“We have a culture where we reward discovery; we don’t reward replication.” ~ Vinay Prasad
As our life expectancy increases, age-related diseases are increasingly consuming more of our attention. (Last week, we discussed The High Cost of Longer Life Expectancy). Given the current trend of increasing medical cost without the subsequent improvement in patient benefits, it’s safe to predict that spending on U.S. healthcare will, in turn, increase at a staggering rate.*
Some people hope the Obama era 21st Century Cures Act will help to reverse this trend because it “brings new innovations and advances to patients who need them faster and more efficiently,” (FDA) however, as a former scientist, I’m doubtful this will be the case.
I recognize and fully appreciate that the bipartisan bill was written with the help of some 1,455 lobbyists acting on behalf of more than 400 companies (NPR) but my skepticism is based on the claims of speed and efficiency to be achieved by lowering the evidentiary standards required for approval. Further, I understand the desire to reduce development time, but as I’ve painfully experienced in my own business, reducing standards and circumventing established procedures can lead to unintended consequences.
In moving away from using the gold standard of randomized trials to assess therapeutic efficacy and risk, it’s reasonable to assume we’re going to see more medical practices in the future that cost a lot of money and do little to improve patient outcomes (or worse). This poses a problem because, as documented in an excellent piece by ProPublica, once a treatment is in wide use, it’s hard to get patients and doctors to stop using it even if years of research show that treatment to be unnecessary and unhelpful.
As noted in the article (emphasis my own):
For all the truly wondrous developments of modern medicine…it is distressingly ordinary for patients to get treatments that research has shown are ineffective or even dangerous. Sometimes doctors simply haven’t kept up with the science. Other times doctors know the state of play perfectly well but continue to deliver these treatments because it’s profitable — or even because they’re popular and patients demand them. Some procedures are implemented based on studies that did not prove whether they really worked in the first place. Others were initially supported by evidence but then were contradicted by better evidence, and yet these procedures have remained the standards of care for years, or decades.
Treatments such as?
How about the use of stents as a preventative measure against heart attacks?
Despite the fact that according to cardiologist and professor David Brown the only people who need a stent are those having a heart attack, hundreds of thousands of stable patients receive stents annually (ProPublica) at an average cost of $30,000 (NYTimes).
Or the arthroscopic knee surgery known as arthroscopic partial meniscectomy (APM) to remedy knee pain?
Despite a large and growing body of evidence that says it doesn’t work for most varieties of knee pain, approximately a half-million APM procedures are done per year at a cost of around $4 billion. (ProPublica)
How about the use of the beta-blocker atenolol to reduce the risk of heart attacks?
Despite the conclusion that atenolol doesn’t reduce heart attacks or deaths compared with using no treatment (ProPublica), according to this database, it’s currently prescribed to over 2.5 million Medicare beneficiaries and demand is so great there is an ongoing shortage of the generic version (MedPage).
All of this begs the fundamental question, what do you do when the evidence says “no” but your doctor says “yes?” With this blog already running long, I’ll save my answer for next week. Until then, how about some music for our Manufacturing Peace of Mind Spotify playlist?
Today I’m going to leave you with “Something to Hope For,” a song off of Craig Finn’s new album I Need a New War. Finn is best known as the frontman to The Hold Steady, a band that until they were featured on Game of Thrones (via the song “The Bear and the Memphis Fair”) were probably best known for the song “Sequestered in Memphis.” In addition to Finn’s song, I’ll be sure to add some tunes from The Hold Steady.
*US health care spending is already at $3.5 trillion, which translates into $10,739 per person and represents a staggering 17.9 percent of our economy as measured by GDP (NHEA).
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