Novartis milestones be proud ! Management take a bow !

Quote
Cyprus Mail
11/30/13

Thalassaemia drug is safe’ insists Novartis

By Peter Stevenson

LOCAL press reports that the Exjade drug used in the treatment of thalassaemia is unsafe are wide off the mark and contain serious inaccuracies, according to distributor Novartis.

Politis reported on Thursday that the health ministry was investigating irregularities dating back to 2011 with the order and supply of the drug and that Exjade (also known as deferasirox) was on the list of ‘most frequent suspected drugs in reported patient deaths’ compiled by the U.S. Institute for Safe Medical Practices in 2009.

The investigation which is being carried out at the auditor-general’s request was confirmed to the Cyprus Mail by acting permanent secretary at the health ministry, Christina Yiannaki.

The investigation, to be concluded by December 9, is being carried out following a suggestion by auditor-general Chrystalla Georghadji after irregularities had been discovered in the purchase of the drug.

Novartis said in a statement that patients being treated with Exjade should not stop their medication without first consulting their treating physician.

It has been used in Cyprus since 2007 to treat chronic iron overload (excess iron in the body) in people who suffer from thalassaemia.

“Exjade is one of the most modern treatments for chronic iron overload, which is caused by repeated blood transfusions and has significantly contributed to improving thalassaemia patients’ quality of life,” Novartis said.

According to Politis, the investigation is focusing on the head of the pharmaceutical services and two orders that were placed for Exjade. The first, which was cancelled, was placed in 2011 at a cost of €7.9m for 118 thalassaemia sufferers. The second order was placed for 68 patients and came to €4.1m, the report said.
 












EU regulators fine Novartis J&J for generic drug deal

Tue Dec 10, 2013 10:40am EST


By Foo Yun Chee

Dec 10 (Reuters) - European Union regulators have fined drugmakers Johnson & Johnson and Novartis 16.3 million euros ($22 million) for blocking the sale of a cheaper generic rival to their painkiller fentanyl.

The EU warned others against such anti-competitive deals.

This is the second penalty imposed by the European Commission over so-called pay-for-delay deals where brand-name companies pay generic rivals not to sell their versions of a drug at a fraction of the original price.

The practice, common in the pharmaceutical industry, has caught the attention of regulators around the world because it raises consumer bills and public healthcare costs.

The EU competition watchdog said on Tuesday that the deal between Johnson & Johnson and Novartis meant cancer patients did not have access to the cheaper generic version of fentanyl for 17 months from July 2005.

Johnson & Johnson and its Dutch unit, Janssen-Cilag, were fined 10.8 million euros while Novartis and Dutch subsidiary Sandoz were fined 5.5 million euros. The agreement ended after another drugmaker unveiled plans to sell its own version.

Sources familiar with the matter told Reuters last month that the fines were planned.

"Today's decision should make pharmaceutical companies think twice before engaging in such anti-competitive practices, which harm both patients and taxpayers," EU Competition Commissioner Joaquin Almunia said.

Novartis and Sandoz disputed the regulator's finding. (BIG SHOCK LOL !!!)

"(We) reject the Commission's allegation that the 2005 co-promotion agreement was intended to deprive patients in the Netherlands of cheaper medicines. We look forward to putting this historical matter behind us," they said in a statement.

The Commission fined Denmark's Lundbeck and eight others in June in its first pay-for-delay case and has two others in the pipeline involving Israel's Teva and its subsidiary Cephalon, and French drugmaker Servier.
 






Once and for all, we must realize we are dealing with, not Bigpharma but Bigpharmafia. Thus everything they do is, either legal or illegal or combination of both. Just like what that other mafia does, originating from that Sicilian village, Corleone.
The biggest and the worse (or best depending on your point of view) Novamafia originates from that Swiss town called Baselone.
Even with Don Vasella gone, the wiseguys continue as per mafia style culture tradition that he brought in in earnest. Before he took over Sandoz that company along with others was just a light weight manipulator of markets and health care systems with little white lies and mild schemes. But nothing what they do today, to the extent that they seriously undermine the whole countries' health care systems. This both in terms of poor services and extensive costs never seen before. You see a thief can steal/loot only as much as he can or as much as he thinks is enough for him to get somewhat better off, but not destroy his victims significantly or completely.
Before Vasella they stole only marginally to get few millions extra from their cutomers/victims, who did not even know they were robbed for it made no difference to speak of. But during and after Vasella, the stealing/looting has increased so much that all the countires they operate in have been significatly damaged by the Novamafia and Bigpharmafia (they all do it). Those countries are still not on their knees, destroyed financially but they are approaching the tipping point.
Fines like these do help but authorities must take a much severe approach in dealing with these, by now ultimate mafiosi.
Just those other mafiosi these bigpharmafiosi must end up in jails for a long, long time. Otherwise this will never end, for fines regardless how large are considered by them, just another cost of doing their crooked biz.
 






Japan to seek criminal prosecution of Novartis: Report
By AFP | 18 Dec, 2013, 09.34AM IST

TOKYO: Japan's health ministry intends to file a criminal complaint against the
local arm of Swiss pharmaceutical giant Novartis over alleged fabrication of drugs data, a report said Wednesday.

Novartis Pharma has been under fire since a
university said the data might have been skewed to promote a popular
blood-pressure drug.

Health Minister Norihisa Tamura has characterised as
"extremely regrettable" the incident in which an employee of the world's number
two drug maker hid his affiliation during a medical study into the effects of
Valsartan.

The ministry, which has since investigated the case, is now
planning to file a criminal complaint seeking punishment not only for the
company but also for individuals involved in the scandal, the Yomiuri Shimbun
reported.

Under Japan's pharmaceutical law, anyone found guilty of exaggerated advertising can be punished with up to two years' prison or a fine of as much as two million yen ($19,400).

A ministry panel of experts concluded in September that Novartis Pharma KK should be held
responsible for studies at various universities that used manipulated data on
the drug.

The studies suggested the drug -- sold under the name Diovan
in Japan and licensed for use in more than 100 countries
had some prophylactic effect on strokes and angina.

The firm used data from the studies to market its drug, playing up its supposed additional
benefits.

Novartis has maintained that the company had no knowledge of
the wrongdoing, in which an ex-employee allegedly failed to disclose his
affiliation with Novartis during various academic studies in which incomplete
clinical data were used.

The worker and other researchers involved in
studies have denied to the the panel that they manipulated the data.

In September Novartis
Pharmaceuticals chief David
Epstein was called to meet with the health minister and promised to
cooperate with Tokyo's probe into the matter.

Epstein apologized for
the concern the incident has caused, but did not admit the company's role in the
allegations.

Tokyo's Jikei University School of Medicine has
retracted research that appeared in respected medical journal The Lancet six
years ago due to data fabrication.

Kyoto Prefectural University of Medicine also
concluded that its studies on the drug used incomplete clinical data.

Chiba
University said Tuesday it could not find intentional data fabrication but
researchers failed to disclose 91 million yen ($880,000) in scholarship
donations from the pharmaceutical company in the three years from 2007 to 2009.
 






Baseleone said:
Once and for all, we must realize we are dealing with, not Bigpharma but Bigpharmafia. Thus everything they do is, either legal or illegal or combination of both. Just like what that other mafia does, originating from that Sicilian village, Corleone.
The biggest and the worse (or best depending on your point of view) Novamafia originates from that Swiss town called Baselone.
Even with Don Vasella gone, the wiseguys continue as per mafia style culture tradition that he brought in in earnest. Before he took over Sandoz that company along with others was just a light weight manipulator of markets and health care systems with little white lies and mild schemes. But nothing what they do today, to the extent that they seriously undermine the whole countries' health care systems. This both in terms of poor services and extensive costs never seen before. You see a thief can steal/loot only as much as he can or as much as he thinks is enough for him to get somewhat better off, but not destroy his victims significantly or completely.
Before Vasella they stole only marginally to get few millions extra from their cutomers/victims, who did not even know they were robbed for it made no difference to speak of. But during and after Vasella, the stealing/looting has increased so much that all the countires they operate in have been significatly damaged by the Novamafia and Bigpharmafia (they all do it). Those countries are still not on their knees, destroyed financially but they are approaching the tipping point.
Fines like these do help but authorities must take a much severe approach in dealing with these, by now ultimate mafiosi.
Just those other mafiosi these bigpharmafiosi must end up in jails for a long, long time. Otherwise this will never end, for fines regardless how large are considered by them, just another cost of doing their crooked biz.
Click to expand...

