June 21, 2011
The trend has gone largely unnoticed by the public at large. Yet more and more clinical studies are being conducted by the pharmaceutical industry in developing, and rapidly-developing countries. The objective of the studies is to test medication for effectiveness and side effects. But non-governmental organizations (NGOs) claim that when conducting tests in the developing countries, drug companies do not abide by the same ethical rules they would follow at home. As a result, participants in clinical trials conducted in developing countries are being abused, critics claim.
Exact figures for just how widespread the phenomenon is worldwide are not available. But as a report by the European Medicines Agency (EMA) reveals, between 2005 and 2009 some 26% of clinical studies submitted to the European Union for approval were conducted in Asia, Latin America, Africa, Middle East and Russia. That doesn't include the 10 new EU member states in Eastern Europe, which make up another 10%. Popular spots for clinical trials are: Brazil, India, China and South Africa – the so-called BRICS countries – and Poland.
The NGOs claim that the pharmaceutical industry is taking advantage of the weak position of people in developing and rapidly-developing countries. For many, signing up to be part of a trial is often the only way to get medication, says Annelies den Boer of Wemos, a Dutch NGO. And because the authorities in those countries don't tend to monitor the trials, participants are insufficiently protected from abuse.
"If a patient suffers from side effects, the companies often deny any connection of those effects with the medication," den Boer says. The burden of proof lies with the trial participant, not the pharmaceutical company. ‘"Proving anything, for participants like this, is exceptionally difficult.""
NGOs like Wemos further reproach the drug companies for breaking treatment off as soon as the clinical trial is completed. The Declaration of Helsinki, a set of ethical principles governing medical research on human beings to which the world's top 10 pharmaceutical companies, recommends the opposite – that treatment continues. This is a clear example, den Boer says, of how the companies often do not abide by the declaration's principles. Working with journalists, Wemos has cited numerous cases of patients who did not continue to receive medication after clinical trials were over.
Who's watching the watchdogs?
A further dimension to the problem is a generally insufficient monitoring over whether the drug companies follow ethical guidelines. Ethical commissions in each country are responsible for this, but they themselves operate with little oversight by local authorities, says den Boer. And although EMA does conduct checks to ensure that approval is not given in Europe for medication that has been unethically tested, the controls are very lax, she adds.
The matter did come up in the EU Parliament in 2009, with the result that the EMA is due to come up with a tighter set of controls by the end of 2011. Review of ethical guidelines has also come on in Switzerland. Patrick Durisch of the Erklärung von Bern (EvB), which describes itself as an independent organization devoted to aid development policy, says he doubts that Swissmedic, which grants licenses for pharmaceutical products in Switzerland, has the capacity to ascertain whether or not ethical guidelines are followed during clinical trials.
However, Verena Henkel, deputy head of Swissmedic's clinical review section, says the organization is well aware of increasing globalization and the consequences of it. The problem challenges all licensing agencies, worldwide, she says, adding that increased international cooperation was important. Henkel says that Swissmedic examines "all documents submitted by the pharmaceutical companies'" and abides not only by international rules such as Good Clinical Practice but also the Declaration of Helsinki.
Henkel says that Swissmedic asks the following questions for each case under review: Before being accepted for a clinical study, were patients fully briefed? Did they agree to participate and sign a document to that effect? Was the corresponding local ethics committee an independent body, and did it approve the study? Did the concept and implementation of the study take ethical guidelines and current science into account?
If there are any doubts, Swissmedic follows up with the company concerned and consults with relevant other authorities, Henkel says. If doubts remain, approval of the medication would not be granted.
There are a number of factors underlying the movement of clinical trials to developing and emerging countries. For the drug companies, the primary concern is cost. According to U.S. research, the cost per participant is about half in China or India as it would be in Europe or the United States. This holds particularly true for the major studies that have to be conducted once the clinical development of a medication has been completed.
Due to increased demands on the part of approving authorities, studies must be carried out on larger numbers of trial participants. For example, one Roche trial for cholesterol medication involved 15,600 patients. But another reason for moving trials to developing countries is access: lucrative markets in Asia and Latin America play an increasing role in sales. Chances of getting the necessary approval to sell a drug in a country are better when trials are conducted in the country. Time concerns also play a role: there are fewer administrative hurdles to clear in Asia and South America, so less time is spent prepping the trial, meaning it can get underway faster.
Finally, people in developing countries are more willing to participate in such studies because it is often the only way to get treatment. These poorer participants also come with a built-in extra advantage for the drug companies: they are much less likely to be on medication for any other condition either, which makes the trial easier and more accurate.
