As controversy about the pricing of EpiPens reverberates from Capitol Hill to school districts across the country, one recurring complaint from consumers is that the high cost is magnified because the drug expires quickly, forcing users to regularly bear the cost of replacing the medicine that saves lives in the event of a severe allergic reaction.
So what exactly determines its longevity? It turns out storage and distribution can play as important a role in the drug’s shelf life as the chemical compounds.
The EpiPen works by injecting into the body the drug epinephrine. That causes a series of physiological changes, including tightening blood vessels and opening airways.
Epinephrine is a generic medication and not very costly, but the drug maker Mylan has a patent on the design of the auto injector that is the key element of the EpiPen. That injector allows users to administer the medication more quickly than other options on the market. Under that patent, the company has progressively raised the cost of the drug since 2007 to about $600 for a pack of two today.
Since the medicine generally expires every year, the cost to replace EpiPens adds up fairly quickly, especially for consumers who do not have insurance or have high-deductible plans in which they must spend money out of pocket before the coverage kicks in.
“This is just a lifesaving medicine,” said Robert Glatter, an emergency room physician at Lenox Hill Hospital in New York. “You can’t let it expire.”This KHN story also ran on Money. It can be republished for free (details).
Environment plays a role the in the EpiPen’s lifespan. The medicine can be stored in areas fluctuating between 59 and 86 degrees, but it should not be exposed to extreme heat or cold. Mylan also advises users to protect the drug from light and not store it in a glove compartment.
According to Julie Knell, director of specialty communications at Mylan, the EpiPen expires every 12 to 18 months, but that period includes the time it takes to distribute the product and reach the patient’s hands.
Glatter said that is similar to the time that hospitals keep vials of epinephrine in stock, too.
Aside from the active ingredient, the EpiPen solution also contains fillers needed to help stabilize the drug. These compounds also break down over time, affecting the drug’s potency. Glatter said EpiPen users should look out for cloudiness or small pieces of matter in the liquid, as that indicates degradation.
Still, he pointed out that a study in 2000 found EpiPens can remain without apparent signs of deterioration for up to 90 months — seven and a half years — after the expiration date.
While he strongly discourages patients from allowing their EpiPens to expire, Glatter said using an expired one is better than none at all.
“They’re willing to take a chance, unfortunately,” he said.
Glatter said he’s seen a rise in people holding onto expired EpiPens because they cannot afford a new dose. And according on FDA standards, no other drug on the market is as effective.
Despite its dominance, consumers can purchase a cheaper alternative that contains the same medication: Adrenaclick’s generic option. That product lasts 18 months — the maximum length of time for the EpiPen — and can withstand the same temperatures as its competitor. Both the generic and EpiPen auto-injectors are designed with a viewing window to check the solution for cloudiness and particle matter.
Unlike the EpiPen, the generic auto-injector requires the user to remove an endcap before injecting the epinephrine. The alternative also stands out from its brand name competitor with its price tag: $395 for a two-pack.
Under intense scrutiny, Mylan announced several initiatives to reduce the cost of EpiPens for its users. Among them is the release of their own generic version, which, according to the company’s website, will be identical to their brand name drug at half the cost. In addition, the manufacturer will provide a direct-ship option, which allows consumers to buy the product directly from the company.
Mylan’s announcement drew sharp criticism last week at a hearing of the House Oversight and Government Reform Committee, with many members claiming the company would profit more from the generic drug than the brand name drug because it cut costs by eliminating the distributor. Mylan CEO Heather Bresch adamantly denied the accusations.
In addition, Bresch also announced the company is “day’s away” from submitting a proposal to the FDA for an EpiPen that expires every 24 months, double the shelf life of the current product.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
Most hospitals offer palliative care services that help people with serious illnesses manage their pain and other symptoms and make decisions about their treatment, while providing emotional support and assistance in navigating the health system. But hospital programs vary widely, and the majority fail to provide adequate staff to meet national guidelines, a recent study found.
