Request for American Psychiatric Association Assistance

Dear Dr Wills

You wrote to Dr. Makary on July 25^th following a July 21^st FDA Panel on Antidepressants and Pregnancy. I was a panel member and hope you won’t object to me taking advantage of your closing invitation to Dr. Makary to avail of APA assistance.

The panelists expressed very different views, so it is unclear whether anything I said concerned you.  I hope not, as my final remark echoed a concern Dr. Makary has, that I imagine APA, in principle, shares – namely creating a situation where doctors can be doctors.

I inserted ‘in principle’ above, as I have had concerns in practice about APA statements, as well as those from the Royal College of Psychiatrists, the American College of Obstetricians and Gynecologists, and most professional medical bodies.

These concerns took shape in 2004, after FDA put a Black Box Warning on antidepressants. APA responded with a letter whose key point I have Black Boxed:

I have used this letter in lectures since, calling it a professional suicide note, contrasting it with what I suggest you might have said:

I have been an expert witness in legal cases, including the 2009 Kilker case, mentioned in my FDA presentation, in which a jury found GlaxoSmithKline (GSK) at fault for a boy’s cardiac defects. Several hundred cases were settled on the back of that verdict.

This case brought home to me the extent to which pharmaceutical companies had penetrated organizations like APA and ACOG. It should not have been a surprise, as I saw this happening while I was a Secretary to the British Association for Psychopharmacology. Getting documents showing this was no accident and pharma view us as stakeholders in ‘its’ distribution channel, and play us accordingly, however, was striking.

Pharma are masters at what in political circles is called entryism – using a strategically placed person to nudge a seemingly ‘reasonable’ position paper toward adoption by an organization.

They also turn to companies like Chemrisk to pump out papers as part of a Doubt is our Product muddying of the waters. Or to claim False Balance at media coverage of treatment harms, if (company) RCTs have not found harms. Or in pregnancy to claim that, as no RCTs have been done, there is no evidence for harms.

In addition, most of the medical literature on branded products is ghostwritten. In several proven cases, but likely many more, fraudulently so. Where the ‘evidence’ APA might refer to comes from company studies, it is almost entirely hearsay. People are the data in trials and other studies and neither APA, doctors in general, nor FDA have access to study participants.

It has become difficult to know for sure how valid any articles like those you reference in your letter to Dr. Makary might be.[1]

Based on what GSK told FDA in 2002, the agency might have pointed out that Study 329 by Keller et al in JAACAP (2001) was fraudulent. It is not, however, FDA’s job to police the medical literature. It is our job to ensure the validity of this literature, but we have tolerated its perversion. Do we want Congress to mandate FDA to police our literature?

Perhaps the word ‘our’ is no longer appropriate. We publish in journals owned by corporations that make $3.5 billion per year from our work. Journals that serve their own business interests rather than our professional interests or the interests of our patients.  The biggest names in academic medicine are chosen by company marketing departments to feature on the authorship line of studies published in these journals, without ever having seen a patient on the drug or in the study. The studies are designed to make pharma and publishers money rather than to inform clinical practice. This is misinformation on an industrial scale.

The result is not surprising – falling US (and Western) life expectancies, especially among the young, reproductive rates falling below replacement rates, rising disability rates that countries like Britain worry jeopardize the viability of welfare systems, along with rising suicide rates among younger and pregnant women that parallel increasing SSRI consumption. While some of these changes may be correlated with rather than causally linked to SSRI consumption, the effects of SSRIs risk compromising any attempts to improve reproductive rates or manage our polypharmacy pandemic.

As I was making many of the above points in 2001, I contacted the British medicines’ regulator (MHRA) and offered to stop if MHRA could pick out anything that was wrong. We met. They did not quibble with anything.

Through FOI requests I found Lilly at this time suggesting putting people in the audience at Healy lectures to see if he says anything that offers a basis to sue him. I have not been sued – perhaps because Lilly later claimed having me lecture about the risks of suicide on SSRIs was doing more for the sales of Prozac than anyone else in the UK was doing.

I will speak to these points, in an extended version of my FDA presentation, at an October 4^th Meeting in Reno. I would welcome your assistance, either informally before the event or live at it, in finding the words most likely to suitably inform the public rather than unduly alarm it.[2]

The Reno meeting is co-sponsored by the Nevada Psychological Association, but I do not shrink in psychology forums from stating a belief in the medical model, links to companies, continuing willingness to prescribe antidepressants even to minors, and unwillingness to criticize FDA for the problems we have. I blame doctors, but, in Reno, I will blame psychologists also.

My concern is that if our medicines are as effective and safe as we claim, we will be replaced by cheaper prescribers like nurses or pharmacists. Given several potent over-the-counter serotonin reuptake inhibiting antihistamines can, but ordinarily don’t, cause all the problems prescription only SSRI antidepressants cause, what value do we add?  As learned intermediaries, perhaps all we offer is a shield for pharma against legal liability for treatment induced injuries.

Can a doctor keep patients safe without embracing what medical organizations increasingly term misinformation – a patient reporting a problem not in the drug label?  As mentioned at the FDA panel, it is not our job to keep to non-existent averages. Our job is to treat people who bring problems to us hoping for help, but who increasingly complain about being gaslit.

We need to restore our ability to be doctors. I would welcome your assistance in this endeavor.

Yours sincerely

David Healy MD FRCPsych

[1] I believe you have offered the wrong interpretation of the findings in some of the referenced studies.

[2] The public may be surprised to hear I’ve had considerable help from friends and whistleblowers within pharma and none from clinical colleagues or professional organizations like APA or RCP to date.