We can repeat this post every time someone reporst the crooked ways of this Co. It'll be very often if not daily.
As the man used to say, "don't let those crooked bastards from Basel, NJ, Dorval, SouPolo, etc. get away with literal-plain murger". Or something like this, but the thing is, we the people (real victims) and the govts around the world let them get away.
 






FDA Puts Out Warning on J&J, Novartis ADHD Drugs


Katey Troutman | More Articles
December 17, 2013

A stimulant drug, methylphenidate, which is used in many leading ADHD medications, has been linked to painful and sustained erections — a condition known as priapism — in males between the ages of 8 and 33, cautions the U.S. Food and Drug Administration. It’s a rare side effect but has provoked labeling changes by the regulatory agency, which has updated the warning labels for drugs containing methylphenidate to include information about the risk for priapism.


Methylphenidate is an active ingredient in both Ritalin, manufactured by Novartis (NYSE:NVS), and Concerta, manufactured by Johnson & Johnson (NYSE:JNJ). The generics of both drugs are widely used to treat ADHD, a disorder that is one of the most common brain disorders affecting children. Last year alone, 20 million prescriptions for ADHD drugs were dispensed by U.S. physicians for medicines containing methylphenidate or dexmethylphenidate.

ADHD also happens to affect more males than females, making it a particularly relevant concern. About 61 percent of those 20 million prescriptions were for male patients, according to the FDA.

Because ADHD drugs are so often prescribed to children, there is also a very real concern that “younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs,” the FDA said, warning that if priapism goes without treatment for more than four hours, it has the potential to cause permanent damage to the penis. The FDA is advising that everyone taking the drugs should be educated about priapism and its dangers, particularly young males.

The news regarding priapism associated with stimulant ADHD medicines containing methylphenidate may provoke physicians to prescribe a non-stimulant alternative such as Eli Lilly’s Strattera, which uses atomoxetine as its active ingredient in place of methylphenidate.
 






Novartis Recalls About 5.3 Million Bottles of Sample Drugs

Company Cites Potential Contamination by a Packaging Chemical

By
Peter Loftus
Dec 19, 2013 5:13 p.m. ET

Novartis AG has recalled about 5.3 million bottles of blood-pressure medications and other drugs that were provided as free samples to U.S. physicians' offices, citing potential contamination by a packaging chemical.

The bulk of the voluntary recall, which was initiated in the summer, was for about 4.7 million bottles of hypertension treatments Exforge and a related drug, Exforge HCT, according to information posted online this week by the U.S. Food and Drug Administration. Other drugs included in the recall were blood-pressure treatments Diovan, Tekturna and Tekturna HCT; Lescol XL cholesterol-lowering tablets; and Stalevo for Parkinson's disease.

A Novartis spokeswoman said the company recalled 127 lots of the drugs after routine testing found that trace amounts of an ink component on shrink-wrapped sleeves surrounding the bottles had migrated and affected some tablets contained in some lots of the physician-sample bottles. Each sample bottle contained seven tablets.

The Swiss company said it concluded the issue didn't pose a safety risk to patients, citing a medical assessment, and that it initiated the recall "to ensure compliance with regulatory standards and quality control."

It is unclear how many samples may have reached patients, which Novartis said it doesn't track. The company sent letters to physicians who had received the samples informing them of the recall, and worked with them on returns, the spokeswoman said. The recall didn't include products held by patients or those distributed via wholesalers and pharmacies.

