September 6, 2005
Distributed healthcare…overcoming the FDA and harmful regulation
On August 31 Dr. Susan Wood resigned from the Food and Drug Administration. She had been Director of the Office of Women's Health. She resigned in protest of the FDA's refusal to allow over-the-counter sales of emergency contraception. This FDA decision is government regulation at its worst, restricting access to care for women and violating the tenants of distributed healthcare.
One of our Center's principles is Distributed Healthcare. As originally coined by the author, the term was used to differentiate a company that supplied information, community, advocacy, and testing supplies, monitoring, feedback, reporting and medications to patients with type 2 diabetes.
In its broadest sense Distributed Healthcare is…
Healthcare when and where you need it.
That may be at home, in the hospital, the workplace, while traveling, or even in the doctor's office.
- Distributed health care meets the needs of the consumer, not the provider
- Information transfers both ways, from the patient and from the provider
- The medical care establishment is allowed to do what it does well – and thereby succeed.
Distributed healthcare is a full circle: prescribing, properly using, monitoring, and then reporting the results of treatment.
As reported on August 31 by the Associated Press on MSNBC Web site, distributed healthcare was assailed by the FDA:
The FDA on Friday postponed indefinitely its decision on whether to allow the morning-after pill, called Plan B, to sell without a prescription. The agency said it was safe for adults to use without a doctor's guidance but that young teenagers still needed a prescription and it couldn't determine how to enforce an age limit — a decision contrary to the advice of its own scientific advisers.
“I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” wrote Wood, who also was assistant commissioner for women's health.
“The recent decision announced by the Commissioner about emergency contraception, which continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advancing women's health.”
The morning-after pill is a high dose of regular birth control that, ta ken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.
Without getting into more of the specifics of the debate, suffice it to say that the FDA works most of the time counter to the principles of distributed healthcare. The FDA has a multi-dimensional mandate concerning food and drugs. Focusing just on FDA's drug control activity, one can reasonably question the value-add for the massive cost imposed by the restriction of access to care. Whether the FDA in its entire history has been a positive or negative force in US healthcare can be debated reasonably. But it seems to be ta ken as an article of faith that they do good because their intentions are indeed good.
The FDA's underlying principle is public protection. Their motivation and incentive is to err always on the side of restriction. If there is no access and no utilization, then nothing bad can happen. Of course, nothing therapeutic can happen either.
In this case, the restriction of access to care seems particularly egregious and motivated by something other than scientific knowledge and common experience (more than 2.4 million users in the US and Europe ). Dare we say “politics?” But no matter, it is a gross violation of free access to care and the principles of distributed healthcare.
This decision impacts the potential health and well-being of women. But it is part of a broader and more insidious philosophy that individuals cannot be trusted to act in their own self-interest with the implication that they are not smart enough or too easily hoodwinked by unscrupulous manufacturers. Although not by intent, FDA activity results in denial to consumers of access, choice, convenience, control, and value, all in the name of “safety.”
One could make the argument that the FDA in its current form should be disbanded for the public good. New approaches are needed. If we are to expend these massive funds on a government bureaucracy to “assure safety,” why not do so and also use the money better? Why not invest in distributed healthcare? Why not invest in the creation of tools and methods that support individuals in getting the healthcare they want for themselves, including taking some risks that would never be “allowed” under current policy?
What we have now at the FDA is of debatable value and contributes significantly to the price of healthcare, diminished quality of life, and in some case, decreased quantity of life. And most assuredly it impacts access, choice, convenience, control, and cost.
What is needed is for the FDA to support distributed healthcare and more reasoned approaches to individual consumer risk management.
