Novartis milestones be proud ! Management take a bow !

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Pharma & Healthcare

5/02/2013 @ 4:44PM |163 views

Japanese Research Scandal Expands To A Second Trial And A Novartis Employee

A Japanese research scandal, which has so far centered on actions taken by the once-prominent cardiologist Hiroaki Matsubara, has now expanded. As has been previously reported, several papers authored by Matsubara have been retracted, including, most notably, the main publication of the Kyoto Heart Study in the European Heart Journal.

Now, however, questions have been raised about another clinical trial, the Jikei Heart Trial, which was published in the Lancet in 2007. (Matsubara was not involved in this trial.) Novartis , which manufactures valsartan (Diovan), the drug studied in both trials, has announced that it is investigating both trials in response to new allegations that a Novartis employee worked on the trials without any disclosure of his company affiliation.


The Novartis employee, Nobuo Shirahashi, was listed as a member of the statistical analysis organization for both the Kyoto Heart Study and the Jikei study. In both cases his only listed affiliation is Osaka City University. Novartis, in a statement, said it “takes these allegations very seriously and has launched a comprehensive investigation with independent third party experts to review these allegations.”

Novartis said that the trials were not used “for registration purposes.” Novartis also said that both Kyoto and Jikei were “investigator initiated trials” which are, ostensibly, “conceived, designed and conducted by independent steering committees of physicians.”

Questions about the statistics used in both trials were raised last year in a letter to the Lancet by Yoshiki Yui concerning the Jikei study. According to Yui, “the mean and SD of achieved systolic blood pressure (SBP) between the valsartan group and the group assigned conventional treatment without angiotensin-receptor blockers (ARBs) is the same. This finding seems strange to me.” Yui said the probability of this occurrence is extremely unlikely. “To my knowledge, of the many hypertensive trials… the mean and SD of achieved SBP is equal in both study groups only in the Jikei Heart Study and the Kyoto Heart Study.” Yui pointed to further statistical anomalies in the two trials, including this:

In the Jikei Heart Study, the coincidence of identical means and SDs for achieved SBP suggests that the normal distribution of the two groups is the same, because the normal distribution is determined by mean and SD; this is very odd. In other words, a randomised but heterogeneous population becomes homogeneous after a 3-year drug intervention. This ought to be the other way round.
 






Novartis Could Face Exclusion From Federal Health Care Programs If Allegations That It Carried Out Widespread Pay to Play Kickback Schemes Hold True

PRWeb
Thursday, May 2nd 2013.

U.S. government's intervention in two whistleblower lawsuits against Novartis, alleging kickbacks and other frauds, could have serious implications for the pharmaceutical giant, according to members of the Qui Tam Team.

As highlighted in a piece by Jonathan Stempel of The Washington Post on April 26, 2013, following two federal lawsuits, including U.S. Attorney Preet Bahara’s complaint (Case Number 11 Civ.0071 (PGG) in the Southern District of New York alleging multimillion dollar kickbacks from 2002 through 2011, inducing doctors to prescribe Novartis drugs that were paid for by federal health care programs, the giant pharmaceutical manufacturer could face possible exclusion from future Medicare and Medicaid reimbursements in addition to massive fines.

In September, 2010, Novartis signed a Corporate Integrity Agreement (“CIA”) with the Office of the Inspector General of the Department of Health and Human Services and paid approximately $422 million in criminal and civil fines and penalties to resolve claims that it had paid kickbacks to prescribers of Trileptal, Diovan, Zelnorm, Sandostatin, Tekturna, and Exforge, in addition to claims that the company had promoted some of these drugs for unapproved uses. Even after entering into the CIA, Novartis persisted in alleged kickbacks to physicians through speakers programs to promote cardiovascular drugs Lotrel and Valturna and diabetes drug Starlix and allegedly failed to monitor speaker programs adequately to prevent alleged, illegal kickbacks, court papers indicate.

“While the pending cases are civil lawsuits, if the government decides that Novartis breached the CIA in persisting with allegedly illegal honoraria and speaker programs, as is alleged in the U.S. Attorney’s complaint, criminal charges could follow, seeking to exclude Novartis from future Medicare and Medicaid reimbursements under Title 42 U.S.C. § 1320a-7,” observes James J. McEldrew, III, Esquire, a member of the Qui Tam Team.

