Getting PrEP’d with James Krellenstein | Crooked Media
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October 05, 2021
America Dissected
Getting PrEP’d with James Krellenstein

In This Episode

PrEP–or “pre-exposure prophylaxis”–has been a game changer in HIV prevention, that is, for people who can access it. But Big Pharma has, once again, put its profits over its patients. Abdul talks about the latest in HIV prevention and speaks with James Krellenstein an AIDS activist and co-founder of PrEP4All.





[sponsor note]


Dr. Abdul El-Sayed: Pfizer submits clinical trial data about the safety and efficacy of their COVID-19 vaccine in children aged 5 to 11 to the FDA in preparation to apply to extend the emergency use authorization. Merck announces results of a clinical trial on a new COVID-19 antiviral pill that they say reduces hospitalizations by 50%. Thousands of health care workers are choosing to lose their jobs rather than get vaccinated, as mandates go into effect. This is America Dissected. I’m your host, Dr. Abdul El-Sayed. There are few countries in the world that have been hit as hard with COVID-19 as the U.S.. A little more than a year and a half since the pandemic began, we’ve crossed 700,000 lives lost to COVID-19, more lives lost than in any other nation. And yet so much of the devastation was of our own making.


[news clip] [chanting] These health care workers you can see behind me say they believe it should be their choice as to whether or not they choose to get the vaccine. Some say they’re even willing to get fired over not getting it. But they say who it really hurts are the patients in the midst of a nursing shortage.


Dr. Abdul El-Sayed: From the jump, Americans balked at the most basic standards of safety in a pandemic: social distancing, lockdowns, masks, contact tracing. An astoundingly large proportion of our country, fueled by politicization by a former president and misinformation by some of our largest corporations, turned on any formal science-driven effort to take this on. Some have chalked this up to a certain anti-authoritarian tendency in Americans, but anti-authoritarianism wasn’t the only uniquely American thing playing out. The other was unbridled corporatism. Many of us thought that while Americans might have pushed back on collective efforts—you know, things that required us to do something to protect someone else—that we’d be saved by something Americans would do to protect themselves. We thought that the minute our pharmaceutical industry could produce a vaccine, Americans would line up in droves. Well, at least some of us did. The rest, the same folks who’d been going HAM on all the other interventions, just turned their ire on the vaccines. Today, 18 months into the most deadly recorded pandemic in U.S. history, only about 55% of Americans are vaccinated. But we Americans, we don’t live on an island. We’re not the only country on Earth. This was, after all, a global pandemic. And while doses spoiled at home as our public officials debated whether to get vaccinated Americans a third dose, millions abroad continue to go without their first doses. The Biden administration announced that it would support a total of 1.1 billion doses. That’s great, if the world weren’t nearly 8 billion people. Meanwhile, governments in high-income countries are doing everything they can to protect the corporations that manufacture these vaccines. We’ve, of course, talked about this before on our show, but for folks who’ve been watching this space, they’ve seen it all before. This isn’t the first global pandemic in our lifetimes as much as we hear that. Before there was COVID, there was this:


[news clip] This triggered an epidemic of a rare form of cancer.


[clip] Mysterious newly-discovered disease, which affects mostly homosexual men, but has also been found in heterosexual men and women. The conditions severely weakens the body’s ability to fight disease.


Dr. Abdul El-Sayed: Make no mistake, the fact that we don’t register H.I.V./AIDS as a global pandemic is a function of the fact that our society has routinely discounted the lives of people who are hardest hit by it, whether it was gay men in America or people living in sub-Saharan Africa where H.I.V. Took millions of lives. Today, there is a safe and effective means of preventing H.I.V.: PrEP or pre-exposure prophylaxis, a series of antiretroviral medications that people without H.I.V., but at risk for contracting it, can take daily or around sex to prevent 99% of infections. Those too are manufactured by major pharmaceutical corporations, the same corporations who fought to impose absurd prices for early H.I.V. treatments. Thankfully, activists around the world fought them tooth and nail, and today there are generic forms of PrEP that are available to folks in countries all over the world. They’ve saved millions of lives. But that story, of activists fighting global corporations backed by high-income governments, it’s happening again. And right now, we’re all losing the fight. Today, we talked to James Krellenstein, an AIDS activist and founder of PrEP4All and now an activist for global vaccine access. He’ll share what we’ve learned from the fight for antiretroviral medications and PrEP and what that means for COVID, after the break.


