Breaking down the dirty of specific pharma companies: #5 Novartis

Novartis has several psych meds you may recognize: Trileptal, Tegretol, Imipramine, Ritalin, Sertraline, Focalin, Exelon patch for Alzheimers, Clozaril and Fanapt for schizophrenia.  With the exception of Fanapt, the rest are generic branded now as well.  I don’t see this drug company often, as they cannot keep reps very well.  Their manager is a jerk, and I let him have it one day when he tried to get snappy and pushy with me on prescribing Fanapt to people.  I have 0 patients on that drug and I will never use it.

They have their share of trouble in the past as well.  n September 2008, the US Food and Drug Administration (FDA) sent a notice to Novartis Pharmaceuticals regarding its advertising of Focalin XR, an ADHD drug, in which the company overstated its efficacy while marketing to the public and medical professionals.  In 2005, federal prosecutors opened an investigation into Novartis' marketing of several drugs: Trileptal, an antiseizure drug; three drugs for heart conditions - Diovan (the company's top-selling product), Exforge, and Tekturna; Sandostatin, a drug to treat a growth hormone disorder; and Zelnorm, a drug for irritable bowel syndrome. In September 2010, Novartis agreed to pay US$422.5 million in criminal and civil claims and to enter into a corporate integrity agreement with the US Office of the Inspector General. According to The New York Times, "Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. But aside from pleading guilty to one misdemeanor charge of mislabeling in an agreement that Novartis announced in February, the company denied wrongdoing." In the same New York Times article, Frank Lichtenberg, a Columbia professor who receives pharmaceutical financing for research on innovation in the industry, said off-label prescribing was encouraged by the American Medical Association and paid for by insurers, but off-label marketing was clearly illegal. "So it's not surprising that they would settle because they don't have a legal leg to stand on."  In April 2013, federal prosecutors filed two lawsuits against Novartis under the False Claims Act for off-label marketing and kickbacks; in both suits, prosecutors are seeking treble damages. The first suit "accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts".^[159] In the second, the Justice Department joined a qui tam, or whistleblower, lawsuit brought by a former sales rep over off-label marketing of three drugs: Lotrel and Valturna (both hypertension drugs), and the diabetes drug, Starlix. Twenty-seven states, the District of Columbia and Chicago and New York also joined.

On 17 May 2010, a jury in the United States District Court for the Southern District of New York awarded $3,367,250 in compensatory damages against Novartis, finding that the company had committed sexual discrimination against twelve female sales representatives and entry-level managers since 2002, in matters of pay, promotion, and treatment after learning that the employees were pregnant. Two months later the company settled with the remaining plaintiffs for $152.5 million plus attorney fees.

Novartis paid $1.2 million to Essential Consultants, an entity owned by Michael Cohen, following the 2017 inauguration of Donald Trump. Cohen was paid monthly, with each payment just under $100,000. Novartis claims it paid Cohen to help it understand and influence the new administration's approach to drug pricing and regulation.  (The backdoor channel when the administration isn’t as bought and paid for as previous administrations were).

So what was Novartis up to during this covid situation?

“Novartis has been active in several cross-industry research initiatives, including the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Welcome, and MasterCard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative. The company also teamed up with R&D leaders throughout the industry as part of the National Institutes of Health (NIH) and the Foundation for NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines partnership initiative.”  Oohhh there is the NIH and the Gates foundation.  Interesting enough, Novartis does not have an actual DRUG in the works for Covid.    They were attempting to create an adenovirus vaccine back in 2020: https://masseyeandear.org/news/press-releases/2020/05/aavcovid-vaccine-program-enters-manufacturing-agreement-with-avexis and this interesting blurb came up:

