This story reported on FDA approval of one of several oral contraceptives now on the market that claims to reduce or stop menstrual periods. The manufacturer claims this drug, Lybrel, is "the first and only low dose combination contraceptive pill taken 365 days a year, without a placebo phase or pill-free interval."
The story didn’t discuss the quality of the evidence for the drug, so it didn’t disclose that many women in the trials dropped out because of spotting or breakthrough bleeding. Some have said that it’s difficult to make the claim that the drug stops periods when women still get bleeding like this – bleeding that is uNPRedictable.
While the story made an attempt to put the new drug into context of other attempts by many women to control their periods with other products already on the market, the story would have been improved with more hard evidence and more scrutiny of the quality of the evidence. It also could have emphasized more clearly what is truly "new" here and what is just new "packaging." If the story could find time to discuss the "big business potential" for the drug, which it did, then it should be able to find time for brief mention of the quality of the evidence.
It was good that the story included at least one expert’s concerns about long-term safety of the drug.
At the end of the story, the anchor referred viewers to the network’s partnering website for more information. Indeed, there was much more complete information once we found the story on that website. But for people who have or use TVs but not computers, that information was lacking in the on-air-only message.
There was no mention of Lybrel’s cost – not even a projection of what Wyeth might charge. Cost of the new product is likely to be substantial, while the same effect can be achieved (and could have been all along) with generic pills.
There were no details on the benefits seen in the trials, which is disturbing since the story did find time to discuss potential sales impact of the new drug. In fact, all that was stated was an overstatement: " the drug not only prevents pregnancy, it eliminates periods, period." It would be good to take into account the experiences of all of the women who dropped out of the trials because of bleeding to see if they consider that the drug eliminated periods, period.
The story stated that doctors studying Lybrel said it’s no riskier than the traditional pill. Then it quoted one researcher’s concerns about long-term safety for bone health, breast cancer, heart disease, and clots especially for young women. But the "harms" of poor cycle control and uNPRedictable spotting and bleeding are very common and certainly impact quality of life and result in an outcome different from what the woman who selects this methods is seeking. And that point was not emphasized in this story. There’s another risk beyond dissatisfaction with bleeding pattern – that is that women stop their contraception completely and are at risk of pregnancies from not contracepting or using an inferior method in the interval before they return to their provider to discuss dissatisfaction and arrange a change.
The quality of the evidence was not discussed and this is a major flaw. Many of the women enrolled in the Lybrel studies dropped out before the studies were over because of bleeding or spotting. That was not discussed.
This is a toss-up. There were elements of disease mongering – calling menstruation a "monster" and "the monthly curse." But the story included comments from two women who felt it was better to let nature run its course. So we’ll give the story the benefit of the doubt.
Mixed bag. One of the trial investigators was quoted, but the fact that she is a paid consultant to the drug company was not mentioned. Another researcher, concerned about long-term safety was also interviewed. But because the story found time to discuss the "big business potential" of the drug, we’ll lean toward ruling this unsatisfactory.
The story stated that women have been manipulating their menstrual cycles with birth control pills for 40 years, and that other drugs are on the market to stop or reduce periods. So the story did attempt to put the new drug in context, although it certainly could have done a better job in clarifying what’s "new" and what’s just "packaging."
It’s clear from the story that the new pill called Lybrel has just been approved. What is not clear yet is how many health plans will cover the new drug. Some women may find it hard to obtain. But it’s also worth noting that the same effect can be achieved with any low dose monophasic pill.
The story stated that women have been manipulating their menstrual cycles with birth control pills for 40 years, and that other drugs are on the market to stop or reduce periods. So the story did attempt to put the new drug in context. But the story could have made more clear how similar this pill is to existing pills and that continuous use of pills is also not new and has been done with conventional monophasics under healthcare provider direction for decades.
Because there were several sources, it’s safe to assume the story did not rely solely or largely on a news release.