Yesterday we had a review of Malcharist by Gary Schwitzer. Today’s review is by Leemon McHenry – see below.
Malcharist, by Paul John Scott, is a fictional account of one of psychiatry’s most influential key opinion leaders (KOLs), his ghostwriter, and a journalist on the trail of a big scandal in the world of Big Pharma. The story didn’t happen in reality, but Scott has done his homework in such a way that one of medicine’s darkest secrets is exposed in all of its sordid detail.
For those of us familiar with industry-sponsored clinical trials such as GlaxoSmithKline’s studies 329 and 352, it doesn’t take much imagination to draw analogies to an all-too-common theme: a psychiatrist and a ghostwriter who helped create an illusion. He takes all the credit for her labors and she disappears into the background. What is presented to the medical community, however, is a story of pharmaceutical marketing masquerading as science.
The narrative begins with a terrifying description of a patient suffering drug-induced akathisia, a side-effect of antidepressants that often ends in suicide. Chapter by chapter, Scott then introduces the central characters, journalist Griffin Wagner, ghostwriter Shivani Patel, and key opinion leader Dr. Jeremy Elton, and then weaves together the plot, in which the drug maker manipulates clinical trial data to hide the dead bodies in the statistics.
In the novel, Jeremy Elton, M.D, PhD, Director of Clinical Research, University of Dallas, Institute of Brain Studies is America’s psychiatrist—overseeing $36 million in NIMH grants, co-author of 10 textbooks, author of 600 medical journal articles, paid consultant for six Fortune 500 pharmaceutical companies, and recipient of royalties from 16 pharmaceutical patents and 13 medical devices. (101) He pushes the blockbuster drug, the antidepressant Serotonal, that is fictional drug maker Krøhn-McGill Pharmaceutical’s goose that lays the golden egg, sold to prescribers and patients to correct the elusive chemical imbalance in the brain.
Vice President for Clinical Research Seamus Cole and ghostwriter Shivani Patel lure the KOLs on board with Krøhn-McGill with lavish gifts delivered at vacation venues such as ski and tropical resorts, golf getaways, and first-class hotels in the big city. Cole’s job is to make the physicians feel a little less like prostitutes and a bit more like heroes conquering debilitating illness as they assume their role as product champions for drug sales. (31) With a disingenuous self-depreciation and flattery for his new crew, he delivers a well-rehearsed message:
“I am not an expert in psychiatry but I know that every one of you are destined for the very top of your profession, and more importantly, that we can learn a lot from you. We know your peers can learn from you, as well, especially when we arm you with cutting-edge scientific presentations to deliver at forums hosted by Krøhn-McGill Psychiatric. I think you will find Krøhn-McGill KOL status is not just an invaluable contribution of your expertise to the advancement of medical practice, but a reliable and generous second revenue stream and a feather in your cap that will elevate your profile within the community of professionals…. Some of the most welcoming resorts in the world have opened their doors to those courageous professionals willing to leverage their authority in the service of eradicating mental illness.” (31-32)
They always buy it―hook, line and sinker.
When it comes to the issue of how the whole ghostwriting business works, Scott nails it in one purple passage, when Griffin says:
“… the pathway to market for everything you find at the pharmacy begins in medical journals, as scientists publish their findings on the experiments that broaden our understanding of human health….. So, I learned a great deal about how much these papers are the work of hired guns…. science written by marketing professionals posing as clinical researchers. It’s troubling. This process of creating evidence for the FDA seems to have become a pantomime of science…. What I mean by pantomime of science … is that we want to make sure these articles are written by scientists, not salesmen. And it turns out that they are almost entirely written by salesmen.… It’s not against the law or even the ethical codes that govern practice in the various specialties. Think of it as a loophole big enough to drive through with a bus wrapped in vinyl humping Bioferex.” (237)
Bioferex, in the story, is the name for a bone drug which treats stress fracture risk syndrome, but the journalist discovers it is really the antidepressant Serotonal, with the same fatal side-effects. (273)
In Scott’s novel, the coding of adverse events in the ghostwritten Study 463 publication, “Serotonal in the Treatment of Major Depressive Disorder,” Jeremy Elton et al., made Serotonal appear safe compared to placebo by hiding completed suicides in the study drug under the code “Suicidal Events” whereas suicidal nightmares, thoughts, and acts of self-harm were also coded as “Suicidal Events” in both the drug and the placebo groups. (126) The suicidal events that occurred in pre-randomization were also inappropriately included in the placebo group. “By inflating suicidal events in the placebo arm,” as Griffin explained the process to a confused KOL, “Makes normal life look more dangerous, and that makes the problem on the drug look more like normal life.” (274)
This general coding strategy is not fiction. Drug makers do it all the time and are caught only when there is discovery due to legal action.
