Waiting on the Government
First, Do No Harm: A Few Simple Rules for the FDA
FDA Horror Stories
The Power of the FDA Must End
Asking the Government for Permission to Live
Freedom from the FDA
Finding Alternatives to the Food and Drug Administration
Free Markets: The Key to New Drugs at a Reasonable Price
A Prescription for Disaster
Waiting on the Government
By Richard E. Ralston
Perhaps those at the Food and Drug Administration (FDA) who are responsible for more delays in the approval of the drug Eteplirsen were inspired by the imaginative approach of their colleagues at the Department of Veterans Affairs, who compared the long delays in treating veterans to waiting in line at Walt Disney World. It is "the quality of the overall experience" that the VA says we should consider, not the time it takes.
We should recall that the scandal about these waiting lists that broke two years ago was not just about the length of the wait time, but the corruption of officials altering records to falsely indicate that patients had removed themselves from the waiting lists. The "quality of the overall experience" at Walt Disney World would not be maintained if guests were involuntarily yanked out of line. Or died while waiting.
Should the little boys with Muscular Dystrophy, who lose their ability to walk as they wait for FDA approval of a new medicationwhile their parents helplessly watch that processtake comfort, before they die, from their "overall experience" with the FDA?
We must replace this ghastly kind of evenhandedness by U.S. government agencies toward military veterans and little boys with adequate and timely treatment.
For many years, private medical care in Canada has not been allowed, and Canadians have had to rely exclusively on the government system they call "Medicare." But there are limits even there. In 2005, the Canadian Supreme Court struck down a law in Quebec that banned private payment for services covered by Medicare Canada no matter how long such services were unavailable through the government system. The court ruled that "access to a waiting list is not access to health care."
Americans should not feel too comfortable about these restrictions in Canada. In the Balanced Budget Act of 1997, Section 4507, the Clinton administration forbade any physician who privately provided a service covered by Medicare from receiving reimbursement from all other Medicare patients for two full years. This has since been modified by litigation and regulation, but the wording remains on the books.
Whenever you hear a politician, government agency, journalist or academic promise that you will be provided with medical treatmentor anything elsebe sure to ask them when, exactly, they will provide it. Then ask from whom they will take it.
These outrages will not get better by themselves. Despite the scandal in 2014, a report just released by the VA inspector general found that a VA medical center in Houston attributed the removal of patients from waiting lists by staff to cancellations of appointments by the patients themselves. That improves their statistics, you see.
Other little problems in the VA bureaucracy were noted last year when thousands of veterans received notifications that their benefits were ending because they were dead.
A frequent response to such incompetence in government agencies is the claim that they need more budget and staff. But the staff at the VA has increased by 130,000 since 2005.
The FDA, with all of its problems, recently announced that sugar is a major threat to our health that requires new powers and regulations to reduce its use. This is while the Department of Agriculture spends billions to subsidize sugar production.
More money and staff to simultaneously limit and promote sugar is unlikely to improve our health. The results can be good only for politicians and government employee unions.
But we must not wait for the major reform and restructuring of these huge government bureaucracies while veterans and other patients suffer and die. We need immediate emergency measures, including the provision of vouchers to veterans that they can use for private treatment, and much more rapid access to new drugs that have met Phase I safety clearanceespecially for terminally ill patients.
What we need is more choice and a lot less government.
Richard E. Ralston is Executive Director of Americans for Free Choice in Medicine.
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