Heartbreak Of Psoriasis: Amgen Rep Cries Foul
16 CommentsBy Ed Silverman // January 3rd, 2008 // 3:00 pm
Last month, we wrote that a former Amgen sales rep in New Jersey sued the biotech for $10 million, claiming she was fired in retaliation for not complying with an improper marketing campaign for its Enbrel med. The case has since attracted interest from the New Jersey Attorney General, according to the attorney for Elena Ferrante. A spokesman for the NJ AG declined to comment, without denying or confirming any conversations have taken place.
Now, another former Amgen sales rep has come forward and he paints a picture of a still broader effort to goose Enbrel sales at a time of increasing competition. The directives to sales reps included pulling patient files from doctors’ offices, letter-writing campaigns to patients and insurers, and orchestrating and attending patient outreach seminars. These activities, however, allegedly involved off-label promotion and patient privacy violations, according to the rep’s attorney, Lydia Cotz, who also represents Ferrante.
“This was a way to get more patients on Enbrel,” says Marc Engelman, a former Southern California sales rep, who agreed to leave last April after objecting to Amgen’s practices and, as a result, receiving poor job reviews. “And I was required to do so by my district manager. Enbrel sales had come to a crawl. And Amgen was gearing up because they knew they were going to take a hit in the marketplace.”
Before we provide further detail, we should note that a spokesman for Amgen, which co-markets Enbrel with Wyeth, wrote us to say 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.†Both rep cases are in various stages of arbitration, by the way, because reps who worked for Immunex, which Amgen acquired in 2001, were required to bring serious disputes to an arbitrator, according to Cotz.
The activities that Engelman describes began in 2005 and 2006, which coincided with the threat of increasing competition from other biologic meds used to treat psoriasis or psoriatic arthritis, such as Genentech’s Raptiva; Abbott’s Humira and Centocor’s Remicade.
Engelman, who his attorney says has filed a notice of claim, charges that an Amgen district sales manager required him…
…to pull patient files as part of a plan to convince insurers to pay for Enbrel for people with mild psoriasis, an unapproved patient population. Enbrel was approved in 2004, but only to treat moderate to severe psoriasis. In 2002, the med was approved for psoriatic arthritis.
According to a taped conversation that we have heard, the district sales manager told sales rep Marc Engelman to pull ICD-9 forms, which contain diagnostic codes, from patient files. After looking at the files, he claims Amgen reps were encouraged to write letters on behalf of doctors to insurers, in hopes of persuading them to cover the cost of Enbrel for patients with all forms of psoriasis. Letters about Enbrel were also sent to all of a doc’s psoriasis patients with an eye toward persuading them to switch to Enbrel or convince those with mild psoriasis to try Enbrel, Engelman further alleges. However, peeking at the files raises questions about patient privacy, otherwise known as HIPAA.
Engelman, 45, apparently wasn’t the only one given such instructions. A memo to sales reps in the South Pacific district tells them about the “importance of proper patient identification. It is one, if not the most important, aspect how the biologic business will grow in 2006. With that said, our focus on office and ICD-9 mailings is a solid ‘target to hit’ in the next few months. This process is a win-win for all involved as the patients that have given up on traditional therapies are educated on new ones, customer’s patient base increases and patient flow for biologics increases,” the memo states.
He also claims that he and other reps were told to coordinate so-called patient outreach programs. “We sent fliers or helped a doctor’s office send fliers to patients. The fliers were advertisements to get patients to come to a community center or a restaurant, where there would be a talk by a physician. We’d pay the physician to talk about biologics. I went to one and it was uncomfortable for me because the patients are right there.”
“We went to patient support groups. We called insurance companies and, sometimes, we pretended to be a person in the (doctor’s) office. The entire purpose was to get whatever was needed for a patient to be approved to be given Enbrel,” says Engelman. “It was a way to increase sales. And we did whatever we had to do to get patients on Enbrel. But I wouldn’t do it. I felt it was wrong and we were crossing lines. But I was punished because other reps were doing these things and having a great success. We received voice mails talking about ’success stories’ involving what other reps had done and ‘you should do this.’ I wouldn’t. And I have to add that, now, some patients are on Enbrel and maybe they shouldn’t be.”
Dan
“following compliance guidelines with absolute consistency” for the Amgen reps as stated by thier spokesperson simply means that the Amgen sales reps probably signed a form stating that they reviewed what was legal yet, due perhaps to lack of internal controls within a sales organization, and this autonomy is possibly designed with deliberate intent and reckless disregard for the well being of others by such pharma companies, activities such as those illustrated in this post happen often with Amgen and many other pharma companies due possibly to the fact that the members of such sales organizations will do absolutely anything, regardless of the consequences, in order to continue to make the large amounts of money in thier present jobs than they would ever obtain in any other vocation they would be able to acquire if they were not involved with pharma sales, regardless of what step they may be on presently with thier corporate ladder. Many may feel quite uneasy about such activities, but understandably do not want to vex thier relationship with thier superiors and therefore conduct such illegal activities.
