A Talk With Francis Collins, MD -- Part 1

 Jeremy Faust, MD, editor-in-chief of MedPage Today, sits down with Francis Collins, MD, former director of the NIH and current science advisor to President Biden, to discuss the goals of the current administration, the future of the NIH, and the politics of science policy.

The following is a transcript of their conversation:

Faust: Hello, I'm Jeremy Faust, medical editor-in-chief of MedPage Today and author of the Inside Medicine newsletter on bulletin.com.

e are here in beautiful Aspen, Colorado, at Aspen Ideas Health, and I am joined today by Dr. Francis Collins. Dr. Collins was the leader of the NIH, the National Institutes of Health, under three presidents. Before that, he was the chief architect or conductor of the Human Genome Project. Now, he currently serves as a scientific advisor to President Biden.

So happy to have you with us, Dr. Collins.

Collins: Glad to be here in this beautiful space.

Faust: So, tell me, what's a day in the life of a scientific advisor to the President of the United States. What do you do?

Collins: There is no day that's like any other, that's for sure. It's been mind-expanding, because I thought I knew a fair amount about biomedical research, but the science advisor has to know about everything else too. So I need to know about fusion energy, and I need to know about wildfires and what we should be doing about them, and why we have a shortage of semiconductors and what could be done to solve that problem. All of that mixed in together with other things, like public health issues and many other issues that you just come across.

One of my jobs is serving as the co-chair of the President's Council of Advisors on Science and Technology, which is a group of 30 incredibly smart people who are used to being the smartest in the room. Yet now, they're all in the room together and it's amazing to see the kind of really intellectual intensity that comes out of that.

We have a lot of really important projects to work on, and we have a president who cares deeply about science and wants to talk about it all the time, much to the dismay of his staff. They know if there's a topic on his calendar to do with science, the rest of the day is not going to go well because he will want to spend more time on it than was originally allotted.

Faust: So, what was the last thing that the president asked you about and you came back with an answer? Just kind of give us a sense of your portfolio.

Collins: Well, he cares about cancer a lot, you know that. He was the main author of the original Cancer Moonshot in the Obama administration, having been so affected himself because of his son's brain tumor.

But now, as president, he wants to reinvigorate or re-initiate -- or whatever the right word is -- to get this to the next level. So, the Cancer Moonshot is, again, moving forward, and he wants me to help along with Danielle Carnival, who is his Moonshot person in the White House to make sure we are coming up with the most significant advances that are going to "end cancer as we know it," that is the phrase we're going with, which is to say, reduce the deaths from cancer by 50%.

Faust: When you get a question from the president, obviously you have a pretty broad portfolio yourself, but you have people who help you, a kind of a team, I would imagine. How does that work? You get asked something and then you assemble the troops and say, "Okay, this is the question of the day." How does it really work?

Collins: Well, there is the Office of Science and Technology Policy, OSTP, which is a brain trust for science and technology for the White House. That is an amazing group of dedicated people with expertise across the board. They don't report to me, they report to Alondra Nelson, but she and I work together extremely closely.

It is a little ironic, when I ran the NIH, I could say I had 40,000 staff; in the White House I could say I have two who actually report to me. But I have a lot of other people whose expertise I can tap into, and that works pretty well.

Faust: Speaking of being in the White House and at the center of everything, science and politics have always been sort of mixed together, and one of my readers asked me to ask you: how do you feel when elected members of government go after scientists, and we've seen this with Dr. Fauci. Have you experienced this? What do you think of all that?

Collins: I have. And I have to say I'm really troubled, Jeremy, about the direction that this seems to be going, just at a time where we need science evidence more than ever, certainly for COVID, but for other things as well -- the next pandemic, climate change. Yet, all the evidence is that trust in science seems to be slipping downward instead of moving upward.

And it's gotten all tangled up with politics in a terribly destructive way. Why your political party should be the main determinant of whether you trust scientific information, does that make any sense at all? Especially when it comes to something life-saving, like a vaccine. Yet here we are. We've somehow allowed the divisiveness in our country over almost everything to infect the way that people view science and whether they trust it.

