Prozac (fluoxetine) went off patent in August 2021. In July 2000, FDA approved Sarafem (fluoxetine) for use in Pre-Menstrual Dysphoric Disorder (PMDD). In June 2010, Lilly stopped marketing Sarafem. In August 2023, Lilly informed FDA they wished to Withdraw Sarafem and its PMDD indication. It is not exactly clear what withdrawing its PMDD indication means. Presumably all use of generic fluoxetine for PMDD is now off-label rather than PMDD should be removed from DSM-whatever.
Trick or Treat?
Now in 2024, in the week leading up to Halloween, we get the withdrawal of Prozac. There is no indication Lilly are also withdrawing the indication Depression. It would be fascinating if they could do this and make all prescribing of generic fluoxetine off-label.
There are complications linked to current laws around generics. Generic companies have to take over the branded label. What happens when the branded drug disappears and no updates to the label are possible?
Who is going to add fluoxetine-induced alcoholism to the Labels, fluoxetine induced infertility or even a clear statement when the time comes that fluoxetine can cause suicide?
The Zyprexa Interlude
After Prozac went off patent, Lilly fished Cymbalta out of the discarded bin/filing cabinet – See Prozac Era – and in a marvellous example of company abilities to get you voting Trump today when you had been a passionate Harris supporter up to yesterday (or vice versa), they were able to make a failed drug into a blockbuster earning double what Prozac had been making.
But Cymbalta paled in comparison to Zyprexa. A drug that everyone knew you were taking because it was obvious you had become a Michelin man, and knew that taking it meant someone thought you were crazy, Zyprexa had years before quickly out-stripped Prozac’s profit rates.
It became a best-seller even though it appears in the trials used to get it licensed to have had the highest rate of suicides and suicide attempts in clinical trial history. No Black Box warning here. Why not – well not letting FDA or anyone else see the data helped.
FDA were scorched by their antidepressant and suicide experience and opted not to put Black Box Warnings on a wide range of drugs such as anticonvulsants – which across a range of indications from epilepsy to migraine to mood stabilization had clinical trial data showing increased rates of suicidal events comparable to rates on antidepressants.
Very early on, there were indications that Zyprexa caused diabetes. How did Lilly handle this? One of the tactics was to wheel out the single nineteenth century quote linking mental illness to diabetes – the only quote there is – to claim a link between the two disorders has always been known about and Zyprexa wasn’t causing the problem schizophrenia is – Diabetes and Psychosis.
Back in 2008, before Type 2 Diabetes had become the epidemic it now is, we found a doubling of the rate of T2D among patients treated with antipsychotics compared with population norms,
Lilly were among the companies most aggressively pushing their antipsychotic for Bipolar disorder – creating the epidemic we now have, This marketing went hand in hand with a marketing that created Adult ADHD to boost Strattera sales. The epidemics we now have unquestionably come from laboratories rather than fish or other markets – company laboratories.
Back to Basics
Lilly became better known outside Indiana a century ago, when in 1923 they were the first company to produce commercial insulin, with sales ramping up in 1924.
They have since been involved in a series of Insulin controversies with moves from porcine insulin to human insulin. Human insulin sounds better but it was genetically engineered and initially there were a range of complications linked to dose leading in some cases to hypoglycemic comas.
More recent controversies have linked Lilly and Novo-Nordisk to Insulin Price Gouging.
It is now fascinating to see Lilly and Novo-Nordisk scrapping over Ozempic for diabetes, aka Wegovy for weight loss and Mounjaro for diabetes, aka Zepbound for weight loss.
For all socialists out there, this image will be appealing. It shows senior figures in Germany’s social democratic party figures with shovels in hand – Olaf Scholz’s bald head in the middle – a suitable image for a working people’s party – see Scholz and Lilly for more on this story.
What’s the celebration? Lilly are investing in a tirzepatide producing plant in Germany rather than taking it to Asia as they had threatened to do if the German government didn’t change their laws to allow Lilly to hide their price gouging (negotiations) with health services and government. The factory hasn’t it seems gone to Asia.
In Britain, when the first NICE Guidelines for Schizophrenia were being produced, Lilly threatened to pull out of Britain if Zyprexa did not feature as a first line treatment for the condition. The threat appears to have worked. At the time, Lilly were dealing with a working people’s party.
