Novartis milestones be proud ! Management take a bow !

Once a witness in Novartis scandal, former Greek adviser now charged with taking drugmaker's bribes
Angus Liu |
Jan 3, 2019 9:50am


Once a protected witness in the alleged bribery case involving Novartis and former Greek officials, Nikos Maniadakis is now a suspect under a travel ban and is accused of taking €120,000 in bribes from the drugmaker.


The former Greek Health Ministry consultant who had advised several ministers had his passport confiscated as he reportedly tried to leave the country with his family, according to local newspaper eKathimerini, which cites judicial sources quoted by Greek media.

Previously one of the three unidentified witnesses assisting prosecutors in the kickback probe, Maniadakis has been charged with passive bribery after the other two witnesses said he accepted €120,000 from Novartis as payment for influencing Greece’s health policies. It's the latest development in a scandal that has gripped the country with a series of dramatic twists, turns and sudden revelations.

Novartis didn't immediately respond to a FiercePharma request for comment. But in an interview with local media outlet Skai on Wednesday, Maniadakis refuted the claims, saying he got into the witness protection program in the first place because he is innocent.

To make the situation messier, the academic and consultant said he was pressured by prosecutors to point fingers at former Greek prime minister Antonis Samaras, former ministers of finance Yannis Stournaras and health Adonis Georgiadis over alleged kickbacks from Novartis. Samaras and Stournaras have reportedly filed lawsuits against the protected witnesses.

Adopting a similar tone used by those accused politicians, Maniadakis said the charges against him are “politically motivated.”

RELATED: Novartis investors demand action amid 'swamp' of bribery allegations in Greece

Rising to public attention in early 2018, the scandal revolves around bribes Novartis allegedly paid to top government officials and doctors to win favorable pricing and boost orders of its products. So far, the accusations largely rest on accounts by the witnesses, but the brouhaha was enough to stir up investor concern at Novartis, and the drugmaker has promised action if any wrongdoing is found.


The escalation in Greece came shortly before news broke of Novartis' $1.2 million payment to President Donald Trump's former personal lawyer Michael Cohen for what Novartis said was insight on the administration's U.S. healthcare policy. Ex-CEO Joe Jimenez and former general counsel Felix Ehrat have taken the blame for co-signing the notorious contract.

But those two were only the latest additions to a long list of scandals at Novartis. Others include data-tampering allegations in Japan dated years ago, doctor kickback accusations in South Korea and China, and U.S. Department of Justice and Securities and Exchange Commission probes over Alcon's marketing practices in Russia and Asia.

In the face of a series of alleged ethical missteps, CEO Vas Narasimhan has elevated the company’s chief ethics position into the executive committee and named rebuilding trust and reputation as one of his top priorities for the company.

 

The End is nigh ...HS Dropouts can now play the sample dropping signature gathering rep monkey....... controlled by Big Brother NVS AI

Novartis puts AI on the job to help reps say the right things to the right doctors
by Eric Sagonowsky |
Jan 9, 2019


Aside from ongoing and upcoming launches for Novartis, the company's pharma president Paul Hudson is excited about a digital shakeup hitting the industry. (Novartis)


SAN FRANCISCO—Artificial intelligence is a big buzzword in R&D right now, but at Novartis, it's hard at work in the sales department, too.

Amid far more meetings with digital companies at the J.P. Morgan Healthcare Conference this year, Novartis’ pharma CEO Paul Hudson said he expects 2019 to be the “beginning of the tech disruption” for pharma, in everything from marketing to supply chain.

In past years at JPM, Hudson mainly checked out early-stage biotech companies for potential partnerships, he told FiercePharma. This year? It’s about half health-tech companies, he said.

Obviously, Novartis is jumping right in, as part of CEO Vas Narasimhan's push to transform the entire company using digital tech. In the field, the drugmaker has equipped salespeople with an AI service that suggests doctors to visit and subjects to talk up during their meetings.

The program's “virtual assistant” helps salespeople “plan better, move better and make sure when they show up to see a healthcare professional, they are talking about the things that the healthcare professional is absolutely interested in,” Hudson said.

“When you turn up at the right time with the right things to say, they’re more interested and put more value in it, and our people like the fact that AI is running in the background helping them plan their day," he added.

