If you could take a pill that completely eliminates your periods, would you?

Turns out the answer is rather emotional for many people. I say people because some men seem to have strong feelings about it too (as they do about many things that affect only women).

Most contraceptive pills entail 21 days of hormones, followed by 7 days of placebo. What follows is a period only in name, since women don't actually ovulate while taking the pill. This fake period was designed into the pill when it was first introduced in 1960 so as not to freak women out too much.

This month, the FDA is evaluating Wyeth's Lybrel, with which women would take hormones for a full year or longer (Women taking Seasonale, available now, still have 4 periods a year), remaining period-free throughout. And this is getting many experts riled up: those who think it might be unsafe, yes, but also those who argue that it is culturally dangerous--as in, it redefines femininity! Ahem.

Last year, I summarized the pros and cons of pills like Lybrel for the mainstream magazine Women's Health, but briefly: the new pill could be healthier, because it cuts down on the hundreds of periods women now have on average as compared with about 50 or so not too long ago. On the other hand, we don't really know what the long-term consequences might be.

So, what would you choose?

Posted by Apoorva Mandavilli at 04:24 PM | Permalink | Comments (11)

One of the biggest problems of the Food and Drug Administration (FDA) is the limited postmarketing surveillance of its approved medicines. It is widely believed that cases such as the Vioxx fiasco could have been avoided if the effects of drugs continued to be carefully monitored after they find their way to the market.

It is therefore good news that the US Senate is supporting a bill that would give the FDA power to require postmarketing studies, the publication of negative clinical trials to bolster transparency, and the authority to fine companies that don't comply with these requirements. Unfortunately, as highlighted by a recent New York Times editorial, the success of the proposed reforms depends on hefty fees imposed on drug manufacturers. Such dependence is problematic, as it might increase the influence of the pharmaceutical Industry over the decisions of the FDA.

There is, however, a more immediate problem: the bill may not be approved at all, as the White House is already threatening to veto it. The point of contention is a proposal to allow the importation of cheaper prescription drugs from Canada and other countries into the US. Critics of this idea argue that it is dangerous for the public to gain access to foreign drugs that may not meet the same safety standards of the FDA or may even be counterfeit.

Fair enough. In fact, officials have been making a similar point since the days of the Clinton administration, stating that they couldn't possibly guarantee the safety of an imported drug. Nevertheless, those in favor of lifting the ban on drug importation dismiss these arguments as mere stratagems of the pharma industry to protect their interests.

But ultimately the pressing question is: should the bill be put at risk of being vetoed for the sake of this evidently controversial issue? It doesn't look like the Senate is going to back down, and we are already painfully aware of how stubborness of the White House. What gives, then? Hopefully not the interests of the public.

Posted by Juan Carlos Lopez at 11:27 AM | Permalink | Comments (2)

It’s always frightening when matters of science are settled in a court of law. And a relief when reason prevails.

Last week, an Australian judge declared that yes, HIV does exist and that it causes AIDS.

The criminal case was filed against a HIV-positive man, Andre Chad Parenzee, for knowingly exposing his sexual partners to the virus. In his defense, he maintained that “the existence of HIV has not been proven” and that “there is no scientific evidence that AIDS is caused by a unique infectious agent.”

The case dragged on for months and although it wasn't covered much outside the US, did create waves in Australia. Robert Gallo, who established the link between HIV and AIDS in 1984, appeared (by videolink) for the prosecution and was grilled by the defense about his research and his notorious squabble with French virologist Luc Montagnier. AIDS denialism has its supporters even among scientists and the dissident Perth Group, led by two Australian doctors, appeared as "expert witnesses" for the defense.

Parenzee had been convicted on three counts of endangering lives and had appealed. Justice John Sulan said last week that the Perth Group witnesses lacked credibility and threw out the appeal.

The two doctors continue to be employed by the Royal Perth Hospital, although AIDS Truth, a loosely banded group of scientists and activists, and other are calling for their dismissal. As I've written here before, AIDS denialism has serious consequences in some parts of the world and is not simply an academic debate. It's time Australian scientists joined these activists in making sure science prevails.

Posted by Apoorva Mandavilli at 06:08 PM | Permalink | Comments (3)