Month: November 2018

The expansive court case seeking to hold drugmakers responsible for the nation’s opioid crisis has a new complication: How does it deal with claims covering the thousands of babies born addicted to the drugs?

Attorneys representing the children and their guardians want their claims separated from the federal case in Cleveland that involves hundreds of local governments and other entities such as hospitals. They told a skeptical panel of judges in New York on Thursday that they have different legal issues, a need for faster relief because the babies need services in the first years of their lives. They also told the judges that as it is, they lack the leverage to exact a settlement from drug companies.

Babies, unlike governments or businesses, have been directly harmed by the actions of drugmakers and are entitled to their own payments, said Scott Bickford, a lead lawyer for the children and their guardians.

Bickford said more than 150,000 babies were born in opioid withdrawal from 2012 through 2016, and that the number grows each year

Federal cases consolidated

He said initial hospital stays for babies born to an opioid-addicted mother can cost $200,000 to $250,000 more than other infants born without complications. 

“Then you have to address their developmental and learning problems,” Bickford said in a Tuesday interview. “A lot of them have organ problems. A lot of them have problems we don’t even know about.”

Drug manufacturers and distributors oppose creating a new structure for the lawsuits over the children and judges on the Judicial Panel on Multidistrict Litigation hearing the matter in New York on Thursday wondered what good it would do.

Opioids — including prescription painkillers, heroin and synthetic substances including fentanyl — killed nearly 48,000 Americans last year, according to the U.S Centers for Disease Control and Prevention. The cost of treatment, providing an overdose antidote, foster care, jail stays, ambulance runs and addressing a growing homeless crisis have added up for governments and taxpayers. Studies have found that opioid addiction also has depleted the workforce, harming the economy.

More than 1,400 plaintiffs have had their federal cases consolidated under a single judge. They include county and local governments, hospitals, unions, American Indian tribes and individuals. Hundreds of others have sued in state courts. Cleveland-based federal Judge Dan Polster has been pushing the parties to reach a settlement.

Children need a voice

The judicial panel’s chairwoman, Judge Sarah Vance, said it’s unlikely any settlement would be reached without considering the children.

“It’s hard for me to see how the defendants are going to settle if they’ve got 150,000 children unhappy because their needs are unmet,” Vance said.

Angela Vicari, a lawyer for the drug manufacturers, told the judge that she wasn’t aware of the lawyers for the babies seeking to negotiate.

But lawyers for the children said they don’t have a voice in the committee of plaintiffs’ lawyers leading the case, making it hard to request the information from the industry that they believe would help prove their case. Attorney Kevin Thompson said it’s essential to request information on any industry laboratory studies on the impact of drugs passed from mothers to children.

Lawyers also worry that any settlement reached by government agencies won’t go to help the people who have been hurt. “They end up paving a road with that,” Bickford said.

Other plaintiffs in the omnibus opioid litigation have not objected formally and did not speak in court Thursday, but some are cool to the idea of separating the cases involving the children. One of the lead lawyers for the local governments, Paul Farrell Jr., said he is trying to get help for children born with opioid dependency and have prenatal care funded by the drug industry.

He said in an interview that the plaintiffs share a goal: holding drug manufacturers liable for the crisis. Unless that happens, he said, no one will get the payouts they’re seeking.

“You’ve only got to shoot the pig once,” he said Tuesday.

Indian tribes allowed to go it alone

Lawyers representing the children and their guardians say there is precedent for their request to go it alone, after Polster granted the American Indian tribes a separate test trial for their claims. In August, the judge denied similar status for the cases brought on behalf of babies.

That decision prompted the lawyers to ask the panel of judges to put their cases under another judge in West Virginia or Illinois.

A ruling is expected in the next several weeks.
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After repeated food poisoning outbreaks linked to romaine lettuce, the produce industry is confronting the failure of its own safety measures in preventing contaminations.

The E. coli outbreak announced just before Thanksgiving follows one in the spring that sickened more than 200 people and killed five, and another last year that sickened 25 and killed one.