In the long run, the program will help the company become more efficient, Hudson said, also citing telemedicine and improved distribution systems as potential digital shakeups heading for the pharma industry.

Under Narasimhan, Novartis has placed a big emphasis on digital. The company in 2017 appointed Bertrand Bodson as its first chief digital officer. In March, the drugmaker teamed with Pear Therapeutics to create software applications to treat patients with schizophrenia and multiple sclerosis. The partners just launched an opioid addiction app this week.

 

Minister to ‘talk to Novartis’ after five-fold cancer drug price hike BusinessHealth
January 10, 2019 - By Robin Pascoe

Health minister Bruno Bruins is planning to talk to Swiss pharmaceuticals giant Novartis this week about the five-fold hike in the price of a drug to treat a rare form of cancer. Bruins told a television talk show on Wednesday evening that the decision to put up the price of a year’s supply to €90,000 is an ‘example of how not to behave’. ‘These are outrageous sums,’ Bruins said. ‘And I am not done with this yet.’ The drug, lutetium-octreotaat, was developed in the mid 1980s by researchers at Rotterdam’s Erasmus Medical Centre but the company which makes it is now owned by Novartis following a string of takeovers. Novartis then registered the drug as an orphan treatment with the European patent office, according to research by Dutch medical journal Nederlands Tijdschrift voor Geneeskunde.

Bruins told the Jinek talk show that the EU rules on orphan drugs are meant to stimulate the development of new medicines and says he plans to raise this abuse of the system within Europe. ‘This expensive medicine is covered in the basic health insurance package so patients will continue to be treated,’ he said. ‘But we are having to deal with so many other really expensive drugs that we really do have to tackle this.’ Several Dutch hospitals make their own version of lutetium-octreotaat at a cost of some €4,000 per drip. A full treatment session comprises four drips.

Apple chief Steve Jobs was among the patients who were treated using the medicine in Rotterdam. Meeting A spokeswoman for Novartis told DutchNews.nl that the company is ‘willing to discusses this topic with all stakeholders including the government’. The company said the until its approval by the European Medicines Agency, the drug, formally known as Lutathera, ‘was only available as an experimental treatment at centers with the facilities and capabilities to manage the compounding of a radioactive product.’ The drug has now undergone major clinical trials and is available as a targeted therapy to patients in Europe and the US, Novartis said.

After its approval in 2018, ‘the price of Lutathera was carefully considered and based on the relative benefit it provides to patients’, the company said. Price Last year, the Dutch healthcare institute Zorginstituut Nederland said insurers should stop paying for expensive drugs if pharmaceutical companies continue to refuse to say how they arrive at the price And in November, Amsterdam’s AMC teaching hospital was given the green light by health ministry inspectors to make its own version of a licenced drug to treat a rare metabolic disorder. The hospital began making its own version of the drug after manufacturer Leadiant ramped up the price by around 500% to €200,000 per patient per year.

The drug has been available since the 1970s but Leadiant only registered it as an orphan medicine with the European medicines agency in 2017. Orphan status, given to drugs which are used to treat very specific and rare illnesses, means a drug cannot be copied commercially for a 10-year period.

Read more at DutchNews.nl:

 

Seems like the novartis way

https://www.washingtonpost.com/business/2019/01/30/stripper-turned-pharma-exec-gave-doctor-lap-dance-get-him-prescribe-drugs-officials-say/?utm_term=.41e0b9a43456

 

NEWS 03.02.2019 : 19:28
Charges expected in Novartis probe
IOANNA MANDROU

• 

Greek corruption prosecutors are expected in the coming weeks to bring charges against politicians implicated in the alleged bribery scandal involving Swiss pharmaceutical company Novartis.

Despite the fact that an ongoing judicial probe has yet to yield any concrete evidence of suspicious payments into the accounts of the politicians in question or their relatives, the prosecutors insist that bribe-taking charges are supported by the testimonies of protected witnesses.

The charges are expected to be leveled against the politicians this month. It remains unclear which of the 10 politicians originally implicated by prosecutors will be charged, though, according to sources, the alleged bribes relate to the period 2010-2012.

Before lodging the charges, prosecutors are expected to ask Parliament to lift the immunity of those suspects who are MPs.

