FDA targets sick mothers

What if two months were shaved off of your life? What if you missed out on 60 days of quality time with your family and friends? Sixty days during which you could walk your daughter down the aisle, see your son graduate from college, experience a book, a movie, a painting. Sixty days to see Paris or the Grand Canyon. What if those two months were taken away from you? I'm willing to bet that you'd think that was a pretty big deal, right?

Well, the FDA doesn't think the same way. Surprise, surprise.

Recently, a panel of FDA "experts" voted against the expansion of the use of the cancer drug Avastin for use in breast cancer patients. The reason? FDA scientists said that patients treated with Avastin and chemotherapy survived an average of 26.5 months, compared with 24.8 months for patients treated with chemotherapy alone. The FDA said this difference was "not significant."

Yipes. If there's ever a situation in which you need an oncologist, take my advice: make sure your oncologist never worked for the FDA.

It seems like every time I manage to get my blood pressure under control, these bureaucratic boobs have another outrage waiting in the wings to burn my posterior. And I can't let this one pass, either. The glibness with which they can call a 60-day extension of life "not significant" really riles me.

Now I know these men are scientists that deal in figures and statistics, and as men of science that's their charge. But these men are also doctors, and this sort of proclamation is more than just bad bedside manner; it's horrendous PR. And it serves to underscore that the FDA has so locked itself in its ivory tower that they're tremendously out of touch with the needs and the fears of the American people. It's a glimpse into their robotic approach to healthcare. Patients aren't people to them; they're statistics and control groups.

For anyone whose lives have been touched personally by the struggle against breast cancer, this must be offensive in the extreme.

Now you'll rarely hear me clamoring for the FDA to put more drugs into the pipeline. But this time, it's different.

The FDA initially approved Avastin to treat colon cancer (as well as some types of lung cancers) in 2004, and it was the first drug ever to fight cancer by stopping nutrients from reaching tumors. It was thought that "targeted therapies" such as these could eliminate the need for chemotherapy, but sadly this hasn't been the case. The maker of Avastin wanted to get the FDA's stamp of approval to treat patients with advanced breast cancer who have not taken other drugs. Some doctors are already using Avastin in this manner, but as you might have guessed, an FDA approval would've significantly increased this treatment.

FDA scientists also questioned the safety of Avastin, saying that patients using the drug had toxicity levels 20 percent higher than with chemotherapy, and that side effects included hypertension and blood clots (maybe it's me, but I'm guessing that a woman with advanced breast cancer wouldn't give a rat's rear-end if she had to end up with a case of hypertension in place of her breast cancer).

Maybe so, but here's the disturbing part: earlier last year, Britain's GlaxoSmithKline received approval for a drug called Tykerb to treat patients with advanced breast cancer. Hmmm … based on what I've written about the power of Big Pharma in FDA decisions, do you think this could, maybe, just possibly have had somewhat of a small, tiny, eensy- weensy part in not approving Avastin? I do. Was Avastin ineffective, or did Glaxo just cut a bigger check?

I don't want to believe that the FDA thinks two months of human life is insignificant. I don't want to believe that the sleazy pharma reps are schmoozing and palm-greasing their drugs past the FDA. But I've been around for a while. And the thought has crossed my mind. The FDA is so damned arrogant that they're not even bothered by the appearance of impropriety.

I still can't get past those 60 days that they'd so casually toss onto the trash heap. And I'm hoping that the FDA's own cold-hearted statement will help you finally hear what I've been saying about the FDA all along - it's time for them to go.

Cell phone use increases tumor risk

Let's go from something that was meant to slow the growth of tumors to something that may cause them to grow. According to an Israeli study published in the American Journal of Epidemiology, the regular use of mobile phones increases the risk of developing tumors.

That sound you just heard was 99 percent of the American population whispering, "uh- oh."

I wish I could say that this was just a scare tactic to get people to stop talking loudly on cell phones at restaurants and on public transportation. But this study is the real deal, and it claims that the risk of developing a parotid gland tumor is 50 percent higher for frequent mobile phone users. "Frequent" is defined as using a mobile phone for more than 22 hours a month.

Again - more gulps.

But that's not all. The risk goes up even higher if users push the phone into the same ear time and time again, or if they do not use hands-free devices. The proliferation of the cell phone throughout our culture is surely what's prompted this study, and if it's even a little true, it's a dangerous sign of things to come. I'm sure that just today you've probably seen over 40 people on the street, in the mall, at work, or in the neighborhood happily chatting away on those insidious little devices, exchanging endless hours of small talk.

I know we've all become enthralled by the rapidly advancing telecommunications technology of our age. But you've got to ask yourself: is this call I'm about to make really necessary? Does this call need to be this long? Is this conversation worth losing my life over? The cell phone habit can be tough to break. But your life is potentially on the line. Do you stick with cell phone use? You make the call.

Or, better yet … don't.