Thursday, February 25, 2010

A few questions for Judith Warner and her editors

The glowing review of Judith Warner's new book, We've Got Issues, in The New York Times this week didn't exactly catch me by surprise -- anyone who has read Warner's guest columns in recent years knows her take on psychiatric drugs -- but it did bewilder me.

Why, I wondered, did the Times choose that particular book to review so prominently in its science section; was it because Warner has such a cozy relationship with the paper, having been a guest columnist for many years?

The reviewer says that Warner "sallied forth to interview all the pushy parents, irresponsible doctors and over-medicated children she could find — and lo, she could barely find any." And that made me wonder just who did Warner actually interview for the book (which, let me admit right off, I have not read). Did she only talk to the parents of children with "issues" and the doctors who prescribed meds for them, as the review makes it sound? If so, she seems to have missed half the story. After all, parents who put their kids on psychoactive drugs and the doctors who prescribed them are probably quite earnest in believing they did the right thing. As a parent myself, I know: it's very hard to admit publicly that you may have done the wrong thing; ditto for the medical profession.

What I want to know is: did Warner bother to interview any of the folks who were forced to take powerful psychoactive drugs as children and grew up to be psychiatric survivors who have since turned to more effective, alternative methods of healing? Did she interview any of the foster children in Florida and other states where these drugs have been used for years as chemical straitjackets to control behavior caused by abuse and neglect? Did she interview the mother of four-year-old Rebecca Riley who was recently convicted of pumping her daughter full of the anti-psychotic drugs that killed her?

Did Warner interview any of the teachers or professors who deal with the detritus of inappropriately medicated children and teenagers every single day?

And where the heck did she get the information that psychiatric drugs help change the structure of the developing brain for the better? I'd like to see the evidence backing up that wild claim.

Finally, I'd like to know who orchestrated Warner's book publicity because it was a stroke of genius to postulate that this woman ever initially believed that children were being over-medicated and then changed her mind after doing the research for her book. Judging from what Warner herself has written over the years, I seriously doubt that claim. But I have to acknowledge: it's a brilliant piece of marketing.

Thursday, February 18, 2010

Does aspirin really reduce the risk of breast cancer? We don't know yet...

In my health and science journalism class at Mount Holyoke yesterday, we were talking about all the questions journalists need to ask in deciding whether and how to report on a new medical finding. Two of the key questions that emerged were: 1. did the results come from a randomized clinical trial -- the gold standard of medical research -- or was it an observational study that examines people over time but has no control sample? And 2. did the study actually show cause and effect or just an association?

As it happened, the day's news furnished me with the perfect case example to illustrate the importance of these two questions. A page-one story in The Boston Globe, headlined "Aspirin may combat cancer, study suggests," trumpeted the results of a study published in the Journal of Clinical Oncology. The study in question was not a randomized clinical trial, i.e., it did not randomly compare what happened to one group who was taking the active drug (in this case, aspirin) with a control group who was taking a dummy pill or placebo. It was an observational study of more than 4,000 nurses (in the Nurses Health Study) who were diagnosed with breast cancer between 1976 and 2002, and it compared what happened with those nurses who regularly took aspirin vs those who did not. What the study concluded was that aspirin was associated with a decreased risk of death from breast cancer.

Associated is the key word here. The study did not find a cause and effect relationship, i.e. that the use of aspirin played a central role in reducing the risk of death from breast cancer. It only found an association between those two events (aspirin use and decreased risk of death). As Gary Taubes so eloquently points out in his New York Times magazine article, there can be a myriad of other reasons explaining such an association. There's something, for example, called the healthy volunteer effect. The nurses who took the aspirin in this particular study could simply be healthier and more concerned with staying healthy than the nurses who didn't, which might explain why they had a lower risk of dying from breast cancer. Until a randomized clinical trial is done, we won't know for sure whether it was the aspirin that kept more of the nurses alive or something other yet unidentified reason.

As Taubes notes, long-term prospective studies like the Nurses Health Study were among the first to show what looked to be an association between hormone replacement therapy and a reduced risk of heart disease and cancer (an association, by the way, heavily promoted by Wyeth and other companies that sold such replacement therapies). And we all know where that led us: to the routine prescribing of estrogen/progestin pills for millions of menopausal and postmenopausal women, a practice that significantly increased the risk of breast cancer for many of these women. This cause and effect and the discovery that hormone replacement therapy was not even protective of heart disease was only discovered years later when the federal government finally got around to funding a randomized clinical trial. In the meantime, thousands of women taking replacement therapies developed breast cancer and many died as a result.

Now I'm not saying that taking aspirin could produce a similarly devastating effect. Not at all. I take aspirin regularly myself to ward off bad headaches and I always keep a bottle handy. What I am saying is that the media needs to do a better job of explaining to their readers the difference between studies that find an association and studies that find an actual cause and effect. The Boston Globe article referenced above did not do a very good job of parsing this important difference and as a result, did a serious disservice to its readers.

Monday, February 8, 2010

Suing doctors who use drugs as chemical straitjackets for children

It's true that the drug industry was hard hit last year with some pretty hefty fines for the illegal off-label promotion of drugs -- $1.4 billion against Eli Lilly for its off-label promotion of Zyprexa and $2.3 billion against Pfizer for doing the same with several drugs. But such fines, many say, are still considered the cost of doing business in an industry that raked in close to $300 billion in U.S. drug sales in 2008 (and more in 2009), according to IMS Health Reports.

Now, Alaska attorney Jim Gottstein has proposed a different and potentially more effective approach toward curbing the systemic over-drugging of economically disadvantaged youngsters in this country, a sad reality which I've written about here and here. According to one recent study, children covered by Medicaid are given anti-psychotics such as Zyprexa and Seroquel (which have serious side effects) four times as often as children whose parents have private insurance. These drugs are often prescribed as chemical straitjackets to control children whose parents or foster families are unable to give them the attention and parenting they need. That was certainly the case for four-year-old Rebecca Riley, who died from an overdose of psychoactive drugs prescribed by a psychiatrist at Tufts Medical Center, Kayoko Kifuji.

Gottstein has launched an initiative to sue doctors like Kifuji who blithely prescribe potent drugs that are not approved for use in children. These lawsuits, filed under a federal Qui Tam complaint, would target not only the individual doctors but the hospitals and clinics that employ them and the pharmacies that fill their prescriptions and submit them to Medicaid for reimbursement. It is Gottstein's contention that these prescriptions constitute Medicaid fraud since they are written for uses that are not medically accepted (i.e. off-label). There is legal precedent for this kind of argument. Indeed, the Department of Justice's news release announcing its $2.3 billion settlement with Pfizer says that the drug giant caused false claims to be submitted to government health care programs for uses that were not medically accepted indications. So if the feds can succeed with this kind of argument, why not individual claimants?

Gottstein is planning to discuss his medicaid fraud initiative in a lecture webinar on Feb. 24, sponsored by the International Center for the Study of Psychiatry and Psychology. So if you know of a disadvantaged child who was slapped on drugs he or she didn't need, you might want to listen in.