Some people have been led to believe that in Germany all cancer care is holistic. In one Internet report it states that "Germany's top cancer doctors … literally cook cancer out of your body while you nap." This is a gross exaggeration of both the power of hyperthermia (heat therapy) and the state of cancer treatment in Germany.

German oncology, like oncology in most countries, is divided into two broad approaches: complementary and alternative medicine (CAM) and academic medicine (Schulmedizin in German). Each has its own philosophy and organizational structure. The CAM approach to cancer is mainly represented by the German Society of Oncology (Deutsche Gesellschaft fur Onkologie [DGO], of which I am an honorary member). By contrast, the orthodox doctors are represented by the German Cancer Society (Deutsch Krebs Gesellschaft, or DKG). One would naturally expect CAM doctors to favor nonconventional treatments such as hyperthermia. But it is was surprising, and gratifying, that recently the orthodox German oncology society issued a press release endorsing broader use of this technique.

According to a translation by the BSD Medical Corp., the German Cancer Society has praised hyperthermia for "putting the heat on advanced cervical cancer." Two trials, it said, have now documented good rates of success using a combination of radiotherapy (radiation therapy) and deep hyperthermia for treating advanced cervical cancer. One treatment option for advanced cervical cancer is the use of radiotherapy in combination with chemotherapy. But chemotherapy is not possible for all patients for general health or other reasons. Also, if a tumor has already spread beyond the cervix and penetrated the surrounding tissues, it is often impossible to eliminate the tumor permanently through the use of radiotherapy alone. In these cases, the German oncologists say, "combining radiotherapy with deep hyperthermia can produce better results."

The papers in question were published in the prestigious International Journal of Radiation Oncology, Biology, Physics in 2008 and 2009. They show that tumor growth can be better controlled and survival rates increased using a combination therapy. The heat in question was generated by electromagnetic radiofrequency (RF) waves. By using computer technology, doctors can then closely target the cancer, while affecting the surrounding healthy tissue as little as possible.

Patients who participated in the trial were women with cancer that was either locally advanced or had already spread to the lymph nodes, other organs in the pelvic area, and organs adjacent to the pelvic area (stages II through IVA). When compared to radiotherapy alone, combined radiotherapy and deep hyperthermia produced improvements in response rates and tumor control.

Furthermore, long-term survival rates improved. In the 2008 paper, overall survival (the most important indicator of benefit) was "persistently better" after 12 years: 20% for radiotherapy alone vs. 37% for the combination, a near doubling, which was also statistically significant (Franckena 2008). So while hyperthermia doesn't exactly "cook cancer while you nap," it certainly does improve one's chances of being alive at 12 years (and therefore probably cured) than with radiotherapy alone.

But here's the part that I find really interesting and encouraging: the organization of orthodox German researchers is now recommending that its members offer "the option of combined radiotherapy and deep hyperthermia to patients who cannot undergo chemotherapy." In fact, at Dutch radiotherapy centers, the combination of radiation therapy plus hyperthermia is already standard practice. "In Germany so far, this treatment option is only offered in specialized centers."

Contrast this to the situation in the US where the use of hyperthermia is limited to a few dozen centers and among conventional oncologists is minimal. Leaving aside the CAM doctors, standard German cancer doctors have now shown themselves to be somewhat more receptive to promising new methods than their American peers.

A Dubious Change in Medicare Rules
Medicare has broadened its payment for new anticancer drugs, according to a recent article in the New York Times (January 1, 2009). At first sight, this might seem like a good development for cancer patients. Medicare will now pay for more drugs! Some CAM practitioners who also use these expensive targeted drugs see it that way. But, as the story makes clear, the change actually raises serious questions about the overuse and promotion of dubious drug combinations that have become popular in recent years.

As background, the Food and Drug Administration (FDA) has approved a variety of new drugs over the past few years that, at best, are minimally effective. Sometimes, they confer a few months of extra survival; oftentimes there is no proof that they do even that. They also may carry an increased risk of serious side effects, and in almost every case they are very expensive.

According to the Times authors, "for many such uses there is scant clinical evidence that the drugs are effective, despite costing as much as $10,000 a month." Medicare approval may therefore waste money and needlessly expose patients to the adverse effect of drugs that might hurt them, and make their final months more miserable.

