ReportWire

Tag: Merck &

  • Merck to end HPV vaccine production in Durham, laying off 154 workers

    [ad_1]

    Merck’s Maurice R. Hilleman Center for Vaccine Manufacturing photographed on Apr. 2, 2021, in Durham, N.C.

    Merck’s Maurice R. Hilleman Center for Vaccine Manufacturing photographed on Apr. 2, 2021, in Durham, N.C.

    ctoth@newsobserver.com

    The pharmaceutical giant Merck will stop producing the HPV, or human papillomavirus, vaccine Gardasil at its north Durham facility, a decision it attributes to lower global demand for its second-best selling drug.

    In a Feb. 24 WARN letter to the North Carolina Department of Commerce and Durham County, Merck said this move will result in 154 layoffs. Separations are expected to begin May 1.

    Merck’s decision comes one year after the New Jersey company unveiled a new $1 billion manufacturing plant on Durham’s Old Oxford Road to make Gardasil and Gardasil 9. This facility added 225,000 square feet of production space to a campus that already produced vaccines against measles, rubella, mumps and chickenpox, among other illnesses.

    In her WARN letter this week, plant manager Amanda Taylor wrote Gardasil production would cease at this site due to “the recent worldwide reduction in demand for this product.” Businesses must file WARN notices to North Carolina officials at least 60 days before conducting certain mass layoffs, including the closing of a site “that affects at least 50 employees during any 30-day period.”

    In its latest annual report, released Tuesday, Merck recorded a significant drop in what remains its No. 2 product: Gardasil. The company sold about 40% less last year compared to 2024, dropping from $8.6 billion in Gardasil revenue to $5.2 billion.

    Merck attributed this decrease to suppressed demand in China and Japan, during an investors call in early February. Its executives noted U.S. sales were up, though “largely due to price.”

    Merck’s long history in Durham

    Merck has been in north Durham since 2004. Last year, the company told The News & Observer it had roughly 1,000 employees in the city. The company has told The N&O its layoffs will only impact HPV vaccine manufacturing operations at the site.

    “We continuously assess our operations and evolving business needs,” Merck’s media relations team wrote in an email.

    Seven years ago, Merck signed incentive deals with North Carolina and local governments to expand its operations in Durham and Wilson County. As of 2022, the company had met or surpassed its incentive requirements by creating 353 jobs and retaining 1,247 positions between these two campuses, state records provided to The N&O show. In 2024, the company estimated its Bull City campus produced 70.7 million doses.

    Merck is the world’s 48th-largest public company, by market capitalization, behind fellow drugmakers Eli Lilly and Roche but ahead of than Amgen and Novo Nordisk. Its top-selling product, by a wide margin, is the cancer treatment Keytruda.

    In July, Merck made one of the last year’s largest health care acquisitions when it spent around $10 billion to buy the British drugmaker Verona Pharma, which has its U.S. headquarters in Raleigh. Verona makes a treatment for chronic obstructive pulmonary disease, or COPD, that the Food and Drug Administration approved in June 2024.

    Related Stories from Raleigh News & Observer

    Brian Gordon

    The News & Observer

    Brian Gordon is the Business & Technology reporter for The News & Observer and The Herald-Sun. He writes about jobs, startups and big tech developments unique to the North Carolina Triangle. Brian previously worked as a senior statewide reporter for the USA Today Network. Please contact him via email, phone, or Signal at 919-861-1238.

    [ad_2]

    Brian Gordon

    Source link

  • Merck’s Dr. Adrelia Allen emphasizes need for clinical trial diversity, especially for African Americans

    Merck’s Dr. Adrelia Allen emphasizes need for clinical trial diversity, especially for African Americans

    [ad_1]

    NEW ORLEANS – While the ESSENCE Festival of Culture is known for fun times, great food, and link-ups with friends. However, it is a time for poignant conversation. Dr. Adrelia Allen is the Executive Director of Clinical Trial Patient Diversity at Merck, Inc. Merck is a global biopharmaceutical company. Before she spoke at the Global Black Economic Forum, Allen discussed how the lack of representation in the research of new treatments can impact our lives.

    First and foremost, clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people.

    “We know that there are differences in how drugs work in different races,” Allen explained. “And for African Americans, knowing that we have the highest mortality of many diseases and cancers, we cannot wait. So it was definitely imperative for Merck to be here. And when we think about who’s attending ESSENCE, and knowing that [the audience is largely] Black women. When you educate a man, you educate an individual. But when you educate a woman, you educate the entire community.”

    How does historical traumas affect participation in clinical trials?

    According to a 2021 study by Johns Hopkins Medicine,  75% of research participants are White. Even though White Americans make up 60% of the United States population. By comparison, 8% of research participants are African-American/Black. Currently,  African-American/Black people are 13% of people in the U.S. There are a lot of historical prejudices, and those traumas do get passed down. Reports and those stories were amplified during the COVID-19 era, when people would bring up the Tuskegee experiment relative to the vaccine. 

    Allen acknowledged the existence of those traumas. However, there is no solution that directly fits all experiences and conditions.  Most Americans are distrustful of medicine. This is not a Black problem. COVID-19 and the anti-vax sentiment that we all ran up against to tell us enough that it’s not about the skin we’re in. it’s about the conditions, the systems, and the processes of care that failed to speak to the wounds.

    Dr. Adrelia Allen, the Executive Director of Clinical Trial Patient Diversity at Merck, Inc., poses for photographs outside the Ernest N. Morial Convention Center during the 2024 ESSENCE Festival of Culture on Saturday, July 6, 2024 in New Orleans, Louisiana. (Photo: Itoro N. Umontuen/The Atlanta Voice)

    She described a moment in which her father, while being diagnosed with prostate cancer, refused to take an MRI. Why? Because it was a trigger for him because of the Tuskegee experiment. He believed that he would be treated as a guinea pig. But, Allen says, the key is building trust.

    “Educating and making sure that we’re talking in communities working with trusted voices, because we can’t go in and simply start talking,” Allen explains. “Helping them understand so that they can be the relay for their communities and talking about clinical trials and in that means we are, keeping patients at the center of what we’re doing. And, we make sure we have community advisory boards that we bring and share recruitment materials, protocols, even procedures that are involved with the clinical trial.” 

