An academic-industrial partnership published last January in the prestigious journal Nature the results of the development of antibiotic teixobactin. The reported work is still at an early preclinical stage but it is nevertheless good news. Over the last decades the introduction of new antibiotics has slowed down nearly to a halt and over the same period we have seen a dangerous increase in antibiotic resistant bacteria.

Such is the magnitude of the problem that it has attracted the attention of the U.S. government. Accepting several recommendations presented by the President’s Council of Advisors on Science and Technology (PCAST) in their comprehensive report, the Obama Administration issued last September an Executive Order establishing an interagency Task Force for combating antibiotic resistant bacteria and directing the Secretary of Human and Health Services (HHS) to establish an Advisory Council on this matter. More recently the White House issued a strategic plan to tackle this problem.

Etiology of antibiotic resistance

Infectious diseases have been a major cause of morbidity and mortality from time immemorial. The early discovery of sulfa drugs in the 1930s and then antibiotics in the 1940s significantly aided the fight against these scourges. Following World War II society experienced extraordinary gains in life expectancy and overall quality of life. During that period, marked by optimism, many people presumed victory over infectious diseases. However, overuse of antibiotics and a slowdown of innovation, allowed bacteria to develop resistance at such a pace that some experts now speak of a post-antibiotic era.

The problem is manifold: overuse of antibiotics, slow innovation, and bacterial evolution.

The overuse of antibiotics in both humans and livestock also facilitated the emergence of antibiotic resistant bacteria. Responsibility falls to health care providers who prescribed antibiotics liberally and patients who did not complete their prescribed dosages. Acknowledging this problem, the medical community has been training physicians to avoid pressures to prescribe antibiotics for children (and their parents) with infections that are likely to be viral in origin. Educational efforts are also underway to encourage patients to complete their full course of every prescribed antibiotic and not to halt treatment when symptoms ease. The excessive use of antibiotics in food-producing animals is perhaps less manageable because it affects the bottom line of farm operations. For instance, the FDA reported that even though famers were aware of the risks, antibiotics use in feedstock increased by 16 percent from 2009 to 2012.

The development of antibiotics—perhaps a more adequate term would be anti-bacterial agents—indirectly contributed to the problem by being incremental and by nearly stalling two decades ago. Many revolutionary innovations in antibiotics were introduced in a first period of development that started in the 1940s and lasted about two decades. Building upon scaffolds and mechanisms discovered theretofore, a second period of incremental development followed over three decades, through to 1990s, with roughly three new antibiotics introduced every year. High competition and little differentiations rendered antibiotics less and less profitable and over a third period covering the last 20 years pharmaceutical companies have cut development of new antibiotics down to a trickle.

The misguided overuse and misuse of antibiotics together with the economics of antibiotic innovation compounded the problem taking place in nature: bacteria evolves and adapts rapidly.

Current policy initiatives

The PCAST report recommended federal leadership and investment to combat antibiotic-resistant bacteria in three areas: improving surveillance, increasing the longevity of current antibiotics through moderated usage, and picking up the pace of development of new antibiotics and other effective interventions.

To implement this strategy PCAST suggested an oversight structure that includes a Director for National Antibiotic Resistance Policy, an interagency Task Force for Combating Antibiotic Resistance Bacteria, and an Advisory Council to be established by the HHS Secretary. PCAST also recommended increasing federal support from $450 million to $900 million for core activities such as surveillance infrastructure and development of transformative diagnostics and treatments. In addition, it proposed $800 million in funding for the Biomedical Advanced Research and Development Authority to support public-private partnerships for antibiotics development.

The Obama administration took up many of these recommendations and directed their implementation with the aforementioned Executive Order. More recently, it announced a National Strategy for Combating Antibiotic Resistant Bacteria to implement the recommendations of the PCAST report. The national strategy has five pillars: First, slow the emergence and spread of resistant bacteria by decreasing the abusive usage of antibiotics in health care as well as in farm animals; second, establish national surveillance efforts that build surveillance capability across human and animal environments; third, advance development and usage of rapid and innovative diagnostics to provide more accurate care delivery and data collection; forth, seek to accelerate the invention process for new antibiotics, other therapeutics and vaccines across all stages, including basic and applied research and development; finally, emphasize the importance of international collaboration and endorse the World Health Organization Action Plan to address antimicrobial resistance.

