Media Watch: Ebola/EVD [to 1 November 2014]
Accessed 1 November 2014
Ebola crisis: Canada visa ban hits West Africa states
Canada is to suspend visa applications from residents and passport-holders from West African countries in the grip of the Ebola outbreak.
The decision follows a similar decision by Australia, which drew criticism from the World Health Organization (WHO).
The ban would apply to countries with “widespread and persistent-intense transmission”, Canada said…
Center for Global Development
Accessed 1 November 2014
How Much Is Actually Being Spent on Ebola?
Amanda Glassman and Sneha Raghavan
How much is actually being spent on Ebola by donor governments, organizations, and private individuals? The short answer is that we don’t really know.
We do know that the US government, the World Bank, and others are committing large amounts of money to Liberia, Guinea, and Sierra Leone through various channels such as the World Health Organization, UNICEF, the CDC, and bilateral aid to affected country governments. We also have UN OCHA’s Financial Tracking service, which is publishing regular updates with donors’ Ebola contributions.
However, compared to the pledges made in press releases, UN OCHA’s numbers come up short for several donors, as of October 24, 2014. The figure below illustrates this discrepancy, with the differences amounting to as much as $391 million in the case of the US government. The World Bank has committed up to $400 million, but UN OCHA’s database only accounts for around $197 million of this, even accounting for uncommitted pledges….
Accessed 1 November 2014
Vaccine-makers and Ebola – Giving it a shot
Drugmakers bet that vaccines will help in the fight against Ebola
Nov 1st 2014 | From the print edition
IN MAY 2013 GlaxoSmithKline (GSK), a British pharmaceuticals firm, bought a small Swiss vaccine-maker for $325m. It acquired Okairos because it had the technology to create vaccines that stimulate stronger than normal immune responses. In a press release Okairos said the deal included a “small number of early-stage assets”.
That passing remark turned out to be a big deal. What GSK had paid for included a preclinical Ebola vaccine candidate, and in March this year it contacted the World Health Organisation (WHO) to let it know what it had. The WHO told GSK at first that its focus was on implementing disease-control protocols, and it was not until August that the company was asked to accelerate work on its vaccine.
The pharmaceutical industry has long neglected vaccines, not least because they are mostly needed by countries too poor to pay much for them. However, as concern about the current Ebola outbreak has grown, work on several candidates has been stepped up. This has involved unprecedented collaboration between companies, regulators, governments and bodies such as the WHO. Two candidates, GSK’s and one from NewLink Genetics, an American firm, will be ready for testing in West Africa by the end of the year. Health-care workers will be the guinea-pigs, so if the vaccines work this would have the fortunate side-effect of protecting a vital group of people.
Johnson & Johnson (J&J), another American firm, is a slightly later entrant and its double-jab vaccine will begin human trials in January. Nevertheless it has just made a commitment of $200m to accelerate and expand production of one of its jabs, and has spent more than $187m on a licensing deal with a Danish vaccine maker, Bavarian Nordic, to acquire the second. This deal includes upfront payments, equity investments, payouts at each important stage of progress and a supply contract. GSK says it can make 230,000 doses by April and 1m a month by the end of 2015. All this suggests it sees strong demand throughout next year.
Staff at GSK and J&J say they are working around the clock to accelerate production and that efforts are being driven by humanitarian need rather than any assumption that they will be profitable, or even work at all. Other vaccines are now being pushed forward but are not as far ahead as these three. Profectus BioSciences recently got two government contracts worth $17m to speed up work on its vaccine.
A lot of collaboration is likely in production, distribution and purchasing. Rival firms’ jabs may be combined into a single treatment. Pfizer, another American firm, is offering to share its specialised production capacity. GAVI, an international agency that procures vaccines for poor countries, is working on a plan to make big advance orders of Ebola jabs, but it will need more money if its work on other diseases next year is not to suffer.
Besides the short-term help with the outbreak that it is providing, Britain has made a commitment to Sierra Leone, a former colony, to help finance the development of any vaccines it needs over the medium term. Other countries are being urged to follow its example. Governments have already provided around $500m since 2008 towards research costs for Ebola drugs and vaccines for poor countries.
