November 28, 2012

The Nov. 25 front-page article “Can drug research still be trusted?” presented a one-sided view of scientific endeavors that produce lifesaving medicines. The assumption that industry funding of clinical research inherently leads to conflicts of interest and bias in results is unfounded.

Biopharmaceutical companies invested $49.5 billion in research and development in 2011, working in a diverse ecosystem with government entities, academic institutions, hospitals, doctors and patients who volunteer to participate in trials. Research is in part based upon the good intentions of all participants, who operate under strict ethical and legal requirements. This article was a disservice to scientific professionals who devote their careers to helping people and improving health, and it ignored important benefits achieved for patients.

The biopharmaceutical industry is perhaps the most transparent research-based sector. At the beginning of every clinical trial involving patients, companies provide information to clinicaltrials.gov. In 2009, biopharmaceutical companies agreed to voluntarily post trial results from discontinued programs online. What other industry reveals basic research for marketed products and discontinued projects for all to see?

We are proud of our commitment to science, the more than 300 medicines approved over the past decade and the 3,200 in the pipeline. We also stand by our commitment to transparency and collaboration and will continue to work toward the best possible research process that delivers safe and effective medicines to patients.

John J. Castellani, Washington

The writer is president and chief executive of the Pharmaceutical Research and Manufacturers of America.

An area where vendor-sponsored research could be biased is in trials where two drugs are compared. For example, the well-respected journal Lancet published in its June 16 issue two well-done randomized-trial comparisons of diabetes drugs. A study favoring the use of Lantus was sponsored by its vendor, Sanofi, and a study favoring the use of Byetta was sponsored by its vendor, Amylin.

A few weeks later, the same journal published a randomized trial favoring the use of the diabetes drug Tradjenta, sponsored by its vendor, Boehringer Ingelheim.

Would we expect to find vendor-sponsored randomized trials to sometimes find in favor of a competitor’s product? Yes, if we’re talking science. No, if we’re talking marketing. In 30 years as a medical school faculty member, I can remember one such trial. It was quite unexpected.

Thomas E. Finucane, Baltimore

The writer is a professor of medicine at Johns Hopkins Bayview Medical Center.

A year ago, I was called for jury duty in Washington and was selected for an interview with the judge after the initial screening. The case involved a young man charged with dealing drugs, and I told the judge that I would not be an appropriate juror, as I believed the charge to be hypocritical.

I mentioned several prescription drugs that had been taken off the market in recent years after evidence of harm was hidden from regulators and the public. I asked, “Were those CEOs indicted for selling harmful drugs?” The judge responded that dealing drugs on street corners is dangerous and erodes the social fabric of a community. I responded, “And you don’t think that people dying from dubious pharmaceuticals sold by corporate hucksters harms families and communities?” I was dismissed from service on that jury.

Barbara Allen, Washington

Drugmakers aren’t alone in privileging positive trials. Top-tier medical journals have long been reluctant to publish negative studies, and published trials sponsored by nonprofit groups are just as favorable as those funded by the industry.

A 2012 Arthritis & Rheumatism analysis of published studies of experimental rheumatoid arthritis medications found no difference in the rate of positive studies paid for by nonprofits and by manufacturers. Yes, the pharmaceutical industry has squandered some of the public’s trust in recent years through deception, data manipulation and flawed trial design. But as the article on drug research noted, these cases have achieved notoriety in large part because of their infrequency: Most experimental drug trials run by the book.

In nearly three decades of working with pharmaceutical companies as an independent science writer, medical educator and public relations consultant, I have seen a pronounced shift toward the full disclosure of clinical research data. Efforts to streamline R&D now underway will reduce some of the financial pressures facing biopharmaceutical companies as they attempt to bring new drugs to market.

Steven Marks, Potomac