Follow the money - who is funding the US transborg?

Another thing mentioned in that article is the determined effort to get the DSM definitions changed. The DSM is the American ‘diagnostic standard’ - so all psychiatric disorders are listed there with criteria. ICD-11 is the version this side of the pond and there has been a huge push to get that changed too.

So the standard of care is being altered here as well. The very definition of what you’re treating and who you treat for it has been changed.

(This to me exposes a huge problem with a lot of psychiatry - it’s the only thing we use subjective diagnosis for and treat medically but that’s a whole other thread and argument for another day and I’m still not entirely sure what my position is in it despite a lot of thought.)

But anyway, the take home from this is that there are lobby groups capable of changing medical definitions of illness. If that doesn’t worry you, it should.

In the USA, if the standard of care is x and prescribers stick to it then they are protected to a degree. In the UK, we have a single payer system - guess who the liability will fall on? Yup - the NHS.

So where from here? This is one reason why I believe it’s vital to keep pushing the scientific and medical side of this. Without opposition that standard of care shifts. With opposition and evidence you have the slightest glimmer of hope that the SOC is something that’s not agreed on by all parties.

Hence my endless, pedantic banging on about ‘science and why it is inportant’ And valuable contributions from medics like george

We have seen cases like this in the past - damaging trends in medicine that are more based on fad than fact. The huge financial/ideological backing for this is fairly new - and I will keep opposing it.

By the way, Babel, excellent comments as usual! I agree completely.

Prescribing "off label" actually occurs fairly often. (Many drugs used in pediatrics are, simply because clinical trials in children can be very difficult to do.) Liability isn't necessarily greater for off label drugs if there is a well-documented or well-supported use for that drug. Here's where standard of care comes in to play, which is critical if trying to prove harm. If a physician follows the standard of care, even if the patient had a severe adverse outcome, the physician is generally protected.

Now this is ugly and sticky: the relevant governing bodies here have largely agreed that "affirmative care" is the right thing for children and teens with gender dysphoria, which may include puberty blockers and/or cross-sex hormones and/or surgery. The professional societies for pediatricians and endocrinologists and psychiatrists have collectively agreed with WPATH that treatment should not be withheld from children, and have published position statements for providers to reference. In other words, this is now the standard of care.

Fast forward ten years from now. Will there be lawsuits? Absolutely. Will the prescribing physicians be defensible? Legally, yes. They can cite the current standard of care and deflect much of the personal responsibility. I'm not saying I agree with this or support this, but very few physicians will be held individually accountable for these practices.

GeorgeFayne

And, adolescents over the age of 14 are legally allowed to make their own decisions (with complete confidentiality from their parents) regarding mental health, sexuality, or substance use/abuse.

So they can decide for themselves whether or not to take cross-sex hormones, but presumably are not legally allowed to consume alcohol?

Insane....

Bowlofbabelfish

Totally agree with your post would have been great to have that insight when we were discussing unlicensed drugs a free weeks back.
the big pharma conspiracies hide like you say the actual grubby practic. any medic or nurse will tell you that these companies offer a lot of insensitives to use there product and I have always admired a consultant that would invite them in with there free lunches for everyone then rip there paid for study to bits. we should always try to use the best drug available but that is not always the newest or most expensive one.

Excellent link...working on getting through it. Thank you!

I posted this at the end of an almost dead thread the other day--a Planned Parenthood ad for self-referral for cross sex hormones.

Here's the update: I called the other day to our local PP office. I asked if they had a practitioner who would treat gender dyphoria. Yes, they did. Did I need to have a referral from a psychiatrist or therapist or other physician? No, I did not. She said they "practice affirmative care." Then I asked about teens and children, at which point I believe she realized she had said too much and told me I'd have to make an appointment or leave my contact information.

