As this month began, a landmark research study and an unusual lawsuit by the state of New York added to the current controversy about whether children and adolescents with depression should be treated with the popular antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs), a class of drugs which includes the best-selling Prozac and Paxil.
On June 1, researchers carrying out a federally funded study at Duke University announced preliminary findings that Prozac works significantly better than talk therapy to combat depression in adolescents, although a combination of the two treatments is the optimum. The early data also suggest that Prozac does not, in fact, raise the risk of suicide in adolescents, and that the benefits of taking it far outweigh the risks if a teen is battling moderate to severe depression.
On June 2, New York State Attorney General Eliot Spitzer filed a consumer-fraud lawsuit against the manufacturer of the antidepressant Paxil, charging that international pharmaceutical giant GlaxoSmithKline deliberately suppressed negative data about Paxil's safety and efficacy when prescribed for depression in children and adolescents.
Specifically, Spitzer's lawsuit alleges that the company suppressed the results of four studies it conducted that failed to demonstrate Paxil's effectiveness against depression in children, and suggested possible increased risk of suicidal thinking and acts. Out of the five studies it conducted, Glaxo released the results only of the one that showed mixed results on efficacy in children and teens, the suit alleges.
As the New York Times story on the lawsuit notes, the suit highlights two particular issues about antidepressants that have recently made headlines and captured medical and public attention. One is the previously mentioned question of whether some antidepressants, specifically some SSRIs, can actually increase suicidal tendencies, especially in children and adolescents. The other is whether, and to what extent, drug companies pick and choose among the data they present to the U.S. Food and Drug Administration when seeking FDA approval for a drug, presenting only those studies that support the drug's efficacy and safety and suppressing any that reach the "wrong" conclusions.
"Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients," Spitzer said of his lawsuit. "By concealing critically important scientific studies on Paxil, Glaxo impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety."
The suit, filed in New York State Supreme Court, also stated that an internal Glaxo document from 1998 shows that the company intended to "manage the dissemination of [the] data in order to minimize any potential negative commercial impact."
It alleges that Glaxo misrepresented the drug to its sales representatives who promote Paxil to physicians, as having "remarkable efficacy and safety in the treatment of adolescent depression," despite the company's studies that suggested differently.
Glaxo issued a statement the same day asserting that the company "has acted responsibly in conducting clinical studies in pediatric patients and disseminating data from those studies.... All pediatric studies have been made available to the FDA and regulatory agencies worldwide."
"As for the 1998 memo, it is inconsistent with the facts and does not reflect the company position," the statement continues.
Paxil has been approved by the FDA for the treatment of depression in adults but not in children. The only antidepressant that has been approved to treat depression in children is Prozac, which is made by Eli Lilly & Co.
It is, however, legal for doctors to use their discretion to prescribe medications for uses other than the approved ones, if clinical practice has shown them to be useful. They are especially likely to do so if the medications are similar to ones that are approved for those uses. This widespread practice is called "off-label" prescribing.
U.S. sales of Paxil to treat mood disorders in children and adolescents totaled $55 million in 2002, the lawsuit states. The suit seeks the return of all profits Glaxo has earned as a result of the alleged misconduct.
Meanwhile, according to a New York Times report, the researchers for the Duke University study announced at a psychiatric meeting in Phoenix that the 12-week data showed that a combination of Prozac plus "talk" therapy worked best for depressed teenagers, with 71 percent of these patients responding well to treatment. Prozac alone worked next best, improving depression in 61 percent of the young patients. Talk therapy alone (specifically, cognitive-behavioral therapy, which previous studies have shown to be the most effective type of talk therapy at combating depression) worked only slightly better than a placebo. Only 43 percent of the patients treated with cognitive-behavioral therapy, versus 35 percent of those taking a placebo pill, showed significant improvement. None of the 378 teens aged 12 to 17 committed suicide, although there were six attempts.
The Duke team, whose research is being funded solely by the federal National Institutes of Mental Health with no drug-company involvement, is currently analyzing the data from the rest of the year-long study.
Sue Wilson is a journalist who writes frequently on health and science topics for such outlets as the New York Times, WNET, and UNICEF
A federal ban on home use of two insecticides has strong benefits to newborns, a new study (In PDF Format) by Columbia University's Center for Children’s Environmental Health. This is the first study to demonstrate the benefits of the ban during pregnancy in human subjects.