In late October drug regulators, industry executives and other officials and experts gathered in Geneva to discuss what were the obstacles to delivering Ebola vaccines, and how to remove them. Regulators in America and Europe are trying to rush out guidelines on the data they would require to grant approval for vaccines to be put into widespread use. Since vaccines are given to healthy people, they must be put through stringent safety tests. Unapproved Ebola drugs, however, have been given to some patients. Pharmaceutical firms say if regulators could harmonise their approvals processes, that could speed up the delivery of new vaccines.
There are also plans for a liability fund overseen by the World Bank. This would recompense those who suffer adverse reactions after being inoculated. Vaccine-makers usually buy insurance for such eventualities, but given the shortened testing schedule for the proposed Ebola jabs, insurers may be reluctant to provide it.
If mass vaccination across West Africa proved necessary, there might be a need for tens of millions of doses. That may sound like an exciting business opportunity for the pharmaceutical firms. But even if the urgency of the situation prompts regulators to waive some of their strict requirements on testing, and even with a liability fund in place, the vaccine-makers will be putting their reputations on the line. If their jabs are rushed into production, at great cost to donors, but prove ineffective or, worse, have serious side-effects, the companies that made them are bound to suffer recriminations.
Accessed 1 November 2014
Ebola Vaccine And Treatment Makers Need Liability Protection
Glenn G. Lammi , Contributor
U.S. politicians and regulators, many of whom ordinarily trend toward hyper-caution on new drug reviews and approvals, are rushing forward with policies aimed at speeding up development of Ebola vaccines and treatments. These measures include coordinated research among public health officials and drug makers, Food and Drug Administration (FDA) pledges of regulatory assistance, and congressional interest in legislation to qualify Ebola-targeted products for an FDA priority-review program. Such cooperation is encouraging, but government also needs to take action on another R&D disincentive which, if left unaddressed, could completely undermine current efforts on Ebola and frustrate future cooperative management of unforeseen pandemics. Ebola vaccine and treatment manufacturers need to have protection from tort liability exposure.
Any medical procedure, pharmaceutical product, or vaccine may have adverse health risks in some instances. Drug manufacturers must consider those risks when deciding whether to invest millions of dollars for product R&D, and the Food and Drug Administration (FDA) must weigh those risks against the benefits when approving a treatment. Such risks, along with the high regulatory barriers and low economic incentives attendant to investing in rare diseases, likely have been factors that explain the dearth of Ebola vaccines and treatments.
The United States government has the motivation and the means to minimize or eliminate such liability risks. Federal health agencies are already directly involved in vaccine development, and they will no doubt also be the major purchasers of the resulting drugs. Those federal entities could include a provision in the R&D agreements or purchasing contracts that would substitute the government as a defendant in any resulting lawsuits against private businesses, or indemnify companies from tort liability. The former option is certainly superior to indemnification, which could require the vaccine and treatment producers to litigate cases and then seek reimbursement for the losses or settlements. The companies would also have to negotiate with the government over whether the indemnification would cover litigation costs, such as attorneys’ fees.
The federal government indemnified manufacturers in contracts for a smallpox vaccine after the September 11, 2001 terrorist attacks. The companies argued that the proposed indemnification was insufficient, and in April 2003, Congress added expanded liability protections to the Homeland Security Act of 2002. For the one-year period of the national smallpox vaccination program (2003-2004), individuals allegedly harmed by a government-purchased smallpox vaccine could only sue the federal government under the Federal Tort Claims Act. Congress could consider the passage of a similar law for Ebola vaccines.
Congress could also legislatively alter the normal rules of liability in a manner beneficial to Ebola vaccine or treatment manufacturers. For instance, in the 2002 Homeland Security Act, Congress included the SAFETY Act. That law required persons allegedly harmed by “qualified anti-terrorism technology” (which could conceivably include vaccines) to file suit in federal court, and it prohibited them from pursuing exemplary damages. The law also limited the manufacturer’s damages to the amount of SAFETY Act-mandated liability insurance. Congress could also consider creating a specific liability compensation program for alleged victims of Ebola vaccines and/or treatments, or bring the nascent vaccines under the rubric of an existing no-fault regime for vaccines, namely the National Vaccine Injury Compensation Program.
