Remember that list Eli Lilly recently released detailing what doctors it's paying $22 million in consulting fees to? Well, the St. Petersburg Times had a great piece the other day on one of Lilly's top doctors in the Tampa Bay area, who is making oodles speaking on behalf of Lilly's drugs.
"Lilly's top earner in the Tampa Bay area was Dr. Maria-Carmen Wilson, a neurologist who is director of Tampa General Hospital's Headache & Pain Center and a professor at USF College of Medicine. She also is director of USF's headache medicine fellowship program, co-director of the division of pain medicine and associate director of both the neurology residency program and pain medicine fellowship program. Her annual salary from USF is $195,410.95."Despite her busy schedule at the university, Wilson found time to moonlight for Lilly, which paid her $54,400 in the first quarter. That put Wilson, 53, among the company's most highly compensated doctors nationwide. In Florida, Wilson ranked second only to Miami internist Manuel Suarez-Barcelo, who received $65,100 from Lilly."
That those amounts were only for the first quarter of the year astonishes me.
Wilson was hocking--I mean was speaking to her valued and no doubt awestruck colleagues about--Cymbalta, Lilly's anti-depressant which is also approved for fibromyalgia and peripheral neuropathy in diabetics. Wilson didn't return the paper's request for comment and only reported her outside work for Lilly to USF earlier this month, according to the paper.
Considering how weak the evidence is for Cymbalta's analgesic effect, you've got to wonder what it is Wilson tells other doctors.
I'm not a big fan of bans or restrictions on people making outside income, regardless of their profession, but when it's doctors who are alleged scientists doing this kind of thing then the public needs to know what's up. So do the doctors' patients. While I'm glad Lilly made its payouts public, I really wish that there much less payola in the medical system in this country.
A new study is out in Pediatrics--it's not online yet--and, according to this account, it found a large increase in the abuse of ADHD drugs:
"The researchers looked for cases of intentional abuse or misuse of ADHD medications in youths 13 to 19 years old from 1998 through 2005."They found that over the eight-year study period, the number of calls to poison control centers regarding ADHD medication use went up 76 percent, from 330 calls during the first year to 581 calls the last year.
"At the same time, overall ADHD prescriptions increased by 80 percent for all children and teens, and about 86 percent for kids between 10 and 19 years old.
"The data didn't include information about whether a teen abusing an ADHD medication was the one who had been prescribed the drug or whether the abuser was a teen without ADHD who was taking the medications."
How much calls to poison centers mirror abuse in the populations as a whole isn't clear, but I know of way too many teens and 20somethings who've told me they abuse Ritalin and Adderall--and absolutely love it. Most of them buy a few pills through street dealers here and there. Earlier this year, the New Yorker had a piece on the rise of neuroenhancers and the underground sale of ADHD drugs wherein young adults were basically dealing Adderall online.
Whatever you make of ADHD, isn't it nice that Big Pharma has created a new class of drugs to abuse--or should I more properly say created a class of drugs that mimic speed and cocaine?--and that it's wrapped in white coat of medicine?
I suspect a few of you are aware of a multi-part series on the MOTHERS Act and what some see as disease mongering by Evelyn Pringle at naturalnews.com. What jumped out at me had little to do wit the Act and everything to do with the chemical imbalance hypothesis of mental illness:
"Dr David Stein, a professor of psychology and criminal justice at Virginia State University, and author of, 'Unraveling the ADD/ADHD Fiasco,' has taught psychopharmacology for 25 years. One of the greatest myths about mental disorders, is that they are caused by a chemical imbalance, he says."'The myth is founded on some of the tricks that are pulled in so-called scientific research in psychology and psychiatry,' he explains.
"'The manipulation of research has become one of the most powerful and most unethical marketing tools ever devised,' he says. 'Not one study can be replicated at the testing labs of hospitals or by laboratories involved in clinical patient care.'
"'Replication is a basic step for all sciences,' Dr Stein explains."
So here we have yet another expert claiming that the serotonin hypothesis of depression--the main chemical imbalance theory out there--is bunk and cannot be replicated, which is basic to proving something as sound science.
I wonder why more Americans--and more doctors--are not aware of this kind of this. I wonder how pharma companies can continue to get away with running ads touting the chemical imbalance theory.
An utterly fascinating piece appeared in the St. Petersburg Times today by Katherine Snow Smith who recounted a series of blow-ups with her three children, the final straw being one over her kids fighting over Miley Cyrus and Hannah Montana DVDs. Mom ends up on meds--she doesn't identify which one--and with the fight over the Disney material the thing is so All-American that it gives a lovely picture of our times.
"Late that night I called my husband, who was out of town, and told him of my blow-up. (My confessional left out the four-letter word.) He said, as he usually did when I came clean about screaming at the kids, that they pretty much deserved it. Maybe just don't reprimand them so loudly the next time."The next morning I had a slight sore throat from yelling. It was like the hangover an alcoholic faces. Or the empty brownie pan soaking in the sink that makes a Weight Watchers' lifetime member cringe because she ate them all, one thin slice at a time, after everyone else was asleep.
"This, I decided, was the last sore throat I would incur from yelling at my kids. It was time to seriously consider joining the thousands of other women in the world who take prescription medication to help control their moods, temper, anxiety or depression.
"About a year before this, a friend of mine had gone on a girls' weekend with eight moms she casually knew. She later told me six of them were on some kind of meds. They compared the benefits and side effects Paxil, Lexapro, Cymbalta, Prozac and others. Some made you gain weight, some made you lose. Some decreased sex drive. All of them, it seemed, made them feel like they were better moms, wives and daughters."
Six of eight? Better moms? Huh? I cannot criticize Smith's personal decision. It's her body, so have at it. But I do have to ask: What the hell is going on with this country and its people that we're getting all doped-up on SSRIs and the like over the stresses of daily life and parenting and think that's making us better? Where has this kind of thing gone on before?
Oh, wait. It was in America in the 50s, 60s and 70s when stressed out, agitated, anxiety-riddled Americans were taking Miltown, Valium and all those other benzos and downers and whatnot. We know how that turned out: Miltown pulled from the market and Valium junkies all over the place. It's difficult to make an argument that anti-depressants are really awesome drugs on a culture-wide basis. The drugs have too many problems. You know about that already.
