EPM published a version of this article a year ago, but with one new study surfacing, and the ubiquity of Tamiflu, it bears repeating.
Share via Email Tamiflu capsules. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaborationa global not-for-profit organisation of 14, 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. 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.
Inthere was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world.
Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: This should have been a pretty everyday piece of work: But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work.
From these 10 trials, only two had ever been published in the scientific literature. For the remaining eight, the only available information on the methods used came from the brief summary in this secondary source, created by industry.
This is science at its best. The Cochrane review is readily accessible online; it explains transparently the methods by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand where the conclusions came from.
Cochrane provides an easy way for readers to raise criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the review.
He 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. First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they were told that this team no longer had the files: Here the problems began.
Roche said it would hand over some information, but the Cochrane reviewers would need to sign a confidentiality agreement.
More than this, the contract said they were not allowed to discuss the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the methods and results of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of people around the world, and on which governments had spent billions.
At this point, many in medicine would either acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was necessary.
He never received a reply. Then, in Octoberthe company changed tack. It would like to hand over the data, it explained, but another academic review on Tamiflu was being conducted elsewhere.Production process complex & capital-intensive Launch of Tamiflu Global Response to Pandemic Threat of Pandemic Influenza Roche’s Response “When Supply is of Public Interest: Roche & Tamiflu” Case .
In the post-exposure prophylaxis trial in household contacts (aged 13 years or older) of an index influenza case, Tamiflu 75 mg once daily or placebo taken orally was administered within 48 hours of onset of symptoms in the index case and continued for 7 days (index cases did not receive Tamiflu treatment).
Tamiflu® (oseltamivir phosphate) is an antiviral medicine for treatment of flu in people 2 weeks of age and older and for prevention of flu in people 1 year of age and older. Indications: Tamiflu is a prescription medicine used to treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than 2 days.
Contact a Tamiflu lawyer to help determine whether your family may be eligible to pursue a case. Tags: Childrens Drugs, Flu, Suicide, Tamiflu Share Your Comments.
If flu-like symptoms have you reaching reflexively for oseltamivir, consider three things: the cost, its very limited efficacy and the problem of creating resistant strains of flu.
EPM published a version of this article a year ago, but with one new study surfacing, and the ubiquity of Tamiflu, it bears repeating. If flu-like symptoms haveRead More. Aug 31, · Psychiatric Symptoms in a Patient with Influenza A (H1N1) Treated with Oseltamivir (Tamiflu): A Case Report Sang Won Jeon and Changsu Han Department of Psychiatry, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea.