An FDA panel recommendation may put us another mile down the road of unnecessary drug dependence

Smarmy Pharma Army

You don’t have to be related to a young person with schizophrenia or bipolar disorder to feel angry about a recent decision at the FDA that could move our drug-happy society another mile further down the road of unnecessary drug dependence.

If the parents of these kids only knew the truth…

Seeing red

A couple of weeks ago, HSI researcher Michele Cagan sent you a Code Red regarding a recommendation from an FDA panel.

Michele wrote: “In a crushingly disappointing decision, the FDA advisory panel has voted to approve three dangerous – sometimes deadly – drugs for use in our children. Even though these drugs are known to increase the risk of weight gain, diabetes, high cholesterol, and DEATH.”

When Michele sent me this information, she included this note: “Check out what one of the smarmy Pharma army had to say… ‘We are pleased that the committee found Seroquel to be effective and acceptably safe for treating adolescents with schizophrenia and children and adolescents with bipolar mania…'”

And why did this rather mild comment infuriate Michele? According to HealthDay News, in 2004 the FDA required the maker of Seroquel to place a black box warning to alert consumers about increased risk of type 2 diabetes and high blood pressure linked to the drug.

And just this past April, an FDA panel advised the agency to NOT approve Seroquel as a first-line therapy for adult depression, primarily because of an increased risk of sudden cardiac death.

So it has to be asked: Really? Acceptably safe? In what bizarro universe is a drug like this acceptably safe for kids?

The other two drugs recommended by the panel are Zyprexa and Geodon. Well…Geodon wasn’t exactly “recommended.” According to the Associated Press, the 18-member panel voted 8-1 to approve the drug. Nine of the panelists abstained from voting because they said the data were incomplete.

This tells me two things: 1) Nine members of the panel didn’t want to anger a drug company so they weaseled out of voting against the drug, and 2) Eight yes votes from an 18- member panel could only be considered an “approval” in FDA World.

Want some straight talk? Diana Zuckerman, president of the National Research Center for Women & Families, told HealthDay News that the panel’s approvals were based on small studies that only ran a few weeks – not really what you’re looking for in a drug that may be taken by patients for years. Furthermore, she says these studies showed that “between 20 to 30 percent of kids were gaining weight, heart rates were increased, many of the kids were so knocked out [sedated] that they could barely function.”

But in FDA World, that’s considered “acceptably safe.”

Guide for parents

Parents of adolescents or teens diagnosed with schizophrenia or bipolar disorder should ask these two key questions before allowing doctors to prescribe any anti- psychotic drugs…

QUESTION ONE: Can my child’s bipolar diagnosis be trusted?

In the e-Alert “Influence By the Numbers” (6/24/08), I told you about Dr. Joseph Biederman, a psychiatrist and Harvard professor. Dr. Biederman accepted more than $1.5 million in consulting fees from various drug companies between 2000 and 2007. During that time he did drug companies a huge favor by aggressively broadening the definition of bipolar disorder so that many more children would be considered candidates for therapy with anti-psychotic drugs.

According to PBS’ Frontline, there was a 4,000 percent increase in the number of children diagnosed as bipolar over the decade that Dr. Biederman and his colleagues expanded the concept of the disorder.

Every parent with a “bipolar” child should also take a look at the e-Alert “Right For You?” which details the profound dangers of Abilify (an anti-psychotic drug often prescribed for bipolar patients), the usefulness of lithium orotate, and the aggravating role that aspartame may play in bipolar disorder.

QUESTION TWO: Can my child’s schizophrenia be treated with vitamin B-3 (niacin)?

HSI Panelist Allan Spreen, M.D.: “The link between B-3 and schizophrenia is not well known except for those in complementary medicine. The response, however, can be remarkable.”

You can read all about B-3 therapy for schizophrenia in the e-Alert “Getting Played (Again)” (1/10/07).


“FDA Panel Backs 3 Psychiatric Drugs for Kids” Matthew Perrone, Associated Press, 6/10/09,
“FDA Panel OKs Newer Antipsychotics for Children” Steven Reinberg, HealthDay News, 6/10/09,