"My doctor said he prescribes mood-enhancing medications about 10 times a week. He showed me a diagram of the brain and how certain medications can restore the balance of serotonin, a natural substance in the brain, which helps improve certain mood problems. [How did that last line get past an editor? The serotonin hypothesis is just that, a hypothesis not settled science.]"My friend called her doctor to make an appointment and talk about going on Paxil. The nurse said she would just call the script into the pharmacy. No appointment necessary.
"These meds are probably overused and too easy to get. I wasn't suffering from depression, which is a very serious problem. Medication has proven to change and save lives of depressed people. I was anxious. I was having meltdowns way too often.
"Maybe moms like me should do more yoga, cut back our responsibilities, see a therapist, exercise more, put duct tape over our mouths every day after 5 p.m. Maybe we should do anything to avoid relying on drugs to become calmer, happier people."
Smith pretty much answers her own question in the last graf, but you've got to wonder--knowing what she knows and acknowledges--what kind of example she's setting for her children in turning to drugs (ones she could become dependent on, at a minimum) in settling her own situational anxiety.
I know these are deeply-trying times in America (and elsewhere, too, of course). They are for me, too. But turning to a class of drugs known to be dangerous in some cases and with a dizzying host of side effects in many cases doesn't strike me as an intelligent way to operate as a culture. And to write about it all so blithely...well, you just don't know what to say.
Yoga, yes. Prozac, no.
Several readers thought I was far too kind to ABC's "Primetime" program of Tuesday night on Mad Pride. Fair enough. I guess I was so staggered that we didn't have the usual major media completely screwing up a mental health story situation that I lost control of my critical faculties.
Fortunately, Liz Spikol live-blogged the show the other night and brilliantly so. Here, she picks things up when the show spins away from dealing with Mad Pride, the stated purpose of the program, and plays the violence card:
"'But critics worry …' That’s journalism-speak for 'We don’t have any specific sources who say this, but we’ll generalize it so we have reason to focus on …'"… violence. That’s what they’re focusing on. Why am I not surprised?
"So of all the things they could talk about related to Mad Pride — and related to mental health — this is what they’ve come up with: criminals and violent crime. Ugh. TV is so predictable and depressing.
"Okay, so now we’re telling the story of a kid with hallucinations and delusions (the CIA, yadda yadda) who KILLS HIS MOTHER? Does the average American viewer understand how fucking rare this kind of thing is? That it’s not the necessary result of deciding not to take meds?"
Liz is right: folks with psychotic disorders going off the reservation, so to speak, and committing unspeakable violence is actually a pretty rare event. What's more, she's right that these rare acts seem to occur independent of someone's medication status. The NAMI and Treatment Advocacy Center crowds rarely acknowledge that. TAC is of course quick to waive the off-meds argument around anytime an incident pops up where a person is off-meds, but is utterly silent when someone happens to be treatment compliant, to use their terminology.
It's also kind of offensive--now that I've reflected on things a bit--to present David Oaks (of MindFreedom, once upon a time diagnosed with schizophrenia), Madigan Shive (who I believe is connected with the wonderful Icarus Project and has a diagnosis of bipolar disorder) and Joe Pantoliano (of Sopranos fame and chronically depressed) as the faces of Mad Pride when none of them have ever been connected with anything violent, ever. It's cheap shot journalism. Oddly enough, Pantoliano's medication status is not discussed on the program. (And how does depression get hooked in with the program's "psychotic and dangerous and off-meds" theme? ABC's evidence would be what?)
Spikol sums it up nicely:
"This show is so bad, it’s like a joke. I guess it all goes back to what producer Ia Robinson told me, when we discussed my being on the show: She doesn’t have any friends or family who have mental problems, so the whole topic was like 'walking on the moon.' Yes, that’s the phrase she used. The show should’ve been blasted out to Mars."
I also spoke with Robinson a few months ago when she was in the early stages of reporting for the show. Within five minutes I could tell she was someone who was way out of her depth with mental health issues and had that typical network news superficial take on things that leads no place good. She then had to go into a meeting for something or other and excused herself. I didn't bother calling her back.
Not to be too much of a dick, but why are folks like that employed full-time in journalism when reporters like me are on the sidelines?
This one is called lurasidone and it's developed by Japan's Dainippon Sumitomo Pharma. The company is so pleased by its phase 3 trials results that it's going to submit it to the FDA early next year for approval as a treatment for schizophrenia. If approved, the drug would be the third new antipsychotic approved by the FDA in about one year's time. Vanda's Fanapt was approved earlier this year although it's not yet on the market and Schering-Plough's Saphris, which was approved earlier this month for use in schizophrenia and bipolar disorder.
It'll be interesting to see how all these new drugs work out in a field crowded with second generation antipsychotics, especially with some of those drugs being off-patent (Risperdal) or about to come off-patent (Zyprexa and Seroquel). These new drugs would have to be pretty spectacular performers--or their makers would need to come up with an appropriate smoke-and-mirrors marketing campaign--to capture many sales because they'll be competing with mostly generic drugs.
A former FDA reviewer has called Saphris flat-out unsafe and there's been some skepticism expressed about just how great Fanapt is as well.
The companies with the new drugs have so far mostly claimed that they work as well as nasty drugs like Zyprexa while having fewer side effects. To my ears, that sounds like what Lilly and its shills in academia were saying about Zyprexa vis a vis Haldol in the 1990s. We know how that turned out.
Here's what a researcher who ran trials of lurasidone said about the drug:
"'If you look at the weight gain, the lipid changes, it's among the most benign of any antipsychotic drugs, clearly better than olanzapine, clozapine and Seroquel,' [Herbert] Meltzer [of Vanderbilt University] said."
Benign and antipsychotic are two terms that I don't think anyone can use together with a straight face.
Remember when the new generation anti-depressants came into the world in the late-80s and 1990s and one of their supposed advantages over older anti-depressants was that a patient couldn't use them to overdose and commit suicide a la Nick Drake, the great singer-songwriter? Well here's the sad, tragic case of Kimberly Hatch, a 40-year-old woman in New York who killed herself last year by OD'ing on anti-depressants.
