Last week he couldn't spell pharmacovigilance. This week he still can't

The NPC Podcast is on the air. The organizers of the National Pharmaceutical Congress are proud to release our new weekly podcast series, hosted by Peter Brenders. Peter's guest this week is Robin Hunter of Mallinckrodt Pharmaceuticals. Listen here now, or download the episode and play it at your convenience. The NPC Podcast is presented in cooperation with Impres Pharma.

⇒ Issue #98 (In numerology, 98 is a building number with humanitarian objectives.)
⇒ Confirmed Covid cases in Canada as of 08/20: 125,408*
⇒ Confirmed Covid fatalities in Canada as of 08/20: 9,095*
⇒ Worldwide Covid cases as of 08/20: 22,242,243*
⇒ Worldwide Covid fatalities as of 08/20: 788,356*

August 20, 2020—Good morning, CurveFlatteners. It's Mitch Shannon at the keyboard today. If, like me, you’ve been watching the long-running nightly farce that is Pandemic Politics American-Style, you still may not have been prepared for the recent plot twist and introduction of the latest wacky character. Who is that taking center-stage in the role of a self-declared medical expert? Why, it’s a Minnesota pillow salesman named Mike Lindell.

Mr. Lindell, familiar to Fox News cable TV audiences as the mustachioed pitchman behind “My Pillow,” has begun tubthumping lately for oleandrin extract, a purported botanical remedy for Covid-19. Please carefully read the following disclosures before continuing this paragraph. (1) There have been no safety or efficacy trials for oleandrin as an antiviral Tx. (2) The oleander plant from which the compound is derived is known to be highly toxic, causing fatal cardiac arrhythmia to humans and animals. (3) Mr. Lindell holds a financial stake in the provider, Phoenix Biotechnology of Texas, and he is a member of the company’s board.
So, Mike’s Magic Covid-Crusher would appear to represent a trifecta of outrageous quackery — that is, to anyone who is not President Donald Trump. Mr. Lindell, a recovered recreational narcotics enthusiast with a definite flair for self-promotion, has been advising the president on re-election strategies. President Trump was asked by a reporter about oleandrin as a potential Covid therapy earlier this week, and he replied: "We'll look at it, we'll look at it, we're looking at a lot of different things... I have heard that name mentioned, we'll find out."

Mr. Lindell continued his peripatetic medicine show with a stop at Anderson Cooper’s Tuesday CNN broadcast (08/18), where the host wondered about clinical studies. This memorable conversation resulted, quoted verbatim:

Lindell: You know what? I got my own study. When I took the — when I've seen the test of 1,000 people that it was safe. That's all I needed.
Cooper: Sir, OK. If you've seen this test, where is this test?
Lindell: I've been taking it since April. I've been taking it since April. I have 100 friends and family — this thing works. It's the miracle of all time.
Cooper: You said — sir, you said you've seen this test, where is it?
Lindell: The tests are out there. The thousand people — phase one, phase two.
Cooper: Where is the test? Show it to us.
Lindell: I don't have the test.
Well, then. Here’s a heads-up to the U.S. FDA. Don’t ever try to talk to Mr. Lindell about pharmacovigilance, because apparently he can’t be bothered to even learn how to pronounce the word. Oh, to be a (pathogen-carrying) fly on the wall of the hearing room if ever an expert regulatory panel is convened to assess the data on what will no doubt be marketed as “My Covid Cure.” (Following quotes are fictitious.)

“Mr. Lindell, the trial datasets you submitted seem to be blank pages.”

“Oh, I got datasets. Lots of ‘em. I got plenty of datasets. Don’t you worry about that. [Pause.] You know what? I guess I don’t got no datasets.”

In that sense, it’s a shame Trump University no longer exists. It would have been the perfect academic home for the Lindell Miracle-of-All-Time Institute for Biopharma Research, where the motto could be, “A World Centre of Research Excellence... Where There’s Guaranteed to be a Pillow Under Every Tuchas.”

COVID CHRONICLE 08/20/20

• American physicians aren’t buying the idea that a Covid vaccine can be brought from bench to clinic before the end of this year. A recent survey by the Physicians Foundation determined only 10 per cent of U.S. doctors think the pandemic will be under control by the end of this year. The Trump administration committed funding to Operation Warp Speed, aimed at just such a timeline, earlier this summer (see DCF passim.) When do the docs think the virus will be controlled? Around half of the 3,513 surveyed said June 1, 2021. Thirty-seven per cent believe it will happen during the first half of next year. Four per cent declared Covid will never be controlled.
• Emerging data from Covid cases continues to suggest that the pandemic is disproportionately harming patient populations who are already vulnerable. A patient study conducted at three Boston-area teaching hospitals finds high rates of disease-related complications, and the need for post-discharge, post-acute care and monitoring. The study was published in EClinicalMedicine, a Lancet journal. According to senior author Dr. Jason H. Wasfy of Massachusetts General Hospital, 30 per cent of Covid patients were Hispanic, 21 per cent were enrolled in Medicaid, and 12 percent were dual-enrolled Medicare/Medicaid, suggesting lower income levels. Said he: "This strongly suggests that there are some built-in disadvantages that fall on these populations' shoulders. They may have more family members living in one home, have greater difficulty accessing care, or other circumstances making them more likely to become infected and sick."
• Testing continues to present a challenge to efforts to track and trace Covid-positive populations. Current test methods rely on reverse-transcription polymerase chain reaction (RT-PCR) analysis, which is expensive, time-consuming, and — not the smallest deterrent — invasive and frequently painful for patients. However, researchers say they have developed a prototype non-invasive device that detects Covid in the exhaled breath of infected patients. Drs. Hossam Haick, Hu Liu, Yueyin Pan and colleagues developed a device similar to a breathalyzer test for intoxication and tested it on 49 confirmed Covid patients and a control group in Wuhan, China. Their report appears in the journal ACS Nano.
• An international literature review of 872 articles from 29 countries indicates the Covid pandemic and lockdown have been harmful to some people accessing mental health services. Two new studies based on the review were published by faculty from University College London and King's College London in the journal Social Psychiatry and Psychiatric Epidemiology. Author Dr. Sonia Johnson said, "Most people we surveyed support partial adoption of remote working, but they caution that telemedicine doesn't work for everyone, and there are still major challenges to be addressed for it to be truly effective. The voices of the digitally excluded are especially in danger of not being heard."

WHAT CHRONICLE IS WORKING ON TODAY

We're getting ready to record next week's NPC Podcast, which will feature Nancy White of Inagene, the Canadian personal diagnostic technology startup. 

WHAT I'M (NO LONGER) READING

The Toronto Noir collection of short stories seemed kind of promising, especially after I enjoyed the Phoenix Noir project about a week ago. Bad call on my part. These crime stories by various local authors set in different parts of Toronto are uniformly inane or pointless, and generally seem as if they were written by a not-especially talented evening class of aspiring college scribblers. After suffering through a hundred or so pages of overly obvious plotting, unconvincing dialogue and painfully precious descriptions of the St. Lawrence Market and Don Valley Parkway (blah-blah, fashionable Yorkville, blah), I found myself skimming a section written by a woman who evidently lives a couple of blocks from my house and who placed her protagonists on the mean streets of my neighbourhood. I will say with some neighbourly best intentions that she needs to find another creative outlet: perhaps metal sculpture, or caring for tropical fish, or she might consider training to take on Joey Chestnut at the next televised competitive-eating competition at Coney Island. My suggestion would be that she never show her stories to anyone else, ever again, lest they react as I did. Noir, indeed.   

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