    Other Barriers to Entry

    Trust is also the vehicle that allows for the doctor-patient relationship to flourish. The doctors will know what trials will be relevant as long as the patient is willing to disclose family histories and so on.

    In addition to race, disability and socioeconomic status are factors that play a role in lack of participation. To that end, Congress has passed the Diverse and Equitable Participation in Clinical Trials Act (also known as the DEPICT ACT) in 2022. Allen says the Federal Drug Administration’s guidance is pending. However, she’s looking forward to building Merck’s action plans. 

    Allen says Merck is working to operate clinical trials at the four historically Black medical schools. Included is Morehouse School of Medicine in Atlanta. These trials will be conducted by investigators and managers of color with participants from underrepresented populations. Additionally, Allen says Merck is also removing financial barriers to reimburse out-of-pocket travel costs for trial participants and providing a solution to ease transportation barriers.

    “Although the finalization of the FDA Diversity Action Plan guidance is pending, we are working across our clinical trial sites to implement mandatory, multi-pronged diversity action plans for all late-stage clinical trials,” Allen said. “We are taking concrete steps to help historically underrepresented communities access our clinical trials.”

    What’s Next

    In the end, every medicine that resides in the medicine cabinet, there must be more African-Americans to ensure that drug is going to be safe for us. 

    “We want to be a part of that,” Allen said while describing the clinical trial process. “The scientific medical innovations that are occurring today are the differences between life and death. Having access to that information is powerful, and we want to have that information before having to make the critical decision.”

    [ad_2]

    Itoro N. Umontuen

    Source link

  • Former Merck CEO Ken Frazier on the responsibility of CEOs to uphold principles despite politics

    Former Merck CEO Ken Frazier on the responsibility of CEOs to uphold principles despite politics

    [ad_1]

    On this week’s episode of Fortune‘s Leadership Next podcast, co-host Alan Murray talks with former Merck CEO Ken Frazier. In a conversation recorded live at a Deloitte Next Generation CEO event in Washington, D.C., Frazier tells Murray why the decisions he made to leave former U.S. President Donald Trump’s presidential advisory council, and to vocally support voting rights, were a matter of principle, not politics.

    Frazier also discusses the challenges he faced in his first few years as CEO of Merck—and the shareholders who trusted his vision enough to support him. Finally, Frazier, who is also the cofounder and former CEO of the the OneTen Coalition and current chairman of health assurance initiatives at General Catalyst, talks about starting the OneTen Coalition after the murder of George Floyd, and because he identified a need to find a common language to talk about ESG and DEI.

    Co-host Michal Lev-Ram joins for the pre-interview chat. Listen to the episode or read the full transcript below.


    Transcript:

    [music starts]

    Alan Murray: Leadership Next is powered by the folks at Deloitte, who, like me, are exploring the changing rules of business leadership and how CEOs are navigating this change.

    Welcome to Leadership Next, the podcast about the changing rules of business leadership. I’m Alan Murray.

    [music ends]

    Michal Lev-Ram: And I’m Michal Lev-Ram. Alan, the next two episodes of Leadership Next are a little bit different and a little bit special, although our episodes are always special. That’s because each of these episodes features an interview that you recorded live earlier in October in D.C., where Deloitte, our podcast partner, hosted a Next Generation CEO event. So to start, can you give us a little bit of context? What is the next generation initiative? And what made it the right crowd for a live Leadership Next recording? 

    Murray: Well, first of all, I wish you had been there, it was really kind of magic. Yeah, this is a program that Deloitte runs for people who’ve been identified by their companies as having a shot at the top job. And it’s really designed to give them a look at what it’s like to be a CEO of one of these large companies. So you’re dealing with about 20 people who are really tuned in to what they’re hearing from the CEOs. And first up was Ken Frazier, who is the former CEO of Merck, the pharmaceutical giant. He’s currently at General Catalyst. And as you remember, Michal, Ken Frazier played a critical role in the history of the stakeholder capitalism movement. He was the one, in 2017, when the Unite the Right rally happened in Charlottesville, and the president made some ambivalent comments about who was responsible and good people on both sides. He was the one who, at that moment, made the decision to resign from the president’s Advisory Council, and really, his resignation prompted a whole bunch of other CEOs to resign as well. And within a couple of days, the whole thing had shut down. So, he is a person of strong opinions. And he really was kind of energized by the Next Generation CEOs who were in the room. So it’s really a fascinating conversation. 

    Lev-Ram: Yeah, talk about leadership. Ken is just a super fascinating person with a really interesting professional and background story. So after graduating from Harvard Law, he started his career as a lawyer for a big Philadelphia law firm. And there he made a name for himself representing a wrongfully convicted death row inmate in Alabama, named Bo Cochran. After 19 years on death row, Frazier and his team worked to get Cochran’s conviction overturned, and it’s just a really amazing story all around. While still at the Philly firm, his future employer, Merck, became one of his clients. And Merck took him on as general counsel in 1992. And he’s been there in different capacities ever since. 

    Murray: He told a fascinating story about the early days when there was an activist investor in his stock trying to push him to cut his research budget so they could make greater profits in the short term. And he stood up and said, No, that’s not the way to run a company. For the long term, we have to be about the science, we have to be about the research. You know, the other thing he did, after the George Floyd murder a couple of years ago, he helped create this OneTen project, which is an effort to take disadvantaged people and get them into good jobs in big corporations. So a fascinating CEO who cares deeply about his impact on society. 

    Lev-Ram: Don’t forget, Alan, another accolade to throw in here. He was named one of Time’s 100 Most Influential People in both 2018 and again in 2021. So I’m very, very disappointed to have missed this live and in person. But looking forward to listening along with everybody else. We have an episode to get to. 

    Murray: Yeah, enough talking about Ken, let’s let Ken talk. Here’s my conversation, before a live audience with former Merck CEO Ken Frazier. 

    [music starts]

    [music ends]

    Murray: I’m Alan Murray, and I’m here today with a man who I’ve been trying to get on this podcast since February of 2020, and finally succeeded: Ken Frazier, the former CEO of Merck—you were still CEO when I first tried to get you on the show. Glad we finally got you here!

    Ken Frazier: Same here, Alan, thanks for having me. Yeah. 

