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Botox: A Marketing Dispute Over an Anti-Aging Drug

04 Sep

On Sept. 1, drugmaker Allergan agreed to pay $600 million to the feds to settle charges that it improperly marketed wrinkle-eraser Botox for uses not approved by the FDA, such as relieving headaches. It caught my eye,  because I’m being asked quite frequently these days to explain why regulators aren’t more attuned to the improper use of anti-aging drugs.

Drug companies are prohibited by law from marketing their products “off label”–that is for uses not cleared by the FDA.

Botox is approved by the FDA to erase wrinkles and treat some muscle disorders. But Allergan has been testing the drug for other purposes, including treating migraines. And last October, it became the first drug company to sue the federal government over the ban on off-label marketing, arguing that the law violated its first-amendment rights to commercial free speech.

As part of this settlement, Allergan agreed to drop that suit. And that pretty much settles it: Drug companies will not be permitted under the laws of this country to market their drugs off-label.

Off-label marketing is a particularly touchy subject when it comes to human growth hormone, another drug commonly prescribed in the anti-aging industry. HGH is in a special legal class, because it’s not only illegal for the drug companies that make it to market it off-label (i.e. for anti-aging), but it’s also illegal for doctors to prescribe it off-label. Normally, physicians can use their discretion and prescribe drugs for uses not approvecd by the FDA. That’s not the case with HGH.

As I explain in Selling the Fountain of Youth, regulators have had only a modest amount of success prosecuting HGH cases. In 2007, Pharmacia (a unit of Pfizer) admitted to improperly marketing its popular HGH drug, Genotropin, but only had  to pay the federal government a fine of $15 million.

Some physicians have faced charges, as well, though most of the prosecutions have been levied against doctors found prescribing HGH to professional athletes.

The government has long vowed to step up its monitoring of off-label marketing, and after the Allergan settlement was announced, Tony West, assistant attorney general for the Justice Department’s civil division, told reporters, “These cases are cases that we will continue to aggressively pursue.”

The point of cases such as this is to dissuade drug companies–and in the case of HGH, doctors–from engaging in improper marketing of any drug. I’ll be interested, however, to see if it actually works.

 
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Exercise: The Only Anti-Aging Routine that Works

21 Jun

I came across a recent column in the Baltimore Sun penned by five-time Olympic speed-skating legend Eric Heiden. In “Exercise: The Anti-Aging Shield,” Heiden–now an orthopedic surgeon–writes about how exercise affects telomeres, which are tiny pieces of DNA that protect chromosomes. Scientists have long suspected that short telomeres are associated with heart disease, diabetes, and early death.

According to recent research at the University of California in San Francisco, exercise lowers stress, which in turn preserves telomere length. (Telomeres are the red bits in the photo on the right.) In essence, exercise prevents cells from aging due to stress.  And you don’t need to put in an Olympian effort: Vigorous physical activity for a total of 42 minutes over a three-day period is plenty, the researchers say. You have to keep it up, week in and week out, over a lifetime. Still, says Heiden, this is the first study to show definitively that exercise is linked to longer telomeres.

As is the case with anything related to anti-aging, though, at least one company is trying to give people an easy way out. When I was researching my book, I met Noel Patton, founder of TA Sciences, a New York company that sells an herbal supplement called TA-65. Patton believes TA-65 lengthens telomeres, and when I met him, he was busy recruiting people to try it as part of his “Patton Protocol”–which costs $25,000 a year. This despite the fact that he has little scientific proof that the supplement, derived from the Chinese herb astragalus, affects telomere length at all.

Exercise, on the other hand, has been proven time and again to have remarkable anti-aging properties. A study by the Institute for Aerobics Research in Dallas found that death rates plummeted among people who started taking half-hour walks a few times a week. Men who became fit decreased their risk of dying of any disease by a staggering 44%.

Yet exercise is still among the hardest chores to get Americans to do. A 2009 Gallup survey found that only one in four Americans were willing to get off their butts and exercise for a scant half-hour, five or more days a week.

It’s not as if moderate exercise is that difficult. Gardening counts, as does taking the stairs instead of the elevator. If the UCSF research proves true, all of that will help lengthen your telomeres and possibly extend your life. I got a dog and started walking between 40 minutes and an hour a day, mixing high-speed and low-speed walking. I lost 10 pounds without really intending to, and my HDL (the “good” cholesterol) went up. My primary care doctor recently told me I don’t really need to worry about doing other sorts of exercise–the dog is plenty.

One thing is certain: My dog costs me a lot less than $25,000 a year, and she’s much cuter than a bottle of TA-65.

 
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Kurzweil and Kin Preach “Singularity”

14 Jun

I read with great interest the recent New York Times story “Merely Human? So Yesterday.” The reporter attended a nine-day course in California called Singularity University, taught by a coterie of executives and scientists who believe in the Singularity, or as the reporter puts it, a time “when a superior intelligence will dominate and life will take on an altered form that we can’t predict or comprehend in our current, limited state.” Believers in this movement have their own Fountain of Youth: They expect that humans can live for hundreds of years, using a hodgepodge of life-extending medicines and technologies, some of which have yet to be invented.

When I was researching my book, I interviewed the chief prosthelytizer of the Singularity, Ray Kurzweil. He’s somewhat of a hero in the anti-aging movement, not only because he believes humans can live forever, but because he embraces some amount of hormone replacement. He doesn’t endorse all the remedies anti-aging types embrace–he loathes human growth hormone, for example–but he does believe some supplements are useful for extending life. He’s a fan of the healthy fats and vitamin D, and he tests his hormone levels every three months to decide if he needs to supplement, say, with testosterone.

“People say ‘do you really think taking Vitamin D is going to help you live 100 years?'” Kurzweil told me last year. “The answer is no. The goal is to live healthfully for another 15 years or so to get through this future point where we will have this maturing of the biotechnology revolution.”

What he was referring to is the idea that people should take supplements and hormones as a “bridge” to a time when technological advances such as biotech and nanotechnology will help us extend our lifespans for real. Kurzweil is a low-key guy, but he got pretty excited talking about research into nano-devices that can travel through the body detecting cancer cells and killing them, or pea-sized gizmos that can be implanted in the brain to treat Parkinson’s Disease. All of that is early research–it’s decades away from reality–which is why Kurzweil is big on the idea of using whatever tools are out there now to extend life.

Kurzweil was 61 when he met, but he claimed his biological age was 40. He walks and works out nearly every day. And he’s constantly tweaking his supplement regimen, which includes one I had never heard of before: phosphatidylcholine. “Ninety percent of the cell membrane in a child is phosphatidylcholine,” he said. “It’s a very useful substance. It gives the cell membrane suppleness, and it also helps everything to work well, to take in nutrients and let out the toxins.” But like most supplements, it’s very lightly regulated by the FDA, which means no one is testing it for either safety or effectiveness. Naturally, then, I’m a skeptic.

Kurzweil, a lifelong inventor, wrote the book The Singularity is Near, which suggests that humans will someday use technology to trump biology, allowing them to live forever. For now, though, Kurzweil is traversing the only bridge he can find to eternal life–one that’s built on supplements and exercise.

 
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