Thursday, September 6, 2007

Before anyone gets too cheery

Here's a more sobering moment. From City Boy blog,

The young girls were raped before execution,
so they would not go to heaven.

A crime against humanity

Never even heard of this before...but now I have.

FDA shuts down company for illegally marketing their product as a drug....nice

Well, this is exactly what it is designed to do, grats to the FDA. From here:

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc. in Hendersonville, Tenn. for the illegal sale and marketing of the product Melanotan II, which is not FDA-approved, on Melanocorp's Web site.

The website is currently a blank page. Luckily we have the internet wayback machine.

The FDA letter is here. A great read. Essentially, they got nailed for saying their product was a drug, but more than that, by saying it was a NEW drug. Looking through the archive above, you can see they claimed it worked when it was "not generally recognized as safe and effective for its labeled uses"(fda words, great phrase).
But the FDA letter is worth a read more because it is so harsh, and they clearly dont believe the company have any valid claims, and have any chance of recovering.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations . Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market Melanotan II, your response should so indicate, including the reasons, and the date on which you ceased production.
That bold part is my favorite. they're saying, "If this letter caused you to shut down, let us know". The height of FDA bureaucratic arrogance, however, and frankly hilarious to me, is the very last paragraph in the letter, which I feel is kind of like "ok buddy, nice try. If you want to make a real drug, you can learn all about that online at this website or write to these kind folks and they'll answer your questions":
A description of the new drug approval process can be found on FDA's internet website at http://www.fda . ,gov/cder/rep-ulatory/anplications/default htm . Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857 .

Favorite Seinfeld Moments

Part three

"The bus was out of control!"

Genius Kramer story, one of the best michael richards deliveries EVER.
My personal favorite moment, right at the end, is going to have to be:

Kramer -"....I kicked him [mugger] out the door at the next stop"
Jerry - "You kept making all the stops?"
Kramer - "Well...people kept ringing the bell!"

Bonus: germanic subtitles (indeterminate language)

More on healthcare issues

So I wrote about the incredible burden of complex bureaucracies on the US healthcare system here, well, here's a really cool piece from Slate about same-day appointments at family doctor practices, something called an 'open access' model. There are huge difficulties in setting up such a system, not the least of which is the process of actually switching over from your appointment system. Another big issue:
Doctors also have to make sure their practices don't take on more patients than they can handle. The total number of patients in a practice, called the panel size, is crucial because it determines the demand for service on a typical day. Obviously, the larger the panel, the higher the number of expected daily appointments, and if demand outstrips supply, waits are inevitable. Yet many doctors have no idea whether their panel size is too large. They track only the patients they see, not the patients who wanted an appointment but didn't get one. That's a formula for underestimating actual demand for service.
Sound like we need more business and economics in medical schools.?..come on people!! Every time I mention this to someone in healthcare, or med school, they tend to enthusiastically agree. Anyway, luckily (or not) some academics are on the case!
Taking into account the total number of appointment requests is the first step to open access, but it doesn't do the trick on its own. It seems like common sense to balance the number of daily appointment slots with the average daily number of appointment requests. But a mathematical model built by operations researchers at Columbia University shows this intuition to be wrong.
Interesting. So I checked out the article, it's published online because they want to make the results as freely available as possible. In fact, they even have a spreadsheet where docs can enter variables about their practice size to get assistance on operating an open access practice. They summarize the above situation in a different way, and I think a little better:
A fundamental feature of patient demand for primary care
is its random nature: the actual number of patients
requesting care on any particular day will vary around the
average daily value, sometimes substantially. It is this
inherent randomness that makes it difficult to determine
the answers to questions such as: “How large a panel size
can be served by a given physician practice?” If not for this
variability in demand, the answer would be obvious—the
panel size would be the one that made the daily demand
for care equal to the daily number of physician appointment
slots available. However, with this variability, making supply and demand equal on average would create chronic backlogs for care and waits for appointments that would likely get longer and longer.
Really, really interesting. I'm looking for a doctor, I need to find me an open access doc, that would be awesome.

My ipod dilemma

So those of my paltry few readers who know me know that I am a born contrarian- socially, ideologically, politically, economically, but above all, technologically. In fact, I distinctly remember passionately arguing the merits of tapes over CDs in a soccer practice stretching circle when I was 10. I have thus resisted cellphones, Facebook and innumerable other important, major innovations since then. Each of these has been overcome in turn. It is a major, major flaw. I'm working on it.

Now comes the last one....I dont own an ipod. In fact, I dont even own an mp3 player of any kind. It's been on my to do list ipod. Well, the announcement of the new iPod touch is obviously turning everything on its head.

I'm wondering....I love the touch, but the nano is also interesting. They've redesigned it and it now has video. On the other hand, the touch is the future! I cant decide. Size or coolness? Portability or wireless?

On a separate note, Apple cut the price of the iphone by $200!, which pissed everyone off who had already bought one. Check out the Consumerist:
Early Adopter Syndrome can strike anyone—our fancy N95 is less than six months old and has just been kicked to the curb by Nokia for a new version that works with US 3G—so we sympathize with all of you who just shelled out $600 for that great iPod/so-so phone combo from Apple. The Unofficial Apple Weblog offers the following five suggestions on how to fix your little $200 problem.
Apple however, has frankly done A+ PR damage control on this. When I first heard this, I thought big deal, I frankly didnt have a lot of sympathy for the early adopters. The blogosphere and internet went wild though, as seen above. To their credit, apple decided to contain the damage and are now offering $100 rebates to everyone who already bought one. Wow. Check out the letter one dude wrote to Steve Jobs from the Consumerist:

The business behind your idea is quite clear, and makes sense I admit. Introduce a product with a higher price and let those who will buy it at that price do so, and then decrease the price after you have saturated demand at the higher price. Despite the good business behind it, even as an owner of Apple stock I am still offended, and disappointed with your decision at the lack of integrity, and penny-pinching which this reflects on you and your company.

Decreasing the price of the 8 GB iPhone without offering some sort of refund or even Apple store credit to the faithful who rushed out to support your product and made it the sensation that it has become is a disservice to your followers; and leaves this fanboy for one not only feeling taken advantage of, but also at least a little less enchanted with you and your company.

I hope that you will take steps to make this right by your loyal followers who feel that they have been taken for fools.

Impressive argument. I have to say it also illustrates that the iphone sales are probably sluggish, largely due to apple's idiotic decision to only go with AT&T, buggy issues, and its lack of true revolutionary stuff. The ipod price only got cut today, after they introduced their own successor. The ipod touch, however, seems pretty awesome to me.