Friday, March 07, 2014
A steep rise in the number of patients who do not respond to antibiotic treatment risks causing a “national health threat”, NHS officials have warned.
Experts say the explosion in the use of antibiotics in the Western world to treat common ailments could become a “catastrophic threat” because increasingly bacteria have become resistant to the drugs, so they do not work when they are really needed.
Officials said the scale of such infections had become a matter of “national concern” with 600 cases reported last year, compared with just five in 2006.
Dame Sally Davies, the chief medical officer for England has previously warned that the threat hanging over the country is equal to that of terrorism.
On Thursday she called for urgent action to reduce the number of antibiotics being prescribed, and improve hygiene in hospitals to prevent the spread of resistant bacteria.
Figures from Public Health England have documented the rise in a group of infections called carbapenemase-producing Enterobacteriaceae (CPE) — which are resistant even to antibiotics that are normally given as a “last resort” because nothing else works.
Patients in this situation still sometimes respond to other drugs, but it can be difficult to find the right treatment in time.
Experts said that the situation was particularly worrying in London and in Manchester, where two NHS trusts, Central Manchester Foundation Trust and University Hospitals South Manchester have each reported at least 100 cases in the past five years.
The report says medical staff need to be trained so they are more aware of the risks of prescribing unnecessary antibiotics, and to improve hygiene to ensure cases of CPE did not spread.
It also says that staff need to be alert to the increased risk of infection from patients from high-risk overseas countries, which include Bangladesh, China, Cyprus, Greece, India, Italy, Malta, Pakistan, Taiwan, Turkey, the United States and all countries in North Africa and the Middle East.
Dr Paul Cosford, PHE’s medical director said: “We need to act swiftly to avoid getting into the situation which has been seen in some other countries, such as Greece, Israel and the United States, where there is significant resistance. “These infections are already causing national concern due to the observed increasing trends in the number of infections, outbreaks and clusters across England.
“We now have a window of opportunity, if we act quickly and decisively, to address this very real public health threat and prevent widespread problems by minimising the negative impact of these organisms.”
He said that, while many countries with such problems were tackling them effectively, Greece was among several where the problem was “out of control”.
Dame Sally said: “Antibiotic resistance poses a real threat to our ability to treat diseases.
“Although there has been an increase in this strain of bacteria, the new toolkit will ensure that hospitals are well placed to detect, manage and control any cases.
“Systems of monitoring for resistant bacteria are essential in safeguarding the effect of our antibiotics.”
She said many of the drugs were being used unnecessarily for mild illnesses that should not be treated with antibiotics — helping to create resistance.
Wednesday, March 05, 2014
"The two companies made an illegal agreement to hamper the spread of the use of a very cheap pharmaceutical, (Roche's) Avastin, in the treatment of the most widespread eye pathology among the elderly and other serious eye diseases, to favour a much more expensive product, (Novartis's) Lucentis, artificially differentiating the two products," read an Antitrust statement. It added that this had cost the Italian national health service over 45 million euros in 2012 alone and that the additional costs in the future could potentially reach 600 million euros a year.
Tuesday, March 04, 2014
Some of the nation’s largest pharmaceutical companies have slashed payments to health professionals for promotional speeches amid heightened public scrutiny of such spending, a new ProPublica analysis shows.
Eli Lilly and Co.’s payments to speakers dropped by 55 percent, from $47.9 million in 2011 to $21.6 million in 2012.
Pfizer’s speaking payments fell 62 percent over the same period, from nearly $22 million to $8.3 million.
And Novartis, the largest U.S. drug maker as measured by 2012 sales, spent 40 percent less on speakers that year than it did between October 2010 and September 2011, reducing payments from $24.8 million to $14.8 million.
The sharp declines coincide with increased attention from regulators, academic institutions and the public to pharmaceutical company marketing practices. A number of companies have settled federal whistleblower lawsuits in recent years that accused them of improperly marketing their drugs.
In addition, the Physician Payment Sunshine Act, a part of the 2010 health reform law, will soon require all pharmaceutical and medical device companies to publicly report payments to physicians. The first disclosures required under the act are expected in September and will cover the period of August to December 2013.
