The ABC television program Primetime Thursday reported January 21st on its investigation of how representatives of Tijuana clinics that offer bogus treatments mislead people with cancer.
Senior correspondent Chris Wallace began the first of three program segments devoted to the investigation with the story of Sacramento television news anchor Patti Lynn Davis who was diagnosed with breast cancer at age 36. Davis decided to forego chemotherapy after having surgery. Instead she received a protocol of coffee enemas and a diet of fruits and vegetables. Only after she discovered that her cancer had spread Davis started chemotherapy, but it was too late. She died less than three years following her initial diagnosis.
Steven Rosenberg, MD, PhD, chief of Surgery Branch at the National Cancer Institute expressed his outrage about desperate people being exploited. Asked about "alternative" therapies as a public health problem, Rosenberg said: "When patients turn down treatments of known effectiveness to receive treatments that have very little chance of being [of] benefit, I see that as a major public health problem."
Primetime presented hidden-camera recordings of the sales pitches of several exhibitors at the 29th Annual Cancer Convention of the Cancer Control Society at a Los Angeles hotel in September. One exhibitor promoted a $500 trampoline to bounce on "to keep your immune system in good shape." Dr. Rosenberg said the exhibitor's claims were "very ridiculous." Another exhibitor claimed a 100% effective cure for pancreatic cancer, a disease that is almost always fatal. Loren Swenson, president of BioPulse International pitched a three-week cancer treatment program of "insulin-induced hypoglycemic therapy" (i.e., daily comas) at a cost of $16,000. One exhibitor stated: "Chemotherapy has never cured anyone's cancer." Another exhibitor stated: "There has no been no appreciable, demonstrable help from chemotherapy since its inception." These statements are false. Commenting on the sales pitches, Dr. Rosenberg said: "A lot of it sounds like outright quackery."
"I wish the word 'alternative" would go away," said Stephen Barrett, MD to Wallace who showed Dr. Barrett's Quackwatch home page. "It's quack cancer therapy." Asked why cancer attracts so many quacks, he responded: "Willie Sutton said that he robs banks because that's where the money is. If you want to make a lot of money doing quackery, you want to get the people who are desperate." Dr. Barrett demonstrated for Wallace the use of a gizmo called the "Zapper" that puts out a low level of current. He explained that promoters falsely claim the "Zapper" kills parasites in your body that they say cause the cancer. [Editor's note: A proposed stipulated Federal Trade Commission final judgment filed in December prohibits Marvin and Miguelina Beckwith of Seattle from making such unsubstantiated claims for the "Zapper Electrical Unit" and unsubstantiated claims for various herbal products.]
The second program segment was a report of a hidden-camera investigation of four of an estimated 50 clinics in Tijuana that promote dubious cancer treatments. Accompanied by two ABC staffers, a woman who has been cancer-free for eight years following breast cancer surgery and chemotherapy posed at the clinics as a breast cancer patient who was apprehensive about chemotherapy. The third program segment showed Wallace's attempts to follow-up on the hidden camera investigation and interview the clinic staff.
At the first clinic, Jorge Cardenas offered a three-week program of "electromagnetic therapy" for $15,000 to control cancer by changing the electric current in "cell walls." Asked if his program is more effective than chemotherapy, Cardenas said: "Well in many cases it is because, first of all, there won't be any side effects." Commenting on the Cardenas tape, Dr. Rosenberg said the statements were "mumbo-jumbo." When Wallace attempted to confront Cardenas, another clinic staffer slammed a door on Wallace. Electromagnetic therapy is not approved in Mexico, Wallace explained.
At Kurt Donsbach's clinic, Hospital Santo Thomas SA DECY, a representative proffered "bioray" treatment and "ozonation" treatment through the ears and rectally. Wallace said the clinic charges $29,000 for a seven-month treatment program. Wallace noted that Donsbach was convicted in the U.S. for tax evasion and smuggling unapproved drugs across the border. Donsbach stated on the videotape: "I can cure rheumatoid arthritis. I can cure lupus and I guarantee it. If I can't cure you, it doesn't cost you a cent. I have scores of multiple sclerosis patients." Wallace said Donsbach turned down repeated requests for an interview. Wallace stated that according to Mexican authorities two of the therapies offered by Donsbach's clinic are unapproved.
