Patenting the Covid-19 vaccine is wrong

The world has recorded at least 166 million cases of Covid-19 and over 3.4 million deaths, according to the Hopkins coronavirus dashboard, and the true numbers are certainly far higher. The only way we will defeat this virus is through vaccines, and fortunately science has delivered the goods, with multiple highly-effective vaccines now being produced. In some countries we are turning the corner: in the U.S. cases have been steadily declining since mid-winter, and are now at their lowest level since last June.

Unfortunately, in many countries the virus is raging unchecked, and vaccines are in very short supply. We won't defeat SARS-CoV-2 until the whole world has adequate supplies of vaccines.

One barrier to wider, more rapid distribution of vaccines is patents. The companies that are making the vaccines have patents on them, which means that no one else can manufacture the vaccines without paying license fees. 

The human species doesn't have time for this nonsense. The profits of a few companies are far, far less important than the lives of millions of people. And yet many governments, including most EU countries, are standing firm behind the patent system. Crudely put, they are defending money over human lives. 

Recently, in a surprising move, President Biden announced support for a "vaccine waiver" that would allow any country to develop vaccines against Covid-19 without licensing the technology from one of the companies that currently holds a patent. The UK is now considering supporting a waiver as well, but other countries in the European Union and the G20 have come out against any waivers. The EU position seems to be that if you can't pay, you can't have the vaccine, even if your own scientists have the expertise to manufacture it themselves.

I've been an outspoken critic of patents for many years, including gene patents (which never should have been allowed in the first place) and software patents (which are frequently filed for trivial ideas and often used primarily to create lawsuits), but patents on the Covid-19 vaccine are objectionable for a different reason: they're unethical. If companies persist in enforcing them, the governments that approved the patents should simply invalidate them.

I know that many people will tell me I'm naive for suggesting this. I have heard their arguments before, many times. These include claims that without the patent system, companies simply won't invest in new inventions, and the public will suffer. These claims are, bluntly put, wrong.

In a famous 1955 interview, Jonas Salk, the inventor of the polio vaccine, was asked by journalist Edward Murrow who owned the patent. 

“Well, the people, I would say," Salk replied. "There is no patent. Could you patent the sun?" 

And yet despite not being patented, the polio vaccine was successfully produced and distributed, and as a result humans have essentially eliminated polio from the world. (It still persists in a handful of countries, due to political and economic reasons as well as vaccine resistance.)

Just a few days ago, epidemiologists Gregg Gonsalves and Gavin Yamey (from Yale and Duke) published a public call for a "people's vaccine," which would require waiving patent rights on Covid-19 vaccines. They point out that vaccine waivers are just one step among several that we need to take, as a species, if humans are going to defeat this pandemic. So if I'm naive, I guess I'm in good company.

Why do we have the patent system at all? When you think about it, the patent system is a government-supported, guaranteed monopoly on a commercial product. The only possible reason for governments to support this is that the citizens of their countries will benefit. The patent system was never designed to guarantee the profits of private corporations and law firms–but of course these groups have profited immensely from patents, and they have created an entire ecosystem to defend the status quo.

But I digress. The Covid-19 pandemic is a worldwide health crisis that surpasses anything we've seen since the 1918 influenza pandemic. Stopping the pandemic, and ending the suffering and death of millions of people, will require getting vaccines into most of the world's population, whether they live in rich countries or poor ones. Patents and the licensing fees that come with them can only slow down this process.

That's why enforcing patent protection on any Covid-19 vaccine is unethical. The companies that are claiming patents could fix this by announcing that they will offer their technology for free to anyone in the world, but we can't expect that to happen. President Biden's announcement that the U.S. supports a patent waiver, and the UK's likely announcement of a similar position in the coming days, are a great move in the right direction. Let's hope that the rest of the world's governments follow suit.

Should women be taking estrogen to treat the effects of menopause? New research says yes.

