EMA is wrong to recommend Mysimba drug (weight management in adults)

Prescrire denounces the unacceptable decision of the European Medicines Agency (EMA) to recommend that marketing authorisation be granted for the dangerous combination naltrexone + amfebutamone (Mysimba/Contrave)

Impending approval of a dangerous amphetamine drug for use in weight control? An unacceptable EMA recommendation that must be overturned.

Prescrire logo
Prescrire denounces the unacceptable decision of the European Medicines Agency (EMA) to recommend that marketing authorisation be granted for the dangerous combination naltrexone + amfebutamone (Mysimba/Contrave).

PRESS RELEASE – Paris, 19 December 2014.

” Today, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced its decision to recommend that marketing authorisation be granted for the combination naltrexone + amfebutamone (also known as bupropion) for use in weight control (MYSIMBA in the EU / CONTRAVE in other parts of the world), despite “uncertainties with regard to cardiovascular outcomes in the longer term”.

A major regression for European patients’ safety. Amfebutamone is an amphetamine drug, as is amfepramone. In 2000, the EMA withdrew the marketing authorisation of several appetite suppressants with a similar mechanism of action to that of amfepramone (clobenzorex, dexfenfluramine, fenfluramine, fenproporex, etc.), in order to protect public health (2). In 2009, sibutramine (Sibutral), an appetite suppressant structurally related to amphetamines, was also withdrawn by the EMA due to disproportionate and serious adverse drug reactions. And benfluorex (Mediator) was also withdrawn from the whole European Union market in 2010.

In addition, in 2013, the EMA rightly refused to authorise the dangerous fixed-dose combination phentermine + topiramate on safety grounds, and the application for the drug lorcaserin (Belviq) was withdrawn by the company following the CHMP’s “provisional opinion that Belviq could not have been approved for weight control in obese and overweight patients”. How is it possible that the CHMP now takes an incongruent decision on the fixed-dose weight-control combination naltrexone + amfebutamone (also known as bupropion) (CONTRAVE/MYSIMBA)?

Health authorities should learn from past public health disasters. A weight loss of a few kilograms achieved through drug therapy cannot in itself justify exposing obese or simply overweight patients to a disproportionate risk of adverse drug reactions, especially since the weight lost is very often regained within months of discontinuing treatment.

Health authorities should learn the lessons from past public health disasters, notably those due to several appetite suppressants subsequently withdrawn from the EU market for disproportionate and serious adverse drug reactions (sibutramine (Sibutral), benfluorex (Mediator), rimonabant (Acomplia)).

Prescrire urges national Drug Regulatory Agencies’ representatives with a seat at the CHMP and who voted against the recommendation on naltrexone + amfebutamone (CONTRAVE/MYSIMBA) to insist that patients’ safety be defended. Member States opposing the recommendation still can and should require arbitration by the European Commission and convene a standing Committee meeting. The EU Commission, as last gatekeeper, also has the possibility of deciding not to follow the CHMP’s  recommendation.

In 2015, weight-control medicines that do more harm than good should no longer be authorised in the European Union. ”

Sources and more information
  • Impending approval of a dangerous amphetamine drug for use in weight control? An unacceptable EMA recommendation that must be overturned, prescrire, 19 December 2014. See also the press release PDF.
  • Mysimba recommended for approval in weight management in adults, EMA, 19/12/2014. See also the press release PDF.
  • FDA approves weight-management drug Contrave, FDA news, September 10, 2014.

Dr. Patrick Soon-Shiong Cancer Genome Sequencing

Disrupting Cancer preview, Dec 2014

Already a billionaire for creating an innovative cancer drug, Dr. Patrick Soon-Shiong is turning heads with more unconventional ways of treating the disease he hopes to conquer.

More information
  • Disrupting cancer… 14:00 to 27:00 – the Preview: Disrupting Cancer video is via the 60 Minutes channel.
  • Read Disrupting Cancer, billionaire doctor fights cancer in unconventional way, cbsnews, Dec 07 2014.
  • Read Here Is What ’60 Minutes’ Didn’t Tell You About The Billionaire Who Is Trying To Disrupt Cancer Care, forbes, 2014/12/07.
  • Watch more research videos on our YouTube channel.