The third clinic promoted coffee enemas to "flush poisons out your body to fight cancer." A clinic representative identified as Dr. Juan Manuel Nunez recommended hyperbaric oxygen chambers in addition to chemotherapy and radiation. He claimed: "When the oxygen go to the cancer cells, open the channels, too, and it's more susceptible for other treatment to destroy the cancer cells." But when later confronted by Wallace, Nunez admitted that hyperbaric oxygen and coffee enemas do not fight cancer. A clinic spokesperson said Nunez was a consultant speaking for himself and that hyperbaric chambers and coffee enemas can be effective when used along with conventional treatment.
The fourth clinic in the hidden camera investigation was BioPulse International's. (NCAHF Newsletter items about the clinic appeared in the May/June 2001 and July/August 2001 issues.) Wallace reported that company president Loren Swenson said told the undercover patient that coma therapy has a proven track record and that no one is too sick for the clinic.
"Our approach is, you know, until they close the lid on the coffin you still have a chance," said Swenson on videotape. "In the United States it is so easy for doctors to say 'you know what, there's nothing we can do for you.'"
Wallace interviewed Win Wiggin whose oncologist told her she had a terminal case of ovarian cancer. Wiggin said she went to the BioPulse clinic because it offered her a 60% chance of recovery. She said she paid $33,000 for one-hour-long comas, five days a week for five weeks, among other treatments. Wiggin said that BioPulse told her the treatment was working and that her cancer was gone. But her doctors in San Francisco said her CAT scans were unchanged. Wallace said he spoke to the families of ten BioPulse patients, all of whom were given good prognoses, but that Wiggin was the only one of them who was still alive. "There wasn't anyone who was helped," said Wiggin. Wallace reported that according to Mexican officials BioPulse has never had authority to perform coma therapy.
Dr. Rosenberg's final comment was: "I think people who exploit desperate individuals for their own benefit are evil."
"NIH is doing studies into alternative therapies and for more on that and details on how to talk to one of our experts, Dr. Stephen Barrett go to ABCNews.com," said Primetime co-anchor Diane Sawyer who concluded the broadcast. ABCNews.com identified Dr. Barrett as NCAHF's vice president. It moderated an online discussion between viewers and Dr. Barrett on January 25th.
The Primetime broadcast did not mention that cancer treatments as bizarre as those in Tijuana are offered in many clinics in the United States and other nations. Nor did it clarify that NIH's National Center for Complementary and Alternative Medicine uses taxpayers' money to fund studies to test irrational treatment programs featuring methods like coffee enemas on people.
Investigators from the Nordic Cochrane Centre in Denmark published a research letter in The Lancet (October 20, 2001) about a new systematic analysis of randomized trials of screening mammography. Ole Olsen and Peter C. Gøtzsche said that the analysis strengthened their previously reported conclusions that screening mammography has not been shown to decrease mortality and is unjustified. They wrote that they followed a Cochrane Collaboration review protocol -- a protocol noted for rigor and quality -- in carrying out their analysis. The investigators published their full review on the Web site of The Lancet.
Editors of the Cochrane Breast Cancer Group insisted on significant modifications to their review. According to the investigators, the version of the analysis that was published in The Cochrane Library did not reflect Cochrane standards as well as the version published by The Lancet. Richard Horton, editor of The Lancet, wrote that the Cochrane editors did not welcome Olsen and Gøtzche's conclusions.
A storm of media coverage and controversy among breast cancer experts ensued. The screening and prevention editorial board of PDQ (Physician Data Query), which writes information summaries for the National Cancer Institute's online database, found Olsen and Gøtzsche's review persuasive. The board said it would rewrite previous statements accordingly. [Kolata G. Expert panel cites doubts on mammogram's worth. The New York Times 1/24/01.] The board noted flaws in previous studies, the lack of evidence that mammography prolongs lives, and concern that mammograms lead to aggressive treatments for tumors that would not have threatened women's lives. The board also said that it was rational for women to decide to have mammograms or to decide not to have them.
On the other hand, a February 3rd letter to the editor of The New York Times from 19 major cancer and medical organizations claimed that many analyses have found mammograms to be life-saving and that women should follow established guidelines to have them. The organizations cited a reassuring research letter to The Lancet published in the February 2nd issue. The Lancet letter presented a new analysis of data from one of the best mammography screening trials conducted; its authors concluded that mammography reduces the risk of death among women with breast cancer.
