re: FDA regulation endangering flu victims in the USA--people dying while FDA stands in way

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You flippantly dismiss things you do not agree with that very important--things like "kills in 24 hours" and "three times as effective"

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BS.

BS.

BS.

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Jacob Sullum of Reason outlines some of the horrifying details.

The Food and Drug Administration’s e-cigarette regulations, which took effect last week, immediately struck two blows against public health. As of Monday, companies that sell vaping equipment and the fluids that fill them are forbidden to share potentially lifesaving information about those products with their customers. They are also forbidden to make their products safer, more convenient, or more pleasant to use. The FDA’s censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA’s requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business… All of this is unambiguously bad for consumers and bad for public health. Yet the FDA took none of it into account…the Family Smoking Prevention and Tobacco Control Act…gave the FDA authority over tobacco products, a category to which it has arbitrarily assigned tobacco-free e-cigarettes, even when they contain nicotine that is not derived from tobacco or no nicotine at all. …A brief that 16 advocates of tobacco harm reduction filed last week in support of Nicopure’s lawsuit notes that the cost of the FDA’s regulations will far outweigh their benefit if they cause even a small percentage of vapers to start smoking again or deter even a small percentage of current smokers from switching. That’s because of the huge difference in risk between e-cigarettes and the conventional kind (at least 95 percent, according to the Royal College of Physicians)… The FDA acknowledges that its regulations might also harm public health by retarding the substitution of vaping for smoking. But it does not include that cost in its analysis, deeming it too speculative. The FDA literally assigns zero value to the lives of smokers who would have quit were it not for the agency’s heavy-handed meddling.

Oh, I suppose I also should mention that FDA red tape is responsible for the fact that Americans have a much more limited selection of condoms than Europeans.

I’m sure there’s a good joke to be made about the bureaucrats screwing us in ways that interfere with us…um…well, you know.

Let’s wrap up with some tiny bits of good news. First, Arizona’s Goldwater Institute has been remarkably successful in getting states to adopt “Right to Try” laws that give seriously ill people the right to try investigational medications.

Sadly, those laws will have limited use until there’s also reform in Washington. Fortunately, there’s some movement. Here’s a video from a congressional hearing organized by Senator Johnson of Wisconsin.



Here’s a second item that sort of counts as good news.

If there is one silver lining to the dark cloud of FDA incompetence, it’s that the bureaucrats haven’t figured out how to criminalize those who use drugs for “off-label” purposes (i.e., for reasons other than what was approved by the government). A good example, as reported by the New York Times, is a tooth desnsitizer that’s only been recently approved by the FDA (after being available for decades in nations such as Japan), and already dentists are using it to fight cavities.

Nobody looks forward to having a cavity drilled and filled by a dentist. Now there’s an alternative: an antimicrobial liquid that can be brushed on cavities to stop tooth decay — painlessly. The liquid is called silver diamine fluoride, or S.D.F. It’s been used for decades in Japan, but it’s been available in the United States, under the brand name Advantage Arrest, for just about a year. The Food and Drug Administration cleared silver diamine fluoride for use as a tooth desensitizer for adults 21 and older. But studies show it can halt the progression of cavities and prevent them, and dentists are increasingly using it off-label for those purposes. …Silver diamine fluoride is already used in hundreds of dental offices. Medicaid patients in Oregon are receiving the treatment…it’s relatively inexpensive. …The noninvasive treatment may be ideal for the indigent, nursing home residents and others who have trouble finding care. …But the liquid may be especially useful for children. Nearly a quarter of 2- to 5-year-olds have cavities

Since I’m not familiar with the history of the FDA, I wonder whether the bureaucrats have ever tried to block medical professionals from using drugs and devices for “off-label” purposes.

Let me close with one final point. Our leftist friends aren’t very interested in reforming the FDA.

Instead, they argue that the big problem is greedy pharmaceutical companies and suggest European-style price controls.

That could save consumers money in the short run, I’m sure, but it would gut the incentive to develop new medications.

One expert looked at the Rand Corporation estimates that such policies would lead to a decline in life expectancy of 0.7 years by 2016. He then crunched the numbers and concluded that the aggregate impact would be worst thing to ever happen. Even worse than the brutality of Mao’s China.

…let me put this in context. In 2060 there will probably be 420 million Americans and 523 million Europeans. And suppose that whatever changes we make in drug regulations today last for one human lifespan, so that everybody has a chance to be 55-60. So about a billion people each losing about 0.7 years of their life equals 700 million life-years. Since some people live in countries outside the US and Europe [citation needed] and they also benefit from First-World-invented medications, let’s round this up to about a billion life-years lost. What was the worst thing that ever happened? One strong contender is Mao’s Great Leap Forward, in which ineffective agricultural reforms and very effective purges killed 45 million people. Most of these people were probably already adults, and lifespan in Mao’s China wasn’t too high, so let’s say that each death from the Great Leap Forward cost what would otherwise be twenty healthy life years. In that case, the worst thing that has ever happened until now cost 45 million * 20 = 900 million life-years. Once again, RAND’s calculations plus my own Fermi estimate suggest that prescription drug price regulation would cost one billion life-years, which would very slightly edge out Communist China for the title of Worst Thing Ever.

