Tamoxifen: Drug trial gambles with participants health

Imagine you have a 15-year-old son who wants to play Russian roulette. Would you let him play?

Absurd question, isn't it? Here's an even more absurd scenario: Imagine your son has no opinion one way or another about playing Russian roulette. Nevertheless, you load the gun and hand it to him.

I know. It sounds crazy. But that metaphor fits a recent study that encourages the off-label use of a drug that could easily put young men in jeopardy of long-term health risks. And when you find out what the desired outcome is, you might wonder how in the world the researchers enlisted parents who were willing to let their children enroll in a study that couldn't possibly promise a 100 percent safe outcome.

Tamoxifen combined with growth hormone given to boys
Tall men have it good. According to the web site for the Baltimore Tall Club, 'Studies have shown that tall men make more money, are more likely to win an election and have an easier time dating.'

Well, as Sigmund Freud famously pointed out: Anatomy is destiny.

But Freud, you know, he's just so 20th Century. Here in the 21st we have the means to tinker with both anatomy and destiny.

The December 2005 issue of the journal Pediatrics includes a study conducted at the Riley Hospital for Children, Indiana University School of Medicine in the US. Seven short teenage boys (their average age was about 15) were given tamoxifen two times each day. Intervention periods ranged from six months to four years. Researchers report that the boys' predicted adult height increased by almost four inches.

Couple of things: 1) Did you catch the word 'predicted'? As the researchers note, additional evaluation will be required to assess whether or not the boys will actually turn out to be taller than expected. And 2) Six of the boys were also taking growth hormones during the testing period.

And one more thing: tamoxifen. Ring a bell? In the e-alert 'The cancer-fighting potential of natural progesterone' (10/1/06) I told you about this synthetic hormone-like drug. It's used to treat oestrogen-driven breast cancers by preventing oestrogen from binding to breast cancer cells. Needless to say, increasing the height of boys of modest stature is an 'off-label' use of tamoxifen. WAY off-label.

Is it worth gambling with your health?
This was not a long-term study, so the extended effects of tamoxifen combined with a growth hormone won't be known unless someone follows up on this research in years to come. Meanwhile, the researchers claim that tamoxifen was used 'without negative effects on sexual maturation.'

Really? How could they possibly come to this breezy conclusion without following the boys' progress for a decade or more?

Here's what I wrote about tamoxifen in last e-alert: 'The most common side effects are not life threatening, but according to breastcancer.org 'they may still decrease your quality of life, sometimes to a considerable degree.' That's because tamoxifen can prompt hot flushes, nausea, vomiting, weight gain, mood swings, depression and a loss of energy. And those are only the annoying side effects. The dangerous side effects include an increased risk of developing blood clots as well as uterine and liver cancers.'

It's safe to say that the boys - whatever their adult height turns out to be - won't experience hot flushes or uterine cancer. But it astonishes me that researchers and parents would consider a few 'predicted' extra inches of height worth the risk of potentially life-threatening health problems.

I guess I shouldn't be astonished at anything like this anymore. After all, one of the bombshells of the recent Vioxx scandal involved children, although most people never heard about this deplorable detail as the larger scandal unfolded.

When Merck pulled the plug on Vioxx in the US in 2004, we found out that the US Food and Drug Administration (FDA) had known for years that the drug was associated with an increased risk of heart attack and stroke. And as unsettling as that is, that's not the bombshell. This is the bombshell: In early September of 2004, the FDA approved the use of Vioxx for kids. And according to WebMD Medical News, this approval was based on a trial that lasted only three months. Not exactly what you'd call a 'long-term' study.

So we shouldn't be astonished that the medical community is comfortable about putting kids at risk as research guinea pigs. Outraged? Yes. Astonished? No.