“It’s noteworthy that court papers indicate that Novartis allegedly enhanced its kickback scheme to sustain market share just as generic competitor pharmaceutical products entered the marketplace,” McEldrew explains.

The U.S. Attorney for the Southern District of New York’s complaint joins a qui tam lawsuit. (Case citation: U.S. ex rel. Oswald Bilotta v. Novartis Pharmaceuticals, Corp., S.D.N.Y. 11-CV-00071-PGG).
 






Feds again go after Pharma, with a couple of twists


POSTED: Tuesday, May 7, 2013, 10:50 AM

Daniel R. Hoffman, Ph.D.

Filed Under: Daniel Hoffman

Last week the US Justice Department filed suit against Novartis that essentially accuses the company of bribing physicians with lavish dinners, trips and speaking fees so they would prescribe the company's drugs. The suit alleges, "In many instances Novartis made payments to doctors for purported speaker programs that either did not occur at all or that had few or no attendees." While Novartis considers these programs as continuing education sessions for physicians, the prosecutors claim "thousands of programs were held all over the country at which few or no slides were shown and the doctors who participated spent little or no time discussing the drug at issue." In other words, there was not even a pretense at medical education.

In fact, the suit contends that "Many speaker programs were also held in circumstances in which it would have been virtually impossible for any presentation to be made, such as on fishing trips off the Florida coast. Other Novartis events were held at Hooters restaurants."

Some physicians even played alternating roles on the party train, servering as speaker at one session and then as an attendee at another session on the same subject.

That suit followed by only a few days another Justice Department suit against Novartis for bribing pharmacists in violation of the 2005 False Claims Act. On this one the federal prosecutors allege that the company paid kickbacks to pharmacists to switch patients from competing brands to Novartis' drugs and/or oppose using cheaper generics to treat the same condition.

At a time when finance runs all of pharma's operations, it seems that even payoffs are subject to their metrics. So Novartis tracked the return on its investment in these lavish payoffs and determined that they resulted in an enormous growth of prescriptions for the drugs they promoted that way.

The federal complaint alleges that by paying off physicians, Novartis caused federal health care programs such as Medicare, Medicaid, TRICARE and the Department of Veterans Affairs to pay million of dollars more for drug reimbursements.

Federal actions against pharma companies for payoffs, off-label marketing and other violations appear almost every week. A couple of things make these two actions stand out. First, the government dinged Novartis two years ago for payoff violations, resulting in a $422 million fine (see here) and a requirement that the company sign and comply with a Corporate Integrity Agreement (CIA).

This time around, the government claims that since Novartis pressured its sales reps to spend their quarterly budget for these lavish speaker programs, the company remains unwilling to comply with the law and the CIA it signed. As one of the federal prosecutors said at the press conference, they "question whether Novartis is getting the message."

Depending on whether the Justice Department wants to make an example of Novartis, the current suits could result in more than just a half-billion dollar slap on the wrist. Since many of the currently alleged kickbacks to doctors and pharmacists occurred after Novartis signed the CIA, the government may be able to exclude it from contracts with huge federal healthcare programs such as Medicare and Medicaid. As the dollar volume of sales to those programs is enormous, the lost revenue could reach into the billions.

Novartis' answer to the federal complaint provides the other differentiating item in this story. In its PR release, Novartis stated, "Physician speaker programs are an accepted and customary practice in the industry." Without reading too much into the piece, it appears Novartis is saying that everyone in pharma does this kind of thing, so they shouldn't be singled out for following an accepted industry practice.

That raises the question of what was worse, the bribes/kickbacks or the attempt to justify it.
 






Novartis' Sandoz unit recalls products from U.S., Poland

Particulate trouble marks yet another problem for Swiss drugmaker

May 21, 2013 | By Eric Palmer

Generic drugmaker Sandoz is recalling two lots of an injectable drug, making yet another manufacturing problem for its parent, Novartis ($NVS).

The company and the FDA said yesterday that Sandoz is voluntarily recalling the methotrexate sodium, a drug used to treat neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The recall was ordered after particulates were found in retained samples of the preservative-free injectable drug. There have been no adverse reactions reported, and the company made clear that the particulates are not associated with microbial contamination. It warned, though, that if particulates are injected, there is always the chance of an embolism. The two lots were distributed in the U.S. and Poland. Sandoz is the second largest generic drugmaker in the world.

