Did Roche Pressure Reps To Push Tamiflu Illegally?
15 CommentsBy Ed Silverman // May 21st, 2010 // 2:24 pm
The drugmaker leaned on its sales staff illegally to sell Tamiflu to people who were not doctors, a former employee alleged in court. John Miller claims Roche’s UK subsidiary promoted the med to companies that wanted to secure supplies for private stockpiles at a time when concern was rising over the likelihood of a flu pandemic, The Financial Times writes.
Miller was in court seeking compensation for unfair dismissal; he claims he was moved around internally and ultimately forced out after complaining of regulatory and ethical breaches. Roche denies the charges and maintains he was an underperformer.
Miller claims he was asked to create a special business unit to sell Tamiflu to companies in 2006, and was given unrealistically high sales targets, given tight legal controls on marketing prescription drugs. He later discovered there was effort to ensure sales reps spoke only to healthcare professionals, as the law requires, and that Roche also sold Tamiflu to intermediaries employing medical staff, which in turn would sell the drug to clients, the FT continues.
He was also concerned that talks with companies about Tamiflu supplies breached competition rules designed to ensure fair allocation of what was a scarce drug, the paper adds. He also wondered whether non-medical customers had facilities safely to store and track the drug. In 2006, the Medicines and Healthcare Products Regulatory Agency investigated a complaint from a business continuity manager who received a call from the Roche sales team, but took no action.
Miller’s manager told the court that Roche decided that it could “speak about business continuity” to non-medical customers, provided it did not mention the efficacy, dose or the name of the drug. Miller was subsequently shifted to another job where he raised concerns that Roche was manipulating a process for selecting wholesalers by choosing them in advance.
Finally, he claimed that Roche overcharged the National Health Service by offering discounts from the official price to pharmacists and distributors to maintain market share, and that Roche gave cash payments and discounts on future orders to customers to buy its drugs rather than lower-priced generic rivals or versions imported more cheaply from elsewhere in Europe.
EDITOR’S NOTE: We modified our original headline in order to note the claims made by the former employee are currently allegations.
John
Ed, while I recognize that there have been an awful lot of marketing scandals lately, I think the journalistically correct title for this article is “Roche ALLEGED to have Pressured Reps to Push Tamiflu Illegally”. Unless of course you have information that was not cited in your article or the FT article that you provided a link to.
A minor point I’m sure, but some might misinterpret this as an example of off-label journalism. :>)
John
Not to beat a dead horse, Ed, but here are two Roche stories from the last two days that I personally found a lot more comment-worthy than the one you chose.
“Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from the Phase III PRIMA study. The data showed that continuing MabThera (rituximab) for two years in patients who responded to initial treatment with MabThera plus chemotherapy, doubled the likelihood of them living without their disease worsening,
known as progression-free survival (PFS), compared to those who did not receive maintenance. The study enrolled patients with previously untreated advanced follicular lymphoma. No new safety signals were observed in this study and the safety profile was consistent with previous experience with MabThera…
Results of the PRIMA study showed MabThera, then used as maintenance, doubled the likelihood of people with follicular lymphoma living without their disease worsening compared to those who stopped treatment (based on a hazard ratio of 0.50, 95% CI, 0.39; 0.64; p=<0.0001). After two-years of follow-up, 82 percent of patients who received MabThera maintenance were in remission compared to 66 percent of patients who did not.”
AND
“An analysis from the ongoing non-randomized Phase IV ARIES observational study evaluated survival in more than 1,000 people with advanced colorectal cancer who initially received Avastin in combination with chemotherapy and then, following growth or spread of the cancer, continued with an Avastin-based regimen.
The results suggested that people who continued an Avastin-based regimen after the cancer progressed lived longer than people who switched to a non-Avastin containing regimen or stopped treatment altogether.
In this analysis, people who continued an Avastin-based regimen after the cancer worsened had a 59 percent decrease in the risk of death compared to those who switched to a non-Avastin containing regimen or stopped therapy altogether (based on a hazard ratio of 0.41, p<0.001).