The study looked at the impact on fetal growth of chlorpyrifos and diazinon - two insecticides whose use in households was banned by the federal government in 2000. These two insecticides had been among the most commonly used for residential pest control and were available in a wide variety of household sprays and other home insecticides; Chlorpyrifos was the most frequently used residential insecticide in New York City. Both are still widely used in agriculture and continue to be found in the food supply.
The research involved 314 infants of African American and Dominican women in Washington Heights, Central Harlem and the South Bronx. The researchers measured the levels of the two insecticides in blood drawn from the umbilical cords at birth, both before and after the ban, and correlated those levels with the babies' birth weight and length.
Newborns arriving before the ban went into effect in January, 2001, who had insecticide in their blood weighed almost a half a pound less, and were smaller, on average, than those with no detectable levels. After the ban, the combined insecticide exposure levels had been reduced substantially, and there was no discernable effect on fetal growth.
"This study demonstrates the positive effect of the federal ban, which has substantially reduced exposures and benefited human health," said Dr. Robin M. Whyatt, principal author of the study. "The differences in fetal growth seen here are comparable to the differences between babies whose mothers smoke during pregnancy and babies whose mothers don't. The fact that the ban was associated with such an immediate change in birth weight and length provides considerable evidence of cause and effect."
"The results highlight the need to address continuing prenatal exposures to these and other toxic pesticides," said Dr. Frederica P. Perera, Director of the Mailman Center and the study team leader.
This research is part of a broader, multi-year research project, "The Mothers & Children Study In New York City," that was begun in 1998. It examines the health effects of exposure of pregnant women and babies to air pollutants from vehicle exhaust, the commercial burning of fuels, and tobacco smoking, as well as from residential use of pesticides and allergens.
Welfare Sanctions
In 2001, Marleny Acevedo, who was on public assistance, missed an appointment with her caseworker because her eight-month-old son had a fever and she stayed home to take care of him. When she tried to reschedule the appointment, her caseworker told her she would be sanctioned. Her bi-monthly benefits were reduced from $68.50 to $51, and then dropped again. What's more, the city hadn't included her son when it calculated her benefits, so Acevedo was being shorted a total of $174 a month in benefits and food stamps.
Altagracia Galindez, a 44-year-old mother of five, never knew that she was entitled to 25 percent more in public assistance than she was receiving. She didn't even know she was sanctioned until two years later. Several months of subsequent fighting her way through bureaucratic red tape led nowhere.
These women eventually received their full benefits, thanks to Acevedo v. Turner, a class action suit brought against the city's Human Resources Administration that was settled in April. Under the terms of the settlement, people facing sanctions will be notified of their alleged noncompliance and given information on how to challenge sanctions. In addition, the Human Resources Administration is now required to lift sanctions within seven business days of its being notified that a person has complied with the requirements.
Approximately 2,000 women are sanctioned by the city annually because they fail to comply with the child support cooperation requirements. Most of those are for inappropriate reasons, charges Randal Jeffrey, the attorney handled Acevedo's case for the New York Legal Assistance Group, such as missing a single appointment. "The question isn't whether the sanction is legitimate, it's whether they can get it lifted at all," Jeffrey says.
Commissioner Bell resigns from the Administration of Children's Services
William C. Bell, the Commissioner of the Administration for Children's Services, is leaving his post in July to work at a private child welfare agency. Bell, who has headed the agency since December 2001, had helped institute a nationally regarded overhaul of the city's child welfare system.
Bell's record is mixed, say child advocates. Under him the agency tried to keep children in their own homes with the help of services from community organizations. The number of children in foster care has dropped by more than half since 1996, to 22,000. But the average stay in foster care in the city is 49 and a half months, well above the national average of 33 months, and the waitlist for low-income childcare has grown to 43,000.
His replacement has not been announced.
Sasha Nyary, formerly on the staff of Life Magazine and the mother of a public school student, edits the newsletter of The Fifth Avenue Committee, a community-based organization.
One of the most heavily stressed goals in the city's sweeping new public health plan is to help as many New Yorkers as possible quit smoking. It's an instance of the health department getting its priorities right and pursuing enlightened policy. In 2002, the last year for which New Yorkers' causes of death were tabulated, smoking killed more city dwellers (approximately 10,000) than alcohol, suicide, homicide, motor vehicle accidents, illegal drugs, and breast cancer combined. That is, smoking-related illnesses like lung cancer and other forms of cancer, heart disease, and stroke were responsible for nearly one out of six of the deaths in the city, according to Dr. Thomas Frieden, commissioner of the city's Department of Health and Mental Hygiene.