"The results of an autopsy and toxicological examination have determined the cause of death to be from respiratory suppression with pulmonary edema, secondary to a drug overdose, a release from the state police says."The drugs present that caused the overdose were determined to be Celexa and Effexor, medications prescribed for depression and anxiety, the release adds. Alcohol was also present."
I've not heard of too many cases where newish anti-depressants were determined to be the cause of death by overdose. So much for anti-depressants being safe in this respect. Tragically so.
I simply don't know what to make of the case of Christopher Pittman who was convicted of shooting his grandparents to death when he was 12-years-old--except that it argues for how risky it is to put young children on anti-depressants. Pittman, sentenced to 30 years in prison, is seeking a new trial and a hearing on that matter is underway in South Carolina.
"Julian Sharman, a psychologist with the Department of Juvenile Justice, described the chaotic two-week period that began with Christopher Pittman's mother abandoning the family's Florida home in October 2001. After that, Pittman felt stress so severe that he ran away from home and later tried to commit suicide. Pittman's father had him placed in a hospital, where he was prescribed the antidepressant Paxil."Soon after, Pittman's father dropped him off at the boy's grandparents' home in South Carolina. Meanwhile, doctors took him off Paxil and switched him to Zoloft, a different antidepressant. Three weeks later, his grandparents would be dead, at the hand of their own grandson...."
"Earlier Wednesday, a pastor whose church Pittman's grandparents attended, also testified.
"'Chris, when you first met him, appeared very shy,' Chris Snelgrove said. 'He had a sheepish grin on his face most of the time.'
"Snelgrove said Pittman, who was very close friends with his own son, appeared changed when the boy reappeared at his grandparents' home in October 2001.
"'It was plain to me that something terrible had happened, something awful,' Snelgrove said. 'There were no conversations, only one-word replies.'"
This sure does sound like a case of someone zonked on Zoloft. Whether or not you can connect that to his crime is something I simply don't know about. I suppose it's possible.
And by OK I mean last night's "Primetime" program on Mad Pride wasn't quite the disaster I fear. There's something about mental illness in the hands of network TV that usually doesn't go too well for us little folks. Hell, the program even got into withdrawal issues with one woman from Massachusetts. That's almost a breakthrough.
Of course, the violence card got played--John Hinkley and so on--and was handled well by David Oaks of MindFreedom. The primary case that got waved around was that of William Bruce, a young man diagnosed with schizophrenia who refused treatment and, deeply delusional, killed his own mother. What the program failed to point out is that Bruce should've been forced--as much as I hate saying that--into treatment as he had committed an act of violence before killing his mom and that was pointing an AK-47 at two people. Why the guy even had a gun is beyond my comprehension.
The big disappointment was the appearance of Penn's bioethicist Art Kaplan. I've read Kaplan's work for years and it struck me as odd that he'd be the contrary voice ABC would find to say it's "reckless" for people with mental illnesses to be off-meds. As far as I know, Kaplan has zero training in psychiatry and he's obviously unaware of the literature on violence and mental illness, which shows a slight increase in risk of violence but that it's mostly connected with people with substance abuse problems regardless of whether someone is on or off-meds. I guess E. Fuller Torrey was busy.
As most ethicists know, using stray examples of any phenomenon isn't a particularly good way to conduct philosophical inquiries nor is it a good way to set medical policies.
Another critique of the program was written by someone named Lee who's connected with the Freedom Center in Massachusetts.
That question is posed in this month's American Journal of Psychiatry because, as things stand now, SAD is lumped in with other affective disorders as a seasonal modifier to familiar diagnostic criteria for major depression, etc. I don't have an strong opinions on the matter--for once, I doubt this is something Big Pharma could turn to its own ends since SAD already exists in the DSM-4.
Anyway, here's the AJP editorial:
"Many convergent lines of research justify its classification as an independent disorder. The clinical picture is distinct: patients with seasonal affective disorder, predominantly women, become regularly depressed in autumn and winter and experience remission in spring and summer. They experience characteristic atypical vegetative symptoms during their depressive episodes and have a history of reactivity to environmental light (the more the better). Seasonal affective disorder increases in prevalence with increasing distance from the equator and has been described in the southern, as well as the northern, hemisphere."
I'm no expert on SAD, but is interesting to me that most studies I know of the disorder talk about how much patients improve with light therapy of same kind or another. That said, I know of plenty of folks in Seattle--which has got to be the SAD capitol of America--who never get light therapy but instead get an anti-depressant.
I'm not sure that having SAD as a separate entity in DSM-5 would affect that very much.
Thoughts?
I knew this was coming. From the AP:
"Dr. Conrad Murray, a Las Vegas cardiologist who became Jackson's personal physician weeks before his death, is the target of a manslaughter investigation by the Los Angeles Police Department. According to a search warrant affidavit unsealed Monday in Houston, Murray told investigators he administered a 25 mg dose of propofol around 10:40 a.m. after spending the night injecting Jackson with two sedatives in an unsuccessful attempt to get him to sleep."
One of the two sedatives was Ativan, which apparently did not work.
Propofol is to blame, according to various press accounts, for Michael's death.
While it's not clear to me why MJ couldn't sleep, it is simply stunning to me that an MD would do this to him.
Earlier this summer I noted the many patient reports I was getting of people having problems with the "new" anti-depressant Pristiq, which is little more than a metabolite of Effexor, soon to go off-patent. Well, the patient reports continue to come in and what's interesting to me is that patients report hitting the wall with Pristiq at about three weeks after beginning the drug.
"I've been on Pristiq for 3 weeks and I feel worse than I did before. I was on Lexapro 20 mg and it wasn't quite doing what I wanted it to, so my Dr. suggested Pristiq. The only positive I've found it the return of my Sex drive, but who can enjoy that when you're a raving lunatic the rest of the time? I've had all of the possible side effects and then some. I'm going back to my doctor and getting back on Lexapro."
Good luck with that.
And another example:
"I took Pristiq fior three weeks. I had every symptom on the paper. I went threw the worst withdrawals. I thought I was going to die but thank God I didnt. I told my doctor. No responce from him yet."
