The superbugs are here, but where are we?

By Chris Gallagher
July 14, 2016

Super bug conceptIn Where Good Ideas Come From, its brilliant author Steven Johnson describes young Charles Darwin’s 1836 visit to the Keeling Islands. Stunned by the multiple life forms inhabiting the Keeling’s coral reefs, although the islands themselves were barren and otherwise surrounded by clear ocean, Darwin began seeing life as it really was rather than what he had been told. This striking contrast between the coral reef’s teeming ecosystem and its lifeless surroundings is known as “Darwin’s Paradox”. Simply stated, although coral reefs may be born in biologically bare environments, they are alive. Like biodiverse rainforests, they create new life with amazing efficiency. Indeed, they now account for 25% of earth’s organic marine species. Scientists attribute such remarkable maternity to the random interactions of wind, sun and sea within coral reefs’ promiscuously interactive ecosystems. Countless microbial encounters among its inhabitants inevitably lead to multiple, evolvied mutations, creating new species that then exponentially procreate  more..

Thanks to Darwin, we now know that nature’s adaptivity is actually evolution’s unconscious but relentless recipe for fitness and survival: individuation, selection, and amplification. These random biological progressions never stop. In fact, invisible microbes have been marching towards continuing survival for two billion years. Though some microbes are good – and we could not survive without them –  some are bad. But all microbes are able to adaptively resist repeated threats to their biotic survival. Indeed, our mindless over-reliance on antibiotics to eliminate the bad microbes ( called pathogens) has triggered adaptive evolutionary adaptive behavior that has made them antibiotic drug resistant. Even diseases like tuberculosis, once thought dead, have resurrected. New pathogens are emerging. And for some we have no cure.

An instructive Newsweek piece explains the problem in layperson terms. It ends with a warning about one new superbug’s recent arrival, demonstrating perhaps that our cherished belief in human biotic superiority may be incorrect.

Antibiotics were one of the most important discoveries of the 20th century. Convincing the research community that a 19th-century idea is the future of medicine is a difficult task, but the discovery of the mcr-1 gene may be the warning sign that jump-starts the conversation.

We had best be wary.  And we must find other ways to deal with superbugs .

The President wisely has formed a National Action Plan. CDC is doing what it can to educate the public. Through its world renowned NIAID subdivision, led by Dr. Anthony Fauci, NIH has recently deployed research grants aimed at developing new antibiotics and other weaponry designed to harness our immune systems, new anti-toxins and even reconstituted former anti-bacterial remedies. Research university life science labs also have joined this important effort, each launching its research responding to the new NIAID incentives. Will these super efforts be too little or too late to stop the superbugs? Two billion years of microbial survival says that superbugs, guided by their morphology, will maintain their ominous momentum and survive.

The more pressing question is ….will we?  Would that the rest of government match the genius and leadership of NIAID’s Dr Fauci. But superbugs have powerful friends in high places. SCOTUS’s patent eligibility criteria emanating from Mayo/Alice’s  mysterious “laws of nature” and credible reports of unremitting turndowns by USPTO applicants portend hard times commercializing much of this research, which means its development and testing may never make it to licensed distribution. In Congress, deficit scolds roll back much needed NIH funding while solons clamor for more military weapons that have long outlived their usefulness. Even sexy pandemics like Ebola, Pan Asian Flu, and Zika and competing with Biden moonshots and precision medicine initiatives are forced to forage for the fiscal nourishment they need to compete and commercialize their critical research.

To populist applause, UN secretary General Ban Ki-moon has proved a High Level Panel whose findings are expected shortly and seems sure to undermine worldwide life science patent reliability by degrading patents while promoting compulsory licensing and other biopharma price controls.  Congressional anti-patent advocates plot new self-serving schemes to degrade patents and destroy their enforceability  Meanwhile ill-informed if well-meaning solons on the Hill whose AIA IPR killing fields are already where many patents go to die, pressure NIH  deployment of cumbersome and ultra vires US price-based Bayh-Dole march-in’s compulsory licensing while presidential candidates and self-appointed special coalitions seek more ways to force price reductions, that will further curtail already dangerously thin investment ion superbug remedies .Indeed the spread of superbugs, created by our misuse and overuse of antibiotics, may actually be boosted by megatech proposals to mis-use patent legislation to institutionalize abusive patent unenforceability while price controllers wait for the next greedy pharmaceutical provider to them a chance to pounce. Populist price control proposals are poised for deployment by our next president whoever wins.

In short, human failure to survive the spread of superbugs may be politically self-inflicted! In simplest terms, two overarching realities at work. First, the superbugs are here. Their expanding hordes are not just festering in some far-off foreign country. They flourish here at home. The super-bug¹s equivalent of Darwin’s species-supportive coral reef is as near as your neighborhood health care center and wherever else our formerly-effective antibiotics were made most available and mindlessly mis-used. We are incubating and accelerating their spread. So whether or not this process causes the world¹s next pandemic, it may well become our country’s next health crisis.

