Considering the fact that no drug company does something for nothing, could the unethical drug trials portrayed, for instance, in Fernando Miereles’s political thriller, The Constant Gardener, could actually happen nowadays? I came to understand the source novel by John le Carré was based on a true story in Kano, Nigeria by American drug firm, Pfizer.
During Meningitis testing in Kano, Nigeria, Pfizer’s drug, Trovan was used in a clinical trial in Nigeria and by the time the clinical trial was discontinued, 200 children were disabled and 11 were dead. This led to a lawsuit from the Nigerian government over the issue of informed consent, which is a core principle in medical ethics, regarding the people who participated in the study.
This film tells us about the motives of greedy politicians and business men compromising company profits over human compassion.
The Constant Gardener (2005): Director: Fernando Meirelles, Writers: Jeffrey Caine (screenplay), John le Carré (based on the novel by)
Conspiracy scenario portrayed in the film
A drug company has been testing some new medicines in Africa. The test results show that the drugs work fine, but have some devastating side-effects. The problems could be fixed, but the time-consuming process of redesigning the product, re-testing, and resubmitting the product for FDA approval would cost them their competitive advantage. By the time they manage to complete the process, another company could beat them to the market, or even to critical patents. That means they wave bye-bye to 100% market share and mega-profits. So they decide to falsify the test results. The heroine of The Constant Gardener gets wind of all that, and it costs her her life.
Her husband sets out to discover why and the answer lies in her discovery of a conspiracy among a Canadian Pharmaceutical Company, an African independent testing lab, and an African distribution company which many UK diplomats have stock in. It seems company A has developed a new treatment for a new antibiotic resistant strain of TB. It has one unfortunate side effect. It kills some people. It could be fixed with another three years of development, but they would likely be too late for the expected epidemic, and their competition might well beat them to market. Determined not to let that stop them, they are conducting their clinical trials in Kenya, and simply only recording the positive results.
Most of the opinions put here are directly taken from The Constant Gardener (2005) from Johnny Web (Uncle Scoopy; Greg Wroblewski) and Tuna critique, which I found as an excellent resource to address the various perspectives raised in the film.
Arguments against the claims portrayed in the film
Selling pharmaceutical products in the USA is the reason to develop medicines in the first place! Among all First World nations, the United States is the only one which does not regulate drug prices. Medicine costs about twice as much in the United States as in Europe, and about four times as much as in Japan. Combining the enormous profit margins with the size of the U.S. market makes FDA approval essential for any pharmaceutical company which actually intends to get a return of their R&D investments.
The controversial scenario depicted in the film is unlikely as the FDA would not accept such biased clinical trials. Furthermore, the drug couldn’t get approved in the United States on the evidence shown in the film, but that it couldn’t get approved in any country where reasonable safeguards exist (including the USA). Such a drug, with inadequately documented results, could only get approved in certain highly corrupt countries, and those countries have no real profit potential, possibly excepting Russia.
We need to assume also a drug company was really that evil that they would hire an independent testing lab, which would involve itself in the falsification of results, and bribe them.
- First of all, it assumes the the national health services and the FDA will simply accept test outcomes which are handed to them by people with a vested financial interest in the results.
- Second, it assumes that drug company executives do not respect normal human codes of conduct, and are perfectly willing to circulate drugs which they know to be capable of serious harm to the entire human race.
- Third, it assumes that a drug company conducting its own testing would hide certain consequences of drug use even though the same consequences would start to appear immediately after the drug was widely marketed.
So how would they then manage to explain that the test results failed to show those same side effects? It is the third point which is the critical one. As the script points out correctly, drug companies are not charitable institutions, and thus base their decisions on maximizing their profitability. In the case presented in this film, the liability resulting from lawsuits, especially in the United States, would be hundreds of times greater than the profits they could hope to gain from selling the product. The decision to falsify those test results would be a bad financial decision. And that’s not even considering the very real fact that their rival corporations would be sneaking off with the drugs and conducting their own tests. Corporations compete against one another – sometimes viciously that their own competitors would have destroyed them even if governments didn’t jump on it. The market has its own sense of balance, even if it does not always seem to produce just results.
