FDA Out of Order

The meager changeFDA glass the FDA is offering now regarding generic drug regulation is far too little to late to help people who have suffered and continue to suffer the enormous injustice of five judges on the high court who have left them no remedy for their injuries. The impossibility defense that the generic drug companies offered in Mensing and Bartlett doesn’t begin to pass the smell test, as judges from the minority made very clear in their dissent in both those cases. It boggles the mind that the Supreme five can let generic drug companies enjoy billion-dollar profits with virtually no accountability. That situation does not obtain in any other industry, and it is particularly absurd and unjust when it comes to drugs that the FDA recommends people take; the agency promotes generic drugs on its web site, yet fails to do all it can to hold generic drug companies responsible when the drugs they make injure people.

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Drug Hazards emerge late

Serious Safety Hazards often Take Years to Emerge

A Public Citizen report today points out that many of a given drug’s side effects are not discovered until several years after the drug has been on the market.

Reglan (generic: metoclopramide), for one, was on the market for nearly 30 years – its brand version had become virtually unavailable – before it received a black boxed warning in 2009, too late to warn hundreds of people who had already contacted the incurable movement disorder of tardive dyskinesia.

Reglan is far from alone.  “At least 53 drugs approved by the Food and Drug Administration (FDA) more than 10 years ago have required new black-box warnings over the past five years,” says the new Public Citizen report.

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ARBs Cancer Link: FDA Dispute

Bucking his superior at the FDA, a senior regulator is questioning the safety of the top-selling class – ARBs (angiotensin receptor blockers) – of blood pressure drugs.

Patients take these medicines daily in hopes of reducing their risk of heart attack, stroke and heart failure. ARBs on the market in the U.S. include candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), telmisartan (Micardis), valsartan (Diovan), losartan (Cozaar), and olmesartan (Benicar).

Dr. Thomas A. Marciniak of the FDA is seeking stronger warnings about these drugs, according to internal documents reviewed by The Wall Street Journal and printed in that publication Saturday.

Dr. Marciniak argues that the drugs – which generated $7.6 billion in U.S. sales in 2012 – may be linked to higher cancer rates. He is not alone in his view, but a top FDA official disagrees, saying evidence does not support a link.

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Medtronic cooks Books

Medtronic has almost developed a corporate motif for its cooking the research books to reflect kindly on its own products. U.S. Senate investigators in Oct. 2012 said Medtronic paid doctors to manipulate Infuse studies to present Infuse as safer than it really is. In 2011,  Medtronic agreed to pay $23.5 million to settle accusations that it paid doctors in a kickback scheme to implant Medtronic pacemakers and defibrillators.

Medtronic was charged by the government with causing false claims submissions to Medicare and Medicaid. The scheme was proliferated by Medtronic’s using two post-market studies and two device registries to pay doctors illegal kickbacks.

In this kickback scheme, according to the Associated Press, Medtronic paid doctors roughly $1,000 to $2,000 a patient. The Feds contended  Medtronic had solicited physicians for post-market research studies in order to prompt the doctors into using Medtronic devices. Postmarket studies are intended to assess medical devices or drugs after they have been approved by the Food and Drug Administration.

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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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GE Infant Warmer Recall

The U.S. Food and Drug Administration (FDA) has announced a Class I recall for GE Healthcare’s resuscitation unit with blender, used with GE’s Giraffe and Panda infant warmers. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”

The FDA web site reports: “The field upgrade kit for GE Healthcare’s resuscitation unit with blender, used with GE’s Giraffe and Panda infant warmers, may impact patient safety. The oxygen and air wall inlet fittings and/or labels on the back panel may have been reversed during assembly. As a result, this could potentially reverse the air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. The settings of the blender knob would no longer be accurate.”

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Steroid leads to Meningitis

Fifteen people have died of fungal meningitis from a contaminated steroid lot, and nineteen more cases related to contaminated steroid injections were reported this week, bringing the national total to 233 in 15 states. The Centers for Disease Control and Prevention said the newly-reported cases are in nine states: Florida, 2; Indiana, 2; Maryland, 1; Michigan, 1; New Hampshire, 2; New Jersey, 2; Ohio, 2; Tennessee, 6; Virginia, 1. Twenty-five of the meningitis cases were previously reported in Tennessee, where more than 900 residents received the drug in the past three months. Other cases have been reported from North Carolina. All are linked to  steroid injections sold by the now-closed New England Compounding Center (NECC) in Framingham, Mass.  (USA Today story)

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Generic Drug recalled by FDA

On the heels of the five extremist judges on the Roberts’ Supreme court voting last summer to shield multi-national generic drug makers from injury lawsuits brought by Americans (Pliva v. Mensing) comes more evidence to show how ill-informed that decision was. The FDA last week asked Teva Pharmaceuticals to withdraw its generic drug Budeprion XL 300.  Testing showed this drug did not release its key ingredient in the expected amounts. Budeprion XL 300 is supposed to be equivalent to GlaxoSmithKline’s popular antidepressant Wellbutrin XL, which is prescribed to treat depression, anxiety and nicotine withdrawal.

Generic equivalency to brand name drugs is not a question the high court considered before ruling against citizens’ safety. It’s worth noting the FDA said this is only the third time in the last five years it has recalled a generic for equivalency issues, but many Americans know from experience that some generic drugs simply don’t work the same way or as well as the brand-name drugs. Nevertheless, insurance companies will often pay only for the generic if a generic is available. That means people are being forced to take a drug from a company that is no longer responsible for it. And eighty percent of the drug prescriptions filled this year were generic.

For more, see “Defective generic pill revives quality concerns” –  click here.

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BPA in Plastic a Toxic Brew

It took the FDA four years to finally ban a substance (BPA) in infant food packaging that has long been known to cause brain damage in developing infants and young children. Industry so controls the U.S. government agency that it took a lawsuit from the National Resources Defense Council to finally force the FDA to rule this summer to ban Bisphenol A (BPA) in infant food packaging. One can only wonder how many babies and infants were developmentally damaged in the interim. Because BPA is also known to cause hormonal problems and worse in adults, it is widely banned in most first-world countries; but in America, where FDA staff enjoy a revolving door relationship with industry, BPA is still widely used in many packaged goods.

The NRDC first filed a petition with the FDA in 2008 requesting that BPA be banned in food packaging, containers and any other material used  in packaged food. When the FDA failed to respond for two years, as required by law, the NRDC was forced to sue the agency in 2010. NRDC had to petition the court to demand a response. When the FDA finally did respond, in July 2012, it was forced to rule on the science and ban BPA from infant food packaging. Meanwhile, BPA is still free to disrupt adult hormones and damage adults’ health.

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Mirena IUD Problems

Mirena Overview

Classified by the FDAMirena Picture as a drug, Mirena is a contraceptive administered as a hormonal IntraUterine Device (IUD). It is inserted into the uterus as a long-term contraception.  Manufactured by Bayer Healthcare, Mirena was approved by the FDA on December 6, 2000 as a contraceptive. It is the only hormonal IUD that has FDA approval. It was designed for long-term application.  After insertion, this T-shaped polyethylene device prevents pregnancy by releasing a synthetic version of progestin hormone for up to five years.  According to claims made by Bayer Healthcare, Mirena is more than 99% effective at preventing pregnancy, which would place it as one of the highest ranking contraceptives for effectiveness.  However, Bayer offers no data in support of this claim.  In October of 2009 Mirena was also approved for treatment of heavy periods involving heavy and excessive menstrual bleeding in women with at least one child birth.  As of 2011, more than 15 million women have used Mirena IUD

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