September 2010 - Selling the Fountain of Youth Selling the Fountain of Youth
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Archive for September, 2010

Anti-Aging Treatments: Profits are Real, but What About the Claims?

28 Sep

The Chicago Tribune printed an interview with me about my book today.

 
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The Search for Eternal Youth, Spanish Style

24 Sep

Imagine my surprise when I opened my e-mail and found a note from a biomedical researcher at the Spanish National Cancer Research Center in Madrid, Spain. His name is Manuel Collado. He  heard about my book, Googled it, and came across this site. “I am totally shocked,” he wrote. Why? Because he also has a blog about the search for eternal youth, “La Fuente de la Eterna Juventud” (http://fuentedelaeternajuventud.wordpress.com). And like me, he is trying to help his readers sort truth from fiction in the many anti-aging claims that are out there.

I asked Manuel for his perspective on anti-aging medicine.

go Q: Your specialty as a scientist is cellular senescence. Explain what that is, in laymen’s terms?

A: All the cells that make up our body have a limited potential of proliferation:  When they have undergone a certain number of cell divisions, they permanently stop proliferating. This phenomenon was originally described in the ´60s by Leonard Hayflick and was considered the cellular basis of the aging process. Accordingly, our bodies would stop regenerating because our cells can no longer divide. Later on, research on the enzyme telomerase and the protective structure at the tips of our chromosomes–the telomeres–showed that the cells “decide” to stop proliferating when they “feel” that their telomeres have reached a critically short length due to the erosion they suffer as a consequence of cell division.

Other processes have also been shown to trigger this cellular senescence response in the cell. Many were considered to reflect the natural process of aging, such as the accumulation of oxidative damage, but in the late years of the last century, cellular senescence was revealed as a natural defense mechanism of our bodies against cancer. When an oncogene becomes activated within the cell due to a mutation, or the cell suffers a potentially oncogenic damage, it will induce senescence as a way to make sure that the defect is not propagated into the daughter cells through cell division to form a tumor. We, and others, identified this type of response in human and mouse tissues.

watch Q: How did this work cause you to become interested in anti-aging medicine?

A: The molecular machinery behind the cellular senescence response is composed of a series of proteins encoded in genes, known as tumor suppressor genes. During cancer development, these tumor suppressor genes are frequently mutated or inactivated to cancel the protective senescence response and allow tumor growth. Strikingly, some of these same tumor suppressor genes appear to become active and increase their expression during aging. This has led many to believe that the increase in tumor suppressors during aging induces cellular senescence, and that the accumulation of these arrested cells causes the dysfunction of tissues characteristic of aging.

Our laboratory has addressed this question by generating mice that were genetically manipulated to express higher doses of these tumor suppressor genes. What we found is that these modified animals are more protected against cancer and at the same time live longer. They developed fewer tumors and less aging-associated pathologies. Their skin, bones, neuromuscular coordination, metabolism, etc, resembled those of younger animals.

At the same time, it is a well-known fact that cancer is mainly a disease of aging. This interplay between cancer and aging, cellular senescence as a tumor suppressor mechanism or the basis of aging, the possibility of enhancing our anti-cancer defenses while at the same time gaining in healthspan (the period of one’s life free from chronic diseases), makes the whole field a very attractive area of research.

see Q: The name of your blog, in English, is “The Fountain of Eternal Youth.” What are some of the subjects you write about there?

A: My intention when I started this blog was mainly to provide information on the fantastic research that has been done on the molecular basis of aging. Many molecular pathways have been proposed to be responsible for the aging process and this knowledge has prompted many to propose potential interventions that could result in healthier aging.

Aging is obviously a process governed by multiple and complex factors that we do not fully understand yet, and it is intricately entwined with basic processes of life whose connections still need to be investigated.

However, the rapid communication of spectacular laboratory results–together with the greed of people willing to cash from the logical human desire to remain forever healthy and young–has launched a plethora of un-tested therapies, “miracle” cures, and even bogus remedies.

The blog is still in its infancy, but we have already covered issues such as cellular senescence, telomeres and telomerase, calorie restriction, antioxidants, stem cell-based therapies, and the like.

Q: As you know, there is a lot of misinformation out there about what has actually been proven to extend life (if anything). What is an example of an anti-aging claim that you’ve come across that you think has been overblown or improperly communicated to patients?

A: To start with the first part of your question, there is absolutely nothing that has proven to be effective extending life or even just preventing age-related diseases.

One of the most astonishing anti-aging claims that antioxidants will help people live young forever and avoid cancer and all diseases. While it is true that there is some good solid research on the possible role of oxidative stress as a mediator of the aging pathologies–as well as in cancer development–a clear causative role is far from being proven. The efficacy of an antioxidant intervention, therefore, is even further away from being established. If anything, when tested in clinical trials involving healthy volunteers, it showed that it is more detrimental than beneficial. Still, we constantly receive the message that we should be eating food and drinks containing plenty of antioxidants and even swallowing antioxidant supplements. There is no evidence and no scientific basis to think that this would do any good, only data showing how dangerous it might be.

Q: What is the one thing you tell people they can do right now–safely and effectively–to help extend their lives?

