Pharma's Orphan Drug Binge: Redefining Corporate Social Responsibility?

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

A few months ago, Senator Elizabeth Warren launched a proposal for a “swear jar” bill that would require law-breaking Big Pharma companies to contribute 1 percent of the profits from each of their blockbuster drugs to NIH research. While this proposal was highly contested by members of the industry, I questioned if there couldn’t be a benefit to this bill apart from punishing law breakers and bolstering drug R&D. Would seeing pharma push more of its profits into research boost the industry’s image?   

It might be a bit of a stretch. After all, this “donation” would be a requirement, not voluntary, and this requirement would be the consequence of illegal activities. But, no secret here, the industry has an image problem. Just two weeks ago, a new survey carried out by Reputation Institute revealed that drug makers haven’t made a whole lot of progress in the fight to improve their reputations. In fact, the 12 companies included in the survey turned out to be quite average across seven attributes — innovation, performance, leadership, citizenship, governance, workplace, and products and services.

According to 15,800 people in 15 countries, the highest-ranking company out of the dozen was Bayer at 68.4 points out of a possible100. Novartis placed at the bottom of the list with 63.6 points. As you can see, there was only a very small margin of difference between Bayer’s and Novartis’ scores. Quality of products and services were ranked the highest for the industry in the survey, while the lowest-ranking attribute was corporate citizenship and responsibility (in terms of ethics and transparency of both pricing and trial results).

Across industries, there’s been a greater push for companies to subscribe to acts of corporate social responsibility (CSR), and for pharma, CSR is defined in several different ways. While CSR doesn’t have a universal definition, according to the Journal of Postgraduate Medicine, it is “a business commitment to contribute to sustainable economic development, working with employees, their families, the local community, and society at large to improve their quality of life.”

There have been a number of recent flare-ups and stories demonstrating the push for CSR, as well as some of pharma companies’ recent initiatives in this area. For instance, Gilead announced a new give away program in the country of Georgia, in which the company will be cutting off the flashy price tag for its Sovaldi and giving it away for free in order to convince governments that wide-scale, effective treatment could basically eliminate hep C. Similarly, Doctors Without Borders (MSF) has been particularly vocal, calling on vaccine makers Pfizer and GSK to lower the prices of their pneumococcal vaccines.

Chances are, there will only be more pressure for CSR in terms of pricing strategies — this time from WHO, which just released the newest version of its Model List of Essential Medicines. Newly included on the list were five hep C drugs (including Sovaldi) and 16 cancer drugs (including Roche’s Herceptin and Novartis’ Gleevac). WHO acknowledged that companies have been making efforts to ensure cost-effective access to their treatments in developing countries. However, one official said there needed to be more “unified strategies” to make the meds more affordable for global use/benefit.

Stepping away from pricing, I also think that pharma’s reputation is closely connected to the disease areas/treatments on which the industry chooses to spend its precious R&D funding. In fact, I’d even go so far as to say that the push for personalized medicine, as well as drug makers’ growing interest in orphan drug development (thanks to the Orphan Drug Act) for patients who have rare and currently untreatable diseases could be viewed as valuable acts of CSR.

Despite the small patient numbers, we are entering into the “Age of the Patient,” and there are patients with illnesses that are off the beaten path. Fine-tuning drug development to target very specific, narrow patient populations strips away the one-size-fits-all approach to drug development and gives once-overlooked populations a chance to benefit. After all, these patients are part of the overall population; to not target them would keep pharma from tackling its ultimate goal of patient-centric drug development, which is essentially ignoring the common good. (Not even close to the definition of CSR.)

However, there’s a lot of pushback in the industry against the increasing investments in orphan drugs. U.S. News & World Report’s Joseph Gulfo goes so far as to argue that the Orphan Drug Act, launched to get more players invested in development for this low-returns space, is now “warping” and “corrupting” pharmaceutical R&D. This act has simply become another way for pharma to make bigger profits off already-highly-priced orphan drugs hitting the market. And Gulfo isn’t alone in his concerns that pharma research is misguided: Sanofi’s Head of R&D Elias Zerhouni has also been speaking out about what he considers to be the industry’s problematic diversion away from the common good in favor of orphan treatments.

Judging from this pushback, it would seem pharma just cannot win when it comes to reputation. Industry efforts to do right by patients are still “seen as self-serving,” according to Reputation Institute’s Nielsen — to those outside and inside the industry.

But perhaps we need to realign our thinking and consider how pharma’s increasingly narrow focus on the orphan population could be setting the stage for a new age of CSR. We are entering the burgeoning age of personalized medicine, and there’s talk of being able to test patients before they even receive a medicine to ensure they have the right genetic makeup to respond to the drug. If this is truly the path we are on, who is to say that, someday, every drug won’t end up being an orphan drug, targeting even smaller groups of people with unique disease characteristics within a specific disease? While there is some dissent and negative chatter about the industry’s focus on the orphan space, it seems that this could be a good step for the industry in its overarching efforts to establish patient centricity, and, in turn, to bolster its reputation in patients’ and the general public’s eyes.