A growing body of research has shown that palliative care can improve the quality of life for patients with serious illnesses and complex, long-term needs. In one study, patients with advanced cancer who had discussions with their doctor about their wishes were less likely to die in the intensive care unit, be put on a ventilator or have cardiopulmonary resuscitation, for example.Insuring Your Health
KHN contributing columnist Michelle Andrews writes the series Insuring Your Health, which explores health care coverage and costs.
To contact Michelle with a question or comment, click here.
Although many people, including medical professionals, continue to associate palliative care only with end-of-life care, it is appropriate for many people in many settings who are living with debilitating long-term illnesses.
In 2013, two-thirds of hospitals with at least 50 beds reported having a palliative care program. At hospitals with 300 beds or more, the figure was 90 percent, according to a study published in the Journal of Palliative Medicine earlier this year.
But not all programs provide the same level of service. In the September issue of Health Affairs, an analysis of 410 palliative care programs found that only 25 percent funded teams in 2013 that included a physician, an advanced practice or registered nurse, a social worker and a chaplain, the four positions that are recommended by the Joint Commission, which sets hospital standards, including those for accreditation. If “unfunded” staffers were counted, those who were on loan from other units, for example, the figure rose to 39 percent.
Study coauthor Diane Meier, a professor of geriatrics and palliative medicine at the School of Medicine at Mount Sinai in New York and director of the Center to Advance Palliative Care, said she wasn’t surprised by the low numbers.
“There are no regulatory or accreditation requirements that enforce the staffing guidelines,” Meier said. Although the Joint Commission recommends a staffing standard, hospitals aren’t currently required to have palliative care teams in order to be accredited, Meier said.
“The hope is to shine a light on the gap in what everyone agrees is the [staffing] standard. If we’re invested in improving the quality of care, this is what it will take.”
Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.
KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.
The Supplemental Nutrition Assistance Program (SNAP, formerly food stamps) delivers more nutrition assistance to low-income children than any other federal program. While SNAP provides only a modest benefit of $1.35 per person per meal for families with children, it forms a critical foundation for children’s health and well-being, as our major new report explains.
Drugmaker Sarepta Therapeutics won a big victory when its $300,000 muscular dystrophy drug was recently approved, but the company had other reasons to celebrate, too.
They were also awarded the drug world’s equivalent of a Willy Wonka golden ticket.
The ticket, known as a rare pediatric disease priority review voucher, is part of a program created by Congress in 2007 to encourage the development of drugs for tropical diseases and later expanded to rare pediatric disorders. Any company awarded a voucher can use it for a fast-track government review of one of its future drugs — or it can sell the voucher to another company.
“The only people who would buy a priority review voucher would be someone who had something that wouldn’t merit its own priority review but they want the priority review,” says Dr. Tim Coté, a former FDA official who now runs a consulting firm for rare disease drugs.
In other words, the companies willing to pay for a voucher are most likely trying to get a medicine that treats a common disease on the market quickly for competitive reasons, he said.
“It might be a blockbuster — say a new statin,” Coté said, referring to a drug that lowers cholesterol. “A priority review would make all the difference in the world.”
A voucher guarantees a company that its drug will be reviewed within six months, as compared to the standard 10. But approval isn’t assured.This KHN story also ran on NPR. It can be republished for free (details).
And the sale of one voucher can earn hundreds of millions of dollars for a small company like Sarepta. Last year, a voucher sold for a record $350 million when AbbVie Inc. bought one from United Therapeutics. The company has not announced plans for the voucher.
It’s those price tags — as well as admonishments from the Food and Drug Administration — that have some industry watchers debating whether the program should continue. The House voted Tuesday to extend the program until the end of the year, after the Senate had already done so. It was set to expire this month.
Members of Congress, the pharmaceutical industry, and rare disease advocates have passionately supported the voucher program as a way to incentivize rare disease drug development. The goal, they say, is to steer more money toward rare disease drug developers by allowing them to sell the voucher to the highest bidder. But others, such as FDA officials and academics, have questioned whether the program is leading to any new drugs for rare diseases.