Within the industry, some companies are reevaluating the role of physician speakers in their marketing repertoire. GlaxoSmithKline announced in December that it would stop paying doctors to speak on behalf of its drugs. Its speaking tab plummeted from $24 million in 2011 to $9.3 million in 2012.
Not all companies have cut speaker payments: Johnson and Johnson increased such spending by 17 percent from 2011 to 2012; AstraZeneca’s payments stayed about flat in 2012 after a steep decline the previous year.
ProPublica has been tracking publicly reported payments by drug companies since 2010 as part of its Dollars for Docs project. Users can search for their doctors to see if they have received compensation from the 15 companies that make such information available online. (We’ve just updated our application to include payments made through the end of 2012, totaling $2.5 billion. Forest Labs, which only began reporting in 2012, reported speaking payments of $40 million, more than any other company in Dollars for Docs.)
Some companies in the database said their declines have less to do with the Sunshine Act and more to do with the loss of patent protection for key products. Lilly, for example, began facing generic competition to its blockbuster antipsychotic Zyprexa in late 2011. Its antidepressant Cymbalta lost its patent at the end of 2013.
“The value of educational programs tends to be higher when we’re launching a new medicine or we have new clinical data/new indication,” Lilly spokesman J. Scott MacGregor said in an email, adding that the drop in speaking payments also reflects the increased use of web conferencing.
Pfizer’s patent on Lipitor, its top-selling cholesterol drug, expired in 2011.
“Like any other company, our business practices must adapt to the changing nature of our product portfolio, based in part on products going off patent and new products being introduced into the market,” company spokesman Dean Mastrojohn said in an email.
Novartis’ patent for its breast cancer drug Femara expired in 2011, its hypertension drug Diovan in 2012 and its cancer drug Zometa in 2013. In a statement, Novartis said that speaking payments dropped in 2012, in part, because of a shift from big blockbuster drugs that many doctors prescribe toward specialty products prescribed by fewer physicians. Resources were also shifted “to support potential future product launches.”
The industry’s increased emphasis on expensive specialty medications for such conditions as multiple sclerosis or Hepatitis C, has been striking, said Aaron Kesselheim, an assistant professor of medicine at Harvard Medical School. A piece in the New England Journal of Medicine last week noted that half of the 139 drugsapproved by the Food and Drug Administration since 2009 were for rare diseases and cancers.
“It’s possible the number of physicians they need to support sales of these items is less, leading to lower payments overall,” Kesselheim said.
In some cases, companies maintained or made smaller cuts to other forms of physician compensation while pulling back dramatically on speaking payments. Pfizer’s spending on consultants dropped 9 percent from 2011 to 2012, far less than its payments to speakers. The company’s spending on research stayed essentially the same.
Lilly increased spending on physician researchers by more than 20 percent, while reducing payments to consultants by more than two-thirds.
Many bioethicists and leaders of major academic medical centers frown upon physicians delivering promotional talks for drug companies, saying they turn doctors into sales representatives rather than leaders in research and patient care.
Officials with the Pharmaceutical Research and Manufacturers of America, the industry trade group, dispute this characterization. They said they are working with their member companies to prepare for the Sunshine Act and have created a campaign to promote the value of drug company-doctor collaborations.
“Companies will make their own independent decisions about how to engage professionals,” said Kendra Martello, PhRMA’s deputy vice president of strategic operations.
Scott Liebman, an attorney who advises pharmaceutical companies on the Sunshine Act, said it’s too early to know how much the law’s requirements are affecting company practices, in part because it’s so new. The fact that some companies are cutting back on speaking while preserving their spending on research and consulting suggests that other business forces could be at play, he added.
“It’s very hard to pinpoint exactly why that’s happening,” Liebman said. “I think there’s a lot of potential answers to that. I just don’t know which is the right one.”
Half of all trials registered on a US clinical study database are not being published in public journals.
Monday, March 03, 2014
“We deeply regret and apologize for the fact that our promotional activities were partially inappropriate,” - Takeda CEO
Yasuchika Hasegawa, Takeda Pharmaceutical Co. president, recently announced in a news conference in Tokyo that the firm used what he described as “inappropriate expressions” in the way in which it promoted one of its drugs used in the treatment of high blood pressure, according to a The Wall Street Journal report. Mr. Hasegawa also said that while “inappropriate expressions” were used, his company did not alter with research data.