Say No to the Sandwich

Free Yourself from Drug Reps – the No Ads Please campaign

Doctors who see medical representatives are more likely to prescribe more medication, more expensively and less according to accepted guidelines. The No Advertising Please campaign encourages doctors to avoid using drug representatives as their “educational” resource, by pledging to not see drug reps at their practice for one year.

Say-No-Sandwich poster
Watch @DES_Journal diaporama and posters album on Flickr
a #NoAdsPlease poster by the @NoAdsPlease campaign.

Sources and more information

On Flickr®

Fertility Clinics in 2013-2015 HFEA Adverse Incidents Report

Lots of useful information brought together all in one place

The Human Fertilisation and Embryology Authority is the UK’s independent regulator overseeing the use of gametes and embryos in fertility treatment and research. The HFEA has released its report on adverse incidents that took place in fertility clinics over the 2013 calendar year.

Download our adverse incidents report for 2014 and for 2015.

HFEA incidents-report-2013 imahe
If you’re exploring fertility treatment, the HFEA is the first place to go for reliable information.

The HFEA report shows that a total of 516 incidents were reported, which is equivalent to less than one percent of the approximately 60,000 cycles of treatment that take place annually. Overall numbers of incidents have remained steady.

There were four ‘A grade’ incidents; 208 ‘B grade’ incidents; 262 ‘C grade’ incidents and 42 cases that were either later classified as near misses or not incidents. This means that ‘C grade’ incidents, the least severe category, represent the majority of all reported cases .

While recognising that the whole IVF sector should continue to report and learn from all incidents so that they can provide better, safer patient care, HFEA Chair, Sally Cheshire, has reiterated her specific call for clinics to reduce the number of ‘C grade’ incidents.

We remain committed to a reporting system that highlights what can go wrong and, most importantly, how clinics can improve care and safety for patients. After the last report, we told clinics that more must be done in particular to reduce the numbers of avoidable grade C incidents. While it is too early to see the full impact of that message, this 2013 report offers a great opportunity to firmly re-state that clinics must make a concerted effort to eradicate ‘C grade’ incidents.

Sending a letter to the wrong address, for example, may seem a small mistake at first glance, but the effect on the patient can be considerable. Clinics must ensure that their administrative and process errors become increasingly rare occurrences.”

‘A grade’ incidents are classified as the most severe. Four were reported in 2013:

  • A storage tank failed, which affected donor sperm samples belonging to 250 patients.
  • An equipment failure meant that embryos for seven patients did not progress as expected and therefore were not suitable for embryo transfer.
  • An affected embryo was replaced in error during a Pre-Implantation Genetic Diagnosis (PGD) .
  • A baby was born with a condition following the transfer of a frozen PGD embryo.
  • ‘B grade’ incidents are the middle category. Most clinical ‘B grade’ incidents relate to incidences of severe or critical OHSS, while non-clinical ‘B grade’ incidents include issues around consent and breach of confidentiality.

Director of Compliance and Information, Nick Jones, urged people to see this as an opportunity to share lessons learned, rather than for naming and shaming:

While the report honours our commitment to transparency, and making the best use of our world-leading data, it is not intended to be used for the naming and shaming of particular clinics. UK clinic staff are highly professional, and are often almost as devastated as the patient when a mistake occurs.

The best means of reducing mistakes is to create a culture of shared best practice and improvement. Clinics must do better, and this report can help them do so.”

The HFEA expects clinics to use this report in conjunction with the earlier 2010-2012 report, and to reflect upon their own practices. The HFEA will be sending a copy of this report to each licensed clinic.

Fracking prohibited in New York thanks to Governor Cuomo

New York Says No Fracking Way!

Governor Cuomo HVHF Cabinet Meeting image
Governor Cuomo held a Cabinet Meeting with members of his administration to provide an update on High Volume Hydraulic Fracturing (fracking) in New York State.

Long Island Lawyer
Paul A. Lauto, Esq.