One final option, which may be the most feasible and immediately beneficial, would be to apply the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) to Ebola vaccines and treatments. As explained in a 2006 Washington Legal Foundation Legal Opinion Letter, the act empowers the Secretary of Health and Human Services (HHS) to declare targeted liability protection for any vaccine or countermeasure in the event of a credible threat to public health or a public health emergency. Any person or entity can seek such a declaration, or the Secretary can make one sua sponte. The PREP Act applies only to tort liability claims, and the Secretary can limit the duration of the immunity and can apply other narrowing factors, such as geographical area and distribution method. Allegedly injured parties can only sue in federal court if the FDA or the Justice Department investigates and finds willful misconduct by the drug manufacturer. The act preempts all state laws that might limit distribution of the declared countermeasure, and it creates compensation funds for injured parties.
The HHS Secretary has previously declared PREP Act protection for six classes of drugs, most recently for the manufacture, distribution, and dispensing of avian influenza virus vaccine.
The passage of new laws, the expansion of current ones, or the use of the PREP Act to address liability arising from the testing, manufacture, and dispensing of Ebola vaccines and countermeasures should be high on Ebola “czar” Ronald Klain’s to-do list. America is fortunate that the feared deployment of smallpox as a bioterror weapon hasn’t materialized, and that the avian flu virus did not proliferate. But government policies to mitigate liability exposure and create programs that cut out avaricious plaintiffs’ lawyers from the injury compensation process successfully helped us to prepare. Similar measures are needed now as the deadly threat of Ebola stares us in the face, measures that may speed development of products that can stem the disease’s spread overseas as well.
New York Times
Accessed 1 November 2014
In Liberia, a Good or Very Bad Sign: Empty Hospital Beds
28 October 2014
For days this month, the ambulances from this Ebola treatment unit went out in search of patients, only to return with just one or two suspected cases. And many times, those people ended up testing negative for the disease. “Where are the patients?” an aid worker wondered aloud as colleagues puzzled over the empty beds at the International Medical Corps treatment unit here in Bong County, Liberia, which opened in mid-September. Around the country, treatment centers, laboratory workers who test for Ebola, and international and national health officials trying to track the epidemic have noticed an unexpected pattern: There are far fewer people being treated for Ebola than anticipated. As of Sunday, fewer than half of the 649 treatment beds across the country were occupied, a surprising change in a nation where patients had long been turned away from Ebola units for lack of space…
The Flu, TB and Now Ebola: A Rare Legal Remedy Returns
26 October 2014
It was nearly 100 years ago that an influenza pandemic led to sweeping quarantines in American cities, and it was more than two decades ago that patients in New York were forced into isolation after an outbreak of tuberculosis. In modern America, public health actions of such gravity are remarkably rare. So the decisions by New York and New Jersey on Friday to quarantine some travelers returning from the Ebola zone in West Africa have taken public officials into unfamiliar legal and medical territory…The quarantine by New Jersey of medical workers returning from Ebola-afflicted areas of West Africa is virtually without precedent in the modern history of the nation, public health and legal experts said on Sunday…
Wall Street Journal
Accessed 1 November 2014
The High Cost of Quarantine – Expenses Range From Police Protection to Takeout Meals
For more than a week, a family of six from West Africa has been serving a mandatory quarantine in West Haven, Conn., one of the first orders enacted on travelers arriving in the U.S. from the Ebola-stricken region.
An unmarked police car and an officer remain outside the family’s house 24 hours a day and a member of the city’s health department comes by regularly to check for fever or other symptoms of Ebola. Other family members, who live in the house and can come and go, bring food and supplies to their homebound kin, said Edward O’Brien, West Haven’s mayor.
The work of enforcing this quarantine, which fell to Mr. O’Brien and his town, hasn’t been cost-free. Depending on how much overtime local police accrue, he estimates the tab at about $1,000 a day or more….