Monday, August 31, 2009

Are meds always the answer for stressed-out moms?

I can relate to Katherine Snow Smith, the mom in Florida who wrote in the St. Petersburg Times about how she lost it with her kids one time too many. But what I can't relate to is Smith's decision that she needs to take a potent psychoactive drug to calm herself down.

Smith talks about how a friend of hers had gone on a "girls' weekend" with eight mothers 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."

This may indeed be true. After all, a relative of mine went on Paxil for much the same reason: because she was yelling too much at her kids and her husband and she found that she is calmer and less anxious on 10 milligrams of the SSRI antidepressant. I'm sure there are times when my husband and sons wish I were on Paxil too, especially in the evening after a long day when they've pushed my buttons once too often.

But are drugs the answer? As Philip Dawdy puts it (a hat tip to him for alerting me to Smith's column) in Furious Seasons:

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.

Is the same thing happening all over again with the new generation of antidepressants? We all know that the SSRIs, especially Paxil, cause serious withdrawal problems and have a host of other unpleasant side effects, including weight gain, decline in sex drive, changes in cognitive alertness, and in some people, an increased risk of suicidal thoughts and behaviors. Does the benefit really outweigh the risks?

As one occasionally stressed-out mom, I would hope that Smith and all these other overburdened mothers consider other alternatives first. Like yoga, meditation, exercise, or dare I say it, a husband who travels a little less and is home more often? Personally, I find aerobics and the occasional dinner out with friends a welcome salve.

At the end of her column, Smith rationalizes her decision to take drugs by saying, "I want to enjoy every minute of it as much as I can." Given what we know about how these drugs can numb the mind, let me add this postscript: be careful what you wish for.

Wednesday, August 26, 2009

Radio Interview: the story behind the deceptive marketing of Paxil

Madness Radio, the radio station affiliated with Freedom Center, a nonprofit advocacy group for people with mental illness, interviewed me about Side Effects, the story behind the deceptive marketing of Paxil, and the ongoing battle to clean up corruption in the medical profession and drug industry. A podcast of the 50-minute interview, which aired today, can be found here.

Monday, August 24, 2009

New study: Antidepressant warnings did not affect suicide rates in young people

Many mental health professionals remain concerned that the regulatory warnings put on antidepressants in this and other countries have had a deleterious effect, possibly leading to an increase in depression and suicides among young people. This concern has been stoked by recent journal articles written by researchers with ties to the drug industry, which I've blogged about here.

Now comes a fairly convincing international finding that there has been no overall effect on suicide rates among young people as a result of the regulatory warnings on antidepressants. As you may recall, the warnings were required by the FDA and other regulatory agencies, beginning in late 2003 and 2004, because of evidence of an increased risk of suicidal thoughts and behaviors among children and young adults on SSRI antidepressants.

The latest study, published in the July issue of Pharmacoepidemiology and Drug Safety, is based on suicide data from 2004 to 2006 provided by 22 nations, including the US, to the World Health Organization. The researchers, from the University of Bristol, found no clear evidence of a beneficial effect on population suicide rates as a result of the warnings. Equally importantly, they did not find evidence of an adverse effect on suicide rates either.

Interestingly, they did find "weak evidence" for a slight increase in suicide rates in young women, aged 15-19, but not in young men. The researchers were at a loss as to how to explain this gender difference. But they did note that in the UK, this slight increase might reflect the two to three-fold higher levels of antidepressant prescribing among young women. In the US, they found the strongest inverse association between SSRI prescribing and suicide mortality among boys under the age of 15; in other words, between 2004 and 2006, when SSRI prescriptions for this age group dropped, as it did for other age groups in wake of the warnings, fewer boys in the U.S. committed suicide.

Not exactly a ringing endorsement of the beneficial effect of antidepressants, is it?

Wednesday, August 19, 2009

Ghostwriting in drug research back in the spotlight

It's good to see The New York Times maintain a spotlight on the widespread practice of ghostwriting in drug research. In her article today, Natasha Singer focuses on Wyeth's use of a ghostwriting firm to prepare an estimated 60 articles favorable to its hormone drugs.