Until about 20 years ago, physicians routinely prescribed the hormones estrogen and progestin for women after menopause, when levels of both of these hormones decline. This seemed like a logical treatment, and the hope was that it would slow down bone loss (osteoporosis), reduce the risk of heart disease, and treat other age-related problems. Estrogen also has the benefit of increasing sexual desire for women.

This all came to a screeching halt in 2002, when the Women’s Health Initiative published its first findings about the effect of estrogen and progestin. Although the initial results did show benefits for osteoporosis, the main finding, trumpeted loudly at the time by NIH and in various press releases, was that the combination therapy (both hormones) increased the risk of breast cancer. As the US Office on Women’s Health says today on their website, the 2002 study found that “women taking combination (estrogen and progestin) hormone therapy for menopause symptoms had an increased risk for breast cancer, heart disease, stroke, blood clots, and urinary incontinence. Although women using combined hormone therapy had a lower risk of fractures and colorectal cancer, these benefits did not outweigh the risks.”

It turns out that this was not the full story.

As detailed in a stinging rebuke by one of the principal investigators of the Women’s Health Initiative, Robert Langer, the announcement in 2002 was deeply flawed, and many of the clinical investigators were “shocked” and “aghast” when they saw the paper announcing the results, which they had no opportunity to comment on before it appeared. Despite many objections, NIH proceeded with a “highly publicized press conference, centered around the inflammatory press release... that pandered to women’s greatest fear–the fear of breast cancer.”

Not surprisingly, the use of hormone replacement therapy plummeted after that, and has remained low since.

Perhaps even more striking, as Dr. Langer wrote in 2017, was that results from the Women’s Health Initiative (WHI) trial of estrogen alone (not in combination with progestin), reported 2 years later, suggested that estrogen alone led to a reduction in breast cancer, and a reduction in coronary heart disease as well.

So it appeared that, despite all its flaws and its premature termination, the WHI study showed that estrogen therapy alone seemed to have major benefits. The problems (if there were any–the termination of the study makes this conclusion somewhat uncertain) arose with a combination of estrogen+progestin.

Another large study of hormone therapy, the Danish Osteoporosis Prevention Study (DOPS), also halted its efforts after the 2002 report from the WHI. However, those women had already been in the study for 11 years at that point, and the Danish scientists continued to follow them for up to 16 years. They reported their findings in 2012, and the results were quite the opposite of what the WHI had found. I’ll just quote them because their findings are so stark:

“After 10 years of randomised treatment, women receiving hormone replacement therapy early after menopause had a significantly reduced risk of mortality, heart failure, or myocardial infarction, without any apparent increase in risk of cancer, venous thromboembolism, or stroke.”

These benefits were confirmed in 2020, when a long-term followup of the women from the original WHI study found that women who took estrogen (CEE, or conjugated equine estrogen) only had lower rates of breast cancer than women who did not.

Even more recently, in a yet-unpublished preprint, NIH scientists Seo Baik and Clement McDonald examined the records of 1.5 million women collected from the Medicare database, looking for the effects of estrogen-only therapy on the risk of cancer, heart disease, and death. They found that the use of estrogen-only led to a 21% reduction in the risk of death, and a similar reduction in the risk of breast cancer, endometrial cancer, and ovarian cancer. Combination therapy using both estrogen and progestin, in contrast, led to an increased risk of breast cancer.

The message now seems pretty clear: despite the hasty, scary announcements made by the Women’s Health Initiative back in 2002, the accumulation of evidence suggests that estrogen-only hormone therapy for post-menopausal women is likely to convey a range of highly significant health benefits, not only for breast cancer, but also for osteoporosis and heart disease. The benefits vary by age, and by whether or not women have had hysterectomies, but the overly simplistic idea that hormone therapy causes breast cancer is simply wrong.