No deaths have been reported in the latest outbreak, but the dozens of illnesses highlight the challenge of eliminating risk for vegetables grown in open fields and eaten raw, the role of nearby cattle operations that produce huge volumes of manure and the delay of stricter federal food safety regulations.

A contested aspect of the regulation, for example, would require testing irrigation water for E. coli. The Food and Drug Administration put the measure on hold when the produce industry said such tests wouldn’t necessarily help prevent outbreaks. Additional regulations on sanitation for workers and equipment — other potential sources of contamination — only recently started being implemented.

FDA Commissioner Scott Gottlieb said he thinks the combination of rules, once fully in place, will make vegetables safer to eat.

“I don’t think any one element of this is going to be the magic bullet,” Gottlieb said.

Health officials say improved detection may make outbreaks seem more frequent. Still, that is intensifying pressure on growers and regulators to prevent, catch and contain contamination.

Prevention

It’s not yet known how romaine got contaminated in the latest outbreak.

The spring outbreak was traced to romaine from Yuma, Arizona. Irrigation water tainted with manure was identified as a likely culprit, and investigators noted the presence of a large animal feeding operation nearby.

Subsequently, growers in Arizona and California adjusted an industry agreement to expand buffer zones between vegetable fields and livestock. The industry says the change was in place for lettuce now being grown in Yuma, which hasn’t been implicated in the latest outbreak. But Trevor Suslow of the Produce Marketing Association said there isn’t consensus about the exact distances that might effectively prevent contamination.

He noted specific buffer zones aren’t required by the new federal rules on produce safety.

“They look to the industry to determine what is the appropriate distance,” Suslow said.

Growers in Yuma also started treating irrigation water that would touch plant leaves with chlorine to kill potential contaminants, Suslow said. But he said such treatment raises concerns about soil and human health.

Meanwhile, the proximity of produce fields to cattle operations is likely to continue posing a problem. Travis Forgues of the milk producer Organic Valley noted consolidation in the dairy industry is leading to bigger livestock operations that produce massive volumes of manure.

Testing

Already, the industry agreement in Arizona and California requires leafy green growers to test water for generic E. coli.

But James Rogers, director of food safety research at Consumer Reports, said it’s important to make water testing a federal requirement. Since romaine is often chopped up and bagged, a single contaminated batch from one farm that skips testing could make a lot of people sick, he said.

Teressa Lopez of the Arizona Leafy Greens Marketing Agreement also said federal regulation can ensure greater compliance, even though the industry agreement has stricter measures.

Despite industry measures implemented after a spinach outbreak more than a decade ago, health officials note d this month there have been 28 E. coli outbreaks linked to leafy greens since 2009.

The produce industry says the failure to prevent the Yuma outbreak could also reflect the limitations of testing water for generic E. coli.

Elizabeth Binh, a food science expert at Cornell University, said the tests look for the amount of fecal matter in water. The problem is, “some feces has pathogens in it, some feces doesn’t,” said Binh, who is part of a federal program helping farmers comply with the new produce regulations.

Testing for specific E. coli strains that are harmful is more difficult, and doesn’t rule out the possibility of other harmful bacteria, Binh said.

Containment

Whole-genome sequencing is making it easier to detect outbreaks, which is pressuring the produce industry.

The FDA warned against all romaine last week because it said it was able to identify it as a likely source early enough. The agency narrowed its warning to romaine from California’s Central Coast after the produce industry agreed to label romaine with harvest dates and regions, so people know what’s OK to eat.

The labeling is voluntary, and the industry said it will evaluate whether to extend it to other leafy greens. Gottlieb said improving traceability would allow targeted health alerts that don’t hurt the entire industry. The FDA recently hired a former Walmart executive who used blockchain technology to improve traceability in the retailer’s supply chain.

Stephen Basore, director of food safety at a Florida romaine grower, said he expects more regulations and self-imposed industry guidelines.

“Anytime there is an issue, the immediate response is saying our protocols aren’t enough,” he said.
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Suicides and drug overdoses helped lead a surge in U.S. deaths last year, and drove a continuing decline in how long Americans are expected to live.

