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How Ebola Is Breaking The Aversion To Using Experimental Drugs

When innovation comes frustratingly slow, some criticize “a tendency to try do no harm at all cost.”

How Ebola Is Breaking The Aversion To Using Experimental Drugs
[Photo: Jonathansloane, Getty Images]

When there’s a health epidemic, here’s how innovation often happens: Lives are tragically lost, then wall-to-wall media coverage leads to public hysteria and then drug companies respond by racing to find treatment.

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Other public health crises, including the AIDS epidemic, swine flu, and the SARS outbreak have followed this same script–and now it’s Ebola’s turn.

As the epidemic continues, killing more than 5,000 people in the process, pharmaceutical companies are now shifting their focus to developing treatments. While there are some promising therapies in the pipeline, health experts say these companies should have made more concerted efforts when Ebola first began killing hundreds of Africans in the 1970s and again in early 2014. Dr. Margaret Chan, the World Health Organization’s director-general, recently lambasted the drug industry, saying it previously wasn’t concerned about creating an Ebola vaccine because there was no money in treating customers in poor countries.

There may be some truth to Chan’s statements, but drug developments of all types can languish for years until there’s an outbreak or public outcry for treatment. Ebola is now in the U.S., and so is a new sense of urgency to fund efforts to eradicate the disease. The FDA has yet to approve any drugs for Ebola, but leading pharmaceutical companies are now racing to develop vaccines and treatments.

There are still challenges in getting these drugs to market, namely making sure that potential treatments are actually effective. The crisis highlights the difficulty of bringing life-saving drugs to the people who need it most, but also the huge economic opportunity that could await U.S. drug manufacturers if they can halt this pandemic.

The Ebola Drug Race

The FDA has given emergency approval for experimental drugs to treat some patients, including TKM-Ebola and most famously, ZMapp. These treatments have had mixed results, and it’s still unclear whether they actually saved lives.

Dr. Eric Bing, a professor of global health at Southern Methodist University who has managed global health programs in Rwanda, Nigeria, and other African countries, says the way the health community approaches epidemics is changing to focus more on prevention. However, “a key part of that prevention is going to be speeding experimental drugs to market.”

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“We have had a tendency to try do no harm at all cost,” Bing says. “[But] we’re beginning to take a serious look at how we bring compassionate drugs to people while minimizing risks.”

Several drug manufacturers already are: NewLink Genetics has developed a vaccine that is currently undergoing human trials; GlaxoSmithKline is working with the National Institutes of Health and other partners to accelerate the development of an Ebola vaccine; and Johnson & Johnson announced in late October that it would invest $200 million to accelerate and expand the production of its Ebola vaccine program. North Carolina-based Chimerix said it will begin a clinical trial of an experimental antiviral drug, while Intellimedix, a company that creates approaches to accelerate drug discovery and development, says it has developed a computer algorithm that can suggest novel drug treatments for Ebola. Then there’s San Diego-based Aethlon Medical, which says its Hemopurifier device that was used to treat an Ebola patient also could be effective.

James Joyce, Aethlon Medical’s CEO, says the device is designed to “tip the balance in favor of the immune system” and has broad spectrum applications for several high-threat viral pathogens–including HIV, Hepatitis C, and Ebola–that could work better than traditional therapies.

“It’s going to be difficult for any one therapy to treat this condition,” Joyce says.

“The first question that needs to be answered for our technology–that also needs to be answered for drug therapies–is, is it safe and can it be well-tolerated?” he adds. “And then the next question is, does it provide a reasonable chance of benefiting the patient? For many therapies that second question remains unknown.”

“One person’s side effect could be another person’s cure,” says Jeffrey Skolnick, a scientific advisor to Intellimedix and the director of the Center for the Study of Systems Biology at the Georgia Institute of Technology.

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Skolnick’s research group has licensed its newly developed algorithm to Intellimedix. The algorithm can suggest the best drugs that target and act on Ebola proteins or the human proteins the virus needs to reproduce.

“We’ve developed a computational pipeline that we’re now remolding to deal with the question of Ebola,” Skolnick says. “What we’re proposing is a computational methodology that’s a ‘look-here, not-there’ kind of idea.”

Paying the Bill

As companies fast-track Ebola treatments that already were in the pipeline, there’s still the question of who will pay for them. The likely answer is wealthy Western nations, especially as the disease emerges in the U.S. and Europe. However, Bing says this issue likely will be handled differently in each country.

“Government will play a major role in preventing disease, because if you don’t have disease you have stable communities,” he says. “You could also have public-private partnerships where drug companies offer these medications at discounted costs.”

Bruce Carlson, the publisher of Kalorama Information, which produces market research on the medical industry, says it’s difficult to quantify how big the market is for an Ebola vaccine or drug therapies. However, the estimated market for biopharmaceutical manufacturing–a category in which certain Ebola treatments fall–was $36.8 billion in 2013.

Carlson cautions that while Ebola is a serious threat, history shows that some governments increase treatment efforts when viruses surge, but then retract once the threat begins to wane. The 2009 swine flu pandemic is a perfect example.

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“The health care community tends to focus on one thing and then move on to another thing because there are so many challenges,” Carlson says. “There was a lot of stockpiling and overspending that went on and there was recoil [during swine flu]. There could be a lot of funding in the beginning and then some of it pulls back because the health care system has so many threats to meet.”

Bing says though diseases come in cycles and waves, focusing on strengthening the health infrastructure in developing countries and accelerating drug development globally could have a lasting impact on how the health community responds to Ebola and other pandemics.

“What the Ebola epidemic is showing us is that when there’s very high demand–and when that demand is not just coming from developing countries, but also developed countries–manufacturers will respond.”

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