Australian entrepreneurs struggle with new regulations on screening

Threats of fines, jail give screening clinics pause

CT screening has had a bumpy ride in the U.S. Physicians have criticized its clinical value amid concerns over unnecessary radiation exposure. And patient demand has been spotty at best. But that's nothing compared to its travails Down Under. Owners of CT screening clinics in New South Wales, Australia's oldest and most populous state, could get hauled into court if they continue offering whole-body scans to healthy walk-in clients.

The state government has introduced a new set of conditions for CT scanning, aimed at controlling the number of speculative "lifestyle" exams being performed. This follows the appearance of Australia's first U.S.-style CT screening clinics in Sydney.

The regulations make it illegal to perform whole-body CTs unless certain conditions are met. Patients must have a written referral from an independent doctor. The screening center must explain to the client the level of radiation dose involved, the possible associated health risks, and the higher risk for anyone under age 50. The center must also obtain written, informed consent from the client.

Individuals who breach these conditions could face fines up to $A27,500 (US$18,000) and two years in jail. Corporations found to be in violation could be fined $A165,000 (US$110,000).

Government officials claim the new rules will protect the public from unnecessary exposure to ionizing radiation. A report issued by the NSW Environment Protection Authority in November 2002 acknowledged the potential value of targeted CT in diagnostic medicine but emphasized the high levels of radiation associated with whole-body exams.

Dr. Paul Condoleon, a general practitioner and director of the Total Health Screening clinic in Sydney, objects to the emphasis on radiation risks in publicity surrounding the regulations. The average 7-mSv dose to which clients are exposed during a screening exam is comparable to other medical x-ray procedures such as barium enema, he said.

"They are trying to use radiation as a scare tactic," Condoleon said. "The regulations are an overreaction by a government that doesn't agree with the philosophy of whole-body CT scanning."

The new conditions actually make little difference to working practices at Total Health Screening. The clinic has always required clients to see a doctor prior to having a scan and has always used consent forms, he said.

Visitors to the Total Health Screening Web site are advised to consider a full-body scan if they have a family history of cancer or heart disease, have ever smoked, live a sedentary or stressful life, or are older than 40. They are also invited to consider buying a CT scan as a "thoughtful gift" for family and friends. The site cautions pregnant women and anyone younger than 20 not to undergo CT screening.

"We have a very high level of patient satisfaction," Condoleon said. "We have found pathology in a significant proportion of our patients. This is life-saving, preventive healthcare, rather than reactive healthcare."

The Royal Australian and New Zealand College of Radiologists does not support the CT screening clinics that advertise their services in Sydney's newspapers. These centers offer head-to-toe scanning at a cost of up to $A900 (US$600), with the promise that the exam will show early signs of cancer or heart disease, according to Dr. Derek Glenn, a radiologist and RANZCR spokesperson. But the scientific evidence supporting the use of CT as a screening tool is just not there.

"The issue is whether people selling them are overpromising," Glenn said. "They are not quoting the false-positive and false-negative figures, and we all know that any medical imaging exam has false positives and false negatives."

The American College of Radiology is similarly unimpressed by entrepreneurs who promote whole-body CT as a medical checkup. The college's policy statement, renewed in September 2002, emphasizes the difference between screening high-risk patient groups for specific disease, an application that may prove clinically valid, and whole-body scanning of apparently healthy people.

Dr. James Borgstede, vice chair of the ACR board of chancellors responsible for developing the policy statement, criticized owners of walk-in scanning centers for using targeted CT research data to justify whole-body screening. Although the NSW government's attempt to clamp down on the clinics is welcome, the merit of using consent forms as a means of regulation is questionable, he said.

"How do patients give their informed consent to a procedure we have no data about?" he said.