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• 'Human' and Animal insulin - facts and patient's experiences

• Hypoglycaemia and loss of warnings

• 'Dead in Bed' Syndrome or sudden unexplained death

• Changing your insulin

• Changing your insulin

• Personal Importation of beef and pork insulin from the UK

• Personal Importation of beef and pork insulin from the UK

• Pork Insulin Available Online Without a Doctors Letter

• Action times of guman and animal insulins

• Storing of insulin

• 'Human' and Animal Insulin Reviewed - Cochraine Review 2002

• News - maybe important to you!

• Press and other reports

Press Reports

Novo Nordisk Pharmaceuticals, Inc., Awarded Novation Contract

Sept. 21 2001

Novation, the Texas-based supply chain management company of VHA Inc. and University HealthSystem Consortium (UHC), has awarded a multi-million dollar contract to Novo Nordisk Pharmaceuticals, Inc. (NNPI) to supply its full line of diabetes products to Novation customers.

The award includes NovoLog(R) Insulin aspart (rDNA origin) injection, rapid-acting insulin analog, NovoPen(R) 3 and Novolin Prefilled(TM) insulin delivery systems, PenFill(R) cartridges, NovoFine(R) 30 needles, the full line of Novolin(R) human insulin (rDNA origin), and Prandin(R) (repaglinide) Tablets. Also covered in the contract is NNPI's family of growth hormone products: Norditropin(R) somatropin (rDNA origin) cartridge, NordiPen(R) delivery system, and NordiPenMate(R) auto-insertion device.  

Novation serves the purchasing needs of more than 2,300 members and affiliates of VHA and UHC. Novation also serves more than 5,400 members of HealthCare Purchasing Partners International (HPPI), another group purchasing organization owned by VHA and UHC. The largest supply chain management company in health care, Novation manages more than $17 billion in annual purchases for VHA, UHC and HPPI members. For more information, go to http://www.novationco.com. Prescribing Information is available by contacting the manufacturer or by visiting http://www.novonordisk-us.com.

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If this succeeds it could help people in the US import cheaper insulin from Canada!

For Price Break on Drugs, Congress Looks to Canada

New York Times, September 9, 2001

By Robert Pear

Congress is taking steps to allow imports of prescription drugs from Canada, in the hope of giving American consumers access to lower-priced medicines. The Food and Drug Administration and drug companies oppose the legislation, but many lawmakers said they know of no serious safety hazards with Canadian imports.

"It would be very hard for anyone to make a credible case that there is a risk in importing drugs from Canada," said Senator Byron L Dorgan, Democrat of North Dakota, who is leading efforts to relax restrictions on such imports. 

A law adopted last year allowed pharmacists, drug wholesalers and distributors to import low-priced prescription drugs from 26 countries including Canada, Japan, Israel and members of the European Union. But the law gave broad discretion to the secretary of health and human services. The Bush administration and the Clinton administration both refused to issue rules to carry out the law. They said they could not certify that the import plan would be safe and would save money for consumers. In an interview, Mr. Dorgan said, "We are narrowing the bill this year to focus on imports from Canada as a first step."  

The broader proposal was included in a spending bill approved last year by votes of 86 to 8 in the Senate and 340 to 175 in the House. A measure dealing just with Canada could pass even more easily, Mr. Dorgan and other lawmakers said. In July, by a vote of 324 to 101, the House approved a bill that would make it easier for people to import low-cost prescription drugs for their own use. Mr. Dorgan plans to offer his proposal on the Senate floor this month.

