China eyes bans for rogue scientists after gene-editing uproar

France24 – AFP, 27 Feb 2019

Chinese scientist He Jiankui has been placed under police investigation and the
government ordered a halt to his research work AFP/File

Beijing (AFP) - China has drafted new rules for biotechnology research, including fines and bans for rogue scientists, after a Chinese researcher caused a global outcry by claiming that he gene-edited babies.

Scientist He Jiankui's shock announcement that his experiment led to the birth of the world's first genetically-modified babies in November put a spotlight on China's lax oversight over scientific research.

He claimed to have altered the DNA of the twins to prevent them from contracting HIV by deleting a certain gene under a technique known as CRISPR.

The new rules unveiled on Tuesday propose to classify technology used for extracting genetic materials, gene editing, gene transfer and stem cell research as "high risk".

Health authorities under the central government would manage such research.

The State Council, China's cabinet, would be responsible for "the supervision and administration of clinical research and applications throughout the country," according to the rules.

The new draft proposes fines of between 50,000 and 100,000 yuan ($7,500 and $15,000) for scientists or institutions that carry out research without proper authorisation, and the government can halt and confiscate the work.

A scientist who earns "illegal income" from unauthorised research would be fined 10 to 20 times the amount of the illicit earnings.

Depending on the severity of the violation, a scientist can be banned from their field of work for six months to one year.

"If the circumstances are serious, their medical practice licence shall be revoked and the individual shall not engage in clinical research for life," the rules say.

He Jiankui has been placed under police investigation and the government ordered a halt to his research work.

A government probe found that He had "forged ethical review papers" and "deliberately evaded supervision", according to state media.

He had recruited eight couples for the gene-altering trial, and the investigation confirmed that a second woman became pregnant.

It is unknown if she has given birth yet.

Gene-editing for reproductive purposes is illegal in most countries, but China does not have a law banning it.

A brief regulation issued by the health ministry in 2003 prohibits gene-editing of human embryos, but does not stipulate any punishments for violators.

Following the storm sparked by He's announcement, scientists have called for an international treaty on gene-editing.

US airlines to offer non-binary gender options

Yahoo – AFP, February 19, 2019

Beginning June 1, 2019, members of Airlines for America, a trade group that
 represents most leading US carriers, will allow consumers to pick "unspecified" and
 "undisclosed" in addition to the traditional two gender options of "male" and
"female" (AFP Photo/SAUL LOEB)

New York (AFP) - US carriers will soon offer passengers additional options besides "male" and "female" when they buy tickets, an airlines trade association said Tuesday.

The shift comes as a handful of US states permit citizens to identify by non-binary genders and as a minority of countries within the European Union permit citizens to self-identify by their gender preference.

Beginning June 1, members of Airlines for America, a trade group that represents most leading US carriers, will allow consumers to pick "unspecified" and "undisclosed" in addition to the traditional two options.

"US airlines value a culture of diversity and inclusion, both in the workplace and for our passengers and we work hard each day to accommodate the needs of all travelers, while delivering a safe, secure and enjoyable flight experience," the group said.

Implementation of the shift will be up to members of the group, which is also known as A4A. Members of the association include American Airlines and Southwest Airlines.

United Airlines, another member, said on Twitter, that "In the coming weeks, customers will be able to select the gender with which they most closely identify during the booking process."

Delta Air Lines, which is not in A4A, also plans non-binary gender options during the booking process, a spokeswoman said.

Seven states in the US and the District of Columbia allow citizens to define as "X" gender, in addition to male and female, said Gillian Branstetter, media relations manager at the National Center of Transgender Equality.

The group applauded the airline announcement.

"Non-binary people face unnecessary, invasive, and discriminatory scrutiny by airlines, airports and security services alike," said Arli Christian, state policy director for the National Center for Transgender Equality.

"A4A's work is in line with other states who offer gender neutral designations on IDs and is an important step toward ensuring safe and smooth travel for all passengers regardless of their gender."

Among the 28 EU member states and three European Free Trade Association states, seven countries currently have or will soon have a model that lets adults self-define their gender, according to a November 2018 European Commission report on trans and intersex equality. However, only one jurisdiction -- Malta -- permits non-binary recognition.

EU countries, as well as the EU itself, "are firmly grounded in a binary conception of sex," said the report.

"While public awareness if improving, trans and intersex people continue to suffer disproportionate social and legal burdens," the report said.

