PFIZER CONCEALS DRUG DATA ON ANTI-DEPRESSANTS

Pfizer concealing reboxetine data, says IQWiG
By Gareth Macdonald, 15-Jun-2009 (excerpts below)


Germany’s IQWiG has accused US drugmaker Pfizer of “concealing data on the effect of a drug Edronax for the treatment of depression.”

Pfizer has “refused to provide a complete list of all published and unpublished trials on reboxetine.” on a controversial antidepresant to a German health group, The Institute for Quality and Efficacy in Health Care (IQWig).

Peter Sawicki, IQWiG director, said: “By concealing study data, the manufacturer is depriving patients and doctors of the opportunity to make an informed decision on different therapy options.”

Sawicki also said that: “deception through concealment is no trivial offence” adding that “in extreme cases, patients may even receive useless treatment if information is incomplete.” He went on to suggest that “publication bias, the selective release of only data that supports a development candidate, has been a growing problem in the drug industry for the last 20 years.”

For complete article-click here

Oldest IVF Recipient Mother Dies-Two Year Old IVF Children Orphans

Oldest woman to give birth dies, leaving twins

by Daniel Woolls, Associated PressJuly 15th, 2009

Maria del Carmen Bousada

A Spanish woman who deceived a U.S. fertility clinic about her age and become the oldest woman to give birth has died at 69, leaving behind 2-year-old twins, newspapers reported Wednesday. For more click link.

Pfizer Loses Worker Compensation Case

Pfizer to pay workers' comp for exposure to organics


By Lee Howard Published in The Day on 7/16/2009

The Connecticut Appellate Court, in a decision that won't be officially released until July 21, has ruled in favor of a former Pfizer Inc. employee in a workers' compensation case.

Ronald C. Chappell of Groton, a former chemical operator in the fermentation department of Pfizer's one-time manufacturing facility in Groton, filed a workers' compensation claim in 2002, saying his exposure to organic molds and other materials - including blood meal and ground-up chicken parts - led to his asthma, which a doctor determined to be an occupational disease.

”In general, employers don't like to pay for occupational diseases,” said Carolyn P. Kelly, who represented Chappell along with lead attorney Matthew Shafner of the New London firm Suisman Shapiro, who estimated that more than half of these claims are contested.

Kelly said Chappell will likely get a lump-sum payment, plus continued compensation for out-of-pocket medical expenses. In addition, his insurer may be able to collect money it has paid for his asthma care in the past as well as going forward.

Kelly said Pfizer could further contest the claim by taking the case to the state Supreme Court, but she thought this step was unlikely. Chappell, throughout his seven-year workers' compensation effort, has received no money for his out-of-pocket asthma care, she added.
Pfizer and its co-defendant, the Wausau Insurance Co., had opposed the claim on technical grounds, including whether asthma in this case constituted an occupational disease. But Pfizer, in this phase of the case, admitted Chappell's asthma arose out of his employment in the fermentation department.

Pfizer was represented by Vernon attorney Erik S. Bartlett.

The appellate court said procedures used to clean tanks at the fermentation facility - where antibiotics were manufactured - exposed Chappell to airborne waste and residue. “(Chappell) did not wear protective respiratory gear during the cleaning procedure, nor was he required to do so by (Pfizer),” the court said in its findings of fact.

”There is no dispute that his exposure arose out of and in the course of his duties as a chemical operator or that it directly led to his asthma,” the court said. “(Chappell's) asthma constitutes an occupational disease because his employment as a chemical operator in (Pfizer's) fermentation department was more likely to cause this disease than would other kinds of employment under the same conditions.”

Chappell's request for workers' compensation had previously been approved by the workers' comp commissioner for the second district and by the workers' compensation review board.
An attempt to reach Chappell proved unsuccessful.

A Pfizer spokesman said the company had not seen the decision and had no comment on it.
l.howard@theday.com
Click here to see story at The Day

The Unethical Patent

Patenting life or genetic molecular entities involved with human medicine have profound negative effects on society in many ways. The patenting of the BRCA1 and BRCA2 genes involved in breast and overian cancer is a good example of the problems capitalistic ownership of "life" can bring to suffering patients.

Here is a story written from another blog:

Will breast cancer gene lawsuit end gene patenting?
Earlier this month, the American Civil Liberties Union joined the Association for Molecular Pathology, the American College of Medical Genetics, the Boston Women's Health Book Collective, and numerous other plaintiffs--including individual breast cancer patients--in filing a lawsuit against Myriad Genetics, the U.S. Patent Office, and the directors of the University of Utah Research Foundation. Myriad Genetics has patents in the U.S. for the BRCA1 and BRCA2 genes, the presence of which has been linked to an increased risk of breast or ovarian cancer. The suit alleges that such gene patenting is unconstitutional, in large part because "ease of access to genomic discoveries is crucial if basic research is to be expeditiously translated into clinical laboratory tests that benefit patients in the emerging era of personalized and predictive medicine," and such patents restrict the use of the genes.