Proposals to allow drug imports appeared unexpectedly on the House floor last year without much study or analysis by the committees that usually handle health care legislation. The idea has attracted serious attention in recent weeks as the federal budget surplus has shrunk, making it more difficult for Congress to add drug benefits to Medicare, the federal health program for the elderly and the disabled. Senators James M. Jeffords, independent of Vermont, and Debbie Stabenow, Democrat of Michigan, are working closely with Mr. Dorgan to push legislation through the Senate. Drug costs were one of the top issues in Ms. Stabenow's campaign last year. She organized bus trips to Canada for Michigan voters who wanted to buy prescription drugs at the lower prices available there. Prescription drugs are subject to price controls in Canada, as in many industrial countries. The bill Mr. Dorgan and his colleagues are drafting, like the one enacted last year, says that imported drugs must comply with all the safety and labeling requirements that apply to drugs made and distributed in the United States. Each batch of imported drugs would have to be tested for purity, to make sure it was not adulterated or misbranded. 

Stephen L. Giroux of Middleport, N.Y., a pharmacist who owns three drugstores about 40 miles from the Canadian border, said, "I would be totally confident and comfortable buying products from Canadian suppliers." At a Senate hearing this week, William K. Hubbard, senior associate commissioner of the Food and Drug Administration, said he "would have a relatively high degree of confidence" in drugs purchased in Canada. But he said that large-scale imports from Canada would pose immense challenges to the F.D.A. 

Drug manufacturers and distributors said they now had virtually complete control over the custody of prescription drugs, from the factory floor to the retail pharmacy. But after drugs leave the United States, they said, they could not be sure of the conditions under which the drugs are stored and handled. Canada has a sophisticated system for regulating drugs. But Mr. Hubbard said he could not give assurances about the safety of products imported from Canada because he did not know how the drug distribution system worked there. "Once a drug goes into the Canadian market, it's outside F.D.A. jurisdiction," Mr. Hubbard said, adding that "all sorts of malevolent things" could happen to drugs there. Senator Dorgan said he considers the drug-import bill a tool to "put pressure on drug companies to lower their prices." 

Congressional aides who have visited Canada and studied the pharmaceutical market there said it was unrealistic to think that the United States could solve its problems by giving United States consumers access to the Canadian market. Canada has a population of 31 million, compared with the United States' population of 285 million.

Alan Sager, a professor at the Boston University School of Public Health, said drug makers could try too thwart Mr. Dorgan's bill by limiting the supply of drugs available in Canada for export to the United States. 

Drug companies would, in effect, be competing with themselves if they sold large amounts of drugs in Canada, only to see the products shipped to the United States for sale here at discount prices. Mary R. Grealy, president of the Health Care Leadership Council, a coalition of chief executives from large health care companies, said Canada could become "a trans-shipment point" for counterfeit drugs being sent to the United States from third-world countries. "You don't know where drugs in Canada came from," she said. "They could have been made or stored in third-world countries with no regulation at all."

Federal law says that a prescription drug made in the United States and exported may not be imported to the United States except by the manufacturer. The law, adopted in 1988, sought to end a "gray market" for drugs that were counterfeit, adulterated or too old to be used safely.

The 1988 law, drafted by Representative John D. Dingell, Democrat of Michigan, was widely seen as a consumer protection measure. Congressional investigators had documented many cases in which counterfeit drugs, including birth control pills, had been imported.

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FOX 13 INVESTIGATES

USA February 2001

Fox 13 has investigated the problems related to human insulin and we report on the programme and subsequent responses.

THE INSULIN CRISIS

There is an epidemic of diabetes in this country. Last year alone, diabetes jumped six percent. Doctors think it has something to do with Diet and a similar rise in the obesity rate. The new epidemic makes this Fox 13 Investigation important to everyone. It deals with something called ‘dead in bed’ syndrome. The unexplained deaths of diabetics who seem in perfect health, but are found dead in or near their beds.

Are some diabetics being harmed by the insulin they take?

FOX 13 Investigates with this Exclusive report from Glenn Selig.

Susan Mescher never let diabetes keep her from enjoying life.

She vacationed a lot – a fringe benefit of being a top travel agent with American Express. Her sister Nancy says you’d never know Susan had diabetes because she managed it so well. She took a couple of shots of beef/pork animal insulin a day and she’d be good to go. So it came as a complete shock to the family when four months ago Susan died.