In a surprise decision to many, Governor Cuomo has decided against hydrualic fracturing (fracking) in the state of New York. The decision has been approximately six years in the making, as detailed in our prior blogs

Governor Cuomo agreed with New York’s acting Health Commissioner Dr. Howard Zucker, who concluded that fracking has a potential widespread negative impact, prospects that are uncertain at best and economic advantages which are now far lower that originally anticipated. Dr Zucker continued by saying that he considered the people of New York to be his patients and that “We cannot afford to make a mistake. The potential risks are too great. In fact, they are not fully known.” Governor Cuomo stated, “I think it’s our responsibility to develop an alternative… for safe, clean economic development.” Although it appears that Governor Cuomo intentionally delayed promulgating his decision until after the recent elections, it is welcomed decision by many, both parties alike.

Perhaps the prevailing factor in this decision was of an economic nature. Recently, Arab countries jointly decided against cutting oil production in order to drive the falling prices of oil upward. This decision, although uncharacteristic in nature, was a well thought out and clever decision. Fracking is an expensive process that reportedly cost an estimated $75 per barrel for oil to produce. Now that oil is just under $60 per barrel on the market, fracking is quickly becoming cost ineffective. If oil prices continue to fall, we will likely see many of the approximate 35 states that currently allow fracking, follow in New York State’s path.

It would appear that the maxim “Half a loaf of bread is better than none,” still rings true today. It unfortunately also appears to still ring true, that money is always the bottom line in all major governmental decisions. Fracking adversaries can at least seek comfort in the end result of governor cuomo’s decision. ”

Sources and more information

  • New York Says No Fracking Way!, liattorney, 12/18/2014.
  • Why New York Banned Fracking, nofrackingway, 2014/12/17.
  • Governor Cuomo Saves New York From Getting Fracked!, nofrackingway, 2014/12/17.
  • High Volume Hydraulic Fracturing Prohibited in New York, nygov.tumblr, 2014/12/17.

Autism Spectrum Disorder and Music

Constructive music education proves to be especially helpful to those with ASD

The reason we have favorite songs is because they have the power to bring us back to a specific place or feeling. That kind of familiarity can find a very explicit type of relief in those who suffer from ASD.

It been shown time and time again how constructive music education is in all areas of cognitive development, but it also proves to be especially helpful to those with ASD. ”

Sources and more information

On Flickr®

Six ways transparency about open payments between pharma and doctors is undermined

How the pharmaceutical industry sabotages the Sunshine Act

image of doctor and money
Sunshine Act effectiveness: how pharma undermines transparency about their financial relationships with doctors .

” Here are some ways that transparency about pharma payouts is blocked, even though it greatly affects the drugs that doctors recommend and prescribe. “

  1. Omnibus disclosure
  2. Use of initials
  3. “Hidden” disclosures
  4. Refers to another publication
  5. Organisation ties camouflage
  6. Password protected

Read Is Your Doctor Paid by Big Pharma? in the dissidentvoice,
a paper about how the pharmaceutical industry undermines the Sunshine Act, written by public health writer Martha Rosenberg,
December 19th, 2014.

Video de l’étude 2013 DES 3 générations: conséquences pour la troisième génération

Interview du Pr Tournaire, 2014

Interview du Pr Michel Tournaire – du comité scientifique de l’étude Réseau DES France Distilbène 3 Générations de 2013 – par Laeticia Dormoy, administratrice de Réseau DES France.
Le Pr Tournaire (qui avait présenté l’étude en nov. 2013) parle des différentes conséquences – malformations et handicaps – pour la 3ème Génération: “petits-enfants DES”.
Vidéo publiée le 1.12.2014 par Réseau DES FRANCE DISTILBENE.

Les résultats publiés

Le Distilbène DES, en savoir plus

Medical Quackery

The modern U.S. “sick care system” has become the laughing stock of the world

Medical Quackery cartoon
Watch @DES_Journal diaporama and health comics album on Flickr.
Image via @HealthRanger

Dan Berger is Cartoonist behind Natural News.

