Archive for June, 2009
Questioning Antipsychotics In Kids, SF Chron Supports Their Use
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.
FDA Pulls Sexual Stimulant Pill Finding It Contains Unapproved Erectile Dysfunction Drug
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.
House Version Of Health Care Reform Out Now, Includes 8 Percent Payroll Tax
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.
How Do You Know?
ClinkShrink was talking about how it annoys her when a patient says he hears voices, and with no other information, the nurse records a diagnosis of “schizophrenia.” One of our readers said they would assume that a prisoner who reported he was hearing voices was seeking specific medications (presumably for reasons other than to stop the voices or directly treat the symptoms of schizophrenia). I read the comment and thought, “Wait, sometimes people hear voices because they have schizophrenia! You can’t just assume he’s drug-seeking for devious reasons!” Just as one can’t assume that hearing voices is 1) an auditory hallucination (it’s not if the voices are actually there and the result of real people talking, or if it only occurs in the time right before sleep) or 2) that the voices aren’t the result of hallucinogenic drugs or alcohol withdrawal in a prison population, or 3) the result of another psychiatric illness as schizophrenia is not the only psychiatric disorder where people hear voices, well, we can’t automatically assume that a patient who hears voices doesn’t have schizophrenia! This is why we take a full history and observe patients over time.
Okay, so I’m sitting with two friends in a restaurant and our waiter is really really skinny. Neither friend is a mental health professional, but we all notice the skinny waiter. One friend says “I wonder if he has anorexia?” The other friend immediately says, “Nah, he’s just skinny.” I said nothing, but I thought, “How do you know?” He could just be very slim, or he could have an illness (AIDS, cancer, TB, cocaine: they all cause weight loss), or he could have an eating disorder. Really, all we knew was that he was skinny, that he wore a colorful t-shirt, and that he brought us the right food. To figure out any more, about either his medical or psychological state, we’d have to ask questions that just weren’t appropriate to the setting. Still, my friend was absolutely certain the waiter didn’t have an eating disorder.
Maybe it’s human nature that we jump to conclusions, but people do it all the time.
FDA Staff Urge Review Of Developmental Delay, Autism Linked To Depakote
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.
AstraZeneca Can’t Exclude Diabetes Expert Witness From Seroquel Trials
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.
WSJ/NBC Poll: Support Soft For Health Care Reform Details
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.
In the Eye of the Storm
Hurricane Katrina was the largest natural disaster in U.S. history, killing more than 1,800 and causing well over $100 billion in damage along the Gulf coast from Florida to Texas. The 2005 storm breached every levee in New Orleans, flooding almost the entire city as well as the neighboring parishes. Yet many residents chose to stay at home and ride out the perilous winds and water.
This perplexed many commentators at the time, including the top officials of the Bush administration. FEMA director Michael “Brownie” Brown blamed the rising death toll on those who refused to take prudent action, as did homeland security chief Michael Chertoff, who told CNN: “Officials called for a mandatory evacuation. Some people chose not to obey that order. That was a mistake on their part.” Many others chimed in, asking in so many words: What were they thinking?
What were they thinking? The general consensus seemed to be that they were irresponsible, indecisive—perhaps even lazy or stupid. Anyone with an ounce of sense would take action in the face of such a threat, make a plan, solve the problem. Passivity was widely denounced as a character flaw.
The problem with these instant analyses is that nobody bothered to ask the people themselves, the ones paddling the boats and clinging to the rooftops. Until now. Stanford University psychologist Nicole Stephens and her colleagues decided to compare the views of outside observers with the perspective of the New Orleans residents who actually rode out Katrina. They suspected that these people had not simply thrown up their hands, but rather that they had a different concept of conscientious action.
To find out, they conducted two surveys, one of observers and one of survivors, to see how they perceived both those who fled and those who did not. The study of observers—including a large group of relief workers, firefighters, physicians, and so forth—basically confirmed the pop wisdom. That is, these close-up observers’ views matched those who watched the tragedy from afar: They perceived those who evacuated their homes in a much more positive light in general—more self-reliant, hardworking. Those who stayed put were described as careless and dependent. Those who stayed were also seen as depressed and hopeless, where the evacuees were characterized as self-righteously angry, primed for action. But here’s perhaps the most interesting point: These observers derogated those who stayed even though they were well aware that these residents lacked the resources to leave—money, transportation, out-of-town relatives. Their disadvantages didn’t soften the view that they were somehow responsible for their own suffering.
The survivors themselves told a very different story, however. When the psychologists surveyed actual Katrina survivors, they found that those who stayed behind did not feel powerless or passive. To the contrary, they saw themselves as connected with their neighbors—communitarian rather than self-reliant. Their stories emphasized their faith in God and their
feelings of caring for others. In short, they didn’t see themselves as failing to take action, but rather as taking a different kind of action—adapting to life’s travails and staying strong despite hardship.
The psychologists also took detailed measures of all the survivors’ well-being—their mood, life satisfaction, mental health, drug and alcohol use. As they report in the July issue of the journal Psychological Science, there was absolutely no difference between those who stayed in New Orleans and those who high-tailed it out. It seems their different “choices” did not reflect differences in well-being. Rather, they were different kinds of actions suitable to different life circumstances.
For more insights into human nature, visit “We’re Only Human” at www.psychologicalscience.org. Selections from this blog also appear regularly in the magazine Scientific American Mind and at the website Newsweek.com.
Is Seroquel Litigation Going Down The Toilet?
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.
HealthCampMd on Friday
HealthCamp is one of these un-conferences (started as a barcamp by Mark Scrimshire) where a bunch of people get together to talk about a subject matter, but they don’t figure out who is going to say what until they get there. The presenters are the audience. These all-day conferences are getting held all over the place, and Maryland’s turn is on Friday, June 19, at Stevenson University, just north of Baltimore.