Wyeth's use of ghostwriters to prepare favorable studies and then find doctors willing to put their names on them is, of course, only the latest in a long string of drug industry campaigns to present new products in the most positive light possible. The makers of the SSRI antidepressants were masters at this tactic. As I reveal in Side Effects, GlaxoSmithKline hired a ghostwriting firm, Scientific Therapeutics, to write the first draft of the controversial Paxil study 329. That draft concluded that Paxil was effective and well tolerated in adolescents, even though the actual data in the clinical trial showed otherwise. See back story here. Indeed, in its re-examination of clinical trial data for all the antidepressants, the FDA labeled study 329 a negative study, finding that Paxil was no more effective than placebo in treating depression in adolescents. Yet Martin Keller, the principal investigator of the Paxil study, and his co-authors, did not object to the ghostwritten version of the study and despite its inaccuracies (which were flagged by peer reviewers), the study was published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001 and used by GlaxoSmithKline to heavily flog the drug for use in children and adolescents.

Why were the authors of study 329 so lax in attaching their names to a study they didn't write? Could it have had anything to do with the fact that Keller and several of his co-authors were getting paid huge amounts of money in consulting and speaking fees by GlaxoSmithKline?

In its marketing of Zoloft, another blockbuster SSRI antidepressant, Pfizer did much the same thing, as I've reported in previous blogs here.

Hence, I'm glad to see that the Senate Finance Committee seems to be putting pressure on the National Institutes of Health to crack down on the practice of ghostwriting and undisclosed conflicts of interest; see letter from Senator Grassley here. As Singer notes, active enforcement by the NIH is crucial since "many of the nation’s top doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could be a powerful lever for enforcing new ethical guidelines..."

Up till now, NIH has been reluctant to take a more pro-active role on the issue of ghostwriting or do much to enforce its own conflict of interest policy (which has been on the books since the mid-90s). So I'm eager to see how Frances Collins, the new director of NIH, handles the issue. Stay tuned...

Monday, August 17, 2009

Now's the time to speak up about meaningful health care reform

It looks like the Obama administration may be backing off its insistence on a public health plan option in the health care reform bill wending its way through Congress. I'm sorry to hear that because I believe that the inclusion of a government-run plan (like Medicare) is the most effective way to both reduce health care costs and provide adequate insurance to many of the 47 million Americans currently uninsured. And while the option that the administration has signaled it would accept in lieu of a public plan -- non-profit cooperatives -- isn't the end of the world, a number of experts point to problems with such cooperatives, the biggest one being their lack of scalability. The few cooperatives that now exist in places like Seattle are relatively small, local affairs, and some question whether they could effectively scale up to compete with private insurers. White House officials raised that concern in The New York Times today, even as they acknowledged that the president might be willing to accept cooperatives in lieu of a public plan.

If this compromise is destined to happen, and I sincerely hope it isn't, then at the very least, the administration should make darn sure there are rules around how these health cooperatives can operate. As Gooznews noted today, such cooperatives should be required to be nonprofit and their members should be allowed to join a pre-paid group practice where physicians are paid annual salaries, rather than getting reimbursed by fee for service, a far more expensive and wasteful practice. In fact, wouldn't it be grand if all physicians in the U.S. were on salary, instead of getting paid for the number of tests, procedures and patient visits they conduct? That's an idea whose time has come and in my opinion, it would come a lot faster if Obama stuck to his guns and insisted on a government-run health plan option.

So for all those of you who want meaningful health care reform, now's the time to call your elected representatives and tell them what you want, especially if you live in states (like Montana, Kentucky, Missouri and Iowa) dominated by lawmakers who are determined to put the kibosh on a public health plan option.

