Wednesday, August 7, 2013

BREAKING NEWS EXCLUSIVE: Lifesaving Cancer Drug Scrapped by GlaxoSmithKline


I've just received some sad and shocking news: The cancer drug that saved my life 14 years ago and has saved the lives of so many other cancer patients is about to be discontinued. A spokesperson for GlaxoSmithKline (GSK), the international pharmaceutical company, sent me a note today informing me that the the company will halt the manufacture and sale of Bexxar on Feb. 20, 2014. 

Bexxar is a so-called radio-immunotherapy (RIT) that is currently approved for the treatment of certain types of non-Hodgkin’s lymphoma, including the most common type, follicular. I was treated with Bexxar in a clinical trial in April, 1999 and have not been treated for my cancer since - though I did fall out of remission recently and am currently mulling over my treatment options. 

Simply put, Bexxar saved my life, and has saved the lives of many of my fellow cancer patients, some of whom are profiled in my book "Hope Begins in the Dark: 40 Lymphoma Survivors Share Their Exclusive Life Stories."

The company says it was announcing its decision now "to give treatment centers in the U.S. and Canada currently offering Bexxar adequate time to consider and, if appropriate, transition to other therapies."

Gee, how thoughtful of them. The note also disingenuously suggests that the decision to discontinue 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. Additionally, there are other treatment options available for patients with relapsed non-Hodgkin’s lymphoma."

But studies have shown that RIT – both Bexxar and its competitor, Zevalin - have given non-Hodgkin's lymphoma patients longer remissions than any other available treatment, including the so-called standard of care: chemotherapy plus Rituxan. Yes, Bexxar is evidently more effective and less toxic than the treatment that is still being used in far greater numbers.

Dr. Mark Kaminski, developer of Bexxar
Bexxar, which was developed by Mark Kaminski, a kind and brilliant hematologist and researcher at the University of Michigan, was simply never given a chance to succeed for a variety of reasons that have nothing to do with how effective it is. 

Bernadette King, a GSK spokesperson, told me today that GSK considered a "range of options" in an attempt to continue to make Bexxar available for patients. But after a "substantial and considered review, the company reached the decision to discontinue the manufacture and sale of the product," she says.

"However, in keeping with GSK’s focus on transparency and collaboration, GSK plans to make available, for legitimate research purposes, the cell line that secretes the anti-CD20 antibody used to make Bexxar," King adds. "Access to the cell line will require that the user first enter a material transfer and other appropriate agreements. Because GSK will provide such access to the cell line, GSK does not plan to replenish antibody supply."

King concluded, "As you know, Bexxar is a therapy that involves very complicated manufacturing and supply chain processes. The cell line is but one component of the product. It is used to produce the antibody for that product. It would be the responsibility of the user to assess the utility of the cell line in the manufacture of a biosimilar in any country, or for research or other purposes, and to obtain any licenses required for any contemplated use, e.g.intellectual property or regulatory licenses."

Is this supposed to make those of us who support RIT feel better about GSK's untenable decision to sack this drug? There are years and years of research dedicated to Bexxar, a highly effective therapy that offers an easy and quick treatment time of about one week. It's very well tolerated and for most people causes few side effects. I had virtually none, other than some tiredness and temporarily low blood counts.

Bexxar often results in very long remissions. I know several people who have been treated with Bexxar who are still in remission more than a decade later. It gave me an almost miraculous 13-plus years of remission. Whereas the chemotherapy I did in 1997 gave me less than two years. Pretty simple math, yes?

But since its approval 13 years ago, it seems no one has known how to market this treatment. RIT has been used by fewer than ten percent of patients who might benefit from it. It's a tragedy, the slow but sure demise of this drug. It clearly has more to do with money, and doctors’ refusal to embrace something new, and drug companies’ refusal to fight for this drug, than with saving lives. 

Thankfully, Zevalin, which is manufactured by Spectrum Pharmaceuticals, is still available. But one must wonder now about Zevalin's future, too.

Over the next six months, GSK says it will continue to provide support services for patients and treatment centers. Physicians and patients with questions can call the GSK Response Center (GRC) at 888-825-5249.

At the bottom of its announcement today, GSK ended with the most offensive line: "GSK’s commitment to the oncology community will continue through our efforts to develop and deliver other therapies to help address the unmet needs of patients living with cancer."

Commitment? Are you kidding? This multi-billion dollar company never did nearly enough to support or promote Bexxar. I tried on an almost daily basis over the past decade to spread the word about this amazing treatment. The drug company simply gave up on it. Shame on GSK.

