Wall Street Journal, Monday, May 19, 2014:
AFRICA NEWS
Melinda Gates Works to Curb Newborn Deaths
Inexpensive, Low-Tech Solutions Urged, Such as Breast-Feeding, 'Kangaroo Care'
May 18, 2014 7:56 p.m. ET
Challenges to the effort include cultural barriers, such as delaying breast-feeding, Ms. Gates said. Agence France-Presse/Getty Images
SEATTLE— Melinda Gates champions high-tech solutions to some of the world's most intractable health problems.
She also says that holding and feeding a newborn the proper way can make the difference between whether it lives or dies.
The co-chair of the Bill & Melinda Gates Foundation is promoting some low-tech approaches as part of a push to improve the survival of newborns, a problem she said has been neglected. In a speech Tuesday at the World Health Assembly in Geneva, she plans to urge global health officials as well as national governments to implement practices that will make deliveries safer and keep newborns alive.
That will require competing for the attention of health ministers deluged with other pressing matters, from expanding HIV services to addressing a growing prevalence of noncommunicable diseases such as cancer and heart disease.
Many newborn deaths, Ms. Gates said in a recent interview, can be prevented by simple, inexpensive measures—such as teaching women to breast-feed, which immediately gives a baby nutrients and hydration, and guards against infection, one of the biggest killers of newborns. Or "kangaroo care"—a technique in which the infant, particularly a preterm baby, is held against the mother's skin to keep it warm and regulate the heartbeat. Or applying chlorhexidine, an antiseptic, to the stump where an umbilical cord has been cut, to prevent infection.
"You could get newborn deaths down substantially in the first couple of years," she said.
Naimot Alabi holds her baby son in 2013 in Lagos, Nigeria. All three of Ms. Alabi's other children have died and even in a country where Unicef reports one in seven perish before turning 5, the 36-year-old mother's case is out of the ordinary. Associated Press
Every year, 2.9 million infants die in their first 28 days of life, while 2.6 million die in the last three months of pregnancy or during childbirth, according to United Nations data. Newborn deaths account for 44% of all deaths in children under 5 years old—a proportion that has grown since 1990 because vaccines, malaria bed nets, and other interventions have helped keep older children alive. The number of children under 5 who died dropped 47% between 1990 and 2012, to 6.6 million.
"It's because we focused on it as a world," Ms. Gates said of the overall reduction in child mortality. "We decided to do certain things in vaccines, malaria and other areas. The piece that to me has always been interesting and that has been left out of that is looking at that first month of life."
Ms. Gates, a 49-year-old mother of three, sees her attention to newborns as an extension of her pledge to help women in the developing world obtain better access to family planning services—an effort for which she has corralled donors but also has been criticized by Roman Catholic groups that oppose using global health and development funds for contraceptives.
"For me it's a continuum of care for women and for babies," she said. "It's the women who are in charge of the health of the children. So if we can keep her healthy, and keep the newborns healthy, you keep the whole family more healthy."
A "newborn action plan" drawn up by Unicef, the World Health Organization, the Gates Foundation, and other organizations calls for training birth attendants who can teach new mothers the methods Ms. Gates describes, ensure supplies of injectable antibiotics and equipment for safer deliveries of babies, and other measures.
The goal, according to Mariam Claeson, director of the maternal, newborn and child health team at the Gates Foundation, is to cut newborn deaths to fewer than 10 per 1,000 live births by 2035. In 2012, there were 21 newborn deaths per 1,000 live births, according to the U.N.
But bringing about change is challenging, Ms. Gates acknowledges. On a visit to a clinic in Senegal, "They were doing all the right things in terms of the checklist of things to do during the birth," she said. "They had two great birth attendants."
But she also saw a woman who wouldn't breast-feed her newborn. It turned out the woman was waiting "for the person to come in from the village who's the religious leader to tell her what's her auspicious date that she can begin to breast-feed," Ms. Gates recalls. "So that's the type of cultural barrier you're often still trying to overcome."
Still, bringing down newborn deaths is "very possible and very doable," said Nosa Orobaton, head of a program that has been working at it for three years in two northern Nigerian states. Nigeria accounts for about a 10th of all newborn deaths annually, according to the U.N.
The program, partly funded by the Gates Foundation in addition to the U.S. Agency for International Development, has trained thousands of counselors to educate communities about safe birthing and newborn practices. It also has helped organize distribution of chlorhexidine gel that helps avert infections when umbilical cords are cut, particularly during home births, where most babies are born, Dr. Orobaton said. The antiseptic used to have to be ordered from Nepal and delivering it would take three months, but recently Nigerian officials arranged domestic production to make supplies cheaper and easier to deliver, he said.
"Once you have community trust, then we are well on our way to making things happen," he said. Then again, "procuring the medicines in a timely manner and getting them to those places in hard to reach areas on time are much more important in determining the success of the program than anything cultural."
Write to Betsy McKay at betsy.mckay@wsj.com
POLITICS AND POLICY
States Open to Drug Options
Expanding Experimental Therapies to the Dying Gains Traction Among Lawmakers
May 18, 2014 10:22 p.m. ET
Mikaela Knapp, of California, died in April at 25 after she failed to qualify for clinical trials because her kidney cancer had spread to her brain. The Knapp Family/We Got This
A push to widen access to experimental drugs for people with terminal illness is gaining traction among lawmakers in several states, highlighting a growing clamor from patients for promising therapies that haven't been approved for sale.
The so-called right-to-try bills, the first of which was signed into law in Colorado on Saturday by Gov. John W. Hickenlooper, may not make a big difference in practice because they generally don't require companies to provide access to the unapproved drugs outside of clinical trials.
The U.S. Food and Drug Administration already grants requests for early access to experimental drugs when companies are willing to provide them, but can't force companies to do so. The FDA approves the "vast majority" of these types of requests, a spokesman said.
Right-to-try supporters hope the movement will sway companies to expand access, and lead to broader changes in a drug-approval process they say takes too long, often several years.
Providing early access to experimental drugs poses a dilemma for companies and federal regulators who don't want to jeopardize patient safety or the integrity of clinical trials needed to get new drugs on the market.
Colorado's right-to-try act would allow people with terminal illnesses who have exhausted other treatment options to take experimental drugs that have cleared early-stage safety trials in humans, as long as the drugs' manufacturer agrees to provide them. Access wouldn't require FDA approval, as it does now.
The Colorado bill received unanimous support from state lawmakers. "If a person has been diagnosed with something terminal, and they don't have any hope, and there is something out there they want to try that might work for them, I am supportive of people being able to do that," said state Sen. Irene Aguilar, a Denver Democrat and physician who co-sponsored the bill.
The Colorado Medical Society didn't take a position on the legislation, saying it hadn't developed a policy on the issue and that the measure was likely to pass without its support. John L. Bender, the group's president, said in a statement Sunday that the law was "unlikely to cause harm, and potentially may help patients on a case-by-case basis."
Arizona residents will vote on a right-to-try referendum this fall, while similar bills have been passed by legislatures in Missouri and Louisiana, but haven't been signed by the governors.
The Goldwater Institute, a Phoenix-based conservative nonprofit advocacy group that designed the proposed state laws, plans to push the measures in legislatures nationwide, said President Darcy Olsen.
The legislation comes on the heels of some high-profile patient campaigns for early access, amplified through social media and online petitions.
At the same time, medical advances have raised hopes for new treatments. For instance, companies including Merck MRK +0.72% & Co., Bristol-Myers Squibb Co.BMY +0.23% and Roche Holding AG ROG.VX -0.45% are developing so-called cancer immunotherapies, which work by unleashing the body's immune system to fight tumors. The drugs, which some companies provide for free, have shown promise in early clinical trials to significantly shrink tumors and extend survival in certain cases.
Keith Knapp of Folsom, Calif., started an online petition earlier this year asking for Merck's immunotherapy MK-3475 for his wife, Mikaela, who was diagnosed with kidney cancer last fall. The petition on change.org got more than 476,000 signatures.
Ms. Knapp didn't qualify for clinical trials of immunotherapies because she had a rare subtype of kidney cancer and it had spread to her brain, said Mr. Knapp. She was unable to receive MK-3475 through an early-access program started by Merck in March because it is only for patients with advanced melanoma, a form of skin cancer. She died in April at the age of 25.
Mr. Knapp said he favors right-to-try laws. "The current way we have this set up, it just doesn't work," he said. The proliferation of online petitions for early access is "a symptom there is some underlying flaw in our current system."
A Merck spokesman said he couldn't discuss specific patient requests, but said the company's first priority is to conduct clinical trials of new drugs. He said Merck allows early access outside of clinical trials when the benefits are likely to outweigh risks. Merck has applied for FDA approval of MK-3475 for melanoma and expects a decision by late October, he added.
A spokeswoman for Roche's Genentech unit said the company has received many requests for access to its experimental cancer immunotherapy, but doesn't have a compassionate-use program in place. The company will continue to evaluate a potential program, she said.
Bristol-Myers is in the process of starting an expanded-access program to allow certain patients with advanced melanoma to take its immunotherapy, nivolumab, a spokeswoman said.
Drug makers and the FDA have expressed concerns about the state proposals. The Pharmaceutical Research and Manufacturers of America, a trade group, said efforts to provide access to experimental medicines that bypass FDA oversight aren't in the best interest of public health.
"Successful completion of the clinical trial process is necessary to demonstrate that an investigational medicine is safe and effective, which is required to obtain FDA approval, so that companies may make the medicine available to a broader patient population when clinically appropriate," said Sascha Haverfield, vice president of scientific and regulatory affairs at PhRMA.
The FDA spokesman said the agency is concerned about "efforts that would be inconsistent with its congressionally mandated authority and agency mission to protect the public from therapies that aren't safe and effective." The FDA said it works with companies to provide access to experimental drugs by helping patients enroll in clinical trials or through expanded access, but it is up to companies to provide them.
Write to Peter Loftus at peter.loftus@wsj.com
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