A New Office....A lot of Work

But it's a lot of fun!

Planning a move. I'm making my list. Checking it 10,000 times. Gotta make sure nothing's missing in there. I'm getting ready for a Big move.

Yeah, I'm planning to move my office this summer. And it's been a work in progress since the Winter. Wow! Along the way, I've managed to accumulate my very own "Entourage." I was thinking today, I must be an adult now (yeah, I know I've been one for a while, but I still feel like a kid in business) -- because I now have a lawyer, an accountant, a broker, a designer, a plumber and a contractor. 3 years after launching my practice, I'm ready to bring it into what I call the heart of the city -- Midtown East. That's where all the major arteries and veins criss-cross. And I have this group of people to help make my vision reality. Sure, I could have moved in with another doctor, shared space, or taken up an old doctor's office, but I didn't want to. As the Sinatra song goes, "I did it my way!" My philosophy is integrative and holistic, and the new space will reflect this. Will it be worthwhile? Yes, I believe, not just for me, but also for my patients.

So, because of this impending move, and because of a confluence of CME hours I've been accumulating, I had temporarily disappeared from the blogosphere. Not sure how much I'll be around in the next month, either, because there's more CME a-coming. It's crunch time, as they say.

The exciting part is shedding the old, and starting with the new as I continue this wonderful experiment we call "running a medical practice." I can't wait to hear what crazy ideas the presidential candidates will have for revamping our healthcare system, because, surely, they will have to have some ideas. What? Do I hear higher reimbursements for the value of time spent by us primary care docs fine-tuning care and implementing preventative medicine measures which ultimately lower the cost of healthcare? No? Not yet? Well, I'll be waiting, until the day I decide to go concierge or boutique or whatever you want to call it -- insuranceless.

Well, things usually come in Pairs.....

How many times have you had a case of sciatica, and you get another patient in an appointment right after with the same symptoms and diagnosis? It's happened to me many times. Two acute nephrolithiasis on the same week, two culture-positive strep throats (unrelated to each other, besides having appeared in my office at the same time), two foot fractures, two cases of Lyme disease. Well, you get the picture. I'm sure these occurances are non-statistically significant random chance events. But maybe, in these days of "The Secret" and the "Law of Attraction," there is some freaky universal thing going on here.

The Law of Two's -- I call it. Of course, it doesn't apply to your most common diagnoses. It only applies to things you only see once every month or less often. It has to be something you wouldn't normally diagnose on a routine week. Once it becomes routine, it is beyond the law of two's. And that's how the law works (if you want to believe in it).

Well, this past week, the FDA took Zelnorm temporarily off the market as it seeks to redefine its roll in treating IBS patients, given the newly confirmed cardiovascular risk profile.

Today, comes another announcement for another drug, Pergolide, used uncommonly in patients with Parkinson's disease (given the availability of newer drugs), that has been taken off the market. This decision was based on two case-control studies published in the NEJM on January 4th, 2007 that showed that the medication, a dopamine agonist, was implicated in valvular dysfunction due to a histologically distinct form of valvular fibrosis. The mechanism of pathology is due to the drug's activation of a serotonin receptor, the 5-hydroxytryptophan-2B receptor. In contrast, Zelnorm is a partial 5-HT4 receptor agonist with moderate affinity for the 5-HT1 receptor. These receptors are having some activity on the heart muscle, its vasculature or the heart valves themselves. I find it interesting that serotonin receptors have been implicated in two drugs that have been removed from the market this week. Hey, maybe the law of two's does work.

The other interesting fact is that depressed persons have higher rates of acute cardiac events. Again, is serotonin implicated here? I don't know whether this statistic relates to depressed patients on anti-depressants or off of them. It is something to explore.

Read the FDA Public Health Advisory for more information on the Pergolide withdrawal.

Another One Bites the Dust!

I had a feeling this was coming soon. The FDA has found another drug in post-launch analysis that was riskier than believed to be by the data revealed during the prelaunch studies. Zelnorm has been found to increase the risk of cardiovascular events by 10-fold compared to placebo in a pulled analysis of 18,000 patients. A Swiss government study (which the FDA relied upon for its decision), showed that in this metanalysis of 29 Zelnorm studies, the drug was found to increase cardiovascular events, such as heart attack, stroke or severe heart-associated chest pain.

For a full article see:

IBS Drug Zelnorm Taken Off U.S. Market on WebMD.

The article states that Zelnorm was taken off the market, but the FDA website says it more politely. The following quote is from the FDA website: "FDA has concluded that the overall risk versus benefit profile for the drug is unfavorable for continued marketing." It's unclear whether it will be taken off the market or if its prescribing will be limited to specialists. However, upon reading the FDA statement further, it sounds like the FDA website tempered its language with euphemisms to perhaps temper the bad press for Novartis. It's not just marketing, the website further states, "Novartis plans to recall Zelnorm and will actively work to remove it from pharmacies."

The FDA in April 2004 also cautioned that Zelnorm could increase the risk of diarrhea and intestinal ischemia. Why did it take them 3 years to discover cardiovascular event risks from older studies? Well, by now, Novartis has probably made a hefty profit from Zelnorm sales.

From Forbes.com: "Zelnorm, which is approved in fifty countries, is one of Novartis best selling drugs with worldwide sales of 561 million USD last year, of which 488 million were recorded in the US alone."

I had recently begun using more caution with prescribing Zelnorm, after one patient told me she experienced unrelenting headaches after 2 weeks on Zelnorm, which resolved by discontinuing the medication. I reasoned that it must be causing some sort of vasospasm in the brain vasculature. Well, if in the brain, it must happen elsewhere. A few weeks ago, I asked the Novartis reps (who were sponsoring a lunch in my office) for any data on this matter, and of course it was not available. They showed me that headaches were (according to their data) not a commonly reported (<10%) side effect.

For Novartis' response, see the Zelnorm website.

Should Zelnorm be taken off the market, or should it simply carry a new black-box warning that would state: "Caution is advised when using Zelnorm in any patient with known cardiovascular disease"? Novartis claims the events occurred only in patients with cardiovascular risk factors. What do you think? Is the FDA overreacting to a rate of 0.11% compared to 0.1%? Or is the FDA wanting to show some muscle as it has been recently under fire for a deficient post-marketing safety analysis of new drugs?