University-Industry partnerships

Therefore, an important cause of our antibiotic woes seems to be driven by economic logic. On one hand, pharmaceutical companies have by and large abandoned investment in antibiotic development; competition and high substitutability have led to low prices and in their financial calculation, pharmaceutical companies cannot justify new developmental efforts. On the other hand, farmers have found the use of antibiotics highly profitable and thus have no financial incentives to halt their use.

There is nevertheless a mirror explanation of a political character.

The federal government allocates about $30 billion for research in medicine and health through the National Institutes of Health. The government does not seek to crowd out private research investment; rather, the goal is to fund research the private sector would not conduct because the financial return of that research is too uncertain. Economic theory prescribes government intervention to address this kind of market failure. However, it is also government policy to privatize patents to discoveries made with public monies in order to facilitate their transfer from public to private organizations. An unanticipated risk of this policy is the rebalancing of the public research portfolio to accommodate the growing demand for the kind of research that feeds into attractive market niches. The risk is that the more aligned public research and private demand become, the less research attention will be directed to medical needs without great market prospects. The development of new antibiotics seems to be just that kind of neglected medical public need. If antibiotics are unattractive to pharmaceutical companies, antibiotic development should be a research priority for the NIH. We know that it is unlikely that Congress will increase public spending for antibiotic R&D in the proportion suggested by PCAST, but the NIH could step in and rebalance its own portfolio to increase antibiotic research. Either increasing NIH funding for antibiotics or NIH rebalancing its own portfolio, are political decisions that are sure to meet organized resistance even stronger than antibiotic resistance.

The second mirror explanation is that farmers have a well-organized lobby. It is no surprise that the Executive Order gingerly walks over recommendations for the farming sector and avoid any hint at an outright ban of antibiotics use, lest the administration is perceived as heavy-handed. Considering the huge magnitude of the problem, a political solution is warranted. Farmers’ cooperation in addressing this national problem will have to be traded for subsidies and other extra-market incentives that compensate for loss revenues or higher costs. The administration will do well to work out the politics with farmer associations first before they organize in strong opposition to any measure to curb antibiotic use in feedstock.

Addressing this challenge adequately will thus require working out solutions to the economic and political dimensions of this problem. Public-private partnerships, including university-industry collaboration, could prove to be a useful mechanism to balance the two dimensions of the equation. The development of teixobactin mentioned above is a good example of this prescription as it resulted from collaboration between the university of Bonn Germany, Northeastern University, and Novobiotic Pharmaceutical, a start-up in Cambridge Mass.

If the NIH cannot secure an increase in research funding for antibiotics development and cannot rebalance substantially its portfolio, it can at least encourage Cooperative Research and Development Agreements as well as university start-ups devoted to develop new antibiotics. In order to promote public-private and university-industry partnerships, policy coordination is advised. The nascent enterprises will be assisted greatly if the government can help them raise capital connecting them to venture funding networks or implementing a loan guarantees programs specific to antibiotics.  It can also allow for an expedited FDA approval which would lessen the regulatory burden. Likewise, farmers may be convinced to discontinue the risky practice if innovation in animal husbandry can effectively replace antibiotic use. Public-private partnerships, particularly through university extension programs, could provide an adequate framework to test alternative methods, scale them up, and subsidize the transition to new sustainable practices that are not financially painful to farmers.

Yikun Chi contributed to this post

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Last week, over 100 experts from across the U.S. came together at the Brookings Institution on the sixth anniversary of the Citizens United decision to analyze its disastrous consequences and how to repair them. The room was as diverse as it was packed. Two dozen current and former members of Congress, representatives of the executive and judicial branches, both state and federal, attended. They sat side-by-side with business leaders and lobbyists, activists and scholars. Conservatives and Tea Party leaders mingled with liberals and progressives. All were united by their agreement that the current system is broken—and their determination to fix it.

Several points of consensus emerged from the half day event.

First, we are facing a crisis due to the flood of money that is drowning American democracy. For example, Congressman Steve Israel expanded on his recent New York Times op-ed describing why he his quitting Congress. He related his experience of calling potential campaign donors from a small cubicle off the Capitol grounds—a practice referred to as “call time.” Invoking images from The Wolf of Wall Street, Congressman Israel compared the practice to “selling penny stocks, only it’s shares of democracy that are being traded.” The result is voter disillusionment– voters increasingly feeling like their voices are not heard because they cannot make large political contributions. Author Peter Schweizer, President of the Government Accountability Institute, argued that businesses suffer under this system as well. From his perspective, “Businesses … are targeted by politicians in the search for cash,” in a type of extortion by which politicians use their influence to benefit only those who can pay up. The Executive Director of Take Back our Republic, John Pudner, argued that the campaign finance system is the single greatest threat to national security—if domestic interests can purchase influence in our system, international interests can figure out a way to do so as well.