The 19 organizations endorsed this statement: "Until carefully thought-out recommendations based on all available information can be offered to the public, we strongly urge all women to follow the advice of their physicians and obtain mammograms per current guidelines." This not-so-carefully worded statement makes it sound like current guidelines were not carefully thought-out before they were issued.
The National Breast Cancer Coalition (NBCC) was not among the organizations that signed the letter. Its president, Fran Visco, was quoted in The New York Times on December 9th: "We know that mammography screening has serious limitations, yet it has been sold as the be-all and end-all for breast cancer. When someone says, 'we have to question that assumption,' we're thrilled. We've been questioning it from the beginning."
"I'm not ready to tell women over 50 not to get screened," she continued. "But what we are telling women is that we don't have a good screening test to detect breast cancer early and we're not sure what to do when we find it early."
Consumers are understandably confused. It's difficult to know whom to trust. It appears that experts can't make up their minds. Recommendations appear to be based on political as well as scientific considerations.
Physicians may also be confused by the controversy. They may wonder whether failure to comply with current guidelines can be construed as malpractice.
The public-health rationale behind any screening program is to detect serious disease at an early phase when treatment can be applied most effectively. Screening turns human beings who have no apparent signs of disease into recipients of medical care. Although it can be helpful to receive medical care, it can also be harmful. Recommendations to the public about who should receive particular screening tests or procedures must take into account the risks and benefits of turning people into patients. For many women, mammography testing is a source of psychological distress. Inevitably, many individuals screened will receive false positive results leading to additional healthcare. And, inevitably, some others will receive false negative results which provide unjustified reassurance. No screening program can guarantee for any particular individual screened that the benefits will outweigh the risks. However, it should be clear before issuing recommendations that, on the whole, the group to be screened will be helped more than harmed.
The U.S. Preventive Services Task Force (USPSTF), an independent panel, has taken a rigorous, conservative approach in developing recommendations about who should receive particular screening tests or procedures. In its 1989 and 1996 reports, the USPSTF recommended mammography screening for women in their 50s and 60s. It found that the evidence to support their recommendation was of high quality. Other medical organizations concurred. Although some experts continued to have serious doubts about the value of mammography, USPTF's recommendation reflected a consensus of expert opinion. USPTF is now working on an update of its assessments and guidelines regarding clinical preventive services. It will be interesting to see what USPTF will say about Olsen and Gøtzsche's analysis.
In 1996 USPTF found insufficient evidence to recommend for or against mammography for women in their 40s and women 70 or older. (Women in their 40s are at lower risk for developing breast cancer than older women, but the breast cancers they do develop are often fast-growing and aggressive. Many experts say that the denser breasts of women in their 40s compared to older women tend to make it difficult to find signs of cancer through mammography.)
Prior to the recent Nordic Centre review, the focus of most of the controversy related to mammography has been on guidelines for women in their 40s. In 1997 an NIH consensus panel also concluded that available data did not warrant a universal mammography screening recommendation for women in their 40s. But the conclusion was contrary to the judgment of the American Cancer Society, Consumer Reports magazine, and various radiology and other medical associations that advised women in their 40s to receive mammograms regularly. The NIH panel advised physicians to inform these women that data are conflicting regarding the utility of mammography screening for their age group and that they should decide for themselves.
The advice was objectionable to many healthcare professionals and consumers. The U.S. Senate voted 98 to 0 for a nonbinding resolution to "reinstate the pre-1993 screening guidelines" from the National Cancer Institute (NCI) which stated that women in their 40s should undergo mammography every one or two years. (In 1993 the NCI had reversed its 1987 endorsement of mammography for women in their 40s. It noted: "Experts do not agree on the value of routine mammography for women ages 40 to 49.")
NCI disregarded the conclusion of the NIH consensus panel and issued a recommendation developed by the National Cancer Advisory Board that women in their 40s at average risk of breast cancer should undergo mammography every one or two years. The guideline opened the doors for more available medical insurance coverage of mammography screening for women in their 40s. University of Wisconsin researchers calculated that if all of the more than 20 million 40-to-49-year-old women in the U.S. were to undergo screening mammography in one year at $125 per mammogram, the total cost -- $2.5 billion -- would exceed the NCI's total budget.