Novartis has for several years now been facing down a number of manufacturing problems. In 2011, the FDA sent Sandoz a warning letter laying out issues it had with plants in Broomfield, CO; Wilson, NC; and Boucherville, Quebec. Late last year, the FDA removed the Broomfield plant from its warning letter watch list, and Novartis CEO Joseph Jimenez has indicated that the other two are making progress toward returning to the good graces of the U.S. agency.


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FORBES - Larry Huston

Pharma & Healthcare

5/23/2013 @ 11:09AM |212 views

Novartis Acknowledges Employees Participated In 'Independent' Trials

Novartis has acknowledged that employees of the company participated in five “independent” investigator-initiated post-registration trials without disclosing their relationship to the company. The company said that a broader “comprehensive investigation with independent third party experts is ongoing” but that it has “provided an update” to Japanese medical societies and to the principal investigators of the five trials.

The Novartis statement is the latest development in a growing scandal involving clinical trials in Japan with Novartis’s former blockbuster drug Diovan (valsartan). As previously reported here, one trial, the Kyoto Heart Study, has been retracted by the European Heart Journal. Several other papers by the trial’s principal investigator, the once-prominent cardiologist Hiroaki Matsubara, have also been retracted. Matsubara subsequently resigned from his post at Kyoto Prefectural University, as reported by Retraction Watch. A second large trial, the Jikei Heart Trial, came under scrutiny when it was revealed that a Novartis employee, Nobuo Shirahashi, was involved with both studies. In both cases his only listed affiliation was Osaka City University.

The new statement from Novartis admits that “one of our former employees [presumably Shirahashi] had varying levels of involvement in five investigator initiated valsartan trials in Japan.” The statement also disclosed that “a second former employee (who reported to the first former employee) had involvement which was limited to one of these trials.” Novartis said that independent investigation is continuing but that so far there has been no indication of a “specific company strategy to integrate the first former employee into the five valsartan investigator initiated trials.” However, the investigation has revealed

“
that some of this former employee’s superiors in Japan knew of his participation in these trials and were supportive of him in these activities. They believed that employees of a business that had academic titles could perform clinical research support as academics, without any conflict of interest issues arising. In addition, there is no indication that any of his supervisors knew or approved of the incomplete disclosure of his affiliation in the published papers for these studies.

Novartis also stated that “some, if not all, of the physicians involved in conducting the studies were aware of his employment by Novartis.” Further:

“
Our current understanding is that the former employee believed he was allowed to engage in research if this was done in his capacity as a part-time lecturer of Osaka City University and took steps to separate his involvement in the studies from his work for the company. This employee, some of his supervisors, and the trial investigators believed that employees of a business that had academic titles could perform clinical research support as academics, without any conflict of interest issues arising.

Finally, Novartis acknowledges that its previous defense of the Kyoto Heart Study was mistaken:

“
When previous statements were made about the involvement of Novartis Pharma K.K. (NPKK), Japan in the Kyoto Heart study, they were provided based on the information which was available at the time and were believed to be accurate. We are correcting those statements by issuing this update based on the latest information which was obtained from the ongoing independent investigation and we apologize for the statements made without verification.
 






