Friday, May 11, 2012

TGIF: Hepatitis Weekly Rewind-Todays HCV News And Research

Good morning folks,
Grab a cup of coffee and catch up on all the HCV headlines and latest research for the week of May 7th, including updates as the day progresses. Click here to view previous or future"HCV Weekly Rewind" articles.

Top Articles Of The Week

May 10th
Hepatitis C Canada-Cancer screening
Audio - Minimal hepatic encephalopathy
Risk of Myocardial Infarction Associated With Chronic Hepatitis C Virus Infection*
Emerging and Re-emerging Infectious Diseases:Hepatitis C

May 9th
Achillion Pan-Genotypic ACH-3102 begins dosing in a Phase 1 clinical trial
New Tests Predict Clinical Outcomes in Chronic Hepatitis C Virus
New Drugs Require New Terms for HCV Virologic Response

May 7th
Bristol-Myers Missing Hep C Data Raises Red Flags, May Boost Gilead, Idenix
Intensive Follow-up Reduces Mortality from Hepatocellular Cancer
Boceprevir in Chronic Hepatitis C Infection
Clinical Trial-Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients
Scarring Cells Revert To Inactive State As Liver Heals
Hepatitis C Therapy Update-Where Are We Now?

In The News

Guest Commentary: Baby boomers and hepatitis C in Colorado
Posted: 05/11/2012 01:00:00 AM MDT
By Nancy Steinfurth

Colorado's "baby boom" generation faces a ticking health care time bomb — and employers have the opportunity this year to help protect the health of their workers and potentially cut their company's health care costs at the same time.

The challenge that employers and baby boom employees alike face is that many Americans born between 1946 and 1964 have the hepatitis C virus (HCV) and don't know it. A quick blood test and a fast diagnosis results in a far more rapid and less expensive course of treatment. These proactive steps not only save lives but in turn help reduce costs and throw a lasso on soaring insurance premiums.

If it were as simple as all that, we know companies would be clamoring to raise workers' awareness. Unfortunately, myth and misinformation about HCV have left millions of Americans blissfully unaware that a serious and life-threatening disease may be brewing inside them — and by the time symptoms are noticeable, it can often be too late.

That's why exploding the myths surrounding HCV are so critical and having the imprimatur of company leaders in businesses large and small in this fight can make a massive difference.

Let's tackle the biggest myth head on. A number of baby boomers go untested because they assume that the only way to have contracted hep C is through intravenous drug use. Wrong. Many Americans — including many veterans — who had transfusions or blood products prior to 1992 were infected with HCV before donated blood was accurately and adequately screened for the disease. Other risk factors include tattooing in unsafe settings and having been on long-term dialysis.

These myths have consequences. Statistics show that more two-thirds of Americans with HCV are baby boomers and 75 percent of those with the disease are living their lives unaware.

Ignorance is not bliss.

Hepatitis C is a contagious liver disease prevalent — and widely undiagnosed — among baby boomers, with experts estimating that two-thirds of those with hep c were born in the baby boom years of 1946 to 1964. In raw numbers, of the 102 million Americans age48 to 66, an estimated 1.3 million are infected with hepatitis C virus but remain undiagnosed. Hepatitis C ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with the hepatitis C virus, which is spread through contact with the blood of an infected person.

The facts are that symptoms of hep C may not appear for 20 years or more and the later that the disease is diagnosed, the more difficult — and expensive — it is to treat.

That's why a federal strategy released in recent days recommends placing a priority on screening Americans by age, moving beyond the less effective method of screening by so-called "risk group." A new national study showed that screening all American baby boomers could save 48,000 lives.

Instead of allowing this status quo to continue, common-sense tells us to focus on the age group that faces the most dire challenges. That's the message we at Hep C Connection, a statewide organization that educates the general public about hepatitis C and provides resources and support for those affected by the virus, are sharing with employers throughout Colorado.

By focusing on this critical age group in every workplace, employers could literally save lives. Studies show that by raising awareness, employers could help ten times more baby boomers to get tested and three times as many men and women being diagnosed and getting early treatment.

At Hep C Connection, we provide free testing in the metro-Denver area and we connect patients with testing locations in other parts of Colorado which, in most cases, provide the screening free of charge.