    Murray: Thanks so much for doing it. I want to talk a little bit about your career as CEO at first. We have a lot of things to talk about. I mean, you’ve been involved in so many interesting corporate businesses, but also social issues over the course of the last few years. And we’re gonna get into all of that. But I just want to start by talking about how you started your career as CEO. You know, we’re here with a group of people who stand on the doorstep of becoming CEOs, they’re in the Deloitte Next Generation program. And we had a conversation earlier, that was based on the Mike Tyson quote, “everybody has a plan until they get punched in the face.” You got punched in the face pretty early. So, talk about the beginning of your career as CEO of Merck and what you did. 

    Frazier: So, I took over Merck Jan. 1, 2011, which was kind of an auspicious time in a lot of ways in the industry. At that time, Wall Street was encouraging CEOs in the pharmaceutical biopharmaceutical engineering industry, not to invest in R&D. In fact, there was  a prominent report by one of the banks that said, the way to create value was to cut your R&D budget and to invest in non pharmaceutical assets, there was a company called Valiant, you might remember them, their stock was going through the roof. And their philosophy is, we don’t invest in science, we invest in management. The challenge that I faced is that my company had five year EPS guidance. By the way, if you ever become CEO, don’t do that.

    Murray: First piece of advice…

    Frazier: Only one and a half years had elapsed. So I had three and a half years, this EPS roadmap 25 days into the job, I decided that that was the wrong thing for Merck, in the long term, it would help keep the stock price up in the short term, because we had in fact promised our shareholders that we’d follow this EPS roadmap. So I called my board 25 days into the job. And I said that you don’t really know me that well, but I just want to let you know, I intend to withdraw the last three and a half years of our EPS guidance. All hell broke loose. Right, my lead director said, We won’t let you do that, and I said, I don’t know exactly what you think you just said to me. But I feel strongly about this. And the board went into executive session, I called my wife and I said, Honey, don’t buy the expensive formica. Okay, not clear how long this is going to last. But they let me stay, and the stock plummeted. But you know, when you look back on things, you see things that you couldn’t have seen before. Every time a share of Merck stock got sold, somebody bought it, and the people who bought it were the right patient, long-term shareholders for a company that intended to invest in R&D. So I got the right shareholders, although the process of the transition was painful.

    Murray: Did your lead director stick with you? 

    Frazier: He did stick with me…with great hesitation. You know, it’s not easy also for the board to fire a CEO 25 days into the job.  It doesn’t make them look great, either. And I’ll be honest here, for a while, this board was not about to give me more money, because they weren’t happy with the stock price performance. And but at the end of the day, I think it turned out well, because Merck has always been a science-based company. And if I cut the R&D budget, I could then talk all I wanted to the scientists about how we’re a science-based company, but they would never believe me.

    Murray: Such an important turning point, as an observer, as a journalist who was watching what was going on from the outside over that period. By 2011, there were many, many polls that showed that your industry was the most hated industry in the country. It was, you know, and it was partly because of that kind of behavior. Right? 

    Frazier: You know, the industry does a lot of great good for a lot of people. I think COVID is an incredible example of that. But I think the challenge is, and it’s not just true for the pharmaceutical industry, as we begin to have this concept that CEOs have a responsibility to maximize returns to shareholders, we sometimes miss the fact that we also have other stakeholders that we have to think about, right? And I don’t think it’s at all inconsistent or, or wrong to think about driving value for shareholders and also driving value, for example, for patients, if you’re in the pharmaceutical industry.

    Murray: You got into the CEO job, by way of a career in law. But can you talk about, I know you were particularly well known, because you took on a someone who had been on death row for 19 years and got them off? Not the usual kind of corporate law practice. Can you talk about that case? 

    Frazier: Yeah. So I represented a guy named Bo Cochran, who was 13 days before his date in Alabama, who is totally innocent of a crime. And I didn’t want to take the case, but it was either I took it or he was going to be executed without being represented, and I took the case, and turns out that we were able to demonstrate after about five or six years of going back and finding evidence that we could prove him not only not guilty, but actually factually innocent. And that was the most important thing I’ve ever done in my life as an individual. 

    Murray: What did you learn from that? 

    Frazier: Well, I learned something that I already knew from having done criminal defense work in other cases, which is that the system that we have, in which—let me put it this way, if we were going to have a system under which someone could be sentenced to death, you would expect of that system a discipline, a consistency, a rigor is the word I’m seeking, that the system completely lacks. It would have to be the most rigorous thing we do in our democracy, and frankly, the way the system works in our country often is, if you’re poor, and you’re from an underrepresented group, the state appoints a lawyer for you, that lawyer often doesn’t do a good job of representing you. The state then runs roughshod over your constitutional rights. And then when you get a lawyer at the end of the process, who wants to vindicate those processes, those rights, often the courts think the concept of finality of the verdict is more important than the factual innocence thing. And so a lot of people in our country, and, you know, the Innocence Project has gotten more than 100 people off death row or life sentences by demonstrating with DNA evidence that they didn’t commit the crime. Now, DNA evidence usually involves rape murders, which is a very small percentage of cases. So we know for a fact that there are lots of people who are on the row who are under sentence of death, who can be demonstrably shown to be innocent. 

    Murray: Let’s fast forward. 2017. Donald Trump is president, he asked you to sit on one of his advisory councils, you agree, you’re the CEO of a regulated industry, you can’t really ignore the president of the United States or the government of the United States. And the Unite the Right rally turned into a disaster, happened in Charlottesville. And the next day, the resident comes out and makes some comments that were highly ambivalent about that event. You resigned. And it had huge effects—all the other resignations, I covered this pretty closely, all the other resignations happened because you resigned the other CEOs, once they saw you walked out, felt they had to do the same. Why did you do it? 

    Frazier: So let me start by saying, you alluded to it. But you know, the country is hugely divided along political lines. We know that. The Gallup poll last year showed for the first time Americans don’t consider themselves to be fundamentally divided by race, religion, or region. They consider themselves fundamentally divided by party affiliation. And that was true in 2017. I did not want to go on the president’s council. But my colleagues at Merck said, you know, we’re representing a pharmaceutical industry. He’s a new president. He’s the only president we have, he’s asked you more than once, you ought to go. So I did that. That took a lot of criticism from my friends on the left. Okay. When the comments were made about Charlottesville, I remember I was furniture shopping with my wife, and so I was paying maybe more attention to my iPhone than I normally do. 

