Induced Hypoglycemic Treatment (IHT) was one of several treatments offered by BioPulse International, a company whose stock was traded over the counter (OTC Bulletin Board symbol BIOP). From 1999 through 2001, the company operated a clinic in Tijuana, Mexico, and hoped to open additional facilities in other parts of the world. According to an August 1999 news release:
Each BioPulse clinic offers a comprehensive alternative medicine program that focuses on cancer, hepatitis C, lupus, lyme disease, and other degenerative diseases. In addition to developing its own regimens, BioPulse continually researches other treatments found throughout the world. The company works towards ensuring that its patients enjoy the most effective treatments available anywhere.
The company's Web site stated that cancer was BioPulse's "primary emphasis" and that:
Insulin-induced sleep therapy increases the alkaline state inside the body, which is adverse to cancerous tumors. During the procedure, the blood oxygen levels increase substantially, which diminishes the production of carbon dioxide, inducing alkalosis, or an alkalinity produces an adverse environment for the tumors. In addition, the induced-sleep stage starves the tumors of glucose. After two weeks of therapy, patients commonly show signs of a flu-like illness, which indicates the tumors are fighting back. In the third week, many patients show a marked decrease in tumor size, leading to the eventual elimination of the tumors.
A chart on BioPulse Web site stated that IHT worked in five ways:
However, this explanation is not logical because:
In December 1999, the "BioPulse program with IHT" cost $5,000 per week for the first four weeks and $3,500 per week thereafter. The available modalities included chelation therapy, 714X, ultraviolet blood irradiation, whole-body hyperthermia, organic germanium, and several other highly questionable treatments. The IHT program usually included "detoxification " with colonic irrigation; intravenous infusions of vitamin, minerals, amino acids, and enzymes; oral supplements; dietary strategies; and referral to "biological dentists" to remedy alleged problems caused by amalgam fillings and root canals. A 4-week program that included IHT and one session of whole-body hyperthermia (an unsubstantiated treatment in which the body's temperature is temporarily raised to 106°F) cost $24,000. The clinics also offered a less expensive 21-day "Rejuvenation Program" that provided "intense treatment" to fight disease and to "restore and fortify the immune system so the body can continue the fight." The sleep sessions were usually done once a day, five days a week, for three to seven weeks. Advance payment was required.
Treatment outside of the United States is not covered by Medicare or Medicaid and is not usually covered by HMOs or other managed-care plans. Biopulse claimed that private medical insurance "may" cover most of its cost. However, most private insurance companies do not knowingly pay for nonstandard treatments.
The BioPulse site included skimpy case histories from four people (one anonymous) who apparently believed that IHT was highly effective against their cancers, but the reports were made only a few months after the treatment was administered. Three of the patients had also had standard treatment. Three of the reports stated that the patients still had evidence of cancer but claimed to have improved or stabilized. The standard way to report cancer-treatment outcome is to collect detailed data for at least five years and to follow enough patients to determine whether the outcome is better than would be expected from other treatment or from the natural course of the disease. Treatment effectiveness cannot be judged from anecdotes, testimonials, skimpy case reports, or short-term follow-up. BioPulse began doing IHT in June 1999 and reported "outstanding results" less than three months later.
Insulin-coma treatment (also called "insulin shock") was legitimately used to treat schizophrenia beginning in the 1930s. Its use declined after electroconvulsive treatment was developed, and it was abandoned, beginning in the 1950s, a potent antipsychotic drugs became available. Permanent measurable complications were rare but have included memory impairment, reduced intelligence, strokes, abnormal heart rhythms, and even death. An Alternative Medicine Digest report states that BioPulse's sleep treatment aimed to lower the patient's blood-sugar levels to "20 mg/dL or below," which is extremely low. Although Biopulse reported no complications, insulin coma should not be regarded as risk-free.
On February 2, 2001, Biopulse was notified that the FTC's Western Region was conducting an inquiry into the company's advertising of its products and treatments. The notes stated that the purpose of the inquiry was to determine whether the company can substantiate its claimed ability to treat cancer and other diseases .
On February 15, 2001, Mexican health department authorities ordered BioPulse to stop using IHT to treat cancer patients at its Tijuana clinic. After several hours inside the clinic, inspectors sealed a large room used to administer devoted insulin-induced comas. According to reports in the San Diego Union-Tribune:
On March 31, 2001 the Union Tribune reported that ten former patients (or family members) were upset about about their negative experiences at BioPulse International. Three stated that they had continued costly treatment after being assured that they were significantly better, but when they returned to the United States, x-ray films and bone scans revealed that their condition was unchanged or worse. Dr. Heriberto Valenzuela, president of Tijuana's Society of Radiologists, said that BioPulse had withdrawn as a client of his radiology group because the group's reports showed no benefit from the clinic's treatments. Valenzuela indicated that other "alternative" clinics have stopped using his services for the same reason . That day, BioPulse's stock price, which had hit a high of $12 in December 2000, fell to 66 cents. It then declined gradually and fell to about a penny in 2002.
Biopulse's April 2002 quarterly report to the Securities and Exchange Commission noted that the Mexican authorities had permitted the clinic to reopen in May 2001, but the clinic did not seek new cancer patients, ran out of operating funds, and closed in January 2002 . A few weeks before it closed, the staff of ABC-TV's PrimeTIME Thursday contacted the families of 10 patients who had been treated at BioPulse. All said that the clinic's doctors gave the patients good news while they were there, suggesting that the treatment was succeeding in eradicating their cancer. However, nine of the 10 patients ultimately died from their cancer. The patient, a 75-year-old from San Jose, Calif., who had been diagnosed with terminal ovarian cancer, said BioPulse doctors told her their coma treatment had a 60% chance of helping her. After undergoing 25 comas over five weeks, she said, the doctors gave her the impression that the treatment had succeeded in eradicating her cancer. But when she got home, her oncologist conducted new tests and found that her cancer was still there and that her CAT scans had not changed .
In July, BioPulse and its principals (Jonathan Neville and Loran Swenson) signed FTC consent agreements under which they are permanenly barred from misrepresenting the safety or effectiveness of IHT or any dietary supplement, food, drug, device, or any health-related service. The agreement also includes a suspended judgment of $4.3 million, due in full if the defendants are found to have misrepresented their financial situation .