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
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 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
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
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
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
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
Abelson, Reed and Pollack, Andrew. Medicare widens drugs it accepts
for cancer. New York Times, January
Abelson, Reed. Drug sales bring huge profits, and scrutiny, to cancer
doctors. New York Times, January
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.
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
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.
Interdisziplinäre Arbeitsgruppe Hyperthermie. www.hyperthermie.org