    Murray: Not your favorite activity.

    Frazier: I saw the president’s comments. And I knew immediately that I could not remain on the president’s ouncil because of what was happening at Charlottesville.

    Murray: But is it your choice? I mean, you represent Merck, you represent a company .

    Frazier: I do, but also represent my family. I came home and my 20-year-old son was waiting for me. He never came home from college, but he was there when I got home. And he was challenging me with what passes for a searching inquiry for a 20-year-old. He said to me, What’s up dad? What’s up? Okay, which is his way of saying, all this talk. You’ve talked all these years about standing up for principle, we’re watching, okay. But what I ended up doing was, I called my board. And I said, I intend to step down from the president’s council. I was actually advised by my PR people to do it quietly. I said, No, actually, you might remember this. I was down there several times. And he always sat me next to him. So my kids are like, Dad, you’re killing us. Right? But I said, I’m going to withdraw, and it’s going to be a noisy withdrawal. I’m going to put out a statement, I’m going to say why I’m withdrawing. I said to my board, however, I do recognize I have a responsibility to the company. And so the question I’m asking you, is in my statement, do you want me to say I’m withdrawing from the council as a matter of my personal conscience? Or do you want me also to say I’m withdrawing because of the company’s values? And I’m happy to say that. Unanimously, they said, we want you to speak to the company’s values. 

    Murray: No debate?

    Frazier: No debate whatsoever. 

    Murray: And did you know at that moment that once you stepped down all the other CEOs would step down and the council would crumble? 

    Frazier: No, I didn’t know that. But that gets to the question of principle. At the end of the day, what’s hard about these decisions that CEOs face? Is what are you making the decision for this principle? And his pragmatism? The pragmatic thing is, why would you piss off the president of the United States? Right. And by the way—

    Murray: Who’s already talking about drug pricing.

    Frazier: Right, he’s already talking about drug pricing. By the way, this is August 2017. He’d been in the White House for about seven months, I think, whether you like President Trump or no, the jury was still very much out about President Trump at that point in time. So the pragmatic decision is, why put your company in that situation? But the principle decision for me was that I felt like someone needed to take a statement, and that if I didn’t, I would be providing my own tacit approval of what the president did and did not do. So for me, that was an easy decision. But I didn’t want to speak on behalf of the company, 

    Murray: Did you get criticism for it? 

    Frazier: Oh, yeah, I got criticism, a lot of criticism. And what the most important thing that I remember thinking about that whole thing was, shortly after I stepped off the council, and then you’re right, everyone sort of followed. Because, you know, frankly, I think people’s employees, a lot of them got challenged by their employees, because someone else had stepped off. So you know, what are you doing? And I had CEOs call me and say, you should have consulted us before you went out on your own. Right? Like, you can’t have your own conscience or whatever. But I do think one of the challenges that we have about political division in this country is that we don’t find a common language to talk about what we’re talking about, or what we’re feeling. So, after I stepped off, one of the first things I wanted to do was to go to one of my manufacturing plants, one of Merck’s manufacturing plants in the south, is located in a town that’s called Stonewall, Georgia. I’ll say it again, STONEwall, Georgia, if you hear me talking, okay. And I went to that plant, I was advised not to go there. But I went there to talk to my plant workers. And I wanted to say to them, I’m the CEO of Merck. I’m not here to tell you who to vote for, or who to like. You’re Merck people. I’m a Merck person. We all have common values. I’m not judging you, you may have many reasons why you support the president, and I support whatever political views you want to have. But you’re damn sure gonna support mine. And I will tell you, when I walked in that room, people’s arms were crossed. And when we finished having that conversation, people came up to me and said, we get you. Because what they wanted to hear was that I wasn’t judging them, and I wasn’t taking a position on them. And I think a lot of the division in our country is because we deal with issues without communicating with each other, and without what I call grace. 

    [music starts]

    Murray: Jason Girzadas, the CEO of Deloitte US is the sponsor of this podcast and joins me today. Welcome, Jason. 

    Jason Girzadas: Thank you, Alan. It’s great to be here.

    Murray: Jason, everyone in business is talking about AI. It clearly has the potential to dramatically disrupt almost every industry, but a lot of companies are struggling. What are some of the barriers that companies are facing in creating business value with AI? 

    Girzadas: Yea, Alan, AI is on every client’s agenda. I think every CEO and board interaction and conversation that I’m a part of proves the fact that the promise of AI is widely held, and the hope is far and deep that it creates business value. But there are challenges, to be sure. What we’ve seen is that the probability of success increases dramatically with strong executive sponsorship and leadership, there has to be a portfolio of investments around AI as well as to link the business ownership with technology leadership to see the value of AI-related investments. Over time, we’re optimistic and confident that the value will result, but it will be a portfolio where other short term opportunities for automation improvements around productivity and cost takeout and then longer-term, medium-term opportunities for business model innovation that are truly transformational. So this is a classic case where it won’t be a single approach that realizes value for AI.

    Murray: It sounds like you take it a step at a time. 

    Girzadas: I think a step at a time, and also a portfolio recognizing that some investments will have short-term benefit where you can see immediate use cases creating financial and business impact, but longer-term opportunities to really invent different customer experiences, different business models, and ultimately create longer-term benefit that we can’t even fully appreciate at this point in time. 

    Murray: Jason, thanks for your perspective. And thanks for sponsoring Leadership Next

    Girzadas: Thank you. 

    [music ends]

    Murray: Continuing the line of conversation: Three years later, Trump is out of office, the state of Georgia decides to adopt a voting rights bill that many people felt would restrict access to minorities in the state. But it also was about as political a piece of legislation, as you could imagine, supported by every Republican, opposed by every Democrat, because it meant Republicans would get more votes and Democrats would get less.

    Frazier: And people had to subscribe to the idea that the election was stolen. That was a big part of it, too. 

    Murray: So you stepped in? My understanding is, you and I’ve never talked about this, but my understanding is you personally called Ed Bastian, the CEO of Delta, you personally talked to Jim Quincy, the CEO of Coca Cola.

    Frazier: Well, Ken Chenault and I divided up the list, Ken Chenault of American Express.

