Category: Technology

Pfizer and iCardiac announce cardiac safety alliance

published date
January 30th, 2007 by

I recently joined the board of iCardiac Technologies, which is commercializing ECG analysis technology from the University of Rochester’s renowned Heart Research Follow-Up Program (HRFUP). I’m excited to pass along the news that Pfizer and iCardiac have agreed to an alliance. According to the press release:

The aim of the research alliance is the further development of iCardiac’s COMPAS platform and advanced ECG markers for use in the safety testing of in-development and on-market drugs, and includes a cross-licensing arrangement by which iCardiac will receive rights to ECG analysis technologies developed within Pfizer.

Under the terms of the agreement, iCardiac and Pfizer will collaborate on a research program comprised of a series of studies, including retrospective and prospective ECG data analyses. iCardiac will receive an equity investment and technology license payment, plus research and development funding over the term of the alliance. iCardiac will retain commercial rights to the validated technology platform and new biomarkers for future application in cardiac safety clinical trials and technologies.

…As part of the Critical Path Initiative, the FDA has stated that there is a significant opportunity to further improve the cardiac safety testing process and identify better markers of cardiac risk. The long-term goal of the alliance is to improve the precision, increase the speed and reduce the costs of cardiac safety clinical trials. Â

Pfizer spokeswoman Kate Robbins said:

“Cardiac safety is one of the most challenging hurdles in developing new medicines. We support the development of new tools that may enhance our ability to predict the safety of potential new medicines in early stages of research and development.”

iCardiac’s tools are exciting in two ways: 1) They may knock out drugs with cardiac safety problems earlier in development –saving lives, money, and time. 2) For certain drugs that are wrongly flagged as potentially dangerous using cruder methods, they may allow development to proceed. That would help more good drugs make it to market.

Congratulations to CEO Mikael Totterman and the entire iCardiac Technologies team.

Commoditizing medicine

published date
January 11th, 2007 by

About five years ago I heard a fascinating talk by Harvard Business School Professor Clay Christensen that applied his well-know “innovator’s dilemma” reasoning to health care. In a nutshell the idea was that tertiary care centers should keep pushing the envelope on complex diagnoses and treatments and that over time diagnoses (though maybe not treatments) that had initially been considered complex and challenging should be systematized and therefore able to be carried out in less expensive settings by less expensive staff. The progression would go from academic medical center to community hospital to doctor’s office to retail clinic.

Clay was interviewed recently by the New York Times where he covered this ground again –lamenting the lack of progress- and also gave a clue as to why there is a shortage of convenient, low-cost diagnostic settings in Massachusetts.

We haven’t moved the health care profession into a world where nurses can provide diagnosis and care. Regulation is keeping the treatment in expensive hospitals when in fact much lower cost-delivery models are available…

In Massachusetts, nurses cannot write prescriptions. But in Minnesota, nurse practitioners can. So there has emerged in Minnesota a clinic called the MinuteClinic. These clinics operate in Target stores and CVS drugstores. They are staffed only by nurse practitioners. There’s a big sign on the door that says, “We treat these 16 rules-based disorders.” They include strep throat, pink eye, urinary tract infection, earaches and sinus infections.

These are things for which very unambiguous, “go, no-go” tests exist. You’re in and out in 15 minutes or it’s free, and it’s a $39 flat fee. These things are just booming because high-quality health care at that level is defined by convenience and accessibility. That’s a commoditization of the expertise. To have those same disorders treated in Massachusetts, you’ve got to go to a regular doctor, go through a long wait in their office, you go in and see the doctor for two minutes. He says, “You have an earache,” which you knew already, and then they charge you $150.

The whole interview is worth a read if you have the time.

“I’ll have what she’s having”

published date
January 2nd, 2007 by

FDA plans to allow cloned meat, according to the Wall Street Journal:

[T]he Food and Drug Administration said it couldn’t find any differences between meat and milk from healthy conventionally bred adult cattle, pigs and goats and that from healthy cloned animals and their offspring. As a result, the agency said it would probably allow the meat and milk of these cloned animals and their offspring to be sold without any special labeling to alert consumers.

Here’s what we can look forward to (from an earlier Washington Post article)

Farmers and companies that have been growing cloned barnyard animals from single cells in anticipation of a lucrative market say cloning will bring consumers a level of consistency and quality impossible to attain with conventional breeding, making perfectly marbled beef and reliably lean and tasty pork the norm on grocery shelves.

I’m not the only one who thinks this is a little whacked:

“The government talks about being science-based, and that’s great, but I think there is another pillar here: the question of whether we really want to do this,” said Carol Tucker Foreman, director of food policy at the Consumer Federation of America.

Backscatter chatter

published date
December 13th, 2006 by

There’s been talk recently of using new “backscatter” machines for passenger screening to detect explosives and other dangerous items that a metal detector would miss. Most of the commentary has been about the threat to privacy, since the machines essentially look through your clothes. That’s to be dealt with by degrading the images to a certain extent.

I’m not too worried about privacy. After all, how much privacy and dignity do we really have left at airport checkpoints these days any way. On the other hand, backscatter is produced by radiation. In other words passengers will be going through X-ray machines. Patients are getting exposed to some alarmingly high doses of radiation from CT without anyone taking notice, so I wondered about the effects of backscatter on frequent fliers like me who might go through them hundreds of times every year.

I got some reassurance from a Health Physics Society article, which reports that it would take 200 screening scans in one year to reach the federally-defined Negligible Individual Dose. The Nuclear Regulatory Commission considers it safe to hit at least 25 times this number, or 5000 scans per year.

Meanwhile Rapiscan, a maker of backscatter systems, says each full-body scan is equivalent to what a person gets in five minutes from background environmental radiation.

I’m not an expert on this topic but from what I’ve read so far I’m not as alarmed as I thought I might be.

Blown Away

published date
November 9th, 2006 by

Blown Away

Using a regular blow dryer, or better yet a modified one called the LouseBuster, does a better job of killing lice and destroying their eggs than chemicals or combing. The blow dryers seem to dry out the lice, killing them. It’s not the type of treatment that lice are likely to evolve resistance to, either. I’m happy about the results, because I’m against hysterical anti-lice policies.

The best blow drying technique, according to MedPage Today was to use the LouseBuster:

The most effective hot-air method was the LouseBuster machine, invented by some of the researchers, in combination with a coarse comb attachment on the hose. It delivered twice the air volume of a handheld hair dryer and eradicated significantly more lice and eggs than comb control.

The authors have filed patents on the LouseBuster, so I’m not sure we can completely trust this research. I also found the discontinuation statistics interesting:

  • 2% among the 54 patients tested with the bonnet-style dryer,
  • 4% in the 26 participants treated with the handheld blow dryer using hair divided into 10 sections,
  • 4% among the 27 children treated with the handheld blow dryer and hair in 20 sections,
  • 13% of the 15 children treated with the wall-mounted dryer, and
  • 0% in both of the 18-patient LouseBuster groups.

I’m guessing users of the LouseBuster weren’t allowed to give up!