This post should be read in conjunction with Are Journalists the Answer to Clinical Medicines Cause and Effect Problem which is on davidhealy.org, or will be, and last weeks Clinical Details Confuse Expert Doctors along with Royal College of Psychiatrist’s Suicide Note.
Several months ago, I agreed to review an article by John Read analyzing the hundreds of antidepressant suicides catalogued on the AntidepAware site. John did an elegant job making it clear that the drugs had likely caused many of these suicides. He was hampered by the fact that the coroners had not returned drug induced suicide verdicts – British coroners have no box to tick for a prescription drug induced death.
My review introduced readers of John’s article to a horrifying idea. When a doctor gives someone an antidepressant and they commit suicide days later, if the doctor thinks the drug caused the problem, as Dr Adams seems to have done in the case of Samuel Morgan, his medical insurer will tell him not to blame the drug.
If the doctor is uncomfortable with this, the lawyer for the insurer will attempt to do the talking for the doctor and will blame the illness not the drug. See Will Medical Insurers Stop Killing People.
The Medical Protection Society had a video demonstrating what insurers can do for doctors facing an inquest about a suicide – this has now disappeared with a shorter version only on their Facebook page.
The role of insurers helps explain why, even if he had a box to tick, it is almost impossible for a coroner to blame the drug
The editor of the journal publishing Johns Article, Don Marks, suggested turning my review of John’s article, into an article in its own right – Diagnosis and Causality. It contained details of Sam Morgan’s case and Romain Schmitt’s – outlined last week in Clinical Details Confuse Expert Doctors.
We are EMA and We are Here to Help You
A few weeks later I got an email from EMA. Or so it seemed.
The email was odd. It asked for some trivial details about Sam and Romain – their weight for instance. There was no interest to make contact with Sam or Romain’s parents to find out what really happened.
Dear Dr David Healy,
I am writing to you on behalf of the European Medicines Agency’s Medical Literature Monitoring service, regarding the following article which you recently published: Healy D. Diagnosis, Verdict Conclusion, and Causality. Ethical Human Psychology and Psychiatry. 2023; 25: 29-37.
The European Medicines Agency is the agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU, working with the regulatory agencies in all EU Member States and the World Health Organization.
We monitor the medical literature for reports of adverse drug reactions (ADRs), turn these into ADR reports and transmit them to regulatory authorities and pharmaceutical companies in the EU and to the World Health Organization. These are used in detecting possible signals that could lead to a change in the understanding of the risk-benefit balance of the medicines.
In your article, you describe a patient who experienced SSRI-induced suicidality and suicide associated with citalopram and more disorganized, aggressive, trouble sleeping, irritability, violent attacks, mood disorders, thought disorders, emotional instability, disinhibition, impaired discernment, suicidality, steady decline in his mental state and committed suicide associated with usage of unapproved paroxetine.
To aid our pharmacovigilance assessors in their understanding of the reactions caused by these medicines, we would be grateful if you could provide a little more information regarding the [patient, drug and the reaction(s).
Any information that you can give us would help. Even approximate information is useful, so, for example, if you only know that the patient was overweight, rather than their exact weight, then that would still be helpful.
We would be grateful if you could send your response by return email to MLM@kinapse.com.
Thank you in advance for your contribution to the ongoing safety surveillance activities of this product.
With best regards, Ankitha Gongalla, EMA Medical Literature Monitoring service
Kinapse and Syneos
Ankitha works for Kinapse, a medical-writing company. Her email to me was copied in to two employees from Syneos.
A now hidden website says: Kinapse is a global leader in post-approval clinical trial transparency services for both EMA and pharmaceutical companies. For companies, Kinapse offer “Marketing authorisation holders’ monitoring and reporting requirements” (Phogat and Vishist 2018).
EMA selected Kinapse in 2010 to provide EudraVigilance data management services (Pharmafile 2010). Kinapse also fill EMA’s demands for plain-language summaries for clinical trial results that can be understood by anyone, which as Pharmafile outlines could create new challenges for sponsors.