The word, “malcharist,” the publisher’s flyer informs us, is a neologism for “bad power,” “bad sacrament,” or “bad spirit.” Like many real-life ghostwriters who went public with their story, Shivani Patel suffers a guilty conscience from her participation in malcharist activities—namely, knowingly misrepresenting the science and misleading doctors and patients. (289) She seeks salvation by teaming up with Griffin to expose Krøhn-McGill’s fraud. Gaining access to “bad data” stored in off-shore locations out of reach of the U. S. legal system, Patel finds the motherlode—but it comes at a price. (288-289)
This book is published by Samizdat House, the fiction imprint of Samizdat Health Writer’s Co-operative. The brainchild of David Healy, Samizdat (Russian: самиздат, self-publishing) is the name for the underground publishing industry that arose from forbidden literature of the former Soviet Union. Healy’s Samizdat House does for medicine what Samizdat did for the Eastern Bloc countries in the twentieth century. By recognizing the need for freedom of thought and freedom of the press, this enterprise dares to take on the pharmaceutical industry and avoids the censor of corporate lawyers working on behalf of the mainstream publishing industry.
Scott’s book, published in this co-operative venture, is the first fiction title. It is a well-written, well-researched, cleverly-crafted novel―a must-read for medical professionals, and especially aspiring key opinion leaders.
Leemon McHenry
Leemon B. McHenry is Professor Emeritus of Philosophy at California State University, Northridge and a consultant in medical ethics to the Los Angeles law firm of Baum, Hedlund, Aristei & Goldman. He is co-author, with Jon Jureidini, of The Illusion of Evidence Based Medicine: Exposing the Crisis of Credibility in Clinical Research (Wakefield Press, 2020).
annie says
Who knows where the wind blows, who knows where the time goes and who knows where the bodies go? Katinka Newman’s https://antidepressantrisks.org helps answer the body question.
GlaxoSmithKline fined $3bn after bribing doctors to increase drugs sales
https://www.theguardian.com/business/2012/jul/03/glaxosmithkline-fined-bribing-doctors-pharmaceuticals
The pharmaceutical group GlaxoSmithKline has been fined $3bn (£1.9bn) after admitting bribing doctors and encouraging the prescription of unsuitable antidepressants to children. Glaxo is also expected to admit failing to report safety problems with the diabetes drug Avandia in a district court in Boston on Thursday.
The company encouraged sales reps in the US to mis-sell three drugs to doctors and lavished hospitality and kickbacks on those who agreed to write extra prescriptions, including trips to resorts in Bermuda, Jamaica and California.
The company admitted corporate misconduct over the antidepressants Paxil and Wellbutrin and asthma drug Advair.
Psychiatrists and their partners were flown to five-star hotels, on all-expenses-paid trips where speakers, paid up to $2,500 to attend, gave presentations on the drugs. They could enjoy diving, golf, fishing and other extra activities arranged by the company.
GSK also paid for articles on its drugs to appear in medical journals and “independent” doctors were hired by the company to promote the treatments, according to court documents.
