Healthy Skepticism Library item: 13084

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Publication type: news

Weeks C.
Drug recall puts overseas inspections in spotlight: Experts question whether North American governments can ensure the safety of drugs made with ingredients from China
Globe and Mail 2008 Mar 7
http://www.theglobeandmail.com/servlet/story/RTGAM.20080307.wlchina07/BNStory/specialScienceandHealth/home

Full text:

Amajor U.S. recall of a blood-thinning drug linked to a Chinese factory
last week is prompting new questions over the ability of government and
industry to ensure the safety of drugs made with ingredients from China.

China has become one of the world’s largest suppliers of pharmaceutical ingredients, but the country’s questionable safety reputation, combined with reports of death and serious illness associated with Chinese products in the past year, has convinced some experts and industry members that North American governments need a more aggressive approach to overseas inspections and safety checks. The issue has reached a boiling point in the United States in recent days after Baxter International Inc. expanded its nationwide recall of heparin, a blood thinner, amid reports it had been linked to 19 deaths and hundreds of illnesses. The affected products are not sold in Canada. The U.S. Food and Drug Administration said this week that the problems may be the result of a counterfeit ingredient from China that was used in the drug. U.S. health officials had never inspected the Chinese factory owned by U.S.-based Scientific Protein Laboratories LLC where some of the raw heparin ingredients were processed. When U.S. inspectors finally visited the plant last month, they found evidence of and quality-control and hygiene problems. The lack of inspections is one of the major problems some U.S. politicians have highlighted in response to the recall, noting it leaves consumers vulnerable to potentially dangerous drugs, particularly after it was revealed the FDA inspects only a handful of Chinese factories each year. Inspections by Canadian health officials are equally infrequent. Health Canada reviews inspection reports compiled by the FDA and other health agencies, or in some cases conducts its own inspections of drug manufacturing plants – few of which are in China. But Health Canada said it doesn’t inspect the Chinese or other overseas factories that supply drug ingredients. The department said drug companies are responsible for ensuring their suppliers are following safety standards. The lack of government inspections is coming under fire on both sides of the border as China becomes an increasingly large supplier of drug ingredients, and health officials struggle to meet the demands of this changing reality with limited funds and staffing resources. While many drugs taken by Canadians are manufactured in North America, a significant portion of the ingredients come from China and other countries. Many drug companies in Canada are reluctant to discuss the identity of their suppliers and how many are located in China, citing competitive reasons. But investment firm Credit Suisse recently estimated that China will be producing one-quarter of the world’s pharmaceutical ingredients by 2010.“If we’re going to see China become a major source of pharmaceutical ingredients, then the regulatory powers need to respond to that by making sure there are appropriate steps taken to ensure these products are going to be meeting our standards,” said Jeff Poston, executive director of the Canadian Pharmacists Association. Russell Williams, president of Canada’s Research-Based Pharmaceutical Companies, an industry association that represents major drug firms, said the government and manufacturers have stringent rules in place to ensure safety. “We take great pride and great vigilance in making sure that there are compliance inspections and verifications every step of the way,” he said. “It’s in no one’s interest to have an ineffective or bad medicine available on the market.” The drug industry has many incentives to ensure its products are safe and avoid the type of wide-scale public recall recently initiated by Baxter. But rigorous safety checks don’t always recognize problems. For instance, although Baxter conducted numerous tests on its heparin ingredient imported from China before the drug went on the market, it didn’t catch the problem that led to the recall. As a result, an increasing number of health experts, advocates and U.S. politicians are calling for greater involvement by government health inspectors to provide an extra layer of quality control. “There is a concern particularly when the ingredients are coming from abroad,” said David U, president and chief executive officer of the Institute for Safe Medication Practices Canada, an independent, government-funded agency. “I think there’s room for improvement, to have an eye on those [companies] whose product is being shipped [to Canada],” he added. One critic said the fact that Chinese factories supplying drug ingredients may never be inspected by North American officials is an example of lax federal oversight and may increase the likelihood of potentially dangerous goods making it to market. “Basically, the industry is self-regulating,” said Michael McBane, national co-ordinator of the Canadian Health Coalition, a non-profit advocacy organization. “I think that drug safety programs in Canada have been gutted to the point where they’ve left consumers extremely vulnerable.”