Private sector can help solve our doctor shortage

 The pandemic has laid bare a crisis we’ve ignored for far too long — our chronic doctor shortage. According to the Association of American Medical Colleges, the United States faces a shortfall of up to 124,000 physicians over the next decade.

This is a supply problem, as the demand for care will only go up. So we must create more doctors — by expanding medical school capacity and increasing the number of residency slots where budding doctors can complete their training.

The causes of this looming shortage are many. Over half of doctors in this country are 55 or older and heading for retirement. Our aging population is increasing the overall demand for medical care.

Burnout is also becoming a bigger problem. Even before the pandemic, long hours, stifling bureaucracy and a lack of autonomy had been causing many doctors to hang up their stethoscopes early. The horrors and stresses of COVID-19 pushed many more out of active practice.

The shortage does not hit all Americans equally. Rural areas and poorer communities are more likely to lack the physicians they need.

We’re in this mess, in part, because of policies that ensued from a flawed, four-decade-old federal government report. In 1981, the Graduate Medical Education National Advisory Committee concluded that America would have a large surplus of physicians. The committee said that medical school enrollment had increased too much during the ’60s and ’70s.

The report is one reason why no new M.D.-granting medical schools were established until after the new millennium.

By 2006, the Association of American Medical Colleges issued its own report claiming that new medical schools were needed to avoid an impending doctor shortage.

Today, we’re graduating far too few doctors. Only 36.2% of those who apply to medical school end up matriculating, according to AAMC data from 2021-22.

The United States cuts a sorry figure in the data for medical graduates per 100,000 people among developed countries. In 2019, Ireland topped the list with 24.8 medical graduates for every 100,000 inhabitants. That year, the United States had just 8.1 per 100,000 people. Italy, Slovakia, Belgium and the Czech Republic all had twice as many medical graduates per capita in 2019 as we did.

Med school admissions are, of course, supposed to be competitive. But how many people are denied the chance to become doctors simply because there aren’t enough desks — not because they wouldn’t make great physicians?

Med school applications have been increasing for decades — by two-thirds since 2005. Last year, a record 62,000 prospective students applied.Acceptance rates are stunningly low, with only 7 of every 100 applicants admitted on average. At Harvard, the figure is 2.8.

There’s no escaping it — more slots are desperately needed.

Money is targeting student enrollment. The University of Utah will use a $110 million donation to increase each class’ size from 125 to 155, as well as to raise the number of residency slots it offers to finish training doctors.

There’s more. UMass Medical School received a “transformational” $175 million gift from the Morningside Foundation. Western Michigan University’s Medical School has received gifts totaling $300 million that could lead to a transformational growth in its student body.

Rowan University in New Jersey recently received an $85 million donation for a new osteopathic school of medicine. Belmont University in Tennessee got $10 million from its board of trustees chair to bolster its med school, and Wake Forest secured $25 million from the Howard R. Levine Foundation to go toward a brand-new medical school in Charlotte.

We could also use more residency slots, the postgraduate sites where medical graduates complete their training. This past December, the federal government committed to fund 200 new slots per year over five years through Medicare. It’s the largest increase in Medicare-funded residencies in more than a quarter-century.

Private philanthropists and other organizations dedicated to improving health care should seriously consider augmenting efforts like this one by funding residencies themselves.

Given the scope of the doctor shortage, we need many more actors to join the fight. This is a crisis we can stop.

Sally C. Pipes is president, CEO, and Thomas W. Smith fellow in health care policy at the Pacific Research Institute. Her latest book is “False Premise, False Promise: The Disastrous Reality of Medicare for All.”

https://www.chicagotribune.com/opinion/commentary/ct-opinion-medical-school-doctor-shortage-covid-19-pandemic-funding-20220315-hl2eabxa2rhrhfy5v7muihdt74-story.html

Biden Plan Would Tighten Medicaid Handcuffs

 

KEY FINDINGS

THE BOTTOM LINE:

STATES MUST OPT OUT OF THE INCREASED FEDERAL FUNDING TO UNLOCK THE HANDCUFFS AND RESTORE INTEGRITY TO THEIR MEDICAID PROGRAMS.

