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The Guardianby Ben GoldacreApril 9, 2014
Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.
And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment… [click here to continue]
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by Fiona Godkee
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by Harlan M Krumholz
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by Tom Jefferson, Mark Jones, Peter Doshi, Elizabeth A Spencer, Igho Onakpoya, and Carl J Heneghan
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by Carl J Heneghan, Igho Onakpoya, Matthew Thompson, Helen D Cohen, Elizabeth A Spencer,Mark Jones, and Tom Jefferson
corruption is the MO for all in power and financial agenda. After all, common sense is the exception these days as a colleague so wonderfully noted to me a year ago! Oh, and how criminal it is to do immoral, illicit, if not frank harmful choices and actions in health care interventions. But, I digress…
http://pharmagossip.blogspot.com/2014/04/scamiflu.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+blogspot%2FDlJuM+%28PharmaGossip%29
And for those with French bent:
http://pharmacritique.20minutes-blogs.fr/archive/2014/04/02/gardasil-un-scandale-international-conference-de-presse-ave-895557.html
Steve Lucas
It is a great story, as Ben Goldacre said, because it’s “a chase”, and a story well told.
As far as corruption goes, the American Tamiflu story is part of a larger story of scaremongering and conflicts of interest. Donald Rumsfeld had tens of millions of dollars invested in the maker of Tamiflu, and was once the Chairman of Roche. At the time, many public health experts were warning that the fears about the Avian flu were misguided and that people should be more concerned about the regular flu that kills tens of thousands of people every year. It’s just a sad fact of life that people, generally speaking, are more afraid of the exotic and cinematic threat than the more pedestrian threats that kill large numbers of people regularly, often when many of those deaths were preventable. This is compounded by sensationalism in journalism, but government officials tasked with public safety should be better educated and have more integrity.
http://realhistoryarchives.blogspot.com/2005/11/rumsfeld-profits-from-avian-flu-cdc.html
Rumsfeld also declared Cipro to be the first line of defense for Anthrax, even though the FDA had not approved it for anthrax at the time. The administration, with its color coded alerts created an atmosphere of hysterical fear and offered non-solutions that gave too many people a feeling of false security. Who knows how many millions of private citizens thought it was stupid not to stockpile Cipro (when a generic or penicillin would have done just as well and private citizens should not have been stockpiling antibiotics in the first place), atropine, gas masks, and the ever so useless prophylactic of plastic sheeting and duct tape for manufactured and overblown threats of unconventional terrorist attacks with mass casualties— Today the twin towers, tomorrow the Greyhound station in downtown Boise!
At one point President Bush was promising a new and untested small pox vaccine for “every man, woman, and child”, that was supposed to be effective against an unknown weaponized small pox . I’d like to buy the people who slammed the brakes on that one a few rounds of beers and listen to them tell their stories. Also, the only difference between manufacturing a virus as a weapon and manufacturing it for a vaccine is intent and the vehicle used to disseminate it. It was all around specious and emotionally overwrought.
Tamiflu is the poster child for more than just missing trial data. Government agencies world-wide need to learn from this and learn it well. Just think of all the effective measures those billions or dollars could have bought or could have been spent on something else entirely. It’s a travesty.
Many people cleaned up on that fear. CEOs and shareholders made out like bandits on Tamiflu, but everyone else was robbed. It does not bode well for a populations’ ability to survive man-made or natural catastrophe when manufacturers of medical goods put their private interests above the health and safety of everyone else while peddling high-dollar snake oil with public funds for private profit. It’s profiteering— very, very lucrative profiteering.
Fortunately, the medical scientists who are tasked with managing public health threats like influenza epidemics and chemical/biological threats, are people adept at thinking in the nitty gritty, calm, painstaking, orderly, and statistically disciplined detail that dealing effectively with such threats requires; while cautioning against reckless and useless responses. Feelings of panic and false security can have tragic consequences and should be dissuaded by public officials. Just reading instructions for decontaminating processes is an exercise in remarkable patience and attention to detail— every single time one must do it. This deliberateness, care, and thoroughness is illustrated in Goldacre’s storytelling in this Guardian article. It’s a very mature and evenhanded way of thinking and speaking about science and reality.
Personally, I have great respect for epidemiology, it’s one of those public services that is taken for granted in an age that gives the public good short shrift. Ben Goldacre’s charm, popular appeal, and ability to explain to laymen problems as complex as the problems of Tamiflu and trial data in a fair manner informs and gives the average person a taste of the thinking that goes into sound scientific analysis and decision making. This— “a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn’t in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment.”— is a thing of great beauty. And this— “Dr Tom Jefferson … realised immediately that he had made a mistake in blindly trusting the Kaiser data. He said so, without defensiveness, and then set about getting the information needed.” is an act of love.
All-trials and the momentum behind this movement is nothing less than wonderful and genuinely exciting. It reflects very well on the global community of medicine, especially epidemiology, which is an unsung hero of human health and longevity. Go, Ben! and many thanks to every doctor and scientist who has contributed to and supported this change for the better to right many wrongs that have cost many lives and wasted so much time, effort, and money. Thanks to present company included (of course). Critical mass has been reached, change for the better is on.