Tag: FDA

The Dangers of Plastic Food Packaging : Food Additives and Child Health Statement

Chemicals in Food May Harm Children, Pediatricians’ Group Says

In their Policy Statement and Technical Report, the American Academy of Pediatrics is urging families to limit the use of plastic food containers, cut down on processed meat during pregnancy and consume more whole fruits and vegetables rather than processed food.

Such measures would lower children’s exposures to chemicals in food and food packaging that are tied to health problems such as obesity, Roni Caryn Rabin reports. Featured image credit Fernanda Rodríguez.

2018 Policy Statement Abstract

Our purposes with this policy statement and its accompanying technical report are to review and highlight emerging child health concerns related to the use of colorings, flavorings, and chemicals deliberately added to food during processing (direct food additives) as well as substances in food contact materials, including adhesives, dyes, coatings, paper, paperboard, plastic, and other polymers, which may contaminate food as part of packaging or manufacturing equipment (indirect food additives); to make reasonable recommendations that the pediatrician might be able to adopt into the guidance provided during pediatric visits; and to propose urgently needed reforms to the current regulatory process at the US Food and Drug Administration (FDA) for food additives. Concern regarding food additives has increased in the past two decades, in part because of studies in which authors document endocrine disruption and other adverse health effects. In some cases, exposure to these chemicals is disproportionate among minority and low-income populations. Regulation and oversight of many food additives is inadequate because of several key problems in the Federal Food, Drug, and Cosmetic Act. Current requirements for a “generally recognized as safe” (GRAS) designation are insufficient to ensure the safety of food additives and do not contain sufficient protections against conflict of interest. Additionally, the FDA does not have adequate authority to acquire data on chemicals on the market or reassess their safety for human health. These are critical weaknesses in the current regulatory system for food additives. Data about health effects of food additives on infants and children are limited or missing; however, in general, infants and children are more vulnerable to chemical exposures. Substantial improvements to the food additives regulatory system are urgently needed, including greatly strengthening or replacing the “generally recognized as safe” (GRAS) determination process, updating the scientific foundation of the FDA’s safety assessment program, retesting all previously approved chemicals, and labeling direct additives with limited or no toxicity data.

Significant decrease in testosterone therapy since 2013

Testosterone Prescribing in the United States, 2002-2016

Testosterone use in the United States tripled from 2001 through 2011, mostly in men without a clear indication.

In late 2013 and early 2014, two studies reported increased myocardial infarction and stroke associated with testosterone use.

The US Food and Drug Administration (FDA) issued a safety bulletin on January 31, 2014.

After a decade of growth, the percentage of US men receiving testosterone prescriptions decreased from 2013,  falling to less than 2% of men by 2016.

This prescribing trends study was published July 10, 2018.

Fake pills are now increasingly common in the United States

Fake And Faulty Drugs: A Problem No One Wants To Talk About

The explosion of Internet commerce, coupled with globalization and increased pharmaceutical use has led to an unprecedented vulnerability in the U.S. drug supply. Today, an estimated 80% of our drugs are manufactured overseas, mostly in India and China. Every link along this supply chain offers an opportunity for counterfeiters, and increasingly, they are breaking in. In 2008, fake doses of the blood thinner Heparin killed 81 people worldwide and resulted in hundreds of severe allergic reactions in the United States. In 2012, a counterfeit version of the cancer drug Avastin, containing no active chemotherapy ingredient, was widely distributed in the United States. In early 2013, a drug trafficker named Francis Ortiz Gonzalez was sentenced to prison for distributing an assortment of counterfeit, Chinese-made pharmaceuticals across America. By the time he was arrested, he had already sold over 140,000 fake pills to customers.

Even when the U.S. system works, as it mostly does, consumers are increasingly circumventing the safeguards. Skyrocketing health care costs in the U.S. have forced more Americans to become “medical tourists” seeking drugs, life-saving treatments and transplants abroad, sometimes in countries with rampant counterfeit drug problems and no FDA.

