Category: Technology

Podcast interview with Mike Totterman, Chairman and CEO of iCardiac Technologies

published date
May 10th, 2007 by

Drug safety is a big issue these days. FDA has been criticized for allowing drugs with safety problems to reach the market. Merck is embroiled in thousands of lawsuits over heart problems allegedly caused by Vioxx. And not a month goes by without the cardiac safety profile of a marketed drug being questioned. Yesterday, the Senate passed a bill granting the FDA greater authority to restrict the use of drugs when safety problems are discovered after launch.
I recently joined the board of iCardiac Technologies, a startup company which is developing new tests that use ECG’s to find cardiac safety problem with drugs early in development. iCardiac has already signed a research alliance with Pfizer and attracted investment from venture capitalists.

I visited the company today and spoke with its Chairman and CEO, Mike Totterman. Listen in and hear what he has to say.

Sauce for the goose and gander in biotech

published date
May 9th, 2007 by

What’s sauce for the goose is sauce for the gander,” the old expression goes. In other words, what’s good enough for one person should be good enough for another.

How does this apply in biotech and the ongoing debate on biogenerics?

The biotech industry has lately made the following contentions:

  • We don’t mind generic competition, but generic companies should have to conduct full-blown clinical trials before introducing their products to the market because how else can we be sure their products are therapeutically equivalent?
  • Follow-on products should be considered as “bio-similars,” not directly substitutable for the original product, because the follow-on product will never be exactly the same as the original product

If the biotech industry were to apply those same principles to itself, they’d have some serious problems:

  • When a biotech company changes its manufacturing process, it just runs a bioequivalence study with a limited number of patients and limited cost. Why should a generic company need to do more than that for its new process? Or are biotech companies prepared to redo all their clinical work when they make a major change in the production process?
  • As a representative of an analytical testing company told me yesterday, his company’s methods often detect significant differences from one batch to the next of the same biotech product. So is the industry saying that its own products should also be considered “bio-similars” or that physicians should write a prescription for a specific batch rather than a specific product?

Like I said yesterday (Credibility and prosperity in biotech)

You shouldn’t exaggerate the truth to get your point across. It could come back to bite you.

The truth should be good enough.

When a doctor is worth only $50

published date
May 3rd, 2007 by

The lead headline in yesterday’s iHealthBeat blared: SureScripts Acquires Chief Rival, Boosts E-Prescribing Network.

The acquisition [of MedAvant] will allow 5,000 to 10,000 more physicians to have electronic access to between 10,000 and 15,000 more pharmacies nationwide, according to SureScripts’ CEOKevin Hutchinson, Healthcare IT News reports.

The purchase could prompt e-prescribing vendors to ensure that their customers have the most updated version of technology and can complete the electronic transactions, Hutchinson said (Monegain, Healthcare IT News, 5/1).

Health care analysts said the purchase could expedite the use of e-prescriptions by physicians because they will not have to choose between the competing firms’ products, the Post reports (Washington Post, 5/2).

Sounds like the merger of XM and Sirius, or Sony and Apple, doesn’t it?

So what’s the purchase price? Only $500,000, of which $100,000 is being held back as a contingency. That works out to $50 to $100 per doc or $35 to $50 per pharmacy.  By contrast, Cablevision is being taken private for $10.6 billion, or over $5000 per subscriber!

So let’s face it, MedAvant has made little progress in the market and is being picked up for nothing.

Another way to reduce radiation dose

published date
April 27th, 2007 by

Another radiation dosage reduction article from AuntMinnie:

In one of the first head-to-head comparisons of radiation dose between dual- and single-source CT, a multi-institutional research team has concluded that for a given noise level, images can be obtained at comparable or lower doses using dual-source CT versus single-source 64-slice CT.

If you’re a radiologist, please read on.

Getting physicians to think seriously about radiation exposure

published date
April 26th, 2007 by

I’ve mentioned a few times on this blog that I’m concerned about the levels of radiation patients are being exposed to as a result of medical imaging, especially CT. Radiologists and referring physicians haven’t taken the issue too seriously because:

  • The scans are useful and, of course, well reimbursed
  • They weren’t aware of the issue
  • There’s generally no easy way to track how much radiation patients have been exposed to

I’ve reported on anecdotal evidence of radiation exposure in the past, and ways to reduce dosages by adjusting scanners. Now a study has reported overall information on exposure. The numbers are high: per capita exposure is up 6x since 1980, and it’s disproportionately due to CT.

Consciousness raising among physicians is a good first step, but patients need to keep track of their own exposure and work in conjunction with their physicians to balance risks and benefits. One thing that’s really unacceptable is having a scan repeated because a previous one is lost or inaccessible.
I’ve always thought one good use of a personal health record is to keep track of lifetime radiation exposure, even if the numbers are just estimates. (The real figures would be even better.) I haven’t seen this functionality yet, though maybe it exists somewhere.