The Irish Catholic children’s home scandal–it’s NOT about vaccines

children-at-st-marysThere’s an appalling story out of Ireland that has dominated the news for the past few days. Over a period of 35 years, St Mary’s Mother and Baby Home, a Catholic home for unwed mothers in County Galway (on the west coast of Ireland), apparently buried some children in a sewer system after dying in that home. You might have heard from some irresponsible journalists that over 800 children were buried in the septic tank, without questioning whether 800 bodies could actually be buried in the septic system, and without determining when the home was moved to a County sanitary sewer system, making it impossible to dump dead children in the septic tank. OK, that’s a small point.

According to the individual who actually uncovered this atrocity, Catherine Corless, an academic historian, she claims, through her research of birth records and other information, around 800 children died at this home over 36 years. The Irish Times reports, “between 1925, when the home opened, and 1937 the tank remained in use. During that period 204 children died at the home. Corless admits that it now seems impossible to her that more than 200 bodies could have been put in a working sewage tank.” OK, it’s sad and maddening that 22 children died every year at this home, even if infant mortality rates were substantially higher back then because of malnutrition and vaccine preventable diseases (like measles, mumps, polio, rotavirus and others) that would run rampant through closed quarters like that.

So the first myth we need to debunk is that there are 800 bodies buried in a septic tank–there aren’t. But, like I’ve said, that’s really just a minor point (setting aside the atrocity itself, which we’ll address later), because there are some other issues that have arisen with this story that also need to be discussed honestly. Continue reading “The Irish Catholic children’s home scandal–it’s NOT about vaccines”

FDA approves first vaccine to prevent H5N1 avian influenza

H1N1_versus_H5N1_pathologyOn 22 November 2013, the US Food and Drug Administration (FDA) announced that GlaxoSmithKline’s vaccine against H5N1 avian influenza was approved for use should the virus threaten to become epidemic in human populations. GSK’s Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, has also received regulatory approval  in Europe and Canada under the brand names, Pumarix™ and Arepanrix™ H5N1, respectively. Though it is not available for commercial use, the vaccine will be added to the national stockpile and distributed by public health officials if such an epidemic were ever to arise.

“This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the globe,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic.”

The evaluation of safety compared approximately 3,400 adults 18 years of age and older who received the vaccine to about 1,100 adults who received placebo in a multi-center study (a type of study that can be ethically performed when the risk of the preventable disease is expected to be near 0 during the time of trial). The most common side effect reported during the clinical studies among the vaccine recipients was injection site pain. Muscle aches, headache, fatigue and injection site redness and swelling were also common, but no serious side effects were observed. To determine the effectiveness of the vaccine, the immune response was evaluated in about 2,000 of the vaccinated adults. The results of the study established that approximately 91% of individuals between the ages of 18 and 64 years and 74% of individuals 65 years and older who received the two-dose regimen developed sufficient levels of antibodies that would prevent infection by the disease.

According to the Centers for Disease Control and Prevention (CDC), the H5N1 influenza has relatively rare. The CDC has reported that more than 600 human H5N1 cases have been reported to the World Health Organization from 15 countries in Asia, Africa, the Pacific, Europe and the Near East since November 2003.  Approximately 60 percent of individuals with documented H5N1 disease have died. Evidence has shown that the virus is highly pathogenic by causing a deadly pneumonia. In addition, there are several studies that have shown that H5N1 can be easily transmitted to humans from avian species through respiratory droplets.

The new vaccine, approved for use in people over the age of 18 who are at increased risk of exposure to the virus, is the first US-approved H5N1 vaccine that contains an adjuvant to boost the body’s natural immune response to the virus, and despite ongoing debate over the safety of such adjuvants, the new vaccine is “the first to show it can confer protection in the event of a pandemic,” Reuters reported.

This vaccine will save lives, many lives, in case of an avian flu epidemic. 

If you need to search for scientific information and evidence about vaccines try the Science-based Vaccine Search Engine.

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Court says Freedom of Speech applies to Big Pharma Sales Reps

pills and pill bottlesIn a strange decision, the United States 2nd Circuit Court of Appeals, which has jurisdiction over  ConnecticutNew York, and Vermont, ruled that a drug sales representative who promotes “off-label” uses of a particular drug is exercising their “freedom of speech.” The Court decided in a 2-1 vote, in United States v. Caronia (pdf), that the criminal conviction of Alfred Caronia, a former sales representative for a pharmaceutical company, be vacated. The case was an appeal of the sales representative’s conviction for promoting an off-label use of the drug Xyrem, which is approved for treatment of narcolepsy. The Court stated that “we construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.”

The Court also found that the FDA allows off-label use by physicians, but “prohibits the free flow of information that would inform that outcome,” while “the government’s prohibition of off-label promotion by pharmaceutical manufacturers provides only ineffective or remote support for the government’s purpose.” The Court also ruled that it construes “the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.”  It also stated “that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” Continue reading “Court says Freedom of Speech applies to Big Pharma Sales Reps”

GlaxoSmithKline fined $3 billion by FDA for improper marketing and unethical behavior

Recently, the US Department of Justice ordered the pharmaceutical giant, GlaxoSmithKline (GSK), to pay $3 billion in criminal and civil liabilities in the largest healthcare fraud settlement in US history. Basically, GSK was caught promoting several drugs for unapproved uses, failing to report safety data, paying kickbacks to physicians, and price reporting. Let’s look at the fraud charges one by one.

Unapproved uses (or off-label uses). By law, pharmaceutical companies are only allowed to market drugs according to what is stated in their package labeling which is approved by the FDA. Off-label uses are the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. Physicians are legally allowed to prescribe drugs off-label (as long as it is not contraindicated), but the pharmaceutical company cannot directly or indirectly influence off-label use. In most cases, off-label use isn’t dangerous, nor is it particularly unethical.

GSK was accused of unlawfully promoting Paxil, an antidepressant, for treating patients under the age of 18, even though it lacked FDA approval for pediatric use. GSK participated in “preparing, publishing and distributing a misleading medical journal article that misreported a clinical trial of Paxil that demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.” What was most troubling was that GSK did not balance its study with data from two other studies in which Paxil failed to demonstrate efficacy in treating depression in patients under 18. Typical of this type of marketing, GSK sponsored dinners, lunches, spas, and similar types of programs to promote the off-label use of Paxil in children. It’s also important to note that Paxil includes a “black box warning“, the strongest FDA warning for a pharmaceutical product, that states that antidepressants make increase suicidal ideation and behavior in patients under 18. Continue reading “GlaxoSmithKline fined $3 billion by FDA for improper marketing and unethical behavior”