Ambassador Eisen with Congressman Steve Israel (D-NY 3) 

Second, there is hope for a fix. There are a wide range of innovative solutions at hand, many of which have already been successfully deployed at the state and local levels. Commissioner and outgoing Chair Ann Ravel of the Federal Election Commission laid out a reform agenda for that organization. John Bonifaz of Free Speech for People advocated for a 28^th amendment allowing for campaign spending limits, reminding the audience, “We have done this before in our nation’s history; 27 times before. Seven of those times to overturn egregious Supreme Court rulings.” Fred Wertheimer urged strategies to capitalize on the small donor revolution that technology has ushered in, as well as a renewed push for public finance. Judges and legislators from states across the union discussed how public finance and other remedies are working at the state and local levels. Still others advocated solutions including a pledge that would commit politicians to ethical fundraising standards and campaign finance reform agendas when in office; reform in the Federal Election Commission to allow greater enforcement authority; corporate governance policies that require publically held companies to openly disclose political contributions and be accountable to their shareholders; and many, many more specific solutions to tackle the problem from all sides.

Third, and perhaps the most important takeaway from the event, was that those fixes are in political reach. Expert after expert, all from vastly different backgrounds and political orientations, argued that we are much closer to achieving these solutions than we think. The entire program was evidence of that—the size, diversity, and passion of the attendees mirroring a nation of voters who are demanding their representatives do what’s necessary to fix our broken campaign finance system. In the concluding panel, Congressman John Sarbanes predicted, “I think the public is going to demand this. That’s why the time is now. The broad public has arrived at a moment where they are demanding a response to the way they feel. If they don’t get it from some of the solutions we’re proposing, because we don’t educate them that those solutions are there, they’re going to grab a pitchfork and they’re going to go somewhere else. But there’s plenty of evidence that the public will not be denied some remedy to the way they feel.”

The full audio of the event, which includes further discussion of many solutions and the reasons why they are so necessary, can be found on the event page. By clicking there, you can see all the featured speakers, and many more experts participated from the audience floor. Give a listen and you will see why it was such a remarkable day, and why change is nearer that you may think.

The 2016 Brown Center Report (BCR), which was published last week, presented a study of Common Core State Standards (CCSS).   In this post, I’d like to elaborate on a topic touched upon but deserving further attention: what to expect in Common Core’s immediate political future. I discuss four key challenges that CCSS will face between now and the end of the year.

Let’s set the stage for the discussion.  The BCR study produced two major findings.  First, several changes that CCSS promotes in curriculum and instruction appear to be taking place at the school level.  Second, states that adopted CCSS and have been implementing the standards have registered about the same gains and losses on NAEP as states that either adopted and rescinded CCSS or never adopted CCSS in the first place.  These are merely associations and cannot be interpreted as saying anything about CCSS’s causal impact.  Politically, that doesn’t really matter. The big story is that NAEP scores have been flat for six years, an unprecedented stagnation in national achievement that states have experienced regardless of their stance on CCSS.  Yes, it’s unfair, but CCSS is paying a political price for those disappointing NAEP scores.  No clear NAEP differences have emerged between CCSS adopters and non-adopters to reverse that political dynamic.

"Yes, it’s unfair, but CCSS is paying a political price for those disappointing NAEP scores. No clear NAEP differences have emerged between CCSS adopters and non-adopters to reverse that political dynamic."

TIMSS and PISA scores in November-December

NAEP has two separate test programs.  The scores released in 2015 were for the main NAEP, which began in 1990.  The long term trend (LTT) NAEP, a different test that was first given in 1969, has not been administered since 2012.  It was scheduled to be given in 2016, but was cancelled due to budgetary constraints.  It was next scheduled for 2020, but last fall officials cancelled that round of testing as well, meaning that the LTT NAEP won’t be given again until 2024.  

