Does the pharmaceutical industry adequately explain the complexity of drug discovery to its stakeholders?

No, and there are several reasons for this. First, the modern pharmaceutical research enterprise is remarkably complex — even for those who are immersed in it. Second, our stakeholders comprise a broad cross-section of society and it is a challenging task to explain a complex system to this diverse group. We need to increase the engagement of the industry with its stakeholders. At Pfizer we bring them to our major R&D sites to learn about what we do. In our experience this is a remarkably effective way to overcome the misperceptions that exist about the industry. But it's a two-way street: visiting our sites takes time and a commitment from our stakeholders to learn about us.

People need to understand who does the 'heavy lifting' in discovering and developing new medicines. Too many people believe that the NIH discovers and develops new medicines and that industry simply manufactures them. The NIH itself has made clear that the vast majority of new medicines are discovered by industry and has published data showing that it has played a role in only 3 of the top 48 major drugs recently discovered (EPO/Procrit (Amgen/J&J); Neupogen (Amgen) and Taxol (BMS)). The NIH funds valuable early studies but relies on industry for the further development and manufacturing. The important discovery work that is needed to prove or disprove these fundamental biological mechanisms, and the subsequent long-term testing to demonstrate the safety and efficacy of new molecules is largely the responsibility of the pharmaceutical industry. In the case of Taxol, there were very challenging issues with synthesis of the drug that nearly prevented its development.

More than anything our stakeholders need to understand the quality and integrity of the research we do and the standards that are in place to validate it, and the best way to demonstrate this is to continue to produce remarkable new medicines.

People need to understand who does the 'heavy lifting' in discovering and developing new medicines.

Does talking publicly about preclinical failures make stakeholders more aware of the challenges of drug discovery and development?

One can, in fact, talk publicly about failures and Pfizer did so in a Wall Street Journal article (2 May 2002) that detailed many years of R&D and the resulting US$71 million that we invested in our attempt to develop a growth-hormone-releasing-peptide mimetic to treat frailty in the elderly. However, people are not generally interested in reading about failures, they'd rather hear about the next new medicine. In addition, preclinical failures are rarely the result of a single flaw. Over the course of several years and various hurdles, we might get a compound with the necessary credentials or we might face the difficult decision to terminate the programme. At that point, there is little to gain in publicizing this.

Failures do not generally make a great media story, and they rarely rate acceptance in major journals. The discovery and development of successful products is far more fascinating. Each success story has its own set of decision points: crossroads at which insight, creativity, sweat and, yes, a bit of luck, led to a product that benefited millions of people around the world. Those are the stories to tell.

The industry seems at liberty to release whatever information it wishes. How do you decide which failures to highlight?

I must first correct any impression that we control data releases and hide failures — that is certainly not the case, nor is it even possible. When we proceed to regulatory filing, we must include all data, including negative results. Clinical trials and post-marketing studies are conducted by leading academics and clinicians, and their trust and partnership are of paramount importance. Recently, journal editors and others have demanded access to trial databases, which Pfizer is willing to co-operate with. But, should we publish everything? No. We don't issue press releases on early undisclosed candidates because the majority of these fail. In the case of the growth-hormone mimic, we disclosed some early details because the science was exciting and the project was well-known. After development stopped, the Wall Street Journal approached us and we allowed their correspondent to talk to the project team. We did so to show how medical progress relies on our industry's willingness and ability to take financial risks.

There have been profound changes in the doctor–patient relationship.

How have recent setbacks for the industry altered its relationship with the public?

The relationship is about trust. For 155 years Pfizer has delivered medicines that improve and extend lives and, during that time, we have gained knowledge that enables us to more effectively measure the risk–benefit of drugs. But there have been profound changes in the doctor–patient relationship. Patients used to rely on their doctors to make risk–benefit judgments. The FDA then began taking a major role, and now patients demand far more authority and information, and are encouraged in this by lawyers, advocates, journalists and politicians. Although empowerment is positive, there is also confusion amid this wealth of data. Patients are not sure whom to trust. However, the professional, ethical and scientific standards in the pharmaceutical industry have never been higher. We all understand that causing harm to the customer is a guaranteed path to failure.