The FDA in Bed…

FDA corruption and Big Pharma, by Matt Carmody

fda-in-bed cartoon image
The FDA´s metamorphosis from the consumer protectors to the industry buddys…
Sources:
On Flickr®

Sign the Petition for Roche to cut Kadcyla Breast Cancer Drug Price

Roche: lower the cost of your breast cancer drug so public health services can afford it!

Care2-logo image
Roche: lower the cost of your breast cancer drug so public health services can afford it!

Text by Margaret Connolly

Thirteen years ago, a five-year old boy told me all he wanted for Christmas was, “Just one thing, Auntie Margaret: Five minutes with my mummy.”

It broke my heart – his wonderful mummy, Helen Mulhearn, had suffered an awful death 16 months before due to late-diagnosed breast cancer. At that time there were not many drugs that could have helped her. Then four and a half years ago, I was found to have breast cancer too. I was lucky – I was diagnosed early, and with standard breast cancer suitable for a drug that cost just pennies, thank God.

A new drug developed by Roche, one of the biggest pharmaceutical gains in the world, could help these young women with advanced breast cancer — but Roche has priced the drug at £90,000, out of reach of both England and Scotland’s public health services. When asked why this drug was so expensive, Jennifer Cozzone — the head of pricing at Roche — actually said it reflects the “value” to the patient, effectively shutting out low-income patients!

Sign our Care2 petition today, and call on Roche to reduce the price of KADCYLA to a level that all public health services can cover! This drug should be available as a matter of course!

Sources and more information:
  • Roche: Lower the cost of your breast cancer drug so public health services can afford it!, Care2 Petition.
  • Petition Calls on Roche to Cut Breast Cancer Drug Price, medscape, October 22, 2014.

Did You make Your Medicine List?

We need safe and appropriate medicine use between consumers and healthcare providers

your medicine list poster
NCPIE created ”TAP” Month in 1986 as an annual observance to call attention to the need to stimulate and improve communication of information to promote safe and appropriate medicine use between consumers and their healthcare providers.
More information:
On Flickr®

Prenatal DES induces malformation of external genitalia of male and female mice in two generations

DiEthylStilbestrol transgenerational effects on the genital tract

Highlights:

Elsevier logo image
Prenatal DES exposure induces malformations of ExG in both sexes and strains of mice, and certain malformations are transmitted to the second-generation.
  • Objective criteria of prenatally DES-induced adult mouse hypospadias are presented for the first time.
  • The incidence of penile and preputial hypospadias was higher in C57BL/6 versus CD-1 mice consistent with enhanced estrogen sensitivity of C57BL/6 mice.
  • The incidence of urethral–vaginal fistula was similar in prenatally DES-treated mice of both strains.
  • Prenatally DES-induced male hypospadias and urethral–vaginal fistula were transmitted to second-generation mice.

Abstract:

Potential trans-generational influence of diethylstilbestrol (DES) exposure emerged with reports of effects in grandchildren of DES-treated pregnant women and of reproductive tract tumors in offspring of mice exposed in utero to DES. Accordingly, we examined the trans-generational influence of DES on development of external genitalia (ExG) and compared effects of in utero DES exposure in CD-1 and C57BL/6 mice injected with oil or DES every other day from gestational days 12 to 18.Mice were examined at birth, and on 5–120 days postnatal to evaluate ExG malformations.

Of 23 adult (>60 days) prenatally DES-exposed males, features indicative of urethral meatal hypospadias ranged from 18% to 100% in prenatally DES-exposed CD-1 males and 31% to 100% in prenatally DES-exposed C57BL/6 males. Thus, the strains differed only slightly in the incidence of male urethral hypospadias. Ninety-one percent of DES-exposed CD-1 females and 100% of DES-exposed C57BL/6 females had urethral–vaginal fistula. All DES-exposed CD-1 and C57BL/6 females lacked an os clitoris. None of the prenatally oil-treated CD-1 and C57BL/6 male and female mice had ExG malformations.

For the second-generation study, 10 adult CD-1 males and females, from oil- and DES-exposed groups, respectively, were paired with untreated CD-1 mice for 30 days, and their offspring evaluated for ExG malformations. None of the F1 DES-treated females were fertile. Nine of 10 prenatally DES-exposed CD-1 males sired offspring with untreated females, producing 55 male and 42 female pups. Of the F2 DES-lineage adult males, 20% had exposed urethral flaps, a criterion of urethral meatal hypospadias. Five of 42 (11.9%) F2 DES lineage females had urethral–vaginal fistula. In contrast, all F2 oil-lineage males and all oil-lineage females were normal.

Thus, prenatal DES exposure induces malformations of ExG in both sexes and strains of mice, and certain malformations are transmitted to the second-generation.

