Or should I say tries to explain, since animal studies are usually fairly tentative in their findings and applicability to humans? That said, researchers have been using a mouse model to examine why some people who take Ambien, the well-known sleeping drug, do things like sleepwalking, sleep-driving and other odd-to-them behaviors, often with no memory of the event.
From Reuters:
"Ambien, made by Sanofi-Aventis, can shut down powerful brain circuits responsible for inhibiting brain activity under certain circumstances, leaving other brain circuits unchecked, researchers at Georgetown University Medical Center in Washington said."'You are kind of releasing the brakes,' said Molly Huntsman of Georgetown, who worked on the study that appears in the Proceedings of the National Academy of Sciences.
"This may stimulate brain circuits that would normally be silenced. 'In a way, Ambien is awakening other circuits because the brakes are not in place,' Huntsman said.
"To study the effects of the drug, known generically as zolpidem, Huntsman and colleagues conducted a series of experiments in mice.
"The team wanted to see how mice on the drug would respond when the researchers trimmed their whiskers, which rodents use as their primary sensory system -- much like humans rely on vision to take in information about the world.
"The team found that mice that were deprived of this sensory information had changes in their brain that affected the way they responded to the drug Ambien.
"'It's a population of neurons that is normally in place to stop activity. We find what Ambien does is inhibit their function to inhibit,' Huntsman said in a telephone interview."
I wasn't able to pull up the paper from PNAS, but that Ambien may be blocking inhibitions in humans sure would explain a lot of the weirdness that's cropped up around the use of the drug such as this recent tale of a man cheating on his wife one night while on the drug or this sad story from earlier this year wherein a man sleepwalked on a bitterly cold night and died.
It would be interesting to see this mice research replicated in humans.
An FDA panel meeting to come up with recommendations to address tens of thousands of overdoses each year of acetaminophen--ie, Tylenol, Excedrin, your favorite private label brand, etc.--voted today to recommend to the full FDA that the strength of OTC acetaminophen be reduced. The FDA is not bound by their recommendations.
The AP sketches out the problems around the painkiller and the votes:
"But despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA."FDA's experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.
"The group was not asked to recommend an alternative maximum daily dose.
"The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Extra Strength Tylenol is 1,000 milligrams, or two tablets.
"In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription."
Not to throw too much cold water on these proposals--it's obvious we have rather large problems with acetaminophen in our culture--I'm not sure that there would be much benefit to the FDA adopting these recommendations, aside from looking like it's doing something proactive. If you lower the dose of acetaminophen by roughly 50 percent, then it's not difficult to imagine that patients will simply up the dose they take, buy more bottles of Tylenol at the store and so on, in order to get the same effect. The opportunities for unintended consequences abound, in my opinion.
Why not simply recommend a black box warning for all OTC acetaminophen warning of liver damage through overdosage, etc.?
It's worth noting that the makers of Tylenol have been running commercials in recent months advising patients to be good to their livers by not taking too much Tylenol.
I know so many people with various mental disorder diagnoses who have taken a benzodiazepine in addition to whatever other medication they were on (and often they were getting a benzo for side effects of, say, anti-depressants) over the years and I've seen many of these people run into very severe withdrawal and addiction problems as a result. The usual suspects are Klonopin, Xanax, and Ativan (there are others of course). Sales of Xanax last year hit $350 million, up almost 50 percent since 2003 and 85 million prescriptions were filled for the top 20 benzos in 2008, an increase of 10 million scrips over 2004, according to this article on anti-anxiety drugs and their problems in today's Washington Post.
Their problems are legendary.
"The ordeal of withdrawing from benzodiazepines can rival that of kicking a heroin habit, according to some who have had success. Abrupt withdrawal can result in hallucinations, seizures and even death, experts say."Last year, after jail officials in Cleveland denied R&B singer Sean Levert's repeated requests for his Xanax, he hallucinated for hours and ultimately died from the effects of withdrawal, according to the coroner's report cited in court records. His widow sued the corrections center and medical staff. The suit is pending."
The article certainly serves as a reminder to me of how commonly these drugs are used--85 million scrips could easily translate into more than 10 million people taking benzos--and how their use has boomed, despite all the bad things doctors know about the drugs, during this very anxious decade.
I've not experienced benzo addiction or withdrawal personally, but I know it's utter hell and I'll try to pay more attention to these issues. I think some docs are prescribing these drugs far too casually and for too long a period of time.
During my 18 years in the mental health system, I was only ever prescribed Ativan at 1 mg. a day to take as need to, drum roll, treat agitation I was experiencing from Seroquel and Lamictal. My then-psychiatrist and I worked out a deal where he would only write me a scrip for 15 pills every two or three months and would only renew the scrip in person instead of over the phone or by fax. He said he wanted to make damn sure I didn't get hooked on the drug and I'm thankful he took that approach, even though I'd been waved away from benzos by other docs and patients for many years at that point.
Ativan was a nice enough drug for me, but then I never took it for more than a day or two at a time.
A friend once gave me a Xanax--I forget which dosage--and it knocked me out so hard that I fell asleep on my usual bus and missed my regular stop by one mile. Not so nice.
This is one of the most discouraging articles I've read in a while: today the Los Angeles Times reports on the case of a 6-year-old girl in LA who is diagnosed with schizophrenia and her parents' desperate attempts to deal with her, find housing, etc. It's a tough read, especially because by its end we learn that the girl is on a cocktail that includes Thorazine, possibly the worst of the first-generation antipsychotics.
The article is well done and duly notes that schizophrenia among children so young is incredibly rare.
I was blown away on Saturday when, during cable news coverage of Michael Jackson's death, two doctors offering analysis were very critical of Jackson's reported long-term, chronic use of both painkillers and anti-depressants and noted that they could affect someone's heart health (while that's likely obvious to one and all with painkillers, it's probably not so obvious with anti-depressants). Sadly, I cannot find transcripts of either doctor on Fox News and CNN, but I can assure you they said it and it was a stunner to me, given how the mainstream media ignored the connection between anti-depressant use and sudden cardiac death in women, as reported by researchers in the Nurse's Health Study. It's also a stunner to me in light of how naive we've been as a culture when it comes to using anti-depressants very casually while assuming that there's no long-term impact from using the drugs.
Jackson was allegedly on a staggering cocktail of prescription drugs: thrice daily injections of Demerol; Dilaudid; Viccodine; and 120 mgs. a day of Zoloft and 40 mgs. a day of Paxil. He was supposedly taking the anti-depressants for OCD and social phobia issues. What Jackson was taking at the time of his death isn't entirely clear, since his toxicology report won't be available for many weeks and also since last night his personal physician, Conrad Murray, reportedly told Los Angeles police detectives that he hadn't injected Jackson with Demerol and, in the words of the doctor's lawyer, "There was no Demerol. No OxyContin."
He said nothing about anti-depressants, however.
So we shall see how all this prescription business plays out. Of course, Jackson was known to have used painkillers for many years to treat chronic pain problems and it's entirely possible that he'd become addicted to them. It's entirely possible that Michael was hooked on anti-depressants as well. Certainly, SSRIs can be very addictive (or create physical dependency, if you prefer) for some people.
That said, I want to make it clear that I am not blaming Zoloft and Paxil for Jackson's death. I am not saying that taking either drug will give any specific person a heart attack. But I am saying that, for now, that the two anti-depressants are inextricably entwined and linked to the death of MJ.
The research on long-term anti-depressant use is thin to begin with and there's not a lot of research on links between anti-depressant use and heart problems, but it is obvious to me that there is clearly something going on here and, as I wrote back in March, the nurse's study should be a big wake up call to doctors who've had patients on anti-depressants for many years and for patients themselves.
"Life & Style reports that Michael Jackson was taking a cocktail of up to seven prescription drugs in the months before his death."And a Jackson family lawyer told CNN he 'feared' the drugs could kill the pop star.
"The star had been taking prescription painkillers including anti-anxiety drugs Xanax, Zoloft and painkiller Demerol in recent months, sources close to Jackson told Life & Style. The insider close to the star said he took a suspected overdose of drugs on Thursday morning, which caused respiratory and cardiac arrest.
"Jackson family lawyer Brian Oxman confirmed Jackson may have had trouble with prescription drugs as he prepared for his London show.
"'This was something which I feared and something which I warned about,' Oxman said on CNN. 'I can tell you for sure that this is something I warned about. Where there is smoke there is fire.'
"Mr Oxman compared Michael to Anna Nicole Smith, alleging that Michael had 'enablers' just like her."
I don't even know what to say, except that there will be much, much more to come on this story.
On a personal level, I am crushed by Michael's death. I grew up on the Jackson 5 and loved "Off The Wall" and "Thriller." Obviously, Michael became a very weird adult, but he sure as hell deserved an opportunity to redeem himself. It's sad that those London concerts will never happen.
That he died of what appears to be sudden cardiac death makes me wonder greatly about what his toxicology results will be.
Last week, PsychCentral.com's John Grohol handed out some journalism awards for writing on mental health issues online, driven by recent media awards from Mental Health America which completely ignored the online world. Freelancers Shannon Brownlee and Jeanne Lenzer won for a Slate.com article on conflicts around "The Infinite Mind" radio show; the New York Times for its "Patients' Voices" series; Danny Carlat won for being Danny Carlat; CL Psych won for being CL Psych; Jeremy Dean at PsyBlog won for writing about limited research behind so-called brain training programs; The Last Psychiatrist won for being The Last Psychiatrist; Vaughan Bell at MindHacks.com won for disemboweling fMRI claims; and, "Like him or hate him (he tends to be polarizing)," yours truly won for thumping out this blog and offering the public court documents and so on.
I certainly appreciate the hat tip, particularly as this year marks the first time since 1999 that I have not won a print journalism award of some kind. That's mostly due to the fact that the freelance market has melted down--a publication I wrote for on occasion told me last week that they have no more freelance money for at least the rest of the year, which is simply stunning--which means I don't get to do much print work these days. Sadly.