Online

 

Doctor payments drove scripts for cancer drugs from Pfizer, Novartis and more: study
by Arlene Weintraub | Feb 8, 2019

Oncologists who received payments from drug companies for three years running were the most likely to increase their prescriptions of the products linked to the payouts, a new study found.

Critics often target physicians who receive money from pharma, but the exact influence those payments have on prescribing is up for debate. In oncology, at least, it’s not one-off payouts but consistent compensation that's most likely to sway prescribing behavior, a new study found.

Published in the journal The Oncologist, the study showed that physicians who received payments over three consecutive years and tied to a specific drug boosted their prescriptions of that product. That pattern applied to oral drugs that treat lung cancer, kidney cancer and chronic myeloid leukemia, but not prostate cancer. Among physicians who received payments from drug companies during only one year, no pattern emerged.

The researchers evaluated payments made to 2,766 physicians between 2013 and 2015. They found that the average amount earned by physicians who took payments over all three years was $5,881, compared with $553 for those paid during one year only. Among the drugs boosted by drug-company largesse were Pfizer’s Inlyta and Novartis’ Afinitor to treat renal cell cancer, and Roche’s Tarceva for lung cancer.

“These findings add to a growing body of work that suggests physicians are more likely to use drugs made by companies that have given them money in the past,” said lead author Aaron Mitchell, M.D., a medical oncologist in the department of epidemiology and biostatistics at Memorial Sloan Kettering Cancer Center, in a statement.

Physicians can receive payments from companies for activities ranging from sponsored meals, during which they talk up specific drugs, to consulting fees, to plane tickets and hotel rooms for medical conferences. The authors of the new study found that consulting fees and travel expenses were more likely to spark increased prescribing than were other types of compensation.

Over the last decade, lawmakers have become increasingly concerned about conflicts of interest (COI) in medicine, leading to federal legislation that requires companies to disclose those payments. Several hospitals and research institutions have adopted COI policies that require physicians to disclose their financial relationships with companies and in some cases to limit those paid interactions.

Mitchell and his co-authors took this trend into consideration in their analysis, examining the relationship between COI rules and physician payments. But they found no clear link between COI policies and physician prescribing behavior.

Does that mean COI rules are completely ineffective? Not necessarily, the authors said. But it does raise questions about the extent to which those policies are actually being enforced. “It is also possible that COI policies may need to be significantly more stringent before changes” in prescribing practices can occur, they wrote.

The controversy over physician payments has engulfed numerous players in the healthcare industry, including Mitchell’s hospital, Memorial Sloan Kettering. It became a target of scrutiny last year, when reports emerged that its then-chief medical officer, José Baselga, M.D., Ph.D., did not properly disclose financial relationships with drug companies that netted him millions.

Some companies have responded to the ongoing controversy by adopting new transparency practices. Last year, for example, AstraZeneca said it would start disclosing all financial relationships with physicians, even in countries that don’t require it. The company had already been making those disclosures in the U.S., Europe, Australia and Japan, and it plans to add 11 countries this year, a spokesman told FiercePharma at the time.

The authors of the new study suggest that more research like theirs should be done to better understand the effects of physician payments both inside and outside of oncology. “Public scrutiny of the industry role in cancer research and care delivery remains high,” Mitchell and his co-authors concluded. “Ideally, institutions may increasingly be able to rely on research findings in order to construct informed, data-driven policies to manage industry relationships within this changing environment.”

 

Tropical disease PRV fix didn’t stop Novartis from winning another

 

https://www.corporatecrimereporter.com/news/200/transparency-international-greece-corruption-novartis/

 

If you people think it's so bad here, either a) quit, or b) fix it. Whining accomplishes nothing.

 

Former Novartis exec wins $1.5 million after claiming she was fired for complaining about a study

By ED SILVERMAN @Pharmalot

FEBRUARY 26, 2019

A former Novartis (NVS) employee was awarded nearly $1.5 million in damages over claims that she was fired in retaliation for complaining that a proposed drug study appeared to be a kickback, although the jury agreed that she violated a company policy.

Min Amy Guo, who had been executive director of the Health Economics and Outcomes Research Group, objected to a study that would have examined unapproved, or off-label, uses of the Affinitor breast cancer treatment, according to the lawsuit she filed in a New Jersey state court in 2014.

