‘Off Label Use’ Of Pharmaceuticals - A High Price For Medical Progress

Who foots the bill if a doctor decides on a treatment option that is not approved for the medical condition in question? Insurers say they’re under no obligation to pay, even if the treatment was effective. And if the doctor’s “off label” choice saves a p

A creative use of pills (
A creative use of pills (

ZURICHDoctors and researchers have expanded treatment options by developing even more medications and therapies. This wealth of alternatives, however, is also creating a growing – though often overlooked – problem: so-called "off label use."

Off label use is when doctors use treatment options that have not been officially approved for a particular malady, and are not on the list of pharmaceuticals insurance companies reimburse. Why would they do such a thing? Because sometimes the medications or therapies are effective, even life saving. But of course they're also expensive, since insurers are not obliged to cover off label treatment. Swiss law makes an exception if the off label approach is used in the context of life-threatening or severe chronic illnesses.

Not surprisingly, off label use of medication and therapies leads regularly to misunderstandings and conflict, and often to court cases. The Swiss government tried to clarify matters by deciding in March 2010 to enforce a regulation stipulating that health insurers have to pay policy holders the cost of "off label use" when "greater therapeutic benefits' would result.

Many, however, argue that this does nothing whatsoever to clarify the situation. Health insurers, for example, say they're still in the dark about where to draw the line. "Our big challenge is figuring out how the ‘greater benefits' of a medicine can be established," says Martina Weiss of the insurance company Helsana.

Because there are very different interpretation possibilities, the insurers are vulnerable to accusations of using arbitrary definitions. Big firms like Helsana and CSS, therefore, make every effort to standardize how they define ‘greater benefits," using criteria such as "improved quality of life, prolongation of life," and more, Gabriella Chiesa Tanner of CSS explains.

In cases that do not match these criteria, the insurers have been asking manufacturers of the drugs to pay for treatment. So far drugs companies have been cooperative. Spokeswoman Silvia Dobry of Roche, speaking for the Swiss pharmaceutical industry in general, says costs should be secondary. What's more important, she says, is that doctors and patients have access to key drugs.

Just how much the manufacturers are willing to pay, however, is subject to discussion. According to CSS's Chiesa Tanner, neither insurers nor the industry are providing figures. One industry expert says that ultimately off label use is lucrative for the industry: if it turns out that medication can be used for several conditions, drug companies will seek official approval for use of the medication to treat those conditions.

The subject of off label use is not about to disappear any time soon. Helsana alone deals with 2,000 cases annually, and the number of cases is on the increase. CSS claims that it deals with about 700 cases a year. The company expects that number to rise as more and more medications become available.

Read the full story in German by Andreas Möckli

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*This is a digest article, not a direct translation

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How Thailand's Lèse-Majesté Law Is Used To Stifle All Protest

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.

Pro-Democracy protest at The Criminal Court in Bangkok, Thailand

Laura Valentina Cortés Sierra

"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.

photo of graffiti of 112 crossed out on sidewalk

Protestors In Bangkok Call For Political Prisoner Release

Peerapon Boonyakiat/SOPA Images via ZUMA Wire

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.

Juthatip Sirikan speaks in front of democracy monument.

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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