Overview

During the COVID-19 pandemic, Congress passed a series of bills meant to address the crisis and offer states fiscal assistance during a turbulent time.1 Part of that package—the Families First Coronavirus Response Act (FFCRA)—provided a 6.2 percent federal funding increase to states to pay for traditional Medicaid costs.2 But the funding came with strings attached.

In exchange for the increased funding, states had to relinquish significant control over their Medicaid programs.3 While receiving the funding, states cannot strengthen eligibility standards or remove enrollees—even if they are ineligible for benefits.4 Enrollees can only be removed if they voluntarily leave the program or relocate to another state.5

These federal handcuffs have caused Medicaid enrollment to skyrocket to unprecedented levels.6 And, unfortunately, recent proposals from the Biden administration and Democrats in Congress could make this already dire situation even worse.

Medicaid enrollment is at a record high

The number of people dependent on Medicaid has skyrocketed in recent years. By December 2021, enrollment sat at an estimated 91 million people—a record high.7 Nearly 18 million enrollees were added within the last two years—the largest increase in program history—with enrollment growing nearly 17 percent annually since the pandemic began.8

Unsurprisingly, the Medicaid handcuffs are responsible for virtually of all of this enrollment growth, having “locked in” ineligible enrollees to the program.9

Based on available state data, 90 percent of Medicaid enrollment growth during the pandemic has been driven by people who are ineligible for benefits.10 Shockingly, that means an estimated 17 million Medicaid enrollees nationwide are receiving benefits, despite not qualifying under Medicaid eligibility standards.11

This level of growth in Medicaid is not only unprecedented, but also unsustainable. A program designed for the truly needy has now increasingly become comprised of ineligible individuals that are siphoning resources from those that need them most.

The handcuffs are costing taxpayers billions per month

When millions of Medicaid enrollees are ineligible for benefits, but cannot be removed from the program, taxpayers are left holding the bag. By the end of 2021, ineligible enrollees were costing taxpayers an estimated $11.3 billion every month.12

Federal taxpayers are also on the hook for an additional $2.9 billion per month—the funding bump provided as part of the FFCRA that states receive in exchange for not removing ineligible enrollees.13

In total, taxpayers are paying more than $14 billion in Medicaid costs every month thanks to the federal handcuffs.14 The handcuffs have taken a bloated program, rife with waste, fraud, and abuse, and exacerbated the problem.15 While the handcuffs remain on, enrollment will continue to spike. As enrollment continues to grow, so will Medicaid costs, as states are trapped without options to remove ineligible enrollees.

Increasingly, the cost of covering ineligible enrollees exceeds the funding boost provided as part of the FFCRA.16 In fact, the costs associated with providing benefits to ineligible enrollees has already created a net loss for 32 states.17

If the Biden administration’s plan is enacted, states will be left with an even larger bill as the plan would slash the enhanced federal funding in the coming months.18

The Biden administration’s plan will make a bad situation even worse

The FFCRA created the Medicaid handcuffs, which led to millions of ineligible enrollees locked into the program, crowding out resources for the truly needy and other state priorities. But if President Biden and Democrats in Congress have their way, states could soon face the prospect of having the enhanced federal funding slashed and then eliminated, while still being unable toimmediately remove all ineligible enrollees from the program.19

Under the Biden’s administration’s plan, the 6.2 percent federal funding increase would sunset in March 2022.20 Over the following three months, the funding boost would sit at three percent— less than half of the current boost.21 The Biden administration would then cut that boost in half again, lowering it to a 1.5 percent bump from July through September.22 At the end of September, the plan would eliminate the extra funding entirely.23

Despite the plan to slash the extra federal funding, states would still be unable to quickly remove all ineligible enrollees from the program. Indeed, the handcuffs will remain firmly locked in place until at least September 2022, with an inefficient and unworkable process to remove only a portion of ineligible enrollees.

