Of course there’s a second Friday the 13th in 2020. I’m not superstitious (except for when my sports teams are playing) so I don’t buy into the nonsense. But, today, I will be a little extra careful not to walk under a ladder and I’ll keep my eyes out for any black cats. The opposite of superstition is science. This Weekly Update is focused on the importance of believing in actual science because we need to separate real science from political science. Featured this week: The potential COVID-19 vaccine and if Joe Biden’s commitment to listening to science extends to the Food and Drug Administration and tobacco harm reduction.

New Vaccine Announcement Should Mean More Deregulation

With the announcement that Pfizer may be close to a vaccine for COVID-19, there finally may be a light at the end of the tunnel for the coronavirus pandemic. Though still in testing, Pfizer’s latest vaccine promises to be 90 percent effective in curbing COVID-19. This figure is particularly encouraging, given the Food and Drug Administration’s (FDA) stated goal of 50 percent efficacy for coronavirus vaccines. But, even if this vaccine proves to be successful, there’s a real fear that the incoming Biden administration will tighten drug approval regulations at the FDA and make it more difficult to develop lifesaving vaccines and treatments in the future. For the sake of millions of Americans with debilitating diseases, President-elect Biden must cut the red tape that stymies medical innovation. If Pfizer’s vaccine proves successful, its approval and mass production will be an unprecedented scientific achievement. With the right regulatory policies, this breakneck pace of innovation needn’t be
a one-off. Under the status-quo, a medication in the beginning stages of testing has around a 10 percent chance of eventually being approved by the FDA. And, even if this process is successful, the process is costly and arduous. The average cost of getting a new medication approved is now north of $2 billion, and it takes more than a decade to get these products to consumers.

In order to clear this high hurdle, medical researchers need access to large testing populations and must repeat the same experiments multiple times. Consider that Pfizer used 43,000 volunteers just in the interim phase of its coronavirus vaccine. While studies of widespread diseases such as the coronavirus won’t have as much trouble recruiting large numbers of volunteers, recruiting is more difficult for rarer diseases. Even after a gene therapy called Glybera was approved by the European Union in 2012 for the treatment of lipoprotein lipase deficiency, the FDA declined to approve the product in the U.S. Only around one in a million people have this deficiency, making it prohibitively expensive for manufacturers to find sufficient numbers of volunteers. Fortunately, President-elect Biden can help fix this dysfunctional status-quo. Biden can and must work closely with FDA Commissioner Dr. Stephen M. Hahn (and whomever he selects as the new commissioner) to relax statistical requirements
and allow medical innovators some much-needed flexibility. Even with the FDA’s relaxed standard of 50 percent required efficacy for coronavirus vaccines, companies such as Pfizer are stepping up and offering products far exceeding that threshold. Flexible standards don’t lead to lousy products. Instead, regulatory reform encourages producers to forge ahead with testing promising products even if they aren’t entirely sure how strongly effective their products will be. And that is beneficial for the millions of Americans suffering from devastating diseases.

Joe Biden’s Belief in Science Must Include the Benefits of Vaping

In the lead up to the 2020 Presidential Election, Vice President Biden frequently spoke of the need to “follow the science” and how decisions should be made on the basis of evidence, and not ideology. It is probably for this reason that his candidacy was widely supported by the scientific community. It would certainly be welcome news were the new administration to decouple science from politics, and to act in accordance with the evidence. In order to do so, they must listen to academics, not activists, and quickly act to reverse one of the most disastrous policies of the Trump aadministration..the war against vaping. The truth is that vaping and new heat-not-burn technology are concrete ways to save millions of lives. These methods are proven to be between two and three times more effective than any other quitting method (like nicotine patches, gums, etc). The rational is easy to explain: The reason for so many deaths attributed to smoking is not the nicotine, a relatively benign substance
that, while addictive, has similar physiological impacts to caffeine. Rather, it is the process of inhaling smoke – with hundreds of associated chemicals and tar – into your lungs that does the damage. This new technology, by using water vapor to deliver nicotine, completely bypasses almost all the risks associated with smoking, in the same manner as nicotine gums, but, by mimicking the ritual elements, at a far more effective level.

