Flu Shot Blues

Many people distrust vaccination shots and avoid them entirely if they can. Others believe in the vaccine jab and get vaccinated every year before flu season. The question remains: Do flu shots work? Is the benefit worth the risk?

The answer would depend on the vaccine batch or batches produced in a given year. It would depend on what given group of people we are discussing. Batches vary yearly, and flu vaccine effectiveness varies accordingly. Recent reports show the 2012-13 flu vaccine protected only nine (9) percent of the elderly. How many of the elderly did the vaccine harm? Did the risk-benefit analysis of the 2012-13 vaccine render it worth taking for the nine percent of the elderly whom it reportedly helped? Does the risk-benefit add up for children or adolescents or young or middle-aged adults? What, exactly, IS the risk-benefit analysis for any vaccine batch and for any group of people? We don’t know the answer. We do know that most of the vaccine studies are done by Big Pharma concerns that generate billions of dollars in profits on vaccines, and we know that the vaccine studies which they fund tend to favor vaccines as a helpful option worth the risk of “side effects.”

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Januvia, Byetta cause Pancreatitis

According to the study assorted medicine with money with spoonpublished on Feb. 25, 2013 in the JAMA Internal Medicine journal, patients taking Januvia or Byetta were twice as likely as those who took other drugs to end up hospitalized with a potentially fatal inflammation of the pancreas known as pancreatitis. Pancreatic lesions and inflammation, research found, can be caused by the drugs. (See the Fierce Pharma story)

Pancreatitis can lead to more serious problems such as pancreatic cancer and kidney failure.

The oral medication Januvia (sitagliptin) and the injectable Byetta (exenatide) can both increase amounts of GLP-1, a hormone in the body that stimulates the pancreas to produce insulin. The pancreas also produces digestive enzymes that, if activated before leaving the pancreas, can literally digest organ tissue and cause inflammation, abdominal pain, fever, nausea.

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Is Bayer Bee Killer?

Scientists across Bayerthe globe have searched for years to find out what is killing off the bees on which humanity as well as animal and plant life depend for  survival. Bees pollinate most of what ends up in our diet, and their mass deaths have made food more scarce and hence driven up food prices. Many scientists feel that microwave radiation, which now emanates all over the world from the telecommunications industry, is the main culprit. Many other scientists feel the main killer is Bayer, the pharmaceutical giant that manufactures neonicotonoids – which are pesticides decimating life as we know it.

Bayer has spent millions on Junk Science trying to prove its neonicotonoid pesticide is not responsible; but an abundance of evidence makes it clear that the German giant needs to do the responsible thing for our long-term survival, not continue to poison our food pollinators for short-term company profits. Please take action by reading and following the relevant links from Roots Action printed here:

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FDA Duplicity: Generic Promo

The Cost of FDA Promotion

In a Feb. 21, 2013 web site article titled “Generic Drugs: Same Medicine, Lower Cost,” the FDA promotes the use of generic drugs; but the article also hides a dirty little secret: The FDA  fails to hold generic drug makers accountable when they are found to cause life-altering “side effects.”

The FDA fails utterly to protect consumers from dangerous generic drugs in the same manner in which the law protects consumers from brand-name drugs. You read that right. If you take a brand-name drug and suffer some horrible, life-altering “side effect,” such as, for example,  tardive dyskinesia (in the case of Reglan) – a debilitating nerve disorder for which there is no known cure – and you were given the brand-name drug by your pharmacist, you have a chance to face that drug’s maker in court and receive compensation for your injuries. If, on the other hand, you were given metoclopramide, the generic version of that same drug and you developed tardive dyskinesia as a result (as fully one in five people can), then you are likely to receive nothing. (See Pliva v. Mensing )

The FDA has the ability to do something about this miscarriage of justice, which occurred when the Supreme Court voted 5-4 in 2011 to insulate generic drug makers from liability when their drugs injure people. (see Alliance for Justice story). Writing for the majority, Clarence Thomas dispensed this pearl: “As always, Congress and the FDA retain the authority to change the laws and regulations if they so desire.”

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NJ Mesh Jury Verdict: $3.35 million

A NJ jury reached a johnson-johnson-pharmaceutical-research-development-logoverdict in favor of a 47-year-old South Dakota woman today for $3.35 million for compensatory damages. The court is deciding now whether to go into the punitives phase in the case.

Linda Gross sued Johnson & Johnson after she required 18 revision surgeries to repair damage wrought by J& J transvaginal mesh which was implanted in her in 2006 to repair pelvic organ prolapse. Her trial against NJ-based J & J lasted nearly a month, beginning Jan. 10 in Superior Court in Atlantic City. The jury deliberated for three weeks before reaching its verdict.

