The Problem at Perck Pharmaceutical;George LaRoche is a research scientist at Perck Pharmaceutical, which is a company headquartered in New Jersey and that develops and manufacturers therapeutic drugs. LaRoche holds a medical degree and started employment at Perck about ten years ago. Two years ago, LaRoche was promoted to Director of Medical Research. His primary responsibility in this position was overseeing the research and development of an allergy and asthma drug.;During clinical trials, the drug was given to large groups of people (Patients between 18 and 90 years old who were referred to cough outpatient clinics with chronic cough and enhanced bronchial hyperreactivity) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that would allow the drug to be used safely. More than 11,000 patients were given the drug in 40 clinical trials.;During the trials, some patients experienced mood swings and depression, which went away when the drug was discontinued. Some patients exhibited even more extreme behaviors while taking the drug, including suicidal thoughts. In total, about one-tenth of one percent of patients experienced some degree of side effects. These results were discussed fully by LaRoche?s research team, which split the opinion of the group. Half the group wanted to conduct a more detailed trial run to focus exclusively on these reactions. The other half thought that the apparent side effects were so statistically insignificant that further trials were unnecessary. LaRoche was undecided but generally was more sympathetic to the researchers that wanted to conduct further trials.;During these discussions among the research team, LaRoche was called to a meeting attended by the marketing and sales team. When asked for his opinion on whether Perck should proceed with its application to the Food and Drug Administration (FDA) for approval, LaRoche hesitated and expressed misgivings. At the meeting, Mike Meyers, the director of marketing interrupted and told the group that he had heard from several researchers on LaRoche?s team who had told him that LaRoche was being overly cautious, had mismanaged the team and couldn?t make a decision. After a heated exchange, a decision was made to seek FDA approval based on the existing trial data.;Over the objections of Myers, LaRoche was left in charge of the application process, which would have to be approved by Susan Smith, Perck?s general counsel in charge of FDA approvals. A draft application was presented to Smith for review. The draft noted that one-tenth of one percent of patients experienced some degree of side affects and concluded: ?due to this result, Perck recommends that the warning label include information on mood changes, anxiety and depression.?;Smith instructed LaRoche to revise the application to read: ?due to the statistically insignificant amount of patients who may have possibly experienced side effects from the drug, it is Perck?s expert opinion that no warning label addressed mood changes, anxiety and depression is necessary.? Outraged with this instruction, LaRoche refused to sign off on the application. In an email to Smith he wrote;?I am appalled by your suggestion that an FDA lawyer knows more about drug research than a trained doctor. I am insulted professionally and personally. What you are doing is more than a discourtesy, it is undermining the integrity of our governance structure, which requires the Director of Medical Research to have the final sign off on all FDA applications. Let me be clear, I refuse to sign the FDA application with the language you are suggesting.?;Attempts at convincing LaRoche to sign the application fail. Instead, Amy Lateef, the Associate Director Medical Research signs the application containing Smith?s revisions. When LaRoche yells at her in front of the team for ?selling out to the marketing sons of bitches? he is fired for unprofessional conduct and for violating Perck?s harassment policy.;Eventually, the FDA approved the drug on the strength of the application, and Perck began to market the drug under the name Singular for the relief of symptoms of seasonal allergic rhinitis (also known as hay fever). A convenient once-a-day tablet, Singular was sold to help relieve a broad range of seasonal allergy symptoms for 24 hours. It was made available to treat seasonal allergic rhinitis in adults and children as young as 2 years of age. The drug became immediately popular as doctors perscribed Singular to hundreds of thousands within the first six months alone.;Over the next 12 months, during the post-approval phase of new drug launch, the FDA observed a spike in suicides nationally. When reviewing the cases, 12% of the people who had commiteed suicide were also taking Singular for at least three weeks. It has initiated an investigation. However, the FDA has suggested that no one should go off of their medication before first talking to their doctor. The FDA suggests that doctors should more closely monitor patients on one of these drugs for changes in mood or behavior, especially related to suicidal thoughts (especially in people who have no prior history of having any).;Within the last month the FDA and Perck have been discussing how best to inform patients and doctors about possible side affects. Perck said it is planning face-to-face meetings with doctors to tell them about possible changes on the warning label and to give them patient leaflets so they can inform their patients about the risks of taking Singular.;Because of the complexity of the investigation, the FDA does not anticipate reaching a conclusion earlier than 9 months' time, when it will publicly announce the findings. In the meantime, in addition to its outreach to doctors, Perck has voluntary issued the following warning: ?Please consult with your doctor if after taking Singular, you experience mood swings, depression or suicidal thoughts.?;Because of all the negative attention that Singular is getting, a class action lawsuit comprised of the families of suicide victims has already filed against Perck. None of this has been lost on LaRoche, who feels that he was unfairly discharged from his high paying job. He is still unemployed and seeks out the advice of a lawyer.;Assignment: Read Pierce v. Ortho Pharmaceutical and the essay on Professional Loyalty. In no more than three pages, discuss whether LaRoche has;Objected to, or refused to participate in any activity, policy or practice which he reasonably believes;1) is in violation of a law, rule or regulation;2) is fraudulent or criminal, or;3) is incompatible with a clear mandate of public policy concerning the public health, safety or welfare.
Paper#33486 | Written in 18-Jul-2015Price : $25