A: Even the more sensible health advice, based on reasonable assumptions, should not be advertized as capable of protecting us from aging or extending our life. Healthy habits such as some regular physical exercise, varied and balanced diet, staying fit and keeping an active network of relationships with friends and family, might not extend our lives, but surely they will make them more enjoyable.

Here’s how to find Manuel:

BLOG: http://fuentedelaeternajuventud.wordpress.com

FACEBOOK: http://www.facebook.com/fuentedelaeternajuventud

TWITTER: http://twitter.com/fuentejuventud

 
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Posted in Science of Aging

 

Huffington Post: When Testosterone and Corporate Deals Merge

21 Sep

I am now blogging on aging for the Huffington Post. Here’s a taste of my first item:

An academic study with a provocative title landed in my inbox the other day. It’s called “Deal or No Deal: Hormones and the Mergers and Acquisitions Game,” and in it, two finance professors from the University of British Columbia argue that CEOs with high testosterone levels are likely to act recklessly in mergers and acquisitions. Testosterone-laden execs have an outsized propensity to initiate deals, the professors found, but they’re also more likely to rebuff acquisition attempts by rivals, or to scrap deals that are already in progress.

Read more here.

 
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New Zealand Radio Catches On To Selling the Fountain of Youth

20 Sep

I was featured during drive-time on Radio New Zealand. Here I am talking about Selling the Fountain of Youth with “Nine to Noon” host Kathryn Ryan.

 
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Latest Coverage of Selling the Fountain of Youth

20 Sep

Boomer-Living.com just posted this article about Selling the Fountain of Youth, in advance of the New-Aging Conference at the University of Pennsylvania, where I will be a featured speaker.

 
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HGH: Court Rules in Favor of Pfizer on Off-Label Marketing Allegations

17 Sep

On September 14, the United States District Court for the District of Massachusetts issued a ruling that effectively ended a whistleblower’s attempts to bring attention to the off-label marketing of human growth hormone for anti-aging and other non-approved uses. Former Pfizer executive Peter Rost filed the qui tam claim in 2003, and I wrote about it in Selling the Fountain of Youth. In short, Rost alleged that Pfizer improperly promoted its HGH drug Genotropin by providing kickbacks to physicians, including all-expense-paid trips to medical conferences in exotic locations.

Rost wasn’t exactly Mr. Popular at Pfizer. After he filed his qui tam, the company started dismantling his 60-person team, moving everybody but Rost from their New Jersey office to New York City. Then men in hardhats showed up and started knocking down the walls around him. Rost ultimately lost his job.

In 2005, the U.S. Dept. of Justice declined to join Rost in his suit and instead investigated Pfizer on its own. Two years later, in a settlement with the government, Pfizer paid a fine of $15 million and admitted that the unit that made Genotropin, Pharmacia, had promoted it for off-label uses such as anti-aging. (The company paid an additional $19.7 million fine related to a separate charge.) In an online posting, Rost dismissed the settlement as “equivalent to a speeding ticket”–a reference to the fact that Pfizer’s profit the previous year had been $11 billion.

Rost continued to fight his whistleblower claim, but it was a struggle. In 2008, a judge ruled that he could proceed as long as he focused only on allegations related to the promotion of HGH for the treatment of short children. His dream of exposing off-label use of HGH in anti-aging clinics was dead.

And now this latest ruling. It states that Rost failed to show that Pfizer’s promotion of HGH violated the False Claims Act. In other words, those activities did not result in improper claims being made to state Medicaid programs, as Rost alleged in his amended complaint. The ruling was made partially on the judge’s determination that the pharmacies that filled the prescriptions were “third parties” who were not knowledgeable about the marketing of the drug. If the pharmacy does not know that the prescription was written because a doctor was induced by the drugmaker to write it, she said, then there is no illegal false claim.

Jim Edwards, a blogger for BNET who mentioned my book in his posting about the case, concluded that this ruling “has made it easier for drug companies to bribe doctors with cash and gifts to prescribe their products.” I’m not sure I would go that far. But I will say this: Rost’s long and dramatic whistleblower story has come to a rather deflating end.

 
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New Press for Selling the Fountain of Youth

16 Sep

Read and hear more about my book at the San Antonio Express-News, and on “Word Of Mouth” on public radio in New Hampshire.

 
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UK Reader Asks Why It’s OK to be “Anti-Age?”

05 Sep

The UK paper the Guardian featured Selling the Fountain of Youth this weekend, and the story has garnered a lot of interesting comments. Here’s my favorite, which I think offers good food-for-thought:

Why is it acceptable to be “anti-age”? We are telling older people in our society they are rejected, useless and that the rest of us will do and pay pretty much anything to avoid being like them. What would we say if we saw jars of creams in the shops promising to make us “anti-women”, “anti-christian” or “anti-gay”?

Scientific American reports that mid-life is the problem not old age: “by the time you are 70, if you are still physically fit, then on average you are as happy and mentally healthy as a 20-year old…”

http://www.scientificamerican.com/article.cfm?id=midlife-misery-is-there-happiness-after-the-40s

Surely spending more time and money on keeping physically active is preferable.

 
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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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Posted in Lifestyle

 

Book Featured on ABC News Web Site

01 Sep

video platformvideo managementvideo solutionsvideo player

Here I am talking about Selling the Fountain of Youth with the folks at ABC News.

 
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