Human Growth Hormone and The Business of Immortality

Last week, James Forsythe, a prominent doctor in Reno, Nevada was acquitted by a federal jury after going to trial on allegations that he trafficked in human growth hormone (HGH). The decision came as a relief to the American Academy of Anti-Aging Medicine (A4M), because among other allegations, the doctor was accused of selling HGH as an anti-aging treatment, which is illegal in the U.S. A4M has a history of pushing for HGH-driven anti-aging treatments.

So what’s so special about HGH when it comes to aging? Beginning in your 40s, the pituitary gland slowly reduces the amount of hormone it produces, a fact that some feel is both responsible for the frailty of age and reversible through the introduction of synthetic growth hormones.

But there is little, if any, reliable scientific evidence about the anti-aging benefits of HGH. In fact, there are no double-blind placebo-controlled studies for most of the anti-aging miracle cures out there. Yet we do know for a fact that HGH can increase the risk of cancer—not to mention edema (retention of fluids), arthralgia (joint pain), carpal tunnel syndrome, diabetes, and gynecomastia (enlarged mammary glands in males).  Oh, and it might actually shorten life.

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When the Government Does What Drug-Makers Won’t Do

Today, Bloomberg News reported that “Deadly Staph Germs May Be Cured by Old, $1-a-Day Antibiotics.” It turns out that generic, World War II-era antibiotics are becoming “the newest weapon of choice in the fight against deadly, drug-resistant staph germs.”

Physicians have discovered that drugs costing less than $1 a day can be very effective when treating methicillin-resistant Staphylococcus aureus, known as MRSA. The bacteria, once found only in hospitals and nursing homes, recently made news by showing up in schools and gyms. Last month, MRSA was linked to the deaths of a student in New York and one in Virginia.  Annually, more than 18,000 Americans are killed by MRSA.

The physicians who mounted the studies of the older drugs were funded by the federal government. Meanwhile, in the for-profit private sector, Bloomberg observes, “drug-makers are spending hundreds of millions developing medicines that cost more than $100 a day to treat advanced cases.”

But physicians know the older, cheaper drugs work. “We have used these
older drugs with success for years,” says Gregory Moran, one of the
study leaders. He is a professor of emergency medicine at the Olive
View-UCLA Medical Center in Sylmar, California, affiliated with the
University of California at Los Angeles.

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We Can’t Fund SCHIP, But We Can Save Merck

Today, Bloomberg trumpeted the good news:  “Merck Profit Gains on Cancer Vaccine, Diabetes Pill.”

“Merck & Co., the third-largest U.S. drugmaker, reported a 63 percent gain in earnings,” Bloomberg reported, a victory made doubly by the fact that Merck has seen some rough times. “Competition from generics and the withdrawal of the pain pill Vioxx in 2004 over heart risks have pulled net income down 39 percent since 2001,” the story explained. Indeed, Vioxx gave Merck a black eye, and it’s still battling lawsuits in the courts. But Gardasil, Merck’s new vaccine to prevent cervical cancer, is turning out to be just the blockbuster the company needed. “Gardasil, introduced a year ago [already] has sales of $418 million”

Those of you familiar with my views on Gardasil may want to skip the below section, as it is pulled from an August post. I promise I won’t do this often, but this is an important subject and it’s example of how, if drug manufacturers and their lobbyists work quickly enough, they can sell their story to politicians and to the public before skeptics in the scientific community have a chance to weigh in. Remember the drug industry saying: “It’s important to sell a new drug while it’s still effective” (i.e. before people know too much about it).

On August 27, I wrote:

Earlier this month the FDA announced that the direct-to-consumer ads Merck has been using peddle its new cervical cancer vaccine, Gardasil, are “half-true . . .information currently being advertised could mislead the public.” 

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The FDA’s Moment of Truth by Niko Karvounis

Soon we’ll see what the FDA is made of.