The FDA classified the action as a "Class 2" recall, which the agency reserves for products that may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health problems is remote.

While drug recalls are common, it is relatively rare for a recall to be specific to the free samples provided to doctors.

Novartis and other drug makers routinely provide free promotional samples of prescription drugs to doctors, who in turn provide them to patients. Drug makers hope the free samples will convert to paid prescriptions, and some doctors say the samples help uninsured or under-insured patients afford drugs.

However, critics have said that samples are more likely to go to insured patients, and that the practice boosts overall health-care costs by promoting expensive brand-name drugs over cheaper generic alternatives. Some medical centers have banned doctors from accepting free drug samples.

Novartis said it discontinued use of the ink component for the sample sleeves, which are produced by a third party manufacturer. The ink component is "Darocur 1173," according to the FDA, which is described as a "photocuring agent."

The recalled drugs were manufactured at plants in Suffern, N.Y.; Stein, Switzerland; and Wehr, Germany; and were distributed by Novartis Pharmaceuticals Corp., East Hanover, N.J.

Novartis has grappled with other product recalls in recent years, including over-the-counter medicines such as Excedrin that were manufactured at a plant in Lincoln, Neb., before the company suspended production at the site in late 2011 to address manufacturing-quality problems identified by the FDA.

Marta Falconi contributed to this article.

Write to Peter Loftus at peter.loftus@wsj.com
 






Criminal Prosecution said:
Japan to seek criminal prosecution of Novartis: Report
By AFP | 18 Dec, 2013, 09.34AM IST

TOKYO: Japan's health ministry intends to file a criminal complaint against the
local arm of Swiss pharmaceutical giant Novartis over alleged fabrication of drugs data, a report said Wednesday.

Novartis Pharma has been under fire since a
university said the data might have been skewed to promote a popular
blood-pressure drug.

Health Minister Norihisa Tamura has characterised as
"extremely regrettable" the incident in which an employee of the world's number
two drug maker hid his affiliation during a medical study into the effects of
Valsartan.

The ministry, which has since investigated the case, is now
planning to file a criminal complaint seeking punishment not only for the
company but also for individuals involved in the scandal, the Yomiuri Shimbun
reported.

Under Japan's pharmaceutical law, anyone found guilty of exaggerated advertising can be punished with up to two years' prison or a fine of as much as two million yen ($19,400).

A ministry panel of experts concluded in September that Novartis Pharma KK should be held
responsible for studies at various universities that used manipulated data on
the drug.

The studies suggested the drug -- sold under the name Diovan
in Japan and licensed for use in more than 100 countries
had some prophylactic effect on strokes and angina.

The firm used data from the studies to market its drug, playing up its supposed additional
benefits.

Novartis has maintained that the company had no knowledge of
the wrongdoing, in which an ex-employee allegedly failed to disclose his
affiliation with Novartis during various academic studies in which incomplete
clinical data were used.

The worker and other researchers involved in
studies have denied to the the panel that they manipulated the data.

In September Novartis
Pharmaceuticals chief David
Epstein was called to meet with the health minister and promised to
cooperate with Tokyo's probe into the matter.

Epstein apologized for
the concern the incident has caused, but did not admit the company's role in the
allegations.

Tokyo's Jikei University School of Medicine has
retracted research that appeared in respected medical journal The Lancet six
years ago due to data fabrication.

Kyoto Prefectural University of Medicine also
concluded that its studies on the drug used incomplete clinical data.

Chiba
University said Tuesday it could not find intentional data fabrication but
researchers failed to disclose 91 million yen ($880,000) in scholarship
donations from the pharmaceutical company in the three years from 2007 to 2009.
Click to expand...

WOW SOME EXECS BEHIND BARS WOULD BE A CHANGE
 






ANOTHER LAWSUIT

Novartis Jacked Up Painkiller Prices, Class Action Claims
By Jeff Sistrunk
Law360, Los Angeles (January 02, 2014, 7:40 PM ET) -- Novartis AG was hit with a proposed consumer class action in New Jersey federal court Tuesday claiming the Swiss pharmaceutical giant sells a popular over-the-counter migraine medication at a higher price than an identical product marketed under a different name.