That sure does sound like a far-too-typical doctor reaction.
In an unusual move, a New York judge has decided to allow a man to offer the so-called Zoloft defense at trial
"A Long Island judge has said she will allow a man accused of punching and kicking his former girlfriend to use the so-called 'Zoloft defense.'"The attorney for Coram resident Brandon Hampson says he plans to argue that his client became violent and beat Lisa Essling on Aug. 25, 2006, because he stopped taking the popular antidepressant Zoloft days before the attack."
The article claims that Zoloft's maker, Pfizer, has said there's no evidence that withdrawal from its drug can cause violent behavior. Anyone who makes that claim has not withdrawn from an anti-depressant or other psych med. I've seen far too many people act oddly coming off psych meds to not believe that there's something going on here. Of course, problems that crop up when someone initially goes on a drug like Zoloft are well known.
The defendant will have a tough time making his case in court I'd wager and the fact that he's an alleged girlfriend beater doesn't make me especially sympathetic to his cause.
This is just a short note to let you all know that I got laid off from my day job of six weeks the other day. Not my fault. They flat out ran out of money. I might get hired back in September but I am not counting on that. It kind of sucks and I am concerned whether there is any future for me in journalism whatsoever. After 15 years in the craft and God knows how many big stories, I sort of feel cheated. And I totally feel Liz Spikol's pain.
I've applied for reporting jobs and had interviews elsewhere in the US over the last year or so, but those jobs aren't coming through for me. I'm apparently a victim of age discrimination: too experienced, you'll cost too much, let's bring in the kids with their vast reportorial skills and so on. (And, yes, people who've interviewed me have said this stuff.) Also, I know that having this website on my resume causes problems as well--most people inherently trust doctors and researchers and their opinions because they are talking "science." And so anyone who criticizes them is somehow suspect, regardless of how much "science" he or she may have on their side.
To top it off, the City of Seattle towed my car the other day for a 72-hour violation in a part of town where they've never enforced that rule and have certainly never towed anyone. It cost $174 I really didn't have to get my car back and the hassle involved was immense. Of course, everyone knows why they're enforcing the rule all of a sudden: It's a way for the city to raise money during a recession. I'm so happy I could help!
I'm amazed that I've been able to keep this site up to date over the last six weeks and I look forward to focusing on it a bit more than I've been able to since early July. Have a nice weekend.
A new study is out in Pharmacoepidemiology and Drug Safety and it asserts that about 50 percent of the time doctors don't know the approval status of certain drugs and, apparently, think they are approved for indications for which they are not. Maybe that's how the crisis in off-label prescribing came about, likely aided and abetted by pharma reps.
"Psychiatrists and primary care physicians were given lists of drug-indication pairs that differed except for six pairs: valproic acid for bipolar disorder, mania; escitalopram (Lexapro) for panic disorder; gabapentin for diabetic neuropathy; trazodone for insomnia; venlafaxine (Effexor) for adjustment disorder; and quetiapine (Seroquel) for dementia with agitation."The authors received 457 usable surveys, 54% from psychiatrists and 46% from primary care physicians. On average, primary care physicians had prescribed 10 of the drugs at least once in the previous year for any indication, and psychiatrists had prescribed 11.
"Respondents knew the correct FDA-approval status of 55% (mean) to 57% (median) of the drug-indication pairs.
"When the pairs were limited to drugs the respondents had prescribed in the past year, the mean accuracy increased to 60% and the median to 63%.
"Overall, psychiatrists demonstrated better knowledge of FDA approval status (66% mean, 71% median) than did primary care physicians (42% mean, 38% median)."
I know doctors need to keep a lot of information in their heads about drugs, but this kind of failure rate is absurd and should give anyone pause who get a scrip from a doc.
News is out that Lilly, makers of the antipsychotic Zyprexa, will pay $22.5 million to settle a lawsuit brought by the State of West Virginia which claimed that the company had illegally marketed the drug for unapproved uses including dementia
Lilly told Bloomberg:
"'We think that putting the issue behind us is not only in the best interest of Lilly but in that of patients, caregivers and health care professionals,' Marni Lemons, a Lilly spokeswoman, said today."
Yes, Lilly always has patients' best interests in mind.
Among other things, America's most trusted news network reports that the signs were there in President Barack Obama's campaign last year--the euphoric emails to supporters, his unflinching belief in the airy concept of "hope."
And so on.
Of the many bloggers on mental health issues, no one has attracted more weird attention than has Bob Fiddaman, the author of Sexorat (Paxil) Sufferers. He's had people impersonate him on forums and blogs and basically defame him, all because Fiddy has pushed so hard on exposing the dangers of Paxil (Seroxat in the UK) and the chicanery of GlaxoSmithKline in promoting its nasty anti-depressant.
Now, people are filing public records requests with the British FDA, the MHRA, seeking to find out what Fiddy's been up to in talks he's had with the agency to, among other things, convince it to take patients seriously.
Here's how Fiddy explains the requests:
"[R]equests under the Freedom of Information and other correspondence made to the MHRA by a couple [could be more] of stalkers who seem to take great delight in wasting the MHRA's time and seem to have a very unhealthy interest in me."
Sounds nice and messy. He's got copies of the FOI requests posted on his blog. It's not entirely clear to me who's behind these requests and other attacks on Fiddy.
Some of you may have seen television ads along the lines of one running in the Seattle area. It's underwritten by PhRMA, the trade group for Big Pharma formally known as Pharmaceutical Research and Manufacturers of America. The ad asks viewers to pick up the phone and thank Senator Patty Murray (D-Washington) for her hard work on health care reform. I wouldn't be shocked if you are seeing a similar version of the same ad running in your part of the country.
For those of you who don't follow politics closely, Sen. Murray is number three in the Senate's Democratic leadership and is a rainmaker of a fundraiser for Congressional Dems. She's kind of become a latter day Henry "Scoop" Jackson, the late Senator from Washington State who was a huge force in the Senate in the 60s and 70s.
