Biogen to pay $900 million to settle allegations of improper physician payments

[agate]

There is a New England Journal of Medicine "Perspectives" article on this case but the link to it might not work, and so here is a news story. To me this was big news as I recall how, over the long years, people with MS have been keenly aware of the way in which the MS drugs were being marketed. I'm not sure how much difference this settlement news will make in the long run but at least there's been quite a hue and cry in protest against the way doctors have been coaxed into prescribing these very costly drugs.

From the US Department of Justice, "Justice News" (September 26, 2022)--"Biogen Inc. Agrees to Pay $900 Million to
Settle Allegations Related to Improper Physician Payments":

Only registered and activated users can see links., Click Here To Register...

This is from the New England Journal of Medicine article:

In this case, the relators were former Biogen employees who had overseen physician marketing and so had firsthand knowledge of the programs. The law firm representing them processed millions of documents obtained during discovery and undertook dozens of depositions of Biogen employees over nearly a decade of litigation.

Such voluminous pharmaceutical marketing data have been analyzed in past investigations. But the Biogen case is exceptional for two reasons. First, it focuses on specialty drugs (generally those with list prices higher than $50,000 per year) — in particular, Avonex (interferon beta-1a), Tysabri (natalizumab), and Tecfidera (dimethyl fumarate). Specialty drugs are the most important drivers of profitability in the pharmaceutical industry; relatively few prescriptions for such drugs can generate substantial revenue. Second, the case pertains to the use of expert physicians as consultants to Biogen and speakers endorsing the benefits of its drugs. Many of these consultants and speakers were also high-volume prescribers of MS medications. The marketing programs provided income for these prescribing physicians, thereby potentially enhancing their brand loyalty.

[from New England Journal of Medicine (November 3, 2022), "Pharmaceutical Marketing Revisited: United States v. Biogen Idec" by Troyen Brennan, MD, MPH, of the Harvard T. H. Chan School of Public Health, Boston]

And another segment from the NEJM article:

The decision to settle came just before new legislation was passed allowing the federal government to negotiate the prices it pays for certain medications. Much of the opposition to this legislation centered on the fear that lower prices could lead to fewer resources being available for drug discovery. Many pharmaceutical firms, however, spend as much or more on sales and marketing as they do on research.

[Virginia]

A pet peeve of mine!

[agate]

I'm so glad you replied! After years and years of reading posts by people with MS who were both angry and amused about the vast marketing campaign directed at us, to get us on the MS drugs that weren't cures but were "disease-modifiers" that just "modulated" the disease process, I'm not so very surprised that it took so long for this case to be settled--and the settlement may not settle anything anyway, but at least it has prompted some protests against this type of drug promotion.

I recall discussions of the Avonex promotional material--the special placemat that was issued to people who chose Avonex, and the way all of their materials had a purple theme, which someone called "Avonex purple."

Directing the campaign towards patients was bad enough but coaxing doctors to prescribe MS drugs by offering them goodies should have been stopped long ago.

[Virginia]

My pet peeve is the amount of money Doctors made off these drugs pitching them to patients. I still get mad about that. For some it was a very lucrative income.

[Sunshine 2]

Biogen hurt me.

Remember when I was injecting Avonex and there were several lots that were recalled. Biogen hid that info in a letter to docs and pharmacies. They hid it by putting the information about the recalled Avonex several paragraphs down from the top of the letter. Those paragraphs above the recall information did not have anything to do with the recall.


When I was hurt by Avonex I had so much trouble breathing -- I could barely walk across the floor. I was unable to work for 6 weeks and then only part time.

The Biogen lawyers were not friendly to my case . Then when Tysabri came out and it seemed like the FDA wouldnt approve it. Biogen called me and said they wanted to re open my case I knew then it was a lie to keep me from talking to the FDA. Once Tysbari was approved, Biogen attorney called and said, "I'm sorry but our position hasn't changed"

To which I said , (and I will make up his name here) "Attorney Blair, how can you live with yourself."

[Virginia]

Sunshine, I remember that happening to you. It is a shame you couldn't do something about it.

[Sunshine 2]

I suppose I could've sued--but I would never sue anyone--it's just the way I am made.

The best I could up with was that phrase, "Attorney Blair, how can you live with yourself."

[Sunshine 2]

Thought I left a reply but it doesn't show up!

[agate]

The cards are all stacked in favor of the drug companies, aren't they? The patient doesn't have much of a chance if harm is being done.

It looks as if Big Pharma was so eager to come out with something, anything, for MS that these drugs were approved without adequate data about them.

That sounds like serious damage, Sunshine. Too bad no more was done to help you. At the time it wasn't known that you had SPS if I remember right? That's the problem. Not very much was known about the drugs, and not enough was known about the patients for whom they were being prescribed.

The symptoms and signs of so many neurological disorders seem to overlap. It must be pretty hard for any doctor to figure out exactly what is going on with many individual patients. I think the drug companies should be reined in and held more accountable, made to be more careful in their trials and other preliminary procedures that they have to go through before a drug is put on the market.