The drug maker’s public admission came after a Japanese health ministry announcement was made indicating that it would be investigating questions that had been asked by a doctor in Japan who said that a graph used in the drug’s marketing did not seem to accurately reflect clinical study results, The Journal reported.
“We deeply regret and apologize for the fact that our promotional activities were partially inappropriate,” Takeda CEO Yasuchika Hasegawa said at the news conference. “Our company hasn’t manipulated or fabricated clinical research data,” he added, according to The Journal.
The issue involves a clinical trial that was conducted from 2001 to 2006 that compared the effects of two hypertension medications: Takeda’s Blopress (candesartan) and a drug manufactured by Pfizer Inc., Norvasc (amlodipine). The news conference was called rather quickly following questions that Takeda Pharmaceuticals appeared to be marketing Blopress as providing increased efficacy over Norvasc, despite that the clinical trial result did not reveal a difference between the two drugs, according to The Journal report.
Takeda officials stated that they used a graph presented during a 2006 academic conference and not the graph that included clinical trial results that had been published in the February 2008 issue of the United States medical journal, Hypertension, according to The Journal. The 2008 graph considered account differences in curves that were used to express the drugs’ effects.
Takeda also admitted that it used verbal expressions in the way in which its advertising could lead to potential misunderstandings regarding Takeda’s drug’s efficacy and as Takeda’s drug being more efficacious when compared to the Pfizer medication, The Journal wrote.
Mr. Hasegawa stated that Takeda Pharmaceuticals had no access to research data; however, the drug maker intends on putting a third-party panel into place to understand why the firm’s marketing was conducted improperly, according to The Journal.
Takeda has been involved in litigation involving its Type II diabetes drug, Actos, over allegations that Takeda hid risks concerning bladder cancer from physicians and patients. Litigation also involves accusations that, because Takeda concealed these risks, consumers were not appropriately warned and continued to take the drug.
Various studies have tied the use of Actos to increased risks of developing bladder cancer at least as far back as 2011.
Sunday, March 02, 2014
Lundbeck Limited, A Menarini Pharma, Bayer plc, HRA Pharma UK and GlaxoSmithKline breach the ABPI Code of Practice
Lundbeck Limited, A Menarini Pharma, Bayer plc, HRA Pharma UK and GlaxoSmithKline have each breached Clause 2 of the ABPI Code of Practice and are the subject of advertisements in the medical, pharmaceutical and nursing press.
Lundbeck – Case AUTH/2617/7/13
A Menarini – Case AUTH/2629/8/13
Bayer plc – Case AUTH/2631/8/13
For each sponsoring one or two speakers and paying for exhibition space at a meeting which was not primarily for educational purposes and the impression given by their involvement, each company was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 9.1 - Failing to maintain high standards
Clause 19.1 - Failing to meet the requirements for meetings.
HRA Pharma UK – Case AUTH/2624/8/13
As a result of emails sent by a representative to a health professional regarding the provision of an emergency contraception service and the use of ellaOne (ulipristal acetate), HRA Pharma was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 7.2 - Making a misleading claim
Clause 7.10 - Making an exaggerated claim
Clause 8.2 - Disparaging a service provision
Clause 9.1 - Failing to maintain high standards
Clause 15.2 - Failing to maintain a high standard of ethical conduct.
GlaxoSmithKline – Case AUTH/2649/10/13
As a result of a voluntary admission that it had not formally certified materials relating to a joint working project with the NHS until some months after the project had started, GlaxoSmithKline was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 9.1 - Failing to maintain high standards
Clause 14.3 - Failing to certify joint working materials before use.
Thursday, February 27, 2014
Wednesday, February 26, 2014
Novartis will cease all operations at its Horsham site later this year it was confirmed today (Wednesday February 26).
The pharmaceutical giant announced in November 2013 that it was consulting on the closure of the site, off Parsonage Road, with nearly 400 jobs at risk.
Following that announcement Novartis, which is one of the largest employers in the town, said today it expected research operations to cease by the end of June.
A spokesperson for Novartis said: “Following the announcement we made in November 2013 about the possible future of the R&D site in Horsham, we can now confirm that we will closing the site later this year. We expect research operations at the site to cease by the end of June.