I mention all of this because if PhRMA is lining up in support of a Democrat, then something weird is going on. The group put out a statement on Tuesday actively supporting health care reform. You can bet that's because whatever deal PhRMA is pushing (and thanking Sen. Murray for) does little to touch Big Pharma's profits. And President Barack Obama keeps saying that health care reform will cut the cost of health care?
Um, sure. I bet the price of patented drugs doesn't go down a nickel under whatever health care reform gets pushed through Congress. It'll be a Medicare Part D party all over again!
BTW, pharma companies are among Sen. Murray's top contributors. She's taken in $156,050 from pharma since 2005, according to opensecrets.org, and likely will face little opposition in 2010 from Republicans in this state.
The AP is out with a report that GlaxoSmithKline had a major ghostwriting program in place to help promote its anti-depressant Paxil.
"An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug."Known as the CASPPER program, the paper explains how the company can help physicians with everything from 'developing a topic,' to 'submitting the manuscript for publication.'"
"The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects....
"According to the memo, which dates from April 2000, the CASPPER program was designed to 'strengthen the product positioning and overcome competitive issues.'"
The AP reports that five published articles from this sleazy program appeared in print between 2000 and 2002 including ones published in the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry. The specific articles are not identified. I think the journals involved either need to retract the articles or issue an explanation of why they contain sound scientific evidence. I suspect that the infamous Martin Keller-led Paxil Study 329 would be one of these papers. It was published in the JAACAP in 2001.
GlaxoSmithKline, Paxil's maker, claims that the program was discontinued several years ago.
Maybe these findings would be painfully obvious to some, but the CDC did a survey in the Seattle-Tacoma area--gee, why'd they pick on us?--and found that the average gamer was 35 years old, overweight and more depressed than non-gamers.
Said a CDC official:
"'Health risk factors, specifically a higher BMI and a larger number of poor mental-health days, differentiated adult video-game players from non-gamers,' he said. 'Video game players also reported lower extraversion, consistent with research on adolescents that linked video-game playing to a sedentary lifestyle and overweight status.'"
Doing this as a survey isn't particularly convincing and the BMI simply isn't a powerful measure of body weight, but it's all semi-interesting. However, a CDC official claiming that a higher BMI (relative to what absolute?) is a health risk factor when there's evidence that being slightly overweight is better than being thin strikes me as pure propaganda.
Posts will be late today as we had a primary election in Seattle last night and I was covering some of it and I am pooped.
Many of the races will take a few more days to decide since it was a mail-only primary, but it appears voters totally rejected a 20-cent-a-bag tax that was on the ballot. It would've applied to both plastic and paper bags from grocery stores. Dumb idea. Glad it got shot down.
I imagine two or three of you remember a study that came out last year asserting that bipolar disorder was being overdiagnosed--or wrongly diagnosed--in almost 50 percent of patients. The study was authored by Mark Zimmerman, a psychiatry professor at Brown University, and colleagues and was quite controversial, although some researchers supported his findings. After all, bipolar disorder is supposed to be underdiagnosed and most of the leading lights in psychiatry consider bipolar to be a fixed diagnosis. Once you're diagnosed with it, there is no escape. Shut up and take your meds or you're living in denial and will die and so on. I wrote a lengthy rant about Zimmerman's findings last year.
I spoke with Zimmerman last year and asked him if such a large chunk of patients didn't have bipolar disorder then what did they have. He didn't want to speculate as he was working on a follow-up paper that would lay out what some of the bipolar overdiagnosees might actually have. My own hunch was that a large proportion of the people would wind up with major depression.
Zimmerman's follow-up paper came out a couple of weeks ago, ahead of print, in the Journal of Clinical Psychiatry. It looked at 82 former bipolars and found:
"Results: The most frequent lifetime diagnosis in the 82 patients previously diagnosed with bipolar disorder was major depressive disorder (82.9%, n = 68). The patients overdiagnosed with bipolar disorder were significantly more likely to be diagnosed with borderline personality disorder compared to patients who were not diagnosed with bipolar disorder (24.4% vs 6.1%; P < .001). A previous diagnosis of bipolar disorder was also associated with significantly higher lifetime rates of major depressive disorder (P < .01), posttraumatic stress disorder (P < .05), impulse control disorders (P < .05), and eating disorders (P < .05), although only the association with impulse control disorders remained significant after controlling for the presence of borderline personality disorder."
So there you have it: lots of depression and a bit of borderline personality disorder. The depression certainly makes sense. I'm not as clear on the BPD and will await a copy of the entire paper before trying to make sense of it. Of course, the new study is based on 82 patients--which doesn't exactly give you population-wide predictability--so it would be nice if some other researchers tried to replicate its findings.
Obviously, Zimmerman's findings do have implications for millions of Americans, psychiatry, Big Pharma and all kinds of alleged advocacy groups, but that's for another day.
A wonderful column appeared in the Los Angeles Times last week in the wake of film director/producer John Hughes' death earlier this month and basically made the point that all those supposedly sad, depressed or wild and wacky teens in his films were in fact pretty much treated as normal by Hughes. But he was making these films largely in the 1980s before the mid-1990s when teen angst and rebelliousness were turned into mental disorders and a cottage industry for Big Pharma. Ah, yes, the days of teen innocence now lost.
Anyway, the columnist pretty much goes for it:
"If the brooding, solitary Andie played by Ringwald in "Pretty in Pink" were in high school in 2009, it's hard to imagine she wouldn't be a candidate for anti-depression therapy. Likewise, if "The Breakfast Club," which is about five teens serving time in Saturday detention, took place in a post-Prozac, post-Columbine America, Ally Sheedy's mostly mute, kleptomaniac misfit would have undoubtedly been medicated, and Anthony Michael Hall's character would have received a lot more than detention for bringing a flare gun to school. As for Ferris Bueller, the kid obviously needed Ritalin."I'm not suggesting that any of us were better off when legitimate disorders went unrecognized and untreated. But in a culture in which diagnoses sometimes seem to get handed out like conservation-awareness fliers in front of the supermarket, it's worth asking ourselves if old-fashioned eccentricity -- of the teen or adult variety -- can too easily be supplanted by the ease of assigning a code from the Diagnostic and Statistical Manual. Hughes, who left the movie business in the early 1990s because he feared the impact Hollywood would have on his children, should be remembered not just for the way he appreciated weirdness but for the way he normalized it -- not with pills but with paisley."