    Murray: And together, the two of you called them and said, You’ve got to speak out. You’ve got to take a stand. You have to go against this. Almost explosive—this 2017, you had Mitch McConnell go on TV saying, you CEOs, this is politics. You CEOs stay out of—stay in your own swim lane. What are you doing telling us how to run—

    Frazier: Except for political donations.

    Murray: Yeah, they’ll take those.

    Frazier: Stay out of politics except for donations to me, please. That’s a principle. 

    Murray: So again, why did you do it was the right thing to do? Did you talk to the board? How did you handle it? Were you still CEO at the time?

    Frazier: I was CEO at the time. This is what’s really hard about being a CEO. I first of all, don’t believe that CEOs or businesses want to be in the middle of political disputes. And I try to be careful about whether or not I want to get into the middle of political disputes. But I also believe that in the long run, we need to have an environment in our country that is conducive to commerce, and it’s conducive to people. And that comes down to a set of principles that we were taught early in school, if we went to school in this country, and there’s certain things like you know, the rule of law, the right to vote, equal treatment, equal opportunity. Go through that list of fundamental American values. And if it’s a fundamental American value, it is my view that if our elected officials are either abandoning or ignoring their responsibility to uphold those principles, it falls to the American people to ensure that those principles are upheld. I happen to think CEOs are among the most influential American people. So if people have a responsibility to stand up for principle, then I think CEOs ought to stand up for those principles. And from my perspective, that’s one of those things that a lot of people will disagree with, because they’ll say that was political. And I said, wait a minute, the right to vote isn’t inherently a political issue. If somebody wants to politicize that principle, that doesn’t mean I have to be quiet about it. And the example that I’ve used recently in talking to CEOs is the American business community has stood in unison for democracy in Ukraine. But we can’t speak to it in Georgia? I mean, come on. It’s the same principle. Right. So at the end of the day, we talked about this later, I think one of the things that makes it possible to make decisions, tough decisions, is to ask yourself, What are your values? Because it’s your values, from your values when you’re hearing all of these contradictory things. I believe that values help you have both the wisdom to figure out what’s right, and the courage to do what’s right. Because if it really comes down to values, and I would say to people, you know, on this issue about the right of Americans to vote, that is so fundamental to democracy. And by the way, Alan, I’m sure you read it. The statement we made was so anodyne, it was so completely unpolitical. It was like, the CEOs in this country support the right to vote. Right? It actually didn’t say anything about Georgia, we avoided …

    Murray: Because some of the critics were saying, Oh, you don’t know what you’re talking about. You haven’t read the bill. You know, the specifics. They did the same thing in Connecticut that we want to do here. You weren’t talking about the specifics. 

    Frazier: We were talking about the right to vote as a principle, a fundamental principle and as I said before, I had read the law. And I was at pains to say, there are some things in this law that are really good. But there are some things in this law that you can say without question—by the way, I’d never said they had to do with race either. Right? When I would go on television, I would say, these provisions are going to make it hard for people who live in densely populated areas to vote. Now, you could figure out who that is. That’s code for some things. But the people actually stood in line for seven, eight hours, you might remember this in order to vote, and I thought, no one should have to do that. 

    Murray: It’s not right. So both of these examples 2017, 2020—those are you taking action to stop something that you thought was negative from happening. But I want to talk about the OneTen initiative, because this happened after the George Floyd killing, and there was an outbreak, that one was instantaneous. Every CEO, and by the way, 10 years ago, 10 years before that, that would not have happened. Yeah, it was, it was a—it was a change that 2017 created. 

    Frazier: I think it was a very hopeful development in our country, if I can be so direct as an African-American. I compare George Floyd to Rodney King, when the Rodney King thing happened, Black people were in the streets. When the George Floyd thing happened, everybody was in the streets, I would see these stories about places in North Dakota, where there were no Black people living, and people were protesting. Right. And, you know, frankly, I’m being a little political here myself, I actually believe that shows that the country is moving to a place where we can empathize with one another. 

    Murray: Yeah. So all these companies, you know, put out statements that double down on their commitments to diversity, equity, inclusion, but you know, I’m interpreting, so you tell me if I’ve got this, right. But you said, Well, wait a minute, if all we do here is all these companies compete for the same talent, then that talent will get higher pay, that’s fine, but we’re not really doing what we want to do, which is restart the escalator of mobility in this country and give these people an opportunity. So you created OneTen, talk about OneTen, what it is…. 

    Frazier: OneTen Coalition, of 70 leading companies that, in the wake of the George Floyd murder, came together and said, we are going to look at our hiring practices systemically, and ask ourselves which jobs really require a four-year degree versus which jobs should be skills-based jobs. Now, how does it relate to George Floyd? Well, in the 2020 census, 76% of African-Americans at age 26 do not have a four-year degree. So, if you reflexively require a four-year degree, systemically, unintentionally, you’re keeping 76% of that population from ever having an opportunity to go to the middle class. 

    Murray: But now wait a second, Ken. So are you saying OneTen is not explicitly about race? 

    Frazier: No, I’m gonna get to that in a minute. Okay. It was initially totally about race, and it continues to focus on communities that are underrepresented. I want to talk about what we’ve done since the Supreme Court case.

    Murray: Yeah, because you’re a lawyer.

    Frazier: Right, but my wife always says, when they say you’re a lawyer, you should add, but not in a pejorative sense of the word. When these companies were saying they wanted to do something to show that they stood for racial justice, we didn’t want to put out statements, we said, What in the wheelhouse of companies is to hire people, right? And if you start hiring people from these unheard, unseen, underrepresented communities, then you can be doing something about that. So that’s how OneTen started, with Ginni Rometty of IBM, Ken Chenault and myself, and Charles Phillips, and Kevin Sherar, who’s the former CEO of Amgen. So we all got together, we’re up to about 110,000 people that we’ve hired into family-sustaining-wage jobs, that’s the key. $50,000 income adjusted, depending on whether you’re in Mobile, Alabama, or Seattle, Washington. So that’s where we went now, explicitly, it was founded, with the mission of creating opportunity for Black talent. We have now changed the mission to make it very clear that while that was what it was founded for, we don’t exclude anybody from it. 

    Murray: And this is because of the Supreme Court. 

