The Biopulse IR person deserves the lowest level of Hades and a special ring of fire.
Some BioPulse patients angry about its claims, results
signonsandiego.com
By Penni Crabtree and Sandra Dibble
UNION-TRIBUNE STAFF WRITER
March 31, 2001
Paul Burns Jr. remembers how the tears came to his eyes when his mother told him the good news.
Gloria Burns called from BioPulse International's clinic in Tijuana last May to tell her son that doctors there declared her bone cancer significantly improved. In some places, she was told, it had even disappeared.
For Paul Burns, a Santa Barbara chiropractor, the news seemed almost too good to be true. And it was.
When Burns' 79-year-old mother returned to the United States, Santa Barbara radiologist John Michal ordered a new set of X-rays and compared them with X-rays taken a few months before she went to Tijuana. The lesions in her skull had increased in size and number.
"I feel deceived, heartbroken and foolish all at once," said Paul Burns, 39, who paid BioPulse $30,000 to treat his mother with the clinic's controversial regimen of experimental insulin-induced comas and cancer vaccines.
As San Ysidro-based BioPulse faces continued scrutiny from regulators in the United States and Mexico, where its alternative cancer therapies were halted in February, former patients and their relatives are struggling with uncertainties and doubts.
In recent interviews, three BioPulse clients alleged that they were persuaded to continue costly treatment at the clinic by BioPulse doctors who assured them their conditions had improved significantly.
Once they were back in the United States, however, independent X-rays and bone scans confirmed that their conditions were unchanged or had grown worse, they said.
BioPulse runs one of the many alternative health-care clinics that operate in Tijuana and cater almost exclusively to Americans.
Most patients arrive desperately ill, seeking last-chance therapies that the established medical community derides as ineffective and risky.
while alternative clinics have a long and dubious history in Tijuana, BioPulse arrived on the scene in 1999 as something different.
Instead of operating quietly and privately, it became a publicly traded company in the United States and Germany, promoting itself in news releases and investor forums as a hip, hybrid "biotechnology" company with alternative
sensibilities.
Yet the company's high profile and claims of success in treating cancer – BioPulse has not conducted clinical trials to determine if its therapies are effective or safe – have led to intense public scrutiny on both sides of the
border.
Baja California health officials last month ordered BioPulse to stop providing patients with alternative treatments the clinic wasn't licensed to perform.
And the U.S. Federal Trade Commission is looking into the company's advertising practices and whether BioPulse can substantiate claims made regarding its therapies.
BioPulse's recent woes have caused its over-the-counter stock to tumble from a high of $12 in December to 66 cents yesterday.
$5,000 more
Paul Burns said that after his mother's telephone call, he spoke with a BioPulse staff member who confirmed that cancerous lesions in his mother's skull were improving, and in some cases had "cleared."
BioPulse recommended another week of treatment, he said, at an additional cost of more than $5,000.
Gloria Burns stayed for five weeks at BioPulse, but on her return her son immediately took her to Santa Barbara Cottage Hospital for the new round of tests that showed the cancerous lesions in her skull had grown.
"You want to believe that you did the right thing and got the miracle cure – and that's part of the problem," said Paul Burns, who recently contacted BioPulse about getting a refund. "The representations BioPulse made are inconsistent with what really happened."
Gloria Burns remains philosophical about her BioPulse experience.
"I'm sorry I went. I didn't get the help I thought I'd get," she said. "They lied. But what can you do?"
Loran Swensen, president of BioPulse, said he could not account for apparent contradictions between what some patients say they were told about their conditions at BioPulse and what U.S. doctors reported to them on their return home.
Swensen said BioPulse doctors rely on tests and reports from independent Tijuana radiologists to make their diagnoses and recommend treatment.
The San Diego Union-Tribune asked three Mexican physicians, including a radiologist and an oncologist, as well as a UCSD radiologist, to review the Tijuana report on Gloria Burns' bone scans, which were taken less than a month apart during her BioPulse stay.
All four concurred: The independent report by Dr. Pablo Higuera Bogarin, a well-regarded Tijuana nuclear medicine specialist who did the tests for BioPulse, showed no conclusive change in Burns' condition.
"The report never says at any moment that the lesions diminished," said Dr. Jorge Zavala Reyes, one of the four who examined the report. He is a prominent Tijuana cancer surgeon.
The report does note that the mixture of radioactive isotopes given to Burns ensure a clear bone scan was not absorbed as much in some bones in the later scan. That could indicate improvement, or a number of other things – including that the bones are too deteriorated to absorb it, the specialists said. Dr. Heriberto Valenzuela, president of Tijuana's Society of Radiologists, said interpretation of diagnostic tests ordered for patients by Tijuana's alternative cancer clinics are often a sore subject between traditional and alternative doctors.
BioPulse was a client of his radiology group for about a year, Valenzuela said, but BioPulse withdrew because of its frustration with the lack of positive results indicated in the radiology group's reports.
"We lose almost all alternative medicine doctors for the same reason," Valenzuela said. "I tell them, 'I see (the patient's condition) is just the same,' and they say, 'But how?'"
Valenzuela said many alternative doctors are "very convinced of what they do.... They believe that they are going to cure."
Dozen interviewed
The Union-Tribune interviewed 12 people – either former BioPulse patients or family members of patients – who agreed to speak on the record.
Most of the patients had been treated at the clinic in recent months. Of that dozen, 10 expressed anger about BioPulse's claims of therapeutic success and the lack of results they achieved there.
BioPulse provided the names and telephone numbers of two additional patients who agreed to speak on the record. Both praised the Tijuana clinic.
