Global Headlines | Britain's Foreign Secretary Quits; Science Exposes the Drug-Money Ties Behind FDA Reviews
Global Headlines is a new QDaily column launched in 2018. It is still a trial run, and it is still committed to helping you know more.
Global Headlines is a new QDaily column launched in 2018. It is still a trial run, and it is still committed to helping you know more.
What the Agenda-Setters Are Talking About
Science: The Hidden Conflicts of Interest — How Drug Companies Sway FDA Reviews
In July 2010, at a Marriott hotel in Maryland, seven medical experts sat as reviewers for the Food and Drug Administration (FDA) and listened to a presentation by the British drugmaker AstraZeneca. They then voted 7 to 1 to approve the company's new cardiovascular drug. Next to its competitors, the drug lowered patient mortality only slightly. It cost more than twenty times as much.
The FDA said nothing about any conflict of interest. But four of the experts soon began receiving money billed as travel or consulting fees; one of them got nearly $2 million for "related research."
The case was exposed in the cover story of the July 6 issue of the top academic journal Science. The Science investigation found conflicts of interest between the FDA's outside reviewers and drug companies to be widespread. Of the 107 physician advisers examined, 40 took more than $10,000 within four years of a vote, 26 took more than $100,000, and 7 took more than $1 million.
Besides this pattern of paying afterward, companies waiting on approval — and their competitors — also handed experts consulting work, travel, speaking fees and research money in the year of the review or the year before. Those arrangements appear in the disclosures attached to journal papers, yet went unmentioned in the FDA's review process. Another common pattern: reviewers resign and join the very drug companies they voted to approve.
Carl Elliott, a medical ethicist at the University of Minnesota, calls funding that arrives later "delayed reciprocity." "You believe a company will pay you back sooner or later, so you do it a favor. And they do pay you back," Elliott said.
The FDA gave no direct answer to Science's questions. AstraZeneca said it knew nothing of any payments made after the fact — apart from the clinical trials and review work these experts take part in routinely.
Some experts admitted taking the money but insisted it was a necessary price for a professional review process, that they had not profited personally, and that it did not compromise their impartiality.
Still, the AstraZeneca case above is a troubling one. In 2009 the company's drug Seroquel was approved for a new use, and several reviewers went on to receive funding. In 2010 the company paid the government $520 million to settle legal disputes over misconduct in clinical trials and marketing; that same year it made more than $5 billion from Seroquel. In 2011 the FDA ordered AstraZeneca to add a risk warning to the drug's label; three weeks later, a patient who had taken it without knowing of the risk died.
The FDA's counterparts abroad have begun testing tighter supervision. The European Medicines Agency (EMA) bars reviewers from holding any concurrent interest in the party under review, and bans or sharply limits participation by experts who have had dealings with a drug company for more than three years. Speaking fees, consulting contracts and research funding all disqualify a reviewer outright.
24-Hour Newsmakers
British Foreign Secretary Boris Johnson has resigned, warning that the "soft Brexit" plan agreed last week would leave Britain in "the status of a colony."
Counting Brexit Secretary David Davis, who quit earlier, three senior officials handling foreign affairs and Brexit have resigned in 24 hours.
Last Friday, the cabinet led by Theresa May "reached agreement" on a Brexit plan. It was milder than expected. Under it, Britain would apply the same rulebook as the EU to all goods, farm produce included, to keep cross-border trade running; set up a "common constitutional framework" for interpreting agreements between Britain and the EU; and write its own tariff rules while avoiding chaos at the border.
Johnson's resignation letter attacked the cabinet plan in fierce terms for giving away Britain's autonomy, saying it could leave the country "truly in the status of a colony." He wrote: "Brexit should be about opportunity and hope... That dream is dying, suffocated by needless self-doubt."
Johnson is regarded as a hardline Brexiteer and was the standard-bearer of the 2016 referendum campaign. In his letter he complained: "I spent all weekend trying out wording [in support of the cabinet plan], and in the end found the words stuck in my throat. Since I cannot wholeheartedly endorse the cabinet's proposal, the sad conclusion is that I must go."
Theresa May put out a short statement thanking Johnson for his work. She announced later that former Health Secretary Jeremy Hunt would take over as Foreign Secretary. Hunt is an ally of May's, but voted against Brexit in the 2016 referendum.
Tuesday's Guardian and Financial Times both led their front pages with the point that May's grip on power is now in crisis. Labour accused May of letting two years of vacillation, hesitation and cabinet infighting destroy her ability to keep leading Brexit; the President of the European Parliament said the departures of Johnson and Davis did nothing to "solve the mess Brexit has created."
May urged the EU to back the plan she put forward last week, warning that Britain could otherwise crash out into a hard Brexit with no deal. The EU's position remains unclear. Many EU officials worry that letting Britain stay inside Europe's free-trade framework would set a bad example for other countries.