    Frazier: It was in response to the Supreme Court. 

    Murray: And how do you feel about that Supreme Court decision? 

    Frazier: Well, that’s a complicated question. But let me try to talk about what I think. 

    Murray: That’s a lawyerly answer. 

    Frazier: I think—I think what Chief Justice Roberts’s majority opinion says, is that colorblindness, or race neutrality, is a good organizing and governing principle for a multiracial, multicultural society. It’s a good aspiration, is what he’s saying. And I don’t think anyone can disagree with that, at the end of the day, that we should all be judged by who we are, as Dr. King said, by the content of our character, not by our outward appearance. But at the same time, I have to say that I do think that while we are now 59 years after the passage of the seminal Civil Rights Act of ‘58, after the Voting Rights Act, the reality of the world is there are vestiges of centuries of racial oppression, slavery, that continue to affect African-Americans differentially.

    Murray: This goes back to your death row case. 

    Frazier: It goes back to the death row. It’s law enforcement. If you look at life expectancy, if you look at education—I don’t want to be autobiographical. I sit here before you because in 1963, the civil leaders of Philadelphia, the social engineers of Philadelphia, decided to engage in what they called school desegregation. My parents were too poor to buy houses that were proximate to where the good schools were. Okay. So my younger sister and I got put on buses against our will and sent across town to all-white schools, where we got an education that was different from our siblings’. That was a race-conscious decision. It wasn’t intended in any way to exclude or hurt someone. But it was a decision that was made for the purpose of addressing the past discrimination. And that’s where I disagree with Chief Justice Roberts. He says any racial classification is invidious. Well, law school professor, that’s like saying in 1964, a sign in the South that said, “Blacks are welcome” is the same as when it says “Blacks are not welcome”. We all know those two things are different. Okay. And so the challenge we have in our society is twofold. On the one hand, again, as an organizing democratic principle, it is best to avoid classifying people on the basis of race, no one can disagree with that. On the other hand, if we’re ever going to address the huge disparities that exist, that I believe no one can disagree, are vestiges of the way this country has run for years, we have to think about, how do we include people without in any way excluding people? And that’s what we try to do at OneTen. What we say is, let’s go into those communities that we normally don’t go into.

    One quick example, one of our members—I won’t identify, the CEO said to me, OneTen company, he said, I did a tour of our plants. And for all of our plants, we would hire from the community surrounding the plant. Except our plant outside Detroit, he said, and then I discovered for some reason, our plant, which is near the interstate, everybody at the Detroit plant came in from the suburbs, went into the plant inside the gate, and then went home that night, and I went to my plant manager and said, why is this plant different? Why are we not hiring from the surrounding community?

    So again, I think it’s important for us, and this is an important issue for our society, to find ways to deal with one another, in such a way as to never take into consideration external factors that really don’t go to the heart of who people are. But I also think, and again I use my own example, I am fortunate that the social engineers in Philadelphia 1963, they must have heard Martin Luther King, and they somehow it pricked their conscience and they said, some of these kids are getting an education. I don’t think that hurt anybody that they did that.

    Murray: Yeah. Ken Frazier, you have now proven I was right to, since February of 2020, push to get you on this podcast. What a fascinating conversation. 

    Frazier: Can I say one more thing, though? What’s missing is a common language in our society. Right? We have to find ways of communicating, so that the other side understands our intent and doesn’t misunderstand what we’re trying to do. I think DEI, ESG, all of those things have become politicized and toxic. And I think we have to find ways to talk about these issues. You know, I like to talk about openness, because no one’s against openness, right? Nobody’s against fairness and opportunity. We have to find a common language in our society that allows us, irrespective of our political views, to see what the other person’s good intent is.

    Murray: But let me challenge you a little bit on that. Of course we need a common language so that we can talk about these issues without descending into fights. But this has been exacerbated by a broken political system. And, and, and my experience talking to CEOs is, and this gets back to where we started this conversation. From day one, you said, Merck can’t be about making money in the short term, it has to be about the long term. And we all know in the long term, what’s good for the company, and what’s good for society are going to start to meld, right? You can’t be a successful company if the planet’s on fire. You can’t be a successful company if you’re in a country that is melting down. Every CEO I talked to these days says, Please, please, please keep me out of politics. I don’t want to have anything to do with it. I don’t like it. I don’t want to be part of it. I don’t understand how that’s consistent with the long-term view of the health of the company, because surely our political dysfunction is at least as big a problem for the future of American companies.

    Frazier: I agree. And that was my point about having an environment that’s conducive to people as well as to commerce. The point I was making, though, is that rather than get dragged into the political fight, just be specific about what you’re doing. Right. Just be very specific about what it is that your company stands for, and don’t get pulled into the political debate about words. Because frankly, the good thing about the politicians is, they’re so shallow in their thinking that, if you call the thing something else, they don’t even talk about it. 

    Murray: Would you ever consider running for office yourself? 

    Frazier: Never!

    Murray: We’d all be better off. 

    Frazier: That’s kind of you to say but my wife would say, don’t go there!

    Murray: Ken Frazier, thank you so much. 

    [music starts]

    Leadership Next is edited and produced by Alexis Haut. Our theme is by Jason Snell. Our executive producer is Megan Arnold. Leadership Next is a product of Fortune Media.

    Leadership Next episodes are produced by Fortune‘s editorial team. The views and opinions expressed by podcast speakers and guests are solely their own and do not reflect the opinions of Deloitte or its personnel. Nor does Deloitte advocate or endorse any individuals or entities featured on the episodes.

    [ad_2]

    Fortune Editors

    Source link

  • Merck KGaA Enters Deal With BenevolentAI, Exscientia for AI-Based Drug Discovery

    Merck KGaA Enters Deal With BenevolentAI, Exscientia for AI-Based Drug Discovery

    [ad_1]

    By David Sachs

    Merck KGaA said that it has partnered with BenevolentAI and Exscientia on an initiative to discover more drugs with artificial intelligence, which the company says will yield higher success rates.