Could HPV vaccination play a role in the increase in the incidence of cervical cancer ?

Increased incidence of cervical cancer in Sweden : Possible link with HPV vaccination

Recently, when the Swedish media discussed the increase in the incidence of cervical cancer, the health authorities were unable to explain the increase.

2018 Study Abstract

The Centre for Cervical Cancer Prevention in Sweden has noted in its annual report a substantial increase in the incidence of invasive cervical cancer, especially during the two years 2014 and 2015. I have sub-grouped the data according to age, using the same statistical database of the National Board of Health and Welfare as used by the authors of the above-mentioned report. The increase in the incidence of cervical cancer was shown to be most prominent among women 20–49 years of age while no apparent increase was observed among women above 50. The FDA has noted in the clinical trials referred to it for marketing approval that women exposed to the human papilloma virus (HPV) prior to vaccination had an increase in premalignant cell changes compared with placebo controls. I discuss the possibility that HPV vaccination could play a role in the increase in the incidence of cervical cancer by causing instead of preventing cervical cancer disease in women previously exposed to HPV. A time relationship exists between the start of vaccination and the increase in the incidence of cervical cancer. The HPV vaccines were approved in 2006 and 2007, respectively and most young girls started to be vaccinated during 2012–2013.

Featured image credit ijme shows increase in incidence of cervical cancer among younger women (<50 years) as compared with women ≥50 years. The data shows the number of cases/100,000 women from 2006 to 2015.

Alex CanRant Unbelievable Story of DES

“I want to show you some of the stuff I’ve learned about what’s happening right now” says Alex

In this video published 15 Sep 2017, Alex unfortunately is mixing the use of DES for poultry, cattle, women, together with its side effects for up to three generations of people.
So, his dates are confusing and Alex’s very short summary of DES is quite one of his own.

Nevertheless Alex raises some very important questions here, and tells us not to take every medical/healthcare information for granted but to keep an open mind. So, we thank Alex for his time and effort in sharing awareness.

Check the links below to learn more.

More DES DiEthylStilbestrol Resources

FDA’s new drug approvals : is there evidence that the public is happy to sacrifice safety for speed ?

Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study

Most drugs today qualify for one of the FDA’s expedited pathways. But what is the evidence that the public is on board with the notion of sacrificing safety for speed?

What is already known on this topic
  • Recent legislation in America opens the possibility for the expansion and increased use of FDA expedited drug development and review pathways designed to respond to public health priorities
  • Evidence on whether drugs approved through expedited regulatory pathways carry higher levels of safety risks that are unknown at the time of approval is conflicting
  • Some studies suggest that the review process does not impact the quality of the safety assessment, whereas others show a difference
What this study adds
  • In this analysis concerning more than 15 years of comprehensive data, expedited pathway drugs had a 38% higher rate of safety related label changes than drugs approved through non-expedited pathways
  • As policymakers continue to expand expedited regulatory pathways, physicians and patients should be aware of the potential safety trade-offs involved in these pathways

2017 Study Abstract

Objective
To determine if drugs approved through the Food and Drug Administration’s expedited development and review pathways have different rates of safety related label changes after approval compared with drugs approved through standard non-expedited pathways.

Design
Retrospective cohort study.

Setting
FDA public records, January 1997 to April 2016.

Participants
382 FDA approved drugs.

Main outcome measures
The number of times a particular safety section of a label (boxed warning, contraindication, warning, precaution, or adverse reaction) was changed during a drug’s time on the market. The relative rate of safety related label changes per year for expedited pathway and non-expedited pathway drugs was compared by forming matched pairs of drugs in the same therapeutic class that were approved within three years of each other.

