The Queen of Big Pharma Talks the Covid-19 Vaccine

          There’s been a pissing match between President Trump and the world’s second-richest man, Bill Gates, and Gates’ wife Melinda, who is from Dallas btw, about the president’s handling of the COVID-19 crisis and for good reason. We won’t go there. Instead what’s interesting is how the individuals involved, none of who is a doctor or has any kind of healthcare training or research cred, has been so sure of what they’re talking about. At the heights of power or wealth you can hire experts. 

            In fact the president has been widely criticized for doing just that, hiring Big Pharma ex-executive Moncef Slaoui—former head of drugmaker GlaxoSmithKline’s vaccine division—to lead the U.S. government’s push for a COVID-19 vaccine. In the early days of the pandemic the Gates Foundation had its own veteran of Big Pharma leading vaccine efforts too. Her name is Susan Desmond-Hellmann—everyone calls her Sue. You can bet Sue was where the Gateses got their information to challenge the president. She's produced a few medicins herself. Then she stepped down from the Gates foundation, perhaps because it’s hard to criticize the president when your science guy, or girl in this case, has worse ethics than his does. Sue has returned to her first love, Big Pharma, as a director of Pfizer. She has just made her own pronouncements on a COVID vaccine and it’s especially scary coming from this scary lady doctor.

            Dr. Desmond-Hellmann served as the Bill and Melinda Gates Foundation’s CEO for almost six years and is an oncologist by training. Described as über-competent and very focused—the way Atilla was—she is a former chancellor of the University of California’s healthcare campus in San Francisco and before that was president of product development at drugmaker Genentech (now owned by Swiss pharmaceutical giant Roche.) While concerns have been raised about the possibility of ethical embroilments for Professor Slaoui, being a Big Pharma alum and all that, and working for President Trump, in the case of Dr. Desmond-Hellmann ethical compromise is not a mere possibility. She’s a full-fledged bio thug. Which may make her a good person to have around in the present pandemic environment. She recently expressed a few thoughts on the search for a COVID-19 vaccine, specifically, and her insights are valuable because the one thing we know about Dr. Desmond-Hellmann is that she doesn’t let sentiment get in the way of creating pharmaceuticals. But, as your mother told you, you still have to consider the source. So, like, a few more words about Sue.

We pick up her background in a passage from A Nigger in Nursing, about the culture of racism and corruption at the University of California’s San Francisco campus, where a young Dr. Desmond-Hellmann served first as chief resident and a couple of decades later returned as chancellor. 

“Her back story was easy to outline because Sue talked a lot about herself: If you spent any time on the university website you got a general idea of her career trajectory without even trying. Medical school in Las Vegas, a very successful residency in oncology and then teaching in San Francisco followed by two years in Uganda doing research that she portrayed as—and well may have been—a genuine effort to help. But which may also have been a first step in another career entirely, Big Pharma, making really big bucks might have been on her radar even in Africa,” Nigger tells us. “Upon return to the U.S. she and her husband, also a physician, worked in practice for a time in her chosen field, in the South, and then she went for the money, first at Bristol Myers Squibb in New Jersey and later at Genentech in South San Francisco. When she came back to UCSF as chancellor in 2010 she had just cashed in her Genentech stock and received $30 million, per press reports. Her husband was already independently wealthy, Hollywood money. Suddenly, Nicholas Hellmann and Susan Desmond-Hellmann were a S.F. power couple with the spotlight on her.”

Or the Wikipedia version: “Returning to clinical research, Desmond-Hellmann became associate director of clinical cancer research at Bristol-Myers Squib Pharmaceutical Research Institute. While there, she was the project team leader for Taxol. In 1995 she joined Genentech as a clinical scientist; she was named chief medical officer the following year, and in 1999 became executive vice president of development and product operations. From March 2004 through April 2009 she was chief of product development, playing a role in the development of two of the first gene-targeted therapies for cancer, Avastin and Herceptin.” Susan Desmond-Hellmann is not a person who thinks of what you can’t do, like a lawyer—what is or is not permitted by law or by custom. She thinks of what you can do, physically, like an engineer or the scientist she is. That’s the source of her success, she has a wider view of possibilities than most people. That’s the source of her genius and is probably what attracted Bill Gates to her in the first place. It’s also what gets Sue into trouble.

            Ethical troubles began almost immediately after assuming office as chancellor of UCSF, on the imposing Mount Parnassus, in Outer Sunset, in Baghdad by the Bay. To set the scene.

            The New York Times reported that her University of California financial disclosure form for 2010, while Sue was serving as leader of the preeminent public healthcare university in the world—that includes a well-regarded, cutting edge cancer research operation, and an anti-tobacco institute, exclusively dedicated to digging dirt on cigarette companies. Sue’s disclosure included major holdings of the maker of Marlboro cigarettes. She explained to the Times that she had merely signed what her investment adviser placed in front of her, yet the financial disclosure was handwritten and her initials appeared beside corrections in the margins. An appalled murmur arose on Mount Parnassus, in Baghdad by the Bay. That was just Sue, you might say, and it was just the beginning. Also on her watch the federal government fined UCSF for a wide variety of inhumane conditions for lab animals. She would eventually be sued in federal court by the African-American who served as UCSF’s diversity coordinator, who said she fired him for speaking up about race issues at this traditionally white UC campus. When she was called on her ties to industry she wrote and published a paper in a scientific journal in which she and UCSF’s then head of commercialization, neurologist Clay Johnston—now dean of the University of Texas Dell School of Medicine in Austin—said that there were not enough ties between academia and Big Pharma. In other words she doubled down.

