However, an FDA spokesperson says no details were available on those “new efforts” the agency will undertake to ensure quality control, though a spokesperson with the Department of Health and Human Services, which oversees the FDA, says more information will be available when Obama releases the more detailed budget in April.

The Bush administration largely opposed the idea because of safety concerns. One cannot soon forget the toll tainted heparin took on the U.S. just last year. More than 80 people died and hundreds more were sickened when vials heparin imported from a China manufacturing plant were found to have been contaminated. FDA admitted then that it didn’t have sufficient staff to properly inspect all food and drug manufacturing plants on foreign soil.

Countries such as Canada sell medicines for much less than in the United States because the government helps control prices. Critics of importation say that buying drugs from foreign countries would leach vital funds from the U.S. drug industry that otherwise would be used to research new therapies and innovations.

In the past several months, the FDA has stepped up quality control measures by setting up offices overseas to inspect food and drugs being imported into the U.S. The first offices were placed in China.

SOURCE: Heparin Recall › New budget supports plan for importation of drugs

Dr. Deborah Cook, academic chair of critical care medicine at St. Joseph’s, is leading a study to determine whether the newer and more expensive version of the blood thinner is more effective for patients in intensive care than the older one. Fifty-six ICUs in Canada, Australia, Brazil, U.S. and Saudi Arabia will participate in the study. Patients will be chosen at random from each of the participating ICUs.

The study also will look at each drug’s side effects, which can include excessive or unusual bleeding.

Heparin, which is used to prevent blood clotting, is routinely given to most ICU patients. The newer version has been touted as being stronger and thus is used most often. The newer heparin costs about $9 per day per patient compared to $2 per day per patient for the older version.

The study, which is called PROTECT and stands for Profhylaxis of Thromboembolism in Critical Care Trial, is funded by the Canadian Institutes of Health Research. No results have yet been posted for the study, which is currently halfway through the 2 ½-year research process.

SOURCE: Heparin Recall › Study compares brands of heparin given to ICU patients

Septic shock is a serious condition that can cause multiple organ failure and death. It is the main cause of mortality in intensive care units (ICU), with a mortality rate of up to 40 percent.

There is only one drug other than antibiotics approved to treat septic shock, and that drug costs about $10,000 per patient. But two Canadian intensive care physicians, Dr. Ryan Zarychanski and Dr. Anand Kumar, who studied the effect of the blood thinner heparin on ICU patients between 1989 and 2005, found that patients with severe sepsis who were given heparin lowered their risk of death by 30 percent. Heparin, a generic drug, costs less than $10.

The research involved nearly 1,400 Winnipeg ICU patients with septic shock. Six hundred and ninety-five of the patients received heparin for suspected heart attacks or blood clots. Another 695 did not. The study found that there were 15 percent fewer deaths among patients who had received heparin.

Heparin for the treatment of septic shock is controversial, says Zarychanski, because it refutes the belief that expensive pharmaceuticals are the best treatment option. Thus, companies are unlikely to invest in researching it for other benefits as there is little or no profit in it.

But the safety of drugs, like heparin that is imported into the U.S. from countries like China, still hangs in the balance. It is just as important to find new treatments for less expensive drugs as it is to ensure the safety of all drugs.

SOURCE: Heparin Recall › Heparin found to reduce septic shock death rate

The blood thinner heparin made news recently when the FDA recalled batches of heparin after more than 80 people died and several others became ill after receiving heparin. It was later determined that heparin made by Baxter International was contaminated in the company’s Chinese manufacturing facility.

While heparin is considered an effective treatment for preventing blood clots and is widely used, it must be injected, which makes long-term therapy difficult. The new drugs would be taken by mouth, which would make dosing easier and eliminate the need for laboratory monitoring.

Heparins garner about $700 million in annual sales, with Sanofi-Aventis’ Lovenox making up nearly two-thirds of the world’s share of the drug. Pfizer’s Fragmin and GlaxoSmithKline’s Fraxiparine account for 6.3 and 5.9 of sales, respectively. Vitamin K Antagonists are responsible for more than $6 billion in sales worldwide, with Bristol-Myers Squibb’s Coumadin, Barr’s Warfarin and Eisai’s Warfarin owning slightly more than half the market’s share.

Three of the five companies are in the late phases of clinical testing, two of which already have been approved in Canada and are awaiting approval in the United States. Two other companies’ drugs have been approved for short-term use in Europe.

SOURCE: Heparin Recall › Pharmaceutical companies developing drugs to fight blood clots

According to the report, aides for both candidates said that recent health scares had dampened their candidates’ enthusiasm of reimportation. Neither candidate has abandoned the prospect; however, they admit it has become a more controversial subject.

Other countries, such as Canada, have government price controls that keep prescription drug costs down, making reimportation of foreign drugs a far more attractive option, especially for those who spend hundreds and thousands of dollars on prescriptions each year. While several U.S. bills on reimportation have been proposed, none have become law, the report stated.

Organizations representing pharmaceutical companies such as the Generic Pharmaceutical Association (GPhA), oppose the practice, arguing that there is no guarantee drugs or goods from other countries would be safe, Reuters/Boston Globe reported.

Earlier this year, American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. According to news report, FDA officials acknowledged they had not inspected that facility and claimed they had insufficient staff and financial resources to regularly inspect overseas manufacturers.

SOURCE: Heparin Recall › Candidates review reimportation of prescription drugs