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Breast Cancer Debacle a Reminder to Be Cautious About Recent HIV News


It's a hard-to-miss story right now: two American men who had been carrying the HIV virus for 30 years are currently virus-free following bone marrow transplants to treat lymphoma. They have even stopped taking their antiretroviral medication. But a review of recent history should urge caution.

A third patient is said to be HIV-free as well following a bone marrow transplant. He received donor cells from an HIV-resistant donor. The other two did not.

This is reason to be cautiously optimistic, but not only are bone marrow transplants from donors fraught with health dangers of their own, including death, there's some historical precedence here regarding apparently successful bone marrow transplants in an patient population and the ensuing war by advocates to get insurers to pay for a costly procedure, only to learn that it wasn't the cure many thought it would be.

HSCT and Breast Cancer Advocates

This is an aspect of the fight against breast cancer that many advocates would prefer to forget.

It was the 1990s. Results from early, single-arm trials indicated that women with breast cancer who underwent high-dose chemotherapy followed by an autologous bone marrow transplant were having much better outcomes than with standard chemotherapy.

Breast cancer advocates took a page from their predecessors, the AIDS activists, and began to put enormous and aggressive pressure on health insurers to pay the $100,000 or more for this alleged breakthrough procedure against breast cancer.

Initially, insurers balked, claiming that there simply wasn't enough evidence to support the therapy in that setting. And in fact an FDA oncology panel agreed.

No matter, advocates enlisted the media and soon shows like 60 Minutes are blasting Aetna for refusing to pay for the procedure until better evidence surfaces.

In the courts, literally hundreds of cases were filed by patients against their insurer for refusing to cover the procedure. Quite a few ended in settlements, including one case in California in which a jury handed down an $89 million judgment against a health care company.

Eventually, these companies were worn down and agreed to pay for the procedure.

There was just one problem: It wasn't any good.

The Fallout

Advocates, having won the fight to get the procedure paid for, now earned the pleasure of knowing that the patients they fought for could now undergo this risky procedure, and untold thousands of women did.

But by the year 2000, a handful of well-designed randomized (not single-arm) clinical trials had demonstrated that not only was this treatment no better than the existing standard of care, it was actually worse: in the standard of care, treatment-related mortality was zero. With high-dose chemo and a stem cell transplant, it was seven percent.

In other words, no patients died from treatment toxicity under the standard of care. Seven percent of those in trials undergoing the transplant died from the toxicity of the high-dose chemotherapy, or from complications including opportunistic infections that took hold when the patient had no immune system to fight them.


We shouldn't forget what's happening here: three patients—a number so incredibly small that no scientist or researcher can take it took seriously—who were HIV positive and also diagnosed with non-Hodgkin's lymphoma had allogeneic stem cell transplants to treat their lymphoma, and all three appear to be free of the virus.

Viral infections are not, as a rule, curable. Traditionally when you contract a virus it is there to stay. It may not show up again in one's lifetime, or, like the virus that causes chicken pox, it might resurface at a later age when one becomes immunosuppressed.

It would be a tragedy if those currently living with the HIV virus but leading an otherwise normal life thanks to antiretroviral began advocating for stem cell transplants as cures only to learn ten years on that in fact they weren't cures, that all the evidence wasn't yet in, and that so many patients needlessly received chemotherapy in such high doses that it wiped out their immune system.


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