Pharmaceuticals conceal drug side effects with the EU’s Court blessing

GSKWhen was the last time you heard about a famous drug that had to be withdrawn from the market after it had cost hundreds or thousands of lives to the patients who had been prescribed with? Did you think it was due to an accident or human error during production? How would you feel if you found out that often pharmaceuticals deliberately conceal information from the test trials of the drug, in order to undermine the potentially dangerous side effects and increase their chances for prompt approval by the market regulator? If this sounds shocking already, wait until you read later in this story that the EU’s General Court supports pharmaceuticals’ “secretive” stance that threatens openly the health of every European.

The EU Court to protect Pharmaceuticals

It was the last day of April that the EU’s General Court ordered the head of Europe’s medicine regulator (European Medicines Agency or EMA) to halt their well established policy to share trial test data of drugs. The order came after two American pharmaceutical companies, Abbvie and Intermune, had filed injunctions against the EMA so that the European regulator does not publish any information concerning the test trials for rheumatoid arthritis drug Humira and the idiopathic pulmonary fibrosis drug Esbriet accordingly. The two companies claim that the sharing of this information with competitors reveals research formulas and secrets and thus their innovation and market share are at stake. Particularly, the two competitors that applied to the EMA for the disclosure of clinical and non clinical data of the two drugs are UCB of Belgium for Abbvie’s Humira and Boehringer Ingelheim for Intermune’s Esbriet. However, in their press release the European, London based, regulator is considering to appeal the court’s interim decision. Let’s see now why the EMA should appeal this unprecedented decision as soon as possible.

Trial data transparency for healthier Europeans

Following the Freedom of Information Act (FOI) in 2000 that gives open access to data held by public authorities like the General Pharmaceutical Council, the EMA has integrated in its policy its “access-to-documents” programme. Moreover, the EMA has initiated the open sharing of clinical trial data of drugs since 2010 and has already received over 600 requests to release data while it has effectively published more than 1.9 million pages with trial reports on drugs. This means that the two American companies were not the only companies concerned in this sharing process but just two raws in a very long list with numerous big or small pharmaceuticals. Nevertheless, Abbvie and Intermune are the only companies in three years to challenge legally the EMA’s policy.

The EMA’s open access policy is widely considered as a huge step forward in the European health system to control better new drugs by having a close look to their side-effects. At the same time this policy has contributed significantly to medical research, doctors and academia that need to have the right to investigate the results of drug trial tests at any time, in order to combat side-effects and develop better innovative drugs in the future. Some of you might still remember the huge pharma scandal of the drug for Diabetes, Avandia, a couple of years ago that was linked to thousands of deaths due to heart attacks. The producer of Avandia then, GlaxoSmithKline, was fined with $3bn in what is considered to be the largest healthcare fraud settlement in the US history. The British multinational pharmaceutical was at the time found to hold back “risky” data about the drug and made safety claims that were not scientifically backed sufficiently. In addition, one should not omit either another big scandal that broke out around 10 years ago when Merck & Co’s arthritis drug Vioxx was proved to have caused 27.785 heart attacks and sudden deaths from 1999 till 2003. Inescapably scandals like those have raised significant doubts on the quality of controls that the pharmaceuticals perform.

Market share above the European patient

Instead of supporting the great work of the EMA in sharing openly trial reports and permitting to the scientific community to actively control the suitability of new drugs, those two Americal companies claiming unfair competition arguments came to raise obstacles in the most democratic until now process of making European drugs better. Unfortunately, they are not alone in this.

Right after the decision of the EU’s General Court was published, the lobbyist group Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement that condemns the “open access” policies of the EMA. I quote here Mr Bennet’s words, Senior Vice President of PhRMA, on the issue: “Biopharmaceutical companies support responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research,” … “Unfortunately, the EMA’s current and proposed policies fail to respect these principles.” At the same time, the European Federation of Pharmaceutical Industries and Associations (EFPIA), joined this rally against transparency in European health by expressing their concerns over the “dreadful” consequences that an indiscriminate release of trial report data would bring to drug developers. It is clear that the industry side seeks to protect its interests here.

