Covid patent fight is about greed, not human health

I suppose I shouldn’t be surprised: one of the companies that developed mRNA vaccines for Covid-19, Moderna, has just sued the companies who make the competing mRNA vaccine, Pfizer and BioNTech, claiming that Pfizer/BioNTech is violating its patents.

Pfizer was surprised though, according to news reports. (Or at least they said they were.)

Moderna had announced, back in 2020, that they wouldn’t enforce patents on their vaccine during the pandemic, but they seem to have changed their mind. Apparently, billions of dollars in profits isn’t enough: they’ve decided the time is right to try to grab even more money.

Let’s make no mistake here: this is purely about greed. Apparently Moderna understands this, since they proudly advertised their earlier plans not to enforce patents on the Covid-19 vaccine. They realized that the public good will generated from such an announcement was valuable.

Not that valuable, apparently.

It’s not even clear that Moderna should have been given the patents it holds. According to a recent story in Science, the key technology behind one of Moderna’s patents was invented, and patented, years earlier by two scientists, Drew Weissman and Katalin Karik√≥, at the University of Pennsylvania. Their work discovered a way to modify the RNA in the vaccine that would make it much more effective. (Here’s a link to the patent.)

As I wrote last year, patenting the Covid-19 vaccine is unethical. At the time, the US had 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. That policy sounded too good to be true–and apparently it was, because no such waiver is in effect now.

The patent system is a creation of modern governments, and they don’t have to let companies get away with this. The profits of a few companies are far, far less important than the lives of millions of people. Allowing companies to restrict Covid-19 vaccine development is, crudely put, defending money over human lives. Maybe it’s time for the international community to institute the vaccine waiver, at least until the pandemic is truly over. 

And make no mistake: even though we have vaccines now, they still need improving, and better vaccines will save lives. Patent disputes will slow down or even prevent work on better vaccines, since the patent holders will have a monopoly. Even the threat of a lawsuit can stymie progress; after all, why would someone invest time and effort on a vaccine that they might never be able to deploy?

Moderna is far from the first company or institution to let greed guide their actions: way back in 2010, I wrote about how MIT and Harvard had filed a patent that was, as I wrote at the time, both inappropriate and harmful. In that case, MIT and Harvard had an incredibly broad patent on a human gene, NF-kB, which plays a key role in our immune system’s response to infections. Granting a patent on NF-kB, as the US Patent Office did, was akin to granting a patent on all drugs that affect nearly any human gene. The universities licensed the patent to Ariad Pharmaceuticals, who filed a lawsuit the day the patent was granted. Neither Ariad nor MIT developed any treatments, but they initially won $65.2 million just because of the patent. (Need I point out that the Harvard and MIT work was mostly funded by the public?)

Fortunately, in the 2010 case, an appeals court threw out the patent, ruling that people and companies cannot patent human genes, because genes are products of nature, not inventions. The mRNA patents, though, don’t fall in this category.

Should I also mention that much of the basic research behind mRNA vaccines was also funded by the public? Or that NIH (and therefore the US government) has patent rights to some of the technology behind the Moderna vaccine?

Moderna, Pfizer, and BioNTech looked like heroes when they first announced their vaccine results–and in some ways, they were. The world was desperate for vaccines against Covid-19, and the mRNA vaccines have saved millions of lives.

But my message to Moderna is simpler: you’re already making billions in profits on the Covid-19 vaccine, so don’t be such greedy assholes. And don’t be evil: drop the lawsuit.

Scientists have re-created the deadly 1918 flu virus and used it to infect animals. WTF?

With all the controversy about gain-of-function research and all the concerns about how dangerous it is, you might think that scientists have stopped doing that kind of work.

Well, no.

In the latest news, a team of scientists in Canada and the U.S. report that they have re-created the 1918 influenza virus and used it to infect macaques. Let’s be clear here: the 1918 flu vanished from the Earth, long ago. It’s simply not a threat, or it least it wasn’t, until someone figured out a way to bring it back.

Why would anyone do this? I’ll get to that, but first a little background.

The 1918 flu pandemic was the worst plague since the Black Death, which occured in the mid-14th century. During World War I, a new flu virus swept the planet, killing upwards of 50 million people. It probably infected a third of the entire world population at the time.

