REUTERS: Drugmakers may need indemnity for fast-tracked Ebola vaccines

[proverbialwisdom]

http://www.reuters.com/article/2014/10/23/us-health-ebola-vaccine-idUSKCN0IC0TZ20141023

Drugmakers may need indemnity for fast-tracked Ebola vaccines

BY BEN HIRSCHLER AND STEPHANIE NEBEHAY
LONDON/GENEVA Thu Oct 23, 2014 9:55am EDT

(Reuters) - Drugmakers are looking for some kind of indemnity from governments or multilateral agencies against possible losses or claims arising from the widespread emergency use of new Ebola vaccines in Africa.

While the issue will not delay the industry's work to accelerate production and clinical testing of three experimental vaccines, it is likely to be discussed at a high-level meeting in Geneva on Thursday.

World Health Organization (WHO) Director-General Margaret Chan will chair the meeting, which includes industry executives, representatives from countries including those affected by Ebola, drug regulators and funders.

GlaxoSmithKline (GSK.L) Chief Executive Andrew Witty said a system of indemnity made sense given the unique situation in which companies are being urged by the WHO to fast-track the supply of novel vaccines in a matter of months rather than years.

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[proverbialwisdom]

1. FORBES: Ebola Vaccine And Treatment Makers Need Liability Protection

http://www.forbes.com/sites/wlf/2014/10/30/ebola-vaccine-and-treatment-makers-need-liability-protection/

Ebola Vaccine And Treatment Makers Need Liability Protection

10/30/2014 @ 1:21PM
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.

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Multiple embedded links at site.

[Warpy]

2. They do.

This is an emergency situation. It's one of those cases when careful double blind studies are utterly immoral. They already know it won't actually harm people. They'll know it's effective when the number of new cases starts to drop off a cliff.

It was the same in the late 80s when unproven drugs were fast tracked into big city teaching hospitals to use on people with AIDS. We didn't know if those collections of letters and numbers would kill them or cure them, we just knew there was nothing else in the arsenal. Some of those drugs bought us time to do the double blind testing on later drugs and now HIV is just a chronic, progressive disease and pain in the ass rather than an immediate death sentence.

I hope the same happens with Ebola, that the drugs being rushed into production provide good early treatment and the vaccine works. In a disaster like the one enfolding in west Africa, things have to be rushed. There is no other way.

[Hoyt]

3. +1. Short of gross negligence for profit, I'd support some kind of indemnity.

[proverbialwisdom]

4. NEW book on the National Vaccine Injury Compensation Program & National Childhood Vaccine Injury Act

This isn't the same topic, of course, but it's similar enough to be relevant, IMO.

http://www.amazon.co.uk/The-Vaccine-Court-Americas-Compensation/dp/1629144525

The Vaccine Court: The Dark Truth of America's Vaccine Injury Compensation Program by Wayne Rohde

A hard look at the National Vaccine Injury Compensation Program and the families desperately trying to navigate their way through it. The Vaccine Court looks at the mysterious and often unknown world of the National Vaccine Injury Compensation Program (NVICP), the only recourse for seeking compensation for those who have been injured by a vaccine. The NVICP, better known as the "Vaccine Court," however, is not without controversy. Established by Congress as a direct result of the passage of the National Childhood Vaccine Injury Act of 1986, the NVICP was supposed to offer a no-fault alternative to the traditional injury claims filed in state or federal courts and was to provide quick, efficient, and fair compensation for those who have been injured by vaccines. The reality, however, is that many cases take several years or longer to complete and require tremendous commitment from families already pushed to the brink of bankruptcy caring for the vaccine-injured family member, only to discover that the end result is manipulated by the government in defense of the US vaccine policy. Mr. Rohde looks into the inner workings of the US Federal Claims Court and the NVICP. He interviews families who have filed petitions and won compensation, families who have been denied compensation, and families still waiting for a decision. By highlighting the journeys of these families--their efforts to find attorneys willing to represent them, the filing of their petitions, and the subsequent mountain of paperwork, medical records, and other documents that span years--Mr. Rohde exposes the bitter truth behind the NVICP. Through his thoughtful interviews and fact-finding research, The Vaccine Court sheds light on how the NVICP has evolved into something far more treacherous than what Congress envisioned with the National Childhood Vaccine Injury Act in 1986.

AMAZON EDITORIAL REVIEWS:

“Few Americans know about the US 'Vaccine Court,' yet it may be their only recourse if they suffer an adverse vaccine reaction. In this groundbreaking book, Rohde details how the ‘court’ works, or rather does not work, and the critical problems that bedevil it. Written with compassion and based on extensive research, Rohde’s book is a must-read for all those concerned about the intended and unintended consequences of US vaccines.”
—Mary Holland, research scholar, NYU School of Law


“Wayne Rohde has lifted the veil over the murky tort reform experiment known as the “Vaccine Court.” In exposing the program’s imbalanced liability protection for powerful vaccine manufacturers, he has performed a valuable public service.”
—Robert J. Krakow, attorney and coauthor of Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury


AOA REVIEWS: (parents)

"A much anticipated book .. as they say .. sunlight is the best disinfectant .. and .. Wayne's book is likely to let the sun shine on a subject that has too long remained hidden in the silent .. dark shaddows .. of injustice to the vaccine injured."
--Bob Moffitt | November 01, 2014 at 07:31 PM


"This book was years in the making. Wayne Rohde diligently and thoroughly investigated the Vaccine Injury Compensation program and the families it served... and failed. The facts presented strip away the public's false assumption that vaccine adverse events receive swift, just reparations.

The social compact continues to be broken by people charged with protecting the public's health. That shameful situation is compounded by media's reporting blackout. Books like "The Vaccine Court" will be referenced in future years in attempts to understand how society could let these atrocities continue happening to some of its most vulnerable members."
--nhokkanen


"Wayne Rohde has relentlessly sought the truth about Vaccine Injury Compensation Program. He has spent countless hours researching, compiling cases and doing something our government has failed to; talk to vaccine injured and their families and really listen to what they are saying. The monster is exposed. Bravo!"
--Louis Conte


"Why has Congress granted vaccine manufacturers in the United States broad legal immunity from families of children seriously injured by their product?

“One argument put forward by the pharmaceutical industry against any application of strict liability is that the drug industry is working for the benefit of mankind in a unique way and cannot be compared with other types of industrial enterprise. It seems that the pharmaceutical industry does not wish to recognize the fact that the main impetus for the running of the pharmaceutical industry, like any other type of industry…is profit.”

Sjostrom and Nilsson, “Thalidomide and the Power of the Drug Companies,” (1972) p. 176."

--Jim Thompson

[fasttense]

5. Why are huge corporations always looking for protection

Why are these hugely profitable corporations crying to get big government involved in their business. Corporations and their wealthy owners really don't want free trade. They want protected trade.