Science & Health
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Trump Nominee to Lead FDA Has Deep Ties to Drug Companies

U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, a White House official said Friday.

If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.

Gottlieb is well-known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by drug companies and pharmaceutical investors. A former FDA official, Gottlieb also sits on the boards of pharmaceutical companies.

“Thank God it’s Gottlieb,” Brian Skorney, an investment analyst at Robert W. Baird, wrote in a research note. “We view this as a favorable development for the sector.”

Gottlieb, 44, is a resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund. He is a former FDA deputy commissioner who has frequently advocated a loosening of requirements needed for approval of new medical products.

“Scott knows how the agency works and he will move it forwards, though maybe not always in ways the agency is comfortable with,” said John Taylor, a lawyer and president of compliance and regulatory affairs with the consulting firm Greenleaf Health and a former acting FDA deputy commissioner.

Picked over O’Neill

Gottlieb was chosen over Jim O’Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a PayPal co-founder who now advises Trump on technology and science matters. O’Neill’s stated view that drugs should be approved before being proven effective generated widespread alarm.

 

Gottlieb, who declined to comment on the nomination, is unlikely to upend the FDA in the way O’Neill might have, but he is nonetheless expected to bring significant change, including moving the agency to increase flexibility in the clinical trial development process.

In this he will be supported by the recently passed 21st Century Cures Act, which instructs the FDA among other things to consider the use of “real world evidence” to support new drug applications. This could include anecdotal data, observational studies and patient reports.

“People don’t want to take chances with safety, but there’s increasingly some clamor to be more flexible on the efficacy side,” said Kathleen Sanzo, who leads the FDA practice at the law firm Morgan, Lewis & Bockius. “You need to have some signal of efficacy. The question is: How much?”

Generic therapeutics

One of Gottlieb’s priorities will most likely be to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards.

A survey conducted by Mizuho Securities USA Inc. of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced.

“He will be a pragmatic leader with an eye toward both expedited approvals and safety,” one executive wrote.

Others were less sanguine, citing his deep ties to industry, including his seat on multiple pharmaceutical company boards, as potential conflicts of interest.

Dr. Michael Carome, director of Public Citizen’s Health Research Group, said Gottlieb “has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry.” If confirmed, he added, “he will have to be recused from key decisions time and time again.”

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Arts & Entertainment
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Lawyer: Muhammad Ali’s Son Detained, Questioned at Airport

A lawyer for Muhammad Ali’s son says he was detained and questioned at a Washington airport before being allowed to board a flight to Fort Lauderdale after meeting with lawmakers to discuss a separate airport detention incident last month.

Muhammad Ali Jr. was stopped at the Fort Lauderdale-Hollywood International Airport after returning from Jamaica on Feb. 7. The late heavyweight champion’s son traveled to Washington on Wednesday to speak to members of a congressional subcommittee on border security about that experience.

On Friday, Attorney Chris Mancini says Ali was detained for 20 minutes as he attempted to board a JetBlue Airways flight. He spoke to Department of Homeland Security officials by telephone before he was allowed to board.

A spokeswoman for JetBlue referred questions to DHS officials.

Ali believes he’s being stopped because he’s a Muslim.

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Silicon Valley & Technology
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Nude Photo-sharing Scandal Rocks US Marine Corps

A Facebook group consisting of thousands of U.S. Marines and Marine veterans has shared nude photographs of women, including fellow Marines, through social media, prompting the U.S. military to launch an investigation into the incident.

The commandant of the Marine Corps, General Robert Neller, told reporters Friday at the Pentagon that when female Marines are subjected to cyberbullying, presumably by other Marines, it “undermines everything” the military branch stands for, as it protects and serves the country.

“There is no honor in denigrating a fellow Marine in any way, shape or form,” Neller said.

The general said fewer than 10 victims have come forward, but evidence provided by a reporter suggested that around 30 women have been victimized by the cyberbullying scandal.

Marine officials say they were informed about the Facebook site that is sharing the nude photos, known as the “Marines United” community page, on January 30. On February 1, the Marine Corps had the site taken down, but learned later about a link to Google Drive files that contained the nude photos. Some of the photos shared were taken without the women’s knowledge.

Neller said an investigation into the incident by the Naval Criminal Investigative Service (NCIS) is under way. In addition, Neller said the Marine Corps is setting up a task force to see what actions can be taken, and to come up with practices that both prevent this violation in the future and prevent the “subculture that gave rise to this.”

Secretary of Defense Jim Mattis released a statement Friday calling the “lack of respect for the dignity and humanity” of fellow military members “unacceptable and counter to unit cohesion.”

“We will not excuse or tolerate such behavior if we are to uphold our values and maintain our ability to defeat the enemy on the battlefield,” added Mattis, a former Marine general.

Neller told reporters he will testify on Capitol Hill about the incident next week. He also has planned to visit Camp Lejeune, in eastern North Carolina, one of the largest Marine bases on the U.S. East Coast.

Marine officials said they are working to ensure the victims’ privacy is protected as the investigation continues. There are reports that some Marines have continued to share the nude photos, despite the ongoing investigation.