[ad break]


Dr. Abdul El-Sayed: All right, I am also recording. OK, let’s, let’s roll. James can you introduce yourself for the tape.


James Krellenstein: Sure. My name is James Krellenstein. I’m a co-founder and managing director of a group called PrEP4All, and we’re a sort of advocacy group that fights for increasing access to both H.I.V. And COVID-19 treatments and vaccines.


Dr. Abdul El-Sayed, narrating: James Krellenstein started his activism as a teenager, when he designed and built the first online directory of providers who provided access to anti-retrovirals for people who may have been infected by H.I.V. In 2017, he discovered a pattern of alleged anti-competitive practices by the nation’s largest manufacturer of H.I.V. medications, which led to a class-action antitrust lawsuit currently being litigated in federal court in San Francisco. He joined me to talk about what the fight for H.I.V. medications can teach us about COVID-19 vaccine access, and the way that Big Pharma keeps lifesaving medications out of the hands of people who need them.


Dr. Abdul El-Sayed: We deeply appreciate your work, and I think it’s apt that we’re talking about PrEP in the context where we are in the midst of a global fight for vaccine equity because there are so many parallels. And just to start, James, can you tell us about the history of H.I.V. /AIDS in this country?


James Krellenstein: Well, that’s a pretty long history. But the first cases of H.I.V. were reported back in the summer of 1981, and it was primarily first identified in a group of gay men, first in Los Angeles and then there was other case reports in New York, and it slowly—well, slowly under, in COVID times, but rapidly actually a public health crisis time—sort of ran out of control, and we really saw H.I.V. starting to—first AIDS and then the virus that causes AIDS, H.I.V. was discovered back in 1984—it really sort of started running out of control, and we didn’t have really effective therapy at all for H.I.V. Infection until 1995 or 1996. So we really went through about 15 years of the epidemic with no effective form of biomedical prevention and no effective form of treatment. And as a result, close to 750,000 people have died of H.I.V. in the United States since those first cases were reported back in ’81.


Dr. Abdul El-Sayed: And H.I.V. quickly became a global pandemic, obviously slower moving than COVID-19, but with very similar consequences. And we see a lot of parallels about who gets medications, and in the case of H.I.V., what medications get researched and produced in the first place. What are some of the lessons for, or were from the H.I.V. epidemic that you are watching play out in real time right now?


James Krellenstein: Well, you know, so I’m 30 years old, I was born in 1991, so when H.I.V. therapy, when the first effective methods of antiretroviral therapy first were discovered, I was five or six years old, four or five years old, actually. So I wasn’t really alive for that initial victory and then the subsequent fight for global access, which is still going on right now. But the basic truth, if you want to distill it down to a couple of sentences is that, you know, the united, people in the United States and in higher-income countries, there was availability at least, hypothetically, of effective treatments for H.I.V. starting in ’95 and ’96. There’s certainly a huge amount of inequity in accessing that treatment, even here in the US—especially actually—but at least it was accessible. But for a large portion of the people, actually for the majority of people globally who are living with H.I.V., especially in places like sub-Saharan Africa, there just wasn’t any access for years and years and years. And it wasn’t until really there were some pretty profound movement first by activists, especially in the global south, especially like groups like Treatment Action Campaign in South Africa, who really sort of pointed out the fact that, you know, the central excuse that the pharmaceutical industry was giving about why we can’t basically access H.I.V. drugs globally was because it was too expensive. But they pointed out that, yeah, it’s too expensive because of the prices that the large pharmaceutical industries charges, but if we actually could make generic versions of these drugs, we could bring the costs down to maybe a couple hundred dollars a year at first. And now where we are, where you know, a year of antiretroviral therapy globally cost about $85, $90 a year. And that, coupled with really significant movement by the US government first, and then by international partners all around the world, has allowed us to, while certainly not solving the global access crisis that we have in H.I.V. drugs, to really implement programs that have saved tens of millions of lives globally from death from H.I.V. Because we have actually highly-effective programs in all sorts of countries around the world, from higher-income countries to lower-income countries. And in fact, many lower-income countries actually do better than the United States does in terms of actually achieving viral suppression, which is the sort of, you know, state that you’re in when you’re on effective antiretroviral therapy. And we’re seeing the exact same thing play out today in COVID, where unfortunately we have developed extremely effective—I mean, FORTUNATELY, we’ve developed extremely effective vaccines for COVID-19. You know, we have vaccines that are easily more than 80%, most cases more than 90%, effective at preventing severe disease and hospitalization from COVID-19 and about that effective, if not more, in preventing death. The basic problem is that as once again, it’s completely unequitable access, unequal access, where we have places in the United States that are contemplating boosters and places in sub-Saharan Africa again, where less than 2% of the population is vaccinated at all. And the basic problem is that to be honest, there isn’t enough vaccine doses, and to put a finer point on this, there aren’t enough vaccine doses of the most effective vaccines that we know, that we’ve developed. And this is once again a pretty large failure, I would say, of the pharmaceutical industry. And I would say of the United States government, for simultaneously failing to really scale up production in a timely manner of the most effective vaccines.


