In an international game of Whac-A-Mol, this week China announced that it would be adding four lethal heroin-like narcotics to a list of controlled substances to help combat the growing opioid epidemic in America. The primary target of the ban is Carfentanil, one of the latest and deadliest synthetic opioids to show up in the United States.
Carfentanil is so deadly that an amount smaller than a poppy seed can kill a person, and until recently, was best known as a tranquilizer for knocking out moose and elephants, or as a chemical weapon. Today you can find it on the streets in Ohio and Indiana.
For decades before being discovered by drug dealers, Carfentanil has been banned from the battlefield under the Chemical Weapons Convention. However, last year drug dealers discovered that large profits could be made by cutting fentanyls into illicit drugs, and US customs authorities seized in the first six months of 2016, 295 pounds of a substance they had rarely seen before.
And overdose rates have sky rocketed.
It is clear that U.S. opioid demand is driving the development and proliferation of a new class of deadly synthetic drugs. According to the DEA, most synthetic drugs like Carfentanil that end up in the United States arrive from China – synthetic opioids that are not widely abused in their country of origin. Produced by nimble chemists to stay one step ahead of Chinese law, drugs like Carfentanil proliferate as soon as a similar substance is banned. For example, after Beijing tightened its focus on other fentanyls late last year, the AP documented how Chinese vendors began to actively market alternative opioids.
Ultimately, the fundamental qualities of the global political structure are making it impossible to fully address this problem. Portable substances spill across national borders, and the need to effectively manage their production permeates every State – even those who have no problem with the substance – as the capacity to manage global issues like drug development and consumption has not kept pace with the evolution of its complexity and danger.
Throughout history, autonomy has been paramount to sovereignty. The current international global governance structure is predicated on the idea of a Westphalian State, and until recently, the slow dispersion rates of people, knowledge, and objects did not necessitate a need for change. However, as the world is flattening, the distance between nations and the idea of a purely independent state is becoming less and less of a possibility. Where a cannon was laborious and difficult to move, newly developed drugs can be mailed via domestic postal services.
How do we fight an opioid epidemic in America when the drugs come in so quickly and easily through our own postal service? Without a unified, global plan, independent nation states will continue to play Whac-a-mole. And people will continue to die. We no longer live in the age of the isolated state, and we must change our global health laws protocols to reflect this reality.
Although the actions in China this week are greatly appreciated and highly cooperative, we must not forget that they are not a solution, but merely a temporary fix to a much larger, global issue.
There is no doubt that viruses, emerging and re-emerging, have become an imminent global health threat. Starting in 2014, we saw the decimation of West African countries as a result of the Ebola epidemic. Soon after came the Zika outbreak that continues to pose a threat to countries in the Americas and around the world. Since December 2016, Brazil has been experiencing a rise in yellow fever cases, and deaths, among humans and monkeys alike. Colombia and Peru have already reported probable cases. As a response to rising human cases of the H7N9 bird flu, China just ordered the closure of all poultry markets in the eastern province of Zhejiang to stop the trade of live poultry.
Experts warn that the question is not whether but when a pandemic will hit. Unknown or little-known viruses currently looming in animal populations undetected pose a especially dangerous risk–we have little to no experience with them, we do not know whether or when they will spill over to humans, and we do not know where they will emerge next.
As recent outbreaks have demonstrated, we are ill-prepared to protect ourselves–we continue to react rather than adopt a more proactive and preventative approach. That said, experts working in this area are challenging the world to think outside the box, and the Global Virome Project (GVP) is exactly that. Envisioned as a global partnership, the GVP would seek to identify 99% to 100% of viruses with potential of becoming epidemics through the use of revolutionary technologies. This ten-year project promises to facilitate the development of various countermeasures, including vaccines and diagnostics. Read More
Stem cell research is a volatile scientific topic in the US, with supporters who are usually divided along political lines. Conservatives tend to view stem cell research – and particularly embryonic stem cell research – with disfavor. Thus, the new administration poses a threat to the continued support of research and innovation in this field, despite the abundance of breakthroughs already made that are on the cusp of providing lifesaving cures and therapies for millions of people.