Globalization means global cos operate all over the world. That also means they use their MO that best works for them, all over the world. Novartis is known and has been found guilty of all kinds of crimes in USA and many mother countries. These crimas go from offlabel promo, to fake trial, to this kind of trials to...you name it they have done it somewhere in the world.
Diovan in Canada was launched very early (before US) and from the very begining they used all kinds of tricks and schemes to push it beyond what was legal and what the drug was approved for. Unlike in US such behaviour is completely safe for there are no strong laws (like FCA) or interest by the govt to fight these common crimes done by pharma with complete impunity. The only "authority" that looks over pharma biz in Canada is co called Rx&D which is a private club for the pharma cos. Actually it is supposed to be a self-regulating body and as they go it is never effective. It simply becomes a body that protects the crooked cos.
For instance Novartis Canada based in a place called Dorval, has done two major postmarketing trials, one called Diovantage 1-5 another Destination. These fake trials were designed to pay off the doctors for Rxing Diovan to their BP patient. no papar work necessary for the trials were fake and they never were designed to publish or use the results. The Diovanage went on for 5 years till smeone blew the whistle to Basel re its illegality. Of course the WBer was fired and the trial was redesigned into Destination. Now someone from the industry complained to Rx&D ( Diovan sold too well) and the Rx&D found Novartis in violation of all the rules governing such trials. And"best" of all Novartis Canada was fined by Rx&D to the tune of $10.000.00. Shocked? Yes you would be for such a crime would have been fined $100 million plus in USA under the good law of False Claim Act.
By the way the type of trial Diovantage and Destination were also against the Np4 codes of conduct that Novartis AG is so proud of. But that is only for PR purposes but not for actual doing of biz by Novartis affiliates wherever they are. They are allowed (and ordered) by the Basel HQ to use any and every trick they can come up with to push their shit beyond what is allowed by regulatory authorities.
So no one should be surprised by anything they hear or read about this crooked co. Even after Vasella this will continue for it has become the way of life and culture in this company.
Poor Swiss who are very decent people have no idea what has happened to this once Swiss pride company.
Yes Novartis management (wise guys) should be proud of what they do. Fuck them
 






Again

FDA Issues Warning Letter to Novartis
ZacksBy Zacks Equity Research | Zacks – 16 hours ago.

Novartis (NVS) recently announced that the US Food and Drug Administration :)FDA) issued a warning letter to the company’s generic arm, Sandoz, regarding its Austrian manufacturing site, Unterach.

Novartis acquired the Unterach site in 2009 through the acquisition of EBEWE Pharma. The warning letter was issued by the FDA following an inspection of the site in Oct 2012.

We note that Novartis has faced manufacturing issues in many of its other facilities in the past, resulting in the loss of sales and market share.

In 2011, the FDA had issued a warning letter to three of Sandoz’s facilities located in Colorado, North Carolina and Canada, raising concerns about these facilities' compliance with the FDA’s regulations on current Good Manufacturing Practices (cGMP).

We remind investors that one of the key objectives for Novartis’ management in 2012 was to strengthen quality control.

Novartis was required to expend considerable resources on the remediation of these sites.

Although the Colorado facility achieved compliance in the fourth quarter of 2012 following a satisfactory re-inspection by the FDA, the other two sites continue to await compliance status.

In addition, Novartis’ ophthalmology division, Alcon, received a warning letter from the FDA in Dec 2012 following an inspection of the company’s laser manufacturing site in California.

The issue has yet to be resolved. We expect the company to work on the timely resolution of the manufacturing issues with the FDA as failure to do so will result in further disruption in the supply of products thereby impacting sales and market share.
 






THE Strong 'CODE of CONDUCT Zero Tolerance' (LMAO) Mgrs at NVS strike again !

Novartis sacks 18 for fabricating sales data

By ET Bureau | 12 Jun, 2013, 04.00AM IST

MUMBAI: The Indian subsidiary of Swiss drug maker Novartis has dismissed some 18 middle-level sales executives for fabricating and inflating the sales numbers of its diabetes drug Galvus, a news report said.

Novartis sales representatives used the sales incentive provided to them by the company to buy stocks from wholesalers and show a spike in the sales of the drug in order to meet their targets, a report in business wire magazine PharmaAsia News said. Novartis IndiaBSE -1.92 % head Ranjit Shahani said the company has initiated an investigation into the matter but did not confirm firing of any employee.

"Novartis has a strong code of conduct and marketing practices guideline with zero tolerance for deviations," Shahani said in an email response to ET query. "In the instance you mentioned, the investigation is currently ongoing, and, as a policy, we do not comment on investigations which are in progress. It would be, therefore, be premature to state what remedial action is being taken," he added.

The PharmaAsia News said Galvus executives are being investigated for allegedly padding invoices and then buying stocks of the drug from wholesalers with cash rewards that had been doled out as incentives.
 






Novartis Can't Duck Elidel FCA Suit

Law360, New York (June 14, 2013, 4:38 PM ET) -- A Pennsylvania federal judge on Thursday refused to dismiss a former Novartis Pharmaceuticals Corp. employee's whistleblower lawsuit, which accuses the drugmaker of ripping off Medicaid by promoting off-label uses of eczema treatment Elidel, but stripped anti-kickback claims from the suit.

