Pandemic IG blasts DOJ memo, urges Congress to clarify mandate

 A watchdog seeking to provide oversight of trillions of dollars in coronavirus spending and other relief has blasted a new Justice Department memo while calling on Congress to clarify his oversight mandate.

Brian Miller, the Treasury Department’s special inspector general for pandemic recovery (SIGPR), said Friday that a decision this week by the Justice Department’s Office of Legal Counsel (OLC) has “permanently reduced oversight” of specific relief programs implemented during the coronavirus pandemic.

Miller in his quarterly report to Congress warned that his efforts have been limited after the OLC held that his oversight jurisdiction applies only to Treasury’s direct loans and the Federal Reserve’s lending programs but not to the Coronavirus Relief Fund, Payroll Support Program and Paycheck Protection Program.

The three programs were established by various acts of Congress last year to provide support to airline employees, states, cities and small businesses impacted by lockdown orders and safety restrictions amid the COVID-19 outbreak. 

Miller in his Friday report said that his office had “been met with resistance” for several months from the Treasury Department and the Treasury inspector general over his oversight on the Coronavirus Relief Fund and the Payroll Support Program. 

Miller, who was appointed by former President Trump, said his office had been tracking fraud and “double-dipping” in relief programs but that starting in the final months of the Trump administration, a turf war among the various inspector generals has eroded his oversight.

The watchdog's update was first reported by The New York Times. The Hill has reached out to the White House and Justice Department for comment on Miller's report.

“All special inspectors general share concurrent jurisdiction with their counterparts and must partner with agency inspectors general to achieve their respective statutory oversight missions,” Miller wrote Friday. “There is nothing more frustrating to achieving these missions than turf battles.”

The pandemic recovery inspector general called on Congress to pass legislation to clarify his office’s “mandate to provide oversight of the Coronavirus Relief Fund, Payroll Support Program, and other pandemic-related programs managed by the Secretary of the Treasury.” 

Miller later in the report referenced his testimony during his confirmation hearing last year before the Senate, when he “promised to be thorough and truthful in alerting Congress ‘if we find out that things are not working well in a particular area.’”

“One year later, SIGPR’s jurisdiction has come to be viewed narrowly, not expansively, and my only conclusion is that ‘things are not working well,’” he wrote Friday.

The report also contained a letter dated Tuesday from Laurie Schaffer, the Treasury Department’s principal deputy general counsel, who argued that Miller had oversight of only Treasury’s direct loans and investments in Federal Reserve facilities, with the other relief funds being tracked by other oversight bodies. 

“Treasury is dedicated to the prevention of waste, fraud and abuse, and we are committed to being responsive and helpful to S.I.G.P.R.,” Schaffer wrote.

Daniel Koffsky, deputy assistant attorney general in the Justice Department's Office of Legal Counsel, wrote in the opinion dated Thursday that his office had concluded that language in the Cares Act passed last year limited the special inspector general's oversight jurisdiction.

A Treasury official told The Hill that the programs under the Cares Act are overseen by several bodies, including the Treasury's inspector general, the Government Accountability Office and the Congressional Oversight Commission. 

In a statement to The Hill, a Treasury spokesperson said that the agency "supports strong oversight, and we will continue to make sure all of our inspectors general, congressional committees of jurisdiction, and other oversight bodies have the information they need.”

The oversight dispute comes as President Biden hopes to pass trillions of dollars in additional relief proposals, including $4 trillion on jobs and infrastructure development programs. The administration is also charged with overseeing another $1.9 trillion in coronavirus relief funds approved in March.

https://thehill.com/homenews/administration/551296-pandemic-inspector-general-blasts-doj-memo-urges-congress-to-clarify

Nobody Wants to Be Narcan'd: Drug Users' Perspectives on Naloxone

Jeffrey T. Lai, MD; Charlotte E. Goldfine, MD; Brittany P. Chapman, BSc; Melissa M. Taylor, BA; Rochelle K. Rosen, PhD; Stephanie P. Carreiro, MD; Kavita M. Babu, MD

DISCLOSURES 

Western J Emerg Med. 2021;22(2):339-345.

 

Abstract and Introduction

Abstract

Introduction: Bystander naloxone distribution is an important component of public health initiatives to decrease opioid-related deaths. While there is evidence supporting naloxone distribution programs, the effects of increasing naloxone availability on the behavior of people who use drugs have not been adequately delineated. In this study we sought to 1) evaluate whether individuals' drug use patterns have changed due to naloxone availability; and 2) explore individuals' knowledge of, access to, experiences with, and perceptions of naloxone.