Dutch Seroxat teen users to sue drug maker for side effects

DutchNews, February 18, 2019

Photo: Jessi Monomen via Wikimedia Commons 

More than 20 people who used the anti-depressant Seroxat (paroxetine) in their youth will make a formal claim against the maker GlaxoSmithKline at the end of this month, the Volkskrant said at the weekend. 

They say that GSK failed to inform them about the serious psychological side effects of the drug, including aggressive behaviour and an increased risk of suicide. 

The SeroxatClaim foundation was set up last year after a Dutchman who took the drug while a youngster successfully sued GSK for the side effects he suffered. 

The side effects were not put down to the drug because they were not noted in the information leaflet provided with the medicine, even though GSK was aware of them, the court said. 

GSK is appealing against that ruling and declined to comment on the new court case, the Volkskrant said. 

In the meantime, the information leaflet has been amended and the drug is no longer prescribed to the under 18s. 

In 2012, The United States Department of Justice fined GlaxoSmithKline $3 billion for  withholding data on paroxetine, unlawfully promoting it for under-18s and preparing an article that misleadingly reported the drug was effective in treating adolescent depression.

Related Article:

GlaxoSmithKline accused of market 'abuse'

Cyprus legalises medical cannabis

Yahoo – AFP, 15 February 2019

Cypriot lawmakers have voted to approve the cultivation and use of medical cannabis

Cypriot legislators on Friday voted to approve the cultivation and use of medical cannabis, joining a growing trend among other European Union nations.

An amendment to the country's Drugs and Psychotropic Substances law introduces provisions allowing the import of cannabis seeds and plants for cultivation for medical purposes.

According to the law, licenses will be given to three producers during the first 15 years, as the authorities aim to attract firms with an international track record and prevent the product ending up on the black market.

Medicinal cannabis will be allowed on prescription to patients suffering from chronic painful conditions, including those associated with cancer, HIV, rheumatism and glaucoma.

Officials have estimated that Cyprus could see medicinal cannabis worth 180 million euros ($200 million) being produced every year, offering a boost for state coffers.

The Cyprus Green Party welcomed the move Friday with a statement saying: "We hope that the process will be launched immediately for hundreds of patients seeking an alternative, non-chemical way to manage their health problems."

"Although we had proposed many more improvements to this legislation, we believe that the road to medical cannabis has opened in Cyprus," it added.

Over a dozen EU countries have authorised the use of medical cannabis.

Greece in November issued its first licenses for the cultivation and processing of medical cannabis.

Amsterdam hospital gets €5m from lottery to make its own medicines

DutchNews, February 11, 2019

Photo: Depositphotos.com

Amsterdam’s UMC teaching hospital has been given a €5m donation by a lottery organisation to prepare more drugs in its own pharmacy and so produce them more cheaply and more quickly than the pharmaceuticals industry. 

The plan to make more drugs is part of a widercampaign by the hospital to improve the availability of medicines for rare diseases which will focus on sharing information and carrying out research into why some drugs are so expensive. 

‘We want to come up with concrete examples of the problems with expensive medicine in terms of price and availability,’ professor Carla Hollack, who is jointly leading the project, told the NRC. 

‘That may lead to friction with the pharmaceuticals industry but that is not our aim,’ she said. ‘It is about identifying and solving mistakes in the system.’ 

Last year the hospital was embroiled in a major row with the drugs industry when it began making its own version of a licenced drug to treat a rare metabolic disorder. 

The hospital began producing the drug, known as CDCA, because it was no longer covered by health insurance after manufacturer Leadiant ramped up the price by around 500%. 

Concerns 

Last week, foreign pharmaceuticals companies in the Netherlands said they are ‘concerned’ that the government is undermining the business climate by trying to force down the price of drugs. 

The companies, including MSD, Gilead and Johnson & Johnson unit Janssen, are all members of Amcham, the American chamber of commerce in the Netherlands, which wrote to health minister Bruno Bruins calling for a rethink.

In January, Bruins reacted angrily to a decision by Swiss pharmaceuticals giant Novartis to put up the price of a drug to treat a rare form of cancer five fold, describing it as ‘outrageous‘. 

The Dutch healthcare institute Zorginstituut Nederland has also said insurers should stop paying for expensive drugs if pharmaceutical companies continue to refuse to say how they arrive at the price.