Judge Gene E.K. Pratter rejected most of Novartis's 295-page motion to dismiss, but agreed that claims based on kickback allegations could not survive based on the first-to-file rule. As a whole, the decision allows former Novartis senior sales consultant Donald R. Galmines to proceed
 






Novartis sales team involved in bribing stockists for over a year


By DIVYA RAJAGOPAL, ET Bureau | 17 Jun, 2013, 04.00AM IST

MUMBAI: Stockists of Novartis in the country's most important regional market warned the company last year of unhealthy practices in the distribution of Galvus, a drug at the centre of a fraud committed by some salesmen in the Swiss pharma giant.

The Pharma Wholesalers Association, (PWA), of the Mumbai region (which also includes Pune) asked Novartis to check certain practises such as massive discounts and freebies to distributors to sell stocks of Galvus. ET has a copy of the letter.

"We solicit this requirement to comprehend and discourage any type of unhealthy distribution practise prevailing in pharmaceutical supply chain." said the PWA letter of the addressed to the distribution manager of Novartis IndiaBSE 0.00 % in June 2012. Stockists told ET that Novartis sales representatives were offering 20% discount to select dealers for the purchase of Galvus.

Last week, Novartis sacked about 18 people for allegedly padding invoices and inflating sales of the drug.

Respondng to an ET query, Novartis said that there is no correlation between last week's sacking and the stockists' letter. "Let us first clarify that these are two independent issues with no correlation. The letter you refer to was related to stockists in Pune and Mumbai was investigated and resolved together with the trade," said Ranjit Shahani, MD Novartis India. He further added that regarding the sacking which happened last week the company requires all employees to follow the Novartis Code of Conduct which sets out principles of ethical behaviour, professionalism and good business practice. "Novartis is committed to high standards of ethical business conduct and regulatory compliance in all aspects of its work. Any deviation from this Code is not tolerated at any level and any non-compliant behaviour is treated with immediate decisive action," Shahani added. Novartis added that it is investigating about its sales executives fabricating data for which they were sacked.

Stockists in the westen region had complained that the sales reps of Novartis had been offering massive dicounts of the drug in order to push sales. They were also givng away the drug for free on some ccasions. The association had asked the Swiss drug maker to furnish the purchase details of all the stockists of Novartis since January 2012.
 






FCA Suit said:
Novartis Can't Duck Elidel FCA Suit

Law360, New York (June 14, 2013, 4:38 PM ET) -- A Pennsylvania federal judge on Thursday refused to dismiss a former Novartis Pharmaceuticals Corp. employee's whistleblower lawsuit, which accuses the drugmaker of ripping off Medicaid by promoting off-label uses of eczema treatment Elidel, but stripped anti-kickback claims from the suit.

Judge Gene E.K. Pratter rejected most of Novartis's 295-page motion to dismiss, but agreed that claims based on kickback allegations could not survive based on the first-to-file rule. As a whole, the decision allows former Novartis senior sales consultant Donald R. Galmines to proceed
Click to expand...

Good for him. Hope everything turns out well. They can use the proceeds from the sale of Elidel to pay for this settlement.
 






Anonymous said:
Good for him. Hope everything turns out well. They can use the proceeds from the sale of Elidel to pay for this settlement.
Click to expand...

Good for you. Novartis pays you to push overpriced branded drugs when generics will work. And they use that to pay for your salary, benefits, and lobbying. There, does that make you sleep better?
 






(JUST LIKE THE NAZI's)

