Community

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ORIGINAL: Bettawrekonize

BTW, thanks for your insights lightshineon.

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Pfizer Inc. could pay $153 million or more to the state of Wisconsin after a jury found a company it acquired artificially inflated prices for years, the state's attorney general said Tuesday.

Jury rules against Pfizer in Wisconsin lawsuit

Hopefully the ruling won't be overturned. When a big corporation does something wrong, they should be punished.

I also found this interesting.

Voting Himself Rich: CDC Vaccine Adviser Made $29 Million Or More After Using Role to Create Market

(both articles originally found on Naturalnews).

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ORIGINAL: lightshineon
I know I sound ignorant

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But a potential conflict of interest stemming from the financial portfolio of Chief Justice John Roberts could sink the crucial court ruling before it is even issued.

Roberts’ Shares of Pfizer at Issue

As of 2006, Roberts admitted owning between $15,001 and $50,000 worth of shares of Pfizer, one the world’s largest drug companies which has announced it plans to purchase Wyeth Pharmaceuticals. While it is unknown whether the Chief Justice still owns the Pfizer stocks, in the past, Roberts has recused himself from cases that involve Pfizer and other entities in which he has a financial interest.
...
Is Wyeth Getting Nervous?

On February 4, 2009, Seth P. Waxman, the attorney of record for Wyeth in the Levine case, wrote a letter to the clerk of the Supreme Court, essentially stating his position that Roberts’ shares of Pfizer should not prevent the chief justice from voting in the pending case.

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RALEIGH, N.C. — A newspaper report says months passed between federal regulators first receiving complaints about tainted syringes produced at a North Carolina plant and action to pull them from the market.

The News & Observer of Raleigh reported Wednesday the U.S. Food and Drug Administration had complaints as early as 2005 about contamination in syringes filled with blood thinner by AM2PAT Inc. at its plant in Angier.

The FDA pulled the product from the market in December 2007.

Authorities say the syringes sickened hundreds of people and are linked to five deaths.

Two company officials pleaded guilty to charges and officials are searching for the company's president.

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RALEIGH, N.C. - A North Carolina syringe factory linked to hundreds of sicknesses and five deaths operated for almost two years without an inspection despite a series of complaints that its needles were dirty or filled with colored particles.

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Court documents in the North Carolina case show the U.S. Food and Drug Administration only inspected the AM2PAT Inc. plant in December 2007 after an outbreak of illness was reported by the Centers for Disease Control and Prevention.

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In 2007, before the outbreak of illness was traced back to the company’s syringes, the FDA received more than a dozen reports of problems with AM2PAT’s products. Some reported “orange specks” floating inside the unopened syringes, while others reported “yellow sediment” or “muddy brown” syringes filled with floating white specks.

22-month gap
FDA records show the agency first received complaints of particles in AM2PAT syringes in November 2005. FDA spokeswoman Siobhan DeLancey said the company was inspected in January 2006 but then wasn’t checked again until the December 2007 inspection: a gap of 22 months.
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Assistant U.S. Attorney Jason Cowley said a person who had the title of “microbiologist” at the company was a teenager who had dropped out of high school.

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Three drugs tested at the Paonta Sahib plant are still in U.S. circulation because they are manufactured at the company’s New Jersey plant. Those drugs are a generic decongestant and generic versions of Merck & Co. Inc.’s Zocor and Bristol-Myers Squibb’s Pravachol. Both are widely used cholesterol drugs.

Those drugs likely underwent new testing when they were transferred to the U.S. for production, regulators said.

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If manufacturers (read: innovators) cannot rely on FDA approval to defend them against lawsuits, they will have less of an incentive to invest in new devices.

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This point rarely makes it beyond the conservative echo chamber.

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The specter of litigation, with different standards in each state, would sometimes stall development of lifesaving devices; it shifts the profit-risk balance so much that it'll be financially prudent to not sell a device.

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...the gold standard of consumer protection: Before any pharmacist can hand over an orange bottle, the FDA must study the data on that drug and approve it.

But a recent report by The Oncologist medical journal has exposed how flimsy that standard really is. The article’s authors counted the number of drug company clinical trials that get published — versus how many trials the companies actually conduct. The answer: only a tiny fraction.
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The pattern these registrations show is shocking. Commercial drug companies published fewer than six percent of all the clinical studies they undertook to test their drugs.

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"Actually, this has been a mild season; we've not seen as many cases this year as in past years, but activity is picking up," said Brenda Williams, communicable disease program manager for the Wicomico health agency.

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But weeks after announcing a ban on the widely used antibiotic cephalosporin last summer, the FDA quietly reversed its decision after getting a trough full from agribusiness and pharma.