In case this doesn't sufficiently scare you, let me recap where my state is in terms of the implications here for teens: a conversion therapy bill was passed that mandates the only approach for gender dysphoria is for providers and therapists to affirm stated gender identity. No watchful waiting. And, adolescents over the age of 14 are legally allowed to make their own decisions (with complete confidentiality from their parents) regarding mental health, sexuality, or substance use/abuse.

I'm 99% certain PP will prescribe to teens with no parental authorization. They can bill the child's insurance or will work on a sliding scale fee system. (What's a little expenditure in the red for a few years when you'll have a lifelong patient?)

Also, any more, most "providers" in the US who work for PP are what we call "mid-level practitioners," not physicians. They have much less schooling and experience, but typically have full prescribing privileges. It's scary.

I applaud Medium for publishing articles from both sides of the debate. They come across as neutral to me which is not the case for most media (print most definitely)

Medium is a blog site where anyone can publish whatever they want

Damn, well done that researcher! But yeah, I've long suspected that after the class action lawsuit filed against the makers of Lupron they were looking for a new market where less questions would be asked, and found one in parents anxious enough about their non-conforming children to attempt to medicate them into a semblance of "straight and normal".

From the same link:

A federal grand jury returned an indictment unsealed today, charging one physician and six TAP managers with conspiracy to pay kickbacks to doctors and other customers, conspiracy to defraud the state Medicaid programs on TAP's obligation to sell products to those programs at its best price, and conspiracy to violate the Prescription Drug Marketing Act by causing free samples to be illegally billed to the Medicare program.

The indictment charges that the TAP defendants offered to give things of value, including free drugs, so-called educational grants, trips to resorts, free consulting services, medical equipment, and forgiveness of debt, to physicians and other customers to obtain their referrals of prescriptions for Lupron to Medicare program beneficiaries, in violation of the anti-kickback statute.

The indictment also charges that the TAP defendants aided and abetted, and caused the billings to hundreds of elderly Medicare program beneficiaries and to the Medicare program directly, for thousands of free samples of Lupron, used in the treatment of prostate cancer, in violation of the Prescription Drug Marketing Act

Here's the info on the TAP / Lupron

www.justice.gov/archive/opa/pr/2001/October/513civ.htm

An excerpt:

(1) TAP Pharmaceutical Products Inc. ("TAP"), a major American pharmaceutical manufacturer, has agreed to pay $875,000,000 to resolve criminal charges and civil liabilities in connection with its fraudulent drug pricing and marketing conduct with regard to Lupron, a drug sold by TAP primarily for treatment of advanced prostate cancer in men. The global agreement includes:

(a) TAP has agreed to plead guilty to a conspiracy to violate the PrescriptionDrug Marketing Act and to pay a $290,000,000 criminal fine, the largest criminal fine ever in a health care fraud prosecution. The plea agreement between the United States and TAP specifically states that TAP's criminal conduct caused losses of $145,000,000.

(b) TAP has agreed to settle its federal civil False Claims Act liabilities and to pay the U.S. Government $559,483,560 for filing false and fraudulent claims with the Medicare and Medicaid programs as a result of TAP's fraudulent drug pricing schemes and sales and marketing misconduct.

(c) TAP has agreed to settle its civil liabilities to the fifty states and the District of Columbia and to pay them $25,516,440 for filing false and fraudulent claims with the states, as a result of TAP's drug pricing and marketing misconduct, and from TAP's failure to provide the state Medicaid programs TAP's best price for those drugs as required by law.

(d) TAP has agreed to comply with the terms of a sweeping corporate integrity agreement which, among other things, significantly changes the manner in which TAP supervises its marketing and sales staff, and ensures that TAP will report to the Medicare and Medicaid programs the true average sale price for drugs reimbursed by those programs.

***

They're not exactly the good guys are they?!

I've just read (OK, skimmed!) this - it's essential reading IMO.

$22 million even!

Thanks for the link. I'm still reading through it but it's very interesting so far.

