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Scientists Must be Held Responsible and Protected by Law

Tuesday, August 4, 2009
Posted in Health Science | Tagged Health, Science

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Scientists are responsible for acquiring new data and evaluating existing data without bias, and should be protected by law for doing so; but if they fail, they too should be liable to prosecution. From time to time, corporations are ordered to pay large damages to people harmed by their products, not because of faults in the manufacturing but because the products themselves are dangerous. Recently, for example, the US Supreme Court ruled that Philip Morris has to pay an award of $150 million to a single plaintiff, the widow of a smoker who died more than ten years ago [1]. In 2007, the pharmaceutical giant Merck agreed to pay $4.85 billion to settle lawsuits brought against it in the US by people who suffered heart attacks or strokes after taking the painkiller Vioxx [2] (see Vioxx, A Mercky Story , SiS 43).

These payouts are especially significant because it is very hard to win damages in such cases. In the first place, it means going to court against an opponent with very deep pockets, and this is only feasible in countries like the US where class actions are allowed and lawyers can act on a “no win no fee” basis. Merck has so far spent over a billion dollars on legal expenses relating to Vioxx [3]. Second, it is not always easy to prove that the product was responsible for whatever harm suffered. Was Mr X’s heart attack the result of taking a drug, or would he probably have had a heart attack anyway? Did Ms Y commit suicide because she was taking antidepressants, or did she just have suicidal tendencies?

Even when the product is to blame , the manufacturers are not liable unless they knew, or ought to have known, that it was dangerous. The heirs of a smoker who died of lung cancer cannot demand damages for harm that was done before the company that sold him the cigarettes could reasonably have been expected to know that smoking causes lung cancer. This is where scientific/medical researchers have a special responsibility.

Scientists carry pivotal responsibility

The researchers are generally the first to know of any problems. They are in a privileged position to acquire new data, to evaluate existing data without bias, and to inform the company, the public and policy-makers accordingly. If they have failed in doing so, then they too ought to be held responsible, but generally they are not, due partly to a misconception that science and scientists are somehow above the law. And this is unfortunate, because it has the effect of encouraging if not rewarding irresponsible science and scientists while penalising those scientists who do take their responsibility seriously, even at the risk of losing their jobs or research grants (see later).

Individuals largely immune from prosecution in case of dangerous products

It is striking that the lawsuits and threatened prosecutions have been directed at companies when it is people that take decisions. To be sure, under the law, a company is treated almost like a person, and in many ways this actually makes sense. For one thing, obtaining redress would be even harder if you had to identify which individual within the company was actually responsible for the harm, and even then it would be very difficult actually to collect any award that was made.

All the same, it does seem remarkable that none of those responsible is prosecuted, whereas this is generally what happens when people are suspected of being grossly negligent or w orse.

After four people were killed in the Hatfield derailment in the UK in 2001, the government ordered an inquiry and both the companies and individuals responsible for track maintenance were charged. While the charges against the individuals were later dropped, it left engineers and others in positions of responsibility in no doubt about the consequences of negligence, to themselves and their careers. Many other people can find themselves in court, including teachers who have not taken proper care of pupils on an outing or drivers who have caused serious accidents by their irresponsible behaviour.

Yet when it comes to products that can be inherently dangerous such as drugs, pesticides, foods, and cigarettes , the investigation is largely left to the victims, and the individuals responsible seem immune from prosecution. Those who believe they were harmed by Vioxx, for example, have been left to fight their case in court at their own expense; the UK government has explicitly taken th e line that this is a matter “properly for the judicial system” and is not allowing legal aid [4].

This immunity from prosecution may help explain one of the most worrying features of these cases: the companies never seem to show any remorse about what has happened, or give an undertaking that it won’t happen again. When Merck and Elsevier were found to have published a fake scientific journal promoting Merck products, Elsevier, the publishing company, acknowledged that they had not lived up to their usual standards, but Merck were totally unrepentant [5], as were the individuals responsible.

There were rare exceptions from immunity

It is significant that the same immunity does not always apply to government officials or the scientists involved. In the 1980s, many haemophiliacs were infected with HIV/AIDs because the people in charge were too slow to recognise the danger and continued to accept blood donations from high risk groups and to use blood that had not been heat treated. Officials in several countries were charged with offences such as negligence for not acting soon enough. Two scientists in the French blood transfusion service were sentenced to prison terms [6] and the then Minister of Health was also convicted, though no sentence was passed.