Nancy Goodman, executive director of Kids v Cancer, is a champion of the bill. She created her foundation after her son died seven years ago of medulloblastoma, a rare pediatric brain cancer.
There were no drugs available for her 10-year-old son, she said.
“I believe and hope we will see a whole crop of pediatric disease drugs because of the program,” Goodman said.
The legislation extending the program passed the House and Senate by unanimous consent and awaits action by President Barack Obama, who is expected to sign it. Advocates are fighting to keep the program authorized until Dec. 21, 2018 as part of the 21st Century Cures Act, which has passed the House and has stalled in the Senate, where backers hope it will be taken up after the elections.
But officials at the FDA, which must implement the vouchers, are at odds with industry and advocates.
Dr. John Jenkins, director of the office of new drugs in the Center for Drug Evaluation and Research at the FDA, has said he supports the overall goal of providing incentives to promote drug development but that the voucher program is wrong.
In December, Jenkins told a reporter at the industry publication Pharmaceutical Executive that vouchers raise safety concerns because the program requires the FDA to give any drug accelerated review — even when reviewers have to address complex issues.
“We’re not making pizza here,” he said.
Jenkins declined interview requests for this story. FDA spokeswoman Sandy Walsh said, the “FDA has not seen evidence that the program is effective.”
Walsh also said the agency is concerned that the voucher program “adversely affects the agency’s ability to set its public health priorities” and “the additional workload from the program strains the agency’s resources.”
The voucher program does require companies to pay a user fee of nearly $3 million to help the agency pay for the program. But the additional money may not be sufficient.
In March, a Government Accountability Office report said FDA officials complain there is too little time to use the money to hire and train additional employees to do accelerated reviews and that the one-time fee does not enable hiring of long-term staff.
The GAO’s report said it was too early to say whether the pediatric priority review voucher program, approved in 2012, is stimulating development of drugs.
Of the seven pediatric review vouchers that have been awarded, four have been sold to other drug companies.
Drugmaker Sanofi has redeemed two of the vouchers. For the first, they paid $67.5 million and used it to expedite review of their cholesterol drug Praluent. Later, Sanofi spent $245 million for a voucher and said in February it would be used to speed up the FDA’s decision on a new type 2 diabetes treatment.
If a voucher is not used, it can be sold an unlimited number of times before being used.
Sarepta plans to sell its voucher, Chief Financial Officer Sandy Mahatme told Wall Street analysts in announcing approval of its drug to treat Duchenne muscular dystrophy. He said the money would help finance other drugs in its pipeline, pay for the scaling up of its manufacturing and support the company’s entry into European markets.
Mahatme said they have already reached out to “a bunch of potential buyers.”
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
The nation’s largest health insurer and the University of California Health system are joining forces to create a new health plan option for employers and expand research into patient data.
Under the 10-year partnership unveiled Thursday, UnitedHealth Group Inc. and the UC system will form an accountable care organization that will be offered to large, self-funded employers statewide. In accountable care organizations, or ACOs, physicians, hospitals and an insurer work together to coordinate care, control spending and share savings.
The for-profit insurer will also open a research lab in the San Francisco area early next year offering researchers at the state-run health system access to a huge national database of patient records.
The collaboration comes as hospital systems and insurers are under increasing pressure from employers, government health programs and their competitors to forge new alliances aimed at improving care and cutting costs. It also reflects the growing importance of data mining to achieve those goals by identifying disease earlier and finding more effective treatments.Use Our Content This story can be republished for free (details).
The deal marks UnitedHealth’s continued interest in growing its California business despite its decision in May to leave the state’s health insurance exchange.
The company’s Optum unit was recently awarded a five-year contract to manage pharmacy benefits for the California Public Employees’ Retirement System, and UnitedHealth is expanding its presence in Medi-Cal, the state’s Medicaid program. The company said it now serves more than 3.5 million Californians.
