THE STRANGE SAGA OF BIOPULSE INTERNATIONAL

In mid-February, BioPulse, one of the most highly publicized cancer clinics in Tijuana, was raided by Mexican health authorities and its most celebrated treatment was shut down. By coincidence, I happened to be visiting that clinic (and others) during the week of the raid.

Since the 1960s, Tijuana has been a "medical Mecca" for patients seeking innovative treatments for cancer. My first trip there was in 1976, when I sneaked away from a scientific meeting in Anaheim, and drove to Tijuana to see what all the shouting was about. I visited Dr. Ernesto Contreras's clinic but hid my Memorial Sloan-Kettering Cancer Center affiliations. One afternoon, I sat in the shaded courtyard talking to patients, and what I heard changed my life. Patients felt passionately that they were being helped. One man said that when he first came there he felt as if someone were twisting a knife back and forth in his throat. After being treated with laetrile, the pain vanished. I became intrigued by what non-conventional treatments had to offer cancer patients.

Over the years, I have watched this sprawling border town grow and 50 to 70 alternative cancer clinics spring up there. It is not as wild as it once was, and the clinics I visited were clean and the staffs were bright, friendly and compassionate. I met patients from all over, including Amish and Mennonites from Pennsylvania, Jehovah's Witnesses from California, and Hasidim from Israel. The patients we spoke to were pleased with the experience and urged others to do as they had done.

In glossy health magazines, American patients now find full-page color advertisements and glowing articles on many of these clinics. In one such magazine, I counted fifteen glitzy ads for alternative clinics, ten of which were located in Tijuana. Their claims are certainly enticing: "…life after cancer…health breakthrough…choices that could save your life…proven alternative…leading edge of excellence…"

Some Mexican clinics, such as BioPulse, have now begun to branch out into biotechnology. Some of their treatments sound identical to the breakthroughs one hears about on the evening news. But these breakthroughs are rarely available when patients need them. By going to Tijuana, patients can get the treatment they desire right now, on a fee-for-service basis.

Conventional cancer researchers fume as they watch potential clinical trial participants head south. "This is the very vocabulary of quackery, dressed up in the current jargon of biotechnology," stormed oncologist Daniel Masys, MD, of the nearby University of California at San Diego. But it is the failure of American medicine to give patients what they want (and deserve) that fuels the daily migration of patients over the border.

If BioPulse really delivered safe and effective treatments, what would be wrong with people going there to receive them? The question is whether those treatments are truly effective, or are they just hype? And are they truly non-toxic, or do they carry potentially dangerous side effects?

On the surface, at least, BioPulse is a modern and attractive in-patient facility with a staff of several dozen. I was shown a construction site where a modern diagnostic radiology center is being installed. In the main treatment room, three or four patients were receiving an intensive insulin coma treatment. I then met with Mr. Loran Swensen, clinic director, as well as Cesáreo Chavez Garcia, MD, a general surgeon, and Heberto Schramm Urrutia, MD.

Mr. Swensen is a former Mormon missionary, whose new mission is to make high-tech alternative treatments available to Americans. He comes across as forthright and friendly, eager to share details of his treatment and business plans. He has held a variety of jobs, most recently selling "motion simulators" to the entertainment industry. His involvement with alternative medicine stemmed from his son's treatment for cerebral palsy at a Mexican clinic some years back. A positive experience led him to start a chain of medical clinics of his own in the US. But he eventually closed these down, by his own admission, just one step ahead of the Food and Drug Administration (FDA).

Mr. Swensen's ultimate aim is to market innovative cancer treatments in the United States. He told a reporter: "We can work out this protocol, streamline it, get it down to where all the bugs are worked out of it…and then take it in and set it up in a clinical trial [in the United States], in all the normal studies and say, "Here is how it needs to be done….And do it for hundreds of millions of dollars less than what it takes to take a drug from concept to market [in the United States]" (San Diego Union-Tribune, 2/8/01).

In their "induced hypoglycemia therapy" (IHT) cancer patients were injected daily with enough insulin to put them into a temporary coma. Supposedly, cancer cells cannot grow when deprived of glucose. Insulin shock therapy was used decades ago as a conventional treatment for depression. In 1962, a doctor in New Brunswick, NJ reported the remission of cancer in two patients who were undergoing this treatment for depression. Recalling that paper, medical writer Wayne Martin wrote communiqués urging doctors to develop IHT as a potentially effective treatment for cancer. Personally, I have never seen any results suggesting that this treatment is effective. On the face of it, it also seems like a perilous idea.

American cancer patients have now paid around $28,000 apiece for the privilege of being treated there. BioPulse patients "know they are guinea pigs," Swensen admitted. "I'm not doing anything different other than I'm a little looser than the rest [i.e., researchers performing clinical trials]-of which they are deadly envious." (ibid.)

Most of BioPulse's problems stem from the fact that it is a publicly traded company in the United States. On November 16, their high-powered public relations consultant announced that BioPulse would be featured on the cover of a popular health magazine. The article was entitled, "A Cancer Vaccine That Works." At one point, it referred to BioPulse's vaccine treatment as "wonderful and effective."