The city's new public health plan, unveiled in April, announced a goal of reducing the percentage of New Yorkers who smoke from 22 percent (in 2002) to 18 percent in 2008; freeing 240,000 individuals from their addiction. If successful, the health department has asserted, this one public health push alone will prevent 80,000 premature deaths among New Yorkers.
It sounded ambitious; but then the health department announced, on May 12, that the number of smokers in New York City had already declined a whopping 11 percent from 2002 to 2003 -- the fastest drop in smoking rates ever recorded anywhere in the nation. In just one year, 100,000 New Yorkers had kicked the habit. This was a decline in the percentage of New Yorkers who smoke from 22 to 19 percent -- making the goal of 18 percent by 2008 seem, if anything, too modest. These new findings come from surveys conducted at the city's behest by the survey unit at Baruch College.
Commissioner Frieden attributes the unprecedented drop to "[t]he increase in the cigarette tax, implementation of the Smoke Free Air Act, our nicotine patch distribution program, and public education about the health risks associated with tobacco." The decline in smoking will prevent 30,000 premature deaths, he said.
The increase in the cigarette tax and the ban on smoking in bars enacted last year undoubtedly played a major role in the decline. The aggressive anti-smoking measures the health department has pursued under Bloomberg, including advertising and the nicotine patch program cited by Frieden, probably account for the rest.
The nicotine patch program, a one-time give-away by the city of six-week supplies of nicotine patches to 35,000 New Yorkers last year, was notably successful, according to a report released by the health department last month. Eleven thousand, or 33 percent, of the participants are now ex-smokers. "The results far exceeded our expectations," Frieden said of the program.
"If you think about everything we did in the New York City Health Department last year, there's no single program that saved anything like this number of lives," he told the New York Daily News.
Most of the smokers who took advantage of the patch offer were black, Latino, or Asian, and/or from low-income neighborhoods. Women and young adults participated at high rates. Roughly 8,500 of the participants were from Brooklyn, 7,500 from Queens, 6,300 from the Bronx, 6,200 from Staten Island, and 5,000 from Manhattan. The city also made follow-up phone calls to participants and provided free counseling to those who wished it, then interviewed the participants after six months to determine the program's success rate.
"Most New Yorkers who smoke want to quit and try to quit each year," said Frieden. "But four of five who tried to quit did so without the benefit of medications or counseling, which we know greatly increase quit rates. Most people who want to quit should receive medications. Doctors should advise their patients to quit and provide medications to virtually all patients who are trying to quit. And families who want to assist their loved ones to quit should encourage them to try medication or counseling. Simply put: Drugs to help people quit smoking work!"
Nicotine patches are estimated to double the likelihood that a smoker trying to quit will succeed.
Although the "patch hotline" was a one-time offer timed to coincide with the enactment of the city's year-old laws prohibiting smoking in bars and restaurants, would-be quitters who lack insurance coverage will still be able to get free stop-smoking aids, including the patch and the stop-smoking drug Xyban, through the New York City Health and Hospitals Corporation's 14 free smoking-cessation clinics, located in Manhattan, the Bronx, Brooklyn, and Queens. Some community clinics and other participating healthcare providers will also offer the services and medications gratis to those who qualify.
Since the city's new health initiative does not have a budget associated with it, it is not clear how much funding will got to the smoking-cessation programs, or if they will be sufficient to reach the ambitious goals set for 2008. If they are anywhere near as successful as the nicotine patch trial, however, they will be a bargain at almost any price: Considering the $2.7 billion in direct medical costs and then the $2.0 billion in lost future earnings, tobacco use costs New York City an estimated $4.7 billion annually.
Aside from the New Yorkers it kills prematurely, the health department estimates smoking has disabled another 240,000 city residents through chronic bronchitis, emphysema, stroke, and heart disease, among other debilitating illnesses. And exposure to second-hand smoke has been demonstrated to contribute to heart disease and cancer beyond a reasonable doubt.
New Yorkers can call the city's help line at 311 for more information about clinics offering stop-smoking aid, including times of operation.
Sue Wilson is a journalist who writes frequently on health and science topics for such outlets as the New York Times, WNET, and UNICEF