After all the efforts by many different communities to promote the need for medical records privacy, security and confidentiality; with the penalties specified in HIPAA (albeit still rarely enforced); and with the increasingly common instances in the news of medical information misappropriation or stealing, one would think the pharma industry would be ultra sensitive to such matters.
This is not to mention that the drug in question, Enbrel, is anything but innocuous, compared to simpler remedies. This medicine interferes with the immune system, an immensely complex system whose pathways and regulatory mechanisms are not entirely understood, to say the least. There are associated complications including severe infections and malignancies such as lymphoma, to name a few.
This story, if true, also would implicate physicians, who most certainly would have known what they were doing was ethically wrong.
If the story is true, heads need to roll (figuratively speaking).
LINDA A. JOHNSON
The Associated Press
TRENTON, N.J. - Two former sales representatives for Amgen Inc. are suing the biotech company, alleging it pushed its sales force to search doctor's confidential medical records for potential patients to boost sales of a drug used to treat psoriasis.
The two former representatives, who are seeking lost pay, punitive damages and other compensation totaling more than $15 million apiece, allege they objected to superiors and refused to go along with the scheme, which legal experts say violates federal patient privacy law.
In addition, the veteran sales reps were encouraged to get insurance companies to approve reimbursement for Enbrel for patients with mild psoriasis, their attorney, Lydia Cotz, said Wednesday.
Enbrel, an injected, genetically engineered drug, is only approved for use in patients with moderate to severe psoriasis; it has severe side effects in some patients, including occasionally fatal infections. The drug is also used to treat rheumatoid arthritis.
... Amgen spokesman David Polk said in a statement that the company "does not comment on pending litigation or personnel matters. Our sales creed emphasizes that Amgen sales representatives follow compliance guidelines with absolute consistency." ... Jim Cohen, a Fordham University law professor specializing in legal ethics and criminal law, and John Thomas, a health law professor at Quinnipiac University School of Law, said that accessing patient medical files violates the federal Health Insurance Portability and Accountability Act, known as HIPAA.
[Surely nobody in 2008 needs experts to tell us that - ed.]
Cotz said the scheme started in 2005 or sooner, after new drugs competing with Enbrel came on the market. Enbrel, one of Amgen's top sellers, had sales of nearly $3billion in 2006.
"Amgen stepped up their marketing practices to ... get all these people who were not indicated for Enbrel" to start taking the drug, she said. "Patients didn't even know what was going on."
Cotz said her clients were instructed to go into dermatologists' offices and get permission to go through files to identify patients with psoriasis based on the diagnostic coding system insurers use for reimbursement. The representatives were told to then call insurers covering patients with mild psoriasis to seek approval for reimbursement of Enbrel, which Cotz said costs $20,000 to $50,000 per year, depending on the severity of the sometimes-painful skin condition.
"They would get on, and they wouldn't identify themselves as Amgen representatives. They would say, 'I'm calling on behalf of Dr. so-and-so,'" Cotz said.
She said representatives also were told to write letters on behalf of doctors, seeking advance approval so doctors could write prescriptions for Enbrel. Doctors writing prescriptions would benefit from frequent patient visits to have the drug injected.
"Respondents (Amgen) unethically and in contradiction of the available scientific data, promoted the prescription of Enbrel for "mild" cases of psoriasis by reinterpreting "moderate" cases" as mild, the lawsuit states, in "a total disregard of the proper care of patient recipients of Enbrel."
Cotz said sales representatives from the northeast to Hawaii have confirmed the scheme's existence.
Thomas said the allegations, if true, implicate any physicians who went along with the scheme for authorizing "marketing of medication not designed to treat their patients."
One also wonders, if true, if there were other "incentives" to physicians to go along with this scheme, besides the hope of more frequent patient visits for injections.