Over the last decade, RIT has been the subject of considerable media attention. Publications ranging from my longtime employer, Newsweek, to the New York Times have reported the fact that this therapy has never been utilized as much as it should by lymphoma patients for reasons that have nothing to do with its efficacy. 

There are all sorts of issues ranging from inequitable Medicare reimbursement rates to unfounded fears by patients and even some doctors that this treatment is dangerous and problematic because of the radiation component.

There are numerous false notions about RIT, and unfortunately neither GSK nor the nation's oncologists have done enough to dispel them. For example, contrary to popular belief, there is no evidence that Bexxar increases the risk of secondary concerns any more than chemo. 

It's also not true, despite what some say, that there is too little data to make an informed decision about using RIT. An enormous amount of data has in fact been collected in the nearly two decades since trials for RIT began in 1990. 

In short, Bexxar saved my life, and saved the lives of many others. It is nothing less than a tragedy that it is being shelved. 


37 comments:

  1. This is very sad. I've already discussed tx with Bexxar upon relapse with my oncologist and he was in agreement with me. I hope there are no plans to discontinue Zevalin.

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    1. I hope so too, Loretta. Stay tuned to this blog, I am reaching out to the makers of Zevalin to find out.

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  2. Jamie:

    Since I have been in touch with you since last year, I have used you to help me get through the difficult period of time when my wife, Sara, was first diagnosed with cancer. Your support was like a rock for me. Right now, it looks like she may have beaten her cancer. As a result, anything you say that is good for cancer patients, I accept without question. Obviously, I don't know nearly as much as you do but I want you to know that I'm in the tank with you on this one. Just let me know what I can do and I'll go into battle right now. Tell me who I have to shoot or who I need to talk to.

    A proud combat veteran, and a loyal friend...........John Cook

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    1. John, my friend, this means a lot to me. I think we need to go to battle to save this drug. We need to contact GSK, and also contact every oncologist we know and insist that they do all they can to save Bexxar! I have also contacted Spectrum and I am waiting to hear back form them regarding the status of Zevalin, whose survival now is more crucial than ever. Thanks again for your support.

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  3. This is tragic. I hope there is a good pr campaign for Zevalin via social media, earned media etc. Perhaps the other company will be eager to save people and grow their business.

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    1. I very much hope this is the case. I have contacted Specturm, the makers of Zevalin, and will keep you all posted on their response and their outlook for Zevalin's future.

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  4. Although Bexxar is a great drug, there are some major problems with it from a business standpoint. It is a very difficult and expensive drug to make, and the incidence of non-Hodgkin’s lymphoma (NHL) which it is intended to treat is relatively low (~4% of all cancers). This means that the product has to be priced very high for the manufacturer to make a profit or just break even. And because the price is very high and because there are other lower cost treatments for NHL (although they may be less effective), insurers and Medicare either do not cover Bexxar or the reimbursement rate for it is poor. Also, because Bexxar is a radio-therapy, it can only be administered in a hospital that is licensed to store and handle radiologic agents. This is not all of them, and depending on affiliation may mean that your doctor will have to refer you to someone else in order for you to receive Bexxar. Many doctors will not do that, especially since there are other treatments available for NHL. I would be willing to bet that before deciding to discontinue Bexxar GSK tried to sell the marketing rights to someone else to not only keep it on the market, but also to make a bit more money from it - and no one was interested because it is unlikely to be profitable. If it were inexpensive and easy to make, some governments might produce it themselves, but for this drug that will not be possible without a large investment in the right manufacturing equipment. The best hope for this product would be if governments offered a private company a financial incentive to continue to produce it. The same thing that is starting to happen with some of the intravenously administered drugs that are hard to make and always in short supply.

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    1. You have absolutely no idea what you are talking about. First of all, please have the courage to identify ourself if you are going to spread such nonsense. The incidence of NHL which it is intended to treat is "relative low."? What are you talking about? As I noted, Bexxar has only been used on 10 percent, or less, of the patients who could benefit from this drug. Bexxar is well suited to treat follicular non-Hodgkin's lymphoma, which is by far the most common type of NHL. You are also wrong about cost. The price can actually often much less than chemotherapy/rituxan, because there is one injection rather than many. And you even admit that other treatments can be less effective and that this is a 'great drug.' If it is the best treatment for a person's cancer, your doctor should recommend Bexxar, even if someone else would have to administer the drug. Period. Your often contradictory and ill-informed rant here just makes you look like a fool. Who are you?

