Unsafe Safety

On March 20^th, Senators Tina Smith and Ben Lujan, and Representatives Andrea Salinas and Becca Balint, sent a letter to the Secretary of the US Department of Health and Human Services, Robert F Kennedy, expressing concern about a promotion of disproven and outright false theories about mental health medications. In separate comments, Senator Smith indicated she had been helped by these medicines in the past.

The Full Letter is Here.

Kim Witczak, a consumer representative on FDA advisory bodies, for several months prior to this had been thinking a meeting with her Senator, Senator Smith, to whom she could bring evidence from a legal case she took following the death of her husband, Woody, two decades previously, might help show many points that concern Secretary Kennedy are underpinned by good evidence.

Senator Smith’s March 20^th letter opened a door for Kim to seek an in-person meeting. Kim was in Washington the week of April 21^st and offered to meet but Congress was in recess that week. Senator Smith’s team – Jeff Lomonaco, Rachel Fybel, Mary Fernandez and Sarah Sandgren – offered an initial 30 minute video-meeting on April 17^th just before recess.  Kim got agreement to bring one person with her – me.

Kim began and ended by expressing a hope that a cross party forum could be set up to engage with the serious issues now in the public domain. She mentioned her participation in the efforts of Senators Grassley (Rep) and Dodds (Dem) in 2005 to advance the safety cause. She held up a folder of documents she could bring to any meeting.

In closing, the Smith team suggested the climate was not conducive to bigger picture bipartisan efforts in a way that had been possible in 2005, but they were open to receiving specific pragmatic proposals they might be able to get behind.

Healy Input

My input to this short meeting was a rushed pitch built on Unsafe Safety, a notion borrowed from Dee Mangin, a Professor of Family Medicine at McMaster University in Canada.

You will not find a more passionate supporter of biomedicine than me, nor any call by me for drugs to be removed from the market – certainly not SSRIs.

All of the major pharmaceutical companies have consulted me. I’ve been an investigator in their drug trials. As Secretary of the British Association for Psychopharmacology I chaired one of the UK launch meetings for Zoloft.

I am also an expert in legal cases in Australia, France and the UK, countries where lawyers cannot get an expert to testify about treatment hazards. But most of what I know comes from being an expert in U.S. suicide and homicide cases where lawyers have also not been able to find credible experts willing to testify. I was an expert in Kim’s case 2 decades ago.

My background means on one side company people have handed over documents that led New York State to take a fraud action against GSK, and later contributed to a $3 Billion fine.

On the other side, I’ve seen data on these drugs FDA has not seen and can support the points below with company or regulatory documents.

SSRI medicines clearly work well for some people, as Senator Smith’s experience proves. But they can cause problems for up to half of those to whom they are given, including suicide and homicide.

Our Unsafe Safety System leads critics to call for these medicines to be removed, when they should call for Safer Safety. The critics are shooting themselves and us in the foot.

But doctors who say there is no problem with these drugs also shoot themselves in the foot. If the drugs work as well and are as free of problems as we are told, doctors will soon be out of business – nurses and pharmacists are cheaper prescribers.

Biomedicine means being cautious about taking a risk with a drug available on prescription only because it’s unavoidably hazardous. It also means knowing when not to take a risk.

I knew Arvid Carlsson, who created the SSRI idea, made the first 2 of them, and inspired all the rest, including Prozac the 6^th SSRI.

Carlsson was a Nobel Prize winner. His view was that SSRIs act on a normal serotonin system, just as LSD does, and just like LSD they can produce good effects in some and bad effects in others including suicide.

SSRIs are weaker than older antidepressants, but they do help some people. A dangerous chunk of misinformation in our Unsafe Safety System says these drugs can take 6 weeks to work. This is wrong. The good and bad effects are obvious to you on treatment or to your family and friends long before recovery or death, but we don’t use this information.

Our safety opportunity lies with those who have bad effects early on. Doctors kill people by telling them to stay on treatment for up to 6 weeks, often doubling the dose or adding other meds on an – “Oh it seems you are more severely ill than we thought” – basis.  Listening to patients having bad effects, Carlsson ran a trial comparing SSRIs to nicotine and found that for those doing poorly on an SSRI, nicotine could be better.

Antidepressant SSRIs come from antihistamines like chlorpheniramine and diphenhydramine, which are also serotonin reuptake inhibitors, capable of causing all the problems SSRIs cause.  But these risky drugs are safer than SSRIs because they are OTC.  How can this be?  Well if we take one and feel strange or start having abnormal thoughts, out of natural caution we stop them. We don’t need to consult a drug label or a doctor.