Overall, there were more than 2.8 million U.S. deaths in 2017, or nearly 70,000 more than the previous year, the Centers for Disease Control and Prevention said Thursday. It was the most deaths in a single year since the government began counting more than a century ago.

The increase partly reflects the nation’s growing and aging population. But it’s deaths in younger age groups — particularly middle-aged people — that have had the largest impact on calculations of life expectancy, experts said.

The suicide death rate last year was the highest it’s been in at least 50 years, according to U.S. government records. There were more than 47,000 suicides, up from a little less than 45,000 the year before.

​A general decline

For decades, U.S. life expectancy was on the upswing, rising a few months nearly every year. Now it’s trending the other way: It fell in 2015, stayed level in 2016, and declined again last year, the CDC said.

The nation is in the longest period of a generally declining life expectancy since the late 1910s, when World War I and the worst flu pandemic in modern history combined to kill nearly 1 million Americans. Life expectancy in 1918 was 39.

Aside from that, “we’ve never really seen anything like this,’’ said Robert Anderson, who oversees CDC death statistics.

In the nation’s 10 leading causes of death, only the cancer death rate fell in 2017. Meanwhile, there were increases in seven others: suicide, stroke, diabetes, Alzheimer’s, flu/pneumonia, chronic lower respiratory diseases and unintentional injuries.

An underlying factor is that the death rate for heart disease, the nation’s No. 1 killer, has stopped falling. In years past, declines in heart disease deaths were enough to offset increases in some other kinds of death, but no longer, Anderson said.

The CDC’s numbers do sometimes change. This week, CDC officials said they had revised their life expectancy estimate for 2016 after some additional data came in.

What’s driving this?

CDC officials did not speculate about what’s behind declining life expectancy, but Dr. William Dietz, a disease prevention expert at George Washington University, sees a sense of hopelessness.

Financial struggles, a widening income gap and divisive politics are all casting a pall over many Americans, he suggested. 

“I really do believe that people are increasingly hopeless, and that that leads to drug use, it leads potentially to suicide,’’ he said.

Drug overdose deaths also continued to climb, surpassing 70,000 last year, in the midst of the deadliest drug overdose epidemic in U.S. history. The death rate rose 10 percent from the previous year, smaller than the 21 percent jump seen between 2016 and 2017.

That’s not quite a cause for celebration, said Dr. John Rowe, a professor of health policy and aging at Columbia University.

“Maybe it’s starting to slow down, but it hasn’t turned around yet,’’ Rowe said. “I think it will take several years.”

Accidental drug overdoses account for more than a third of the unintentional injury deaths, and intentional drug overdoses account for about a tenth of the suicides, said Dr. Holly Hedegaard, a CDC injury epidemiologist.

Other findings

The CDC figures are based mainly on a review of 2017 death certificates. The life expectancy figure is based on current death trends and other factors.

The agency also said:

A baby born last year in the U.S. is expected to live about 78 years and 7 months, on average. An American born in 2015 or 2016 was expected to live about a month longer, and one born in 2014 about two months longer than that.
The suicide rate was 14 deaths per 100,000 people. That’s the highest since at least 1975.
The percentage of suicides from drug overdose has been inching downward.
Deaths from flu and pneumonia rose by about 6 percent. The 2017-2018 flu season was one of the worst in more than a decade, and some of the deaths from early in that season appeared in the new death dates.
West Virginia was once again the state with the highest rate of drug overdose deaths. The CDC did not release state rates for suicides.
Death rates for heroin, methadone and prescription opioid painkillers were flat. But deaths from the powerful painkiller fentanyl and its close opioid cousins continued to soar in 2017.
The CDC did not discuss 2017 gun deaths in the reports released Thursday. But earlier CDC reports noted increase rates of suicide by gun and by suffocation or hanging.

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A Chinese researcher who claims to have helped make the world’s first genetically edited babies says a second pregnancy may be underway.

The researcher, He Jiankui of Shenzhen, revealed the pregnancy Wednesday while making his first public comments about his controversial work at an international conference in Hong Kong.