Four companies in the USA - Bayer, Baxter International, Rhône-Poulenc and Alpha Therapeutic - agreed to pay $660 million to more than 6 000 haemophiliacs who had become infected. In contrast, no charges were brought against any employees of these or any other companies. Only in Japan were drug-company executives charged as individuals [7].

Scientists should be held responsible and protected by law for telling the truth

Companies seldom if ever apologise for what went wrong, or announce that the employees responsible are to be sacked, starting with the scientists researching the product, the head of research, the head of marketing, and up to the CEO. In this ‘chain of command’, it is the research scientists at root that hold the ultimate responsibility. If they fail to perform their research and interpret their findings with competence, care, and integrity, or worse, if they engage in manipulating, dismissing, or falsifying key research results, they should be liable to prosecution. But if their research had been properly conducted and the findings honestly reported, then those others in positions of responsibility are surely culpable, and especially so if they abuse their positions to dismiss or suppress the research findings; which is all too often the case.

It is unconscionable and intolerable that scientists who do take their responsibility seriously are invariably victimised. Shiv Chopra is one of three Health Canada scientists who testified before a Senate Committee in 1998 that Health Canada managers had pressured them to release suspect veterinary drugs into the food chain without the evidence of safety, as required by Canada’s Food and Drugs Act . These revelations led to the widespread rejection of recombinant bovine growth hormone (rBST) for boosting milk production of dairy cattle in Europe and Canada even though it had been already approved in the USA. Chopra and the other scientists lost their job, and ligations continue to this day [8]. In August 2008, Chopra and fellow scientists were vindicated as massive and sustained rejection of rBST worldwide forced Monsanto to stop producing and selling the hormone [9].

We have featured a number of other scientists who tried to tell the public what they know: Arpad Pusztai (Pusztai Publishes Amidst Fresh Storm of Attack - The Sorry State of ‘Sound Science’. ISIS News 3 ) [10], Nancy Olivieri ( Big Business = Bad Science? ISIS News 9/10) [11], David Healy ( The Depressing Side of Medical Science , SiS 39 [12], Aubrey Blumsohn ( Actonel: Drug Company Keeps Data from Collaborating Scientists , SiS 30) [12], and I rina Ermakova ( GM Soya Fed Rats: Stunted, Dead, or Sterile , SiS 33 ) [13]. Without exception, they found not just the corporations, but the universities and the scientific establishment turned against them.

Recently, 26 scientists in the US submitted a statement to the Environment Protection agency protesting the “technology/stewardship agreements” they have to sign in order to obtain GM seeds. As a result, “no truly independent research can be legally conducted on many critical questions regarding the [genetic modification] technology.” [14] (see Corporate Monopoly of Science , SiS 42).

At the same time, the hazards of GMOs are being ignored despite the large amount of evidence that has accumulated [15, 16] ( GM is Dangerous and Futile . SiS 40; GM Science Exposed. ISIS CD book). The evidence includes the extreme toxicity of the world’s top selling herbicide glyphosate and its Roundup formulations currently used on more than 80 percent of GM crops grown globally [17, 18] ( Ban Glyphosate Herbicides Now , and Glyphosate Herbicide Could Cause Birth Defects , SiS 43) , that should be banned immediately.

A culture has developed that systematically condones, encourages, and rewards scientific irresponsibility while penalising conscientiousness and integrity. If we expect scientists and the corporations to act responsibly, we must ensure that the incentives point them in that direction.

The people who decide whether to continue marketing tobacco or other dangerous products, or to go ahead with a drug, who decide what trials to carry out, what information to pass on to the regulator, even what information to share with their academic collaborators, have a very important duty of care to the public. They should know that if they are grossly negligent, or especially if they deliberately conceal relevant information, then they are liable to the same sorts of penalties that others can expect when they fail in this duty.

Prof. Peter Saunders and Dr. Mae-Wan Ho

A fully referenced and illustrated version of this article is posted on ISIS members’ website. Details here

An electronic version of the full report can be downloaded from the ISIS online store. Download Now