Antipsychotic Drugs Prescribed to Kids Get More Scrutiny

Alison Bass directs our attention to the tragic story of Denis Maltez, a 12-year-old Miami boy who died of serotonin syndrome after being given two anti-psychotic medications (Seroquel and Zyprexa) plus an anti-seizure drug and tranquilizer. Serotonin syndrome occurs when a combination of drugs causes the brain to produce excess serotonin. Denis had severe autism and was living in a Rainbow Ranch group home; the lawsuit just filed by his mother, Martha Quesada, says the drugs were used as a "chemical restraint to control Denis's behavior."  Florida shut down Rainbow Ranch shortly after Denis's death.

Denis is not the only child to have died after being given a cocktail of psychiatric drugs. In 2006, 4-year-old Rebecca Riley died from an overdose of drugs prescribed for bipolar disorder and ADHD.   The Wall Street Journal's David Armstrong reports that prescriptions of psychiatric drugs for children increased 44.6% between 2002 and 2007, and many of these drugs are not approved for use in children. The good news is that since Riley's death, states are increasing scrutiny of psychiatric drugs prescribed for children, and this scrutiny is starting to have an effect. Armstrong writes:

Some states began moving to require special approval before they would cover a claim for an antipsychotic. A group of 16 states started studying the use of psychiatric medication in children in 2007 in an effort they dubbed "too many, too much, too young," says Jeffrey Thompson, the medical director of the Washington state Medicaid program.

In California, the number of children six and under using psychiatric medications has fallen to 4,200 from 5,686 since a 2006 prior-authorization plan was put in place, the state's top Medicaid official says.

Florida's state Medicaid agency says the number of prescriptions for atypical antipsychotics written for children under age six in the second half of last year dropped to 1,137 from 3,167 a year earlier.

The agency says the decline was the result of a state program started last year under which prescriptions for children under six are reviewed for appropriateness by state-hired psychiatric consultants before Medicaid will cover them.

Washington has created a system to flag the use of psychiatric drugs that may contain too high a dose for young children or have side effects that it regards as particularly dangerous. From May 2006 to April 2008, the system flagged 1,032 cases for review by outside consultants.

Attorneys general from 11 states are also investigating Eli Lilly for allegedly marketing its antipsychotic Zyprexa for non-approved uses; the company has already agreed to a $1.4-billion settlement over its marketing of the drug.

In her post about Denis Maltez's death, Alison Bass brings us back to the larger question:

Why, you might ask, do some psychiatrists prescribe these potentially lethal drugs to young children and then not monitor them for side effects? I can't answer that question. What I do know is that many doctors and consumers think these drugs are safe and effective for such off-label uses in large part because drug companies have paid big bucks both to KOLs [Key Opinion Leaders] and "patients" like Andy Behrmann and Jim McNulty to shill for them. And that's precisely why we need public disclosure laws like the one that the Vermont Legislature passed this week -- see New York Times article here -- so that everyone knows who the shills are and can take what they say with a hefty dose of skepticism. Here's hoping Congress passes the Physician Payment Sunshine Act and makes this a national trend.

The new Vermont law she references requires pharmaceutical companies to publicly disclose all payments given to healthcare providers with prescribing authority, and it bans nearly all gifts (including free meals) given to healthcare providers and other health-related staff. Vermont already requires pharmaceutical companies to report marketing expenses, but the new legislation closes a loophole that had allowed companies to use the "trade secret" designation to keep some expenses private.

Minnesota already requires pharmaceutical companies to report their payments to healthcare providers, and these reports are made available to the public. In 2007, New York Times reporters Gardiner Harris, Benedict Carey, and Janet Roberts analyzed Minnesota's records and found a correlation between financial relationships between doctors and pharmaceutical companies and an increase in the prescriptions of atypical antipsychotics for children:

From 2000 to 2005, drug maker payments to Minnesota psychiatrists rose more than sixfold, to $1.6 million. During those same years, prescriptions of antipsychotics for children in Minnesotaâs Medicaid program rose more than ninefold.

Those who took the most money from makers of atypicals tended to prescribe the drugs to children the most often, the data suggest. On average, Minnesota psychiatrists who received at least $5,000 from atypical makers from 2000 to 2005 appear to have written three times as many atypical prescriptions for children as psychiatrists who received less or no money.

The article goes on to note that "no one has proved that psychiatrists prescribe atypicals to children because of drug company payments," and that some prescribers of these drugs for children receive no payments from the pharmaceutical industry.

There are many reports of children with serious mental health issues benefiting from psychiatric drugs; it's likely that for many children, the benefits of atypical antipsychotics outweigh the risks, which include "rapid weight gain and blood sugar problems, both risk factors for diabetes; disfiguring tics, dystonia and in rare cases heart attacks and sudden death in the elderly." For other patients, less-risky treatments might also be effective and should be tried first.  The drop in psychiatric-medication prescriptions for children in states that have instituted prior authorization suggests that prior to these programs, some doctors were writing these prescriptions without have first tried these less-risky options.

Increased scrutiny from regulators responding to disturbing trends seems to be improving prescribing practices around psychiatric drugs for children. Increased transparency in Minnesota has enabled journalists to draw attention to potential conflicts of interest, which can prompt doctors to examine their own prescribing behaviors and may result in additional regulatory measures. When it comes to drugs that can result in serious health problems and even death, vigilance and transparency are key.