Under the Biden administration’s plan, states could start removing some ineligible enrollees from their Medicaid rolls when the extra funding is first cut.24 But the conditions in which they would be able to do so are impractical.

First, states could only remove ineligible enrollees if they have been on the program for at least a year.25

Second, states would not be allowed to remove enrollees who have moved to other states, based on returned mail, unless bureaucrats have attempted to repeatedly contact them through multiple methods and given them notice they are being removed.26

Finally, states would only be allowed to perform eligibility redeterminations on, at most, one out of every nine enrollees in a given month—with House Democrats wanting that reduced even further to just one out of every 12 enrollees.27-28 The Biden administration’s plan would leave states holding the bag for months, prohibiting them from quickly removing all ineligible enrollees while simultaneously slashing the extra federal funding.

The result will be much higher Medicaid costs for states. If the Biden administration’s plan were to take effect, taxpayers will be forced to pay an estimated $100 billion in 2022 for ineligible enrollees locked into state Medicaid rolls due to the handcuffs.29 In 46 states, the price tag for these ineligible enrollees will far outweigh the increased federal funding states wouldreceive.30 Altogether, states will be left paying $16 billion more for ineligible enrollees this year under the Biden administration’s plan than the extra federal funding will cover.31

The Biden administration’s plan simply further locks state policymakers into the spiral of Medicaid uncertainty. As the increased federal funding gets cut, states will be left with few options to quickly remove ineligible enrollees. With each passing quarter, states will be left with higher and higher Medicaid costs, and enrollment that is still bloated with ineligible individuals.

Ineligible enrollees are costing state taxpayers

While the national outlook is bleak, individual states are faring no better. Ineligible enrollees are siphoning resources from the truly needy, overcrowding state Medicaid programs, and leaving a massive bill for taxpayers.

MEDICAID MAYHEM IN THE TREASURE STATE

Montana’s Medicaid program is growing rapidly, reaching nearly 290,000 enrollees by the end of 2021—a record high.32 Ineligible enrollees are driving the vast majority of this growth, with an estimated 48,000 ineligible enrollees sitting on the state’s Medicaid rolls by December 2021, costing taxpayers more than $6.4 million per month.33 The state’s cost to cover ineligible enrollees already exceeds the additional federal funding provided under FFCRA, but would get even worse under the Biden administration’s latest plan.34 If the Biden administration’s plan were enacted, Montana taxpayers would be on the hook for an estimated $30 million more in additional state costs to cover ineligible enrollees than the extra federal funding would cover for the rest of 2022.35

MISSOURI’S MEDICAID MISHAPS

Missouri’s Medicaid program reached nearly 1.2 million enrollees by the end of 2021.36 That enrollment is expected to soar even higher as the state expands eligibility to a new class of able-bodied adults under ObamaCare.37 Even before expansion, Medicaid consumed nearly 40 percent of the state budget.38 Those costs are set to skyrocket in the coming months.

By December 2021, an estimated 285,000 ineligible enrollees sat on Missouri’s Medicaid program, costing taxpayers more than $64 million each month.39 Those costs far outstripped the extra federal funding provided by FFCRA, leaving state taxpayers holding the bag.40 

But the Biden administration’s plan would shift even more costs onto the state. Under President Biden’s plan, Missouri taxpayers would be on the hook for nearly $300 million in additional state costs in 2022 to cover ineligible enrollees above and beyond the extra federal funding provided.41

WEST VIRGINIA’S WHOPPING COSTS

Enrollment in West Virginia’s Medicaid program has exploded in recent years, reaching nearly 620,000 by December 2021—a record high.42 But the vast majority of this growth has been driven by those who are no longer eligible for the program or may have never been eligible in the first place. By the end of 2021, an estimated 110,000 ineligible individuals were enrolled in West Virginia’s Medicaid program due to the handcuffs.43 

The Biden administration’s plan would hit West Virginia taxpayers particularly hard, forcing them to find an additional $10 million in state funds to cover ineligible Medicaid enrollees beyond the costs covered by any additional federal funds.44

THE BOTTOM LINE: States must opt out of the increased federal funding to unlock the handcuffs and restore integrity to their Medicaid programs.

