How the Feds block Ebola cures

[boedicca]

If only our government's impact were limited to just plain old vanilla incompetence. Sadly, it actively works to prevent progress.

As a side note, the author says that the FDA is applying 19th century science to today's problems. That's just a subset of the 19th century philosophy and world view that Progressives apply to everything.


We have technology to potentially control Ebola and other viral outbreaks today. But the federal bureaucracy refuses to catch up with 21st-century science.

For example, diagnostic startup Nanobiosym has an iPhone-sized device that can accurately detect Ebola and other infectious diseases in less than an hour.

Two other companies, Synthetic Genomics and Novartis, have the capacity to create synthetic vaccine viruses for influenza and other infectious diseases in only four days. Both firms can also share data about outbreaks instantaneously and make real-time, geographically specific diagnosis and vaccine production possible.

These companies could start producing Ebola vaccine/treatments tomorrow — except that the Food and Drug Administration’s insistence on randomized studies and endless demands for more data means firms have to spend millions on paperwork instead of producing medicines.

And for every small company drained by such tactics, many others conclude it’s not even worth trying.

These advances aren’t available because the FDA is using 19th-century science to decide which medical technologies should be used in the 21st century....

How the feds block Ebola cures New York Post

 

[Moonglow]

so you are saying that the FDA is holding back drugs developed by companies to fight Ebola? Are not many of these companies not on US soil and could already be collaborating yet can't decide the profit margin?

 

[Vigilante]

Ebola deaths in Liberia are ‘far higher than reported’ as officials downplay epidemic
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The Guardian (UK) ^

The true death toll from the Ebola epidemic is being masked by chaotic data collection and people’s reluctance to admit that their loved ones had the virus, according to one of west Africa’s most celebrated film-makers. Sorious Samura, who has just returned from making a documentary on the crisis in Liberia, said it is very clear on the ground that the true number of dead is far higher than the official figures being reported by the World Health Organisation. Liberia accounts for more than half of all the official Ebola deaths, with a total of 2,458. Overall, the number of...

 

[Valerie]

What is ZMapp?

ZMapp, being developed by Mapp Biopharmaceutical Inc., is an experimental treatment, for use with individuals infected with Ebola virus. It has not yet been tested in humans for safety or effectiveness. The product is a combination of three different monoclonal antibodies that bind to the protein of the Ebola virus.

How effective is the experimental treatment?

It is too early to know whether ZMapp is effective, since it is still in an experimental stage and has not yet been tested in humans for safety or effectiveness. Some patients infected with Ebola virus do get better spontaneously or with supportive care. However, the best way to know if treatment with the product is efficacious is to conduct a randomized controlled clinical trial in people to compare outcomes of patients who receive the treatment to untreated patients. No such studies have been conducted. It's important to note that the standard treatment for Ebola remains supportive therapy.

This includes the following measures:

• balancing the patients' fluids and electrolytes;
• maintaining their oxygen status and blood pressure; and
• treating them for any complicating infections.

In addition, the most effective way to stop the current Ebola outbreak in West Africa is meticulous work in finding Ebola cases, isolating and caring for those patients, and tracing contacts to stop the chains of transmission. It means educating people about safe burial practices and having health care workers strictly follow infection control in hospitals. This is how all previous Ebola outbreaks have been stopped.

Why aren't more people getting ZMapp?

At this time, very few courses of this experimental treatment have been manufactured. The manufacturer has indicated that the available doses have been distributed. Since the product is still in an experimental stage, it is too early to know whether ZMapp is effective. The manufacturer of this experimental treatment continues to research and evaluate the product’s safety and effectiveness. It has not yet been tested in humans for safety or effectiveness and much more study is needed.

Did the NIH play a role in getting the experimental therapy to the two U.S. patients in Liberia?

This experimental treatment was arranged privately by Samaritan's Purse, the private humanitarian organization, which employed one of the Americans who contracted the virus in Liberia. Samaritan's Purse contacted the Centers for Disease Control and Prevention (CDC), who referred them to the National Institutes of Health (NIH). NIH was able to provide the organization with the appropriate contacts at the private company developing this treatment. The NIH was not involved with procuring, transporting, approving, or administering the experimental treatments.

Will patients in West Africa be able to access this experimental treatment? How much supply is there?

