Funding research with integrity

All of us at one point or another need to go to a drug store, pick up some pills that our doctor prescribed and ingest them to treat a medical problem. We trust that the medication is safe and will do what it is expected to do, i.e., correct or moderate our medical condition. Sometimes the medicine is taken chronically. For example, I take pills to help control blood pressure, and they seem to be working, but I wonder what the longer-term costs might be to my health. We trust scientists and regulatory agencies to protect us and ensure that the medicines are effective, even over the longer term.

The New England Journal of Medicine (NEJM), one of the premier medical research journals, just published a three-part series on the ethics involved in the funding of research by the pharmaceutical industry. The relationship between the pharmaceutical industry and scientific independence has many different ethical implications. Can we trust researchers who are funded by industry? What are the consequences if we don’t trust them? Do we lose important positive advances if we don’t take advantage of their findings?

Bringing medicine to market is an expensive exercise. Safety testing on animal and humans is necessary and, as experience has shown, needs to be done carefully; think about the consequence for babies of the insufficient testing of thalidomide in pregnant mothers. In all countries there are complicated safeguards in place to reduce the chances that drugs with adverse consequences will make it to market. The system is not perfect, and the regulations are constantly being updated as we recognise new issues that need to be considered. This safety-oriented process is sometimes referred to as drug development, in contrast to drug discovery, which involves finding new chemicals that can treat a medical condition. Our need to be protected in drug development means that from the initial suggestion that a drug might be useful for a medical condition to the point at which it reaches market can cost in the high hundreds of millions of dollars.

Choking our advances?

Researchers carry out a range of studies, from pre-clinical determination of drug action to safety and efficacy testing in humans. The costs needed to carry out this process dwarf what is typically available for research funds from government and non-profit agencies. Drug companies become involved in this process, providing many of the resources necessary to bring promising drugs to market.

The relationship between drug companies, who are ultimately concerned about profit, and the scientific independence of researchers studying these drugs has been complicated by these funding interactions. Should we trust the advice of a scientist who has been funded by the company that stands to profit from the drug if it comes to market?

We have all heard stories about the interference by the pharmaceutical industry in the scientific process and about episodes of unacceptable behaviour (in Canada, Dr. Olivieri’s work looking at drugs to treat blood defects is a prominent example). Thus conflict-of-interest rules exist between researchers and pharmaceutical companies. Most scientific journals require author disclosure around industry relations, and universities also have procedures in place to make sure that research is not tainted by the source of the funding. But if you are funded by a pharmaceutical company to do research on a new drug, your ability to provide independent advice to government or to publish your research findings will be questioned, and your work might not be published.

The problem identified by the articles in the NEJM is that these barriers and restrictions on researchers who are funded by industry may be hurting us as they may prevent us from accepting lifesaving advances. Few would doubt an industry-funded researcher who discovers problems with a drug or new medical advance, but if a researcher reports that the drug works well or the procedure is an improvement over the best current treatment, we are reluctant to accept their findings. How do we balance the true costs and benefits of a new drug if we only believe the negative findings?

Are our prejudices against the pharmaceutical industry blinding us to the benefits they can provide? How much can we trust the scientists to give us unbiased advice in situations where the only way to do the research is to accept industry involvement? Has our regulatory climate made drug approval so expensive that we are choking off the advances we need? There are no simple policy answers to these questions, which affect Christian and non-Christian alike. Pray for the people who work in the background providing the regulations that govern how we approve and oversee our medical advances.