Target: J. Michael Pearson, Chief Executive Officer of Valeant Pharmaceuticals
Goal: Call on the company to abandon “cost-cutting measures” that sacrifice consumer safety in its search for profits
Before a new pharmaceutical product can be sold to consumers it must be tested to ensure safety and effectiveness. These safety studies can be expensive. Valeant Pharmaceuticals has grown to dominate the market in recent years by merging with competitors and acquiring drugs already on the market or else in late-stage development, allowing the company to avoid spending money on expensive tests. Valeant’s cost-cutting philosophies have driven the company to avoid conducting safety trials even when required to by the Food and Drug Administration (FDA), side-stepping consumer safety laws and potentially putting the public at risk.
Sculptra was initially used by patients suffering from HIV-related facial wasting. The drug was approved for these cosmetic touch-ups, but not for use by the general public. According to ProPublica when Valeant acquired the drug it also assumed responsibility for conducting studies to ensure Sculptra was safe for cosmetic use by patients who were not HIV-positive. Executives fretted over the requirement, estimated to take five years and cost upwards of $40 million, and instructed researchers to “do the minimal amount of work necessary to show progress.” The general attitude at the time was, recalls one executive, “Well, let’s just take our time doing the study.”
Valeant insists its “commitment to patient safety and regulatory compliance is absolute.” Prolonged efforts to avoid complying with the FDA’s request failed to sway the agency, which continued to pressure Valeant to complete the study. The company made a big show of designing the study, yet never actually started it. All the while it continued to sell Sculptra to the unwitting public.
Former executives with the company, speaking with ProPublica while asking to remain anonymous, expressed other concerns as well. Frequent mergers have meant frequent layoffs, and have left management unprepared to tackle challenges and unwilling to voice concerns.
Clearly, Valeant’s business model disregards the importance of regulations and consumer safety. Call on the company’s leadership to uphold its responsibilities to consumers and to comply fully with all requirements intended to protect the public.
Dear Mr. Pearson,
Numerous concerns have been raised as the public learns about Valeant’s disregard for federal regulations. While satisfying shareholders’ desire for profits may seem like the top priority, consumers demand that adequate safety trials are conducted prior to the release of products onto the market. Sacrificing required safety trials as an unnecessary expense shows a clear disregard for the health and well-being of the public.
Make no mistake: such negligence can also impact shareholder profits. Failure to address concerns over leaking packages of the drug Jubila, for example, cost your company valuable time and allowed competitors to gain the advantage. Rather than downplaying these concerns, if Valeant had instead addressed the problem it would have brought Jubila onto the market much sooner.
Safety trials are not a wasteful expense, as you seem to believe. They are your legal and ethical responsibility. I call on you and your company to commit yourselves to complying with all regulatory requirements, in a timely fashion and without seeking to avoid such responsibilities.
[Your Name Here]
Photo credit: PhotoLizM via Pixabay