More importantly, a PBS documentary "Depression: Out Of The Shadows" recently won a Peabody Award (one of the biggies in TV journalism) as well as recognition from Mental Health America (see above link). But now the Columbia Journalism Review picked up on the fact that the much-discredited Emory University psychiatrist Charles Nemeroff had appeared on the program and made some spurious claims:
"Some might argue that little about this episode matters, since Nemeroff’s downfall took place in October and Depression: Out of the Shadows aired five months earlier. Yet a simple Google search would have alerted McPhee to the fact that Nemeroff, though the author of hundreds of research papers and well respected in his field, has been dogged by conflict of interest allegations for years. In 2003, he came under fire for praising three pharmaceutical products in the journal Nature Neuroscience without disclosing he held a financial stake in their success, one of which he held the patent on....""But what made the praise bestowed on this PBS documentary particularly troubling were the erroneous, drug-industry serving statements made by Nemeroff within the film—statements which had the potential to negatively affect public health, and which the documentary left unchallenged. During a segment on the FDA’s 2004 decision to require “black box” safety warnings stating that antidepressants can increase the risk of suicide in children and teenagers, a risk it extended in May of 2007 to users under twenty-five, Nemeroff seized the occasion to claim that the federal safety warning was mistaken."
Oh, yes. The CJR writer questions the validity of the Peabody award in regards to all of that. Personally, I don't have much taste for being a journalist questioning other journalists' awards, so I'll leave it at that. I felt the program was OK-ish and in writing about it last year ignored an appearance by Emory University's conflict of interest king Charles Nemeroff as I was simply exhausted by earlier news about the doc. I was furious about the program's pimping for ECT, however.
For what it's worth, I sure didn't set out to be polarizing when I began this blog almost four years ago and I don't try to be polarizing each day. I realize that that dynamic is out there and that I have that reputation, earned or not, and that it sometimes loses me readers and contributors. The reality is that I have taken a very firm stance that the public--the ones footing the bill for psychiatry and Big Pharma--has an absolute right to know how convoluted the game has become and who is behind the curtain and so on.
As I noted last year when I wrote about responses to my writing on David Foster Wallace's suicide, if no one pushes the intellectual envelope and if no one asks difficult questions, then nothing ever changes. And things have got to change.
There are a few bits of news in this post but they are tough to organize: suffice to say that the politics around the forthcoming DSM-V are becoming very intense and nasty and, slightly connected, psychiatrist-bloggers Doug Bremner (Emory University) and Danny Carlat (Tufts University) are drawing the ire of some colleagues for writing honestly about psychiatry's epic conflict-of-interest problems, earning both a marginalization campaign from others in psychiatry. Yes, it is getting ugly out there.
First, Bremner notes an in-press article at Psychiatric Times by Allen Frances, a psychiatrist who chaired the DSM-IV committee, is deeply critical of the deeply secretive DSM-V process and delivers a stern assessment of the process, the kind that might embiggen the heart of an anti-psychiatrist (article obtainable at Bremner's site):
"The work on DSM-5 has, so far, displayed an unhappy combination of soaring ambition and remarkably weak methodology."
Bremner summarizes further:
"[Frances] then goes on to explode the statements by Kupfer that the DSM-5 will lead to a 'paradigm shift' in psychiatry, which he describes as an 'absurd statement' based on the fact that there still is not a single lab test for diagnosis, and the gains are small and incremental in descriptive research. In the absence of evidence, changes in diagnostic criteria are arbitrary and often driven by a single strong member of the sub-committees. Furthermore, the incorporation of sub-threshold diagnoses as official psychiatric diagnoses will be a 'bonanza' for drug companies who will expand their markets to new legions of the 'newly' mentally ill and rush to 'educate' doctors about the new criteria, which they will use to expand drug usage. It will also serve to expand stigma."
I agree with Frances' points. I've made similar points before and, of course, when I've noted the incrementalism of bipolar disorder type 2 and how it created a new, mostly unnecessary market for pharma companies, I've taken a thorough drubbing. So it's nice to see that Frances, by implication, has my back on some of this.
Bremner himself has created a "Shadow DSM Team" to track the new DSM. This seems to have landed him in some hot water with colleagues, as a post he wrote last month on proposed Developmental Trauma Disorder in children mentioned that some involved in developing possible criteria for the disorder came from institutions (Brown, Dartmouth) with huge conflict-of-interest problems. For this Bremner is paying a price:
"I got an email from someone on the DSM Anxiety, OCD, PTSD and Dissociative Disorders committee whom I thought was a 'friend' un-inviting me to be an author on a paper about another topic (that was after I had already spent several days working on the paper)."
There's some nice revenge. What's interesting is that Bremner has always written about Emory's many conflict of interest problems and that seems to have PO'd some at that school who then used a long-ago Bremner post (part serious, part satirical) about my smoking and losing my housing over the same to demand that Bremner disassociate his blog from the fair, driven-snow reputation of Emory. That's how lame it's getting out there in academic psychiatry.
It gets lamer still. Danny Carlat reports on his blog that some folks within the American Psychiatric Association are trying to keep him off a guidelines review committee over a comment someone left on his blog earlier going after Stanford's Alan Schatzberg, who recently became president of the APA. Read his post for the details.
I know that Bremner and Carlat are both disturbed by the academic snubbing from their colleagues and I imagine their surprise is large as well since the two are moderate critics within their field, mostly of conflicts of interest and rampant pharma-funding of continuing education. I say they should wear their shunning as a badge of honor and realize just how deeply out of touch with reality some of their colleagues seem to be.
Perhaps we can come up with a new disorder in DSM-V to describe the condition.
I've noted before that the DC media has had much fun poking at President Barack Obama about how much he still smokes and how I think the media ought to stay out of the President's private life (or do they plan on asking what he eats each day, if he drinks soda pop and whether he and the First Lady have sex?) and stick to far more important questions.
But, no. During yesterday's press conference a reporter who identified herself as a former smoker went after President Obama about smoking. If I've watched one trend over my 15 years as a reporter, it's that once a media person stops drinking or smoking (or whatever), they become most virulent in attacking that which they once did. For instance, I know of recovering alcoholics in the press corps who will go hammer-and-tong on homeless housing programs where chronic inebriates are allowed to drink, even though there's good evidence that such programs are helpful, simply because the method of stopping drinking that worked for them must work for one and all (no, I won't get into any names here). You'd think their editors would be smart enough and attentive enough to questions of unfair bias to assign such stories to clearer minds, but when it comes to that perceived to be a vice all those old standards fall apart.
Here's yesterday's exchange (deep down in this transcript) between McClatchy's Margaret Talev and President Obama:
"Q: How many cigarettes a day do you now smoke? Do you smoke alone or in the presence of other people? And do you believe the new law would help you to quit? If so, why?""THE PRESIDENT: Well, first of all, the new law that was put in place is not about me, it's about the next generation of kids coming up. So I think it's fair, Margaret, to just say that you just think it's neat to ask me about my smoking, as opposed to it being relevant to my new law. (Laughter.) But that's fine, I understand. It's an interesting human -- it's an interesting human interest story.
"But I've said before that, as a former smoker, I constantly struggle with it. Have I fallen off the wagon sometimes? Yes. Am I a daily smoker, a constant smoker? No. I don't do it in front of my kids, I don't do it in front of my family, and I would say that I am 95 percent cured, but there are times where -- (laughter) -- there are times where I mess up. And, I mean, I've said this before. I get this question about once every month or so, and I don't know what to tell you, other than the fact that, like folks who go to AA, once you've gone down this path, then it's something you continually struggle with, which is precisely why the legislation we signed was so important, because what we don't want is kids going down that path in the first place. Okay?"
If the President was once a pack-a-day smoker, then 95 percent cured would translate into something on the order of seven cigarettes a week as his current consumption (rumor has it he smokes Parliament Lights, or P-Funks as they are known), plus all that nicotine gum he reportedly chews--and the media is chipping him up about it? And asking if he smokes in front of others? Does Talev ask stupid, biased questions in front of the world? Please. I'm glad the President called Talev, clearly religious on the matter (hopefully, her bureau chief chewed her ass out afterwards), out for messing with him on what is fundamentally a trivial matter and a personal choice.
That said, I'm a bit tired of watching the President handle the smoking question with such selfishness (I don't know another term to use here, but I can assure you that his smoking is not all about him). The reason the media keeps pressing him on smoking has very little to do with him per se and everything to do with a culture war over smoking and other Nanny State concerns (food, soda pop, weight, exercise, guns, etc.). Between 40 million and 50 million American adults smoke cigarettes regularly and there are millions more closet smokers out there as well. The sheer persistence of this bloc of smokers drives the anti-smoking advocacy groups (funded with billions of dollars from pharma companies, pharma-connected foundations and a huge slush fund from the Master Tobacco settlement of the 1990s) and Nanny State health departments absolutely batty. They've been rolling out their smoking education programs since the early-1990s (often making spurious claims about smoking), running smoking ban initiatives throughout the country (often making unscientific claims about secondhand smoke), driving up the price of cigarettes and other tobacco through their tax-loving minions in various state legislatures and the Congress and, finally, getting regulation of tobacco into the hands of the FDA. And yet 40 million to 50 million adult Americans make the choice each day to light up. (For the record, I am one of them.)
What the anti-smoking advocates want is a big symbolic victory, their grand teaching moment and they want it in the form of President Obama.
I think that the President should use the opportunity to shift the conversation from one of when is he going to quit 100 percent (from the looks of things, I'd say never) to pointing out to his occasional interrogators on the subject that the tens of millions of Americans who do smoke also have rights and that those rights are being trampled on a regular basis. I don't even think I need to get into the housing discrimination that smokers now face across the country and that a lot of that discrimination disproportionately targets lower-income Americans and, in some cases, Americans with mental illnesses such as schizophrenia (some of the most disadvantaged Americans of all). The President ought to use questions about his smoking to point out how nutso this kind of discrimination has gotten (real world example: a friend of mine in Seattle was recently denied a new apartment due to the fact that he told the landlord he wouldn't smoke on the property and the landlord told him that he wouldn't rent to a smoker under any circumstances regardless of where they smoked), particularly in regards to a product that is legal (or are we going to start denying rental housing to someone who drinks a six-pack a week?). It would be really nice to hear the President go all-contrarian and community organizer on the ex-smokers who toy with him.