The drug labels for prescription only SSRIs, and our doctors tell us to keep taking them. This is how companies and FDA risk killing us and are killing medicine.

We get told FDA are there to keep us safe. FDA is a bureaucracy whose job is to look over license applications and ensure companies don’t claim their drug will help us live a perfectly healthy life from here on and get straight to heaven when we die.

The name Food and Drugs Administration tells you FDA set a standard for foods like chocolate or butter or drugs like antidepressants.  Meet the standard and FDA license the use of these words. Their contribution to safety is ensuring companies don’t go too far with their claims.

FDA don’t tell us this is a good chocolate, or butter is good for us, or antidepressants save lives.  They can’t let companies claim any drugs save lives because the licensing trials are too short to show this and typically more lives are lost on new treatments than on placebo.

Ideally FDA’s existence would ensure companies write all the hazards of their drugs into the labels of their drugs. Companies used to do this to a greater extent than they now do, but they have learnt how to run rings around both FDA and doctors.

Keeping you safe on prescription drugs is a job for doctors like me. That job is getting harder and harder – as you might guess from the difficulties lawyers world-wide have to find a expert to defend you in the event of a drug induced injury.

One reason for this is that the articles on these drugs and vaccines in the medical literature are ghostwritten. Neither the ghost writers nor the academics on the authorship line of these papers ever gets to see the data.

Study 329 was a trial of Paxil in depressed teens published in 2001 in a good journal with 22 authors, none of whom had seen the data.  Sally Laden was the author, but her name is not on the authorship line.  Study 329 claimed Paxil works well and is safe.

A year later, GSK applied to FDA to license a claim Paxil is an antidepressant for adolescents. GSK told FDA Study 329 and 2 other trials in adolescents were all negative.  FDA agreed to license GSK’s claim and agreed not to mention in the Paxil label that all adolescent trials were negative.  FDA had done the same in the case of Prozac and adolescents.

Around 2004, all pediatric depression articles were glowingly positive, while all trials were negative. Many adult licensing trials were also negative but published as positive.

You may be wondering what are FDA doing. FDA are bureaucrats who stick to their job description, which does not include policing the medical literature. Policing the literature is a job for doctors and journal editors and they are letting us down.

The company ‘trials’ we’re talking about here are assays designed by companies to get a license. They are not clinical trials designed to inform clinical practice. Strictly speaking they should not be published in medical journals and certainly should not provide most of the so called evidence underpinning guidelines – standards of care – or so-called Evidence Based Medicine (EBM).

The commonest effect of an SSRI – good or bad – is to numb genitals, mute orgasms and kill libido. You are not told this – nor is your partner whose life may be affected as much as you.  Neither of you are told that after you stop treatment, these sexual problems can last the rest of your life – as can visual, balance and other problems.

If male your sperm count may be wiped out. If female your ability to carry a pregnancy to term is affected. Partners aren’t told about this, and the county is not having a conversation about this – is not being told we need immigrants to fill jobs and pay taxes because the natives can’t reproduce.

FDA play a part in ensuring Senator Smith doesn’t get to know about this by approving the drug labels companies write. It is probably not right to say FDA’s censor information as it’s not their job to decide what drugs cause. That’s a job for doctors and companies.

Companies have stopped doing it and have stopped doctors doing it.  Medical journals don’t publish the articles on hazards that doctors once wrote because lawyers tell journal editors they might get sued. Doctors and their journals are innocents who get Yippy when a company bluffs about suing them.  Maybe they should read The Art of the Deal. Prescription-only means companies cannot make money if doctors don’t prescribe. Doctors have a lot of weight they could throw around.

We now face serious problems linked to all this. There is still a place for giving an SSRI to a minor but adolescents and twenty-somethings are now the group most commonly starting these meds. We have escalating rates of disability and a Health Crisis that resembles the 2008 financial crisis. In 2008, money chased money while poverty rose. Now drugs chase drugs while our health gets worse.

Unlike pilots who have an incentive to keep us safe – if we die, they die, in 2008 bankers had no incentive to keep us safe. In 2025 our Unsafe Safety Systems do not incentivize doctors to keep us safe.

We now get neither good healthcare nor justice.