Since Covid-19 appeared, the 1918 flu pandemic has been cited often (sometimes called the Spanish flu), usually to compare or constrast it with Covid-19. Sure, Covid is bad, but at least it’s not as bad as what the world experienced in 1918.

About 20 years ago, a small team of researchers led by Jeffery Taubenberger and Ann Reid figured out how to sequence the genome of the 1918 flu. In a series of papers spread over six years, they described how they recovered pieces of the flu virus from human samples that had been frozen for nearly 100 years, including corpses buried in the permafrost of Siberia and Alaska. In 2005, they reported the complete sequence in the journal Nature. Their main discovery was that the 1918 flu had originally been a bird flu, which jumped into humans sometime before 1918. Taubenberger and others, including Adolfo Garcia-Sastre at Mt. Sinai School of Medicine, also re-constructed the virus and tested it on mice, that same year. Not surprisingly, the mice died.

It didn’t take long before gain-of-function researchers said “hey, why don’t we reconstruct the flu virus and see what happens in primates?” The tools of modern genetics make it possible to reconstruct a virus from scratch, using just the sequence.

In 2007, only two years after the 1918 flu sequence was completely decoded, influenza researcher Yoshihiro Kawaoka at the University of Tokyo and the University of Wisconsin described, in a paper in Nature, how he and his colleagues used the sequence to create live, infectious 1918 flu viruses. To demonstrate that these really were flu viruses, they infected 7 macaques with them. Not surprisingly, the macaques got severely ill, and the scientists eventually euthanized all of them.

(Insiders may recognize Kawaoka’s name: he and Dutch scientist Ron Fouchier are widely known for their gain-of-function research that aimed to give deadly bird flu the ability to infect mammals. I’ve called them out on this in the past, and I’ve openly asked why NIH was funding this work.)

In the new paper, a team of researchers at the Public Health Agency of Canada, the University of Manitoba, and Oregon Health & Science University re-created the 1918 flu virus again, and infected 15 macaques. This time they used more realistic doses, and the macaques didn’t get so sick, suffering only “mild” or “moderate” disease. Maybe macaques “are not ideal for the development and testing of novel pandemic influenza-specific vaccines and therapies,” they concluded.

So let’s review: flu scientists have been using the sequence of a long-vanished, extremely deadly virus to reconstitute the virus and infect animals, and then observe how sick they get. (Kawaoka did it a second time, in a study published in 2019.)

Why do they do it? All of the papers give essentially the same reason: these experiments, they say, will help us develop animal models in which we can test vaccines. These same justifications have been used for decades, but flu vaccines haven’t improved one whit, as far as I can tell.

But hold on a minute! Even if you accept their argument that infecting macaques and other animals with influenza virus will help develop better vaccines, why use the 1918 influenza virus at all?

They don’t answer that question, because there really is no good answer. The fact is that the experiments will be more relevant if they use currently circulating flu strains–because those are the strains that we need vaccines against.

I imagine that the scientists doing this work truly believe the arguments they make, about how their work will help design better vaccines and therapies. But they’ve been making similar arguments for decades, and it just hasn’t played out that way.

The 1918 flu disappeared long ago, and there’s no way it could possibly re-appear naturally. There’s only one way that the 1918 flu becomes a threat to human health again: through a lab leak. Re-creating the virus in a lab makes that possible.

We’re still trying to figure out if Covid-19 had a natural origin or whether it started as a lab leak. Even if it turns out to have a natural source, the intense discussions about the lab leak hypothesis have been useful, because they made it clear that lab leaks happen, and that they should be considered a genuine risk.

In recognition of this risk, scientists and non-scientists alike have called for a worldwide ban on gain-of-function research. That hasn’t happened yet, although NIH has issued a carefully worded statement about the kinds of work that it supports.

Most of the recent controversy over gain-of-function research has focused on research that makes viruses more deadly. I hope it’s clear that re-creating a deadly virus from scratch is another form of gain-of-function research, one that carries equally great risks with little or no potential benefit. We should put a halt to both types of work.

There’s an easy way to eliminate the risk that a lab leak might release the 1918 influenza virus into the human population: stop re-creating the virus. The 1918 flu disappeared from the natural world long ago–or to be more precise, it evolved into a much, much milder form of influenza. The deadly form that was recently re-created in several labs does not exist in nature today. Let’s keep it that way.

