and undertake other research into the natural course of bipolar disorder (or disorders). Maybe Eli Lilly and AstraZeneca would like to help! Um, probably not.

5. That said, the Sher study is an important piece of evidence. Coupled with a study last year by Mark Zimmerman, a Brown University psychiatry professor, asserting that almost 50 percent of diagnoses of bipolar disorder are wrong (they are commonly cases of depression), it argues for some skepticism both within psychiatry and the media on what we think we know about bipolar disorder and what we think we know about people diagnosed with the disorder.

It also argues for doctors, mental health advocates and some in the media to stop describing bipolar disorder as chronic and lifelong.

6. The research state--and here I am paraphrasing--that one possible reason for "chronic and lifelong" tag is that much research is done in settings (commonly around public mental health systems and hospitals) where bipolar patients are more ill, for lack of a better term, than in other settings. In other words, there's a bias built into what researchers in those setting would conclude.

7. So why would bipolar disorder be so heavily weighted towards the late-teens and 20s? Why would it then "resolve spontaneously" in the 30s?

According to emaxhealth.com:

"One possible reason for the shift, according to Kenneth J. Sher, Curators’ Professor in the Department of Psychological Sciences and a coauthor of the study, could be the stress associated with life changes and social expectations experienced by young adults ages 18 to 24. As these individuals reach their late twenties, they have begun to adjust to these changes."

Or as researchers put it in the study:

"With respect to onset processes, late adolescence and emerging adulthood are associated with increased risk for a range of internalizing (e.g., panic disorder; Eaton, Badawi, & Melton, 1995), externalizing (e.g., alcohol use disorders; Kessler et al., 2005), and psychotic (e.g., Riecher- Rossler & Hafner, 2000) disorders, and this increased risk can stem from a range of both developmental stressors (e.g., leaving home transition; Schulenberg, Sameroff, & Cicchetti, 2004) and neurodevelopment (Alloy, Abramson, Walshaw, Keyser, & Gerstei, 2006). Moreover, this period of life is associated with exposure to psychoactive drugs, which can presumably have relatively strong neurodevelopmental effects in vulnerable individuals during this sensitive period of brain development (e.g., Caspi et al., 2005)."

That ought to make the blood of all genetic determinists and neuropsychopharmacologists boil over. Good.

It also ought to be a positive challenge--and perhaps ray of hope--for each and every person diagnosed with bipolar disorder.

Posted by Philip Dawdy at 12:03 AM | Comments (33)

October 06, 2009

Live Blogging Oprah On 7-Year-Old With Schizophrenia

Thanks to all of you who made me aware that the Oprah Winfrey Show was doing a program today on Jani Schofield, a 7-year-old girl in South California who's been diagnosed with schizophrenia, which is extremely rare in children so young. Globally, the program wasn't bad, but it sure was tough watching a cute kid wrestle with all that she's got to address. You see clips and whatnot from the show here.

I know it caused a lot of controversy on this site back in July when I noted that Jani's father had written on his blog that he and his wife had both hit and, at times, starved their child in an attempt to control her behavior. The father has since excised that admission from his site and, curiously, Oprah doesn't ask him or Jani's mother about it. I know Oprah's staff was scouring the Net for information on Jani a couple of months ago, so it strikes me as odd that they didn't confront the parents at all. Just saying.

The show opens with Oprah saying the parents are "going to ends of earth to keep both of their children safe and alive."

Lots of talk about Jani's drawings of rats and cats, the evil ones who tell her to hurt people.

Says Dad, "All the hallucinations come back....She had to be stimulated constantly."

Jani says, "I take Clozi cuz of the rats." That's a reference to Clozaril, which she takes at 200 mgs. a day plus 600 mgs. of Lithiium.

Jani's raised separately from her baby brother and they live in two different apartments. "She would attack him...." No cleaning supplies, knives, etc. in Jani's apartment.

The goal, says Dad, is to "give her as many happy moments as we can."

"Jani can't entertain herself."

Says Dad, "We have to make her hallucinations happy."

Ask Oprah, "How do you discipline her?" "Are you afraid of her?"

Mom says she was "getting hit constantly with shoes."

We see Jani in a park. She hits another kid and Mom has to take her home.

Parents say there are "basically no services at all." And that the State of California wanted to send her out of state to a specialized psychiatric facility.

Says Dad, "We want her in our lives. We love her."

We then meet another young girl, Becca, diagnosed with paranoid schizophrenia. It's a play date for her and Jani.

