From The New York Times

Johnson & Johnson Hit With $8 Billion Jury Verdict in Risperdal Suit

October 8, 2019

A Philadelphia jury on Tuesday hit Johnson & Johnson with an $8 billion verdict over its marketing of the anti-psychotic drug Risperdal, siding with a Maryland man who argued that the health care giant downplayed risks that the drug could lead to breast growth in boys.

The verdict in the Philadelphia Court of Common Pleas was the first to award punitive damages against Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, said Thomas R. Kline, a lawyer who is part of a legal team representing the man and more than 10,000 people in similar lawsuits.

A Philadelphia jury on Tuesday hit Johnson & Johnson with an $8 billion verdict over its marketing of the anti-psychotic drug Risperdal, siding with a Maryland man who argued that the health care giant downplayed risks that the drug could lead to breast growth in boys.

The verdict in the Philadelphia Court of Common Pleas was the first to award punitive damages against Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, said Thomas R. Kline, a lawyer who is part of a legal team representing the man and more than 10,000 people in similar lawsuits.

Compensatory damages of $680,000 were already awarded in the case in March 2016….

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‘Value’ of Care Was a Big Goal. How Did It Work Out?

September 23, 2019

For most of its history, Medicare paid for health care in ways that encouraged more services — whether they improved health or not.

Critics called it an emphasis on volume, not value.

The Affordable Care Act was intended to change that, and Medicare started a number of programs to do so, including several new ones this year. Nearly a decade after passage of the A.C.A., is value-based payment working?

For most of its history, Medicare paid for health care in ways that encouraged more services — whether they improved health or not.

Critics called it an emphasis on volume, not value.

The Affordable Care Act was intended to change that, and Medicare started a number of programs to do so, including several new ones this year. Nearly a decade after passage of the A.C.A., is value-based payment working?

The Obama administration’s goal was for 90 percent of Medicare payments to hospitals and doctors to be tied to measures of quality by 2018. Although distancing itself from specific targets, the Trump administration has also committed to this goal….

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Why Aren’t There Better Cancer Drugs? Scientists May Have Picked the Wrong Targets

September 12, 2019

Twenty years ago, the fight against cancer seemed as if it were about to take a dramatic turn.

Traditionally, cancer doctors fought the disease with crude weapons, often simply poisoning fast-growing cells whether they were cancerous or healthy. But then a team of researchers hit on a new strategy: drugs targeting proteins produced by cancer cells that seemed necessary to their survival.

Twenty years ago, the fight against cancer seemed as if it were about to take a dramatic turn.

Traditionally, cancer doctors fought the disease with crude weapons, often simply poisoning fast-growing cells whether they were cancerous or healthy. But then a team of researchers hit on a new strategy: drugs targeting proteins produced by cancer cells that seemed necessary to their survival.

Once such drug, Gleevec, worked spectacularly in patients with chronic myeloid leukemia. But the clinical trials that followed mostly have produced disappointments. According to a study published earlier this year, only 3 percent of cancer drugs tested in clinical trials between 2000 and 2015 have been approved to treat patients.

A study published on Wednesday in the journal Science Translational Medicine offers one reason for the failure: Scientists are going after the wrong targets….

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Opioid Treatment Is Used Vastly More in States That Expanded Medicaid

August 22, 2019

States that expanded Medicaid under the Affordable Care Act have seen a much bigger increase in prescriptions for a medication that treats opioid addiction than states that chose not to expand the program, a new study has found.

The study, by researchers at the Urban Institute, a nonprofit research group, adds to the evidence that the 2010 health care law is playing a significant role in addressing the opioid epidemic.

States that expanded Medicaid under the Affordable Care Act have seen a much bigger increase in prescriptions for a medication that treats opioid addiction than states that chose not to expand the program, a new study has found.

The study, by researchers at the Urban Institute, a nonprofit research group, adds to the evidence that the 2010 health care law is playing a significant role in addressing the opioid epidemic. The researchers found that the number of Medicaid-covered prescriptions for buprenorphine, which eases cravings and withdrawal symptoms, increased almost fivefold nationally — to 6.2 million from 1.3 million — between 2011 and 2018.

“Expanding Medicaid is probably the most important thing states can do to increase treatment rates,” said Lisa Clemans-Cope, the study’s lead author. “But even some states that did expand Medicaid look like they are falling short in meeting the treatment needs….”

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Novartis Hid Manipulated Data While Seeking Approval for $2.1 Million Treatment

August 6, 2019

The drug maker Novartis concealed manipulated data from the Food and Drug Administration while applying for approval of an extremely expensive gene therapy treatment and then delayed reporting the issue, the agency said on Tuesday.

Officials said the inaccurate data, which involved testing in mice of two different strengths of the treatment, did not affect the safety or efficacy of the therapy, Zolgensma, used to treat a rare, often fatal genetic disease called spinal muscular atrophy.

The drug maker Novartis concealed manipulated data from the Food and Drug Administration while applying for approval of an extremely expensive gene therapy treatment and then delayed reporting the issue, the agency said on Tuesday.

Officials said the inaccurate data, which involved testing in mice of two different strengths of the treatment, did not affect the safety or efficacy of the therapy, Zolgensma, used to treat a rare, often fatal genetic disease called spinal muscular atrophy.

Approved in May, the treatment’s price — set at $2.1 million — stoked concerns about the astronomical costs of potential cures for rare diseases and upset parents who initially could not get insurance coverage for the breakthrough treatment….

Read the full The New York Times article