British Insulin Maker Fights To Bring Animal Insulin to the United States
Beef-pork insulin will soon disappear in the United States, leaving thousands of people with diabetes without the insulin they feel is essential to their lives. Ever since insulin manufacturers Eli Lilly and Novo Nordisk announced that they would no longer sell beef-pork insulin, American activists have been fighting to import it from the United Kingdom and Brazil, where it is still made and widely available. The activists work on behalf of those who say that human insulin causes side effects in them, the most frequently reported being that they no longer get any physical warning when their blood sugars drop.
"To date, I weigh what I did as a teenager, and have never had any degenerative complications," reports Martin. "At 52, I'm stronger than I have ever been in my life. I have accomplished this by using two separate vials of beef insulin: Ultralente and Semilente."
Martin has tried human insulin, and does not believe he would have such good control on it.
"All this tranquil success was grossly upset by the insulin manufacturers' discontinuing Semilente in 1993 and Ultralente in 1994," he recalls. "I really had to scramble to re-establish my insulin regimen. I even tried human insulin while I could still use my beef Ultralente for basal. Human insulin's slamming on and slacking off of insulin activity totally destabilized my blood sugar. It was a disaster. I'd be dead by this time if I had had to continue."
British Pharmaceutical Company Faces FDA
Active in the fight to keep animal insulin on the U.S. market, Martin believes that, at least, CP Pharmaceuticals should be able to sell beef and beef-pork insulins here.
Along with the Americans, Charles Savage, the chief executive officer of British insulin manufacturer CP Pharmaceuticals, has been negotiating with the U.S. Food and Drug Administration (FDA) to bring his company's beef and pork insulins into America.
Savage says he has faced some bureaucratic road blocks, but has also made some progress.
"Ever since we heard that Eli Lilly was about to discontinue its production of the mixed bovine-porcine insulin," says Savage, "we have been seeking to make contact with the FDA in order to obtain accelerated U.S. marketing authorizations for our products."
An Illegal Drug
The United States considers CP's insulins to be illegal drugs because they have not gone through the FDA's approval process. The answer seems simple, CP can apply as a new drug and get approved. But there is a snag, and that snag is far from simple. It's "bioavailability data," and the FDA wants it.
"A test drug-in our example, insulin from CP-is injected into a number of well (as distinct from ill, or, in our case, diabetic) human volunteers," says Savage, explaining the bioavailability study. "The drug against which the sample is to be tested for bioavailability-in our example, Iletin I-is injected into a further group of volunteers."
Then, the FDA tests the blood, and compares the two. According to Savage, "The FDA will be looking to see whether the two sets of results are comparable, i.e., whether the two samples metabolize at the same rate in the two sets of test subjects."
Two Years Away?
These bioavailability studies could take two years, according to Savage. He wants the FDA to reconsider the necessity of the bioavailability studies.
Britain's drug approval agency, the Medicines Control Agency (MCA), has not required bioavailability studies because the beef and pork insulins have been around a long time and meet the country's manufacturing standards.
"CP has been the sole manufacturer of bovine [beef] insulins in the United Kingdom, and sole supplier of them to the U.K. market, for more than 25 years," states Savage. "To date, there have been no product recalls, no quality issues, no problems. The MCA can testify to this, if necessary, to the FDA."
Nobody Else Wants Tests
Beef-pork insulin is being withdrawn all over the world, but it seems that the United States government is the only one that wants these bioavailability studies.
"Rumors are that Novo Nordisk will soon withdraw pork insulins from Switzerland," claims Savage, "and CP is in a similar process for importation approval there. The Swiss government, however, is not insisting on bioavailability data."
Nor are the Canadian or French governments. CP is now in talks with them.
"We were advised, and expect that both governments will follow the lead given by the Swiss," says Savage.
Savage wants the FDA to consider alternatives. CP has suggested to the FDA that two factors should be most important in the agency's decision for importation approval. First, CP has long-standing, proven manufacturing standards, which Savage has invited the agency to review.
"The MCA is prepared to advise the FDA in detail, but equally, the FDA is welcome to conduct an audit here in Wrexham at any time," he says.
Secondly, the FDA should consider the sources of CP's insulin, and the safety profile of the insulin crystals used to make it. Savage says the source of CP's insulin is "actually the pancreases of cows reared in the United States."
These two considerations are more relevant than bioavailability studies, according to Savage. He points out four factors diminishing bioavailability's importance:
- individual differences among people who take insulin
- variations from different timing, site, angle and depth of injections
- People with diabetes have already learned how to adjust their doses according to what they eat and what is going on in their lives at the time of injection
- Study participants are nondiabetic people who will be made sick from insulin overdoses.
Not Badmouthing the FDA
Savage disagrees with the FDA requirements, but respects its difficult position and the standards it has to uphold.
"We have always found the FDA to be courteous and helpful," says Savage, "but mindful of their role as public servants, defending issues of public health, and unable to move outside their strict guidelines."
Savage appears to be attempting a move around the FDA requirements through American politicians. "We have long been aware that the key to unlocking these issues lies with the politicians and legislators."
It was a politician, George Nethercutt Jr. (R-WA), who helped Savage convince FDA commissioner Dr. Jane Henney to establish a personal importation program for CP's animal insulins. The personal program allows an individual to receive a three-month supply, and is currently in effect. (See above.)
Savage needs political assistance with the large-scale importation, but he wants help, not hindrance.
Only Hurting the Cause
"Currently a number of diabetics, in their desperation, are starting to write very aggressive letters alleging all kinds of conspiracies," reports Savage in an email sent to Americans involved with his cause. Savage feels Americans need to work within the system, as he is doing. "I feel that I should try to dissuade the writers from this course of action, and instead try to encourage them to follow more positive lines."Click Here To View Or Post Comments