With the LTT NAEP on hold, only two international assessments will soon offer estimates of U.S. achievement that, like the two NAEP tests, are based on scientific sampling:  PISA and TIMSS.  Both tests were administered in 2015, and the new scores will be released around the Thanksgiving-Christmas period of 2016.  If PISA and TIMSS confirm the stagnant trend in U.S. achievement, expect CCSS to take another political hit.  America’s performance on international tests engenders a lot of hand wringing anyway, so the reaction to disappointing PISA or TIMSS scores may be even more pronounced than what the disappointing NAEP scores generated.

Is teacher support still declining?

Watch Education Next’s survey on Common Core (usually released in August/September) and pay close attention to teacher support for CCSS.  The trend line has been heading steadily south. In 2013, 76 percent of teachers said they supported CCSS and only 12 percent were opposed.  In 2014, teacher support fell to 43 percent and opposition grew to 37 percent.  In 2015, opponents outnumbered supporters for the first time, 50 percent to 37 percent.  Further erosion of teacher support will indicate that Common Core’s implementation is in trouble at the ground level.  Don’t forget: teachers are the final implementers of standards.

An effort by Common Core supporters to change NAEP

The 2015 NAEP math scores were disappointing.  Watch for an attempt by Common Core supporters to change the NAEP math tests. Michael Cohen, President of Achieve, a prominent pro-CCSS organization, released a statement about the 2015 NAEP scores that included the following: "The National Assessment Governing Board, which oversees NAEP, should carefully review its frameworks and assessments in order to ensure that NAEP is in step with the leadership of the states. It appears that there is a mismatch between NAEP and all states' math standards, no matter if they are common standards or not.” 

Reviewing and potentially revising the NAEP math framework is long overdue.  The last adoption was in 2004.  The argument for changing NAEP to place greater emphasis on number and operations, revisions that would bring NAEP into closer alignment with Common Core, also has merit.  I have a longstanding position on the NAEP math framework. In 2001, I urged the National Assessment Governing Board (NAGB) to reject the draft 2004 framework because it was weak on numbers and operations—and especially weak on assessing student proficiency with whole numbers, fractions, decimals, and percentages.  

Common Core’s math standards are right in line with my 2001 complaint.  Despite my sympathy for Common Core advocates’ position, a change in NAEP should not be made because of Common Core.  In that 2001 testimony, I urged NAGB to end the marriage of NAEP with the 1989 standards of the National Council of Teachers of Mathematics, the math reform document that had guided the main NAEP since its inception.  Reform movements come and go, I argued.  NAGB’s job is to keep NAEP rigorously neutral.  The assessment’s integrity depends upon it.  NAEP was originally intended to function as a measuring stick, not as a PR device for one reform or another.  If NAEP is changed it must be done very carefully and should be rooted in the mathematics children must learn.  The political consequences of it appearing that powerful groups in Washington, DC are changing “The Nation’s Report Card” in order for Common Core to look better will hurt both Common Core and NAEP.

Will Opt Out grow?

Watch the Opt Out movement.  In 2015, several organized groups of parents refused to allow their children to take Common Core tests.  In New York state alone, about 60,000 opted out in 2014, skyrocketing to 200,000 in 2015.  Common Core testing for 2016 begins now and goes through May.  It will be important to see whether Opt Out can expand to other states, grow in numbers, and branch out beyond middle- and upper-income neighborhoods.

Conclusion

Common Core is now several years into implementation.  Supporters have had a difficult time persuading skeptics that any positive results have occurred. The best evidence has been mixed on that question.  CCSS advocates say it is too early to tell, and we’ll just have to wait to see the benefits.  That defense won’t work much longer.  Time is running out.  The political challenges that Common Core faces the remainder of this year may determine whether it survives.

Medicare Hospital Insurance and Social Security would not add to deficits because they can’t spend money they don’t have.

The dog days of August have given way to something much worse. Congress returned to session this week, and the rest of the year promises to be nightmarish. The House and Senate passed budget resolutions earlier this year calling for nearly $5 trillion in spending cuts by 2025. More than two-thirds of those cuts would come from programs that help people with low-and moderate-incomes. Health care spending would be halved. If such cuts are enacted, the president will likely veto them. At best, another partisan budget war will ensue after which the veto is sustained. At worst, the cuts become law.