“This is a result of a global review of our R&D locations and where best to co-locate research teams to support collaboration. It is part of the company’s ongoing efforts to align resources to serve patients and customers better in a challenging healthcare marketplace.
“This will be difficult news for our employees, and supplier partners, based at the site and we will work closely with everyone over the next few months to provide them with suitable support.
“Associates impacted by these changes have been engaged in a full and committed group consultation process. Novartis has provided support to associates throughout this process and will continue to do so during the individual consultations which will now take place.
“We do not yet know the future of the site but are committed to exploring a range of options, working closely with our partners to identify potential new owners. These options could include the use of part of the site for a science or business park.
“This news does not affect the rest of Novartis current UK business in developing, manufacturing and marketing prescription and over the counter medicines, vaccines and eye care products for patients who need them, as well as animal health products.
“Novartis will continue to employ over 2500 people and be a major inward investor to the UK. We will retain an extensive footprint in the UK with manufacturing sites at Grimsby (Chemical Operations), Liverpool (Vaccines) and Dundee (Animal Health), commercial offices in Surrey, and a team at Sittingbourne, Kent, developing near patient diagnostic testing products.”
Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show.
Boehringer gave U.S. regulators one analysis of data gathered after the drug’s October 2010 approval that showed the number of people who died from bleeding was less than expected, according to internal documents made public in lawsuits over the product. The company didn’t share a second analysis showing a higher death rate, the documents show.
The Food and Drug Administration was reviewing the bleeding as part of a safety check spurred by results seen in adverse incident reports sent to the agency. Andreas Clemens, an executive who oversees Pradaxa, acknowledged the Ingelheim, Germany-based company shared only one of the analyses and said he couldn’t say why, according to the unsealed court filings.
“Having run an analysis in several ways, there is no good reason not to disclose all the results,” said Harlan Krumholz, a Yale University cardiologist in New Haven,Connecticut, who is leading an effort to get companies and researchers to share their findings fully.
Boehringer gave the FDA the underlying data and provided an analysis using what the drugmaker considered to be the most appropriate comparison, said Marjorie Moeling, a company spokeswoman, in an e-mailed response to questions. “The company is completely confident that all of the facts will show that Boehringer Ingelheim acted appropriately and responsibly.”
A company filing this month said Boehringer faces more than 2,000 suits involving Pradaxa, a treatment used to prevent strokes in patients who suffer from atrial fibrillation, a heart-rhythm disorder. Regulators cleared the drug, which generated $1.4 billion in 2012 sales, as the first alternative to warfarin, a product sold by Bristol-Myers Squibb Co. under the brand name Coumadin that’s been used for 50 years to avert strokes caused by blood clots.
Patient lawsuits contend Boehringer knew the drug posed a deadly risk when it won FDA approval. While warfarin offers a way to counteract excessive bleeding, there’s no approved antidote available yet for those on Pradaxa. In November, the company released data from the first human study of an antidote in 145 healthy volunteers.
Boehringer’s decision to provide only one analysis on Pradaxa’s use after the drug’s approval may complicate the company’s defense as it prepares to face the first trial of claims that it hid the medication’s health risks.
“It is important to resist selective presentation of results, especially when the finding depends on which analysis is done,” said Krumholz, who isn’t involved in any of the Pradaxa lawsuits, by telephone. “The fact that different analyses of the same data can yield different conclusions makes it imperative that we promote an opportunity for independent analyses through data sharing so that these issues will be out in the open.”
In the Pradaxa case, the regulators asked Boehringer to compare fatal bleeding reports received by the FDA against the number of patients using the drug in order to establish a death rate. The request was made to allow the FDA to “evaluate the need for modifications to the Pradaxa label or future study,” according to a letter made public as part of the court files.
The company reported back that 6.1 of every 10,000 patients who used the drug after approval developed fatal bleeding, the court documents showed. The regulators also asked Boehringer to reanalyze results from an earlier study used to gain approval to see how that rate compared.
That effort produced two separate analyses by the company, according to the unsealed court documents. One, looking only at people whose primary cause of death was bleeding, found 5.8 of 10,000 patients died per year. The other, which included anyone who had a major bleeding event and died for any reason, found a rate of 19.5 fatal events per 10,000 patients per year, the documents show.