The prevention of serious, life-threatening conditions as a result of the early screening is huge with, for example, an estimated 28,000 prevented cases of liver cancer and 6,000 liver transplants being avoided.

In addition to the benefit to lives saved and diseases prevented, the cost of treating these and other serious conditions is very high. For employers, this means the savings of billions of dollars in employee health care costs — and health insurance premiums — going forward.

That is perhaps the most important, common-sense reason for business owners and executives to raise awareness among their baby boomer employees. But there is a bottom-line, dollars-and-sense reason as well. National studies show that age-based testing would save billions of dollars, including more than $4 billion in savings from the prevention of advanced live disease.

Coloradans living longer lives and employers lowering health care costs. By sounding the hep C alarm to baby boomers across our state, businesses can do well by doing good.

Nancy Steinfurth is excutive director of Hep C Connection, a statewide organization that educates the general public about hepatitis C and provides resources and support for those affected by the virus. .
EDITOR'S NOTE: This is an online-only column and has not been edited.
Source: The Denver Post

Man pleads guilty in Hepatitis C case
JACKSONVILLE — A former Jacksonville radiology technician has pleaded guilty in federal court to stealing syringes of painkillers during patients' procedures and replacing them with syringes of saline contaminated with Hepatitis C.

The U.S. Attorney's office said Friday that 48-year-old Steven Beumel tampered with the syringes from 2006 through 2008 while working at the Mayo Clinic branch in Jacksonville.
Epidemiologists from the hospital and public health agencies worked for more than three years to solve the Hepatitis C outbreak and it was eventually linked to Beumel. He was fired and clinic authorities reported him to police.

The clinic tested thousands of patients who were potentially at risk. Two patients from that testing effort were linked to Beumel and one died.

May is a Special Month
All during the month of May, the American Liver Foundation will be promoting Hepatitis awareness through our "Did You Know…" series of facts about the disease.
Read more…

Thomas Jefferson University Hospital Creates Comprehensive Hepatitis C Center
May 11, 2012
Thomas Jefferson University Hospital recently opened its new Jefferson Hepatitis C Center, one of only a few comprehensive, multidisciplinary centers dedicated to the study of hepatitis C virus and hepatic disease in the Pennsylvania, New Jersey and Delaware tri-state area.

According to the Centers for Disease Control and Prevention (CDC), 3.2 million Americans are infected with chronic hepatitis C – a virus that affects the liver...News & World Report among the nation's top hospitals. It has over 950 licensed acute care beds with major programs in a wide range of clinical specialties. Jefferson Hospital, Jefferson Hospital for Neuroscience, and Methodist Hospital in South Philadelphia. Jefferson Health System and a partner of Thomas Jefferson University.
For the original version on PRWeb visit:

Charges stand in hep C case against former doctor
LAS VEGAS — A prominent former Las Vegas physician and state medical board member who operated clinics where health officials say patients became infected with hepatitis C in 2007 will face all 28 felony charges filed against him almost two years ago, a state court judge decided Thursday.

Having lost a nearly two-year battle to show he is physically and mentally unfit for trial, Dipak Desai sat impassively in the courtroom while Clark County District Court Judge Valerie Adair ruled the grand jury indictment met statutory and constitutional requirements.

Adair conceded the charges could have been clearer. But she rejected defense attorney Richard Wright's argument that the 35-page indictment returned in June 2010 was unconstitutionally vague and confusing. Trial is scheduled in October.

Prosecutors allege that Desai directed a penny-pinching scheme at his Endoscopy Center of Southern Nevada and Desert Shadow Endoscopy Center that included requiring staff to use anesthesia that remained in previously opened vials and to reuse colonoscopy scopes and bite plates from patient to patient during outpatient procedures.

Southern Nevada Health District officials in February 2008 began notifying more than 50,000 Desai patients to be tested for hepatitis and HIV. Authorities later determined that nine people contracted incurable hepatitis C, and said cases involving another 105 patients might have been related.

"It's clear what they are charging," the judge said Thursday. "They're charging that these people were infected as a result of their treatment at the facility and as a result of the facility's ongoing failure and disregard for appropriate medical and sanitary practices."

Wright derided the charging language as "prosecution by multiple guess or mystery." He accused prosecutors of alleging that hepatitis was transmitted "by methods unknown."

The defense lawyer sought dismissal of 15 counts in the indictment, including a key racketeering charge and seven felony charges each of criminal patient neglect and disregard for patient safety.

Wright said allegations of a pattern and practice of business amounting to felony racketeering didn't provide enough specificity for Desai and two former clinic nurse-anesthetists, Ronald Lakeman and Keith Mathahs, to mount defenses.

The three men are also charged with insurance fraud, theft and obtaining money under false pretenses. Each has pleaded not guilty.

"Principal? Aider and abettor? Conspirator? Which is he?" Wright asked. "This is not specific enough to determine what Desai is accused of doing on what date to what patient."

Prosecutor Michael Staudaher countered that Desai was "the one who was running the show."

"His specific role in these crimes overlaps. He is all of those things," Staudaher said.

Staudaher and prosecutor Pamela Weckerly have turned back months of effort by Wright to have Desai declared mentally and physically unfit for trial due the effects of strokes in 2007 and 2008.

Attorneys Michael Cristalli and Frederick Santacroce, representing Lakeman and Mathas, watched Thursday's arguments but didn't take part. Desai's wife, Kusum Desai, sat in the courtroom gallery.
Source: CBS News

Big Pharma

Ahead of the Bell: Gilead 'Quad' pill faces review
Gilead Sciences Inc. received a positive endorsement Thursday from a panel of FDA advisors for one of its HIV treatments and will likely receive another good review Friday, according to analysts.

A Food and Drug Administration panel recommended approval of the daily pill Truvada for use in preventing HIV infection. The recommendation is for healthy people who are at high risk of contracting HIV. The FDA, which usually follows the panel's advice, is expected to make a final decision next month.

Gilead, based in Foster City, Calif., has marketed the drug since 2004 as a treatment for people already infected with the virus that causes AIDS. Doctors usually prescribe it as part of a drug cocktail to repress the virus.

Because Truvada is already on the market for this, some doctors also prescribe it as a preventive measure. FDA approval would allow Gilead Sciences to formally market its drug for that use.

On Friday, an FDA advisory panel will review the effectiveness and safety of Gilead's "Quad" pill, an HIV and AIDS treatment that combines four different medications. Analysts have said this potential drug is key to Gilead extending the line of treatments it has for HIV.

Safety questions for the panel's review will focus on potential kidney issues, but Stifel Nicolaus analyst Joel Sendek said in a research note he doesn't anticipate any significant concerns. He wrote that data from two late-stage clinical studies overwhelmingly supports approval.

An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body's immune system to breakdown, leading to infections which are eventually fatal.
Gilead shares rose $1.47, or 2.9 percent, to $52.75 in premarket trading Friday.
Source: CBS News

Inside The Secret World Of Drug Company Rebates
Matthew Herper, Forbes Staff
The free market is alive and well when it comes to drug prices – if you’re an insurance company or a government program. But not if you’re a consumer.
Top-selling pharmaceuticals, protected by patents, often seem priced in a manner that has little to do with the laws of supply and demand. Want that new cholesterol medicine ($2,000 per year), that cancer treatment ($60,000 per year) , or the medicine for your child’s rare disease ($300,000 per year)? No negotiation. It’s your money or your life.
Continue Reading @ Forbes

Healthy You

New Cautions About Long-Term Use of Bone Drugs
May 9, 2012, 6:32 pm
In an unusual move that may prompt millions of women to rethink their use of popular bone-building drugs, the Food and Drug Administration published an analysis that suggested caution about long-term use of the drugs, but fell short of issuing specific recommendations.
The F.D.A. review, published in The New England Journal of Medicine online on Wednesday, was prompted by a growing debate over how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva, as well as Novartis’s Reclast.
Continue Reading @ The New York Times

Caffeine consumption: How much is too much?
Chocolate, coffee and cola are perhaps three of your favourite consumables; however, they are also three caffeine-rich substances which all contribute to your daily caffeine consumption.
Continue Reading........