Named plaintiff Kerri Yingst alleges that Novartis sells the painkiller Excedrin Migraine at a higher price than Excedrin Extra Strength, which has an identical formulation and dosage. Yingst, of Cherry Hill, N.J., bought Excedrin Migraine repeatedly during the past eight years to treat her recurrent migraines
 






Lawsuit #2 ......and counting ........( in 2014)

January 6, 2014, 5:05 p.m.
ET.Microbix Sues Novartis for Infringement of its VIRUSMAX®

TORONTO, Jan. 6, 2014 /CNW/ - Microbix Biosystems Inc. (TSX: MBX) ("Microbix" or the "Company"), an innovator of biological products and technologies, announced today it has commenced a patent litigation against Novartis Vaccines and Diagnostics, headquartered in Basel, Switzerland, alleging infringement of its proprietary VIRUSMAX technology. The complaint was filed in the Eastern District of Texas. Microbix was granted patents for the VIRUSMAX technology in twenty-one countries between 2006 and 2011.

The Company's VIRUSMAX technology is useful for increasing virus yields in egg-based vaccine manufacture. The patent application was first published internationally in 2004 when the global market for influenza vaccine was US $1.6 billion. At that time, governments, the WHO and public health authorities worldwide expressed growing concern about limited global vaccine manufacturing capacity and supply, especially in light of a potential influenza pandemic.

The influenza vaccine market has experienced significant growth in the past ten years and is predicted to reach US $4 Billion in 2014. An independent study published in the Journal of Vaccine in 2006 reported that the application of VIRUSMAX technology led to a significant increase in flu virus production in eggs. These trials used methods comparable to those employed in seasonal influenza vaccine manufacture. The Company has also demonstrated substantial yield increases over conventional manufacturing processes for a number of influenza vaccine strains using its technology.

Vaughn Embro-Pantalony, President and Chief Executive Officer said, "VIRUSMAX is a novel technology that was developed by our Company at significant cost. The technology provides significant efficiencies to the influenza vaccine industry and it benefits the global supply of vaccine. We intend to enforce our intellectual property rights surrounding this technology."
 






LOL ! doesn't take long does it

Novartis Accused of Paying Kickbacks for Exjade Sales
By Christie Smythe Jan 8, 2014 8:26 PM ET

A Novartis AG (NOVN) unit was accused by the U.S. and a group of states of paying kickbacks to a specialty pharmacy to boost sales of Exjade, an iron-control drug that can cause kidney and liver failure.

U.S. District Judge Colleen McMahon in Manhattan today unsealed a complaint filed against Novartis Pharmaceuticals Corp. by the U.S., 26 states and the District of Columbia alleging that the drugmaker had paid kickbacks to BioScrip Inc. (BIOS) to encourage patients to refill prescriptions.

Separately, federal and state officials announced that the Elmsford, New York-based specialty pharmacy agreed to pay $15 million to resolve the claims against it.

Federal and state officials alleged that government health programs Medicare and Medicaid paid tens of millions of dollars in reimbursements based on false claims for the drug.

“This arrangement between Novartis and BioScrip was dangerous for patients and is against the law,” New York Attorney General Eric Schneiderman said in a statement. “Our lawsuit against Novartis and our agreement with BioScrip send a clear message: Drug companies cannot pay pharmacies to promote drugs directly to patients.”

Kickbacks, Calls

According to the complaint, Novartis paid kickbacks to BioScrip from February 2007 to May 2012 in the form of patient referrals and rebates. To hold up its end of the bargain, BioScrip made tens of thousands of calls to patients to try to convince them to keep taking the drug, federal and state officials alleged.

Julie Masow, a spokeswoman for Basel, Switzerland-based Novartis, said in an e-mailed statement that the company disputes the allegations in the complaint related to its interactions with BioScrip and intends to defend itself.

