On Women, the FDA and Drug Risks- Public Citizen Warns Against Low-Dose Birth Control PillsSomervell County Salon-Glen Rose, Rainbow, Nemo, Glass....Texas


On Women, the FDA and Drug Risks- Public Citizen Warns Against Low-Dose Birth Control Pills

6 February 2007 at 2:19:18 PM

Can we always say that because the FDA has approved a drug that it is safe to take? No.

Public Citizen says the pills increase a woman's risk of a potentially deadly blood clot more than other pills do.

All contraceptive pills carry a very low risk of blood clots.

It is a side effect of the pills' hormones, estrogen and progestin.

But the advocacy group says "third-generation" oral contraceptives that contain a certain type of progestin (desogestrel) can double that risk.

Public Citizen says that translates to about 30 blood clots per 100,000 users, compared with 15 blood clots per 100,000 for older "second-generation" pills that it says are just as effective.

Here's info from the Public Citizen site.


Desogestrel and Ethinyl Estradiol


While I was looking at that, I was reminded how women had HRT therapy pushed on them for years by Big Pharm, even though it was known it could cause breast cancer (and this last year it was finally definitively proven that it DOES cause breast cancer).

I'm Dr. Sidney Wolfe of Public Citizen. In a best-selling 1966 book, Feminine Forever, Dr. Robert Wilson argued that if women started using estrogens at the time of menopause they could stay young, attractive and healthy. The promotion of this book, funded by Wyeth-Ayerst, manufacturer of the estrogen Premarin, resulted in greatly increased use of this drug.

By then, however, much research was already pointing to the increased risk of breast cancer in women using these drugs.

Since the 1970’s, Public Citizen has pushed for stronger warnings about estrogens and breast cancer and, in 1991 we stated that “Female Replacement hormones may someday be remembered as the most recklessly prescribed and dangerous drugs of the [20th] century.” In 2002, a large study, the Women’s Health Initiative, was stopped because there was an increase in invasive breast cancer, heart attacks, strokes, and blood clots in women using menopausal estrogens. Now comes evidence that the epidemic of estrogen-caused breast cancer is diminishing with the decreased use of these drugs. For more information about this and other dangerous drugs, go to WorstPills.org.

I want to reiterate the issue involved here. Just because Big Pharm pushes a drug and the drug has been approved by the FDA doesn't really mean it's SAFE. Women are not guinea pigs.

P.S. Who remembers that the Bush administration decided it would be a good idea to have Lester Crawford, who is a VETERINARIAN in charge of the FDA? Oh, the outcry about that (And he also faced a criminal inquiry for lying to Congress -apparently only a fine for this jackass.) Even the new guy seems to have his issues.

According to Dr Graham, the FDA's decision to approve Ketek, "was made in the absence of reliable data disproving the concern expressed in 2001 by the advisory committee."

He reports that an analysis of the FDA's post-marketing database showed that the rate of reporting of acute liver failure was 3.5 to 11 times as high for Ketek as for other antibiotics on the market, with a reporting rate of 167 cases of acute liver failure per 1 million person-years of use, as compared with the expected rate of 1 case per 1 million.

In the NEJM letter, Dr Graham points out that without accounting for underreporting, which could be 10 times higher, this rate is greater than that of three other drugs previously removed from the market by the FDA because of the risk of acute liver failure.

For many months, Dr Graham has been unsuccessfully calling for the removal of Ketek from the market and in his NEJM letter, he offers some free advice "Given that telithromycin is neither clinically superior to other drugs prescribed for respiratory tract infections nor uniquely life-saving," he wrote, "physicians, patients, and third-party payers might wish to reconsider their choice of antibiotic for such infections."

In a recent statement refusing to fully respond to the latest round of questions from Senator Grassley, von Eschenbach said full disclosure of the information could not be released because it "poses an inherent threat to the integrity of the executive branch's enforcement and litigation functions," and there would be a "chilling effect" on employees.

Yuh.Huh. TELL Me that the FDA isn't protecting Big Pharm

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