A review of two new books that attack the DSM-5, psychiatry’s “bible”

I reviewed two books now circulating about the DSM and the current controversy over the DSM-5 for The American Scholar — see review here. The two books are The Book of Woe: The DSM and the Unmaking of Psychiatry by Gary Greenberg, and Saving Normal: An Insider’s Revolt Against Out-of-Control Psychiatric Diagnosis, DSM-5, Big Pharma, and the Medicalization of Ordinary Life by Allen Frances.

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Plot twists in Soderbergh’s new movie Side Effects strain belief

I went to see Steven Soderbergh’s new film, Side Effects, with anticipation and dread. The movie, after all, carries the same name as my 2008 book, Side Effects and from what I could tell of the trailers, its plot seemed loosely based on the issue I explore in my book: the sometimes dangerous effects of antidepressant drugs. Soderbergh’s film turns out to be a cleverly done thriller with lots of twists and turns, but it is clearly not based on reality – either the reality of mental illness or the reality I expose in my book about how drug companies hid the negative effects of antidepressants.  What the film does get right (but only touches on tangentially) is the extent to which drug companies lure doctors into selling their souls in return for lucrative consulting gigs to promote their drugs.

The plot line is this: Emily, a young woman with a previous history of depression tries to kill herself after her husband (the hunky Channing Tatum) is released from prison after serving four years for insider trading. Her new psychiatrist, the appropriately named Dr. Banks (ably played by Jude Law) prescribes an antidepressant in the class known as selective serotonin reuptake inhibitor (SSRIs), which includes Prozac, Zoloft, Paxil, and Celexa. The drug (we aren’t told which SSRI she gets) makes Emily nauseous and deprives her of her sex drive (both actual side effects of SSRIs), and Emily asks if she can take another new antidepressant she has heard about, the fictitious Ablixa. The new drug causes Emily to sleep walk and after a few weeks on it, she stabs her husband to death, ostensibly while she is sleepwalking. Right here, the movie departs from reality, since sleepwalking is not a common side effect of any SSRI that I am aware of; it is, however, a dangerous side effect of sleeping pills like Ambien and Lumina.

As the plot thickens and Emily (played with haunting intensity by Rooney Mara) goes on trial for the murder of her husband, it seems as though the movie is going to be a screed against doctors who prescribe potent drugs without knowing their side effects. At one point, one of Banks’ colleagues even mentions the black box warnings put on antidepressants by the FDA to warn people about the increased risk of suicidal thoughts and behaviors in young people.  But in another break from reality, Banks appears to never have heard of these warnings. I found this implausible since the 2004-2005 warnings received so much publicity (both for and against the FDA’s decision) that any semi-conscious psychiatrist practicing in New York would have known about them.  At any rate, Emily is declared not guilty by reason of insanity (because of the sleepwalking) and remanded to a local psychiatry hospital, where she is assured by her psychiatrist and lawyer that she will be released as soon as they deem her no longer dangerous to herself or others.

Here is where the plot starts turning. Banks’ reputation has been tarnished by all the publicity over the trial, his partners no longer want him in their practice and even the New York medical board is investigating him.  At the same time, Banks begins to believe that Emily is lying about how and why she killed her husband. Here Soderbergh rachets up the drama by bringing to light an earlier case in which a mentally ill patient of Banks accused him of sexually abusing her. These accusations turn out to be false but they are enough to seed doubt in Banks’ wife about his integrity. (The movie takes another page from my book with this plot turn, since one of the real psychiatrists I profile was falsely accused of sexual misconduct by a troubled female patient). So when compromising pictures hinting at a sexual relationship between Banks and Emily are sent to his wife, that’s enough to provoke her into taking their young son and leaving him. That’s when Banks realizes he is being framed and it is up to him to solve the mystery of why Emily really killed her husband.