” The closer you look at conventional medicine, the more you realize just how much it’s based on quackery. From the exaggerated claims of drug advertisements (which imply that swallowing patented chemicals will solve your life problems) to the absurd pro-drug, anti-nutrition regulatory proclamations by the FDA, the modern U.S. “sick care system” has become the laughing stock of the world….” 

… continue reading: Medical Quackery,
by Mike Adams, the Health Ranger.

All our posts about doctors. See more comics

On Flickr®

Watch @DES_Journal diaporama, and health comics album on  DES Diethylstilbestrol's photostream on Flickr

If you already have a flickr® account, add us as a contact
Email your photos to des.daughter@gmail.com with a short description and title :-)

Fertility Treatment in 2013-2016 HFEA Trends and Figures Report

Lots of useful information brought together all in one place

The Human Fertilisation and Embryology Authority is the UK’s independent regulator overseeing the use of gametes and embryos in fertility treatment and research. The HFEA has released new figures and trends on fertility treatment in 2013.

Download the fertility trends report for 2014 – 2016.

HFEA 2013 fertility trends report image
If you’re exploring fertility treatment, the HFEA is the first place to go for reliable information.

Report Overview:

  • More treatment cycles than ever before; success rates remain constant
  • Multiple birth rate falls again
  • Number of women over 45 using donor eggs outnumbers those using their own
  • Number of IVF cycles using donated eggs and donated sperm more than doubles in five years
  • Number of same-sex female couples receiving treatment increases
  • New figures on fertility treatment released today by the Human Fertilisation and Embryology Authority (HFEA) reveal a continuing rise in the overall number of IVF cycles in the UK, with more undertaken in 2013 than ever before.

The report, “Fertility treatment 2013: trends and figures“, contains key statistics on fertility trends in the UK. It covers treatment cycles and outcomes for treatments started in 2012 and 2013 and how these coincide with short and long term trends. It is the fourth of its kind to be published by the HFEA.

In 2013, 49,636 women had a total of 64,600 cycles of IVF and 2,379 women had a total of 4,611 cycles of donor insemination (DI), representing an increase in both categories from the previous year. Overall, success rates have remained constant at around 25%.

Women over 40 represent the minority of all patients treated, with women aged over 45 accounting for just 2.% of all treatments. More than two-thirds of women undergoing treatment are aged 37 and under, while the average age for treatment remains static at 35. The report also shows that a majority of women over 45 are using donor eggs rather than their own when trying to conceive.

The number of IVF treatment cycles involving same-sex female couples has increased by nearly 20% year-on-year, rising from 766 treatments in 2011 to 902 in 2012. The number of donor insemination cycles involving same-sex couples (DI) rose by nearly 15%, from 1,271 in 2011 to 1,458 in 2012. These amount to a minority of overall treatments undertaken in the period covered.

Elsewhere, the HFEA’s “One at a Time” campaign to reduce multiple births is shown to have had good impact, with multiple births continuing to decrease. The report shows that multiple births occurred in 16.9% of treatment cycles in 2012, down from 18.8% in 2011.

The report also shows that the number of IVF treatment cycles using both donor eggs and donor sperm has doubled over the last five years, while the use of frozen embryos is now involved in more than 20% of all treatments.

Sally Cheshire, Chair of the HFEA welcomed the publication of the report:

At the HFEA we are committed to ensuring high quality care for everyone affected by assisted reproduction, and this report is key to that commitment. It offers unrivalled insight into one of the world’s most advanced IVF sectors, helping to inform the decisions of patients and clinicians alike.

We are very pleased to see that outcomes in most categories are improving each year, and are particularly heartened by the continuing downward trend in multiple births, something we’ve worked hard with professionals to achieve.

But as well as providing data, over time these reports offer us a unique insight into the changing nature of social norms, whether that is same-sex parenting or older mums. In that sense they have become a fascinating resource not just for patients and clinicians, but for everyone.”

Other findings include:

  • Pregnancy rate (per embryo transfer) rises for all age ranges
  • The live births rate is at highest-ever level
  • Number of IVF cycles using fresh donated eggs up more than 50% in five years
  • London and South East account for over a third of all treatments