A Lesson from Life

It was 1996, the days I taught at the University of California, Los Angeles (UCLA). Now I was browsing the bookstore at the University of California, San Francisco (UCSF). A sensationalist title in the new arrivals section, Deadly Medicine, caught my eye.

Some general audience health books are based on scientific evidence but others utilize questionable data. Bogus claims proliferate. My training and work have taught me to adopt a sharply critical stand on any health related assertion. In a field vital for human welfare, one cannot be too careful. Assessing the reliability and volume of evidence, reanalysis of the data and reading papers that counter the claim are essential. And that is what I normally do. Having taught courses on evidence-based medicine at universities in the US, Norway and Tanzania, and with published papers in the field, I am not easily fooled.

I flipped through Deadly Medicine and perused the reference list. My first impression was of a solidly researched text that extensively cited papers from major medical journals. I purchased it and spent three evenings going from cover to cover.     

The topic was treatment of irregular heart rhythms. Our heart pumps blood in a regular fashion. But when its electrical conduction system is not stable, the pumping pattern becomes irregular. Such arrhythmias occur in several forms, and may be mild or life threatening. Electrocardiograms are used for diagnosis. 

The book focuses on Tambocor, a drug widely prescribed in the USA in 1980s to treat varied forms of arrhythmia. It firstly describes and gives the history of scientific methods like clinical trials used to evaluate the efficacy of medical treatments. It then details the step by step process by which Tambocor was discovered, tested and finally approved by the US Food and Drug Administration (FDA). Around the mid-1980s millions of prescriptions for Tambocor were being filled in the USA alone.

Yet there were serious problems. As the book painstakingly documents, the pre-approval studies had major flaws. Sample sizes often were unduly small, follow up period, too short and data analysis was questionable. The key question is: Does this drug reduce mortality rate from arrhythmia as well as the total mortality rate? Yet, none of the clinical trials had used this outcome as the evaluative endpoint. Instead they had used an intermediate endpoint: Does it suppress arrhythmia? The book also demonstrates that all the stages of the process including assessment by the FDA had given the drug the benefit of the doubt when the evidence was not equivocal, a clear illustration of systemic pro-corporate bias. And tellingly, while the drug had been tested on people with severe arrhythmia, it was being prescribed for people with mild and moderate arrhythmias too. Huge profits were being reaped.

Fortunately, because of its popularity, a team of researchers at the US National Institutes of Health (NIH) was able to secure funds to address the key concern, the effect of Tambocor on mortality. A well designed, multi-center, large sample, double blind clinical trial to compare the efficacy, as measured by death rate, of Tamboco with a placebo was launched. For a drug that has recently been approved by the FDA, such a study is a distinct rarity. 

Some two years on, interim analysis of the data gave startling results. While the death rate in the placebo group was around 2%, in the Tambocor group, it was 4%. And the difference was statistically significant. Now a jump from 2% to 4% death rate does not sound striking. But the fact that millions of people were on the drug translates into large numbers. For every million consumers, the number of excess deaths would be 20,000.

The findings were deemed so grave that for the first time, the heads of the FDA and the NIH took a joint public platform with the US Secretary of Health to announce an immediate withdrawal of Tambocor from the market. The announcement grabbed the headlines, company share price tumbled and tens of thousands of doctors who were prescribing it were left in a bind.

Yet, in the ensuing furor, no official body or medical researcher posed the obvious query: How many excess deaths were caused by Tambocor? The author of Deadly Medicine does. With a careful analysis of available data he arrives at a conservative estimate of 50,000 deaths. According to him, this single drug killed more Americans than did the war on Vietnam.

++++

That fall I was scheduled to teach a course on the ethics of clinical trials at UCLA. I considered this book relevant for the course. Hence upon return to my base, I placed a course order for the book through the UCLA bookstore. Two days on, the store manager called me. The book was out of print. That was curious – a book recently published but not a block buster going out of print so soon. When our departmental secretary called the publisher, she got the same response – the book was unavailable. But I was able to track down the author, Thomas J Moore, a research fellow at the Center for Health Policy Research, George Washington University.

He informed me that other professors had also inquired about the non-availability of his book. The book was not out of print. Thousands of copies were warehoused. The publisher had ceased distribution because the drug manufacturer had threatened a lawsuit if it was not done. This sort of action had been anticipated by the publishing editor and the author. Hence, prior to publication the manuscript had been reviewed thoroughly by medical experts and lawyers. The book was on a solid factual ground. Nonetheless, the executives at the publishing firm had decided to pull the plug.