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  6. You write that Glaxo Smith Kline "never did nearly enough to support or promote Bexxar." "Shame on GSK." In fact, the company has lost tens of millions of dollars over the last decade supporting Bexxar. There are other problems with marketing Bexxar and Zevalin, but it is primarily the oncologists who have killed the RIT drugs. Most oncologists are intrinsically opposed to using Bexxar and Zevalin because it normally causes them to turn their patient over to another department or hospital, i.e. the oncologist loses the patient. This is well known among lymphoma oncologists and I consider it a scandal -- doctors not using the best treatment for a cancer because it might hurt them financially.

    Calling Glaxo a "multi-billion dollar company" is true but misleading. They're still quite profitable but their earnings and cash on hand is dwarfed by a whopping $30 billion in debt. If their new drug pipeline can't replace the present patent protected drugs they're selling, Glaxo will be facing extinction just like Bexxar. In short, this isn't the company to continue the charity that Bexxar has become.

    I'm neither a spokesperson for Glaxo or a shareholder, my knowledge comes from also being a follicular lymphoma patient who received Zevalin in 2012. I had to go through 5 doctors at 4 hospitals before finding one that agreed to use Zevalin.

    Zevalin's sales aren't trending any better than Bexxar's and their company, Spectrum Pharmaceuticals, is doing even worse. Zevalin's sales were $6.8 million in the last quarter while the company lost over $10 million on just over $30 million in total sales. Needless to say, Spectrum won't be in business much longer with results like that. Perhaps now that they've obtained the rights to market Zevalin in Europe, things will improve, but I'm clutching at straws.

    Bexxar and Zevalin should each have a billion dollar in sales annually but due to opposition from oncologists, they seem unable to survive on their own.

    Sorry to hear about your relapse. For the cancer to return after thirteen years in remission is almost a record as far as the information I have. If your bone marrow's up to it, Zevalin might be a good choice for treatment.

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    1. Please identify yourself, or stop posting on my news blog. And no, it is not a record. I know several folks who have had even longer remissions from Bexxar, some are in my book. You are right about only one thing: oncologists! They are indeed party to blame for this. But you are wrong to defend GSK. Much, much, much more indeed could have been done to woo doctors, to reach out to the national patient community, to work with patient advocates, and to advertise this drug. Yes, advertise!!! GSK gave up on this drug quite some time ago, and it is shameful. If you create awareness in the patient population, which GSK utterly failed to do, then there would have been an increase in patient demand and oncologists would have acquiesced. Your thesis here is fatally flawed. This drug works, it kills cancer with typically few side effects, and it is arguably criminal to trash something that saves lives. GSK could have done so much more to champion this amazing drug, to get oncologists on board, to reach out, to do whatever had to be done. If theny had, they you can talk to me, with a straight face, about GSK's alleged "commitment" to cancer patients. And for you to say that it is misleading to call GSK a multi-billion dollar company is misleading is ridiculous. i'm glad you were able to use Zevalin. Stop "clutching at straws" and get off your butt and help RIT survive. Shout it from the rooftops. This therapy works. There is no excuse for drug company the size of GSK to let this drug die, when millions and millions and millions are being spent advertising so many MORE PROFITABLE but less essential drugs like Alli. Give me a break anonymous. You sure know a lot about GSK and Spectrum's books. And if you post again without telling us who you are, it will be deleted.

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    2. My good friend Teresa Singh was diagnosed with stage IV non-Hodgkin's lymphoma in 1996 and did an early Bexxar clinical trial. She has been in remission for 17 years http://hopebeginsinthedark.com .

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  7. I received Bexxar as my first-line treatment in 2007, and have been cancer-free since January 2nd, 2008. One of the main reasons I was able to convince my insurance company to pay for the treatment? It actually cost LESS than the standard chemotherapy regimen R-CHOP, at least at that time.

    As has been discussed, the underutilization of Bexxar has many contributing factors. But chief among them are: 1) Lack of awareness among patients; and 2) Lack of support among community oncologists. With Jamie's points about GSK's failure to successfully market the product noted, the sad fact is: community oncologists, who know chemotherapy and make money from administering it, just aren't going to refer you to a nuclear medicine facility and give up their own control (and, yes, profit).

    I spoke about Bexxar at a conference for nuclear medicine last month, and no fewer than three NHL patients in the audience were mad, or at least shocked, they'd never heard of Bexxar. "My oncologist never told me about this," one man said to me afterward. I suppose we can lay the blame for this at the door of GSK; simple marketing strategy should have told them they needed to bypass the gatekeepers--the community oncologists--and go directly to the end consumers in a big way. They didn't, for reasons that mystify me.

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    1. Thanks for setting the record straight. TL. You are right on the mark. If GSK had done more (much more) to reach out to the nationwide lymphoma patient population, those patients would have demanded that Bexxar be part of the conversation and the drug would have been used far more often. The fault lies at the feet of both doctors and GSK.

