Vincristine and Essential Drug Shortages
Over the past few weeks, the leukemia world – and, no doubt, many other cancer communities – have been in turmoil over a much publicized drug shortage.
Vincristine is one of the most essential drugs in the treatment of leukemia – it’s given across multiple phases of treatment, and for many patients is a necessary evil, one that doctors are hesitant to compromise on. Wesley has suffered many short- and long-term side effects from vincristine chemotherapy, but it’s considered so useful, so effective, that the damage it does is thought to be worth all but the most severe, life-threatening side effects. This is amongst the most difficult choices a parent could have to make – imposing a medical treatment on your child – seeing the immediate and visible damage it does but going ahead on the faith and knowledge that the long-term benefit is worth it. In the case of vincristine, the long term benefit may well come down to survival, and we’ve accepted motor function impairment, peripheral neuropathy, slurring and balance issues, and bouts of severe pain to help insure his survival. If you’ve seen Wes and wondered why he wears leg braces, it’s because of vincristine.
Imagine making these incredibly hard choices, and then waking up to find that amongst all the other challenges there’s now the distinct possibility that your child won’t have an available supply of this drug? In the wealthiest society that’s ever existed you find that human beings – not an act of God – made choices that led to your kid not being able to get this drug. That’s what the last few weeks have been for thousands of families across the US.
Let’s back up.
Vincristine is one of the earliest drugs found to significantly help in treatment of leukemia, and it’s remained largely unchanged since those early days. It’s on the WHO’s list of Essential Medicines – those drugs deemed to be essential to a functioning healthcare system. It was originally produced from the Madagascar periwinkle, but it can now be synthesized at low cost and it’s incredibly cheap to make relative to many other cancer drugs, with a typical child’s dose costing a few dollars.
So what happened?
In early July, one of two manufacturer in the US, Teva Pharmaceuticals, notified the FDA of their intent to discontinue their vincristine production, leaving only a single supplier for all US patients, Pfizer. Around the same time, Pfizer had an unspecific manufacturing problem that resulted in delays of some shipments, and an immediate shortage across the market.
Not all hospitals were affected – some had enough inventory on hand to get by for the time being, but there are many families who reported their facilities having no supply, or having to ration and limit or skip doses for some patients.
Many people were understandably outraged at Teva, and reached out to them for comment. Teva provided the following statement:
Good Morning,
Thank you for contacting Teva Pharmaceuticals Customer Service. We understand your concern, however the availability of the Teva product has not contributed to the shortage that is being experienced today. Teva evaluated data from 2017 to assess the market need for Vincristine. At that time, the market share split was on average 85 percent brand and only 15 percent generic/Teva (and this year the share each month available was no greater than 3%). Based on this information about usage and availability and an annual business assessment, Teva decided to discontinue the product, and alerted the FDA of its decision in March 2019.
I hope this information has been helpful in addressing your concerns. Please feel free to call us at 1-800-545-8800 or email at tevacs@tevapharm.com if you have any additional questions. Thank you very much for contacting us and please enjoy the rest of your day.
Best regards,
Customer Service
Let’s ignore the obvious tone-deafness of the letter – responding to concerned parents of children with cancer with “please enjoy the rest of your day” is hard to overlook emotionally, but focusing on it doesn’t add much to this story.
More importantly, let’s address the substance – a deeply cynical response that glosses over reality by citing facts without context. It’s a huge over-simplification, and self-serving, neither of which should be surprising.
When one of two suppliers leaves a market, it leaves the market much more vulnerable to production problems by the remaining supplier because now all eggs are in one basket. This is basic supply chain reality, and we’ve seen how this plays out with Erwinia, for instance – most of the time Jazz produces Erwinia just fine; but when they have a production problem it can cause an enormous ripple across the supply because there are no alternative sources for US patients; if there was even a single alternative provider of Erwinia, and even if they only produced 5-10% of what Jazz does, it would go a long way to smoothing out the supply chain problems.