Update: The verdict is on appeal; so no recovery has been made despite the verdict.

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NRDC fights Pebble Mine

The National Resources Defense Council (NRDC) announced today that thanks to donations from thousands of concerned supporters, a hard-hitting ad against the Pebble Mine – featuring NRDC Trustee Robert Redford – just appeared in The Washington Post. The NRDC is now calling for more support to run the ad in more media outlets to build pressure on President Obama to stop the disastrous project.

The ad asks President Obama to prevent the destruction of Alaska’s spectacular Bristol Bay by stopping the disastrous Pebble Mine.

The ad had an impact inside Washington, according to NRDC sources at the White House, in the EPA and on Capitol Hill.

According to NRDC, “The mining giants have launched a blitz of disinformation, whitewashing their monstrous project and attacking the EPA. They’re hoping to freeze the White House into inaction.”

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Fosamax Trial win for plaintiff

Plaintiffs won their second bellwether trial to date against Merck Pharmaceuticals, the maker of Fosamax. Merck has won most Fosamax trials so far, but it faces another 800 lawsuits in state and federal courts alleging a link between Fosamax and femur fractures.

Reuters reported on Feb. 5, 2013 that an eight-person federal jury awarded plaintiff Rhoda Scheinberg $285,000 in her Fosamax lawsuit. Ms. Scheinberg alleged Fosamax was a defective product and that it caused her jaw bone disease following dental surgery. The jury rejected the argument that Fosamax is defective, but it did find that Merck failed to adequately warn of Fosamax’s associated risks.

Merck has won five of seven Fosamax cases so far. Plaintiff Shirley Boles (Boles v. Merck & Co., Inc., 06-cv-09455) was awarded $8 million in her lawsuit which alleged Fosamax caused her to develop osteonecrosis of the jawbone. A judge later reduced the award to $1.5 million. Boles consequently filed another lawsuit, which concluded – according to Law360 (9/18/12) – when Merck and Boles reached a deal, though the company said the deal was not considered a settlement.

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Infuse trouble off-label

Mectronic’s Infuse might be effective in the one surgical use for which it was approved by the FDA – in the lumbar spine for single-level, frontal approach fusion surgeries – but its off-label use has caused serious, sometimes life-threatening problems.Infuse Image

Infuse is the trade name for bone morphogenetic protein – or BMP-2 – which is packed inside a thimble-sized (LT) cage implanted in a patient to encourage bone growth. The problem is that Medtronic aggressively moved to market Infuse for many off-label uses without first doing the proper research to ensure that Infuse would work for those uses.

Medtronic’s Infuse hit national news in October 2012 when a U.S. Senate investigation referenced Medtronic’s paying 13 doctors $210 million to manipulate data in order to profit from expanded applications of the product despite limited FDA approval.

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First Actos Trial set for March

Matthews & Associates and Freese & Goss law firms’ continue to aggressively litigate their Actos cases.  Richard Freese and his associates are busy taking depositions and reviewing thousands of pages of documents to build the strongest possible case against Actos’ maker Takeda Pharmaceuticals. takeda logo

The firms have also been busy defeating several important motions, positioning our cases for the best possible result.  We have filed numerous, to date, in the Circuit Court of Cook County, Illinois, as well as in the Circuit Court in St. Louis, Missouri.

Additionally, in the last few months Consumer Reports released a statement advising consumers that the risks of using pioglitazone (Actos) far outweigh its benefits.  Consumer Reports pointed to bladder cancer as one of those risks.  These statements, as well as the statements of other consumer advocacy groups, affirm our position in this litigation: that Actos causes bladder cancer and Takeda knew of this risk but failed to warn or disclose this information to the FDA.

As these cases continue to develop, we grow more and more confident in our ability to achieve desirable outcomes for our clients.  The firms’ first case is set for trial March 3, 2014.

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Lawsuit calls Zoloft a Fraud

Pfizer is being sued by a woman who says the company’s popular anti-depressant Zoloft doesn’t work. Plaintiff Laura A. Plumlee claims that the drug failed to work in the three years she took it. Her suit argues that patients who took Zoloft should be reimbursed for their costs.  (See AP story)

Pfizer Inc., the world’s biggest drugmaker, told the Associated Press last week that clinical studies and the experience of millions of patients and their doctors in more than two decades prove Zoloft effective. Pfizer called the lawsuit frivolous and was backed in the AP story by four psychiatry experts.

Plumlee’s attorney, R. Brent Wisner of the Los Angeles firm Baum Hedlund Aristei Goldman, argues that the FDA should not have approved Zoloft because Pfizer failed to publish the clinical studies that found Zoloft about as effective as a placebo.

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