I think President Obama should use future questions about his smoking to make the point that, like it or not, nicotine is a stimulant, well-known as such for hundreds of years and that it does have beneficial effects (as does caffeine, as do other stimulants). The President could even use these supposed teaching moments for a teaching moment of his own and ask why if so many millions are into nicotine while the most common delivery method of said nicotine is allegedly so bad, then why hasn't some smarty pants come up with a better, safer nicotine delivery method. I can assure you that nicotine gum is not a replacement and neither are the Swedish snus and the e-cigarettes. There is something deeply magical about a cigarette and perhaps it's time for a federal stimulus program to find a way to replicate that magic in a more socially-acceptable form.
In other words, it's time for President Obama to stop acting so conflicted about his own smoking and embrace it a bit more, at least psychologically, and also realize that the game is far bigger than his own smoking and that it speaks to the concerns, in all directions, of many millions of Americans who smoke and are feeling quite put upon these days.
It sure would be a hell of a lot simpler than figuring out what tone to strike on Iran, dealing with the economy or engineering a victory on health care reform.
Sen. Charles Grassley (R-Iowa) has struck again, today sending a letter to 23 medical schools and asking them to reveal policies on conflicts of interest and requirements for disclosure of financial relationships between faculty and Big Pharma. The 23 schools had previously not responded to a similar request from the American Medical Student Association.
"'There's a lot of skepticism about financial relationships between doctors and drug companies,' Grassley said in a statement. 'Disclosure of those ties would help to build confidence that there's nothing to hide.'"
Schools on the list include Tulane University School of Medicine, Dartmouth Medical School, Howard University College of Medicine, Louisiana State University School of Medicine - New Orleans, New York College of Osteopathic Medicine of the New York Institute of Technology, University at Buffalo School of Medicine and the University of South Carolina School of Medicine.
It ought to be fun to see what kinds of responses the Senator gets.
It happens each year and usually in June, and so far this week I've seen very little news on interest or import on the mental health front. I doubt that the trend lasts, so I expect to be back to a vaguely regular pace soon, perhaps later today.
Elissa Ely, a Massachusetts psychiatrist, has an interesting essay in the New York Times:
"Psychiatry is a relatively safe profession, but it has a hazard that is not apparent at first glance: if you are in it long enough, there may be no one to talk to about your own problems."
As Ely writes there are some psychiatrists who have been psychotic and were able to return to practice--although shouldn't a patient get a full disclosure on that kind of thing?--and it made me wonder what percentage of psych docs have ever been on psych meds. I have no idea.
Anyway, as it turns out, psychiatrists turn to other psychiatrists for help with their own problems. No surprise there. I wish I knew how they felt about the experience.
From time to time, I simply shake my head at the quality of health journalism in the US, particularly as regards children's mental health. Today's example comes to us from the San Francisco Chronicle in an article entitled "Antipsychotic drugs for kids raise hope, worry." While the article does get at both the hope and worry around the use of these drugs in kids, it remains uncomfortably biased toward promoting the use of antipsychotics in kids to the point where you've got to wonder who the reporter's sources were and who the hell is editing at the Chron these days.
The trouble starts in the lede:
"Increasingly powerful antipsychotic drugs available on the market, and growing evidence that starting these medications early can help children with conditions like bipolar disorder, is putting doctors under more pressure than ever to diagnose and treat young people with mental illnesses."As a result, some doctors say, mental illness, especially bipolar disorder, has been overdiagnosed much the same way attention deficit hyperactivity disorder was in the 1980s."
OK, how would the availability of a drug put docs under pressure to diagnose and treat people? What growing evidence that starting these medications early helps children with alleged bipolar disorder? Certainly, the article offers no evidence and, to date, there's no long term "evidence" to support the use of these drugs in kids and the shorter-term studies aren't particularly conclusive either. But there it is in black and white and you've got wonder if there's a skeptical eye at the paper at all, especially when we're talking about a diagnosis--pediatric bipolar disorder--that is deeply controversial within child psychiatry itself when applied to kids younger than 12 or so.
And the antipsychotics are "increasingly powerful?" Compared to what? Older antipsychotics? Really? That's a statement that makes no sense.
The article does a decent job of talking about of overdiagnosis of bipolar disorder in kids and teens and fleshes out some docs' concerns about misdiagnosis, but at core the paper completely accepts the validity of the disorder in children and then sets about quoting a NAMI official:
"Dale Milfay, vice president of the National Alliance on Mental Illness in San Francisco, said it's crucial that children with mental illness get a correct diagnosis as soon as possible and start treatment right away. There may be medical advantages to early treatment, she said, but children also benefit from staying in school and developing crucial relationships with friends and family."'The earlier people are diagnosed, the better their chances,' Milfay said. "'But you wouldn't want these drugs to be overused. There needs to be some real criteria that this is not something a primary care doctor can just diagnose.'"
While I appreciate someone from pharma-funded NAMI striking a cautionary note, I'd really love knowing where their evidence is of early diagnosis being crucial to child development, especially when you have some experts in child psychiatry who claim that kids who get hit with bipolar diagnoses as kids don't wind up having bipolar disorder as adults.
Like I said above, I sure do wonder about the state of health care journalism these days and my concern isn't idle given that health care comprises about 25 percent of the American economy these days.
That headline is not a joke:
"FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all products sold under the name Stamina-Rx. FDA lab analysis found that the product contained the undeclared ingredient − benzamidenafil − a drug in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction. Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product. Stamina-Rx is sold predominantly in health food and drug stores nationwide. Consumers who have this product in their possession should stop using it immediately."
I wouldn't even know where to begin with wondering how such an unlicensed compound would get into an over-the-counter pill. Man, is the company ever going to have some PO'd customers.
Via the New York Times's The Caucus blog, comes news that the House version of health care reform has been released. There's a link on that blog to the very large pdf of the proposed legislation, which would of course have to be reconciled with any Senate bill.
The Times notes:
"The House proposal unveiled on Friday was a decidedly progressive measure, which reflected many of the ideas championed by the White House, including such initiatives as the creation of public insurance plan, which Republicans have said they will never support."In the Senate, lawmakers have been working on a number of potential compromise proposals, including the creation of nonprofit health care cooperatives that could compete with private insurers but would be regulated rather than controlled by the federal government.
"The House proposal also included a requirement that employers either provide health insurance or pay a fee equal to 8 percent of their payroll. The House chairmen said that the 8 percent figure, along with virtually every other aspect of the draft legislation, was negotiable and intended as a starting point for deliberations.
"But Republicans have voiced opposition to imposing any such requirement on employers, arguing that it would effectively lead to the elimination of jobs."
While the 8 percent figure may represent one approach to keeping businesses from dumping their employees onto the public option in the plan, I need to know a lot more about how all of this will work. Funding programs by imposing a new payroll tax on businesses during a deep recession may not be a great idea. I remain to be convinced at any rate.
In news just out this morning, FDA scientific staff urge the agency to undertake further review of the anti-seizure drug Depakote, commonly used for various seizure disorders as well as a so-called mood stabilizer in bipolar disorder, due to possible links to cases of developmental delay and autism in children of mothers taking the drug while pregnant. Depakote, made by Abbott Labs, is also known as divalproex in generic form.
"Six cases received since its approval in 1983, including two siblings reported to have autism, 'raise concerns,' Food and Drug Administration staff wrote in a May 6 memo released on Friday."Limitations in the reports 'make it impossible to definitively conclude' the drug played a role, and genetics or other factors may have contributed, especially in the two sibling cases of autism, the FDA reviewers said.
"'Further study is needed to further elucidate causality and degree of risk of fetal exposure to (Depakote) and subsequent developmental delay in children,' they added."
In April, a study found that Depakote use during pregnancy led to significantly lower IQ scores in offspring. Last year, a British study reported a sevenfold increase in the risk of developing autism in the offspring of mothers who took Depakote in utero.
Depakote has also been linked to ovarian cysts.
As I noted yesterday, a few plaintiffs' cases against AstraZeneca over accusations that its antipsychotic Seroquel caused diabetes have been dismissed in Delaware Superior Court recently partly due to a judge's finding that one expert witness could not establish a link between the drug and diabetes. It sure made one wonder where the many thousands of other Seroquel cases were headed.
Now a judge in US District Court in Florida, where about 6,000 Seroquel cases currently reside, has ruled that AZ cannot exclude the testimony of a separate plaintiffs expert witness who will argue a link between the drug and diabetes in some patients. Donna Arnett, professor and chairwoman of the epidemiology department at the University of Alabama at Birmingham, argues that Seroquel causes metabolic changes, which can lead to diabetes.
The ruling affects only cases in federal court.
According to Bloomberg, Tony Jewell, an AZ spokesman, said in an emailed statement:
"'The heart of these cases are unproven claims that Seroquel causes diabetes in individual patients.'"'Judges at both the federal and state levels have dismissed the initial cases prepared for trial, concluding that plaintiffs did not have sufficient evidence to establish that Seroquel was responsible for their alleged injuries,' he said. 'In the cases prepared for trial to date, plaintiffs have been repeatedly unable to prove their claims in court.'"
Yes, but none of those cases have gone to trial to date or been heard by a jury. It's beginning to look as though at least some cases will go to trial, unless AZ's lawyers have further rabbits to pull out of the hat.
In an Arnett deposition released earlier this year, she called Seroquel unsafe, said it led to an increased risk of diabetes and that it hadn't helped the majority of patients in clinical trials as the majority of patients in clinical trials for the drug had dropped out of the trials.
It will indeed be interesting to see how all of this plays out.
A new Wall Street Journal/NBC News poll came out yesterday, allegedly gauging all sorts of things abotu what Americans think about President Barack Obama and his policies to date. The results aren't especially encouraing for the President's attempts to reform health care, even more so because the poll was completed days before discouraging new details came out about how many people health care reform would actually cover.
