Full Investigation · Salt Lake City, San Diego & Tijuana · 1998–2006

BioPulse: Insulin Comas for Cancer, Sold to Patients and Shareholders

A Utah company with no doctors among its founders opened a Tijuana clinic that put cancer patients into insulin-induced comas, injected them with a "vaccine" made from their own urine, and charged up to $50,000 for the course. Its stock doubled on a wave of press releases. Then a San Diego reporter, Mexican health inspectors, ABC's Primetime and the Federal Trade Commission caught up with it.

Who ran it

Loran Swensen and Jonathan Neville incorporated BioPulse in Utah in June 1998, while also running a 3-D animation company called Multi-Dimensional Studios. According to the company's SEC filings, Neville was a lawyer who had been general counsel to a turf-seed company. Swensen, then 43, told the San Diego Union-Tribune he never earned a college degree; his businesses had included security windows and motion simulators for amusement parks.

His one earlier venture in health care was not in the SEC filings. In 1989 he was a principal in the Omega Centers, a chain of drug-rehabilitation clinics that treated patients with a device emitting electronic pulses to the brain. Swensen said he closed them in 1991 after the FDA balked at the untested device. A 2001 profile in the Townsend Letter, an alternative-medicine magazine, described him as a former Mormon missionary who got into alternative medicine after his son was treated for cerebral palsy at a Mexican clinic, and who closed his American clinics, by his own admission, "just one step ahead" of the FDA.

What patients were sold

The centrepiece was "insulin-induced hypoglycemic treatment": insulin injected to drive the patient's blood sugar down until they lost consciousness for about an hour, repeated daily for weeks. The theory was that cancer cells would starve without glucose. Insulin shock had once been used on psychiatric patients and was abandoned long ago. Dr. Daniel Masys, director of clinical trials at the UCSD Cancer Center, called it "very, very frightening," warned it could cause seizures and brain damage, and said he would not subject "a family member or a pet" to it.

The second was a cancer "vaccine" of BioPulse's own, licensed from a private Arizona company, Aidan Inc., which had published nothing on it; the method involved extracting antigens from the patient's urine and came from an alternative clinic in Wichita, Kansas. Swensen claimed "anecdotal evidence" of benefit in some of 140 patients, but acknowledged that fewer than a dozen had been followed to the end of treatment. Dr. Brian Czerniecki, who was running a properly controlled trial of a dendritic-cell vaccine at the University of Pennsylvania, warned that a vaccine like this could "activate the immune system in the wrong direction and make things worse."

The FTC later added a third: "Acoustic Lightwave Therapy," based on Rife-machine claims that particular frequencies destroy disease-causing cells.

Swensen did not dispute that his patients were experimental subjects. "It's almost like we have too many damn clinical trials," he told the Union-Tribune. "They know they are guinea pigs. I'm not doing anything different other than I'm a little looser than the rest."

Selling it to investors

BioPulse traded on the OTC Bulletin Board. Its shares averaged about $4 for most of 2000. In October 2000 it hired Liviakis Financial Communications of San Francisco, which arranged investor calls, a listing on a German exchange and press releases headed "Major breakthrough in treatment of solid tumors." The price nearly doubled, reaching about $12. Liviakis was paid in stock, 1.5 million shares, making it the company's largest shareholder at 13 percent; Swensen and Neville held about 10 percent each. In early February 2001 the company announced $3 million in private financing and its sights on the American Stock Exchange, and it was moving into a 17,000-square-foot building in San Diego's Miramar area, closer to the chain of Mexican clinics and vaccine laboratories it planned to open.

Chronology

• June 1998 BioPulse incorporated in Utah.
• January 1999 Clínica BioPulso opens in Tijuana under a management contract with a Mexican-licensed doctor; BioPulse takes all revenue and pays all expenses. More than 90 percent of the company's revenue comes from the clinic. A partnership with a clinic in Germany, begun in November 1999, earns $395,000 before key staff leave in spring 2000.
• November 2000 Baja California issues the clinic a permit as an ambulatory clinic practising conventional medicine. It includes no authorisation for alternative treatment.
• 2 February 2001 The FTC writes to BioPulse that it is examining whether the company can substantiate its claims; BioPulse discloses the letter in an SEC filing on 13 February. A BioPulse spokesman, John Liviakis, calls it "a non-event." The stock falls 35 percent in a week.
• 8 February 2001 The San Diego Union-Tribune publishes Penni Crabtree's front-page investigation. Baja's director of clinics and hospitals, Dr. Alfredo Gruel Culebro, says the clinic is not authorised to provide alternative therapy and will be reinspected.
• 14 February 2001 Dr. Gruel tells the Union-Tribune: "insulin-induced hypoglycemic coma is not authorized in Mexico no matter what."
• 15 February 2001 Mexican health inspectors close the clinic's insulin-therapy room, according to the company's own SEC filings.
• 22 February 2001 The Union-Tribune reports that the landlord of the new San Diego building wants a letter of credit, and that BioPulse is changing its name to California BioScience.
• 9 May 2001 The treatment room reopens after the clinic applies for licences for four protocols: insulin therapy, chelation, colonics and dendritic-cell therapy. The clinic stops taking new cancer patients until they are approved.
• 16 May 2001 A Santa Barbara chiropractor sues, alleging BioPulse induced him to pay $27,500 for insulin coma therapy for his terminally ill mother by misrepresenting its success.
• June 2001 BioPulse stops managing the clinic and instead leases it equipment and licenses it technology.
• 14 November 2001 Annual report: revenue down $970,000; cash nearly gone; most staff laid off; officers' salaries unpaid; the company is in default on a $500,000 loan secured by Swensen's and Neville's own shares.
• December 2001 ABC's Primetime films the clinic with a hidden camera. It is accepting patients again.
• 21 December 2001 Quarterly report: "almost no revenue." The clinic's rent is $42,000 a month and $329,000 is overdue.
• 24 January 2002 Primetime broadcasts its investigation of Tijuana cancer clinics, including BioPulse.
• 24 July 2002 The FTC files suit and settles the same day (see below).
• 10 March 2006 The SEC opens proceedings to suspend or revoke the registration of BioPulse's securities. The company has missed 14 filings; its last periodic report covered the quarter ended 30 April 2002.