After 37 years the 49year old switched to Humulin, a lab created drug invented by Eli Lilly and Company. A drug that appears revolutionary for most of the people using it. Three weeks after Susan took her first shot she died.

Diabetics in the United States and Canada are switching to Humulin because the beef/pork insulin they had been taking is no longer being produced. Humulin is by far the most widely used insulin drug. But how often do patients have problems?

FOX 13 Investigates examined the Food and Drug Administration records and over a 12 month period, the agency received complaints from doctors and family members about 92 people who died while taking Humulin. In most cases there is no explanation given but three of them were notated as Sudden Death and Unexplained. That’s not all the records show. More than 600 people claim to have been hospitalised.

Eli Lilly says that anyone can make the switch to Humulin. That it is better than any animal insulin because it is identical to a human’s genetic makeup. In a letter to FOX 13, the company says, "There’s no question about the safety of Lilly’s human insulin. Millions of patients and physicians around the world can attest to the immeasurable benefits of this life-saving drug".

Dr John Hunt an endocrinologist and diabetes specialist in Vancouver, Canada, isn’t one of them. He says all insulins are not the same and some might be better than others for some people. Dr Hunt says that with diabetes, remedies and dosages vary from person to person so you might have three different diabetics on three totally different regimes and insulins. Dr Hunt told FOX 13 "You can’t say one insulin fits all, or one schedule fits all because everyone is different and each person has their own particular requirements."

The FDA would not be interviewed for this report, but in a statement, the FDA for the first time acknowledges that the drug may not be right for everyone. But the Agency says there's no crisis because there are options "if patients cannot tolerate human insulin." The FDA says one option is Pork Insulin which Eli Lilly still produces. But there's no mention of pork insulin on the company's website and we called around and only about one in ten pharmacies we contacted had it in stock.

The family of Susan Mescher wants the FDA to determine for certain whether Humulin caused Susan's death.

FULL TEXT OF FDA’S RESPONSE TO QUESTIONS

FROM FOX 13 INVESTIGATIVE REPORTER GLENN SELIG

1. What is the FDA's knowledge of insulin dependent diabetics who claim they cannot stabilize on Humulin and require beef or beef/pork animal insulin?

There are patients who report that they have more hypoglycemia with human insulin than with animal insulin. For these individuals, pork insulin continues to be available (Lilly's Iletin 2 line) in the U.S. Patients who believe that they cannot use human insulin can use pork insulin. It is notable that since the approval of the first human insulin product in the early 1980's, most newly diagnosed Type I diabetics are treated from the start with human insulin.

For some patients being treated with animal insulin, the switch from animal insulin to human insulin may be complex. The drugs are not directly interchangeable for a variety of reasons. Intrinsic characteristics of the drug products that affect their speed of onset and duration of action may lead to more or less pronounced effects on glucose levels depending on the specific product used. In addition, most people taking animal insulins develop antibodies to the foreign insulins that affect speed of onset and duration of action. When such individuals switch to human insulins, the levels of these antibodies fall such that the speed of onset and duration of action of the human insulins are not similarly affected.

For these and other reasons, diabetics who switch from animal to human insulin products should do so under the guidance of a physician and may need to initiate therapy with a lower dose of the human insulin and carefully titrate their human insulin dose.

None of the points mentioned above is intended to suggest differences in the safety of animal insulins versus human insulins. All insulins can cause hypoglycemia, an adverse effect that may be associated with severe consequences including seizure, coma, heart attack, stroke, and in rare instances, death. It is important to note that most patients can switch to human insulin without difficulty.

2. Does the FDA acknowledge that Humulin may not work well for some people? If so, what would the approximate number be?

See the answer to question 1. As above, most patients are able to switch from animal insulins to human insulin without difficulty. Nevertheless, this switch should be undertaken with physician supervision, and, as stated previously, pork insulin products are still available in the U.S. for those patients who believe that they cannot use human insulin. We do not have a reliable estimate of the number of patients who believe that they cannot use human insulin.

