Study finds hormone therapy in transgender adults safe
In the most comprehensive review to date addressing the relative safety of hormone therapy for transgender persons, researchers from Boston University School of Medicine (BUSM) have found that hormone therapy in transgender adults is safe.
2015 Study Abstract
Some providers report concern for the safety of transgender hormone therapy (HT).
This is a systematic literature review of HT safety for transgender adults.
Current literature suggests HT is safe when followed carefully for certain risks.
The greatest health concern for HT in transgender women is venous thromboembolism; increase risk of thrombosis..
HT among transgender men appears to cause polycythemia.
Both groups experienced elevated fasting glucose.
There is no increase in cancer prevalence or mortality due to transgender HT.
Although current data support the safety of transgender HT with physician supervision, larger, long-term studies are needed in transgender medicine.
Sources and more information
Study finds hormone therapy in transgender adults safe, BostonUNews, February 24, 2015.
What do you think of the Commission’s public consultation on endocrine disruptors? Are you happy with the process?
If we talk about the consultation itself, it’s a good thing. When talking about the whole process, we’re concerned because it’s too slow. It has already been delayed and the timeline for a definition of endocrine disruptors has not been respected. We are in an uncertain situation. It makes a lot of unclarity for the evaluators at the EFSA (the European Food Safety Authority) level, for the risk managers, the member states and of course also for our members. The sooner the criteria is established and validated, the better it will be.
Contrary to what some NGOs think, we have not worked to slowdown the process.
You would prefer stringent criteria adopted fast rather than the opposite?
No. Since the current regulation was adopted, we have been fighting hard against the so-called hazard criteria. Until now, all our products were risk-based evaluated. That means that every technology including natural products can come under the label ‘hazard’. Based on the use, crops and the amount, there is an exposure which is big or low and if we combine the hazard with the exposure, then the risk manager can say that we can put the product on the market based on this. Europe is the only place in the world where we have this approach now.
Does this also include minimum residue levels for pesticides?
Yes, and this issue will become hotter this year due to the TTIP (Transatlantic Trade and Investment Partnership) negotiations. Endocrine disruptors and TTIP can be linked due to the residue levels. We don’t want them to be linked too much, but some people want them to be linked.
People from the Commission?
No, the new Commission in fact has a new way of looking at things. Our understanding is that they prefer to check and be sure that the current regulation is working. If it’s not working, they want to make it work before they consider new regulation.
Before the new Commission took office we thought that the current regulation, which really hasn’t been working yet, would be revised as soon as possible. Now, if the Commission says it’s better to really make the current regulation work, then that’s a fine idea.
But the public consultation is taking place to update the regulation, right?
The consultation is specific to endocrine disruptors. The problem with it is that it’s not a general public consultation. In fact, you do need a little bit of knowledge about the file. This is more for experts. This topic really is the hot topic of the coming months and we have of course been contributing to the consultation. As one of many important stakeholders in this debate, we take the issue of endocrine disruptors seriously. We welcome a vigorous, informative and reasonable public dialogue to fully consider the consequences of the criteria for endocrine disruption.
These criteria will be used to regulate endocrine disruptors in sector-specific chemicals legislation, such as for general chemicals, biocides and pesticides. The application of these criteria could have significant consequences for consumers, agriculture and trade. That’s why the public consultation is so vital to the process.
Our position is that the EU’s criteria should evaluate endocrine active substances based on risk assessment, considering both hazard and exposure, and that the final criteria should clearly distinguish those substances that are of high regulatory concern from those that are not.
The number of active substances available for the industry to use has consistently been reduced due to regulation…
Not only because of the regulation, but also because of us. In the 1990s, we had around 1,000 substances available on the European market. Today, the number is 250 because regarding 60-70% of the substances, we have decided not to maintain them as we knew they would be technically outdated and we would have better solutions for the farmers. Then we had 80 substances where we were trying to renew them, but this was not accepted due to risk concerns. At the same time, on top of the 250 substances, 150 new substances have been developed.
