The recent murder suicide of an elderly couple in Newton, Massachusetts brought to mind a horrific story I heard while attending the ICSSP conference in Syracuse a few weeks ago. In 2006, David Crespi, a former banking executive with no criminal record or history of violence, killed his twin five-year-old daughters, stabbing them multiple times with a kitchen knife. He then called the police and sat with his daughters, blood all over him, until they arrived. Crespi, who was living with his wife and family in Charlotte, North Carolina (they have three other children), pled guilty to avoid the death penalty and is now serving a life sentence for the murders.
What wasn't mentioned at the time is the fact that Crespi was taking Prozac when he killed his daughters, along with the sleeping pill Ambien. He was taking the drugs (and had previously taken Zoloft and Paxil) because he couldn't sleep and was very anxious about losing his job with Wachovia Bank. Crespi became agitated and delusional on Prozac, according to his wife, Kim. Seven days after starting the drug, he killed their twin daughters, Tess and Samantha.
In the 25 years since Prozac and the other SSRI antidepressants have been on the market, there has been a long litany of cases like Crespi's, where someone with no history of violence, became agitated and violent after taking these drugs, either killing themselves or their loved ones. Indeed, as I write in Side Effects, Dr. Martin Teicher and his colleagues at McLean Hospital in Belmont, first reported on the phenomenon of akathasia among several patients on Prozac in a seminal case study published in the American Journal of Psychiatry in 1990.
In 2001, a Wyoming jury ordered GlaxoSmithKline, the maker of Paxil, to pay $6.5 million to the relatives of Donald Schell, who two days after starting the drug, murdered his wife, daughter and granddaughter before killing himself. And just last week, a Kansas jury acquitted a prisoner of beating a corrections officer, essentially buying the prisoner's defense that high doses of Prozac made him go ballistic; for more on this case, read Furious Seasons.
Which brings me back to the murder suicide in Newton last week. I have no idea if William Wyman was on antidepressants -- family members and police aren't talking -- but that could explain why this 86-year-old man would take a knife with a three-inch blade to his wife (also 86), stabbing her repeatedly in the neck and then killing himself in the same brutal manner. According to The Boston Globe and the Newton Tab, Wyman and his wife had health issues. So he could have decided to end both their lives for that reason alone. But most elderly people who kill themselves because of poor health and an uncertain future don't do it quite so violently. They usually take an overdose of pills or they leave the car running and the garage door closed.
My heart goes out to the Wyman family, as it does to Kim Crespi and her three surviving children. Kim says she has filed an appeal based on the argument that the public attorneys who defended her husband were incompetent (they're the ones who convinced David Crespi to plead guilty and didn't raise the issue of his medication history).
While the FDA has insisted on black box warnings about the suicidal risks of these antidepressants, there has been no similar warnings about their link to violence, even though it is well-documented that these drugs cause some people to become agitated and unbalanced. So I just have one question: when is the FDA going to insist that the drug companies, who continue to earn billions from the sale of these antidepressants, do the kind of large-scale post-approval safety studies that can resolve this issue one way or the other?
Monday, October 26, 2009
Wednesday, October 21, 2009
Why scientific fraud is on the rise
At the NASW annual conference this past weekend, I happened to sit next to a scientist who studies ethical violations in scientific papers. Over lunch, Harold (Skip) Garner, a professor of biochemistry and internal medicine at the Unviersity of Texas Southwestern Medical Center, told me and the other folks at our table that research shows an increase in the incidence of data manipulation in published papers, ranging from manipulating results on submitted manuscripts and images to plagiarism, duplication and fabrication.
I've blogged about this problem before here, and it is, of course, not news to the many medical journals who have had to invest in sophisticated software to unearth such shenanigans. (It was with software like this that the editors of the New England Journal of Medicine discovered that the researchers who submitted a seminal trial of Vioxx to them in 2000 had erased data showing that the Cox-2 painkiller increased the risk of heart problems among patients. (Unfortunately, the journal only discovered that manipulation years later).
Even so, I was curious as to what Garner thought might be beyond this growth industry in cheating. Garner offered a two-fold reason. First, the opportunity is there: ever more sophisticated technologies allow scientists to cut and paste and slice and alter data submitted electronically. Second, as funding for NIH grants grows scarcer, there is greater competition and more pressure on scientists to publish and win those grants. Garner himself admits to such pressures. "We're always worried about getting the next grant," he said.