Marilyn Lemak, an esteemed Chicago Nurse, killed her 3 children and tried to kill herself when put on Zoloft. Whether or not you agree with me that Zoloft likely caused this, she did not get a fair trial. Her lawyer could not run a Zoloft defense. The law has changed, and she might get a fair trial 25 years later but for the last 4 years Governor Pritzker has been sitting on a clemency plea that Kim and I played a part in.  See Clemency Hearing and When the Music Stops.

Even with a law change, juries will need to grapple with the contradictions Unsafe Safety Systems pose. The lawyers for James Holmes – the Batman Killer – in 2015 in a State that did allow a Zoloft defense chose not to run one figuring among other things they might not have the skills needed to convince juries that:

• FDA let drugs on the market their makers know can cause mass homicide
• FDA don’t see key data on the medicines they approve
• Most articles reporting the results of company assays in the New England Journal of Medicine and other leading journals are ghostwritten and often fraudulent.

Whether you think as I did after interviewing him that 12 people would be alive today but for Zoloft, Holmes didn’t get a fair trial.  Our Unsafe Safety Systems are neither Safe nor Just.

UnSafe Safety: Proposals

Swallowing chemicals is hazardous.  A medicine is a chemical that comes with information designed to keep us as safe as possible.  The points below center on this information. Are they ones that those on either side of the political aisle might be able to endorse?

1. Company assays designed to get a license should be distinguished from medical trials designed to inform clinical practice.
2. Medical journals should only publish the latter.
3. Guidelines (Standards of Care) and EBM should only be based on medical studies.
4. Mentioning the names of medical writers in small print at the end of company assay publications does not solve the ‘ghostwriting problem’.
5. People not numbers are the data in clinical trials. In order to understand what a trial (not an assay) has shown, investigators need access to the people recruited.
6. Consent forms for company assays state we will not share your data with anyone – these commercial protections have no place in medical consent forms.
7. Individual cases, not company assays, establish whether a medicine has the capacity to cause a problem like suicide.
8. Medical journals should be able to publish clinical reports written by doctors, without fear of a company legal action or other reprisals – or perhaps should just toughen up.
9. FDA are a bureaucracy, that scrutinizes company license applications – this gives them a minor safety role.
10. It is not FDA’s job to establish cause and effect links between medicines and effects.
11. Companies can draw cause and effect conclusions but stopped doing so two decades ago and need to resume doing so.
12. Doctors and medical journals can also establish cause and effect links and need to resume doing so.
13. If we want new drugs, we need to accept that company assays cannot last for years and as a result these assays can establish an effect rather than effectiveness.
14. Treating healthy people for risk factors, which do not need treating, is how companies make most of their money – this might need a separate regulatory system.
15. Nobody should be left on legacy drugs.
16. FDA misleadingly claim they license medicines on a positive benefit-risk basis. The licensing of SSRIs for PTSD on the basis of a marginal and debatable benefit in a subset of patients in a minority of trials, while everyone who takes an SSRI has sexual dysfunction. This one adverse effect which will likely be significant to all affected, and can be life-changing, happens in double the number of those who might receive a benefit. In the case of males, such as those in the U.S. military, taking Zoloft there was no demonstrable benefit at the time of licensing.
17. Benefit-risk assessments are primarily a matter for the person on treatment. A regulatory line implying treatment should continue regardless of the person’s views is dangerous – as the recent case of Thomas Kingston in the UK and Woody Witczak over 20 years ago demonstrate.
18. Allowing companies to improve the information content of Generic Drug labels could drive change – Legislative Lacunae – FDA considered this but got Yippy.
19. Doctors have lost sight of the role they and their patients have in assessing what is happening on a medicine.  As Austin Bradford-Hill who created RCTs and Louis Lasagna who introduced them into the 1962 FDA Act said – RCTs and EBM tell us nothing about how to treat the patient in front of us.

References

1. Mangin D, Lawson  et al.  Legacy drug-prescribing patterns in primary care.  Annals of Family Medicine 2018, 16, 515-520.
2. Healy D. Randomized Controlled Assays and Randomized Controlled Trials.  A Category Error with Consequences. Ethical Human Psychology and Psychiatry 2023, 25, 119-134, http://dx.doi.org/10.1891/EHPP-2023-0006
3. Healy D.  Cause, effect and adverse events.  Evident Based Medicine or Evidence Based Medicine. Indian J Medical Ethics, February 14, 2025. DOI: 10.20529/IJME.2025.011
4. Healy D. Big Data, Artificial Intelligence and Clinical Experience. Indian J Medical Ethics February 28, 2025. DOI: 10.20529/IJME.2025.017

Kim Witczak 2005

I was involved in with Senators Grassley (R) and Dodd (D) around post-market safety and clinical trial transparency. I believe these prior legislative efforts provide a strong foundation to build on. The 2007/08 PDUFA negotiations initially had the strongest drug safety additions but subsequently were horrible for the public and mostly helped industry.