Paxil – which was only approved for adults – was promoted as suitable for children and teenagers by the company despite trials that showed it was ineffective, according to prosecutors.
Children and teenagers are only treated with antidepressants in exceptional circumstances due to an increased risk of suicide.
GSK held eight lavish three-day events in 2000 and 2001 at hotels in Puerto Rico, Hawaii and Palm Springs, California, to promote the drug to doctors for unapproved use.
Those who attended were given $750, free board and lodging and access to activities including snorkelling, golf, deep-sea fishing, rafting, glass-bottomed boat rides, hot-air balloon rides and, on one trip, a tour of the Bacardi rum distillery, all paid for by GSK.
Air fares were also covered for doctors and spouses, in most cases, and speakers at the event were paid $2,500 each.
Before one event, the compere said: “We have a wonderful and unforgettable night planned. Without giving it all away, I can tell you – you’ll be experiencing a taste of luxury.”
Not everyone was impressed, though. One psychiatrist complained: “The style of the conference would have been suitable for a convention of cosmetics sales reps; this is supposed to be a scientific meeting. To me, the music, lights, videos, emcees are offputting and a distraction, even demeaning.”
GSK also published an article in a medical journal that mis-stated the drug’s safety for children, despite the journal asking several times to change the wording.
Copies of the misleading article were given to sales representatives to pass on to doctors in the hope that it would secure more business. Tickets to sports matches were exchanged for discussions about Paxil, with one doctor writing: “Dinner and a Yankee game with family. Talked about Paxil studies in children.”
Despite knowing that three trials had failed to prove its effectiveness on children, Glaxo published a report entitled “Positioning Paxil in the adolescent depression market – getting a headstart”.
The second drug to be mis-sold was Wellbutrin – another antidepressant aimed only at adults.
The prosecution said the company paid $275,000 to Dr Drew Pinsky, who hosted a popular radio show, to promote the drug on his programme, in particular for unapproved uses – GSK claimed it could treat weight gain, sexual dysfunction, ADHD and bulimia.
Pinsky, who had not declared his GSK income to listeners, said Wellbutrin could give women 60 orgasms a night. A study of 25 people using the drug for eight weeks was pushed by a PR firm hired by GSK, generating headlines including “Bigger than Viagra? It sounds too good to be true: a drug to help you stop smoking, stay happy and lose weight” and “Now That is a Wonder Drug”.
When a GSK-funded doctor refused to remove safety concerns about the drug from an article he was writing, GSK removed his funding.
The investigation also found that sales representatives set up “Operation Hustle” to promote the drug to doctors, including trips to Jamaica, Bermuda and one talk coinciding with the annual Boston Tall Ships flotilla. Speakers were paid up to $2,500 for a one-hour presentation – up to three times a day – earning far more than they did working in their surgeries.
One speaker, Dr James Pradko, was paid nearly $1.5m by GSK over three years to speak about the drug. He also produced a DVD funded by the company, which was claimed to be independent. It was shown more than 900 times to doctors.
The hope was that doctors would be persuaded to prescribe the drug to patients over its rivals.
The last drug under scrutiny was Advair, GSK’s bestselling asthma treatment.
The drug was launched to sales representatives in Las Vegas using images of slot machines, emphasising the bonuses they could make through sales. At the event, the then chief executive, Jean-Pierre Garnier, said: “What is the number one reason why you should love to be a GSK sales rep? Advair’s bonus plan. Yeah!”
The company pushed the drug as the ultimate answer for tackling asthma, saying it should be the drug of choice for treating all cases. However, it had been approved only for treating severe cases, as other drugs were more suitable for mild asthma. GSK published material calling mild asthma a “myth” in an attempt to boost sales, according to the prosecution.
About $600,000 a year was given to district sales representatives for entertainment, including regular golf lessons, Nascar racing days, fishing trips, and baseball and basketball tickets.
US attorney Carmin Ortiz said: “The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts.”