After a long hiatus, Lilly are now again dealing with a working people’s party in Britain, whose Health Secretary, Wes Streeting, is talking about getting everyone who is not working on weight loss drugs drugs to get them fighting fit and able to get back to work – Embracing Healthcare Opportunities.
See Harriet Vogt’s comment on The Prozac Era post. In it she cites Kathleen Stock’s Unherd article on Wes and his dealings with Lilly and potentially with pharma in general that risk becoming ridiculous.
When it comes to health technologies that are billed as innovative – the Left have always been suckers. This goes back over a century to left wing endorsements of eugenics. If we can’t persuade society to change, perhaps we can inject some common sense into it.
This image is scrambled. It’s got it’s drugs and companies mixed up.
Treat
Having made these points about governments and how readily they will sell their soul, everyone taking semaglutide or tirzepatide has access to a scientific and clinical goldmine. These drugs likely have extraordinary effects other than the ones their companies want you to hear about. It would be great to get Reports to RxISK – outlining interesting and even beneficial things they are doing.
The interesting angles are they can almost certainly trigger suicidality in some. What do they do to libido, alcoholism and other problems?
The beneficial is they are likely a treatment for PGAD, PMDD and all kinds of conditions that are linked to akathisia – Antidotes for Akathisia and Dysregulation.
Be the first to report a breakthrough. We need more people to celebrate along with Anne-Marie and others – see Getting a Juggernaut to Stop and Think.
‘the trial would test the long-term effectiveness of the drug in the “real-world”.
Investigate Europe
For Eli Lilly, however, the deal is likely to be worth its weight in gold. This is because the company launched a weight loss injection at the end of 2023. With a similar drug, its competitor Novo Nordisk has just become the most valuable company in Europe.
Weight loss jabs like Ozempic linked to TEN deaths, officials confirm
https://www.msn.com/en-my/news/other/weight-loss-jabs-like-ozempic-linked-to-ten-deaths-officials-confirm/ar-AA1tlBa5?ocid=BingNewsSerp
The medicines watchdog has received reports of ten deaths linked to the use of weight loss jabs, it has revealed.
There have also been 7,228 reports of nausea, vomiting and diarrhoea associated with the likes of Wegovy and Ozempic.
The medicines watchdog has received reports of ten deaths linked to the use of weight loss jabs, it has revealed.
There have also been 7,228 reports of nausea, vomiting and diarrhoea associated with the likes of Wegovy and Ozempic.
Of these, 68 patients were admitted to hospital, the Medicines and Healthcare products Regulatory Agency (MHRA) said.
The numbers are based on users or healthcare workers informing the regulator of adverse reactions to the drugs, known as glucagon-like peptide-1 receptor agonists (GLP-1RAs).
A reported death or adverse reaction does not necessarily mean it has been caused by the medicine, only that someone had a suspicion it may have been.
An Open Letter From Eli Lilly and Company Regarding Certain Practices Related to Mounjaro® and Zepbound®
https://investor.lilly.com/news-releases/news-release-details/open-letter-eli-lilly-and-company-regarding-certain-practices
How will weight loss drug trial for unemployed work?
https://www.bbc.co.uk/news/articles/crej4xpx2dvo
The first “real-world study” into the effectiveness of a weight loss drug is set to measure the impact on the job prospects of people living with obesity in Greater Manchester.
The five-year clinical trial was announced as part of a £279m plans by US pharmaceutical giant Eli Lilly to work with the UK government to address public health challenges like obesity.
The anti-obesity drug Tirzepatide, created by Eli Lilly and sold under the brand names Mounjaro and Zepbound, will be used in the study.
Illnesses relating to obesity cost the NHS £11bn a year, Health Secretary Wes Streeting said.
Who will be involved in the trial?
The trial will be run by Health Innovation Manchester in partnership with Eli Lilly, along with the University of Manchester and local digital trials company NorthWest EHealth.
The group of Greater Manchester health organisations behind the study have not revealed exactly who will be given the drugs.
But up to 3,000 people in the city-region will eventually take part, those behind the project have said.
They say the study will examine the “real-world” effectiveness of tirzepatide on weight loss, and on preventing diabetes and obesity-related complications.