Results
Among the 382 eligible new drugs, 135 (35%) were associated with an expedited development or review pathway, and matches were available for 96 (71%). The matched pairs were associated with a total of 1710 safety related label changes during the study period. Expedited pathway drugs were characterized by a rate of 0.94 safety related label changes for each drug per year, compared with 0.68 safety related label changes per year for non-expedited pathway drugs (rate ratio 1.38, 95% confidence interval 1.25 to 1.52). Compared with non-expedited pathway drugs, expedited pathway drugs had a 48% higher rate of changes to boxed warnings and contraindications, the two most clinically important categories of safety warnings (1.48, 95% confidence interval 1.07 to 2.06). A qualitative review of changes to the boxed warning sections revealed that less than 5% (3/67) were changed to describe reduced risks for patients.

Conclusions
Expedited development and regulatory review pathways can accelerate the availability of new drugs, but drugs approved through these pathways are associated with increased safety related label changes after approval, particularly for the types of changes representing the highest risk warnings. To inform appropriate policy interventions, additional research should explore the causal factors contributing to these different rates.

More Information

  • Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study, BMJ 2017;358:j3837, 07 September 2017.
  • Speed vs safety in the FDA’s new drug approvals—speed wins, again, blogs.bmj, September 12, 2017.
  • Featured image credit stickergiant.

How big data’s big bias is bringing noise and conflicts to US drug regulation

Jeanne Lenzer investigates, The BMJ, July 2017

A little known private foundation to support FDA’s “regulatory science” takes money out of the FDA’s coffers to support analyses using levels of evidence recommended by industry; many of the foundation’s directors have financial links to the drug and device makers that the FDA regulates.

Overview
  • No drug risks identified
  • Reagan-Udall Foundation
  • Directors’ ties to industry
  • Panel stacking
  • Funding the foundation
  • Funding the Medical Evidence Development and Surveillance (IMEDS)
  • Light touch FDA

“Big data can be used cautiously to examine real world outcomes and to improve surveillance of drug safety. For example, it has been used to identify overuse of some interventions and can show drug and device complications in real world settings rather than idealized controlled trials.

However, big data are a noisy mess, and analyses by entities with profit motives may identify spurious associations that support fast track approvals and indication creep (broadening the indications for drugs and devices).” …

…continue reading Jeanne Lenzer investigation Big data’s big bias: bringing noise and conflicts to US drug regulation on The BMJ, 18 July 2017.

About The Personal Care Products Safety Act

Bill would help protect consumers from chemicals that disrupt hormones

Endocrine Society applauds new push to regulate chemicals in personal care products

Washington, DC – The Endocrine Society praised the reintroduction of a Senate bill to ensure consumers are protected from hazards associated with exposure to chemicals in personal care products such as cosmetics and lotions.

The Personal Care Products Safety Act, co-sponsored by U.S. Sens. Dianne Feinstein and Susan Collins, would set a rigorous safety standard for personal care products and provide the public with more information about the chemicals in the products they are purchasing. This is an area of concern for the Society and its 18,000 members, including researchers studying how endocrine-disrupting chemicals (EDCs) disrupt the body’s hormones.

An EDC is a chemical or mixture of chemicals that can cause adverse health effects by interfering with hormones in the body. There are more than 85,000 manufactured chemicals, of which thousands may be EDCs. EDCs are found in everyday products and throughout the environment.
The evidence is more definitive than ever before that EDCs disrupt hormones in a manner that harms human health. EDC-related health outcomes include male reproductive disorders, premature death, obesity and diabetes, neurological impacts, breast cancer, endometriosis, female reproductive disorders, immune disorders, liver cancer, osteoporosis, Parkinson’s disease, prostate cancer and thyroid disorders.

The Personal Care Products Safety Act calls for some chemicals found in shampoo, deodorant, cosmetics and other personal care products to be reviewed for safety for the first time. The Society applauded the bill’s inclusion of propyl paraben, a potential EDC linked to reproductive disorders, as one of the first five chemicals slated for review.
By providing the necessary authority and fees for the FDA to properly regulate personal care products, the Society believes that this legislation will effectively and efficiently ensure a safer marketplace for personal care products and reduce harms from exposure to EDCs and other toxic chemicals.