The company “is dedicated to improving patient health and supports patient medication adherence programs,” including outreach by pharmacies, Masow said.

Exjade was approved by the U.S. Food and Drug Administration in November 2005 to treat chronic iron overload due to blood transfusions, according to the complaint. In January 2010, the agency required the drug to feature a “black box” warning highlighting the potential for kidney failure, liver failure and gastrointestinal hemorrhage that in some cases were fatal, according to the complaint.

Increasing Refills

Novartis wanted to increase the refills of the drug because “its own market research had shown that a significant percentage of physicians and patients were opting to discontinue Exjade therapy” because of side effects, the officials said in the complaint.

In late February 2007, Novartis told BioScrip that because it generated lower levels of refills compared with other pharmacies, it had been placed on a “performance improvement plan,” according to the complaint.

Novartis “expects that the specialty pharmacies it works with conduct vital patient outreach in a manner wholly consistent with NPC’s commitment to patient care,” Masow said. “BioScrip reached out to patients using its own protocols to provide education, counseling and information about proper administration of the medicine and to fulfill prescriptions that have been prescribed by a patient’s treating physician.”

Officials are seeking triple damages against Novartis and civil penalties under the False Claims Act.

The case is ABC v. DEF, 1:11-cv-08196, U.S. District Court, Southern District of New York (Manhattan).

To contact the reporter on this story: Christie Smythe in federal court in Brooklyn, New York at
 






8th Circ. Affirms Novartis Loss In Aredia, Zometa Suit
by Greg Ryan law360

New York (January 09, 2014, 3:35 PM ET) -- The Eighth Circuit on Thursday upheld a verdict against Novartis Pharmaceuticals Corp. in a lawsuit over a jaw injury allegedly caused by a woman's use of the bone drugs Aredia and Zometa, even though her physician said he did not read drug warnings.

The decision affirms the $225,000 in compensatory damages awarded to the estate of Ruth Baldwin, the now-deceased plaintiff, in April 2012. Baldwin claimed that Novartis failed to warn that her use of Aredia and Zometa could cause her to develop osteonecrosis of the jaw
 






SINKING SHIP...........................................................

Jan. 12, 2014, 10:41 p.m. EST

Novartis cancer chief departs

By MarketWatch

ZURICH-- Novartis AG said Sunday that the head of its cancer business had left the company for a new job, creating a vacancy at the top of one of its most important franchises.

Basel-based Novartis said Herve Hoppenot, who had been president of Novartis Oncology since 2010, would be replaced on an interim basis by Alessandro Riva, who is in charge of the unit's development and medical affairs.

A Novartis spokesman declined to comment on how long the search for a successor to Mr. Hoppenot might take. Mr. Hoppenot joined the company in 2003 as head of global marketing

Oncology is one of Novartis's biggest therapeutic areas. Gleevec, a leukemia treatment, was the company's top-selling product in 2012, generating $4.7 billion in sales. Three other oncology drugs, including Sandostatin and Zometa, were in the company's top 10.

In 2012, Novartis's oncology products generated roughly a third of its pharmaceutical business's $32.2 billion in net sales.

Last week, Novartis found itself the target of authorities in Japan and the U.S. Japanese health regulators called for a criminal investigation into the Japanese arm of the Swiss pharmaceutical giant for allegedly misleading advertising to support Diovan, its anti-hypertension drug.

In the U.S., New York Attorney General Eric Schneiderman filed a lawsuit against a U.S. unit of the company for an alleged kickback scheme related to its iron-reduction drug, Exjade, one of its oncology products.

The spokesman said Mr. Hoppenot's departure was unrelated to the lawsuit.

Novartis has said it takes the Japanese matter "extremely seriously" and would continue cooperating fully with authorities. It also has said it "deeply apologized" for the "troubles' caused by the situation.

A Novartis representative has said Novartis disputes the allegations in the New York lawsuit and intends to defend itself.

