Memorial Sloan Kettering’s Season of Turmoil – The New York Times

America’s health care research system has many problems. The overall result is poor return on the money spent. The lure of big $ is a factor in many of them. Two specific problems:

  • What gets research $ (including from Federal $) is heavily driven by profit potential, not medical potential. Ideas that can’t be patented get little research.
  • Academic career incentives distort both topics of research (what will corporate sponsors pay for?) and publication. The “replicability crisis” is not just in social sciences.

This NYT article illustrates one way that drug companies indirectly manipulate research agendas: huge payments to influential researchers. In this article, Board of Directors fees. Large speaking fees for nominal work are another common mechanism. Here are some others:

Flacking for Big Pharma

Drugmakers don’t just compromise doctors; they also undermine top medical journals and skew medical research. By Harriet A. Washington | June 3, 2011

I could go on and on about this problem, partly because I live in a biotech town and work at a biotech university. I have posted about this elsewhere in this blog. But since it’s not an area where I am doing research, I will restrain myself.

Each new generation needs to learn the lesson of Theranos: appearance ≠ reality

Every 10 years or so, a conspicuous bubble bursts, and in doing so it resets the expectations of the next generation of young adults.

  • Enron
  • 2008 financial collapse
  • Now Theranos

Reading this article, I’m astonished at how little substance the adulation of Elizabeth Holmes was based on. And how much secrecy her investors allowed her. Given that she was claiming that her system would be ~100x better than established technologies, why didn’t they demand evidence? Why was it left to a reporter to figure out that the emperor had no clothes? And, was she nothing more than a successful con-artist with no genuine scientific expertise?

“In a searing investigation into the once lauded biotech start-up Theranos, Nick Bilton discovers that its precocious founder defied medical experts—even her own chief scientist—about the veracity of its now discredited blood-testing technology.”

Source: Exclusive: How Elizabeth Holmes’s House of Cards Came Tumbling Down | Vanity Fair

Hospital Hand-Washing – how long should it take?

There is a large literature on the importance of frequent hand washing in hospitals, to prevent spreading infectious diseases among patients. It’s a major problem, since hospital-caused infections are growing, and have nasty effects.image5b135d

Brad Stats recently sent me two papers he co-authored on the topic. Both are based on an analysis of  behavior by 4100 caregivers. They led me to ask two sets of questions. First, if everyone did comply with the recommendations on hand-washing frequency and duration, how much time would it take out of their work day? Second, while there have been lots of projects using  electronics for monitoring compliance, has there been any work on straightforward manufacturing-style interventions to make compliance easier?

Here are my questions in more detail, taken from an email to Brad.

Continue reading

Zika virus: Forbes columnist can’t bear to say “market failure”

Here’s a column by a Forbes blogger about Zika saying that “we should not wait so long to develop vaccines against tropical diseases.” He concludes:

 Many pharmaceutical companies don’t focus on a disease until it becomes common enough to be highly profitable. The trouble is the vaccine world has become a bit like the plot line for “She’s All That” or “Cinderella.” Attention towards a person or thing does not occur until a cool person notices he or she or it. But when it comes to disease and stock market opportunities, as the saying goes, once your grandmother knows about it, it is usually too late.

Source: Zika Vaccine: Another Example Of Waiting Until It’s Too Late? – Forbes

This is not news. And it’s a classic situation where market forces are not enough to give socially desirable behavior. Developing a vaccine for a disease that is not in rich countries has low expected profitability. Even if the disease goes epidemic, pharma company will have to sell at a price near marginal cost.

The only solution is to use a different way to fund development. Contests, grants (Gates foundation), purchase guarantees (used by US DoD) all work. But waiting for the traditional patent system + pharma profit motive won’t lead to timely development of medication for poor-country diseases.

I guess a Forbes columnist is not allowed to point this out.

JAMA — Ensuring Integrity in Industry-Sponsored Research: Primum Non Nocere, Revisited, March 24/31, 2010, DeAngelis and Fontanarosa 303 12: 1196

The evidence on false conclusions from drug trials, and their publications, is mounting. I am forced to the conclusion that, most likely,

1) This has been going on for a long time; the big change is that it’s occasionally getting noticed now, and

2) The results of this over many years must be that  doctors are prescribing based on incorrect evidence. Specifically, lots of drugs are getting prescribed when they shouldn’t be.

According to the article by Nissen,1 the report of the Senate investigation,2 and published media accounts,8-9 the manufacturer of rosiglitazone exerted inappropriate influence during the conduct of a pivotal safety study of this drug, the RECORD Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes clinical trial,10-11 which included undertaking nonprespecified unblinding of study data; attempting to undermine the authority and responsibilities of the study steering committee; expediting publication of an unscheduled interim analysis,10 specifically to counter2 the publication of a meta-analysis by Nissen and Wolski12 that suggested increased cardiovascular risk associated with rosiglitazone; having employees extensively involved in statistical analysis,11 and preparation of the manuscript10 reporting the results of the trial; and reportedly2 failing to fully acknowledge the significant cardiovascular risk associated with this drug.

via JAMA — Ensuring Integrity in Industry-Sponsored Research: Primum Non Nocere, Revisited, March 24/31, 2010, DeAngelis and Fontanarosa 303 12: 1196.

From Art to Science: what it means

Most of my research right now is about the evolution of technologies. They go from crafts, requiring skilled experts, to “engineering science,” i.e. mostly automated and very precise. For example, firearms manufacturing took 200 years to undergo this shift. Flying took about 100 years to go from the Wright Brothers, to autonomous aircraft (not just unmanned, but self-directed). How does this happen? Is it a good thing?

Here is a talk I gave on this topic. (Caution: 5 MB PDF file) The subtitle is Why old tasks get easier, but everything gets more complex.

Bohn knowledge evolution 2007

I’m working on a book on this subject, which does side-by-side comparisons of:

  • Flying
  • Medical care – several kinds
  • Firearms manufacturing (from Napoleon to 1980)
  • Semiconductor manufacturing

Each of them has undergone major transformations, with similar patterns.