Sources

  • Prenatal diethylstilbestrol induces malformation of the external genitalia of male and female mice and persistent second-generation developmental abnormalities of the external genitalia in two mouse strains, ScienceIndex, stories/4604450, 18 Oct 2014.
  • Full text: Elsevier, article/pii/S0301468114000553, DOI: 10.1016/j.diff.2014.09.005.
More DES DiEthylStilbestrol Resources

Antibiotic Resistance Leaflet

Become an Antibiotic Guardian

antibiotic_resistance_leaflet image

antibiotic resistance leaflet image

Sources:

More information:
On Flickr®

Chest radiation to treat Wilms tumor childhood cancer increases risk of breast cancer later in life

Breast cancer in female survivors of Wilms tumor:
a report from the National Wilms Tumor late effects study

Wiley Online Library logo image
Breast cancer in female survivors of Wilms tumor: a report from the National Wilms Tumor late effects study

A new study has found that patients who received chest radiation for Wilms tumor, a rare childhood cancer, face an increased risk of developing breast cancer later in life due to their radiation exposure. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the findings suggest that cancer screening guidelines might be re-evaluated to facilitate the early diagnosis and prompt treatment of breast cancer among Wilms tumor survivors.

Wilms tumor is a rare childhood kidney cancer that can spread to the lungs. When this spread occurs, patients receive a relatively low dose of 12-14 Gray of radiation therapy to the entire chest. To see if such exposure to radiation affects patients’ risk of developing breast cancer, Norman Breslow, PhD, of the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle, led a team that studied nearly 2500 young women who had been treated for Wilms tumor during childhood and who had survived until at least 15 years of age.

Of female Wilms tumor survivors who received radiation to the chest, over 20% developed breast cancer by age 40 years (3/4 invasive, 1/4 non-invasive), in contrast to only 0.3% in female Wilms tumor survivors who did not receive radiation. The researchers also found an intermediate risk (4%) of breast cancer among female Wilms tumor patients who had received abdominal but no chest radiation as part of their treatment for Wilms tumor. The rates for females receiving chest irradiation, abdominal radiation and no radiation are nearly 30, 6, and 2 times those expected among women of comparable age in the general population. This high incidence of breast cancer, including invasive cancer, was an unexpected finding.

Current guidelines call for early screening for breast cancer among survivors of childhood cancer if they have received 20 or more Gray of radiation therapy to breast tissue. This would exclude a large majority of patients who had received whole chest radiation for Wilms tumor,” said Dr. Breslow. “Our results suggest that the risk of early breast cancer among Wilms tumor survivors is sufficiently high that early screening might be considered an option for them also.”

In an accompanying editorial, Jennifer Dean, MD and Jeffrey Dome, MD, PhD of Children’s National Health System in Washington, DC, noted that Wilms tumor survivors at high risk should undergo breast cancer surveillance with mammogram, breast MRI, or both starting at age 25 years. However, they pointed to research indicating that less than half of childhood cancer survivors considered to have a high risk for breast cancer follow through with surveillance guidelines. “Because compliance with breast cancer surveillance is low in adult survivors of childhood cancer, barriers such as education of both survivors and providers should be addressed and mitigated,” they wrote.

Sources and more information:

  • Chest Radiation to Treat Childhood Cancer Increases Patients’ Risk of Developing Breast Cancer,
    WileyCDA Press Release, October 27, 2014.
  • Breast cancer in female survivors of Wilms tumor: A report from the National Wilms Tumor late effects study,
    Wiley Online Library, DOI: 10.1002/cncr.28908, 27 OCT 2014.

Huh? What’s will All the Pink?

Pink Washing: a Cartoon by Dave Granlund

image of a Dave Granlund cartoon
Read #RethinkThePink: dealing with #PinkWashing during Breast Cancer awareness
Sources:
On Flickr®

Common mistakes to avoid with your prescription drugs

We need safe and appropriate medicine use between consumers and healthcare providers

In honor of Talk About Your Medicines Month, read up on common mistakes to avoid with your prescriptions.
  • You get the brand name over generic
  • You mix your meds with the wrong foods (or drinks)
  • You don’t check your Rx label at the pharmacy
  • You don’t talk to your pharmacist
  • You store your meds in the wrong spots
  • You don’t dispose of old meds properly

” you still need to be cautious when it comes to any drug…”

Sources and more information:

  • 6 Prescription Mistakes You’re Making,
    News.Health, October 8, 2014.
  • Talk About Your Medicines” Month, NCPIE, October 2014
  • Know Your Source: Protecting Patients from Unsafe Drugs,
    FDA ucm389121, 09/23/2014 .
  • BeMedicineSmart

La différence entre une diminution relative affichée et sa valeur absolue

Toujours se rapporter aux valeurs absolues pour évaluer l’efficacité d’un traitement ou d’un dépistage!

Toujours se rapporter aux valeurs absolues pour évaluer l’efficacité d’un traitement ou d’un dépistage!