He claims to have altered the DNA of twin girls born earlier this month to try to make them resistant to infection with the AIDS virus. Mainstream scientists have condemned the experiment, and universities and government groups are investigating.

The second pregnancy is in a very early stage and needs more time to be monitored to see if it will last, He said.

Leading scientists said there are now even more reasons to worry, and more questions than answers, after He’s talk. The leader of the conference called the experiment “irresponsible” and evidence that the scientific community had failed to regulate itself to prevent premature efforts to alter DNA.

Altering DNA before or at the time of conception is highly controversial because the changes can be inherited and might harm other genes. It’s banned in some countries including the United States except for lab research.

He defended his choice of HIV, rather than a fatal inherited disease, as a test case for gene editing, and insisted the girls could benefit from it.

“They need this protection since a vaccine is not available,” He said.

Scientists weren’t buying it.

“This is a truly unacceptable development,” said Jennifer Doudna, a University of California-Berkeley scientist and one of the inventors of the CRISPR gene-editing tool that He said he used. “I’m grateful that he appeared today, but I don’t think that we heard answers. We still need to understand the motivation for this.”

“I feel more disturbed now,” said David Liu of Harvard and MIT’s Broad Institute, and inventor of a variation of the gene-editing tool. “It’s an appalling example of what not to do about a promising technology that has great potential to benefit society. I hope it never happens again.”

There is no independent confirmation of He’s claim and he has not yet published in any scientific journal where it would be vetted by experts. At the conference, He failed or refused to answer many questions including who paid for his work, how he ensured that participants understood potential risks and benefits, and why he kept his work secret until after it was done.

After He spoke, David Baltimore, a Nobel laureate from the California Institute of Technology and a leader of the conference, said He’s work “would still be considered irresponsible” because it did not meet criteria many scientists agreed on several years ago before gene editing could be considered.

“I personally don’t think that it was medically necessary. The choice of the diseases that we heard discussions about earlier today are much more pressing” than trying to prevent HIV infection this way, he said.

If gene editing is ever allowed, many scientists have said it should be reserved to treat and prevent serious inherited disorders with no good alternatives, such as sickle cell anemia and Huntington’s disease. HIV is not an appropriate candidate because there are already safe ways to prevent transmission, and if contracted it can be kept under control with medications, researchers said.

The case shows “there has been a failure of self-regulation by the scientific community” and said the conference committee would meet and issue a statement on Thursday about the future of the field, Baltimore said.

Before He’s talk, Dr. George Daley, Harvard Medical School’s dean and one of the conference organizers, warned against a backlash to gene editing because of He’s experiment. Just because the first case may have been a misstep “should in no way, I think, lead us to stick our heads in the sand and not consider the very, very positive aspects that could come forth by a more responsible pathway,” Daley said.

“Scientists who go rogue … it carries a deep, deep cost to the scientific community,” Daley said.

Regulators have been swift to condemn the experiment as unethical and unscientific.

The National Health Commission has ordered local officials in Guangdong province to investigate He’s actions, and his employer, Southern University of Science and Technology of China, is investigating as well.

On Tuesday, Qui Renzong of the Chinese Academy of Social Science criticized the decision to let He speak at the conference, saying the claim “should not be on our agenda” until it has been reviewed by independent experts. Whether He violated reproductive medicine laws in China has been unclear; Qui contends that it did, but said, “the problem is, there’s no penalty.”

He called on the United Nations to convene a meeting to discuss heritable gene editing to promote international agreement on when it might be OK.

Meanwhile, more American scientists said they had contact with He and were aware of or suspected what he was doing.

Dr. Matthew Porteus, a genetics researcher at Stanford University, where He did postdoctoral research, said He told him in February that he intended to try human gene editing. Porteus said he discouraged He and told him “that it was irresponsible, that he could risk the entire field of gene editing by doing this in a cavalier fashion.”

Dr. William Hurlbut, a Stanford ethicist, said he has “spent many hours” talking with He over the last two years about situations where gene editing might be appropriate.

“I knew his early work. I knew where he was heading,” Hurlbut said. When he saw He four or five weeks ago, He did not say he had tried or achieved pregnancy with edited embryos but “I strongly suspected” it, Hurlbut said.