So we have 400 substances now, and they are generally safer. They represent less risk and really answer our needs as consumers and citizens. With the new regulation on endocrine disruptors, our guess is that between 50 to 60 substances can again disappear, knowing that all the current 400 will have to go through the screening again.
Have you identified those 50-60 substances?
Yes, and among those potential ones, there are ones which are bringing technical solutions that are very useful for the farmers and we don’t really have alternative solutions available yet. This could result in substances disappearing from the market so that, for example, wheat production, which is an important crop in Europe, can be negatively impacted.
We want an approach that is really pragmatic, based on use.
The 50-60 substances that you think could be taken off the market… Is this something the industry is already taking for granted and already phasing out? Do you agree that the risk may too high for some of them?
Today, based on the knowledge available and on the current risk-benefit analysis, which has been done, there’s no obvious reason. We potentially have some insecticides which have been largely used, with a lot of benefits, which could disappear.
We have been bringing new families, new benefits, more targeted and environmental-friendly products to the market. Of course we can always do more. This is what our research and development teams are working on. But for a product, we need more than ten years before bringing them to the market. We cannot make those changes in a split second.
The number of products reaching the market is declining because companies are not taking risks when there are so many discussions on criteria profile to continue to push for them being on the market.
The concern is still about the products in the pipeline or those already on the market. It’s more and more complicated to find new product families. If we rely too much on the same product families, the risk of resistance will be increased, and then the farmers won’t be able to control the problem.
I’m guessing you are trying to meet with Commissioner Frans Timmermans, the First Vice-President responsible for Better Regulation. Are you telling the Commission to drop this legislation?
No. We have looked at impact assessments from the beginning so that we remain consistent. What we just want is an acceleration of the process. We don’t know yet what the outcome will be.
What will be the desirable outcome from your point of view?
The desirable outcome for us would be that before taking the decision to exclude a substance, they go through a risk-benefit analysis which is not the case today from the current regulation. If you have classified a substance as an endocrine disruptor, whatever the criteria is, because they are still being discussed, then it will be dropped.
Do you think the Commission is listening to this argument?
With the new Commission, I don’t know. But there were different opinions in the previous different Commission units.
The new Commission has a new approach which is more centralised, which could help making your point, no?
We have not yet had the opportunity to really… We have had a meeting in one of the cabinets, but it was more like an introductory meeting.
Impact assessments are being reviewed at the Commission with a more systematic cost-benefit analysis being considered. You must see this as going in the right direction, no?
In principle, of course it goes in the right direction. This is for the future. But for today and for the endocrine disruptors, the fight has already been quite emotional that I can’t imagine that this impact assessment will continue to the end and then stop.
On the other hand, we’re not interested in stopping it because that would keep it in the grey area. We are really happy that the public consultation will close on Friday.
The impact assessment, I believe, has already started and some input will be used from the public consultation to make the final proposal of the criteria which will be discussed by the Council and Parliament. The only concern we have is the planning, because we don’t expect the criteria to be agreed by the Commission, Parliament and Council before the end of 2016. It’s not going to be tomorrow. In the meantime, the debate will continue. – 16/01/2015.
The uterus response differs following high versus low doses of neonatal exposure
2004 Study Abstract
Outbred CD-1 mice received subcutaneous injections on neonatal days 1-5 with DES (0.0001-1000 microg/kg per day), a model xenoestrogen. At 17 days of age, uterine wet weight increase in response to estrogen was altered in neonatally DES-treated mice compared to controls. The response varied depending on the neonatal DES dose; a low dose (0.01 microg/kg) caused an enhanced uterine response but higher neonatal doses dampened the response. Western blots and immunolocalization of estrogen receptor alpha (ERalpha) showed high ER levels at DES 0.01 microg/kg, but decreased levels at higher doses compared to controls. Genes responding through ER-mediated pathways (c-fos, proliferating cell nuclear antigen (PCNA), and lactoferrin (LF)) mirrored altered wet weight responses, i.e., enhancement at low doses and dampening at higher doses. A similar dose-response curve was seen in 4 months old ovariectomized DES-treated mice suggesting the altered response was long-term. These data suggest xenoestrogen exposure during critical developmental windows alters hormone programming so that the uterus responds abnormally to estrogen later in life, and that the response differs following high versus low doses of neonatal exposure.
