Every October for the last 34 years, practitioners of complementary and alternative medicine (CAM) have taken over the spa town of Baden-Baden for a huge conference called "Medicine Week." A central part of Medicine Week is the meeting of the German Society of Oncology. The society was founded by Hans Nieper, MD and is now headed by Josef Beuth, MD of the University of Cologne. Three years ago, I was inducted as an honorary member of the Society, the first American to be so honored. My appointment coincided with the publication in German of my book, Questioning Chemotherapy.

This year, I once again spoke on the chemical approach, in a talk entitled "The Grand Illusion of Chemotherapy." In the last five years, I told my German colleagues, about 275,000 peer-reviewed articles have appeared on the topic of cancer, including 25,000 on cancer chemotherapy. Out of this vast amount of research a total of 70 new approvals have been made by the Food and Drug Administration (FDA) for drugs used in cancer therapy.

But the main question I considered was whether or not cancer chemotherapy is any more valid today than it was when my book Questioning Chemotherapy appeared five years ago. I reviewed with them the track record of half a dozen new drugs.

For example, advertisements for Arimidex (anastrozole) claim "56.1 percent survival" for breast cancer patients treated with this drug. This implies that more than half the women are significantly benefited, if not saved from their cancer. However, the ads are referring to two-year survival in comparison with an older drug, Megace. In fact-as the advertisement itself notes in the fine print-women treated with Arimidex had a median time to death of 26.7 months compared to 22.5 months for patients treated with Megace. The actual difference between the two groups was just 4.2 months, a difference that was not statistically significant.

We next looked at Taxotere, a semi-synthetic derivative of the Pacific yew tree. In non-randomized clinical trials in breast cancer, there was a very high rate of responses. While only 2 out of 37 patients had complete responses, another 18 (49 percent) had partial responses. But what did this mean for the patients? The median survival time was 15 months with Taxotere compared to 14 months with Adriamycin, a gain of one month. Meanwhile, 87 percent of patients had fluid retention or other serious side effects {J Clin Oncol 1996;14:58-65}.

Taxotere has also been approved to treat non-small cell lung cancer. According to advertisements, Taxotere is "the first single agent to show a significant one-year survival benefit." However, when they compared both a high-dose and a low-dose regimen to placebo, scientists at the M.D. Anderson Cancer Center, Houston, had to concede that "overall survival was not significantly different between the three groups" {J Clin Oncol 2000;18:2354-62}. This fact is omitted from the company's four-and-a-half page advertisements.

In May, 1996, FDA approved the first drug for the treatment of pancreatic cancer, Gemzar (gemcitabine). It has also been approved for the treatment of stage IV breast cancer. There has been a non-randomized clinical trial at the Charité Hospital in Berlin that involved just 42 patients. It showed 6 partial responses, with an overall response rate of 14.3 percent . The median survival of patients was 15.2 months.

There was also a 1996 British study of 40 evaluable patients, which provides an illustrative contrast. In the British study there were 3 complete and 7 partial responses. Thus the overall response rate was nearly double, at 25.0 percent. Yet in the British study the median survival was 11.5 months. or four months less than in the German study {Semin Oncol 1996;23(5 Suppl 10):77-81}.

Rituximab (Rituxan) received FDA approval in November 1997 for the treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's lymphoma (NHL). In 1998, a trial centered at M.D. Anderson Cancer Center in Houston. showed 6 percent complete responses and 42 percent partial responses. The median duration of the response was 11.6 months and the median time to progression for the responders was 13.2 months {Blood 1998;92:414a-415a}. Rituxan is widely used, but was not subjected to a Phase III randomized trial comparing it to either placebo or best conventional care; overall median survival data is lacking.

Oxaliplatin has not yet been approved by the FDA. By adding it to the standard 5-FU+leucovorin regimen for colon cancer, researchers increased the response rate from 16 to 53 percent. Yet, despite this dramatic difference, the median survival was 19.4 months in the oxaliplatin-added group compared to the longer 19.9 months in the standard 5-FU+leucovorin group {J Clin Oncol 2000;18:136-47}.

"This is just one illustration out of many," I told the German doctors, "that there is no predictable correlation between response rates and median overall survival. The data is all over the map. Perhaps the increased toxicity required to achieve these increased responses actually injures the patients to the point that they die sooner, thus canceling out any positive effect. Oncologists need to abandon the idea that response rates translate into patient benefit and accept the fact that increased overall survival, and improved quality of life, are the legitimate goals of treatment."

I closed with the following quotation from the New York Times website (10/12/00).

GARLIC MAY PREVENT STOMACH CANCER

People who consume either raw or cooked garlic regularly have half the risk of stomach cancer and two-thirds the risk of colorectal cancer as people who eat little or none. This, according to a new study by Dr. Lenore Arab, professor of epidemiology and nutrition at the University of North Carolina, Chapel Hill, NC.

"There seems to be a strong, consistent protective effect for people who are regular garlic consumers," she said recently. It was once was thought that garlic only benefited people in distant climes. but Dr. Arab has shown that it "doesn't matter if they're consuming garlic in China or in the United States, the effect is still there."

However, researchers could not show similar benefits from the consumption of garlic supplements. Dr. Arab speculates that the active ingredients in garlic might be destroyed in processing or storage. "Another possibility," she adds, "is that some of the people who turn to garlic supplements are sick already. That could skew the results."

"The findings looked overwhelmingly consistent," she concluded.

NOW, WHALES ARE DYING OF CANCER

There is a colony of beluga whales in the upper St. Lawrence River that do not migrate, but patrol a stretch of the waterway where there is abundant plankton. "They are stuck there since 10,000 years ago," said veterinary pathologist Dr. Daniel Martineau of the University of Montreal, who studies causes of disease among these whales.

About 100 years ago, the population of these beautiful white whales numbered 5,000. Today only about 650 remain and they are dying at an alarming rate. Between 1983 and 1998, Dr. Martineau and his colleagues had examined 94 dead whales. "Seventeen beluga (18 percent) died of cancer," he has explained. In 1999, he studied nine more carcasses. "There isn't a whale population anywhere in the world in which you've seen that many tumors," he said. Whales have also been found dead with AIDS-like opportunistic infections.

Not surprisingly, the St. Lawrence is one of the most polluted waterways in North America. Because of rampant pollution, the State of New York limits fishing in the river. Scientists have found high concentrations of toxic chemicals in the whale bodies, such as organochlorides and polycyclic aromatic hydrocarbons (PAHs). Some of these chemicals are well known to cause cancer in experimental systems and to suppress the immune system.

It is hard to avoid the conclusion that this pollution is actually causing cancer in whales. But some scientists remain skeptical and propose that St. Lawrence whales are generally older than ocean-roving whales and that older animals, like older people, are prone to cancer. They also complain that since Dr. Martineau hasn't actually injected whales with chemicals he cannot claim that industrial pollution cause their disease.

Dr. Martineau answers: "Such a high percentage [of cancer deaths] had never been observed in any wild animal species, terrestrial or aquatic with the important exception of fish" (who are also subjected to the same carcinogens as the whales). And indeed, among whales that roam the oceans, there is no equivalent cancer epidemic, according to scientists at the Mystic Aquarium in Connecticut. Dr. Martineau's studies provide yet another link between environmental pollution and the cancer epidemic. We ignore such ominous signs at our own peril.

WORMS SHOW ANTIOXIDANT POWER: Scientists have confirmed that a powerful antioxidant can make the nematode worm live three times its normal life span. The worms normally live three weeks. But when given a synthetic antioxidant developed by Eukarion, Inc. of Bedford, MA they live 70 days.

"There's good reason to think that if it extends the life of the nematode it could be beneficial to humans," said Earl Stadtman, an antioxidant researcher at the National Institutes of Health (NIH).

The experiment gives a powerful boost to the free radical theory of aging. Eukarion's drug is a look-alike of the natural antioxidant superoxide dismutase (SOD). Naturally, the company is busy promoting the superiority of its product. But any synthetic substance is likely to have side effects. While the effects of dietary antioxidants (such as I discuss in my book, Antioxidants Against Cancer) may be less dramatic, they are also much safer for long-term consumption.

NCCAM GEARS UP

Recently, at breakfast in a foreign hotel I was accosted by a critic of the war on cancer, whom I shall call Mr. Alternative. "What's with the government's office of alternative medicine?" he asked, aggressively, knowing I am an advisor to that office. "Name one thing they've done in all the years that we taxpayers have been paying for their existence."

I had to admit that the output of the Office of Alternative Medicine (now elevated to the National Center for Complementary and Alternative Medicine, or NCCAM), has been disappointing. But I also recalled how enemies of alternative medicine had blocked most OAM initiatives and told him I refused to chime in with attacks on the office. Mr. Alternative looked at me skeptically. "You sound like you're doing public relations for the NIH," he sneered. Well, hardly. I have been among the most outspoken critics of OAM inaction. However, I also believe in the mission of the center and want to help it test promising CAM cancer therapies.

I am happy to report that NCCAM has now given out its biggest cancer-related grant yet: to Johns Hopkins Medical Cener, for a five-year, $7.8 million project to establish a center to study complementary and alternative approaches to the treatment of cancer. This grant puts the quackbusters in the doghouse. In the past, they crowed that no major cancer center would have anything to do with alternative medicine and demanded that the government stop funding NCCAM.

According to a U.S. News publication, America's Best Hospitals, Johns Hopkins is the number one medical center in the United States. It's going to be difficult to denigrate their findings. The first projects that Hopkins will undertake will be to investigate whether tart cherries alleviate cancer pain and to see if prayer can help African-American women heal from breast cancer. They will also pursue alternative treatments for prostate cancer (such as the herbal mixture PC-SPES) and train physicians and medical students in alternative medicine and research techniques.

"Our aim is to reconcile scientific method with alternative medicine treatments-two areas currently in opposition in the West," says Adrian S. Dobs, MD, MHS, the principal investigator of the new center, who is also an associate professor of endocrinology. Dobs, who also directs Hopkins' Clinical Trials Unit, serves as vice chair for the Department of Medicine. Steven Piantadosi, MD, PhD, co-principal investigator for the CAM Center, is a professor of oncology at Hopkins and director of biostatistics for the Johns Hopkins Oncology Center.

"We have assembled a top-notch team of cutting-edge Hopkins scientists and leaders in alternative medicine, and we will proceed with an open mind and a healthy amount of skepticism." That is the kind of investigation that even Mr. Alternative should welcome.

Ralph W. Moss, Ph.D. is the author of eleven books on cancer topics, including Cancer Therapy and Antioxidants Against Cancer. He directs The Moss Reports, a comprehensive information service for cancer patients on treatment alternatives. Readers are encouraged to sign up for his free newsletter at www.cancerdecisions.com.