Healthy Skepticism Library item: 11678

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Nagle M.
Eli Lilly: drug safety revolution 'within our grasp'
DrugResearcher.com 2007 Oct 4
http://www.drugresearcher.com/news-by-product/news.asp?id=80305&idCat=0&k=Eli-Lilly--drug-safety

Full text:

The head of Eli Lilly has called for a reform of the US drug safety system, saying that an information revolution is ‘within our grasp’.

Sidney Taurel, CEO of the pharma giant, used a speech at the Cleveland Clinic, US, this week to rebuke the health care industry, medical community and the US government, saying that not enough was being done to take advantage of advances in information technology (IT) and ensure drug safety.

“The use of prescription medicines always will be a matter of balancing benefits and risks,” Taurel said. “Fortunately, systems are now within our grasp to more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use.”

“The time is ripe for [US Food and Drug Administration] the FDA, the health care industry, and the medical community to collaborate on a reform of our nation’s pharmacovigilance system,” he added.

Although the US government is doing more to ensure pharma companies are obliged to conduct post-marketing (Phase IV) clinical trials, both to assess efficacy and safety, there are still plenty of examples of drugs being withdrawn from the market due to serious side effects.

One of the problems facing regulators is that Phase IV trials to gauge how safe a drug is have to be conducted on a large scale over a long time. The costs are high and this often makes pharma companies reluctant to conduct them.

Taurel outlined how a well-functioning health IT system could serve not only to frame hypothesis for Phase IV clinical research, but also become the practical equivalent of massive, real-world trials.

The data for such a system could be gathered from day-to-day medical practices, with an end result of a more accurate picture of a drug’s efficacy and safety. Electronic Medical Records (EMR) already exist and are patient-specific repositories of clinical information on diagnoses, treatments and outcomes.

The system needs to be more widely implemented though, said Taurel, and the data needs to be properly blinded to protect patient privacy. If this data was combined with genetic information as well, it would become an extremely powerful tool for a personalised medicine approach to therapy.

Taurel said that as EMR systems are built up, they provide what amounts to a ‘commons’ in which organisations can collaborate to share health information.

Currently, Eli Lilly, Pfizer and Johnson & Jhonson are collaborating with the not-for-profit group e-Health Initiative to test how safety signals can be located and understood using existing data. The Indiana Health Information Exchange and the Partners Healthcare System in Boston are also involved in the partnership.

“This sort of public-private experiment, along with national standards and regional expansion, will soon create a mass of basic infrastructure that could produce the sort of knowledge that will truly revolutionize patient care,” concluded Taurel.

“We need to open our minds to the notion that electronic health care data represents a legitimate resource – to which access should in most cases be widespread and easy.”