Free Viagra for Jobless

With tears in their eyes, Pfizer participants at a leadership training meeting decided to institute a program to provide free Viagra to people who have lost their jobs and health insurance.

OK, I'm, being a tad facetious (but only a tad):

TRENTON, N.J. – Pfizer Inc. says it will provide 70 of its most widely prescribed prescription drugs — including Lipitor and Viagra — for free to people who have lost their jobs and health insurance.

The world's biggest drugmaker said Thursday it will give away the medicines for up to a year to Americans who lost jobs since Jan. 1 and have been on the Pfizer drug for three months or more.

...

Applicants will have to sign a statement that they are suffering financial hardship and provide a "pink slip" or similar employer notice. Applications will be accepted through Dec. 31, with medication provided for up to 12 months after approval — or until the person becomes insured again.

Starting Thursday, patients can call a toll-free number, 866-706-2400, to sign up, and those whose drugs are not included in the program will be referred to other company aid programs. Starting July 1, patients can also apply through the Web site, http://www.PfizerHelpfulAnswers.com, which has information about the other Pfizer aid programs.

The article goes on to mention some of the drugs included in the program, you know, other than Viagra (emphasis mine):

The 70-plus drugs covered in the program include several diabetes drugs and some of Pfizer's top money makers, from cholesterol fighter Lipitor and painkiller Celebrex to fibromyalgia treatment Lyrica and Viagra for impotence. Drugs from several other popular classes such as antibiotics, antidepressants, antifungal treatments, heart mediations, contraceptives and smoking cessation products also are included.

I took the liberty to select a few drugs that I think will be of interest to you:

• Cytotec® (misoprostol)

• Depo-Provera® (medroxyprogesterone acetate)
• depo-subQ provera 104™ (medroxyprogesterone acetate injectable suspension)

• Diflucan® (fluconazole)
• Flagyl® (metronidazole)
• Zithromax® (azithromycin)

• Estring® (estradiol vaginal ring)
• Provera® (medroxyprogesterone acetate)

(sorry, no direct link; go here, click on "Search by medicine", click on, say, D then Depo-Provera, then click on "Get your results" to get to the applications page)

I hope these drugs will be covered under the new free drugs program but, for now, Pfizer has two patient assistance programs for these meds, Connection to Care and Pfizer Pfriends.

Pregnant While On The Pill

Photo by Lew57

Becoming pregnant, while on the Pill, with twins. Twice! And you thought you had a bad day:

Proud mother Carly O'Brien has beaten odds of 11.3 million to one to give birth to two sets of twins - despite being on the contraceptive pill.

The 22-year-old and her partner John Grant, 28, were amazed when she gave birth to her first set of twins Brandon and Daisy.

Now, two years on, Carly has stunned experts by giving birth to another miracle set of twins - Dylan and Lilly.

...

Carly, from Portsmouth, Hants, had been using the contraceptive pill since she was 17 and never imagined she could get pregnant while using it.

She and John, who installs air conditioning units, had been together for only a year and having children had not crossed their minds.

But when Carly missed a period and started being sick, she may be pregnant.

A pregnancy test confirmed it but it wasn't until her 12 week scan she discovered she was carrying twins.

...

New mum Carly was overjoyed with her two children and, certain she did not want any more, she opted for a stronger contraceptive pill, which had to be taken twice a day.

But, just 18 months later, when Carly missed a period she couldn't believe the supposedly impossible had happened again.

A six-week scan revealed she was again carrying twins - beating odds of more than 11 million to one.

She said: 'I just couldn't believe it and didn't know how it could have happened to me again - especially as I was on a stronger pill.

Now, after the first pregnancy while on the Pill, what could Ms. O'Brien have done to lessen the chance of another contraceptive failure?

Option 1: Double-up.

While the simultaneous use of two methods of birth control, for example the Pill and a male condom, sounds great in theory, it can be problematic. A lot of couples, especially those in long-term, monogamous relationships, are not too keen on using a condom; the risk of noncompliance is quite high.

