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Meningitis Scare: What are the Legalities of Pharmacy Compounding?

10 Oct

Reprint from Huffington Post:

The outbreak of meningitis that has claimed 11 lives so far has brought to light a little-understood segment of the pharmaceutical industry: compounding pharmacies, which make their own concoctions of medicines and sell them directly to the public. The steroid-based back-pain drug that has been linked to the outbreak was made and marketed by the New England Compounding Center in Framingham, Mass., according to an October 6 statement by the U.S. Food & Drug Administration.

So what exactly are compounding pharmacies, and why are they allowed to make drugs and sell them largely outside of the bounds of the federally regulated drug industry? I found the answers to some those questions while researching my book about the anti-aging industry, Selling the Fountain of Youth. Compounding pharmacies have become high-profile members of the anti-aging industry, because they offer hormones, supplements, and other medicines often prescribed by anti-aging doctors.

First, a definition of compounding: The traditional role of compounding pharmacists is to take ingredients from commonly marketed drugs and tailor them to the needs of specific patients. For example, compounders might turn pills into syrups for elderly patients who have trouble swallowing their medicines, or they might put a pain drug into a lollipop for a child with cancer. This is all perfectly legal.

But over the last 15 years or so, a tangled web of conflicting laws and rulings has raised questions about what, exactly, compounding pharmacies are allowed to do. The problems started in 1997 with the Food and Drug Administration Modernization Act (FDAMA), which exempted compounders from having to abide by the strict quality-control practices that major pharmaceutical companies have to follow.

Under FDAMA, compounding pharmacies also don’t have to seek FDA approval for the medicines they make, provided they use ingredients from drugs that have already been approved and that they don’t advertise their products.

According to a recent report by the AP, the New England Compounding Center created the back-pain drug–a steroid called preservative-free methylprednisolone acetate–by combining a powder-based substance with a liquid. The pharmacy’s Web site says that drug and other products have been recalled voluntarily.

The FDA does claim some control over compounding pharmacists. In 2002, the agency re-issued a “compliance policy guide” on compounding, which lays out several requirements. For example, the guide says the FDA can take action against pharmacies that make bulk quantities of compounded drugs in anticipation of receiving prescriptions–a major no-no for compounding pharmacies, which are supposed to make drugs in response to a physician’s prescription.

The FDA re-issued the compliance guide in the wake of a Supreme Court ruling in Thompson v. Western States Medical Center–a case in which a group of compounding pharmacists challenged the advertising restrictions in FDAMA on the grounds that they violated their First Amendment rights. The Supreme Court agreed with the pharmacists, effectively striking down the compounding restrictions in FDAMA as unconstitutional.

Ever since the FDA decided to take control over compounding by re-issuing its compliance guide, there’s been a war between the compounders, who believe their rights are protected by the Supreme Court, and the FDA, which believes it needs to protect public health by holding these pharmacies to strict standards of manufacturing and marketing.

In 2009, when I was reporting my book, I visited an official at the FDA named Steven Silverman, who had dealt with compounding issues as an assistant director in the FDA’s office of compliance. I asked him what could be done to clarify and perhaps strengthen the restrictions on compounding pharmacies. “Congress can amend our legislation to make it clear what it is they want the [FDA] to do,” he told me. Or, he said, the FDA could petition the Supreme Court to revisit the issue.

So far, neither one of those scenarios has been pursued. But it will be interesting to see if the current meningitis crisis prompts the federal government to take a fresh look at the rules and regulations governing compounding pharmacies.

Check out the original Huffington Post item and reader comments here.

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Posted in Bio-Identical Hormones


AARP: The Dangers of Trying to Live Forever

13 Jan

AARP Bulletin featured Selling the Fountain of Youth in its regular series “The Author Speaks.” Here’s an excerpt:

Q. What started the modern antiaging movement?

A. In 1990, scientist Daniel Rudman published a sensational study. He gave human growth hormone (HGH) to about a dozen healthy men over 60. They significantly increased their lean body mass, including muscle, and they lost about 14 percent of their fat.

