April 8, 2013 | By Márcio Barra
The demand for more transparency in clinical trials activities and results is a hot topic at the moment for all stakeholders, but one that is rooted for quite some time in the Parma’s industry behaviour to protect their IP. Pharmaceutical companies argue that to protect their commercial data and the patients’ private data, some amount of information has to remain classified to the general public and competitors.
But patients might not think that way, and they have expressed concerns several times on this subject. In the annual 2012 PatientView survey, “The Corporate Reputation of Pharma – The Patient Perspective”, forty percent of the patients surveyed said pharma’s reputation had suffered in 2012, attaining a “poor” record for drug pricing and a “poor” rating for transparency (1). Society is right to be concerned, as potentially essential information is being kept from the public in the current times, where information is expected to be free in the Internet. This fact is aggravated when taking into account that a clinical trial with positive results is twice more likely to be published than one with negative results(2). This selective publishing practice goes against the 8th revision of the Declaration of Helsinki, which states that “every clinical trial must be registered in a publicly accessible database before recruitment of the first subject”(3) (1).
While pressure for the pharmaceutical industry to release more information has existed before, it gained new strength with the release of the book “Bad Pharma” in the UK back in September last year and last February in the US, with its author, Ben Goldacre, becoming one of the most notable spokesperson for more transparency in pharma (4) (5).
The arguments Ben Goldacre brings are significant, and his all trials campaign(6) for more transparency in pharma affairs is catching momentum, with companies and institutions starting to take notice. While every clinical trial has to be registered, in the case of the US in the www.clinicaltrials.gov website registry, not every trial complies with the requirement of publishing the results of the trial within a year, as mandated by US law (7).
But registries like Clinical Trial Gov for the US, EudraCT for Europe and others are a step in the right direction, especially with strong regulatory pressure and the watchful eye of authorities. More and more, institutions and regulatory authorities are creating registries for clinical trials, and companies have to oblige to publishing results, good or bad, in face of stricter regulatory scrutiny.
The International Clinical Trials Registry Platform for example, was created by the World Health Organization, and is aiming to improve transparency and the public trust on clinical research. They hope that their platform encourages the registration and full disclosure of clinical trial information. In short, the creation of these kinds of databases is very important, as it displays to society all the information attained on a medicinal product, ensuring that health care decisions are made with all the available information in mind, patients are protected from ill-advised prescriptions and even increase the likelihood of potential medical breakthroughs (9) (10).
In this discussion, the British Medical Journal has been a very active player in the push for more transparency. Besides the aforementioned articles, in October last year they launched a campaign for greater transparency in clinical trial data, with its sights set to Roche’s flu medicine, Tamiflu (11).
The case of Roche’s Tamiflu started a few years ago and has been the main instigator of this debate. Back in 2009, Cochrane Collaboration was preparing a systematic review on the efficacy of Tamiflu in treating flu, and it had to stop when some important information of its clinical trials were not published. Cochrane requested Roche the information, but Roche denied, as the Cochrane reviewers refused to sign a confidentiality agreement on the information (11) (12). Roche’s refusal, while comprehensible if understood as a move to protect their IP, was very harmful for their public relationships.
Since then further data has been released to the Cochrane reviewers, and Roche, after years of pressure from the public and authorities, has decided in April this year to release the full information of Tamiflu (11) (13).
But even regulatory authorities, when creating registries and applying more pressure to companies, can have a few missteps in paving the way for more transparency. The proposed new clinical trial regulation by EMA, aiming to replace the old and much criticized European clinical trial directive 2001/20/EC, has been coming under fire for deficiencies that allow clinical trial sponsors to effectively withdraw information(14) from clinical trials.
EMA is planning an update on its policy regarding transparency in 2014 (15).
And lastly, the pharmaceutical companies are starting to catch on the need to be more open with their clinical trial info. GlaxoSmithKline has become the first major drug company to commit to publish clinical trial data in February. GSK will start publishing the CSRs for all their approved medicines, dating back to the formation of the company in 2000 (16).
Other companies, however, like the already mentioned Roche and AbbVie, take a different stance when they feel that their intellectual propriety is under risk by revealing information to the general public and their competitors. AbbVie, a spin-off from Abbott created at the beginning 2013, sought back in March an injunction to block EMA from releasing clinical trial information of its blockbuster drug, Humira, as UCB Pharma was reportedly seeking confidential Humira’s reports from EMA. UCB has a rival drug in the market for rheumatoid arthritis, Cimzia, approved in the EU in 2009.
AbbVie filed two lawsuits against EMA at the European Union General Court in Luxembourg, issuing a statement where it says that it was “seeking to protect AbbVie’s confidential and commercially-sensitive information.” and that it supports “transparency of clinical research and safety information for the benefit of patients and healthcare professionals [but not] the disclosure of commercially confidential information that does not meaningfully contribute to the scientific review or evaluation of our products.” (17)
It’s a delicate issue, and AbbVie’s stance on the matter is understandable. There might be sensitive information that, if revealed, would make the company lose a market edge, especially when Humira is the product that sustains the company (18).
Nonetheless, AbbVie, alongside a group of pharmaceutical companies including AstraZeneca
Pharmaceuticals, BiogenIdec, Bristol-Myers Squibb, EMD Serono, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Novartis, Novo Nordisk A/S, Roche, and Takeda Pharmaceuticals International, Inc.are helping the American Institute of Medicine in planning a consensus study with recommendations on the topic of sharing clinical trial data. This study will take into account the input of the mentioned companies and other stakeholders like academic institutions, private industry, patient advocacy groups, government and regulatory agencies. The group hopes that this study will provide the basis for a model to improve the access to clinical trial information (19).
This collaboration shows that AbbVie and the rest of the industry recognize that there is an issue in transparency, and if not addressed, it could lead to further impact on public perception. And public perception is key in the pharmaceutical industry.
The debate on transparency in clinical trial is here to stay. The advent of the internet and sharing of information brought a new concept of information freedom that has extended to clinical trials, and transparency seeped into the current R&D paradigm. Companies have to adapt to the new reality, as regulatory pressure continues to mount, the number of registries increases throughout the world, and the demands of the general public increase.
References available in the comments