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Biotech medicine including GM insulin side-effects and lawsuit

Biotech medicine:
1. biotech industry strategy: Bayer forms alliance with CuraGen
2. nlpwessex on GM insulin: - multiple items
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1. Biotech industry strategy: Bayer forms alliance with CuraGen

Recently it was reported in the Financial Times that biotechnology stocks had lost about 25 per cent of their value over just a couple of weeks, prompting fears of a bursting bubble in the sector. The following item from Lucy Michaels at Corporate Watch indicates how some of the big players see the future with genomics.
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Bit of an insight into biotech industry strategy and the 'tailored' drug concept. With the proposed GATS agreement threatening to liberalise the health service further, its pretty obvious whose health will not be economically viable to research.

Lucy
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Bayer forms alliance with CuraGen
By Victoria Griffith in Boston
Published: January 16 2001

Bayer, the German pharmaceuticals and chemicals group, and CuraGen, the US biotechnology company, have formed a $1.5bn 15-year drug development alliance, the highest-priced such partnership ever created.

CuraGen will have marketing and sales rights to products emerging from the venture, a concession showing the newly elevated status of the biotech industry.

CuraGen's share price rose 24 per cent in morning trading to $33.38. The deal includes an $85m equity investment by Bayer.

About $39m is targeted to the fast growing field of "pharmacogenomics", which among other things aims to predict how individuals will differ in their reactions to certain drugs.

The rest of the deal focuses on diabetes and obesity drugs. Bayer will invest $750m in research expenses; CuraGen will put in $375m.

In addition, CuraGen has promised to deliver 80 drug "targets" - indications for possible products - valued at $226m. Bayer will have 56 per cent ownership in jointly developed drugs, with CuraGen holding the remainder.

Within five to 10 years, Bayer will also have the option of purchasing from CuraGen a "gene factory", an integrated informatics system to process genomics data. The price has yet to be determined.

CuraGen will help Bayer prioritise drugs for development. Through genetic profiling, for instance, the company will eliminate sub-groups of the population unlikely to respond well to treatment.

"We have now a 10 per cent success rate in clinical development. We want to predict which are the winners," said Wolfgang Hartwig, Bayer's head of global research.

Jonathan Rothberg, CuraGen chief executive, said his company's strong cash position allowed him to negotiate an equal partnership. Investor enthusiasm for the biotech industry last year helped CuraGen raise $186m in a secondary offering.

The move is reminiscent of a $465m deal that Bayer signed with Millennium Pharmaceuticals in 1998, though Millennium retains no ownership rights to the drugs it helps develop.

Even with its rich cash reserves, CuraGen felt it did not have the resources to build a portfolio of small molecule drugs itself.

"The problem with small molecules is that from target to anything like a drug is two years," said Mr Rothberg. "You've got nothing to show in the meantime, nothing that's publishable or that you can get investors excited about."

Mr Rothberg said he needed to retain ownership of drugs in the alliance to secure CuraGen's future.

"Over the next few years, you'll get the low hanging fruit of genomics," he predicts. "If you don't have ownership then, it's over, because the next batch of drugs will be much more difficult to come by." --- nlpwessex on GM insulin: - multiple items

Court cases are now springing up on various parts of the globe over GM insulin, but only many years after its introduction.

The latest is in the UK: "I'm hoping this will lead the way for others. I have no doubt that at least 70 people in the UK have lost their lives as a result of incorrect treatment."

GM insulin was originally decribed by one of its manufacturers as a "one hundred percent a safe drug".  Just like GM foods in fact. How long now before the cases from GM foods start croping up, which are much less rigorously tested than GM drugs and which are distributed to the whole population without their consent?

No wonder GM insurance cover is problematic and the biotech industry actively lobbies to try and block GM liability legislation.

For more on the GM insulin cases see additonal information at end.

In the words of Craig Venter, the scientist whose company completed the sequencing of the human genome in 2000, in a recent interview:

*"We don't know shit about biology".*

From the 'top man'. Great. These ignorant people are attempting to change the fundamental biology of the planet and we're letting them do it.

NATURAL LAW PARTY WESSEX This email address is being protected from spambots. You need JavaScript enabled to view it. www.btinternet.com/~nlpwessex * From: "Decoding the genome" Ralph Brave,

Jan.9, 2001
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DIABETIC TO SUE DOCTORS OVER INSULIN BODY

AN Edinburgh-born diabetic is suing doctors in the hope of changing the way thousands of people are treated for the condition. Derek Beatty, 49, nearly died as a result of an undetected hypoglycaemic attack. Now he hopes to prove the insulin treatment he received was to blame - and that it changed his personality, making him aggressive.

His problems started when doctors switched his animal insulin treatment for a genetically modified version, allegedly failing to tell him about the possible side effects. The former Edinburgh medical sales representative says the new drug masked the warning signs of the attack, which triggered a change in his behaviour, even leading him to attack his ex-wife.