Option 2: Change Birth Control Methods

This is the one I would've advised. When you've already experienced a failure while taking the Pill, and with twins and no desire to become pregnant again it's time to move on to a more reliable birth control method.

For the Pill, the first year typical-use failure is ~8%.

Compare that with the typical-use failure for the most effective methods:

- Implants (Implanon) 0.05% and IUDs (Mirena, CuT) 0.2% and 0.8%, respectively

- Male sterilization 0.15%

- Depo-Provera 3%




(via)

Depo-Provera and Bone Mineral Density News

Photo by ad-vantage

If your method of birth control is the Depo-Provera shot (depot medroxyprogesterone acetate; DMPA), or if you're considering using this method, make sure your physician is aware of the latest ACOG Committee Opinion, in particular:

1. Most of the DMPA bone loss is temporary and is similar to the BMD loss caused by pregnancy and breastfeeding [~3%-5% vs. 2%-8% and 3%-5%].

2. Its use should not be limited to 2 years.

3. Concurrent low-dose estrogen supplementation to slow DMPA bone loss is not recommended.

4. Implants and IUDs--effective, long-term methods of contraception that have no effect on bone density--should also be considered as first-line methods for adolescents.

5. The scientific basis for the 2004 Food and Drug Administration black box warning discouraging the use of DMPA for more than two consecutive years is caca*.

*Okay, that characterization is entirely mine. According to ACOG, the FDA's warning is based on intermediate effects on BMD which may or may not be relevant to increased risk of fracture (former adult DMPA users have BMD rates similar to nonusers) and, while low BMD is linked to an increased risk of fracture in older women, no studies have linked DMPA bone loss with increased rates of fracture in younger women with a low-fracture risk.

N.B. Speaking of Depo-Provera, don't forget you also have a lower-dose version, Depo-subQ, available.

Skip Your Period and Period Control Options

Good AP article on the available options for period control, as well as some coming attractions.

Among the existing methods:

- Seasonale: 30 μg of estrogen (ethinyl estradiol, or EE)/150 μg of progestin (levonorgestrel), taken continuously for 84 days, followed by 1 week off.

- Ortho Evra patch: 0.75 mg estrogen (EE)/ 6.00 mg progestin (norelgestromin) [20 μg estrogen/150 μg progestin per day], one patch per week for 8 or 12 weeks in a row, followed by 1 week off.

- NuvaRing vaginal ring: 2.7 mg estrogen (EE)/11.7 mg progestin (etonogestrel) [15 μg estrogen/120 μg progestin per day], one ring in place for 3 weeks at a time, for 6 or 12 weeks total in a row, followed by 1 week off. [Alternatively, one ring can be left in place for 4 weeks at a time.]

- Depo-Provera [and Depo-subQ provera 104] shot: 150 mg progestin (medroxyprogesterone acetate) [104 mg progestin], one injection four times a year.

One more existing brand worth mentioning is Loestrin 24 Fe. The innovation here is the shortened placebo interval--one estrogen/progestin pill taken for 24 days, followed by one iron-containing placebo pill taken for 4 days. [Of course, if you're already taking the Pill, and you want a shorter placebo interval, you can use your existing brand to do that. Just take 4 placebo pills, instead of the usual 7, followed by a new pack.]

And some newer developments:

- Seasonique: 30 μg of estrogen [EE]/150 μg of progestin [levonorgestrel]), and 10 μg EE, one estrogen/progestin pill taken continuously for 84 days, followed by one estrogen-only pill for 7 days; no placebo interval.

- Lybrel: 20 μg ethinyl estradiol/90 μg levonorgestrel, one estrogen/progestin pill taken daily with no placebo intervals.

- Implanon*: 68 mg progestin (etonogestrel) [~40 μg progestin per day], one-rod implant lasting up to 3 years.