I couldn't agree more. Outside of the realms of psychosis and suicidal behavior (and, hell, maybe not even there, the skeptic in me sometimes says), it's sometimes best to let human nature be human nature. Can you imagine Matthew Broderick on Ritalin? I sure can't.
I'm a generational compadre of Hughes' characters and I can assure you all that I had never heard of a kid or teen being given psychotropics of any kind until the early-1990s when I worked at a middle school and had to go take a 14-year-old to the nurse's office so he could get his Prozac. Nice kid, too.
Ironically enough, there's now pretty solid research establishing that much of the response to anti-depressants among kids and teens is in fact a placebo effect in many cases and there's also solid research establishing that anti-depressants increase the risk of suicidal ideation in kids and teens.
You'd think that would argue for some caution--and perhaps some conservatism--in how we are treating teenage wasteland these days.
A new study from Australian researchers in the International Journal of Cancer asserts that some antipsychotics can kill lung, breast and brain cancer cells. This was established in in-vitro lab experiments. The big winner among the cancer-killing antipsychotics is reported to be pimozide, otherwise known as Orap, an old first-generation antipsychotic that is among gnarliest in its side effects and is rarely used in treating schizophrenia (I have a friend whose mother has schizophrenia who was rendered catatonic on Orap). In second place was our old pal Zyprexa.
From sciencedaily.com:
"In the new study, pimozide was the most lethal of six anti-psychotic drugs tested by a team from UNSW and the University of Queensland. Rapidly-dividing cancer cells require cholesterol and lipids to grow and the researchers suspect that pimozide kills cancer cells by blocking the synthesis or movement of cholesterol and lipid in cancer cells."Analysis of gene expression in test cancer cells showed that genes involved in the synthesis and uptake of cholesterol and lipids were boosted when pimozide was introduced.
"To test the idea that pimozide acts by disrupting cholesterol homeostasis, the researchers combined pimozide with mevastatin, a drug that inhibits cholesterol production in cells. The two drugs were more lethal in combination against cancer cells than when either drug was used alone."
That's a fascinating finding, one that obviously needs to be replicated in vitro and in animal studies before finding any applicability to humans. But given how aggressive lung, breast and brain cancer cells can be--and how difficult they are to stop with current therapies--expect to see more studies of this potential use of antipsychotics in the fairly near future.
BTW, apparently what spurred this line of research was the observation that people diagnosed with schizophrenia who take antipsychotics had lower incidences of cancer, despite the fact that many people with schizophrenia smoke like chimneys, and researchers wondered if there wasn't some kind of cancer-protecting effect attached to antipsychotic use.
Obviously, these drugs are awful for people with schizophrenia over time and lead to a host of well-known problems such as diabetes and, well, you name it, but that's probably not relevant to whatever use antipsychotics might have in treating cancers, since patients would probably not take the drugs long term.
Les Paul died earlier today, aged 94. I don't even know where to begin with this great, great man. He was the inventor of multi-track recording, designed one of the greatest guitars ever (Gibson's Les Paul), wrote a hit song with his one-time wife Mary Ford ("How High The Moon") and continued to play weekly shows at a New York City club well into his 90s. He was also a great guitarist, his style a mix of jazz, blues and country. His death isn't tragic. Paul lived a long and interesting life and his contribution to American (and world) culture is obvious. The guy was only semi-responsible for pop music.
The fact that he died on my birthday utterly silences me.
I don't especially care for this video of Paul and Ford but it's pretty much all YouTube has got for "How High The Moon," which is a classic song.
A new study out in the BMJ and authored by several FDA staffers found after examining data from 372 clinical trials and almost 100,000 patients:
"Conclusions: Risk of suicidality associated with use of antidepressants is strongly age dependent. Compared with placebo, the increased risk for suicidality and suicidal behaviour among adults under 25 approaches that seen in children and adolescents. The net effect seems to be neutral on suicidal behaviour but possibly protective for suicidal ideation in adults aged 25-64 and to reduce the risk of both suicidality and suicidal behaviour in those aged ≥65."
It's of course old news at this point that anti-depressants can induce both suicidality and suicidal ideation--hence the FDA-mandated black box warnings on anti-depressants--but this study does address mounting attempts, most recently in June, by some researchers to cast doubt on the warnings, especially for young adults aged 18 to 25. Looks like they lose yet again.
While I know that 25 to 64 age cohort is standard public health accounting, it would be useful if that data were broken down into four age groups since it covers four decades. The reason I say this is because I know of many, many people who were in their late-20s and 30s and 40s who experienced massive problems on anti-depressants and, if anti-depressants are somewhat less problematic with advancing age, then it would be nice to know when that effect kicks in.
Apparently, the risk of suicidality and suicidal ideation varies among anti-depressants--no surprise there--and according to the AP:
"[T]he odds of suicidal behavior by people taking Pfizer Inc's Zoloft, or sertraline, were around half of those who took placebo. By comparison, Forest Laboratories Inc's Celexa, or citalopram, and Lexapro, or escitalopram, 'seem to increase the risk of suicidal events,' Geddes and colleagues wrote [in an accompanying editorial which I don't have access to].
I am a bit surprised to not see Paxil/Seroxat getting a mention.
Anyway, don't be surprised to soon see a paper from defenders of anti-depressants claiming something completely different on these issues.
Now, let's watch the AP drink some Kool-Aid:
"Many psychiatrists have criticized the warnings, saying they scare people away from effective treatment for depression, the leading cause of suicide. In fact, recent studies have suggested the warnings triggered an 8 percent rise in suicide among youth and teens in 2004, the biggest one-year gain in 15 years."
Actually, it was only one study that made that claim, a controversial and much-criticized 2007 study by Robert Gibbons which was ripped apart by the New York Times, myself and others. Gibbons later attempted to address his critics. For the AP to pretend that the Gibbons paper is settled science is simply bad, lazy journalism.