Courthouse News Service

Wednesday, June 19, 2013

Off-Label Marketing Puts Novartis in Hot Water

By ROSE BOUBOUSHIAN

(CN) - Novartis Pharmaceuticals must face claims that it promoted the use on infants of a drug that U.S. regulators have deemed harmful, a federal judge ruled.
While working as a senior sales consultant for Basel, Switzerland-based Novartis in its dermatology and respiratory division, from 2001 through 2006, Donald Galmines marketed and sold the atopic dermatitis drug, Elidel.
The Food and Drug Administration had authorized the marketing of Elidel as a second-line treatment for patients aged 2 and older after it found that the drug posed safety risks to infants in December 2000.
Though regulators refused to approve the drug for patients older than 3 months of age, Galmines said Novartis soon began marketing Elidel as safe for children under the age of 2 and as a first-line treatment.
This marketing allegedly continued even after the FDA revealed in 2005 that the drug increased the risk of cancer in animals and respiratory infections in children younger than 2.
Galmines said Novartis trained him and paid Dr. Lawrence Eichenfield, a pediatric dermatologist, to convince doctors that Elidel was safe for infants.
The drugmaker also allegedly funded and publicly touted Dr. Alexander Kapp's report that Elidel was safe for children over 3 months old.
Galmines said Novartis created visual aids for him and other sales reps to engage in off-label marketing of the drug and had him host and pay for $1,000 dinners for doctors who prescribed high amounts of Elidel for chronic use. Novartis also allegedly had Galmines use "preceptorships" in which he followed a doctor for a few hours and paid him or her for prescribing the drug.
A federal judge unsealed the 2006 whistle-blower complaint Galmines filed against Novartis under the False Claims Act (FCA) in Philadelphia after the government declined to intervene.
Novartis responded with a 295-page motion to dismiss in May 2011, but U.S. District Judge Gene Pratter preserved some claims on Thursday.
"The first amended complaint plausibly suggests that at least some of the claims submitted to government healthcare programs for Elidel prescriptions were not reimbursable, because it also alleges that these programs do not pay for drugs that are 'not prescribed for a medically accepted indication,' and that at least 1.2 million Elidel prescriptions were written off-label in a manner that put the health of the children receiving those prescriptions at risk," Pratter wrote. "Therefore, Mr. Galmines has sufficiently pled that false claims for Elidel prescription reimbursements were submitted to the government."
Though another pair of former Novartis employees, Gina Moyer and Judith Shelton, also brought a 2005 qui tam action over Elidel in Michigan, the court found that the first-to-file rule bars only Galmines' claims of kickbacks. He can still pursue claims over off-label-marketing because the Moyer complaint discusses the allegedly unlawful promotion of Elidel for psoriasis and seborrhea, and Galmines "makes almost no allegations about these diseases."
"Mr. Galmines has injected precision into his off-label marketing allegations by pleading a myriad of details about how such marketing occurred," Pratter wrote. "The first amended complaint details with specificity how Novartis trained its personnel to engage in off-label marketing, how it equipped those personnel with reports and visual aids to support such marketing, how it used medical experts to promote the off-label use of Elidel, and how Mr. Galmines was reprimanded when he declined to market Elidel for such uses. These allegations, together with the first amended complaint's allegation that at least 1,218,000 off-label prescriptions were written for Elidel, 'are sufficiently specific both to inform [Novartis] of the "precise misconduct" charged, and to make it unlikely that [Mr. Galmines] has commenced this action in bad faith.' Therefore, the court will not dismiss the first amended complaint under Rule 9(b)."
 






UK Health Watchdog Doesn't Recommend Novartis's Afinitor

By Dow Jones Business News, July 07, 2013, 07:15:00 PM EDT

By Jessica Hodgson and Marta Falconi

LONDON--Britain's healthcare cost watchdog Monday said in draft guidance that it wouldn't recommend Afinitor, a Novartis AG ( NVS ) drug for advanced breast cancer, because it was "not good value for money."

The National Institute for Clinical Excellence's decision is a blow for Novartis
 






(LETS HEAR THE SPIN FROM THE ANTI GOVT MORON ON THIS ..MORE 'ISOLATED' INCIDENTS ? LMMFAO!!!)


University admits clinical study of hypertension drug rigged
7/12/2013

THE ASAHI SHIMBUN

KYOTO--Kyoto Prefectural University of Medicine has admitted that data recorded by its research team during clinical studies of Novartis Pharma AG’s blockbuster hypertension drug Diovan was falsified, possibly to claim additional side benefits.

“Data was manipulated,” Toshikazu Yoshikawa, president of the university, told a news conference July 11, referring to clinical studies conducted by the university on Diovan. “We apologize for causing serious trouble.”

Yoshikawa said he will return his salary to take responsibility for the scandal, but did not clarify the figure and for how long.

