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.

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!!!

October 30, 1982, Saturday, 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.

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.

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.