A third reason Garner didn't mention is the increasing commercialization of science and medicine, which has spawned an army of researchers on the take from health product companies. And a fourth reason is an appalling lack of enforcement by federal and state agencies that are supposed to monitoring scientific misconduct. According to The New York Times, a new Congressional report shows that the FDA takes years to investigate researchers accused of scientific fraud, which means that many of these scientists remain eligible to conduct research even after they have been convicted of fraud by local law enforcement.
Similarly, the Office of Research Integrity at the NIH only investigates one in 100 cases of suspected data manipulation and it rarely resolves the cases it does investigate. The commitment to policing scientific fraud should come from the top, but I haven't heard anything about this problem from Francis Collins, the new director of the NIH.
The NIH can certainly do far more to investigate allegations of fraud and restrict grants to labs and universities where there is evidence of irregularities. But it can't clean house by itself. Universities and academic institutional review boards (IRBs) have got to get a lot tougher in policing ongoing research studies and requiring the disclosure of financial conflicts of interest that tempt researchers into manipulating data in the first place.
Btw, I'm glad to see that Ed Silverman has Pharmalot up and running again, if only for news nuggets like this. You go Congresswoman McCollum!
I've blogged about this problem before here, and it is, of course, not news to the many medical journals who have had to invest in sophisticated software to unearth such shenanigans. (It was with software like this that the editors of the New England Journal of Medicine discovered that the researchers who submitted a seminal trial of Vioxx to them in 2000 had erased data showing that the Cox-2 painkiller increased the risk of heart problems among patients. (Unfortunately, the journal only discovered that manipulation years later).
Even so, I was curious as to what Garner thought might be beyond this growth industry in cheating. Garner offered a two-fold reason. First, the opportunity is there: ever more sophisticated technologies allow scientists to cut and paste and slice and alter data submitted electronically. Second, as funding for NIH grants grows scarcer, there is greater competition and more pressure on scientists to publish and win those grants. Garner himself admits to such pressures. "We're always worried about getting the next grant," he said.
A third reason Garner didn't mention is the increasing commercialization of science and medicine, which has spawned an army of researchers on the take from health product companies. And a fourth reason is an appalling lack of enforcement by federal and state agencies that are supposed to monitoring scientific misconduct. According to The New York Times, a new Congressional report shows that the FDA takes years to investigate researchers accused of scientific fraud, which means that many of these scientists remain eligible to conduct research even after they have been convicted of fraud by local law enforcement.
Similarly, the Office of Research Integrity at the NIH only investigates one in 100 cases of suspected data manipulation and it rarely resolves the cases it does investigate. The commitment to policing scientific fraud should come from the top, but I haven't heard anything about this problem from Francis Collins, the new director of the NIH.
The NIH can certainly do far more to investigate allegations of fraud and restrict grants to labs and universities where there is evidence of irregularities. But it can't clean house by itself. Universities and academic institutional review boards (IRBs) have got to get a lot tougher in policing ongoing research studies and requiring the disclosure of financial conflicts of interest that tempt researchers into manipulating data in the first place.
Btw, I'm glad to see that Ed Silverman has Pharmalot up and running again, if only for news nuggets like this. You go Congresswoman McCollum!
Monday, October 12, 2009
Pushing back against the drugging of our nation's youth
When my son was in kindergarten, he wrestled with his classmates and bit one of them, and his teacher (who was one or two years out of school) suggested that I get him tested for "neurological issues." I ran her suggestion past my son's pediatrician, and he said that my son's behavior was well within normal range for an active five-year-old. "He doesn't need to be tested," he said.
My son is now a healthy, well-adjusted 20-year-old excelling in college. But that long-ago episode came back to me this weekend when I was listening in on several panel sessions at the ICSSP conference in Syracuse (where I had been invited to speak). The theme of the conference was how to help parents deal with difficult children through "evidence-based" interventions rather than medicating them.