Diovan has been a best-selling drug in the Japanese market, raking in 108.3 billion yen ($1.09 billion) last year alone.

Novartis Pharma KK, the Japanese sales arm of the Swiss drug giant, touted its benefits for other ailments in addition to reducing high blood pressure, such as reducing the risk of stroke and angina, in literature presented to doctors based on the reports by the university.

Hiroaki Matsubara, former professor of cardiovascular internal medicine at the university, led the group that analyzed the effectiveness of Diovan in clinical studies. The group released a report in 2009 that concluded the drug was also effective in preventing stroke and angina, compared with other hypertension drugs.

Matsubara left the university in February after allegations surfaced about the credibility of the report.

The group’s study involved about 3,000 Japanese patients.

The university put together an investigative panel that looked at the medical records of 223 of those involved in the study. Of the 223, the records of 34 patients falsely stated that they may or may not have suffered a stroke.

Based on their new statistical analysis, the panel concluded that Diovan was no more effective than other similar drugs in reducing the risks of stroke and angina.

Similar clinical studies concerning Diovan were also conducted at Jikei Unversity, Shiga University of Medical Science, Chiba University and Nagoya University. Investigations are under way to find out if data was also falsified in those studies.

In the research conducted by Kyoto Prefectural University of Medicine, an employee of Novartis Pharma in Japan was involved in conducting statistical analysis for the study, a fact not listed in the university’s report.

The university’s panel contacted Novartis Pharma in Japan with a request to interview the former employee. The drug company declined, stating the person had left the company.

Novartis Pharma in Japan has denied the allegations.

“No intentional data manipulation has been confirmed,” the company said in a statement on July 12.

In regards to the interview of its former employee, the drug company said, “Novartis Pharma did not decline a request to interview the former employee. Although we contacted the former employee about the request, the interview did not materialize because the former employee strongly wanted it that way.”

Shinji Fushiki, the university’s vice president who also attended the news conference, said the panel was at a loss over how to determine who altered the data. But he added that the university will not investigate further into the matter.

“The university is limited in what it can do,” Fushiki said.

University officials said they will take steps to prevent the recurrence of data manipulation in the future by bolstering their ability to confirm the veracity of such studies.

The university’s panel opened its investigation in March after suspicions outside the university were raised about the credibility of the data, and after the university had earlier denied allegations of rigged data in January.

Asked about the disparity in the university’s recent conclusion, Fushiki said, “In January, we concluded that there were errors in inputting data, which had nothing to do with impropriety. But this time, we found that there was manipulation that puts the very substance of the clinical studies at stake.”

An official overseeing such clinical studies in the health ministry expressed regret over the university’s findings.

“The allegations that data was possibly manipulated is highly regrettable,” the official said. “We intend to weigh the best possible preventive measures once we receive the reports from the four other universities on their investigations into the matter.”

(This article was written by Ryoma Komiyama, Nobutaro Kaji and Ryosuke Nonaka.)
 






Novartis buries a PhIII kidney cancer failure behind Q2 successes


July 19, 2013 | By John Carroll

Two years ago, investigators for Novartis ($NVS) pulled into ASCO flagging a slate of high-profile cancer drugs at the top of its oncology pipeline, including the mid-stage results for dovitinib (TKI258), a tyrosine kinase inhibitor the pharma giant believed had a good shot at besting Nexavar in treating kidney cancer. Yesterday, if you dug down past its PR on second-quarter successes and into a more detailed description of its pipeline work, you would find that dovitinib failed the head-to-head showdown in Phase III.

In a terse summary, Novartis noted: "Results of the Phase III trial evaluating the investigational therapy TKI258 showed the drug did not meet its primary endpoint of progression-free survival compared to sorafenib in patients with metastatic renal cell carcinoma (mRCC) after failure with prior therapies. The TKI258 program continues with ongoing solid tumor studies."

According to clinicaltrials.gov, Novartis recruited 564 renal cell carcinoma patients for the study, looking to examine PFS after 386 deaths.

A spokesperson for Novartis did not immediately return a message from FierceBiotech.

But then, they rarely do. Aside from the occasional sit-down with The Wall Street Journal and other such financial pubs, Novartis remains one of the least transparent companies of all the Big 10 pharma giants. Success is heralded, failure barely warrants a footnote. And the company clearly doesn't care to publicly discuss pipeline setbacks.