I don’t want to spoil the ending for those of you who haven’t seen the film; suffice it to say that the plot twists from here on in strain credulity. I found it very hard to believe, for instance, that Emily’s previous psychiatrist, played by the ever beautiful and indomitable Catherine Zeta-Jones, would be stupid or desperate enough to have sex with a female patient and then get involved in a plot to kill for money. (I covered many cases of sexual abuse by psychiatrists when I was mental health reporter for The Boston Globe and none of them involved a woman having sex with her patient).  In addition, it is exceedingly unusual for a woman, even a very troubled one, to kill her spouse for money; the vast majority of women kill their husbands after years of physical and/or psychic abuse.  But what I found myself most disappointed by was Soderbergh’s unwillingness to tackle head-on what should have been the heart of this story: the dangers posed by a medical-industrial complex that sometimes cares more about profit than it does about patient safety.

This blog was originally published under my byline on The Huffington Post.

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One solution to prescription drug overdoses: make Oyxcontin and similar drugs safer

In my previous blogs about West Virginia’s shockingly high rate of prescription drug overdoses — the Mountain State has the second highest rate of overdoses in the nation — I focused on “the culture of disability” that created this problem and what should be done to curb the over-prescribing of addictive painkillers by doctors — see here and here. I also talked about how the state’s inadequate health care system tends to feed into the problem, making it difficult for addicts in Appalachia to get the help they need when they want it. But I overlooked one very important solution to this crisis: making the drugs themselves safer.

Opiate painkillers like Oxycontin and Vicodin not only dull pain but when taken in high doses, they produce a high that can become quite addictive. Addicts often have to consume larger and larger quantities of the drug to keep that high coming. The problem is that when taken in such large quantities, such drugs also cause respiratory failure, which is why prescription drug overdoses now kill more West Virginians each year than car accidents do.

The drug companies that make these potent painkillers now have the technology to reduce this abuse and save lives, says Dr. Jeffrey Coben, professor of emergency medicine and director of the Injury Control Research Center at West Virginia University. These companies have already developed pain killers that contain an antidote to the ingredient in the drug that causes respiratory failure (as well as the high), and this antidote is released whenever the drugs are crushed. (Many addicts like to crush the pills to enhance their effects; once crushed, they can be snorted or injected directly into the bloodstream).

With the new technology, the antidote would be released if the drug is crushed and addicts would not get the same high or respiratory effect, Coben says. These drugs are called agonist-antagonist medications, and in some cases, they are already on the market. Other companies are developing tamper-proof prescription dispensers that are timed to release a pill only every eight hours so that dangerous drugs like methadone (which is prescribed to help people wean themselves off of heroin addiction) could only be consumed every eight hours, as prescribed. (Methadone is frequently abused in West Virginia and also causes overdose fatalities).

So why are these new drugs and devices not being marketed and prescribed in place of the older more dangerous painkillers ? The reason is simple: money. They are more expensive to produce and drug companies make tons of money from the addictive painkillers like Oxycontin and Vicodin, so they’re in no rush to provide a solution. The higher costs have also kept many of these drugs from being approved for use by health care insurance providers. Coben says the only way drug companies will market these new drugs is if they are forced to.

“That’s what happened with the car companies,” Coben says.

Coben says airbags and other safety mechanisms that prevent fatalities in car accidents were available long before car companies began installing them in vehicles. It wasn’t until the companies began to get sued by families who had lost loved ones in car accidents that airbags were installed as a matter of course. And the number of fatalities from drunk driving and other car accidents nosedived.

“It was the tort system at work,” Coben says. “The same thing has to happen to the drug companies.”

It’s too bad, of course, that our state and federal regulators can’t seem to muster the political will to require the marketing and prescribing of safer opiate painkillers. Indeed, the federal Department of Health and Human Services could ensure that Medicare and Medicaid include agonist-antagonist drugs in their drug formularies and save many lives in one bold sweep. But until the feds get their act together — are you listening,  President Obama? — it’s up to the families who have lost loves ones to prescription drug overdoses to sue the drug makers and force change.

Posted in biotech industry, drug marketing, medical devices, opiods, pharmaceutical industry, prescription drug abuse, public health, Uncategorized | Tagged , , , , , , , | 3 Comments

West Virginia’s prescription drug problem: a gift from the coal mining industry?

