Category Archives: regulation

FDA’s Drug Approvals

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Charles Hooper and David Henderson are on the right track.

The Federal government requires pharmaceutical companies to prove that their drugs are both safe and effective before putting them on the market. Before 1962, companies needed to prove only safety. While there is some appeal to this two-hurdle approach, evidence suggests that there is only a slight benefit and a tremendous cost. With the COVID-19 pandemic sweeping the world, there has never been a better time to revoke the Food and Drug Administration’s efficacy requirement.

I suggest the FDA move to a two-stage approval process. The first stage should focus on safety: does the drug do no harm, at least compared with the condition it’s aimed at treating (because all drugs have side effects).  Once it’s determined the drug is safe, it should be released to the market, limited strictly to on-label use. Let prescribing doctors and patients determine whether the drug is useful, let market forces do their trick. The FDA’s imprimatur for this stage, should be limited to “safe as prescribed, not determined to be effective.”

The second stage should proceed without delay, overlapping the first stage to the extent feasible; in this stage, investigative focus should be on efficacy—does the drug actually have the effect on its target condition that’s intended. Only after the trials associated with this stage have been successfully completed could the drug receive its full-up FDA stamp of approval—and authorization for use, under prescription, off-label.

This modification to the pre-1962 requirement would cheapen development, and it would provide more drugs of greater utility faster to market and to the doctors and patients who use them.

YGTBSM

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And now the Greens, the climatistas, have shown their true colors. Valentin Dupouey, Head of the Communications Unit at European Green Party, say this, as paraphrased by Eric Worrall, writing for Watts Up With That?:

[A] major overhaul of Democracy is required to force acceptance of the economic de-growth required to address the climate crisis.

Because we’re just too screamingly stupid to know what’s good for us, so to hell with us—the Greens will do democracy for us.

And this, a direct quote from the Right Reverend Dupouey [emphasis Dupouey’s]:

we need to be able to say to a Chinese average citizen that he will never be able to reach the material lifestyle of a French minimum-wage worker.

To hell with all of us. No aspiration for better lives—you won’t be allowed better lives.

Wow.

Progressive-Democrats and their…Preferences

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House Speaker Nancy Pelosi has buried another item in her 1,400+ page demand list of “relief” supports that she is requiring in quid pro quo for her support for the Senate Wuhan Virus relief bill that her minions in the Senate are actively blocking: $35 million for operations and maintenance for New York’s JFK Center for the Performing Arts. Pelosi’s bill would provide funding for

…employee compensation and benefits, grants, contracts, payments for rent or utilities, fees for artists or performers….

Notice that: Pelosi is actively denying the same relief for average Americans and the small, medium, large businesses that employ them unless she can have her Precious Ones subsidized—by those same out-of-work employees and closed-down small and medium-sized businesses, especially, who must pay the taxes for Pelosi’s demands.

Your Progressive-Democratic Party in action—not working for anyone’s benefit but their own.

Holding Some Back

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Forty-three million students are doing homework at home due to the current Wuhan virus situation.

Here’s the shocker about that:

Some public schools are calling online work “enrichment,” not part of the curriculum, because they can’t guarantee that all students will have access to it.

The work, which was part of the curriculum when school was in session, won’t be graded, won’t count.  This is another example of the Left’s view of equality: hold back the successful because the less successful don’t, or can’t, keep up.  Don’t take steps to help the less successful do better. No, that’s too hard.

Remember this view of equality next November.

Scapegoating

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…and fake apologies.

Recall that Doctor Li Wenliang, a resident of Wuhan, Hubei Province, People’s Republic of China and an ophthalmologist at Wuhan Central Hospital, gave early warnings about the dangers and contagious nature of the Wuhan virus. Recall further that subsequent to his warnings, the police were sicced on him and that they threatened him if he didn’t shut the hell up. Li subsequently died of that same Wuhan virus.

Now the Communist Party of China is pretending to apologize to his family for that behavior.

The party’s top disciplinary body said the police force in Wuhan had revoked its admonishment of Dr Li Wenliang that had included a threat of arrest.
It also said a “solemn apology” had been issued to Li’s family and that two police officers, identified only by their surnames, had been issued “disciplinary punishments” for the original handling of the matter.

Punishing two cops who were caught up in the early stages of the CPC’s attacks: nothing like a couple of scapegoats to put an end to the escapade.

Sure.