The ACLU suit points out that:
Because of the patents, defendant Myriad has the right to prevent clinicians form independently looking at or interpreting a person's BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer. Because of the patents and because Myriad chooses not to license the patents broadly, women who fear they may be at an increased risk of breast and/or ovarian cancer are barred from having anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder. [...] Many women at risk cannot even be tested because they are uninsured and/or cannot afford the test offered by Myriad.

For more on this topic go to the author's blog site ...here.

ref:http://cluttermuseum.blogspot.com/2009/07/will-breast-cancer-gene-lawsuit-end.html

SPERM MADE FROM EMBRYONIC STEM CELLS

UK scientists create human sperm for the first time

The announcement from the Institute, which is made up of Newcastle and Durham Universities and Newcastle National Health Service
Foundation, marked the first time human sperm had been created in a laboratory and threatened to reopen the fierce debate over embryo research. It was reported in the journal Stem Cells and Development.
Click here for entire story

Gibbs Makes Case for Lab Origin of Swin Flu

Virologist to make his case for lab origin of swine flu

http://www.petersnewyork.com/GIBBS.html

By Peter Duveen

PETER’S NEW YORK, Wednesday, July 1, 2009--The scientist who made headlines in May by positing a laboratory origin for the swine flu that has swept the world will defend his theory in the scientific literature, Peter’s New York has learned. Dr. Adrian Gibbs, a Canberra, Australia-based virologist with more than 200 scientific publications to his credit, said that over the weekend he submitted his latest work on the swine flu to a prominent scientific journal, and is awaiting a response. Gibbs, 75, was part of a team that developed the antiviral drug Tamiflu.

In May of 2009, Dr. Adrian Gibbs of Canberra, Australia, shown here on Bloomberg TV, achieved notoriety for his theory that the new swine flu may have been the result of an error in the vaccine manufacturing process.