"On health care, the public remains open to persuasion. Without being told anything specific about the Obama plan in the survey, about a third of people said it's a good idea, about a third said it's a bad idea and the rest had no opinion. When given several details of his approach, 55% said they favored it, versus 35% who were opposed."There was also support for the Democratic push to let people sign up for a public health-care plan that would compete with private companies, one of the toughest issues in the health-care debate. Three in four people said a public plan is extremely or quite important. But when told the arguments for and against the plan, a smaller portion, 47%, agreed with arguments in support of the plan, with 42% agreeing with the arguments against it.
"At the same time, nearly half the participants said it was very or somewhat likely that their employer would drop private coverage if a public plan were available.
"As for how to pay for the package, estimated at more than $1 trillion over 10 years, the public favors proposals to require all Americans to get insurance, to raise taxes on the rich and, to a lesser extent, to require all but the smallest businesses to offer insurance or pay into a fund.
"But majorities oppose plans to tax health benefits, even if the taxes only apply to particularly generous plans. The public is divided about cuts to Medicare."
Extract from all of that what you will.
My own view is that support for health care reform wanes once people learn the details and that does not bode well for broad public support for the "plan"--whatever that plan might actually be. The other thing worth reemphasizing is that this poll was finished two day before the Congressional Budget Office reported that the Senate's Kennedy-Dodd plan, considered the main Obama-backed health plan, would only provide coverage to another 16 million Americans at a cost of $100 billion a year, leaving another 30-plus million Americans without insurance. It will be interesting to see how health care reform pans out in future polls.
It's also deeply troubling that about half of respondents said their employer would cut their health coverage and kick them onto the public plan, if such a plan passed. That would create a budgetary catastrophe. As I've noted before, it is essential that President Obama address this kind of possibility in some fashion, especially if he wants to beat back conservatives who claim he's trying to engineer a government takeover of health care.
Anyway, let's look at an example of how the plan pencils out. At $100 billion a year for 16 million people, that works out to $6,250 a year in insurance cost for each newly covered person or $520.83 a month. Not to be too much of a skeptic, but that strikes me as a very costly plan per person. Right now, I can go out and purchase health insurance coverage for myself through Group Health Cooperative (the big HMO in Washington State) for about $225 a month. The deductible stinks of course, but that's well under half the cost of the Senate plan (according to the CBO's number crunchers) and so this makes me wonder what gives exactly.
Interestingly, a few years ago I know that the COBRA payment for King County (Seattle area) employees was a little over $500 a month for one person and that the coverage was gold-plated: small co-pays for office visits and prescriptions and pretty much everything else covered to a great extent. I'm not saying the proposed Kennedy-Dodd plan is the same thing, but that dollar amount sure does make me wonder.
I'd like to see health care reform pan out (hell, I've been uninsured for two years), but it's beginning to sound, absent a miracle, as if the plan is DOA.
Recent reports indicate that several of the initial Seroquel cases brought by plaintiffs against AstraZeneca, the antipsychotic's maker, have been dismissed in Delaware Superior Court. Two were dismissed due to a judge's finding that plaintiffs' expert witness could not tie plaintiffs' diabetes to use of the drug and, in another case, a case was dismissed on the odd grounds that plaintiff hadn't listed possible proceeds from the case on a financial disclosure form.
While I'd imagine plaintiffs' attorneys will appeal the dismissals, these cases make it clear just how hard AZ's attorneys are fighting various Seroquel lawsuits. To date, AZ has not settled a single Seroquel related case among the 15,000 or so claims it faces including several brought by various states such as Arkansas over accusations the company knew it was selling a diabetes-inducing drug and accusations of off-label marketing of the drug, among other accusations. No cases have gone to trial either. Word amongst legal sources is that AZ's lawyers are using every possible angle to keep cases from going to trial or to grind plaintiffs into submission through the sheer expenditure of time. Fair enough.
Contrast that, however, with Eli Lilly's approach in various Zyprexa cases--fight and then settle. To date, Lilly has settled $2.7 billion in claims concerning its handling and marketing of the drug Zyprexa, an antipsychotic similar to Seroquel, and is quite possibly in a position where it may have to settle other Zyprexa cases in New York federal court for billions more.
Why the companies have pursued such different legal strategies is hard to tease out.
Janssen/J&J also face many lawsuits--including ones brought by various states--over its handling and marketing of Risperdal, another antipsychotic. So far, none of those cases are in advanced enough states to determine how J&J's lawyers will respond to plaintiffs' claims.
It's been a bit slow the last couple of days, but it is nice not have any of the usual and newer outrages popping up. Of course, that means look for the FDA to approve Seroquel for depression any day now (OK, I'm kidding, half-kidding).
Things were slow over at CNN's "No Bias, No Bull" program, too, and so the show's host Campbell Brown had a debate on the question of "Are we overmedicating America's children?" Kelly O'Meara (author of "Psyched Out") and Charles Sophy of the Los Angeles Department of Children and Family Services batted about a few of the common themes--"It's not science!" versus "We're helping children with real disorders!"--to no real impact. But the fact that it was on CNN lends the debate a sheen of mainstream credibility.
Transcript here (scroll down about halfway to "The Great Debate").
This is kind of major: a new study out today in JAMA asserts that an earlier 2003 study that claimed to identify the single gene 5-HTTLPR (a serotonin transporter) as the prime driver of depression is in fact wrong. In the new study authors claim "meta-analysis yielded no evidence that the serotonin transporter genotype alone or in interaction with stressful life events is associated with an elevated risk of depression in men alone, women alone, or in both sexes combined."
Stressful life events, however, were significantly linked to depression.
That may sound ever so basic to many readers, but when the 2003 study came out it got a ton of attention, as the New York Times reports today, and spread the "it's in the genes" hypothesis of depression far and wide and also boosted the chemical imbalance theory of depression in the bargain.
"The authors conclude that the widespread acceptance of the original findings was premature, writing that 'it is critical that health practitioners and scientists in other disciplines recognize the importance of replication of such findings before they can serve as valid indicators of disease risk' or otherwise change practice."Dr. Caspi and other psychiatric researchers said it would be equally premature to abandon research into gene-environment interaction, when brain imaging and other kinds of evidence have linked the serotonin gene to stress sensitivity.
"'This is an excellent review paper, no one is questioning that,' said Myrna Weissman, a professor of epidemiology and psychiatry at Columbia. 'But it ignored extensive evidence from humans and animals linking excessive sensitivity to stress” to the serotonin gene.'"
Obviously, this new finding is going to be debated hotly for some time to come, but at a minimum it strikes a serious blow to genetic/brain chemistry advocates in the land and, hopefully, shifts debates about depression causes back to where they properly belong--environment, human development, stress and, gasp, human psychology.
If I may pat myself--and many readers--on the back for a moment, this new finding is also a small validation of what I have been saying on this site for four years: that evidence for genetics and neurochemistry as drivers of depression and other mental disorders were in fact weak and that using them to displace considerations of environment, etc. was buying us all a lot of trouble especially since the newish theories weren't proving out over time. Some people derided me as a kook for saying so.
I wonder who the kooks are now.
The nonpartisan Congressional Budget Office was out yesterday with an analysis of the main health care reform legislation plan under consideration in Congress and things do not look good for President Obama and Congressional Democrats.
"The office concluded that a plan by the committee’s Democratic leaders, Senators Edward M. Kennedy of Massachusetts and Christopher J. Dodd of Connecticut, would reduce the number of uninsured only by a net 16 million people. Even if the bill became law, the budget office said, 36 million people would remain uninsured in 2017."
If that's the best health care reform advocates can achieve with an estimated $1 trillion in spending over 10 years, then count me out. What's more, the article states that Dems are seriously considering new taxes to pay for their plan, which would come in the form of a tax on soda pop or a national value-added tax. Again, count me out. To get me to support a new tax of any kind, the resulting health care plan would have to cover everyone or it's simply not worth doing.
Stay tuned.
As much as I am not a fan of President Barack Obama--I'm kind of neutral on him so far--I've long been impressed by his salesmanship of ideas and programs, even where I sharply disagree with him. The President can literally sell snow to the Eskimos. That's why I am more than a little surprised at his halting, half-formed attempts to sell his health care reform plan to the public and yesterday's speech before the American Medical Association was a clear indication--to me at least--that President Obama might need to run his plan (it's really just a grab bag of ideas and goals at this point) through the typewriter once again because he's continuing to fail to address several key issues and what he is talking about so far fails to impress me. He's not doing really well with doctors either and was briefly booed during his speech for saying he was against malpractice award caps (I might have cheered him on that point).
In fact, I am even beginning to wonder how well thought out President Obama's plan is (or if he's just mouthing things various policy wonks have whispered to him) or if this is going to be a replay of his attempt to close Gitmo (I have a hunch that he won't be able to close the place because there are some detainees there who are so evil that they are in the right place already) and the torture photos back-and-forth that's frankly become an embarrassment and a pointless distraction. I'd like to see him do better on health care reform since I am one of 47 million Americans without health insurance of any kind. And that's why I am being critical of his plan to date and asking a few tough questions. I'd actually like to see it work.
Several points in his AMA speech troubled me (an AP account is here). President Obama seems much enamored of the potential for electronic medical records (time savings, cost savings, less duplication of effort) to the point where I wonder if he knows how medicine is done and what huge privacy concerns are at-play. I for one don't want my medical records on a computer network anywhere (totally hackable) and if we do get such a system I will find a way to opt out of it. I simply don't trust it and know I am not alone in that. What's more, my own experience with computerized medical records has not been positive. Several years ago, I used to see a psychiatrist here in Seattle (one my insurance company picked out for me, always dangerous) who had all his patient records and notes on a computer. The trouble with this was that it created a situation where my doctor could be lazy, not listen to me and most of the time didn't even seem to know who I was (this was the doc who messed me up on Lexapro even though I repeatedly insisted to him that SSRIs had messed me up in the past. I went along with him because he was a very convincing salesman for Lexapro). I'm much more in favor of old school approaches such as doctors actively listening to patients instead of relying on electronic notes tapped into the system by some other doc who wasn't listening to the patient either. (I could see where electronic records might be useful for ER and surgical situations and ICU cases, but for general medicine and psychiatry...not so much.)