GSK chief executive Andrew Witty said: “Whilst these [matters] originate in a different era for the company, they cannot and will not be ignored. On behalf of GlaxoSmithKline I want to express our regret and reiterate that we have learnt from the mistakes that were made.”
Despite the large fine, $3bn is far less than the profits made from the drugs. Avandia has made $10.4bn in sales, Paxil took $11.6bn, and Wellbutrin sales were $5.9bn during the years covered by the settlement, according to IMS Health, a data group that consults for drug makers.
P. 252 He felt a growing horror over what he had escaped. The signs had been all around and yet he’d taken up the logic as that of his own free will. Once he got home, Griffin couldn’t believe what had become of his apartment. On a spot over his television, two knives had been driven into the wall. Is that how he had made Lee Majors so frightened?
‘Spilling’ the ‘Secrets’ …
Dr. David Healy says
Fascinating how well this guardian article maps on to Malcharist. Someday we’ll have to get Paul Scott to reveal the secrets behind what influenced him
DH
Justin Oxley says
I made a withdrawals symptoms analogy some time ago to being trapped in a psychological equivalent of a drowning dam. When you have this condition you will perform less well in a forced swimming test especially in an actual physical drowning dam. Withdrawals increase behavioural despair and so you cannot deal with enviromental demands that before might have been fun. Feeding depressed Rats antidepressants sending them for a swim in a measuring cylinder is one of the tests they do to figure out if they improve the Rats struggling times. Withdrawals from ssris are far more severe than having some mild anxieties/low mood which is what I think the vast majority of people tend to be prescribed them for. Prescribing a drug that is more addictive than heroin for amelioration of mild anxieties and low mood sounds a bit silly to me. Maybe I’m wrong and others know better than I do but the anxiolytic supplements might be alot less powerful but they work and are alot safer. My supplement regimen has reduced the severity of my symptoms, it abolishes the headaches, diminishes the uncomfortable overload states and other unpleasantness. I am still very fatigued I didn’t expect the supplement regimen to fix everything but they have helped to make withdrawals much less of an unpleasant endurance test. I have accumulated quite a few supplements based on information/papers I found online.
mary H says
I find your comment regarding being “very fatigued” interesting. You have worked so hard with supplements, finding relief to some extent by using them and yet the fatigue remains.
My son suffers terribly with “fatigue” or “exhaustion” or whatever word you may choose to try to explain the state. To my mind, NO WORD can truly describe what you, my son and so many others go through. He has tried building up slowly, doing a tiny bit more each day; he has tried pushing himself and going beyond his comfort zone; he has tried getting the bare minimum done in blocks during a day and has also tried doing all that is screaming out to be done in a day done first thing of a morning. The result has always been the same – he has to take a rest ( as in lie on his bed or even sleeping a while) and even then the following days he will be left unable to do hardly anything at all.
What he DOES manage to do is take his dog for a walk. he takes it three or four times a day for about 10 – 15 minutes each time. He manages that five days a week and we help out at the weekend. He builds his life around the needs of the dog and his inability to use energy in a “normal” manner. He accepts that his condition now is far better than it was around four years ago and yet he is so far from being able to lead the life that a man of his age should be able to lead. He now accepts that it’s unlikely that his energy levels will improve much further. What a price to have to pay for doing no more than trusting doctors and taking medications as described.
If you come across anything that relieves your exhaustion in any way, Justin, please let us know as I’m sure he’d be very interested in hearing about it. I wish you all the best.