For such plots to happen, it would require a massive collusion between the corporation and various governments, as well as a intricate web of corporate malfeasance. Such a thing is possible. Companies are capable of extremely intricate maneuvering to falsify reports, and corporations can have friends in very high places. Put them together and a scandal like the one pictured in The Constant Gardener could happen, but it would not be a simple matter.
If they were going to attempt such a thing, it would require the falsification of results from an independent testing lab, and it would require that no connection could ever be established between the pharmaceutical company and an established, trusted lab. In such a case, the drug company would not be held responsible for the inaccurate reports, because they would have come from a completely independent firm, and therefore, the drug company would reap the profits while being in a position virtually immune from lawsuits. This scenario is virtually impossible, however, because it is not enough simply to create the independent results. The key point is 100% deniability, therefore immunity from lawsuits. That’s almost impossible to pull off.
- First, it would be difficult to keep the guilty knowledge in the drug company confined to one trusted individual, although that would be necessary.
- Second, it would be difficult to hide the connection between the drug company and the bribed scientists. Sooner or later somebody will drink too much and let something slip, or somebody will buy a house that they shouldn’t be able to afford, and then it will backfire.
- Finally, it is an inhumane act and people responsible would not cover up potentially fatal or horrible side-effects. The directors and officers of large corporations may be greedy and under pressure to produce, but they are human beings, just like the rest of us.
Arguments in favour of the occurrence of such events
On the other hand, the things that happen in real life, which are just as harmful to Africa, involve financial decisions which are excellent from corporations’ point of view. It’s just that they are not the best decisions for Africa or, for that matter, for the human race.
Various past medical testing in human populations living in impoverished conditions, in my previous post, have been reported and gives the benefit of the doubt for such things could happen, though the level of savage motives shown in this film could be anti-parallel with the mentality and compassion of today’s society, which we are part of.
The writer argues how such scandals could happen by presenting a real-life scenario, different from what had been portrayed in the film:
Drug companies currently make enormous market-driven profits from selling items at a vast premium over their cost of ingredients. They sell each AIDS cocktail for several dollars, and the cocktails can probably be manufactured for a few cents. It is the market which determines the price of the medicine. Therefore, you could create a very healthy business by creating the same pills in your basement for the same few cents and selling them for one dollar. In fact, if you were allowed to do so, you could cut the price by as much as 95%, still make a profit, and take nearly 100% of the market. Not only that, but by making the drug more affordable, you would get the drugs into the hands of more people who need it. Of course, you are not allowed to do that. The drugs you wish to manufacture are undoubtedly protected by the international laws and agreements respecting intellectual property. The formula probably belongs to somebody, and you can’t just start making it in your basement and selling it from your kids’ roadside lemonade stand. This, however, is a complex issue which balances morality and profits. Liberal activists have a very strong point when they say that if we can relieve the worldwide AIDS epidemic, we should do so, even if it means lower profits for the drug companies. For many this is a matter of simple human compassion, as well as a long-range strategy to prevent the epidemic from spreading to the developed nations. Many of the African governments agree with this position, and some are even creating the generic medicines in their own figurative basements. The drug companies are opposed to this, of course, and have in the past even pressured American legislators to create sanctions against South Africa for these allegedly vile infractions.
How could the film have been rewritten to really grab the audience with a realistic motive
Of course Africa really is headed for an apocalypse, so one can make a great fictional story from the real issues. In fact, one could have made this same damned movie using plausible circumstances!
Rachel Weisz could have been an activist who somehow stumbled on evidence of some dirty dealings between drug company lobbyists and American politicians. Theoretically, her evidence, if revealed to the world, could be enough to persuade South Africa to defy international sanctions permanently for the greater good of its population. As a result South Africa would ignore patent law and opt to produce or import cheap generic knock-offs of AIDS medicine. (They really would do this. Indeed, they really did do this, pretty much.) With billions of dollars and many distinguished reputations at stake, and ol’ Rachel in the way, she might easily end up dead, and we would still have the same movie. The authors of the film (including John le Carre, who wrote the source novel) did not choose that route, which would have required presenting a balanced and realistic look at a complex, two-sided struggle which needs to be resolved by compromise and mutual goodwill. (Of course it’s two-sided. Not only are the drug companies defending legitimate intellectual property rights, but they also, after all, justify their astronomical gross profits by the fact that those dollars finance current and future research and development, which is a good thing. The top ten pharmaceutical companies spend about 25 billion dollars per year on R&D.) Instead, the story presented some brain-dead one-dimensional paranoid fiction far from the realm of plausibility, if not totally impossible.
The film’s overview of the relationship between the drug companies and Africa
The film suggests that the drug companies use Africa for their testing and dumping grounds. I’m sure there is a lot of truth to that, but it is a point which is pre-spun negatively by the very phrases which describe it.
- Is it really a bad thing that the pharmaceutical companies test new products in poor countries?
- Is giving poor people the latest experimental medicines worse than the alternative – which is for poor people to have no medicine at all?
- Is the film suggesting that medicines should not be tested? If so, how are the developers to determine whether the medicines are effective and safe, and how are the national health services and the FDA to make informed decisions about approving them?
Those are complex questions which cannot be solved with a dismissive wave of the hand. Testing is a complex multi-sided issue. On the other hand, dumping actually is not. It is an issue about which compassionate liberals are simply wrong.
Let us assume that the pharmaceutical corporations have vast amounts of still-potent drugs which have passed their expiration dates.
Do you want them to destroy those drugs, as the farmers destroyed their rotting, unsellable oranges during the Great Depression, or would you rather they offer them to the world health and relief organizations, who would recommend them to the Third World as their own scientists and doctors see fit? The screenplay of The Constant Gardener seems to indicate that all of that expired medicine is worthless junk, but frankly, that’s just a lot of malarkey. That medicine is almost always just as good as the medicine you and I take from our medicine cabinets. (In fact, if you actually look at the bottles in your medicine cabinets, you’ll probably find that a lot of your medicine has “expired.”) I worked for years in the food industry, and we had a similar controversy. We donated expired food products to organizations like homeless shelters. This was not something which we did publicly in order to reap a harvest of goodwill, but simply our response when charitable organizations asked us, “Say, that stuff you’re going to throw out, can we have it? We’ll pick it up, and it will be no trouble for you.” And yet, inevitably, some crusaders would appear from time to time and accuse us of dumping spoiled food on the poor. The same food, mind you, that I would often take home myself when given the chance. (Expiration dates are not calculated to take products to the very edge of their useful shelf life, to say the least.) What should we have said? “No, we need to destroy it!” There is no way for the food conglomerates to achieve a winning position on this chessboard because the game is rigged. The reason we started donating unmarketable food in the first place is because the liberal activists accused us of immorally destroying perfectly good food while people were starving! We are immoral if we give unmarketable food to the poor, and we are immoral if we destroy that food while people are starving. Frankly, there doesn’t seem to be a correct moral position. The drug companies are in the identical position with regard to expired medicines. Do you want them to throw away that perfectly good medicine when millions of people in the world could use it? That makes no sense to me.
On the other hand, some studies have indicated that something like 90% of drugs, both prescription and over-the-counter, are perfectly good to use after the expiration date – and sometimes as much as 15 years after that date!
You would expect that if you understand the process. The drug companies themselves set those expiration dates, not government agencies, and it is to their benefit to have your drugs “expire” as soon as possible so you will buy more. As a general rule, drug expiration dates are a marketing tactic rather than a set of public safety guidelines. The manufacturers set the shortest period they think they can get away with, without arousing the ire of consumer protection groups. That’s usually about 1/2 to 1/3 of the drugs’ expected shelf life. It is quite an interesting process to study, and the marketing strategies are quite brilliant. The manufacturers set a short expiration date, then calculate the typical usage for that period, and then package the drugs in a larger quantity than that typical usage. If the average consumer uses 30 aspirin tablets in the “safe” period, for example, the manufacturers might push the bottle of 100 as their standard size. The 70 left in your expired bottle will be good for years and years after the expiry date, but the manufacturer doesn’t want you to know that because it’s simply not as profitable for the drug companies if you are aware that you can still use medicine you bought many years ago. The ominous date motivates you to discard-and-restock, thus lining the pockets of the pharmaceutical company.