Back in April, when the first cases of swine flu were diagnosed in Mexico, Gibbs examined the genetic structure of the virus that had been posted on a public database. His analysis led him to speculate that the virus may have been the result of a laboratory error. He contacted the Geneva, Switzerland-based World Health Organization with his conjecture, and scientists there scrutinized his findings, concluding, however, that the virus was most likely a product of nature. In a series of email exchanges with Peter’s New York, Gibbs said he was not satisfied with the WHO’s critique, indicating that the basis for it was ambiguous. “The WHO stated that they had no evidence to support my suggestion,” Gibbs said. “They made a very fair statement. However the principle reason for my conclusion remains—that none of the genes of the new virus had been sampled/found/caused epidemics since at least 2000, despite probably coming from at least two different parents on two continents, where other strains had been sampled.” Gibbs said that might have been a coincidence, but the unusual placement of the virus on what what virologists call phylogenetic trees—a sort of schematic family history of the virus--also piqued his interest. On top of that, Gibbs observed that there was a lack of evidence that pig populations in North America, from which the virus is believed to have emerged, had been infected. Only the pigs on one farm in Canada have as yet been shown to have contracted the virus. It has been established, said Gibbs, that swine easily contract the new flu from humans, and spread it among themselves. The absence of infection in the North American swine, Gibbs noted, may be evidence that the swine had already contracted the disease and built up immunity, or that they were vaccinated against viruses that resembled the novel swine flu closely enough for them to have been protected against it. Gibbs said the one Canadian herd that came down with the novel swine flu had not been inoculated, and that the evidence therefore leans toward inoculation as the reason North American pigs are disease free. That, in turn, would support a theory, according to Gibbs, that "the virus in the vaccine may be the immediate progenitor of the new human virus. " Gibbs said he would have been more satisfied if scientists at the WHO had examined the lists of all the vaccines licensed for production in the United States and Mexico and determined that none of them harbored strains from which the swine flu could have descended. He said he had been unable to locate such lists to make the determination himself. Gibbs spells out fairly clearly how he thinks the new virus might have emerged due to a laboratory error. In manufacturing a vaccine, each of the viruses to be protected against must first be bred and then sterilized to prevent their further multiplication. When a subject is inoculated, the body reacts to the “killed” viral fragments and produces antibodies that provide protection against the live virus. Gibbs said that if the sterilization process was not carried out properly, pigs could end up being given live viruses, and instead of being protected, would contract the disease. The live viruses would then have a chance to multiply and exchange genetic material within the infected pig in a process known as reassortment, and a new virus could emerge and spread to humans as a “swine flu.” The study of viruses is overlaid with a complex nomenclature and labyrinthine concepts and arguments in the field of genetics that are unfamiliar to the average layman. But the implications are far reaching, a fact not lost on the general public or on Gibbs. Early this year, the Deerfield, Ill. based drug firm Baxter International Inc. shipped experimental vaccines for human flu that were contaminated with the bird flu. The cocktail of influenzas, if it had not been discovered by alert laboratory specialists in the Czech Republic in February, could have been administered to subjects, after which, some experts feared, the two viruses could have undergone reassortment, producing a new virus that possessed the lethality of bird flu and the communicability of human flu. Bird flu is a deadly disease that kills close to half its victims, but resists spread from human to human. Human flu, on the other hand, is far more benign, but is easily spread through human contact. A recombined virus with the characteristics of each of the two could conceivably wipe out almost half the world’s population. Gibbs steers clear of elaborate intrigues that some believe are behind the new flu’s emergence. “Whenever I’ve thought something has resulted from a conspiracy, it usually turns out to be from a ‘cock-up,’” he said. The importance of establishing whether or not the flu emerged from a laboratory, he emphasized, is “to try to avoid a recurrence.” He did admit, however, that there was a definite risk to the public of escaping pathogens held in government and private facilities. “There are many historical precedents that are conveniently forgotten,” said Gibbs. “The recent Baxter incident seems to have been one.” “The reappearance in 1977 of the H1N1 (virus) last seen in 1950 after a period of non-evolution,” which he speculated could represent “suspended animation in a freezer,” was another instance in which pathogens might have escaped from a laboratory. Gibbs also cited the escape of foot-and-mouth disease from a British government laboratory facility in 2007. Asked if the resurrection of the viral agent for the deadly 1918 “Spanish” flu, which was reconstituted in 2005 by scientists at the Centers for Disease Control and Prevention for research purposes, was a safe proposition, he answered, “No, definitely not.” “It’s exactly the same principle as should apply to all high security labs,” said Gibbs. “If it ain’t ‘there’ it can’t get out, whereas if it is, then there is always the possibility, however remote, that it might get out.” The 1918 flu, which spread to every corner of the globe in the two years immediately following World War I, had a rate of lethality some 30 to 50 times greater than other strains of human flu. Tens of millions of people died in the pandemic worldwide. While some aspects of his presentation have been updated, Gibbs said his basic premise remains unchanged, and has, in fact, been reinforced by recent additions to the scientific literature. And while the WHO gave the appearance of having put the final nail in the coffin of Gibbs’s theory, in a rare show of scientific honesty for a public institution, it affixed the lid rather loosely, leaving itself room to revisit Gibbs’s hypothesis once it is published. In the mid-May press conference in which the WHO addressed Gibbs’s analysis, which by that time has spread far and wide throughout the mainstream media, Assistant Director Keiji Fukuda praised the virologist who had contributed to the field for more than fifty years of professional work, calling Gibbs “a credible scientist, a credible virologist.” In answer to a reporter’s question about whether Gibbs’s theory had been refuted, Fukuda said: “I think that it is fair to say that in the world of science, nothing is ever totally excluded, nothing is ever ended.” On the issue of whether Gibbs’s theory may actually prove true or not, he said: “We feel very comfortable based on the analyses which have been done, based on the rigor in which it has been looked at, that we are not dealing with a laboratory-created virus. However, I do not expect that the debate itself will stop.” The world awaits Gibbs’s response.

Money Talks

Money and Influence

"We live by the Golden Rule. Those who have the gold make the rules." B. Bavasi

The following is from Freshlife Inc. July 2, 2009, Issue 128, volume 10

- do you wonder how it’s possible for ideas that are opposed by a vast majority of Americans to become the law of the land – or at least the policy of the federal government? What ever happened to democracy, and how did we become a “corporatocracy”. It’s simple, really - money talks.

These are the amounts spent by the corporations listed. However, most of these corporations also contract out to private lobbying firms, so the amounts you see here are probably NOT the total amounts spent on lobbying in Q1-2009. For example, Monsanto spent $2,094,000 for its in house lobbying but then contracted out to Arent Fox LLP; Lesher, Russell & Barron, Inc. ($60,000); Ogilvy Government Relations ($60,000); Parven Pomper Strategies ($40,000); Sidley Austin LLP; TCH Group, LLC ($50,000); The Nickles Group, LLC ($63,000); The Washington Tax Group, LLC ($40,000); and Troutman Sanders Public Affairs Group ($30,000) - for a total of $2,437,000 in first quarter 2009. That’s right – nearly 2 million dollars in 3 months spent convincing our legislators that GMOs (and other Monsanto profit-making ideas) are a good idea.

Numbered by most dollars spent and separated by category – this is the money that poured into Washington during January, February and March of this year. (2009)

Health Care, Health Insurance, & Pharmaceuticals3.