President Obama also made it clear that his health care reform would include a provision requiring--read: forcing--every American without health insurance to participate in his new, ill-defined program whether they like it or not. (There would be an out for hardship cases who cannot afford his plan.) Hate to be a contrarian here, but what if someone doesn't want health insurance? The government is going to force it down their throats? For what reason? On what Constitutional grounds?
Look, there's been way too much forcing going on with President Obama and the Congress: we've just spent God knows how much on a so-called stimulus package and various bailouts (and in GM's and Chrysler's cases they were both failures and epic wastes of tax monies) and you, me and everyone is going to be forced to pay that off for years to come. I've simply had it up to my neck with this kind of thing and I think President Obama ought to work on drumming up some incentives for everyone to participate in the new system instead of jamming them against a wall. Call it compassionate progressive-liberalism.
While more specifics about how health care reform might be paid for are trickling out of the Obama Administration, I am not convinced that he can pull off $1 trillion-plus in costs by shifting around various Medicare/Medicaid payments and cutting payments to hospitals without instituting a new tax of some kind. And from the AP's coverage of his AMA speech, here comes a hint of new taxes:
"Aides had said previously that the administration wants to keep the cost around $1 trillion, while also acknowledging it might go higher."Obama has taken steps in recent days to outline where money could be found.
"He wants to cut federal payments to hospitals by about $200 billion and cut $313 billion from Medicare and Medicaid over 10 years. He also is proposing a $635 billion in tax increases and spending cuts in the health care system as a 'down payment' for his plan."
I think that new taxes of almost any kind will at this point cause big problems for the American economy. I'll leave it at that and await more details of what's going on here.
And now let me repeat several questions I first posed last week about the President's health care reform proposal, ones that he continues to avoid providing details on.
"How are we going to keep employers from cutting off their employees in order to shunt them onto the public system and save themselves money? [The President really needs to address this one, especially if he wants to beat down conservatives' accusations that he's engineering a government takeover of health care.]"How can we add 40 million to 50 million people to whatever health insurance system we wind up with while utilizing roughly the same number of doctors, nurses, etc. and expect to provide the same level of access to care and services?
"How are we going to drive down costs in the health care system? The President and his people keep insisting they will make this happen, but how? [Does anyone seriously think that pharma companies and health care systems will accept smaller profits?]
"What services are going to be covered under the public component of the ill-specified plan and at what price? And for that matter, beyond general PCP types of things, will naturopaths, chiropractors and other alternative medicine providers be covered?"
These questions deserve serious answers if President Obama expects people like me to support his health care reform push.
News is just out that the FDA's ongoing review of the safety of stimulants (Adderall, etc.) used to treat ADHD in children has found an "association" between the meds and sudden death in otherwise healthy children. The FDA specifically noted:
"FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication."
I'm not sure why the study wouldn't prompt such action or at least a deep reexamination of stimulants a child may be taking.
Any study like this does have limitations and the data for the FDA's study go back into the 1980s, but this new finding should give parents and doctors much pause.
You can read the full study here and an accompanying editorial in the American Journal of Psychiatry wherein researchers hail the power of stimulants and call the sudden death risk "very small."
Not if it's your kid.
I'm not even sure how to explain the relationship between Lilly and a subsidiary of CVS, the huge pharmacy company, so I'll just pinch from Bloomberg's fine coverage:
"A unit of CVS Caremark Corp. used its access to doctors to market Eli Lilly & Co.'s Zyprexa antipsychotic while it was under contract to bargain with the drug maker on behalf of health insurers, internal Lilly files disclosed in a multibillion-dollar lawsuit by insurers show. "The subsidiary of CVS, the largest US drugstore chain, touted Zyprexa starting in 2003, according to e-mails made public by lawyers suing Lilly for overpayment. CVS's AdvancePCS, a pharmacy benefit manager, or PBM, offered to send 120,000 letters to doctors promoting the drug, Lilly's top-seller with $4.7 billion in sales last year, according to a confidential 2004 proposal. The CVS unit said it would charge $5 per letter."CVS's contracts with insurers and pensions meanwhile place it in an adversarial posture with Lilly, requiring it to use its buying power as leverage in drug-price negotiations.
"'The problem is that PBMs are negotiating these hidden deals while at the same time telling employers that they represent them at the negotiating table,' said Gerry Purcell, a former PBM executive who advises companies on their drug plans. 'These documents will add fuel to the perception that the companies and the PBMs are in cahoots with each other.'"
I don't know who's more at-fault here--Lilly or CVS--but these kinds of relationships certainly cannot be much good for patients or doctors.
Bloomberg has been doing a fine job with the recently released round of Zyprexa documents and the news just keeps getting more disgusting: Eli Lilly openly and illegally marketed Zyprexa off-label for dementia while the company knew from its own studies that the antipsychotic did nothing to address behavioral issues in the elderly and while knowing that its drug was killing elderly people. Lilly has already settled allegations around all of that with the feds and 30-plus states and pleaded guilty to a criminal misdemeanor in January over its marketing of the drug for use in the elderly, where the company did not have FDA approval, so these new documents simply flesh out corrupt behavior--I don't know what else to call it--on Lilly's part. Read the above-linked article for details.
I'm attempting to get my hands on the documents that Bloomberg has but so far the lawyers handling this case haven't made up their minds as to whether they will release them. I'm not sure why they are playing favorites with Bloomberg, but that's how it goes sometimes.
Here we go again, much like a study last year linking Paxil to sperm damage and significant sexual dysfunction, a new study in Fertility & Sterility reports some grim news (via the Chicago Tribune):
"In a new study, New York researchers report that as many as half of men taking the anti-depressant paroxetine (brand names, Seroxat and Paxil) have higher levels of sperm fragmentation. "The study was published online today by the journal Fertility & Sterility."'It’s fairly well known that SSRI anti-depressants negatively impact erectile function and ejaculation. This study goes on step further, demonstrating that they can cause a major increase in genetic damage to sperm,' said Dr. Peter Schlegel, the study’s senior author and professor of reproductive medicine at Weill Cornell Medical College in New York.
"'Although this study doesn’t look directly at fertility, we can infer that as many as half of men taking SSRIs have a reduced ability to conceive. These men should talk with their physicians about their treatment options,' he added."
While the study involved but 35 men taking Paxil for five weeks, it's obvious at this point that this and the previous study should be a major wake up call for patients, male and female, and doctors everywhere.
Anyone care to tell me how salubrious Paxil is?
A new batch of Zyprexa documents was unsealed in US District Court in New York last month, something that escaped my notice due to all the Seroquel documents being released elsewhere. Bloomberg got the documents--which I'll attempt to obtain myself--and yesterday had a wire story on Lilly openly ghostwrote articles for allegedly independent researchers and then shepherded their publication, a true manipulation of the academic publishing process. Apparently, this goes on a fair amount in pharma circles, leading one expert to tell Bloomberg that such ghostwriting has created "a huge body of medical literature that society can’t trust."
Do ya think? What's interesting is that the FDA has no regulations to address this sort of thing.
"Ensuring that medical journal articles presented Zyprexa study results in a positive light was one way for Lilly to reach its sales goal, company officials said in its plan, according to the documents."To do that, Lilly officials hired ghostwriters to prepare submissions to journals such as Progress in Neurology and Psychiatry, according to the unsealed documents.
"'The paper for the Progress in Neurology and Psychiatry supplement has been completed and sent to the journal for peer review,' Kerrie Mitchell, an employee of the public relations agency Cohn & Wolfe, wrote in a Feb. 23, 2001, e-mail to Michael Sale, a Lilly marketing official. The message was among the unsealed files.
"'We "ghost" wrote this article and then worked with author Dr. Haddad to work up the final copy,' Mitchell said in the e-mail. Eric Litchfield, a spokesman for Cohn & Wolfe, didn’t immediately return a call seeking comment.
"Peter Haddad, a researcher at Greater Manchester West Mental Health NHS Foundation Trust in the U.K., was listed as the article’s lead author. Haddad didn’t respond to requests for comment.
"The global Lilly team approved a draft of Haddad’s ghost- written paper in 2000, according to the unsealed documents. Lilly’s U.K. team had to give final approval to the article because Progress in Neurology and Psychiatry was based there, Mitchell said in the February 2001 e-mail."
This sounds like the Lilly we know and love, as in this February 2007 piece of mine on how Lilly discussed how to spin glucose increases associated with Zyprexa in a study. As usual, Lilly claims nothing is amiss here:
"'Plaintiffs are releasing one-sided, cherry-picked documents obtained in discovery to selected news media in an effort to try their cases' there, said Lilly spokeswoman Marni Lemons. 'Lilly remains prepared to defend ourselves against all of these allegations in the appropriate venue, a court of law.'"
To date, Lilly has not let a single Zyprexa lawsuit go to trial and has settled $2.7 billion worth of cases with perhaps s much as another $6 billion to $8 billion to go. Methinks, it won't take any of those cases to trial.
My hunch is that most of the revelations from Lilly corporate documents were already made in the earlier batch of leaked documents made public on this site in February 2007, but that there still may be some interesting bits out there.
Thanks to three contributors yesterday, the summer fundraiser met its overall $4,000 goal and set a contributor record at 90 people. Many thanks to all of you who've contributed. It's most humbling.
In other news, residents of my building found out last night that the entire building and each unit are being inspected on Monday. That's not happened before in my time here nor in at least 10 years, so it's clear that the building is either being sold to new owners (and rents will go up) or is going to undergo condo conversion (or perhaps something else). Sigh.
So I watched President Barack Obama's health care town hall meeting this morning and went away seriously unimpressed because there are several key questions about health care reform that the President failed to address today and which his aides seem incapable of addressing either.
How are we going to pay for this, consistently and over time, without taxing the public to death?
How are we going to keep employers from cutting off their employees in order to shunt them onto the public system and save themselves money?
How can we add 40 million to 50 million people to whatever health insurance system we wind up with while utilizing roughly the same number of doctors, nurses, etc. and expect to provide the same level of access to care and services?
