Where did the testosterone go?

Back when I was giving talks on men’s health, I would talk about testosterone and how it goes down with age and that there is also a decline from one generation to the next: the testosterone levels in a 60-year-old in 1988 were higher than a 60-year-old in 1996, which were higher than one in 2003. Understandably, the men were shocked and demanded to know why. At that point, all I could say is that no one knows for sure, but it’s probably some chemical we’ve been adding to the environment and mentioned the feminized male alligators in Florida where PCBs had been dumped in the lake years earlier.
Well, we finally do have a candidate for a cause of the lower hormone levels in men: phthalates, specifically DEHP. The
Journal of Andrology published a study showing that higher levels of the DEHP metabolite MEHP consistently accompanied lower levels of testosterone and estrogen. This also implies that it will cause similar hormone disruption in women (earlier studies have shown an association between phthalates and genital defects in infants), making it a good thing to avoid.
These phthalates are mostly used in making flexible vinyl for flooring, wall coverings, “food contact applications” (food packaging, though this is illegal in Europe), and medical devices. Other, lighter, phthalates (DEP and DBP) are used in lotions, perfumes, cosmetics, lacquers, coating, varnishes, acetate, and in some time release medications.
Interestingly, DEHP is relatively insoluble in water, so little will migrate from the plastic (DEHP doesn’t become a permanent part of the plastic) into a mainly water containing liquid. Because of this, US law permits DEHP in packaging of food that is primarily water. However, since DEHP accumulates in fat over your entire lifespan and persists in the environment it is likely the only safe level of it is none.
One this stuff gets in you, how do you get it out? Well, there’s no good answer for that right now. Sadly, the only sure way to be sure to move it out of a human is to have a baby: some of those phthalates will leave inside the baby. There have been some attempts to do it with Olestra (the non-absorbed fat in Wow chips), but it didn’t work (though it might work if you have just been exposed to the fat-soluable chemicals before they have gotten into your fat).
I had switched to phthalate-free medical supplies (mostly IV tubing) long ago, so applying the precautionary principle in my office has paid off. I wonder when the government will put the health of its citizens over corporate profit. Right now, they hear more from the corporations’ lobbyists (paid for out of the money we pay for their stuff) than from us, so as long as we sit on our hands and keep quiet it won’t change.

Why, oh why, Wyeth?

Fireworks tomorrow, 31 days early!
In case you haven't heard, Wyeth, the maker of Premarin and Prempro (Premarin + Provera), has been plotting to maintain their marketshare by restricting women's freedom to choose safer medications for themselves. Ever since the Women's Health Initiative revealed in 2002 that Prempro increased the risk of stroke, breast cancer, heart attacks, and blood clots (a finding that I, in residency at the time, thought was obvious since Provera was well known to increase the risk of clots), Wyeth has been struggling to maintain its sales of these patent medicines.
Wyeth has managed to keep a monopoly on PREgnant MARe urINe (PREMARIN, get it?) products in the US since it was introduced in 1942 by
dubious legal and political maneuvers including using at least seven women's advocacy groups it funded to influence congressional hearings in 1995. By maintaining this stranglehold on relief of menopausal symptoms, Wyeth has extended its dominion well past the 20 year patent protection and in 2001 had over 11 million women using its hormone medications and over $2 billion in sales of those medications. Following the revelations of the Women's Health Initiative, sales of Premarin and Prempro drop and by 2006 sales are half of 2001 levels (though they had dipped even lower before Wyeth made lower strength versions and pushed for more prescribing).
As women flock to safer treatments like bioidentical hormone replacement (using hormones identical to the ones originally in the women's body), Wyeth decides to protect its profits at the expense of women seeking relief of menopausal symptoms and preventing other changes related to loss of estrogen like osteoporosis and memory loss. In 2005, Wyeth files a "citizen's petition" with the FDA that pushes the FDA to ban estriol, an estrogen naturally produced by women, as an unapproved new drug. Within 70 days, 11 organizations, mostly funded by Wyeth (in a stunning repeat of their tactics 63 years earlier), submit letters of support for this petition. Again, May 19, 2008, members of congress received a letter (coordinated by Wyeth) from 14 organizations (all with major funding from Wyeth) supporting the FDA's actions.
Besides estriol having a 50 year history of use and listing in the US Pharmacopeia, it was in the precursor to Premarin (that was made from pregnant women's urine- but it proved too difficult to collect), and is used by Wyeth itself in products sold overseas. Recent research has shown estriol may reduce the risk of breast cancer and be beneficial in treating multiple sclerosis.
This year, in response to Wyeth's petition, the FDA bans the use of estriol (though the FDA does not have jurisdiction over compounding pharmacies, so this is also a power grab by the FDA) despite admitting that there have been no reports of adverse events associated with its use ever. Somehow, the FDA has managed to put an import restriction on estriol as well, so even though compounding pharmacies shouldn't be subject to the FDA's decrees they are having trouble getting supplies of estriol. Under the FDA's plan, it would require a physician to file an Investigational New Drug form (with the associated $50,000 fee to the FDA) to order estriol for patients.
In the end,
women are losing their options so Wyeth can make more profits.
So, what's with the fireworks? Well, Tuesday, June 3, is the day that hundreds of compounding pharmacists will descend on capitol hill to support H. Con. Res. 342 at the same time the
AAHF is delivering independent letters of support, and a full page ad will appear in Roll Call.
Learn more about this issue
here, and learn more about estriol specifically here.
Corporations will only be able to get away with this as long as we remain quiet, so speak up for this and get active in politics: corporations pay big money to bend the laws in the direction of increased profits whatever the human cost, so the humans have to speak up. It's time.

