This month the news has been full of tamoxifen shortages. The drug shortages continue, but Canada is doing nothing about it! Not even measuring it, in the manner that our little team demonstrated last year.
Since October, Canada, USA, England, and other countries are hearing about worrying shortages of tamoxifen. It is a trusty, old, reliable drug that helps to keep breast cancer under control for around half of the people diagnosed with the disease. Normally, they take the pills for 5 years after surgery and/or chemotherapy.
Unfortunately at the time of writing, no fewer than 1960 other drug products are also in shortage according to the government’s database (licensed to Bell Canada). This site is simply a list that is never analyzed or summarized. The shortages include other important cancer drugs, such as vincristine for childhood leukemia, BCG for bladder cancer, and etoposide.
I am often called upon by journalists to talk about this and other shortages. I always agree to do so because we need people and government to be aware. We need more openness and information. This week it was CBC.
Reporters always ask about the cause. Honestly after a decade of chasing the answer, I still don’t know why we have these shortages–or why they came after 2009 with its economic crisis. Seventeen robust potential causes are listed and explained at my website. Many of them have to do with the international market. To know which cause applies when, and to what drug, is beyond me.
Lately it is apparent that the prices of generics have fallen so low (simply by not being raised through time) that their manufacture is unprofitable. Companies simply drop out. The case of Tamoxifen seems to illustrate this point well. I published a similar study of beta-blockers in the CMAJ in September 2019, although changing practice guidelines may also have played a role in the case of beta-blockers. Not so, for tamoxifen which is and has been a mainstay of breast cancer care for more than three decades.
Since 1985 when the patented version of tamoxifen was released in Canada, a total of 11 companies have licensed and sold the drug in this country at one time or another. (This information is available at the Health Products database.)
Between 1996 and 2010 there were at least eight different suppliers. But gradually companies stopped making the drug; seven companies have dropped out since 2003. And of course, by 2014 we started seeing shortages (The shortage information is available at the current shortages site and its predecessor, no longer accessible, which we downloaded in 2017 for our 2018 report).
Sanofi, the first company to licence tamoxifen, dropped out in 2011 after 25 years. Now there are only 3 companies still marketing tamoxifen in Canada: Apotex, Teva, and Astra Zeneca. They have been in the tamoxifen business 30, 29 and 23 years, respectively. They make 10mg and 20 mg doses, but Astra Zeneca dropped its 10 mg dose back in 2003. See the graphs above.
As for the price of tamoxifen, it is difficult to obtain older information. The provincial formularies offer the best source for current prices, but most provinces do not keep old formularies on the web. Newfoundland is exceptional in that it has a digital archive back to 2010–not very far back when we want to know the price since 1985, but better than nothing. The price in Newfoundland has been similar to that elsewhere in the country. Right now generic tamoxifen is listed at 19 cents for 10 mg and 38 cents for 20mg tablets.
Recently Alberta has even seen a small decline in price in terms of real dollars between 2015 and 2019. But the cost of living has increased. So expressing this information in dollars of equal value (thanks to the Consumer Price Index) shows that the generic price has indeed been declining in constant dollars. See the graph above of recent prices in constant dollars.
Thanks to the help of Dr. Joel Lexchin, I have been able to get the price of Tamoxifen in Ontario since 1985. It was first released at $1.34 for a 10 mg tablet ($2.88 in 2019 dollars). It fell steadily to the current $0.1705 per 10 mg tablet. Remarkably the list price of generic tamoxifen has not budged since 1998. See below–graph of number of companies (same as above) with the price of tamoxifen in constant dollars. We can only assume that in the 20+ years since 1998, the cost of making it (raw materials and labour) must have risen at least somewhat. Doesn’t that mean the profit margin will decline?
Key: number of companies (orange); price (blue)
When there are only a few makers, the margin in the system is narrow. Any manufacturing problem will result in shortage. The remaining companies (if any) will encounter a big, unexpected increase in demand and they too will report shortages. Anger against the companies that are making the drug is somewhat unfair; at least they have not dropped out… yet, and we hope that they won’t.
Any normal commercial entity would want to supply and sell its product if it could. But we as a society accept the notion that drug marketing and drug development belongs in the private sector. We also regulate the price. These private companies are not charities; if they are losing money, they stop making the drug so that they can keep paying their employees and their stakeholders.
As for why we are hearing about Tamoxifen, in particular, when so many other equally life-saving drugs are missing is a very interesting question. Sure, it is used to treat a very scary cancer, but experts reassure us that missing doses for a few weeks is not as risky as many fear. So some of the explanation comes from the articulate, motivated, frightened, and basically healthy people who are affected– the vast majority being adult women. They are able to draw the attention of journalists and policy makers and (hopefully) industry and government. It would be wonderful if this energized and effective cohort would remember all the other patients who are coping with dreadful shortages–children, the mentally and physically disabled, those in poverty–when their own issue is resolved.