This opinion is based on my years of experience as a big pharma rep. This comment is not meant to be interpreted as myself in any way being bitter or angry, but the words that have flowed in this comment are intended to have more of a tone of awareness to attempt to illustrate my strong desire for change within the pharma industry that is clearly necessary for the benefit of others who the pharma industry serves in the health care system, as perceived by the public, I believe.
Dan
Addendum to my previous comment regarding this post.
Notice that the ‘ICD-9′ Best Practices’ memo appears to be unauthored. This illustrates my point in my previous comment that the pressure placed on reps. to perform tactics that are wrong on many levels is never directly an order mandated by an organization. It’s only perceived to be a tactic to be performed by others, which most do for fear of losing thier jobs, as, I surmise, these reps view such memos must be implemented to meet expectations that are now defined.
If the company believed that the contents of this memo in this post was the right thing to do, then why did no one acknowledge writing this memo? Raises questions, does it not?
Bruce
Dan,
Check out the name under the Amgen logo. It is authored.
Dan
Thanks for the correction and catching that, Bruce.
Bookmarks Tagged Improper
[...] online community. The best part is … it’s all 100% free! check them out here: Join Hey Nielsen! Heartbreak Of Psoriasis: Amgen Rep Cries Foul saved by 1 others UltramasterBDJ bookmarked on 01/03/08 | [...]
Pharma News 1_04 « Impactiviti blog
[...] The latest lawsuits for off-label promotion - Pfizer and Lipitor, Amgen and Enbrel. [...]
Heidi
Several reps in So CA have left Amgen because of the DM that was insisitng on “illegal” or borerline actions. Carrie, the Enbrel Rep in SD, actually filed a compliant with Amgen’s HR Dept to document the DM’s pushy & unwelcome tactics in offices.
Patient
I received these mailings from Amgen and was very curious at the time as to how they knew to target me as a patient - now I know… nice to know my patient “right to privacy” were violated so freely
Shame, shame on YOU Amgen
Mariel
What about the doctors office that allows sales rep access to their patient files? Shame on them!
Shady/illegal sales tactics can be expected from the pharma companies, but complicity from the doctors office can only happen in countries where health care is a business and not a service.
Patient
Oh I agree - shame on the doc’s office as well - actually the whole system/practics is shameful. I would NEVER use Enbrel for this reason alone (never mind whatever side effects or benefits) knowing the mfr is this shady puts me “off” to using any of their products.
Karma
And who usually facilitates these best practices between districts? I wonder if the West Region Director is nervous…huh Tex?
ex-manager
Wah wah waaaahhhh from more reps who want to get paid 6 figures for not working. These reps will find out, because they’ll never get hired in the industry again.
Hank
Thanks for all the excellent comments except the last, if I understand it correctly.
I happened to be doing some on-line research for a family member who recently developed psoriasis (mild). Embrel virtually screams from every page. I understand it could be argued that this is simply a way of “making it known” for severe cases. But I can’t recall so aggressive a use of web search engines. The apparent “rest of the story” doesn’t surprise me.
C. Dianne
No one has discussed yet how some doctors offices are installing and using software/”free” computer systems they receive from pharma that automatically feed patient diagnoses outside of the privacy of the doctor’s office. When an outside entity has access to the data that is computerized within private offices, even if patient names are not divulged, it still paves a way for other entities to Farm the Data. The whole era of electronic medical record has made it almost laughable that privacy in medicine even exists today. My frame of reference is that I was a long term staff member of a medical office. The Amgen memo above is old news to me. I was asked many times to scan specific diagnosis codes to identify patients with specific diagnoses for designer studies to further bring income into the “group” practice. Drug reps can only get access to what doctors allow them to access. Some of it may be for the good of the patient, but it all potentially adds profits to the bottom line. Now, with the news about new meds for diagnoses that may not even be diseases, I see huge conflict-of-interest issues. Physicians should strictly adhere to the AMA code of ethics and to the hipoccratic oath to “do no harm.” Thank God for the NY Times reporters who have the guts to report this stuff. Right now, it looks like they are the best advocates the poor patients have and I commend them for their ethics.
Pete
As a former Amgen employee, i can attest that this is merely the top of the scab; start peeling it back and you will surely find a host of other unethical practices being performed on a routine basis. It is sad how such a great company that Amgen once was could be corrupted by greed and brought to the position they occupy now.
Turning up the heat on Amgen
[...] problems don’t stop there. Ed Silverman, writing for Pharmalot, notes that the Senate Finance Committee is also investigating Amgen as part of a broader [...]