No test or procedure does a better job of detecting evidence of tiny breast tumors or of noting the absence of evidence of tiny breast tumors than mammography. Estimates of mammography's sensitivity are as high as 83 to 95%; estimates of its specificity are as high as 94 to 99%. Despite all the controversy about mammography recommendations, it would be simply wrong to dismiss mammography as a bogus procedure.
But erroneous results are still a problem with mammography screening. The vast majority of women in populations to be screened for breast cancer will never develop the disease. The lower the prevalence of breast cancer at a detectable pre-clinical phase in a population, the lower the percentage of positive findings from mammography in that population that are true rather than false positives. False positives are inevitably more common than true positives.
We need an approach to breast cancer screening that doesn't just detect tumors. We need an approach that specifically detects tumors that are responsive to treatment. As explained in a January 3rd letter to The New York Times by Elizabeth M. Whelan, ScD, MPH, president of the American Council on Science and Health:
The medical literature on screening contains this analogy: To keep three animals -- a turtle, a bird, and a rabbit -- from leaving your farm, a screen for the bird would be useless; it would just fly away (metastasize). The screen for the turtle would be useless because it is going nowhere. But for the rabbit, the screen could help.
What we need are cancer screening techniques that ignore the 'turtles,' realize that the 'birds,' are beyond cure and focus on the 'rabbits.' Such techniques would save lives by treating those cancers that have clear potential for metastasis, but have not yet spread.
Unfortunately, when a tumor is identified, we have no way of knowing which animal it will act like. Many women who believe they would now be dead from breast cancer if their disease not been detected early through mammography may actually have had "turtle" tumors that would never have killed them. One reason why ineffective cancer treatments may seem effective to some doctors and patients is that some patients don't develop advanced disease because they have "turtles."
"I am personally convinced that had my two sisters had access to mammography that they would not have died so young because of this terrible disease," Senator Tom Harkin (D-Iowa) told The New York Times. [See Feb. 5 issue.] No one knows whether Harkin's sisters had "bird" tumors, but if they did, mammography followed by aggressive treatment would have made no difference. Harkin, who, based on his personal beliefs in dubious remedies like bee pollen sponsored legislation that created the NIH Office of Alternative Medicine and then the National Center for Complementary and Alternative Medicine, will be holding hearings on mammography.
At this point, it is unlikely that many women would be willing to participate in a new randomized, controlled clinical trial designed without the methodological shortcomings of previous trials of mammography. Many women have strong feelings one way or the other about the value of mammography. It would be hard to find women to participate who would feel comfortable having random assignment rather than personal choice determine whether they will be screened. Many experts already believe the issue has already been settled in favor of mammography and that further study would be ethically indefensible.
Controversy over the meaning of old and new mammography data will continue. Such controversy is a strength, not a shortcoming, of scientific inquiry about healthcare innovations. Medical scientists submit their work for systematic scrutiny by others. Challenges to research conclusions contribute to medical progress. We have no satisfactory alternative to the processes of science for validating claims for healthcare products and services. Critics who claim that healthcare is too scientific are mistaken. An important lesson from the current mammography controversy is that testing of potentially valuable technologies for early detection of disease needs to be as scientifically rigorous as possible before leading people into becoming patients.
Hovey-in-the-Hills, Florida residents whistled and cheered in response to the resignation in December of its mayor, Greg Bittner, who had falsely claimed in the town's October newsletter that colloidal silver is a cure for anthrax. Bittner called the nostrum "the greatest medicinal item that has ever come along." Residents were aware that medical authorities had criticized Bittner for enthusiastically promoting colloidal silver. [Erickson S. Mayor ridiculed for anthrax 'cure' quits. Orlando-Sentinel.com 12/12/01.]
In 1999 the FDA declared all over-the-counter drug products containing colloidal silver or silver salts to be misbranded and not recognized as safe and effective. Ingesting silver preparations can cause a permanent skin discoloration known as argyria.
Utah H.B. 261, sponsored by Rep. Mike Thompson, modifies the Mental Health Professional Licensing Act to restrict physical or mechanical restraint on or to minors or nonconsenting adults to special circumstances delineated in the bill. These circumstances do not include the dubious and dangerous treatments of so-called rebirthing or holding therapy to treat children with the spurious condition of attachment disorder. Rep. Thompson's e-mail address is firstname.lastname@example.org.