Ever heard of the term “culture of disability?” It was first coined by Judith Greenwood, who published a paper in the ’80s about how the coal mining industry in West Virginia, because the jobs were so difficult and dangerous, had created a culture where injured or unemployed miners endeavored to get a diagnosis that would earn them a disability check so they could continue to feed themselves and their families. When doctors began readily prescribing potent opiate-based painkillers (like OxyContin and Vicodone) more than decade ago, the reliance on these drugs fed right into this culture of disability and created a monstrous public health problem in West Virginia.

As I blogged about here, West Virginia now has the second highest rate of prescription drug overdoses in the country, and a large part of that problem can be traced back to the state’s culture of disability, according to one health researcher at West Virginia University. For instance, you might have an injured worker who wants out of mining and if he can prove he is disabled for life, that gives him a way out.

These drugs, of course, are extremely addictive and in West Virginia, it is no longer just former coal miners who are addicted to such potent opiates as Oxycodone, Vicodone and fentanyl.  Many people, including the sons and daughters of coal miners, are getting high from these drugs and ripping apart the fabric of their communities, according to Days of Destruction, Days of Revolt, the powerful book about poverty in America by Pulitzer-Prize winning author Chris Hedges and Joe Sacco.

As Hedges and Sacco note, “the reliance on government checks and a vast array of painkillers and opiates has turned towns like Gary [in McDowell County] into modern opium dens.” West Virginians are getting these drugs not only from illegal online pharmacies (which appear and disappear faster than the authorities can shut them down) but also from dealers who travel from clinic to clinic in Florida to stock up on the drugs and then sell them out of the back of trucks in West Virginia.

They’re also getting the pills from grandma and grandpa. As Hedges and Sacco report:

“Those who have legal prescriptions also sell the drugs for a profit. Pushers are often retirees. They can make a few hundred extra dollars a month on the sale of their medications. The temptation to peddle pills is hard to resist.”

As a result, West Virginia not only has the second highest rate of prescription drug overdoses in the nation, but it has a growing crime problem as well. People who are addicted to legal and illegal drugs are desperate to make the money to buy their next fix. So some will do whatever they can do to get that money, even it involves stealing or robbing someone at gunpoint.

This might explain why theft is such a problem even in a college town like Morgantown, which sits pretty in the hills of northern West Virginia. The pickings, after all, are easy: inebriated college students stumbling home from the downtown bars late at night. For a recent assignment, one of my journalism students quoted West Virginia University’s Police Chief Bob Roberts saying that WVU’s downtown campus had a particular problem with theft. He counseled students not to wander around late at night by themselves and to be careful about displaying an expensive ipod or smartphone even during the day.

West Virginia is now beginning to clamp down on doctors in the state who prescribe opiods and the pharmacies that dispense them, no questions asked. The university is also developing educational programs for the secondary schools to raise awareness about the dangers of opiate painkillers. But the cat is out of the bag and improving the state’s record on prescription drug abuse will take a concerted effort on the part of its health and law enforcement officials.

As Hedges and Sacco note, it will also take a recognition on the part of state officials that the mining or “extractive” industry as it is known, has systematically stripped West Virginia of much of its natural resources and left very little in return, other than a trail of pain, addiction and poverty.

 

 

 

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Falsely inflated statistics about sex trafficking in the U.S. make bad policy and laws

Wasn’t it Mark Twain who said that a lie can travel halfway around the world while the truth is still putting on its shoes? I thought of his famous quote when my husband passed along a link he had received (from a social work listserv he subscribes to) to a trailer for a slick documentary about sex trafficking. The press kit for the film cited the US State Department as the source for this statement: “80 percent of all trafficking victims are women and children who are forced into the commercial sex trade.”

The only problem with this statement is that it’s not true, especially in the United States. According to several presenters at a conference I attended in D.C. this weekend, sex trafficking here (which the U.S. defines as “a commercial sex act induced by force, fraud or coercion” — see here) is often erroneously conflated with sex work by adults who choose to work in the sex trade. As Ejim Dike, who is executive director of the US Human Rights Network, a nonprofit organization working for domestic human rights, notes, true trafficking is a serious human rights violation. But the sex trafficking numbers currently bandied about, she said, are highly inflated by conservative groups and anti-prostitution advocates who view all prostitution as a form of oppression against women and fail to recognize that there are people in the sex trade by choice.