Justin Oxley says
I just think about my withdrawal symptoms and go off searching for supplements which have proven utility in alleviating those symptoms. It seems a logical thing to do to me.
https://www.healthline.com/health/food-nutrition/basil-benefits#brain-benefits
susanne says
Is it worth trying to get tested for mineral and vitamin deficiencies? Are there any studies which test for this after taking drugs? I don’t know anyone personally who is taking them now but nobody I knew before was ever given this kind of follow up except (rarely)to check on organs There are some tests on-line but who knows if they are reliable …Also wondering if it wouldn’t necessarily be just a deficiency but could be taking drugs leads to needing extra top up vits and minerals than normal. ie the tests could find normal results but miss that extra is needed after taking drugs. I use marmite for vit B deficiency which works well for me, Would it be useful to weigh up what vits and minerals are in the food eaten and maybe discount that in the amount of vits and minerals added on. if no tests available info is on web eg Minerals in Marmite (high salt is a problem for some but no salt marmite is available )_
Mineral Deficiency
Medically reviewed by Natalie Butler, R.D., L.D. — Written by Shawn Radcliffe — Updated on March 15, 2018
What is a mineral deficiency?
Minerals are specific kinds of nutrients that your body needs in order to function properly. A mineral deficiency occurs when your body doesn’t obtain or absorb the required amount of a mineral.
The human body requires different amounts of each mineral to stay healthy. Specific needs are outlined in recommended daily allowances (RDA).
The RDA is the average amount that meets the needs of about 97 percent of healthy people. They can be obtained from food, mineral supplements, and food products that have been fortified with extra minerals.
A deficiency often happens slowly over time and can be caused by a number of reasons. An increased need for the mineral, lack of the mineral in the diet, or difficulty absorbing the mineral from food are some of the more common reasons.
Mineral deficiencies can lead to a variety of health problems, such as weak bones, fatigue, or a decreased immune system.
What types of mineral deficiency are there?
There are five main categories of mineral deficiency: calcium, iron, magnesium, potassium, and zinc.
Calcium deficiency
Calcium is needed for strong bones and teeth. It also supports proper function of your blood vessels, muscles, nerves, and hormones.
Natural sources of calcium include milk, yogurt, cheese, and small fish with bones, beans, and peas. Vegetables such as broccoli, kale, and Chinese cabbage also provide calcium. Some foods are also fortified with the mineral, including tofu, cereals, and juices.
A calcium deficiency produces few obvious symptoms in the short term. That’s because your body carefully regulates the amount of calcium in the blood. Lack of calcium over the long term can lead to decreased bone mineral density called osteopenia.
If left untreated, osteopenia can turn to osteoporosis. This increases the risk of bone fractures, especially in older adults.
Severe calcium deficiency is usually caused by medical problems or treatments, such as medications (like diuretics), surgery to remove the stomach, or kidney failure. Symptoms of a severe deficiency include:
cramping of the muscles
numbness
tingling in the fingers
fatigue
poor appetite
irregular heart rhythms
Iron deficiency
More than half of the iron in your body is in red blood cells. Iron is an important part of hemoglobin, a protein that carries oxygen to your tissues.
Iron is also a part of other proteins and enzymes that keep your body healthy. The best sources of iron are meat, poultry, or fish. Plant-based foods such as beans or lentils are also good sources.
Iron deficiency develops slowly and can cause anemia. It’s considered uncommon in the United States and in people with healthy diets. But, the World Health Organization estimated in a 2008 report that iron deficiency causes approximately half of all anemia cases worldwide.
The symptoms of iron-deficiency anemia include feeling weak and tired. You may be performing poorly at work or school. Children may exhibit signs through slow social and cognitive development.
Magnesium deficiency
The body needs magnesium for hundreds of chemical reactions. These include responses that control blood glucose levels and blood pressure. Proper function of muscles and nerves, brain function, energy metabolism, and protein production are also controlled by magnesium.
Roughly 60 percent of the body’s magnesium resides in the bones while nearly 40 percent resides in muscle and soft tissue cells. Good sources of magnesium include:
legumes
nuts
seeds
whole grains
green leafy vegetables, such as spinach
Magnesium deficiency is uncommon in healthy people. The kidneys can keep magnesium from leaving the body through the urine. Still, certain medications and chronic health conditions like alcoholism may cause magnesium deficiency.