How are we going to drive down costs in the health care system? The President and his people keep insisting they will make this happen, but how?
What services are going to be covered under the public component of the ill-specified plan and at what price? And for that matter, beyond general PCP types of things, will naturopaths, chiropractors and other alternative medicine providers be covered?
I know what President Obama is trying to do is deeply complicated and fraught with political risk, but that doesn't excuse him from answering some fundamental questions about health care reform if he expects the support of moderates such as myself. I'm in favor of health care reform--I am one of the 47 million Americans without health insurance--but I want to know what I am getting into.
Another $50 from two people came in yesterday, bringing the totals so far to $3,914.21 from 87 people. That leaves $85.79 to go to reach the overall goal of $4,000 from 100 or so people. It'd be really great if the fundraiser could hit its overall goal today. Eighty-five bucks can be cleared up by five or six contributors really quickly.
As usual the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll send you my mailing address.
Thanks to all of you for your support.
Many of you know that an FDA advisory panel yesterday recommended that the agency approve Zyprexa, Seroquel and Geodon--atypical antipsychotics all--for use in teens 13 to 17 with schizophrenia and kids 10 to 17 with alleged pediatric bipolar disorder. I heard from a bunch of readers about how distressed they are over the committee's finding and while there is something disgusting about the idea of these drugs being given to youths, the committee's recommendation, which I expect the FDA to follow, may not actually mean too much in a real world way. That said, there are a couple of things that blow my mind about what's gone on here.
I doubt that we're going to see a massive consumer advertising campaign for any of these drugs--schizophrenia is rare and rarer in teens so there's not much of audience to advertise to, and the doctors who would be targets of any direct to physician campaign (ie, psychiatrists) already likely know of the three drugs and have already prescribed them off-label for several years. On the pediatric bipolar front, in recent years the FDA has approved Risperdal and Abilify for this disorder and that hasn't led to a DTC campaign that I'm aware of, so I'd be surprised if Lilly, AZ and Pfizer mounted a teens with bipolar ad campaign, especially since the drugs are already widely used off-label in teens and younger kids.
But the companies did go out of their way to run clinical trials for the drugs and those don't come cheaply, so they'd likely want to see some kind of return on their investment, especially since Seroquel and Zyprexa go off-patent in 2011 and Geodon in 2012. Who knows, maybe we will get TV and magazine ads targeting "troubled" teens and angry adolescents?
What does blown my mind is that the members of the committee voted to approve drugs for a disorder--pediatric bipolar disorder--that doesn't exist in the DSM and has such a shaky evidence base that it remains a controversial diagnosis within psychiatry. What's more, pediatric bipolar disorder is a diagnosis largely ginned up and slapped together by researchers at Harvard (and elsewhere) who've literally been on the payroll of pharma for years, by the pharma companies themselves and then by the FDA itself. And now the committee's recommendation is going to be decided upon by the FDA's director of psychiatry products, Thomas Laughren, who several years ago helped researchers and pharma companies design the very clinical trials for the alleged disorder. Yes, my mind is blown.
What also shakes me up is that for this committee hearing a whole collection of mental health advocacy groups submitted a joint statement of support for the drugs (I've not been able to locate an online copy, but I can assure you it made the email rounds). That's an unusual move, as I cannot think of the last time NAMI, Mental Health America (the old NMHA), the APA, the American Society for Suicide Prevention and so on issued such a statement for a drug's potential approval (all of these groups get millions a year from pharma companies). I wonder what prompted them to do so this time out.
Obviously, there are a lot of other things to consider here (diabetes, brain shrinkage, etc.), but I'm going to leave it at that for now.
Yes, it's happened yet again, as the Wall Street Journal's Health blog reported yesterday, Sen. Charles Grassley has uncovered yet another psych researcher who was getting oodles of money from pharma companies while also doing federally-funded research, this time on the use of anti-depressants in pregnant women. Emory University psychiatrist Zachary Stowe allegedly got $154,400 from GlaxoSmithKline in 2007 and $99,300 during the first 10 months of 2008. Apparently, there is no bottom to this sort of mad love between pharma companies and academic researchers.
Stowe is of course the second Emory psych researcher to come under Grassley's glare. Charles Nemeroff is the other and last year he stepped down as chair of the university psychiatry department.
My Grassley back catalog is here.
I knew this was going to happen: news is just out that the FDA's psychopharmacology advisory committee today voted to recommend that the FDA approve three atypical antipsychotics for use in treating teens aged 13 to 17 with schizophrenia and in kids aged 10 to 17 for alleged pediatric bipolar disorder. The drugs in question are Zyprexa, Seroquel and Geodon. These drugs have already generated huge problems in adults--diabetes, heart attacks, rapid weight gain--and bear black box warnings about sudden death in elderly patients. Off-label use of these drugs in kids has also lead to the same kinds of problems.
Panel members did express concerns about long-term use of the drugs due to their side effects:
"'I'm concerned about the lack of true long-term studies' especially in younger patients 'who will have a long lifetime, hopefully,' said panel member Ruth Day, a researcher at Duke University."
The FDA is not bound by the recommendation and will now ponder whether to approve the drugs.
Another $175 came in yesterday from four people, bringing the totals to $3,864.21 from 85 people. That leaves a mere $135.79 to go to reach the overall goal of $4,000, so the end is very near.
Thanks to all of you who've contributed to date.
If you'd like to help close things out, the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll send you my mailing address.
Thanks again to all of you for your support.
Seriously people, this is how embedded the antipsychotic Seroquel has become in our culture both as a psych med and as a street drug--earlier this week a man in Lawrence, Mass. was shot dead while trying to buy Seroquel from a drug dealer. The man, Roberto Plaza, allegedly wanted to take the drug for sleep problems. While that strikes me as dubious (you'd go to a drug dealer for a sleeping pill?), even if he was trying to get the drug to snort it and get high (or low) he threw his life away over a damn antipsychotic.
These stories continue to get weirder and weirder, and some of them keep popping up in Massachusetts. Um, hello Boston Globe.
A new study--unpublished to date, I should add--is getting loads of attention today. Using various NIH survey data from the mid-1990s, researchers at Columbia University determined that teens allowed to stay up past midnight experienced a 42 percent greater likelihood of depression than kids whose parents required a 10 p.m. bedtime and experienced a 30 percent higher incidence of suicidal thoughts. That's an interesting finding, but the study remains unpublished and it is based on data from 15 years ago, which makes me somewhat dubious of its power.
What I found most interesting is that the late-bedtime teens slept 7 hours 30 minutes a night compared with 8 hours 10 minutes for the earlier-bedtime group. I find it difficult to believe that 40 minutes of sleep could make that much difference, but maybe it can.
This isn't really news per se, but I've noticed a huge uptick in appearances of the Abilify for depression TV ads--the one where people go from being depressed to being at a party or taking out the mail (and who wouldn't want to be at a party on an antipsychotic?). I've caught it on everything from cable news to the History Channel, even during the middle of the day.
Have the rest of you seen this ad much?
Another $150 came in yesterday from two people, bringing the totals to date to $3,689.21 from 81 people. That leaves a mere $310.79 to go from 19 people to hit the overall goals of $4,000 from 100 people. Thanks to all of you who've contributed so far.
If you'd like to help close out this fundraiser, the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll send you my mailing address.
Thanks in advance for your support.
I'm reasonably certain that not too many of you all are Fox News Channel viewers, but it continues to be the only TV news network to report on the insanity and inanity around psych meds in the US. The network has reported on anti-depressants and their problems, the recent Zyprexa settlement, the use of antipsychotics in kids and Glenn Beck has openly called anti-depressants terrible drugs on his show. And, yesterday, an FNC reporter in Florida reported on the use of antipsychotics in young foster children in that state, calling them "chemical restraints." I cannot find the transcript, but I assure you this actually happened, and while he did screw up some of the details (claiming that the meds were for manic depression when in fact they are being given to kids mostly for ADHD in that state), I'm glad to see FNC giving this important issue some attention. Besides, something like 2 million people watch FNC during the afternoon, so a lot of people saw the piece.
Whatever you might think of FNC, CNN, MSNBC, and NBC haven't delved into these issues much that I am aware of, and that's kind of bizarre when you consider that on the order of 40 million Americans take some kind of psych med each and every day. CBS and ABC do take occasional swipes at such stories, but not with the consistency of FNC. I wonder why.
So reports the New York Post in an article on a former prison inmate named Dawud Yaduallah who had his daily Seroquel dose upped by 25 percent while in jail in New York State (the article doesn't say why he was taking Seroquel). He soon developed what is described as a painful erection, went to see a jail nurse for help, was ignored (one has to wonder why), and had an erection for a reported 55 hours before being taken to a hospital.
Yaduallah, who's out of jail now, has permanent damage to his penis and is suing the nurse for cruel treatment.
This side effect of Seroquel was unknown to me--I thought I'd heard them all--and is not listed in the drug's PI, but according to Drugs.com:
"Seroquel may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems, such as impotence. Contact your doctor right away if this happens."
Geez. And doctors are giving this drug to little boys?
Another $365 from six people came in over the weekend bringing the totals so far to $3,539.21 from 79 people. That leaves $460.79 from 21 people to go to hit the overall goals of $4,000 from 100 people.
Thanks to all of you who have contributed so far.
There's not much left to go to reach the fundraising goals. If you'd like to help close this out and shut me up, then the PayPal button is on the right. If you prefer snail mail, shoot me an email and I'll send you my mailing address.
Thanks in advance for your support.
Longtime readers know that from time-to-time I've pointed to published articles, academic and journalistic, identifying how widely Seroquel is being used in prisons and elsewhere and that the drug has developed quite the reputation as a street drug, its peaceful, easy feeling when snorted akin to that of heroin. Or so I am told.
Now, the UK's Daily Mail reports that Seroquel is flooding the streets of Scotland, in injected and snorted form, and is being used by cocaine addicts to reduce withdrawal symptoms. It goes for a reported 5 Pounds ($10 or so) per pill and I assume that's the 300 mg. size.
Quite an interesting drug Seroquel has turned out to be.