Dr. Wright joins the fray!

Yikes! I just found out that Dr. Jonathan Wright has joined up as the 11th speaker for the BHRT World Summit that starts tomorrow. Now there's no excuse not to listen in! Also, they've relaxed the listening constraints for the $10 option so you have more flexibility about when you listen.

Bioidentical Hormone Replacement Therapy World Summit

I just found out there's an interesting series of audio conferences coming up: the BHRT World Summit. It starts May 14 and runs through June 2. Lots of doctors who use bio-identical hormones are lined up for this, though I've only heard of a few of them. Sadly, my favorite BHRT guru, Jonathan Wright MD, isn't on the slate.
It does look promising. I'll check it out myself, too, even though it's aimed at regular people. They'll let you listen in each evening for only $10 for the whole series. They also have additional options to listen to the interviews, either by listening on your own schedule or even getting CDs and text from the interviews.
BHRT World Summit
Yes, I know the banner says it ends May 29, but they've added more interviews, so it's an even better deal.

"Pharmacologic Treatment of Osteopenia Not Usually Indicated"

A recent American Family Physician journal, citing a JAMA article, puts the lie to the idea that people (particularly women) with osteopenia (low bone density) should be on medications. With all the evidence that these medications (like Fosamax or its friends) shouldn't be first-line treatments, why are doctors still prescribing them so quickly? If your doctor pulls out the pad for this, ask them when the last time they saw that drug rep and whether they are pushing the doc to use it as a preventative. This kind of behavior is occurring more and more, so let your doctor know that it's getting so obvious and blatant that even the patients are picking up on it. There are some movement among conventional docs to limit their exposure to drug reps, No Free Lunch for practicing physicians and Pharmfree for medical students. Sadly, the No Free Lunch doesn't turn up any drug-rep free primary care physicians in Ann Arbor (though it does find a pediatrician in Ypsilanti).
Interestingly, the article points out that the
only treatment that has been shown to reduce nonvertebral fracture risk in women with osteopenia is estrogen. Bioidenticals, anyone?

Insurance companies reject bioidentical hormones!

I just got a note from SaveMyMedicine.org about the latest way that insurance companies are working to help the drug companies: by refusing to pay for compounded hormones. You'd think they'd be smart enough to see that by covering compounded bioidentical hormones they could be saving themselves drastic amounts of money: Premarin or Prometrium are about $45 a month each and testosterone gel or patches are upwards of $200 a month, while compounded estrogen (usually a combination of estrone, estradiol, and estriol), progesterone, or testosterone each start at around $25 or so a month (they can go a little higher at higher doses). Add the additional costs of higher incidences of breast cancer in women taking Provera and they could really be making out by supporting bioidenticals.
Aetna's going to stop on October 1, while BCBS changed their policy back in May (note that BCBS cites an unscientific 2001 FDA study that even the FDA doesn't support).
As the note I got says: If you are an Aetna or BlueCross BlueShield customer, please contact your employer’s HR department and ask them to petition your health insurance company to reinstate coverage of bioidentical hormones and other compounded medicines. Remind them that healthy employees are productive employees and your health depends on these drugs. Your doctor has decided that compounded medicines such as bioidenticals are the best treatment option for you. Both your employer and your insurer have a responsibility to provide you with the medicines you need at a reasonable cost.

Hormones and cardiovascular risk

Sometimes I'm disappointed by the journals. Circulation recently had an article on reducing women's risk of cardiovascular risk, in which hormone replacement was listed as class III (not useful/effective, may cause harm). A summary of the article in Medscape breaks down the variation in risk:

Researchers found that "route, type, and dose" of hormone therapy matters, in the Estrogen and Thromboembolism and Risk Study (ESTHER), a multicenter study conducted in 8 hospitals in France that included 271 cases and 610 controls. Compared with nonusers, oral estrogen users had an odds ratio of 4.2 (95% confidence interval [CI], 1.5 - 11.6) and 0.09 [this is probably a typo and the risk should be 0.9] (95% CI, 0.4 - 2.3) for transdermal estrogen. Norpregnane derivatives were linked to a 4-fold increase in venous thromboembolism; but there was no risk for venous thromboembolism with micronized progesterone and pregnane derivatives in the study.

So, there is risk in the standard hormone treatment of oral estrogen and progestins (synthetic progesterone-like molecules): each raises the risk of a clot 4-fold. However, it also shows that transdermal estrogen doesn't increase the risk and may lower it and that progesterone similarly doesn't raise the risk. Using bioidentical hormones in a smart manner, then doesn't raise the risk and likely lowers it going from this article.
Sadly, they also list folic acid and antioxidants in the same class that says "may cause harm". Clearly, no one has died from antioxidants or folic acid. There has been a limited number of studies showing some increase in risk with fractionated antioxidants (beta-carotene or alpha-tocopherol alone) in certain circumstances, so it is important to get use full-spectrum antioxidants when using higher doses (mixed carotenoids with selenium or mixed tocopherols).
Sadly, newspapers often pick up these articles without any background and trumpet it as fact. It pays to read in more depth, and be cautious about people who paint all hormone replacement with the same brush: there are clear differences in risk between approaches, and this is why I do not use oral estrogen at all.