Dr. Abdul El-Sayed: But what you’re getting at here is the way that late-stage capitalism, the fact that we leave biomedical pharmaceutical manufacturing to huge pharmaceutical corporations, that that implicitly ties the value of a life when you’re talking about a life-saving medication or a preventive medication to the dollar amount that a government, in this case, will pay. And when you do that, what you’re basically saying is that giving a third dose to an American life is worth more than giving a first dose to a sub-Saharan African life, which we understand to be deeply inequitable but those are the incentives and logic of of the market that we continue to allow to pattern access to these resources. I want to zoom in on PrEP because I think it’s a really important case study here. Can you tell folks what PrEP is and why it’s such a game changer for it, for H.I.V. prevention?


James Krellenstein: So PrEP is right now a form of oral medication that you take daily. There’s two different FDA-approved drugs—one brand name is Truvada, the other one is Descovy—that you take every day that dramatically reduced your risk of H.I.V. infection. So once again, this is a medication for people who are H.I.V. negative, who don’t have H.I.V. yet and maybe are at risk for H.I.V. infection and don’t want to get infected. So I, for example, I take generic Truvada every single day. I do not have H.I.V. right now, and that reduces my risk of getting H.I.V. by over 99%. So basically, if you take PrEP every day, right now it is as effective than most vaccines are for other vaccine-preventable diseases. So the basic story is we don’t have an H.I.V. vaccine, but we have a drug that we can take every day that basically works like an H.I.V. vaccine. It’s extraordinarily effective at preventing new, you getting H.I.V.


Dr. Abdul El-Sayed: And how does one get access to PrEP, which stands for pre-exposure prophylaxis—and for folks who, you know, can’t cut through the medical jargon, exposure is when you first come into contact with the virus, so it’s pre, before the exposure, and then prophylaxis is the name for something you take to prevent something. So how do you get access to it? Like, what is your protocol if somebody you know came to you and said, James, I want to get on PrEP.


James Krellenstein: Great question.


Dr. Abdul El-Sayed: What would be the process for them?


James Krellenstein: So basically, you go to a physician, hopefully a physician who is knowledgeable about PrEP, which is one of the big barriers that we have to access, and say, look, I’m at risk for H.I.V. infection, I’m gay and I engage in sort of, you know, to be blunt, you know, I have anal sex, and that’s a very-high risk activity in terms of H.I.V. transmission. It’s what I explained this to my physician and my physician did a couple of tests. He tested to make sure that I didn’t already have H.I.V. He then tested that my kidneys were OK. He tested me for some other STDs. When all of that came, you know, was basically, you know, I didn’t have him, when it was all negative, he wrote a prescription for Truvada or for the generic. And I go to my pharmacy every month and I pick up a 30-day supply of the drug, and I go back to my doctor every three months. So every three months I have to go see my doctor, they check again and they write me another prescription with three results. So that’s the basic sort of protocol that we have for PrEP. There’s other ways of doing it. It’s just, and it’s important, maybe for people to understand there’s also another form of PrEP that’s the same drug, called intermittent PrEP, where rather than you taking it every day, you just take two Truvada pills, or generic Truvada pills, right before, up to an hour before you have sex, and you take one the day after, and one the day after that. And that’s also highly effective at preventing H.I.V. infection.