“They add the numbers of people who are engaged in the sex trade by choice with those who are trafficked,” Dike said. “That’s why the numbers are so high.”

While there are no accurate statistics about sex trafficking in the U.S. and the Government Accountability Office admits as such — see here — a recent survey by the Coalition to Abolish Slavery and Trafficking found that the highest number of trafficked people in the U.S. were in the domestic service industry (maids), followed by agriculture and lastly by the sex trade, according to Kate D’Adamo, a community organizer for the Sex Workers Outreach Project in New York City, who also spoke at the conference.

The result of such misperceptions, D’Adamo and Dike note, is bad policy and bad laws that actually make it harder for human rights organizations to aid those women and children who are truly being trafficked. Currently, U.S. laws mostly end up penalizing sex workers who are in the trade by choice rather than the traffickers (usually men) who force women and children into prostitution.

For example, as part of the push to eradicate sex trafficking in the U.S., some states have passed laws that increased penalties for men who buy sex (known as johns). In 2005, New York state passed such a law and what happened? According to Melissa Sontag Broudo,  an attorney for the Urban Justice Project in New York City, arrests for sex workers went up and arrests for johns went down. New York police began using condoms as evidence against sex workers and made it more difficult for them to ply their trade in safe environments.

“This law ended up pushing the sex industry further underground,” Broudo said at the conference. “And it made it more difficult for sex workers to negotiate condom use.” (Studies show that an overwhelming majority of sex workers prefer to use condoms to protect themselves and their customers from sexually transmitted diseases, like AIDS)

As Broudo and other conference speakers noted, when prostitution is criminalized, workers on the street who are typically low-income and people of color are the ones most likely to get arrested. And once someone has been convicted of prostitution, it’s far more difficult to find other employment or obtain a Pell grant to go back to school and get an education.

“So getting out of sex work is that much harder,” D’Adamo says,  It’s a catch-22 and exactly the opposite of what anti-trafficking advocates had in mind when they pushed for such harsh penalties in the first place.

As I’ve blogged about here, if we truly wanted to end the sex trafficking of women and children, we would legalize or decriminalize adult consensual prostitution and take all the millions of dollars spent every year in entrapping and arresting people who are selling sex by choice and spend that money on rescuing minors and immigrants who are actually being coerced into sex against their will. We would also put more resources into helping teenage runaways (who comprise the vast majority of under-age prostitutes) get off the streets and into programs that keeps them safe and out of the hands of predators.

We would, as Ejim Dike says, tackle the “root causes” of what propels many people into the sex trade into the first place — economic necessity.

“There are people who choose to engage in sex work, many of them because they have limited economic means,” she says. “We need to tackle those root causes first.”

 

 

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Why West Virginia has second highest rate of prescription drug overdoses in the nation

Did you know that West Virginia has the second highest rate of deaths from prescription drug overdoses in the country? I didn’t, until I moved to the Mountain State to live and work and became curious as to what was behind this tragic statistic. According to a recent CDC report, drug overdoses now kill more West Virginians each year than car accidents do, which, if you’ve ever tried to navigate the treacherous mountain roads around here, is saying a lot.

Prescription drug overdoses, of course, are a national problem. As I’ve blogged about before, more Americans now die from taking too many legal drugs than from overdosing on illegal drugs like heroin and cocaine. A large part of the problem in both West Virginia and the nation is the exponential increase over the last decade in the use of legally prescribed opiate pain killers (like OyxContin and similar meds); these drugs were involved in 74 percent of the prescription drug overdoses in 2008 (the latest year stats were available), according to the CDC report. Doctors are prescribing these powerful painkillers too readily to patients who quickly become addicted to them and crave more.

