Thursday, January 10, 2008

Amgen reps instructed to poach medical records?

I very much hope the following accusations prove to be inaccurate or exaggerated. If not, what is described here is almost unbelievable.

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).

Ex-Reps Say Amgen Used Patient Records


The Associated Press

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.

-- SS


Anonymous said...

I can't speak to the rest of the post, but there is no monetary incentive for dermatologists or other physicians to prescribe Enbrel. Enbrel is injected at home by the patient subcutaneously like insulin. Not in the office. It even comes in a "sureclick" formulation sort of like an epipen. I see my Enbrel patients far less than those on older more dangerous medications that require more frequent monitoring.

Anonymous said...

Two recent pieces come to mind regarding this issue. The first is the WSJ Health Blog report on Jan. 9 that Washington DC is trying to license drug reps with the following stipulations:

The bill explicitly bars reps from “any deceptive or misleading marketing of a pharmaceutical product, including the knowing concealment, suppression, omission, misleading representation or misstatement of any material fact.” It also prohibits promoting drugs for unapproved uses.

In the Dec. 27 WSJ’s letters to the editor section Dr. Adriane Fugh-Berman of Georgetown notes:

“Of 150 million off-label prescriptions in the U.S. in 2001, 73% were for conditions for which there was little or no scientific support or efficacy. Certainly drug manufacturers can maximize profits by expanding their market to those whom proven risk outweigh unproven benefits.”

One of the most frightening pieces of television I have recently viewed was PBS’s The Medicated Child. The unfettered drive on the part of some doctors to medicate, medicate, medicate, was simply blatant.

We seem to be seeing a backlash politically, inside and outside the drug companies against their sell, sell, sell policies. Unfortunately all the laws in the world will do no good unless someone steps forward to report the violations.

Steve Lucas

Robbie said...

Sounds interesting.
So what do you mean really?

Anonymous said...


Have you found this product to be more aggressively marketed than similar products?


Steve Lucas