⇒ Issue #186 (In numerology, 186 signifies family and family well-being.)
⇒ Worldwide Covid cases as of 05/07: 156,117,850*
⇒ Worldwide Covid fatalities as of 05/07: 3,257,754*
⇒ Confirmed Covid cases in Canada as of 05/07: 1,274,206*
⇒ Confirmed Covid fatalities in Canada as of 05/07: 24,497*
⇒ Number of vaccine doses administered to Canadians as of 05/07: 14,924,694*
May 7, 2021—Good morning, CurveFlatteners. It’s Mitch Shannon at the keyboard this morning, and I'm wondering what all that anguished screaming might be about, coming from just across the 49th parallel.
Up until today, we were all feeling pretty good about our global industry’s response to the Covid pandemic, weren’t we? Bringing effective vaccines from bench to worldwide clinics in practically no time at all seemed like a historic breakthrough for the drug sector, achieved during the direst conditions. More than a billion doses have already been administered around the globe. Putting it plainly, we achieved the extraordinary and saved our species from a viral apocalypse. For once, it was good to be Big Pharma.
However, the warm and fuzzy feeling ended abruptly on Wednesday (05-04-21) when the Biden Administration in Washington delivered a gut punch in the form of proposing suspension of intellectual property rights for Covid vaccine producers.
“Golly!”, exclaimed investors, as shares in BioNTech fell 14 per cent in early European trading yesterday (05/06). Moderna and Novavax both dipped as much as 6 per cent on Wednesday (05/05.)
U.S. President Joe Biden’s support for a patent waiver displeased the International Federation of Pharmaceutical Manufacturers (IFPMA), the industry’s global lobby group, based in Switzerland.
The World Health Organization has promoted schemes to suspend intellectual property rights to vaccines, currently for Covid, and previously for HIV/AIDS. Sixty member-nations of the World Trade Organization are said to support a waiver of patents on Covid vaccines.
The stunning announcement of the U.S. position came only 24 hours after Pfizer released its quarterly financial results. The company rang up US$3.5 billion in Covid vaccine sales in the first three months of this year, representing a quarter of total corporate revenue. Pfizer has been clear in making known its intention to derive profits from the vaccine, which it offers through a collaboration with BioNTech. However, the company has been criticized for production and logistics delays, as have its peers.
While the proposal by the federal government to interfere in the commercial marketplace for pharmaceuticals caused shockwaves in the U.S., it will sound entirely familiar to Canadians in the life sciences sector. In Canada, there’s even a name for the manoeuver: “Allan-Rockism.” Drugbiz veterans will recall Mr. Rock as the federal health minister who unilaterally attempted to expropriate Bayer’s Canadian patents on ciprofloxacin and award a manufacturing deal to Barry Sherman of Apotex, as an unjustifiable response to an imagined anthrax scare in 2001. Mr. Rock’s attempted actions were regarded as draconian, potentially unlawful, and borderline hysterical, and the Liberal party quickly climbed down from the effort.
The idea of expropriating intellectual property as a reaction to the Covid pandemic may seem equally ill-advised. Former U.S. FDA Commissioner Scott Gottlieb cautions there are few practical benefits to the move. Says he: "Standing up new manufacturing, even in a circumstance where you have a full tech transfer and are cooperating closely with a new manufacturing partner, which isn’t the case here, would still take six months in the best cases, and usually much longer."
Questions remain. Might the kerfuffle have been avoided if Pfizer and other vaccine-makers emphasized a more philanthropic and somewhat less capitalistic posture back in October? Is this, at root, a public relations fiasco with sector-altering consequences? As the eloquent consumer advocate, Roseanne Roseannadanna used to say back in simpler times, "It just goes to show ya! It's always something!"
The NPC Podcast is back for another season. The National Pharmaceutical Congress organizers are proud to release our new weekly podcast series, hosted by Peter Brenders. Peter's guest this week is Brenda Irwin, Founder and Managing Partner of the Relentless Venture Fund. Listen here now, or download the episode and play it at your convenience. The NPC Podcast is presented in cooperation with Impres Pharma
COVID CHRONICLE 05/06/2021
- Is Covid vaccination possibly affecting women’s menstrual cycles? Researchers led by Dr. Kathryn Clancy, of the University of Illinois, are initiating a study of reported symptoms associated with menstrual bleeding in patients who have recently received at least one dose of a vaccine. Dr. Jen Gunter, a California obstetrician and gynecologist tells the Los Angeles Times a link is theoretically possible. Dr. Gunter notes the uterine lining, shed during the menstruation process, is known to contain immune cells.
- There have been fewer than a dozen cases reported in North America of the Covid variant known as B.1.617, but reports from India have raised concern among epidemiologists. The Indian health ministry terms the virus a “double mutant” that has accounted for around 2 per cent of that country’s staggering caseload, which totalled 412,262 yesterday. The U.K.’s Daily Mail newspaper quotes Dr. Sujeet Singh, director of India's National Center for Disease Control, suggesting the variant is driving the current wave of infections. He adds: “We have not been able to establish the epidemiological and clinical correlation completely yet.”
- While half the UK population has received at least one Covid vaccine dose, British researchers are concerned that ongoing research efforts aren’t adequately representing a diverse participant population inclusive of age, ethnicity and backgrounds. Researchers from England’s University of Birmingham, reporting in the journal Trials, found only 41.4 per cent of respondents were interested in participating in vaccine trials. The majority of respondents were either not interested (27.6 per cent) or unsure (31.1 per cent.) The least interested groups of Black, Asian and Minority Ethnic (BAME) backgrounds, those residing outside urban areas, and those aged 70 and above. The researchers note the elderly and BAME participants represent two high-risk priority groups. The study concludes “there’s a need to design interventional and public health strategies to engage and encourage trial participation.”
- In analyzing Covid fatalities, obesity may be a stronger risk factor in men than in women, according to a study published in the European Journal of Clinical Microbiology & Infectious Diseases. The same gender bias may apply to Covid-associated cases of severe pneumonia and the subsequent need for intubation. Researchers at Montefiore Medical Center in New York City analyzed data for 3,530 hospitalized Covid patients between mid-March and April 2020. Dr. Arcelia Guerson-Gi and co-authors found that patients with class II and III obesity had a higher likelihood of mortality, particularly when compared to patients in the normal weight group. The authors found the association was stronger as the obesity class increased.
TODAY CHRONICLE IS WORKING ON
Chronicle.Academy is announcing a new program in Direct-to-Consumer Marketing for Canadian life science professionals. The program will be offered in three interactive modules, concluding with a live seminar. Find out more about this innovative structured learning opportunity by clicking here.
WHAT I'M WATCHING TONIGHT
For once, I'm just a mere three years behind everyone else in discovering a TV series worth watching. "A Very English Scandal" depicts the rise and fall of Jeremy Thorpe, the talented Member of Parliament who led the U.K. Liberal Party and played a significant role in British politics during the early '70s. This three-part series first screened on the BBC and currently on streaming services, offers a nuanced and unflinching look at how Thorpe's public countenance couldn't successfully co-exist with his private appetites. Hugh Grant is surprisingly effective -- in fact, perfect -- as Thorpe, depicting several aspects of a gifted, flawed, ultimately doomed political specimen, who exemplified his peculiar place and times.
THAT'S ONE MORE WEEK GONE...
We are so grateful to whoever came up with the brilliant idea that is the weekend. Kylie Rebernik will be back slinging Covid news at you next Thursday. On Monday, watch for the Skin Spectrum Weekly e-newsletter, and on Tuesday, the NPC Healthbiz Weekly will be in your inbox at 6 a.m. Get some rest, everyone.
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