The History of the Pharmaceutical Industry - Part Three: The Tamiflu Transparency Scandal
In 2009, the pharma industry stood -once again- at the edge of yet another scandal referred to as Tamiflu. It was not as deadly as the Thalidomide scandal, but Tamiflu was still serious enough to require changes in the way the pharma industry operates.
After the Thalidomide scandal, pharma companies are much more thorough in their research before releasing a new drug onto the market. Millions of dollars are spent annually on pre-clinical and clinical trials. These pre-clinical trials identify which substances can be used against diseases and aid in the development of candidate drugs. Then, researchers further analyze these drugs in clinical trials to determine whether they truly work and if they are safe for patients. At the same time, during the clinical trial phases, the finance department reviews whether or not the drugs can financially benefit the company. It is the latter part of the clinical trials, which involves commercial benefits for the companies, that has kick-started a new era for the pharma industry.
In the 1990s, Roche, a giant in the pharma industry, following the proper research guidelines, started researching a drug called oseltamivir, also known as Tamiflu. The pharma company claimed its product to be capable of reducing flu complications and a series of other problems including pneumonia, confusion, and convulsion which are considered neurologic issues, thus decreasing the number of hospitalizations. After years of research, Roche submitted Tamiflu to the U.S. Food and Drug Administration (FDA) for approval, which was granted in 1999. Then, the European Medicines Agency (EMA) followed suit in approving Tamiflu. Just two years later, in the U.S., Europe, and Japan, the drug was deemed safe for children’s use as well.
While several news sources claimed that the Tamiflu fiasco started in 2009, in truth, its beginning was probably much earlier. In 2007, Japanese authorities restricted Tamiflu’s usage on children. Reports on abnormal behaviors and even deaths had prompted the Japanese government to conduct their own studies on Tamiflu, which revealed a risk of abnormal behaviors by over 50% on the first day of taking the drug. The abnormal behaviors may include meaningless speeches and movements, hallucinations, and misidentifying awareness. The results reached Roche in the same year, but the company made no moves in reporting the neuropsychiatric side effects of the drug. As a result, the same reported side effects like hallucinations and self-injury appeared around the globe.
The heart of the event started in 2008. An outbreak of the H1N1 pandemic in 2009 and 2010 prompted many nations to stockpile Tamiflu, which was advertised by Roche to be highly effective against H1N1. Countries like the UK, Australia, and the U.S. were quick to invest billions in Tamiflu to prepare their population for imminent disaster. The giant investment, however, also prompted several governments, such as the UK and Australia, to ask for a renewed Tamiflu assessment from the Cochrane Collaboration.
Cochrane Collaboration is a well-respected independent organization in medicine. They are an international network of clinicians, patients, caregivers, researchers, and policymakers, who all aim to improve health outcomes for the general public. Periodically, the organization gathers data, evidence, and research in order to renew assessments on medicines, so that their information on these drugs is always up-to-date. All of this information is readily accessible online. Due to their transparency, Cochrane Collaboration was entrusted by several governments to provide a thorough evaluation of Tamiflu.
Dr. Jefferson was the head of Cochrane Collaboration when they headed the Tamiflu evaluation. He immediately noticed the inconsistencies in Roche’s reports of Tamiflu, prompting him to request more data from Roche and the author of those reports. His request for these reports failed. All papers related to Tamiflu trials were then locked away by Roche and not even the original author could access them. When Cochrane contacted Roche, they were met with an NDA. The NDA, or non-disclosure agreement, required Cochrane Collaboration to avoid disclosing any vital information about Tamiflu’s trial results to the public, which was against Cochrane’s policy.
The case dragged on into 2009 when Roche changed tactics and dumped seven dozen-page documents of irrelevant information on Cochrane’s doorstep. Their reports of the phase three trial were completely absent. Their “collaboration” was, in other words, very performative. By this time, not only Cochrane, but other medical organizations also joined in on the investigation.
The inconsistent reports from Tamiflu usage around the world did not paint Roche in a positive light. The Food and Drug Administration (FDA) and the Japanese regulator did not report any benefits of Tamiflu against pneumonia, whereas the U.S. Centres for Disease Control and Prevention and the European Medicines Agency (EMA) did. The desire for fully transparent clinical reports rose as a result. At the same time, unreported side effects of Tamiflu appeared around the world including vomiting, headache, and psychiatric effects - such as delirium, panic attack, delusion, convulsion, and suicide. By all means, none of those side effects was considered too deadly, however, the most important thing – and the heart of the scandal - was that none of the side effects made an appearance in any of Roche’s trial reports.
Requesting information from all sides became some sort of tug of war between the company, the governments, and independent organizations, which lasted from 2008 to 2013. When Roche finally relented, the company revealed that they had blown Tamiflu’s benefits out of proportion while covering up its harmful side effects. Worse, their trials were not even done accordingly, with most patients self-reporting on their well-being. Roche’s decisions regarding Tamiflu raised questions on the reliability of the drug reports.
As a result, it turned out that governments around the world had invested billions of dollars in a hoax. Surprisingly, Roche did not break a single law while withholding vital information about a drug that affected billions of people on the planet. When Dr. Jefferson, from Cochrane Collaboration, filed a lawsuit under the U.S. False Claims Act against Roche and Tamiflu in 2014, federal prosecutors declined to join his case.
Tamiflu remained a stalemate for several years until Roche – after securing billions in profits – quietly switched its focus to a new flu drug called Xofluza. Meanwhile, governments and organizations were still struggling to construct a transparent system of drug research and approval for the pharma industry. Untransparent cases such as Tamiflu are unfortunately the norm for the pharma industry and at the time of the scandal, there was no law requesting pharma companies to be fully transparent in their drug reports. Regulatory policies needed to improve immediately to filter out and prevent such scandals from repeating themselves. For instance, the EMA has committed itself, in 2014, to publish all clinical data submitted by pharma companies.
However, like all systematic failures, we still have a long way to improve. It is difficult when giant pharma companies have the means to lobby their ways out of trouble, but for the safety of everyone, changes need to be made. The world was lucky that the hidden side-effects of Tamiflu were not extremely long-lasting and deadly like those of Thalidomide. However, who is to say we will be lucky again in the future?
Tamiflu is a product from the Roche company, which is advertised to be highly effective against the flu.
In 2008, Cochrane Collaboration detected inconsistencies in Roche’s reports on Tamiflu’s benefits.
In 2014, Roche relented and released all information about Tamiflu, which included several side effects and superficial clinical trials. However, Roche’s omission of vital information was not illegal.
The scandal revealed the urgent need for transparency and better regulatory policies in the pharma industry.