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The Future of Clinical Trials at Pfizer

BY JESSICA DaMASSA

From de-centralized clinical trials to real world data (RWD), real world evidence (RWE), and even social media, the future for clinical research at Pfizer sounds increasingly tech-enabled and focused on meeting and engaging patients where they are.

Pfizer’s Head of Clinical Trial Experience, Judy Sewards, and Head of Clinical Operations & Development, Rob Goodwin, drop in to chat about what Pfizer’s approach to clinical research looks like now, after the rapid evolution it underwent to “lightspeed” the development of the Covid-19 vaccine.

The big change? Rob says they are “obsessed” with de-centralized trials, with nearly 50% of clinical trial visits still happening virtually. And, beyond the convenience factor, both point to de-centralization as a critical factor in being able to recruit more patients into trials as well as improve the diversity of their participant groups. In the end, the decentralized approach, says Judy, is “not just a matter of equity, but good science as well.”

And what about improvements to the cost of drug development? Is it too soon to tell if de-centralization will make an impact on the bottom line? Innovation may be expensive to implement at first, but, explains Rob, “If you can recruit your trial faster, overall, the cost of development goes down and speed to the patient goes up.”

We chat through the full suite of benefits that de-centralized clinical trials are bringing Pfizer and its patient populations, and get into the utility of real-world data, which also saw new notoriety when the Covid-19 vaccine was being developed. How is RWD impacting clinical research even when it’s not being used as evidence in a regulatory approval process? Watch and find out more about how data innovation is shaping the future of pharma!

Constructed of star dust, will Guardian Angels continue to exist?

BY MIKE MAGEE

EXCLUSIVE: Royal beekeeper has informed the Queens bees that the Queen has died and King Charles is their new boss in bizarre tradition dating back centuries. … He placed black ribbons tied into bows on the hives, home to tens of thousands of bees, before informing them that their mistress had died.”

So read John Dingwall’s exclusive in the Daily Mail posted at 03:48 EDT, 10 September 2022. In defense of what might first appear a bizarre practice, others were careful to provide evidence that the practice, of informing fellow natural creatures of important human losses, is well documented in art and literature, such as in “Der Bienenfreund” (“The Bee Friend”), an 1863 painting by the German artist Hans Thoma.

That painting arrived on the scene nine years after the death of German philosopher Friedrich Wilhelm Joseph von Schelling, a stalwart of “German Idealism.” His focus (in part) was on “humankind’s relationship to nature,” a subject that has received a spotlight as our planet’s “climate emergency” status  has become undeniable.

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Vaccine Myocarditis Update

BY ANISH KOKA

The European Medicines Agency decided on July 19, 2021 that myocarditis and pericarditis be added to the list of adverse effects of both messenger RNA (mRNA) based vaccines (BNT162b2 [Pfizer-BioNTech] and mrna-1273 [Moderna]) against COVID-19. This advice was based on numerous reports of myocarditis that followed a clinical pattern that strongly suggested a causal link between these particular vaccines and myocarditis/pericarditis. The adverse events that appeared to be predominantly in young men typically occurred within a week after injection, and were clustered after the second dose of the vaccine series. A recent national database from France sheds some light on the approximate rates of mrna vaccine related myocarditis.

Between May 12, 2021 and October 31, 2021 within a population of 32 million persons aged 12-50 years, 21 million first doses of the BNT162b2 (Pfizer) vaccine and 2.86 million first doses of the mrna-1273 (Moderna) vaccine. In the same period, 1612 cases of myocarditis and 1613 cases of pericarditis with myocarditis were recorded in France. Compared to matched control subjects, the risk of myocarditis was markedly increased after 1st and 2nd doses of the vaccine. For the Pfizer vaccine, the odds of myocarditis were 1.8 times the expected background rate for the 1st dose and 8 times the expected background rate for the 2nd dose. The Moderna vaccine, which delivers about three times the dose of the Pfizer vaccine has an even higher risk of myocarditis — a stunning 30 times the expected background rate after the second dose. A prior history of myocarditis was associated with an odds-ratio of 160.

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We Should Channel People Into Medicare Advantage Plans Where They Won’t Have Amputations or Go Blind (Part 2)

By GEORGE HALVORSON

Former Kaiser Permanente CEO George Halvorson has written on THCB on and off over the years, most notably with his proposal for Medicare Advantage for All post-COVID. He wrote a piece in Health Affairs last year arguing with the stance of Medicare Advantage of Don Berwick and Rick Gilfillan (Here’s their piece pt1pt2). We also published his criticism (Part 1Part 2Part 3) of Medpac’s analysis of Medicare Advantage.  Now Medpac is meeting again and George is wondering why they don’t seem to care about diabetic foot amputations. We published part one last week. This is part two– Matthew Holt

We have more amputations and we have more people going blind in our fee for service Medicare program today because we buy care so badly and because we have no quality programs or care linkages for our chronically Ill patients and our low income people in that program.

We have far better care in our Medicare Advantage programs at multiple levels today, and we should be building on that better care for everyone.

The important and invisible truth is that we have major successes in providing better care to Medicare Advantage members across the entire spectrum of that package of care. The sad truth is that MedPac actually keeps those huge differences in care performance by the plans secret from the Congress and from the American public for no discernable or legitimate reason.

We have an epidemic of amputations that are causing almost a fifth of our fee for service diabetes patients who get foot ulcers to lose limbs. The number of patients in both standard Medicare Advantage and in the Medicare Advantage Special Needs Programs who undergo amputations and who have that functional and dysfunctional care failure is a tiny fraction of that number.