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Silicon Valley & Technology
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Tech and Hollywood Head to Texas SXSW Festival

Movie stars, tech moguls and music artists are among those converging in Austin, Texas, starting this week, as part of South by Southwest Conference and Festivals.

Known by its shorthand SXSW, the nine-day event, now in its 31st year, mixes music, film, comedy and digital entertainment, as well as technology and politics.

The event in the Texas capital, normally a low-key tech hub, has become an important nexus where the already successful mix with the aspiring. New movies premiere, music acts perform and startups pitch their wares. Twitter gained traction at SXSW in 2007, putting up flat-panel screens in the hallways.

But not every new tech or its CEO can call SXSW experience a success. Facebook CEO Mark Zuckerberg struggled through his keynote interview in 2008. Meerkat, a video streaming app that took off in SXSW 2015, quickly faded.

This year, among the actors, musicians and tech celebrities, Buzz Aldrin, the former astronaut who walked on the moon in 1969, will speak about human space exploration.

U.S. government officials and American politicians also come to mingle with the celebrities and tech executives. At last year’s SXSW, President Barack Obama and first lady Michelle Obama spoke to the festival-goers.

FBI Director James Comey was expected to speak at this year’s event, but he canceled. In his place, James Baker, the FBI’s general counsel, is scheduled to discuss the “intersection of national security, technology and First Amendment rights.”

On Sunday, Joe Biden, the former U.S. vice president, will speak about his work on cancer research as part of the Biden Cancer Initiative.

The intersection of politics and technology is one major theme this year, with SXSW organizers creating a “Tech Under Trump” series of discussions. Topics include immigration, self-driving cars and the effects that artificial intelligence may have on jobs. One panel, “Startup investing in the Trump years,” will look at how the Trump administration could affect the investment landscape.

Some panels tout how technology can be used to achieve goals such as helping people seeking faith. Yasmin Green, head of research and development at Jigsaw — a technology incubator that is part of Alphabet, Google’s parent company — will discuss how technology can be used to fight extremism.

Other sessions focus on bleaker possibilities, like how technology can potentially hurt people, such as robots taking jobs.

Ultimately, SXSW this year, as in the past, is a giant party with thousands of people looking for the next big thing.

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Science & Health
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Do You Trust Information You Don’t Want to Hear?

In America’s current polarized climate, social observers have noted, people tend to turn to news sources that reflect their political beliefs and avoid listening to anything that challenges them. But without a shared understanding of what’s going on, it becomes difficult, if not impossible, to achieve cooperation and compromise.

It is not only regarding politics that people avoid or ignore information that may be useful, according to a new study from Carnegie Mellon University. Dieters may choose to overlook how many calories there are in a rich dessert. People with a family history of a genetic disease may skip screening tests that could reveal whether their health is at risk.

Writing in the Journal of Economic Literature, the study’s authors explain how and why people deliberately avoid information that could threaten their happiness and well-being. “People often avoid information that could help them to make better decisions if they think the information might be painful to receive,” said George Loewenstein, who co-founded the field of behavioral economics.

Loewenstein and his colleagues found that when people cannot avoid encountering information that goes against their beliefs, they may discount it; they point to widespread disbelief and doubts about scientific evidence of climate change. By the same token, questionable evidence may be treated as credible if it confirms what someone wants to believe.

There can be understandable reasons for avoiding information. Not taking a genetic test could allow someone to enjoy life until illness can’t be ignored. Not following the stock market could keep investors from selling in a panic.

Co-author David Hagmann notes that “bombarding people with information that challenges their cherished beliefs … is more likely to engender defensive avoidance than receptive processing.”

To reduce the political divide, “we have to find ways not only to expose people to conflicting information, but to increase people’s receptivity to information that challenges what they believe and want to believe,” he said.

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Science & Health
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Kenya Firing Doctors in Dispute Over Collective Bargaining Agreement

A decision by the government to fire doctors who went on strike three months ago has left Kenya’s health care sector in crisis.

Kenyans remain in limbo after the two sides failed to agree on and sign documents that cover a range of issues, including better pay and working conditions for the doctors, improved health facilities and security for medical staff.

Peter Munya is the governor of the state of Meru and chairman of the council of governors. He says the government remains firm in its decision to penalize doctors who refuse to return to work.

“The decision we took still stands and I am told people are following the processes of laying off those who have not reported back to work,” said Munya. “I am told [disciplinary measures] have been given. So that is what we are implementing.”

12 medics fired

On Wednesday, the biggest hospital in the county, Kenyatta National Hospital, fired 12 medics and put 48 others on notice.

Kenyan media report a handful of physicians returned to work.  

Dr. George Got is with the union that represents the doctors. He said its national advisory council agreed to proposed amendments presented in a collective bargaining agreement (CBA) that now awaits the signatures of both parties.

“I can only confirm, we were told that the CBA would be signed with the amendments,” said Got. “I will not tell you exactly which amendments because that’s fairly confidential. So the third document to be signed is a formal return-to-work formula checking out the procedures of returning to work.”

