Tag: Novartis

  • Novartis, Sanofi and Pfizer engaged in illegal kickbacks and bribery

    Novartis, Sanofi and Pfizer engaged in illegal kickbacks and bribery

    There’s a long history of pharmaceutical companies engaged in bribery and other illegal activities. The pharmaceutical industry routinely puts its interests before the public health every way it can. In the last week, Novartis, Sanofi and Pfizer have been called out for engaging in illegal kickbacks and bribery.

    Stat News reports that Sanofi is paying nearly $12 million for violating the Anti-Kickback Statute, in this case, paying kickbacks to people with Medicare through charitable donations. Older adults and people with disabilities using Lemtrada to treat multiple sclerosis received the money to cover their copays. In addition to Sanofi, Johnson and Johnson, Amgen, Pfizer, Biogen and Novartis have settled similar lawsuits.

    The federal Anti-Kickback Statute forbids pharmaceutical companies from paying money to people with Medicare and others in federal programs to use their medicines. Sanofi refused to admit guilt, claiming it was simply supporting charitable organizations.

    Stat News reports that Novartis is paying $678 million to settle charges of illegal kickbacks to doctors in the US in the form of high honoraria for prescribing large amounts of its drugs. Novartis held more than 80,000 sham events since 2011. According to an FBI official, Novartis also bribed doctors to prescribe more of its drugs.

    Stat News also reports that Novartis is paying $345 million to the Securities and Exchange Commission and the US Department of Justice to settle a federal criminal case. The government had charged Novartis with bribing doctors, hospitals and clinics in South Korea, Vietnam and Greece to prescribe its prescription drugs, in violation of the Foreign Corrupt Practices Act. The health care providers allegedly cooked their books in order to hide the bribes.

    If this weren’t bad enough, Novartis also allegedly inappropriately conducted clinical trials in an effort to better market its drugs. An audit found no compelling scientific reason for the trials. Novartis paid health care providers who prescribed its drugs to attend conferences around the world.

    High level Novartis executives were implicated. They appear to be getting off scot-free.

    Meanwhile, Pfizer has brought a lawsuit that challenges the legality of laws that prohibit it from paying Medicare Part D drug copays for people with a severe heart condition. It says it wants to help people pay for tafamidis which is prescribed to treat the heart condition and costs $225,000 a year.  Of course, the easiest way to help patients would be to lower the cost of the drug.

    Instead, Pfizer wants either to pay copays directly or to pay copays through charities. But, the underlying motive is to boost sales for the very expensive drug, while keeping the drug price high. And, the Office of the Inspector General treats such activities as fraud.

    Pfizer’s argument is that there is no other drug for this condition. So, it cannot be engaged in illegal steering for this drug. It further claims that it is unconstitutional, violating the equal protection clause and the first amendment, to bar the company from supporting charitable organizations. People with Medicare not poor enough to qualify for Medicaid or other federal programs to cover the cost of the drug and not wealthy enough to pay for the drug’s out-of-pocket costs themselves are hurt.

    Senator Sheldon Whitehouse and Senator Elizabeth Warren are leading a charge to fight these pharmaceutical company practices. Drug companies get big tax breaks and profits from their “charitable donations.”  Their drug prices need to be lower.

    Here’s more from Just Care:

  • Novartis gains White House support after paying $1.2 million to Michael Cohen

    Novartis gains White House support after paying $1.2 million to Michael Cohen

    Despite campaign claims to rein in prescription drug prices and drain the swamp of corruption in Washington, President Trump appears to have strong and unseemly links to Pharma. Novartis gained White House support for its prescription drug policies after making $1.2 million payment to President Trump’s one-time lawyer Michael Cohen. According to Stat, an investigation by Senate Democrats uncovered emails and other documents revealing that Novartis’ positions on drug pricing, which it shared with Cohen, ended up in Trump’s blueprint on drug prices.

    Between 2017 and 2018, Novartis paid Cohen $1.2 million for help connecting to top policymakers. And, Cohen obliged. Novartis misleadingly had suggested it had had only one “communication” with Cohen for that fee. In fact, the Senate investigation shows that Novartis had multiple contacts with Cohen and shared with Cohen its proposals for addressing drug costs. At the time, the White House was developing its list of ideas for addressing drug costs.

    Among other things, Novartis wanted value-based pricing and outcomes-based contracting for its $475,000 CAR-T cancer treatment. Novartis felt Medicare should pay for “value” if patients responded to its treatment by the end of the first month. After the revelation that Novartis had paid Cohen for access to the White House, the Centers for Medicare and Medicaid Services (CMS) canceled its plans to test this so-called “value-based” approach to paying for the drug.

    Senator Patty Murray stated: “The more we learn about the arrangement between Michael Cohen and Novartis, the more alarming it appears. The public was rightly concerned to learn President Trump’s close associates are selling access to the Administration and getting million dollar contracts from drug companies.”

    If you want Congress to rein in drug prices, please sign this petition.

    Here’s more from Just Care:

  • Beware of researchers with conflicts of interest

    Beware of researchers with conflicts of interest

    When reading about health care, it’s sometimes hard to know who’s telling the truth and who’s burying it. That’s why I try to base all JustCare posts on findings from independent researchers, information from consumer organizations and government agencies and other generally trustworthy sources. But, when things get technical, even seasoned reporters at the New York Times fail to beware of researchers with conflicts of interest and bury the lede.

    Josh Freeman writes on Medicine and Social Justice that Denise Grady at the New York Times promotes a Novartis-funded study published in the New England Journal of Medicine on the effect of canakinumab (Ilaris) on heart attack survivors. The findings, he says, and cardiologist Michael Gilson, M.D., agrees, are not surprising and unremarkable–fewer heart attacks and strokes for patients taking the drug. But, overall, the people taking the drug died at the same rate as the people not taking the drug because the drug “decreases the body’s immune response,” leading to sometimes lethal infections.

    Freeman and Gilson’s conclusion: The drug offers no clinical advance. For $200,000 a year–the cost of the drug–fewer people die of heart attack and stroke but, because of the drug’s side effects, they have the same likelihood of dying as people who don’t take the drug. Moreover, an unknown number of people who take the drug do not die from it but suffer significantly from the infections caused by the drug, including tuberculosis, sepsis, pneumonia and cellulitis.

    In short, contrary to the New York Times article, this drug is “no major milestone.” It costs a fortune, does not decrease people’s risk of death, and it increases their risk of serious infections. In the second half of her NYT article, Grady does cover these issues, but the article headline, “Drug Aimed at Inflammation May Lower Risk of Heart Disease and Cancer,” and its opening paragraphs are terribly misleading.

    N.B. Also beware of doctors with conflicts of interest. Stat News recently published a Pharma puff piece by Dr. Robert Yapundich, who, according to Pro Publica, has received $215,000 from Pharma. If Stat was not aware of the Pro Publica database revealing which doctors take money from Pharma, it should be. If it was aware and still thought the piece offered value for its readers–which is hard to understand–it owes its readers a prominent note about the author’s conflict of interest.

    Here’s more from Just Care: