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Moral decay at GSK reaps record US$3 billion fine
Editorial
Corbis
Holding on to a huge victory for American health
See World Report page 14
For more on the Supreme Court ruling see http://www. supremecourt.gov/ opinions/11pdf/11-393c3a2.pdf
The past week was a historic one for health in America. In a much-anticipated decision, the country’s highest court—the US Supreme Court—ruled that most provisions in President Barack Obama’s Patient Protection and Affordable Care Act (ACA) were constitutional. President Obama’s health reform, designed to expand coverage to nearly all Americans, passed into law in 2010 but it has faced many challenges, culminating in the Supreme Court case. One provision under question was a mandate that required individuals to pay a penalty for not obtaining health insurance. However, the Court of nine judges ruled 5–4 that this penalty met the criteria for a tax and that it was Congress’s constitutional authority to levy taxes. The ruling means that millions of Americans will be financially protected in the event of illness. The Court did strike down one provision in the law. The Court said that Congress could not coerce states to expand Medicaid—the joint federal–state programme that provides health care to people who are poor or disabled—by withholding existing federal payments for the programme. Now states can opt-out
of expansion. This means that the predicted 32 million more Americans set to gain from the ACA could now be potentially halved. Some Republican governors have already stated that they will not participate in the expansion, meaning that some lower earners in those states will lose their chance to gain coverage under the ACA. As observers have noted, these low earners are disproportionately black or Latino. The federal government will have to come up with substantial incentives to encourage states to participate in the Medicaid expansion. It must also ensure that insurers and employers do not begin to circumvent the ACA provisions by closing any potential legal loopholes. And it needs to raise public awareness about the immense health benefits of the ACA. Presumptive Republican presidential nominee Mitt Romney, whose response to the Court decision was a promise to repeal the act on his first day if elected as president, has placed health care centre stage in the run-up to the Nov 6 election. The ACA provides a vital social safety net for Americans. It should remain as law for the future health of the nation. The Lancet
Moral decay at GSK reaps record US$3 billion fine
Tom Hevezi/AP/Press Association Images
On July 2, UK-based GlaxoSmithKine (GSK) agreed to plead guilty to criminal charges of fraudulent promotion of its drugs and pay the US Government a settlement of US$3 billion. If accepted, this will be the largest fine imposed on a drug company, surpassing the $2·3 billion paid by Pfizer for inappropriate marketing in 2009. The amount adds to GSK’s $750 million settlement in 2010 over manufacturing quality. What is particularly egregious about GSK’s fraud is the calculated deceit and potential human cost of its aggressive and misleading marketing. For instance, while evidence was emerging that showed an increased suicide risk in adolescents prescribed selective serotonin reuptake inhibitors for depression, GSK was actively encouraging off-label prescription of paroxetine to individuals younger than 18 years. This was not an isolated incident; off-label use was also encouraged for bupropion. For rosiglitazone, safety data were withheld from the US Food and Drug Administration and altered, potentially delaying restrictions on the drug’s use and putting people to 2
whom it was prescribed at increased risk of cardiovascular complications. The company is also accused of cheating Medicare. Such behaviour is not only illegal, it is immoral. As Machiavelli observed, “he who seeks to deceive will always find someone who will allow himself to be deceived”. Sadly, in the case of GSK, this has involved doctors who were all too ready to be beguiled by illegal kickbacks and lavish hospitality. Multibillion-dollar fines are inadequate to tackle misconduct when penalties can be paid from post-tax profits. Indeed, there seems to be such an arrogance about money, that on the same day that GSK was being fined $3 billion, the Association of the British Pharmaceutical Industry argued that the UK Government should reinvest the $5 billion expected from NHS drug savings back into the industry. GSK and other drug companies have come adrift from the standards of the societies they seek to serve. They need to rediscover corporate citizenship, beginning with the individual integrity and accountability of their employees. The Lancet www.thelancet.com Vol 380 July 7, 2012