For Pete's Sake, Stop Taking Vitamin D Supplements!

Way back in 2014, I wrote a column about vitamin D supplements, explaining that they don’t work. I added vitamin D to my previous list, the Top 5 Vitamins That You Should Not Take, to create a list of 6 useless vitamin supplements.

Together, these two columns had well over 1,000,000 views. And yet it seems the message didn’t get through. Well, now a massive new study published in the New England Journal of Medicine reports that I was right all along: taking vitamin D pills isn't good for you. Let’s review the findings, shall we?

In 2014, I wrote about two studies, both published in The Lancet. The first paper, a massive review of 462 other studies, concluded that taking supplemental vitamin D did not help to prevent heart disease, weight gain, mood disorders, multiple sclerosis, and metabolic disorders, all of which had been linked to lower vitamin D. Nope, they said: it appears that low levels of vitamin D are a result of bad health, not the cause.

Ah, you might be thinking, but vitamin D is mostly about bone health, right? Well, the second study that I wrote about in 2014 looked precisely at that question. That paper concluded that vitamin D supplements do not improve bone density, and they do not reduce the risk of osteoporosis.

In other words, vitamin D supplements are a complete waste of money.

Nonetheless, people keep taking vitamin D, and doctors in the U.S. continue to recommend it (based on published guidelines that urgently need revision), on a very large scale.

So now we’ve spent millions of dollars on a huge new trial, which followed nearly 26,000 men and women for more than 5 years, to see if vitamin D supplements would do anything to prevent bone fractures. (And by “we” I mean U.S. taxpayers, who funded this study through grants from the National Institutes of Health.)

The result: people who took vitamin D had exactly the same risk of bone fractures as those who didn’t. It didn’t matter how much vitamin D they took, nor did it help if they also took supplemental calcium at 1200 mg per day. And it didn’t help people who had relatively low levels of vitamin D either. Taking vitamin D supplements just didn’t make any difference to anyone.

So we should stop taking vitamin D–but there’s more. In an editorial accompanying the new study, Steven Cummings and Clifford Rosen point out that “More than 10 million serum 25-hydroxyvitamin D tests are performed annually in the United States.” These tests add costs to our already exorbitant health care system, and they don’t provide patients with any benefit.

Cummings and Rosen put it bluntly: “providers should stop screening for 25-hydroxyvitamin D levels or recommending vitamin D supplements, and people should stop taking vitamin D supplements to prevent major diseases or extend life.” Or as my Hopkins Eliseo Guallar, Lawrence Appel, and Edgar Miller wrote back in 2013, “Enough is enough: stop wasting money on vitamin and mineral supplements.”

At the top of this article I mentioned that my list of useless vitamin supplements has 6 vitamins on it, so here they are:

  1. Vitamin C
  2. Vitamin A and beta carotene
  3. Vitamin E
  4. Vitamin B6
  5. Multi-vitamins
  6. Vitamin D

If you want to know the science behind the other 5, take a look at my column on The Top Five Vitamins You Should Not Take.

Finally, I should point out that although routine supplementation is worthless and megadoses of vitamins can be harmful, if you think you have a vitamin deficiency, consult with your doctor. Serious vitamin deficiencies might be the result of other health problems that your doctor can help you address, and treatments for specific conditions or diseases may include vitamins.

Journal publisher retracted a study claiming poison oak could cure itching. Well done.

None of these plants will cure itching. 
Today I want to tell a positive story, where a science journal did the right thing.

I’ve written a lot over the years about bad science. A particular gripe of mine is when bogus scientific results, sometimes fraudulent, sometimes just sloppy, manage to sneak into the peer-reviewed scientific literature. This happens all too often, especially as the number of papers published each year has grown. These bad papers are then used by fraudsters and charlatans (and sometimes by innocent people who just don’t have the expertise to understand) to “prove” an unscientific claim.

Fortunately, a growing number of journals–the better ones, in general–are showing more concern than in the past, and taking actions (sometimes) to retract papers, even over the objections of the authors.

Before I get to the good news, a reminder about the most notorious scientific paper in recent memory: Andrew Wakefield’s fraudulent study in The Lancet, published in 1998, which claimed to find a link between vaccines and autism. The Lancet, to its everlasting shame, failed to retract the article until 2010, despite an avalanche of evidence that began appearing in 2002. Ten of the original 13 authors even published their own “Retraction of an Interpretation” in 2004, but The Lancet still refused to retract unless all the authors agreed. Wakefield, who was already leading the anti-vaccine movement and is now adored by anti-vaxxers, refused.