The 49-year-old is demanding pounds 230,000 compensation for what he claims was medical negligence and psychological damage. And his case could open the floodgates for hundreds of other diabetics who also claim to have suffered from side-effects. Speaking from his home in St Albans, Herts, Mr Beatty, now remarried, said: "I lost everything - my ex-wife, my only daughter. I could not work and all because the doctors changed my insulin without explaining any side effects." He added: "I'm hoping this will lead the way for others. I have no doubt that at least 70 people in the UK have lost their lives as a result of incorrect treatment." Mr Beatty will have his latest action heard at Watford County Court on Friday. No-one at Mount Vernon Hospitals NHS Trust which Mr Beatty is suing was available for comment.
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New Labour, GE insulin, and ill health
2 October 2000 21:20

Remember how safe GE foods are and how great GE in medicine is? Well this is what some diabetics in the US are now claiming GE (rDNA) insulin is doing to them (see Associated Press report and court filing below). Given that GE drugs have to go through tougher testing procedures than GE foods there will be considerable concern that amongst other things one or both of the two defendant biotechnology companies stand accused in this 'class action' of having:

*  failed to conduct appropriate and adequate clinical trials 'such that the long-term effects of these drugs are not known nor documented'.

*  'paid for, arranged for and caused rapid approval' from the Federal Drug Administration 'despite having knowledge of the potential life-threatening side effects from these drugs and despite that the long-term effects of these drugs have not been determined'.

*  given rise through such products to personal injuries including 'disfigurement, loss of consortium and death'.*  failing to provide adequate warnings to doctors that 'such products could result in antibody production, arthritic syndromes and other potentially injurious, life-threatening symptoms in diabetic patients.'

*  'intentionally, recklessly and maliciously suppressed information which would inform the diabetic public as to potential injurious side effects'.

*  'intentionally, recklessly and maliciously failed to provide other, less risky alternatives for treatment in full knowledge of the potentially injurious, life-threatening side effects to diabetics'.

It has taken nearly 20 years for this situation to come to full public attention. Meanwhile the less rigorously tested GE foods are being given to entire populations especially in the US. The allegations of adverse effects from GE insulin are arising despite the fact that at least one of these products (according to its manufacturers) is: "structurally identical to the insulin produced by your body's pancreas".  By contrast genetically 'modified' or 'engineered' foods do not have to be 'structurally identical' to their natural counterparts but only 'substantially equivalent'. For more on the structural characteristics of such insulin products see:http://members.tripod.com/diabetics_world/Diabetics_World_Insulin_Struc ture.htm

According to its manufacturer one of these rDNA insulin products:"is synthesized in a non-disease-producing special laboratory strain of Escherichia coli [E.coli] bacteria that has been genetically altered by the addition of the human gene for insulin production." and another:"is made by a special non-disease-producing laboratory strain of Escherichia coli [E.coli] bacteria that has been genetically altered by the addition of the gene for this human insulin analog."

In addition to the defendant companies in the New Mexico court case another corporation manufacturing GE insulin is Aventis, the company whose GE crops are currently featuring in UK farm-scale trials. Aventis has recently refused to call expert witnesses to defend their product against biosafety concerns being raised in a public hearing relating to GM maize in the UK ( see http://www.connectotel.com/gmfood/ti031000.txt ).

More information on the effects of their GE insulin is available at: http://members.tripod.com/diabetics_world/aventis_human_worsens_retinopathy .htm and http://www.webtribe.net/d/diabetic/avent.htm . 

Aventis is also engaged in an insulin patent dispute with one of the GE insulin manufacturers cited in the New Mexico case (http://www.novo.dk/press/nowuk/91.asp ).

Private Eye reports (6.10.2000 - see end of this message) that at last month's Labour Party Conference UK Health Secretary, Alan Milburn, spoke for the 'Fabians' (a group perceived by the media as being at the cutting edge of Labour modernisation: see http://www.fabian-society.org.uk/yf/) on "modernising the NHS" at an event sponsored by Aventis. Apparently Alan Milburn considers drug firms are "important not just for the health, but also for the wealth" of the nation and does not subscribe to the argument about "getting the drugs bill down".

Meanwhile at another event at the party conference Labour Health Minister John Hutton spoke for the Zito Trust sponsored by Eli Lilly (makers of Prozac and one of the GE insulin defendant manufacturers in the New Mexico class-action detailed in the Associated Press report below). Also featuring at the Labour Conference was party funder Paul Adamson, of Adamson BSMG Worldwide, whose involvement in forcing GM 'standards' on the EU parliament has included advising the European and American pharmaceutical industries "in securing the adoption of key legislation in the field of biotechnology".

More information on GE insulins is available at: http://members.tripod.com/diabetics_world/BDA_Human_Animal_Coverup.htm
http://www.netlink.de/gen/Zeitung/2000/000414a.html
http://www.diabetes-ernaehrung.ch/fis/news-e.shtml
http://members.tripod.com/diabetics_world/Australians_at_Risk_Human.htm

See also correlation between increasing use of synthetic insulin and diabetic road accidents in Switzerland:http://members.tripod.com/diabetics_world/Synthetics_and_Accide nts.htm

Also see Fox TV report on current class action law suit in New Mexico at:http://members.tripod.com/diabetics_world/Movies/fox13-suit.ram

Given their track record of cover up (including negative biosafety experiences with genetically engineered rBGH used for milk production in US dairy cows, but banned in the EU: see http://www.foxBGHsuit.com ) are we happy to place the future of the world's food supply in the hands of the genetic engineering industry?

It has taken nearly 20 years after its official approval to reveal this situation with GE insulin (first licensed in USA, UK, Switzerland and other countries in 1982) despite tests carried out at Guy's Hospital in London reported as early as 1980 which suggested "further continuous careful surveillance of unexpected side-effects".