However, that’s not the whole story, as a new study out of West Virginia indicates. The study, by researchers at West Virginia University (full disclosure: that’s where I teach), found that a greater proportion of people who had overdosed on prescription drugs in the Mountain State shopped around for doctors and pharmacies to fill their drug addiction. What I found surprising about this study was not that people who overdosed were doctor shoppers — that’s common sense — but that only 25 percent of those who died were shopping for prescriptions. That means that 75 percent of those who were killed by prescription drugs in West Virginia may not have been opiate drug addicts looking for a quick fix, but people who had no idea that the drugs they were legally prescribed by doctors could be lethal in some combination. Sadly, they may not have been fully informed that these drugs had dangerous side effects, side effects that could kill them.

Remember Heath Ledger, or the actress Brittany Murphy? They are among a growing army of Americans lulled by drug company marketing into thinking that legal drugs are safe and can help them sleep or feel better; after all, isn’t that what all those soothing TV ads promise? Since 1997, when Congress allowed the drug industry to market their wares directly to consumers, the number of Americans taking prescription drugs has soared nearly 40 percent and many of those people are imbibing multiple drugs, as I’ve blogged about here.

So why is the problem of prescription drug overdoses most acute in states like New Mexico, West Virginia, Nevada and Utah? I think socioeconomic factors play a big role here — in states where poverty, high unemployment and inadequate access to education may breed a sense of despair and hopelessness, there may be a greater reliance on powerful painkillers and psychoactive drugs to dull both physical and mental anguish. A health care system where some doctors hand out too many prescription drugs without fully alerting their patients to the side effects may only compound the problem. (The Charleston Gazette ran an excellent series last year on the problem and noted that many West Virginia doctors don’t use an available database to monitor prescriptions — see here and here).

Interestingly enough, Massachusetts (the state I lived in for many years before moving to West Virginia) has the lowest rate of prescription drug deaths — see CDC report. Again, the same factors could be at play here: the people in Massachusetts are among the most highly educated in the nation and the unemployment rate there is lower than the national average. In addition, Massachusetts was the first state in the nation to adopt universal health care, which means its residents have better access to quality health care than folks in West Virginia. And quality care means doctors and nurses who don’t over-prescribe potent drugs and who monitor their patients for dangerous side effects.

It also means consumers who educate themselves about the possible risks and think twice before taking a fistful of prescription drugs or sharing them with friends.

 

 

Posted in antidepressants, antipsychotic drugs, drug marketing, health care costs, patient care, pharmaceutical industry, prescription drug overdoes, public health | Tagged , , , , , , , , | 5 Comments

Martin Keller, principal investigator of Paxil study 329, retires from Brown University

I just learned that Dr. Martin Keller, principal investigator of the controversial Paxil study 329, has retired from his position as a professor of psychiatry at Brown University — see here. As Pharmalot notes, Keller quietly retired June 30 in the midst of an ongoing campaign to have the Journal of the American Academy of Child and Adolescent Psychiatry retract the Paxil study he led while chair of psychiatry at Brown; this study and Keller’s role in it was a major focus of my book, Side Effects, published in 2008 and which I’ve blogged about since — see here and here.

A Brown spokesman declined to elaborate on why Keller retired when he did, but it seems clear the timing is linked to the growing pressure to retract study 329 in the wake of GlaxoSmithKline’s $3 billion settlement with U.S. Department of Justice over claims that the study was misleading and fraudulent — see here and here.

Now it remains to be seen whether the journal will acknowledge the extensive evidence that study 329, published in 2001, contained major errors and omissions and retract it.

Hat tip to Paul Thacker for alerting me to news of Keller’s retirement.

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Calls for action against authors of controversial Paxil study are getting louder

In the wake of GlaxoSmithKline’s record-breaking $3 billion settlement with the U.S. Department of Justice, a number of psychiatrists and researchers have redoubled their efforts to get Paxil study 329 retracted. As mentioned here and in other news accounts, the federal prosecutors who won the recent settlement concluded that study 329 constituted scientific fraud, as I and many others had previously argued. Yet nothing has been done to retract this dangerously misleading study or penalize the academicians who co-authored it — see here.

Given such shocking indifference to scientific ethics, psychiatrist Mickey Nardo, the author of 1boringoldman, has devoted at least eight blogs in the last week to dissecting study 329 again — the latest is here. Not only was the study ghostwritten by a medical contractor for GlaxoSmithKline but, as 1boringoldman notes, the co-authors didn’t do much of the science themselves. As he says, the authors:

farmed out the science to others who had a very specific agenda, selling Paxil to sick kids… They didn’t do the science [or even much see it until it was done].

