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fter a two-year investigation, the European Ombudsman has concluded that the European Medicines Agency should not have allowed AbbVie to redact certain information about its Humira drug in order to settle a legal battle over disclosure of clinical trial data.

Ombudsman Emily O’Reilly also suggested that EMA officials should take a tougher stand against companies that claim certain trial data is commercially confidential in order to push for redactions. And she issued a stern reminder that the agency should weigh public interests against commercial interests when considering whether data should be accessible to other researchers seeking to duplicate findings.

“The justification for a redaction must be based on a convincing argument that the disclosure of the information would cause specific harm,” she wrote in a 17-page report about the AbbVie redactions. She added that “the entirety of a clinical study report should ultimately be disclosed, with the sole absolute exception being any personal data of patients that might be contained in a report.”

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At the same time, O’Reilly did praise the EMA for eventually releasing more information than was initially redacted after its dispute with AbbVie was resolved two years ago.

Her findings cap an uncomfortable round of scrutiny of the EMA. The agency was pushing companies to release more clinical trial data, but, in 2013 it found itself in court when AbbVie objected to the release of information about its best-selling rheumatoid arthritis treatment. After the EMA backed down and allowed AbbVie to redact certain information as part of the settlement, O’Reilly quickly raised objections and began her inquiry.

The episode suggested larger implications because it arose as the pharmaceutical industry faced growing pressure to disclose more trial data following scandals over safety or effectiveness data that were not publicly shared. Drug makers have argued that disclosing certain data may compromise trade secrets or patient privacy. Consumer groups, meanwhile, have countered that such information is kept out of reach at the expense of patients.

In this instance, O’Reilly was concerned about the extent to which the EMA may have established a precedent with the AbbVie settlement. She openly wondered whether the EMA would too easily accommodate industry concerns about releasing confidential information and impede researcher access to details in clinical study reports, which contain trial methods and results.

Her probe also began as the EMA sought to finalize its policy for clinical trial redactions. The agency released guidelines in March that drew a mixed reaction. While the policy garnered praise, some patient advocates and researchers also expressed concerns about the ways that commercially confidential information will be defined and, perhaps, used to create a stalemate with the European regulator over disclosure.

Nonetheless, the EMA breathed a bureaucratic sigh of relief upon seeing the report from O’Reilly. An EMA spokeswoman wrote us that the agency is “pleased” that the Ombudsman did not find any “maladministration” in its handling of the Humira redactions and maintained her findings support the agency approach to redacting commercially confidential information, or CCI.

The EMA also argued that there is no agreed or binding definition of commercially confidential information in European Union legislation, and that its own guidance “makes clear that the vast majority of the information contained in clinical reports is not considered CCI. The guidance clarifies which type of data the EMA would typically refuse as being CCI and how the redaction of such data will be handled.”

The agency also maintained that information contained in a clinical study report changes over time, which means that some data that is initially considered confidential may no longer be classified that way later on, because “a company’s development plans that were once considered confidential are meanwhile publicly available.”

In her report, O’Reilly seized on an EMA decision to allow AbbVie to redact lot numbers for Humira; tables containing data on clinical responses to Humira in different subgroups; tables containing data related to clinical reactions at different points in time; and a detailed description of the procedure used by AbbVie for collecting, storing, and shipping blood samples.

O’Reilly wrote that she still harbors concerns and is not convinced by the EMAʹs explanation as to why the majority of the Humira information could not be released. She noted that the EMA decided to disclose some of the data anyway and did not adequately explain why some information remains commercially sensitive.

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As an example, O’Reilly argued that lot numbers may, in fact, have clinical value. If a specific clinical effect occurs in relation to a given batch of drugs, but not to other batches, she maintained it may be due to that specific batch. “It is thus important for clinicians and other researchers to know if the lot numbers of one test correspond to the lot numbers in other tests,” she wrote.

She also maintained that the clinical data contained in the tables is of the “utmost relevance. Even if the redacted data is commercially sensitive, it is regrettable that EMA did not assess whether there is an overriding public interest for the tables to be disclosed in their entirety.”

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  • Thoughts:
    An average patient will just be confused by too much information, or even become anxious, particularly if the patient has a serious condition that must be treated.
    The majority of patients probably do not have enough knowledge to glean much from anything other than very brief summaries of CT data.
    Patients should rely on the expert evaluation provided in the product summary and their physicians’ judgement of the suitability of the drug treatment for them.
    The PIL for most medicinal products contains enough caveats to make anyone think twice about taking even the most simple remedy, if one reads it carefully enough.
    Too few patients read the PIL completely anyway!

    Nevertheless, kudos to EMA for insisting that pharma provide CT data (they would never do it otherwise), and there is a good case for requiring full disclosure to bona fide researchers, particularly for company’s like AbbVie.
    Once the marketing exclusivity period and patents have expired, full disclosure of CT data should be the norm, in the public interest.

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