The UC system runs five academic medical centers in Los Angeles, San Francisco, San Diego, Irvine and Davis, including hospitals, medical groups, clinics and other outpatient facilities. They will continue to work with other insurers such as Anthem Inc. and Blue Shield of California as network providers and in other ACOs.
But UnitedHealth offered several advantages compared to its rivals in terms of data-mining capabilities and administrative support for hospitals and physician offices through its consulting unit, said David Kraus, chief contracting and clinical strategy officer for the UC Health system.
“What was unique about UnitedHealth is they are more than just a health plan,” Kraus said. “This collaboration helps us advance things quicker.”
Kraus said the university system and UnitedHealth want to learn from the mistakes of earlier ACOs and offer employers a more centralized approach that can tap into real-time data as patients move through the health care system.
“A lot of employers have a physical health product unrelated to a mental health product unrelated to their wellness program, which is completely unrelated to the pharmacy benefit. We think it needs to be all together, and we get to build this ACO from the ground up,” Kraus said.
The financial terms of the partnership weren’t disclosed. Kraus said a joint governing board will establish the specific financing for individual projects and determine how much each organization contributes.
“We will look at pilots and talk about which ones to invest in and where,” Kraus said. “It could be 80 percent-20 percent or 60-40. We haven’t boxed ourselves into a preordained structure.”
Steve Valentine, vice president and West Coast consulting leader at the health care firm Premier Inc., said the deal brings together two highly regarded organizations, but he said some employers chafe at the high cost of UC facilities.
“UC has to address its whole cost structure,” Valentine said. “They tend to be more expensive so they will need to address pricing to be competitive.”
UnitedHealth is playing catch-up in a crowded market. Anthem, the nation’s second-largest health insurer, has been the dominant player in California for self-funded employers. In that scenario, large employers have the financial resources to pay their own medical claims. They hire an insurer to administer the health plan and create a provider network.
Anthem had a 37 percent share of the 6.4 million Californians covered by the self-funded market in 2014, according to data from the California Health Care Foundation. Cigna Corp. was second with 24 percent market share, followed by UnitedHealth and Blue Shield of California at 13 percent apiece. (California Healthline is an editorially independent service of the California Health Care Foundation.)
HMO giant Kaiser Permanente has a smaller presence in the state’s self-funded market. In the fully insured market for large employers, Kaiser Permanente leads the state with a nearly 50 percent share.
Under the new deal, the insurer will establish an office in the San Francisco area for OptumLabs. UnitedHealth founded OptumLabs, a collaborative research center, with the Mayo Clinic in 2013 and the headquarters is in Cambridge, Mass. Other partners such as AARP, Harvard Medical School and Pfizer later joined the research effort.
OptumLabs said it will provide UC researchers and physicians access to one of the nation’s largest databases of medical claims, although it will not be publicly available and patients’ identities will not be revealed. It contains claims information on more than 150 million people going back two decades. It also includes electronic medical records on another 50 million patients.
In one research project, OptumLabs has examined whether scanning the narrative portion of electronic medical records could indicate which patients are at risk of developing Alzheimer’s disease rather than waiting for physician tests down the road.
“There is so much depth of knowledge in the University of California system and we are certain when some of that expertise is applied to the data at OptumLabs it will really move us forward,” said Dr. Paul Bleicher, chief executive officer of OptumLabs. “We work on the most difficult problems in health care.”
The two organizations also want to use the California office of OptumLabs to lure young data scientists into the medical field rather than lose them to game developers or social media in Silicon Valley.
“Everybody is struggling with the fact that Facebook, Google and other tech companies are very attractive and obvious targets for new graduates coming out,” Bleicher said. “This will help bring in UC students to work on our data.”
As events and educational activities mark this year’s Hispanic Heritage month, we are marking recent progress in expanding health coverage among Latinos and seeking further progress.
Seventy years ago – on October 1, 1946 – the Nuremberg trial, one of the most prominent trials of the last century, concluded when the International Military Tribunal (IMT) issued the verdicts for the main war criminals of the Second World War. The IMT sentenced twelve of the defendants to death, seven to terms of imprisonment ranging from ten years to life, and acquitted three.
