Heart Stents, Tricycles, and an Argument for Consumer Protections (Regulations)

Heart Stents, Tricycles, and an Argument for Consumer Protections (Regulations)

A staple of Republican and many Democratic politicians is to bemoan government regulations. These intrusions on individual liberty and free markets are claimed to be part of the giant regulatory state that chokes off innovation, initiative, and competition. The need for consumer protections is driven by a central operating principle of capitalism, externalize any costs you can, getting someone else to pay for your activities. If a product or service does harm or doesn’t work that is the consumer’s problem.

Heart Stents No Better Than a Placebo

heart stent illustration

borrowed from quora.org

A new study of heart stents1 showed that “In patients with medically treated angina and severe coronary stenosis, PCI (heart stents) did not increase exercise time by more than the effect of a placebo procedure.” The NYTimes picked up the story2 pointing out that globally more than 500,000 people a year undergo this procedure.

The whole industry of medical devices is substantially unregulated. A medical device can be put into use without any studies to demonstrate its safety or efficacy. The only requirement is that the device makers are supposed to gather evidence post-facto. There are no requirements that the uses of devices must be registered or tracked. In an age when WalMart knows exactly where and when every head of lettuce is purchased anywhere in their stores, it seems hard to imagine how we have a medical device market in which things are put into people bodies without being required to track them in case of problems. Further, beyond safety is the obvious issue of the enormous sums of money paid for products that don’t do what they claim to do. In the US this procedure costs between $11,000 and $41,000.3

Tricycle Deaths and Injuries

kid's tricycleAnyone who has ridden on a tricycle as a little kid has experienced the inherent instability of the design. Who didn’t tip over?? Any mechanical engineer could explain the instability in terms of the poor kinematics. Fortunately, the low speeds of peddle-powered tricycles keeps the death rate down.

Despite both the common sense experience and engineering analysis, off road powered tricycles were widely marketed, especially to kids, from the mid 60s into the 1980s because the manufacturers could externalize the deaths and injuries their products would inevitably produce. No surprise, when you add an engine that can readily drive these three wheeled all terrain vehicles to 20 mph (32 kph) and more, the resulting crashes produced many deaths and serious injuries. 

Here are reports from CBS News from 1987, “The Most Dangerous Vehicle”.

(WARNING: some of the reporting is gruesome.)

and

Are Government Consumer Protections Bad for Us??

Since corporations have every reason not to worry about the safety and efficacy of their products, we do in fact need a third party, the government, to represent our interests. Common sense and obvious ethics suggest that a company should be required to establish the safety and efficacy of their products and services BEFORE selling them. In a world better balanced to the needs and interests of the vast majority this would be a required step.


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Also published on Medium.

Footnotes

  1. Al-Lamee, Rasha, et al. “Percutaneous Coronary Intervention in Stable Angina (ORBITA): A Double-Blind, Randomised Controlled Trial.” The Lancet, vol. 391, no. 10115, Jan. 2018, pp. 31–40. www.thelancet.com, doi:10.1016/S0140-6736(17)32714-9. accessed 2/21/2018.
  2.  Kolata, Gina. “‘Unbelievable’: Heart Stents Fail to Ease Chest Pain.” The New York Times, 2 Nov. 2017. NYTimes.com, https://www.nytimes.com/2017/11/02/health/heart-disease-stents.html. Accessed 2/21/2018
  3. See the NYTimes article