            There’s a classic Sue story, told by former UC President Mark Yudof, who actually hired her to lead UCSF. No moral giant himself, Yudof nonetheless marveled over the audacity and impropriety of her management proposals, in an oral history given to a UC Berkeley researcher in 2018. You have to imagine the scene. It’s 2012 at a UC Regents meeting. In San Francisco, Chancellor Desmond-Hellmann is planning to ram through construction of a new campus in Mission Bay—including a Genentech Hall for Regents’ meetings—displacing a formerly minority neighborhood in the process and God knows how many low-income residents. But we digress. President Yudof picks up the narrative from there. Press reports were that the Regents’ response to her new idea was icy but It wasn’t gentrification that upset them. Sue had decided she wanted to privatize the whole San Francisco campus.

“One thing I’ve discovered in life,” Yudof told the Berkeley historian, “is you can spend a lot of time trying to move around the black boxes and get nowhere by saying the answer to our problems is in a restructuring of governance. [But] it’s in the [California] constitution, the governance of the University of California. You’ve got the speaker of the Assembly; you’ve got the California superintendent of public instruction; you’ve got the lieutenant governor on the board; you’ve got regents that are there. We’re not going to turn the world upside down and establish a new board for UCSF. If we were on a blank slate, maybe there could be movement in that direction. And we’re not a private university. Even though they’re only paying 5 percent of the bills, the taxpayers say, ‘Wait a minute, we built this place over all these years,’ and now you want to be free of what I call public accountability? So it just was not to be. Sue made some governance changes, which I think were all good, but at the end of the day — to be honest with you, I didn’t make many phone calls," Yudof said. “It was going nowhere. I told her that — the structural stuff. Everything else she was doing was really first-class, but I just couldn’t see how it would work. Every time someone says, ‘Let’s take one of our campuses private,’ I don’t know what that means. The taxpayers built a lot of the buildings; they built it over 100 years, 150 years. The legislature’s not going to do it. The people are going to vote for a constitutional amendment to set a campus free? I wasn’t going to waste a lot of time, but I also wasn’t going to campaign against it because I knew it would never happen.” That’s Sue again. In the end her academic career was done in by another media report, much like the one about her investment choices, this time in the Washington Post.

The story was about two Genentech drugs—Avastin and Lucentis—one that costs $50 and the other $2,000 a dose and both of which do the same job in preventing blindness from macular degeneration. So, like, the story was about Sue’s time as Genentech's head of product development, the five years right before she came to UCSF as chancellor, basically, and as the Post recalled, the extreme efforts she took to push the more expensive drug by misrepresenting the cheaper one.

“’When Lucentis did go on sale,’” the Post reported, “'Genentech’s blockbuster drug already had a competitor [Genentech’s already existing and cheaper cancer drug, Avastin, which works just as well for macular degeneration]. How could the company convince doctors and hospitals that Lucentis had any major advantage over Avastin? Over and over again [The Company] sought to discourage use of Avastin by raising concerns about its safety. They told doctors that Avastin was not approved by the FDA for use in the eye—Lucentis was. They reminded doctors that if the repackaging firms cutting Avastin into smaller doses were careless, infection could be introduced. And despite the lack of conclusive evidence on the point, they said that Avastin patients might suffer more side effects than Lucentis patients. Sometimes, senior FDA officials said, these warnings stretched the truth.’ The named culprit in the misrepresentation in which patients facing blindness were forced to pay $2000 a dose for a medication rather than $50 was one Susan Desmond-Hellmann—incumbent chancellor of the University of California San Francisco, although the authors of the Post story did not appear to know that when they published. 

“Genentech stopped selling Avastin to repackaging companies that cut the med into smaller doses,” the Post said, in order to force sales of the 4000% more expensive Lucentis. On Sue's watch. The result was that Genentech under Sue’s leadership pushed a med that was 40 times more expensive and no more effective because that math was better for her company. Which is Sue too. Despite being an innovator and thinking what no one else dares to think, including massively overcharging patients, she is oh so conventional in one respect. Sue likes money. Actually she spoke on that very issue, in a Zoom conference at UCSF in early June, after leaving Bill Gates’ employ. The conference was intended to address recent shocks to the American system of health care, the George Floyd murder and COVID—race, money and disease, in other words. And how things might change in the future? And here, at first, her wisdom was conventional.

