Earlier this year, the FDA recommended that emergency contraception, or Plan B, should be available without prescription to girls under 17 as it is currently available by prescription only to this age group. In an unprecedented move, the US Health and Human Services secretary Kathleen Sebelius vetoed the FDA's recommendation to make Plan B available without prescription to all women of childbearing age in the US. Mr. Obama said the secretary felt a 10- or 11-year-old should not be able to buy emergency contraception “alongside bubble gum or batteries."

What is Plan B or emergency contraception? Plan B is a pill that consists of the hormone progestin that works by preventing an egg from being fertilised. It must be used within 120 hours after unprotected sex, is safe and effective with few side effects and none dangerous.

Unlike some misconceptions, the availability of emergency contraception dose not change rates of sexual activity or increase the frequency of unprotected sex among adolescents.

Unintended pregnancies are an emotional and controversial issue, invoking deep-rooted religious, political and ideological beliefs. The US has one of the highest rates of unintended pregnancies with nearly half of all pregnancies unintended. In particular, adolescent birth rates in the US are much higher than rates in other developed countries.

Side stepping the issue of induced abortion, what is the effect of unintended pregnancy on women? A recent Lancet editorial discussed the results of a comprehensive review into the mental health outcomes of women after having an induced abortion. The key study finding was that having an unwanted pregnancy leads to an increased risk of mental health problems, not having an induced abortion.

The US should be leading the battle to reduce unintended pregnancies. Indeed the American Academy of Pediatrics (AAP) “encourages abstinence plus comprehensive sexuality education as the best way to help prevent unintended pregnancy and sexually transmitted diseases.” Further, they support the availability of emergency contraception, or Plan B, for adolescents.

Given that only 20-25% of health care providers discuss emergency contraception with adolescents, the restriction of Plan B to prescription only to adolescents under 17 seems a major barrier to access.

What is the likelihood that a 15-year-old who had unprotected sex is going to get a prescription for Plan B? She will be able to purchase acetominophen (i.e. Tylenol or Paracetamol) without a prescription, a medication that can potentially cause fatal liver damage and lead to liver failure if used inappropriately, yet she cannot purchase Plan B to prevent an unintended pregnancy.

Rather than rely on evidence, emotion wins. But the real loser are adolescents under 17 who may face life-long mental health problems. When emotion wins, we all lose.

Do You Know Who Frances Kelsey Is? I didn’t

I came across this article in the excellent Pharmalot site on Frances Kelsey by Ed Silverman

He’s right, ‘The odds are that you don’t.’

Fifty years ago Frances Kelsey transformed the way prescription drugs are regulated. As a new FDA employee she was assigned to review Kevadaon, better known as its brand name drug thalidomide.

Kelsey at the time questioned the drugs safety. “It just came with so many extravagant claims that I didn’t believe.” Sounds familiar to me.

Kelsey’s work led to the amendment of the Food, Drug & Cosmetic Act, requiring safety and effectiveness testing and informed consent in clinical trials. At this time the drug company Merrell were giving thalidomide to more than 1,000 US docs to distribute to 20,000 patients as part of a ‘so-called’ investigational trial. Some trial; many patients were not informed they were actually participating in a study.

They say the good die young. I think it’s more like the good don’t retire young: Kelsey retired from the FDA in 2005 at age 90.

There is more on the story at the New York Times

If you weren’t aware last week, Rosglitazone or Avandia as it is known in the trade, was in front of the Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee at the FDA to see if it should remain on the market.

Overall the panel voted 20-12 to keep it on the market. That means 1/3rd of the panel wanted the drug removed from sale as they considered the harms so bad they outweigh any potential benefits. 17 of the panellists in favour wanted either tighter prescribing restrictions or more warnings about cardiovascular risks. Based on the evidence I'd have voted for its removal.

This is where it gets bad. Endocrinologist David Capuzzi, who was on the panel confirmed he has been a Glaxo's speakers for several years. Get this ‘he doesn't see the relationship as a conflict,’ of course not. Capuzzi defended the drug during the meeting. Oh, by the way he was one of three members who wanted the drug to remain on the market with no additional earnings or restrictions.

Dr Capuzzi received $3,750 from GSK between April 2009 and March 2010. He has also received $8,000 in speaking fees form GSK before that period and $3,000 in the 2nd quarter of this year, total $14,750.
One member who voted to keep Avandia on the market, Arthur Moss , said "I'm surprised we weren't told.” Do you know what, I’m not surprised, are you? It seems the information was never given to the committee or to the public, and the FDA is investigating.

Because they didn’t get 32 individuals without conflicts they should hold the panel meeting and vote again. Outrageous!