John C. Goodman is one of the top thought leaders in health care. He is politically careful, but at least brave enough to insinuate the obvious. Using children who have lost hands as an example, he reports in a recent Forbes piece ("Save the Children from the FDA"), "An artificial hand — at least one approved by the federal government — costs as much as $50,000 or more."
Another artificial hand, one not approved by the FDA, created by a research scientist using 3-D printing, can be produced for as little $50. It is not FDA approved because its inventor does not have the millions of dollars, nor can he ethically justify the years, or decades, it costs to get its approval when thousands of children need them today. It cannot hurt them. It works. Still, the FDA requires its approval before it can be sold.
So, he gives them away.
Goodman also points out that "Whenever the FDA gets involved, the cost of approval for any new invention or technology will be huge. The time it takes to get approval will be measured not in years but in decades."
Goodman also draws the obvious conclusion: mission creep. The FDA, which was created to keep our food and drugs safe, has become a bureaucratic behemoth that now controls virtually everything having to do anything with food, drugs, medical devices, and even benign 3-D printed artificial hands for children. If one can't pony up huge sums and wait until patents are virtually expired to get a product to market even with the most compassionate or beneficial innovation, "Hundreds of thousands of innovations that could have helped you and me will never come to market," Goodman observes.
When you take a step back and look at how federal agencies treat healthcare as a whole, it is impossible to not see that their mindless, autistic, iron grip to control our lives has ceased to benefit us, keeping costs high, people sick, and diminishing our collective quality of life.
Nonetheless, these departments are necessary. But, how can they be made to work in the interest of the people they constitutionally serve and protect? The solution is straightforward:
1. Eliminate political appointments to HHS, CMS, and the FDA – require leaders to be qualified managerially and to understand the consequences of their decisions.
2. Make these agencies independent of the administration and limit congressional involvement to approving and monitoring budgets and the return on taxpayer's investment.
3. Empower agency leadership with the authority and indemnification to make necessary changes and hold them and management (all the way down to middle-managers) accountable by making breaches of the public trust — including putting people's lives at risk through inaction and political expediency — criminal offenses with stiff penalties; particularly for collusion and conflict of interest with the private sector.
4. Clearly enumerate what those breaches of trust are in the areas of spending, quality, clinical outcomes, safety, and efficacy.
5. Establish a joint agency oversight commission comprised of people who understand the healthcare system and hold them similarly accountable.
6. Give the commission the effective grand jury power to hold private healthcare management responsible for breaches of the public trust by recommending them for prosecution and liability for stiff fines.
This, however, is the real world and it will take a political miracle to put the American people, and humanity as a whole, before what the federal government has become.
My sense is that a presidential candidate or party who would pick up this platform would get a lot of support from the American people, who are waking up to the reality that we don't need the federal government to protect us to this extent, we need the administration to protect us from it.
They, regardless of party, would have my vote.