Thursday, August 13, 2009

Study confirms that antidepressants double suicide risk In young adults

In recent weeks, researchers with ties to the drug industry have once again tried to drum up opposition to the FDA's black box warnings on antidepressants for children and young adults. The latest dart came in an Archives of General Psychiatry study in June trumpeting a "persistent decline" in the diagnoses of depression among children and adults in the years after the FDA warned that antidepressant usage in children and young adults can increase the risk of suicidal thoughts and behaviors. As one of the study authors (who by the way consults for several SSRI makers) told WebMD, this proves that the FDA warnings have had dangerous "unintended consequences" and should be repealed.

Not so fast. Leaving aside the contention that a drop in depression diagnoses is a terrible thing -- some bloggers like Philip Dawdy at Furious Seasons argue otherwise -- now comes a definitive new study published in the British Medical Journal, confirming the increased risk in suicidal thoughts and behaviors among young adults taking antidepressants. After examining proprietary data from 372 clinical trials and almost 100,000 patients, the authors (FDA staffers) conclude that the "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 study also found a smaller, less significant risk in adults between 25 and 64 and that antidepressants actually reduced the risk of suicidal thoughts and behaviors in those aged 65 and up.

Aside from these findings, which largely confirm earlier research, what I found particularly revelatory about the BMJ study was its refutation of the idea (espoused by many psychiatrists) that the increased risk of suicidal ideation among people taking antidepressants comes from a lessening of their depression (which allows patients to entertain and report suicidal thoughts). As the authors note, this "ascertainment bias cannot easily explain the observed age relatedness of the findings or the stronger apparent increase in suicidality in non-depressed psychiatric patients."

The authors go on to note that "these findings support the idea that antidepressant drugs can have two separate effects: an undesirable effect in some patients that promotes suicidal ideation or suicidal behaviour and a therapeutic effect in others that alleviates depression and reduces suicidal sequelae from depression." Doctors, they conclude, should take into account the "age dependent increase in suicidality" in deciding if the benefits of antidepressants outweigh the risks.

Obviously, FDA researchers have an inherent interest in supporting their agency's actions. But it's hard to argue with raw data from 372 clinical trials done over the years by the drug companies themselves (who, after all, have a vested interest in making their drugs look safe).

Wednesday, August 5, 2009

Is the financial meltdown of the media becoming a public health threat?

At a conference I attended yesterday in Boston on Reinventing Journalism, the talk was all about how online social media tools are introducing new models of sharing information and helping journalists do their jobs better. The panelists made scant reference to the financial meltdown of the mainstream press and only one speaker mentioned in passing his concern that this crisis is impairing the ability of journalists to dig up important facts and connect the dots -- i.e. do the kind of investigative reporting that newspapers used to be known for.

Yet the evidence that this is happening is all around us and its impact is particularly glaring to me (as a longtime medical news junkie) in health coverage. As once-respected newspapers like The Boston Globe close their health and science sections and fewer papers report the reality behind the news coming out of medical journals and conferences, what we have left are television talk shows and wire services giving us a shallow and unskeptical view of new drugs and technologies.

On his HealthnewsReview blog yesterday, Gary Schwitzer makes a convincing argument that the palaver provided by the network television morning shows is actually a public health threat. Their health segments, he argues, "unquestioningly promote new drugs and new technologies" and give viewers false expectations about new treatments that may actually do more harm than good. As just one example, Schwitzer points to ABC Good Morning America's recent segment on an experimental obesity drug that it presented as a silver bullet for people wanting to drop a few pounds, without examining the possible side effects or conflicts of interest among the drug's researchers.

Another case in point: this AP story on a newly published study in the Archives of General Psychiatry announcing the existence of chronic depression in preschoolers. The AP story quotes experts saying that children as young as 3 have a chemical imbalance that predisposes them to chronic depression, the inference being that they need to be treated with potent antidepressants. And indeed, the AP story ends by noting that a "rising numbers of preschoolers are taking psychiatric drugs, including Prozac, which is used to treat depression."

As Philip Dawdy at Furious Seasons, notes with a wee bit of sarcasm: "AP just swallows the chemical imbalance theory of depression wholesale. That's some nice skeptical journalism there."