PharmExec Blog

Antibiotics Discovery: Time for a ‘Manhattan Project’

by Susan Crowley

The innovative pharmaceutical industry is under attack from critics around the world for failing to develop new antibiotics to treat emerging infections. The charge has been furthered by statements from World Health Organization (WHO) director Margaret Chan. In 2012, she warned that bacteria were starting to become so resistant to common antibiotics that it could bring about “the end of modern medicine as we know it” and earlier this year, she asserted that the world is entering a “post antibiotic era.” The health agency notes that antibiotics are losing effectiveness in every country. Marie-Paule Kieny, WHO assistant director-general who heads the program responsible for intellectual property policy-making, together with other programs that include research, has been quoted asserting that there is “no market” for antibiotics.

Dire warnings from the WHO and others have prompted calls for new innovation models that would provide alternatives to the patent-based intellectual property system – models that would apply beyond antibiotics and extend to cutting-edge therapies for cancer, hepatitis and other categories that fuel the research enterprise of innovative firms.

Garance Upham, president of Safe Observer and administrative board member of the World Alliance Against Antibiotic Resistance, was quoted at a recent meeting  saying that John-Arne Røttingen, chair of the Advisory Panel for the WHO’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), told her that “delinking between innovation and product prices applies to neglected diseases and is also relevant to the problem of antibiotic resistance.”

Knowledge Ecology International, led by James Love, put forward a proposal to WHO, further to demonstration projects called for by the CEWG, that proposed  “new open innovation business model for the development of antibiotic drugs.” The proposal suggested financial innovation incentives such as the use of grants and prizes to delink the cost of innovation from product prices.  It also proposed incentives for “open source development of new antibiotics” and sharing of technology, as well as competitive production of generic supplies of products.**

Additionally, a well-known critic of the current IP system, Kevin Outterson, professor at the Boston University School of Law, where he co-directs the Health Law Program, wrote a paper titled, “New Business Models for Sustainable Antibiotics,” that was published by Chatham House in February, 2014. The paper explores all the antibiotic delinkage models in the existing literature, as the author believes, “Antibiotic delinkage may offer the most promising avenue for a sustainable, global approach.” The South Center’s Martin Khor, anticipating discussion of  this topic on the agenda of the May, 2014 World Health Assembly, called for “Promoting the development of new antibiotics and in ways (including financing) that do not make the new drugs the exclusive property of drug companies.”

Rather than allowing anti-IP activists to use the trough in antibiotic research as a cudgel to attack the IP system, the R&D industry could take steps along the lines it took in decades past to tackle HIV/AIDs. In the mid-1980’s, then President of Pfizer, Dr. Gerald Laubach, convened a group of competitor pharmaceutical firms at Pfizer headquarters in NY to float the idea of industry collaboration to develop treatments to address HIV/AIDS, and called for mounting a new “Manhattan Project” (the  research and development project that produced the first atomic bombs during World War II). Discussions continued at a 1987 session of an Institute of Medicine meeting. A series of negotiations ensued until, in 1993, the Inter-Company Collaboration for AIDS Drug Development (ICC) was launched, despite skepticism about the business wisdom of sharing scientific data with competitors—even for the goal of addressing a pressing global health need.

The sharing of substantive scientific information began immediately at the Collaboration’s first formal meeting. Three companies presented data on antivirals then in development: Bristol-Myers Squibb, Hoffmann-La Roche, and Merck & Co., Inc. At the second meeting, several months later, six more companies came forward with data: Astra AB, Boehringer Ingelheim, Burroughs Wellcome, Eli Lilly, Glaxo, and Hoechst AG.

Though the prospect for addressing the HIV/AIDS pandemic in the mid-1980’s looked bleak, given the enormous challenges posed by the ever-mutating virus, innovative drug companies have successfully rolled out successful HIV/AIDS medicines over the past 25 years, innovated a range of access initiatives, and provided compounds that enabled generic firms to subsequently manufacture in high volumes. As a result, in developed countries, HIV/AIDS has become a manageable chronic condition. According to WHO, at the end of 2012, close to million people living with HIV were receiving antiretroviral therapy (ART) in low- and middle-income countries. Of this, about 640,000 were children. This is more than a 30-fold increase in the number of people receiving ART in developing countries between 2003 and 2012, and almost a 20% increase in just one year (from 8 million in 2011 to 9.7 million in 2012).

Given the industry’s record of success, and the need to withhold ammunition from anti-IP activists, innovative pharmaceutical companies ought to consider mounting a new “Manhattan Project” to develop critically-needed new antibiotics.

Susan Crowley is president of Multilateral Consulting, LLC. She can be reached at scrowley@multilateralconsulting.com

**Note: PharmExec spoke with Novartis’s Paul Herrling in May 2012 about his role on the CEWG, and his delinking proposal, here.

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4 Comments

  1. Victor Rossi
    Posted May 13, 2014 at 9:19 am | Permalink

    Consider

    Is pharma too busy attempting to discover new “boner” drugs to redirect their efforts at developing new antibiotics for the benefit of the global community?

    Personally, this writer would prefer having an effective combatant drug in the medicine chest over having a raging erection to please my current female lover.

  2. Posted May 13, 2014 at 9:41 am | Permalink
  3. Les
    Posted May 13, 2014 at 12:33 pm | Permalink

    Well let’s see. It takes about 10-15 years for a new drug to come to market and a billion dollars. When a company has 20 of these in the pipeline and most all of them fail…that money doesn’t get recovered. When people complain about pharm prices, they choose to ignore this fact. Nobody wants to pay for drugs, yet everybody wants new and better drugs. I don’t blame the pharma companies one bit…..they are constantly villified and for some reason expected to not profit from their work as does EVERY other industry. As far as antibacterial drugs, the bacteria get resistant to them so fast that they lose their effectiveness and the drugs become obsolete. I realize there are greedy pharma execs out there, but the industry has allowed for longer lifetimes with better quality of life….that fact cannot be debated…but yet you hear the aholes say that the industry has a cure for all of these diseases, but choose not to use them because they make more money off of treating the symptoms of disease. It’s just simply not true…and if people don’t like the pharm industry then don’t use their products. If you are your family falls ill, or is in an accident….by all means, do not use any meds.

  4. Posted May 15, 2014 at 10:40 am | Permalink

    As my old FDA mentor used to say, the R&D-based pharma industry is the greatest story never told. We live longer because of the industry. Our children survive what once killed. The last polio epidemic in this country claimed 50,000 victims – but no more. There is now even a vaccine that prevents cancer.

    To quote my former mentor again, the industry in the face of criticism is like a big fat bear, it moves slowly and once shot bleeds profusely. The industry should learn from Jamie Love, who communicates in simple terms his proposals – albeit untenable and unrealistic – like prizes directly through brown bag lunches to Congressional staffers, multi-lateral organization employees and law school students. Instead, industry continues to move slowly and bleed profusely by funding expensive academic studies that never get read – and repeating a tired old mantra that clearly falls on deaf ears about how this or that will undermine innovation.

    In closing, all stakeholders are at fault in the current crisis of antibiotic resistance. Prizes are not going to create the new class of drugs that are needed. The life blood of innovation is cash flow during the new drug discovery and development process – not at the end like a diploma at graduation. And that simple fact has not been communicated by industry and hence is not understood even by Jamie.

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