Les promoteurs du dépistage affichent souvent un flamboyant chiffre de -30% de décès grâce au dépistage. Cela semble diablement efficace. Alors? Oui, mais ce qu’on oublie souvent de préciser, c’est que ce chiffre correspond à une diminution RELATIVE du taux de décès.

Regardez plutôt:

  • Sans dépistage, le taux de décès par cancer du sein dans la tranche d’âge 50-69 ans est de 3 décès pour 1000 femmes.
  • Avec dépistage, il n’est que de 2 décès pour 1000 femmes.
  • On a donc une diminution de risque de 3 à 2 ce qui fait bien une diminution relative de 30%.
  • Mais en valeur ABSOLUE, on passe de 3/1000 à 2/1000, donc une diminution de 1 décès/1000, soit en vérité 0,1%

Ce stratagème est très souvent employé par les laboratoires pharmaceutiques lorsqu’ils veulent convaincre les médecins peu regardant que leur nouveau médicament est super efficace…
Toujours se rapporter aux valeurs absolues pour évaluer l’efficacité d’un traitement ou d’un dépistage!

Drkalee et DrParagliding abordent les grandes lignes d’un problème extrêmement débattu ; le dépistage systématique (ou “aveugle”) de toute femme présumée sans risque connu de cancer du sein:

  • Qu’est-ce qu’un dépistage?
  • Avantages estimés du dépistage
  • Dommages possiblement liés au dépistage
    • Les risques de sur-diagnostic et de sur-traitement
    • Les fausses alertes
    • Les loupés du dépistage
    • Le risque de cancer radio-induits

Lisez Octobre Morose sur mg generation 2.0, oct 2013.
Les auteurs précisent que les personnes à risque – telles que fils/filles distilbène – ne sont pas concernées par l’article à titre personnel.

En savoir plus:
  • Surdiagnostic et dépistage du cancer du sein, Formindep.
  • La martingale du dépistage organisé, Formindep.

Early exposure to air toxics linked to childhood autism risk

Association of National Air Toxics Assessment Exposures and the Risk of Childhood Autism Spectrum Disorder

Researchers found that children highly exposed to two specific air pollutants - styrene and chromium - during their mother's pregnancy or up to the age of 2 years were more likely to have autism.
Pitt Public Health researchers found that children highly exposed to two specific air pollutants – styrene and chromium – during their mother’s pregnancy or up to the age of 2 years were more likely to have autism.

Children with autism spectrum disorder (ASD) were more likely to have been exposed to higher levels of certain air toxics during their mothers’ pregnancies and the first two years of life compared to children without the condition, according to the preliminary findings of a University of Pittsburgh Graduate School of Public Health investigation of children in southwestern Pennsylvania.

Abstract

Background:
Autism spectrum disorders (ASD) constitute a major public health problem, affecting one in every 68 children. There is little understanding of the cause of ASD despite its serious social impact. Air pollution contains many toxicants known to have adverse effects on the developing fetus.

Methods:
We conducted a population-based case control study in six southwestern PA counties estimating the association between ASD and USEPA census tract modeled NATA levels for 30 neurotoxicants. Cases were recruited from local ASD treatment centers. There were two different control groups:

  1. Interviewed controls with complete residential histories from pre-pregnancy through age two recruited through mailings using the Pennsylvania Department of Health birth registry (2005-2009).
  2. 5,007 non-interviewed controls from a random sample of the birth records using residence at birth.

Logistic regression analysis was conducted using quartiles of exposure, adjusting for age of mother, smoking, race, and education.

Results:
There were a total of 217 cases.

  • For the first group of 224 controls, median levels of chromium, styrene, cyanide, and polycyclic aromatic hydrocarbons were higher in cases compared to controls (p<.05). Women in the highest quartile of exposure to styrene had an odds ratio of 1.78 (95% CI: 1.035-3.068) of having a child with ASD compared to the lowest quartile, after adjustment for covariates.
  • In the second control group, each increase of interquartile range exposure to cyanide resulted in a 16% higher odds (95%CI; 1.04-3.46) of ASD in the adjusted logistic model. Additionally, women with the highest quartile of exposure to chromium had 1.65 (95%CI; 1.10-2.47) times the odds of having a child with ASD compared to the women in the lowest quartile of chromium exposure.

Conclusions:
Chromium, cyanide and styrene exhibited elevated odds ratios using two different control groups. These findings need to be verified with exposure assessment at the individual level.

Sources and more information:
  • The Association of National Air Toxics Assessment Exposures and the Risk of Childhood Autism Spectrum Disorder: A Case Control Study, American Association for Aerosol Research, October 20, 2014.
  • Pitt Public Health Finds Association Between Air Toxics and Childhood Autism, UPMC/University of Pittsburgh Schools of the Health Sciences, Oct. 22, 2014.
  • Early exposure to air pollutants linked to autism risk, medicalnewstoday, Oct. 23, 2014.
  • Association between air toxics and childhood autism, eurekalert, Oct. 22, 2014.