"This fast growing, profitable, San Diego-based biotech company is enjoying high success rates in treating cancer and other diseases," their spokesperson exulted. Another time he announced that the company had tested a cytokine product that "results in rapid liquification of solid tumors" in humans. The company's stock soared over $12 per share, but it also appeared on the radar screen of the regulatory authorities.

There were persistent rumors about the company, its treatments and officers. (One investor on the RagingBull.com chat room predicted: "This is an over-pumped, over-hyped piece of junk that will be trading in the pennies sometime this year.") There was also talk of ominous side effects. This was followed by a devastating report at Bloomberg.com, and then the front-page exposé in the Union-Tribune.

On Feb. 13, the day after my visit, the company also announced that the Federal Trade Commission (FTC) was conducting an inquiry into its advertising of health-care products and treatments. The purpose of the probe (said BioPulse) was "to determine whether we have engaged in unfair or deceptive acts or practices, including whether we can substantiate claims we have made relating to treatments for cancer and other diseases." Three days later came the raid by Mexican health authorities and the "induced hypoglycemia therapy" (IHT) treatment facility was shut down.

BioPulse "did not have the proper permits for handling certain prescription medications and for certain forms of experimental treatments," the company conceded. There followed a string of resignations from the company's board, including the co-founder and the chairman of the board. By late February the stock had fallen to around one dollar!

Some readers may see BioPulse as the victim of a conspiracy by conventional medicine (or stock manipulators). But few people in Tijuana are rallying to their defense. Most of the clinic directors I spoke to viewed the treatment with trepidation, fearing that IHT was too potentially toxic to be handled in the low-tech environment in which they worked. Even a German clinic that once gave IHT backed away from it last May.

BioPulse still administers a dendritic cell (DC) vaccine in a laboratory facility created by Mr. Neil Riordan of Aidan, Inc., Tempe, AZ. Dendritic cell vaccines are a hot area in cancer immunotherapy right now. But how does Aidan's vaccine compare to those being used at conventional medical centers (or at alternative clinics in Europe)? Again, where is the data? Anyone can claim to have a "dendritic cell vaccine." How can we tell the phonies from the real McCoy? Without carefully gathered data, you simply can't. You are at the mercy of the market, and the market isn't very merciful.

Mr. Swensen told the Union-Tribune that "people who've made a difference through the centuries were considered nuts and idiots, so I consider myself in good company." However, not every nut or idiot is a misunderstood genius. Some of them are just nuts and idiots. The time is long past that patients need to settle for vague promises and grandiose schemes. It is time for alternative cancer therapies to grow up and prove themselves scientifically.

GOING TO MEXICO? Don't get me wrong: there are also some solid places with experienced and ethical physicians, whose only "fault" is that they work in a Mexican border town. Some of the other Mexican clinics that I visited on this trip included Cell Specific Cancer Therapy (now renamed Zoetron International), CHIPSA, San Diego International Immunotherapy Center, and International BioCare. These vary greatly in their approaches, facilities and philosophies, but all are sincerely seeking to help patients in need. For the conceivable future, Tijuana will remain a major resource for international cancer patients seeking alternatives.

Patients who are considering going to a foreign clinic should learn an array of possibilities. They should not become enamored with one clinic because of a magazine article or pin all their hopes on a single far-out idea. There is no magic bullet! Be sure to ask probing questions. Remember that those clinics making the loudest and boldest claims are usually the least dependable. Explore all of your options…and don't assume that just because something calls itself "alternative" it is necessarily safe or effective.

DATA ON SIDE EFFECTS LACKING

Conventional doctors who get all worked up about the misrepresentation of alternative therapies should first clean up their own house. For example, a new study in the Journal of the American Medical Association shows that information on conventional drug side effects is often omitted from published reports on clinical trials {JAMA 2001;285:437-443}. The authors looked at 192 such trials. Adverse effects were spelled out in only 39 percent of the papers. When patients withdrew from a study because of toxicity, less than half of the papers told why. Overall, less than a third of a page was allocated to the discussion of safety, about the same as for the names and affiliations of contributors! The authors called safety data in clinical trials "largely inadequate." That's an understatement. In fact, downplaying side effects is common in discussions of conventional cancer treatments. It leads patients to make incorrect decisions about which treatments to take.

ARE FDA-APPROVED DRUGS SAFE?

Pres. Clinton once urged the FDA to view the drug industry as their "partners, not adversaries." Yeah, sure. Now the cost of this permissive attitude is becoming clear. Seven drugs approved since 1993 have been withdrawn from the market after reports of over 1,000 deaths, according to the Los Angeles Times. The FDA disregarded danger signs and blunt warnings from its own specialists. In cancer, dangerous drugs are routinely approved under the perception that they save lives. However, anticancer drugs only need to show that they shrink tumors, not that they actually increase survival. We must learn to ask hard questions about the safety of all proposed cancer treatments.

A PARTING WORD: "Heretics are given us so that we may not remain in infancy. They question, there is discussion, and definitions are arrived at to make an organized faith."--Augustine of Hippo (354-430)

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