Fatty Acids in Fish May Lower Liver Cancer Risk
By: MARY ANN MOON, Oncology Report Digital Network
May 11-2012
The consumption of fish rich in n-3 polyunsaturated fatty acids was inversely related to the risk of developing hepatocellular carcinoma in a population-based study of Japanese adults, Dr. Norie Sawada and colleagues reported in the June issue of Gastroenterology.

In addition, higher intake of several individual n-3 polyunsaturated fatty acids (PUFAs) – particularly eicosapentaenoic acid, docosapentaenoic acid, and docosahexaenoic acid – also correlated with lower hepatocellular carcinoma (HCC) risk.

The associations were dose dependent for intake of n-3 PUFA-rich fish and for intake of individual fatty acids, said Dr. Sawada of the National Cancer Center, Tokyo, and associates.

Dietary n-3 PUFAs, also called omega-3 PUFAs, have long been thought to lower the risk of developing several cancers, but few studies have examined a potential protective effect against liver cancer in particular. One recent prospective study in the United States showed an inverse association between consumption of "white meat," including fish, and liver cancer, but other studies have found no such correlation.

Dr. Sawada and colleagues examined the issue by analyzing data from a large cohort study launched in the 1990s and supervised by the Japanese department of public health. The investigators analyzed detailed dietary data from 90,296 adults who were aged 40-69 years at baseline and were followed for an average of 11 years.

The study subjects completed questionnaires regarding their usual intake of 138 food items during the previous year, using standard portions or units of consumption. Nineteen items on the questionnaire asked about dietary fish and shellfish, which in Japan includes salted fish; dried fish; canned tuna, salmon, or trout; and bonito, tuna, cod, sea bream, mackerel, sardine, mackerel pike, roe, eel, squid, octopus, prawn, clam, crab, vivipara, as well as various fish pastes.

The investigators used the subjects’ responses to calculate daily fish consumption. They also calculated daily intake of all n-3 PUFAS combined, and intake of four individual fatty acids. They separately calculated the consumption of fish rich in n-3 PUFAs, namely salmon, trout, sea bream, mackerel, sardine, mackerel pike, and eel.

Blood samples that had been taken during general health check-ups were screened for hepatitis C antibodies and hepatitis B surface antigen to determine whether the subjects were carrying hepatitis C or B.

A total of 398 cases of incident HCC developed during follow-up (Gastroenterology 2012 Feb. 20 [doi:10.1053/j.gastro.2012.02.018]).

Total fish consumption showed a weak inverse association with risk of HCC, with a multivariable hazard ratio of .64 for highest vs. lowest quintile (95% confidence interval, 0.41 to 1.02, P for trend = .07). The association reached statistical significance when the analysis was confined to fish rich in n-3 PUFAs with a HR of 0.64 (95% CI, .42 to .96, P for trend = .04).

Strong, dose-dependent inverse associations also were found between HCC risk and dietary intake of eicosapentaenoic acid, docosapentaenoic acid, and docosahexaenoic acid.

These results did not change substantially when the data were adjusted to account for subject age, sex, smoking status, and body mass index. The findings also persisted across several subgroups of patients such as alcohol drinkers and coffee drinkers.

The inverse association between consumption of fish high in n-3 PUFAs and HCC risk also was strong in the subgroups of patients positive for hepatitis B or hepatitis C.

The reasons underlying this protective effect against liver cancer are not yet known. It is likely that the anti-inflammatory properties of polyunsaturated fatty acids play a role, "given that HCC is an inflammation-related cancer which has a background of chronic inflammation triggered by exposure to hepatitis virus infection or toxic compounds such as ethanol," Dr. Sawada and associates said.

This study was somewhat limited in that it was necessary to estimate the consumption of fish and individual fatty acids rather than measuring these amounts directly. Also, the dietary data were based on subjects’ self-report at only a single time point.

The study was supported by the National Cancer Center Research and Development Fund and the Ministry of Health, Labor, and Welfare of Japan, both in Tokyo. The authors reported no financial conflicts of interest.
Source: Oncology Report

Fish tied to lower colon cancer risk: study
NEW YORK | Thu May 10, 2012 3:32pm EDT
(Reuters Health) - People who eat plenty of fish may have a lower risk of colon and rectal cancers, a new report suggests.