The putative justification for these cuts is that the nation faces insupportable increases in public debt because of expanding budget deficits. Even if the projections were valid, it would be prudent to enact some tax increases in order to preserve needed public spending. But the projections of explosively growing debt are not valid. They are fantasy.

Wait! you say. The Congressional Budget Office has been telling us for years about the prospect of rising deficit and exploding debt. They repeated those warnings just two months ago. Private organizations of both the left and right agree with the CBO’s projections, in general if not in detail. How can any sane person deny that the nation faces a serious long-term budget deficit problem?

The answer is simple: The CBO and private organizations use a convention in preparing their projections that is at odds with established policy and law. If, instead, projections are based on actual current law, as they claim to be, the specter of an increasing debt burden vanishes. What is that convention? Why is it wrong? Why did CBO adopt it, and why have others kept it?

CBO’s budget projections cover the next 75 years. Its baseline projections claim to be based on current law and policy. (CBO also presents an ‘alternative scenario’ based on assumed changes in law and policy). Within that period, Social Security (OASDI) and Medicare Hospital Insurance (HI) expenditures are certain to exceed revenues earmarked to pay for them. Both are financed through trust funds. Both funds have sizeable reserves — government securities — that can be used to cover short falls for a while. But when those reserves are exhausted, expenditures cannot exceed current revenues. Trust fund financing means that neither Social Security nor Medicare Hospital Insurance can run deficits. Nor can they add to the public debt.

Nonetheless, CBO and other organizations assume that Social Security and Medicare Hospital Insurance can and will spend money they don’t have and that current law bars them from spending.

One of the reasons why trust fund financing was used, first for Social Security and then for Medicare Hospital Insurance, was to create a framework that disciplined Congress earmarked to earmark sufficient revenues to pay for benefits it might award. Successive presidents and Congresses, both Republican and Democratic, have repeatedly acted to prevent either program’s cumulative spending from exceeding cumulative revenues. In 1983, for example, faced with an impending trust fund shortfall, Congress cut benefits and raised taxes enough to turn prospective cash flow trust fund deficits into cash flow surpluses. And President Reagan signed the bill. In so doing, they have reaffirmed the discipline imposed by trust fund financing.

Trust fund accounting explains why people now are worrying about the adequacy of funding for Social Security and Medicare. They recognize that the trust funds will be depleted in a couple of decades. They understand that between now and then Congress must either raise earmarked taxes or fashion benefit cuts. If it doesn’t raise taxes, benefits will be cut across the board. Either way, the deficits that CBO and other organizations have built into their budget projections will not materialize.

The implications for projected debt of CBO’s inclusion in its projections of deficits that current law and established policy do not allow are enormous, as the graph below shows.

If one excludes deficits in Social Security and Medicare Hospital Insurance that cannot occur under current law and established policy, the ratio of national debt to gross domestic product will fall, not rise, as CBO budget projections indicate. In other words, the claim that drastic cuts in government spending are necessary to avoid calamitous budget deficits is bogus.

It might seem puzzling that CBO, an agency known for is professionalism and scrupulous avoidance of political bias, would adopt a convention so at odds with law and policy. The answer is straightforward—Congress makes them do it. Section 257 of the Balanced Budget and Emergency Deficit Control Act of 1985 requires CBO to assume that the trust funds can spend money although legislation governing trust fund operations bars such expenditures. CBO is obeying the law.

No similar explanation exonerates the statement of the Committee for a Responsible Federal Budget, which on August 25, 2015 cited, with approval, the conclusion that ‘debt continues to grow unsustainably,’ or that of the Bipartisan Policy Center, which wrote on the same day that ‘America’s debt continues to grow on an unsustainable path.’ Both statements are wrong.

To be sure, the dire budget future anticipated in the CBO projections could materialize. Large deficits could result from an economic calamity or war. Congress could abandon the principle that Social Security and Medicare Hospital Insurance should be financed within trust funds. It could enact other fiscally rash policies. But such deficits do not flow from current law or reflect the trust fund discipline endorsed by both parties over the last 80 years. And it is current law and policy that are supposed to underlie budget projections. Slashing spending because a thirty-year old law requires CBO to assume that Congress will do something it has shown no sign of doing—overturn decades of bipartisan prudence requiring that the major social insurance programs spend only money specifically earmarked for them, and not a penny more—would impose enormous hardship on vulnerable populations in the name of a fiscal fantasy.

Editor's Note: This post originally appeared in Fortune Magazine.