Related Article:

Big pharma firms criticise Dutch campaign to slash drug prices

Supreme Court blocks Louisiana abortion law

Yahoo – AFP, February 8, 2019

The case was considered a test for the Supreme Court to the right under
President Donald Trump (AFP Photo/MANDEL NGAN)

Washington (AFP) - The US Supreme Court on Thursday blocked a Louisiana law that critics say would limit access to abortion in the southern state.

The decision was made by a narrow majority -- 5 votes to 4 -- with Chief Justice John Roberts joining the court's progressive justices to block the legislation, which would have taken effect Friday.

It was considered a test for the high court, swung to the right under President Donald Trump.

The law would require doctors at Louisiana's abortion clinics to have admitting privileges at a hospital less than 50 kilometers (30 miles) away.

According to pro-choice advocates, that is too restrictive -- leaving only one doctor able to perform the procedure in the whole state.

But the state of Louisiana argued that due to risks of complications, it was vital to be able to transfer patients to neighboring hospitals.

That convinced an appeals court, which after years of hearings, allowed the law to finally come into force this week.

But those challenging it filed an emergency brief in the Supreme Court asking for it to block the law as they sought an appeal.

They argued that even if they were to win later, the impact of the law coming into effect would be irreversible and closed clinics would not be able to reopen.

In doing so, they highlighted a similar law in Texas that the Supreme Court in 2016 found to be unconstitutional.

The law was backed by conservative judges Neil Gorsuch and Brett Kavanaugh -- both picked by President Donald Trump.

Two years ago, Chief Justice Roberts voted to uphold the law in Texas. But with his vote on Thursday, he brought new balance to the court.

Miracle treatment or dangerous drug? Indonesia cashes in on Kratom

Yahoo – AFP, Harry PEARL, with Aseanty Pahlevi in Pontianak, 8 February 2019

The sweltering backwaters of Indonesian Borneo have become the unlikely ground
 zero for the global production and export of Kratom, a tree leaf hailed by some
as a miracle cure for everything from opioid addiction to anxiety.

Part of the coffee family, the leaf has been used for centuries in Southeast Asia and Papua New Guinea for its pain-relieving and mildly stimulating effects but it is now sold in powder form and exported worldwide -- alarming some health regulators who have raised concerns about safety.

Kratom stimulates the same brain receptors as morphine, although it produces much milder effects.

"I take Kratom and have had no problems. Every strain has its benefits – some help you relax, others can treat insomnia or treat drug addiction. Some help increase stamina," grower Faisal Perdana told AFP.

Fellow farmer Gusti Prabu, who now exports 10 tonnes of the drug a month, agreed.

"Our ancestors used Kratom and there were no negative side effects. It can help eliminate drug addiction and help people detox," he explained.

But its popularity is causing concern -- the drug is unregulated, and has had little clinical testing to assess its safety or side effects.

Kratom is already banned for domestic consumption in Indonesia, Malaysia and Thailand, though the former allows its export in unprocessed form.

Health authorities in the United States -- now the drug's top importer -- have linked consumption of the plant and its derivatives to dozens of deaths, warning it could aggravate a deadly opioid epidemic gripping parts of the country.

Kratom is already banned for domestic consumption though it allows its 

export in unprocessed form

Compounds found in Kratom are opioids, which expose users to the same risks of addiction and death as illicit opiates, according to the US Food and Drug Administration.

But for farmers in Kapuas Hulu, West Kalimantan -- the centre of production -- demand for Kratom is such that they have moved away from traditional commodities such as rubber and palm oil to start growing the tree, turning it into a major cash crop.

And at the main post office in Pontianak, the key trading post for this part of Indonesian Borneo, it's clear the health warnings have done little to dampen interest.

"Around 90 percent of our shipments from West Kalimantan province are Kratom that's been sold to the United States," post office head Zaenal Hamid said.

As many as five million Americans use the drug and that number is growing, according to the American Kratom Association.

Data from 2016 showed that the region was shipping some 400 tonnes abroad every month -- worth about $130 million annually at current global prices of some $30 a kilogramme.

Most Kratom customers are reached through online platforms such as Facebook, Instagram and Chinese e-marketplace Alibaba.

The trend for alternative medicine has been credited with increasing interest in Kratom from Europe and America, where it is usually consumed as a tea or in capsules.

As many as five million Americans use kratom and that number is growing, 

according to the American Kratom Association

Opioid epidemic

The US is struggling with an opioid epidemic, fueled by addiction to prescription painkillers as well as street drugs like heroin and synthetic versions such as fentanyl.