Write to Andrew Morse
 












Novartis Hit With Another Research Snag in Japan

Company Says Employees Were Involved in Transferring Clinical Test Results for Cancer Drug

By Alexander Martin

Jan. 17, 2014 12:56 p.m. ET

TOKYO—Employees of Novartis AG's Japanese subsidiary inappropriately transferred clinical test results for one of its cancer drugs, the company said Friday, an admission that comes as the Swiss pharmaceutical company is entangled in an alleged data-tampering scandal over a separate drug study.

The company said the problems occurred when results of tests on its Tasigna cancer drug were transferred from research institutes to a hospital where the tests were being analyzed. The tests were designed to gauge whether Tasigna, also known as nirotinib, produced fewer side effects than Novartis's Gleevec, which goes by the generic name imatinib, or Bristol-Myers Squibb Co. BMY -0.80% 's dasatinib, sold under the brand name Sprycel.

Novartis employees transferred the test results to University of Tokyo Hospital from the research institutes where the tests had been conducted, a breach of protocol for the study. The research institutes had been expected to fax the results directly to the hospital for analysis without the participation of Novartis employees.

"It was inappropriate for MRs [medical representatives] from our company to receive the surveys from doctors at medical institutions and we are regretful," Novartis said. The company didn't say how many test results its employees had transferred or whether the practice went against its compliance rules. NHK, Japan's national broadcaster, reported the issue earlier on Friday.

The troubled data transfer marks the second potential setback for Novartis in Japan this month. Last week, the country's health regulators called for a criminal investigation of Novartis, alleging its Japan unit had misled consumers by using altered research in advertisements for Diovan, its best-selling blood pressure medicine—an accusation the company denies.

On Friday, the University of Tokyo Hospital said it was re-examining test results it had received but had uncovered no evidence that Novartis employees had manipulated any of the data during the transfers.

The hospital had originally asked medical institutions involved in the clinical studies to directly fax the results to the hospital, a spokeswoman said. But of 255 test surveys the hospital had received, 133 had been sent by methods other than fax. Of those, as many as 125 could have been handled by Novartis employees, the hospital said.

The hospital has rechecked almost all of the tests that could have been handled by Novartis employees and all of the results matched the original data, a spokeswoman said.

A hospital spokesman declined to say whether other pharmaceutical companies had ever had similar involvement with clinical test trials or whether such practices were common in Japan.

Novartis's earlier problem with Diovan came when some Japanese universities found that research conducted by the universities had been falsified. The universities also found that a Novartis employee had participated in all of those studies but hadn't acknowledged his affiliation in published papers.

Novartis executives have denied the company's involvement in the Diovan research or running misleading advertising touting the drug. But executives have acknowledged that the involvement of the company employee was a conflict of interest.

The drug maker shook up management of its Japanese unit in October, and cut the pay of the top executives of Novartis Pharma K.K., citing inadequate internal controls that allowed the conflict of interest to occur.

Write to Alexander Martin
 






Desperation to show some non existent benefit of tasigna over gleevec which is losing patent protection in the country where apparently data is easily manipulated at least until you get caught.......... what a shocker lol
 






Cherry Hill woman sues Novartis over marketing of Excedrin pain medicines(Alexi Friedman/The Star-Ledger)

January 19, 2014 at 10:30 AM, updated January 19, 2014 at 10:42 AM

The two kinds of Excedrin have distinctly different looks.

Extra Strength comes in a green box and says it treats headaches, colds, muscle aches, sinusitis, toothaches and premenstrual cramps.

Excedrin Migraine, packaged in red, only treats migraines.

Even the lettering on the two boxes are in different positions so consumers can tell them apart. But because both pain medicines contain the same amount of the same active ingredients — acetaminophen, aspirin and caffeine — they are essentially identical.

One key ingredient is different: price.

Excedrin Migraine generally costs about 12 percent to 15 percent more than Excedrin Extra Strength for the 24-, 100-, 200- and 300-count bottles.

That means consumers can spend between 50 cents and $1.50 more per bottle for the migraine medicine, which ranges from $10 to $18.