Likewise, Teva’s departure from the market absolutely has a role in the recent shortage – as has been discussed repeatedly and touched on in the NYTimes coverage, it’s not a mystery that Pfizer had a production problem, nor that Teva was a minority supplier. However, production problems happen and if there was still an alternate supplier in the market this problem would not have resulted in a shortage. Pfizer has apparently overcome their production challenges and has ramped back up, expediting shipments to fill the backlog and hopes to have all current needs met by next week, and a completely stable supply by end of year.
So why did Teva leave the market? One of the main defenses of Teva is simply that we are a capitalist society and as red-blooded Americans we can’t force a company to make products that aren’t profitable. This misses the point, widely, for a number of reasons. First, some background.
In late 2017 Teva was in a financial crisis with its stock price plummeting since Jan 2016; towards the end of fall it brought on a new CEO to answer to its shareholders, whose primary mission was to juice its stock for shareholder benefit. This change in management resulted in dumping business units and layoffs, which helped their stock rebound significantly. Unsurprisingly, a substantial part of his nearly $35M income last year was linked, in various ways, to stock performance. Still, in early 2019 not all was stable at the company – they faced a number of challenges, including entanglement in the opioid crisis and the potential for massive liability. Vincristine was, obviously, seen as dead weight, and they made the choice to quietly discontinue it.
So it’s not lost in the weeds, it has to be said: there’s zero reason to believe Vincristine isn’t profitable.
Why does this matter? Because no one is asking a company to make an unprofitable product.
So if it’s profitable, why wouldn’t they keep doing it?
Stock market performance is not an indicator of the health of a business; it’s primarily about growth. A good, stable business that makes plenty of money but has no desire/ability to grow isn’t going to perform well on the stock market. So when companies (and their execs) are focused on stock performance, they are really focused on growth.
Not all businesses or products have that kind of growth – many don’t. For instance, a generic drug like Vincristine can be profitable – it earns more money than it costs to produce/sell – but if its not seeing enough growth it will be seen as dead weight by businesses focused on the stock market.
There are two main ways to get growth: increasing margins (by making it more efficiently and/or raising prices), and increasing the market.
Vincristine doesn’t fit either of these – it’s been around a long time, so we can assume if there was a way to significantly improve efficiency they would have done it a long time ago. And the market – various cancer patients – isn’t growing faster than the population, nor are there likely to be newly discovered uses for this drug. So this is a low-growth product, but that doesn’t mean it’s not profitable.
In addition, the rage directed at Teva for making a market-based decision is precisely a market reaction. You can’t ask for a system to be allowed to be governed by the primary aim of enhancing shareholder value – a so-called “market based economy” – and then object when market, cancer patients, react. This is market feedback. When the only supermarket in town takes a beloved product off the shelves you go and complain to the manager. That’s what happened here, so spare me the sympathy for the company or their CEO – I’m sure his $35M a year allows him to sleep at night.
This entire incident underscores a key weakness in the US pharmaceutical industry, though. If there are essential drugs – life or death products, depended on by millions, and largely impossible for individuals to buy directly from other sources like Canadian pharmacies – and these drugs are by choice no longer manufactured in the US, what are US patients to do?
We could call to tear down the entire industry and rebuild it on a new model, but whatever the moral imperatives are that kind of change will be massive, slow, and in our current political climate virtually impossible to complete. Fighting to dismantle one of the largest industries in the country, with many companies having wealth larger than all but a handful of countries, is a solution many of us can’t wait for.
Or we could fight for pragmatic solutions that address the core problem.
The easiest answer is demanding the right to purchase drugs from Canada and the EU when supplies of essential drugs are in shortage. This doesn’t force American companies to do anything their shareholders don’t want them to, and guarantees American patients have the same access when we need it as our friends in other countries. The right to access to foreign-made drugs is apolitical, and appeals to nearly everyone. We’ve all read stories of Americans driving to Canada to buy insulin – let’s make those drugs available directly to our hospitals, doctors, and pharmacies, allowing them to order from safe supplies in other developed nations.
Longer-term I think the important solution is public manufacturing of essential drugs – we can’t depend either on profit-oriented companies or on foreign supplies for basic, essential drugs – but this requires the creation of policy, law, and an entire new infrastructure to support it, which will rightly take time.
In the meantime let us buy what’s needed where we can.