Over ten years later one manufacturer was still willing to go on record as claiming that its GE insulin product "is one hundred percent a safe drug". Similar safety claims are currently being made by biotechnology companies in relation to genetically engineered foods despite their much lower standards of testing than for GE drugs. 

Do we wish to wait 20 years to find out how reliable those claims are too?  Do we have to wait 20 years for Professor Pusztai's concerns about the safety of GM foods to be proved right all along? 

From the GE insulin law suit in New Mexico it seems there may be nothing new about the suppression of data which reveals the damaging effects of products created by the biotechnology industry and the failure of the regulatory system to identify such effects."There is still no positive proof of a causal relation between the use of thalidomide during pregnancy and malformations in the new-born." Frank Getman, President Merrill Company, Feb 2nd 1961.

"Almost everything we grow, everything we eat is the root result of human intervention, human breeding and so on. But this [genetic modification through recombinant DNA technology] is unnatural in a different sort of way from the kinds of breeding programs that have characterized humanity for ten thousand years.... So the question which people have, I believe, not only a right but a duty to ask, is how wisely will we use these unprecedented new powers? What are the risks associated with doing something this new and this profound at the very wellsprings of life?... Certainly, humanity's record for using technology wisely, sensitive to its potential effects on society, on people, on environment is, at best, mixed and hardly encouraging.... We have not yet identified, yet alone cloned, the gene for wisdom, and some skepticism about our ability to manage powerful new technologies is appropriate.”
Robert Shapiro, Chief Executive of Monsanto - speech on genetically modified food, State of the World Forum, San Francisco, October 27, 1998 (emphasis added).

"We're in a crisis position where we know the weaknesses of the genetic concept, but we don't know how to incorporate it into a more complete understanding. Monsanto knows this. DuPont knows this. Novartis knows this. They all know what I know.  But they don't want to look at it because it's too complicated and it's going to cost too much to figure it out." 
Richard Strohman, Professor Emeritus, Department of Molecular and Cell Biology, University of California, Berkeley (Safe Food News, Mothers for Natural Law of the US Natural Law Party www.safe-food.org). For more on the NLP's global campaign for an immediate ban on GM foods see:
http://www.natural-law-party.org/key_issues/immediate_global_ban_of_gm_food .htm

For more on the relationship between politicians and the 'bioscience' industries see: www.btinternet.com/~nlpwessex/Documents/compliance.htm

NATURAL LAW PARTY WESSEX This email address is being protected from spambots. You need JavaScript enabled to view it. www.btinternet.com/~nlpwessex
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N.M. Diabetic Sues Over Insulin Firms & Product Change Cited
New Mexico
ALBUQUERQUE Journal
SATURDAY. APRIL 8, 2000
© 2000 Associated Press

A class-action lawsuit against Eli Lilly and Co. and Novo Nordisk alleges the drug makers’ biosynthetic insulin products can hurt diabetics.

The lawsuit, filed last week in Federal court in New Mexico, also contends the two companies have recklessly reduced the production alternative medications.

Rene Ostrochovsky, a lawyer handling the lawsuit for Roehl Law firm in Albuquerque, said Thursday it was too early to discuss the lawsuit.

The lawsuit was filed on behalf of Suzan Kawulok, a diabetic from New Mexico. She wrote on a dia?betes Web site that she took Lilly biosynthetic insulin, called Humulin, in 1987, and it caused “unbearable pain and loss of most use (of) my arms.”

She went back to animal insulin - then tried the biosynthetic version again in 1998 and experienced the same problems, she said.

“It was the human insulin causing these horrible symptoms,” said Kawulok, who now takes pork insulin. Both types of insulin -; the biosynthetic versions made from human DNA and the animal-based versions made from the pancreas glands of cows and pigs -; help control blood sugar levels for diabetics.

The Indianapolis based Lilly and Novo Nordisk began marketing the biosynthetic versions of the drug in the 1980s. Since then, human insulins have gradually replaced animal-based insulins.

Novo Nordisk is based in Bagsvaerd, Denmark, just north of Copenhagen.

In the past five years, Novo Nordisk stopped selling all its animal insulins in the United States and Lilly dropped its beef-pork mix, which was once the nation’s most-used insulin.

The only animal insulin left on the U.S. market is a pure pork product sold by Lilly.

The 18-page lawsuit says Lilly and Novo Nordisk ‘recklessly and maliciously discontinued or significantly reduced the manufacture of animal-based insulins knowing that diabetics had serious adverse symptoms” from the biosynthetic products.

The lawsuit also alleges the two companies failed to warn patients that human insulin can cause injurious, life-threatening symptoms,” including arthritic syndromes and a lack of awareness of low blood sugar.

It also accuses Lilly and Novo Nordisk of trying to prevent other companies from making animal-based insulins, and asks that the firms be ordered to release their formulas for animal-based insulins to another manufacturer.

“We stand behind the safety of our drug,” said Lilly spokeswoman Doyla Chadwick.

She said more than 3 million people rely on human insulin injections to live, and “the safety of human insulin has been proven by regulatory authorities almost 20 years ago. Human insulin is identical to the insulin produced naturally by the body. ... and is less allergenic than animal insulin.”

David Groves, a Birmingham, Ala., business consultant who runs an Internet discussion board on animal insulins, blames Novo Nordisk’s human insulin for his near-death in a car crash years ago.

He called the lawsuit a good thing, but questioned how the law firm will identify plaintiffs who can point to human insulin as the cause of their health problems.