Read the original article in German.
Photo - mynameisharsha
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Once meant to protect the royal family, the century-old law has become a tool for the military-led government in Bangkok to stamp out all dissent. A new report outlines the abuses.
October 22, 2021
"We need to reform the institution of the monarchy in Thailand. It is the root of the problem." Those words, from Thai student activist Juthatip Sirikan, are a clear expression of the growing youth-led movement that is challenging the legitimacy of the government and demanding deep political changes in the Southeast Asian nation. Yet those very same words could also send Sirikan to jail.
Thailand's Criminal Code 'Lèse-Majesté' Article 112 imposes jail terms for defaming, insulting, or threatening the monarchy, with sentences of three to 15 years. This law has been present in Thai politics since 1908, though applied sparingly, only when direct verbal or written attacks against members of the royal family.
But after the May 2014 military coup d'état, Thailand experienced the first wave of lèse-majesté arrests, prosecutions, and detentions of at least 127 individuals arrested in a much wider interpretation of the law.
The recent report 'Second Wave: The Return of Lèse-Majesté in Thailand', documents how the Thai government has "used and abused Article 112 of the Criminal Code to target pro-democracy activists and protesters in relation to their online political expression and participation in peaceful pro-democracy demonstrations."
Criticism of any 'royal project'
The investigation shows 124 individuals, including at least eight minors, have been charged with lèse-majesté between November 2020 and August 2021. Nineteen of them served jail time. The new wave of charges is cited as a response to the rising pro-democracy protests across Thailand over the past year.
Juthatip Sirikan explains that the law is now being applied in such a broad way that people are not allowed to question government budgets and expenditure if they have any relationship with the royal family, which stifles criticism of the most basic government decision-making since there are an estimated 5,000 ongoing "royal" projects. "Article 112 of lèse-majesté could be the key (factor) in Thailand's political problems" the young activist argues.
In 2020 the Move Forward opposition party questioned royal spending paid by government departments, including nearly 3 billion baht (89,874,174 USD) from the Defense Ministry and Thai police for royal security, and 7 billion baht budgeted for royal development projects, as well as 38 planes and helicopters for the monarchy. Previously, on June 16, 2018, it was revealed that Thailand's Crown Property Bureau transferred its entire portfolio to the new King Maha Vajiralongkorn.
Protestors In Bangkok Call For Political Prisoner Release
Freedom of speech at stake
"Article 112 shuts down all freedom of speech in this country", says Sirikan. "Even the political parties fear to touch the subject, so it blocks most things. This country cannot move anywhere if we still have this law."
The student activist herself was charged with lèse-majesté in September 2020, after simply citing a list of public documents that refer to royal family expenditure. Sirikan comes from a family that has faced the consequences of decades of political repression. Her grandfather, Tiang Sirikhan was a journalist and politician who openly protested against Thailand's involvement in World War II. He was accused of being a Communist and abducted in 1952. According to Sirikhan's family, he was killed by the state.
The new report was conducted by The International Federation for Human Rights (FIDH), Thai Lawyer for Human Rights (TLHR), and Internet Law Reform Dialogue (iLaw). It accuses Thai authorities of an increasingly broad interpretation of Article 112, to the point of "absurdity," including charges against people for criticizing the government's COVID-19 vaccine management, wearing crop tops, insulting the previous monarch, or quoting a United Nations statement about Article 112.
Activist in front of democracy monument in Thailand.
Shift to social media
While in the past the Article was only used against people who spoke about the royals, it's now being used as an alibi for more general political repression — which has also spurred more open campaigning to abolish it. Sirikan recounts recent cases of police charging people for spreading paint near the picture of the king during a protest, or even just for having a picture of the king as phone wallpaper.
The more than a century-old law is now largely playing out online, where much of today's protest takes place in Thailand. Sirikan says people are willing to go further on social media to expose information such as how the king intervenes in politics and the monarchy's accumulation of wealth, information the mainstream media rarely reports on them.
Not surprisingly, however, social media is heavily monitored and the military is involved in Intelligence operations and cyber attacks against human rights defenders and critics of any kind. In October 2020, Twitter took down 926 accounts, linked to the army and the government, which promoted themselves and attacked political opposition, and this June, Google removed two Maps with pictures, names, and addresses, of more than 400 people who were accused of insulting the Thai monarchy. "They are trying to control the internet as well," Sirikan says. "They are trying to censor every content that they find a threat".
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