Wit (directed by Mike Nichols, screenplay by Emma Thompson based on Margaret Edson’s play): Jason, the resident (Jonathan Woodward) has disregarded Miss Bearing (Emma Thompson), the patient’s request to be DNR on the grounds “she’s research!” Suzie, her nurse (Audra McDonald), is protecting the space around Miss Bearing.
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine” (Marcia Angell, “Drug Companies & Doctors: A story of corruption”, NYRB, Jan 15, 2009)
The “commercialization of science” in universities, gov’t agencies and organizations has led to “research supported by for-profit entities [that] will yield results consistent with the financial interests of those entities … “the push to commercialize the university”, “a planned coordinated effort” “had been one of the biggest Ponzi schemes this side of Bernie Madoff and Allen Standford” (Sheldon Krimsky, reviewing Philp Morowski’s Science-Mart: Privatizing American Science in The American Scientist, 99 (2011):330-32).
The Doctor (directed by Randa Haines, screenplay Robert Caswell from Ed Rosenbaum’s memoir, A Taste of My Own Medicine): Jack McKee (William Hurt) is comforted by his wife, Ann (Christine Lahti) after Jack suffered an enforced barium enema, administered by mistake (indifference and carelessness led to it, and there’s hardly any apology at all).
First, do no harm. Cure seldom, relieve often, comfort always.
Dear friends and readers,
Among Helen Epstein’s many important essays published in the New York Review of Books is “Flu Warning: Beware the Drug Companies” where she carefully shows how various drug companies, the doctors and researchers they pay, and distributors and advertisers they use so skewed research in the area of flu vaccine that it is not possible to get past the conflicts of interest, unacknowledged biased behavior and results to see that the strongly probabilities of flu epidemics and need for flu vaccine was partly manufactured by the drug companies. Epstein concludes:
Six years ago, John Ioannidis, a professor of epidemiology at the University of Ioannina School of Medicine in Greece, found that nearly half of published articles in scientific journals contained findings that were false, in the sense that independent researchers couldn’t replicate them. The problem is particularly widespread in medical research, where peer-reviewed articles in medical journals can be crucial in influencing multimillion- and sometimes multibillion-dollar spending decisions. It would be surprising if conflicts of interest did not sometimes compromise editorial neutrality, and in the case of medical research, the sources of bias are obvious.
The pervasiveness of overt and covert corruption in the medical establishment is hard for ordinary citizens to credit. They are surrounded by such expert propaganda ceaselessly poured out on TV, in movies, and in creditable print. It is nonetheless true. It not only is destroying scientific knowledge in the US; it constitutes a present danger to consumers who may be led to take drugs whic do not help them, might and do do them harm and cost them hugely.
No where is this more common than in the area of mental health where the terrain for diagnosis is partly subjective and where social problems and distresses in our competitive brutal environments in schools, universities and the job market lead to people desperately seeking solutions for success where it is so hard to achieve. One way they relieve their mental troubles and try to help their children in the newly relentless networking environment is to medicalize the problem. Insurance companies collude by offering money if the condition identified can be found described in the Diagnostic and Statistical Manual of Mental Disorders, which has become, an Angell and others have shown,
“the product of a complex of academic politics, personal ambition, ideology, and, perhaps most important, the influence of the pharmaceutical industry.”
Two recent articles by her in the NYRB dwell just on the area of mental health. The arguments in “The Epidemic of Mental Illness” (NYRB, June 23, 2011) and “The Illusions of Psychiatry” (NYRB, July 14, 2011), are fundamentally accurate, though the second article has a significant flaw in its lack of compassion for the real increase in mental illnesses across the board in patient-consumers today, its failure to acknowledge that increase in diagnosis has led to progressive empathy and understanding of mental and social stresses and help for people, as well as its repetition of ill-informed gossip which (very like Reagan on mythical Welfare queens) exaggerate the amount of help mentally disabled people get (for adults hardly anything at all). Still, she is fundamentally correct: she shows the harm that the substitution and erasure of the talk cure in favor of handing out drugs is ill-advised, a move that makes profit for the drug companies and saves doctors and the medical establishment money and having to help people for real.