Researchers will also measure how the drug affects the employment status of a patient, as well as the number of sick days they take.
Why is it in Greater Manchester?
The trial will make use of the Greater Manchester Care Record – an innovative joined up database of patient information from health and social care providers in the region.
About 600,000 adults live with obesity in Greater Manchester, according to Mark Fisher, chief executive officer of the NHS Greater Manchester Integrated Care Board.
He said the condition “reduces their quality of life and puts additional pressure on the health and care system” and welcomed the study in his region.
Mayor of Greater Manchester, Andy Burnham, said: “Greater Manchester is world-renowned as a hub for innovation in health and life sciences.”
Laura Rooney, director of strategy at Health Innovation Manchester, said the announcement of the trials was a “huge achievement”, and testament to strength of the health and care and academic sectors in the city.
The researchers said the plan was to release more details about the study at a later date.
What will the results be used for?
All the evidence gathered from the five-year trial will be used to demonstrate the long-term effect of weight loss medication.
Those behind the study say the results could help develop the care pathways set by health services for treating people with obesity.
Martin Rutter, who is a professor of Cardiometabolic Medicine at the University of Manchester said the trial would test the long-term effectiveness of the drug in the “real-world”.
Prof Rutter, who is the lead investigator for the trial, said the the results would look into how the drugs works in “a primary care setting compared to usual care”.
Primary care is the first point of contact for health care for most people and is mainly provided by GPs, but would also include community pharmacists, opticians and dentists.
‘A reported death or adverse reaction does not necessarily mean it has been caused by the medicine, only that someone had a suspicion it may have been.’
‘After a long hiatus, Lilly are now again dealing with a working people’s party in Britain’ …
Speaking as one who has dug actual foundations, I find groundbreaking ceremonies — in which senior officials scoop up a shovelful of earth and throw it into the air for the cameras — a bit distasteful.
Each of us has his job to do. If it’s not your job to dig the foundation, fine. But why pretend that it is?
The spectacle of drugmakers threatening to close manufacturing plants if their wares were not touted as first-line treatments reminded me of the modern-day conundrum: what does gross domestic product even mean when so much of what is produced — cigarettes, internet porn, time-sucking video games, and poisonous psychiatric medications — is inimical to human life and works?
‘The interesting angles are they can almost certainly trigger suicidality in some. What do they do to libido, alcoholism and other problems?’ – maybe we should be warning Wes and doctors of these possibilities? They’re not likely to hear such news elsewhere are they!
‘The beneficial is they are likely a treatment for PGAD, PMDD and all kinds of conditions that are linked to akathisia – Antidotes for Akathisia and Dysregulation’. The idea that this is likely to be greeted with open arms by those attempting to withdraw from psychotropic drugs, is misguided if those who meet with us by zoom are anything to go by. When it was shared with them that there may be some antidotes that they could try to, possibly, make matters easier, all hell broke loose! There is no way that they will let any such suggestions pass their lips! Once bitten twice shy – indeed, but what a waste if their very reaction to an antidote could help others in the future? Their fear, absolutely understandable of course, seems to block a possible source of, – dare we dream? – a way forward tin understanding akathisia and other ailments.
Such a difficult challenge!
Being once bitten and twice shy is understandable and one reason for not trying something else. But an unwillingness to try an antidote is a side effect of a belief in hyperbolic tapering whose advocates tend to figure there is no proper way to stop other than hyperbolically.
Peter Groot with his tapering strips is much more pragmatic and open to the idea that there may be steps that will help some other than just tapering
D
NEETS* and The Party for Working People.
*Not in Employment, Education or Training: – How many members of this sad, disadvantaged and expanding cohort are suffering social isolation and rejection as a direct result of lifelong injuries and harms caused by mainstream psychiatry’s misdiagnosis of AKATHISIA, disinhibition and emotional blunting; followed by unjustified incarceration, cruel and sadistic actions of “nursing” staff and forced, contraindicated drugging with fluoxetine, olanzapine and a cascade of other toxic, psychotropic drugs?
Each withdrawal syndrome and each deluge of drug-induced, multiple, psychotropic drug Adverse Drug Reactions – (serially misdiagnosed as ‘Serious Mental Illness’) – exacerbates the iatrogenic NEET Syndrome.
