Cancer Treatments and Care

Provenge: The Battle for a New Prostate Cancer Treatment

2007-08-07T14:29:00.000-04:00

Right now, there is a public drama being played out between the FDA and a company called Dendreon, whose product Provenge is being developed for treatment of prostate cancer. What distinguishes this particular drug approval process is the public nature of the debate, with strongly worded statements from advocates and investors who each have large stakes -- though not necessarily the same stakes -- in the ultimate outcome of the FDA decision.

Before a drug can be sold in the US, it must be approved by the Food and Drug Administration (FDA) as being safe and effective for its stated purpose. As you might imagine, the stakes for a company seeking drug approval are very high. The only hope for a return on their investment in the drug is the ultimate approval, which allows them to market the product.

The FDA approval process begins at the time before major studies are conducted on a drug. The manufacturer will often meet with the FDA, and lay out a series of clinical trials and goals to be met for approval. Usually in cancer medicine, the company and the FDA will negotiate a particular endpoints such as time before tumor progression, or percentage of responses in patients with advanced cancer, or improvement in overall survival. In general, if the subsequent clinical trial meets those endpoints, FDA would consider granting approval.

However, there are additional layers to the approval process. FDA conducts an internal review of the data and also appoints expert panels that advise FDA. Those panel recommendations may, or may not, be honored in final FDA deliberations.

Sometimes the discussions get very complicated and intense. For instance, studies might meet some endpoints (like improving the length of tumor control), but not others (like improving overall survival). In other cases, side effects might emerge which undermine the anticipated safety of the drugs.

FDA, like many regulatory agencies, is relatively short-staffed, and must confront requests from innumerable parties such as drug manufacturers, advisory panels, patient advocates, and others in reaching their conclusions.

Here are several recent newspaper stories on this battle. It will be interesting to see what happens.

Seattle Times: FDA Sued over Provenge Delay
Washington Post: FDA Delay in Cancer Therapy is Attacked
Boston.com: Prostate Therapy's Delay Sets Off a Fight

Do you think the FDA is right to study this drug further before approving it, or should experimental cancer therapies be fast-tracked through the approval process?

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Technorati Tags: provenge, dendreon, FDA, prostate cancer, vaccine

Doctors and Money: The Rising Cost of Cancer Care

2007-07-05T16:40:00.000-04:00

It is no surprise that doctors earn a living caring for patients, and that cancer specialists are paid to care for cancer patients. But many may not be familiar with how doctors in the US are paid, nor how closely linked are specific treatment recommendations and doctor's earnings. In the next several blogs, I wanted to touch on aspects of doctors and money.

The issue of oncologist earnings has been put forward recently as part of a larger emerging dialogue that centers on the growing cost of cancer care. Because of progress in helping treat cancer and alleviate symptoms in cancer patients, the cost of cancer care is continuing to rise steadily. Much of this may represent genuine progress - the availability of new, effective anti-cancer drugs, and the utilization of better supportive care have been dreams for patients and doctors for decades. But such progress comes at a cost. An aging population, longer survival with cancer, higher prices for new drugs, and rising expectations for fewer side effects all have contributed to increasingly expensive oncology practices.

In medical oncology, physicians (or their group practices, hospitals, or affiliated cancer centers) are paid both for consulting services - that is rendering opinions and guidance - and for delivering care with chemotherapy or other interventions. This creates the potential that treatment choices are driven by consideration of financial remuneration. This is not fundamentally different from other medical specialties (for instance, surgeons get paid to operate), or for other professions (lawyers are paid for services they render). But the implications in oncology, where there are more and more treatment choices emerging, are only beginning to be studies.

A recent article in the New York Times highlights some of the areas of controversy for doctors and patients, and money.

I would be interested in your experiences. Do you think that your treatment, or aspects of it such as drug choices or schedules, have been influenced by the kind of reimbursement the medical team got? If so, add your voice to the discussion.

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Technorati Tags: oncologist, cancer treatment, payment, money, health and wellness

Cancer Treatments: A Peek Into the Future

2007-06-11T14:10:00.000-04:00

The 2007 ASCO (American Society of Clinical Oncology) meeting lacked a "blockbuster" headline. Perhaps the most notable clinical advance was the report for use of sorafenib for advanced hepatocellular (primary liver ) cancer. Hepatocellular cancer is more common in East Asia, and is related to the endemic spread of hepatitis B virus. Historically, there have been few if any effective treatment options for this type of tumor. In a randomized trial of the multi-targeted kinase inhibitor, sorafenib, against a placebo for advanced hepatocellular cancer, the use of sorafenib led to improved period of tumor control (2.8 months versus 5.5 months, on average) and improved survival among these cancer patients. Because there are no drugs with substantial activity in this tumor type, it is expected that sorafenib will garner FDA approval in this setting based upon these data.

While there were many other important advances at ASCO, there were relatively few that would prompt clinicians to change radically their treatment practices in the coming weeks.

There was a subject frequently on the minds of meeting attendees, it seemed. The subject was cost. The increasing price of cancer therapy, and the increasing concern over regulation of those prices and practices, was a common note sounded by many oncologists with whom I had conversations. This concern was less in response to specific clinical reports or new data and more seemingly from an growing sense that there are going to be many new, reasonably effective drugs in cancer medicine, which are enormously expensive. How to pay for this progress? Who will foot the bill?

I'll write more about the business side of oncology practice in future blog entries.

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Technorati Tags: cancer, cost, medicine, treatment, health and wellness

Cancer Confusion

2007-05-21T16:27:00.001-04:00

Does "X" cause cancer? Does "Y" prevent cancer? Each day seems to bring a new announcement that one can bring cancer upon oneself, or spare oneself from cancer, by simply changing something about diet, lifestyle, or some other small modification. There is one enormous example of this - smoking. Smoking clearly causes lung, head and neck, bladder, esophageal, pancreatic, cervical and other cancers, and is the #1 source of preventable cancers.

Beyond that, much of what passes for "cancer prevention" is supported by very limited data, conjecture, and may even be misleading. This is particularly true for claims about vitamins, foods, or nutrients that might be linked, or not, to cancer risk or prevention.

The study identified in this recent WebMD article suggests that the bombardment of claims about cancer causes and prevention has led to massive confusion in the public mind.

Are you puzzled? Where do you think reliable information about cancer risk comes from? What things do you believe might prevent cancer? I'll start with quitting smoking, getting regular exercise, and using effective sunscreen.

Now it's your turn. Post a comment and tell me what you think of all the cancer studies in the news.

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Technorati Tags: cancer, cancer prevention, health and wellness

Welcome to the WebMD Cancer blog

2007-05-21T16:21:00.000-04:00

Welcome to the WebMD Cancer Treatment and Care Blog. I am a medical oncologist at Dana-Farber Cancer Institute. I have been part of the WebMD community for many years, staffing the Cancer Treatment Message Board. That has been a very gratifying experience for me, and hopefully readers.

Cancer is a common disease in our society, affecting many families throughout the US and across the world. Cancer treatment and care are subjects that stir strong emotions because of the serious nature of a cancer diagnosis, the often-unsatisfactory treatment options, and the deep hopes and fears of cancer patients, their friends, and loved ones.

This blog will try to give people interested in cancer a forum for discussing advances in cancer treatment, and to comment on the social and cultural aspects of cancer. I hope it will be an interesting venue for readers and patients, and a compliment to our message board.

Thanks for joining us.

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