“For me, I don’t think you can or should blow up the existing medical system,” she said, speaking for example of the important role of academic medicine. “I think that there are tools that one can use with existing infrastructure to drive more productive outcomes. I actually think that UCSF or Stanford in and of themselves are less an impediment than the number of doctors who go into expensive specialties. I think that is an impediment if you just say we don’t need that many surgeries of this, or interventions on that. Because if you don’t drive medicine that way—humans do what they’re incentivized to do. If you pay differently, people will go where the money is. So, the one thing I found at UCSF and at Genentech, less so at Gates Foundation, because we didn’t have that much money, but the money matters.” Where she really got interesting—innovative or anti-innovative, depending on your point of view—was the subject of vaccines and research on vaccines. Cue COVID-19. To set the scene.

            As a Big Parma executive and research university chancellor, Sue was a big proponent of speed in studies and speeded-up approval of drugs by the federal government. Apparently no longer. Asked about the flood of unvetted research on the COVID virus, she said, in UCSF’s Zoom conference, “I think it’s mostly bad. And I’m surprised to hear me say that.” Again she referenced her time at Genentech. “One of the most important assets that a [drug] product developer has is confidence. When I was at Genentech, it was just, ‘Be sure about it,’" she said. “Not uncommonly we would use more time or more [test] patients to have more confidence. What I think is the downside to the speed that’s going on now—and you see it, you follow Twitter, it’s the wild west, and I’m not talking about crazy people,” she said, but instead established scientists. “The papers are coming out so fast that people are having to change things. The latest is the hydrochloroquine study. You do not want to have a bunch of retractions. So, I’m pretty negative about the early publications when people haven’t seen the source data, or just going too fast.” 

But she draws a distinction between publication and product development, where she’s more gung ho. “I think you can go very fast but you have to have a clear asterisk. So, it’s not uncommon in oncology and cancer medicine to say I’m getting an accelerated approval and people who are very sick and are going to die of cancer can get this medicine, while in parallel, we do a trial. And if that trial is negative the drug is gone because that asterisk is on there. There are ways with products that you can do that. Here is what I don’t know how to do. I don’t know how to do a vaccine approval—an accelerated approval—if three hundred and thirty million people are going to get it.” 

She returned to her favorite subject. 

Money

            “So, now, I could make a case that you could do a vaccine, because there’s so much money. You have so many patients that you have a big big database, that you feel good about it, or you have a small safety database and you go to small groups of individuals who are at particularly high risk, and so you build your safety database. But for me the two things are confidence, number one, because once you screw up on confidence, it’s over.” Sue changed the Gateses but apparently the foundation has changed her too. Because she said her second concern is transparency, something she wasn’t known for before, on Mount Parnassus.

            “The second thing is just clarity of communication. If this is an accelerated approval, if it’s conditional—if this is, ‘we’re not sure yet,’ tell people you’re not sure yet. People can go with that. But this aura of confidence, especially when you’re not confident yet, makes me very very concerned, especially with vaccines. I think with vaccines it has to be safe and effective unless you’re really clear about who you give the vaccine and then those people know how much you know about it.”

            On the subject of a COVID 19 vaccine, presumably including the one being developed by her own Pfizer, “I think it’s great they’re going as fast as they are. This vaccine speed is truly unprecedented. And not being done sloppy, not being done bad, but when it’s ready for approval, just think, okay, you’re in charge of the vaccine program, you start Phase 3 [trials] in July, you go to December, you have six months of data, and the wrap-up of the patients in the trials, and in January you’re going to treat two hundred million patients with your vaccine? You’ve got to make sure you know enough.” Which turned out to be the case.

            “Here’s the thing,” Sue said during her Zoom comments at the Covid end-of-the-world conference on the Mount. “So, this is for most product developers. This is binary. If you had a cure for COVID 19, have at it—have a human challenge model. If you don’t have a cure—if you’re 25, if you’re 40, if you’re 15—I’m not going to challenge somebody when I don’t have a remedy for what I’m challenging them with. There’s a human challenge model for malaria, but we have drugs for malaria. My own belief is that the enthusiasm for a human challenge [model for COVID 19] kind of went up, and then it went away. And it may be because of that, because there’s just no cure.” She was asked on Zoom, by Dr. Robert Wachter, head of the Department of Medicine at UCSF—an institution where money is used as a reward, a tool and a cudgel—medicine can be a dirty business. 

            Dr. Wachter asked her about just paying test participants for taking the COVID-19 vaccine—for the danger incurred by being guinea pigs, and all. 

            “You could make the argument, and you could pay them,” Sue said, “and make sure they really volunteered and all that. I don’t think it’s crazy that—let me be clear—I don’t think it’s crazy. I don’t think it’s crazy at all—and I [also] understand why people are avoiding it.” Sue's other recent gig has been Facebook, where she resigned from the board last year. For most of the last decade she's been the lead independent Facebook director which meant she was responsible for keeping Mark Zuckerberg & company on the straight and narrow path of ethics. We know how that turned out. 

            The point is that Sue has the moral development of a nematode and if she's concerned about the development of a COVID-19 vaccine, even by her own company Pfizer, how should that make the rest of us feel?