By Jamie Reno - These are the final days for Bexxar, a lifesaving cancer treatment that drug giant GlaxoSmithKline (NYSE:GSK) announced last summer would be discontinued on Feb. 20 because it wasn’t earning the company enough money. That harsh reality has begun to sink in for those who adamantly oppose GSK’s decision to scrap this effective, safe, FDA-approved therapy for lymphoma, the nation’s seventh most common cancer for men and women.
“As a corporate CEO, I understand that GSK might kill a drug that loses money, but what I don’t understand is why they seemed to not be willing to make the modest investments required to make this lifesaving treatment a success,” said Michael Werner, who runs several companies, is a lymphoma survivor, and sits on the board of directors for the Lymphoma Research Foundation, the nation’s largest nonprofit dedicated to funding lymphoma research.
Werner said GSK, the fourth-largest pharmaceutical company in the world with revenues in the third quarter of 2013 of $10.1 billion, had all the tools to make Bexxar successful.
“It seems like maybe they lacked the will,” he said. “What a shame that thousands of patients will now be denied a treatment that might have saved their lives. It shouldn’t and doesn’t have to be this way.”
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.
Bexxar, a radio-immunotherapy (generally known as an RIT), approved in 2003 in the U.S. for people with non-Hodgkin’s lymphoma, homes in on tumor cells with a radioactive isotope, iodine-131, killing the cancer but generally sparing normal tissue. Numerous studies show that Bexxar gives non-Hodgkin’s lymphoma patients longer remissions than any other treatment, including the standard of care: chemotherapy plus the monoclonal antibody drug Rituxan, and with fewer harsh side effects.
But the therapy, which was touted by NBC’s Dateline back in October 1998 as a new wonder drug, never really caught on with oncologists and hematologists, who typically prefer to prescribe traditional chemo plus Rituxan, which can be given in a doctor’s office. Because of its radiation component, Bexxar must be administered by a doctor who is licensed in nuclear medicine or radiation oncology.
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, compared with far higher profits for a blockbuster drug such as Viagra, which earned Pfizer a reported $2.05 billion in sales in 2012.
In a statement last August, GSK said its decision to stop manufacturing Bexxar involved a “thoughtful and careful evaluation of patient needs and the clinical use of the therapy. The use of Bexxar has been extremely limited and is projected to continue to decline.”
Loveman said GSK “invested substantially in Bexxar throughout its lifecycle,” and said that the company’s “commitment to patients with cancer and the oncology community will continue through our efforts to develop and deliver other cancer therapies aimed at strengthening standards of care and addressing unmet needs.”
GSK would not divulge how much money was spent to market Bexxar, or why the drug was never advertised in print or on television, or what, if any, efforts were made to sell the drug to another company rather than just dump it. But a number of patient advocates, patients and oncologists interviewed for this story questioned GSK’s commitment to the therapy, and asked if this or any drug company should be legally allowed to simply stop manufacturing a cancer drug that works so well.
“No other treatment has shown to produce the results that Bexxar has shown,” said Betsy de Parry, a patient advocate, 12-year lymphoma survivor and author of "Adventures in Cancer Land." “Given the recurring nature of lymphoma, which requires successive treatments, and Bexxar’s results, it is tragic to lose this option. I know people who took Bexxar in clinical trials as long as 19 years ago who remain disease-free. Don’t others deserve that same chance? These are real human beings we’re talking about, not statistics, not profit margins.”
Tom Stark, also a patient advocate who was treated with Bexxar two years ago, said that if GSK advertised the drug, perhaps more people would know about it and would have asked their doctor.
“I only knew about Bexxar because I spent around 100 hours researching lymphoma on the Internet,” Stark said. “Not everyone has the time or the ability to do that. Bottom line: Bexxar saves lives, and losing it means that more people will die needlessly.”