Faust: I don't know you well, but my sense of you is that you're kind of an optimist. I don't know if that's due to your Shenandoah upbringing or something, but that sounds pessimistic. How do we come back from the edge of that?

Collins: Yeah, I am an optimist. I do believe we can come back from the edge. I'm sort of making the diagnosis now that we need to come back from it, that this is a dark moment for our country in terms of the way in which we are treating the value of truth and how we've figured out who we trust and who we don't trust.

I think that realization is becoming a bit more obvious to more and more people, as we see the consequences, for our democracy as well. But getting that turned around is going to require a realization by a lot of people who currently, I think, are fearful of what the consequences would be of going back to any other situation than where they are. We've kind of gone off to our separate corners, and we need to come out again and talk to each other.

I'm working with a group called Braver Angels that aims to try to address this by bringing people with a very different perspective, sometimes some of them pretty militant about it, and actually encouraging a conversation, and also encouraging people to say what you might be wrong about, as well as what you're sure you're right about.

I need to do that, too. We all do. You know, scientists, doctors, sometimes we come across as a little bit elitist or a little bit too sure of ourselves or a little bit unwilling to admit that we've made mistakes, and you know, we do make them.

Faust: I mean, look, I think you and I have been on different sides of issues during this pandemic, and I don't sense any problem here. I literally know that I'm here because Leana Wen likes the way we disagree, and so Leana said, "Oh, they should get Jeremy to come talk ... and we'll do a thing."

So I think there's hope, but I agree that it's a dark moment and I think it takes thick skin to do what you do.

Collins: You would not be a happy person if you took every negative comment as something that's going to ruin your day. Because there's too many of them.

Faust: Yeah. Let's talk about your time at the NIH. Again, you served under three administrations, a long tenure, with 40,000 employees, a very high-profile job, and a lot happened during that time. What's the best thing that you can think of that happened while you were leading the NIH?

Collins: It's hard to pick a thing. One of the things I got to do though, as NIH director, is to survey the entire landscape of medical research and look for opportunities that were ripe. They were ready for a big push that would require bringing people together who maybe hadn't planned to be part of a team, but they could get that vision and get excited about it. We did that for the Genome Project back in the 1990s. Why not for other things?

As NIH director, the Brain Initiative fit right into that. We're now 7 years into an amazing project teaching us about what's going on between our ears. The All of Us Project, precision medicine and precision health to really drill down into how we're all different, and one-size-fits-all is not the best answer to medicine. That came together. And other things like Cancer Moonshot. I'm pretty excited about where we are with cancer immunotherapy because of the big push that's possible to do there.

And right at the moment, seeing the benefits of gene therapy, the advent of gene editing, bringing those things together to cure diseases like sickle cell. Wow. That's hard not to look at and feel really good about.

Faust: Do you think that the funding infrastructure or architecture is set up to reward incremental change, and that people who try something big and fail don't get to come back for more? Is that a problem that you sensed when you were there?

Collins: It's a bit of a problem. We've been trying our best to fight against that. And it's interesting because the scientific community agrees that that could be a problem, but when they sit on study sections and do reviews, sometimes they end up being very conservative about taking risks on things that might fail.

I think we should do even more of that. We've developed a number of programs in the course of the last 10 years that have encouraged high-risk, high-reward research to come forward and not get dinged if it didn't have any preliminary data, things like the Pioneer Awards. And now with ARPA-H, which we should talk about because it has the very explicit goal of identifying things that are going to be high risk, we expect probably half of them to fail, and that's not a bad thing. That says you really took the risk. That's emerging right now. We hope to have a new director, an inaugural director, announced in the fairly near future, and away we go.

Faust: So tell us about ARPA-H. This is the Advanced Research Projects Agency for Health, which is now, if I'm correct, housed at the NIH. Actually one question is, is that the right place for it? How are they going to find a leader for that?

Collins: So in terms of the right place, I think it needed infrastructure to get started. You can't have an organization of this sort without IT support and contracting agents. All that NIH is providing is that kind of infrastructure.

ARPA-H needs to be very independent, be very much a different culture, and bring in people who, for the most part, have not been at NIH. Certainly, the director should be somebody who has credentials from having worked in DARPA or one of the other ARPAs, but is not a standard NIH investigator by any means. I think we're pretty close to having that kind of a person announced.

