You stated: “The treatments given in the control arm included some of the most barbaric and outdated treatments such as len-dex (alone), boretezomib-melfalan-pred, bortezomib-dex. These have not been standards for many years.”
I’m puzzled. Do you mean not standards for smoldering only? It seems that they are all used in first line treatments for various levels of MM. are they barbaric for MM as well?
This is really disturbing. Aggressive use of Velcade in patients who clearly did not have multiple myeloma was one of the charges that got the notorious Dr. Farid Fata sentenced to 45 years in prison. The line between “mere” over-treatment and criminal exploitation of patients may be thinner than we imagined.
More and more, we learn less and less from most of the published literature. Years ago, David Taggart from Oxford made quite a stir pointing out that we could predict the outcomes of many CABG vs. stent trials by simply looking carefully and the enrollment criteria. Medical device companies, Pharma companies and the journal publishing companies have contaminated the literature to the point of making it almost useless for anything other than embellishing one’s CV.
I don’t want ANY disease, but if I get one I hope it has an adjective as moody as smoldering. I want to be on the disease naming committee and also the drug naming committee. So many horrible drug names.
This is too far out of my wheelhouse for me to have any meaningful opinion.
But I was discussing yesterday with a colleague about the new light shed on PLATO (at This Week in Cardiology, on Cardiology Trials, and on Stop and Think) which is very much in our wheelhouse. And he surmised that perhaps Dr. Mandrola can no longer say “this is not nefarious”.
I am the point where if I haven't got symptoms then I don't need medication and I am even including testing unless symptoms exist. Of course normal healthy living to be continued ie no smoking, sensible alcohol, exercise etc and highish vit D dose for the immune system.
Fool me once, shame on you: fool me twice shame on me.
Thank you for this and your incredibly interesting and informative columns.
I have a different wish list, but I also want your wish granted.
I would like clinicians, patients, families and the public to be informed about the low and very low quality evidence in gender medicine, including that
1. it is unknown (except for the very young, where it is a small minority) how many do have long term gender distress--distress--not non-conformity.(**I had mis-typed, the statement is correct now--only a small number **do** have long term gender distress into mature adulthood.) It is more generally unknown what the natural history is, i.e. the likely outcomes if there is no medical or social transition, if only psychological or other mental health support or other support is given.
2. It is unknown how to reliably determine for whom in particular cross gender identification is likely to endure into and throughout adult maturity
3. Of the latter, it is unknown for whom medical or social intervention is likely to have a favorable benefit/risk ratio
----assessments for medical intervention readiness have not been compared to long term outcomes, check out the interview with Dr. Tishelman of Boston Children's Hospital in the Boston Globe last week
----the number who detransition or regret long term has not been reliably measured, even up to an order of magnitude.
4. it is even unknown how many have had beneficial vs. adverse outcomes from medical intervention long term, beyond short term honeymoon effects.
5. It is unknown what the likely medical risks are of medical intervention (associated cardiovascular, reproductive system, bone density, immune system, brain harms are reported, as are cancers, but not well characterized), in addition to the unknown likely medical effect on gender distress of these interventions.
I would also like the clinicians, etc., to have access to information that is not being made available, such as unrevealed outcomes from studies (reported in the NYT regarding the Olson-Kennedy led puberty blocker study, or the rest of the associated hormonal trial's outcomes as listed in the protocol, for instance) and systematic reviews (e.g., listed in PROSPERO as commissioned by WPATH and completed, reported about in part in the BMJ by Block and by the Economist) to further enable informed consent.
Thank you for your work and I hope people listen to you!
strangely enough....a lot of the studies for everything else, like the 857 or however many vaccines on the schedule now, food studies, or even ( insert your favorite study here)...and yeah even the studies that claim vaccines don't contribute to autism, but maybe your breakfast cereal does......drum roll....have people that work for or consult for BigPharma.
Thankfully, and hopefully ( if they can all make it to Jan 20 alive) we might get an administration that fosters the processes of getting this science quagmire straightened out and transparent enough to be able to carry the high bar from here on out.
You stated: “The treatments given in the control arm included some of the most barbaric and outdated treatments such as len-dex (alone), boretezomib-melfalan-pred, bortezomib-dex. These have not been standards for many years.”
I’m puzzled. Do you mean not standards for smoldering only? It seems that they are all used in first line treatments for various levels of MM. are they barbaric for MM as well?