What is “stem cell research”?
First, let us go over that exactly is the topic at issue here. Stem cells are defined by the National Institute of Health as unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity.
The beneficial potential for stem cells is that under certain physiologic or experimental conditions, they can be induced to become tissue- or organ-specific cells with special functions. The research underway in this field is to determine how scientists can trigger these unspecialized cells and instruct them to become specialized and form into new tissue or organs, such as healthy pancreas cells for someone with Type 1 Diabetes, or new neurons for someone whose nerve cells were damaged by Parkinson’s Disease.
Stem cells can be sourced from embryonic tissue, which usually comes from unused and donated embryos from in-vitro fertilization treatment. Some tissues and organs of the body also produce undifferentiated cells, called adult or somatic stem cells.
Since embryonic stem cells were discovered in 1998, political and ideological beliefs have significantly influenced the support and progress of research in the US. In 2001, President George W. Bush banned federal funding for embryonic stem cell research, citing that the use of these embryos, which would otherwise be discarded or would deteriorate in long-term storage, diminishes the value of human life. Scientists have identified other possible sources of stem cells, such as somatic cells. However, the completely unsullied nature of newly formed and undefined embryonic cells holds untold promise to scientists in this field who think they may be a more versatile means of generating healthy human tissue. President Obama lifted the embryonic research ban in 2009, but by then 8 years of critical research time was lost. Some states, like California, enacted legislation and provided funding to continue funding stem cell research during the Bush ban years. California implemented a $3 billion dollar state program – The California Institute for Regenerative Medicine (CIRM) – in 2004 to mitigate the effects of the federal ban. This program has already committed 75% of the $3 billion, and is estimated to deplete the fund by 2020. California is now faced with figuring out how to sustain its research initiative in the wake of another possible federal funding limitation or other encumbrances that could be imposed by the Trump Administration.
An Uncertain Outlook
Congressman Tom Price, the President’s nominee to run the Department of Health and Human services, previously sponsored a bill that defined the beginning of human life as starting at conception. He has made statements that were sharply critical of embryonic stem cell research, stating that Obama’s lifting of the embryonic ban would “force taxpayers to subsidize research that will destroy human embryos.” It stands to reason that if confirmed, he will not be an advocate for continued or increased funding for embryonic research, thus once again slowing progress in this promising area.
The Possibilities are Endless
Scientists see immeasurable potential for stem cell therapy if the research is allowed to continued unfettered and with robust support. Illnesses from Diabetes, to Cancer, to Parkinson’s and Alzheimer’s could be cured within our generation. Incredible advances in vision restoration and burn treatment have been realized with stem cell therapy. This video showing skin restoration on a burn victim is an incredible example of the life-changing treatments possible through stem cell therapy.
It is hard to imagine a world free of the ravages of cancer, Alzheimer’s, or ALS. But, scientists doing pioneering research tell us that this future is not merely a flight of imagination, but an attainable reality. Our government has a responsibility to support the continued preservation of the health and welfare of the American people. This responsibility does not vacillate based on which party is in power. It should not ebb and flow based on partisan loyalties or ideologies. It should be rooted in sound, objective judgment and facts. The promise of stem cells is a fact. The benefits it has already yielded are facts. The need to continue to support this research is a fact. The detriment to the public health if it is not pursued, and the blame that will fall squarely on the shoulders of those who impede this scientific progress, are facts that should never be allowed to become realities.
Germany joins the growing cannabis experiment
On January 19th, Germany joined the growing list of countries who have legalized marijuana for medical purposes. The bill, which was passed unanimously by the German Parliament after being first approved by the country’s cabinet in May 2016, will come into effect March 2017. The law allows doctors to prescribe cannabis to patients with multiple sclerosis and other severe illnesses as well as to those patients for whom the substance could alleviate certain symptoms, such as nausea or chronic pain, or who may see a positive effect on their disease progression.