The World Health Organization advises the poor countries about which expired drugs they should accept. If the drugs are not potent, it is that organization which is to blame, not the pharmaceutical companies, and they should advise the countries to accept less. In fact, the “real world” problem is the exact opposite of the problem portrayed in the movie. Most experts believe that the W.H.O. should tell the poor countries to take MORE expired drugs, not less!
Misconception about Big Pharma and their policy towards the Third World
The real problem with the film is that, in offering the science-fiction plot as a misdirection, it draws attention away from the real problems in Africa.
- First of all, most sub-Saharan African families simply cannot afford the drugs, not even at deeply discounted prices, not even at cost. A years’ supply of antiretroviral drugs in the developed countries costs as much as $15,000. The average annual income per family in sub-Saharan Africa is around $400, and that doesn’t allow a lot of discretionary income. Even lowering the price of the drugs from $15,000 per year to $200 still leaves the price out of financial reach for the vast majority of those who have the disease.
- Second, it is really the internal corruption in those Third World countries which causes the problem, just as much as the drug companies. Cheap or free drugs intended to provide charitable relief in places like Nigeria often end up getting hijacked and sold in more developed countries for a massive profit, all the while hurting legitimate pharmaceutical sales in those developed markets. As a general rule, the poorest countries are also the most corrupt, and the aid never seems to get to the people for whom it is intended.
- When the pharmaceutical companies think it is good business to sell deeply discounted products for a tiny margin in Africa, as Coca-Cola does, they will (and sometimes already do) do it, because a little profit is better than none at all. In fact, because their actual cost of goods is so low, the drug companies could probably be persuaded to give drugs away in the Third World – IF their contributions would stay in the Third World. The problem is that they fear that those tiny profits and/or losses in sub-Saharan Africa could cause market disruptions elsewhere.
To be fair, we should note that the pharmaceutical companies have taken some actions to alleviate the suffering in Africa. Merck, Abbott, Bristol-Myers Squibb, Pfizer and Glaxo have contributed millions of dollars to the fight against AIDS in developing nations. The assistance has taken various forms: donating drugs outright; reducing their price to cost; investing in medical infrastructure and education programs; and voluntarily waiving patent rights so that generic, less costly versions of their drugs can be sold. The question is, however, “how much more should they do, given the enormous profit margins in pharmaceuticals?”
The stakes they play for are enormous. The top ten pharmaceutical companies average about forty billion dollars per year in profits, and they put nearly twenty cents of every sales dollar on the bottom line. (The average for a Fortune 500 company is two cents.) Merck, for example, puts almost as much on the bottom line as Wal-Mart, which is the world’s largest company, as defined by sales or by the number of employees. Look at the differences in scope, from Forbes Magazine’s annual info.
|Sales||$30 billion||$256 billion|
|Net profits after taxes||$7 billion||$9 billion|
The question “what should the pharmaceutical companies do?” is complex and nuanced, because the pharmaceutical giants don’t actually make any of that profit in impoverished nations. Indeed, they would like to ignore those countries altogether. The solution therefore requires both sides to approach the negotiations with an open mind and a sensible eye to compromise, concepts which are anathema to the film-makers involved in The Constant Gardener.
Consensus on the film
The film got everything wrong, but Africa really does have major problems related to the pharmaceutical companies, and there has to be a solution for this crisis. Unfortunately, it cannot be a facile, simple-minded solution because the root cause doesn’t involve cartoon evil, fake tests, and hit squads. It simply involves the fact that the drug companies operate for profit, and there’s no way to get an adequate return on investment in the Third World. Of course, the process of watching reasonable people hammer out compromises doesn’t make for good cinema, but a real-life solution will have to be crafted with compromise on both ends, because the drug companies have valid gripes. They are guarding their legitimate financial interests.
A corporate president might rationalize deaths in the test situation on that basis. I myself would do so. It is better to save some lives than none.
And a corporate president could justify covering up some insignificant side-effects to expedite approvals by the national health boards, on the basis of “Why not make money AND do good at the same time?” But no corporate president, unless completely mad, would justify the mass world-wide distribution of a product which is known to have truly pernicious side-effects, all the while authorizing hit squads to murder people around the world. That would be not only at a Dr. Doom or Lex Luthor level of evil, but would also be completely stupid financially. That is where the film crosses over into science-fiction territory.