The IMT was established on August 8, 1945 by the United Kingdom (UK), the United States of America, the French Republic, and the Union of Soviet Socialist Republics (U.S.S.R.) for the trial of war criminals whose offenses had no particular geographical location. The defendants were indicted for (1) crimes against peace, (2) war crimes, (3) crimes against humanity, and of (4) a common plan or conspiracy to commit those aforementioned crimes. The trial began on November 20, 1945 and a total of 403 open sessions were held. The prosecution called thirty-three witnesses, whereas the defense questioned sixty-one witnesses, in addition to 143 witnesses who gave evidence for the defense by means of written answers to interrogatories. The hearing of evidence and the closing statements were concluded on August 31, 1946.
The individuals named as defendants in the trial were Hermann Wilhelm Göring, Rudolf Hess, Joachim von Ribbentrop, Robert Ley, Wilhelm Keitel, Ernst Kaltenbrunner, Alfred Rosenberg, Hans Frank, Wilhelm Frick, Julius Streicher, Walter Funk, Hjalmar Schacht, Karl Dönitz, Erich Raeder, Baldur von Schirach, Fritz Sauckel, Alfred Jodl, Martin Bormann, Franz von Papen, Arthur Seyss-Inquart, Albert Speer, Constantin von Neurath, Hans Fritzsche, and Gustav Krupp von Bohlen und Halbach. All individual defendants appeared before the IMT, except for Robert Ley, who committed suicide in prison on October 25, 1945; Gustav Krupp von Bolden und Halbach, who was seriously ill; and Martin Borman, who was not in custody and whom the IMT decided to try in absentia. Pleas of “not guilty” were entered by all the defendants.
Influence of the Nuremberg Trials on International Law
The establishment of the IMT served as a model for other international tribunals and the principles developed and recognized in the IMT Charter and in the judgement of the IMT had a major impact on the development of international criminal law. After the verdict was announced, the United Nations (UN) Secretary General stated that
[i]n the interests of peace and in order to protect mankind against future wars, it will be of decisive significance to have the principles which were employed in the Nuremberg trials and according to which the German war-criminals were sentenced, made a permanent part of the body of international law as quickly as possible.
The ILC formulated the following seven Nuremberg principles:
- Any person who commits an act which constitutes a crime under international law is responsible therefor and liable to punishment.
- The fact that internal law does not impose a penalty for an act which constitutes a crime under international law does not relieve the person who committed the act from responsibility under international law.
- The fact that a person who committed an act which constitutes a crime under international law acted as Head of State or responsible Government official does not relieve him from responsibility under international law.
- The fact that a person acted pursuant to order of his Government or of a superior does not relieve him from responsibility under international law, provided a moral choice was in fact possible to him.
- Any person charged with a crime under international law has the right to a fair trial on the facts and law.
- The crimes hereinafter set out are punishable as crimes under international law:
a. Crimes against peace:
(i) Planning, preparation, initiation or waging of a war of aggression or a war in violation of international treaties, agreements or assurances;
(ii) Participation in a common plan or conspiracy for the accomplishment of any of the acts mentioned under (i).
b. War crimes:
Violations of the laws or customs of war which include, but are not limited to, murder, ill-treatment or deportation to slave-labour or for any other purpose of civilian population of or in occupied territory, murder or ill-treatment of prisoners of war, of persons on the seas, killing of hostages, plunder of public or private property, wanton destruction of cities, towns, or villages, or devastation not justified by military necessity.
c. Crimes against humanity:
Murder, extermination, enslavement, deportation and other inhuman acts done against any civilian population, or persecutions on political, racial or religious grounds, when such acts are done or such persecutions are carried on in execution of or in connexion with any crime against peace or any war crime.
- Complicity in the commission of a crime against peace, a war crime, or a crime against humanity as set forth in Principle VI is a crime under international law.