 

hate this place, quitting on Friday. will let my dumbass manager know at the end of the day. no 2 week notice.

 

Novartis Hit With $1.5M Whistleblower Verdict In NJ
Morristown, N.J. (February 26, 2019, 1:01 PM EST)

A New Jersey state jury on Tuesday slammed Novartis Pharmaceuticals Corp. with net damages totaling nearly $1.5 million over a former company executive’s claims she was fired in retaliation for objecting to a biased flawed study

 

For Novartis, the Michael Cohen affair just won’t stay dead


By MATTHEW HERPER @matthewherper

FEBRUARY 27, 2019

Michael Cohen, President Trump's former personal lawyer, testifies before the House Oversight and Reform Committee in Washington Wednesday.ALEX BRANDON/AP
During congressional testimony Wednesday, President Trump’s former lawyer, Michael Cohen, explained why the drug giant Novartis paid him $1.2 million to act as a consultant on the Trump administration.

“They came to me based on my knowledge of the enigma Donald Trump,” Cohen said in response to Rep. Mark Meadows (R-N.C.). He said company representatives came to him, calling the pharmaceutical company “a multibillion-dollar conglomerate looking for information.” How often did he interact with them for that $1.2 million? At first, Cohen said he didn’t recall. When pressed, he responded: “I spoke to them on several occasions. Six times.”

The apparent goal of Meadows’ questioning was to undermine Cohen, who is making serious charges against the president, by portraying him as a shady operator who cannot be trusted. Meadows cited a May 2018 STAT article that disclosed the Novartis payment and reported that Cohen reached out to Novartis’s then-chief executive Joseph Jimenez in early 2017, promising help gaining access to Trump and influential officials in the new administration.

Meadows tried to portray the situation as one in which the firm used Cohen as an unregistered lobbyist, a characterization Cohen denied. “Novartis sent me their contract, which stated they wanted me to lobby. That paragraph was crossed out by me,” he said.

Novartis’ relationship with Cohen has become a repeated reputational headache for the drug giant. The relationship began after Cohen was introduced to Jimenez by a third party. Jimenez has said that he was moving quickly out of desperation. “You remember what it was like back then,” he said previously. “This was right after the election. Things were moving fast. The rhetoric around the Affordable Care Act was huge and we moved too fast without doing our due diligence.”

Initially, Novartis said that it had ceased contact with Cohen immediately after having a first meeting in which it became clear that he did not understand health policy well. The case cropped up again last July, when a congressional investigation revealed that the contacts between Novartis and Cohen had been more numerous than had been previously suggested.

At the time, Novartis said that Cohen had initiated contact with Jimenez, including one case in which Cohen asked for ideas on how to lower drug prices. Jimenez had sent him a list of what Novartis called “well-known ideas.”

The news of Cohen’s relationship with Novartis proved a kind of a trial-by-fire for Novartis’s current CEO, Vas Narasimhan, who told the audience at an event held by Forbes last year that he found out about it while in the car. “I was not mentally prepared, nor prepared from a crisis-management standpoint,” he said. “It’s not the phone call you expect to get from your mother, which was one of the first people I heard from.”

In a statement, a spokesman for Novartis said, “We have previously addressed all questions regarding our relationship with Essential Consultants and we consider this matter closed.”

During a break in Wednesday’s hearing, Meadows reiterated that he was concerned Cohen had been engaged in improper lobbying and had referred the issue to the Justice Department.

 

How deep does the rabbit hole go???


Congressman calls for criminal investigation of Cohen over Novartis relationship - MedCity News

 

Novartis agrees to pay $23m following charges it used charities to pay kickbacks to Medicare patients


By ED SILVERMAN @Pharmalot

MARCH 1, 2019

• 

You can add Novartis (NVS) to the list of drug makers settling allegations that donations made to patient charities amounted to kickbacks paid to Medicare patients as a way to cover their out-of-pocket costs.

The company reached an agreement in principle to pay $23 million in response to a probe opened three years ago by the U.S. Attorney in Boston regarding assistance provided to Medicare patients who were prescribed various medicines, including the Gleevec cancer medicine and the Gilenya multiple sclerosis treatment, according to its latest annual report. The settlement was not previously disclosed.

