In placebo-controlled trials the effect of a drug is compared against the effect of a placebo – an inactive substance, often a sugar pill. Subjects do not know whether they are receiving real or placebo treatment. The results obtained in the different groups are then compared. In theory, this is an effective way to determine a treatment’s efficacy. In practice, this means that some patients don’t actually get treatment. This is why placebo-controlled trials have always been controversial. According to the Declaration of Helsinki, which regulates clinical trials worldwide and was adopted by the World Medical Association in 1964, placebo-controlled trials can be conducted only in circumstances where there is no proven treatment available. Additionally, it stipulates that “extreme care must be taken to avoid abuse of this option.” Although not binding, the document serves as a reference for organizations and governments alike. Current EU legislation requires that results from unethical clinical trials that have not been conducted in accordance with the Declaration of Helsinki not be accepted for marketing authorization. Yet, according to a report by the Dutch Center for Research on Multinational Corporations, this principle is being violated. In 2008 the U.S. Food and Drug Administration (FDA) ruled that drug companies no longer needed to comply with these international guidelines in clinical trials conducted outside the United States. This made it easier for companies and their subcontractors to conduct clinical trials in countries with poor regulatory systems.
South Africa appears to have one of the highest rates of placebo-controlled trials in the world. For the pharmaceutical companies, they have two advantages: first, it is easier to show efficacy when testing a new drug against a placebo instead of against an existing therapy; second, studies which compare existing and new drugs require more patients and consequently more time and more money. Widespread poverty and lack of access to adequate and affordable health care means it’s easy for companies to recruit trial subjects: for the most vulnerable, taking part in clinical trials is often seen as a way to get treatment that’s otherwise out of reach. Drug companies are quick to exploit this opportunity. According to the report, the clinical trial business in South Africa is valued at around €250 million ($329 million).
For example, over the past years, South African patients have participated in numerous psychiatric clinical trials for multinational companies, often with the use of placebos. One of them is a study started in 2010 to evaluate the efficacy of a substance called Paliperidone Palmitate in preventing the relapse of schizoaffective disorder. Initially, all trial subjects receive Paliperidone. But only some of them will be eligible to continue: half continue to receive Paliperidone, whereas the other half get a placebo. Proving the efficacy of the test drug means that the patients in the placebo group must experience a relapse in their psychiatric conditions more frequently and sooner than the Paliperidone group.
According to the Declaration of Helsinki, this type of trial can never justify the use of placebo because it involves withholding treatment from seriously ill patients who may run the risk of serious or irreversible harm. In addition, proven current interventions are available. The pharmaceutical company involved has another drug, Risperone, used to treat the same condition, but whose patents will expire in 2014. This has led experts to suspect that the trials are actually an opportunity to have a new brand-name drug available once the patent on the older one runs out. This seems to be a common practice: by adding minor variations to their blockbuster drugs, companies try to put a ‘new’ product on the market by the time the patent of the old drug has expired, thereby preserving their revenue stream. This serves their financial needs instead of clinical needs.
Additionally, some experts believe there is no need for new drugs in that field; they say the ones that exist are pretty good if used properly. The problem is that regulators such as the FDA don’t judge whether there are enough anti-depressants or anti-psychotics on the market or whether there is a public health need for such a drug; nor do they require new drugs to be significantly better than existing ones. Instead, they treat drugs like they treat any other commodity, i.e. the company just has to jump through the regulatory hoops – which includes having two placebo trials even when these have no scientific value.
In 2000, the Declaration of Helsinki, in an attempt to address the potential exploitation of patients as trial subjects, introduced the principle of post-trial access to drugs for people who participate in clinical trials. Yet, according to the Wemos report, post-trial access to medication remains a rare perk in South Africa. Professor Doris Schroeder, Director of the Centre for Professional Ethics at the University of Central Lancashire (UK), concedes that “it seems eminently unfair to discontinue access to drugs to clinical trial participants who are responding well, when it is clear that their national health service will not pick up where the trial left off. It means refusing to help somebody whom one could easily help. And in the worst case, the participant dies. That’s utterly horrendous, when help is so close.”
Taken from here
South Africa appears to have one of the highest rates of placebo-controlled trials in the world. For the pharmaceutical companies, they have two advantages: first, it is easier to show efficacy when testing a new drug against a placebo instead of against an existing therapy; second, studies which compare existing and new drugs require more patients and consequently more time and more money. Widespread poverty and lack of access to adequate and affordable health care means it’s easy for companies to recruit trial subjects: for the most vulnerable, taking part in clinical trials is often seen as a way to get treatment that’s otherwise out of reach. Drug companies are quick to exploit this opportunity. According to the report, the clinical trial business in South Africa is valued at around €250 million ($329 million).
For example, over the past years, South African patients have participated in numerous psychiatric clinical trials for multinational companies, often with the use of placebos. One of them is a study started in 2010 to evaluate the efficacy of a substance called Paliperidone Palmitate in preventing the relapse of schizoaffective disorder. Initially, all trial subjects receive Paliperidone. But only some of them will be eligible to continue: half continue to receive Paliperidone, whereas the other half get a placebo. Proving the efficacy of the test drug means that the patients in the placebo group must experience a relapse in their psychiatric conditions more frequently and sooner than the Paliperidone group.
According to the Declaration of Helsinki, this type of trial can never justify the use of placebo because it involves withholding treatment from seriously ill patients who may run the risk of serious or irreversible harm. In addition, proven current interventions are available. The pharmaceutical company involved has another drug, Risperone, used to treat the same condition, but whose patents will expire in 2014. This has led experts to suspect that the trials are actually an opportunity to have a new brand-name drug available once the patent on the older one runs out. This seems to be a common practice: by adding minor variations to their blockbuster drugs, companies try to put a ‘new’ product on the market by the time the patent of the old drug has expired, thereby preserving their revenue stream. This serves their financial needs instead of clinical needs.
Additionally, some experts believe there is no need for new drugs in that field; they say the ones that exist are pretty good if used properly. The problem is that regulators such as the FDA don’t judge whether there are enough anti-depressants or anti-psychotics on the market or whether there is a public health need for such a drug; nor do they require new drugs to be significantly better than existing ones. Instead, they treat drugs like they treat any other commodity, i.e. the company just has to jump through the regulatory hoops – which includes having two placebo trials even when these have no scientific value.
In 2000, the Declaration of Helsinki, in an attempt to address the potential exploitation of patients as trial subjects, introduced the principle of post-trial access to drugs for people who participate in clinical trials. Yet, according to the Wemos report, post-trial access to medication remains a rare perk in South Africa. Professor Doris Schroeder, Director of the Centre for Professional Ethics at the University of Central Lancashire (UK), concedes that “it seems eminently unfair to discontinue access to drugs to clinical trial participants who are responding well, when it is clear that their national health service will not pick up where the trial left off. It means refusing to help somebody whom one could easily help. And in the worst case, the participant dies. That’s utterly horrendous, when help is so close.”
Taken from here
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