FierceBiotech http://www.fiercebiotech.com/story/...-behind-q2-successes/2013-07-19#ixzz2ZWvSo1Bj
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Novartis vaccine division hit by Bexsero setback

Reuters
10 hours ago 7/24/2013

ZURICH (Reuters) - Swiss drugmaker Novartis suffered a fresh blow to the turnaround prospects of its loss-making vaccines division as a key committee advised against including its meningitis B vaccine on Britain's routine vaccination program.

The UK Joint Committee on Vaccination and Immunisation (JCVI) said on Wednesday that it had taken the interim decision not to recommend Bexsero because the vaccine is unlikely to prove cost-effective.

Bexsero won European approval this year to become the first vaccine against "MenB", a bacterial infection that can kill in 24 hours and poses the greatest risk to infants.

The declining incidence of MenB, however, means that cash-strapped governments may be reluctant to administer the vaccine broadly as a preventative measure.

Bexsero is seen as crucial to the Novartis vaccine unit, which has struggled to catch up with the market leaders - GlaxoSmithKline, Sanofi and Merck - and was the only one of the Swiss company's five divisions to report an operating loss in the second quarter.

"Today's decision represents a material setback to Novartis's beleaguered vaccine division. In the absence of a successful appeal, Bexsero revenue will likely be restricted to a minimal private-payer market," Citi analyst Andrew Baum said.

"More importantly, it could force Novartis to sell, partner or more likely integrate its vaccine business within its pharmaceutical infrastructure."

Novartis said the committee's decision underestimated the "potentially devastating impact" of the disease.

"It's disappointing to see that the decision was mostly driven by financial considerations and without any pricing discussion with Novartis," said Andrin Oswald, head of the Novartis Vaccines and Diagnostics division.

The drugmaker said it would supply information on pricing before the recommendation is finalized.
 






NO! 2 Bexsero said:
Novartis vaccine division hit by Bexsero setback

Reuters
10 hours ago 7/24/2013

ZURICH (Reuters) - Swiss drugmaker Novartis suffered a fresh blow to the turnaround prospects of its loss-making vaccines division as a key committee advised against including its meningitis B vaccine on Britain's routine vaccination program.

The UK Joint Committee on Vaccination and Immunisation (JCVI) said on Wednesday that it had taken the interim decision not to recommend Bexsero because the vaccine is unlikely to prove cost-effective.

Bexsero won European approval this year to become the first vaccine against "MenB", a bacterial infection that can kill in 24 hours and poses the greatest risk to infants.

The declining incidence of MenB, however, means that cash-strapped governments may be reluctant to administer the vaccine broadly as a preventative measure.

Bexsero is seen as crucial to the Novartis vaccine unit, which has struggled to catch up with the market leaders - GlaxoSmithKline, Sanofi and Merck - and was the only one of the Swiss company's five divisions to report an operating loss in the second quarter.

"Today's decision represents a material setback to Novartis's beleaguered vaccine division. In the absence of a successful appeal, Bexsero revenue will likely be restricted to a minimal private-payer market," Citi analyst Andrew Baum said.

"More importantly, it could force Novartis to sell, partner or more likely integrate its vaccine business within its pharmaceutical infrastructure."

Novartis said the committee's decision underestimated the "potentially devastating impact" of the disease.

"It's disappointing to see that the decision was mostly driven by financial considerations and without any pricing discussion with Novartis," said Andrin Oswald, head of the Novartis Vaccines and Diagnostics division.

The drugmaker said it would supply information on pricing before the recommendation is finalized.
Click to expand...

Andrin Oswald and his fleet of overpaid idiots are to blame. Wrong clinical studies, bad assays.
 












Anonymous said:
They should have done it in adolescents like the agency advised them to.
Click to expand...

They didn't have a choice because of the conflicts mentioned here becuase pressure due to the lack of profitability and their jobs. Unlike the expectations that they set, Menveo was a dog in the market so they had to pull a rabbit out of the hat and go for it, so the infant indication was the only way to do that.

If Novartis keeps NVD, in a much scaled down form, it will be Adrin and his leadership teams successors to refile and try and save something.
 






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