Sunday, March 28, 2010

No News Usually Good News: Bisphosphonates (Fosamax)

I was once at a Chinese restaurant and when I opened my fortune cookie at the end of the meal I found no fortune. When I told the waiter, he smiled and said, "no news is good news."
It seems to me, that it least when it comes to reporting on medical news, the media tends to only report on one thing: bad news. Medical headlines are often about a common drug that has now found to be dangerous or what you are eating/doing that will probably kill you. The rare exception tends to be a story about the latest miracle cure (usually with little to no evidence to support it). This is one of the reasons I started this blog: to give a broader, balanced physician's perspective on media headlines; to allay fears or let patients know when they are actually warranted. One of my frustrations with the media has been lack of reporting on additional research after a major story, especially when that research is actually reassuring.

One of the best examples of this has been Avandia. Recently, the media was quick to pick up on a Senate report regarding concerns on the way the company (GSK) and the FDA handled Avandia's safety data. The Avandia story first made headlines in May, 2007 when Dr. Nissen's meta-analysis on Avandia was published the New England Journal which claimed that Avandia increased the risk of heart attack by 43%. However, the media never really covered the RECORD trial, whose results were released in July, 2009 that showed Avandia does not in fact increase heart attacks. Even if they felt it was not necessary to mention the RECORD study in July 2009, it was inexcusable not to mention this when reporting about the recent Senate report, which bashed the drug and it's maker, but failed to mention any of the new, reassuing data.
When I prescribe Avandia to patients, they are still convinced that the drug is dangerous. This is because the media reported the bad news (back in 2007, and more recently with the Senate report), but never the good news. In fact, in response to the Senate report, a group of cardiologist who had been studying this class of medications extensively released their report earlier than planned. This report was extremely reassuring regarding Avandia safety. Yet, there was no mention of this in the press.

The latest example is bone fracture and bisphosphates. I blogged about this last month, when two reports from a medical conference surfaced, and these concerns were given significant media attention, including a Diane Sawyer piece on ABC. The class of drugs is called bisphosphonates and include medications like Fosamax (now available as generic alendronate), Actonel, and Boniva- the drug pitched by celebrity spokesperson Sally Field. These drugs are designed to treat osteoporosis which is a condition where the bones become brittle; but there had been some reports of rare, but serious bone fractures. In my blog post back then, I noted how the FDA was aware of the reports, had looked at the issue, and found no compelling reason to issue a warning. I also noted that most of these fractures occurred in women who had been on bisphosphonates for a long time, and that new evidence suggests five years is enough. After looking into the issue further, I found that there was a population study that suggested there was no link between these medications and dangerous fractures.

Now for the good news! In the current issue of the New England Journal of Medicine, several researchers took this issue head on. They combined the data from large, randomized controlled trials to look for any risk. In the three trials they examined, which included over 14,000 patients, they found no increased risk.

They state, "the occurrence of fracture of the subtrochanteric or diaphyseal femur was very rare, even among women who had been treated with bisphosphonates for as long as 10 years. There was no significant increase in risk associated with bisphosphonate use, but the study was underpowered for definitive conclusions."

This study, along with other information is very reassuring for the millions of women taking these medications, now wondering whether or not they are safe. Why did the media not give this new study even 5% of the attention they gave to some of the initial concerning reports? Why is it that the media reports only when there are concerns about treatment, and virtually never reports about studies that subsequently show that these initial concerns are unfounded? Why does the media feel it can only attract readers/viewers with tales of woe?

Bottom Line: Often you will never hear about good news regarding medical treatments because the media does not cover this information. Ask your doctor, or go online yourself, before completely discounting a recommended medication or treatment due to safety concerns you may have heard about. Regarding bisphosphonates like Fosamax and Boniva, these appear to be safe medications, though I would still not recommend taking for more than 5 years.


Rich Meyer said...

Very well said !!! The media only covers the negative because it's easier to sell than positive stories. Prescription drugs have take a lot of big hits but the fact remains that a lot of people are living longer healthier lives because of the drug industry.

Figaro said...

Thank you as always for your thoughtful analysis. You've always provided us with very important information and advice.