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Last Updated: 10/27/04 10:46 AM

Mary Ford was kind enough to share some articles she found with us that help to explain how Lilly and Novo and the FDA may have fallen into our current problematic situation quite honestly.  The fact is that we all had high hopes for "human" insulin as the first bioengineered medicine ever developed.  The tragedy is that none of the high hopes have proven meritorious and many unforseen problems have been demonstrated. The 5 articles which follow express many of the hopes we had for human insulin.  None of them has come to prove true.  We all had high hopes back then.  It is tragic that the profiteers of diabetes can't seem to learn from listening to us. Not one of the hoped for benefits from human insulin has been found to be, and many problems are being covered up because it is so much more profitable to sell.

  1. A NEW INSULIN GIVEN APPROVAL FOR USE IN U.S. 30 October 1982

  2. IDEAS & TRENDS: Gene-Spliced Insulin Receives Speedy Approval - 31 October 1982

  3. Switch to human insulin will be slow; Humulin -- January 1983

  4. Eli Lilly woes; warnings against genetically engineered human insulin; Business -- 14 October 1989

  5. Research, development, production, and safety of biosynthetic human insulin. 1993

We must pause to wonder, however, what is going on when we see the warnings that Lilly has posted for 18 years and the original clinical trials, by honest Doctors like Sotos Raptis prophetic comments from his typically sized clinical trial group of 10, that we would all suffer  REDUCED SYMPTOMS!!!


Copyright 1982 The New York Times Company

The Now York Times

October 30, 1982, Saturday, Late City Final Edition

SECTION: Section 1; Page 1, Column 2; National Desk

LENGTH: 990 words

HEADLINE: A NEW INSULIN GIVEN APPROVAL FOR USE IN U.S. 30 October 1982

BYLINE: LAWRENCE K. ALTMAN

BODY:

The Food and Drug Administration yesterday approved the marketing of human insulin made artificially from gene-splicing techniques. It is the first such product of genetic engineering to be granted Governmental approval for human use.

The new insulin, called Humulin, is manufactured by a technique known as recombinant DNA, which involves inserting human genetic instructions into a bacterium that then produces the drug.

The approval by the Food and Drug Administration came five months (we now know that it was actually 2 1/2 months) after application was made by Eli Lilly and Company of Indianapolis, Indiana. Normally, such approval takes 20 to 30 months.

Note: See "The Significant Minority" at: http://www.gene-watch.org/genewatch/articles/16-6romano.html and the follow up letter from Lynne Born, medical writer at: http://members.tripod.com/diabetics_world/born_comments.htm

To Be Available in 1983

The efforts to produce the artificial human hormone commercially began four years ago, after scientists at the City of Hope National Medical Center in Duarte, Calif., and Genentech Inc. in South San Francisco first succeeded in producing it in the laboratory.

The new insulin is expected by its manufacturer to be available in drug stores without a prescription sometime in 1983. A spokesman for Lilly said Humulin was expected to cost about twice as much initially as the animal insulins now used by an estimated two million of the 10 million diabetics in the United States.

Called a Major Step Forward

Dr. Henry Miller, the medical officer in charge of Humulin at the FDA said the development was a major step forward in the "scientific and commercial viability of "recombinant DNA techniques. "We have now come of age," Dr. Miller said.

Dr. Irving L. Spratt, president of the American Diabetes Association, said: "The announcement is an exciting event in medicine. It demonstrates the melding of intensive research in genetic engineering with complex pharmaceutical production."

The new insulin is being manufactured by Lilly under license from Genentech. The insulin now used to treat diabetics is derived from animals, usually pigs and cattle. Although no shortage of animal insulin exists now some experts believe one may arise in a decade or so. Production of insulin in genetically engineered bacterial "factories" promises to make unlimited amounts available.

The artificial hormone is made in the laboratory with gene-splicing techniques perfected in the 1970's. Technicians assemble genes carrying the code that normally instructs a human's pancreas to produce insulin. In a diabetic, the pancreas fails to produce that insulin, or enough of it, to perform its required function of helping to convert blood sugar into body fuel.

These insulin genes are then inserted into plasmids, packages of a genetic material taken from bacteria. The plasmids can then be inserted into bacteria and the bacteria are then stimulated to begin synthesizing the human insulin, which the technicians can extract from the bacteria.

Humulin differs from the animal insulins in that its molecules are more nearly like those produced by the human Pancreas gland.

Few Clinical Advantages

Humulin was found to be safe and effective in tests involving about 400 patients in 12 medical centers in the United States, according to Dr. Miller. So far, Humulin has not shown clinical advantage over animal insulin except in the very rare cases in which diabetics develop insulin resistance due to formation of antibodies, Dr. Miller said.

The FDA, in announcing its approval, said that "any change in insulin should be made cautiously and only under medical supervision" in keeping with the general warning to diabetics about switching insulin made from one species of animal to another.

The decision to switch from animal insulin to Humulin will depend on the discretion of individual physicians, Dr. Miller said.