FDA approves new drugs only for specific indications, and these drugs cannot be assumed to work in other circumstances. For a dozen or so years, however, industry has succeeded in chipping away at these FDA barriers. Now the dam has broken. Medicare has in effect overridden the carefully constructed FDA barriers and agreed to pay for a much wider degree of "off-label" use. These uses are sanctified by various guidelines, called compendia, that are often written – according to the Times – with the eager input of drug company representatives.

"We have very little faith that those indications that make it into the compendia are safe, let alone effective," said Dr. Allan M. Korn, the chief medical officer for the Blue Cross and Blue Shield Association. Medicare is now providing "carte blanche in treatment for cancers," according to Steven Findlay, a health policy analyst for Consumers Union. He also said that such coverage encourages doctors to use patients as guinea pigs for unproved therapies. But skeptical views like this are overwhelmed by a chorus of cheers coming from Big Pharma and its many friends in the oncology community.

What will this change mean in practice? For example, Medicare will now cover Avastin (bevacizumab) – at $100,000 per year one of the most expensive of the newer drugs – for ovarian cancer. But does Avastin actually work for ovarian cancer; that is, does it increase the patient's overall survival? No one can say, since randomized controlled trials (RCT), formally required for FDA approval, have never been done. But the new Medicare ruling "makes it easier to give drug after drug," said Andrew Berchuck, MD, director of gynecologic oncology at Duke University, "and keep the fantasy alive."

Keep the fantasy alive! The "fantasy" in this case is the idea that orthodox oncologists actually have effective pharmaceutical solutions to intractable ovarian cancer, when they do not.

Implications for CAM
Oncologists have hailed the change as a way of generating new knowledge about what works and what doesn't. But I suspect that, on the contrary, these new rules will further reduce the motivation to do rigorous research. Who now will bother if you can get compensation based just on a drug industry-influenced compendium?

This also has serious implications for CAM. On the one hand, I realize it may make it easier for the few CAM practitioners, who utilize these drugs in off-label ways, to get compensated for doing so. But, on the other hand, the rules will further decrease the attractiveness of alternative treatments, since now patients will perceive their conventional doctors as the source of a wider array of potential treatments (without evidence that they can actually increase survival).

What I find particularly disturbing is that the double standard has just gotten much wider. CAM treatments that have a considerable amount of data behind them still have little chance of being accepted by FDA or paid for by Medicare. They are expected to jump through all the hoops of a lengthy testing process, including prohibitively expensive randomized clinical trials. This is virtually impossible for them to do, but Big Pharma – which has the money to do such trials – now gets a free pass.

At the same time, the combined forces of the FDA, Medicare, the American Society for Clinical Oncology (ASCO), and their friends continue to prevent accurate information on these competitive treatments from reaching the ears of oncologists. Take, for example, ASCO's guidelines on exhibiting at their massive annual meeting:

"Dietary supplements that (i) make any claim to diagnose, mitigate, treat, cure, or prevent any disease, specific class of disease, disease symptom, or abnormal medical condition; or (ii) claim an effect similar to that of an approved drug, biological product, or medical device must not be exhibited".

Is it any wonder, then, that rank-and-file oncologists remain ignorant or scornful of the effects of less-toxic or botanical compounds, and eagerly turn to the products of Big Pharma? In addition, although not mentioned in the Times article, readers should be aware of several excellent articles by the same journalists on the "chemotherapy concession." This means, essentially, that oncologists in private practice are allowed to sell chemotherapy in their offices at a profit, a privilege granted to few other medical doctors. They may also receive rebates from these same companies when they prescribe a high volume of their products.

Medicare does not pay for most CAM cancer treatments, even when they have extensive testing behind them or have been approved as legal treatments in other countries. The high regulatory barrier remains in place for nutritional, nontoxic, or unconventional approaches. But the products of Big Pharma, once they have gained a foothold in a single indication (often in the absence of proof of life-prolongation), are now eligible for compensation for many other indications. This is a move that primarily benefits Big Pharma and profit-oriented oncologists, and not cancer patients in search of more effective treatments.