Even the hearings on the Hill in September sponsored by the Subcommittee on Livestock, Dairy and Poultry flew under the public's radar. They were termed a "review" of "advances in animal health within the livestock industry."

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In documents unsealed last week, a 1997 e-mail message from Richard Lawrence, an AstraZeneca official, praised Lisa Arventis, the Seroquel project physician at the time, for minimizing adverse findings in a "cursed" study. "Lisa has done a great 'smoke-and-mirrors job," Lawrence wrote.

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A few months ago, Coca-Cola announced it would begin using its stevia-derived sweetener Truvia in a few products, prior to being approved by the FDA.
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Recently, I saw both Truvia and PureVia on the shelf at my grocery store.
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Both PureVia and Truvia are made by extracting rebaudioside A (Reb A) from the leaves of the stevia plant. While the FDA has not yet approved the use of whole-leaf stevia or stevia extracts as sweeteners, they have issued a "No Objection Letter" to the use of Reb A, saying that it's "generally safe

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The Supreme Court on Wednesday enhanced the ability of people to hold drug companies financially responsible for injuries. In a 6-3 decision, the court ruled that federal law does not block a lawsuit in state court by a woman who lost an arm to gangrene after receiving an injection of an anti-nausea drug.

The ruling, a rejection of the Bush administration's position, affirms a Vermont jury's $6.7 million award to Diana Levine, a former guitarist, who sued drugmaker Wyeth for the loss of her arm after she had gone to a local health clinic in April 2000 for treatment of a migraine.

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doctors are asking patients to sign agreements that bar them from posting comments on everything from review sites to blogs, and then attempting to have the reviews removed if they break the gag order.

In fact, these doctors are going so far as enlisting the help of monitoring companies that watch for negative posts attempting to in check. One such company ... [has an] entire business ... built upon pushing patient waivers to doctors and then hunting out their commenting indiscretions online.
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"They're basically forcing the patients to choose between health care and their First Amendment rights, and I really find that repulsive," RateMDs cofounder John Swapceinsk told the AP.

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The six largest manufacturers of baby bottles will stop selling bottles in the United States made with bisphenol A ...
The manufacturers declared their intentions after Connecticut Attorney General Richard Blumenthal, joined by the attorneys general in Connecticut and New Jersey, wrote to the bottle makers and asked them to voluntarily stop using the chemical.

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WASHINGTON -- The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.
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Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions.
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In one instance, emails show the FDA's integrity office excising language from a draft letter an FDA lawyer said would "document special treatment for ReGen."
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Dr. Mabrey also says, "In retrospect, I think they [the FDA] were stacking the committee to get the decision the company wanted."

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You ignore the very special circumstance that doctors are in: patients can say anything they want, but doctors can't respond to a review without breaking confidentiality rules and risking their medical license.

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Mr. Zerden’s minor stir four years ago has lately grown into a full-blown movement by more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard’s 17 affiliated teaching hospitals and institutes.
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The students argue, for example, that Harvard should be embarrassed by the F grade it recently received from the American Medical Student Association, a national group that rates how well medical schools monitor and control drug industry money.

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Of Harvard's 8,900 professors and lecturers, 1,600 admit that either they or a family member have had some kind of business link to drug companies — sometimes worth hundreds of thousands of dollars — that could bias their teaching or research. Additionally, pharma contributed more than $11.5 million to the school last year for research and continuing-education classes. The Times covered these details in its stories and included the ... fact that during the November demonstration, a Pfizer employee was on campus photographing protesters with a cell-phone camera.

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(NaturalNews) Internal FDA documents have revealed that top agency officials strongly objected in 2006 and 2008 when the Bush administration took steps to enshrine a "preemption" policy for drugs.

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In 2006 and 2008, the FDA sought to strengthen its preemption policy by requiring drug companies to get agency approval before making any changes to the safety section of drug labels.

At the time, top FDA officials blasted these changes as "naive to what actually occurs in practice," and said they were based on "false assumption," "false and misleading" assertions" and "gross overstatement."

"Much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real time basis," objected Office of New Drugs head John Jenkins. "We know that such an assumption is false. ... We know that many current approved drug labels are out-of-date and in many cases contain incorrect information. ... It is unwise to suggest that FDA approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information."
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The report notes that the new preemption rules may have already led to consumer harm. It cites the case of when Glaxo sought to change the label of its breast cancer drug Tykerb to warn of the potential for pneumonitis or interstitial lung disease, but the FDA delayed on approving the change for three months. The FDA delayed for the same amount of time when Johnson & Johnson sought to add warnings of the potential for liver toxicity to its antibiotic Levaquin.

