Glimmers of hope in new therapies to battle killer Ebola and lethal TB strain

pretomanid-300x122Rare good news on destructive infections is emerging from Africa: Medical scientists, Good Samaritans, and public health officials are hailing the successes of powerful new therapies in treating a deadly and extremely drug-resistant strain of tuberculosis and Ebola, a killer viral hemorrhagic fever that spreads like wildfire.

Americans may skip over dispatches about these “foreign” news developments. They would be wise not to do so, because they have heightened importance these days, domestically, including in providing key lessons to be learned about how to safeguard the public health.

The TB care that is winning great attention overseas requires patients to take three drugs in a regimen in which they take five pills a day for six months. That already is a boon compared with other, now common therapies in which they might need 40 pills a day for as long as two years, or daily antibiotics shots with bad side effects like deafness, kidney failure, and psychosis.

The key to the new therapy appears to be the antibiotic Pretomanid, which has just won the approval of the federal Food and Drug Administration, paving the way for the drug’s use in TB treatment worldwide. Pretomanid (as shown above) will be teamed with bedaquiline and linezolid, a “BPal” combination that has shown great effectiveness in combating XDR, a TB strain that had become a death sentence for many due to its virulence and resistance to families of antibiotics commonly used to treat the disease.

This treatment is not controversy free, nor are new therapies showing significant promise in dealing with Ebola. The Ebola therapies involve monoclonal antibodies, blood treatments that get the body’s own disease-battling proteins to wrap around viruses to prevent them from entering and infecting cells. Two drugs, both of which the makers say can be produced in the large quantities that may be needed, have shown high effectiveness in halting what has been patients’ inevitable decline into horrible, bloody deaths.

The dire circumstances surrounding both XDR TB and Ebola chastened medical scientists and public health officials, forcing them to hasten what can be careful but painfully slow tests of drugs and treatments for diseases, as Donald G. McNeil Jr. has vividly reported in the New York Times.

He found, in repeat visits, that South Africans with drug resistant TB have been quarantined in grim facilities and subjected to painful, invasive, and tormenting treatments — care that public health officials deemed necessary to prevent the disease’s epidemic spread. He wrote of XDR TB:

“Tuberculosis has now surpassed AIDS as the world’s leading infectious cause of death, and the so-called XDR strain is the ultimate in lethality. It is resistant to all four families of antibiotics typically used to fight the disease. Only a tiny fraction of the 10 million people infected by TB each year get this type, but very few of them survive it. There are about 30,000 cases in over 100 countries. Three-quarters of those patients die before they even receive a diagnosis, experts believe, and among those who get typical treatment, the cure rate is only 34%.”

As for Ebola, which has killed thousands at a time in multiple outbreaks and is surrounded in Africa by “an aura of terror,” he noted:

“Since its discovery 40 years ago, the virus has haunted Africa. Until now, many believed that anyone catching Ebola was doomed to die alone among space-suited strangers and to be buried without ceremony in a bleach-misted body bag. Fear of the virus and mistrust of health workers have been major obstacles to combating Ebola’s spread in eastern Congo, where terrified families often hide their sick and even attack health teams.”

As with so many medical matters, the new presence of optimism about treatment — even of “cures” — will be of significant help in battling with XDR-TB and Ebola, McNeil reported.

Big Pharma and making money vs. saving lives

But here’s the First World problem that care for these two scourges underscores: Medicine too often can be all about money, not people. For Big Pharma, in particular, the incentives may be lacking to save many lives, as opposed to making fat profits.

Pretomanid is a novel therapy because it was pioneered not by a drug maker by the nonprofit, New York-based TB Alliance. It describes itself as “a product development partnership, or PDP … [that seeks to] build partnerships between the public, private, academic, and philanthropic sectors to drive the development of new products for diseases of poverty.” It says its mission is to “discover, develop and deliver better, faster-acting and affordable drugs to fight tuberculosis.”