The UN General Assembly never formally adopted or rejected the Nuremberg principles after the codification by the ILC, but the principles have been reaffirmed and further developed in the statutes of the International Criminal Tribunal for the former Yugoslavia (ICTY), the International Criminal Tribunal for Rwanda (ICTR), and the International Criminal Court (ICC) and in international and national case law. The Nuremberg principles are today widely considered to represent customary international law. Some principles are even regarded as peremptory norms of international law (jus cogens).
Law Library of Congress Resources
For more on the subject, we invite you to review the resources of the Law Library of Congress, which include, among others, the official records of the trial of the major war criminals before the IMT (“The Blue Series”). In addition to primary sources, the Law Library of Congress holds numerous secondary source materials on the Nuremberg trial of the major war criminals and subsequent trials, and the general subject of international criminal law. A small selection of primary sources and recent secondary English-language titles includes:
- Trial of the major war criminals before the International Military Tribunal, Nuremberg, 14 November 1945 – 1 October 1946 [electronic resource]. The 42-volume series contains the official record of the trial of the major civilian and military leaders of Nazi Germany who were accused of war crimes.
- The trial of German major war criminals by the International Military Tribunal sitting at Nuremberg, Germany. Buffalo, N.Y., 2001. Contains the opening speeches of the chief prosecutors, the closing speeches of the prosecutors for the case against the indicted organizations and for the case against the individual defendants, and the judgment of the IMT.
- Bartlomiej Krzan (ed.), Prosecuting International Crimes: a Multidisciplinary Approach. Leiden; Boston: Brill Nijhoff, 2016.
- Priemel, Kim Christian, The Betrayal: The Nuremberg Trials and German Divergence. 1st edition. New York, N.Y.: Oxford University Press, 2016.
- Kamuli, Raphael. Modern International Criminal Justice: The Jurisprudence of the International Criminal Court. Cambridge, England; Antwerp; Portland, Oregon: Intersentia, 2014.
- Crowe, David. War Crimes, Genocide, and Justice : A Global History. 1st edition. New York, N.Y.: Palgrave Macmillan, 2014.
- Margaret Wood, War Crimes Resources – A Research Guide, In Custodia Legis, June 27, 2013.
- Kim C. Priemel/Alexa Stiller (eds.), Reassessing the Nuremberg Military Tribunals: Transitional Justice, Trial Narratives, and Historiography. New York: Berghahn Books, 2012.
- Heller, Kevin Jon, The Nuremberg Military Tribunals and the Origins of International Criminal Law. Oxford; New York: Oxford University Press, 2011.
After months of bickering, Congress agreed Wednesday to allocate $1.1 billion toward curbing the spread of the Zika virus, a primarily mosquito-borne disease that has raised public health alarms.
The package is part of a larger spending bill to keep the federal government running until Dec. 9. It comes as the virus — which can cause birth defects if contracted by pregnant women — is actively spreading in Florida. More than 3,000 cases have been reported in the continental United States, though most were contracted by people traveling abroad.
So what exactly has Congress done? And, from a public health standpoint, how much will it help? Here is a breakdown of what you need to know.
First Things First: A Reminder Of Why Zika Causes Concern
Zika is a virus that has been spreading globally since last year. It is transmitted by mosquitoes and also through sexual intercourse. The virus has already moved through African and Latin American countries. Currently, mosquitoes are carrying it in parts of Florida. Experts worry these mosquitoes will spread to other Gulf Coast states — such as Texas, Louisiana and Georgia, where hot, humid climates are particularly friendly to the insects.Use Our Content This KHN story can be republished for free (details).
For most of the population, Zika doesn’t appear to be a huge deal. About 80 percent of people who are infected don’t show symptoms at all. Those who do typically suffer a flu or maybe a bad rash.
But for pregnant women, it’s a different story. Zika can cause severe birth defects in children — including but not limited to microcephaly, which stunts brain development – and has been linked to other complications in pregnancy.