Unforgivable diagnostic and therapeutic incompetence.
Time for personal, professional accountability for grievous bodily, economic and emotional harm: –
(GBEEH, or simply Grievous Bodily Harm – GBH)?
The commitment to “Saving the NHS” is welcomed by one who afforded a lifetime of commitment to this treasured institution.
However, Is it really possible to save the NHS without having the courage to identify its failures?
Of these, the forty years of failure of drug-dependent, biological psychiatry must have cost £billions with such terrible outcomes, patient harms, injuries and deaths.
Predictably, those in power will be convinced by psychiatry’s “Defenders of The Faith” that all will be well with enough additional expenditure.
Looks like the DM are on a roll, the Evening Standard does much better
Eli Lilly might cheer, from the sidelines…
What’s the difference between Saxenda and Ozempic?
Ozempic and Saxenda have different active ingredients but both work to mimic a hormone, GLP-1, which controls appetite and blood sugar.
Ozempic, which uses semaglutide, is primarily used to treat type 2 diabetes but is often prescribed for its ‘off label’ weight loss effect.
Saxenda, which uses liraglutide, is primarily prescribed for weight loss.
Ozempic requires weekly injections while Saxenda is injected daily.
Both are owned by Novo Nordisk, founded in Denmark.
My dad died after 19 days on a miracle weight loss drug: Grieving daughter reveals the first sign something was terribly wrong – after he blamed his symptoms on burnout
https://www.dailymail.co.uk/health/article-13696067/Ozempic-Saxenda-death-Australia.html
Evening Standard
Sound research from this reporter
Ozempic, Wegovy or Mounjaro: the battle of the weight-loss injections
https://www.msn.com/en-us/health/other/ozempic-wegovy-or-mounjaro-the-battle-of-the-weight-loss-injections/ar-AA1t3KrP?ocid=BingNewsSerp
At the moment, only Wegovy is available on the NHS in England, Wales and Scotland, but Mounjaro – nicknamed the “King Kong” of weight-loss drugs and manufactured by Eli Lilly – will soon be available too. 1.6 million people are set to be offered the jabs over the next 12 years as part of a phased rollout.
Other drugmakers are working on versions too. Israel’s Teva Pharmaceutical Industries, the world’s largest generic drugmaker, launched a generic version of Victoza (used to treat type 2 diabetes) in the US in July. Among others in the arms race are Pfizer, AstraZeneca and London-based Novartis, who are exploring various innovative approaches to obesity treatment.
How effective a long-term obesity strategy weight-loss injections will be remains to be seen. But what is clear is that they have already shaken up the pharmaceutical industry, and are here to stay.
Us, lightweights, can look at this realistically- as so much attention is drawn away from the deadly ADs
Throwing good money after bad has never, ever been a good idea has it. Throwing psychotropic prescriptions at those who are more in need of a “listening ear” than taking a ‘happy pill’ isn’t either. Just because doctors are short of time during an appointment with a patient does not justify that prescription either.
Throwing Ozempic, or one of the other weight-loss prescriptions, at the NEETS group would not only be cruel, it would also throw that group into utter despair. They already feel almost invisible due to all that’s happened to them. Rather than these suggested prescriptions, how about spending the money on creating many more short-working-day slots, often created by local councils, for the purpose of giving these people some dignity in life. The feeling of “earning your own crust” is far reaching – and possibly exactly what is needed to support many of them to eventually progress into full time work.
To my mind, Wes Streeting’s thinking would be acceptable if he was opening up a route out of the over-prescribing of these powerful drugs for the thousands who certainly don’t need to be on them. Has he thought through the fact that a high number have gained many extra pounds in weight simply because they have followed their doctor’s instructions and swallowed their pills?
I certainly hope that he rethinks the position of the NEETS in a more acceptable and confidence-boosting way,
There will always be a group who are far too ill to entertain the idea of even part-time or voluntary work, of course. Tim, you have rightly described such a case. They must never be made to feel that they are a drain on society – we should be proud to carry their needs at all times…….especially when they belong to a group who took on trust the words and actions of their doctor. Neither accidental nor self-inflicted injuries – simply caused by mis-management and greed. No-one, in or out of parliament, should ever begrudge this group their Benefits but should rather count ourselves so lucky that we were not one of their number.