Nycomed Amersham recalls tracer due to “mad cow” disease concerns

Nycomed Amersham is in the process of recalling a batch of lung imaging radiopharmaceuticals after learning that the batch may have been derived from blood serum donated by a person who later died of new variant Creutzfeldt-Jakob disease, the human form of bovine spongiform encephalopathy, also known as "mad cow" disease. Although there is no evidence that the batch was contaminated, the Buckinghamshire, U.K. company initiated the recall to allay concerns over the safety of the product.

The product in question is Amersham Pulmonate II, a technetium-labeled radiopharmaceutical that Nycomed Amersham sells in 40 countries in Europe and in other global markets. The product is not sold in North America or in Japan.

Amersham Pulmonate II is derived from human serum albumin (HSA), a blood by-product produced through a heat denaturing process. The process removes the major biological components from blood to make it an acceptable body fluid that can be injected into patients as part of a radiopharmaceutical, according to Alan Huw Smith, corporate affairs director for the company. Nycomed Amersham used serum received from the Bio Products Laboratory, an arm of the U.K.'s National Blood Service, which collects blood for transfusion and for the development of blood by-products.

Unfortunately for Nycomed Amersham, the National Blood Service received a blood donation in the early 1990s from a patient who died in 1997 and was diagnosed post-mortem with new variant Creutzfeldt-Jakob disease. The Bio Products Laboratory mixed that donation into a group of blood by-products that was used to produce HSA, which was sold to Nycomed Amersham. The company then used the serum to manufacture Amersham Pulmonate II. Whether the donor was infected with CJD when the donation was made is unknown.

According to recently enacted rules promulgated by the European Committee for Proprietary Medicinal Products, the medical histories of patients who have Creutzfeldt-Jakob disease must be reviewed. In the process of this review, authorities learned that the donation was part of the group used to make Nycomed Amersham's serum.

Bovine spongiform encephalopathy (BSE) first appeared in British cattle in the 1980s, and is believed to be spread through an infectious protein ingested when eating contaminated beef. Some 25 people in the U.K. and France have died from CJD in recent years, according to researchers at the University of California, San Francisco.

Whether CJD can be spread through medicinal products such as blood donations is still unclear. However, Nycomed Amersham made the move to recall the batch of Amersham Pulmonate II to assuage any concerns about transmission.

"There is no evidence that the product, or the serum, or the blood was contaminated or defective," Huw Smith said. "We see this as a purely precautionary measure, to put the issue beyond a doubt."

Nycomed Amersham produced about 14,000 doses of Amersham Pulmonate II from the questionable serum, and shipped the doses between June and October 1997. The company began the recall in November, after an autopsy revealed that the donor in question had CJD. As of mid-December, the company had received about 2000 vials of Amersham Pulmonate II from hospitals, or 15% of the total shipped.

Although the incident would seem to be a public relations problem for the company, reaction has been muted, and European regulatory authorities examining the issue have found the risk of transmission to be low.

Nycomed Amersham's share price has not been affected by the scare. Indeed, the company's shares rose on the London Stock Exchange in mid-December after the firm was added to the prestigious Financial Times Stock Exchange 100 index, the London bourse's equivalent to the Dow Jones Industrial Average. Nycomed's listing was made possible by the merger of FTSE 100 members Guinness and Grand Metropolitan.