The Biden administration’s plan will only make the situation worse for states, as funding is set to be slashed over time, leaving states responsible for the cost of covering millions of ineligible enrollees. Democrats in Congress are moving in this direction quickly, and if states are to avoid disaster, they must act now.

Lawmakers should opt out of the enhanced federal funding, allowing states to retake control over their Medicaid programs. Unlocking the handcuffs would allow states to restore integrity to their programs, save taxpayers billions, and allow Medicaid to return to its original purpose— protecting the truly needy.

REFERENCES

1 Hayden Dublois, “Locked-in: How Congress’s handcuffs have caused Medicaid to spiral out of control,” Foundation for Government Accountability (2021), https://thefga.org/paper/congress-medicaid-handcuffs.

2 Ibid. 

3 Ibid. 

4 Ibid. 

5 Ibid. 

6 Hayden Dublois and Jonathan Ingram, “The Medicaid crisis is here: How Congressional handcuffs are causing Medicaid to implode,” Foundation for Government Accountability (2021), https://thefga.org/paper/congressional-handcuffs-causing-medicaid-to-implode.

7 Ibid. 

8 Ibid. 

9 Hayden Dublois, “Locked-in: How Congress’s handcuffs have caused Medicaid to spiral out of control,” Foundation for Government Accountability (2021), https://thefga.org/paper/congress-medicaid-handcuffs.

10 Ibid. 

11 Ibid. 

12 Hayden Dublois and Jonathan Ingram, “The Medicaid crisis is here: How Congressional handcuffs are causing Medicaid to implode,” Foundation for Government Accountability (2021), https://thefga.org/paper/congressional-handcuffs-causing-medicaid-to-implode.

13 Ibid. 

14 Ibid. 

15 Hayden Dublois and Jonathan Ingram, “Ineligible Medicaid enrollees are costing taxpayers billions,” Foundation for Government Accountability (2022), https://thefga.org/paper/ineligible-medicaid-enrollees-costing-taxpayers-billions.

16 Trevor Carlsen, et al., “Millions of ineligible Medicaid enrollees come at a high cost to states,” Foundation for Government Accountability (2022), https://thefga.org/paper/ineligible-medicaid-enrollees-high-cost.

17 Ibid.

18 Senate Finance Committee, “Senate Finance mark-up on Build Back Better Act: H.R.5376,” U.S. Senate (2021), https://www.finance.senate.gov/imo/media/doc/12.11.21%20Finance%20Text.pdf.

19 Ibid.

20 Ibid.

21 Ibid.

22 Ibid.

23 Ibid.

24 Ibid.

25 Ibid.

26 Ibid.

27 Ibid.

28 House Rules Committee, “Rules Committee print 117-18: Text of H.R. 5376, Build Back Better Act,” U.S. House of Representatives (2021), https://www.congress.gov/117/cprt/HPRT46234/CPRT-117HPRT46234.pdf.

29 Authors’ calculations based upon data provided by a proprietary microsimulation model that incorporates data on monthly Medicaid enrollment disaggregated by state, per capita monthly costs disaggregated by state and eligibility group, the distribution of ineligible enrollees at annual redetermination disaggregated by eligibility group, states’ blended FMAP rate based on the distribution of expected ineligibles due to lock-ins, and the share of new enrollment attributable to reported lock-ins disaggregated by state, and changes to .

30 Authors’ calculations based upon data provided by a proprietary microsimulation model that incorporates data on monthly Medicaid enrollment disaggregated by state, per capita monthly costs disaggregated by state and eligibility group, the distribution of ineligible enrollees at annual redetermination disaggregated by eligibility group, states’ blended FMAP rate based on the distribution of expected ineligibles due to lock-ins, and the share of new enrollment attributable to reported lock-ins disaggregated by state, and changes to the federal funding bump and lock-in policies as set forth in the Senate Finance mark-up of the Build Back Better Act. State costs would be significantly higher than those presented here if the version of the Build Back Better Act that passed the House were to be enacted.