Corbis
Holding on to a huge victory for American health
See World Report page 14
For more on the Supreme Court ruling see http://www. supremecourt.gov/ opinions/11pdf/11-393c3a2.pdf
The past week was a historic one for health in America. In a much-anticipated decision, the country’s highest court—the US Supreme Court—ruled that most provisions in President Barack Obama’s Patient Protection and Affordable Care Act (ACA) were constitutional. President Obama’s health reform, designed to expand coverage to nearly all Americans, passed into law in 2010 but it has faced many challenges, culminating in the Supreme Court case. One provision under question was a mandate that required individuals to pay a penalty for not obtaining health insurance. However, the Court of nine judges ruled 5–4 that this penalty met the criteria for a tax and that it was Congress’s constitutional authority to levy taxes. The ruling means that millions of Americans will be financially protected in the event of illness. The Court did strike down one provision in the law. The Court said that Congress could not coerce states to expand Medicaid—the joint federal–state programme that provides health care to people who are poor or disabled—by withholding existing federal payments for the programme. Now states can opt-out
of expansion. This means that the predicted 32 million more Americans set to gain from the ACA could now be potentially halved. Some Republican governors have already stated that they will not participate in the expansion, meaning that some lower earners in those states will lose their chance to gain coverage under the ACA. As observers have noted, these low earners are disproportionately black or Latino. The federal government will have to come up with substantial incentives to encourage states to participate in the Medicaid expansion. It must also ensure that insurers and employers do not begin to circumvent the ACA provisions by closing any potential legal loopholes. And it needs to raise public awareness about the immense health benefits of the ACA. Presumptive Republican presidential nominee Mitt Romney, whose response to the Court decision was a promise to repeal the act on his first day if elected as president, has placed health care centre stage in the run-up to the Nov 6 election. The ACA provides a vital social safety net for Americans. It should remain as law for the future health of the nation. The Lancet
Moral decay at GSK reaps record US$3 billion fine
Tom Hevezi/AP/Press Association Images
On July 2, UK-based GlaxoSmithKine (GSK) agreed to plead guilty to criminal charges of fraudulent promotion of its drugs and pay the US Government a settlement of US$3 billion. If accepted, this will be the largest fine imposed on a drug company, surpassing the $2·3 billion paid by Pfizer for inappropriate marketing in 2009. The amount adds to GSK’s $750 million settlement in 2010 over manufacturing quality. What is particularly egregious about GSK’s fraud is the calculated deceit and potential human cost of its aggressive and misleading marketing. For instance, while evidence was emerging that showed an increased suicide risk in adolescents prescribed selective serotonin reuptake inhibitors for depression, GSK was actively encouraging off-label prescription of paroxetine to individuals younger than 18 years. This was not an isolated incident; off-label use was also encouraged for bupropion. For rosiglitazone, safety data were withheld from the US Food and Drug Administration and altered, potentially delaying restrictions on the drug’s use and putting people to 2
whom it was prescribed at increased risk of cardiovascular complications. The company is also accused of cheating Medicare. Such behaviour is not only illegal, it is immoral. As Machiavelli observed, “he who seeks to deceive will always find someone who will allow himself to be deceived”. Sadly, in the case of GSK, this has involved doctors who were all too ready to be beguiled by illegal kickbacks and lavish hospitality. Multibillion-dollar fines are inadequate to tackle misconduct when penalties can be paid from post-tax profits. Indeed, there seems to be such an arrogance about money, that on the same day that GSK was being fined $3 billion, the Association of the British Pharmaceutical Industry argued that the UK Government should reinvest the $5 billion expected from NHS drug savings back into the industry. GSK and other drug companies have come adrift from the standards of the societies they seek to serve. They need to rediscover corporate citizenship, beginning with the individual integrity and accountability of their employees. The Lancet www.thelancet.com Vol 380 July 7, 2012