This article in the Topeka Capital-Journal and what it describes are disgusting, so I'll summarize: parents named tk and tk have a young 3-year-old daughter in Council Grove, Kansas, named Destiny. The parents are former drug addicts and both are diagnosed with bipolar disorder. The girl begins experiencing mood swings, bangs her head against a wall, tries suffocating a dog and so on. The parents take Destiny to a counselor, who presses them to take their daughter to a psychiatrist.
The parents do as instructed, taking their daughter to a 70-something psych doc who prescribes both Seroquel and Geodon to control Destiny, who weighs 37 pounds. The article doesn't specify what diagnosis the child was given, but based upon the meds we're in bipolar child country here. Eventually, the doctor ups the Seroquel dosage to 600 mgs. a day--yes, in a 3-year-old, 37 pound girl--and that's the high end of adult dosages of the drug.
At some point in 2006, Destiny's parents became uncomfortable with the dosage of drugs their daughter was getting and scheduled an appointment to get her weaned off meds. About that time, Destiny begins complaining of a stomachache, and when the pain gets too intense her parents take her to a small hospital. Destiny is diagnosed with a blocked colon and needs emergency surgery, which never gets performed because a doctor at the hospital wants to handle things there. By the time, she's transported to Kansas City, it's already too late. Destiny dies from fecal impactation.
The article identifies a blocked colon as a known side effect of Seroquel and Geodon. I was not able to find it identified in the Seroquel PI, but it is a known side effect of some of the atypical antipsychotics. See this 2002 case study of colon blockage and fecal impactation in Australian patients taking Clozaril.
While there could possibly be other causes of fecal impactation, in a 3-year-old you'd have to look at the meds she was taking, especially Serqoquel in an extremely high dose for a small child. An autopsy found she had antipsychotics in her in "concentrations considered therapeutic in adults."
Her parents sued the doctors and hospital, but in late-2008 the lawyers handling their case walked away, likely due to the parents' drug-using past (it never goes over well with juries). Meanwhile, the State of Kansas investigates the psychiatrist and finds that he violated state laws in treating Destiny and a few other children.
I don't know what to say beyond the bare facts above, except to note that I am tired of this bipolar child crap. It's killing kids and that ain't right. Rebecca Riley and Destiny Hager and I'm sure there are more out there.
The FDA psychopharmacology advisory committee next week is slated to meet to evaluate safety and efficacy data for three atypical antipsychotics (Seroquel, Geodon and Zyprexa) for use in 13 to 17 year olds diagnosed with schizophrenia and with 10 to 17 year olds diagnosed with so-called pediatric bipolar disorder. The committee will then vote on what recommendations to make to the full agency on these drugs which have proven extremely problematic in adults
Today the FDA itself released its briefing package for committee members (note: the packages are huge and not recommended for download unless you have a technical need for them) and in his introduction FDA psychiatry products chief Thomas Laughren put it like this:
"Although the Division has not yet reached a final conclusion for these applications, we generally are in agreement that the sponsors have provided adequate support to suggest effectiveness for these products for the claimed indications. In addition the safety profiles for these products in these pediatric populations studied appear to be qualitatively similar to those observed with these drugs in adult patients...."All of these drugs also have significant risks that must be considered, both by FDA in deciding whether or not to approve these claims and also by clinicians in deciding whether or not to use these medications in treating these serious disorders. Adverse reactions that can occur with drugs in the class of atypical antipsychotic drugs include, among others, somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms, and tardive dyskinesia. These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of possible effects on growth and development."
I have no idea where the committee will go with all of this, but you'd hope that if they recommend approval for either indication then they would do so with a plea that the agency order significant warnings be placed on the drugs for use in kids. There is simply so much weight gain in the Seroquel and Zyprexa packages to justify making parents, kids and doctors highly aware of the problem.
Another $25 from one person came in later yesterday bringing the total raised so far to $3,174.21 from 73 people. That leaves $825.79 from 27 people to go to reach the fundraiser's goals of $4,000 from 100 people. Thanks to all of you who've contributed so far.
I'd originally aimed to end the fundraiser today, but I'm going to extend it by a few days. I'll also be catching up with posts later today, as it finally started to cool off late last evening.
If you'd like to contribute, the PayPal button is on the right. If you prefer snail mail, send me an email and I'll shoot you my mailing address.
Thanks in advance for your support.
Cancer-related psychological issues are way out of my wheelhouse, but unpublished results of a study of Paxil's use in treating mental impairment due to chemotherapy were presented this week at a conference.
"'Cancer and its treatment impact important areas of cognitive function such as attention and memory, which are essential to patients' effective psychosocial functioning and quality of life,' Dr. Pascal Jean-Pierre, from the University of Rochester, New York and colleagues point out in a meeting paper."'Both depression and cancer-related cognitive dysfunction share the same networks in the brain,' Jean-Pierre explained in an interview with Reuters Health, Therefore, he and his colleagues looked into Paxil treatment in close to 800 cancer patients aged 22 to 87 years.
"The researchers found "significant differences" between the participants' reports of memory problems after their first round of chemotherapy (before Paxil) and after four cycles of chemo and treatment with Paxil.
"Paxil had a significant beneficial effect on cancer-related mental impairment. Even after taking depression out of the equation, 'we still saw a significant effect of Paxil on cognitive function,' Jean-Pierre told Reuters Health."
That's an intriguing finding, but I'll wait to see the full published data before leaping to any conclusions.
Another $160 from seven people came in yesterday and this morning bringing the total raised so far to $3,149.21 from 72 people. That leaves $850.79 from 28 people to go to reach the fundraiser's goals of $4,000 from 100 people. Thanks to all of you who've contributed so far.
I'd originally aimed to end the fundraiser tomorrow, but I'm going to extend it by a few days, partly because I haven't been able to keep up with posting this week as I'd like due to the ridiculous heat in my apartment (and the lack of A/C almost anywhere else in Seattle).
If you'd like to contribute, the PayPal button is on the right. If you prefer snail mail, send me an email and I'll shoot you my mailing address.
Thanks in advance for your support.
I'm discouraged to pass this along: actor David Carradine, 72, was found hanged in a Bangkok hotel yesterday. Press reports indicate that Thai police are calling his death a suicide. Carradine was best known for his role as "Caine" in the 1970s TV serious "Kung Fu" (a how I watched a lot as a kid) and he'd returned to some prominence in recent years following his appearances in "Kill Bill."
Yesterday, it was 90-plus in my neighborhood and just as hot in my apartment, which like most housing in Seattle has no air conditioning. As a result, I couldn't write last evening and will play catch up later this morning. When I hope it's far cooler. It's rarely this hot this early in the Summer in Seattle, but I sure have to admit to liking all this sunshine a whole bunch.
Another $20 came in yesterday from one person, bringing the total raised so far to $2,989.21 from 65 people. That leaves $1,010.79 to go from 35 people or so to reach the overall goals of $4,000 from 100 people on or about June 5, aka this Friday. Thanks to all of you who've contributed so far.
I suspect yesterday was likely slow due to hot weather around the country--it was 88 in Seattle, bizarrely hot for this time of year, and I simply could not be in my apartment long--so it'd be great if things picked up today.
As usual the PayPal button is on the right. Or if you prefer snail mail, let me know and I'll send you my mailing address.
Thanks in advance for your support.
Recently, I noted that Wyeth's year-old Son of Effexor anti-depressant Pristiq was not being widely used (the company's not even reporting sales figures) and was still racking up adverse events reports at quite the pace for a new drug. We can all now look forward to more sales of Pristiq and more adverse events reports. That's because Wyeth began running a national TV ad for its sluggard drug last night and also has a big ad out in Newsweek.
You can view the TV ad here. And please do view it as it features a women with a wind up doll (yes), noting how depression forces her to wind herself up each day, then comes the obligatory chemical imbalance graphic, then comes the happy woman playing with her children and husband in the sunshine while the voiceover walks through the side effects (suicidality, hypertension and so on). It's classic stuff.
Notes the drug's website:
"Depression can make you feel like you have to wind yourself up to get through the day...Depression can take so much out of you. PRISTIQ can help."
And only you can help Wyeth.
Another $680 came in yesterday from five contributors, bringing the total raised so far to $2,969.21 from 64 people. That leaves $1,030.79 from 36 people to go to reach the overall goals of $4,000 from 100 people on or about June 5. Thanks very much to all of you who've contributed so far.
I'd really love to close this fundraiser out on June 5, and that's this coming Friday, so if you haven't contributed already, please consider doing so.
As usual the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll send you my mailing address.
Thanks to all of you for your support.
A new NIH-funded study is out in the Archives of General Psychiatry and it looked into the efficacy of using Celexa as a treatment for repetitive behaviors in autism spectrum disorders (anti-depressants are somewhat commonly used in ASD cases). Here's what researchers determined:
"Results:"There was no significant difference in the rate of positive response on the Clinical Global Impressions, Improvement subscale between the citalopram-treated group (32.9%) and the placebo group (34.2%) (relative risk, 0.96; 95% confidence interval, 0.61-1.51; P > .99). There was no difference in score reduction on the Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders from baseline (mean [SD], –2.0 [3.4] points for the citalopram-treated group and –1.9 [2.5] points for the placebo group; P = .81). Citalopram use was significantly more likely to be associated with adverse events, particularly increased energy level, impulsiveness, decreased concentration, hyperactivity, stereotypy, diarrhea, insomnia, and dry skin or pruritus."
In scientific terms, that's a complete wipeout for Celexa and I've got to wonder what some in the autism community will make of the study. I make the latter point because after CBS News last week aired a report on Risperdal leading to breast development in young boys some in autism community went absolutely batshit on CBS News for daring to point out that an approved treatment for autism had serious problems (even though most of the kids in the report were getting Risperdal for ADHD and bipolar). To whit, from the Autism Science Foundation blog's Alison Singer:
"Reporter Sharyl Attkisson has had some outrageous pieces on the CBS Evening News, but her story Sunday night about risperdal has to be the most desperate. Apparently ridiculing the life-saving value of vaccines is not enough, and she has now moved on to poo poo the only drug FDA approved for children with autism, because, tragically, a handful of children experienced a well known, but highly unfortunate side effect; increased level of the hormone prolactin. For Ms. Attkisson, any product that comes out of a pharmaceutical company is just inherently bad, no matter how well tested or efficacious, no matter how many lives it saves, enhances or improves."