Dr. Abdul El-Sayed: So there are, of course, a whole bunch of barriers to seeing a doctor, to getting your prescription filled. Can you walk us through some of the barriers that that folks can face when they’re trying to get prep?


James Krellenstein: So exactly, I mean, even if we pull back to the specific barriers, if you actually look at what the impact of PrEP has had, even in the United States, where PrEP has been hypothetically available since 2012, so nearly a decade ago, most people who need PrEP are not on PrEP. Most people who need PrEP can’t access PrEP. As a result, the number of H.I.V. infections that we see every year in this country really hasn’t changed that much. We still today, despite the fact that we have this ability to take a pill that reduces your risk by over 99%, 35,000 people every year in just the United States alone become newly infected with H.I.V. That’s more than for an hour every day, 24 hours a day. And then one of the biggest barriers why we haven’t seen PrEP really translate into public health progress is because we don’t have a system to ensure universal access to it. So as you said, PrEP initially when it came on the market, despite the fact this is a drug that was almost exclusively developed by the federal government, the federal government allowed a manufacturer called Gilead Sciences to charge $2,000 a month for Truvada, despite the fact that it cost less than $6 a month to be, when it was available generically. So, it cost less than $6 a month to make, they were charging $2,000 a month. So it was a huge barrier initially, was that the extremely high price of the drug, was just required you to use a mail order pharmacy, to use a copay card, you sometimes would have to pay in the early days a huge amount of money out of pocket to hit your deductible. And this is all for people who had health insurance. But if you didn’t have health insurance, you had problems not only necessarily accessing the drug, but accessing a physician or some sort of health care provider who could actually do that test, who could write that prescription. You had you had problems, still, paying for the laboratory costs. And this is still a problem that is, that is continuing to this day. To your point about sort of late-stage capitalism, the insane part of this whole thing is to get less than 20% of the people who actually needed PrEP on it, we are paying Gilead every single year, $2 billion, the health care system as a whole. More than $2 billion, in fact. And if you actually just had a generic version of Truvada, which we now do have, and you actually put just a small fraction of that money into paying for people’s health care, paying for their laboratory costs, making it universally accessible, we could have gotten every single person who needs PrEP in this country on PrEP, and we could have prevented tens of thousands of H.I.V. infections every year. Not only obviously making people healthier, probably preventing a lot of illness and possibly even death, but also saving the health care system tens of billions of dollars because, you know, an ounce of prevention is really worth a pound of cure here.


Dr. Abdul El-Sayed: Also that we can allow a major corporation who manufactured a drug paid for, whose R&D was paid for by the federal government, to make billions of dollars in profit off of the goal of preventing H.I.V. in our country. And mind you, you know, listeners of the of the show will remember back to an episode in the first season where we profiled the same corporation, Gilead, and the way that they played games with the pricing of Hepatitis C drug, Sovaldi, that kept it out of the hands of people who needed it. What is PrEP access like abroad? And can you talk about the ways that, you know, Gilead and other corporations have interfered with the globe’s ability to prevent H.I.V. transmission?