“The affected class has no way of knowing they’re affected. It took me years and years and two additional auto accidents to make me aware human insulin was the cause of my accident, and I’m no dummy.”

“It was the human Insulin causing these horrible symptoms,” said Kawulok. Who said she now takes pork insulin.

Since Lilly and Novo introduced them In the 1980s, biosynthetic Insulins made from human DNA have gradually replaced animal-based Insulins made from the pancreas glands of cows and pigs.

In the past five years, Novo stopped selling all its animal Insulins in the United States and Lilly dropped its beef-pork mix, which was once the nation’s most-used insulin. The only animal Insulin left on the U.S. market is a pure pork product sold by Lilly.

The 18-page lawsuit says that Lilly and Novo “recklessly and maliciously discontinued or significantly reduced the manufacture of animal-based insulins knowing that diabetics had serious adverse symptoms” from the newer biosynthetic products.

The suit also charges that the two drug companies failed to warn patients that biosynthetic human insulin Can cause “Injurious, life-threatening symptoms” including arthritic syndromes and a lack of awareness of low blood sugar......
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Associated Press Article re Class-Action Suit

UNITED STATES D1STRICT COURT STATE OF NEW MEXICO SUZAN KAWULOK, INDIVIDUALLY AND AS REPRESENTATIVE TO THE CLASS; VARIOUS UNNAMED JOHN DOES AND VARIOUS UNNAMED JANE DOES INDIV AND ON BEHALF OF THE CLASS,

Plaintiffs,

vs.     NO. CIV 00 0459 BB / LFG

ELI LILLY AND COMPANY; and NOVO NORDISK,

Defendants.

FIRST AMENDED COMPLAINT FOR NEGLIGENCE, PRODUCTS LIABILITY AND PUNITIVE DAMAGES

Plaintiffs complain against The Defendants as follows:

1.Suzan Kawulok is a resident of Bernalillo County, New Mexico and is the named representative of this multidistrict class action

2.Defendant Eli Lilly and Company (“Lilly”) is a corporation doing business In the State of New Mexico.

3.Novo Nordisk is a corporation doing business in the State of New Mexico.

4.For purposes of Federal Rule of Civil Procedure 23 and federal diversity jurisdiction, each plaintiff in this national class action is bringing a claim for damages in excess of $80,000.00.

5.In accordance with Federal Rule of Civil Procedure 23, the nation-wide class will be properly expanded during the pre-trial stages of this action.

GENERAL ALLEGATIONS

6.All of the Plaintiffs in this class have been injected with Humulin® or Humalog® manufactured by Defendant Lilly, or insulin prepared with recombinant DNA (rDNA), or synthetic human insulin manufactured by Novo Nordisk within the last three years. Upon information and belief, recombinant DNA or rDNA is made from a sample of human DNA by cloning a synthetic product from the human DNA.

7.All of the Plaintiffs in this class have expedience harmful or painful side effects as a direct result of injecting Humulin® or Humalog® manufactured by Defendant Lilly, or insulin prepared with recombinant DNA (rDNA), or synthetic human insulin manufactured by Defendant Novo Nordisk

8.Defendant Lilly designed, manufactured, produced, packaged and distributed both Humulin® end Humalog®, without adequate warnings about possible side effects of these drugs.

9.Novo Nordisk designed, manufactured, produced, packaged and distributed rDNA human-based Insulin and synthetic human insulin without adequate warnings about potential side effects of these drugs.

10.All defendants knew or should have known that Humulin®, Humalog®, rDNA human-based insulin or synthetic insulin would carry with its injection n potential for Injurious side effects.

11.All Defendants failed to adequately warn Plaintiffs in this class of the potential Injurious side effects which Could result from Injecting Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin,

12.All Defendants intentionally and maliciously suppressed information which would inform the diabetic public at potentially Injurious side effects which could result from Injecting Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin.

13.Upon information and belief, all Defendants intentionally discontinued or significantly reduced the manufacture of animal-based insulins, knowing that diabetics had serious adverse symptoms from injecting Humulin®, Humalog®, other rDNA insulin or synthetic human insulin.

14.Upon information and belief, all Defendants have intentionally prevented companies from manufacturing animal-based insulins, knowing that diabetics adverse symptoms from injecting Humulin®, Humalog®, other rDNA insulin or other have synthetic human insulin.

15.Humulin®, Humalog®, other rDNA insulin and synthetic human insulin has the potential to cause antibody production in the human body and can cause inter alia, a syndrome which results in arthralgia, arthritis and myalgia-like symptoms in diabetics. Upon information and belief, human-based or synthetic human insulin also prevents diabetics from having proper warning signs of hypoglycemic symptoms until blood sugar ranges are dangerously low resulting in confusion, distress, Coma and even death.

16.Upon information and belief, Humulin® Humalog®, other rDNA insulin and synthetic human insulins have the potential to produce a variety of serious side effects which could be and have been potentially life-threatening to diabetic individuals who inject these products. Those products are designed, manufactured, packaged and distributed by Defendants.

17.Upon information and belief, Defendants have repressed the flow of relevant medical information to medical practitioners prescribing Humulin®, Humalog®, other rDNA human-based Insulin and synthetic human insulin resulting in prescriptions without proper warnings to patients about possible antibody production, arthritic syndromes and other injurious, life-threatening symptoms.