The Kinapse profile on LinkedIn states that Kinapse, a Syneos Health company, is recognized as a leading advisory and operational services provider to the global life sciences industry. Founded by professionals from the biopharmaceutical sector, the company provides its services across the full clinical and commercialization lifecycle, collaborating with its clients to improve the lives of patients, through a unique Advise – Build – Operate Delivery Model. Many of the top 20 global biopharmaceutical companies rely on the breadth of Kinapse’s world class advisory and operational services to analyze, implement and perform a wide range of projects and programs across global markets, delivering quantifiable business benefits and operational success. Headquartered in the U.K., Kinapse has over 600 staff located in Europe, India and the U.S.
Syneos Health (formerly InVentiv Health Incorporated and INC Research) is a Nasdaq listed American multinational contract research organization based in Morrisville, North Carolina. It specializes in helping companies with late-stage clinical trials. In January 2018 INC Research acquired inVentiv Health, the parent company of a subsidiary, Syneos, and the resulting company was named Syneos Health. In April of 2021, Syneos partnered with Medable to leverage DCT technology solutions to expand patient access to clinical trials.
On May 10, 2023, an investment consortium comprising Elliott Investment Management, Patient Square Capital and Veritas Capital, agreed to take Syneos private in a deal worth $4.46 billion, or $7.1 billion including debt. Michelle Keefe, the current CEO of Syneos Health, was previously a Pfizer Vice-President of sales, and regional president.
It was time to write to EMA – whose CEO is Emer Cooke.
Dear Emer Cooke
I am puzzled by the email below that came my way. I am used to pharmaceutical companies getting in touch when their drug is linked to an adverse event. I am not used to a regulator like EMA or MHRA getting in touch and even less so when the EMA/MHRA function seems to be contracted out to a private company.
It is usually clear that the pharmaceutical company is ticking a few bureaucratic boxes with no interest in the lives or deaths of those affected by treatment and no interest to establish causality or to think about how to put things right.
I ordinarily give company emailers the contact details and invite them to contact the surviving relatives of patients and to engage in an effort to establish what is going on.
I can remember a time when pharmaceutical companies took seriously what they viewed as a legal obligation to establish causality in the case of adverse events but this changed around 2000 and now companies like Pfizer ‘report’ adverse events, cutting and pasting almost irrelevant details like patient weight into a report that is sent off to EMA or FDA or whoever.
Things appear to have developed even further in this direction following the Dolin case where companies are manoeuvring to avoid liabilities from generic products. They are outsourcing liability.
I didn’t expect what appears to be something similar from EMA. I have the details being asked for in the report below but there seems to be absolutely no point in sending them on to whoever Kinapse really is
I have copied the families of those affected in scenario 1 and 2 into this email – the Morgans and Yoko Motohama and Vincent Schmitt. I expect they would be happy if EMA were to contact them, even though I have already let them know that EMA’s standard operating procedure – the removal of names from accounts of events – makes it impossible for EMA to establish cause and effect in the case of any adverse event (making the irrelevant details being asked for doubly irrelevant).
I found out about this aspect of EMA’s SOP – removal of names – some years ago when engaging with EMA about a problem called PSSD.
(I have cut a mention that I was copying three journalists in here).
The emergence of Kinapse into this story may have provided all three journalists with what might be an important element in the stories of what happened to the two boys who died in these cases. Perhaps I should have said an important element in the stories of why nothing ever happens following terrible events like these.
David Healy MD
To be Continued:
The research on Kinapse and Syneos was done by Yoko and Vincent who found out a lot more detail, forwarded to EMA, about contributions from pharmaceutical companies to Syneos and disbursements from Syneos to French institutions supposedly keeping French citizens safe.
This sequence of events illuminated what is going wrong in pharmacovigilance which will be summarized in the next post.