Then that director will hire program managers, also most of them with DARPA experience, to bring that whole attitude where they say, "Okay, let's find something that seems almost impossible and let's figure out how to do it by bringing together partners." Some of them will be businesses that would never write a grant to NIH, but if they got engaged in a project like this with sufficient funds, they'd say, "Sure, we'll play."

Then the program managers really become managers, and this is more like a venture capital kind of initiative approach, but it's very much the model that DARPA has been utilizing for decades and which has turned out pretty well. Except DARPA had one customer, the Department of Defense. ARPA-H has all of us as customers trying to develop these translational breakthroughs that we all want to see happen.

Faust: I think it's a huge project and it's an important project, and I love that failure is built into it. Because, I mean, knowing your work, you've had a lot of successes, but we skip past the parts where it's hard. And I think that the model that builds in failure and that builds in aggressive ideas that have dead ends, I think that's how we find things.

Of course, things that are developed in one area don't always have the degree of applicability that we thought. No one really thought that GPS would come out or the internet would come from where it came from, but we have these great things. And I think that it's investing in the multiverse that is the ingenuity that we have.

Collins: Well said. And it certainly also reminds us that if we try to be too targeted in our research -- if we're going to put all the money on Alzheimer's disease -- we might miss the big breakthrough, which came from completely somewhere else that needs to be supported too. That's the argument for basic science, of course, and NIH is still the largest supporter of basic science. And, well, they should continue to be.

https://www.medpagetoday.com/special-reports/exclusives/99523

Facebook is bombarding cancer patients with ads for unproven treatments

 The ad reads like an offer of salvation: Cancer kills many people. But there is hope in Apatone, a proprietary vitamin C–based mixture, that is “KILLING cancer.” The substance, an unproven treatment that is not approved by the FDA, is not available in the United States. If you want Apatone, the ad suggests, you need to travel to a clinic in Mexico.

If you’re on Facebook or Instagram and Meta has determined you may be interested in cancer treatments, it’s possible you’ve seen this ad, or one of the 20 or so others recently running from the CHIPSA hospital in Mexico near the US border, all of which are publicly listed in Meta’s Ad Library. They are part of a pattern on Facebook of ads that make misleading or false health claims, targeted at cancer patients.

Evidence from Facebook and Instagram users, medical researchers, and its own Ad Library suggests that Meta is rife with ads containing sensational health claims, which the company directly profits from. The misleading ads may remain unchallenged for months and even years. Some of the ads reviewed by MIT Technology Review promoted treatments that have been proved to cause acute physical harm in some cases. Other ads pointed users toward highly expensive treatments with dubious outcomes. 

CHIPSA, which stands for Centro Hospitalario Internacional del Pacifico, S.A, was founded in 1979 and refers to itself as a community hospital offering integrative treatments for cancer. On Facebook, the facility describes itself as being at the “cutting edge” of cancer research. But the hospital’s foundational diet-based therapy, called the Gerson Protocol, is “all nonsense,” says David Gorski, a surgical oncologist at Wayne State University in Michigan and the managing editor of the website Science-Based Medicine. Developed by a German doctor in the 1920s to treat migraines, the regimen consists of a special diet and frequent “detox” procedures. It has been discredited for decades in the medical community

CHIPSA did not respond to repeated requests via phone and email for comment.

MIT Technology Review alerted Meta to five CHIPSA ads, along with three ads from another international clinic called Verita Life. In response, Meta spokesperson Mark Ranneberger said that it had removed “several of the ads for violating our misleading claims policy, which prohibits claims of cures for incurable diseases.”  

When asked for the specifics of the ads removed, Ranneberger said that two were rejected: the one claiming that Apatone was “killing” cancer and another that mentioned “growing distrust” of the US health-care system while advertising exclusive cancer treatments. Another ad using identical text to that second one but a different image remains active. On Monday, after the publication of this article, Meta noted that it had removed three additional ads using the same language.

“Us cancer patients and survivors, we are just bombarded with all these kinds of alternative things all the time,” says Nikhil Autar, a medical student in Australia who has acute myeloid leukemia. Autar started seeing ads for cancer treatment centers on Facebook in 2019—just as Facebook and other platforms began rolling out new policies designed to limit the reach of health misinformation.