    The German science and technology company said on Wednesday that the partnership with the two U.K. AI firms includes access to an…

    [ad_2]

    Source link

  • The Cold-Medication Racket

    The Cold-Medication Racket

    [ad_1]

    You wake up with a stuffy nose, so you head to the pharmacy, where a plethora of options awaits in the cold-and-flu aisle. Ah, how lucky you are to live in 21st-century America. There’s Sudafed PE, which promises “maximum-strength sinus pressure and nasal congestion relief.” Sounds great. Or why not grab DayQuil in case other symptoms show up, or Tylenol Cold + Flu Severe should whatever it is get really bad? Could you have allergies instead? Good thing you can get Benadryl Allergy Plus Congestion, too.

    Unfortunately for you and me and everyone else in this country, the decongestant in all of these pills and syrups is entirely ineffective. The brand names might be different, but the active ingredient aimed at congestion is the same: phenylephrine. Roughly two decades ago, oral phenylephrine began proliferating on pharmacy shelves despite mounting—and now damning—evidence that the drug simply does not work.

    “It has been an open secret among pharmacists,” says Randy Hatton, a pharmacy professor at the University of Florida, who filed a citizen petition in 2007 and again in 2015 asking the FDA to reevaluate phenylephrine. This week, an advisory panel to the FDA voted 16–0 that the drug is ineffective orally, which could pave the way for the agency to finally pull the drug.

    If so, the impact would be huge. Phenylephrine is combined with fever reducers, cough suppressants, or antihistamines in many popular multidrug products such as the aforementioned DayQuil. Americans collectively shell out $1.763 billion a year for cold and allergy meds with phenylephrine, according to the FDA, which also calls the number a likely underestimate. That’s a lot of money for a decongestant that, again, does not work.

    Over-the-counter oral decongestants weren’t always this bad. But in the early 2000s, states began restricting access to pseudoephedrine—a different drug that actually is effective against congestion—because it could be used to make meth; the Combat Methamphetamine Epidemic Act, signed in 2006, took the restrictions national. You can still buy real-deal Sudafed containing pseudoephedrine, but you have to show an ID and sign a logbook. Meanwhile, manufacturers filled over-the-counter shelves with phenylephrine replacements such as Sudafed PE. The PE is for phenylephrine, but you would be forgiven for not noticing the different name.

    “Thet switch from pseudoephedrine to phenylephrine was a big mistake,” says Ronald Eccles, who ran the Common Cold Unit at Cardiff University until his retirement. Eccles was critical of the switch back in 2006. The evidence, he wrote at the time, was already pointing to phenylephrine as a lousy oral drug.

    Problems started showing up quickly. Hatton, who was then a co-director of the University of Florida Drug Information Center, started getting a flurry of questions about phenylephrine: Does it work? What’s the right dose? Because my patients are complaining that it’s not doing anything. He decided to investigate, and he went deep. Hatton filed a Freedom of Information Act request for the data behind FDA’s initial evaluation of the drug in 1976. He soon found himself searching through a banker’s box of records, looking for studies whose raw data he and a postdoctoral resident typed up by hand to reanalyze. The 14 studies the FDA had considered at the time had mixed results. Five of the positive ones were all conducted at the same research center, whose results looked better than everyone else’s. Hutton’s team thought that was suspicious. If you excluded those studies, the drug no longer looked effective at its usual dose.

    All told, the case for phenylephrine was not great, but the case against was no slam dunk either. When Hatton and colleagues at the University of Florida, including Leslie Hendeles, filed a citizen petition, they asked the agency to increase the maximum dose to something that could be more effective. They did not ask to pull the drug entirely.

    There was more damning evidence to come, though. The petition led to a first FDA advisory committee meeting, in 2007, where scientists from a pharmaceutical company named Schering-Plough, which later became Merck, presented brand-new data. The company had begun studying the drug, Hatton and Hendeles recalled, because it was interested in replacing the pseudoepinephrine in its allergy drug Claritin-D. But these industry scientists did not come to defend phenylephrine. Instead, they dismantled the very foundation of the drug’s supposed efficacy.

    They showed that almost no phenylephrine reaches the nasal passages, where it theoretically could reduce congestion and swelling by causing blood vessels to constrict. When taken orally, most of it gets destroyed in the gut; only 1 percent is active in the bloodstream. This seemed to be borne out by what people experienced when they took the drug—which was nothing. The scientists presented two more studies that found phenylephrine to be no better than placebo in people congested because of pollen allergies.

    These studies, the FDA later wrote, were “remarkable,” changing the way the agency thought about how oral phenylephrine works in the body. But experts still weren’t ready to write the drug off entirely. The 2007 meeting ended with the advisory committee asking for data from higher doses.

    The story for phenylephrine only got worse from there. In hopes of making an effective product, Merck went to study higher doses in two randomized clinical trials published in 2015 and 2016. “We went double, triple, quadruple—showed no benefit,” Eli Meltzer, an allergist who helped conduct the trials for Merck, said at the FDA-advisory-panel meeting this week. In other words, not only is phenylephrine ineffective at the labeled dosage of 10 milligrams every four hours, it is not even effective at four times that dose. These data prompted Hatton and Hendeles to file a second citizen petition and helped prompt this week’s advisory meeting. This time, the panel didn’t need any more data. “We’re kind of beating a dead horse … This is a done deal as far as I’m concerned. It doesn’t work,” one committee member, Paul Pisarik, said at the meeting. The advisory’s 16–0 vote is not binding, though, so it’s still up to the FDA to decide what to do about phenylephrine.

    In any case, phenylephrine is not the only cold-and-flu drug with questionable effectiveness in its approved form. The common cough drugs guaifenesin and dextromethorphan have both come under fire. But we lack the robust clinical-trial data to draw a definitive conclusion on those one way or the other. “What really helped our case is the fact that Merck funded those studies,” Hatton says. And that Merck let its scientists publish them. Failed studies from drug companies usually don’t see the light of day because they present few incentives for publication. Changing the consensus on phenylephrine took an extraordinary set of circumstances.

    It also required two dogged guys who have now been at this work for nearly two decades. “We’re just a couple of older professors from the University of Florida trying to do what’s best for society,” Hatton told me. When I asked whether they would be tackling other cold medications, he demurred: “I don’t know if either one of us has another 20 years in us.” He would instead like to see public funding for trials like Merck’s to reevaluate other over-the-counter drugs.