Up until now, only certain people with serious medical conditions could be granted permission to use the drug for self therapy, and the bar was set fairly high. Only around 1,000 people in the whole country currently have been given permission to use the drug. Personal possession of the drug remains illegal in Germany, though small quantities in possession are not usually prosecuted.
Germany will provide patients with cannabis through a state-regulated program, allowing cannabis products to be grown under state supervision. Private producers could eventually also apply, but the requirements for approval would be very strict. The idea for a state-regulated program is that it will help in ensuring the plants quality. Until they are able to launch this program and grow enough plants, the products needed for patients will be imported.
Additionally, the Federal Health Minister, Hermann Gröhe, announced that “costs of using cannabis for medicinal purposes will be met by the health insurance companies of the critically ill, if no other form of treatment is effective.” Another win for public health is that along with the legalization, Germany is also planning to launch research to study the positive effects of such therapy, the appropriate dosage of the drug, and also its side effects. For this purpose, anonymous data on patients will be transferred to the Federal Institute for Drugs and Medical Devices (BfArM).
Growing information on existing evidence
A week before Germany legalized cannabis for medical cannabis, a new report from the National Academies of Sciences, Engineering, and Medicine was presented on the risks and benefits of cannabis use. “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research” is one of the most comprehensive studies of recent research on the health effects of recreational and therapeutic cannabis use, offering a rigorous review of relevant scientific research published since 1999. This report summarizes the current state of evidence regarding what is known about the health impacts of cannabis and cannabis-derived products, including effects related to therapeutic uses of cannabis and potential health risks related to certain cancers, diseases, mental health disorders, and injuries. More than 100 conclusions about the health effects of marijuana, including claims of both helpful and harmful effects, were evaluated by the National Academies of Sciences, Engineering and Medicine. The report is the product of 16 experts in their fields, including neurologists, oncologists, epidemiologists and child psychiatrists.
The report concludes that there is not enough research to reach conclusive judgments on whether marijuana can effectively treat most of the symptoms and diseases it is advertised as helping. However, the same is also true of many of the risks said to be associated with using cannabis.
There was only enough evidence to conclusively support treatment for three therapeutic uses, the study found: to reduce nausea and vomiting from chemotherapy, to treat chronic pain and to reduce spasms from multiple sclerosis.
The following is a list of some of the therapeutic uses analyzed with the existing scientific and medical evidence (the definitions used in the report can be accessed here):
There is conclusive or substantial evidence that cannabis or cannabinoids are effective:
There is moderate evidence that cannabis or cannabinoids are effective for:
There is limited evidence that cannabis or cannabinoids are effective for:
There is limited evidence of a statistical association between cannabinoids and:
There is limited evidence that cannabis or cannabinoids are ineffective for:
All signs point to the need for more research
While the paper is broad and wide-ranging, it is unlikely to end debate on any number of treatments. One researcher studying the therapeutic impacts of the cannabis compound cannabidiol on children with epilepsy said researchers’ conclusions were broadly “conservative”, and on epilepsy “wrong”.
“For science to do what it does, I think when they do a scientific review they should incorporate all the evidence that is out there for that disorder, and I don’t think they did that for epilepsy,” said Orrin Devinsky, director of New York University Langone Medical Center’s comprehensive epilepsy center. Still, he called the report “very valuable”.
However, even though there may be some controversy surrounding the report, one thing is clear: there is a need for more and better research. Among the review’s most fervent calls were for more investigation with many researchers stating that conclusive evidence about the positive and negative medical effects is hard to come by.
The report also took the unusual step of calling for private funding sources to advance marijuana research. Researchers found it “difficult to gain access to the quantity, quality, and type of cannabis product necessary”, the report said. “A diverse network of funders is needed to support cannabis and cannabinoid research.” Currently, because cannabis in the US is a Schedule I drug, research is prohibited. Only the University of Mississippi is allowed to grow research-grade marijuana, making the supply extremely limited. If we want to obtain the research to obtain conclusive evidence, it will be necessary to have bigger and more studies.