Second, the anti-patent advocates and worldwide health care hand-wringers both are effectively pursuing IP degradation and other biopharma price controls that will kill our life science innovation ecosystem’s capacity to effectively respond to the superbugs. The system cannot work without private investment. We now are nowhere near ready to disrupt, much less degrade superbugs’ elusive shapeshifting. Worse, we are witnessing more destruction of the means to obtain effective countermeasures. Instead of encouraging the deployment of financial incentives needed to support the herculean efforts of Dr Fauci, we are doing just the opposite.

Read the short NIH report, or at least the excerpts below. They describe the situation NOW.

The development of new antibiotics by the pharmaceutical industry, a strategy that had been effective at combating resistant bacteria in the past, had essentially stalled due to economic and regulatory obstacles. Of the 18 largest pharmaceutical companies, 15 abandoned the antibiotic field. Mergers between pharmaceutical companies have also substantially reduced the number and diversity of research teams. Antibiotic research conducted in academia has been scaled back as a result of funding cuts due to the economic crisis. (Emphasis my own)

Antibiotic development is no longer considered to be an economically wise investment for the pharmaceutical industry.14 Because antibiotics are used for relatively short periods and are often curative, antibiotics are not as profitable as drugs that treat chronic conditions, such as diabetes, psychiatric disorders, asthma, or gastroesophageal reflux. A cost­ benefit analysis by the Office of Health Economics in London calculated that the net present value (NPV) of a new antibiotic is only about $50 million, compared to approximately $1 billion for a drug used to treat a neuromuscular disease. Because medicines for chronic conditions are more profitable, pharmaceutical companies prefer to invest in them.

Another factor that causes antibiotic development to lack economic appeal is the relatively low cost of antibiotics. Newer antibiotics are generally priced at a maximum of $1,000 to $3,000 per course compared with cancer chemotherapy that costs tens of thousands of dollars. The availability, ease of use, and generally low cost of antibiotics has also led to a perception of low value among payers and the public.

NIH concludes as follows:

Rapidly emerging resistant bacteria threaten the extraordinary health benefits that have been achieved with antibiotics.14 This crisis is global, reflecting the worldwide overuse of these drugs and the lack of development of new antibiotic agents by pharmaceutical companies to address the challenge.14 Antibiotic-resistant infections place a substantial health and economic burden on the U.S. health care system and population.1 Coordinated efforts to implement new policies, renew research efforts, and pursue steps to manage the crisis are greatly needed.

Imagine what will happen if the anti patent,  price controlling have their way with Congress and a new Administration.

In short, the superbugs are scary. Our life science ecosystem that so effectively responded to once unmet biomedical needs is not able or ready to disarm them. As NIH notes above, the usual risk-reward incentives are badly out of balance. Predictable ROI is insufficient to attract investment, which means it is time for government, academia, biopharma, and special healthcare interest groups to close ranks and fall in behind NAIAD’s Dr Fauci. Finger-pointing slogans by self-appointed saviors of the world’s down-trodden will not end this evolutionary crisis. Caving in to big tech’s anti-patent crusade or politically imposed price controls will surely make matters worse. Relying on biopharma to fight these fights alone will not resolve the problem. The superbugs aren’t coming — they are here! We need nothing less than a collaborative life science coalition to simultaneously fight this multi fronted  evolutionary battle in the courts, our research labs , our medical centers and especially on Capitol Hill.

Drug developers compete in a world-wide market. Perceived return on investment (ROI) is the linchpin for life science commercialization. So in the private sector, where traditional ROI incentives no longer work patents either must be strengthened or ROI targets must be adjusted down. The only certainty in todays uncertain IP world is the politically weakening our innovation ecosystem with patent degradation and price controls is plainly counterproductive. In the global marketplace, it doesn’t matter whether foreseeable future market demand is shrunk, or predictable ROI is masked by the intrusive uncertainties of Bayh-Dole price-based March-in, Colombian compulsory licensing, Indonesian “process-product” word games, India and China’s mercantilism or Canada’s Promise Doctrine. If early stage investment in the war against the superbugs fails to enable adequate predictable ROI, commercialization and development simply will not happen.

Coordinated political response is especially needed. Special interests must leave their silo’ed battlements and join together. Today’s superbug crisis is not some academic theory. It does no good to advocate for the narrowly aimed and dangerous policy solutions preordained by Ban Ki-moon’s precooked HLP on Medical Access. We need action now, not more pieus policy pronouncements. Joint action in the battle grounds where we are losing the war today against these superbugs must be heightened, however untraditionally cooperative or financially unrewarding such concerted cooperative activity ay be. If politically we cannot strengthen our nation’s innovation ecosystem, we cannot collectively stand by while it is weakened. If self-serving anti-patent measures like HR 9 and S.1137 or if well-meaning but medically threatening price-controllers have their way,  we will have welcomed the lethal superbugs with open arms. Darwin was correct. Evolution never stops. The superbugs are on an evolutionary march. Sitting on the sidelines as if they won’t soon attack us all is strategic folly. Failing to collectively fight back is not just tactically stupid, it thus s suicidal.