The 150 doctors, therapists and school counselors in attendance were concerned not only about the deleterious side effects of many psychoactive drugs (like Risperdal, Seroquel, Zyprexa, Ritalin, Paxil, Zoloft, Prozac etc.). But they also had a lot to say about the bankrupt promise of biological psychiatry and the role that the pharmaceutical industry has played in promoting this model. One neurologist noted that there is no evidence that the educational outcome of children labeled with mental disorders and prescribed drugs is any better than those children similarly labeled who don't take medications. In fact, he said, children who are diagnosed as ADHD and prescribed stimulants like Ritalin often do worse in school than those similarly diagnosed but not on drugs.
Yet in session after session, therapists talked about how hard it was to resist the presumption that the only way to deal with unruly children was to put them on meds. As Dr. Jock McLaren, a psychiatrist at Australia, said, "It takes an extremely brave parent to stand up to the assembled multitude of nurses and school officials insisting on drugs and operating under a spurious biomedical model."
Yet many of the therapists at the conference seemed determined to help parents do just that. And toward that end, speaker after speaker presented research showing the effectiveness of alternative methods of treatment for troubled children, ranging from family therapy to positive behavior modification to interventions in residential care.
Listening in on some of these presentations, it struck me anew how lucky I was, as a young mother, to have found a pediatrician who viewed the biological model (then just gaining steam) with skepticism and understood the importance of spending time talking to parents. Rather than whipping out his pen and writing my son a prescription, he took the time to chat with me and suggest safer, more effective ways of dealing with my son's behavior. This pediatrician, Dr. Howard King, has since emerged as a champion of working with families, and he spearheads a pilot project called the Children's Emotional Health Link.
I will always be grateful for this one doctor's wisdom, and this weekend in Syracuse I was gratified to see that many other health-care professionals and parents have joined the fight and are pushing back against the wholesale drugging of our nation's youth. To paraphrase Hillel: If not them, then who?
My son is now a healthy, well-adjusted 20-year-old excelling in college. But that long-ago episode came back to me this weekend when I was listening in on several panel sessions at the ICSSP conference in Syracuse (where I had been invited to speak). The theme of the conference was how to help parents deal with difficult children through "evidence-based" interventions rather than medicating them.
The 150 doctors, therapists and school counselors in attendance were concerned not only about the deleterious side effects of many psychoactive drugs (like Risperdal, Seroquel, Zyprexa, Ritalin, Paxil, Zoloft, Prozac etc.). But they also had a lot to say about the bankrupt promise of biological psychiatry and the role that the pharmaceutical industry has played in promoting this model. One neurologist noted that there is no evidence that the educational outcome of children labeled with mental disorders and prescribed drugs is any better than those children similarly labeled who don't take medications. In fact, he said, children who are diagnosed as ADHD and prescribed stimulants like Ritalin often do worse in school than those similarly diagnosed but not on drugs.
Yet in session after session, therapists talked about how hard it was to resist the presumption that the only way to deal with unruly children was to put them on meds. As Dr. Jock McLaren, a psychiatrist at Australia, said, "It takes an extremely brave parent to stand up to the assembled multitude of nurses and school officials insisting on drugs and operating under a spurious biomedical model."
Yet many of the therapists at the conference seemed determined to help parents do just that. And toward that end, speaker after speaker presented research showing the effectiveness of alternative methods of treatment for troubled children, ranging from family therapy to positive behavior modification to interventions in residential care.
Listening in on some of these presentations, it struck me anew how lucky I was, as a young mother, to have found a pediatrician who viewed the biological model (then just gaining steam) with skepticism and understood the importance of spending time talking to parents. Rather than whipping out his pen and writing my son a prescription, he took the time to chat with me and suggest safer, more effective ways of dealing with my son's behavior. This pediatrician, Dr. Howard King, has since emerged as a champion of working with families, and he spearheads a pilot project called the Children's Emotional Health Link.
I will always be grateful for this one doctor's wisdom, and this weekend in Syracuse I was gratified to see that many other health-care professionals and parents have joined the fight and are pushing back against the wholesale drugging of our nation's youth. To paraphrase Hillel: If not them, then who?
Monday, October 5, 2009
Will younger doctors be more resistant to drug company blandishments?
A week or so ago, I gave a talk to about 120 senior citizens at Brandeis University's Lifelong Learning Institute. The crowd was largely receptive to the topic -- how American consumers have been routinely misled about the safety and effectiveness of new drugs and treatments. They asked intelligent questions, and one retired psychiatrist even stood up to say how much he regretted having taken money from a drug company -- in the form of a free junket to a tropical locale -- to hear speeches about how wonderful its SSRI antidepressant was. He wouldn't do that now, he said, and he was sorry he had done it then.