3. What is the FDA doing to help these diabetics?

As you know, Lilly recently stopped U.S. marketing of Iletin 1 (beef/pork insulin mixture containing mostly beef insulin). Lilly's decision to stop marketing Iletin 1 was a corporate decision and was not made at the request of the FDA. Thus, at present no beef insulin-containing product is marketed in the U.S., however, as noted above Lilly continues to market a pork insulin product in the U.S. It is important to note that there has not been a pure beef insulin product on the market in the U.S. for a number of years.

The FDA is willing to work with any sponsor interested in marketing animal insulins in the U.S. Approval of any new animal insulin product will require that the sponsor submit data to the FDA to assure that the new insulin product meets the standards established by the Food, Drug, and Cosmetic Act for safety, effectiveness, and quality. The FDA has met with sponsors interested in marketing beef insulin products in the U.S. on a number of occasions and has worked to reduce the regulatory burdens the sponsors must meet to obtain FDA approval for their beef insulin products. An important safety concern for beef insulin is possible contamination with the agent that causes bovine spongiform encephalopathy (BSE). This concern raises issues related not only to the sources of bovine pancreas (i.e., from BSE-free herds) but also related to processing in designated plants to avoid potential contamination with BSE from materials from non-BSE-free herds.

In addition, FDA has exercised its regulatory discretion to allow personal importation of unapproved beef insulin (up to a 6-month supply) by patients whose doctors certify cannot be controlled on other available therapy.

4. Why isn't the FDA doing more to make doctors and diabetics aware that a problem may exist?

The FDA website has detailed information on the beef insulin issue, including the safety concerns surrounding the use of non-U.S. approved beef insulin products. In addition, it provides explicit information on importation for personal use. While FDA cannot endorse the use of products that have not been determined by FDA to be safe and effective for human use, we do describe the mechanism by which patients can obtain beef insulin (up to a 6-month supply) for personal use through special importation procedures. As noted above, FDA has exercised its regulatory discretion to allow personal importation of beef insulin.

5. How does the FDA interpret its own adverse reaction data where diabetics and/or their families have blamed Humulin or Humulin for deaths and hospitalizations.

insulins, whether animal or human, can cause hypoglycemia and serious adverse reactions related to hypoglycemia. As stated above, some individuals have difficulty switching from animal to human insulins. This should be undertaken with physician supervision, and if patients still cannot tolerate human insulin, pork insulin is available in the U.S. and beef insulin may be imported for personal use.

6. What investigating has the FDA done to follow-up on those adverse reaction reports?

We are aware of these reports and they have been evaluated through the same process that FDA uses to evaluate all adverse event reports received for marketed drugs. Adverse events related to hypoglycemia have been received for all types of insulin products, and underscore the importance of careful dosing and titration of insulin in addition to other interventions (e.g., dietary compliance) to assure the safe use of these drugs.

7. What dialogues have taken place between the FDA and CP Pharmaceuticals of the UK?

For reasons of confidentiality we are not at liberty to discuss interactions between FDA and a drug sponsor.

8. Why does the FDA consider the UK insulin a BSE risk when the company uses American cows?

Regardless of the specific commercial sponsor, the potential for BSE contamination of beef insulin is related not only to the source of livestock but also to the manufacturing facilities and equipment used to process the material into the final drug product. Material obtained from BSE-free herds may become contaminated if processed in the same facilities and using the same equipment that are used to process materials from herds that are not certified to be BSE free.

9. What is the FDA requiring the UK company to do to be able to sell and market its insulin in the US?

For reasons of confidentiality we are not at liberty to discuss interactions between FDA and a drug sponsor on development of a drug product for U.S. approval. FDA has met on several occasions with sponsors interested in gaining approval to market beef insulin in the U.S. and we remain committed to working with any sponsor interested in submitting the data necessary to gain FDA approval for beef insulin.