18.Upon information and belief, Defendants have repressed the flaw of relevant medical information to pharmacists tilling prescriptions for Humulin®, Humalog®, other rDNA human-based insulin and synthetic human insulin resulting in prescriptions without proper warnings to patients about possible antibody production, arthritic syndromes and other potentially injurious, life-threatening symptoms.

19.Upon information and belief, Defendants have repressed the flow of relevant medical information such that medical practitioners and pharmacists are failing to adequately train their employees as to communicate to diabetics the possible side effects of antibody production, arthritic syndromes and other potentially injurious, life-threatening symptoms in diabetic patients who are taking Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin.

20.Upon Information and belief, Defendants have repressed the flow of relevant medical information resulting in a nationwide administration of the potentially dangerous and life-threatening substances of Humulin®, Humalog®, other rDNA human-based insulin or synthetic human Insulin to diabetic patients.

21.Upon information and belief, Defendants have repressed the flow of relevant medical information such that medical practitioners have tailed to diagnose and treat the injuries and &de effects which Plaintiffs in this class sustained as a result of injecting Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin.

22.Upon information and belief, Defendants have failed to Implement and supervise adequate protocols for supervising patients who were prescribed Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin for the first time.

23.Upon information and belief. Defendants have failed to inform medical practitioners such that they would be aware of relevant medical information to implement and supervise adequate protocols for supervising patients who were prescribed Humulin®. Humalog®, other rDNA human-based insulin or synthetic human insulin for the first time,

24.Upon information and belief, Defendants have failed to provide other, less risky alternatives for treatment in full knowledge of the potentially injurious, life-threatening side effects to diabetics.

25.Upon Information and belief, Defendant Lilly paid for, arranged for and caused rapid approval of Humulin® or Humalog® from the Federal Drug Administration despite having knowledge of the potential life-threatening side effects from those drugs and despite that the long-term effects of these drugs have not been determined.

26.All Plaintiffs in this class have suffered personal injuries due to their injection of Humulin@, Humalog®, other rDNA human-based insulin or synthetic insulin and have claims for damages which may include pain and suffering, medical expenses, lost wages, lost range-of-motion, loss of opportunity, emotional distress, disfigurement, loss of consortium and death.

27.Plaintiffs’ injuries have been directly and proximately caused by Defendants’ actions and omissions regarding Humulin®, Humulin® Humalog®, and other rDNA human-based insulin or synthetic Insulin.

COUNT 1 -; NEGLIGENCE-- ELI LILLY

28.The Plaintiffs incorporate the prior allegations of this Complaint.

29.Defendant Lily was negligent in failing to provide adequate warnings in its packaging that Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin could result in antibody production, arthritic syndromes end other potentially injurious, life-threatening symptoms in diabetic patients.

30.Defendant Lilly was negligent in falling to provide adequate warnings to medical facilities and doctors that Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin could result in antibody production, arthritic syndromes and other potentially injurious, life-threatening symptoms in diabetic patients.

31.Defendant Lilly was negligent in reducing or aborting its production of animal-based insulins which are required for Humulin®, Humalog® other rDNA human-based or synthetic human insulin-5ensitive diabetic patients in maintaining quality of life.

32.Defendant Lilly was negligent in failing to advise about other, less risky alternatives for treatment because of the potentially injurious, life threatening side effects to diabetics.

33.Defendant Lilly was negligent in the design of Humulin® and Humalog® such that its defective design causes side effects which are potentially injurious and life threatening to diabetics.

34.Upon information and belief, Defendant Eli Lilly was negligent in conducting adequate clinical trials with Humulin® and Humalog® such that the long-term effects of these drugs are not known nor documented,

35.The negligent actions and omissions of Lily were a direct and proximate cause of Plaintiff& injuries.

WHEREFORE, Plaintiffs seek judgment against Defendant Lilly for compensatory damages, punitive damages, attorneys fees, costs and all other appropriate relief as the Court may deem proper. Additionally, Plaintiffs seek an Injunction from the Court requiring Defendant Lilly to release its formula for animal based insulin to a domestic drug manufacturer so that it may produce animal insulin under United States FDA guidelines.

COUNT II -; NEGLIGENCE NOVO NORDISK

36.The Plaintiffs incorporate the prior allegations of this Complaint.

37.Defendant Novo Nordisk was negligent in failing to provide adequate warnings in Its packaging that its rDNA human-based Insulin or synthetic human Insulins now marketed to the public could result In antibody production, arthritic syndromes and other potentially injurious, life-threatening symptoms in diabetic patients.

38.Defendant Novo Nordisk was negligent in failing to provide adequate warnings to medical facilities and doctors that its rDNA human-based insulin or synthetic human insulins now marketed to the public could result in antibody production, arthritic syndromes end other potentially Injurious, life-threatening symptoms in diabetic patients.

39.Defendant Novo Nordisk was negligent in reducing or aborting its production of animal-based insulins, which are required for diabetics who cannot tolerate rDNA human-based or synthetic human insulins because of the potentially injurious, life-threatening effects.

40.Defendant Novo Nordisk was negligent in falling to advise the public and medical practitioners about other, less risky alternatives for treatment than rDNA human-based or synthetic human insulins because of the potentially injurious, life threatening side effects to diabetics.

41.Defendant Novo Nordisk was negligent in the design of its rDNA human-based or human insulin drugs such that the defective design of these drugs causes side effects which are potentially life-threatening to diabetics injecting these drugs.

42.Upon information end belief, Defendant Novo Nordisk was negligent in conducting appropriate and adequate clinical trials with its rDNA human-based or human insulin drugs such that the long-term effects of these drugs are not known nor documented.