James Krellenstein: So H.I.V. is an interesting space in that for a lot of lower and middle-income countries, but mainly lower-income countries—very complicated in the middle-income countries space—lower-income countries, we generally actually have for H.I.V. antiretroviral drugs, we actually do have relatively permissive licensing. So we have a huge amount of competitive generics. We have over a dozen generic companies all around the world who make generic versions of Truvada. And in lower-income countries, they’re allowed to actually distribute those drugs even before the patent had expired. And just to go a little bit back on the American side, what was crazy about the American situation is when a generic drug company would try to go and make and introduce a low-cost version of Truvada to America to distribute it in the United States, Gilead would go to court and they would, and they would allege that they were infringing on these patents that Gilead had some rights to. The irony of that is that the patents, the research that formed the basis of those times that Gilead used to prevent Americans from accessing low-cost generic versions of the drug were not paid by Gilead—the research that formed the basis of the patent was paid by us, the taxpayer. So Gilead would literally use a taxpayer-funded patent and go into federal court and say you cannot bring a low-cost generic version to American taxpayers because of a research that American taxpayers paid for. And that was the profound fundamental irony, is that Americans were getting sick, getting infected with H.I.V. because they couldn’t afford a drug that they themselves paid for the research and development of. To go to the global situation, here’s the crazy aspect of what, of how bad PrEP pricing was, is that even globally, even in higher-income countries like the United Kingdom, like the U.K., the UK could not for years and years and years put PrEP on their national health care system, on the National Health Care Service, on the NHS, because of these exact patents—that once again we, the American taxpayer paid for—the NHS could not access low-cost versions of generic Truvada. And as a result, it simply was too expensive for even a universal health care system like the National Health Care Service to actually pay for and put on their formulary. So for years and years and years, UK activists had to basically set up systems where they would import drugs from India sort of illegally to the United Kingdom and had to jerry-rig an entire system, even in a country that has a pretty good universal health care system, precisely because the price of this drug was just so absurd that even the UK couldn’t afford it. So we had two actual problems on the global access front. On the higher-income countries we had initially, the drug pricing problem. That has kind of gone away as we have at least sort of allowed the patents to expire and allowed generics to happen. On the lower-income countries, despite that the drug is relatively cheap, we don’t actually have the funding for the health care system to deliver PrEP in a very, very high level. There are PrEP pilot projects all over lower-income countries. But right now, one of the big challenges that we have is actually bringing PrEP to scale to actually meet the demand in those lower-income countries. And that is something that I think we and global activists are really going to be working on in the coming years.


Dr. Abdul El-Sayed: And the important thing here, right, is the role of generics, which of course, has been a major fight on the COVID-19 vaccine front, to bring this back to the parallels, which is the fact that, you know, a number of high-income countries have been balking at the idea that we would violate the sanctity of patents for these huge corporations that are making billions of dollars selling products of publicly-funded research to end a global pandemic. And so we don’t have those generics online in the way that we would need to, to be able to to take this on. I want to, I want to ask as we think about this moment, it took a lot of effort on the part of activists and advocates and academics coming together to take this research forward to hold pharmaceuticals and the governments that have enabled their greed, accountable. What does that look like right now, and can you tell us about how your organization PrEP4All is part of a broader community of activists that are taking the fight to the corporations and their enablers on the COVID vaccine?


James Krellenstein: So what’s important to understand about vaccines versus what we call small molecule drugs, like the types of drugs that are in anti-retrovirals like Truvada, like in PrEP, is that it’s not as easy to make a generic version of a vaccine. In fact, I think you could credibly argue there is no such thing as a generic vaccine, right? When we talk about what happened in the H.I.V. space, it really was just a matter of us getting rid of the intellectual property. And in that case, we had literally dozens of manufacturers all around the world who within a couple of months figured out how to make a version of Truvada and who were able to trivially demonstrate that their version of Truvada was basically the exact same thing as the brand name and the doctor didn’t have to worry when he prescribed Truvada and his patient or her patient got a generic version of the drug. It was the same thing. Vaccines are kind of different than that. Vaccines require not only that we get rid of the intellectual property barriers, but that we also teach the ability to actually make them, that we actually be able to replicate the entire manufacturing process. And then we’re able to go to a regulator like the Food and Drug Administration or the W.H.O. and say, Look, this actual version of the vaccine that we’re manufacturing is equivalent to the version that the quote so-called “originator” like Pfizer or Moderna actually originally manufactured. And that requires really intervention, not only the companies to say we’re not going to enforce our intellectual property, but really them to say, actually, we’re going to work with other companies around the world to teach them how to actually make these versions of, to make a version of our drug, that’s exactly—of our vaccine that exactly the same. And we’ve seen actually companies when they want to do this, we see them do this all the time, even in the vaccine space. So take a company like Moderna. Moderna basically was a small little biotech when they had at the beginning of 2020, they realized all of a sudden they have a global huge market in the higher-income countries, they want to make enough of it, they don’t know how to make it. So they went to a company in Switzerland called Lonza, and they shared with Lonza all the sort of ways that they can make their COVID vaccine. And they said, Lonza, start building this in your factories and we’ll work with you to make sure that those factories are online. And in fact, every single dose of Moderna that has been administered outside of the United States has not been made by Moderna, but is instead been made by a company in Switzerland, and a little bit in the United States, called Lonza. That’s exactly the model that we’ve been calling for. And we recognize, though, that that might take a lot of time to do it so we really need the US government to step up and force these companies to work with contract manufacturers all around the world to actually make the versions of sort of Moderna and Pfizer all around the world. And we really should do this as fast as possible. So one of the things that we have been strongly advocating for is that the United States actually create their own facility, first in the U.S., and use that to train people all around the world to actually manufacture more doses of these COVID vaccines. And we call that a GOCO, it’s a government-owned, contractor-operated facility. The idea there is that the U.S. government should actually control actually vaccine manufacturers as a matter of national security and be able to teach people all around the world, not rely on Moderna, not rely on Lonza, but actually have their own facility that they can teach people how to make these vaccines and transfer that knowledge. But the Biden administration, I’ll just be frank at this point, has been seemingly more interested in protecting the pharmaceutical industry than saving the millions of people who have died from COVID-19 since we’ve had highly-effective vaccines. And that’s really why we are in a situation today where we have almost no global manufacturing. We have no manufacturing that the government controls, even though we paid for the research and development of especially the Moderna vaccine. And it’s a real stain on this presidency. There’s no way around this. What we are as activists are doing is putting as high of pressure on this administration as possible to actually take the steps that they have. President Biden could sign a piece of paper on his desk today that would force Moderna to do this, but he’s refusing to. And that’s really the fight that we’re in right now. And I have to say, it is astounding the number of people who have died, who are dying from COVID right now. More than one person is dying every five seconds from COVID-19 globally. And we have highly, highly-effective vaccines that we can bring to scale as fast as, within six months, if we wanted to.


