Scientific studies have the purpose of being unbiased and objective. When it comes to researching a new drug’s effectiveness, researchers are expected to accept and publish their discoveries, regardless of the outcome. Regrettably, the reality of the situation is far from ideal. Negative results are frequently buried by pharmaceutical companies eager to make their products appear superior, and they are putting in overtime to maintain this status quo.
Currently, the pharmaceutical industry is exerting immense pressure on European regulators to prevent them from forcing drug companies to disclose secret documents related to drug trials. The Guardian, a British news source, has obtained a memo that explains how two pharmaceutical trade organizations, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the European Federation of Pharmaceutical Industries and Associations (EFPIA), are coordinating their efforts to form patient groups that will oppose the release of information about drug studies.
The memo was authored by Richard Bergström, director general of EFPIA, and sent to multiple pharmaceutical companies, such as Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis, and several smaller firms. The leak came from an employee of one of the drug companies. Health Action International, an advocacy group responsible for uncovering the patient groups funded and orchestrated by pharmaceutical companies, provided insight into the situation. Tim Reed from Health Action International explained that the industry’s willingness to use patient organizations to fight on their behalf showcases the hidden agenda these patient groups have as fronts for the pharmaceutical industry.
Clinical trials of pharmaceuticals are only fully published around 50% of the time. If a study generates positive results, it is twice as likely to appear in a journal than research that discloses a drug does not work as advertised.
The Negative Consequences of Unpublished Clinical Trials
Although suppressing negative results may seem advantageous to drug companies looking to make a profit, it is ultimately harmful to patients who rely on accurate information about the medications they take. Physicians may prescribe a medication they believe is effective based on the information available, but in reality, it may not be the best option for the patient. Furthermore, the cost of healthcare can rise because ineffective medications are being used.
The Push for Transparency in Clinical Trial Reporting
Various groups and organizations are fighting for more transparency in clinical trial reporting. In response, the pharmaceutical industry has been creating and funding patient organizations to advocate on their behalf, preventing the release of clinical trial information.
In addition to greater accessibility of clinical trial information, there must be a thorough screening of potential conflicts of interest between pharmaceutical companies and patient organizations. Transparency in patient organizations regarding their funding sources and links to the pharmaceutical industry is also vital.
Possible Solutions for Enhanced Transparency
The saga between the pharmaceutical industry and its attempts to conceal negative clinical trial results may seem dire, but there are potential solutions to enhance transparency and ensure patients are informed about the medications they are taking.
- Establish a mandatory registration of all clinical trials with results available in a public database.
- Enforce penalties for non-disclosure of clinical trial results, such as fines or the suspension of drug sales.
- Develop clear guidelines for the publication of clinical trials and insist on disclosing any potential conflicts of interest among researchers and patient organizations.
- Encourage peer review and the replication of clinical trials by publishing all results.
- Mandate the formation of independent data monitoring committees to assess the safety and efficacy of clinical trials during their conduct.
The Importance of an Informed Public
The pharmaceutical industry’s tendency to suppress negative clinical trial results has far-reaching consequences for patients, physicians, and the healthcare system at large. Ensuring that clinical trials are transparent, with results accessible to the public, is not only important for patients to make informed decisions about their treatment options, but it also helps physicians make evidence-based prescriptions and prevents unnecessary healthcare expenses.
Enhanced transparency in clinical trial reporting, as well as in the relationship between patient organizations and pharmaceutical companies, will enable patients and physicians to make better decisions about medications and improve overall healthcare outcomes.