That article has probably contributed indirectly to the deaths of thousands of people from vaccine-preventable infectious diseases. And given what we knew about it by 2002, The Lancet had no excuse for delaying retraction until 12 years after publication.

But I digress. Today I want to highlight an article whose retraction I called for a few years ago, one that the journal, Scientific Reports (published by Nature Publishing Group) did indeed retract, about 9 months later.

The paper I called out was a study that claimed that an extract of poison oak can be used to treat pain. If that sounds kind of ridiculous, that’s because it is. The actual paper sounded very science-y, as I pointed out in my original column. It was titled “Ultra-diluted Toxicodendron pubescens attenuates pro-inflammatory cytokines and ROS-mediated neuropathic pain in rats.”

Toxicodendron pubescens, in case you’re wondering, is poison oak. It’s not a tree and it has nothing to do with oaks–it’s a cousin of poison ivy, and both plants contain oils that can cause extreme itching and painful rashes on contact.

How on earth could poison oak be used to treat pain? Well, it can’t. The paper was actually about a homeopathic treatment. One of the core tenets of homeopathy is that “like cures like,” as long as you dilute it sufficiently. So the poison oak paper started with the premise that since poison oak causes pain and itching, you can also use it, after you dilute it, to treat pain and itching!

Homeopathy, as I’ve written before, is a highly implausible and easily disprovable set of beliefs about medicine. I use the word “belief” intentionally here, because homeopathy really has no claim to be a type of medicine, or even a hypothesis. It’s just a 200-year-old collection of beliefs that turned out, long ago, to be wrong.

If this sounds absurd, well, selling these products is a highly profitable business. For example, check out Boericke & Tafel’s Oral Ivy Liquid ($15 for a 1-ounce bottle on Amazon.com), a homeopathic product that is made from poison ivy, poison oak, and poison sumac. It claims to be “for the prevention and temporary relief of contact dermatitis associated with poison ivy, poison oak or poison sumac.” What’s in it? Poison oak, at very low levels. (Actually this product isn’t really diluted to homeopathic levels: the packaging says it contains 0.02g of poison oak in each drop. So it might actually cause an allergic reaction–I’d stay far away from this stuff.)

Back to the study: in the paper, the authors diluted a preparation of poison oak down to levels as low as 10-30, a common practice in homeopathy. The problem is, at that level of dilution, not even a single molecule of the original substance would remain. There’s simply no possibility that such a dilution could have any therapeutic benefit, but somehow they found an effect. Hmm.

A number of scientists wrote to the journal complaining that this result was extremely implausible, and that the experiments didn’t support the conclusions. To their credit, the journal editors took the complaints seriously and investigated. The retraction notice (read it here) pointed out another major problem as well: some of the figures were duplicates! Each figure is supposed to represent a different experiment, so duplication is a big problem, added to the fundamental implausibility of the study.

As is often the case when fraud is detected, the authors did not agree with the retraction.

When I wrote my column complaining about this study, I said the “the right thing to do would be to retract this paper, because its results are simply not valid. We'll see if that happens.” Well, about 9 months later, that’s exactly what happened.

A few years ago, I was in direct contact with the Editors-in-Chief at both Scientific Reports and PLoS ONE (about different papers than the one I’m discussing above), and they expressed genuine concern about fraudulent research, as well as a determination to do better at rooting it out. When journals do the right thing, we should applaud them. So here’s to Scientific Reports, who got it right this time.

USAID is pouring $125 million into collecting dangerous viruses in the wild. What could possibly go wrong?

 

Bushmeat market in Africa. Photo by Alexandra
Mannerings / BBC, 2014.

I just learned that the US Agency for International Development, USAID, is pouring $125 million into an effort to seek out novel viruses in remote areas of the world. This is pretty much exactly what many scientists, including me, have been warning against for years.

How did I miss this? It was announced last October, along with articles about how excited Washington State University was to lead the project, and how pleased the University of Washington was to go out and hunt down animals that were carrying dangerous new viruses.

In any case, I know about it now, and I’m joining the voices (here and here, for example) that are warning that this is a truly terrible idea.

