November 17, 2014 — Bye, Bye Bexxar

There are many ways our market-driven healthcare-funding system in the United States is just plain crazy, but one of the most damaging is the way it tends to suppress certain vital and effective medications. This has evidently just happened to Bexxar, which is no longer available. Along with its competitor Zevalin, Bexxar is a radioimmunotherapy agent.

Radioimmunotherapy is an ingenious bonding of a monoclonal antibody drug — Rituxan (rituximab) — with tiny radioactive particles. It delivers a one-two punch: the Rituxan chemically seeks out the cancer cells and the radioactive particle destroys them.

Radioimmunotherapy has proven to be very effective, and has the added advantage of doing its job in just one dose, with minimal side effects.

What’s not to like?

The people who really don’t like it are oncologists. And why? Because not many of them have the proper qualifications to administer it. As a hybrid of nuclear medicine and oncology, radioimmunotherapy requires doctors either to be dual-certified in both disciplines or to be part of a large clinic or group where both specialties are represented (a rare thing, in this case).

Many oncologists profit on two levels: both their professional fees and the fees they charge for running a chemotherapy suite. If their chemo suite doesn’t offer nuclear medicine as well, they lose a big chunk of change by referring a patient out.

An oncologist who refers a patient for radioimmunotherapy loses tens of thousands of dollars in billable fees. That’s a powerful financial incentive to stick with traditional chemo — even though that treatment takes longer (many months of infusions as compared to a single injection) and often has arduous side-effects.

This is not a problem for a large, multi-specialty clinic, but the typical oncology practice — which includes a group of oncologists only — can’t handle it. As Dr. Bruce Cheson of Georgetown University puts it, “patients had to be referred from one doctor to somebody somewhere else, which meant not only losing control of the patient, but also losing income from the patient.”

In many cases, radioimmunotherapy agents cost less — not as a single dose, but when averaged out over the total time required for treatment.

“There is actually no other drug out there with a track record like this,” writes Dr. Mark Kaminski of the University of Michigan, who helped devlop Bexxar. “Approximately 30% of patients can achieve long-term remission with Bexxar lasting over a decade. That's the biggest disappointment with this drug, now that it's gone, for patients with this disease — it was an easy treatment, it took only one week to finish, and if there were any side effects, they were all reversible. I've been giving Zevalin lately because I don't have Bexxar to work with, but I don't have as much confidence that it will be a solution for patients as much as Bexxar would have been.”

If we had a single-payer healthcare system (like Medicare), and if doctors practiced in multi-specialty clinics like the Mayo Clinic or the Cleveland Clinic — where they receive a salary rather than billing patients by the hour — then doctors wouldn’t stand to lose by recommending radioimmunotherapy. More patients would benefit.

Why do we expect physicians to be both medical practitioners and entrepreneurs? Sometimes those two functions are in conflict with one another, and this is a prime example.

Too often in our healthcare system, profits come first and patients second.

December 27, 2012 - Profit Centers

If you’re a cancer patient who has received chemo treatments in your doctor’s office, here’s an article that may give you pause.  It’s a Reuters article by Andrew M. Seaman, dated yesterday: “Some cancer docs say their income tied to treatments.”

As the article makes clear, it’s not a question of whether oncologists actually do make more money administering treatments in their offices (as opposed to referring patients to a hospital’s outpatient clinic). The question is whether the doctors THINK they do.

If they do think that’s the case, then there’s the potential for a disturbing conflict of interest.

Here’s the $50,000 (or more) question: “In the case of oncologists who also run chemo clinics, what takes first priority in their minds — the medical necessity of a given round of treatment or their potential to realize a higher profit?”

I’d like to think most doctors are above such venal considerations. Yet, I’m also enough of a Calvinist to believe no one is immune to that sort of temptation. Better to eliminate the temptation, I say, than to count on human nature to always pursue the most ethical course, when there are pecuniary considerations at work.

Speaking for myself, I have to say I still have great personal confidence in Dr. Lerner, my oncologist, even though he and his colleagues in the medical group do own a chemo clinic (where I did, in fact, receive my treatments). That’s because of a certain experience I've had. When, just after my R-CHOP chemo treatments had ended, the question came up about the advisability of maintenance Rituxan treatments in my case, Dr. Lerner recommended against it. He said, at the time, that in his view the body of research was still not there to declare that this was, indeed, the right thing to do.

I do realize it’s now over 6 years later, and the results of some more recent clinical trials would perhaps lead my doctor to give different advice today, but  the important thing, to me, is that he declined on medical grounds to recommend that expensive treatment that would have put more profits in his pocket.

It’s these very same maintenance Rituxan treatments, that can continue monthly for many years after initial chemo treatment, that some doctors refer to as their “Rituxan retirement plan.”

The historic pattern, with most medications, is for doctors to write a prescription and for a pharmacy to fill it. Unless the doctor also happens to own the pharmacy, there’s no conflict of interest. When doctors own outpatient chemo clinics, however, it’s as though the doctor owns the pharmacy.