Boston, Mass. — The AAVCOVID vaccine program Massachusetts Eye and Ear and Massachusetts General Hospital, members of Mass General Brigham, has entered into a manufacturing agreement to produce its novel genetic vaccine with an industry leader in gene therapy, AveXis, a Novartis Company. AveXis will begin manufacturing the vaccine this month while AAVCOVID undergoes further safety and efficacy testing in preclinical studies taking place at academic medical institutions including Mass. Eye and Ear. AveXis, will lead the manufacturing efforts of the new vaccine, utilizing its cutting-edge AAV technology for treatment of rare and life-threatening neurological genetic diseases. AveXis is one of the first companies in the world to have successfully scaled up gene therapy manufacturing with over 1 million square feet of manufacturing capacity.  Again with the Mass General Hospital pipeline that other drug companies use to test/write papers/hop in bed with Harvard etc.  I love how they call it gene therapy in this 2020 press release.  Partnered right up with their gene therapy division the other company they own to attempt a covid vaccine option. Hmmmm.

“The COVID-19 pandemic is the most urgent public health crisis of our time and we recognize the significance of evaluating the potential role of a gene-based vaccine,” said Dave Lennon, president of AveXis. “As one of the world’s leading gene therapy companies, we are pleased to lend our unparalleled manufacturing expertise, technology and supply chain to produce a COVID vaccine for use in clinical trials. Having developed and produced one of just two, FDA-approved AAV gene therapies, we are uniquely poised to help the team move quickly toward this accelerated effort.”

This was interesting as well:  “The AAVCOVID vaccine program is a gene-based vaccine strategy that seeks to deliver genetic sequences of the SARS-CoV-2 using an AAV vector. Vaccination delivers genetic DNA fragments SARS-CoV-2 which generates an antigen protein, which is designed to elicit an immune response to prevent infection. This approach is supported by extensive experience with the safety of the AAV technology platform in other diseases, including the use of AAVs in two FDA-approved medications.

AAVCOVID is an academia-industry collaboration led by Dr. Vandenberghe, the Grousbeck Family Chair in Gene Therapy at Mass. Eye and Ear, who is a world-renowned leader and pioneer of viral gene transfer and therapeutic gene transfer.”  Now correct me if I am wrong here, but isn’t the viral material RNA not DNA? What DNA fragments of SARS COV2 are they using???  It is an RNA virus.

We also have this little link: https://www.novartis.com/us-en/news/life-science-companies-and-bill-melinda-gates-foundation-joint-communique

COVID-19’s existence anywhere poses a threat to communities everywhere. The health, social, and economic impacts can only be addressed through the collective actions of stakeholders across private, public, and philanthropic sectors in partnership with civil society. As organizations dedicated to improving and protecting global health, with our varied skills, roles, and resources, we remain committed to doing our part in ending this pandemic worldwide. Earlier this year AstraZeneca; Bayer; bioMérieux; Boehringer Ingelheim; Bristol Myers Squibb; Eisai; Eli Lilly; Gilead; GSK; Johnson & Johnson; Merck & Co. (known as MSD outside the U.S. and Canada); Merck KGaA, Darmstadt, Germany; Novartis; Pfizer; Roche; and Sanofi together with the Bill & Melinda Gates Foundation each pledged ourselves to the fight against COVID-19.  Ahhh yes good ol Bill Gates and his Covid R&D Alliance squad.  With a few additional players thrown in there.  This link is their Global Access commitment, and each of these pharma companies signed at the bottom of the letter.  Click this and check it out!  https://www.novartis.com/us-en/sites/novartis_us/files/2022-03/covid-19-global-access-communique_0.pdf

“This pandemic will go down as one of the defining moments of our time, and no one - regardless of their country, their income, or anything else - should have to worry about whether they will have access to the care and innovation that could help them and their loved ones combat COVID-19. This is also a defining moment for the life sciences industry - a moment for a new kind of leadership - and with this agreement, we’ve committed to collectively pursuing a healthier, more equitable future for the good of mankind.

Vas Narasimhan, CEO of Novartis

How much did the government pay THEM to work behind the scenes?