The report sent to the FDA, though, contained only the analysis indicating the death rate from the earlier research was much higher than the numbers seen after approval, according to the court filings. Potentially, such a finding could head off any after-market action by the FDA because the data showed the drug was safer after it was approved and widely used.
Boehringer’s Clemens, mentioned in the e-mails including in the court documents as one of the executives who decided what information to give the FDA, said it would have been possible to provide both numbers.
He said that Boehringer’s decision to withhold the analysis showing the lower bleeding rate in the pre-approval research may have been driven by concerns about the “quality of this number,” according to the filings.
Moeling, the Boehringer spokeswoman, said the 5.8 per 10,000 number wasn’t an appropriate comparison because it reflected a limited number of cases where doctors determined the bleed was the primary cause of death. Because reports to the FDA aren’t always complete, the company wasn’t able to identify the same specific subgroup after the drug’s approval, she said.
The FDA, meanwhile, hasn’t identified any unrecognized risk factors for bleeding with Pradaxa, said Sandy Walsh, an agency spokeswoman, in an e-mail. The FDA, though, is continuing to evaluate “multiple sources of data in an ongoing safety review,” according to Walsh, who declined to comment on the pending litigation.
Selective disclosure of Pradaxa information may have camouflaged a serious safety signal, according to an assessment report from European Medicines Agency’s Committee for Medicinal Products for Human Use in August 2012. That agency is the European Union’s drug regulator, equivalent of the U.S. FDA.
“If the reporting rate in the post-marketing phase had been higher than in” Boehringer’s study, “there would clearly have been a safety concern,” agency officials wrote. European drug regulators have Pradaxa under review and American regulators are planning another assessment of the drug’s safety as part of its program to monitor FDA-regulated products.
Boehringer’s conduct regarding Pradaxa may also have a negative impact on future requests for regulatory approvals, said Erik Gordon, a University of Michiganbusiness and law professor who teaches classes about how drugs are developed and regulated in the U.S.
“These are the kinds of drug-company actions that can drive a stake through the heart of an FDA approval process that is based on the idea that companies will be forthright with the data about their products,” Gordon said.
If drugmakers are allowed to continue to select the safety information they share with regulators, consumers can’t be sure the disclosures aren’t being driven by financial concerns, Gordon said in a telephone interview.
This case “should raise some eyebrows,” he said.
Pradaxa suits filed against Boehringer in federal courts across the country have been consolidated for pretrial information exchanges before U.S. District Judge David Herndon in East St. Louis, Illinois. Other cases have been filed in state courts in Delaware, California, Illinois and Connecticut.
Herndon set the first case for trial among the consolidated federal suits for August, according to court dockets. He also ordered Boehringer to pay almost $1 million in fines for withholding or failing to preserve files about the drug’s development and marketing.
The case is In re Pradaxa Products Liability Litigation, 12-MD-02385, U.S. District Court, Southern District of Illinois (East St. Louis).
Tuesday, February 25, 2014
WASHINGTON - February 25 - Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S.
The urgent petition is based on growing evidence of the risks of heart attacks and other cardiovascular dangers from many individual randomized studies going back as far as 2010 and a recently published overall analysis (meta-analysis) of 27 studies going back as far as 20 years. Although 13 of these studies, funded by the drug industry, collectively showed no increased risk, the 14 studies not funded by the industry collectively showed a highly significant increased cardiovascular risk.
More than five million U.S. prescriptions for testosterone products were filled in 2013. The most common of those, making up more than 90 percent of the testosterone prescriptions filled in 2013, include Androgel, Axiron, Testim and Fortesta.
The petition also was prompted by the most recent study, involving the experience of 55,000 men before and after starting testosterone. The risk of heart attacks among men 65 and older during the first three months of using the drug was twice the risk seen in the year before use. Further, the study found, for the first time, a 2.9-fold increase in heart attack risk among men under 65 with a history of heart disease who took testosterone.
The FDA-approved labeling for testosterone-containing products does not mention testosterone-induced cardiovascular risk.
Despite all of these studies, the FDA stated on Jan. 31 that it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”
“In the face of this accumulating evidence, this statement is reckless and is a betrayal of the FDA’s role as an agency in the U.S. Public Health Service,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.”