Already Approved in Britain

The FDA's action follows by one month approval by British officials of Humulin for use in Britain. The reason for the, speedy action in the United States despite the newness of the product, was attributed to "the vast amount of prior experience with the animal insulins, which are very closely related to Humulin," Dr. Miller said.

Animal and laboratory studies have shown that the potency of the genetically engineered human insulin appeared to be virtually indistinguishable from that of the purified pork insulin.

There has been a flurry of activity in preparing other recombinant DNA products for human health care use. Among those under review at the FDA are human growth hormones and several types of interferon, a protein used experimentally to inhibit the growth of viruses and to treat several types of cancer.

Initially More Costly

Ronald Culp, a spokesman for Eli Lilly & Company, said the initial cost of the new insulin will be higher than that for animal insulins now available. "We expect the average daily patient cost to be between 50 and 55 cents a day for the treatment," he said. "That compares with between 26 and 30 cents. The long-term desire is that the cost will come down, but at this point we cannot speculate on just how far. The ultimate aim is to make it cheaper, however."

Lilly has completed two new facilities for making the new artificial human insulin, in Indianapolis and in Liverpool, England. The new product, Mr. Culp said, "means there will be a more purified form of insulin available to the patient." For now, he emphasized, the majority of the patients would continue to use animal insulin.

Mr. Culp said the human insulin would be given a "phased introduction" to the public. "Lilly believes that diabetes specialists should be given an opportunity to become familiar with Humulin before it is available commercially," he said.


  1. A NEW INSULIN GIVEN APPROVAL FOR USE IN U.S. 30 October 1982

  2. IDEAS & TRENDS: Gene-Spliced Insulin Receives Speedy Approval - 31 October 1982

  3. Switch to human insulin will be slow; Humulin -- January 1983

  4. Eli Lilly woes; warnings against genetically engineered human insulin; Business -- 14 October 1989

  5. Research, development, production, and safety of biosynthetic human insulin. 1993


Copyright 1982 The New York Times Company

The New York Times

October 31, 1982, Sunday, Late City Final Edition

SECTION: Section 4; Page 7, Column 1; Week in Review Desk

LENGTH: 216 words

HEADLINE: IDEAS & TRENDS: Gene-Spliced Insulin Receives Speedy Approval - 31 October 1982

BYLINE: Margot Slade and Wayne Biddle

BODY:

In the remarkably short time of five months, the Food and Drug Administration last week gave Eli Lilly and Company the right to manufacture insulin using gene-splicing techniques. The new product -Humulin- should be available without a prescription sometime in the next year.

It was the first time the Government has approved a substance made by gene-splicing techniques, in which part off a cells genetic instructions is inserted into a bacterium, which then follows the instructions. For Humulin, the instructions were for the manufacture of insulin, a substance produced by the pancreas to help convert blood sugar into body fuel. Diabetics fail to make insulin, or enough of it, to do the job.

The FDA is reviewing applications for the gene-splicing manufacture of other products. But Humulin's approval may hold the record for speed; the process usually takes 20 to 30 months. Agency officials said they could proceed with haste because Humulin closely resembles the animal-derived insulins used by some two million of the nation's 10 million diabetics. There is no shortage of animal insulin but some experts believe one may arise in a decade or so. The artificial hormone will secure an unlimited supply.


  1. A NEW INSULIN GIVEN APPROVAL FOR USE IN U.S. 30 October 1982

  2. IDEAS & TRENDS: Gene-Spliced Insulin Receives Speedy Approval - 31 October 1982

  3. Switch to human insulin will be slow; Humulin -- January 1983

  4. Eli Lilly woes; warnings against genetically engineered human insulin; Business -- 14 October 1989

  5. Research, development, production, and safety of biosynthetic human insulin. 1993


Copyright 1983 Information Access Company, a Thomson Corporation Company

ASAP

Copyright 1983 Medical Economics Publishing

RN

January, 1983

SECTION: Vol. 46; Pg. 139; ISSN 0033-7021

LENGTH: 242 words

HEADLINE: Switch to human insulin will be slow; Humulin -- January 1983

BYLINE: Rodman, Morton J.

BODY:

The new artificial human insulin is scheduled to go on the market sometime this year, but don't expect it to come into widespread use immediately. For one thing, the new insulin will initially cost about twice as much as animal insulins, over which it has so far shown no marked clinical advantages for the majority of diabetics.

Humulin, manufactured by Eli Lilly and Company may benefit some of those relatively rare diabetics who develop resistance or allergic reactions to animal insulins, because the artificial insulin more closely resembles insulin produced by the human pancreas. However, findings in this area are still inconclusive. Precise indications remain to be determined.

A Lilly spokesman stressed that animal insulins will continue to be produced and warned patients against switching to the new insulin without first consulting their physicians.

Humulin is the first drug produced by genetic engineering techniques to gain Food and Drug Administration approval for human use. It's made by inserting human genes responsible for insulin production into E. Coli bacteria, thus stimulating the bacteria to synthesize insulin. Because this technique can produce large quantities of insulin, the artificial insulin is expected to help alleviate a shortage of animal insulins predicted to occur within the next decade. Humulin has so far proved safe and effective in FDA clinical trials involving more than 400 patients.


