By STEPHEN STEED
Special to The Leader
Agents with the Food and Drug Administration worked undercover for 21 months before staging a raid that may be the death knell for a company already saddled with a $2.5 million judgment for fraud, negligence and misrepresentation for its claims that it cures cancer through laser treatments.
Lase Med, Inc. operated in Jacksonville for a few years before relocating to Broken Arrow, Okla., and, later, to nearby Owasso, where FDA agents on July 11 seized several boxes of patients’ records, employee payroll records, medical equipment, promotional materials, images off computers, various solutions and injectable ointments used in its practice, and $7,800 in cash from an office safe.
The FDA, in its application for a search warrant, said the agency suspected Lase Med Inc., and its owner-operator, Marie Antonella Carpenter, of wire fraud, causing a drug to be “misbranded” and a medical device to be “adulterated,” and failing to register as a drug-manufacturing establishment.
“Carpenter is preying on patients and giving false hope to those who are seeking treatment options for their disease,” wrote Agent Jeremy Bain of the FDA’s Office of Criminal Investigations. “In turn, she charges fees for the treatments that are not covered by insurance. She utilizes interstate communications, via e-mail and telephone calls, to induce prospective clients to participate in her scheme.”
Lase Med and Carpenter lost a lawsuit in U.S. District Court in Little Rock in July 2011. The jury awarded Therese Westphal of Tarzana, Calif., $2.5 million in punitive and compensatory damages. However, Westphal, whose breast cancer returned after spending $6,250 for seven days of treatment at Lase Med’s clinic in Jacksonville, hasn’t been able to collect any part of the judgment.
The FDA is continuing its investigation. In the end, the agency can refer the case to the U.S. Attorney for the Northern District of Oklahoma for criminal charges or seek civil penalties against Lase Med through the FDA administrative division.
Carpenter didn’t return a reporter’s phone calls seeking comment, but she has written about the raid on a Lase Med website, blog and other Internet sites friendly to Lase Med. Her blog post a day after the raid referred to FDA agents as “government thugs.” Carpenter has shown similar disdain for other Lase Med critics, including former patients, calling them shills for the medical industry.
The raid essentially puts Lase Med out of business, because so much equipment and office records were seized, Carpenter wrote. “Dr. Carpenter has been rendered bereft and unable to make a living now, all because she offers an effective treatment for cancer which does not involve deadly poisons and cancer-causing radiation,” her blog stated.
The FDA said in the filing that it began an undercover investigation October 12, 2010, after a Lase Med patient complained that his treatments for throat cancer were a failure. Working undercover, agents posed as relatives of a fictitious cancer patient, “Mary Hart,” and sought information packets from Lase Med, in Broken Arrow at the time. The packet included an information sheet that stated, “We at Lase Med have been successfully treating patients since the inset (sic) of this millennium and continue to send our patients home, free of cancer.”
The FDA said Carpenter mixes saline solution and Black Walnut Green-Hull extract to “form a product the Lase Med website calls OxyM,” which is applied to cancer patients topically or by injection, and then uses a laser to heat the cancerous area to a temperature high enough to kill the tumor. The FDA said in its search-warrant application that “OxyM” is not FDA-approved, contrary to Carpenter’s claims. The FDA also has never approved the use of lasers for cancer treatments, contrary to Carpenter’s claims, Bain wrote.
By mixing the saline and extract to form OxyM, Baine said, Lase Med was manufacturing a drug but had not registered with the FDA as a drug manufacturer, as required by law.
During an undercover visit at Lase Med’s facilities, the FDA wrote, an agent was told by Carpenter, “Every patient that leaves here has got a dead tumor. It cannot survive. The way I do everything, there is nothing left alive, nothing at all.” The FDA said Carpenter also advises her patients to not consult other physicians or oncologists while, or after, receiving Lase Med treatments.
When the undercover agents questioned Carpenter about her education and background, Carpenter “claimed to be a physicist, not a physician or medical doctor,” according to the search-warrant application.
The FDA said Carpenter also told the agents that if the fictitious patient, “Mary Hart,” suffered any discomfort, lidocaine would be provided. The FDA said lidocaine, an anesthetic, can be purchased, dispensed and possessed only by a licensed and registered medical practitioner, and that Carpenter was illegally providing patients with the drug.
Bob Babecka, of Powder Springs, Ga., whose wife, Cyndi, received Lase Med treatment in 2008, said Friday he was happy to hear of the FDA’s action against Lase Med but lamented that it took so long. “I hope it keeps her (Carpenter) from hurting other people, at least for a while,” Babecka said.
Cyndi Babecka received a few days’ worth of Lase Med treatment and then was told all the cancer was gone, Bob Babecka testified last year in the civil lawsuit against Lase Med. The cancer returned less than a year later, even breaking through the skin. Cyndi Babecka was encouraged by Carpenter not to seek treatment from oncologists. She died in May 2010.