Although the FDA agrees that testosterone is “only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition,” the hyped-up nature of the low-T[estosterone] advertising campaigns, not adequately regulated by the FDA, assures that many men in the U.S. prescribed testosterone do not meet the FDA-specified criteria of both low testosterone levels and an associated medical condition due to hypogonadism. Evidence can be seen in the recent finding that almost 25 percent of men prescribed testosterone in this country had not previously had a blood test to even determine if their testosterone level was low.
“Unless the FDA immediately begins to provide strong, adequate black-boxed warnings about the risks of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks, many in people who are not even candidates for testosterone, will continue,” Wolfe said. “At the present rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country. Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks.”
In addition, the petition urges the FDA to delay its decision date on approving a new long-acting injectable testosterone product Aveed (testosterone undecanoate, Endo), now set for Feb. 28, because its approval, absent the new black box warning, would cause further cardiovascular damage to new users.
The petition is available at http://www.citizen.org/hrg2184.
Monday, February 24, 2014
The Malvern, Pa., drugmaker will pay $171.9 million in civil false claims settlements largely to the federal government, with $34.2 million from that total going to 47 states and the District of Columbia. Endo also agreed to pay $20.8 million as part of a deferred prosecution agreement.
Federal prosecutors said Friday that Endo Health Solutions Inc. marketed the drug for unapproved uses between 2002 and 2006.
Endo said it was pleased to resolve the issue, and it has programs in place to help it comply with the agreements. The drugmaker had already set aside $194 million to cover settlement costs.
By Jonathan Stempel
(Reuters) - CareFusion Corp agreed to pay $40.1 million to settle a federal government lawsuit accusing it of paying kickbacks to boost sales of a pre-surgical skin treatment, and marketing the product for unapproved uses.
The accord announced on Thursday by the U.S. Department of Justice resolves allegations that CareFusion violated the federal False Claims Act by paying $11.6 million to a doctor to promote its ChloraPrep product to healthcare providers.
That doctor, Charles Denham, received the kickbacks while serving as co-chair of the safe practices committee of the nonprofit National Quality Forum, which makes recommendations on healthcare practices, the Justice Department said.
"Corrupting the standard-setting process through kickbacks can affect the healthcare treatment choices that doctors and hospitals may make for patients," Stuart Delery, assistant attorney general for the Justice Department's civil division, said in a statement.
The lawsuit also claimed that CareFusion promoted ChloraPrep from September 2009 through August 2011 for unapproved uses.
The U.S. Food and Drug Administration had approved ChloraPrep to prepare patients' skin for surgery or injections.
CareFusion said on Thursday that it set aside funds for the settlement in the first quarter of 2013.
Chief Executive Officer Kieran Gallahue said the San Diego-based company is pleased to settle, and has made "significant investments" to improve its quality and compliance practices, including in sales and marketing.
Denham could not immediately be reached for comment.
The accord resolved a whistleblower lawsuit first brought in September 2010 by Cynthia Kirk, a former vice president of regulatory affairs at a CareFusion infection prevention unit.
She will receive $3.26 million through the settlement, which along with the lawsuit was unsealed this week by the federal court in Kansas City, Kansas.
In afternoon trading, CareFusion shares were up 81 cents at $41.12.
The case is U.S. ex rel. Kirk v. CareFusion Corp et al, U.S. District Court, District of Kansas, No. 10-02492.
(Editing by Jan Paschal)
Sunday, February 23, 2014
Last month, the Japanese Health Ministry filed a complaint against Switzerland-based drugmaker Novartis AG’s (NYSE:NVS) Japan unit after the company used allegedly false data to advertise for its best-selling blood pressure drug, Diovan, theWall Street Journal reports.
Reuters reports that prosecutors in Tokyo broke into the company’s offices in Japan on Wednesday as part of a criminal investigation of the company following charges that the drugmaker violated the law by releasing misleading advertisements.
The advertisements in question cited research which the Japanese Health Ministry says were manipulated to support the company’s claims regarding Diovan’s benefits; the studies were originally conducted by researchers at Japanese universities and were later found to have been falsified, possibly by a Novartis employee who participated in all of the studies without ever acknowledging his affiliation with company.
A spokesperson for Novartis’ Japanese unit declined to comment, although Novartis has said in a statement that it will “cooperate fully with the prosecutors’ investigation,” according to Reuters.