One of those two patients, Marva Winters, said BioPulse's therapies have helped her fight breast cancer. She insists alternative clinics are often unfairly targeted by the medical establishment – and it is patients who suffer.
"Who do you go to?" said Winters, 65, of Bigfork, Mont. "I don't trust the (traditional) doctors. One of them in the U.S. told me essentially to go home and die."
Winters, whose breast cancer had spread to her lungs, said she benefited from BioPulse's treatment during a September stay. Citing tests she received at BioPulse, Winters said her tumors shrank by 30 percent.
Winters acknowledged that she has not had new tests in the United States to verify the results. But she says she has seen a visible reduction in the number and size of her tumors.
"I have no qualms going to BioPulse, whether they are authorized to do the therapies or not," Winters said.
Yet other former BioPulse patients and family members expressed serious qualms.
William Osco of Los Angeles said he was with his mother, Betty Osco, when a BioPulse doctor told them that her cancer, which started in the lung and spread to the brain, had receded since she had come to the clinic in mid-December.
"He (the BioPulse doctor) pointed at the X-rays and said, 'This is smaller, this is smaller, they are shrinking,'" recalls William Osco, 47. "I was so happy when they told me that Mother's tumors were shrinking. We were making plans for the future."
By late January, however, Betty Osco, 72, had grown listless and unresponsive. Osco said BioPulse doctors assured him on Jan. 31 that she was suffering from "low sodium."
The next morning, on Feb. 1, Osco said BioPulse doctors told him that his mother had a small infection in her lung and asked to transfer her to a Tijuana hospital. Osco instead ordered an ambulance to drive his mother across the
border to Scripps Memorial Hospital Chula Vista.
She died there nine hours later of septicemia, a deadly bacterial infection, complicated by pneumonia – neither of which BioPulse doctors had diagnosed or treated, according to Osco.
Reviewed tests
After his mother's death, Osco hired a U.S. radiologist to compare BioPulse diagnostic tests with tests taken by Scripps Hospital the day Betty Osco died. The Scripps tests confirmed that his mother's cancer had not receded or improved, he said.
"It was nonstop lies," Osco said. "They really took advantage."
Swensen disputed Osco's version of events and said the clinic did treat Betty Osco for pneumonia. He said BioPulse interviews with patients are recorded or videotaped, and that in the Osco case BioPulse doctors were recorded telling them that Betty Osco wasn't going to get better by continuing BioPulse therapies.
Swensen declined to let the Union-Tribune review the recordings. Nor would he directly answer whether there are recordings of Osco being told at any time that the therapies were working or her condition improving.
"She (Betty Osco) was making improvements, but not enough to bring her out of it," Swensen said.
Another former BioPulse patient, Ann Bhasin of Clearwater, Fla., also alleges that she was encouraged to continue costly treatments because of promises that her cancer was improving.
Bhasin said she checked into BioPulse's clinic in mid-November to undergo a three-week course of cancer vaccines to treat breast cancer that had spread through her bones.
Once she was there, Bhasin said, BioPulse doctors told her that if she stayed longer and added coma therapy, the chances of remission would rise from 50 percent to 76 percent.
Weeks later, a BioPulse physician called Bhasin and her daughter, Dawn, into the office.
"They put the (bone) scan up in front of me and said, 'Look, there is no cancer in the head; it's gone from the shoulders, nothing in the ribs,'" said Bhasin, 60. "He said I should continue to do more comas because it was making it (the cancer) go away – and I believed him."
After more weeks, Bhasin said a BioPulse physician told her the coma therapy was no longer helping, and that she should try a new therapy.
At that point, Bhasin took her BioPulse records to another Tijuana physician for a second opinion. He reviewed the independent Tijuana radiologist report, which was in Spanish, and concluded that her condition had not improved, she said.
Bhasin said she went back to BioPulse, packed her bags and left. She returned to Florida on Feb. 3 and was hospitalized the next day. There, new tests confirmed the bad news: Bhasin's bone cancer hadn't improved, and there were new tumors to battle.
"It was all still there, in the head, in the shoulders. They lied to me," said Bhasin, who sobbed with rage during a recent telephone interview from her Tampa hospital bed. "I went crazy when I found out. I just couldn't believe they would do that."
Swensen also disputes Bhasin's version of events, and said doctors ultimately encouraged her to go home because she wasn't going to get better. He did not directly answer whether Bhasin had ever been told by BioPulse that her condition had improved.
Since Feb. 15, when Baja California health authorities ordered BioPulse to cease all alternative therapies at its Tijuana clinic, the clinic has been allowed to offer only traditional therapies.
BioPulse has informed the health department that it will seek federal permission to conduct alternative cancer treatments.
Swensen said the company will continue to operate the clinic, reversing the decision it announced last month to sell its assets there.
The chief asset is a management contract that gives BioPulse administrative and financial control over the Tijuana clinic and provides most of BioPulse's revenues and profits. The company says it is also developing a
cancer-screening test.
If Mexican authorities agree to give BioPulse permits to conduct alternative therapies, authorization will take "quite a few weeks," said Dr. Alfredo Gruel Culebro, who oversees clinics and hospitals for the Baja California Health
Department.
And the patients who say they were misled? "They can come to us," said Gruel. But so far, the office has received no patient complaints about BioPulse.
Swensen said BioPulse has received only one patient complaint.
"In any service-related business you are going to have people who feel like they didn't get good service – I don't care if it's flipping burgers or medical care," Swensen said. "All I can say is if they got a beef, why don't they call us?" |