The NIH Office on Women’s Health still has this wrong, but the Women’s Health Initiative website is much more up-to-date, featuring an announcement from 2020 that describes the “enduring protective benefit of estrogen-alone therapy.”

As with most medical treatments, the true picture is complicated, but millions of women today might benefit from estrogen. If you think you might be one of them, talk to your physician.

Europe's pause on the AstraZeneca COVID vaccine plays right into anti-vaxxers' hands

Last week, more than a dozen European countries suspended the AstraZeneca Covid-19 vaccine. They claimed it was out of an excess of caution, but instead they played right into the hands of those who continue to spread anti-vaccine misinformation.

On Thursday, the European Medicines Agency announced that there was nothing to worry about, that the AstraZeneca vaccine was safe, and that all countries should resume using it.

Too late, I fear. The harm has already been done.

I’ve been fighting the anti-vax movement for years, as have many other scientists, doctors, and science bloggers. We’ve seen their strategies, and they don’t play fair. They don’t care about facts, and they love to scare people. This latest incident gives them plenty of fodder.

First let’s talk about the “fear” part. A very, very small number of cases were reported in which people had blood clots soon after getting the vaccine. This sounds scary.

But wait a minute. We are giving the vaccine to millions of people. If you look at a group that large, how many of them will have blood clots in a given week? The answer, not surprisingly, is greater than zero.

So the first thing that public health authorities should have asked is, obviously, are we seeing more blood clots than expected? But no, they didn’t do that. Instead, out of an excess of caution (so they claimed), they halted the AstraZeneca vaccine while they investigated. This meant that literally millions of vaccine doses were not administered.

Fortunately the investigation took only a few days. What did they find? Well, here’s the answer, directly from the European Medicines Agency itself:

“the number of thromboembolic events reported after vaccination ... was lower than that expected in the general population.”

In other words, the vaccine clearly doesn’t cause blood clots. If anything, it might even prevent blood clots, because the number observed was lower than expected. (No one is claiming that it actually prevents blood clots; I’m just pointing out how wrong the decision to halt the vaccine was.)

Now the unfounded fear of vaccine-induced blood clots has spread through Europe and beyond. You can’t “unsay” something like this, and anti-vax websites and social media groups are already using it to scare more people. (I won’t link to any of them because I don’t want to give them the traffic.) Indeed, several northern European countries still haven’t resumed use of the vaccine, and Germany, France, and Italy are including a warning (an incorrect one) that the vaccine might cause blood clots. This is just wrong.

Halting the AstraZeneca vaccine without doing some very basic number-checking was a huge blunder. Let’s just hope this decision doesn’t cost too many lives.

We've totally crushed the flu virus this year

 As awful as the Covid-19 pandemic is, it’s given us at least one benefit: we’ve utterly crushed the flu virus.

That’s right–the flu has almost completely disappeared this year. A combination of social distancing, closed schools and businesses, dramatically reduced travel, and high flu vaccination rates has achieved something that most flu experts never thought possible.

Flu levels are so low, in fact, that one has to wonder if the flu will even come back next year. The levels now are far lower than we’ve ever seen in modern history. Let’s take a look at the numbers:

nfluenza cases reported to the CDC by US public health laboratories, 2020-2021 season. Data from the CDC, graph created by the author.

As you can see here, the very worst week had just 24 confirmed cases in the entire U.S. That is truly astonishing. And in 2021 so far, we’ve had 5 or fewer cases in the entire country each week. Basically, the flu is gone. To see how dramatic this is, let’s look at data from last year (the winter of 2019-2020), which was a typical flu season:

Influenza cases reported to the CDC by US public health laboratories, 2019-2020, season. Data from the CDC, graph created by the author.

As you can see above, the U.S. had about 3,000 cases per week in January and February of 2020, with a peak at nearly 4,000 cases.

The rate of influenza this year is over 100 times lower than it’s ever been. Why did this happen? It’s obvious: all of the precautions we’re taking to reduce the spread of Covid-19 have worked wonders to prevent the flu as well. In fact, they’ve worked far better for influenza than for the Covid-19 virus.