But all was not lost. His contract allowed him to get the non-distributed stock at a rock bottom price. And thereby, he had bought a large number of copies which I could buy at cost price. The $25 hard-copy was on sale at $3.50, including mailing cost! I immediately placed an order for four boxes with 24 copies each; one for my class and three for future use. Not only did my students save substantially, but the book generated a lively discussion and was well liked by the students.

++++

It was a shame that such a well-researched, educational text was facing a premature death. Its existence needed publicity. Accordingly, I wrote a long review of the book for Statistics in Medicine, one of the premier journals in the field. In two weeks, I got response from the book review editor saying that even though they do not publish unsolicited, lengthy book reviews, he had been so impressed by my review that he had accepted it for publication. It was scheduled to appear in the following month’s issue.

Having published several technical papers in this journal in the past, this was a particularly fast response. But I was in for a surprise. Come the next month, my review was not there. Well, delays do occur. So I waited. Three months, no issue carried my review. Concerned, I inquired with the editor. He informed me that my review was being examined by the lawyers of the journal! That was astounding. Unless there is concern about fraud or plagiarizing, papers in a technical journal are not put under legal scrutiny. And for a paper that has been accepted for publication, it is unheard of. I could do nothing but wait. Eventually my review came out but a year later. By that time, only a few copies were available on Amazon. And none knew that it was directly available from the author. And it appeared that even the author had decided to move on. The next book he brought out was also a finely documented work on the adverse effects prescriptions drugs. But the critical, anti-corporate, comprehensive edge of Deadly Medicine was gone. I was lucky to have three boxes of a valuable text for future use in class.

++++

In Africa, we are not strangers to the suppression of vital information. Draconian laws and extra-legal measures by state authorities turn speaking the truth a risky exercise. Media are banned; journalists are detained and beaten, or worse. Internet access is curtailed at critical junctures. Out of fear, media and reporters indulge in self-censorship. Major media outlets, generally owned by tycoons, also have their own reasons for not educating the public about the realities under the surface. People know that the news and commentaries are a distortion of the actuality. Only a few brave souls continue to expose official and business mendacities.

But there is another and as effective a form of censorship that only a few discerning activists know about. It has no central censor but operates under an inbuilt systemic process that favors some kind of information but disfavors another kind. Critical views are not banned. They face major, multi-institutional but seemingly explainable hurdles which drastically lower the chance that they, especially if they take a systemic perspective, will gain wide currency. Funding sources dry up. Academic promotion of those who persist is in jeopardy. One example sends the message. It is better to conform than to try to rock the boat. In the long run, masked censorship is more effective than direct censorship because the public is under the impression that they live in a free society. And it is a form of censorship that prevails in the Western capitalist societies.

My experience with Deadly Medicine illustrates one manner in which this mode of suppression of crucial information operates. In the 2000s, when I had moved to Dar es Salaam, I was often invited to teach short courses on evidence based medicine at UCLA, the University of Oslo and the University of Oslo. The attendees included research fellows, academic staff, junior doctors as well as seasoned medical specialists. I would normally pose the question: What was the greatest medical tragedy that struck the US in the past? Invariably, they would point to the thalidomide episode of the late 1950s. Pregnant women were routinely being given this supposedly harmless drug for morning sickness. Yet it caused gross deformities in the newborn. Hundreds of deformed babies were born before the cause was realized and the drug was banned. But not a single person mentioned the Tambocor episode even though it had generated global headlines in 1989. When I told them than an estimated 50,000 people had perished as a result of taking this drug, they were stupefied. How could they have not known? And I know from experience that if you ask any cardiologist about this episode today, he or she will not have a clue.

Indirect censorship is subtle, systemic, implicit and masked. It affects not just history, politics, economics and the arts but also science and medicine. Many people feel that modern medicine is compromised by money. But lacking a conceptual foundation, it leads them to adopt cynical, anti-science views and uncritically embrace alternative medicine. While there are good ideas in alternative medicine, it is also full of hocus pocus.

Denying science is harmful. Science is the only reliable way we have of gaining reliable knowledge. That science is subverted by financial interests and unethical scientists is no reason to abandon such a vital tool that has developed through centuries. It is a reason to refine our critical faculties and be aware of the illuminating dictum of a revolutionary thinker.

The ruling ideas of each age have ever been the ideas of its ruling class.

Karl Marx

It is a lesson not learned in a classroom. It comes from self-education. Our task then is to unravel the truth beneath the fog of conventional wisdom and employ it in the struggle for a just and human society.

Related Posts