The paper from the June Archives of General Psychiatry which I mentioned above made the wild claim that the FDA warnings were causing fewer diagnoses of depression in the US. In taking it apart, I noted:
"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."
There is now a ton of solid peer-reviewed evidence out there on anti-depressants and suicidality. It's time for the forces of religious orthodoxy in psychiatry to fold up their tents and leave town.
I bring this up because it's been four months since an FDA advisory panel very reluctantly recommended that the FDA proper approve AstraZeneca's atypical antipsychotic Seroquel (in XR form) as an add-on, or adjunctive treatment, for depression. The same panel recommended against FDA approval of the drug for anxiety as well as a maintenance therapy for depression (meaning long-term use) and as a monotherapy for depression (meaning a replacement for SSRIs and SNRIs). The panel found that the drug didn't meet safety and efficacy standards to merit its approval as anything except an add-on therapy.
While there's no set schedule for when the agency must accept or reject an advisory panel's findings, the agency generally doesn't wait for four months to make a determination. So something fairly unusual is going on here.
My own guess is that one of two things is happening to account for the slowdown:
1. AZ is lobbying the FDA like crazy to convince them that the panel had it wrong and that Seroquel is awesome for anxiety and depression, not just as an add-on for depression. Technically, the FDA is not bound by a panel's recommendation and can go in whatever direction it likes with approval or non-approval.
2. The FDA is wrestling with the panel's approval recommendation for add-on status in light of the drug's very small advantage over placebo--just 5 percent, according to Tufts University psychiatrist Danny Carlat. Technically, the FDA has to approve any drug that can demonstrate any level of efficacy over placebo, regardless of how small the advantage, so my hunch is that the slowdown could well have to do with safety questions around the drug.
There are other possibilities, of course, but it does strike me as unusual that this is going on and I thought I'd note it for you all. I bet the drug's limbo status is driving AZ bonkers.
Personally, I hope the FDA finds the drug non-approvable for any new indication due to its teensy efficacy and rotten side effect profile.
The Wall Street Journal last week had the first piece I've seen in the major media in the US on Proteus Biomedical's digestible drug monitoring pill and I thought I'd flag it for readers. Here's what the buzz is about:
"Doctors might decide to intervene, for example, when they notice a heart patient isn't sleeping well or is taking incorrect dosages -- problems that could lead to congestive heart failure."Proteus isn't alone. Dozens of large and small companies are turning to wireless technology to achieve what the Obama administration is seeking through legislation: a health-care system that keeps people healthier for less.
"'Wireless applications have the potential to change every one of these areas,' said Eric Topol, a cardiologist and genomics professor at Scripps Research Institute, at an industry event in San Diego last week."
While I'm sure there are conditions and treatments for which this kind of thing makes sense, I am still troubled with how broadly they could be used--would everyone under Medicaid and Medicare be required to take part?--because I see a range of privacy concerns and patients being forced to take medicines that areallegdely evidence-based treatments but are in fact the result of pharma companies and academic researchers twisting evidence to suit their needs. As I noted in April when news of this digestible first popped up in the UK press:
"Do any women really want their docs monitoring what they put in their bodies in such a fashion? Is there anyone who takes anti-depressants who wants his or her doc probing their medication compliance so intimately? I doubt it. What would the doctor even say if a woman missed taking the Pill for a week? 'Hi, we've noticed a disturbing pattern in your estrogen intake. Oh, you are trying to get pregnant? Come into my office for mandatory counseling and depression screening? I need to sell you pills of some kind.'"
Obviously, if someone voluntarily consents to such monitoring, then have at it. But I bet things are trickier for those of us who refuse.
A truly discouraging piece in yesterday's New York Times details the many, many problems surrounding tens of thousands of youths diagnosed with various mental illnesses and incarcerated in America's "juvie" system, often because there is allegedly no better place to put them or treat them. I doubt that anyone with brain cells expects the kids to get better in such a situation and no matter where you stand on the meds/no-meds, diagnosed-well/overdiagnosed divide, this situation is gross and unacceptable. Some of the kids in the story, doped on antipsychotics, have been bounced around the juvie system since elementary school where they've encountered all sorts of fun:
"The investigators [in California] also recounted how staff members body slammed unruly juveniles, often breaking their bones."In May, a reporter toured the Los Angeles County Central Juvenile Hall with Eric Trupin, a consultant hired by the Department of Justice to monitor mental health services in California’s juvenile justice system. Dr. Trupin, a psychologist, said some detainees appeared to be held there for no reason other than that they were mentally ill and the county had no other institution capable of treating them."
I don't even know what to suggest to begin to address this problem, but something clearly must be done. This kind of classic warehousing should not be allowed to stand.
I suspect readers of The Trouble With Spikol are just now realizing that Liz Spikol is no longer at Philadelphia Weekly and that her well-read blog is now pretty much shuttered, since it's technically owned by the paper. She told me by email last night that she's feeling rather glum, but intends to get back to blogging...just not right away. So stay tuned.
In an article that came out on Monday in the LA Times the paper delves into the reality of anti-depressant withdrawal problems. The article is a sidebar to a longer piece on depression in America, which pretty much concludes that depression is undertreated. I cannot make myself get into tearing that one apart.
More interesting is the reporter's explanation of withdrawal syndromes:
"The biology behind symptoms is unclear. Antidepressants boost levels of brain chemicals such as serotonin and dopamine, but they also dampen the system that transports these chemicals, researchers believe. When there's suddenly less drug in the brain, it takes time for the system to pick itself up again. And since these brain chemicals control more than just mood (they also influence digestion, sleep and motor control, for example) withdrawal reactions can be broad."
What the article fails to say is that what you just read there is a compelling argument for drug-free depression treatment, especially given that CBT and other psychotherapies work about as well as anti-depressants.
All the same, I appreciate the paper's honesty in reporting on withdrawal problems with anti-depressants. Many in the media ignore the phenomenon when they write about depression.
I ask this question in all seriousness in connection with an article in the paper today about "revelations" that pharma giant Wyeth paid ghostwriters to compose "scientific" papers, later published, that touted the benefits of the company's hormone replacement therapies Prempro and Premarin while obscuring problems caused by the drugs. Look at how the paper's lede casts matters:
"Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known."