No one knows what the flu season will look like next year, but for now, at least we’ve won a clear victory against the influenza virus. That’s a bit of good news.

RNA vaccines have arrived. Let's starting making them for influenza, right now.

The race to end the Covid-19 pandemic will be won by vaccines. We now have at least four approved vaccines, and the first two–the fastest to be developed and approved–were both RNA vaccines, a new technology that has never before been used on a large scale.

As I’ve written before, these RNA vaccines are a scientific triumph. Both the Moderna vaccine and the Pfizer/BioNTech vaccine are 95% effective against the virus. Both were developed in a matter of days–days!–after the genome sequence of the Covid-19 virus, SARS-CoV-2, was first revealed.

Now that we know that RNA vaccines work, what’s stopping us from designing and deploying this technology for many other infections that we don’t yet have under control? Simply put: nothing. We just need to have the will to do it, and it will happen. By which I mean, we need the government to pay for it.

Once Covid-19 fades, as it will, we’ll still have to deal with influenza, which sweeps through the population every year, often mutating significantly from the previous year. That’s why we need a new flu vaccine every year: the flu itself mutates to escape the protection we have from last year’s vaccine.

(Aside: we’re in the midst of the mildest flu season in decades, perhaps ever, thanks to the Covid-19 restrictions. The CDC reports fewer than 100 confirmed cases of influenza in the entire country, at a time when we’d usually be seeing thousands of cases per week.)

RNA vaccines are remarkably easy to design, and they’re much cheaper than conventional vaccines too. We should be thinking about making them for a raft of illnesses now: not just flu, but malaria, HIV, and others. But let’s start with the flu.

We already know that we need a new flu vaccine every year, so here’s a not-so-radical proposal: let’s create an RNA vaccine for the flu, right now, paid for by the government. It’s almost certain to work, and it will likely work far better than the current vaccine. Here’s why.

For the current flu vaccines, we create a new vaccine every year based on what’s currently circulating among humans. For the Northern hemisphere, we choose the vaccine strain right around now (late January or early February), because it takes 6 months to prepare the vaccine for the following fall.

The flu vaccine production uses a crude, decades-old process. After choosing a vaccine strain, the manufacturers (GlaxoSmithKline is one) isolate the virus and then inject it into chicken eggs, where they let it grow for 4-5 days. The virus is then extracted from the eggs, killed, and stuck into a syringe. That’s basically it. (This is why people who have egg allergies are sometimes warned not to get the flu vaccine.)

There are loads of problems with this process. First, it often turns out (and this is not widely known) that the first choice for a vaccine strain doesn’t grow well in eggs. In those years, the manufacturers move on to a second, third, or fourth choice, until they find one that grows in chicken eggs. These inferior choices, in turn, lead to vaccines that are less effective at conferring immunity.

Second, the process requires huge, messy chicken farms, which means it is slow and costly. Third, even though the virus is a killed virus, there’s always a small chance that some live virus will survive and infect people.

RNA vaccines, in contrast, can be manufactured precisely to match the virus that you wish to target. There’s no need to grow it in chicken eggs. And it’s far cheaper to make. In addition, you only need a fragment of a virus to make the vaccine, so there’s zero chance that anyone can ever be infected from the vaccine. And we know exactly what to target on the influenza virus: the hemagluttinin and neuraminadase proteins that cover the surface of the virus.

If RNA vaccines are so good, one could argue, why not allow the free market to produce them? Because it just won’t happen: the flu vaccine is not very profitable, and getting an entirely new vaccine approved is very expensive. Private companies just aren’t going to do it; on the contrary, several past flu vaccine manufacturers dropped out of the business because it just wasn’t profitable.