*Just like so many other methods before it (Mirena, Depo-Provera), Implanon has been available for over a decade outside the U.S.. This pretty much insures Implanon's status as a "cutting edge" method over here.

Surrogate Markers and Clinical Risks of Contraceptive Use

Another good article from Contraception: Is some of the information on contraceptive risks in the package inserts accurate and useful, or is it a barrage of innuendo and pseudo-science?

The development of safe and effective contraceptive options for women is the direct result of advances in laboratory-based research, which has provided an important foundation for the development of an evidence-based approach to contraceptive management. This marriage of laboratory and clinical investigation has not only served to better delineate pathophysiological processes but also has expanded our understanding of the mechanisms of therapeutic actions. However, when laboratory-based studies alone are used to explain clinical outcomes, prediction of clinical outcomes can be corrupted by a lack of clinical information and replaced by a process replete with unsupported assumptions, premature declarations and unfounded concern about the safety and effectiveness of therapeutic interventions. Such a disingenuous application of high-quality laboratory investigation is unfortunately now more commonly used to predict clinical risks of contraceptive use. In several instances, warnings and specific language have been included in the package inserts of contraceptives based on nonclinical studies.

Nonclinically based outcome variables, or surrogate markers, are studied to ostensibly better understand the pathophysiological basis of clinical outcomes associated with the use of particular drugs or therapeutic interventions. However, when such surrogate markers are studied to predict clinical outcomes in the absence of data assessing clinical outcomes, they may lead to unsubstantiated clinical predictions. An example of a surrogate marker and its inappropriate application for predicting clinical outcomes is the measurement of the size and number of ovarian follicles among users of oral contraceptive pills. Those pills associated with more numerous and larger ovarian follicles are "assumed" to be less potent and thus place a woman at a potential increased risk for pregnancy while using that pill. However, the presence or absence of follicles has never been actually correlated with contraceptive pill efficacy. Only a direct determination of pregnancy rates among users of specific contraceptive methods can provide meaningful information about the actual effectiveness of a given contraceptive.

Other examples of using surogate markers to predict risk:

Depo-Povera shot and the risk of bone fracture

In the past, the language of the package insert and all emboldened and boxed warnings communicated well-defined clinical risks, such as the increased risk of adverse cardiovascular events in women who smoke and use estrogen-containing oral contraceptives after the age of 35. Unfortunately, the language and warnings of package inserts have increasingly incorporated surrogate marker studies to arrive at pronouncements of clinical risk. For example, a black box warning in the package insert of Depo-Provera CI warns that the use of the product will diminish the calcium stored in bones and that this could cause an increased risk of fracture. Have studies consistently shown reduced bone mineral density among women using Depo-Provera CI? Yes, studies of a wide spectrum of women using Depo-Provera CI have consistently demonstrated reduced bone mineral densitometry measurements among Depo-Provera CI users. But has there been any study that has demonstrated an increased risk of fracture among any women (pre- or postmenopausal) using Depo-Provera CI? The answer is no. The measurement of bone mineral density in reproductive-age women is a surrogate marker with no known clinical relevance. Moreover, the suggestion that women should consider using an alternative method after 2 years of Depo-Provera CI use is not based on scientific or clinical evidence and may cause clinicians to inappropriately switch their patients to less effective contraceptives. Such changes will place women at increased risk for unintended pregnancy and induced abortion.

Finally, the language of the Depo-Provera package insert also suggests that clinicians "test the bones" of women who wish to continue this method for more than 2 years. As bone densitometry has been shown to be ineffective and inappropriate for assessing fracture risk in the vast majority of premenopausal women, what test is being suggested?

