Are devices dying?
Re: "Biotech's hidden stepsister,"1 about the current hurdles facing the device industry, I was the founder and CTO of Avocet Medical, a medical device start-up producing a hand held meter to prevent strokes by monitoring proper level of oral anticoagulants. We raised $38 million in venture capital financing between 1991 and 2001.
Although we obtained FDA approval, the FDA changed the rules on us by insisting at the last minute, after all clinical trials were done, that users do additional (and redundant) safety checks each time they used our product. These redundant checks pushed the cost per use from $6 to $21, and made the product uneconomic.
We had to exit the field. Although this hurt our investors and employees, the much bigger damage was probably to the thousands of patients per year that we might have been able to save. Failure of a...
"Are Devices Dead?" I can't believe how anyone could splash such a ludicrous title across the cover of such a prestigious journal. The medical device industry is alive, well, and birthing new baby companies every day. It is probably one of the healthiest industries around, with many members being generously sprinkled within the Fortune 500, with major layoffs (think the auto industry) being uncommon.
Theory? Hypothesis? Law?
Re: "What makes science 'Science'?"1 I am a biology professor at a community college in Texas trying to get this precise information across to freshman non-science majors. We have had class discussions about the theory of evolution and the cell theory, so I think I'm getting "theory" across to them. But then we have an exam, and nearly everyone misses the point again. Understanding this basic philosophy is a topic that should be part of what science students learn in high school, not in college-level science courses.
Present your students with a simple observation (e.g. malaria cases in country X have been seen to increase over period Y). Ask the students to construct 4 or 5 hypotheses that could account for these observations. Then, ask them to devise observations or, preferably, experiments that could falsify each of the hypotheses.
Among the many hundreds of students I taught, more than 95% would readily admit that they had never been exposed to this kind of critical-thinking exercise during their entire undergraduate and graduate careers. But this kind of thinking should be at the very core of scientific training. The reason for this educational failing is obvious: Universities are far more adept at teaching students what to think than how to think. And the reason for that is also obvious: Designing a curriculum to teach critical-thinking skills in science is bloody hard work.
Stephen M Smith
St. Agatha, Ontario
The Author Responds:
First, we should have some kind of agreed set of definitions (and yes I know that will not please everybody) which in itself will take time and probably lots of disagreement. Next, we must ensure that college-level science reinforces and uses these terms correctly. How can we expect college graduates who do not understand key terminology or who have not studied history and philosophy of science to successfully teach it to students in high school?
University of Sussex
Happy Birthday, ODA
While "The Orphan Drug Act Turns 25"1 raises some important questions, this legislation can never be reduced to a simple cost-benefit ratio. According to FDA sources, more than 12 million Americans now have treatments for diseases that might not have been developed without the ODA. The driving impetus behind the ODA was not to bring economic benefit to society, but to acknowledge that every life counts.
Furthermore, research on rare diseases often provides quantum leaps in basic understanding of biological processes that occur in common diseases.
Medical Advisory Committee
National Organization for Rare Disorders (NORD)
I was surprised to see Tacrolimus, Enbrel, and Copaxone on the list of blockbuster orphan drugs. This highlights another shortcoming of the Act. These only qualify as orphans because they aimed at a smaller indication initially, and convinced the Office of orphan drugs that they met the criteria. Tacrolimus is used to prevent rejection in liver and kidney transplants, not only cardiac transplants. Enbrel is used in rheumatoid arthritis, not just the juvenile polyarticular course. It's a big indication, not an orphan.
My point is that these drugs were the focus of significant research and have significant patient populations. Tacrolimus and Enbrel would have been developed for the market with or without the Orphan Drug Act but the drug makers were clever to take advantage of the government giveaway.