Sadly, however, the FDA under President Trump went against their own internal advice as to its benefits and restricted access to these life-saving products. And the results are potentially catastrophic. According to a comprehensive study by George Washington University Medical Center involving eleven of the world’s leading researchers in the field, if the FDA was to change its stance and encourage smokers to quit through vaping, this simple change would lead to a staggering 6.6 million fewer premature deaths, with 86.7 million fewer life years lost in the next ten years (a similar analysis by the University of Michigan was slightly less optimistic, averaging “only” 44 million few life years lost). To give just a few examples of the corruption of science in this field, one widely trumpeted multi-million dollar taxpayer funded ”study” claiming vaping caused heart attacks was retracted after subsequent analysis determined the majority of the heart attacks happened before people vaped (actual
studies have determined that smokers who switch to vaping have a significantly reduced risk of cardiovascular disease, heart attacks, and stroke within a month of making the switch). Another study showing increases in youth smoking as a result of e-cigarettes was “corrected” after the entire premise was based on an error in statistical weighting – in reality, no such link existed once the error was fixed. Another claimed they produced formaldehyde – only for it to be discovered lab conditions were such that could never occur in the real world. When some politicians tried to claim vaping increased the risk of Covid-19, a fact contradicting over 750 academic studies, the one taxpayer-funded paper they used was promptly debunked for being riddled with errors, with multiple other scientists calling for its retraction. In another case, politicized bureaucrats at the FDA claimed vaping caused a “mysterious lung disease” in 2019, until they finally admitted what was known by experts all along –
that the culprit was actually illegal bootleg THC devices laced with Vitamin E acetate. The end result of this campaign is millions of people will continue to smoke and die from combustible tobacco – something that could easily be prevented.

If the likely Biden administration wants to be true to its promise to depoliticize science, then their first priority should be to listen to actual scientists and not activists, and enact policies that will help Americans – and not protect big tobacco companies. Cleaning up the FDA, and restoring integrity in science, is an essential step that they must take. Millions of lives depend upon it.

BLOGS:

Monday: Watchdog: FTC’s Misguided Attempt at Past Fortune Telling Should Be a Warning for Future Antitrust Action ([link removed])

Thursday: Defeating COVID Means Continuing to Defeat Onerous Regulations ([link removed])

Friday: Watchdog Group Calls for Postal Reform After $9.2 Billion Net Loss ([link removed])

MEDIA:

November 9, 2020: WBFF (Fox, Baltimore) interviewed me about what President-elect Joe Biden and Mayor-elect Brandon should do once in office.

November 9, 2020: The Center Square ran TPA’s op-ed, “After mail-in election, Biden must deliver on postal reform.”

November 9, 2020: TPA was quoted by WBFF (Fox, Baltimore) about the new position of city administrator in Baltimore, Md.

November 9, 2020: I appeared on American Family Radio (nationally syndicated) to talk about TPA’s new antitrust project.

November 12, 2020: I appeared on WBOB Radio (600 AM AND 101 FM Jacksonville, Fla.) to talk about the economy and Joe Biden’s potential cabinet.

November 12, 2020: The Livingston Parish News (Denham Springs, La.) ran TPA’s op-ed, “After mail-in election, Biden must deliver on postal reform.”

November 12, 2020: Issues & Insights ran TPA’s op-ed, “With More FDA Reform, Coronavirus Vaccine Needn’t Be A One-Off.”

November 12, 2020: Inside Sources ran TPA’s op-ed, “Defeating COVID Means Continuing to Defeat Onerous Regulations.”

November 12, 2020: WBFF (Fox, Baltimore) interviewed me about tariffs.

November 12, 2020: I appeared on KMOX radio (St. Louis, Mo.) to talk about Biden’s tax plan.

Have a great weekend, stay safe, and as always, thanks for your continued support.

Best,
David Williams
President
Taxpayers Protection Alliance
1401 K Street, NW
Suite 502
Washington, D.C. xxxxxx
www.protectingtaxpayers.org ([link removed])

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