I guess the bottom line is that the FDA is a typical regulatory agency, both incompetent and expensive. But if the statists have their way, things could get a lot worse.

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One expert looked at the Rand Corporation estimates that such policies would lead to a decline in life expectancy of 0.7 years by 2016. He then crunched the numbers and concluded that the aggregate impact would be worst thing to ever happen. Even worse than the brutality of Mao’s China.

…let me put this in context. In 2060 there will probably be 420 million Americans and 523 million Europeans. And suppose that whatever changes we make in drug regulations today last for one human lifespan, so that everybody has a chance to be 55-60. So about a billion people each losing about 0.7 years of their life equals 700 million life-years. Since some people live in countries outside the US and Europe [citation needed] and they also benefit from First-World-invented medications, let’s round this up to about a billion life-years lost. What was the worst thing that ever happened? One strong contender is Mao’s Great Leap Forward, in which ineffective agricultural reforms and very effective purges killed 45 million people. Most of these people were probably already adults, and lifespan in Mao’s China wasn’t too high, so let’s say that each death from the Great Leap Forward cost what would otherwise be twenty healthy life years. In that case, the worst thing that has ever happened until now cost 45 million * 20 = 900 million life-years. Once again, RAND’s calculations plus my own Fermi estimate suggest that prescription drug price regulation would cost one billion life-years, which would very slightly edge out Communist China for the title of Worst Thing Ever.

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The power of that precept stems from the fact that, as a government agency, FDA is a political entity, subject to intense pressure from Congress and media. The precept is also strengthened by the huge difference between the FDA’s two choices in approving new therapies:6, pp 9-13 If FDA approves a drug that turns out to be disastrous, people will suffer; if it delays or denies a needed drug, people will also suffer. Both mistakes are medically harmful.

But from a political standpoint, there is a huge difference between them. Those injured by an incorrectly approved drug will often know that they are victims of FDA mistakes. Their stories make riveting news, and their testimony, or that of their surviving families, is powerful. But for victims of incorrect FDA delays or denials, who are prevented from using drugs that could have helped them, the situation is far different. All they know is that their doctors told them that nothing more could be done to help them. Only a fraction of these people will understand the reason for this—namely, that a useful drug was bottled up at FDA.

Unlike in the first scenario, these people do not realize that they too are victims of FDA mistakes. Their suffering or death is simply viewed, by them and others, as reflecting the state of medicine rather than the status of an FDA drug application. In short, victims of incorrect FDA approvals are highly visible, while victims of incorrect FDA delays or denials are practically invisible.

For example, consider FDA’s incredibly long delay in approving beta-blockers to reduce the risk of second heart attacks. By the mid-1970s this had been documented in clinical trials, and a number of beta-blockers were approved for this use in Europe. But in the U.S., FDA imposed a moratorium on beta-blocker approvals due to the drugs’ carcinogenicity in animals. (Among the staffers involved in this delay was that fastidious driver, John Nestor.2, p 195) In effect, FDA was denying needed cardiac drugs to people at high risk of heart attacks because of the unproven possibility that those drugs might cause cancer years in the future.

Finally, in 1981 FDA approved the first such drug, boasting that it might save up to 17,000 lives per year. That meant, of course, that as many as 100,000 people may have died waiting for FDA to act5, p 118—an explosive point, but one that very few journalists pursued. For all practical purposes, these people were invisible in a very literal sense—we’ve all seen photographs of thalidomide victims, but I suspect that not one of us has ever seen a photograph of someone who suffered or died because of FDA’s beta-blocker moratorium.

Similarly, in the early 1990s it took FDA more than 3 years to approve interleukin-2 as the first therapy for advanced kidney cancer. By the time FDA acted, the drug was available in nine European countries. In clinical trials, the drug had produced remissions of 6 months or longer in 15 to 20 percent of patients.

Then why did FDA delay so long? Its attention was occupied by the drug’s toxicity; it resulted in the death of approximately five percent of those who took it. This concern obscured the fact that metastatic kidney cancer has the even worse side effect of killing 100 percent of its victims. If we
roughly estimate that the drug might have helped 10 percent of those who otherwise die of kidney cancer, then FDA’s delay might have contributed to the premature death of more than 3,000 people.3, p 39 Have we seen any photographs of them?

These episodes clearly illustrate the political and journalistic differences between the opposing goals of avoiding both incorrect approvals and incorrect delays and denials. Medically, both types of agency action are harmful, but politically there is no comparison between them. One has impact; the other doesn’t. In the words of FDA Commissioner Alexander M. Schmidt: “In all of FDA’s history, I am unable to find a single instance where a congressional committee investigated the failure of FDA to approve a new drug. But, the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren’t able to count them.... The message to FDA staff could not be clearer.”6, p 5

He went on to note: “Congressional pressure for our negative action on new drug applications is, therefore, intense. And it seems to be increasing, as everyone is becoming a self- acclaimed expert on carcinogenesis and drug testing

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wrong

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Deaths from influenza and pneumonia, which are closely tied to each other in the winter months, were responsible for 1 of every 10 deaths last week, and that’s likely to rise, Schuchat said in a conference call Friday. There were 40,414 deaths in the U.S. during the third week of 2018, the most recent data available, and 4,064 were from pneumonia or influenza, according to the CDC data. The number for that week is expected to rise more reports are sent to the agency.

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