LA Times reporter Shari Roan appears on the show. "She's better on the Clozaril."

Dad admits he became so desperate at one point that he swallowed half his anti-depressants and then backed out of his suicide attempt.

At the end, the parents deliver a plea for some kind of specialized day school for children like Jani.

Posted by Philip Dawdy at 05:19 PM | Comments (20)

Study: SSRIs Linked To Pre-Term Deliveries

A Danish study out in the Archives of Pediatric & Adolescent Medicine asserts that women taking an SSRI anti-depressant while pregnant had double the risk of having a pre-term baby and had almost two and one-half times the risk of having their baby wind up admitted to a neo-natal ICU.

The study comes on the heels of an earlier study this year linking anti-depressant use during pregnancy to premature births.

The SSRI portion of the study was small--it involved 329 women who were taking SSRIs--so I don't think it's a nail in the coffin type of study. But with all the studies that have come out this year showing just how tricky anti-depressant use is, it's another brick in the wall, so to speak. Last month, a study came out linking anti-depressants to birth defects. Earlier this year, another study linked long-term anti-depressant use to sudden cardiac death in women. Another study linked long-term anti-depressant use to increased diabetes risk.

At a minimum, people have got to be very, very careful when taking anti-depressants.

Posted by Philip Dawdy at 12:03 AM | Comments (3)

Study: Mediterranean Diet "Protective" Against Depression

A new study out in the Archives of General Psychiatry asserts that strictly following a Mediterranean diet is protective against depression. It's been long known that diet can be influential on mood (with wide variations in different humans), but I don't think I've ever seen researchers claim that a particular diet is protective against depression. The Mediterranean diet includes lots of fish and olive oil, so there's plenty of Omega-3s and perhaps that offers some explanation of the claimed effect.

The study followed 10,094 Spaniards for an average of 4.4 years and found that those who followed the Mediterranean diet most closely benefitted the most, seeing a 30 percent reduction in depression risk.

All of that said, I'm not sure how applicable the study's main finding is to the US--the sociocultural differences between America and Spain are vast, and the stress we put on ourselves and that is forced upon us over here is much greater, and I bet the food isn't so good here--but it sure is suggestive. So who wants some fish?

Posted by Philip Dawdy at 12:01 AM | Comments (3)

October 05, 2009

2,500th Post

Yep, this is the 2,500th post on this site. It feels like a pretty significant milestone so I thought I'd make a note of it.

Posted by Philip Dawdy at 01:00 PM | Comments (5)

CNN Reports 7 Percent Of College Students Taking Adderall Illegally

Seriously, it's gotten that crazy out there with Adderall and as CNN reports in this piece (follow the link, as I couldn't get the embed code to work) a good number of them wind up addicted to the drug, which is readily available on college campuses for $10 for three pills. Ah, college crack.

What's even more stunning to me is that some students say they feel at a disadvantage versus their Adderall-taking friends when it comes to studying. Crazy.

Posted by Philip Dawdy at 12:07 PM | Comments (1)

Study: Paxil Is Worst Drug For Suicide Attempts

An interesting paper came out in PLoS last week in which researchers from the University of Alabama looked at suicidal ideations reported in the FDA's adverse events database for 832 prescription drugs and compared that with suicide attempts reported in the database. The study covered 2004 through 2008 and found that Paxil was by far the worst drug of any kind on the market with 1,323 suicide attempts.

Interestingly, Paxil accounted for about one-third of all suicide attempts reported for all 32 anti-depressants (1,323 for Paxil and 3,572 for all anti-depressants). Analgesics had the most suicide attempts reported with their use at 4,184, although I'm completely unclear if those reports involve suicide attempts via overdose of analgesics or what.

A reader emailed me over the weekend and asked if anyone still prescribes Paxil (paroxetine in generic form), given all of its well-known problems. The answer is "Yes," but I don't know how many scrips a year are written for the drug in the US. I know several people in Seattle who take Paxil. So it's still fairly commonly prescribed as far as I know.

Posted by Philip Dawdy at 12:03 AM | Comments (4)

October 02, 2009

Botox Maker Sues FDA, Challenging Off-Label Marketing Rules

Seriously. Allergan, Botox's maker, yesterday sued the FDA in federal court in Washington, D.C., asserting that off-label marketing rules which prohibit drug makers from marketing drugs for unapproved uses violate the company's First Amendment rights. That's a novel argument and it'll be interesting to see how the court sorts it out.