Facebook has drastically stepped up its efforts to stop the spread of sensational and false health claims over the past few years. After a series of local measles outbreaks in the US in 2019, it announced it would start treating misleading health claims like spam, reducing their reach on news feeds and limiting the visibility of private Facebook groups promoting dubious treatments. When the covid-19 pandemic began, the company rolled out more comprehensive efforts to remove or limit such claims as conspiracies about the virus, masks, and vaccines spread on its platform. 

These attempts to combat pitches for miracle cures and dubious medical advice have been a step in the right direction, says Rachel Moran, a postdoctoral fellow at the Center for an Informed Public at the University of Washington. However, many such ads continue to slip through. 

One from Verita Life, in Bangkok, Thailand, targeted Australians like Autar, falsely claiming that a hypothermia treatment offered there would “destroy cancer cells.” When Autar took a screenshot of the ad in his news feed in August of 2020, it had more than a thousand likes and 600 shares. 

Autar reported the ads he saw to Facebook using its in-platform systems, but they remained up. At one point, he says, he used a Silicon Valley connection to try to flag the ads directly to Facebook management. He stopped seeing the clinic’s ads in the Ad Library and on his own feed after that, but they returned a few months later. 

Both CHIPSA and Verita Life had several ads running on Facebook and Instagram before MIT Technology Review inquired about them, according to the Ad Library. Verita Life was able to place an ad as recently as June 18, 2022, promoting the testimonial of a patient with prostate cancer. MIT Technology Review flagged that ad, along with two others promoting the same testimonial. All three remain active.

Meta reviews new ads through a largely automated process before they go live. The company noted that ads and posts from CHIPSA’s Facebook page and Instagram account are eligible to be flagged and fact-checked by third-party fact checkers. If a company repeatedly violates its policies, Meta says, it will temporarily suspend the company’s ability to place ads. 

While Meta has rules pertaining to, for instance, misleading claims in ads, all Facebook and Instagram ads must also follow Meta’s community guidelines. The guidelines ban content “promoting or advocating for harmful miracle cures for health issues” when those claims both contribute to serious injury or death and have no legitimate health use. 

Those rules, even when swiftly enforced, can leave a lot of gray area for sensational claims, Gorski says, because “a lot of quackery could have a legitimate health use.” For instance, he says, “vitamin C obviously has legitimate health uses; it just doesn’t cure cancer.” 

So what about Apatone, the treatment advertised by CHIPSA? Pre-clinical research indicates some anti-cancer effect, but it “has not been demonstrated to be more beneficial than standard treatments we are using currently in humans,” says Skyler Johnson, a cancer researcher who studies misinformation at the University of Utah.

The danger is not simply that the treatments are unproven or ineffective. Some alternative cancer treatments advertised on the platform can cause physical harm. Coley’s toxins, a treatment developed in the late 19th century and offered at CHIPSA, comes with risks including infection, site reactions, anaphylaxis, and in severe cases shock, says Johnson. 

Unproven treatments can also interact poorly with conventional treatments like chemotherapy should a patient decide to pursue alternative care on their own. Moreover, simply delaying the start of proven therapies by detouring into unproven ones can allow the cancer to advance, complicating and diminishing the effectiveness of further treatment. 

Johnson’s research has demonstrated worse survival rates for patients who seek unproven cancer treatments at first. In a 2017 study, he found that after about five years, patients with breast cancer who delayed conventional treatment in favor of alternative medicine were more than five times more likely to die. 

There’s the financial burden, too—because clinics like CHIPSA aren’t generally covered by insurance, patients often have to raise money to afford their treatments. One recent GoFundMe campaign for a cancer patient seeking treatment at CHIPSA included a screenshot of a bill for the “base amount” he’d have to pay. It was $36,500 for three weeks of inpatient care in Mexico. That cost would increase once the facility decided on a treatment plan.   

CHIPSA has spent about $5,000 since mid-2018 advertising on Meta about social issues, politics, or elections, according to information available in the Ad Library before Meta removed two of its ads. CHIPSA did not respond to requests for details on its ad spending or the cost of the treatments it offers.