43.The negligent actions and omissions of Novo Nordisk wore a direct and proximate cause of Plaintiffs’ injuries.

WHEREFORE, Plaintiffs seek judgment against Novo Nordisk for compensatory damages, punitive damages, attorneys’ tees, costs and all other appropriate relief the Court deems proper. Additionally, Plaintiffs seek an injunction from the Court requiring Defendant Novo Nordisk to release its formula for animal based insulin to 2 domestic drug manufacturer so that It may produce animal insulin under United States FDA guidelines.

COUNT III -; PRODUCTS LIABILITY -; ELI LILLY

44.Defendant Lilly was negligent in failing to provide adequate warnings in its packaging that Humulin® and Humalog® or other rDNA human-based insulin or synthetic human insulins marketed to the public could result in antibody production, arthritic syndromes and other potentially injurious, life-threatening symptoms in diabetic patients.

45.Defendant Lilly was negligent in failing to provide adequate warnings to medical facilities and doctors that Humulin® and Humalog® or other rDNA human-based insulin or synthetic human insulins marketed to the public could result in antibody production, arthritic syndromes and oilier potentially injurious, life-threatening symptoms in diabetic patients.

46.Defendant Lilly was negligent in failing to advise the public, medical practitioners and pharmacists about other, less risky alternatives for treatment than Humulin® and Humalog® or other rDNA human-based insulin or synthetic human insulins now marketed to the public, because of their potentially injurious, life threatening side effects to diabetics.

47.Defendant Lilly defectively designed Humulin® and Humalog® such that its defective design causes harmful side effects which are potentially life-threatening to diabetics injecting these drugs.

48.Upon information and belief, Defendant Lilly was negligent in conducting adequate clinical trials with Humulin® or Humalog® such that the long-term effects of these drugs are not known nor documented

49.The negligent actions and omissions of Lilly were a direct and proximate cause of Plaintiffs’ injuries,

WHEREFORE, Plaintiffs seek judgment against defendant Lilly for compensatory damages, punitive damages, attorneys’ fees, costs and all other appropriate relief vs. the Court may deem proper. Additionally, Plaintiffs seek an injunction from the Court requiring Defendant Lilly to release its formula for animal based insulin to a domestic drug manufacturer so that it may produce animal insulin under United States FDA guidelines.

COUNT IV -; PRODUCTS LIABILITY - NOVO NORDISK

50.The Plaintiffs incorporate the prior allegations of this Complaint.

51.Defendant Novo Nordisk was negligent in failing to provide adequate warnings in its packaging that its rDNA human-based insulin or synthetic human insulins marketed to the public could result in antibody production, arthritic syndromes and other potentially injurious, life-threatening symptoms in diabetic patients.

52.Defendant Novo Nordisk was negligent in failing to provide adequate warnings to medical facilities and doctors that its rDNA human-based Insulin or synthetic human insulins marketed to the public could result in antibody production, arthritic syndromes and other potentially injurious, life-threatening symptoms In diabetic patients

53.Defendant Novo Nordisk was negligent in falling to advise the public, medical practitioners and pharmacists about less risky alternatives for treatment than human based insulins because of the potentially injurious, life-threatening side effects to diabetics.

54.Defendant Novo Nordisk defectively designed its rDNA human-based insulin or synthetic human insulin drugs marketed to the public such that their defective design causes side effects which are potentially life-threatening to diabetics injecting these drugs.

55.Upon information and belief, Defendant Novo Nordisk was negligent in conducting adequate clinical trials with its rDNA human-based insulin or synthetic human insulin drugs now being marketed to the public such that the Long-term effects of these drugs are not known nor documented.

56.The negligent actions and omissions of Novo Nordisk were a direct and proximate cause of Plaintiffs’ injuries.

WHEREFORE, Plaintiffs seek judgment against Novo Nordisk for compensatory damages, punitive damages, attorney’s fees, Costs and all other appropriate relief the Court deems proper. Additionally, Plaintiffs seek injunction from the Court requiring Defendant Novo Nordisk to release its formula for animal based insulin to a domestic drug manufacturer so that it may produce animal insulin under United States FDA guidelines.

COUNT V -; PUNITIVE DAMAGES. - ELI LILLY

57.The Plaintiffs incorporate the prior allegations of this Complaint.

58.Defendant Lilly knew or should have known that Humulin®, Humalog®, n-based insulin or synthetic Insulin would carry with its injection a potential side effects.

59.Upon information and belief, Defendant Lilly intentionally, recklessly end suppressed information which would Inform the diabetic public as to potential injurious side effects which could result from injecting Humu1in®, Humalog®, other rDNA human-based insulin or synthetic human insulin.

60.Upon information and belief, Defendant Lilly intentionally, recklessly and maliciously discontinued or significantly reduced the manufacture of animal-based insulins knowing that diabetics had serious adverse symptoms from injecting Humulin®, Humalog®, other rDNA insulin or synthetic human Insulin.

61.Upon information and belief, Defendant Lilly has intentionally, recklessly and maliciously prevented other companies from manufacturing animal-based insulins knowing that diabetics have adverse symptoms from injecting Humulin®, Humalog®, other rDNA insulin or synthetic human insulin.