The finding comes from an analysis of 41 past studies on the link between fish in the diet and new diagnoses and deaths from colorectal cancer.

"People who rarely eat fish may experience health benefits in a variety of areas -- heart disease, reproductive and now colon cancer -- by increasing their fish consumption somewhat," said Dr. Michael Gochfeld, a professor of environmental and occupational medicine at University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School.

"If you eat fish very frequently, it's not clear whether your benefit continues to go up (by eating even more)," he told Reuters Health.

And although the new study focused specifically on fresh fish, the authors noted they were unable to pinpoint what types of fish people ate or the manner in which fish was prepared in the prior studies.
"Cooking temperatures might affect the risk of colorectal cancer," Dr. Jie Liang of Xijing Hospital of Digestive Diseases in Xi'an, China, who worked on the study, wrote in an email to Reuters Health.
Liang cited recent evidence that suggests eating lots of meat and fish barbecued or grilled over high heat may actually be tied to an increased cancer risk.

According to the Centers for Disease Control and Prevention, approximately 143,000 Americans were diagnosed with colorectal cancer in 2007, the most recent year with available data. The disease affects the large intestine and is one of the leading causes of cancer-related deaths in the United States.
For the new report, Liang and his colleagues combined results from 41 studies published between 1990 and 2011 that measured fish consumption and tracked cancer diagnoses. That included research from the U.S., Norway, Japan, Finland and elsewhere.

Overall, regularly eating fish was tied to a 12 percent lower risk of developing or dying of colon or rectal cancer, the researchers found.

That was after taking into account study participants' age, alcohol and red meat intake, family history of cancer and other risk factors.

The protective effect tied to fish consumption was stronger for rectal cancer than colon cancer.
People who ate the highest amounts of fish had a 21 percent lower risk of getting rectal cancer than those who ate the least. That compared to just a four percent lower risk of colon cancer -- which was so small, it could have been due to chance.

"Rectal cancer is much rarer, so we'd rather have a larger reduction (in risk) for colon cancer," Gochfeld said.

The study, published in the American Journal of Medicine, was partially funded by the National Natural Science Foundation of China.

Liang's team did not investigate why eating fish may have a positive effect on colorectal cancer risk. The study also can't prove that it's the fish, itself, that was responsible for a lower cancer risk in some participants.

"It doesn't tell us whether the benefit you get from fish has to do with specific nutrients in the fish, or with the fact that people who tend to eat fish tend to adopt other healthful lifestyles, such as avoiding red meat or processed meats," said Gochfeld, who was not involved in the research.
If fish indeed is behind the lower colorectal cancer risk, the added benefit could be coming from the omega-3 essential fatty acids found in certain fish such as salmon and sardines, Gochfeld said.
But even if the high omega-3 levels in fatty fish have a protective effect, it's unclear whether or not the same benefit extends to supplements such as fish-oil capsules, he said.
SOURCE: American Journal of Medicine, online April 18, 2012.
Read More @ Reuters Health

Researchers Test Three-Second Rule, With Mixed Results

Continue Reading @ Download PDF Newsletter Here

HCV Advocate
May 2012 Newsletter

Hepatitis C Personal Blog Updates

Hep C Treatment Journey Day 31: Get Up and Go
Today is Day 31 of Hepatitis C Treatment Journey. The morning started out slow, picked up a little speed, then I ran out of gas. My Get Up and Go, Got Up and Left. I thought today would be a good day to introduce you to “Dudley.” Dudley gives you a pretty good description
Continue Reading...