1. Fair Access to Clinical Trials (FACT) Act – 2005

Co-sponsored by Senators Grassley and Dodd, this bill was designed to increase transparency and public access to clinical trial results. It emerged in response to safety concerns following drug scandals like Vioxx and aimed to address:

• Suppression of unfavorable trial results by pharmaceutical companies
• Creation of a national clinical trials database through an expanded ClinicalTrials.gov
• Public disclosure of all trial outcomes—positive and negative
• Greater transparency into internal FDA drug evaluations and approval documentation

The goal was to enhance independent oversight and reduce agency secrecy.

2. Key Proposals from the 2007-2008 PDUFA IV Negotiations

During the reauthorization of the Prescription Drug User Fee Act (PDUFA) in the 2007-2008 period (leading to PDUFA IV, enacted as part of the Food and Drug Administration Amendments Act of 2007, or FDAAA), Senator Chuck Grassley was a vocal advocate for reforms aimed at enhancing drug safety and improving transparency at the FDA. His key requests for legislative changes focused on the following areas:

• Strengthening Post-Market Drug Safety Oversight Increased Authority for FDA: Grassley advocated for stronger FDA authority to ensure post-market surveillance of drugs. He emphasized the need for the FDA to have tools to monitor drug safety after approval, including mandating post-market studies and swiftly acting on safety concerns. He supported the establishment of the Risk Evaluation and Mitigation Strategies (REMS) program, requiring additional safety measures for drugs with significant risks.
• Greater Independence for the FDA’s Office of Drug Safety: Grassley pushed for reforms to make the FDA’s Office of Drug Safety more independent from the Office of New Drugs. He believed this structural change was essential to eliminate conflicts of interest and prioritize patient safety over expedited drug approvals.
• Improved Transparency Grassley consistently called for greater transparency regarding clinical trial data and FDA decision-making processes. He criticized the FDA for being too secretive, particularly about adverse events and safety concerns. He championed the ClinicalTrials.gov database expansion, requiring more comprehensive registration of clinical trials and public disclosure of trial results. Creation of a national clinical trials database through an expanded ClinicalTrials.gov
• Addressing Conflicts of Interest He advocated for stricter rules on conflicts of interest within the FDA’s advisory committees. Grassley criticized the frequent waivers granted to advisors with financial ties to pharmaceutical companies and sought stronger conflict-of-interest policies.  This became the Sunshine Act.
• Funding and Independence Grassley expressed concerns about the pharmaceutical industry’s influence over the FDA due to PDUFA user fees. He supported increasing congressional appropriations to reduce the FDA’s reliance on industry funding.
• Improved Transparency Grassley consistently called for greater transparency regarding clinical trial data and FDA decision-making processes. He criticized the FDA for being too secretive, particularly about adverse events and safety concerns. He championed the ClinicalTrials.gov database expansion, requiring more comprehensive registration of clinical trials and public disclosure of trial results.
• Whistleblower Protections Grassley supported measures to strengthen protections for FDA employees and scientists who reported safety concerns or undue influence by the pharmaceutical industry. He believed that whistleblower protections were crucial for fostering accountability within the agency. These proposals reflected Senator Grassley’s broader focus on enhancing the FDA’s regulatory framework to better protect public health while addressing systemic issues of transparency, independence, and accountability. Many of these reforms were incorporated into the FDAAA of 2007, marking a significant expansion of the FDA’s authority and responsibilities.

Moving Forward

The Grassley-Dodd proposals were serious proposals aimed at tackling serious problems – the Vioxx and Antidepressants and Pediatric Suicide crises of 2004.

Industry are very good at turning to their own advantage the efforts of figures concerned to make things safer.  And it now looks like our Safety Systems are more Unsafe than before.  See Big Data.

We need your ideas on what might make a difference.  We don’t need to hear your thoughts about what Heaven should look like.  We need your appreciation that we are dealing with people and forces that have managed to turn what have looked like excellent proposals aimed at advancing safety into the fuel for bandwagons to increase the use of drugs and if anything reduce our protections.

For the moment, we are holding some radical proposals in reserve.