Wednesday, February 23, 2005

Our Back-and-Forth with Canada

For a while now, old folks near the U.S.-Canada border have been making trips up to Canada to score inexpensive prescription drugs. It's especially handy for old folks who are among the millions of Americans with no health insurance.

Well, that was taking money out of Americans' pockets. From current pharma employees to the old guys in golf shirts at the Red Lobster who give the current lifers shit about the day's 5 cent drop in stock price, pain was being felt. So something had to be done. The U.S. had to raise a sense of fear about drugs from Canada being unsafe.

A statement from the Pharmaceutical Research and Manufacturers of America, which designed the ad described earlier, insists that buying drugs abroad carries risks not found at home.

"Federal law on prescription drug imports and reimports reflects well-documented concerns about the safety of imported drugs, and the probability that many such drugs will be unapproved, adulterated, contaminated or counterfeit," the group said.

If that weren't bad enough, there was the mad-cow beef scare of May 2003, which raised safety concerns about Canada's beef as well and led to a blocking of beef from Canada (starting March 7, imports of Canadian animals younger than 30 months will be allowed).

Earlier this month, Canada banned the ADHD drug AdderallXR, made by UK company Shire, after 20 sudden unexplained deaths. In the US, the FDA is taking action, too. They are going to 'carefully evaluate data'. If you think that's not enough, rest assured Shire will put some lawyers to work drafting label language that will 'minimize shareholder exposure', too.

Last year U.S. pharma Merck voluntarily pulled Vioxx in the wake of a study showing it increased the risks of heart attack and stroke. The FDA approved Vioxx, and it was launched in 1999.

After Vioxx, similar concerns were raised about other COX-2 inhibitors, Bextra and Celebrex. They now have the blessing of an FDA advisory panel. Thank God for that!

Recently in the UK, the MHRA issued a warning about potential liver damage risks from the Adult ADD drug Strattera (perhaps Lilly can put a sticker on the bottle encouraging people to drink alcohol while taking Strattera, to minimize their culpability in the case of a big class action lawsuit).

So, remember, the message here is, Canada is lax about safety! Say no to drugs from Canada! They're a bunch of crazy wild-eyed socialists up there!

Do not cry for our Canadian neighbors, though. As China continues to gain influence and its economy and demand for natural resources continues to grow, Canada will likely do just fine, according to this recent article by Jim Willie, CB, from the highly entertaining and informative 'Golden Jackass' site.

the USA will need Canada to interrupt the process whereby the USA is locked out of the supply chain for minerals and resources. Much will be learned during the current growing conflict over cheaper prescription drug commerce, as the USA has coerced cooperation with Canada. Each acquisition represents an event leading to removal of supply from the system, and creation of a direct line from Canada to China.

Monday, February 21, 2005

Polite Computers

First off, I'd be remiss if I didn't give mad props to Pharma Watch. Michael Lascelles of Australia is the man behind that blog, which casts a much wider net than 'Your Attention, PLEASE', covering the whole spectrum of abuses in the world of pharmaceutical promotion. I'd say something about how I chose to use this exact same blog template independently, before I was aware of Pharma Watch, but nobody will believe me.

Here's a good article by Katie Hafner from the New York Times, thoughtfully reprinted by the Spartanburg Herald-Journal, so you won't have to mess with that annoying as all get out 'free registration' that the NYT wants you to do: You there at the computer: pay attention.

The article discusses how a combination of email, IMs, and the Web conspire together to time-slice our attention spans into oblivion. Help is on the way, though, even if you don't want to roll the dice with Strattera and possibly trade in your comfortable old nickname 'absentminded professor' for 'constipated curmudgeon'. It seems HCI (human/computer interaction) researchers at the University of Maryland and the University of Washington are working on ways to make computer applications less annoying.

Researchers at Microsoft's R&D labs (lately also referred to as 'people who couldn't get jobs at Google Labs', which is not very nice, so stop it) have the ambitious goal of developing software that can tell when it's a good time to interrupt you!

"We can detect when users are available for communication, or when the user is in a state of flow," said Eric Horvitz, a senior Microsoft researcher who directs the project.

Given the people possessing fully functional human brains I've worked with who never seemed to have a clue about when was a good time to interrupt me, I remain skeptical. Still, these goals are worthy, certainly more noble than figuring out new ways to thwart Hotmail's spam filters, and I can only wish them success with their efforts.

