Sunday, July 20, 2008

Am I A Prophet Or Am I Just Really Smart? It's Hard To Say Sometimes

I'm leaning toward prophet this night. Totally towards prophet. Because you know what the first thing I said was when I read about Reclast?

First you should probably know though, before I amaze you with my brainpower, that Reclast is a treatment for osteoporosis. It's a member of a class of meds called biophosphates, like Fosamax, Actonel, and Boniva, that have been around for years. Reclast's claim to fame when it hit the market was that it only had to be given once a year. Seriously. They stick it into your veins and it does its thing for a full 12 months. So, getting back to my amazingness, you know what the first thing I said was when I read about this?

"Holy crap, what happens if you find out there's some freaky side effect to this stuff the day after they shoot you up with it? Screwed for a whole friggin year you are"


Of course I didn't say it here. But really, I said it. I'll bring in my keystone tech to verify if I have to.

Anyway, here we go:

New questions have emerged about whether long-term use of bone-building drugs for osteoporosis may actually lead to weaker bones in a small number of people who use them.

The concern rises mainly from a series of case reports showing a rare type of leg fracture that shears straight across the upper thighbone after little or no trauma. Fractures in this sturdy part of the bone typically result from car accidents, or in the elderly and frail. But the case reports show the unusual fracture pattern in people who have used bone-building drugs called bisphosphonates for five years or more.

Some patients have reported that after weeks or months of unexplained aching, their thighbones simply snapped while they were walking or standing.

Welcome to the information vacuum. The first thing to pop into your head when you read that was probably something like "Well how likely is it that someone taking biophosphates can be standing around and have their leg snap in half?" I'm sorry, but even my supernatural mental prowess can't give you an answer on that one. This is the kind of situation you'll find yourself in when you approve a drug for sale based on tests on 3 or 4 thousand people, then require absolutely no follow up as it's sold to 3 or 4 million:

Last year, The Journal of Bone and Joint Surgery published a Singapore report of 13 women with low-trauma fractures, including 9 who had been on long-term Fosamax therapy.

“I have several similar patients myself,” said Dr. Susan M. Ott, associate professor of medicine at the University of Washington. “Prior to these recent articles, there were a few cases here and a few cases there, but they are kind of starting to add up.”

My spidey sense tells me Big Pharma won't hesitate to say that there's very little evidence of leg snapping while taking the biophosphates. They'd be right. There was also very little evidence the earth was round before Christopher Columbus set sail. And until you start to look, you're not gonna find much evidence. Not many people have been looking until now.

And here's the thing Big Pharma. We can't trust you anymore. After Baycol, after Bextra, after Duract, Posicor, Propulsid, Tequin, Redux, Trasylol, Seldane, and Vioxx. After you withheld evidence that Paxil may raise the suicide risk in children, After the way you sat on data in order to prop up sales of Vytorin and Zetia, after we found out the estrogen you were pushing on the MILFS was giving them breast cancer, your words aren't nearly as reassuring as they were when I was a wet behind the ears new graduate telling patients not to be overly concerned about their Rezulin.

Don't get me wrong. Osteoporosis and hip fractures are not to be fucked with. They can kill you. As long as you take into consideration the risks involved, preventing or slowing osteoporosis is a good thing. In order to do that though, you kinda have to know what those risks are.

Oh, and I haven't even mentioned the jawbone rot yet.

Good luck.

9 comments:

Scritches.com said...

Ah, I was going to mention the jawbone rot if you hadn't. My dentist warned me about these drugs last year because of the jawbone rot. Now, everytime I see Sally Field hawking Boniva I wonder how her jaws are doing.

bernadette said...

golly,mr. drugmonkey duuuude.
you are SO cynical.
i think those gals w/ the "spontaneous" leg fractures
are just pure coinky-dinks.
just take a little lorazepam and RELAX!!!

bernadette said...

1 more thing.. I LOVE YOUR PLAYLIST!!!!
it makes me want a quaalude.....

Jane Shevtsov said...

So how does this stuff keep working for a year, anyway? I'd understand if it was a time-release implant, but an IV?

Anonymous said...

I actually read about this concern a while back. No case reports of no trauma leg fractured were reported yet back then but it was mentioned that there is concern about the long term effects of bisphosphonates based on their mechanism of action. Bisphosphonates work basically by inducing apoptosis of osteoclasts. Osteoclasts have the important function in bone architecture of chewing up old bone while osteoblasts replace it with new bone. The concern was that is you disable too many osteoclasts the micro damage that occurs every day in normal bones will start to accumulate. The result being that you will have nice dense bones that look great on a DEXA but are covered in micro damage and are extremely brittle because of this. The theory I’ve heard is that bisphosphonates should probably only be used for 1-5 years… basically until your t-score looks good. Then they should be D/Ced to prevent this dense but brittle bone phenomena. Of course word on that didn’t get out to quickly since that would cause people to use less expensive medicine… not more. Big pharma would never stand for that.

Anonymous said...

@ Jane Shevtsor,
Bisphosphates have really, really long half-lives. A half-life is the time it takes 50% of the medication to no longer be in the body. Boniva's half-life is about 10 years. Which means that if you take one today, it will still be in your body 10 years or more from now. Most medications have half-lives in terms of hours or days at the most.

Gourmandish said...

Yeah, it can mess up your renal function, too.

Reclast, Zometa, zoledronic acid, whatever you want to call it, is extremely potent. We use it in our breast and prostate cancer patients to treat bone pain from metastatic disease. Frankly, when there are other options available, I don't think it's a wise choice in postmenopausal osteoporosis. One would hope these patients would be at least able to take a pill once a month (or even once a week).

Anonymous said...

Reclast is undetectable in the blood within 24 hours of infusion. After that it is in the bone for a long time...just like fosamax and the others. If you don't have side effects in the first couple of days you are not likely to have one at all. Reclast is being studied right now to see if it can be taken for three years and stopped. As far as comparing Reclast to Zometa (name of Reclast when used in oncology) Please keep in mind that Zometa is given 4mg every 4 to 6 weeks where as Reclast is given 5mg per year. One more point about the leg bone no trauma fracture. Studies have shown that 50% of patients on oral bisphosphonates like fosamax stop taking their pills after the first year. Yet they continue to mislead their physicians into believing they are taking them 100% correctly all the time. That being said, the nine strange fractures from fosamax patients could have been from not taking the pills. Ask everyone you know who is on the treatment if they take their pills religiously. The answer is no in more than half the people you ask. Finally Jaw rot...168 cases of ONJ. Onj is charactorized by delayed healing after a tooth extraction. The majority of osteonecrosis of the jaw have taken place in Oncology patients who are being treated for bone metz. These people are on chemo, steroids, are immuno suppressed, and are being with a host of other things that can also cause delayed healing. In May 2008 in a jounal called JADA- the dentist version of JAMA, the cover story was about ONJ. The journal stated when an otherwise healthy patient needs treatment for osteoporosis their is no reason to avoid the use of bisphosphonates. That is in the dentists' own journal. Look it up.

Anonymous said...

Yesterday, I learned that drinking from a straw can improve jaw stability. I prefer the crazy twisty ones myself.

www.krazystraws.com

The longest straw is 6 feet long. SIX FEET LONG. That's bigger than me. That's almost as big as you.