Median survival after the first disease
progression was:
16.3 months for patients who continued an Avastin-based regimen
8.5 months for those who received a non-Avastin containing regimen
5.2 months for those who stopped therapy altogether”
It’s your blog, but its hard for me to understand how you found the unsubstantiated accusations of a British sales rep more interesting than these.
Doc
While others may find this article less worthy than others concerning Roche, the bottom line is that “the beat goes on”. Promoting drugs to non-qualified prescribers doesn’t seem a whole lot different than off-label promotion in my mind.
Once again, the quest for profits overrides public safety.
John
Allegedly, Doc. If accusations are going to be treated the same as established facts, you better get out your checkbook every time a patient accuses you of malpractice.
Dead patients are dead patients, whether due to inappropriately promoted drugs or cancer. If your primary interest is in the well-being of patients, I think you have to take an interest in reports of medical breakthroughs, and not just in allegations of misconduct. If you are just grinding an axe, that’s a different story.
Ed Silverman
Hi John,
Thanks for your note and I agree that the use of the word allegedly in the headline would have been ideal. The simple problem was space, but the point is taken.
And I chose the Tamiflu piece because, in part, there have been some questionable marketing ‘scandals’ and, in this case, there have also been questions about the extent to which the H1N1 pandemic may have been promoted as a severe health issue. This is something in which the WHO is now immersed.
In any event, I do link to study results and will highlight those that offer truly meaningful results, although I generally give them more play when they wind up prompting additional indications.
But again, thanks for writing in.
ed
John
Ed, thank you for your response, I recognize that the purpose of this blog is not for you to engage in one-on-one exchanges with readers, and that I was pushing the envelope a bit here.
I continue to believe that the you chose for this article states a conclusion than is not fully supported by the article contents, and that it should be changed.
But of course, it is your blog….
Ed Silverman
Hi John,
Actually, I do engage with readers somewhat regularly. I think of this site as something of a community and I’m happy to chat, at least when I think it’s warranted – I don’t want to intrude in other conversations or give the appearance that I am dictating the discussions.
In any event, this particular post is about an allegation, as is most any lawsuit that is written about here or in any other media. Miller makes various claims, and I used the word claims or alleged several times. Whether his claims are valid and can be substantiated and affirmed by a court remains to be seen (I’ve no idea). And so this amounts to a snapshot in time. Coverage of any court proceeding is similar in this regard.
Again, I chose to post this because it raised questions about marketing practices, and also related to the wider debate about the handling of the H1N1 outbreak. And as I indicated before, headline writing is an imperfect art. A lot of second guessing takes place and I’m always happy to learn from debates and mistakes. In this case, I did my best and I understand your point.
Regards
ed
JaT
I’m not sure this discussion didn’t make an allegation about patients and malpractice suits…
;)
Ed Silverman
John,
Here’s an update. The headline has been modified with a question mark to more closely hue to the notion that the allegation is, for now, still an allegation. Should’ve thought of this earlier. Again, thanks for writing in.
Regards
ed
John
Thank you Ed. I’m appropriately impressed by your open minded response to my completely unsolicited criticism.
Sceptic
John, you work for Roche, right? Because that would explain alot!
amanzimtoti
I disagree with John. I think an article like this is very important. It exposes possible illegal practices and people need to be aware that these sort of things are happening and to be more watchful. I think the research Roche is doing is marvelous and we should all be grateful that this kind of research is in progress, but if these allegations are true, we cannot excuse them because Roche is also doing ood work.
amanzimtoti
good work
John
No actually, I do not work for Roche.
Agree that if this is going on, it should be exposed and is not excused by all the good research that is going on there.
Very strongly disagree that an accusation by a single individual constitutes proof. This reps claims have not been examined and ruled on by any court of law or other impartial body. Let’s wait and see what happens.
Ed, the two comments above do a nice job of illustrating why I was concerned about your original headline. As a journalist I think it is important not only to do good investigative research, but also to be a good role model with regard to prejudgment and when it is appropriate to draw conclusions. People look up to you.
John
Misunderstood Amanzimtoti’s post on first read thru, apologies for this.
Think he may have misunderstood mine also.