31 Ibid.

32  Medicaid and Health Services Branch, “Montana Medicaid enrollment dashboard,” Montana Department of Public Health and Human Services (2022), https://dphhs.mt.gov/interactivedashboards/medicaidenrollmentdashboard.

33 Trevor Carlsen et al., “Millions of ineligible Medicaid enrollees come at a high cost to states,” Foundation for Government Accountability (2022), https://thefga.org/paper/ineligible-medicaid-enrollees-high-cost.

34 Ibid.

35 Authors’ calculations based upon data provided by a proprietary microsimulation model that incorporates data on monthly Medicaid enrollment disaggregated by state, per capita monthly costs disaggregated by state and eligibility group, the distribution of ineligible enrollees at annual redetermination disaggregated by eligibility group, states’ blended FMAP rate based on the distribution of expected ineligibles due to lock-ins, and the share of new enrollment attributable to reported lock-ins disaggregated by state, and changes to the federal funding bump and lock-in policies as set forth in the Senate Finance mark-up of the Build Back Better Act. 

36 MO HealthNet Division, “Monthly management report December 2021,” Missouri Department of Social Services (2022), https://dss.mo.gov/re/pdf/fsd_mhdmr/1221-family-support-mohealthnet-report.pdf.

37 Hayden Dublois and Jonathan Ingram, “Ineligible Medicaid enrollees are costing taxpayers billions,” Foundation for Government Accountability (2022), https://thefga.org/paper/ineligible-medicaid-enrollees-costing-taxpayers-billions.

38 Ibid.

39 Trevor Carlsen et al., “Millions of ineligible Medicaid enrollees come at a high cost to states,” Foundation for Government Accountability (2022), https://thefga.org/paper/ineligible-medicaid-enrollees-high-cost.

40 Ibid.

41 Authors’ calculations based upon data provided by a proprietary microsimulation model that incorporates data on monthly Medicaid enrollment disaggregated by state, per capita monthly costs disaggregated by state and eligibility group, the distribution of ineligible enrollees at annual redetermination disaggregated by eligibility group, states’ blended FMAP rate based on the distribution of expected ineligibles due to lock-ins, and the share of new enrollment attributable to reported lock-ins disaggregated by state, and changes to the federal funding bump and lock-in policies as set forth in the Senate Finance mark-up of the Build Back Better Act.

42 West Virginia Bureau for Medical Services, “Managed care and fee for service monthly report 2021,” West Virginia Department of Health and Human Services (2022), https://dhhr.wv.gov/bms/Members/Managed%20Care/MCOreports/Documents/Managed%20Care%20Monthly%20Enrollment%20Report%20December%202021.pdf.

43 Authors’ calculations based upon data provided by a proprietary microsimulation model that incorporates data on monthly Medicaid enrollment disaggregated by state, the distribution of ineligible enrollees at annual redetermination disaggregated by eligibility group, and the share of new enrollment attributable to reported lock-ins disaggregated by state.

44 Authors’ calculations based upon data provided by a proprietary microsimulation model that incorporates data on monthly Medicaid enrollment disaggregated by state, per capita monthly costs disaggregated by state and eligibility group, the distribution of ineligible enrollees at annual redetermination disaggregated by eligibility group, states’ blended FMAP rate based on the distribution of expected ineligibles due to lock-ins, and the share of new enrollment attributable to reported lock-ins disaggregated by state, and changes to the federal funding bump and lock-in policies as set forth in the Senate Finance mark-up of the Build Back Better Act.

DOWNLOAD PAPER

https://thefga.org/paper/bidens-plan-would-tighten-the-medicaid-handcuffs/

FDA Delays Decision on Merck's Pediatric Pneumococcal Vaccine

 Merck announced Friday that the U.S. Food and Drug Administration extended the Prescription Drug User Fee Act date for its supplemental Biologics License Application (sBLA) for Vaxneuvance, a pneumococcal conjugate vaccine intended for preventative use in infants and children. The final decision on the vaccine is expected on July 1, 2022.