Magnesium needs are also highly influenced by the presence of disease. In this situation, the RDA for magnesium may not be sufficient for some individuals.
Early signs of magnesium deficiency include:
fatigue
weakness
loss of appetite
nausea
vomiting
Magnesium deficiency can lead to the following symptoms if left untreated:
numbness
tingling
muscle cramps
seizures
abnormal rhythms of the heart
Potassium deficiency
Potassium is a mineral that functions as an electrolyte. It’s required for muscle contraction, proper heart function, and the transmission of nerve signals. It’s also needed by a few enzymes, including one that helps your body turn carbohydrates into energy.
The best sources of potassium are fruits and vegetables, such as bananas, avocado, dark leafy greens, beets, potatoes, and plums. Other good sources include orange juice and nuts.
The most common cause of potassium deficiency is excessive fluid loss. Examples can include extended vomiting, kidney disease, or the use of certain medications such as diuretics.
Symptoms of potassium deficiency include muscle cramping and weakness. Other symptoms show up as constipation, bloating, or abdominal pain caused by paralysis of the intestines.
Severe potassium deficiency can cause paralysis of the muscles or irregular heart rhythms that may lead to death.
Zinc deficiency
Zinc plays a role in many aspects of the body’s metabolism. These include:
protein synthesis
immune system function
wound healing
DNA synthesis
It’s also important for proper growth and development during pregnancy, childhood, and adolescence. Zinc is found in animal products like oysters, red meat, and poultry. Other good sources of zinc include:
beans
nuts
whole grains
dairy products
Zinc deficiency can cause loss of appetite, taste, or smell. Decreased function of the immune system and slowed growth are other symptoms.
What causes mineral deficiency?
One major cause of mineral deficiency is simply not getting enough essential minerals from food or supplements.
There are different types of diets that might result in this deficiency. A poor diet that relies on junk food, or a diet that lacks adequate fruits and vegetables can be possible causes.
Alternately, a very low-calorie diet may produce this deficiency. This includes people in weight-loss programs or with eating disorders. Older adults with poor appetites may also not get enough calories or nutrients in their diet.
Restricted diets may also cause you to have a mineral deficiency. Vegetarians, vegans, and people with food allergies or lactose intolerance might experience mineral deficiency if they fail to manage their diet effectively.
Difficulty with digestion of food or absorption of nutrients can result in mineral deficiency. Potential causes of these difficulties include:
diseases of the liver, gallbladder, intestine, pancreas, or kidney
surgery of the digestive tract
chronic alcoholism
medications such as antacids, antibiotics, laxatives, and diuretics
Mineral deficiency can also result from an increased need for certain minerals. Women, for instance, may encounter this need during pregnancy, heavy menstruation, and post menopause.
mary H says
Thanks for this comprehensive list Susanne. Whether your body can accept supplements of this nature is, I guess, a case of trial and error. Some of the drugs that people are prescribed should not have certain supplements, or even foods, taken alongside them should they. Grapefruit comes to mind as being one that should not be ingested with certain medications. Shane has tried a variety of multivitamins over the years but his body does not tolerate any that he has used. The nearest was one called Orovite. My sister used that to recover from a dose of flu many years ago. It was recommended to my mother, by a pharmacist, when she’d gone for a bottle of Sanatogen for my sister’s recovery. The Orovite worked remarkably well – and from then on was considered the ‘pick-me-up’ of choice in our family. So, when Shane was going through a severe bout of fatigue, having unsuccessfully tried the multivitamin tablets, I remembered about the magical Orovite and hunted it down. His body tolerated this but it barely relieved his condition. Now, he relies on the food that he eats, still waiting for spurts of energy!
Ron says
My 21 year old granddaughter committed suicide on October 25, 2019 upon surrendering to PSSD caused by the Zoloft given to her as a sixteen year old. Her journal describes a descent into the hell of akathisia. What kind of society let’s its doctors kill our children for greed?