Health Business Blog

Health care business consultant and policy expert David E. Williams share his views

Pharmacogenomics and personalized medicine –still a long way off

The major news outlets gave prominent coverage to Tuesday’s release of a guidance document on pharmacogenomic data submissions for clinical trials. The New York Times said,

The Food and Drug Administration took a significant step yesterday toward the development of so-called personalized medicine, in which drugs would be tailored to individuals based on their genetic profiles.

The truth is, we are still far away from this vision. Consider the following:

  • During the hype surrounding the Human Genome Project in the late 1990s, Celera Genomics, Human Genome Sciences and others talked about pharmacogenomics as though it were already here. The new guidance document points out that, “the field of pharmacogenomics is still in early developmental stages, and [its] promise has not been realized.”
  • We’ve seen in our consulting assignments that innovation in clinical trials is very slow. Sponsors are reluctant to try anything new because they fear it will slow down the approval process with ethics committees and delay FDA approval. As a result, outdated endpoints with dubious significance are used routinely, just because they’ve been used in the past. One example is the Hamilton Anxiety Scale, a 40 year old measure that is a weak indicator, at best, of whether a drug works.

It’s good to see the FDA move forward with this guidance. However, well organized and assertive patient groups and clinical leaders are at least as important in spurring innovation in clinical trials. This is most apparent in HIV/AIDS, where the old ways of doing things have been discarded.

Hospital fall alert

An interesting juxtaposition of stories in the Wall Street Journal today:

Hospitals Aim to Curb Injuries from Falling; Risk for Young Patients, describes the surprisingly large number of injuries and deaths from patients falling in the hospital. Apparently there are more than 1 million falls per year. Contributing factors include patients who are disoriented after surgery or by medications, understaffing, lack of fall prevention procedures, and poor equipment.

But one equipment based solution seems to have its own problems:

Hospital Beds Seized Following 7 Deaths describes the seizure by Federal Marshals of Vail Products beds, “which have a tent like structure as part of the bed designed to keep patients… from falling out.”

At least 30 people have become entrapped in the beds, and some died as a result.

Medicare hires ombudsman to be “voice” of the beneficiary

CMS has hired an ombudsman as mandated by the Medicare Modernization Act of 2003. The ombudsman has a number of responsibilities:

  • Assist with complaints and inquiries from beneficiaries
  • Assist in collecting information for filing appeals
  • Help with enrollment and disenrollment problems
  • Assist with premium issues
  • Work to ensure beneficiaries understand and can exercise their rights

The ombudsman, Dan Schreiner, is currently a health care policy analyst. He has worked in the Dept. of Health and Human Services before and at T. Rowe Price, where he focused on participant services.

It will be interesting to see how Mr. Schreiner defines the role and what he can achieve.

Coal fired autism?

A study in the journal Health and Place documents a correlation between mercury emissions from coal plants and autism rates in 1200 Texas school districts. According to the abstract,

There was a significant increase in the rates of special education students and autism rates associated with increases in environmentally released mercury. On average, for each 1000 lb of environmentally released mercury, there was a 43% increase in the rate of special education services and a 61% increase in the rate of autism. The association between environmentally released mercury and special education rates were fully mediated by increased autism rates.

No one has been able to figure out what is happening with autism. Some studies have suggested the incidence of autism has risen by a factor of 10 in recent decades, while other argue it can be explained by increased diagnosis. It will be a long while before we really understand what is happening and why.

Increasing disclosure of hospital pricing

The Hospital Price Disclosure Act has been introduced in the House. It would require hospitals to report average and median prices for their 25 most common procedures and 50 most prescribed medications, reports Modern Healthcare.

According to a press release from co-sponsor Rep. Dan Lipinski (D-IL),

When consumers start comparing health care facilities on costs, the facilities will respond accordingly, driving costs down and quality up.

Don’t hold your breath.