(Interesting story: about 15 years ago, I attended a talk by Anthony Fauci about influenza. At the time, I was leading a large-scale effort to sequence thousands of influenza viruses, a project that continues to this day and that is run by Dr. Fauci’s institute, NIAID. At the end of his talk, I asked Dr. Fauci why the NIH itself couldn’t sponsor flu vaccine development. He answered that it just wasn’t done that way–that NIH handled the basic research, but left vaccine development to industry. Well, Covid-19 has changed all that.)

We don’t have to create a new government-run facility to make the vaccines in order for this to work. Instead, we can do exactly what we did for Covid-19: pre-purchase a large supply of RNA-based flu vaccines, and provide generous funding to pay for the vaccine development and testing. Then companies like Moderna and Pfizer will have proper incentives to use their technology on influenza.

The health benefits of new, better vaccines are far too important to leave this to private companies, who are motivated more by profits than by an interest in public health. Let’s use the scientific success of RNA vaccines to change the way vaccine development works in a big way. We can save untold numbers of lives if we do.

Should we pay people to get vaccinated? Well, maybe.

This past week, a major US retail company, Dollar General, announced that it would pay its employees the equivalent of four hours’ salary if they would get the Covid-19 vaccine. That’s about $40, based on the average pay at Dollar General. The idea is to give employees an additional incentive, and also to cover the time they might need to take off work to get vaccinated.

This is an excellent idea. Let me explain why.

First, though, I should point out that several prominent economists, including Harvard’s Gregory Mankiw and the Brooking Institution’s Robert Litan, have already proposed paying people to be vaccinated–but their proposal is, frankly, terrible. So let’s start with that.

Now that we have two vaccines, from Moderna and Pfizer/BioNTech, with more on the way, we can finally see an end to this awful pandemic. At the moment we have a supply problem: there aren’t enough vaccines to go around. But soon, perhaps in a few months, we’ll have plenty of vaccines. Then the problem becomes getting enough people vaccinated to create “herd immunity.”

(Aside: herd immunity has been discussed ad nauseum this year, so I won’t get into any details, but it essentially refers to the situation where so many people are immune to the virus that it doesn’t spread any more. We probably need 60% of the population to be immune (estimates vary) in order to reach herd immunity.)

A well-informed person might think this won’t be a problem: billions of people are desperate to get the vaccine right now. But the anti-vaccination movement has been spreading misinformation about Covid-19 vaccines since the beginning of the pandemic, long before we even had a vaccine. (Yes, I know it’s patently ridiculous to make claims about a non-existent vaccine, but they did, aplenty. I’m not linking to any of their claims here because I don’t want to give them the traffic.)

As a result of the relentless anti-vax propaganda campaign, a substantial portion of the population is at least “vaccine hesitant,” meaning they’re not sure if they want the vaccine. They are worried primarily about safety, even though the data is very clear that these vaccines are remarkably safe. (It’s true that a tiny number of people have had allergic reactions, but this data is public and no one’s hiding it.)

So we need to convince some people that it’s in their own best interests to get vaccinated. A small number of deeply confused anti-vaxxers, such as the people behind the mis-named NVIC, are probably unreachable. They simply won’t listen, preferring to believe their own misinformation and conspiracy theories. But for the large number of people who are merely hesitant, a positive incentive might be just the thing to convince them to get vaccinated.

Enter the economists. Robert Litan first proposed paying people to take the vaccine back in August, and Gregory Mankiw strongly endorsed the idea, writing:

“what’s the best way to achieve herd immunity? Again, simple: Once a vaccine is approved, pay people to take it.”

Such confidence! Actually it’s quite a good idea in principle. But Litan and Mankiw then went off the rails, proposing that we pay everyone $1000 each to get the shot. Litan admitted that he didn’t have any data to support this particular amount, but he called it a “strong hunch.”

That’s a $300 billion program. Neither Litan nor Mankiw was bothered by this.