    There are other effective decongestants on pharmacy shelves. Even though phenylephrine does not work in pill form, “phenylephrine is very effective if you spray it into the nose,” Hendeles says. Neo-Synephrine is one such phenylephrine spray. Other nasal sprays containing other decongestants, such as Afrin, are also effective. But the only other common oral decongestant is pseudoephedrine, which requires that extra step of asking the pharmacist.
    Restricting pseudoephedrine has not  curbed the meth epidemic, either. Meth-related overdoses are skyrocketing, after Mexican drug rings perfected a newer, cheap way to make methamphetamine without using pseudoephedrine at all. This actually effective drug still remains behind the counter, while ineffective ones fill the shelves.

    [ad_2]

    Sarah Zhang

    Source link

  • Merck sues U.S. government over plan to negotiate Medicare drug prices, claiming

    Merck sues U.S. government over plan to negotiate Medicare drug prices, claiming

    [ad_1]

    Drugmaker Merck is suing the U.S. government over its plan to allow Medicare to negotiate prices for a handful of drugs, calling it “extortion.”

    The plan, part of the 2022 Inflation Reduction Act, is expected to save taxpayers billions of dollars on common drugs the government pays for. The law directs the Center for Medicare and Medicaid Services to select 10 drugs with no generic or biosimilar equivalents to be subject to government price negotiation. (The list will eventually expand to 20 drugs.) 

    In its lawsuit, filed on Tuesday in federal court in the District of Columbia, Merck called the program “a sham” that “involves neither genuine ‘negotiations’ nor real ‘agreements.’” Instead, the pharmaceutical firm said the U.S. Department of Health and Human Services selects drugs to be included and then dictates a discount, threatening drugmakers with “a ruinous daily excise tax” if they refuse the conditions.

    Merck added that it expects its diabetes treatment, Januvia, to be subject to negotiation in the first round, with diabetes drug Janumet and the cancer drug Keytruda affected in later years.

    The Rahway, New Jersey-based drugmaker is seeking to end the program. “It is tantamount to extortion,” it said in the complaint.

    Health and Human Services Secretary Xavier Becerra, who is named as a defendant in the suit, said in a statement that the agency plans to “vigorously defend” the drug price negotiation plan.

    “The law is on our side,” he said.


    How to choose the right Medicare plan for you

    03:35

    The lawsuit also names HHS and Chiquita Brooks-LaSure, administrator of the Centers for Medicare and Medicaid Services, as defendants.

    Merck said the program violates elements of the Constitution, including the Fifth Amendment’s requirement that the government pays “‘just compensation’ if it takes ‘property’ for public use,” according to the complaint.

    The drugmaker noted that Congress could have simply allowed HHS to state a maximum price it would pay for a drug, but that would have enabled drugmakers to walk away from talks, leaving millions of Medicare beneficiaries without essential medications, the complaint said.

    Instead, Merck said the government uses the threat of severe penalties to requisition drugs and refuses to pay fair value, forcing drugmakers “to smile, play along, and pretend it is all part of a ‘fair’ and voluntary exchange.” This violates the First Amendment, the suit claims, calling the process “political Kabuki theater.”

    Patient advocate slams Merck

    David Mitchell, founder of the advocacy group “Patients For Affordable Drugs Now,” slammed Merck’s suit as an attempt to “unilaterally set prices that are untethered to quality at the expense of patients.”

    “The reality is, drug corporations that are subject to Medicare’s new authority – and who already negotiate with every other high income country in the world – will engage in a negotiation process after setting their own launch prices and enjoying nine years or more of monopoly profits,” Mitchell said in a statement.

    He added, “Medicare negotiation is a desperately needed, long-awaited rebalancing of our drug price system that will help millions of patients obtain the medications they need at prices they can afford while ensuring continued innovation.” 

    Medicare is the federally funded coverage program mainly for people who are age 65 and older. Currently, drug companies tell Medicare how much a prescription costs, leaving the federal government and Medicare beneficiaries to pay up.

    The Inflation Reduction Act’s drug negotiation provisions mark the first time that the federal government will bargain directly with drug companies over the price they charge for some of Medicare’s costliest drugs. Government negotiation with drugmakers and price caps on drugs are common in other developed nations.

    Republican lawmakers have also criticized President Joe Biden’s administration over the drug pricing plan, saying it could deter drugmakers from developing new treatments.

    The federal government is expected to soon release rules for negotiating drug prices. In September, it is scheduled to publish a list of 10 drugs that it will start price negotiations on next year. Negotiated prices won’t take hold until 2026.

    With reporting by the Associated Press.

    [ad_2]

    Source link

  • China Approves Merck’s Molnupiravir for Emergency Use, Regulator Says

    China Approves Merck’s Molnupiravir for Emergency Use, Regulator Says

    [ad_1]

    China’s top drug regulator said Friday that it approved Merck & Co.’s Molnupiravir for emergency use on Thursday, as the country grapples with waves of infections after Beijing abruptly reversed its stringent Covid-19 restrictions earlier this month.

    The National Medical Products Administration said it is requiring the approval holder to continue relevant research, complete conditional requirements and submit follow-up research results in a timely manner, according to a statement posted on its website Friday.

    Write to Singapore Editors at singaporeeditors@dowjones.com

    Corrections & Amplifications

    This item was corrected at 0856 GMT to reflect China’s top drug regulator said it approved Merck & Co.’s Molnupiravir for emergency use on Thursday. The original version incorrectly said the approval came on Wednesday in the first paragraph.

    [ad_2]

    Source link

  • WSJ News Exclusive | Amgen in Advanced Talks to Buy Horizon Therapeutics

    WSJ News Exclusive | Amgen in Advanced Talks to Buy Horizon Therapeutics

    [ad_1]

    U.S. biotechnology company was the last of three suitors standing in an auction for Horizon

    [ad_2]
    Source link

  • Moderna Stock Takes Off on Cancer Vaccine News

    Moderna Stock Takes Off on Cancer Vaccine News

    [ad_1]



    Moderna


    stock shot up after


    Merck


    said it is exercising an option to work on a personalized cancer vaccine with the Covid-19 vaccine maker.

    Merck (ticker: MRK) will pay


    Moderna


    (MRNA) $250 million for the joint development and future commercialization of the vaccine, which is currently in Phase 2 clinical trials. The two companies had announced a “strategic collaboration” in June 2016.

    [ad_2]

    Source link