MedPac pretends the program does not exist. They did a lengthy study on the overall special needs dual eligible program for Medicare a year ago without mentioning the plans or describing any of the things that the plans to do make care better for those patients.

We know that in fee for service Medicare, 20% percent of diabetes patients routinely get ulcers and 20% of those ulcers to turn into amputations. There are far fewer amputations for Medicare Advantage plan members—and we have failed our overall Medicare population badly by not sharing that information more broadly at open enrollment time.

Medicare Advantage Five Star quality plans that have created a culture of quality improvement at many care sites. Those plans compete fiercely on quality goals and take pride in attaining and celebrating the highest scores.  We started with less than 10% of plans with the highest scores for the first enrollment periods. Now more than 90% of Medicare Advantage members are able to choose between four and five star plans.

The quality measurements that are missing from the set of consumer choices are the ones that relate to the most serious issues for the consumers—and that’s where MedPac should be putting the right set of information on the table to compare the two systems of care. Large amounts of data show that amputations caused by diabetes follow very predictable patterns.  

Roughly 33% of Medicare patients will have diabetes. 20% of diabetics will have ulcers. That number goes up to 30% for some patient groups—but you can count of at least 20% overall to have ulcers.  We know that the overarching pattern in fee for service Medicare is for 20% of those ulcers to end up needing and getting amputations.

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You Need Some Smarter Clothing

BY KIM BELLARD

Much as I’d love to write about Instagram’s feud with the Kardashians over changes to the Instagram feed, and how that and proposed changes to Facebook’s feed reflect Meta’s efforts to combat TikTok’s growing influence, I’ve already given healthcare plenty of warnings about TikTok.  Instead, I’ll write about something else that the Kardashians care about: fashion.

Well, not fashion per se, but clothing. If the old, sexist statement was “clothes make the man,” then soon we may be saying “clothes make your health.” 

The Washington Post got my attention when it reported last week about robotic clothing, because, as anyone who has been reading me for long knows, I am fascinated by robots and their role in healthcare.  One of the advances the article discussed works on “smart fluid textiles” done by Dr. Thanh Nho Do and colleagues at the University of New South Wales Medical Robotics lab.

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Quickbite Interviews: Veda

I was at the AHIP conference in Vegas late last month and caught up with a number of CEOs & execs for some quick bite interviews — around 5 mins getting (I hope) to the gist of what they & their companies are up to. I am dribbling them out –Matthew Holt

Next up is Meghan Gaffney, CEO, Veda.

Global Warming and Disease

BY MIKE MAGEE

A study eight years ago, published in Nature, was titled “Study revives bird origin for 1918 flu pandemic.” The study, which analyzed more than 80,000 gene sequences from flu viruses from humans., birds, horses, pigs, and bats, concluded the 1918 pandemic disaster “probably sprang from North American domestic and wild birds, not from the mixing of human and swine viruses.”

The search for origin in pandemics is not simply an esoteric academic exercise. It is practical, pragmatic, and hopefully preventive. The origin of our very own pandemic, now in its third year and claiming more than 1 million American lives, remains up in the air. Whether occurring “naturally” from an animal reservoir, or the progeny of an experimental lab engaged in U.S. funded “gain-of-function” research, we may never know. What we do know is that viruses move at the speed of light, or more accurately, at the speed of birds.

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What’s Up, Docs

BY KIM BELLARD

Here’s how I’ll know when we’re serious about reforming the U.S. healthcare system: we’ll no longer have both M.D.s and D.O.s.

Now, I’m not saying that this change alone will bring about a new and better healthcare system; I’m just saying that until such change, our healthcare system will remain too rooted in the past, not focused enough on the science, and – most importantly – not really about patients’ best interests.

Let me make it clear from the outset that I have no dog in this hunt.  I’ve had physicians who have been M.D.s and others who have been D.O.s, and I have no indication that there have been any differences in the care due to those training differences. That’s sort of the point: if there are no meaningful differences, why have both?  

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A deal on AHIP in Vegas!

I’m going to AHIP in Vegas next month and you should come too!

It’s time to be together again. It’s also time to save. Register for AHIP 2022 (formerly Institute & Expo), June 21 – 23 in Las Vegas with code THCB and save. Together, we’ll explore the ideas, innovations, and forward-thinking driving health care’s transformation. Check out the agenda and Register today with code THCB.

Defanging HIPAA: How Your De-identified Data Was Re-identified For Profit.

BY MIKE MAGEE, M.D.

Arthur Sackler continues to demonstrate just how wealthy one can become by advantaging patients and their diseases.

He’s been dead since 1987, but his ghost continues to access your personal health data, pushes medical consumption and over-utilization, and expands profits exponentially for data abusers well beyond his wildest dreams. Back in 1954, he and his friend and secret business partner, Bill Frohlich, were the first to realize that individual health data could be a goldmine. That relationship would still be a secret had it not been exposed in a messy family inheritance feud unleashed by his third wife after Sackler’s death.

That company, IMS Health, was taken public and listed on the NYSE on April 4, 2014, transferring $1.3 billion in stock. I’ll come back to that in a moment. But in the early years, the pair realized that the data they were collecting would multiply in value if it could be correlated with a second data set. That dataset was the AMA’s Physician Masterfile which tracked the identity and location of all physicians in America from the time they entered medical school. 

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