The Ortho Evra patch and the risk of serious adverse events

Unfortunately, this trend in drug warnings continues with the recently added language and new warnings incorporated into the package insert of the transdermal patch Ortho-Evra®. The new emboldened warning for Ortho-Evra is not based on studies of clinical outcomes, but rather nonclinical pharmacokinetic studies that have found that women who use the transdermal contraceptive patch have a greater overall exposure (approximately 60%) to ethinyl estradiol than those women who use a conventional oral contraceptive with 35 μg ethinyl estradiol. A recent study by van den Heuvel et al. compared the exposure to ethinyl estradiol among users of the transdermal patch, the vaginal ring (Nuva Ring) and an oral contraceptive containing 30 μg ethinyl estradiol and 150 μg levonorgestrel (Microgynon), and found that although women using the oral contraceptive had higher peak serum levels of estradiol than the other two agents, users of the transdermal patch had an overall higher exposure to estrogen (AUC or "area under the curve") than users of the other two formulations. The authors state that a lower exposure to ethinyl estradiol is desirable because of reduced "estrogen-related side effects..."

However, the term "estrogen exposure" that is used in the above study is actually a surrogate marker that the authors are using to predict the risk of estrogen-related adverse events with these products. No epidemiological data exist that demonstrate that the use of Ortho-Evra® results in higher rates of estrogen-associated adverse outcomes such as thromboembolic events. It is essential to have epidemiological information derived from rigorously performed clinical trials to make such clinical predictions. In the case of the three agents studied, the different doses and delivery systems likely are important for determination in the actual contraceptive effectiveness and safety. To this end, what if the peak concentration of ethinyl estradiol associated with the use of a contraceptive (Cmax) turns out to be the most important predictor of adverse outcomes instead of the area under the curve? Only epidemiological data will provide an accurate comparison of clinical risks between transdermal and other contraceptives. In fact, the new language in the Ortho-Evra® package insert specifically states that it is not known whether the pharmacokinetic differences are associated with an increase in the risk of serious adverse events in women using the contraceptive patch compared with women using oral contraceptives containing 35 μg ethinyl estradiol. If the package insert is meant to provide clinical warning concerning the use of a particular drug, this statement, which appears in various forms throughout the package insert, truly defies logic.

Women who use Ortho-Evra®, or any other estrogen-containing contraceptives, have an increased risk of developing a thrombolic event. However, a greater increase in the risk of such events compared to users of combination oral contraception has thus far not been determined to be present in the more than 5 million women who have used Ortho-Evra®. Unfortunately, the assumption that will be made by many who read the new package insert language, the van den Heuvel et al. study and the resulting press releases is that the transdermal patch is associated with an even higher rate of adverse events because the "area under the (estrogen) curve" was greater than that observed with vaginal ring or oral contraceptive use. Indeed, a recent article in the Wall Street Journal reports that numerous physicians and clinics are actually encouraging women to consider other contraceptive options or to discontinue the use of the patch altogether. Why would clinicians do this without any clinical evidence of an increased risk of adverse events? And why would an organization or agency communicate such information knowing full well the likely response of many women's health care providers?

The article concludes:

[T]here is one fundamental fact that must be in the forefront of contraceptive study and practice: without epidemiological data to support a clinical correlation, outcomes from surrogate marker studies can result in poor clinical practice. The irony is that the women who should be the beneficiaries of these package inserts changes actually become the unknowing victims of poor clinical practice. Recommendations made in the absence of data on clinical outcomes may lead to choices that increase the likelihood of unintended pregnancy.

In addition to the potential harm of using surrogate markers to develop warning statements concerning the risks associated with the patch or any other contraceptive option, another potential adverse outcome of continuing this practice is the eventual loss of confidence in our regulatory agencies and professional organizations to provide accurate information for professionals and consumers alike. The continuing inappropriate use of nonclinical studies to formulate warnings about the safety of contraceptives and other drugs may result in an interpretation to disregard these warnings by professionals and the public that will obscure real clinical risk associated with a particular drug or device. The true risks may be obscured by the continuing barrage of innuendo and pseudo-science on the package inserts of many drugs and devices.