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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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THCB Gang Episode 99, Thursday July 28

This was a special early in the day edition of #THCBGang. It was at 9.15am PT/ 12.15 pm ET (so if you are coming at 1pm it won’t be live today at the normal time as it’s already happened!). It was part of the Primary Care Transformation Summit which has been running since Monday and continues to the end of Friday. It’s a who’s who of everyone in primary care. You can check out the wider agenda but we were on immediately before the day 3 keynote from head of CMS Innovation, Liz Fowler.

Joining Matthew Holt (@boltyboy) to discuss primary care and more were are WTF Health host & Health IT girl Jessica DaMassa (@jessdamassa); futurist Jeff Goldsmith; & Dan O’Neill (@dp_oneill) who is now at primary care group Pine Park Health.

You can see the video below & if you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels.

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.

Matthew’s health care tidbits: Texas is the present future of abortion care

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

In this edition’s tidbits, I have to return to the stunning impact of the Dobbs ruling. We know will happen because it is already happening in Texas where the 6 week law was already being enforced in contravention of Roe v Wade.

Taxpayer money is going to “pregnancy crisis centers” that flat out lie to vulnerable patients about the impact of abortions on their health. Doctors are questioning women who have miscarried–at a moment that is already terrible for them, and women who have miscarried are being denied basic D&Cs–which can kill them.

Don’t get me started on the absolute nonsense being talked–and passed into law –about ectopic pregnancies, of which there are over 130,000 each year in the US, being carried to term. How unlikely is it that an ectopic pregnancy makes it to term with no ill effects? Let me tell you a story. My dad was an OBGYN. He and his anesthetist saved the life of a woman and her baby who somehow had made it to term while being ectopic. During the surgery she needed 12 pints of blood (a normal woman has 7-8 pints in her body) and he considered it the greatest piece of surgery he did in his entire career. He thought that he and the patients were very lucky. So I demand that crazy legislation saying ectopic pregnancies have to be carried to term also mandates that my dad is around to do every single C-Section. Unlikely, as he’s dead, but no crazier than the legislation in Indiana.

Then there’s the impact on telehealth. Most abortions are done using drugs but more and more of the pandemic-era exemptions to prescribing drugs and seeing patients over telehealth across state lines are being withdrawn. Clearly the state-based licensing of doctors is itself ridiculous in an age of online commerce, but despite the DOJ statements the legality of prescribing abortifacients across state lines is very unclear and, as Deven McGraw explained in this harrowing piece on THCB Gang, HIPAA doesn’t protect patient privacy from local law enforcement. So what happens to someone in a state where abortion is banned if they have to go to hospital because of a complication from taking an abortifacient? Trump thinks they should go to jail.

What is clear is that bans on abortion don’t stop abortions. But they do endanger women. And if the pregnancy crisis center stops a woman from getting an abortion, do they help afterwards? Why yes, if you mean by “helping”, they have a celebratory dinner and light a fricking candle.

American health care leaders are not blameless today

By MATTHEW HOLT

It is a very sad day for America. Roughly 30% of our country is part of a quasi-religious cult. In general these people reject science and the enlightenment. This week the Jan 6th committee has shown they are prepared to use and support any tools or tactics–up to and including the overthrow of the government, in order to get what they want. 

The overturning of Roe vs Wade is the most visible artifact of a 40-year campaign. The campaign was funded by business leaders like the Koch brothers who want to revoke all environmental, labor and rational restrictions on their activities. Using dark money and the passion of religious zealots who want to control women’s bodies and discriminate against anybody who doesn’t believe what they believe, they have turned this nation back to the 18th century, using the Supreme Court as their vehicle.

The biggest of those dominos has now fallen and women’s right to control their own bodies has been taken away in most states. We can assume a nationwide ban (such as happened in Poland) will be coming here soon, maybe as soon as 2025 if the Republicans win the 2024 elections. And note that the rolling coup described by the witnesses at the Jan 6 hearings show that the Republicans are already blatantly taking over the supposedly neutral election process.

But the American health-care system is not blameless. Abortion and other reproductive health services are clearly part of health care. Yet uniquely in this country the provision of the services has not been from mainstream health care institutions. The leaders of our health care organizations, in particular our major hospital systems, have completely avoided delivering these services. They have been more than happy to allow Planned Parenthood and other specialist organizations to provide reproductive care, and have just looked the other way in the debate. 

Worse, many of our religiously affiliated institutions,  particularly those with a Catholic heritage which represent an enormous amount of hospitals in this country, have banned not only abortion but many other forms of reproductive health care such as female sterilization. The Hyde Amendment, ironically named after a religious bigot who was an appalling adulterer and hypocrite to boot, bans Federal funding for abortions. That means that private Medicaid plans which now cover most births in this country have never offered a full suite of reproductive health care.

Even in recent weeks when the fate of Roe became clear I have heard nothing from major leaders of hospital systems or health plans about this. Some of the newer provider organizations focusing on women, such as Maven and Tia, have been outspoken, as have many non health care-related employers. But the general silence from all major health care organizations in America on this topic has been deafening.

Today there is plenty of shame and blame to go around.

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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