10. How long will that process take?

It is not possible to comment on how long the approval process for beef insulin might take. When FDA receives an application for approval of beef insulin that is satisfactory for filing and review, the application will be reviewed and a decision regarding approval will be made in the time frames required by the Prescription Drug User Fee Act as amended in 1997.

11. Can the FDA do anything to fast-track the process? Or is there a compromise that can be reached? If so, what would it take?

As noted above, FDA is willing to work with any sponsor that is interested in submitting an application for

12. Does the FDA in any way consider this an emergency or a crisis?

As stated above, there are many insulin products available as options for patients with diabetes who require insulin for control. These include various types of human insulins, pork insulins, and, if necessary, the option of personal importation of beef insulin. Recognizing that some patients believe that their diabetes cannot be controlled without beef insulin, FDA has exercised its enforcement discretion to allow importation of unapproved beef insulin for personal use. We have worked to make the personal importation process less burdensome for patients including allowing patients to receive up to a six-month supply rather then the usual three-month supply. We believe that working with their individual physician, patients can utilize one or more of the available insulin options to treat their diabetes safely and effectively. 

13. Some diabetics claim the FDA is "protecting them to death." What is your response?

As noted above, patients have many insulin options, including the option to obtain beef insulin through personal importation if their doctor believes that beef insulin is necessary for their care. We believe that in order to fulfill FDA's public health mission, the potential risk of BSE contamination of beef insulin must be taken very seriously and adequately addressed before any beef insulin product is approved for U.S. marketing. We have tried to balance these public health concerns with the needs of individual patients by exercising our enforcement discretion to allow personal importation of beef insulin.

14. Anything else the FDA would like to add relating to this that perhaps has not been covered in the questions and answers?

Nothing additional. Please direct patients and physicians to the FDA website for further information regarding beef insulin.

FULL LETTER FROM ELI LILLY

January 25 2001

TO INVESTIGATIVE REPORTER GLENN SELIG

Dear Mr Selig,

Thank you for contacting Eli Lilly and Company regarding another story about the discontinuation of mixed beef/pork insulin in the United States.

Your station aired a program in November 1999 that inappropriately frightened patients with diabetes and alarmed healthcare professionals in the Tampa area. Specifically, many patients from the Tampa area who were not experiencing diabetes-related problems were so concerned by your report that they literally considered stopping their life-saving insulin therapy. We hope that the report you plan to air on February 8 will take an entirely different approach. However, the fact that you are actively seeking negative comments from patients through your station’s website and a letter writing campaign leads us to believe that you are headed down this dangerous path again.

Lilly decided to discontinue Iletin 1 [animal source beef/pork] insulin in 1996 because of the important technological advancements that led to human insulin in 1982. Human insulin is identical to what the body creates naturally but made through recumbinant DNA technology.

There is no question about the safety of Lilly’s human insulin, Humulin. Your hypothesis that animal based insulin safer than human insulin is completely without merit. In fact the American Diabetes Association states that "Human insulin has become the insulin of first choice for newly diagnosed patients with diabetes and is recommended by the American Diabetes Association for patients beginning insulin therapy."

Millions of patients and physicians around the world can attest to the immeasurable benefits of this life-saving drug. Based on 2000 Roper Starch Syndicated Research, nearly 3.725 million people in the United States use insulin to treat diabetes. In contrast, less than 1% of these patients use animal insulin, the majority of which is represented by a currently marketed product, Iletin ll, purified pork insulin.

For over 75 years, Lilly has been a leader in diabetes care and research. Today, we continue the quest to make life easier for all people with diabetes. And as a member of the Tampa community, you are undoubtedly concerned with the health and safety of your friends and neighbors with this disease. To repeatedly cause undue concern and alarm is not only harmfu8l but also irresponsible.

Sincerely

John H Holcombe, M.D.
Medical Adviser, US Diabetes Care
Eli Lilly and Company. 

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