  1. A NEW INSULIN GIVEN APPROVAL FOR USE IN U.S. 30 October 1982

  2. IDEAS & TRENDS: Gene-Spliced Insulin Receives Speedy Approval - 31 October 1982

  3. Switch to human insulin will be slow; Humulin -- January 1983

  4. Eli Lilly woes; warnings against genetically engineered human insulin; Business -- 14 October 1989

  5. Research, development, production, and safety of biosynthetic human insulin. 1993


Copyright 1989 Information Access Company, a Thomson Corporation Company

ASAP

Copyright 1989 Economist Newspaper Ltd. (UK)

The Economist

October 14, 1989

SECTION: Vol. 313; No. 7624; Pg. 85; ISSN: 0013-0613

LENGTH: 358 words

HEADLINE: Eli Lilly woes; warnings against genetically engineered human insulin; Business -- 14 October 1989

BODY:

Eli Lilly woes

THINGS could hardly be worse for Eli Lilly, An American drug giant that makes genetically engineered human insulin, a drug for treating diabetes. Reports by British doctors have associated at least 17 deaths among Britain's 200,000 diabetics with such drags, which are made by several manufacturers, British health officials have put out a warning, but it is still unclear whether the drug may have to be withdrawn.

Eli Lilly is not the only maker of this drug, but it is extremely bad news for the company. Most of the adverse reactions to the human insulin were spotted in one produced by rival firm Novo/Nordisk. Humulin, the brand name for Lilly's version of the drug, accounts for only around 10% of the company's $ 4 billion annual sales, but it hoped that the product would turn into a big earner. Eli Lily has been planning to build two new Humulin plants, one in America and the other in Europe, representing a $ 200m capital investment.

Eli Lilly has few other potential blockbuster products, apart from an anti-depressant known as Prozac. In 1982, the company was forced to withdraw its anti-arthritic drug, Opera, after nearly 100 deaths among patients who had taken it. Lilly is only now settling the liability claims that arose from the incident. [Ed - Lilly was subsequently criminally convicted for improper adverse reaction reporting on Oraflex or Opren to FDA.]

It is still not clear why Humulin may be harming diabetic patients. One possibility is that the human form of insulin promotes a peculiar reaction in the diabetic patients. But why, no one knows. Another possibility is that the human insulin preparation is impure. Such a finding would do the company no favors. Last month, America's Food and Drug Administration (FDA) sharply criticised Eli Lilly for its quality control procedures and shut down a manufacturing plant at its headquarters in Indianapolis. Ten of Eli Lilly's drugs, which were made at the plant, have also been recalled. Three other manufacturing plants are under FDA investigation. Eli Lilly blames technical aberrations. The drugs industry is already going through a massive bout of reorganisation. If Lilly's share price falls too far it could find itself the next takeover target.


  1. A NEW INSULIN GIVEN APPROVAL FOR USE IN U.S. 30 October 1982

  2. IDEAS & TRENDS: Gene-Spliced Insulin Receives Speedy Approval - 31 October 1982

  3. Switch to human insulin will be slow; Humulin -- January 1983

  4. Eli Lilly woes; warnings against genetically engineered human insulin; Business -- 14 October 1989

  5. Research, development, production, and safety of biosynthetic human insulin. 1993


TITLE: Research, development, production, and safety of biosynthetic human insulin. 1993

AUTHOR(S): Chance RE, Frank BH

SOURCE: Diabetes Care 1993 Dec v. 16 Supp 3 p. 133-42 

NOTES: Number Refs: 108, JOURNAL ARTICLE; REVIEW; REVIEW, ACADEMIC I English, ISSN: 0149-5992, Reprint Address: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.

ABSTRACT: This paper provides some historical aspects on the research and development of Humulin (rDNA origin), the first human health-care product derived from rDNA technology more than a decade ago. Also referred to as biosynthetic human insulin, Humulin is currently produced via the human proinsulin route, using an Escherichia coli fermentation process. The authenticity, high purity, and safety of RHI has been investigated and verified by a complex battery of analytical and physicochemical methods. The daily treatment of more than two million diabetic patients worldwide with this rDNA human insulin not only demonstrates the value of rDNA technology in providing an important medical product, it is assurance that diabetic patients will have unlimited supplies of this vital hormone as well as potential analogue refinements.


It is tragic that the profiteers of diabetes can't seem to learn from listening to us.

  1. A NEW INSULIN GIVEN APPROVAL FOR USE IN U.S. 30 October 1982

  2. IDEAS & TRENDS: Gene-Spliced Insulin Receives Speedy Approval - 31 October 1982

  3. Switch to human insulin will be slow; Humulin -- January 1983

  4. Eli Lilly woes; warnings against genetically engineered human insulin; Business -- 14 October 1989

  5. Research, development, production, and safety of biosynthetic human insulin. 1993

We must pause to wonder, however, what is going on when we see the warnings that Lilly has posted for 18 years and the original clinical trials, by honest Doctors like Sotos Raptis prophetic comments from his typically sized clinical trial group of 10, that we would all suffer  REDUCED SYMPTOMS!!!


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