Kratom is legal in 43 states, but the FDA is pushing for greater restrictions and has already put an import alert on it, which means shipments entering the US can be confiscated.

In a statement, the organisation warned consumers not to use the drug and said it was "concerned that Kratom appears to have properties that expose users to the risks of addiction, abuse, and dependence."

Scientists say that while Kratom may have positive attributes, very little research has been done into the drug.

"It has great potential as a remedy for pain and opioid addiction given its pharmacology and its potential accessibility," Michael White, head of the department of pharmacy practice at the University of Connecticut, told AFP.

"It is promising and not proven," he added.

Advocates insist it's a safe alternative to prescription drugs and can actually help opioid addicts.

Health authorities in the United States -- now the kratom's top importer -- have 

linked consumption of the plant and its derivatives to dozens of deaths, warning

it could aggravate a deadly opioid epidemic gripping parts of the country

"Of the 44 deaths on record involving Kratom, they all involve poly-drug use," said Ryan Leung, a spokesman from kratom lobby group Botanical Education Alliance (BEA).

"The FDA health warnings...(have) proven to be misguided by multiple experts," he added.

For now, Indonesian producers are waiting to see how the regulatory battle in the US unfolds.

And while bad weather and a salmonella scare dented exports in 2017, provisional data showed Kratom shipments bounced back strongly last year.

Kratom farmer Prabu insisted: "The Kratom market has been very good over the past decade and it still has potential in the years ahead."

He added: "People will see its usefulness, sooner or later."

Related Article:

Thai farmers giddy over new medical marijuana law

Big pharma firms criticise Dutch campaign to slash drug prices

DutchNews, February 5, 2019

Photo: Depositphotos.com

Foreign pharmaceuticals companies in the Netherlands say they are ‘concerned’ that the government is undermining the business climate by trying to force down the price of drugs.

The companies, including MSD, Gilead and Johnson & Johnson unit Janssen, are all members of Amcham, the American chamber of commerce in the Netherlands, which has written to health minister Bruno Bruins calling for a rethink. 

The organisation says Bruins is not sufficiently aware of the investment needed to develop new drugs and that the return on investment in the sector has now shrunk to 1.9%. This, Amcham says, ‘is too low to ensure the sector remains attractive for investors’. 

Bruins has made strongly worded statements about the industry following two high profile cases involving soaring drug prices. 

In January, Bruins reacted angrily to a decision by Swiss pharmaceuticals giant Novartis to put up the price of a drug to treat a rare form of cancer five fold, describing it as ‘outrageous‘. 

And in November, Amsterdam’s AMC teaching hospital was given the green light to make its own version of a licenced drug to treat a rare metabolic disorder. The hospital began making its own version of the drug after manufacturer Leadiant ramped up the price by around 500% to €200,000 per patient per year. 

Insurers 

The Dutch healthcare institute Zorginstituut Nederland has also said insurers should stop paying for expensive drugs if pharmaceutical companies continue to refuse to say how they arrive at the price. 

‘Asking companies to provide transparency about price setting on a product level doesn’t take into account that the primary goal of pharmaceutical companies is not to recoup R&D costs, but to invest today in the medicines of tomorrow,’ the Amcham statement says. 

In addition, the government strategy ‘would also send the wrong signal to other so-called “priority sectors” of the Dutch economy, which together produce more than a quarter of the Dutch GDP’ Amcham said. 

The Netherlands hopes to attract more pharmaceuticals firms to locate here following the successful bid to host the European Medicines Agency EMA, which has to leave London due to Brexit.

Related Article:

Amsterdam hospital gets €5m from lottery to make its own medicines - New

EU states destroy suspect Polish beef as scare spreads

Yahoo – AFP, Michel VIATTEAU, February 1, 2019

Poland's chief veterinarian Pawel Niemczuk confirmed that 2.7 tonnes of the
suspect beef was exported (AFP Photo/CHARLY TRIBALLEAU)

Warsaw (AFP) - Several EU countries on Friday seized and destroyed suspect beef from a Polish slaughterhouse where allegedly sick cows were butchered, despite assurances from Warsaw that the meat did not pose a health risk.

Poland's chief veterinarian Pawel Niemczuk confirmed that 2.7 tonnes of the suspect beef was exported, while the European Commission said the meat was traced to 13 member states where it was being withdrawn and destroyed.