Sources and Full Study
Developmental exposure to diethylstilbestrol (DES) alters uterine response to estrogens in prepubescent mice: low versus high dose effects, Reprod Toxicol. 2004 May;18(3):399-406. PMID: 15082075.
New ingredient in plastic bottles, receipts has same effect on lab animals as the old chemical does
Exposure to bisphenol-S (BPS), an ingredient that has replaced BPA in many items, caused irregular heartbeats in female lab rats, according to the study by Hong-Sheng Wang and colleagues published this 26 February 2015. The findings were “remarkably similar—if not identical to—what we find in BPA” Wang said.
Bisphenol S (BPS) is increasingly been used as a substitute for BPA in some “bisphenol A (BPA)-free” consumer goods and in thermal papers. Wide human exposure to BPS has been reported; however, the biological and potential toxic effects of BPS are poorly understood.
Objective: To elucidate the sex-specific rapid impact of BPS in rat hearts and its underlying mechanism.
Rapid effects of BPS in rat hearts were examined using electrophysiology, confocal and conventional fluorescence imaging, and immunoblot.
In female rat hearts, acute exposure to 10-9 M BPS increased heart rate and in the presence of catecholamine-induced stress condition, markedly increased the frequency of ventricular arrhythmia events. BPS increased the incidence of arrhythmogenic triggered activities in female ventricular myocytes, and altered myocyte Ca2+ handling, particularly spontaneous Ca2+ release from the sarcoplasmic reticulum. The dose responses of BPS’ actions were inverted-U shaped. The impact of BPS on myocyte Ca2+ handling was mediated by estrogen receptor β signaling and rapid increases in the phosphorylation of key Ca2+ handling proteins including ryanodine receptor and phospholamban. The pro-arrhythmic effects of BPS were female-specific; male rat hearts were not affected by BPS at the organ, myocyte and protein levels.
Rapid exposure to low-dose BPS has pro-arrhythmic impact on female rat hearts; these effects at the organ, cellular and molecular levels are remarkably similar to those reported for BPA. Evaluation of the bioactivity and safety of BPS and other BPA analogs is necessary before they are used as BPA alternatives in consumer products.
Sources and more information
Chemical in BPA-Free Products Linked to Irregular Heartbeats, nationalgeographic news, FEBRUARY 25, 2015.
Rapid Responses and Mechanism of Action for Low-Dose Bisphenol S on ex Vivo Rat Hearts and Isolated Myocytes: Evidence of Female-Specific Proarrhythmic Effects, Environ Health Perspect; DOI:10.1289/ehp.1408679, 26 February 2015, full study PDF.
Quanticate hosted a free symposium, which took place at the Royal College of Surgeons, September 2013
Dr Ben Goldacre, author of ‘Bad Pharma‘ presented a keynote speech at the Clinical Data Live! symposium. In this video hear Ben Goldacre present ‘ALLTrials: Transparency is moving forwards, industry can benefit from doing the right thing‘. This symposium was hosted by Quanticate who support Pharma and Biotech companies with statistical consultancy services.
Pharmaceutical companies have more power than ever, and the American people are paying the price—too often with our lives …
” … as physicians, we have very little good information to go on. Even our most prestigious journals publish research based on falsified studies, according to Charles Seife, a journalism professor whose class spent a semester trying to figure out why the data don’t get corrected once research fraud comes to light. “As a result,” Seife writes, “nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.”
If no one knows which data is bogus, we obviously have a big problem in conventional medicine. Perhaps we shouldn’t be so focused on marketing shenanigans, and more concerned about the original study data before something becomes standard of care. Standard of care, of course, is driven by “research” that is incorporated into academic guidelines and is the basis of customer demand.”