Here’s a piece from the Center for Economic and Policy Research that claims to have the whole high-drug-price problem figured out. It’s “incredibly inefficient research”, just so you know. How does the CEPR know, you ask? They do a comparison of the costs of research (as provided by the Center for the Study of Drug Development at Tufts) with the costs reported by the Drugs for Neglected Diseases Initiative (DNDI):
On their tenth anniversary, DNDI produced a report describing some of their accomplishments. The figure below shows some of the highlights and their price tag and compares them to DiMasi’s estimate of what it costs the big pharmaceutical companies to develop a single drug.
As the figure shows, DNDI was able to develop ASAQ, a combination drug for treating Malaria, for $17 million. More than 250 million dosages have been distributed since 2007. It developed Fexinidazole, a new drug candidate and new chemical entity, intended to treat sleeping sickness, at a cost of $38 million. DNDI developed SSG&PM, a combination therapy for visceral leishmaniasis at a cost of $17 million. DNDI’s entire budget for its first 10 years of existence was $242 million, less than one-tenth of what DiMasi estimates it costs the pharmaceutical industry to develop a single new drug.
Now, the DNDI are good people, and they’re doing good work. The Center for Economic Policy Research, however, is being either ignorant or deceptive here. They go on to say that this isn’t quite an apples-to-apples comparison, because they don’t include the cost of capital (which the DiMasi/Tufts estimate certainly does). But that completely misses the most important part of the entire comparison, which is that the examples that the CEPR cites are from known drugs that others have already spend development money on. And they also neglect to mention that the DNDI works with the pharmaceutical industry to develop the drugs it has, and that these costs are not included in the figures shown above.
Let’s take them in order. ASAQ is the combination of artesunate and amodiaquine, a treatment that had been in use (as separate pills) for many years before the DNDI became involved. Artesunate is a soluble ester of artemisinin, part of the class of drugs that won its discoverer a Nobel last month. It has been around since 1987, and is a well-known antimalarial. Amodiaquine has been around since the 1940s, when it was discovered by Parke-Davis, as part of a large partnership to discover new antimalarials during World War II. The combination of the two into a single tablet (which is a real advance for dosing under the conditions of malaria treatment) was not the discovery of a new drug; it was the reformulation of two well-known ones, in a combination that was already being used. The later stages of development and production were turned over to Sanofi, one of the larger drug companies in the world, who had been working on the same combination. Sanofi handled the largest clinical trials, the regulatory filings around the world, and the launch of the drug. They agreed to make this new combination available without patent protection, and also agreed to pay the DNDI a fixed percentage of the sales of the branded version (Coarsucam) of the combination pill for several years.
Next up is fexinidazole, which the CEPR says is a “new drug candidate and a new chemical entity”. That is false. It was a new drug candidate back in the early 1980s, when it was discovered and partially developed by the drug company Hoechst. This effort was halted later in the decade, but the drug’s revival was another partnership between DNDI and Sanofi (the company that Hoechst eventually became a part of over the years). The DNDI did excellent work by going back over a collection of nitroimidazole drug candidates and discovering that fexindazole was worth developing further, but they were looking over the products of prior drug research, and they already knew the most promising chemical class to investigate (the nitroimidazoles).
The next drug combination mentioned is SSG/PM. That’s sodium stibogluconate (yep, an antimony compound), which was discovered as an effective therapy in 1945, and paromomycin, which was introduced by Parke-Davis in 1960. The combination of the two drugs was first explored systematically during the late 1980s. DNDI conducted the Phase III trial in Africa for registration of this combination therapy – its efficacy and its safety profile were both the same as with SSG monotherapy, but the course of treatment is 17 days versus 30, which is a significant advance.
But the Center for Economic and Policy Research is completely misinterpreting what DNDI has accomplished. Their press release is all about the cost of new drugs:
“. . .it is hard to escape the conclusion that DNDI research is far more efficient than patent supported research by the pharmaceutical industry. And no one has to struggle to come up with tens or hundreds of thousands of dollars to buy the drugs developed by DNDI. They are all available as low-cost generics.”
That’s because almost all of them were low-cost generics to start with. Comparing these projects with current drug research is disingenuous at best, and I’m not sure how ignorant I can believe that the CEPR people really are. Alzheimer’s, the various types of cancer, drug-resistant infections, pick your therapeutic area: these things are not going to be solved by reformulating compounds that were discovered decades ago. That can be a perfectly good approach in the neglected-tropical-disease field, as the DNDI and others have demonstrated, but it builds on the work of (and often depends on cooperation with) actual drug research companies.
Pretending otherwise is idiotic. Any organization that releases such stuff cannot be taken seriously when they talk about drug research, and you have to wonder how seriously they can be taken when they talk about anything else. If you want to read something intelligent about drug prices, read Jack Scannell.