The same is true for the “outpatient surgi-centers” that have sprung up all over the place — which are typically owned by the very same doctors who refer patients to them (and, in most cases, perform the surgeries as well). They’re essentially little freestanding, specialized operating-and-recovery rooms. They make it possible for patients to undergo outpatient surgery, complete with general anesthesia, without ever setting foot in a hospital. (An ambulance is permanently parked out back, to whisk patients to the hospital, should complications develop.)

The problem — for non-profit hospitals, anyway — is that the for-profit surgi-centers siphon off many of the operations that typically bring in more money than they cost to perform. This leads to underused hospital operating-rooms and a corresponding decline in hospital income. The hospitals, then, are stuck with paying all the costs of operations and outpatient treatments for uninsured or underinsured patients, who would never make it through the door of the doctor-owned facilities.

At the very least, I think you’ll agree: this is something worth pondering, right?

August 7, 2011 – Drug Shortage

On Friday, I rode the train into Manhattan for a consultation with Dr. Stephanie Fish, my newly-assigned endocrinologist from Memorial Sloan-Kettering.

I found Dr. Fish to be well-informed about my case, and ready with answers to all my questions about my upcoming radioactive-iodine treatment (the routine follow-up to my thyroid surgery recommended by the surgeon, Dr. Boyle).

I did encounter one problem I hadn’t expected. Dr. Fish explained that, as an essential part of my preparation for taking the radioactive-iodine pill, I will be injected with a drug called Thyrogen a few days before. There’s currently a shortage of this drug, due to some manufacturing problems at Genzyme, the company that makes it. It’s simply not available.

Genzyme has been acquired by a larger pharmaceutical company, Sanofi-Aventis. I don’t know if that acquisition has any role in the supply problem. I did learn that there were some quality-control issues with Genzyme’s manufacturing process for Thyrogen, which led the FDA to order a temporary suspension of sales.

This shortage was reported in the New York Times in May, although I missed reading about it.

Genzyme has issued an advisory statement about future availability of the drug.

Dr. Fish explained that Memorial Sloan-Kettering is the single largest user of Thyrogen in the country (and is therefore Genzyme’s best customer), so they expect to be at the head of the line when the medicine is finally handed out. Even so, she doesn’t expect that to be for several weeks at least, and even that is uncertain.

What Thyrogen does, she explained, is to raise the level of TSH, or thyroid stimulating hormone, in the body. For people who still have their thyroids, TSH is what tells the thyroid to ratchet up its production of thyroid hormone. In order for the radioactive iodine to be effective in hunting down and destroying any stray particles of thyroid tissue that may still be present after surgery, the level of TSH must be high.

The old-fashioned way to do this is to have patients simply stop taking their thyroid medication (synthroid or levothyroxine) for a couple of weeks. This makes them feel really lousy, as the body copes with the acute shortage. Thyrogen directly raises the TSH level, without the side effects, so it’s by far the most desirable way to conduct the radioactive-iodine treatment.

This would be well and good, were Thyrogen presently available. But, it’s not. So, patients are faced with an undesirable choice between two options. They can either proceed with the treatment and brave the miserable side-effects, or wait until the drug is available, and risk the consequences of delaying treatment.

In my case, she says, there’s no extreme hurry. The papillary thyroid cancer I have is generally slow-moving, and even though my tall-cell subtype is a bit more aggressive, still there’s nothing to be lost from waiting till sometime in the fall to undergo the treatment.

Even so, this shortage makes me uneasy, and also a bit angry. The pharmaceutical companies are protected by patents, which allow them to make a great deal of money for a period of time after they bring out a new drug. This, they claim, is the only way they can recover their substantial research and development costs. Yet, that also means that, if there's a manufacturing or distribution problem, the patients are out of luck. There's no competitor to fill the gap.

Dr. Fish’s office will call me as soon as they know for sure when they’ll have my Thyrogen injections in stock, so we can get some dates on the calendar.

There’s a lot more to say about the details of the radioactive-iodine treatment, the extensive dietary preparation leading up to it, and the safety procedures that must be followed afterwards, but I’ll save that for a subsequent blog post. The drug-shortage problem must be overcome first.

November 18, 2010 – Help! I’m a Market Segment

I ran across this link recently, describing a subscription newsletter issued by a financial-information firm, communicating the latest news and statistics on “the global NHL market.”

Yes, that’s right. The “NHL” in “NHL market” refers to non-Hodgkin lymphoma. There are actually financial analysts out there who make it their business to study the strength of companies developing drugs and other therapies to treat NHL.

We all know that health care in this country is profit-driven, but this displays the seamy underside of that reality. Some of these technological developments tracked by this service represent life and death for people like me. We follow this information in order to stay as healthy as we possibly can. Subscribers to this newsletter follow the same information in order to make a buck. Lots of bucks, actually.

I read this stuff and I end up feeling vaguely dirty, for no particular reason. How does it strike the rest of you, especially folks who are dealing with cancer?