Thursday, February 17, 2005

Conservatives dis their big pharma suitors

Eli Lilly and other big pharma companies give Big Money to the Republican Party (typically 70% of contributions go to the GOP) , and this is the thanks they get: some smart-ass (Shawn Macomber) from the American Spectator whips out the sarcasm for an article on Strattera Advertising on the decidedly conservative site 'The American Enterprise Online'.

Choice bits:

For a mere $2.85 per pill and the willingness to deal with the drug's most common side effects--namely, "constipation, dry mouth, nausea, decreased appetite, problems sleeping, sexual side effects, problems urinating, and menstrual cramps"--parents can finally even the playing field with their children. Hallelujah!

also:

"Every one of my bosses, every one of my general managers, anybody who was above me in the chain of command, thought I was difficult to work with, a jerk, hot tempered, and so forth," Guy says. Even when his doctor posited that he had ADD, Guy demurred. "I told my doctor he was full of crap," he said, before relenting when the doctor starts listing off symptoms of Adult ADD, which basically boils down to being a not very nice person. Apparently Eli Lilly is attempting to tap the vastly underserved Jerk Market.

This kind of parallels what I said a few entries back about ODD, which I still maintain is the hip disorder for jerks.

If that weren't bad enough, now the FDA is getting all focused on drug safety. They're really taking the eye off the ball. It's supposed to be about 'streamlining the approval process'.

Hey FDA guys:

"It may be beneficial for you to talk with your healthcare professional about an evaluation.”

Tuesday, February 15, 2005

A Brief Background, Plus Assumptions Are Revisited

A revision to my hypothesis is probably in order. I concede that Adult ADD was not made up by the marketing team for a large pharmaceutical company.

Though adult ADD seems to have come out of nowhere, it has been recognized by the psychiatric community for a few decades. Childhood AD/HD is a condition that has been treated for nearly a century, but until recently it was believed children would outgrow the problem by puberty.

The current thinking is that the hyperactivity-related symptoms diminish, but the underlying organizational and attention related problems remain.

It is estimated that 67% of children with AD/HD will continue to have symptoms well into their adult lives.

For more info, see Fact Sheet #7 from www.chadd.org.

In the 90’s, a few books addressing the problem were published, including ‘You mean I’m not lazy, stupid, or crazy?’ by Kate Kelly and Peggy Ramundo (1996) and Driven To Distraction : Recognizing and Coping with Attention Deficit Disorder from Childhood Through Adulthood by Edward M. Hallowell and John J. Ratey (1995).

It is still interesting to note that a lot of the recent press regarding Adult ADD seems to focus on getting adults who have never been diagnosed as having AD/HD or ADD to consider the possibility that they may have it. The Strattera website (www.strattera.com) and adult-add.com both have handy Adult ADD screening tools, which direct you to print out the results and take them to your doctor if your answers are consistent with the DSM-IV symptoms for ADD. Actually they don’t tell you to go tell your doctor to give you a prescription, a team of lawyers came up with this:

"It may be beneficial for you to talk with your healthcare professional about an evaluation.”

The idea that much of the press given to Adult ADD is marketing-driven is not novel by any means. A story on CNN’s site from July 2003 of asks: Adult ADD: Common disorder or marketing ploy? This article appears on numerous ADD/ADHD websites (sometimes without crediting the authors, Elizabeth Cohen and Debra Goldschmidt. Shame, shame!)

Coincidentally, 2003 is also the year Eli Lilly launched Strattera, a non-stimulant drug for treating ADHD/ADD, and the only drug with FDA approval to treat adults with the problem. The fact that it is a non-stimulant drug means there is less potential for abuse, and this also removes many of the pesky controls in place for stimulants, including only being able to obtain a month’s worth of the drug at any given time, and having to make an in-person visit to the doctor to get a new prescription everytime you need it (the prescription can not be phoned in).

Tune in for the next installment of YOUR ATTENTION PLEASE.

Note to self and others: Never again am I going to keep notes and write this stuff in Microsoft Word before cutting and pasting it here. It tries to be clever and convert what you had to HTML, but it ends up being an ugly mess that's more trouble to clean up than writing it all from scratch. Next time I'll use Emacs if I need a scratch pad. Sheesh!

Friday, February 11, 2005

The Statement of Purpose thingy

Adult Attention Deficit Disorder. WTF is it? How come it's only really registered in a big way in the 'public consciousness' recently? Is it really even a disorder, or is it one of those made-up things, like saying people we used to, back in my day, call assholes actually have ODD (Oppositional Defiant Disorder)?