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Doctors who push new drugs do not have to admit that they are being funded by the pill makers

A lot of hope has suddenly appeared in depression therapy: the ‘party’ medicine, ketamine. Best known as a tranquilizer for horses, it is also used as an anesthetic in hospitals.

But ketamine can cause a high peak and is used illegally, with potentially nightmarish results; the drug is addictive and can cause psychosis.

Leading depression experts recently attended a London briefing to explain how a developed version of the drug, called esketamine, promises a breakthrough in providing fast-acting help to patients with treatment-resistant depression.

This serious form of depression has a very high risk of suicide. According to a Dutch study published last year, about a third of those affected will try to commit suicide.

During the briefing, the experts stated that while conventional SSRI antidepressants can take weeks or months to take effect, esketamine, a nasal spray of the ketamine type, can deliver lasting benefits within hours.

More than four in ten British health workers who take money from pharmaceutical companies do not disclose those payments and do not say where the money came from according to the latest figures.

More than four in ten British health workers who take money from pharmaceutical companies do not disclose those payments and do not say where the money came from according to the latest figures.

This made the headlines in British national newspapers and The BMJ. Countless internet news sites then knew the excitement around the world.

Newspapers reported to Professor Allan Young, director of the Center for Affective Disorders of the Institute of Psychiatry, Psychology and Neuroscience, King’s College London, the briefing: ‘We haven’t had anything really new for 50 or 60 years. What is especially exciting is the arrival of a new type of treatment; and that is ketamine.

“It has a different pharmacology. It is not just the same old steam engine. It seems to work in a different way and it seems to work faster. “

Dr. Carlos Zarate, head of experimental therapies at the US National Institute of Mental Health, who conducted the first clinical trial with ketamine for depression in 2006, added his authoritative voice and said, “Ketamine is now the prototype of the future generation of antidepressants that will have fast, robust effects within a few hours. “

The third expert, Dr. Rupert McShane, a consultant psychiatrist and associate professor at the University of Oxford, who runs the UK’s only experimental ketamine depression clinic, said that although there were concerns about the safety of the drug, “Ketamine, in my experience, is esketamine powerful and potentially transforming antidepressants’.

EXAMINES BIAS FINANCING?

What was not mentioned in the briefing reports is that Professor Young, Dr. McShane and Dr. Zarate have conflicts of interest that could jeopardize their independence as advocates of ketamine and esketamine.

A document issued during the briefing acknowledged that Dr. McShane and Professor Young have links with Janssen-Cilag, the maker of esketamine, have been paid for by Janssen and have carried out tests to reinforce claims for the benefit of esketamine.

Such links are far from unusual these days. However, they are a growing concern because studies show that when research is funded by drug manufacturers, it is likely to be much more likely to draw positive conclusions about the effectiveness and safety of the financiers’ drugs.

The need for transparency is of the utmost importance if the medicinal product concerned can cause serious side effects and potential addiction. And even more when the drug is expensive: esketamine costs an estimated £ 29,000 to treat a patient for a year.

Janssen, a subsidiary of the American multinational Johnson & Johnson (for which Professor Young says he is a consultant), is lobbying British and European authorities to have esketamine approved for depression.

Dr. Zarate can therefore benefit from this. He owns patents that entitle him to royalties on future sales of ketamine-like drugs for major depression.

Professor Young, who according to the King’s College London website is ranked as one of the world’s leading scientific minds according to the King’s College London website, has made few previous disclosures of his links with Janssen-Cilag.

He appears regularly in briefings organized by the Science Media Center in London, a charity that promotes communication between scientists and journalists, and while the recent briefing has outlined his potential conflict of interest, he has not mentioned Janssen in his income data on Disclosure UK.

This online register was set up in 2016 by the official body of pharmaceutical companies, the Association of British Pharmaceutical Industry (ABPI) to create transparency by enabling healthcare providers to show payments and hospitality from pharmaceutical companies.

In his 2016, 2017 and 2018 ABPI earnings information, Professor Young declares the receipt of £ 14,700 from three other companies. From 2016-2017, Professor Young was the principal investigator on a research contract for £ 163,635 from Janssen. Because the scholarship was paid to King’s College London instead of Professor Young, he did not have to declare it as a personal income.

It is high time that doctors were forced to disclose their funding

More than four in ten British health workers who take money from pharmaceutical companies do not disclose those payments and do not say where the money came from according to the latest figures.

The shocking statistic was revealed in June by the Association of British Pharmaceutical Industry (ABPI), which manages a database where pharmaceutical companies disclose their payments to healthcare providers – and where these professionals can indicate what they have received in terms of reimbursements, sponsorship and expenses.

