Recently, the FDA announced its approval, upon accelerated review, of a new drug, Adcetris (brentuximab) for patients with Hodgkin’s lymphoma that has relapsed after bone marrow transplant and for some patients with T-cell anaplastic large cell lymphoma (ALCL).
This interests me for a lot of reasons, among them that I used to work in the field of lymphoma immunology and spent some time in my life studying molecules like CD30, the protein to which the new antibody binds.
First, a mini-primer on the disease and numbers of patients involved: Read more »
*This blog post was originally published at Medical Lessons*
Last Sunday’s New York Times featured an op-ed by Dr. Ezekiel Emanuel, on the oncology drug shortage. It’s a serious problem that’s had too-little attention in the press:
Of the 34 generic cancer drugs on the market, as of this month, 14 were in short supply. They include drugs that are the mainstay of treatment regimens used to cure leukemia, lymphoma and testicular cancer.
Emanuel considers that these cancer drug shortages have led to what amounts to an accidental rationing of cancer meds. Some desperate and/or influential patients (or doctors or hospitals) get their planned chemo and the rest, well, don’t.
The FDA [has] issued an alert about a possible link between breast implants — saline or silicone — and a rare form of lymphoma called anaplastic large cell lymphoma (ALCL). These lymphoma cases are exceedingly rare, but the association appears to be significant.
The FDA identified a total of approximately 60 ALCL cases in association with implants, worldwide. Of these, 34 were identified by review of published medical literature from 1997 to May, 2010; the others were reported by implant manufacturers and other sources. The agency estimates the number of women worldwide with breast implants is between five and 10 million. These numbers translate to between six and 12 ALCL cases in the breast, per million women with breast implants, assessed over 13 years or so.
In women who don’t have implants, ALCL is an infrequent tumor, affecting approximately one in 500,000 women is the U.S. per year. This form of lymphoma — a malignancy of lymphocytes, a kind of white blood cell — can arise almost anywhere in the body. But ALCL cases arising in the breast are unusual. The FDA reports that roughly three in 100,000,000 women are diagnosed with ALCL in the breast per year in the U.S.
These are very small numbers. Still, the finding of ALCL tumors by the implant capsules is highly suggestive. Almost all of the implant-associated ALCL cases were T-cell type, whereas most breast lymphomas are of B-cell type. The lymphomas arose in women with both silicone and saline-type implants, and in women with implants placed for purposes or augmentation and for reconstruction after mastectomy. Read more »
*This blog post was originally published at Medical Lessons*
Four-year-old Devan Tatlow’s struggle with leukemia has caused quite a stir on the Internet, prompting celebs like Paris Hilton and Kim Kardashian to encourage people to donate their bone marrow. Dr. Jon LaPook talks with Devan’s family about their search for a match.
Imagine throwing a lifesaving treatment in the garbage. That’s exactly what happens in the United States over ten thousand times a day because we do not routinely offer to collect precious umbilical cord blood at the time of birth. Thousands of Americans — many of them children — needlessly die annually because they cannot find either a bone marrow or umbilical cord blood match to help treat conditions like lymphoma and leukemia. Yet umbilical blood is discarded as medical waste in the vast majority of the more than four million births occurring each year. Read more »
I saw one of the most disturbing things of my career recently — and that is really saying something.
This was a young woman, barely out of her teens, who presented with a tumor in her distal femur, by the knee. This was not a new diagnosis — it had first been noted in January or so, and diagnosed as a Primary B-Cell Lymphoma. By now, the tumor was absolutely huge, and she came to the ER in agonizing pain. Her physical exam was just amazing. The poor thing’s knee (or more precisely, the area just above the knee) was entirely consumed by this massive, hard, immobile mass about the size of a soccer ball. She could not move the knee; it was frozen in a mid-flexed position. She hadn’t been able to walk for months. The lower leg was swollen and red due to blood clots, and the worst of the pain she was having seemed due to compression of the nerves passing behind the knee. It was like something you see out of the third world, or historic medical textbooks. I have never seen its like before.
So we got her pain managed, of course, and I sat down to talk to her and her family.
What I learned was even more amazing. The patient had been seen by the finest oncologists in the region upon diagnosis. They had all recommended the standard treatment of a combined regimen of chemotherapy and radiation. She had, however, steadfastly refused this treatment. She preferred, she said, the “Gerson Protocol.” This is, she continued, “a way for the body to heal itself with a combination of detoxification and boosting the immune system.”
In a less grave situation I might have laughed and asked “So how’s that working for ya?” As it was, the tears from her only partially-controlled pain took any humor out of the situation. She was very frustrated that the Gerson therapy wasn’t working yet, but she did not perceive this as a failure of the treatment. Her theory was that the severity of her uncontrolled pain was keeping her immune system suppressed and preventing it from working. If, she hoped, she could just get her pain under control, she would finally start to get better.
I spent a lot of time with this young lady. Listening as well as explaining. She was dead set against chemo, which to her mind was equated with the “toxins” which had caused her cancer in the first place. She wrote off the oncologists as pushing chemo “because that’s all they know how to do, and it never works.” She had, in fact, burnt all the bridges with the various oncologists who had treated her, and was now left with only a pain specialist and a primary care doctor trying to do what little they could for her. She was equally frustrated by doctors in general, who “won’t do anything to help me.”
I could see why she felt that way; when a patient refuses the only possible effective treatment, there is not really much we can do to help her.
I did what I could. I talked to both her doctors, and I called a new oncologist. The oncologist, a wonderful man, promised to make time to see her in his clinic, even fully forewarned of the “baggage” she would be bringing with her. She was happy to receive the referral, though I warned her that the new oncologist would be recommending more-or-less standard treatments. Ultimately, she went home and I was left to reflect on the futility of the situation and the absolute wickedness of the charlatans and hucksters out there who promote this sort of thinking. From the late Dr Gerson, to his modern-day counterparts Andrew Wakefield and Jenny McCarthy.
Most woo is harmless — but that’s because most woo is directed at chronic, ill-defined, or otherwise incurable conditions. Think chronic fatigue or fibromyalgia. Wave a magnet at somebody, get them to do a lot of enemas and go on a special diet, and you get to write a book and go on Oprah and collect a lot of money. If the subjects of the “magical thinking medicine” think they are better from the intervention, then so much the better.
But the really pernicious thing about allowing fantasy medical theories and treatments into the mainstream is that when they gain enough credence among the masses, they will tend to be used in place of real medical treatments that work. Like vaccines. Even the anti-vaxxers have a limited and indirect harm — of the many thousands of children who go unvaccinated, only a very few get measles and even fewer die. It’s a real harm, but one which is easy to miss if you’re not affected personally. But when woo supplants real medicine against lethal diseases that actually have effective treatments, the harm is so much more severe and so apparent that it cannot be left unrecognized. Because of the practitioners of “alternative” medical treatments who irresponsibly and dishonestly teach people to distrust medicine and embrace unscientific treatments, this young woman is enduring incalculable pain, and may well lose her life.
It’s sad, and it’s an outrage.
*This blog post was originally published at Movin' Meat*
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