What Primetime found

In December 2001 ABC correspondent Chris Wallace took a breast-cancer patient, with hidden cameras, to several Tijuana clinics. At BioPulse she was offered a three-week course of insulin comas for $16,000, and Swensen told her breast cancer "responds very well to this therapy." Dr. Steven Rosenberg, chief of surgery at the U.S. National Cancer Institute, reviewed the tapes and said he was "outraged."

Primetime then contacted the families of 10 BioPulse patients. All said the clinic's doctors had given them good news while they were there. Nine of the ten had since died of their cancer. The tenth, a 75-year-old woman from San Jose with ovarian cancer, said she had been told the coma treatment had a 60 percent chance of helping her; after 25 comas in five weeks she was left with the impression that her scans were clear. Back home, her own oncologist found the cancer unchanged. "Nothing they had told me was the truth," she said. Primetime took her back to Tijuana to confront Swensen, who said no one at the clinic had been "out to hurt anybody."

The FTC settlement, July 2002

On 24 July 2002 the FTC sued BioPulse International, BioPulse, Inc., Jonathan Neville and Loran Swensen in the Northern District of California (Civil Action C023511). It alleged that they had no substantiation for their claims that insulin therapy and Acoustic Lightwave therapy effectively treated cancer and other serious diseases, and no basis for their safety claims for the insulin treatment, which ran for up to seven weeks at up to $39,900. The defendants settled the same day without admitting wrongdoing. They were permanently barred from misrepresenting the safety of insulin therapy and from making any health claim for any treatment, device, drug or supplement without competent and reliable scientific evidence. A $4.3 million judgment was suspended on the strength of their financial statements, to be revived if those proved false. "In any language, health fraud trades on hope," said the FTC's consumer-protection director, J. Howard Beales III.

Where Loran Swensen went next

The 2002 order has no end date. In recent years Swensen has described himself, in a podcast biography, as president and co-founder of Solex LLC, founded in 2020, and co-founder of Innergy Development, founded in 2008, which makes "non-invasive health devices" including a "multimodality neurostimulation pod" now sold as the Theta Chamber. The same biography credits him with founding BioPulse clinics in Mexico and Germany "with a special focus on cancers." The consumer site BehindMLM reports that Solex markets a subscription "AO Scan" frequency system through a multi-level sales force, and argues that its health claims breach the 2002 order. That is BehindMLM's view; whether any claim breaches the order is a question for the FTC.

Related

Sources

1. Penni Crabtree. "'Biotech' cancer therapy disputed: But Baja clinic lures patients, investors." San Diego Union-Tribune, 8 February 2001, p. A-1.
2. Penni Crabtree. "A medical mecca: Thousands travel to Tijuana for a go at alternative clinics." San Diego Union-Tribune, 8 February 2001, p. A-18.
3. Penni Crabtree and Sandra Dibble. "FTC checks BioPulse's cancer-treatment claims." San Diego Union-Tribune, 14 February 2001.
4. San Diego Union-Tribune, 22 February 2001 (landlord's letter of credit; name change to California BioScience).
5. Penni Crabtree. "Ex-client sues BioPulse over care claims." San Diego Union-Tribune, 16 May 2001.
6. Townsend Letter for Doctors and Patients, "The Strange Saga of BioPulse," May 2001.
7. BioPulse International, Inc. Annual report (Form 10-KSB) for the year ended 31 July 2001, filed 14 November 2001; quarterly report (Form 10-QSB) for the quarter ended 31 October 2001, filed 21 December 2001.
8. ABC News, Primetime. "False Promises? Alternative Clinics Say They Help Treat Cancer; Other Doctors are Skeptical." 24 January 2002.
9. Federal Trade Commission. "Company Touting Unproven Cancer Treatment Agrees to Settle FTC Charges," 24 July 2002; FTC v. Biopulse International, Inc., et al., Civ. No. C023511 (N.D. Cal.), stipulated final judgments, 24 July 2002.
10. U.S. Securities and Exchange Commission. Order Instituting Proceedings, Biopulse International, Inc. and Summit National Consolidation Group, Inc., Release No. 34-53465, 10 March 2006.
11. Inspire Health Podcast. "Loran Swensen" (guest biography).
12. BehindMLM. "Solex Review: Loran Swensen continues to violate FTC Act."

Patients are described rather than named, except where a patient chose to speak publicly. Settlements without admission of wrongdoing are reported as settlements. Corrections are welcome and are recorded on the page.