The discrepancy was enough to give Kerri Yingst another headache, and led the Cherry Hill woman to file a federal lawsuit charging drugmaker Novartis with violating New Jersey consumer fraud law.

Filed earlier this month, the proposed class-action suit accuses the Swiss pharmaceutical company of selling Excedrin Migraine at a higher wholesale price than Extra Strength.

Novartis, whose U.S. base is in East Hanover, is "engaging in an unconscionable business practice" that violates the New Jersey Consumer Fraud Act, according to the complaint filed in Newark.

While it has not filed a response to the suit yet, Novartis spokeswoman Julie Masow said over-the-counter medications are regulated by the U.S. Food and Drug Administration, which reviewed Excedrin data to determine the appropriate doses.

"Excedrin Extra Strength and Excedrin Migraine are not considered the same based on their indications for use and clinical studies conducted to support these indications," Masow said. Novartis doesn’t disclose pricing strategy, she said, but added, "several factors are taken into consideration in our pricing decisions, including cost of goods."

The lawsuit will likely hinge on whether the plaintiff can prove Novartis misrepresented the way Excedrin was marketed and whether "a consumer relied on that perceived misleading statement to buy that product," said David Noll, an assistant professor at Rutgers Law School in Newark who specializes in civil procedure.

When someone is at the mercy of a migraine...you can't balance, you can't have any light, and you'll do anything to get relief"

Yingst has used Excedrin Migraine for eight years to relieve her acute headaches, said her attorney, Todd Muhlstock. Yingst noticed the price difference one day while walking through a drugstore and snapped a photo.

Muhlstock said his client "didn’t understand why she was paying more for the same product. It didn’t seem right."

Muhlstock, who has used Excedrin in the past, said the suit wasn’t about the different labeling. "It’s about the charging more."

The proposed class-action would include anyone who purchased Excedrin Migraine at a higher price than Excedrin Extra Strength on or after Aug. 1, 2005, essentially when Novartis took over the brand from Bristol-Myers Squibb. Muhlstock alleged that Bristol-Myers had sold the two medicines at identical prices.

The complaint listed the proposed class as more than 100 people and damages at more than $5 million.

Muhlstock and another attorney on the case, Eric Gibbs of San Francisco, have filed identical suits in New York and California, and now have 48 plaintiffs. Muhlstock said he estimates a potential pool of 250,000, given Excedrin’s popularity. Novartis sells more than 1 billion Excedrin pills a year, according to Muhlstock’s estimates.

Novartis does not disclose sales for individual over-the-counter products, Masow said. But Excedrin Migraine remains a widely popular and by far the most-recommended migraine headache medicine by pharmacists, according to a recent survey by Pharmacy Times and U.S. News and World Report.

A similar class-action lawsuit was filed in state court against the chemical company, BASF, contending it had violated New Jersey consumer fraud law.

That case involved a group of farmers from Minnesota and other states who alleged BASF, whose North American headquarters is in Florham Park, deceptively marketed and sold two herbicides for different uses and prices, although they contained the same ingredients. In that 1997 filing, a jury awarded the plaintiffs $15 million, which was affirmed on appeal.

"On that case, the argument was when the company went to the regulators, they didn’t tell them it was the same product," said Prentiss Cox, an associate professor at the University of Minnesota Law School, who saw strong parallels to the Novartis suit.

"So you had a scheme to create two different products out of one product, to make more money," said Cox, who was head of consumer protection division at the Minnesota Attorney General’s Office during the BASF suit, and filed an accompanying brief on the case. "But if it’s the exact same thing and you convinced the regulators that you need two different labels without telling them it was the exact same thing, that’s deceptive."

Muhlstock, a New York-based attorney, said that’s exactly what he alleges Novartis did.

"Part of the implication is that Excedrin is targeted for migraines and that somehow, it’s going to relieve the migraine better, quicker or differently than the Extra Strength," he said.

That’s an alluring promise, he said, when "someone is at the mercy of a migraine and you can’t balance, you can’t have any light, and you’ll do anything to get relief."
 


















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