In December 2021, Merck announced that the FDA accepted the sBLA for Priority Review. It included data from Phase II and III clinical studies of the vaccine candidate's efficacy in a patient population aged six weeks to 17 years. 

The data supported the use of Vaxneuvance in a variety of clinical settings, including the immunization of infants and toddlers with increased risk for infection, such as those with sickle cell disease or human immunodeficiency virus (HIV) infection. The clinical trials also investigated the efficacy of using the pneumococcal conjugate in conjunction with PCV13, an existing pneumococcal vaccine for infants and children with lower valency.

Now, the FDA has extended its review of the vaccine candidate. The regulatory agency requested additional data analyses from the pediatric studies that Merck stated it has submitted. No new studies were requested by the FDA.

 "We are confident in the strength of the data from our pediatric studies with VAXNEUVANCE and will continue to work expeditiously with the FDA to bring this important vaccine forward to infants and children in the United States as soon as possible," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

Vaxneuvance received approval from the FDA in July 2021 for use in adults over the age of 18. The pneumococcal vaccine covers 15 different strains of the bacteria that cause pneumococcal disease, S. pneumoniae. Approval was based on seven clinical studies assessing safety, tolerability and immunogenicity in adults, with clinical data showing that the immune responses elicited by Vaxneuvance were non-inferior to the currently available PCV13, which covers 13 different strains of bacteria.

Additionally, Vaxneuvance was superior to PCV13 in immune responses to serotype 3, 22F and 33F, with 22F and 33F being unique to Vaxneuvance. The clinical results were similar to Merck's clinical studies evaluating the vaccine's efficacy in younger populations.

Pneumococcal disease presents a significant risk to children younger than two years old. Depending on the strain contracted, pneumococcal disease in children can cause a host of systemic disorders, including pneumonia, meningitis, middle ear infections and blood infection. Although infections with the bacteria may result in only mild illness, it can also spark very dangerous pathology that can lead to lifelong disabilities, including deafness, brain damage or loss of limbs.

Merck is up against several other biopharmaceutical companies hoping to edge into the pediatric market with pneumococcal conjugate vaccines. In June 2021, the FDA approved a new version of Pfizer's pneumococcal conjugate vaccine dubbed Prevnar 20, which delivers protection against 20 strains of bacteria in adults. Although no recent updates have been shared on clinical progress regarding Prevnar 20's efficacy in children, Pfizer's previous pneumococcal conjugate vaccine, Prevnar 13, is indicated for use in children.

Inventprise is also in the race to develop an effective pneumococcal conjugate vaccine with $90 million in funding from the Bill & Melinda Gates Foundation. IVT-25 boasts the broadest serotype coverage in development and is currently gearing up for Phase I and II clinical trials.      

https://www.biospace.com/article/fda-extends-date-for-approval-of-merck-s-pneumococcal-vaccine/

Pfizer asks hourly staffers to return overpayments in aftermath of vendor's cyberattack

 A little extra cash is always a welcome surprise—until your employer asks you to pay it back, that is.

In December, a ransomware attack struck Ultimate Kronos Group, a vendor that Pfizer uses to track work time and pay out hourly staffers, WWMT reported earlier this week. Employees were under- and overpaid as a result, according to a letter from the company obtained by the CBS/CW-affiliated news outlet.

Now, the drug behemoth is repaying those who were shortchanged—but it’s also asking overpaid staffers to return their surplus cash.

One anonymous employee told WWMT they hadn’t realized they were overpaid and had already spent the money Pfizer’s now requesting.

“We all feel this is Pfizer’s payroll mistake,” the employee told the outlet. “We never asked for this money, we were never consulted on whether we wanted extra money.”

"Pfizer has and continues to take a fair and equitable approach to the unforeseen situation created by the Kronos ransomware attack,” a company spokesperson told the news channel. “Our priority always has been to ensure colleagues receive their weekly pay in a timely fashion.”

Pfizer did not immediately respond to Fierce Pharma’s request for comment.