One thing that has leapt out for me is that funding for lesbians is at $4m and declining whereas funding for transgender people is at $20 million and rising. No wonder the LBGT organisations are so willing to throw us lesbians under the bus!

Getting teens tied into a lifetime of hormone treatment could be perceived as an excellent marketing strategy by BigPharma. Those late-transitioners in their 50s.... nah, why bother.

Follow the money indeed.

I can highly recommend Dr Malcolm Kendrick. He is a practising GP in the UK and writes a blog.
He explains the facts behind the published statistics. He is a very sceptical man.

Sorry missed a line out there *And there has to be a presumption that doctors should act in best interests of patients and sometimes that is indeed using a drug that not licenced

Disclaimer: the usual one that I’m a scientist not a medic!

Yes it’s common. Look for uncritical articles about a specific drug, always always always look at people’s affiliations - all interests should be listed in papers. If you’re unsure go into PubMed and look at their other papers and google them. ‘Cast of thousands’ author lists are a giveaway too in biological fields (and totally normal in physics.)

So off label usage isn’t always bad. It can and does save lives, but it’s something that shouldn’t be done lightly and is a big responsibility. By label, we mean the indications that the drug is tested and approved for by the relevant body (FDA in America, MHRA in the Uk.) to get approval for an indication you must conduct trials and present the data to the body and they must approve it.

Pharma companies CANNOT MARKET for indications that are off label. Less of a problem in the UK because you can’t market direct to patient here but huge in the US and where you can.

A prescribing doctor retains responsibility for their prescriptions.

Lots of off label use is legit. For example, if you’re dying and there’s a promising but I tested cancer drug that might give you a few extra months. Or it’s just that the drug has never specifically been tested in kids or pregnancy women (most of the drugs for hyperemesis have never been tested in pregnant women, but they have long useage records with good safety.)

In some cases it’s that the drug has been around forever like aspirin and it’s used for all sorts of stuff without any trials ever being done.

Or things like antidepressants used for anxiety or as mild antipsychotics. That sort of stuff.

The legal stuff is fuzzy. The FDA don’t regulate what the drugs are used for atcthe doctor level - they only say what they have been approved for and can be marketed for. And there has to be a presumption that. Doctors are NOT compelled legally to tell the patient that the use is off label but they can be held responsible for what they prescribe.

That’s the level my knowledge of the legalities stops I’m afraid - it’s a balance between the responsibility of the medic to treat and their responsibility to be ethical.

Where pharma companies push doctors or even provide incentives to get them to prescribe you have an ethics breach. Where they are pushing to prescribe for off label use that breach is even more serious because it creates direct conflict between the interests of the patient and that of the company.

Incidentally, let me see if I can find the ruling... a little drug called Lupron was in 2001 involved in such a case (kickbacks mainly) which was the biggest ever at the time. Scroll down to TAP/Lupron here:

en.m.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements

Tangled web...

Yes I’m on the sofa and feeling frankly a bit horrid :) thinking of serving an eviction notice on the little bugger ...

This is such a good article - particularly on the astroturfing and lobby groups - and well worth the effort to read it carefully.

Medium isn't really a publication in the normal sense - it's more a web-hosting service for amateur/citizen journalism/op-ed pieces (like a journalistic version of Wordpress). So, some interesting stuff, but no editorial filtering.

Seconding "Bad Science". I'd also add "Merchants of Doubt", a fantastic book about astroturfing, privately funded think tanks, paid scientists, sponsored op-ed pieces in mainstream media, the exploitation of the rules around journalistic balance,and a host of other techniques developed and used by the fossil fuel industry and big tobacco to muddy the waters over climate change and health risks respectively. You can see so many of the same techniques being used here once you know what to look for.

Bookmarked to read later.

The Federalist has been discounted by many for being a right wing source although I agree that article is great.

Indeed. If only left wing sources were discounted equally. Doesn't seem to happen.

Planned parenthood needs somewhere to spend their money now that the clinics they used to find offering contraception and abortion have been closed down.