Yesterday the AP reported that “doctors told the Food and Drug Administration advisers that the over-the-counter [cough and cold] medicines shouldn’t be given to children younger than 6 because they don’t help them and aren’t safe.” The final recommendation of an advisory panel of outside experts tasked with determining whether or not this is the case is due to the FDA late today.

By “not safe” petitioners don’t necessarily mean that the medicines themselves cause harm, but that they encourage reliance on “quick fixes,” an approach that can mask symptoms of more serious ailments.

This is obviously a problem in and of itself, but becomes an even a bigger deal when one considers that there are no known benefits to the medication. The drugs have never been tested on children—something the FDA has known since 1972. Instead, drug makers “have used extrapolated data from studies in adults to come up with dosing recommendations based on a child’s age or size.” Hardly rigorous medical science.

The threshold for unacceptable risk is a lot lower when a medicine does nothing. Michael Shannon from the Children’s Hospital Boston pediatrician and Harvard Medical School puts it best: “when a treatment is ineffective, its risks — if not zero — always will exceed its benefits.”

So what should worried parents do when their kids have a cold?

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The Real Danger of Socialized Medicine by Niko Karvounis

Last week The Washington Post ran a good opinion piece by Ezekiel J. Emanuel, Director of the Clinical Bioethics Department at NIH (and brother of Congressman Rahm Emanuel) on the insidiousness of labeling any and all positions on health care apart from free market fundamentalism as being “socialized” medicine, doomed to failure.

Emanuel notes that “ ‘socialized medicine’ is when the doctors are state employees; when the hospitals, drugstores, home health agencies and other facilities are owned and controlled by the government…” As Emanuel rightly points out, none of the universal coverage proposals being debated in the U.S. today “can be characterized as socialized medicine. None calls for government ownership or control over U.S. hospitals, drugstores or home health agencies, or for making doctors employees of the federal or state governments.”

This is right on the money—maybe even more so than Emanuel intends. Opponents of “socialized” medicine are wrong three times over: not only do most reformers not want socialized medicine, but even European health care systems (often used as examples of socialized medicine) do not meet the criteria outlined above. Further, publicly-run health care carries with it some significant benefits that are evident right here in the U.S.

To dispel the myth of monolithic government-run European health care, look no further than Germany, where most of the population (88%) receives health care through “sickness funds"–non-profit, third-party pools of money devoted to health services. Sickness funds are built on the principle of “subsidized self-governance”: they receive public funding, but the funds must be financially self-sufficient (i.e. be able to govern themselves) and also allow a high degree of freedom on the part of patients and doctors (the former can choose their doctors and hospitals, and the latter have much flexibility in treatments).

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Class and Health

When compared to other developed countries, the U.S. ranks near the bottom on most standard measures of health. Many people assume that this is because the U.S. is more ethnically heterogeneous than the nations at the top of the rankings, such as Japan, Switzerland, and Iceland. But while it is true that within the U.S. there are enormous disparities by race and ethnic group, even when comparisons are limited to white Americans our performance is “dismal” observes Dr. Steven Schroeder in a lecture  published in the New England Journal of Medicine yesterday.

Why? It’s not the lack of universal access to healthcare" says Schroeder, though that’s important. And it’s not just that we don’t exercise enough and eat too much—though that is a major cause. But there is one factor undermining the nation’s health that we just don’t like to talk about in polite society: Class. When it comes to health, class matters.

Schroeder, who is the Distinguished Professor of Health and Health Care at the University of California San Francisco (UCSF) underlines how poorly even white Americans stack up when compared to the citizens of other countries by pointing to maternal mortality as one measure of health. When you look at “all races” you find that in the U.S. 9.9 out of 100,000 women die during childbirth.  Focus solely on white women, and the number is still high—7.2 deaths out of 100,000 –especially when compared to Switzerland where only 1.4 women out of 100,000 die while giving birth.