What Else Happened in the World
US President Donald Trump has nominated Brett Kavanaugh to the Supreme Court, filling the seat left by Justice Kennedy. Kavanaugh's positions on abortion, healthcare and similar questions are read as ambiguous. He now faces questioning and a confirmation vote in the Senate.
The cave rescue in Thailand continues. Rescuers have brought out 8 boys; 4 boys and their coach are still trapped.
A train derailed in northwestern Turkey, killing at least 24 people and injuring more than a hundred. Officials blame ground damage from days of heavy rain.
Record rainfall in western Japan has killed 126 people, with 79 missing. The Meteorological Agency has now lifted all of its "heavy rain emergency warnings."
YouTube says it will take a series of steps against false information and support established news organizations. Among them: adding text previews to videos about breaking news.
Someone Said
"A miraculous day. I get goosebumps just thinking about it."
After Ethiopian Prime Minister Abiy Ahmed visited Asmara, the capital of Eritrea, Asmara resident Mela Gebre Medhin called it a "historic day." The joint declaration formally signed by the two heads of state ends the state of war and restores trade and diplomatic relations.
Ethiopia and Eritrea fought a border war in the late 1990s in which tens of thousands died. From 2000 the two signed an agreement and settled into a state of "no war, no peace." The boundary commission the agreement created ruled that the disputed town of Badme belonged to Eritrea; Ethiopia refused to accept the ruling, and the standoff has lasted ever since.
The hostility reached well beyond the border. On nearly every issue the two took opposing sides. In Somalia, for instance, Ethiopia backed the internationally recognized government while Eritrea backed Islamist groups.
The turn came in April this year, when Abiy was elected prime minister of Ethiopia. Much was expected of him. Just before his trip to Eritrea, Abiy lifted the state of emergency, released political prisoners and announced economic reforms. He even said Badme could go to Eritrea.
Badme's fate is not settled, and protest is still audible in Ethiopia. But the gains from normal relations are concrete: besides restored communications and transport and reunited families, Ethiopia can now use Eritrea's Red Sea ports. It has been landlocked since Eritrea's independence in 1991.
You Might Also Be Interested In
The World Health Organization (WHO) credits Paraguay's success to a national health system that works: it can diagnose malaria cases quickly and tell whether they were caught locally or brought in from abroad. WHO officials expect Argentina to beat malaria soon as well.
Across South America, though, the fight is not going well. Panama, Nicaragua, Peru and Venezuela all recorded more malaria cases in 2016 than in 2010, and Colombia's cases doubled between 2015 and 2016. Worldwide, cases rose from 211 million in 2015 to 216 million in 2016.
Part of the blame lies with poor sanitation in the countryside, but most of it lies with the carrier — the mosquito. Extreme flooding has helped mosquitoes breed, and the two species that spread malaria have grown resistant to insecticides. As long as mosquitoes exist, countries that have eliminated malaria can see it come back. As one health official put it, mosquitoes don't see borders.
Since the Montreal Protocol took effect the ozone hole over Antarctica has kept shrinking, clear proof that the effort to protect the ozone layer and control greenhouse gases works. In the past few years the trend has reversed. Researchers blame a pollutant called Freon-11 (CFC-11). Freon-11 has been banned worldwide since 2010.
An investigation published on Monday by the NGO Environmental Investigation Agency traced the Freon-11 emissions to foam factories in China. Of 21 factories the investigators visited, 18 were using the chemical illegally, and many manufacturers admitted it cheerfully, saying everyone in the trade does the same. China has thousands of small and mid-sized foam producers like these.
The American research team that spotted the unexplained rise in Freon-11 emissions said it was surprised by the findings, and noted that other explanations cannot yet be ruled out. If China is confirmed as the source, they hope new environmental measures take hold fast.
The Environmental Investigation Agency has passed its evidence to Chinese government departments, which are now taking samples. A 2016 report by Shandong province's environmental protection bureau had already noted that illegal use of CFC-11 remained widespread. Even so, with high profits on one side and light penalties on the other, many companies choose to run the risk and play cat and mouse with inspectors.
On This Day
July 10, 138: Hadrian, emperor of Rome, died.
July 10, 1652: Britain declared war on the Netherlands, beginning the First Anglo-Dutch War.
July 10, 1940: the Battle of Britain began.
July 10, 1985: French intelligence agents bombed and sank the Rainbow Warrior, the Greenpeace ship used to monitor and protest nuclear tests, in New Zealand.
July 10, 1991: Boris Yeltsin was sworn in as the first President of the Russian Federation.
July 10, 2007: Zheng Xiaoyu, former head of China's State Food and Drug Administration, was executed.
July 10, 2011: Britain's News of the World, brought down by the phone-hacking scandal, printed its last issue.
Cover image from: publicdomainpictures.net
Translated from the original QDaily article. Original publication date retained.