Methods: We conducted a pilot study of adults presenting to the emergency department whose medical history included non-medical opioid use. Semi-structured interviews were conducted with participants and thematic analysis was used to code and analyze interview transcripts.

Results: Ten participants completed the study. All were aware of naloxone by brand name (Narcan) and had been trained in its use, and all but one had either currently or previously possessed a kit. Barriers to naloxone administration included fear of legal repercussions, not having it available, and a desire to avoid interrupting another user's "high." Of the eight participants who reported being revived with naloxone at least once during their lifetime, all described experiencing a noxious physical response and expressed a desire to avoid receiving it again. Furthermore, participants did not report increasing their use of opioids when naloxone was available.

Conclusions: Participants were accepting of and knowledgeable about naloxone, and were willing to administer naloxone to save a life. Participants tended to use opioids more cautiously when naloxone was present due to fears of experiencing precipitated withdrawal. This study provides preliminary evidence countering the unsubstantiated narrative that increased naloxone availability begets more high-risk opioid use and further supports increasing naloxone access.

https://www.medscape.com/viewarticle/949003

DexCom Drops After Revenue Guidance Misses

 Shares of DexCom  (DXCM) - Get Report slipped Friday even though the diabetes-monitoring equipment maker reported first-quarter earnings and revenue that exceeded analysts' expectations. Full-year revenue guidance, however, missed analyst estimates.

Shares of the San Diego company dropped 6.27% to $395.25 at last check.

For the quarter ended March 31, DexCom posted GAAP earnings of $40.3 million, or 41 cents a share, compared to $19.9 million, or 21 cents a share in the year-ago period. Adjusted net income stood at $32.8 million, or 33 cents a share.

Revenue for the first quarter rose 25% to $505 million.

A survey of analysts by FactSet produced consensus estimates of GAAP earnings of 29 cents a share, or an adjusted 31 cents, on revenue of $486.6 million.

For the full fiscal year, DexCom expects revenue to grow 17% to 22% to between $2.26 billion and $2.36 billion, or a midpoint of $2.31 billion. That fell short of FactSet's consensus estimate for 2021 fiscal year revenue of $2.34 billion. 

“Dexcom is off to a great start in 2021, including several key advancements of our strategic priorities in the first quarter,” DexCom's Chairman, President and Chief Executive Kevin Sayer said in a statement. 

"Based on the strength of our first-quarter results and the significant market opportunity ahead of us, we are pleased to raise our 2021 revenue guidance," Sayer added.

DexCom stock has 18 buys, 2 holds and 2 sells according to Bloomberg data.

https://www.thestreet.com/investing/dexcom-drops-as-revenue-guidance-misses

Serum Institute plans to start vaccine production outside India

 

The Serum Institute of India, which manufactures the AstraZeneca COVID-19 vaccine, is planning to start vaccine production in other countries as it struggles to meet supply commitments, its chief executive officer told The Times.

"There's going to be an announcement in the next few days," Adar Poonawalla was quoted as saying by the newspaper in an interview published on Friday.

Poonawalla said last week that the Serum Institute would be able to raise its monthly output to 100 million doses by July, later than a previous timeline of end-May. Several states in India have run out of vaccines against COVID-19.

He hoped to increase the Serum Institute's production capacity from 2.5 billion to 3 billion doses a year within six months, the Times reported, adding that he flew to London before Britain banned travellers from India eight days ago.

Coronavirus cases and deaths have surged in India as the world's second-most populous country has reported more than 300,000 new infections daily for nine consecutive days, hitting another global record of 386,452 on Friday.

The surge has led to a public health crisis and forced the government to seek oxygen, medicines and other essentials from abroad.

The nation's coronavirus cases may peak between May 3-5, according to scientists advising the government.

Some health experts said India became complacent when new cases were running at about 10,000 a day and the novel coronavirus seemed to be under control. Authorities lifted restrictions, allowing the resumption of large festivals and political rallies.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-India-s-Serum-Institute-plans-to-start-vaccine-production-outside-India-The-Tim-33126519/

CDC’s reign of error has done incalculable harm

 For 14 months, the Centers for Disease Control and Prevention has recommended draconian restrictions on Americans’ daily lives to combat the spread of COVID-19. The CDC disregarded the psychological hardships and economic losses the restrictions inflicted. Now the evidence is emerging that the restrictions were based on flimsy science or sheer guesswork.      