62.Upon information and belief, Defendant Lilly has intentionally, recklessly and maliciously repressed the flow of relevant medical information to medical practitioners prescribing Humulin®, Humalog®, other rDNA human-based insulin and synthetic: human Insulin resulting in prescriptions without proper warnings to patients about possible antibody production, arthritic syndromes and other injurious, life threatening symptoms.

63.Upon information and belief, Defendant Lilly has intentionally, recklessly and maliciously repressed the flow of relevant medical information to pharmacists filling prescriptions for 1-lumulin®. Humalog®, other rDNA human-based insulin and synthetic human insulin resulting in prescriptions without proper warnings to patients about possible antibody production, arthritic syndromes and other potentially injurious, life threatening symptoms.

64.Upon information and belief, Defendant Lilly has intentionally, recklessly and maliciously repressed the flow of relevant medical information such that medical practitioners and pharmacists are failing to adequately train their employees as to communicate to diabetics the possible side effects of antibody production, arthritic syndromes and other potentially injurious, life-threatening symptoms in diabetic patients who are taking Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin.

65.Upon information and belief, Defendant Lilly has intentionally, recklessly and maliciously repressed the flow of relevant medical information resulting in a nationwide administration of the potentially dangerous and life-threatening substances of Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin to diabetic patients.

66.Upon information and belief, Defendant Lilly has intentionally, recklessly and maliciously repressed the flow of relevant medical information such that medical practitioners have failed to diagnose and treat the injuries and side effects which Plaintiffs in this class sustained as a result of injecting Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin.

67.Upon information and belief, Defendant Lilly has intentionally, recklessly and maliciously failed to implement and supervise adequate protocols for supervising patients who were prescribed Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin for the first time.

68.Upon information and belief, Defendant Lilly has intentionally, recklessly and maliciously failed to inform medical practitioners such relevant medical information to implement and supervise adequate protocols for supervising patients who were prescribed Humulin®, Humalog®, other rDNA human-based insulin or synthetic human insulin for the first time.

69.Upon information and belief, Defendant Lilly has intentionally, recklessly and maliciously failed to provide other, less risky alternatives tar treatment in full knowledge of the potentially injurious, life-threatening side effects to diabetics.

70.Upon information and belief, Defendant Lilly paid for, arranged for and caused a rapid approval from the Federal Drug Administration of Humulin® or Humalog® despite having knowledge of tile potential life-threatening side effects from Humulin® and Humalog® and despite that long-term effects of these drugs have not been determined.

71.Upon information and belief, Defendant Lilly conducted inadequate clinical trials of Humulin® and Humalog® such the long-term effects of these drugs are not known nor documented.

72.Upon Information and belief, Defendant Lilly conducted clinical trials of Humulin® and Humalog® on human subjects who were known to be chronic alcohol abusers or chronic drug users, which had the effect of distorting trial results of these drugs.

73.All Plaintiffs in this class have suffered personal injuries due to the injections of Humulin® Humalog®, other rDNA human-based insulin or synthetic insulin and have claims for damages which include hut may not be limited to pain and suffering, medical expanses, lost wages, loss of range-or-motion, loss of opportunity, emotional distress, disfigurement, loss of consortium and death.

74.Plaintiffs’ injuries have been directly and proximately caused by Defendant Lilly’s actions and Omissions regarding Humulin®, Humalog® other rDNA human-based insulin or synthetic insulin.

WHEREFORE, Plaintiffs seek Judgment against Defendant Lilly for compensatory damages, punitive damages, attorneys’ fees, costs and all other appropriate relief as the Court may deem proper. Additionally, Plaintiffs seek an injunction from the Court requiring Defendant Lilly to release its formula for animal based Insulin to a domestic drug manufacturer so that It may produce animal irI3uIin under United States FDA guidelines.

COUNT VI- PUNITIVE DAMAGES -; NOVO NORDISK

75.The Plaintiffs incorporate the prior allegations of this Complaint.

76.Defendant Novo Nordisk knew or should have known (hat Humulin®, Humalog®, rDNA human-based insulin or synthetic insulins marketed to the public would carry with its injection a potential for injurious side effects.

77.Upon information and belief, Defendant Novo Nordisk intentionally, recklessly and maliciously suppressed information which would inform the diabetic public as to potential injurious side effects which could result from injecting Its rDNA human-based insulin or synthetic human insulins marketed to the pubic.

78.Upon information and belief, Defendant Novo Nordisk intentionally, recklessly and maliciously discontinued or significantly reduced the manufacture of animal-based insulins knowing that diabetics had serious adverse symptoms from injecting its rDNA insulin or synthetic human insulins marketed to the public.

79.Upon information and belief, Defendant Novo Nordisk has intentionally, recklessly and maliciously prevented other companies from manufacturing animal based insulins knowing that diabetics have adverse symptoms from injecting Its rDNA insulin or synthetic human insulins marketed to the public.

80.Upon information and belief, Defendant Novo Nordisk has intentionally, recklessly and maliciously repressed the flow of relevant medical information to medical practitioners prescribing Humulin®, Humalog®, other rDNA human-based insulin and synthetic human insulins now being marketed to the Public resulting In prescriptions without proper warnings to patients about possible antibody production, arthritic syndromes and other injurious, life-threatening symptoms.

81.Upon information and belief, Defendant Novo Nordisk has intentionally, recklessly and maliciously repressed the flow of relevant medical information to pharmacists filling prescriptions for Humulin®, Humalog®, other rDNA human-based insulin and synthetic human insulins marketed to the pubic resulting in prescriptions; without proper warnings to patients about possible antibody production, arthritic syndromes and ether potentially injurious, life-threatening symptoms.