Allergan told Reuters that the lawsuit is not connected in anyway to a criminal probe of the company over, wait for it, accusations of off-label marketing of Botox. And the moon is made of blue cheese.

I hope the court kicks Allergan's suit to the curb because if it finds in the company's favor, it would open the door to some epic problems and truly weird advertising campaigns. Even under current rules, off-label marketing has caused a lot of damage to patients (Zyprexa being perhaps the prime example) and it seems appropriate to have some kind of restrictions on the marketing of drugs that can be quite dangerous in some instances.

Posted by Philip Dawdy at 11:20 AM | Comments (8)

More Than 50 Percent Of Clinical Trials Not Properly Registered

First, I need to apologize for not catching this JAMA study that came out in early September, since it is indeed serious stuff: a study by David Moher of the Ottawa Hospital Research Institute found that many researchers are in violation of a 2005 rule requiring that all clinical trials be registered in a public database, ClinicalTrials.gov. The rule was put in place by the International Committee of Medical Journal Editors and was a precondition for member journals publishing researchers' studies.

In reviewing 323 published clinical trials published in 2008 involving cardiology, rheumatology, and gastroenterology, only 45.5 percent (147 trials) were registered before the end of the trial and had the trial's outcome properly specified. That means that 54.5 percent of published clinical trials were not properly registered: 27.6 percent had no trial registration whatsoever; 13.9 percent were registered after trial completion; and, 12 percent were registered with no outcome measure or an unclear outcome measure.

Stunningly, 31 percent of the trials that were considered adequately registered had a discrepancy between the outcome measure at registration and what outcome measure was actually published. So much for integrity in science.

This is so unacceptable that I don't have words for it. I'm sure there are many journal editors who are furious right now. And many researchers who look stupid.

Not that the media looks much better, since it almost entirely missed Moher's study. The New York Times had a teensy mention of it deep inside the paper and the Ottawa Citizen had an article on the study. That's it.

Lame all the way around.

Posted by Philip Dawdy at 12:05 AM | Comments (6)

The Nanny State Gets Into Senate Health Reform Bill

The media hasn't paid much attention yet to an amendment slid into the Senate Finance Committee's health care reform bill, which passed out of committee yesterday and is set for a Senate vote next week, by Sen. John Ensign (R-Nevada). The amendment would, as described by the Las Vegas Sun:

"The healthy lifestyles amendment passed on a vote 19-4, with a handful of Democrats opposed.

"It would allow employers to offer steep discounts of up to 30 percent for workers who lead healthy lifestyles – with discounts of up to 50 percent allowed at the discretion of the Health and Human Services secretary.

"Currently, employers can only offer discounts of up to 20 percent."

What healthy lifestyles would those be? Ensign's measure would apply to people who quit smoking, lost weight or met other "healthy lifestyle goals." The measure was opposed by the American Cancer Society and other public health groups who fear its punitive nature.

I've never agreed with the ACS and the public health crowd on much before, but this amendment amounts to discrimination against smokers and people who are overweight and it's completely out of line. It's straight up Nanny State nonsense and it's ironic that it comes from a Senator who was caught having an affair with a campaign aide. That it comes from the Senate's only Pentecostal Christian makes my blood curdle (no offense, but Pentecostals have always creeped me out).

I don't even want to get into how the amendment--and increasingly much of the bill itself--flies in the face of personal choice and American individualism.

We just don't need this kind of nannying coming from the federal government, not only because it's intrusive as things stand now, but because it could create a slippery slope of intrusion. How far away are we from Sen. Ensign or one of his colleagues proposing forced depression treatment--or creating punitive penalties for those who refuse treatment--on the basis that depression supposedly costs America $60 billion or more in missed workdays and that therefore if a doctor diagnoses you with depression, then you must undertake treatment or face a penalty of some kind. They could make the same argument with ADHD/Adult ADD. Or cholesterol. Forced statins for all!

I fear that we are not far away from that kind of scenario.

I've not seen the precise language of Sen. Ensign's amendment since the Senate Finance Committee's chair, Sen. Max Baucus (D-Montana) is refusing to allow it be posted online ahead of next week's expected Senate vote. That's some nice transparency and accountability.

