ACRO Comments on Bad PharmaFebruary 5, 2013 2:58 pm
ACRO Statement on Bad Pharma
FEBRUARY 4, 2013, WASHINGTON, DC — Association of Clinical Research Organizations (ACRO) Vice President of Public Affairs John Lewis today made the following statement regarding the release of Dr. Ben Goldacre’s new bookBad Pharma:
“In Bad Pharma Dr. Goldacre raises many issues, some of them legitimate and none of them new. Our comments are focused on his discussion of CROs, of which Dr. Goldacre demonstrates a rudimentary understanding.
“Dr. Goldacre refers to CROs as ‘fast, efficient, focused and cheap.’ While true that CROs are very effective in helping to streamline the drug development process, Dr. Goldacre ignores the industry’s commitment to patient safety and misses the value CROs add in helping to bring new medical treatments to patients more quickly. Unfortunately, Dr. Goldacre ties ‘cheap’ to globalization, ignoring the other benefits of conducting research outside the ‘traditional’ markets of the US and Western Europe.
“This view is arrogant and elitist – not to mention dead wrong. The United States and Western Europe comprise a little more than 10 percent of the world’s population yet account for two-thirds of clinical trials. In an interlinked global economy, where disease knows no boundaries, this is neither desirable nor sustainable. Why should research be limited to 10 percent of the world’s population? The primary reason to conduct research globally is access to patients. Drugs are developed for all markets and all patients, regardless of region, income, and economic status.
“Global trials often bring training, medical infrastructure and economic activity to developing countries. Should the same standards of patient protections, ethics and quality be applied everywhere? Absolutely. ACRO members, research sponsors and regulators work in tandem to ensure this.
“On the subject of data quality and integrity, on one hand, Dr. Goldacre states data may not be equal among established and emerging markets but then goes on to state that he has no proof that it’s not. In fact, a study published in the Drug Information Journal shows that the data quality is equal and there are no statistically significant differences between or among regions. ACRO is committed to continuing research in the area of quality as well as in the area of ethics.
“Further, we should not allow perceived conflicts of interest to impede necessary medical research that will benefit all mankind. A perspective that any acceptance of industry funding by a physician presents a conflict of interest is beneficial to no one and impedes research.
“Similarly, risk-sharing between CROs and sponsors does not create a conflict of interest because CROs cannot be compensated for producing positive results. CROs can, however, be compensated based on quality or efficiency measures, thus aligning the interests of the sponsor, the CRO and, ultimately, patients who may receive a new drug years sooner.
“We must work together to continue to ensure quality, integrity and patient protections in clinical trials. We all must work harder to develop more clinical investigators and to encourage more people to participate in clinical trials. That some recent efforts by Dr. Goldacre actually discourage clinical trial participation is troubling.
“We shouldn’t let biased critics like Dr. Goldacre discourage patients from participating in clinical trials. And, we shouldn’t let their perceptions impede necessary medical research that will benefit all mankind.”
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that support the development of new pharmaceuticals, biologics and medical devices. The association provides an active voice for the CRO industry globally. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 75,000 professionals worldwide and annually conduct more than 11,000 clinical trials involving nearly two million participants in 115 countries. For more information, please visit www.www.acrohealth.org. Twitter @acrohealth. YouTube @ACROHealthChannel.