|Copyright SAN DIEGO UNION TRIBUNE PUBLISHING COMPANY Feb 8, 2001|
TIJUANA -- Silvia Drucker says she doesn't believe in herbs, coffee enemas, chanting Tibetan monks or other trappings of "alternative" medicine.
But talk about biotechnology and her eyes shine like a True Believer's.
That's why the 53-year-old Essex Fells, N.J., homemaker -- energetic, witty and dying from a lung cancer that has spread to the brain -- trekked thousands of miles to this border town to be treated at the BioPulse Research Center.
"There are sound scientific studies and preliminary data on these therapies," says Drucker, who is paying the clinic $50,000 for an eight-week course of unconventional treatments, including an unproven, experimental cancer vaccine.
"But before a cancer vaccine gains approval in the U.S., I'm looking at two to five years, maybe seven years -- and I don't have that kind of time."
For terminally ill cancer patients like Drucker, the lure of BioPulse's advertised "biotech" therapies -- which include using insulin to induce daily comas in patients, and injecting them with a vaccine derived from elements in their own urine -- is proving irresistible.
More than 300 cancer patients, most from the United States, have made their way to the BioPulse clinic since 1999.
The clinic now sees about 30 new patients each month and they pay anywhere from $27,600 for BioPulse's monthlong vaccine and coma treatments to $10,800 for a three-week "rejuvenation" program.
Through its publicly traded U.S. parent company, BioPulse International, the clinic is also a hit with investors. BioPulse's stock price has almost doubled in recent months, thanks in part to a vigorous public relations campaign.
Business is so good that BioPulse International is moving its Salt Lake City headquarters this month to a new 17,000-square-foot facility in San Diego's Miramar area, where it will be closer to the chain of Mexican cancer clinics and vaccine-producing laboratories it hopes to open.
Yet despite BioPulse's popularity with some cancer patients -- and a growing number of investors -- some U.S. medical and biotechnology industry experts warn that the company's science is anything but sound.
Though BioPulse says in news releases and on its Web site that its treatments are "tested" and it "enjoys high success rates in treating cancer and other diseases," the company has not conducted clinical trials to determine if its therapies are effective or safe.
Baja California Health Department officials also say the BioPulse clinic may not be operating with the proper permits and is not authorized to perform alternative therapies.
U.S. medical experts warn that some of BioPulse's treatments are not only unproven but potentially dangerous -- such as using insulin shock as a cancer treatment. At best, the therapies are merely ineffective, critics warn.
"This is the very vocabulary of quackery, dressed up in the current jargon of biotechnology," says Dr. Daniel Masys, an oncologist and director of clinical trials at the UCSD Cancer Center. "It preys on desperately ill people who will grasp at any straw and are more than receptive to the idea that there is a magic bullet, even if one doesn't exist."
The charge of quackery is one that Loran Swensen, BioPulse's outspoken president, says he's heard before -- and dismisses. BioPulse is a pioneer, a company that gets promising therapies quickly to sick patients, he says.
And if that means giving patients therapies that haven't been proven through the rigors of properly controlled clinical trials, Swensen says, so be it.
"It's almost like we have too many damn clinical trials," Swensen says. "Why don't we start doing something that's helping the bottom line -- and that's the people.
"I'm not doing anything that puts these patients at more risk. I may be doing it in an unconventional way, but at least it's getting done," he says. "People who've made a difference through the centuries were considered nuts and idiots, so I consider myself in good company."
BioPulse's unorthodox philosophy may stem from the business background of its founders -- Swensen, 43, and partner Jonathan Neville, 46 -- which is strong on entrepreneurial initiative but lacking in medical or scientific credentials, according to filings with the U.S. Securities and Exchange Commission.
Swensen and Neville incorporated BioPulse in Utah in June 1998, during the same time the partners ran another Utah firm called Multi- Dimensional Studios, a 3-D animation video company.
According to SEC filings, Neville, BioPulse's chief executive, is an attorney who served for a time as general counsel for a turf seed company.
In 1994, Neville joined with Swensen in forming Multi-Dimensional Studios.
Swensen, who says he never earned a college degree, started his first company, which sold security windows, in 1980. He went on to form other small firms, including Enhanced Simulation, which made motion simulators for the amusement industry, according to SEC documents.
Swensen's only apparent brush with the health-care business, not detailed in SEC documents, is his experience as a principal in the Omega Centers.
The chain of alternative drug rehabilitation clinics, launched in 1989, treated patients with a device that emitted electronic pulses to stimulate the brain.
Swensen said he closed the clinics in 1991 after the FDA balked at the device, which hadn't been tested or approved for use in the United States.
On Wall Street, where financial health is the crucial test of credibility, BioPulse appears to be just what the doctor ordered.
The company reported a profit of $87,518 on revenues of $1.1 million in its latest fiscal quarter, a success that has helped boost BioPulse's stock.
Also working in the stock's favor is its investor relations firm, Liviakis Financial Communications. From January through October of last year, the price of BioPulse's closely held stock averaged $4, but things began to change in October when BioPulse hired Liviakis.
The firm and its president, John Liviakis, have arranged investor conference calls, made introductions to investment banks, helped get the company listed on the German stock exchange, and issued press releases with such breathless headlines as "BioPulse announces important development of new cancer vaccines" and "Major breakthrough in treatment of solid tumors."
Since Liviakis' hire, BioPulse's stock price has almost doubled, averaging $8 and hitting a high of about $12.