This is not required. Disclosure is voluntary and doctors and researchers can edit information provided by pharmaceutical companies to the ABPI on any payment or relationship without giving reasons.

Last year, 43 percent of healthcare professionals did this – compared to just 35 percent at the launch of the database in 2016.

This is troubling because studies show that commercial money can influence researchers to get clinical trials to swing in favor of the funders’ products.

A study in the British Journal of Psychiatry in 2017 of 45 studies comparing talk therapy with antidepressants showed that studies sponsored by pharmaceutical companies were increasingly preferring the drugs.

The ABPI figures have prompted the authoritative Academy of Medical Royal Colleges to oblige British doctors to fully disclose the financing of pharmaceutical companies – a campaign that the Daily Mail now supports.

The president of the academy, professor Carrie MacEwen, told Good Health: ‘Doctors should not be deregistered from the ABPI database. As such, the system is fundamentally defective. “

Since 2013, medical companies in the US must legally record all payments made to researchers and healthcare providers in a publicly accessible database.

The Council for Evidence-Based Psychiatry, which campaigns for responsible prescribing of psychiatric drugs, calls on the UK to do the same with similar so-called sunshine legislation.

“Equivalent legislation is active in France, Australia and the Netherlands,” a spokesperson told Good Health.

“In Britain, patients and doctors could better understand the relationships between key opinion leaders and drug makers.”

A spokeswoman for the Association of The British Pharmaceutical Industry, who manages a database, said, “We support all doctors who disclose the important work they do with the industry and encourage others to do the same.”

She added: “We are constantly working with the NHS to improve the disclosure rate, in the interest of transparency for patients.”

DOCTORS WERE STORED

According to the ABPI’s interpretation of data protection rules, he does not actually have to disclose any payments: individual healthcare providers can demand that information about their payments be withheld – without having to give a reason why.

The British Association for Psychopharmacology, chaired by Professor Young, received £ 22,000 in sponsorship from Janssen last year and had Dr. Zarate as a guest speaker at her recent annual conference.

Dr. tires. McShane with Janssen, on the other hand, are relatively easy to distinguish.

In various newspapers he mentions himself as the principal investigator for Janssen’s trials with esketamine and as a consultant for the company.

His voluntary disclosure of ABPI shows that he received £ 9,937 in fees and expenses from Janssen in 2018. Such transparency is important, as financing of pharmaceutical companies is vital for the creation of new medicines, British health professionals, regulators and the public must can understand whether an expert opinion is possibly biased.

This does not have to be intentional or corrupt, but the fact is that there are indications that links between pharmaceutical companies can influence the opinion of experts in ways that can be so subtle that they are subliminal.

For example, a review by the highly respected Cochrane group in 2017 concluded that clinical trials generally find more favorable results on a drug company’s products if the company sponsors the trial. Moreover, an editorial in The BMJ last year warned that it is becoming increasingly difficult to unravel the links between pharmaceutical companies and pilot research: “Without greater transparency, we risk undermining the integrity of some of the most influential studies in medicine.”

But like Dr. Ben Goldacre, the best-selling author of Bad Science and research transparency campaigner, Good Health told us, we are often on a split stick because we depend on funds from pharmaceutical companies to investigate new therapies. “How do you get” fully independent researchers “on any subject?” he asks. ‘Who else will pay for it? Rightly or wrongly, the reality is that all companies pay for researching their own products. “

Dr. Solution Goldacre is that we should legally demand that all potential financial conflicts of interest are fully stated in an easily accessible database (see box).

“Unfortunately, such conflicts are usually not disclosed,” he says. “This could be resolved by the position of the medical profession, by policymakers who set clear rules for disclosure, and by professional organizations that punish offenders.”

PATIENTS MISS OUT ON WHOLE PHOTO

The need for complete transparency is of the utmost importance with a drug that is controversial like ketamine.

The possible side effects, including hallucinations, dizziness, anxiety, psychosis and blood pressure, mean that patients can only get the medicine under supervision in a clinic room – and are kept there two hours after every weekly dose, while being monitored by trained personnel in handling with hallucinating, cardiac and respiratory problems.

Another concern is that scientists disagree about how the drug might work.

In February, Professor Young wrote a paper in the journal PeerJ suggesting that ketamine can work against resistant depression by inhibiting areas of the brain associated with troublesome emotions and memories (he stated in the magazine that he had no competing interests).

Alan Schatzberg, an eminent professor of psychiatry at Stanford University in the US, however, published a study last year that showed that ketamine works by activating brain opioid receptors – just like drugs such as morphine and heroin – whatever such drugs can do make addictive.

When Professor Schatzberg’s team introduced a drug that blocked these opioid receptors, the effects of ketamine stopped. This suggests a high risk of becoming addicted to ketamine-like drugs and then suffering from withdrawal pain.