The USAID’s announcement seems utterly oblivious to the enormous dangers posed by this program. Their own headline says they want to find viruses that could cause pandemics! The program, called DEEP VZN (”deep vision,” get it?) is funding scientists in the US and in Africa, Asia, and Latin America to venture (”deep”) into unpopulated areas of the jungle, and to find animals carrying viruses that might infect humans. They’re particularly interested in viruses that could cause the next pandemic.

What could go wrong? Oh nothing, says USAID and the scientists who are happily taking the $125 million in funding. They’ll be super careful! So we should all be pleased with how the government is preparing for the next pandemic.

Uh, no. As I wrote last year:

It’s also time to ask, very critically, whether anyone should be venturing out into remote areas to collect animals that are infected with possible pandemic-causing microbes, and bringing those animals [or just the viruses] back to densely populated areas. Rather than preventing pandemics, these activities are more likely to cause them.

The only tiny nod to risk in the USAID announcement is that they will “safely discover and understand new viruses from animals at high risk locations” (emphasis mine). They make no mention of how they will guarantee this is safe–because they simply can’t guarantee any such thing. 

Oh wait, isn’t this how some people think the Covid-19 pandemic started? Because humans were collecting bats from remote caves? Oh, but perhaps that was different, because some of those bats were being collected for food, and the people collecting them weren’t careful enough.

Never mind that the debate about whether Covid-19 was caused by a lab leak has never been fully resolved. And never mind that the debate itself has made it clear that lab leaks happen all too often, and that it’s clearly possible that a lab leak could cause a pandemic.

(For more on the risks of lab leaks, see my previous articles, from March 2022, June 2021, October 2021, or January 2015 (when the threat was from influenza), or this New Yorker story from 2021.)

The details of DEEP VZN are even more alarming: they plan to collect over 800,000 samples from animals in the wild, and they hope (!) to discover 8,000 to 12,000 new viruses, any one of which might have the potential to start a worldwide pandemic. They’ll focus especially on coronaviruses (the family that includes the Covid-19 virus), Ebola-like viruses, and a group called paramyxoviruses.

Great, so maybe they’ll cause a novel Ebola outbreak too. I’m feeling very comforted now!

I have to note here that USAID, the funder for DEEP VZN, also funded EcoHealth Alliance to collect coronaviruses from bats in China, and EcoHealth partnered with the Wuhan Institute of Virology in that project. As I and many others have written over the past two years, the Wuhan Institute of Virology is a possible source, through a hypothesized lab leak, of the Covid-19 pandemic. We may never know if WIV was involved, because China shut down all access to the lab early in the pandemic.

But it seems USAID didn’t learn any lessons at all from the many publicly expressed concerns about whether it was wise to go into caves in remote areas of China and collect coronaviruses from bats. On the contrary: with DEEP VZN, they are doubling down.

Why do USAID and the scientists at Washington State and UW think this is a good idea? Well, here the story is very familiar. They are making the same pie-in-the-sky claims we’ve been hearing for years: “The hope is that this improved understanding will lead to prevention of future pandemics,” said a UW scientist in their press release. Or “to make sure the world is better prepared for these infectious disease events, we need to be ready” according to a Washington State scientist.

I and others have pointed out the flaws in these claim before, but it’s worth re-stating a few of them:

  1. First, there’s not a shred of evidence that collecting these viruses will help prevent a pandemic, and we now have evidence providing the opposite. Scientists have been collecting coronaviruses since the first SARS outbreak, in 2003, and that work didn’t prevent the Covid-19 pandemic, even though both outbreaks were caused by coronaviruses.
  2. Second, the act of going into remote areas and looking for viruses is highly likely to bring deadly new viruses back into human cities, creating opportunities for a lab leak that could easily cause a new pandemic. And despite some protests to the contrary, lab leaks can and do happen, even from the most secure facilities.
  3. Third, having viruses in labs, even if they’re secure, will do little to help anyone design vaccines against future pandemic viruses. As expert virologists have pointed out, we simply can’t predict what viruses will cause the next pandemic: there are far too many of them, among other reasons.