It’s unclear how often those complications result, though, and researchers are still investigating other possible consequences Zika might have in terms of fetal development, and for both mother and child’s long-term health. So, long story short: The virus can be incredibly damaging. How often that’s true, though, remains unclear.
This $1.1 Billion — What Will It Actually Do?
The funding consists of two pots: one, totaling almost $935 million, for efforts curbing Zika’s spread at home; and another, for about $175 million, targeting it abroad.
Domestically, the money’s split among prevention, responding to the virus and developing treatment. So far, there’s no vaccine or cure for Zika. Congress has approved $152 million for the National Institute of Allergy and Infectious Diseases (NIAID), which is researching potential vaccines.
The Centers for Disease Control and Prevention gets $394 million, which the agency can use in areas affected by Zika. Another $387 million is for the U.S. Department of Health and Human Services’ public health emergency fund, and will be used for activities like providing Zika testing and caring for people who have been affected by the virus.
That money will be essential in states and territories where Zika poses a threat, said Chris Gould, senior director for federal government relations at the Association of State and Territorial Health Officials. The CDC’s funds, for instance, could support programs that eliminate mosquitoes, monitor the virus and educate people at risk.
“This amount, even though it’s long overdue, still will certainly go a long way in terms of helping states get what they need,” Gould said.
On the foreign aid side, the money will go to the State Department to support activities such as evacuating eligible pregnant Americans from countries where Zika is spreading and helping hard-hit foreign nations address their own Zika issues.
How Does This Funding Amount Compare To What Public Health Experts Want?
This falls short of the $1.9 billion President Barack Obama originally sought. But it’s fairly similar to a package the Senate first floated in May. Here, the key difference is increased funding for domestic efforts, with less for the State Department’s international efforts.
How does this hold up, then? Public health advocates said more money, of course, would have been better, but said this is a meaningful start.
In this measure, Congress provided less research funding than the NIAID requested – the agency would ideally get $40 million more, said director Anthony Fauci. That said, the funds should be enough to maintain “critical vaccine studies,” though the agency will have to trim other Zika work, he added, such as “more fundamental research” on the virus and its properties.
Also, the bill passed by the Senate in May snagged after the House of Representatives argued that Congress would somehow have to offset any new funding — repurposing dollars intended for use elsewhere, for instance — and pressed to include language barring Planned Parenthood affiliates in Puerto Rico from getting federal dollars.
Planned Parenthood isn’t mentioned in the final agreement. About $400 million of the new package comes from repurposed money, much of it originally meant for combating the Ebola virus and for implementing provisions of the 2010 federal health law.
Borrowing against Ebola funding is problematic, argued Lawrence Gostin, a professor at Georgetown University and faculty director of its O’Neill Institute for National and Global Health Law. “That money is needed to fulfill our promise to be vigilant about Ebola,” he said.
Congress Has Been Fighting About Zika For A Long Time. Has That Delay Had Any Consequences?
Yes. Mosquito season generally peaks in the summer, though it’s certainly longer in states like Florida and Texas. So for many at-risk states, it’s too late to do any real prevention work — at least this time around.
For instance, it’s possible that Zika is being actively spread in states other than Florida, said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. No one would know, he said, because there has not been enough money to support thorough surveillance.
“We will not know how well we’re doing until next April or May when we see if babies with microcephaly are being born,” he said. “We have to be on top of it — we have to hold our breaths until April or May.”
In the meanwhile, he added, while the funding may be too late to really make a difference this year, it could lay the groundwork to undermine future Zika threats.
So What’s Next? Is The Zika Problem Solved?
Probably not. While mosquitoes die down in the fall, experts say Zika will likely present a public health concern for the next few summers and that, in all likelihood, more money will be needed if Congress hopes to keep the virus at bay.
Right now, states should be able to appropriately respond to Zika with the funds Congress is allocating, Gould said, assuming the virus does not suddenly spread much more quickly than it has been so far. But there needs to be an understanding that “when this money runs out, Zika may not run out.”
“We’re not going to measure Zika in this one cycle,” Gould said. “We’re talking years.”