Dr. Abdul El-Sayed: Yeah, I’m confident that when the history of this pandemic is written, our failure to vaccinate the world as one of the leading originators of COVID-19 vaccines, will stand out as one of the biggest failures, if not the biggest failure. I know all of us are so worried about COVID here, and we’re having this conversation about boosters here, but the idea that while others are struggling to get their first doses, we’re having a robust debate about our third dose is itself, is an indictment on our failure to recognize, yet again, our role in a global community of humanity. I want to just ask you one last question before we let you go. There was a movement in the public health space to recognize that moralizing around people’s behaviors was never going to work, and we went from an abstinence-driven kind of approach to a harm-reduction approach on everything from, you know, pregnancy to H.I.V. prevention. And yet when it comes to COVID, it’s like we’ve sort of forgotten how to do harm reduction. And I want to ask you, you know, what can we learn from the experience of harm reduction when it comes to COVID and both the vaccine, but then also, you know, masks and other policies—what should we have learned from the experience of H.I.V. prevention that that we failed to?


James Krellenstein: You know, I think one of the most important parallels and analogies we often have is the condom debate. You know, for years and years and years, even actually after PrEP was FDA-approved, people argued against bringing PEP because it will stop people from using condoms. And the point I always made is the point of the H.I.V. prevention is not to have people wear condoms, the point of H.I.V. prevention is to prevent H.I.V. And I think that basic logic should be applied to everything that we do with COVID-19. The point of COVID-19 prevention methods is not to make people wear masks or to get vaccinated, we probably want them to do both these things and not argue against them, obviously—the point is to prevent COVID-19. And what we should be looking for is the most effective methods that we have to prevent COVID-19. So right now, that is vaccination. We want people to get vaccinated. We want people right now in this place where we have the Delta variant transmitting with this huge level of transmission going on, we want people to be wearing masks in certain contexts, but we want to be ultimately looking for technology, biomedical technology, that allows us to restore to a normal, you know, so-called normalcy. And one of the points that we make is that this whole debate that we’re having right now against boosters, right, for the United States, versus global access, that was a policy choice that we made, right? And that goes back to the point that we should have made as a national priority, the idea that we need to get, you know, vaccines to everybody around the world, because ultimately that is going to be the most effective harm reduction method that we have. The most effective form of harm reduction we’ll have for COVID-19 is ensuring global vaccination, right, which will ultimately bring the global level of transmission down so much that we reduce the risk of infection not only to the U.S. but around the world. And most importantly, we really reduce the risk of development of variants like Delta that really pose a threat to the public health of the US. But I think what we have to look for is going forward is what are the most effective methods of preventing COVID-19? Not getting attached to any particular method or the other, right? I mean, condoms for years was really the most effective method of preventing H.I.V., and it would have been insane for me to say, you know, condoms aren’t inextricably linked to H.I.V. prevention. But we had a technology that actually performed better than condoms, people shouldn’t have argued, well, we shouldn’t use that better technology because it’s going to make us not use condoms. And that’s, I’m not so sure we’re yet at that point in the COVID debate, I don’t think we are. What I am ultimately looking for is the development of a COVID vaccine that actually assures durable protection from actual infection risk. And I think that is possible, and we could go into that discussion, and there’s actually a possibility that boosting may actually achieve that—we don’t have the data yet on whether it’s durable or not. But the question that we have to deal with is why are we making this sort of choice between boosting here and globally vaccinating? You can’t fight scarcity with scarcity. The basic problem we’ve had is we’ve chosen not to make enough of these vaccines.