Sources and Press Releases

  • Endocrine Society applauds new push to regulate chemicals in personal care products, TheEndoSociety, May 15, 2017.
  • Senators Seek Enhanced Safety Looks at Cosmetic Ingredients, promomarketing, May 15, 2017.
  • Personal Care Products Safety Act Would Improve Cosmetics Safety, ewg.
Endocrine Disruptors

Why Dissent Matters

Because Some People See Things the Rest of Us Miss

The thalidomide tragedy was averted in the United States because Dr. Kelsey, alone and in the face of fierce opposition, did her job. Her perspective was educated, fresh and unique. If there had been no thalidomide crisis, the United States, with the rest of the world following, would still at some time have brought pharmaceutical regulation into the 20th century. But thalidomide created one of those moments when something had to be done. It could not be ignored in 1961-62, and it led immediately to a better and stronger regulatory system. Maybe someone else would have stopped thalidomide in the United States had Dr. Kelsey not been assigned the NDA, but, interestingly, no one else stopped it anywhere else until it was too late. Dr. Kelsey was the only person in the entire world who said no. She said no to a bad drug application, she said no to an overbearing pharmaceutical company and she said no to vested interests who put profits first. She was one brave dissenter. In the end, the question is not what made Frances Kelsey, but why aren’t there more like her?

Because Some People See Things the Rest of Us Miss

The nature writer Rachel Carson identified an emerging environmental disaster and pulled the fire alarm. Public protests, individual dissenters, judges, and juries can change the world – and they do.

A wide-ranging and provocative work on controversial subjects, Why Dissent Matters tells a story of dissent and dissenters – people who have been attacked, bullied, ostracized, jailed, and, sometimes when it is all over, celebrated.

William Kaplan shows that dissent is noisy, messy, inconvenient, and almost always time-consuming, but that suppressing it is usually a mistake – it’s bad for the dissenter but worse for the rest of us. Drawing attention to the voices behind international protests such as Occupy Wall Street and Boycott, Divest, and Sanction, he contends that we don’t have to do what dissenters want, but we should listen to what they say. Our problems are not going away. There will always be abuses of power to confront, wrongs to right, and new opportunities for dissenting voices to say, “Stop, listen to me.” Why Dissent Matters may well lead to a different and more just future.

Read This is Dr. Frances Kelsey’s story, the globe and mail, MAY 11, 2017.

Drugs stalled at FDA far more likely to have unpublished trials than licensed ones: 46% vs 10%

Nonpublication of Trial Results for New Neurological Drugs: A Systematic Review

May 2017 Study Abstract

Objective
To evaluate nonpublication rates among trials of new successful and unsuccessful neurological drugs – A Systematic Review.

Methods
‘Licensed’ drugs consisted of all novel agents receiving FDA licensure 2005 to 2012 inclusive in seven neurological disorders. ‘Stalled’ drugs included all experimental agents tested in the same domains that had at least one completed phase III trial in the same timeframe but failed to receive FDA approval. Trials of these drugs were included in our sample if their primary outcome collection occurred before October 1, 2010. We determined the publication status of eligible trials using searches of clinicaltrials.gov, Google Scholar, PubMed, Embase, sponsor websites, and direct electronic query of trial contacts and sponsors. The primary outcome was time to journal publication (or results reporting in other media) after study completion.

Results
The adjusted hazard ratio for publication was 1.79 (95% confidence interval 1.20 to 2.67) in favour of licensed drugs. Based on the criteria for nonpublication in this report, 14,092 and 33,882 volunteers participated in unpublished trials of licensed and stalled neurological drugs, respectively. Result data were not publicly available in any form for 10% (16/163) and 46% (94/203) of trials of licensed and stalled drugs, respectively.

Interpretation
Results of trials for stalled drugs are heavily underreported. This deprives research and care communities of evidence about pathophysiology, drug class effects, and the value of surrogate endpoints in trials.