I'm afraid I'm not going to be able to support whatever health reform bill eventually makes its way to President Barack Obama for his signature. The Senate version was the bill that I figured had the greatest chance of being sane. But in recent days the bill has become larded with all kinds of measures that I oppose: a provision requiring all Americans without employer-provided health insurance to buy health insurance through a non-profit cooperative, something I'm not convinced is Constitutional; significant fines (as high as $25,000) and up to one year of jail time for people who fail to pay a penalty (as high as $1,900 by some estimates) for not having coverage; and, what appear to be actual tax increases (we'll have to wait for the CBO's analysis, but I keep hearing they are in there).

Now with this Nanny State amendment added to the mix, I am afraid I won't be able to support whatever bill gets hammered out later this month between the two houses of Congress. Not that Congress cares very much about what individual Americans think anymore. But, keep in mind, I haven't had health insurance in over two years and I was biased in favor of getting something done here that would benefit tens of millions of Americans. If someone like me is turning against health care reform, then Congress is in deep disconnect mode.

Posted by Philip Dawdy at 12:03 AM | Comments (14)

October 01, 2009

UK Girl Who Died After HPV Vaccine Injection Had Advanced Cancer

For now, this settles questions raised earlier this week after a 14-year-old girl in England died soon after receiving an injection of Cervarix, an HPV vaccine. As it turns out, the poor girl had advanced cancer that had gotten into her heart and lungs and that's now being called her cause of death instead of the injection until full autopsy results are available.

Posted by Philip Dawdy at 02:38 PM | Comments (1)

Sexual Abuse Strongly Associated With Suicide Attempts By Women

This study may state the obvious, at least for some readers, but a new study out in the American Journal of Psychiatry asserts that a history of sexual abuse is strongly related to a history of suicide attempts in women, as opposed to in men. That's a correlation, of course, and doesn't pencil out to causation, but the broad finding doesn't surprise me in the least. The study employed data on men and women in the UK, but I'd assume it is fairly applicable to the US.

Among women in the study who reported suffering sexual abuse 28 percent reported a history of suicide attempts and suicidality, men at a 7 percent rate. It's not clear what kind of sexual abuse was going on--the data wasn't broken out into rape and other forms of abuse--or at what age the abuse occurred, but it's yet another powerful bit of evidence for the long-lingering effects of sexual abuse and for why it should be stopped.

Posted by Philip Dawdy at 12:54 PM | Comments (28)

ABC's "20//20" Seeking Parents With Psychotic Kids

A reader passed along a web page whereon ABC's "20/20" program asks "Does your child suffer from a psychotic disorder?" And continues:

"Does your son or daughter suffer from schizophrenia? It's normal for kids to act out, but what happens when your child can't control his actions and behavior? Do you worry about what might happen when you're not home? Is your child a threat to you and the rest of your family?

"Are you struggling to find a safe and therapeutic place for your child?"

Yes, ABC News is looking for parents to respond, tell them their "situation" and maybe a producer will get back with them. I've got no idea what "20/20" might do with these situations, but given the network's recent go at mental health and "Mad Pride," I won't be holding my breath for anything good. I hope ABC isn't trying to find young children for whatever program is cobbling together. I guess it depends on what the meaning of "child" is.

There does seem to have been a bit of an uptick in coverage of serious mental illness on big time TV lately (PBS has done something as well). I wonder what's driving all of it.

Posted by Philip Dawdy at 12:05 AM | Comments (12)

Farewell Prozac

That's the name of a new blog that first appear in early September and which I ran into yesterday. It's an ongoing account of a British writer and "wage slave" who's recently taken his last hit of Prozac and walked away from medicating depression after six years of Lexapro, Celexa, Cymbalta and Prozac. He's a pretty good writer.

"Last weekend, on Saturday morning, without fanfare or drama, I swallowed what will hopefully be my last ever antidepressant tablet with a mouthful of orange squash, looked out of the kitchen window and then got on with my day. It was an entirely unremarkable act which means nothing unless I find that I'm able to cope without it ever happening again, which is what I hope.

"I'm aware, of course, that addiction to something as pervasive as nicotine is an entirely different pair of trousers to the kind of discontinuation syndrome associated with SSRI antidepressants. But I wonder if there might be some way of drawing parallels between the two. Having what might turn out to be my last antidepressant reminded me of the day I had my last cigarette, and how that marked a similar change in my life between everything that was before and everything that was after. Sometimes these things happen, and they do mark a change - not the towering epiphany of predictable fiction, but an event that really does mark a difference between one time and another."

It goes from there. I hope it all goes well for him.

Posted by Philip Dawdy at 12:03 AM | Comments (3)