Oh My Aches And Pains
In eight weeks, I've moved from the hard part of Hepatitis C treatment into the uphill climb portion of the journey.
Continue Reading @ Oh My Aches And Pains


Insurers Back FDA Plan for New Drug Category
Paige Winfield Cunningham
(The Washington Times, May 7, 2012)
"Health insurers gave a tentative the Food and Drug Administration’s [FDA] proposal to make drugs treating chronic conditions available without a prescription by classifying them in an all-new category...If the FDA decides to move ahead with the plan, it would create a third category for classifying drugs. Called 'safe use' drugs, patients wouldn’t need a prescription but neither could they obtain them over the counter. Instead, people could only buy the drugs after diagnosing their ailments online or in the pharmacy. Seeking a way to expand access to drugs for Americans who struggle with common conditions such as high cholesterol, migraines and diabetes, the FDA has raised the idea several times over the past decade and brought it up again in March, asking the public to weigh in."
Continue Reading @ The Washington Times

U.S. may speed approval of "breakthrough" drugs
WASHINGTON | Wed May 9, 2012 2:26pm EDT
WASHINGTON (Reuters) - Experimental drugs that show a big effect early in development for treating serious or life-threatening diseases would get a faster and cheaper path to U.S. approval, under a proposal likely to become law this year.
U.S. drug regulators would be able to label such treatments "breakthrough" therapies, and work with companies to speed up clinical trials, for example by testing the drugs for a shorter time or enrolling fewer patients.

The U.S. Food and Drug Administration has said it supports the proposal, which is included in both versions of an FDA "must-pass" funding bill currently working its way through Congress and set to be passed by the end of the summer.

The plan fits with President Barack Obama's aim to foster innovation as a means of spurring job creation, and may pacify some critics who say the FDA lags European countries in approving new medicines or medical devices.

Dr. Janet Woodcock, head of the FDA's drugs center, has said the FDA needs more flexibility to bypass "business as usual" when it sees unexpected effects, or when a new medicine can greatly help patients.

"What happens when you have a breakthrough drug that shows an effect that's never been seen before?" she told reporters in March, discussing the proposal.

"If we'd done business as usual during the AIDS epidemic, we would have never controlled that epidemic," Woodcock said.

During a spike in new cases of AIDS in the early 1990s, the FDA created an "accelerated approval" process to get new AIDS drugs to the market more quickly by allowing companies to show indirect measures of how the drug helped people.

Jeff Allen, executive director of Friends of Cancer Research, said the time was right for another avenue to speed innovative treatments to patients.
Allen said new understanding of human biology and of diseases meant companies could create more effective drugs, but with fewer side effects, because they would be more targeted to specific patients or disease types.

He said a good example was Roche Holding AG's skin cancer drug Zelboraf, approved last year; people taking the pill were 63 percent less likely to die from melanoma than people on standard chemotherapy.
There was also Pfizer Inc's targeted lung cancer drug Xalkori, which could shrink or eliminate tumors in 10 to 12 months for people with a specific genetic mutation.
"The most promising drugs show an effect early," Allen said. "(But) there's a mentality among drug developers or FDA reviewers that you have to go through this multi-step approach" to get a drug to market.

"We're hoping to encourage getting away from that," he said.
Allen said the FDA would retain its power to require companies to do post-approval studies, or withdraw drugs from the market if initial evidence of benefit was not shown in follow-up trials.
(Reporting by Anna Yukhananov)
Source: Reuters

Off The Cuff

From Heartwire
Whistleblower Suit Claims Pioglitazone Cover-up
Suit Implicates Dr Steven Nissen, Cleveland Clinic
Shelley WoodMay 10, 2012 (Boston, Massachusetts) — Lawyers representing Takeda Pharmaceuticals have one more day to either file an answer to or challenge the validity of a whistleblower suit centered, in part, on the underreporting of congestive heart failure (CHF) events with the company's diabetes drug, pioglitazone (Actos).

Dr Helen Ge, a former employee at Takeda, alleges that false claims for payment were made to Medicare and other federally funded healthcare programs on the grounds that the company "was able to capture a majority of the diabetes drug market by falsely portraying Actos as safer than it actually was."

"But for Takeda's fraud, government healthcare programs would have paid for substantially fewer Actos claims" and physicians would have prescribed it less, the whistleblower suit alleges.

Suit goes it alone
Ge's qui tam suit, launched in June 2010, is seeking damages and civil penalties from Takeda on behalf of the US government; her attorneys are proceeding with the litigation, despite a decision by the feds and the 25 states with similar false claims act legislation to decline to intervene in the case.
One of Ge's lawyers insisted to heartwire that it is "not unusual" for government to decline to intervene; in this case, the Justice Department spent a year and a half reviewing the case before opting out, attorney Michael Baum explained.