The product is still in an experimental stage, and the manufacturer reports that there is a very limited supply, so it cannot be purchased and is not available for general use. The manufacturer has been planning for phase 1 clinical trials and does not have the capacity to manufacture large quantities of the treatment. The drug has not gone through clinical trials, meaning its safety and effectiveness has not yet been tested in humans. The manufacturer of the experimental treatment continues to research and evaluate the product's safety and effectiveness. The most effective way to stop the current Ebola outbreak in West Africa is meticulous work in finding Ebola cases, isolating and caring for those patients, and tracing contacts to stop the chains of transmission. It means educating people about safe burial practices and having health care workers strictly follow infection control in hospitals. This is how all previous Ebola outbreaks have been stopped.

Is ZMapp available under the Food and Drug Administration's expanded access to investigational drugs?

Currently there are only experimental treatments for Ebola virus infection in the earliest stages of development. When a drug is not approved, the FDA can authorize access to potentially promising products through other mechanisms, such as through an emergency Investigational New Drug (IND) application. In order for an experimental treatment to be administered in the U.S., such a request must be submitted to and authorized by the FDA. The FDA cannot comment on the specifics of ongoing drug development programs and cannot reveal information that is not otherwise public concerning submissions covering such programs such as IND applications submissions. The FDA stands ready to work with companies and investigators treating these patients.

Is ZMapp a vaccine?

No. ZMapp is being developed as a therapeutic product for treatment of people infected with Ebola virus, but not to prevent infection in the same manner as a vaccine. The best way to prevent infection currently is with stringent infection control measures.

What's the difference between therapy and vaccine?

Vaccines are usually given to people before they are exposed to a virus or bacteria that causes a disease. A vaccine stimulates the immune system to generate antibodies and cellular immunity that can fight off an infection if it were to occur. Typically, therapeutics are provided to people who are already infected with the virus. With the experimental ZMapp treatment, the monoclonal antibodies bind to the virus, so that the human immune system can clear the virus.

Are there Ebola vaccines available for use or in development?

There are currently no FDA approved vaccines for Ebola. The NIH’s National Institute of Allergy and Infectious Diseases is working on developing an Ebola vaccine. NIH recently announced they are expediting their work and are launching phase 1 clinical trials of an Ebola vaccine.

On August 28, 2014, NIH announced that initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults. Testing will take place at the NIH Clinical Center in Bethesda, Maryland.

The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. The others are to launch in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.

In parallel, NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali.

NIH is also supporting the Crucell biopharmaceutical company in its development of an Ebola/Marburg vaccine as well as Profectus Biosciences in its development of an Ebola vaccine. Additionally, NIH and the Thomas Jefferson University are collaborating to develop a candidate Ebola vaccine based on the established rabies vaccine.

Is the U.S. government involved in the development of ZMapp?

The U.S. government, specifically, the NIH's National Institute of Allergy and Infectious Diseases, the Department of Defense's Defense Threat Reduction Agency (DTRA), and the HHS' Biomedical Advanced Research and Development Authority (BARDA), has provided support for the development of this experimental treatment.

Are there other companies developing experimental treatments or vaccines?

Two other companies, Tekmira and Biocryst Pharmaceuticals, receive funding from the Department of Defense's Defense Threat Reduction Agency and have therapeutic candidates for Ebola in early development. The Department of Defense is working with a company called Newlink to develop an Ebola vaccine candidate. BioCryst, with NIH support, is working to develop an antiviral drug to treat Ebola virus that is expected to begin Phase 1 testing later this year.

Questions and Answers on Experimental Treatments and Vaccines for Ebola Ebola Hemorrhagic Fever CDC

 

[Vigilante]

Mutant Ebola warning:LeadingU.S.scientist warns deadlyvirus is already changing to become more contagious!

The London Daily Mail ^

The deadly Ebola virus could be mutating to become even more contagious, a leading U.S scientist has warned. The disease has killed nearly 4,000 people, infecting in excess of 8,000 - the majority in the West African nations of Guinea, Sierra Leone and Liberia. Communities lie in ruins, thousands of children have been orphaned, millions face starvation but the virus continues its unprecedented pace, invading and destroying vast swathes of these countries. Meanwhile three nurses, two in the U.S. and one in Spain have caught the infection while treating Ebola patients, despite wearing protective suits. Now U.S. scientist Peter Jahrling...

 

[boedicca]

Perhaps people who have tested positive for Ebola should have the choice whether or not to use experimental drugs.