The Author

Chris Gallagher

Chris Gallagher is President of IP Strategic.com and a perennial selection to The Best Lawyers in America. Having spent years as one of the most influential and highly regarded advocates in the New Hampshire Legislature and state administrative agencies, Chris is now focused primarily on federal policies in Washington, DC. Chris has been involved in nearly every substantial New Hampshire economic regulatory initiative over the last 25 years. He has served as general counsel for the New Hampshire Bankers Association and has represented New Hampshire utilities, hospitals, insurers, aggregate manufacturers and numerous other entities. This experience provides him with a uniquely respected voice on Capitol Hill, enabling him to communicate effectively with members whose federal decision-making must reflect and respect the complexities of their home-state constituents.

A frequent speaker and commentator in local and national media on policy issues, regarding financial services, privacy, business and government, Chris has testified on financial services issues before U.S. House and Senate Committees and has been a panelist in Capitol Hill briefings on intellectual property issues. He can be reached at chris@ipstrategic.com

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 6 Comments comments.

  1. Jim July 14, 2016 4:30 pm

    Well this is a new one – Mayo/Alice is threatening the human race.

  2. Richard Abramson July 15, 2016 11:05 am

    The argument has some force but seems to me overwrought and one-sided. Big Pharma didn’t seriously invest in antibiotics (or vaccines for that matter) prior to Mayo. Patentability, while relevant, is not a primary mover here. As with so many of our problems, our dysfunctional political system simply lacks the ability or will to allocate research monies and — be not shocked — technological subsidies to address critical issues that are not adequately addressed by market forces.

  3. Gene Quinn July 15, 2016 1:22 pm

    Richard A-

    I’d agree with you to some extent. Pharma has never invested in antibiotics to the level that I think society wishes they would. Having said that, there have been some exciting discoveries in recent years that have been rejected at the PTO as unpatentable because of the law of nature doctrine. In once case I’m familiar with there was a discovery of a naturally occurring compound that kills antibiotic resistant bacteria. It was a huge discovery. Because it occurs naturally no patent. But with no patent no one will ever develop it because of the extraordinary cost of going through the FDA process to get a product approved for market. No one would ever invest the money required to take that product to market when as soon as it would get to market anyone else could simply make and distribute the resulting approved product.

    -Gene

  4. step back July 16, 2016 5:35 am

    Also there is the incredibly naive and dangerous notion in Washington DC of Yes We Can –Make It So Number Two (aka Moonshot Biden Man) with respect to launching wars against cancer, against drugs (opioids), and against scientific research efforts that do not immediately or ever turn a “profit”.

    When the aliens land on this humanoid free and dinosaur free planet, they will wonder, what were those humanoids thinking? They had the brain power. But did they worship the free markets/ no-patents thing so much as to rush over the cliff like lunatic lemmings in frenzied quest of their “precious”?

    http://patentu.blogspot.com/2016/05/moonshooting-ourselves-in-foot.html

  5. Chris Gallagher July 16, 2016 5:47 pm

    Richard A
    That drug-makers underinvested in anti-bacterial therapies before Mayo is absolutely true. But it also is true, as Gene points out, that time, risk and high costs sunk into their availability must produce adequate ROI. Pre-Mayo underinvestment proves that very point. Because quick cures reduce demand, anti-bacterial therapy provides less ROI and less investment. As long as biopharma therapies are dependent on private sector investment, ROI will shape the type and the amounts invested in life science commercialization. Patents, market exclusivity, biologic data protection and smart economic laws like the Orphan Drug Act complement medical advances by intelligently acknowledging this economic reality. On the other hand, by ignoring it, Mayo has made matters worse. Anti-patent efforts in Congress resulting in AIA’s IPR have exposed “presumptively valid” patented technology to expedited invalidation after those sunk cost are expended. This has affected investment in all drugs especially those with lower predicted ROI like anti-bacterials. HR 9 and S. 1137, either of which could completely kill commercialization, are committee approved and await floor action in their respective bodies. If either become law commercialization will be further diminished. Price controls assure the the same effect. Drug resistant bacteria and new virus borne diseases call for smart judicial and political response if we hope to benefit from medical progress certain to emerge from our world class life science innovation ecosystem.
    Chris G

  6. Kelly Nevins July 21, 2016 2:59 pm

    I enjoyed the article and think this would make an excellent topic for a Hackathon I’m involved in that will take place in Kingston, RI, Oct. 14-16. Do you know someone in/near RI who might be willing to speak on this topic for 15 minutes on Oct. 14 to open the session?