But there were at least two people in the audience who didn't like what I had to say at all. In my talk, I had suggested a number of needed reforms, including passage of the Physician Payment Sunshine Act, which I've blogged about here. I even suggested that until that bill is passed, consumers might ask their doctors if they are getting any payments from drug companies that could possibly skew their prescribing habits.
During the Q&A, one man, who said he was a retired doctor, said that if a patient of his ever asked a question like that, he or she would be shown the door. Another doctor, a retired ob-gyn, took issue with what I'd said about the industry's longstanding practice of misleading consumers about new drugs, going back to the hype over hormone replacement therapy (HRT) on up to the current aggressive promotion of cervical vaccines like Gardasil. He accused me of exaggerating the dangers of HRT and practicing "sensationalistic journalism."
Rather than engage in verbal fisticuffs. I merely cited the recent studies showing that HRT increases the risk of breast cancer in women and repeated my concern that parents of young girls now targeted for the Gardasil vaccine in this country and Cervarix in the UK may not be getting the full story about the risks and benefits of these vaccines in treating cervical cancer. (For more on this issue, read Schwitzer health news and Gooznews).
But what struck me (and others in the audience) was the inability of these two doctors to understand that the winds of change are blowing and that the way they once practiced medicine -- with absolute deference from patients who viewed them as gods -- is a thing of the past. Consumers are waking up to the fact that doctors are human and thus susceptible to the same human frailties that tempt all of us. Money talks and can taint a doctor's judgement as much as it can anyone else's.
This was a major theme of Side Effects, and in the talks I've given since the book came out, I have stressed the need for full disclosure of financial conflicts and called for a ban on researchers receiving consulting and speaking fees from drug companies. Which is why it was so good to see the editorial in The Boston Globe last Thursday calling for much the same reforms. (The editorial followed an excellent article by Liz Kowalczyk earlier in the week).
Change is never easy. But I'd like to think that the newer generation of doctors are more savvy about the ways in which drug makers try to influence their judgement -- and a little more understanding of their patients' desire for transparency.
But there were at least two people in the audience who didn't like what I had to say at all. In my talk, I had suggested a number of needed reforms, including passage of the Physician Payment Sunshine Act, which I've blogged about here. I even suggested that until that bill is passed, consumers might ask their doctors if they are getting any payments from drug companies that could possibly skew their prescribing habits.
During the Q&A, one man, who said he was a retired doctor, said that if a patient of his ever asked a question like that, he or she would be shown the door. Another doctor, a retired ob-gyn, took issue with what I'd said about the industry's longstanding practice of misleading consumers about new drugs, going back to the hype over hormone replacement therapy (HRT) on up to the current aggressive promotion of cervical vaccines like Gardasil. He accused me of exaggerating the dangers of HRT and practicing "sensationalistic journalism."
Rather than engage in verbal fisticuffs. I merely cited the recent studies showing that HRT increases the risk of breast cancer in women and repeated my concern that parents of young girls now targeted for the Gardasil vaccine in this country and Cervarix in the UK may not be getting the full story about the risks and benefits of these vaccines in treating cervical cancer. (For more on this issue, read Schwitzer health news and Gooznews).
But what struck me (and others in the audience) was the inability of these two doctors to understand that the winds of change are blowing and that the way they once practiced medicine -- with absolute deference from patients who viewed them as gods -- is a thing of the past. Consumers are waking up to the fact that doctors are human and thus susceptible to the same human frailties that tempt all of us. Money talks and can taint a doctor's judgement as much as it can anyone else's.
This was a major theme of Side Effects, and in the talks I've given since the book came out, I have stressed the need for full disclosure of financial conflicts and called for a ban on researchers receiving consulting and speaking fees from drug companies. Which is why it was so good to see the editorial in The Boston Globe last Thursday calling for much the same reforms. (The editorial followed an excellent article by Liz Kowalczyk earlier in the week).
Change is never easy. But I'd like to think that the newer generation of doctors are more savvy about the ways in which drug makers try to influence their judgement -- and a little more understanding of their patients' desire for transparency.
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