Political Implications
President Barack Obama, as everyone now knows, came into office with a promise to reduce the cost of medical care. According to his official website (barackobama.com), he will lower health-care costs in part by investing in prevention. He will promote public health by, among other things, investing in preventive services, including cancer screenings. But how does increasing the expenditure for unproven and expensive drugs fit into that overall plan? In 2007, Medicare already spent $2.4 billion on anticancer drugs. Should we feed increasing amounts of money into a system that has failed to prove – in the majority of cases – that it actually increases patients' longevity?

Might we not be better off with a system, such as Britain's National Institute for Health and Clinical Excellence (NICE), that looks critically at the actual effectiveness of various treatments before agreeing to pay for them? For instance, NICE recently recommended against approving Tarceva (erlotinib) for people who have locally advanced or metastatic non-small cell lung cancer, who cannot take docetaxel, and have already tried one chemotherapy regimen but it has not worked. They have also recommended against Tarceva for people who have already tried two chemotherapy regimens, including docetaxel, but they haven't worked (www.nice.org.uk). These are indeed tough decisions; but at the end of the day, aren't patients better served by knowing what really works or doesn't work in treatment? Doesn't this put unproven drug treatments on a par with unproven unconventional treatments?

According to the Times, the recent Medicare change – which was quietly put through in the waning months of the Bush administration – will almost certainly raise the federal drug bill, "while making it more difficult for the new administration to rein in spending on unproven medical treatments." So the question is this: what will President Obama do about it? We know he wants to lower health-care costs. But is he ready to take on the combined forces of ASCO, which approved the change, and Big Pharma? And what about the patient groups, some of which have been carefully cultivated for many years by these same vested interests? Won't some of them scream with displeasure if Medicare refuses to fund new (albeit unproven or ineffective) drugs? Can Obama stand up to this sort of pressure? It will be interesting to see.

It will also be interesting to hear the opinions of his chief of staff, Rahm Emanuel, whose brother, Ezekiel J. Emanuel, MD, PhD, is a breast oncologist and chief of bioethics at the National Institutes of Health (NIH). He has been a spokesperson for Merck and has also bewailed his own inability to invest in drug company stocks while serving at the NIH. A spokesman for the Obama administration declined to comment on the new Medicare rules. But stay tuned.

Ralph Moss, PhD
www.cancerdecisions.com

References
Abelson, Reed and Pollack, Andrew. Medicare widens drugs it accepts for cancer. New York Times, January 26, 2009.
Abelson, Reed. Drug sales bring huge profits, and scrutiny, to cancer doctors. New York Times, January 26, 2003.
Abelson, Reed. Pay method said to sway drug choices of oncologists. New York Times, March 8, 2006.
Alliance for Human Resource Protection. NIH scientists gripe at ethics rule: no stocks in pharmaceutical companies. March 5, 2005. www.ahrp.org/infomail/05/03/05a.php.
American Society for Clinical Oncology. The ASCO Cancer Foundation policies for exhibitors and other organizations at ASCO meetings. September 5, 2008. Available at: http://www.asco.org; search for "exhibitor policies."
Brownlee, Shannon. Feeding the cancer machine. New York Times, April 1, 2007.
BSD Medical Corporation, trans. Putting the heat on advanced cervical cancer. Available at: http://www.globenewswire.com/newsroom/news.html?d=159263.
Department of Bioethics. Our people: Ezekiel J. Emanuel, MD, PhD. National Institutes of Health [Web page]. http://www.bioethics.nih.gov/people/emanuel-bio.shtml.
Elliott C. When ethicists have conflicts of interest. Dissent. Fall 2005. Available at: http://www.tc.umn.edu/~ellio023/documents/DissentFall2005-Elliott.pdf.
Franckena M, Lutgens LC, Koper PC, et al. Radiotherapy and hyperthermia for treatment of primary locally advanced cervix cancer: results in 378 patients. Int J Radiat Oncol Biol Phys. 2009;73:242-250.
Franckena M, Stalpers LJ, Koper PC, et al. Long-term improvement in treatment outcome after radiotherapy and hyperthermia in locoregionally advanced cervix cancer: an update of the Dutch Deep Hyperthermia Trial. Int J Radiat Oncol Biol Phys. 2008;70:1176-1182.
Interdisziplinäre Arbeitsgruppe Hyperthermie. www.hyperthermie.org (in German).