Looking for new drugs is a trip into backwardsland when so many natural substances are available.
This is really disturbing. Aggressive use of Velcade in patients who clearly did not have multiple myeloma was one of the charges that got the notorious Dr. Farid Fata sentenced to 45 years in prison. The line between “mere” over-treatment and criminal exploitation of patients may be thinner than we imagined.
An introduction to Dr. Fata’s saga here:
https://rxisk.org/the-maintenance-man-fata-nomics-the-cancer-plaguing-healthcare/
Thank you for continuing to bravely ‘tug on Superman’s cape
Dr. Ionnidis wrote years ago that 95% of the articles in medical journals were worthless. I see no evidence of improvement.
We don't have enough contempt for these people.
More and more, we learn less and less from most of the published literature. Years ago, David Taggart from Oxford made quite a stir pointing out that we could predict the outcomes of many CABG vs. stent trials by simply looking carefully and the enrollment criteria. Medical device companies, Pharma companies and the journal publishing companies have contaminated the literature to the point of making it almost useless for anything other than embellishing one’s CV.
I don’t want ANY disease, but if I get one I hope it has an adjective as moody as smoldering. I want to be on the disease naming committee and also the drug naming committee. So many horrible drug names.
At this point it's clear that NEJM is simply not a credible journal, and it is best for those who actually seek the truth to ignore it entirely.
This is too far out of my wheelhouse for me to have any meaningful opinion.
But I was discussing yesterday with a colleague about the new light shed on PLATO (at This Week in Cardiology, on Cardiology Trials, and on Stop and Think) which is very much in our wheelhouse. And he surmised that perhaps Dr. Mandrola can no longer say “this is not nefarious”.
This article conjures up those same sentiments.
I am the point where if I haven't got symptoms then I don't need medication and I am even including testing unless symptoms exist. Of course normal healthy living to be continued ie no smoking, sensible alcohol, exercise etc and highish vit D dose for the immune system.
Fool me once, shame on you: fool me twice shame on me.
Same
Thank you.
Thank you for this and your incredibly interesting and informative columns.
I have a different wish list, but I also want your wish granted.
I would like clinicians, patients, families and the public to be informed about the low and very low quality evidence in gender medicine, including that
1. it is unknown (except for the very young, where it is a small minority) how many do have long term gender distress--distress--not non-conformity.(**I had mis-typed, the statement is correct now--only a small number **do** have long term gender distress into mature adulthood.) It is more generally unknown what the natural history is, i.e. the likely outcomes if there is no medical or social transition, if only psychological or other mental health support or other support is given.
2. It is unknown how to reliably determine for whom in particular cross gender identification is likely to endure into and throughout adult maturity
3. Of the latter, it is unknown for whom medical or social intervention is likely to have a favorable benefit/risk ratio
----assessments for medical intervention readiness have not been compared to long term outcomes, check out the interview with Dr. Tishelman of Boston Children's Hospital in the Boston Globe last week
----the number who detransition or regret long term has not been reliably measured, even up to an order of magnitude.
4. it is even unknown how many have had beneficial vs. adverse outcomes from medical intervention long term, beyond short term honeymoon effects.
5. It is unknown what the likely medical risks are of medical intervention (associated cardiovascular, reproductive system, bone density, immune system, brain harms are reported, as are cancers, but not well characterized), in addition to the unknown likely medical effect on gender distress of these interventions.
I would also like the clinicians, etc., to have access to information that is not being made available, such as unrevealed outcomes from studies (reported in the NYT regarding the Olson-Kennedy led puberty blocker study, or the rest of the associated hormonal trial's outcomes as listed in the protocol, for instance) and systematic reviews (e.g., listed in PROSPERO as commissioned by WPATH and completed, reported about in part in the BMJ by Block and by the Economist) to further enable informed consent.
Thank you for your work and I hope people listen to you!
strangely enough....a lot of the studies for everything else, like the 857 or however many vaccines on the schedule now, food studies, or even ( insert your favorite study here)...and yeah even the studies that claim vaccines don't contribute to autism, but maybe your breakfast cereal does......drum roll....have people that work for or consult for BigPharma.
Thankfully, and hopefully ( if they can all make it to Jan 20 alive) we might get an administration that fosters the processes of getting this science quagmire straightened out and transparent enough to be able to carry the high bar from here on out.