Justifying the Means

When it comes to ethics, the adage "hindsight is 20/20" is especially applicable. Countless medical and psychological experiments—such as the 1932 Tuskegee syphilis study or Zimbardo's 1972 Stanford mock-prison experiment—were conducted in the name of science and are now plainly recognized as enormous violations of ethical and human rights.

Kaylynn Chiarello-Ebner

The line between ethical and unethical is often drawn and redrawn over time, depending on what seems most important at the moment. And sometimes, as Maya Angelou once said, "The needs of society determine its ethics."

In mid-January, two Imperial College (London, UK) professors made headlines by claiming to have a model for "ethical pharmaceuticals" that will bring low-cost drugs such as hepatitis C to poor nations. Given public skepticism about drug safety and high pricing, the intriguing ring of "ethical pharmaceuticals" grabbed the attention of industry and the public alike.

Professors Sunil Shaunak and Steve Brocchini say the model is to change part of an existing drug's molecular structure, put the candidate through clinical trials in India, and submit the new molecular entity for regulatory approval. The university would hold the patent, thereby slashing costs for the drugs.

But, there's a catch. A big one. Pharmaceutical companies would take the blow from lost intellectual property (IP) and the very ethics of IP and innovation would be at risk.

I very much support researchers doing all they can to bring low-cost drugs to developing nations and it is imperative that industry never lose sight of the need for such products. But this model (despite its good intentions) sets a dangerous precedent. If some researchers pursue a redesign-only model, the others are, in essence, penalized for innovation. Industry might even become reluctant to develop certain new drugs that could be targets of a model such as this.

It should not be forgotten that innovating a new drug is another form of "ethical pharmaceuticals." It is in the public interest to keep the field moving forward and to bring the best, highest-quality, new drugs to market. It would seem unethical to give up on innovation and only strive to tweak rather than create something new.

Kaylynn Chiarello-Ebner is the managing editor of Pharmaceutical Technology, kchiarello@advanstar.com.