And that's good news for Liviakis: BioPulse paid Liviakis with 1.5 million of its shares for his company's services, making Liviakis the largest single BioPulse shareholder, with a 13 percent stake. Swensen and Neville own about 10 percent each.
BioPulse is now poised to exit the no man's land of bulletin- board trading and enter the more respected ranks of the American Stock Exchange.
The company announced yesterday that it has closed on $3 million in private financing, the last hurdle to meeting financial requirements to trade on the exchange.
BioPulse's rising public profile promises to make it a standout among Tijuana's famed alternative clinics, where the terminally ill flock for therapies that many medical experts dismiss as useless.
Swensen acknowledges Tijuana's reputation for clinics that provoke skepticism, but insists that BioPulse is different.
On its Web site and in press releases, BioPulse presents itself to patients and investors as a hip hybrid that treats deadly diseases with a blend of biotech and alternative therapies.
Alternative therapies include the use of acoustic lightwaves (which involves sitting a patient in front of a machine that emits a light); massive doses of vitamin C; and colonics, or intense enemas.
To those, BioPulse adds therapies billed as "biotech," including its so-called insulin-induced hypoglycemic treatment, which uses insulin to lower the blood sugar while rendering patients unconscious for an hour.
The idea behind the therapy -- once used in the United States to treat mental illness, but discarded long ago -- is to starve cancerous cells of glucose, according to the company.
Masys of the UCSD Cancer Center termed the treatment "very, very frightening." At best, he said, it is ineffective, though it has the potential to cause seizures and brain damage.
"I'd not subject a family member or a pet that I felt strongly about to insulin shock therapy," Masys said.
Another therapy is BioPulse's own version of a dendritic cell cancer vaccine, other forms of which are being tested in the United States.
No controlled trials
Though made in different ways, the idea behind the vaccine is to use immune-stimulating white blood cells, called dendritic cells, to prod the immune system into recognizing and attacking cancer cells.
Such vaccines have shown promise in eradicating tumors in mice and in small numbers of patients enrolled in early clinical trials.
However, BioPulse's version has never been tested for effectiveness or safety through controlled clinical trials, let alone approved by the U.S. Food and Drug Administration as a treatment.
Swensen says there is "anecdotal evidence" that BioPulse's vaccine produced positive results in some of the 140 patients treated by BioPulse in the last six months. Yet less than a dozen patients have been tracked by BioPulse through the end of their therapy, Swensen acknowledges.
Medical experts say anecdotes aren't evidence, and a six-month track record, with only a few patients followed, can't be a measure for success.
Some critics are also skeptical about the technology behind BioPulse's vaccine. BioPulse, which employs 16 people in the United States and about 30 in Mexico, licensed the technology from Aidan Inc., a privately held company based in Tempe, Ariz.
Aidan has not published clinical studies or scientific papers on the vaccine technology, which includes extracting cancer antigens (a substance that causes the immune system to create a cancer-fighting antibody) from a patient's urine.
Developed in Kansas
The method was originally developed at The Center for the Improvement of Human Functioning, an alternative clinic in Wichita, Kan., that offers nutritional and other therapies, according to SEC documents.
Though BioPulse's technology has scoffers, at least one medical researcher says it might be possible to make a vaccine using BioPulse's method, and the resulting vaccine might activate the immune system.
And that's the problem, according to Dr. Brian Czerniecki of the University of Pennsylvania Cancer Center.
"Harm could be done. You could activate the immune system in the wrong direction and make things worse -- and I'd say at this point it's easier to activate it in the wrong way than in the right way," says Czerniecki, who is conducting a clinical trial in the United States to test a dendritic cell vaccine in skin cancer patients.
"Obviously, in this country you wouldn't be treating patients with something that hasn't been tested."
Swensen dismisses the notion that BioPulse's vaccine could harm patients. He insists that unrelated studies done in the United States by other researchers on other dendritic vaccines should serve as sufficient evidence that BioPulse's approach is safe and promising.
He says the company intends to seek permission from the FDA this year to conduct clinical trials on the vaccine in the United States - - with volunteer patients paying BioPulse for the vaccine it is testing. He said the company also plans to test in the United States a cancer diagnostic test it is developing.
Wild, Wild West??
Meanwhile, BioPulse will continue to treat patients in Mexico with the vaccine, or let them take it over the border and treat themselves -- something U.S. law allows.
BioPulse's philosophy -- treat now and worry about a clinical trial later -- places the company in the biotechnology equivalent of the Wild, Wild West, critics say. If so, Swensen seems comfortable in the role as the biggest cowboy on the range.
Swensen says BioPulse and its Tijuana clinic do the same thing that biotechnology companies and academic researchers do in clinical trials in the United States -- experiment on willing patients.
"They (BioPulse patients) know they are guinea pigs," Swensen says. "I'm not doing anything different other than I'm a little looser than the rest (researchers performing clinical trials) -- of which they (researchers) are deadly envious."
Such arguments stun local biotech leaders like Joseph Panetta, chief executive of BIOCOM, San Diego's leading biotechnology trade organization.
"There is a long, established process under the FDA for the conduct of clinical trials for any drug or therapy," Panetta says. "Those who choose to operate outside of the system, such as BioPulse, raise very serious questions as to whether their product is either safe or efficacious.
"Cancer patients who would consider these therapies should recognize that we don't operate in such a manner in the U.S. -- for good reason."[Illustration]
Credit: STAFF WRITER
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Food & Drug AdministrationDuns:13-818-2175Sic:922190Sic:9400