Gynecomastia is hardly a well-known side effect, as Singer claims, and it's appropriate for a news organization to do a story on it. But you've got to wonder if Singer will go after the researchers of the Celexa study.
I just about fell over laughing yesterday when a couple of readers passed along a new study from the Archives of General Psychiatry, which purported to examine US national rates of depression diagnoses and anti-depressant use from a selected database. This is all part of an attack by orthodox, conservative forces in psychiatry and public health who remain utterly freaked out that the FDA issued black box warnings on anti-depressants for suicide and suicidality in 2004 and 2006, shattering the public image of the drugs as totally safe for one and all. Ever since, the orthodoxy has been striking back on a regular basis, desperate to prove that anti-depressants are safe, efficacious and that depression treatment always works.
The results of the AGP study were that between 1999 and 2004 the rate of depression diagnosis among children (ages 5 to 18), young adults (19 to 24) and adults (25 to 89) increased appreciably as did anti-depressant use, but after 2004 rates of diagnosis dropped back towards 1999 levels when researchers had projected that they would increase annually at the same rate as between 1999 and 2004, quite the wild assumption on researcher part. Even worse, according to the researchers, is that depression diagnoses among people seeing PCPs fell 44 percent among children, 37 percent among young adults and 29 percent among adults.
Personally, I count such findings as a victory, although I've got to note that the researchers' database doesn't exactly dovetail with what's gone on in the broader culture--an increase in anti-depressant prescriptions since 2004 (up 2.4 percent in 2008 as I noted in April), presumably tied to an increase in diagnosing of depression. But I'll take their figures at face value.
Perhaps I'm too much the contrarian, but I'd think one of the takeaways from this study ought to be that either Americans are less depressed than they were before (which would be a wondrous finding) or they are refusing to participate in a system of care where the evidence base is corrupt and the treatments are often ineffective with deleterious results for many patients. Both of those would strike me as possible and positive explanations for the dynamic. But not for researchers, who noted:
"The findings suggest that initial unintended consequences of the FDA warnings have continued through 2007, the authors conclude. 'Diagnosing decreases persist,' they write. 'Substitute care did not compensate in pediatric and young adult groups, and spillover to adults continued, suggesting that unintended effects are nontransitory, substantial and diffuse in a large national population. Policy actions are required to counter the unintended consequences of reduced depression treatment.'"
What unintended consequences would those be? The suicide rate isn't much changed in this country and anti-depressant use was up in the US in 2008, so you have to wonder what planet these researchers are on and why none of the article's peer reviewers pointed this out to them.
And when public health researchers demand "policy actions," it's time to head for the hills. Who knows what policy actions those would be? Forced depression diagnoses? Forced treatment with anti-depressants? Rates of depression diagnoses to meet researchers' prior forecasts or else? The orthodox wing of psychiatry has lost its mind.
The thing that troubles me the most about these sorts of studies is that they rest on the assumption that ivory tower researchers know what level of depression and diagnosis of the same is "right" for America, that anything less than that level or a suitable annual increase is unacceptable and demands policy intervention, that anti-depressants are always curative and healthful, and that depression can never be allowed to go untreated with medications. And for them to act unaware of the recent WHO study on anti-depressants and suicidality (which found plenty especially among kids and teens), a 2007 study out of the STAR*D research which found over 8 percent suicidality induction in adults in the study (hell, it was published in AGP, so how could they ignore it?) and last year's British study finding that suicide rates went down after the UK banned most anti-depressant use amongst people aged under 18 is simply blind religiosity. It's the Nanny State run amok.
It's time for it to run away.
It's also worth noting that the researchers reported having received funding in the past from Eli Lilly, Forest Pharmaceuticals, Lundbeck and the American Foundation for Suicide Prevention.
Just as I finished writing this post, the AP's coverage of the study appeared. Look at what one of the study authors claims:
"The new research can't explain why diagnosis rates have declined, said lead author Anne Libby of the University of Colorado Denver. Diagnosis rates for anxiety and bipolar disorder, also sometimes treated with antidepressants, also fell."'It could be that people who have depression aren't coming forth and getting diagnosed,' Libby said. 'It could be that providers are increasingly reluctant to diagnose cases of new mental health problems.'
"Libby said the FDA 'should reopen its discussion about the boxed warning on antidepressants.'"
While I need to see the full study before deciding how much to celebrate drops in bipolar and anxiety diagnoses, I can assure Libby that any attempt to rescind the FDA's black box warning will be met will extreme resistance from the patient community.
Also from the AP:
"Pinning the slumping diagnosis rates on the FDA warning is a leap, said Dr. Peter Lurie of Public Citizen's Health Research Group, which has warned of antidepressant risks in kids. There could be other explanations."'It's possible that the drive toward more diagnosis and treatment had been nearing a point of exhaustion,' Lurie said. 'The data are interesting but the conclusion seems forced.'
"Lurie also questioned the authors' suggestion that the FDA overreacted.
"'Is the implication that patients would be better off kept in the dark (about risks)?' he asked."
It's been clear to me for a long time that the orthodox camp does want patients kept in the dark about risks. If anyone thinks anti-depressants are super safe, please review this post of mine from yesterday.
Longtime readers will remember my writing of Seattle's Aurora Bridge and how it's been the site of hundreds of suicides over the years. Over the years, more people and businesses have moved in around the bridge and encountered the ugly phenomenon that many of the jumpers don't jump over the Lake Washington Ship Canal, which the bridge spans, but jump onto dry land. With all the new residents and businesses--many of them high tech shops like Adobe and Google--loads of people are seeing the sorry results of a suicide and walking away traumatized. What's more, Seattle police and firefighters respond to potential jumpers on the bridge twice a week and they are at great risk as well. So people and workers in the neighborhood have been pushing for a suicide barrier of some type on the bridge. Not long ago, it looked as if the project would happen easily.
Today, Knute Berger (my former boss at Seattle Weekly) writes at Crosscut.com that the price of the barrier has exploded to $8 million (it was closer to $3 million two years ago) and that some historic preservation advocates are decrying the proposed barrier designs, which are admittedly butt ugly (but the bridge is no fashion model either). I have no idea how the government and neighbors are going to sort this all out, but the $8 million cost sure makes it hard to support the project in very tough budgetary times, as I'm quoted in Berger's piece. Anyway, it's an interesting piece.
In other news, it appears that officials in the Bay Area have settled upon a net as opposed to several proposed barriers for the Golden Gate Bridge. Some in Seattle would prefer seeing a net under the Aurora Bridge as well.
I'm sure most of you are aware that George Tiller, an infamous late term abortion provider, was murdered yesterday at his church in Wichita, Kan. News is out today that the suspected killer, Scott Roeder, is, according to his family, mentally ill. There's no further detail on his mental health history, so it's pretty much speculation at this point as to whether it may have played a role in his alleged acts.
The big question I have, however, is why did Roeder even have a gun. He was convicted of possessing explosives in the mid-1990s and felons are not supposed to be able to own guns.
I guess we'll learn more about this in coming days.
Another $779.21 from 21 people has come in since Friday's update, bringing the total raised so far to $2,289.21 from 59 people. That leaves $1,710.79 from 41 people to go to hit the overall goals of $4,000 from 100 people on or about June 5, which is this Friday.
Thanks to everyone who's contributed so far.
If you'd like to join them, the PayPal button is on the right. Or if you prefer snail mail, shoot me an email and I'll send you my mailing address.
Thanks in advance for your support.
BTW, I will be back with more posts later this morning--aside from the anti-depressants and breast cancer one up now--as it was a very warm evening in Seattle last night and far too glorious to be inside.
The bad news for anti-depressants continues to roll out. In a study presented over the weekend at the American Society of Clinical Oncology's annual meeting, in Orlando, Fla., researchers from Medco, a health benefits analysis company, reported that breast cancer survivors taking an anti-depressant to mute hot flashes caused by tamoxifen, a commonly used breast cancer medication, have the benefits of tamoxifen blocked by the anti-depressant and are at-risk of a recurrence of the cancer. From what I've read so far, it sounds as if the anti-depressants in question are mostly SSRIs (Prozac, Paxil, etc.). I should caution that these findings have not been published yet, so they've not gone through formal peer review yet, but since they were accepted at a conference you can assume that they'll wind up being published soon enough.
Confoundingly, a second study presented at the same conference found no anti-depressant/tamoxifen problems, but researchers still said women ought to consult with their doctors about other ways to manage hot flashes. There are an estimated 192,569 new cases of breast cancer in the US each year, according to the American Cancer Society.
What's striking to me--besides the results of the first study--is that there have been numerous studies published in the last 18 months or so reporting problems with anti-depressants on several different fronts: last month there were studies outlining increased risks of birth defects associated with anti-depresant use and an increased risk of diabetes associated with anti-depressant use (neither of the two studies got a column inch of media attention); in March, a study linked anti-depressant use to sudden cardiac death in women (again, there was little media attention to that aspect of the study and, separately, you've got to wonder if there are heart issues for men with anti-depressant use); last year, a fascinating study asserted that a large amount of anti-depressants supposed efficacy was actually due to placebo effect (zero press attention here); and, also last year, two different studies established that anti-depressant efficacy was much less than previously claimed due to pharma companies hiding negative trials data from the public and doctors (lots of press attention for one of the two articles).
The findings on anti-depressants and tamoxifen did get quite a bit of attention on the wires over the weekend, but one has to wonder why some of these others studies haven't. I don't want to question anyone in the mainstream media's motivations, but it seems quite odd to me that some of these studies get a ton of attention and some do not.
Anyway, even with the matter of anti-depressant-induced suicidality aside, I'm beginning to ponder why some doctors and psychiatrists remain so enthusiastic about anti-depressants. They strike me as an incredibly weak technology that produces problems by the boatload, so why are 30 million people taking them in the US every day?