This statement was given by Professor Timothy Westmoreland on January 31st, 2017 to the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce. Prof. Westmoreland is a Senior Scholar at the O’Neill Institute for National and Global Health Law and Visiting Professor at Georgetown University Law Center. Any questions or comments can be directed to Timothy.Westmoreland@georgetown.edu.
Mr. Murphy, Ms. DeGette, and Members of the Subcommittee, thank you for the invitation to speak to you today.
My name is Tim Westmoreland. I am a professor from practice at Georgetown University Law Center, where I teach health law, among other topics. I do want to be clear, however, that I am testifying in my personal capacity today and that the views I present are my own. I believe that the reason I was invited today is not because of my academic work but because I was the director of the Medicaid and CHIP programs during the last years of the Clinton Administration.
Because of that work, I take a backseat to no one on program integrity issues in the Medicaid program. When I took the Medicaid director job, combatting fraud and abuse was one of my top priorities. I worked closely with both the GAO and the OIG at that time and, in fact, have testified several times with them before the Congress. Ensuring program integrity is often a thankless task, but people who care about Federal programs have to work to ensure that Federal funds are well used.
Program integrity problems are, however, not new. Military contractors cheated the Union Army during the Civil War. This gave rise to the False Claims Act of 1863, sometimes known as “Lincoln’s Law.” This law is still actively used to protect the Federal fisc, including on some occasions, the Medicaid program. From at least 1863 onward, it is a truth universally acknowledged that any place where money is being spent—whether it be private, State, or Federal, and no matter how good the cause—there are bad actors trying to steal some of it.
Program integrity efforts are especially important in Medicaid. This is because billions of dollars are at stake as are the health and well-being of the most vulnerable people in America. Those bad actors who steal from this program are not engaged in a heist of luxury goods; they are stealing the very means of survival from people who have nowhere else to turn and from the honest doctors and hospitals who furnish needed services to them. This importance is well illustrated by the fact that at the same time the Affordable Care Act (ACA) expanded Medicaid coverage, it also made significant improvements in program integrity efforts (as the GAO and OIG each observe).
But, as important as combatting fraud and abuse in Medicaid is, policymakers should keep it in perspective. No statistic makes sense if you do not consider the denominator as well as the numerator. As big as they are, the numbers must be viewed as what they are and as a whole.
First, we should all be careful about our terms. Not all of what is labeled “improper payments” are fraud or even mistaken; many are appropriate but simply badly documented (and may even be underpayments), and the actual loss to the government is much smaller than it may appear.
But, even so, the worst of the worst estimates using the broad term “improper payments” in Medicaid (including underpayments, overpayments, errors, and insufficient documentation) is 10%. That is a bad number that should be dramatically reduced. But, keeping it in perspective, it is actually less than the overhead-and-profit costs that are routine in private health insurance, costs that do not represent the provision of needed health services but that are taken for granted. 
Moreover, as the prepared statements of the GAO and OIG witnesses at today’s hearing have outlined, HHS has already implemented many efforts to address the more serious problems of program integrity. Some of the efforts are longstanding and some of them are just underway, but there are many activities focused on making sure that Medicaid is spending its money well and they are having an effect.
This is wrong. Program integrity problems are meaningful only when they are considered in the context of the many successes of Medicaid. Oscar Wilde defined a cynic as someone “who knows the price of everything and the value of nothing.” In that vein, too often the discussion is just of the payments of Medicaid, when in fact you can understand the real value of the program only by looking at what it is paying for.
For example, the Medicaid Expansion of the ACA means that:
The Medicaid Expansion of the ACA has fundamentally repaired a longstanding mistake in the program. For almost 50 years, Americans could get help only if they were poor and something else: Poor and pregnant, poor and a child, poor and with a disability, poor and elderly. Just being poor and uninsured was not enough. People had to fit into some sort of category.