"Broader than perviously known?" Is the Times kidding us? Or itself?
Industry influence--hidden and overt--is pervasive in the medical literature and this fact has been well-known for a long time. Danny Carlat, a psychiatrist, has a few examples on his blog today. The way that pharma companies manipulated the literature in psychiatry--oops, I mean neuroscience!--is legendary and my understanding is that there's been quite a bit of hinky-dinky going on in cardiology, pain management, orthopedics, diabetes care...and on and on.
This should be well-known to the Times since the paper has covered some of the controversies. Perhaps it's time for an editor at the paper to put one of its reporters onto a story connecting the dots on just how pervasive pharma influence has been in the medical literature. Headline it "Pharma's Broad Influence." It would be a good story. I guarantee it.
We're crossing the Rubicon with this one: a new study in the Archives of General Psychiatry alleging that children as young as 3-years-old can and do suffer from chronic depression. I simply don't much to say about this, except to note how the AP handled the following:
"Though sure to raise eyebrows among lay people, the notion that children so young can get depressed is increasingly accepted in psychiatry."University of Chicago psychiatrist Dr. Sharon Hirsch said the public thinks of preschoolers as carefree. 'They get to play. Why would they be depressed?' she said.
"But depression involves chemical changes in the brain that can affect even youngsters with an otherwise happy life, said Hirsch, who was not involved in the study.
"'When you have that problem, you just don't have that ability to feel good,' she said."
Oh, yes, us silly lay people out here with our outdated, traditional, hunter-gather notions of human development and moods, we just need to get with it and enter the glossy age of 21st Century psychiatry where all the little ones are disordered and must be medicated into the ground.
It also amuses--by which I mean, disgusts--me greatly that the AP just swallows the chemical imbalance theory of depression wholesale. That's some nice skeptical journalism there.
The AP came out yesterday with a report on how the various health care reform proposals of Congressional Democrats and President Barack Obama are penciling out in terms of adding to the federal deficit (or not), requiring new taxes (or not) and whatnot. It doesn't look good for any proposal right now:
"Obama claims his health effort will not dig the nation deeper into debt and over time will help reduce deficits. He has vowed to not sign any health bill that raises deficits."But even the nonpartisan Congressional Budget Office says that none of the health plans pending on Capitol Hill would control long-term spending, and that ones with the elements Obama wants would add around $1 trillion to the deficit over the next 10 years.
"Furthermore the CBO said an administration-backed independent council of medical experts to recommend Medicare cuts would only yield modest savings.
"The White House stands by its claims. Its allies claim that [Congressional Budget Office] forecasts, for instance, don't reflect potential future cost savings that might be expected from the prevention of illness achieved from wider health care coverage."
It goes from there.
I've become pretty pessimistic about the chances of health care reform getting through Congress, covering the many instead of getting a few million more, and doing so without requiring new taxes or adding to the deficit (I don't think our shaky economy can handle much of the latter two right now). Absent a "September surprise" of some kind, it's beginning to look as though no one's plan will pencil out. And that means at least some Democrats in the House and the Senate will vote against the proposals and that really imperils getting health care reform done anytime in the next few years.
I haven't had health insurance in over two years now and was fairly hopeful that something could get done here. Oh, well, so much for that sliver of hope.
A new study is out today in the Archives of General Psychiatry telling the world what many of you already know: that the use of anti-depressants has exploded upward from the 90s to the 00s.
From Reuters:
"About 6 percent of people were prescribed an antidepressant in 1996 -- 13 million people. This rose to more than 10 percent or 27 million people by 2005, the researchers found."
Yes, America is one doped-up nation.
Researchers tried to account for this increase during a time period when DTC advertising of prescription drugs was legalized (in 1997) and when anti-depressants were heavily-advertised.
"The survey did not look at why, but the researchers made some educated guesses. It may be more socially acceptable to be diagnosed with and treated for depression, they said. The availability of new drugs may also have been a factor."'Although there was little change in total promotional spending for antidepressants between 1999 ($0.98 billion) and 2005 ($1.02 billion), there was a marked increase in the percentage of this spending that was devoted to direct-to consumer advertising, from 3.3 percent ($32 million) to 12 percent ($122.00 million),' they added."
I'm sure this increase occured for a host of reasons, but at the end of the day those DTC ads and astroturfing campaigns had to play a huge role.
One doctor whom Reuters quoted decried the trend of more and more anti-depressants being used:
"Dr. Eric Caine of the University of Rochester in New York said he was concerned by the findings. 'Antidepressants are only moderately effective on population level,' he said in a telephone interview."Caine, who was not involved in the research, noted that several studies show therapy is as effective as, if not more effective than, drug use alone.
"'There are no data to say that the population is healthier. Indeed, the suicide rate in the middle years of life has been climbing,' he said."
I've made these points before, so it's nice to see someone from the research world echoing my thoughts (and many of your thoughts as well).
Via the Wall Street Journal's Health blog comes word that Eli Lilly has just released a list of payouts to doctors acting as consultants for the company and likely speaking on behalf of their drugs to other doctors. The payouts total $22 million in the first quarter of 2009.
I did a quick read of the list, but none of the usual suspects from the world of psychiatry jumped out at me. Feel free to look it over yourself and let me know if you see anything noteworthy. Of course, Lilly is deeply involved in areas outside of psychiatry, especially cancer and diabetes treatments.
For what my opinion is worth, although I find many of these consulting arrangements to be sleazy, I admire Lilly for detailing them publicly.
A new report out in the Australian Adverse Drug Reactions Bulletin details cases of serotonin syndrome reported in connection with patients taking Cymbalta, which was recently approved for use in depression in Australia. About 200,000 prescriptions for the drug--which is a blockbuster for Lilly in the US--have been filled in Oz so far and led to reports of serotonin syndrome in seven people. Yes, I know that's a small number--unless you happen to be one of the seven. (There are 135 reports of serotonin syndrome in the FDA's adverse events database.)
Serotonin syndrome is essentially a reaction to having too much serotonin in the central nervous system. Symptoms include autonomic dysfunction, cognitive-behavioral changes and neuromuscular dysfunction.