“I disagree with the notion of stepping out of the general consensus of the scientific community,” Hurlbut said. If the science is not considered ready or safe enough, “it’s going to create misunderstanding, discordance and distrust.”

Jennifer Doudna and David Liu are paid by the Howard Hughes Medical Institute, which also supports AP’s Health & Science Department.
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A Chinese researcher has publicly defended his claim he has created the world’s first genetically-edited babies.

He Jiankui addressed a crowd of fellow scientists Wednesday at a biomedical conference in Hong Kong, two days after he posted a video online claiming to have used a gene-editing technology dubbed CRISPR to alter the DNA of twin girls born to an HIV-positive father to prevent them from contracting the virus that causes AIDS.

Dr. He said he conducted his research in secret. His work has not been independently verified, and Dr. He has not submitted his report to any scientific journals where it could be examined by experts. But he told his colleagues that he felt “proud…proudest” of his achievement.

His claims have set off a firestorm of skepticism and criticism. The Southern University of Science and Technology, the university in the southern Chinese city in Shenzhen that employs him, says he has been on unpaid leave since February. The school denounced his research for violating “academic ethics and codes of conduct,” and the Chinese government is urging local authorities to launch an investigation into He’s work.

Shortly after He’s speech before the Second International Summit on Human Genome Editing, American biologist David Baltimore, a Nobel laureate in physiology or medicine and a leader of the summit, called Dr. He’s work “irresponsible” and a “failure of self-regulation by the scientific community.”

Genetic editing has the potential to remove inherited diseases from the gene pool, but scientists and ethicists worry it could be used to create so-called “designer babies.” They also worry any genetic changes could lead to other genes being altered in unpredictable ways.
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Feeding a hungry planet is growing increasingly difficult as climate change and depletion of land and other resources undermine food systems, the U.N. Food and Agricultural Organization said Wednesday as it renewed appeals for better policies and technologies to reach “zero hunger.”

Population growth requires supplies of more nutritious food at affordable prices, but increasing farm output is hard given the “fragility of the natural resource base” since humans have outstripped Earth’s carrying capacity in terms of land, water and climate change, the report said.

About 820 million people are malnourished. The FAO and International Food Policy Research Institute released the report at the outset of a global conference aimed at speeding up efforts to achieve zero hunger around the world.

“The call for action is very clear. It is possible in our lifetime and it is also realistic to end hunger and malnutrition,” Inonge Wina, vice president of Zambia, told the gathering.

Food security remains tenuous for many millions of people who lack access to affordable, adequately nourishing diets for a variety of reasons, the most common being poverty.

But it’s also endangered by civil strife and other conflicts. In Yemen, where thousands of civilians have died in airstrikes by a Saudi-led coalition, the aid group Save the Children says 85,000 children under 5 may have died of hunger or disease in the civil war.

In Afghanistan, severe drought and conflict have displaced more than 250,000 people, according to UNHCR, the U.N. refugee agency.

FAO Director-General Jose Graziano da Silva noted that the number of hungry and malnourished people in the world has risen to levels last seen a decade ago.

“After decades of gains in fighting hunger, this is a serious setback and FAO and the U.N. sister agencies, together with member governments and other partners, are all very concerned,” Graziano da Silva said in a videotaped address to the conference.

Hunger is still most severe in Africa, but the largest number of undernourished people live in the Asia-Pacific region, the report said. It said good public policies and technology are the keys to improving the situation.

The FAO estimates that global demand for food will jump by half from 2013 to 2050. Farmers can expand land use to help make up some of the difference, but that option is constrained in places like Asia and the Pacific and urbanization is eating up still more land that once may have been used for agriculture.

Increasing farm output beyond sustainable levels can cause permanent damage to ecosystems, the report said, noting that it often causes soil erosion, pollution with plastic mulching, pesticides and fertilizers, and a loss of biodiversity.

China destroys 12 million tons of tainted grain each year, at a loss of nearly $2.6 billion, according to the report.

 
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