Gorski is blunt about his view on whether Facebook will effectively address cancer misinformation: “The only real way to combat such misinformation on Facebook would require an army of fact checkers that Facebook is never going to pay for, given its past record even on covid-19 misinformation and dangerous political conspiracy theories.” 

And as the University of Washington’s Moran points out, misinformation like this rarely stays confined to the platform where it’s originally posted. While Facebook plays a key role in getting sensational claims about dubious cancer treatments in front of desperate patients, the groups and ads carrying those claims often link to other sites and networks that reinforce them.

Johnson, using data from 2017 to 2019, has observed that articles and videos containing myths about cancer treatment often receive more social media engagement than those from “safe” sources. And although it’s tricky to say for sure, his and other research in this area suggests that as many as one in three online articles or videos posted online about cancer may contain harmful misinformation. 

“Especially when you are experiencing a medical crisis, you are looking at an incredible amount of information,” Moran says. “It seems good to you that you are doing your research, you're going from one site to the next. But they all belong to the same ecosystem.” 

This post has been updated with additional information from Meta

If you or a loved one has been treated for cancer, we'd like to talk to you for future stories about sensational health claims on social media. If you are a member of support groups for cancer patients or their loved ones, or have experience with clinics like the ones mentioned in this story, please be in touch: abby.ohlheiser@technologyreview.com

https://www.technologyreview.com/2022/06/27/1054784/facebook-meta-cancer-treatment-ads-misinformation/

Fatal Flaw in Hospital Price Transparency Rules

 The Hospital Price Transparency rule celebrated its first birthday in January, and as of July 1, the enforcement of a similar requirement for payers and health plans began through the Transparency in Coverage rules. Regrettably, the U.S. is still far from achieving price transparency's intended outcomes (more shoppable healthcare), or perhaps even understanding what the outcomes are supposed to be. Key compliance metrics vary, and indeed there is also variance in the very definition of "compliance," which has resulted in estimates ranging from as low as 6% to more than 50%, depending on how you slice the data.

True "compliance" means that a hospital has published price data that is both user-friendly and located prominently on their website (and yes, this includes making the information easily retrievable via search engines). By this definition, compliance is undoubtedly low since many hospitals have not created accessible resources to locate and understand their pricing. This is perhaps unsurprising as hospitals balance myriad challenges like staffing crises, COVID-19 surges, and struggles in revenue recuperation.

Given these hurdles, hospitals that have yet to comply will not feel pressure to make changes unless additional incentives, either positive or negative, come into play. Vague requirements and a lack of repercussions have not created the sense of urgency that regulators hoped for. So where do we go from here?

While price transparency rules are well-intentioned, they suffer from a fatal flaw: too much room for interpretation in the definition of compliance. Healthcare stakeholders need to ask themselves what compliance actually entails. Are hospitals required to publish prices in well-labeled, easy-to-locate areas on their website, or can they get by in placing these numbers on a hidden page? If the industry hopes to improve compliance, then the Centers for Medicare & Medicaid Services (CMS) must lay out clear rules, including what is expected and what is forbidden, and ensure they have closed any potential loopholes in the process.

Many providers view this rule as more of a regulatory compliance burden than a potential opportunity to distinguish themselves from their competitors and increase market share, so they see little incentive to comply. Remember that hospitals tried and failed to block these transparency requirements in the courts. Additionally, the initial civil money penalties associated with noncompliance were laughably low if intended as deterrents. CMS did recently issue their first ever fines for noncompliance, which total over $1 million, so there is hope for an uptick in compliance efforts. On the contrary, only two hospitals were fined, despite CMS sending written warnings of noncompliance to hundreds of hospitals in recent months. While these fines may get the attention of a hospital chief financial officer, we still don't know if they will view these fines as merely a "cost of doing business" -- even a million dollar fine can be a rounding error on a hospital bottom line. CMS can significantly ramp up pressure on hospitals to comply if it so chooses, either by increasing civil monetary penalties, or by linking compliance with the transparency rules to the conditions of participation in the Medicare program, much like they did with their requirement that nursing home employees be vaccinated. However, it is not entirely clear if the statute covering conditions of participation would permit CMS to take this type of action.