Dr. Abdul El-Sayed: I, I deeply appreciate that point in the recognition that we should not be holding on to the kinds of technologies that our new technologies make anachronistic, and doing so risks putting millions of people’s lives in harm’s way. James, really appreciate you taking the time to share your expertise, your insights, and your experiences with us. We appreciate your leadership at PrEP4All.That was James Krellenstein. He is co-founder and leader of the organization PrEP4All. We thank you again, James, thank you again for your time.


James Krellenstein: Thanks so much, Abdul.


Dr. Abdul El-Sayed: As usual, here’s what I’m watching right now. The Delta surge appears to be ebbing, as cases continue to trend downward across the country. Nevertheless, we continue to see thousands of deaths a day, twice as many in rural communities where vaccination rates are lower. Make no mistake, this decline in cases is great news, but we’ve really got to ask what we do to keep it this way. On that note, vaccine mandates work. Take Tyson Foods, for example. Across their 120,000 employees, their vaccine mandate yielded a 91% vaccination rate. That said, thousands of health care workers are choosing to lose their jobs rather than get vaccinated as mandates go into effect. This puts our health care system, already reeling from COVID-19, at real risk. Stepping back, though, you’ve got to question how someone goes about using science-based reasoning to make choices for patients every single day and then refuses to accept that same reasoning for themselves.


In other news, Pfizer submitted clinical trial data toward FDA emergency use authorization for children aged 5 to 11 on their COVID-19 vaccine. Though they haven’t formally applied for authorization, FDA analysts aren’t taking any time to get started in their review. It could mean that children five and up could be getting their vaccines as early as the end of the month. Wouldn’t that be great? And finally, the drug manufacturer Merck announced that their new antiviral medication molnupiravir reduces hospitalizations and deaths to COVID-19 by 50%. They’ll apply for FDA emergency use authorization in the next few weeks. The drug could be a breakthrough in COVID treatment. Unlike monoclonal antibodies, the current standard of care, which require an I.V. infusion, molnupiravir is a four-pill regimen, taken twice a day for five days upon symptoms. That said, it’s absolutely no replacement for vaccines.


That’s all for today. And don’t forget, we’re doing a live taping at the American Public Health Association annual meeting in Denver on October 24th. So if you’re going to be at APHA, make sure you plan to join us at six o’clock on Sunday. On your way out, do me a favor, go to your podcast app, rate and review our show. It goes a long way to getting it to other folks. And if you really like the show, you can go on over to Crooked Media store and pick up some merch. We’ve got our new logo tees and mugs, our Safe and Effective shirts, and our Science Always Wins shirts and dad caps.


Dr. Abdul El-Sayed: America Dissected is a product of Crooked Media. Our producer is Austin Fisher. Our associate producer is Olivia Martinez. Veronica Simonetti mixes and masters the show. Production support from Tara Terpstra, Lyra Smith and Ari Schwartz. The theme song is by Taka Yasuzawa and Alex Sugiura. Our executive producers are Sarah Geismer, Sandy Girard, and me, Dr. Abdul El-Sayed, your host. Thanks for listening.