But this “categorical eligibility” has never made sense. Poor women need health insurance both before and after they have their babies. Poor children keep needing health insurance even when they turn 19. Poor people with chronic illnesses need health insurance before they become totally disabled. Poor older adults need health insurance when they’re 64, not suddenly when they are 65. The real problems are poverty and uninsurance. Categorical eligibility has irrationally rationed a sensible response.
In the 32 States that have adopted the Medicaid Expansion, we are making this part of the American insurance system sensible and fair for vulnerable people. Please do not turn back this response.
Lincoln did not give up the Civil War because the government was sold bad mules. We do not stop buying drugs because drug-makers charged a fraudulent price. We punish wrongdoers, correct the price, and get the treatment to people in need. That is what should be done here.
Don’t reverse all this progress by rationalizing that program-integrity problems demand wholesale legislative change in Medicaid. There are real babies in that bathwater.
The hearing documents can be found here.
 See L. Lahman, “Bad Mules: A Primer on the False Claims Act” (Oklahoma Bar Journal, April 9, 2005), available at http://www.okbar.org/members/BarJournal/archive2005/Aprarchive05/obj7612fal.aspx (“The Federal False Claims Act (FCA) was enacted in part because of bad mules. During the Civil War, unscrupulous early day defense contractors sold the Union Army decrepit horses and mules in ill health, faulty rifles and ammunition, and rancid rations and provisions among other unscrupulous actions.” [Citations omitted.])
 See, e.g., “Celebrating the 150th Birthday of Lincoln’s Law” (Forbes, March 6, 2013), available at http://www.forbes.com/sites/realspin/2013/03/06/celebreating-the-150th-birthday-of-lincolns-law-privatized-fraud-fighting/#3135614a47da
 See, e.g., Department of Justice, “Justice Department Recovers over $3.5 Billion from False Claims Act Cases in Fiscal Year 2015” (Press release, December 3, 2015), available at https://www.justice.gov/opa/pr/justice-department-recovers-over-35-billion-false-claims-act-cases-fiscal-year-2015
 See PaymentAccuracy.gov at https://paymentaccuracy.gov/faq/; also “Medicaid and CHIP 2015 Improper Payments Report” (HHS, November 2015) available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicaid-and-CHIP-Compliance/Downloads/2015MedicaidandCHIPImproperPaymentsReport.pdf , saying “[T]hese errors do not necessarily represent payment to illegitimate providers who should have not been enrolled in Medicaid or CHIP and do not necessarily represent examples of abuse or fraud. Rather the majority of erroneous payments represented situations where information required for payment was missing from the claims or states did not follow the appropriate process for enrolling providers. Had such information been on the claims and/or had the state followed the correct enrollment process, the claims may have been payable.”
 See CMS, “Medicaid and CHIP 2015 Improper Payments Report,” id.
 D. Archer “Medicare is More Efficient than Private Health Insurance,” (Health Affairs Blog, September 20, 2011), available at http://healthaffairs.org/blog/2011/09/20/medicare-is-more-efficient-than-private-insurance/; cf. “The average adjusted [ACA Medical Loss Ratio] was 89.5% in the large group market, 85.0 percent in the small group market, and 78.8 percent in the individual market.” GAO, “Medical Loss Ratios” (GAO-12-90R, October 31, 2011) available at http://www.gao.gov/new.items/d1290r.pdf
 Indeed, the ACA’s imposition of a Medical-Loss Ratio that limits private insurance overhead and profit to as much as 15-20% was greeted with some controversy. See, T. Jost, “Implementing Health Reform: The Minimum Loss Ratio and Summary of Benefits and Summary of Benefits and Coverage” (Health Affairs Blog, May 13, 2012), available at http://healthaffairs.org/blog/2012/05/13/implementing-health-reform-the-minimum-loss-ratio-summary-of-benefits-and-coverage/
 See, e.g., “Health Care Fraud Abuse Annual Report: 2015” (HHS and DOJ, February 2016), available at https://oig.hhs.gov/publications/docs/hcfac/FY2015-hcfac.pdf; D. Heath, “Senate Report Recommends Ouster of Large Dental Chain from Medicaid” (Center on Public Integrity July 23, 2013), available at https://www.publicintegrity.org/2013/07/23/13029/senate-report-recommends-ouster-large-dental-chain-medicaid-program; K. Young and R. Garfield, “Spending and Utilization of Epi-Pen Within the Medicaid Program” (Kaiser Family Foundation (KFF), October 7, 2016), available at http://kff.org/medicaid/issue-brief/spending-and-utilization-of-epipen-within-medicaid/#footnote-199903-10;