The feds will continue to monitor the case, and if litigation is successful or if discovery turns up information that changes their minds, "they might intervene earlier," Baum said. "Our view, having worked on a lot of pharmaceutical cases and having a pretty good idea from our whistleblower what things we will find in discovery, we feel that the case should proceed and we should conduct discovery, and discovery will bear out Dr Ge's allegations."
Ge's lawyers hope to "obtain internal emails and publication plans and marketing plans that will provide further support to our contentions in the complaint," Baum said.

Underreporting of known, serious side effects
Ge's suit alleges that Takeda failed to properly report CHF cases to the FDA and instructed medical reviewers, Ge included, to not report hundreds of nonhospitalized or nonfatal CHF cases as "serious" after the boxed warning was added to thiazolidinedione (TZD) drugs in 2007.
Only "serious" adverse events for older drugs end up in the FDA's Adverse-Event Reporting System, the suit alleges, thus boosting the company's alleged aim of positioning its drug as safer than rosiglitazone.

Ge says her contract with Takeda was terminated after she complained to three superiors about the downgrading of CHF events. Her suit also states that the number of CHF reports dropped dramatically in 2010, after she was fired from the company, despite rising sales of the drug.
Ge's suit also details alleged cover-up of reports of other adverse events, including cancers, suicidal ideation, renal failure, and cardiomyopathy, among others.

Financial conflicts alleged with Nissen, Cleveland Clinic
Ge's suit names only the pharmaceutical company as defendant but does allege that financial connections between the Cleveland Clinic's Dr Steven Nissen "should be considered when analyzing Actos's risks compared with Avandia's."

Nissen, with Kathy Wolski, famously published the rosiglitazone meta-analysis that set off the TZD firestorm, showing a 43% increase in MI with pioglitazone's chief competitor. Ge's suit cites the Nissen paper as a key factor in Takeda's efforts to position pioglitazone as a safer alternative to rosiglitazone. Nissen, the suit notes, was principal investigator for the phase 3 PERISCOPE trial, which used intravascular ultrasound (IVUS) to screen patients for trial eligibility, then repeat IVUS imaging for trial participants. Ge's suit estimates that "payment Nissen received from Takeda through Cleveland Clinic Foundation was estimated to be $8 million to $10 million" for PERISCOPE and that IVUS procedures likely brought in over $13 million in revenue for the Cleveland Clinic.

Pharmalot, which reported Ge's original suit in early March, quotes Nissen as pointing out that Ge's calculations were off base, since reimbursement would have been divided among all of the enrolling centers, of which there were more than 100 globally.

Contacted by heartwire yesterday, Nissen characterized the lawsuit as old news and called the claims "total nonsense," stressing that he "got not one dime."

Asked about the millions allegedly made by his institution, Nissen said that the Cleveland Clinic, as well as the Duke Clinical Research Institute and other academic research centers, "do clinical trials and the institutions get revenue, but that is completely irrelevant to this lawsuit."

He notes that Takeda funding for PERISCOPE was disclosed in the JAMA article and "there is nothing there that has not already been in the public domain for years."

Nissen also points to the fact that the Justice Department and 25 states had declined to intervene. "They did not find any merit in this, and they refused to try the suit. So the thing, as far as I can tell, is completely dead."

Hundreds of millions?
Baum, however, points out that the government opts not to intervene "in most cases and has stated that that does not mean the case has no merit. . . . They are relying more and more on the private sector to litigate the case to begin with and wait and see what discovery turns up."

Baum also stressed that Nissen "is not a party; he is identified because he was working on the PERISCOPE trial [with Actos] on behalf of Takeda at the same time he was conveying this information regarding Avandia. And we want to see what communications occurred between Dr Nissen and Takeda and see what information Takeda was funneling to him."

If successful, Ge's suit could see her stand to win 15% to 30% of the civil settlement in the case. Her lawyers would not put a number on this, but the suit itself estimates that the government has "suffered hundreds of millions of dollars of damages."

Takeda has not responded to heartwire's request for comment; the company will need to file its response to Ge's claim tomorrow. The company had previously asked for--and was granted--an extension to an earlier response date last month.
Source: Medscape

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