Big Pharma battling to continue to hide drugs trials data

Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies’ claims about the safety and efficacy of drugs.

Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that show drugs do not work or cause dangerous side-effects.

While some companies have agreed to share data more freely, the industry has broadly resisted the moves. The latest strategy shows how patient groups – many of which receive some or all of their funding from drugs companies – have been brought into the battle.

The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.

The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee.

The email describes a four-pronged campaign that starts with “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data”. Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare…

A recent review of medical research estimated that only half of all clinical trials were published in full, and that positive results were twice as likely to be published than negative ones.

Which shouldn’t surprise anyone. Like insurance companies, big banks, investment brokerages, any number of robber barons, pharmaceutical manufacturers fear transparency like a literal plague. Who knows? Honesty in marketing might be forced upon them next.

Nate Silver of FiveThirtyEight Blog will be joining ESPN

Nate Silver, the statistician who attained national fame for his accurate projections about the 2008 and 2012 presidential elections, is parting ways with The New York Times and moving his FiveThirtyEight franchise to ESPN, the sports empire controlled by the Walt Disney Company…

At ESPN, Mr. Silver is expected to have a wide-ranging portfolio. Along with his writing and number-crunching, he will most likely be a regular contributor to “Olbermann,” the late-night ESPN2 talk show hosted by Keith Olbermann that will have its debut at the end of August. In political years, he will also have a role at ABC News, which is owned by Disney…

Before creating statistical models for elections, Mr. Silver was a baseball sabermetrician who built a highly effective system for projecting how players would perform in the future. For a time he was a managing partner of Baseball Prospectus.

At public events recently, he has expressed interest in covering sports more frequently, so the ESPN deal is a logical next step.

Mr. Silver’s three-year contract with The Times is set to expire in late August and his departure will most likely be interpreted as a blow to the company, which has promoted Mr. Silver and his brand of poll-based projections…

Speculation about the future of Mr. Silver and FiveThirtyEight heated up shortly after last November’s election, and he was wooed by no small number of other news organizations. Jill Abramson, the newspaper’s executive editor, and Mark Thompson, the chief executive of The New York Times Company, said earlier this year that they would try hard to sign Mr. Silver to a new contract…

He occasionally hinted in interviews and public appearances that his relationship with The Times had moments of tension. But it was mutually beneficial. The news organization gained Web traffic and prestige by hosting his work, and he received a salary, a wider audience and editorial support.

The same will most likely be true at ESPN.

Given that ESPN had the smarts to hire Nate Silver away from the TIMES, I also imagine the last couple of sentences will be true at ESPN. In another few weeks the new Fox Sports channel will debut and NBC’s first season of carrying sports from around the whole world will kick off with start of the English Premier League season of proper football.

Japan approves landmark stem cell trials

Japan’s government has given its approval to the world’s first clinical trials using stem cells harvested from a patient’s own body.

Health Minister Norihisa Tamura signed off on Friday on a proposal by two research institutes that will allow them to begin tests aimed at treating age-related macular degeneration (AMD), a common medical condition that causes blindness in older people, using “induced Pluripotent Stem (iPS) cells”…

The tests will be jointly conducted by the Riken Center for Developmental Biology and the Institute of Biomedical Research and Innovation (IBRI) Hospital in Japan.

Riken will harvest stem cells, using skin cells taken from patients, a spokesman said…The trial treatment will attempt to create retinal cells that can be transplanted into the eyes of six patients suffering from AMD, replacing the damaged part of the eye…

Groundbreaking work done in 2006 by Shinya Yamanaka at Kyoto University, a Nobel Laureate in medicine last year, succeeded in generating stem cells from adult skin tissue.

Like embryonic stem cells, iPS cells are also capable of developing into any cell in the body, but crucially their source material is readily available.

The question of how much freedom scientists should be allowed to carry out research on embryonic stem cells is considered one of the great ethical issues of our time.

The research is controversial because it requires the destruction of the embryo, a process that religious conservatives, among others, oppose.

This is not a difficult or controversial question among scientists or most medical professionals. Focusing on efforts to provide the greatest good for the greatest number is sufficient. The rest of the crap arguments follow their own convoluted path through the byways of brains accustomed to considering the number of angels that fit on a pinhead roughly equivalent to or greater than, say, aiding starving children or preventing the spread of dangerous disease.

Pic of the Day


Click to enlargeREUTERS/Mandel Ngan/Pool

An aerial view shows the Zaatari refugee camp, near the Jordanian city of Mafraq…U.S. Secretary of State John Kerry spent about 40 minutes with half a dozen refugees who vented their frustration at the international community’s failure to end Syria’s more than two-year-old civil war, while visiting the camp that holds roughly 115,000 Syrian refugees in Jordan about eight miles from the Syrian border.

Noises in tourist’s head were from flesh-eating maggots


She can smile about it, now

A British woman returned from a holiday in Peru hearing scratching noises inside her head to be told she was being attacked by flesh-eating maggots living inside her ear.

Rochelle Harris, 27, said she remembered dislodging a fly from her ear while in Peru but thought nothing more of it until she started getting headaches and pains down one side of her face and woke up in Britain one morning with liquid on her pillow.

Thinking she had a routine ear infection caused by a mosquito bite, she sought medical treatment at the Royal Derby Hospital in northern England, where a consultant noticed maggots in a small hole in her ear-canal.

“I was very scared. Were they in my brain?” said Harris, recounting her ordeal in a new Discovery Channel documentary…

Doctors tried first to flush the maggots out of the ear using olive oil.

“It was the longest few hours that I have ever had to wait… I could still feel them and hear them and knowing what those scratching sounds were, and knowing what that wriggling feeling was, that just made it all the worse,” she said.

When flushing the maggots out failed, the medics resorted to surgery and found a “writhing mass of maggots” within her ear, raising concern they could eat into her brain.

The surgery removed a family of eight maggots. Analysis found that a New World Army Screw Worm fly had laid eggs inside Harris’s ear.

Eeoough!