 

Head of Novartis generic drugs business steps down Richard Francis’s departure from Sandoz likely to spark speculation about its future

The head of Novartis’s generic drugs business, Sandoz, has stepped down, sparking fresh speculation about its future. Vas Narasimhan, chief executive of the Swiss drugmaker, said that Richard Francis, who has run Sandoz for the past five years, had “decided that for personal reasons he cannot commit to stay with Sandoz” for the duration of “a multiyear transformation programme”. Mr Francis’ departure will revive speculation that Mr Narasimhan, who has sought to focus the company on its higher margin innovative medicines business since taking charge last year, is eyeing a potential spin-off of Sandoz.

 

Swiss drugmaker Novartis must face doctor kickback suit, U.S. judge rules

NEW YORK (Reuters) - Novartis AG must face a U.S. government lawsuit accusing it of paying millions of dollars in kickbacks to doctors so they would prescribe its drugs, after a federal judge ruled in a decision released on Monday that the government had offered evidence of a “company-wide kickback scheme.”

U.S. District Judge Paul Gardephe in Manhattan also rejected the Swiss drugmaker’s bid to keep key government evidence out of the case, and ruled that the government does not have to prove a direct “quid pro quo” agreement between Novartis and doctors for the company to be liable.

The ruling means that, unless Novartis settles, the case is headed for trial.

 

DOJ's Novartis Kickback Case Cleared For Trial (April 1, 2019, 10:01 PM EDT) -- The U.S. Department of Justice has adequately described a “company wide kickback scheme” at Novartis Pharmaceuticals Corp. to pump up prescriptions, a New York federal judge said in a ruling released Monday...

 

Swiss drugmaker Novartis must face doctor kickback suit, U.S. judge rules

Brendan Pierson

NEW YORK (Reuters) - Novartis AG must face a U.S. government lawsuit accusing it of paying millions of dollars in kickbacks to doctors so they would prescribe its drugs, after a federal judge ruled in a decision released on Monday that the government had offered evidence of a “company-wide kickback scheme.”U.S.

District Judge Paul Gardephe in Manhattan also rejected the Swiss drugmaker’s bid to keep key government evidence out of the case, and ruled that the government does not have to prove a direct “quid pro quo” agreement between Novartis and doctors for the company to be liable.

The ruling means that, unless Novartis settles, the case is headed for trial.

“We are disappointed in today’s decision and look forward to presenting our case at trial,” Novartis spokesman Eric Althoff said in an email. “We continue to believe that the government has insufficient evidence to support its claims.”

The case began in 2011 as a whistleblower lawsuit filed by Oswald Bilotta, a former Novartis sales representative. Such lawsuits, brought under the federal False Claims Act, allow individuals to sue on behalf of the government, which may choose to intervene.

The U.S. government and the state of New York both intervened in the case in 2013, accusing Novartis of paying doctors kickbacks so they would prescribe several of its drugs, including hypertension drugs Lotrel and Valturna and diabetes drug Starlix.

Those kickbacks included speaking fees for doctors at “sham” educational events, the lawsuit said, with one doctor being paid to speak at his own office eight times. The company also treated doctors to lavish meals, including a $9,750 dinner for three at a Japanese restaurant, according to the lawsuit.

Government health insurance programs Medicare and Medicaid were billed millions of dollars from 2002 to 2011 for drugs prescribed by doctors who took kickbacks, the lawsuit said, violating the False Claims Act. The government is seeking damages of three times what it was billed for allegedly fraudulent claims.

Novartis has previously settled U.S. allegations that it used illegal methods to promote its medicines.

In 2010, it agreed to pay $422 million to settle various civil and criminal allegations, including claims of paying kickbacks to doctors. Novartis pleaded guilty to mislabeling one drug as part of that settlement, but otherwise did not admit wrongdoing.


In October 2015, Novartis agreed to pay $390 million to settle claims that it paid rebates to specialty pharmacies to push two of its drugs, without admitting wrongdoing.

(This story has been refilled to make clear decision was made public on Monday)

 

All this dirty laundry will be leverage for the administration to negotiate a new pricing scheme in the second term. This is hard ball folks. If you think the department of justice doesn’t know what’s been going on you’re either blind or stupid. DOJ perhaps has been complacent but the paper trail is there. Put your seat belts on should be fun.