Last week, MIT researchers showed that the CDC’s 6-foot social-distancing rule has no basis in science. If you’re indoors, your risk is the same, whether an infected person is 3 feet away from you, 6 feet away, or even 60 feet away.  

So much for carefully standing 6 feet apart in the grocery store line. It’s a joke. On you. 

In the Proceedings of the National Academy of Sciences, the MIT researchers explained that an infected person emits the virus in an aerosol that can waft across indoor space, traveling 60 feet or more. The 6-foot rule, which restaurants, churches, schools, gyms and retailers follow, offers no protection. The key factors are whether you’re wearing a mask and how much time you spend in the space.

On Sunday, White House health guru Anthony Fauci pulled the veil off another CDC guideline: wearing masks outdoors. He admitted the risk of contracting COVID outdoors is “really, really quite low.” Scientists have known that for months because outdoor air movement will disperse the aerosol. You’d have to be talking nose-to-nose with an infected person to catch COVID outdoors.  

On Tuesday, President Biden announced that the CDC’s guidance is eliminating most outdoor masking for people who are vaccinated. Truth is, outdoor masking is ridiculous in nearly all circumstances. It’s inconsistent with what scientists have learned about how the virus spreads.

When the pandemic hit, in February 2020, scientists suspected the virus was transmitted on surfaces and through droplets emitted when people sneeze or cough. With no knowledge about COVID-19, they applied what they knew about influenza. When a person with the flu coughs, droplets land on the floor or a surface within 6 feet. That was the origin of the 6-foot rule.

It was guesswork. As former Food and Drug Administration head Scott Gottlieb says, CDC bureaucrats should disclose when they’re uncertain about the science behind a recommendation so the public can decide “how seriously we want to take it.” 

By June, “super-spreader” events showed that COVID-19 differed from flu. Though COVID can be spread on surfaces and through droplets like flu, it more often floats across indoor spaces and is blown away outdoors. 

That’s when the CDC should have reconsidered the 6-foot rule and the outdoor-masking rule. Instead, Americans are struggling to comply.   

At the Doubletree in Syracuse, hundreds of banquet department jobs depend on hosting big weddings. That’s not possible because New York state is requiring that tables be 6 feet apart, in keeping with CDC guidance.

The same 6-foot rule has been “the biggest barrier to getting kids back in school,” notes Harvard infectious disease specialist Westyn Branch-Elliman. In March, the CDC revised guidelines, but only for elementary schools. This week, as New York students return to class, the 6-foot rule is still being applied in middle and high schools, needlessly limiting capacity. 

Johns Hopkins surgeon Marty Makary faults the CDC’s “counter-science track record of being late and wrong.” 

Even less scientific than the 6-foot rule is the agency’s guidance for the fully vaccinated. The agency tells them to “continue to wear masks, maintain physical distance and practice other prevention measures when visiting with unvaccinated people.”  

That guidance eliminates a major incentive for getting the shots in the first place and will slow America’s recovery. Infections among the vaccinated do occur, but very rarely, and serious illness is even rarer. The Pfizer and Moderna vaccines reduce the risk of developing COVID by 90 to 95 percent, compared with being unvaccinated. US data show the risk of getting infected after these vaccines is a minuscule 0.008 percent.

The science is clear: Get vaccinated and enjoy life again.

Betsy McCaughey is a former lieutenant governor of New York.

https://nypost.com/2021/04/27/the-cdcs-reign-of-error-has-done-incalculable-harm-to-america/

Carlyle Group puts $435M on controlling stake in vaccine, gene therapy services firm

 The Carlyle Group has put a target on life sciences in recent years, looking for opportunities to take controlling stakes in promising firms. After shelling out nearly half-a-billion dollars last year on a one-fifth stake in an Indian CDMO, the DC investors have their eyes set on a company specializing in vaccine and gene therapy services.

Carlyle shelled out $435 million to acquire more than 90% of Unchained Labs, a six-year-old California-based firm, from Danish asset manager Novo Holdings and VC firms TPG Biotech and Canaan Partners.

The company has 170 employees, and expects to generate $75 million in revenue this year, according to a release. In October, Unchained launched its gene therapy tool Stunner, a platform designed to give researchers a speedy readout on AAV capsid concentration and viability. In January, it launched a mRNA vaccine application on Stunner that measures the size distribution of lipid nanoparticles and the total amount of mRNA at the same time.

In a press release, CEO Tim Harkness said:

The Unchained team has solved a ton of problems for researchers over the past few years, but we are just beginning to scratch the surface of the biologics and gene therapy opportunity. I am thrilled to welcome Carlyle as our new partner! They have the team, the vision, the conviction, the experience, and the capital to help us accelerate organic and inorganic growth and realize our full potential. I have never been more optimistic about our future and I am truly excited about joining Carlyle for the next part of our journey.

The company has grown by more than 30% year over year, according to Carlyle managing director Robert Schmidt, and the investment was made out of the $18.5 billion Carlyle Partners VII fund.

At the start of April, Unchained announced another gene therapy and vaccine application dubbed Big Tuna, that focuses on the buffer exchange, concentration and clean-up of AAVs and lipid nanoparticles.

Carlyle bought 20% of CDMO Piramal back in the summer of 2020, in a deal that brought $490 million in cash, and acquired a majority stake in health research network TriNetX. The company is leaning on Unchained’s R&D and digitization, and hinted at expansion, as Schmidt said that they hope to accelerate the company’s “aggressive growth plans.”

https://endpts.com/the-carlyle-group-shells-out-435m-for-controlling-stake-in-vaccine-gene-therapy-services-company/

Pandemic can't hold down global drug spending: IQVIA

 Despite its long-reaching effects in global markets, the Covid-19 pandemic is not expected to broadly impact global sales on medicines in the near-term future, according to a new report from IQVIA.

Over the next five or so years, through 2025, global spending will grow at an estimated 3% to 6% rate annually and reach $1.6 trillion in sales. Notably, that figure does not include an additional $157 billion expected to be spent on Covid-19 vaccines, which will mostly come from now through the end of 2022.

Those growth rates are more or less in line with the previous five-year period, per report author Michael Kleinrock, who serves as lead research director at the IQVIA Institute for Human Data Science. Though sales were sharply affected at the beginning of the Covid-19 outbreak in early 2020, projections have essentially returned to their pre-pandemic levels.

“Without the vaccine spending, outside that, it’s only really moved [the compound annual growth rate] by about one-tenth,” Kleinrock told Endpoints News. “The reason was the shark bite taken out of early 2020, then the normal trend resumes fairly close to that.”

For the world’s largest market in the US, where medicines spending sat at 4.2% annual growth from 2016 to 2020, IQVIA is predicting a range of 2% to 5% for the next five years. Other developed nations will also see similarly flat growth rates, IQVIA predicts, with about 1.5% to 4.5% growth annually on average after clocking in at 3.8% in the previous five years.

It’s a bit of a different story for emerging pharma markets — or as IQVIA refers to them, “pharmerging” markets — where annual spending is expected to increase slightly. This group is largely headed by efforts in China, where estimated spending will increase by 4.5% to 7.5% each year, compared to 4.9% in the earlier period.

These figures, Kleinrock said, represent the invoice levels and don’t include the rebates and other discounts some countries might negotiate with pharma companies. Typically, drug spending makes up about 1% to 2% of any country’s GDP, he added.

Spending on the Covid-19 shots is notable, with Kleinrock saying the prices represent “tremendous value.” He compared the dollar figure to that of the wave of new hepatitis C drugs about seven years ago, noting that there was about $130 billion spent on a much smaller patient population.

Among the biggest growth areas IQVIA predicts are oncology and immunology which, despite biosimilar pressure, are continuing to see innovation in narrowing and more precise patient populations. There’s also a lot of excitement in neurology, though Kleinrock is more cautious here given the sheer amount of drug failures in the past 25 years.

Much of IQVIA’s estimates rely on a model of mass global vaccinations, where their best-case scenario sees the world reaching herd immunity by the end of 2022. That would involve inoculating 5.5 billion people, a tall task by any standard. But Kleinrock is optimistic that this total could be reached, or at the very least something close to it.

The “straight-line” projection, or the estimate if everything held at the same pace it currently does, for vaccinations, will see 2 billion people reaching immunity by the end of 2021. IQVIA’s base scenario projects the total to be about 500 million higher than that, particularly if the US vaccination campaign continues at its pace and then shares its excess supply with other countries.

There is potential for continued vaccine hesitancy and supply disruptions, which would prevent Covid-19 from morphing into something that can be kept in an endemic state, Kleinrock said. But on the whole, he feels confident in the IQVIA model, saying it’s “very likely” the base case scenario will be realized.

https://endpts.com/the-covid-19-pandemic-hasnt-slowed-down-global-drug-spending-iqvia-reports-with-cash-expected-to-keep-flowing/