So, flawed as is part of Angell’s second article, all else she writes in both articles is frighteningly sound, and, as Sheldon Krimsky shows, the direct result of commercialization of science everywhere in the US so that universities are directly dependent on private companies for funds for basic research.
About the serious issue of what causes depression and mental illness, Angell is concerned to show the fundamental flaws in the argument that a lack of certain chemical causes depression. She tried to show (or said the books under review showed) that we cannot prove these prescription drugs sold at high prices do what they are said to do. In the first case she showed the tautology of the thinking: the drug companies are in effect saying we have discovered that aspirin gets rid of headache; there is no aspirin in people’s bodies, hence it must be a lack of aspirin in the body itself that is causing the headache. So we will go out and invent new and improved versions of aspirin for you to shoot yourself up with. The side effects of these new and improved drugs are dangerous, not well-understood. She shows that in both that the research conducted by these companies is so shot through with techniques designed to prove the drugs are needed, good for people, you can’t believe what is published. The placebo tests are flawed and when they don’t produce the results wanted phony (by suppression of evidence).
She didn’t deny that the drugs calm people, children too and relieves symptoms of depression, anxiety, rage; she is aware that these results are partly why the drugs are taken by millions of people. She said we don’t know what the result of taking these drugs for decades will one for many; one result for some is addiction; for others high weight gain (bad for you). I can understand how someone who has used these drugs and feels they have helped him to survive would be taken by the pragmatic arguments that they help control one’s symptoms. I take 2 240 milligram tablets of surfak (docusate calcium) every day, and have been doing this for 30 years. I’d be desperate if they were taken away. They are needed stool softeners for me, I trust they have no bad side effects and think they do help me for my bad constipation.
Her review is just a review nothing more. She doesn’t go into what she thinks of the “talking cure” beyond suggesting such session are useful and that the dropping of them is wrong because they are another important way of helping people. I don’t think she is interested in this issue in itself nor just the medicine invented for mental troubles and illness but as these are aspects, symptoms, instances of what the article you pointed to is true: the total corruption of the drug and medical establishment in the US. It’s that she is endlessly writing about, trying to expose. The whole enterprise is filled with rottenness. She wants sweeping and fundamental changes in the FDA, the NIH (watch dogs and research institutes), the way medicine is delivered, and strong controls on the way these companies do business.
The primitive personal or honest question is, Do I agree or think that my own depression, anxiety, troubles are chemical or physiological as well as psychological. Yes. Is this because something is wrong with me or it’s in my nature to be melancholy, my physiology. Both are different ways of saying the same thing. Some people have a tendency to be cheerful, aggressive; others the opposite, and these natures we are born with are exacerbated or countered by what happened to us as we grew up and later in school and life. So I had two parents who were very ill suited and on some level hated one another. My mother should not have had any children as she is cold, indifferent, selfish, obtuse — of course the world is filled with people like this who have children. My father was made miserable about his job, his life, a frustrated thwarted man who never developed intellectually as he could have. He turned to me and should not have. Both of them were (Larkin’s phrase) fucked up and they fucked me up too.
But if I agree that it’s partly physiological, chemical, that does not mean that these drugs these companies sell are based on a reasonably logical theory which can then be used to prove their efficacy. Far from it.
Titicut Follies (Frederick Wiseman, 1965)
On Angell’s article Part 2: yes, the more I have been thinking about it the more at long last (after a number of important wholly sound articles), she does show her privileged life. The article had a glaring heartlessness. She took gossip about SSI and wrote about how Aspergers people are getting sums of money equivalent to welfare (as if that had been a loadstone). She did not take into account that while the Manual might reify diseases (make diseases exist by definition) and be a political document, that does not mean that mental trouble/illness is not widespread in the society. Atul Gawande’s Complications quoted and substantiates 33% or more of Americans have major depressive episodes over the course of their lives. In his book he shows that pain, both physical and psychological, is a social problem of real seriousness, one that needs to be addressed medically, by talk cures, and by government and social reforms of our daily lives and the norms we live by. That’s the implication of his “The Pain Perplex.”