Further, there are additional external factors that can impact the shift to greater price transparency, including the fact that the hospital rule does not exist in isolation. While it is difficult to predict the impact of the hospital price transparency rollout on the forthcoming payer transparency rule, one can only hope that payers have been paying attention to the struggles of their counterparts. There may be some confusion at first where payers learn of varying negotiated rates with the same provider organizations. However, these rules in conjunction may deliver an opportunity for greater synergy between payers and providers. I remain hopeful that this rollout can improve on the shortcomings of its predecessor and ultimately help us achieve our true end goal: empowering consumers with the best information to guide their care decisions.

It is important for me to end on an optimistic note. While we have endured clear setbacks on the road to greater transparency, that we remain on the road represents incredible progress in less than a decade. Until 2013, information on provider pricing was almost impossible to obtain, and in fact, CMS was legally prohibited from releasing information that could identify physician reimbursements. The release by CMS of physician-level reimbursement information was considered groundbreaking at the time, but information on prices for people with private sector health insurance remained hidden until recently. We have made unambiguous progress, and although the road is bumpy, our healthcare leaders owe it to patients to continue pushing ahead.

Niall Brennan, MPP, is chief analytics and privacy officer at Clarify Health. He previously served as the chief data officer at CMS, where he led the Obama administration's healthcare transparency efforts.

https://www.medpagetoday.com/opinion/second-opinions/99542

DOJ Says J&J Talc Bankruptcy 'Violates Congressional Mass Tort Rules'

 The U.S. Justice Department told a federal appeals court that Johnson & Johnson's strategy for moving talc injury litigation to chapter 11 violates the regime Congress has authorized for litigating mass torts.

The U.S. Trustee Program, a Justice Department unit monitoring bankruptcy courts, said in a Thursday filing with the Third U.S. Circuit Court of Appeals that Johnson & Johnson's decision to put a newly formed subsidiary into chapter 11 to drive settlements of talc litigation circumvented federal multidistrict litigation procedures which have been prescribed by Congress as the way to deal with mass torts. Johnson & Johnson used an emerging restructuring transaction called a Texas divisive merger to send the talc liability to the subsidiary before it filed bankruptcy, a strategy that will be scrutinized by the appeals court.

The U.S. Trustee and talc injury claimants want the Third Circuit to reverse a bankruptcy judge who authorized the Johnson & Johnson talc subsidiary to stay in chapter 11.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/DOJ-Says-J-J-Talc-Bankruptcy-Violates-Congressional-Mass-Tort-Rules-40879600/

After Layoffs, Big Life Sci Companies Advance and Small Firms Retrench

 After the spring reductions in the workforce that left thousands of biotech employees searching for jobs, larger companies are, for the most part, moving forward, while some of the smaller ones are struggling to optimize operations and cut costs.

Further reductions in the workforce can be expected, along with more mergers and acquisitions as some financial analysts say the U.S. is in – or will soon be in – a recession (defined as two consecutive quarters of declining economic growth), as the Federal Reserve Board increased the primary credit interest rate 1.75% – a 0.75 percentage point increase -  effective June 16. In contrast, NASDAQ, citing consumer spending, predicts a recession “probably won’t occur for at least the next year.”

Here’s a look at what some of the biotech companies are doing now, after their layoffs and what prompted their employee furloughs.

Athersys Considering Options Following Phase III Failure 

Athersys laid off 70% of its staff in June – including its COO, CSO and CFO – after its stroke therapy failed in Phase II/III trials. The company's stock closed at $0.27 on June 17, down from its 52-week high of $1.81. The company postponed its annual shareholder’s meeting from June 15 to July 28 to allow time for a proposal authorizing the board of directors to amend the company’s certificate of incorporation to create a reverse stock split in an attempt to return share prices to the $1 minimum required for NASDAQ listing.

After Aduhelm, Biogen Prioritizes Biosimilars, Emerging Markets

In March, Biogen began laying off employees after lower-than-anticipated sales of its Alzheimer's drug, Aduhelm. It also backed out of its agreement to purchase Karyopharm Therapeutics and its amyotrophic lateral sclerosis (ALS) asset. Biogen's stock opened at $192.11 per share on June 17, down from a 52-week high of $391. The company has stated plans “to continue to return cash to shareholders through share repurchases.”

