Herr Großkopf, the huge animated head, graced the Siemens booth, touting Amyvid. My new Intevo SPECT/CT was perpetually scanning a rather eerie half of a patient, also created by the geniuses of Legacy Effects. (By the way, if you want to see more on the production of Herr Großkopf, try this YouTube video: http://ift.tt/1oqQ7um
The discontinuation of Bexxar is an extreme example of a lifesaving drug being eliminated due to its relatively low profitability. In most cases, when a pharmaceutical company concludes that a niche drug is not making enough money, the product is sold to another, smaller company which continues to make it available. But continued availability is left to the discretion of the company (or companies) that owns the rights to the drug, which is how pharmaceutical companies can withhold potentially lifesaving experimental drugs that have not yet been approved by the FDA — often, due to concerns that a potential problem resulting from such use could jeopardize the drug’s ultimate approval.
Luke Timmerman, on Xconomy.com, traces Bexxar’s history:
Bexxar, developed in the late ‘90s by South San Francisco-based Coulter Pharmaceutical and acquired in 2000 by Seattle-based Corixa, had a lot going for it. The drug was aimed at a protein marker called CD20, which was already a validated molecular target for cancer, based on the success a couple years earlier of a so-called “naked” antibody from Genentech and Idec Pharmaceuticals, rituximab (Rituxan). Corixa had a well-respected CEO in Steve Gillis who attracted scientific talent, and raised lots of cash. It had a Big Pharma partner in Glaxo to help it manufacture and market the drug to the fullest.
Corixa, unable to turn Bexxar into a profit center, ended up being acquired by GlaxoSmithKline in 2005.
But there was a catch. Oncologists who saw these non-Hodgkin’s lymphoma patients could prescribe rituximab at an infusion center, along with chemotherapy. These doctors made money on every patient that went through their infusion center. Prescribing Bexxar meant they’d have to forgo that revenue stream, and refer the patient to a nuclear medicine pharmacy or radiation oncologist who could handle Bexxar or Zevalin.
“There were complicated logistics with having oncologists refer to another part of the healthcare system they normally didn’t interact with,” Rivera says. “We couldn’t get them to change their habits. The doctor would usually say ‘Oh, I’ll give the patient another course of R-CHOP’ (Rituxan plus a specific chemo regimen) instead.”
Younes, the chair of lymphoma at Memorial Sloan-Kettering, has heard the story about oncologists rejecting Bexxar because they didn’t want to refer patients to medical centers that might be seen as competitors. He says that point is “exaggerated” and notes that oncologists refer patients to other specialists all the time. He points to other problems with Bexxar’s commercialization. “It’s almost a comedy of errors,” he says.
Are we to believe that the very people who were supposed to be saving patients walked away from a cure over profit? I’m trying hard not to… There were other factors, though:
There was a muddled clinical trial strategy, Younes said. Multiple trials were opened up to expand Bexxar usage, which may have been well-intended, but the plan ended up confusing physicians about where the drug was most useful, Younes said. A lot of clinical trials were sponsored, making it possible for many patients who might have paid to get the drug to instead get it for free. Then at one point, Glaxo abruptly shut down all the trials, Younes said.
“They ended up pissing off a lot of people,” he said.
There were headaches in manufacturing an antibody that was linked to radiation. The radioactive piece of the drug came from a supplier in Canada, and the occasional snowstorm would throw the whole supply chain out of whack, causing patients infusions to be delayed, Rivera said. That was a big inconvenience for some patients who sometimes had to drive hours for a scheduled infusion at a big academic medical center, Rivera said.
So what constitutes bad sales? Reno gives us the numbers:
While Bexxar saved this writer’s life in a clinical trial in 1999 with virtually no side effects and has saved many other lives, sales of the drug did not meet GSK’s expectation. Catalina Loveman, GSK’s director of U.S. external communications, oncology, told IBTimes that total sales of Bexxar in 2012 in the U.S. and Canada were approximately $1 million; for comparison, the blockbuster drug Viagra earned Pfizer a reported $2.05 billion in sales in 2012.
Everything is relative. I guess it didn’t occur to GSK that those who survive lymphoma might eventually become Viagra customers. Oh, well. I guess a few thousand lives pale in comparison to a few million…well, need I say it?
Zevalin will remain on the market because its owner has a different outlook:
Like Bexxar, Zevalin has also struggled in the marketplace. In the third quarter 2013, Zevalin’s profits were $8 million. But unlike GSK, Spectrum Pharmaceuticals, makers of Zevalin, is committed to keeping this drug on the market.
“What is happening with Bexxar is virtually unprecedented,” said Spectrum’s chief operating officer, Ken Keller, who came to Spectrum a year and a half ago from California-based Amgen, the world’s largest independent biotech company. “I do not know of a single example of a drug company that has walked away from a drug that is this effective. Typically, when a company gives up on a treatment that works this well, they will a find a smaller company to sell it.”
Keller acknowledged that neither Bexxar nor Zevalin has been able to break through and become the blockbuster drugs that he says they both should be.
“I’ll be honest: We don’t gain a lot of value from Zevalin,” he said. “We have the data that shows how well it works, but it has still not caught on with many doctors. However, Spectrum will continue to manufacture Zevalin because our CEO [Raj Shrotriya] is on a mission to make RIT the standard of care for lymphoma in the U.S.. If this were only about finances, it could lead to different decision. But this treatment saves lives, and we believe we have an obligation to cancer patients. They deserve to have access to it.”
It occurs to me that this whole episode (put very nicely) represents a complete disservice to our patients. We have in Bexxar a VERY good treatment, a lifesaving treatment, and it was scuttled because oncologists wouldn’t use it, and they wouldn’t use it because they couldn’t make money on it, so neither could GSK. Does anyone else find this sickening?
But I’m prompted to think outside the box.
I’ve become mildly addicted to Kickstarter and Indiegogo, crowd-funding sites that promote anything from researching burritos to sending people on a one-way trip to Mars. (I’ve personally funded a couple of smart-watches that haven’t come to fruition and probably won’t, and a few other frivolous items.)
I don’t know IF GSK would consider selling the rights to Bexxar, and if they would, I don’t know how much they might want for something they buried in their corporate backyard. If the price was reasonable, I would buy the rights myself and find a way to get Bexxar back on the market. Assuming the price tag is a bit above my weekly allowance, the next step might be a Kickstarter campaign for interested parties to pick up the tab. This would include not only people like me who want Bexxar to be available, in my case as a physician, but also patients and their families as well. It would, of course, be critical to attract folks who have connections in the pharmaceutical industry who could actually put Bexxar back into production.
To my knowledge, this has not happened before. We’ve all heard of orphan drugs, but I can’t think of any/many that were actually completely suppressed in this manner. Nor have I ever heard of a consortium of the type I propose above rescuing a valid treatment from oblivion. But this needs to be done, and I challenge you to join me to do it.
GSK? Docs? Patients? Family members? Are you listening?
via Blogger http://ift.tt/1qN5bPQ June 14, 2014 at 03:56PM