So, that while it’s true the drug companies have faulty logic (=you get depressed because you don’t have X [say aspirin]in your system when they find giving X makes you cheerful so that means aspirin is what your system lacks); and it is true that their tests for drugs are corrupt (dismissive of evidence that shows they don’t work or do harm); nevertheless, that does not mean many many US people are not in trouble and need help. They do. This is insufficiently recognized in her part 2. Especially bad is the implication that Aspergers people are living high off gov’t money. She is so absorbed in the corruption here and now she forgets there has been progress.
On this a friend wrote me as follows:
“I was thinking of the Angell articles when I was watching The Kennedys the other night (it has only just arrived here) – I had not realised that the horrific Joe had one of his daughters lobotomized – I had to leave the room when it showed the effects; as I commented before however ineffective or indeed misdirected medicalization may be when one considers that 50 years ago this barbaric practice (mainly on women as far as I can see) was still a medical commonplace there has been progress. The historical perspective – institutionalizsation, lobotomy, ECT – must be kept in mind. Certainly things are still a long way off good but at least I have never been in danger of having a chunk of my brain cut out.”
Having acknowledged this, I want to provide a short review of Angell’s other articles so that this flaw will be seen in the larger perspective. In “Body Hunters” (NYRB, 51:12, October 6, 2005), a review of Fernando Mereilles’s film adaptation of John Le Carre’s The Constant Gardener, she demonstrated that although the murder of Tessa Quayle and Arnold Bluhm is improbable, much else that we find in the book is not just probable, but everyday business in testing drugs for phamaceuticals.
For example (the incident which lies behind the film), in 1996 Pfizer, the American pharmaceutical giant, opened a clinic in Kano, Nigeria, during a meningitis outbreak in order to test the drug Trovan, which had yet to be approved for use on children. There is no Tessa Quayle in this story, but there are doctors from the humanitarian group Medecins sans frontieres. There were no formal ethics-approval protocols in place for the tests, nor were the patients properly advised that they were participating in an experiment, nor was proper long-term follow-up implemented. Consequently, of 200 children treated, eleven died, while others suffered serious meningitis-related symptoms, such as deafness, lameness, blindness, seizures, and disorientation. Patients deteriorating on Trovan were not taken off it and given another antibiotic. Children given higher doses of deftriaxone to make the contrast look better yet it made for more pain. While I was at a Wagner conference, a man who used to be the Ambassador to Kenya was there, and he saw me with this novel (endlessly rereading you see), and confirmed that testing is done as a prerequisite for other care and the people don’t know what they are taking.
In 1997, Trovan was approved by the FDA to treat certain infections, but not for children and not for epidemic meningitis. The FDA found dozens of discrepancies in the documents from Nigeria. Trovan quickly became a highly profitable antibiotic widely used against a variety of infections. However, after less than two years on the market, there were over a hundred reports that the drug produced liver toxicity, causing several deaths. It is no longer sold.