Pharmaceutical Research and Manufacturers of America: $6,910,0006. Pfizer, Inc: $6,140,00012. American Medical Association: $4,240,00018. American Hospital Association: $3,580,00019. Eli Lilly and Company: $3,440,00037. America's Health Insurance Plans, Inc: $2,030,00039. CVS Caremark Inc: $2,005,00047. Blue Cross and Blue Shield Association: $1,800,00049. GlaxoSmithKline: $1,780,00063. Merck & Co: $1,500,00065. United Health Group, Inc: $1,500,00069. Sanofi-Aventis U.S. Inc: $1,460,00076. Novartis: $1,347,13487. Abbott Laboratories: $1,260,00089. Astrazeneca Pharmaceuticals, LP: $1,250,00092. Medtronic, Inc: $1,238,000

Oil2.

Exxon Mobil: $9,320,0004. Chevron U.S.A. Inc: $6,800,0007. Conoco Phillips: $5,980,93516. BP America, Inc: $3,610,00020. Marathon Oil Corporation: $3,380,00045. American Petroleum Institute: $1,810,000

Defense5.

Lockheed Martin Corporation: $6,380,00011. General Electric Company: $4,540,00028. Northrop Grumman Corporation: $2,570,00030. Boeing Company: $2,410,0051. Honeywell International: $1,760,00073. Raytheon Company: $1,360,000

Telecoms10.

AT&T Services, Inc: $5,134,87314. Verizon (excluding Verizon Wireless): $3,760,00021. National Cable and Telecommunications Association: $3,370,00023. Comcast Corporation: $2,760,00068. Motorola, Inc: $1,470,000

Automotive22.

General Motors: $2,800,00027. United Services Automobile Association: $2,590,24452. Ford Motor Company: $1,750,00084. Toyota Motor North America: $1,290,00086. Alliance of Automobile Manufacturers: $1,264,400

Financial32.

Financial Services Roundtable: $2,260,00033. Prudential Financial, Inc: $2,180,00041. American Bankers Association: $1,890,00061. Visa, Inc: $1,540,00074. Investment Company Institute: $1,359,91775. Securities Industry and Financial Markets Association: $1,350,00082. J.P. Morgan Chase Bank, N.A.: $1,310,00090. Citigroup Management Corp: $1,250,00090. Credit Union National Association: $1,250,000

Biotech36.

Monsanto: $2,094,00040. Biotechnology Industry Organization (BIO): $1,920,00044. Bayer Corporation: $1,843,672

Railroads24.

Association of American Railroads: $2,759,54554. Union Pacific Corporation: $1,717,10871. BNSF Railway: $1,400,000

Life Insurance42.

American Council of Life Insurers: $1,867,07544. New York Life Insurance Company: $1,840,00064. State Farm Insurance: $1,500,00093. The Northwestern Mutual Life Insurance Company: $1,237,000

Other1.

Chamber of Commerce of the U.S.A.: $9,996,0008. National Association of Realtors: $5,727,0009. U.S. Chamber Institute for Legal Reform: $5,480,00013. AARP: $4,090,00015. Southern Company: $3,650,00017. Altria Client Services Inc: $3,580,00025. Amgen, Inc: $2,750,00026. National Association of Broadcasters: $2,600,00029. Edison Electric Institute: $2,550,00031. Fedex Corporation: $2,370,00034. Textron, Inc.: $2,140,00035. General Dynamics Corp: $2,101,94538. International Business Machines (IBM): $2,030,00043. United Technologies Corporation: $1,860,00046. Recording Industry Association of America: $1,810,00048. CTIA-The Wireless Association: $1,790,00050. Time Warner Inc. $1,780,00053. The Dow Chemical Company: $1,735,00055. American Electric Power Company: $1,716,91356. Microsoft Corporation: $1,650,00057. Qualcomm, Incorporated: $1,620,00058. Wal-Mart Stores, Inc: $1,600,00059. L-3 Communications: $1,580,00060. Exelon Business Services, LLC: $1,540,00062. Johnson & Johnson Services, Inc: $1,530,00066. Norfolk Southern Corporation: $1,485,02667. Koch Companies Public Sector LLC: $1,480,00070. American Airlines: $1,450,00072. Oracle Corporation: $1,390,00077. Air Transport Association of America, Inc.: $1,340,00078. Disney Worldwide Services, Inc.: $1,330,00079. Sepracor, Inc: $1,324,15780. National Association of Home Builders: $1,320,00081. UPS: $1,316,42683. Siemens Corporation: $1,300,00085. Duke Energy Corporation: $1,282,77094. Distilled Spirits Council of the U.S., Inc: $1,230,00095. Business Roundtable: $1,220,00096. Wellpoint, Inc: $1,220,00097. American Wind Energy Association: $1,212,50498. F. Hoffmann-La Roche Ltd: $1,206,42799. National Rural Electric Cooperative Association: $1,200,00099. CBS Corporation: $1,200,000

reference: Freshlife Inc. July 2, 2009, Issue 128, volume 10