Q. How did we get from a single splashy study to an entirely new industry?

A. A small group of doctors latched on to the idea that if you replace your hormone levels to where they were in your 30s, you’ll feel as great as you did back then. Rudman’s study inspired the formation of the American Academy of Anti Aging Medicine and has been cited on the Web something like 50,000 times.

Q. What are the cornerstones of the antiaging industry?

A. It started with HGH and expanded into alternative estrogen and progesterone products for menopause, as well as testosterone, which has recently become quite a sensation in this industry. It’s being prescribed not just to men, but also to help improve women’s libido.

Q. What are proponents claiming about these products?

A. They say if you replace those hormones, you can prevent osteoporosis, shield yourself from Alzheimer’s, improve your sleep, lose weight, gain muscle mass and boost your sex drive.

Q. Does any good science support those claims?

A. Antiaging doctors often say HGH is one of the most studied hormones. Well, that’s true, but many of those studies were in children with growth hormone deficiencies, and you can’t extrapolate from those children to healthy adults. The original Rudman study of HGH in adults was very small, and some scientists have been disturbed by the popularity of it. Some antiaging doctors twist the research to fit their viewpoints.

Read more here.

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Posted in Selling the Fountain of Youth


Suzanne Somers at the Movies: More of the Same on Hormone Replacement

05 Nov

Last night I ventured out to my local multiplex and sat through the hour-and-a-half long movie Suzanne Somers’ Breakthrough–which was a video of her speaking at an unnamed conference in Canada. During this speech, she repeated much of the same inaccurate information about bio-identical hormones as she has talked about in many previous speeches, and in her three best-selling books on the topic. Thus the only positive thing I have to say about the movie is that only 15 poor souls showed up.

For fun, let’s look at a few of her major points:

Somers Says: Forgetfulness, bloating, migraines and farting in public can all be blamed on a lack of estrogen.
I Say: Smart people accept these symptoms as signs of growing older–not signs of a disease that needs to be treated with estrogen.

Somers Says: “You’ll lose weight sleeping if you sleep with balanced hormones.” (That is a direct quote–I can’t make this stuff up.)
I Say: Show me the double-blind, placebo controlled study that proves people on hormones lose weight in their sleep.

Somers Says: Thyroid hormone keeps her strong, cures her constipation and thickens her stringy hair.

Ok, this one deserves a little closer attention. She didn’t mention in the speech what type of thyroid she takes. But in her books she parrots the advice given by the anti-aging industry, which is that everyone should take Armour thyroid, which is derived from pigs. I investigated this claim while reporting my book, and I don’t buy it. Armour thyroid fell out of favor in the 1950s, when drug companies learned how to synthesize copies of T4–one form of thyroid, which the human body processes into another form called T3. The problem with Armour is that it contains both T4 and T3, which can cause an overdose of T3. That in turn can put patients at risk of atrial fibrillation and arrhythmias.

And there’s another problem. Throughout this speech and her books, Somers expresses disdain for Premarin and PremPro, the estrogen products for menopausal women that are derived from the urine of pregnant horses. Somers believes bio-identical estrogens and progesterones, derived from soy and yams, are safer and more natural menopause remedies than Premarin and PremPro–a claim that’s never been scientifically proven.

Here’s a more basic question: Why is pig thyroid good but horse urine bad? And don’t tell me that pig thyroid mimics what the human body does naturally–I just explained to you why that’s not true.

During the speech, Somers also glorified the work of a controversial doctor named Stanislaw Burzynski, who specializes in alternative cancer treatments. But as Newsweek pointed out last year, Burzynski synthesizes peptides from human urine for one of his so-called cures. So how is it that this synthetic version of a urine-derived compound cures cancer, but Premarin (derived from horse urine) causes it?

Perhaps the most disturbing part of this movie is what happened at the end. As I left the theater, a man handed me a business card and said “call us if you want more information on bio-identical hormones.” His card said his title was “bio-identical hormone coach.” I checked out his Web site. He doesn’t appear to be either a doctor or a pharmacist. He has merely appointed himself an expert in bio-identical hormones, clearly without any medical training.

I guess if Somers can dole out questionable advice on aging to an unsuspecting public, anyone can.

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