Stimulating Big Pharma to Invest in Medications for Stimulant Addiction

In my Wall Street Journal article on vaccines for addiction to stimulant drugs (e.g., cocaine and methamphetamine), I lament the fact that the development of these remarkable medications is moving slowly due to a lack of private sector investment. Grants from the U.S. National Institute on Drug Abuse are a pittance in comparison to the resources big pharma can bring to bear, but so far the industry has largely stayed on the sidelines.

I mention one reason for industry’s diffidence regarding stimulant drug vaccines in the article: Few doctors specialize in addiction. For a new medication that has to be prescribed, this would be constrain potential profit.

A related problem is that a disproportionate number of people with drug problems have no health insurance, further hampering the profitability of addiction-related medications. Pharmaceutical companies also fear liability risk because drug addicted people are at high risk of overdose, suicide and HIV contraction.

The combined effect of these barriers is to discourage pharmaceutical investment. Dr. Barbara Fox, CEO of Avaxia Biologics Inc, had a hand in producing the first cocaine vaccine in the early 1990s and subsequently founded a company that specialized in addiction therapies. She told me “I saw a huge social need that no company was meeting, so I thought it was a great opportunity. I should have realized that when no one is in a market space, there’s a reason!”. Her addiction-focused company could not raise significant funds and she has since founded a new company focused on other areas of pharmaceutical product development.

Recent federal government policy may ameliorate the situation. The Affordable Care Act expands health insurance, including among people addicted to drugs, which should make the addiction medicine market more financially attractive to medication developers. The same law also includes incentives for training health professionals that could increase the number of prescribers of any vaccine product that was brought to market.

Other supportive government actions are possible. Current government-subsidized liability protection for vaccine makers could be extended to manufacturers of cocaine and methamphetamine vaccines. The government could also consider designating addiction an orphan disease. Normally only rare diseases are so designated, but the attached federal incentives may be necessary to augment investment in addiction-related therapies. Neither of these potential policy changes qualifies as a hot topic in Washington at the moment, though there are certainly political players with a longstanding interest in addiction who might advocate for them when the next Congress is sworn in.

In the meantime, vaccine reseachers such as Professor Tom Kosten, whom I highlighted in WSJ, soldier on with limited funds from the government or from small firms and donors who are willing to take a chance. The scientists’ desire for more investment is palpable, but so is their determination to persist regardless. Reflecting on the fact that his clinical trial of a cocaine vaccine might have generated stronger results had he had access to the superior proprietary vaccine materials of large pharmaceutical firms, Kosten was philosophical rather than resentful. “They live in a different world”, he laughed, “Getting angry at them is like getting angry at God”.

Comments

  1. Maynard Handley says

    I don’t want to be a dick here, but why do the pathologies of the US medical system affect the profitability of creating such a vaccine? There are stimulant addicts all over the world, in both rich and poor countries. It seems to me a strange claim that the US is so uniquely profitable that it has to be part of the target market.
    Yes, other countries negotiate better deals on medication than does the US. But a better deal does not mean a deal so bad that it’s unprofitable.

    To me this seems like a classic case of “9/11 proves that all my political theories are correct”. We have an empirical fact (no money being spent on these vaccines) being used to claim support for a specific political agenda (bipartisan in this case, on the one hand “big pharma needs to be able to charge whatever prices it likes”, on the other “the Feds should give big pharma whatever money it wants”); whereas the more likely situation is, I suspect, that the people who have been asked to pony up the money have looked at the state of the research and have considered the gap between it and a product to be too large right now.
    This is a standard problem in medicine, usually solved by NHS money, but not solved by the suggestions provided in this post.

    • Maynard Handley says

      To make it clear, when I said “no money being spent on these vaccines” I meant “no private money being given to fund the research of these vaccines”.

    • says

      Why “a strange claim that the US is so uniquely profitable that it has to be part of the target market”?

      It’s a comparative-advantage thing: given a choice between investing in a drug that will enable you to charge the, um, extreme prices characteristic of the US market and investing in one that will only enable you to charge the prices characteristic of the rest of the world, a sensible investor will, all other things being equal, invest in the one that has a large US market. (And by US market I mean, of course, the part that pays retail or close to it, which describes only a tiny sliver of addicts.)

      Of course, with drug treatment there’s also the problem that any medication that doesn’t involve substantial suffering on the part of the drug abuser will be opposed by many of the stakeholders involved in approval for widespread use.

      • Ed Whitney says

        FWIW, http://www.oecd.org/health/healthpoliciesanddata/41303903.pdf estimates that “Nine OECD countries account for about 80% of the value of global sales of pharmaceuticals. The United States, with a 45% global share, is the world’s largest market, followed by Japan, which accounts for 9% of global sales, France (6%), Germany (5%), the United Kingdom (4%) and Italy (4%).”

        That would make the US a major part of any target market.

  2. Ed Whitney says

    If I am not mistaken, some of the early anti-retroviral drugs for HIV were considered orphan drugs even though the number of cases in the US population exceeded the numbers usually expected for orphan drug designation. I do not know what criteria go into the designation to get the tax credit, but it seems that absolute numbers of cases make up only one criterion.

    • Ed Whitney says

      To amplify the above point, compare and contrast the responses to AIDS in the early 1980s with the response to addiction today. Early in the course of the HIV epidemic, there was a stigma attached to the disease; it was one of those things you got from doing things that “people like us” don’t do. Two or three factors changed a moral stigma into a public health issue. Surgeon General Koop made it a public health problem; well-organized and vocal advocacy groups demanded a more enlightened response, and deaths of prominent celebrities like Rock Hudson changed public perceptions of the disease. It may have helped that ambitious researchers smelled Nobel Prize laurels in pursuing the identification of the causative agent and in developing targeted therapies against it.

      These factors are not evident in the public response to cocaine addiction. These may be differences that make a difference. But if attitudes around the condition were to change, the funding of research would change with them.

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