There’s one more threat I have to mention. DEEP VZN proudly proclaims that it’s going to make all of its data public, including the genome sequences of the viruses that it collects. This strategy blithely ignores the fact that it’s now possible for hostile actors to use these sequences to create deadly new bioweapons. An MIT engineer estimates that some 30,000 people around the world already have this capability. Even if that is a bit alarmist (and I tend to think it is), it’s not so far-fetched to believe that generating all of these sequences greatly increases the risk that someone will create a rogue virus.

If USAID wants to help prevent the next pandemic, there are far, far better ways to spend $125 million of taxpayer money. Here are a few ideas:

  1. Use the money to reduce the consumption of “bushmeat” in countries where this is still practiced. This could be done in many ways, such as training people in better farming methods, or even just providing food directly.
  2. Put a halt to the use of wild animals for ineffective “traditional” medicines, which don’t cure anything and which are one of the main incentives for hunting exotic animals. This would have the additional benefit of saving a number of animal species from extinction.
  3. Use the money to develop faster ways to produce and deliver vaccines, so we don’t have to wait months or years from the time a pathogen starts spreading until we have a vaccine.

Look, I know that some scientists are very excited about going out and finding new viruses, and some of them truly believe this will help prevent future pandemics. But they’ve been saying this for years, and the evidence is now overwhelming that this is a pipe dream. Sending humans out into the wild to gather viruses that would otherwise never make their way into population centers is just a terribly dangerous plan.

Or let’s put this another way: if you discovered that a research facility in your home town were working with hundreds of deadly viruses, would you have any concerns? Any at all? I know I would.

An amazingly effective new hair loss treatment for alopecia areata


Today I’m writing with a bit of good news. A new treatment for hair loss seems to work miracles, at least for some patients. But for starters, let me be clear that this treatment doesn’t work for ordinary, age-related hair loss, where people (men especially) gradually lose the hair on their heads. It only treats alopecia areata, a far less common but much more damaging condition.

Alopecia areata is an autoimmune disease that causes dramatic and devastating hair loss. It’s nothing like normal age-related hair loss. In severe cases of alopecia areata, people can lose all their hair, often very rapidly, even their eyebrows and eyelashes. Sometimes they even lose the hairs in their nose and ears, which can lead to sinus infections and hearing problems. In milder cases, people develop bald spots on their scalp, and for some people the hair will grow back. In other cases, though, hair loss is permanent.

Alopecia affects about 300,000 Americans, and in addition to the physical symptoms, it often causes severe emotional distress. As a doctor explained to the New York Times this week, it “robs a person of their identity.”

The good news is that just a few days ago, the FDA approved the first-ever systemic treatment for alopecia areata, one that is genuinely effective, even if it doesn’t work for all patients. The new drug, called Olumiant, was developed by Eli Lilly and approved 4 years ago for treatment of rheumatoid arthritis. Its use for alopecia is an unexpected benefit.

The best way to illustrate the success this new drug is to look at a photo of one of the patients from the clinical trials, which were published on May 5 by an international group of doctors and scientists in the New England Journal Medicine. Below is one of the patients after 36 weeks of treatment:

The NEJM article included photos of 6 patients, all of them just as dramatic as this one. Over the course of eight or nine months of treatment, many of the patients had virtually all their hair grow back.

How does the new drug work? In patients with alopecia areata, their immune system attacks their own hair follicles, for reasons that aren’t fully understood. It may be caused by both genetic and environmental factors. Olumiant (also called baricitinib) blocks the action of a protein called Janus kinase (JAK), which is one of the genes involved in the disease. This apparently allows the follicles to heal, and hair just starts growing again. As far back as 2014, a different JAK inhibitor was reported to induce dramatic hair re-growth in an alopecia areata patient, a young man who had lost all the hair on his body. That report and others like it were the motivation for conducting the just-reported clinical trials.

An important caveat is that not all patients responded equally well. Both studies had a low-dose and high-dose option, and the higher dose clearly worked better, with 36% of patients in one study and 39% in the other study experience dramatic re-growth of hair during an 8-month period. Most side effects were mild, but the studies will continue to monitor patients for longer-term side effects.

Even if it only works for some patients, this is clearly a dramatic breakthrough for alopecia areata. One downside is cost: as with many drugs in the U.S., Olumiant is really expensive. The NY Times reports that the cost is currently $2500 per month, which means an 8-month course of treatment will cost $20,000. Thanks to the FDA’s approval, insurance will probably cover it, but no drug should cost that much.