In June the company announced positive Phase III data for its biosimilar version of tocilizumab for rheumatoid arthritis, a license and collaboration agreement for a GBA2 inhibitor to treat Parkinson’s disease and launched the biosimilar Byooviz (ranibizumab-nuna) in the U.S. for three ophthalmology indications.

Biogen expects two more regulatory filings this year and plans call for expanding its biosimilars business, as well as increasing its focus on R&D, reducing costs and enhancing productivity. The company said it will be focusing on “key emerging markets, such as China and certain markets in both Latin America and the Middle East.” It is also providing support for humanitarian efforts in Ukraine.

bluebird bio Bounces on Positive Gene Therapy Recommendation 

In April, bluebird bio announced a comprehensive restructuring that has resulted in a 30% reduction in the workforce as part of its effort to save approximately $160 million over the next two years. The company is transitioning to new headquarters in an effort to save $120 million over the next six years.

An FDA Advisory Committee unanimously recommended that the FDA approve betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel) recently. Beti-cel is scheduled to come before the U.S. Food and Drug Administration on August 19, while eli-cel is scheduled for review on September 16. After falling from a 52-week high of $21.74, bluebird bio’s stock rallied on positive news, jumping more than 34% to $3.84 in midday trading on June 1 before closing at $3.56. The surge was attributed to a positive message from CEO Andrew Obenshain at the European Hematology Association Hybrid 2022 Congress regarding its cell therapies for sickle cell disease and beta thalassemia.

Gilead Realigns Following Immunomedics Acquisition 

Gilead laid off 114 employees in March after acquiring Immunomedics in 2020. First-quarter revenue this year was up 3% in year-over-year earnings. It made a $725 million collaboration opt-in payment to Arcus Biosciences, repaid $500 million in debt, paid $945 million in dividends and repurchased $352 million of common stock. Its stocks opened at $57.37 on June 19, down from a 52-week high of $74.12. The Q1 report said the company's effective tax rate for the quarter was 107.9%, compared to 23.9% for Q1 2021 because of a $2.7 billion in process research and development (IPR&D) impairment related to the Immunomedics deal in 2020.

Merck Invests in U.S. and Global R&D Infrastructure

After acquiring Acceleron in 2021, Merck laid off 143 employees in March. That doesn’t make a dent in its 71,000-employee headcount but is part of the larger biotech trend this spring as companies realign their workforces. Going forward, Merck says it is “making significant investments in [its] research and discovery facilities and infrastructure in the U.S. and around the world.” That includes the recent expansions of the Exploratory Science Center in Cambridge, MA and its West Point, PA site, as well as the development of the 220,000-square-foot London Discovery Center. Merck’s website lists hundreds of job openings throughout the company. 

Novartis Axes 8,000 Jobs in Accelerated Restructuring 

Novartis accelerated its restructuring in April to accelerate its overall growth and strengthen its pipeline. On Tuesday, the company revealed it would be cutting 8,000 jobs in hopes of saving at least $1 billion by 2024. 

Sales, operating income, net income and earnings per share all increased in Q1, although free cash flow, core net income and core earnings per share each decreased. Q2 results are not yet available. A Strategy and Growth function is being created, along with a new operations unit to generate economies of scale and enhance productivity.

Since its Q1 report was issued, Novartis has resumed its business in Ukraine and is supplying medical and humanitarian aid. It has signed a manufacturing deal with Samsung Biologics while Greece has filed a bribery lawsuit for €214 million, alleging a payout to doctors.

Overall

Layoffs didn’t cease with the March culling and may continue as the economy slows. For example, in June, Genocea ceased operations, Atreca announced layoffs are part of corporate restructuring and Praxis reduced its workforce after the failure of a Phase II/III clinical trial. Amarin and Vincerx Pharma also announced layoffs. Biotech employees, therefore, should prepare for tumultuous times ahead.

https://www.biospace.com/article/after-the-layoffs-big-companies-advance-and-small-firms-retrench/