There are some gigantic problems with this proposal. First, because it’s such an enormous amount, it’s extremely unlikely that it will ever happen. It’s just the kind of hypothetical, pie-in-the-sky proposal that gives academics a bad name. Because it will never happen, Litan and Mankiw will never have their idea tested in real life, and no doubt they will continue to claim it would have worked.

Second, though, is a much bigger problem, as pointed out by economists George Loewenstein and Cynthia Cryder in the New York Times, and by medical ethicists Emily Largent and Franklin Miller in JAMA. The problem is that if you offer to pay a lot of money to do something, then people conclude “this is something you would not want to do without compensation.” In other words, it’s dangerous or somehow bad.

Thus a large payment may merely heighten people’s suspicions that the government (or “Big Pharma”) is up to no good, and that’s why they have to bribe people to take their suggestions. The last thing we need right now is to increase people’s mistrust of vaccines.

In addition, paying so much money for each shot is, as Largent and Miller point out, a bad investment. Sure, $300 billion is much less than Covid-19 is costing us right now, but it’s still a huge sum, and those funds could be better spent on many other things, such as helping to support states that are still struggling to set up facilities to administer the vaccine.

Now let’s go back to the Dollar General plan. Dollar General is paying the equivalent of four hours’ worth of salary, about $40 on average, to each employee who gets vaccinated. As I said above, this is an excellent idea.

Why is this better than the $1000 per person plan from the economists? First of all, it costs far, far less than the economists’ plan, which makes it far more likely to happen. Second, Dollar General is paying people to defray the actual costs–in time–that they will incur in order to get the vaccine. So it’s not so much a bribe as it is a modest reimbursement. Third, by providing a modest payment, they provide a relatively bigger incentive to low-income groups, and they avoid paying billions of dollars to high-income people who are already highly motivated to get the vaccine.

I suggest we adopt a version of Dollar General’s plan for the entire U.S. population. Why not offer a cash payment of $20 to everyone who gets the vaccine, and pay it immediately? Obviously there would be some logistical challenges to this–we’d need security procedures to make sure the $20 payments were actually handed out and not stolen–but it would be far simpler than arranging the $1000 payments so blithely proposed by the academic economists. And it would only cost $6 billion rather than $300 billion.

A payment of $20 provides a small positive incentive, and it can be justified as paying people for the time they spend getting the shot. Because it won’t seem like a bribe, it will be much less likely to raise suspicions that the vaccine is harmful (which it isn’t, I hasten to add).

So Litan and Mankiw were sort of right: paying people might encourage more people to get vaccinated. But they’re wildly wrong about the size of the payment, which other economists and bioethicists have pointed out would likely create distrust. Dollar General is getting it right: let’s offer everyone a small cash payment if they’ll take the time to get the vaccine. It might just work.

A meditation on the year to come

A mountain in the Eiger valley, Switzerland.

So we've just experienced one of the hardest years in the past 50. The world is still reeling, but we have reasons to hope that our lives on this planet will get better–much, much better–in 2021. Entering the new year, I'm offering this brief meditation (a technique that I would have dismissed in years past, but that I've discovered during the pandemic) with my hopes for better times ahead. Vaccines will soon free us, at long last, from the prison of social distancing that the virus has imposed on the entire population. Emerging from our months of isolation, what will we do first? Next?

Let's imagine, as we meditate, that we will travel, as many of us desperately long to do. On a train, or a plane, or just in a car, finally going somewhere far away with a close companion, with no masks required. Viewing the sights, taking photos, eating at a crowded restaurant, or just walking through a shopping district filled with people. Enjoying the freedom that we took for granted for our whole lives, until the pandemic shut everything down in March of 2020. Sipping an Aperol spritz on a terrace with a scenic mountain view.

Everything we've lost will return again. Let's imagine, closing our eyes for a few moments, what we'll do once we get beyond these last months of the pandemic, once we are free again. Anything is possible, and the future will be better.