Statistics on infant mortality reveal the same pattern: among “all races” 6.8 American children who were born alive die during infancy; limit the analysis to “whites only” and 5.7 infants die—compared to just 2.7 out of 1,000 in Iceland. .) When researchers compare maternal mortality and infant mortality in white America to rates of death in the 29 other OECD countries, white America ranks close to the bottom third in both categories.

Turn to life expectancy, and you find that white women in the U.S. can expect to live 80.5 years, only slightly longer than American women of all races (who average 80.1 years). Both groups lag far behind Japanese women (who, on average, clock 85.3 years). The gap between “all American men” (who live an average of 74.8  years) and white men in the U.S. (75.3 years) is wider—but not as wide as the gap between white men in the U.S. and men in Iceland (who live an average of 79.7 years).

“How can this be?” asks Schroeder. After all, as everyone knows, the U.S. spends far more on health care than any other nation in the world.

The answer is a stunner: the path “to better health does not generally depend on better health care,” says Schroeder. “Health is influenced by factors in five domains — genetics, social circumstances, environmental exposures, behavioral patterns, and health care. When it comes to reducing early deaths, medical care has a relatively minor role. Even if the entire U.S. population had access to excellent medical care — which it does not — only a small fraction of premature  deaths could be prevented. [my emphasis]

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HILLARY CLINTON’S NEW PLAN

   I have written two posts analyzing Hillary Clinton’s healthcare plan. You will find them on www.tpmcafe.com (where I am a contributor). You can comment there.

   

    

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If We Mandate Insurance, Should 20-Somethings Pay Less?

Should insurers be able to offer less expensive policies to the young and healthy? Or should they be required to offer the same benefits to everyone at the same price?

In states where insurance is mandated, should twenty-somethings get a break? In a post on Health Care Policy and Marketplace Blog Robert Laszewski addresses these questions. He begins by focusing on a report  just released by the health insurance trade association (AHIP). The study looks at state health insurance reforms of the 1990s that tried to eliminate discrimination by insisting that insurers must sell “individual” policies to people who are not covered by an employer or another group without discriminating on the basis of health, age or gender. According to the AHIP, these reforms have had some “unintended consequences.”

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Commenting on “The FDA Betrays its Mandate”

Commenting on "The FDA Betrays its Mandate,"  Gregory D. Pawelski  responded:
Take Physicians Out of the Retail Pharmacy Business
Lee Newcomer, with United Health Group, had stated at the 12th annual conference of the National Comprehensive Cancer Network, 44% of patients having blood work-ups indicated they were not anemic. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, reiterated that Newcomer was right on the spot on this. Few drugs work the way we think and few physicians/scientists take the time to think through what it is they are using them for.

A New York Times article stated that anemia drugs, given by injection, have been heavily advertised, and there is evidence that they have been overused, in part because oncologists can make money by using more of the drug. Lichtenfeld told United Press International, "Probably more than a billion dollars is spent on erythropoietin each year, which makes it one of the most expensive cancer drugs."

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Wall Street, Cancer and the FDA: A Cautionary Tale

Only in America do physicians who evaluate new drugs need bodyguards. You may have read about the brouhaha surrounding Provenge, a vaccine designed to extend the lives of men suffering from late-stage prostate cancer. In March, a Food and Drug Administration (FDA) advisory panel voted 13 to 4 to recommend approval. The next day, shares of Dendreon, the drug’s sponsor, doubled. But shareholders did not celebrate for long. Two of the dissenting votes were cast by the panel’s two prostate cancer specialists: Sloan-Kettering’s Howard Scher and the University of Michigan’s Maha Hussain. And they did not just vote “no”—following the hearing, both wrote to the FDA arguing that Dendreon offered no solid evidence that Provenge works.
   
The FDA listened. And in May it told the company it wouldn’t approve the drug until it had more data. That is when the two oncologists began receiving threatening e-mails, phone calls, and letters. Many were anonymous

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