82.Upon information and belief, Defendant Novo Nordisk has intentionally, recklessly and maliciously repressed the flow of relevant medical information such that medical practitioners and pharmacists are failing to adequately train theft employees to communicate to diabetics the possible side effects of antibody production, arthritic syndromes and other potentially injurious, tile-;threatening symptoms in diabetic patients who are taking Humulin®, Humalog® or Novo Nordisk’s rDNA human-based insulin or synthetic human insulins.

83.Upon information and belief, defendant Novo Nordisk has intentionally, recklessly and maliciously repressed the flow of relevant medical information resulting in n nationwide administration to diabetic patients, the potentially dangerous and life threatening substances of Humulin®, Humalog®, or Novo Nordisk’s rDNA human-based insulin or synthetic human insulins.

84.Upon Information and belief, Defendant Novo Nordisk has intentionally, recklessly and maliciously repressed the flow of relevant medical information such that medical practitioners have failed to diagnose and treat the injuries and side effects which Plaintiffs in this class sustained as a result of injecting Humulin®, Humalog®, or Novo Nordisk’s rDNA human-based insulin or synthetic human insulins.

85.Upon information and belief, Defendant Novo Nordisk has intentionally, recklessly and maliciously failed to implement and supervise adequate protocols for supervising patients who for the first time were prescribed Humulin®, Humalog®, or Novo Nordisk’s rDNA human-based insulin or synthetic human insulins.

86.Upon Information and belief, Defendant Novo Nordisk has intentionally, recklessly and maliciously failed to inform medical practitioners such that they would be aware of relevant medical Information to Implement and supervise adequate protocols for supervising patients who for the first time were prescribed Humulin®, Humalog®, or Novo Nordisk’s rDNA human-based Insulin or synthetic human insulins,

87.Upon information and belief, Defendant Novo Nordisk has intentionally, recklessly and maliciously failed to provide other, less risky alternatives for treatment In full knowledge of the potentially injurious, life-threatening side effects to diabetics from its rDNA human-;based or synthetic human Insulins.

88.Upon information and belief, Defendant Novo Nordisk has manufactured produced and distributed us rDNA human-based insulin or synthetic insulin drugs without knowing the long-term effects of such drugs on diabetic patients.

89.All Plaintiffs in this class have suffered personal injuries due to their injecting Humulin®, Humalog® or Novo Nordisk’s rDNA human based insulin or synthetic insulins and have claims for damages which include but may not he limited to pain and suffering, medical expenses, lost wages, loss of range-of-motion, loss of opportunity, emotional distress, disfigurement, loss of consortium and death.

90.Plaintiffs’ injuries have been directly and proximately caused by defendant Novo Nordisk’s actions and omissions regarding Humulin®, Humalog®, other rDNA human-based Insulin or synthetic insulins marketed to the public.

WHEREFORE, Plaintiffs seek judgment against Defendant Novo Nordisk for compensatory damages, punitive damages, attorneys’ fees, costs and all other appropriate relief as the Court may deem proper. Additionally, Plaintiffs seek an injunction from the Court requiring Defendant Novo Nordisk to release Its formula for animal based insulin to a domestic drug manufacturer so that it may produce animal insulin under United States FDA guidelines.

Respectfully submitted THE ROEHL LAW FIRM, P.C.

/s/ J. J. Roehl Jerrald J. Roehl René Ostrochovsky Attorneys for Plaintiffs 300 Central Avenue SW. Suite 2500 East Albuquerque, New Mexico 87102 Voice: (505) 242-6900 FAX: (505) 242-5903

Associated Press Article re Class-Action Suit
Lawsuit as filed
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The Euro

A squillionaire with a big role at conference was Paul Adamson, of Adamson BSMG Worldwide.  Labour's accounts reveal that Adamson is a donor of "£5,000 or more" for the second year running.

Adamson GSMG sponsored a fringe meeting of the Foreign Policy Centre on "How to win the Euro Referendum", with Adamson himself in the chair.

The FPC has Tony Blair as a patron, Robin Cook as its president and Mark Leonard, Labour's "rebranding Britain" idealogue, as its director. Labour Lords Levy and Paul are on the advisory board.

They face an uphill struggle in fighting for a win in a future Euro referendum because of suspicion that \the EU is an unaccountable, distant organisation wholly at the mercy of big business and lobbying special interests.  So who better to front the pro-Euro debate than Adamson, whose firm lobbies for, er, big business and special interests at the European level?

Adamson BSMG advertises itself with the slogan "Managing Government". Its brochure offers firm "lobbying/advocacy" including "developing contacts with key officials".  Adamson BSMG boasts:  'The experience and contacts we have built up while working with the European Commission, European parliament and the Council of Ministers give us an 'insider's view'."  And the firm brags about some extraordinary lobbying efforts. While John Prescott tried to defend petrol taxes from the green point of view, Adamson proudly announces:  "We advised and advocated on behalf of a major US auto-maker regarding proposed new EU fuel quality emission standards."

Adamson also trumpets its involvement in forcing GM standards on the EU parliament, claiming:  "We advised the European and American pharmaceutical industries in securing the adoption of key legislation in the field of biotechnology".  Whether the chicken legs, quiches and devilled egg pastry shells served to the Labour delegates at the FPC/Adamson meeting were full of GM materials is not known.

ENDS