Good For Business, Not Good for Patients
This isn’t the only time in recent memory that a drug company appears to have made a decision that has more to do with what is good for business than with what is good for patients. Last year, pharmaceutical companies Merck and Bristol-Myers Squibb (BMS) both declined to give their lifesaving treatment to a 41-year-old husband and father of three young children who was dying from stage 4 melanoma.
Nick Auden bravely campaigned for access to a clinical trial of anti-PD-1, a treatment currently being tested separately by Merck and BMS, but could not convince either company to give him the drug. His family initiated an Internet campaign to urge the drug companies to allow Auden special consideration. A petition on Change.org generated more than a half million signatures.
Stage 4 melanoma has long been considered incurable, but this new anti-PD-1 drug, which helps the immune system attack the cancer, is showing remarkable, unprecedented results in these trials for patients like Auden. Studies of Merck’s version of the drug found that 52 percent of participants who took the higher dose of the drug in a clinical trial saw their tumors shrink. Auden’s doctors told him they believed it was his only chance to survive, and several other prominent oncologists that the family contacted agreed.
But the drug companies were unmoved, and Auden died on Nov. 22. Bristol-Myers Squibb cited safety concerns for not giving Auden the drug, while Merck said it didn’t have enough of the drug to give it to him. Auden’s widow, Amy Auden, doesn’t believe either company is telling the truth.
“These were late phase-three clinical trials. These drug companies both knew full well this drug was safe,” Amy Auden told IBTimes. “This was all about the companies not wanting to do anything to jeopardize the [FDA’s] approval of their product. It could have cost them millions of dollars if something bad had happened in Nick’s case and it somehow delayed that approval. They put profit above people.”
As for the decision to dump Bexxar, a spokesperson for GSK noted that there are other treatment options available for patients with relapsed non-Hodgkin’s lymphoma. And that is true: There is still chemotherapy and Rituxan. And there is Zevalin, a drug that, like Bexxar, is an RIT, and has been shown in studies to be very effective. Some patients respond better to one treatment than the others. As Stark said of Zevalin, “The radiation is different, it does not travel as far, and while it is good, it is in my opinion not as good as Bexxar.” Others disagree with that assessment, but no one disputes that both drugs are safe and very effective cancer fighters, and almost everyone interviewed for this story -- other than GSK -- said patients should have access to both.
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.”
Dr. Lawrence Piro, a Los Angeles oncologist and president and CEO of The Angles Clinic and Research Institute, uses Bexxar as well as Zevalin in his clinic. He said he strongly believes both drugs should remain available to patients, and said the blame for the demise of Bexxar must be shared by GSK and American oncologists.
“While we can talk about how sad it is for patients that a drug company makes a decision like this, we also have to look to the oncology community and ask why it never adopted or supported this therapy,” Piro said. “Some doctors resisted it because it was easier to give chemo and/or Rituxan, and some had fears that there would be as-yet undetermined long-term consequences to this treatment. And for many doctors, Bexxar was problematic because in most cases the oncologist does not administer the therapy; you need a nuclear medicine doctor to administer it. All of this resulted in a disconnect and made doctors feel like it was too complicated and out of their comfort zone.”
But, Piro emphasized, “The truth is Bexxar is a highly effective cancer therapy, and none of these factors are compelling enough for doctors to not tell patients about it as an option. I believe that it is important for patients to hear about all of their options, and I am very sorry to see it go. However, I am happy that there is another RIT available for patients who might want to use it.”
Critics of GSK’s decision to discontinue Bexxar, as well as critics of Merck and BMS’s decision to not allow Auden to be treated with their respective drugs, believe that new laws should be passed to compel drug companies to consider sick and dying patients and not just the bottom line.
“I don’t believe a drug company should ever be allowed to just get rid of a cancer treatment that works so well,” Stark said.
Added Amy Auden, whose campaign for her husband attracted support from cancer experts, politicians, celebrities and even the FDA: “I am hoping we will see legislation someday soon that forces drug companies to provide compassionate access to potentially lifesaving medicines in late-phase trials.”