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  8. At first my oncoloogist from a community cancer center balked at the idea of RIT and said I could use Rituxan again at relapse. At my next visit, he said he would refer me to a hospital for RIT and he admitted it would provide me with the longest remission possible. He is one of the good docs who cares about his patients versus dollars.

    Jamie let me know what I can do to assist you in your efforts.

    Loretta

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    1. Thanks Loretta. My personal email is jreno@san.rr.com. I do need your help. Let's rally thee troops. We need to save this drug.

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  9. dx FALL 1998 Stage IV Follicular B-Cell NHL. Bexxar June 1999, Stage II clinical trial - NY Presbyterian Hospital, Dr. John Leonard. Clinical and molecular remission dx'd September 1999. Remission since.

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  10. Jamie:
    Thanks for the great post. I'm a follicular survivor treated initially with Rituxan + chemo. Somewhat shocked not to have heard of Bexxar. Wondering if the studies comparing RIT to Rituxan + chemo looked at R-CHOP or BR (Bendamustine + CHOP). I know BR appears more effective/less toxic than R-CHOP from everything I've read/seen.
    Glad to help rally any troops to try and save Bexxar.

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    1. Thanks Michael very much. Please connect me with any others who have done Bexxar. Cheers, Jamie

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  11. GSK is still under contract to manufacture the drug Bexxar until Oct 2014. The company hired to manufacture the drug ( Nordion ) was shocked by the news to terminate the drug.....

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    1. Thanks for sharing that info. Please send me a private email at jreno@san.rr.com, I would like to know who you are and how you know about Nordion's reaction. Thanks!

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  12. Thanks Jemie-
    It's a great information for me. From this blog I got to know Bexxar and Zevalin. I did not hear anything about this drug from all the oncologist I met in Bangladesh when I was diagnosed with NHL(Intermediate stage-B Cell Lymphoma). I still remember I did ask some oncologists of other drugs for NHL when I was prescribed to receive rituxan with CHOP. All of them said that RITUXAN is a only drug developed so far(2012) for NHL. Your article makes me feel fortunate thinking I did not take RITUXAN for some reasons. I must discuss about this drug next I meet my oncologist. I am feeling great that if my NHL meets me again(relapse)I must think of dexxar though I am not sure I will find it.

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    1. I wish you the very best. I don;t know about the drug's availability in your country. But I would urge your oncologist to make it available to you if you ever need it. But Bexxar will only be available for another few months.

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    2. Thank you much Jamie. It's sad to know of its availability. I'd like to contact you if I need it anytime. This is great a platform for survivors.

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    3. Thanks, Moshaddek, yes, contact me any time at jreno@san.rr.com

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  13. Yes, Bexxar is evidently more effective and less toxic than the treatment that is still being used in far greater numbers dewatangkas.net

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    1. What a smug response to the elimination of an outstanding cancer therapy. Do I know you? Where is this being done, and who is being trained? Name one cancer center that even has this radiolabeling of which you speak on its radar? Your information doesn't "help" at all, because no one is doing this process you cite. Give me examples. No, GSK didn't drop Bexxar because of the reasons you suggest. And, no, I have never been treated with Rituxan. I did CHOP chemo in 1997, and then did Bexxar in 1999. Thanks for checking in.

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  17. After tracking durable Bexxar remissions such as above, my father (DLBCL) enrolled in a low-dose Zevalin clinical trial in ~2003. He had a partial response that unfortunately was not durable. His platelets always seemed lower after the treatment. Although I was thankful for the partial response, I always suspected that the radioactive options tend to have more permanent impact on the bone marrow. I agree about the issue around oncologist disincentives. I just don't know if anything could have made Bexxar break even.

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  18. The impact to the bone marrow for Zevalin [or Bexxar] is temporary, as it doesn't affect the haematologic stem cells, and so your white cell and platelet numbers return to normal. However, things are different if you have significant bone marrow involvement with your disease and as such, the doctors need to be careful.

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  19. I live in Germany, where Bexxar is not available to us. Zevalin is very expensive. However, the hospital in Berlin, where they will be going to give myself 131I rituximab. They said it works exactly like Bexxar - but it's better as I have less chance of severe allergic reactions if I need retreatment.

    Do you know of anything like this? I am worried that I am not getting best treatment.

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    1. yes, this is radio-immunotherapy. you should be fine with this. http://clinicaltrials.gov/show/NCT01676558
      http://www.ncbi.nlm.nih.gov/pubmed/15937686

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