Why Aren’t There More Cancer Vaccines?

Because of the way drug patents work:

The duration of patent protection in the U.S. is 20 years. All drug innovations get patented at the time of discovery, but late-stage cancer treatments will work their way through the clinical trials required for FDA approval much more quickly, since the effect on patient survival will be apparent within a couple of years. That means fewer years of the patent clock ticking without revenues coming in. For a preventive treatment like the HPV vaccine, the 20 years of patent protection will be long expired before any clinical trial can show whether lives are being saved, which in turn makes vaccines far less alluring investments for biotech companies. It’s yet another indication of America’s patent system’s desperate need for a makeover…

Generally, to get approval for a new cancer drug you need to show that patients live longer. It doesn’t take long to determine whether a new treatment adds months of life in the case of metastatic cancers (those that have spread throughout the body): 90 percent of patients with such cancers are dead in less than five years. But it can take more than a decade to see whether survival is affected for localized cancers that remain confined to a single organ. And for treatments aimed at cancer prevention — the holy grail of cancer research — it could take multiple decades to prove a treatment’s efficacy.

Full Ray Fisman post worth reading.

Comments (14)

Trackback URL | Comments RSS Feed

  1. Buster says:

    I read the article. I see Fisman’s point but I’m not sure what can be done about it. HHS could provide more seed funding for cancer. Maybe FDA could even provide more years of exclusivity. But this all sounds a little worrisome. This dilemma sort of reminds me how companies that challenge a patent use to get 30 months additional exclusivity to litigate. The problem: they got 30 months for every challenge no matter how frivolous. Frivolous patent challenges became a way to extend patents. The solution has to take into consideration potential unintended consequences.

    • Bosh says:

      This is why patent laws is so harmful to the U.S. market.

      • Brian says:

        Why do you say that?

        • Bosh says:

          I say that because allowing people to patent products harms competition, which is what a capitalist economy needs to thrive.

          • Kraimer says:

            It also allows companies to artificially increase prices which harms peoples access to these product, because they become to expensive.

      • Jimmy says:

        Patent laws are so harmful to the U.S. market!

      • JD says:

        You guys are right on about patent laws, unfortunately I don’t think that there are enough people in this country that recognize the problem.

        • James says:

          Patent laws are genuine, its how many of them get handed out for asinine reasons. Recently, Monsanto was able to patent the genetic structure of a modified soybean. Their soybean has replaced every other soybean on the planet, thus owning every soybean, including those which replicate themselves. Much to many farmers dismay.

          • JD says:

            Exactly, but what part of the structure of the patent system would we need to change to decrease bad patents while not affecting good? It seems like the answer is: better discretion.

  2. Duveaux says:

    “The duration of patent protection in the U.S. is 20 years. All drug innovations get patented at the time of discovery, but late-stage cancer treatments will work their way through the clinical trials required for FDA approval much more quickly, since the effect on patient survival will be apparent within a couple of years.”

    That is quite the difference in time.

  3. Randall says:

    I have only heard bad things about our patent system. Reforming the whole thing could be the best option.

  4. Linda Gorman` says:

    Uh, maybe because we don’t know whether an infectious agent that can be vaccinated against is the cause of various cancers?

    So far there are vaccines for two viruses that can cause cancer, HepB and HPV. There is a long way to go before the biology of cancer is well understood.

    Those two vaccines belong to the group that that the author apparently thinks the patent system would prevent as their effect is long term–immunize the teens now to prevent infection with the virus that causes cancer in some people 20 or 30 years from now.

    Therapeutic cancer vaccines stimulate the immune system to attack specific targets unique to specific tumor cells. A bunch of ideas are in early stage trials. There is one “vaccine” on the market for advanced prostate cancer. It is an individualized treatment. A specific type of patient immune cell is cultivated and sent to the drug manufacturer. It attaches a protein to the cells. They are then infused back into the patient.

    And the approval process for vaccines does not require that lives are saved, just that the vaccine show effectiveness against the entity that causes the problems and is well tolerated by the patient.