The martyrs of the European health

As it was expected, this unjustified interim decision of the EU’s General Court to put a brake on the democratic sharing of clinical trial data of those two American drugs has caused the furious reaction of various stakeholders in Europe.  According to the EMA, after the filing of that injunction it has received more than 30 statements of support from stakeholders like the European Ombudsman, national competent authorities, members of the EMA management board, Members of the European Parliament, academic institutions, NGOs, citizens’ initiatives and scientific journals. Many of them have also applied to participate as defense in the court in favour of the EMA at this case.

Moreover, the EMA’s executive director, Guido Rasi, said last week that the EMA welcomes the opportunity for legal clarification of the concept of commercially-confidential information but also expresses his regret for the decisions of the President of the General Court. He also argues that if the Court orders the EMA to completely stop the release of clinical trial data, “that would be the worst possible boomerang for the industry. The most powerful weapon we have to tackle distrust is transparency”.

Another warm supporter of the free sharing of this kind of information on drug trials is Dr Ben Goldacre, the author of the book Bad Pharma and founder of the AllTrials campaign that calls for complete transparency in the pharmaceutical sector. Referring to the EU’s Court decision, he described it as “a disgrace” underlining that “forcing them (the EMA) to hide this information is nothing short of absurd”. Also, Tracey Brown, head of Sense About Science, who is one of the founders of the AllTrials campaign initiative as well, commented that “The European courts are indicating that they are on the wrong side of history.”

What is also here interesting to report is the opinion on the issue of Dr Richard Lehman, a British GP that has signed the AllTrials campaign petition: “It is a scandal that doctors like myself often prescribe treatments without knowing their true benefits and harms, because research evidence from human trials has been withheld. That means that over my 35 years as a GP, I have unintentionally spent large sums of NHS money on treatments that did not work, and some patients have suffered avoidable harm. We need immediate access to all the data relating to all the drugs and devices which we use on millions of people every day.”

The bigger picture

The filing of the injunction by the two American pharmaceuticals came after last year’s EMA’s pledge for proactive publication of trial data once the drug will have completed the marketing-authorization process. This process was expected to begin at the beginning of 2014. It is understandable that this causes a great deal of stress to the industry that is arguing about the potential risk of infringement that an “uncontrolled” sharing of data would cause and also about the “violation” of patients’ data privacy. However, given the pressure, there are pharmaceuticals giants today like GSK and Roche that have already accepted to release data from all clinical trials of their medicines.

It seems, though, that all those industry worries are rather unjustified since the EMA gave an immediate answer to all the critics of its policies at the same day the EU’s Court decision was issued (Last Tuesday). The EMA issued final advice from advisory groups aiming to develop its data sharing policy in a sustainable way that “ensures transparency in the best interest of public health without impinging on the company’s intellectual property rights”.

Apparently, the EMA’s goal is to make the European drugs and health better by sharing crucial clinical trial data with stakeholders, while at the same time it invites the industry to an open dialogue on the issue. It is clear that it is not in the EMA’s interest to take action on the matter without finding the golden section with pharmaceuticals. This can be documented with Mr Rasi’s statement, the executive director of the organization, that the EMA will set “rules of engagement” to prevent any possible infringement of copy rights by stakeholders that will be granted with access to those data. In this way, the pharmaceuticals will be protected as well.

The crucial question then is: Since the intention of the EMA is to find a viable solution that will protect the European health, but will also respect the pharmaceuticals’ worries, why did the two American companies had to set fire to the betterment of European drugs with that filed injunction, instead of grabbing a seat at the table of discussion? And most of all how is it possible for the EU’s General Court to back this kind of actions that jeopardize the fundamental right of every European to health?

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Comments

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