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The FDA, Jewell added, had access to Study 15 when it declared Seroquel safe and effective.

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FDA’s proposed regulatory revision was the result of three notifications submitted to the agency under the Federal Food, Drug, and Cosmetic Act.

The first notification referred to by FDA was the so-called seafood processors notification - which included the companies Alaska General Seafoods, Ocean Beauty Seafoods, and Trans-Ocean Products. The second notification was submitted by Martek Biosciences Corporation, while the third notification came from Ocean Nutrition Canada.

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Coast Independent Review Board, of Colorado Springs, was recently snared when undercover federal investigators created a sham medical study to see how closely companies like Coast evaluate the studies they are paid to review. Two of Coast’s competitors refused to approve the study’s design. But Coast approved a trial, involving a make-believe surgical product called Adhesiabloc and researchers who did not exist.

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In documents Pennock obtained as part of the lawsuits, the most serious of the possible conflicts detailed involves Armenteros.

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"How can someone sit as chair of an FDA advisory committee crucial to AstraZeneca and Seroquel for five years even though he was an extensively trained speaker for AstraZeneca on Seroquel?" asked Pennock, a lawyer for the New York firm Weitz & Luxenberg.

The revelations come amid intense scrutiny of the FDA and of relationships between researchers and drug companies.

"The industry is infected with greed," said Sheller, who runs the Philadelphia law firm that bears his name. "You can't trust the approvals, you can't trust the studies, and now you can't trust the FDA."

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However, general manager of Big Tree Organic Farms Wendy Larson told FoodNavigator-USA.com that she believes “it is the end of the line for unpasteurized almonds” and criticized those that raised the case for being under-involved in the discussion process.

“There were numerous discussion and education opportunities presented to the entire almond industry – organic included – well in advance of the mandatory pasteurization rule being put in place and that was the time to iron out concerns,” she said. “It’s time for them to come back to the conference table and participate in innovation.”

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There are also concerns about the cost of pasteurization, its availability, and how acceptable it is to consumers who prefer organic produce.

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The primary reasons for passing this law are two isolated outbreaks of salmonella, in conjunction with conventional almond farms a few years ago. To the best of our knowledge no salmonella outbreaks have EVER been associated with organic almonds.

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This means that the Almond farmer will have to truck thousands of pounds of almonds to one of the five facilities that are already set up for the pasteurization process and then truck them back again to the processing plant.

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Besides having a vital part of our food supply pasteurized--against our will, it will now have a huge cost attached to it.

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“it is the end of the line for unpasteurized almonds”

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The problem is the law has been passed with little public input (if any) or notification whatsoever.

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“It’s time for them to come back to the conference table and participate in innovation.”

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In addition, all pasteurized almonds available in the marketplace will still be labeled as raw almonds. Can this be considered fraudulence or an outright lie?

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The Centers for Disease Control (CDC), in response to major evidence of an alarming link between mercury in vaccines and autism a number of years ago, went to great lengths to cover it up and fund a new study designed to rule out mercury’s link to autism.

It made its database available to a private company, kept it from independent researchers, and to prevent financial losses to vaccine manufacturers, the CDC and FDA bought up large supplies of mercury-containing vaccines for export to developing countries as they prepared to phase them out here. Robert F. Kennedy, in a piece published in Rolling Stone a number of years ago exposed a level of corruption that shocked even me; the story is available online for those interested.

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Sandpoint, ID–Congressional investigators and federal health officials have
secreted a report prepared by experts proving vaccine mercury is harming
children far worse than previously known. The “Thimerosal VSD Study: Phase I”
document was secreted in 2000, and subsequent congressional hearings and news
reports neglected it.

The study, conducted by scientists commissioned by the Centers for Disease
Control (CDC), shows statistically significant links between vaccine-injected
mercury and “neurological developmental disorders” including misery,
depression, and suicide. Additional links to autism were strongly suggested by
the data that heavily discourages the use of the drug Thimerosal containing
mercury used for vaccine sterility.

The official documents marked “CONFIDENTIAL . . . DO NOT COPY OR RELEASE” were
obtained by class action attorneys through Freedom of Information petitions
and posted this week on the Internet attached to a filmed commentary by public
health expert, Dr. Leonard G. Horowitz. The iMovie is viewable on YouTube.

“This is an obvious vaccination genocide,” Dr. Horowitz said. He called it
“gross criminal negligence and murderous official malfeasance” that the report
was secreted by congressional investigators and public health protectors.
“These traitors have purposefully manipulated and impaired millions of
American children, and the economic burden of caring for their special needs
with be catastrophic.”