The scare recalls a 2013 scandal in which horsemeat was passed off as beef and used in ready-to-eat meals sold across Europe.

Brussels will send a team of auditors to Poland to assess the situation on the spot, said Anca Paduraru, a spokeswoman for the European Commission.

French authorities said 795 kilogrammes (1,750 pounds) of beef from the slaughterhouse -- which has now been closed -- had been imported.

More than 500 kilogrammes have already been seized and destroyed, said France's Directorate General of Food.

French Agriculture Minister Didier Guillaume said nine French companies had been "duped" into importing beef from the abattoir in Kalinowo, a village some 100 kilometres (60 miles) northeast of Warsaw.

Lame or diseased?

Portuguese authorities said they had destroyed 99 kilogrammes of suspect Polish beef, while Romania said it had eliminated 1,432 kilogrammes as a "safety measure".

The cows were slaughtered late at night when veterinary authorities were 

unlikely to visit (AFP Photo/ADRIEN MORLENT)

Sweden's National Food Agency said that just under 100 kilogrammes of the total 239 kilogrammes of suspect Polish beef delivered to the country had already been consumed, while the rest has been seized.

The beef was also exported to the Czech Republic, Estonia, Finland, Germany, Hungary, Latvia, Lithuania, Slovakia and Spain, according to the European Commission.

Niemczuk said another seven tonnes were sold to about 20 outlets in Poland but insisted that tests found it did not pose a health risk.

Despite the assurances, Polish beef producers are reeling from the scandal with prices falling by around seven percent since an undercover TV report on the slaughter was aired on Saturday.

"All segments of the Polish (beef) market are worried," Jerzy Wierzbicki, head of the Polish PZPBM meat producers' association, told AFP on Friday.

Wierzbicki insisted that the cows shown in the report by the TVN24 commercial news channel were lame but not diseased.

"They were lame cows... such cattle should not be taken to a slaughterhouse but should rather be put down on the farm by a person who is qualified to do so," Wierzbicki said.

A criminal probe was launched after a TV report aired footage of apparently sick 

or lame cows being dragged across the floor and then butchered in Poland (AFP Photo/

Janek SKARZYNSKI)

'Isolated case'

"This is an isolated case, concerning a single company, the concerns are unfounded," he said, conceding that the scandal could deal a blow to Polish beef producers who rely on exports.

A leading pork supplier in the European Union, Poland also produced some 415,000 tonnes of beef last year and nearly 90 percent of it was exported, Wierzbicki said.

Poland's Agriculture Minister Jan Krzysztof Ardanowski said on Friday that "pathologies" in the agri-food industry would be "cauterised with a hot iron".

"A police investigation is underway regarding the owners of the slaughterhouse and anyone involved in this process," he said, adding that there was "zero tolerance" for anything that could harm Polish exports.

The criminal probe was launched after TVN24 aired footage of apparently sick or lame cows being dragged across the floor and then butchered.

The TVN24 report said dealers bought lame or sick cattle at much lower prices. A journalist working undercover at the abattoir used a hidden camera to film the secret late night slaughter when veterinary authorities were unlikely to visit.

The European Commission has not commented on the quality of the meat in question, but issued a statement that raised concerns about the treatment of the sick animals, which it insisted could not be considered fit for human consumption.

"The practice of dragging animals unable to walk, as described (in the Polish report) is prohibited by European Union legislation on the protection of animals in slaughterhouses," it said.

#UPDATE The Polish beef was identified in lots prepared by wholesalers, butchers or restaurants mixed with meat of other origin, a French agriculture ministry official told AFPhttps://t.co/bn8ufJAXhb

— AFP news agency (@AFP) February 2, 2019

Burnout, work-related stress is on the rise, costing society over €9bn

DutchNews, January 31, 2019

Burnout is an increasing problem among the working population and work-related illness is costing society some €9bn a year, according to a new report by the TNO research institute. 

Employers have an increasing number of tasks but less say and this is translating into a rise in burnout complaints,’ the organisation said on Thursday.

But despite having worse working conditions, call-out and temporary staff have considerably less burnout problems than workers on permanent contracts or who are employed via staffing agencies.’ 

Approximately one in four sick days is due to psychiatric problems, stress and burnout the institute said. The figures relate to 2017, when the absentee rate was around 4%, in line with the 10 year average. 

In total, just over 16% of the 8.5 million people in work – both as employees and self-employed – experienced burnout related complaints in 2017, compared with 11% in 2017.