The alliance has stepped in and up to deal with Big Pharma’s unwillingness to research, develop, market, and sell crucial medications like antibiotics to fight infections like TB, as the Washington Post reported:

“Drug companies have largely abandoned development of antibiotics because they can cost upward of $1 billion to bring to market but yield far less revenue than drugs for chronic conditions, such as high blood pressure and high cholesterol, or specialty drugs that can reap hundreds of thousands of dollars or more in revenue per dose. Antibiotics are often inexpensive and are taken for days or weeks at a time, whereas drugs for cancer and chronic diseases are taken for months or years. All antibiotics approved in the last decade have had disappointing sales, and Achaogen, a company that had an antibiotic approved last year, filed for bankruptcy in April.”

TB, and the rise of antibiotic resistant strains, persists as a health concern in America, though XDR TB infections are rare in this country.

In the United States, some patient safety groups resisted the FDA’s expedited approval of Pretomanid, suggesting it needed much more proving in rigorous clinical trials. But advocates, including the TB Alliance, made the case that its benefits far outweighed its harms, especially because of the known damages that existing treatments cause.

A scientific attack on a dreaded killer

With Ebola, McNeil cited Dr. Anthony S. Fauci, a pioneering HIV-AIDs researcher and director of the National Institute of Allergy and Infectious Diseases, as crediting Dr. Jean-Jacques Muyembe, director of Congo’s National Institute for Biomedical Research, for his crucial efforts. As McNeil reported:

“Dr. Muyembe, 77, whom Dr. Fauci referred to as a ‘true hero,’ has been fighting Ebola since it first appeared in what was then Zaire in 1976. Decades ago, he pioneered the use of survivors’ blood serum — which contains antibodies — in order to save patients. The two experiment treatments that proved successful last week descend in part from his original research.”

Time magazine noted that the battle against Ebola has created innovations for future medical investigations into combating contagions, notably international cooperation and exchanges of important scientific information. Most important, as Fauci emphasized, is trying to maintain rigorous science in calamitous situations, rife with strife and heartbreak. If the Ebola therapies hold up, it will be based in large part in clinical trials conducted of them. They can be run in difficult circumstance, and they improve long-term decision-making because they prove which therapies work and which don’t.

In my practice, I not only see the harms that patients suffer while seeking medical services, but also the importance for all of us in keeping out of potentially risky medical care by staying as healthy as possible. This may be a growing challenge as technological and transportation advances shrink the globe, even as economic disparities widen the gaps not only between the haves and have-nots but also those with good versus poor health. Poverty, a lack of hygiene, homelessness, and abuse of opioids and other drugs has brought infectious diseases raging back across this country, with outbreaks of measles, meningitis, mumps, typhus, and, yes, hepatitis. As the nonprofit Kaiser Health News Service reported about this summer’s situation:

“The [hepatitis A] virus has stricken more people in Ohio than any other state but Kentucky, where it infected more than 4,800 people and killed at least 60. Kathleen Winter, a University of Kentucky epidemiologist, said more populous Ohio is on pace to surpass it as her state’s outbreak wanes. Relentlessly, the virus continues its march across the nation. Pennsylvania declared an outbreak as recently as May. In early August, Florida and Philadelphia declared public health emergencies, which, among other things, signal to health care providers the need to vaccinate the vulnerable. Case counts now exceed 1,000 in six states … the virus reaches beyond homeless people and drug users. One in 5 Kentuckians sickened from August 2017 through mid-2019 fit neither group. Nearly 40% of Florida’s cases from 2018 and the first half of 2019 had no or unknown risk factor. Simon Haeder, an assistant professor of public policy at Pennsylvania State University, said the outbreaks show how the addiction crisis and the diseases it fuels endanger everyone, while also revealing cracks in the nation’s patchwork, poorly funded public health system. A recent report by Trust for America’s Health found only 2.5% of U.S. health spending in 2017 went to public health.”

This is not good. We have much work to do to:

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