Amersham’s radiotracer recall prompts panic in Hong Kong

Media may have overreacted to mad-cow threat

The recall of a Nycomed Amersham radiotracer due to concerns over possible contamination with the protein that causes mad-cow disease prompted near hysteria in Hong Kong last month. Public health officials reassured the public that the risk of infection was low, after television and newspaper reports indicated that the radiopharmaceutical was administered to 111 patients last year, seven of whom have since died.

Nycomed Amersham of Buckinghamshire, U.K., began a recall of the lung imaging agent, Amerscan Pulmonate II, after learning that the product had been manufactured using serum derived from a blood donation given by a patient who was diagnosed post-mortem with new variant Creutzfeldt-Jakob disease (SCAN 1/14/98). CJD is the human form of bovine spongiform encephalopathy, also known as mad-cow disease.

Some 14,000 doses of Amerscan Pulmonate II were produced with the serum, and Nycomed Amersham began recalling the doses on Nov. 17 after learning of the blood donor's background. The company said its move was purely a precautionary measure, as there is no evidence that any of the doses were contaminated or that it is possible to contract CJD through a radiopharmaceutical.

The Hong Kong media seized on the more sensational aspects of the recall, however, perhaps due to increased sensitivity in the Chinese territory toward health issues following the recent outbreak of an avian flu virus that spread to humans. Attention specifically focused on why Hong Kong health authorities waited to disclose the recall to the public until two months after they were initially alerted by Nycomed Amersham.

Despite the uproar, nothing has changed regarding the basic facts of the recall, according to Nycomed Amersham spokesperson Alan Huw Smith. There is still no evidence that the Amerscan Pulmonate II doses are defective or have infected any patients with CJD.

"There have been misunderstandings and misreportings from Hong Kong which have been carried on the newswires, making the all-too-easy assumption that this product is in some way defective," Smith said. "That is not the case. This is a precautionary recall."

Hong Kong health authorities believe the deaths of the seven patients who received the radiopharmaceutical can't be attributed to CJD infection because the disease has an incubation period that is many years long, sometimes as long as two decades. The patients received the doses in the second half of last year.

The fact that several patients have died is not unusual, according to Smith. Amerscan Pulmonate II is typically used in patients with late-stage lung disease.

"It's highly likely that a sample of 100 will show deaths as outcomes in the following six months," he said.