Union remains optimistic

Got said the union had yet to receive word whether the government would sign the documents, but that union officials remained optimistic.

“The national advisory council remains committed, and so far we have not received any communication that those documents will not be signed.” Got said. “We are just waiting for our negotiators to brief us as when they sign, and they advise us to resume work; we already gave them our blessing, and we shall resume work.”

Governor Munya confirmed to VOA that changes were made to the previous collective bargaining agreement of 2013 in which doctors sought a pay raise of up to 180 percent. The government’s offer stands at 40 percent.

Foreign doctors may be hired

Munya says the government is considering hiring foreign doctors.

“We want to start working out the process of hiring doctors from outside the country, and the minister of health is already working on that,” Munya said. The minister “has spoken to friendly countries that can provide doctors, and he is also working on the legal framework to register these doctors locally.”

This is not the first time the government has announced the plan to fire doctors and bring in physicians from abroad.

The state plans to hire physicians from neighboring Tanzania as well as Cuba and India. Before that happens, an appeals court will have to rule on the matter.

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Science & Health
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WHO: Half a Million Africans Die From Cancer Annually

The World Health Organization says about half a million Africans die of cancer each year, or six percent of global cancer deaths annually.

The leading cancers in Africa affect the breast, cervix and prostate, according to WHO.

Dr. Andre Ilbawi, the technical officer for cancer control at WHO headquarters in Geneva, says the cause of the illness in Africa is not always clear, though factors that may contribute to breast cancer include alcohol use, obesity and lack of physical activity.

Weakened immune systems also play a role, making people susceptible to many infections and diseases, including the human papilloma virus, or HPV, which can cause cervical cancer.

“Women in Africa have a higher rate of HIV, which makes worse the effect of HPV,” Ilbawi said, “so we see the combination of infectious causes really can explain the majority of cervical cancer cases in Africa and elsewhere.”

Ilbawi says other infections, besides HPV, also can lead to cancer.

“We know the immune system plays a very important role in fighting cancer. And in some situations, infections can cause cancer themselves,” he said. “It’s not always as easy as saying malaria triggers cancer years down the line for someone exposed to malaria, but we do know there are some cause and effects for infectious causes of cancer in Africa. Some include hepatitis B and C, [which] contribute to liver cancer. … There are infections in the stomach that can contribute to gastric cancer … so infections both directly and by weakening the immune system can contribute to cancer cases.”

Early detection

Not all cancers are fatal, especially if detected early. The WHO is working to encourage governments to adopt measures that are low cost, but high impact, especially on the local, or primary care, level.

“Early diagnosis has a strategic position in health expenditures because if we are able to detect cancer early, then the costs of treatment are lower,” Ilbawi said. “We know from high-income countries that detecting cancer at stage one or two [out of four] reduces the cost of treatment between two- to four-fold in some settings.”

He also says earlier detection makes it likely that less toxic medications can be used.

WHO guidelines suggest inexpensive ways to improve cancer detection, beginning by educating the public and health workers on how to recognize potential symptoms.

“We need that provider to identify high-risk symptoms and say to a patient, ‘I understand you are having bleeding in your stool or a lump or mass that may be concerning to you. It could be many possible diseases. But what you need to do is get from the primary care level to the diagnostic facilities, where you can access biopsy and pathology to confirm whether it’s cancer,'” Ilbawi said.

“The first-level provider is critical because that’s where most patients go first. And we have to bring those providers into the health system for cancer — not just focus on high-cost treatment at a centralized facility when most people can’t get there, can’t afford those treatments or get there far too late,” he added.

Low-cost options

Other low-cost options include providing social workers and patient navigators who can help direct patients to facilities that provide blood and tissue testing — and treatment.

Ilbawi says therapies for cancer patients do not have to be costly. They might involve surgery, chemotherapy, and oral and hormonal treatments.

The WHO advises countries on how to improve cancer care, including insurance and other mechanisms that make treatment more affordable.

Ibawi says it’s a coordinated effort that includes governments, advocacy groups, the U.N. and donors. Together, they help identify where strategic investments can help improve health services and extend the lives of hundreds of thousands of people.

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Economy & business
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Ross: US Hopes to Launch NAFTA Talks in Just Over 90 Days

U.S. Commerce Secretary Wilbur Ross said on Friday he hopes to launch formal talks to renegotiate the North American Free Trade Agreement with Canada and Mexico in a little over three months.

U.S. President Donald Trump was strongly critical during his election campaign of NAFTA and other trade agreements that he said harmed American workers, pledging to review such deals.

Ross told reporters that “sometime in the next couple of weeks” he hopes to send a letter notifying Congress that the Trump administration intends to launch NAFTA negotiations in 90 days.

“That’s what triggers the beginnings of the formal process itself,” Ross said at a news conference with Mexican Economy Minister Ildefonso Guajardo.

That timing would put the likely start of NAFTA talks around early July.

Ross added that he was consulting on the NAFTA talks with leaders of Congress’ two trade panels, the Senate Finance Committee and the House of Representatives Ways and Means Committee.

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