During several years of trials sponsored by Janssen, six people who received esketamine died, unlike none on placebo. Three dead were suicides.

The US drug licensing authority, the Food and Drug Administration (FDA), said it was difficult to consider deaths as drug related. However, Professor Schatzberg says the deaths resemble the way addicts kill themselves during withdrawal from opioids. Two suicides had occurred within three weeks after the patients had stopped treatment.

THE PSYCHEDELIC DRUGS ARE SUPPORTED FOR MENTAL HEALTH BENEFITS

In recent years, scientists have increasingly looked at psychedelic drugs as promising therapies for therapy-resistant mental disorders.

Currently, such mind-expanding drugs are largely illegal in the US.

However, ongoing clinical studies suggest that drugs that were once loved by hippies and club kids can also have medical benefits.

Scientists investigate:

Ketamine

The club medicine and tranquilizer have been tested for several years for the treatment of depression.

In March 2019, the US Food and Drug Administration approved the first nasal spray version of the drug.

Ketamine works much faster than traditional antidepressants, and scientists believe it encourages new neural connections that can help overwrite unhealthy, depressive thinking patterns.

psilocybin

The active ingredient in ‘mushrooms’ is psilocybin a powerful hallucinogen.

It also works much faster than traditional drugs and is being analyzed for use in patients with both depression and PTSD.

Psyilocybin helps to stimulate neurplasticity and it is thought to dampen the ‘standard mode network’ in the brain and activate the ‘salience network’ involved in medication.

In August, the FDA has so far approved the largest clinical trial for psilocybin.

MDMA

The MDMA club drug – sometimes called ‘Molly’ – is currently being tested to treat PTSD.

MDMA appears to be a quiet activity in the amygdala and hippocampus, brain regions involved in emotional processing and anxiety reactions, which are overactive in people with PTSD.

Patients participating in MDMA trials take a dose of the drug and sit for eight hours with two therapists who guide their experience.

LSD

The psychedelic composition LSD has a similar structure to the chemical in the brain, serotonin.

The discovery of LSD played a role in our discovery of how serotonin works in the brain and why neurochemical imbalances are involved in depression and anxiety.

Tests with LSD-assisted therapy to treat anxiety are ongoing and have shown early promise.

“For me, these deaths are related to the use of the drug,” Professor Schatzberg argues.

Dr. McShane is also concerned about the potential for addiction. “Because ketamine makes you feel better so quickly, you want to use it again if you fall back,” he told reporters in March.

‘If the dosage and frequency become too high, it becomes toxic. It is possible that people treat themselves with illegally obtained ketamine. “(He also stresses that the use of the drug must be closely monitored.)

Critics also claim that ketamine-like drugs have not proven their effectiveness in treating depression. In two of the three short-term studies sponsored by Janssen, esketamine was little or no better than a placebo in relieving depressive symptoms.

Dr. McShane’s own Janssen-sponsored study in 138 elderly patients was inconclusive and showed that the drug was only useful when the pool of patients in the study was limited to the over-75s.

When esketamine was licensed by the FDA in the US in March, it was only based on clinical studies funded and conducted by Janssen, rather than independently.

Meanwhile, separate clinical pilot projects of ketamine for depression in Australia and New Zealand, not funded by Janssen, were abandoned last year due to concerns about dangerous side effects and lack of effectiveness.

WHY THIS IS IMPORTANT FOR YOU

In Great Britain, esketamine could already get the green light in November for depression under the brand name Spravato. It is currently being considered by the British medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

However, some fear that ketamine may prove to be a case of history that repeats itself disastrous. Large-scale withdrawal problems associated with conventional SSRI antidepressants – as emphasized by Good Health – have finally been officially recognized by UK agencies such as the Royal College of Psychiatrists. Could the medical authorities soon be able to add a drug with similar hazards?

Dr. James Davies, lecturer in psychotherapy at Roehampton University and spokesperson for the Council for Evidence-Based Psychiatry, who raises awareness of the damage that can be caused by psychiatric drugs, Good Health said: “We are deeply concerned about the proposed approval of esketamine. It works through an opioid mechanism and probably causes serious problems of addiction and withdrawal.

‘No one should forget the troubled history of psychiatric medication, where supposedly safe and effective medication appears to be addictive and harmful with long-term use. We urge the MHRA to refuse a license for this drug, at least until the long-term safety and efficacy studies have been completed. “

Professor Young and Dr. Zarate had not responded to the Mail’s requests for comments before they went to press.

Dr. McShane pointed out that in all discussions with journalists, he emphasizes his potential conflicts of interest. A spokesperson for Janssen said: “We actively encourage the health professionals we work with to publicize payments they have received from both Janssen and the wider industry.”

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