The Constant Gardener (based on LeCarre’s book, directed by Fernando Mereilles, produced by Simon Channing-Williams, screenplay Jeffrey Caine): Justin Quayle (Ralph Fiennes) tries to decipher Tessa’s computer files (see Todd Hoffman, “The Constant Writer: LeCarre Spies a New Villain”, Queen’s Quarterly, Spring 2001)
A second incident:
Thousands of HIV infected women were given a placebo while another group given a course of AZT very strong dosage for shorter time. They should have compared women being given drug as normal and at a usual rate; instead they consigned babies to HIV/AIDS and women to quicker death. The argument made was just that of LeCarre’s villain: the women in a pregnancy test would have died anyway. A Pfizer doctor contests this view, and argues that the mortality rate in his clinic was as low as, or lower than, at the MSF clinic. But this falls to respond to the ethical question of giving children an untested drug and the choices made about how to treat individuals once they are on it. The Pfizer attitude resembles that of Sandy Woodrow regarding Dypraxa, “We’re not killing people who wouldn’t otherwise die. I mean, Christ, look at the death rate in this place. Not that anybody’s counting”
Near Death (Frederick Wiseman, 1989): What Wiseman does is find the people with power in an institution and he films them for hours: here we listen to a chief of staff discussing what to do about certain patients with other medical personnel
Most of the time the trials run in these 3rd world countries are for diseases that afflict wealthy societies (arthritis, obesity, cholesterol, cancer). Research should not be done in the third world unless it concerns diseases that are virtually confined to those regions. And regulations governing research in poor countries should be every bit as stringent—and enforced just as vigilantly as in well-to-do countries. There is no justification for the present situation in which the standards are looser precisely where human subjects are most vulnerable.
Generally, there’s no question that the US and other rich countries have been conducting more and more clinical research in Africa and other parts of the third world. Although exact figures are hard to come by, it is likely that tens of thousands of studies sponsored by first-world drug companies and governments are now underway in Africa, parts of Latin America and Asia, and the former Soviet Union. Most of this research is intended to find new treatments for use in well-to-do countries. Standards are low or non existent.
These companies, called contract research organizations, or CROs, hire local doctors to find people who will take part in clinical trials, and while the payments to the doctors per patient are lower than in first-world studies, by local standards they are munificent. Doctors can multiply their income tenfold or more.
Patients, too, are readily enticed by small amounts of money and promises of free care. In fact, as in LeCarré’s story, enrolling in a trial may be the only way they can get any care at all.
Hospital (Frederick Wiseman, 1970): Wiseman also seeks out unusually candid and articulate people and films them
Finally, in “Your Dangerous Drugstore” (NYRB, 51:10, June 8, 2005), Angell makes visible the corruption found along the entire system of developing, testing and using prescription drugs. She goes over trials and shows all the problems were known and shoved under rug. Clinical trials are dropped or argued against while money spent on advertising.
The FDA has on its boards people who were or are in the pay of drug companies or affiliates. They get to decide what comes to market. At best you get a mild warning on packet.
Startlingly obviously bad is the “user fee:” the part of the FDA doing evaluating gets its funding from drug companies who they are evaluating!
Taking people’s testimonials is highly problematical. People want to believe they are different and in their case this is helping. All long for magic miracle drug.
Angell does suggest that the US public said to be growing sceptical of drug companies’ claimed disinterest: we see escalating prices; we see government bills intended to stop agencies acting for us from negotiating lower prices; we see that most research for new drugs done in university and government labs. That companies often go for “me-too” drugs.
The value of Epstein’s article is she uses a case where people are inclined to believe drug companies because flu can be a killer and vaccination can prevent illness and death. She shows how difficult it is to catch these people are their lies, pretenses, skewing of evidence.
Finally, Krimsky’s review (unfortunately, not online) shows that the very structuring of American medicine since the 1980s by neo-liberal voodoo economics has created this dire situation. How to stop it? Nothing short of universities monitoring its professors and laboratory technicians’ research for real, and firing anyone who is found to falsify results, take personal bribes, or allow his or her name to appear on research he or she did not do. In an atmosphere where all that is cared about is getting grants from companies for funding this is not about to happen tomorrow. A wholescale cleaning out of these be-shitted stables is called for.
I can confirm the accuracy of Wiseman’s portrait. In 1989 I spent a week in Metropolitan Hospital (the place he filmed for Hospital) after I was in an automobile accident. It was like a crowded bus station everywhere. When I came in I had a fractured knee with no cast or anything on it for hours. There was that weekend one man in the whole hospital doing x-rays. Jim, my husband, promptly called him “The bottleneck.” He was not gentle doing x-rays; he was in a hurry you see.