 O. Wilde, “Lady Windermere’s Fan” (1892) in The Plays of Oscar Wilde (1988).
 R. Rudowitz, S. Artiga, and K. Young, “What Coverage and Financing is at Risk Under a Repeal of the ACA Medicaid Expansion?” (KFF, December 6, 2016), available at http://kff.org/medicaid/issue-brief/what-coverage-and-financing-at-risk-under-repeal-of-aca-medicaid-expansion/
 CMS, “Medicaid and CHIP: Strengthening Coverage, Improving Health (January 2017), available at https://www.medicaid.gov/medicaid/program-information/downloads/accomplishments-report.pdf
 R. Rudowitz and R. Garfield, “New Analysis Shows States with Medicaid Expansion Experienced Declines in Uninsured Hospital Discharges,” (KFF, September 2015), available at http://files.kff.org/attachment/issue-brief-new-analysis-shows-states-with-medicaid-expansion-experienced-declines-in-uninsured-hospital-discharges
 J. Perkins and I. McDonald, “50 Reasons Medicaid Expansion is Good for Your State” (National Health Law Program, January 2017).
 D. Bachrach, P. Boozang, A. Herring, and D. Reyneri, “States Expanding Medicaid See Significant Budget Savings and Revenue Gains” (State Health Reform Assistance Network, March 2016), available at http://statenetwork.org/wp-content/uploads/2016/03/State-Network-Manatt-States-Expanding-Medicaid-See-Significant-Budget-Savings-and-Revenue-Gains-March-2016.pdf
 J. Paradise, “Community Health Centers: Recent Growth and the Role of the ACA” (KFF, January 18, 2017), available at http://kff.org/report-section/community-health-centers-recent-growth-and-the-role-of-the-aca-issue-brief/
 CMS, supra, n. 12.
 B. Han, et al., “Medicaid Expansion Under the Affordable Care Act: Potential Changes in Receipt of Mental Health Treatment Among Low-Income Nonelderly Adults With Serious Mental Illness,” (American Journal of Public Health, October 2015), available at http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2014.302521?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed
 D. Bachrach, P. Boozang, A. Herring, and D. Reyneri, “Medicaid: States’ Most Powerful Tool to Combat the Opioid Crisis,” (State Health Network, July 2016), available at http://statenetwork.org/wp-content/uploads/2016/07/State-Network-Manatt-Medicaid-States-Most-Powerful-Tool-to-Combat-the-Opioid-Crisis-July-2016.pdf
 L. Hu, et al., “The Effect of the Patient Protection and Affordable Care Act’s Medicaid Expansions on Financial Well-Being” (National Bureau of Economic Research, April 2016), available at http://nber.org/papers/w22170.
 T. Gross and M. Notowidigdo, “Health Insurance and the Consumer Bankruptcy Decision: Evidence from Expansions of Medicaid” (Journal of Public Economics, March 2011), available at http://isiarticles.com/bundles/Article/pre/pdf/48303.pdf
 See, e.g., comment by Joe Parks, director of the Missouri Medicaid program, a State that has not expanded coverage: “The best way to get treatment if you’re addicted to drugs in Missouri is to get pregnant.” Bachrach, supra.
 Department of Justice, “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data: Largest Health Care Fraud Settlement in US History” (Press Release, July 2, 2012), available at https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report; see generally, Office of Inspector General (HHS), “OIG Compliance Program Guidance for Pharmaceutical Manufacturers” (April 2003), available at https://oig.hhs.gov/fraud/docs/complianceguidance/042803pharmacymfgnonfr.pdf
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.