Nardo concludes that, as I did in Side Effects four years ago, that study 329 was “misguided science, deceitfully written, and reaches an unsupportable conclusion.”

For all these reasons, Dr. Jon Jureidini and Leemon McHenry, who have written papers debunking the study (see here), are writing yet another letter to Brown University’s current president Christine H. Paxson asking her to take action against the principal investigator of study 329, Dr. Martin Keller, who is still a full professor at Brown’s School of Medicine and receives substantial grant money from the NIH. (Keller’s work for the drug industry and his role in helping GlaxoSmithKline publish study 329 is chronicled in Side Effects). Paxson told the Chronicle of Higher Education in August that she didn’t see any reason to take further action against Keller or pressure the Journal of the American Academy of Child and Adolescent Psychiatry to retract study 329. None of Keller’s co-authors appear to have penalized for their part in the study either.

In recent days, however, the calls for action seem to be getting louder. In his Health Care Renewal blog, Dr. Roy Poses, a Clinical Associate Professor of Medicine at Brown, takes the university’s administrators to task for stonewalling on study 329. As he says:

…the appearance of continued stonewalling, now going on for years, can easily be interpreted to imply that the institution has something really big and bad to hide.

Amen.

 

Posted in antidepressants, clinical trials, conflicts of interest, drug marketing, ghostwriting, National Institutes of Health, pharmaceutical industry, scientific journal retractions, scientific misconduct, university industry collaboration | Tagged , , , , , , , | 2 Comments

Why academic researchers involved in fraudulent Paxil study escape scrutiny

The Chronicle of Higher Education this week ponders why various universities have taken no action against the academic researchers who co-authored the notorious Paxil study that formed the crux of GlaxoSmithKline’s recent $3 billion settlement with the Department of Justice — read more about that case here. The Chronicle article noted that even before federal prosecutors sued GlaxoSmithKline, others (including myself in researching Side Effects) had unearthed evidence that Paxil study 329 “constituted scientific fraud.” But neither the journal that published the Paxil paper or academia have done anything to sanction the researchers involved. As the Chronicle reported:

And yet for years, the publisher of the article, the Journal of the American Academy of Child and Adolescent Psychiatry, and the universities whose researchers’ names were on it resisted calls to retract the study and publicly rebuke its “authors.”

The Chronicle specifically mentions the lead author of study 329, Dr. Martin Keller, then chief of psychiatry at Brown University (who features prominently in Side Effects), and reports that the new president of Brown, Christina H. Paxson, doesn’t see any reason for further action against Keller (he stepped down as chair a year after my book came out). Other universities with which Keller’s co-authors are affiliated expressed much the same indifference. As Chronicle reporter Paul Basken noted:

Universities could act on their own to demand that the journal retract the article, said Fiona Godlee, editor in chief of BMJ, another leading medical journal. But, she said, “it is proving hard to get those who should do something to act.”

In the meantime, several of the authors on the Paxil study (including Keller) are still bringing large federal grants to their universities. Perhaps this explains why the universities involved have been sitting on their hands. They don’t want to jeopardize such a lucrative source of funding and are willing to compromise their moral scruples to keep those coffers full. But it doesn’t explain why the NIH hasn’t sanctioned the researchers or taken away their grants. One can only hope that this latest inquiry, published in the must-read publication for academia, will finally toggle the moral compass of a few federal and university officials.

Posted in antidepressants, clinical trials, National Institutes of Health, pharmaceutical industry, scientific journal retractions, scientific misconduct, university industry collaboration | Tagged , , , , , | 3 Comments

Moving to the Mountain State lock stock but no barrels…

For those of you haven’t heard, I’ve accepted a tenure-track teaching position in the School of Journalism at West Virginia University and am moving to Morgantown — see WVU’s announcement here.

With all the packing and unpacking the move entails, I won’t be blogging for a few weeks. Wish me luck!

 

 

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