In its letter to employees, meanwhile, Pfizer said those who were overpaid could return the money over one, three or six months. “Please be assured that money will not be taken from your paycheck without prior notification,” the company added.

To compensate employees for their trouble, Pfizer also said it’s offering $250 to those affected by the Kronos outage—however, if the employee was overpaid, that amount will be deducted from the balance they owe.

One employee told the channel they owed more than $800 in overpayment, while another said the issue was affecting hourly workers across the company.

Pfizer isn’t the only corporation dealing with the fallout of last year’s cyberattack. Tesla and PepsiCo have filed a class-action lawsuit that contends Ultimate Kronos Group owes damages because it was negligent in guarding against an attack, Endpoints News points out. 

While Pfizer’s experiencing some headache from this incident, it’s nothing like the Merck & Co. attack back in 2017. The New Jersey pharma was just one of many global companies hit by the Russian military-linked strike in June of that year.

The cyber assault hamstrung Merck’s in-house API production and affected its formulation and packaging systems, plus R&D and other operations.

Merck and its insurers are still fighting over more than $1 billion in losses from the attack, though the company in January notched a win when its insurers lost a bid to exclude the so-called NotPetya incident under an “act of war” exclusion.

The insurers’ rationale? The attack originated from the Russian government as part of its hostility toward Ukraine. Merck, for its part, took the opposite stance, and a New Jersey judge agreed, concluding the act of war exclusion doesn’t apply since it’s intended for actual armed conflict.

Separately, numerous COVID-19 players, Pfizer included, were swept up in a spate of breaches and cyberattacks in 2020. Moderna, AstraZeneca and BioNTech were among those affected, with coronavirus vaccine data often a prime target.

https://www.fiercepharma.com/pharma/pfizer-asks-staffers-return-overpayments-aftermath-timeclock-service-cyberattack

Finch clips wings of hepatitis B program, hitting pause on clinical plan to focus on C. diff and autism

 Finch Therapeutics has joined the ranks of biotechs that are narrowing their focus. With its lead program under clinical hold, the microbiome specialist has pulled out of a planned study in chronic hepatitis B.

Development of CP101 in chronic hepatitis B is on pause after a strategic review persuaded Finch to preserve its cash for programs targeting recurrent Clostridium difficile infection and autism. Finch made the decision to focus on those two internal programs, plus partnered work with Takeda on inflammatory bowel disease, to make the best use of the $133.5 million it had in the bank as of the end of 2021.

The removal of hepatitis B from the list of priority programs at Finch marks a sharp shift in strategy. Back in August, Finch signaled its intent to expand a planned phase 1b in hepatitis B, doubling the number of cohorts to enhance its ability to detect a signal among key exploratory endpoints.

At that time, Finch planned to start the phase 1b trial, RECLAIM, early in 2022. The timeline would have put Finch on track to deliver an initial safety readout in the first half of 2022 and follow up with top-line results in multiple cohorts by the end of the year. Those targets are now delayed indefinitely. 

Finch still plans to advance its autism spectrum disorder prospect, FIN-211, but its progress into the clinic has hit a delay. One month ago, the FDA put Finch’s phase 3 trial of CP101 in recurrent C. difficile on hold as it sought more information about SARS-CoV-2 donor screening protocols for the microbiome therapy. 

The autism candidate is different, but, as it also uses donor-derived components, Finch has determined it will be affected by the FDA’s request. Finch needs to complete additional manufacturing activities for components of FIN-211 and expects at least a one-quarter delay to the start of the phase 1b trial. 

Enrollment in the phase 3 C. difficile trial remains paused, but Finch is working toward the resolution of the impasse. Since disclosing the clinical hold in early March, Finch has sent a complete response to the agency and received additional feedback. Again, Finch expects at least a one-quarter delay.

Each delay moves Finch closer to the end of its cash runway. Finch, which has seen its share price fall 50% to $5 this year, expects its cash reserves to last through to mid-2023. 

https://www.fiercebiotech.com/biotech/finch-clips-wings-hepatitis-b-program-hitting-pause-clinical-plan-focus-c-diff-and-autism