Man, 66, died of bacterial infection after being treated for skin cancer, diabetes, report says
msnbc.com msnbc.com
updated
7/1/2011 6:13:18 PM ET 2011-07-01T22:13:18 Federal health officials are investigating whether contaminated alcohol prep products from a shuttered Wisconsin firm led to the death of a 66-year-old man who developed a bacterial infection after being treated for skin cancer and diabetes.
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The death is among eight reports of fatalities, 11 infections and nearly 250 other problems now associated with medical products manufactured and distributed by the Triad Group and H&P Industries Inc. of Hartland, Wis., newly released records from the federal
Food and Drug Administration show.
The death is the second fatal report to the FDA that specifically cites a rare infection with the bacteria Bacillus cereus in a patient who used Triad Group alcohol prep pads. Last month, the Wisconsin firm was legally barred from making or distributing the products because of potential contamination with that life-threatening bacteria.
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The man was receiving outpatient radiation for squamous cell skin cancer, and he had used home testing supplies to monitor diabetes when he developed a blood infection, the report by the FDA Office of Surveillance and Epidemiology showed. No other details were included.
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Special report: Tracking tainted wipes
Parents blame toddler's death on tainted wipes
The parents of a 2-year-old Houston boy who died from a rare infection are suing makers of recalled alcohol prep pads, claiming contaminated wipes caused fatal bacterial meningitis.
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FDA knew of problems at plant that made tainted wipes
FDA defends actions on tainted wipes
Colo. hospital blew whistle on tainted wipes
Pressured firm closes line that made tainted wipes
Infection risk triggers new recall of wipes
Two-thirds of alcohol wipes contaminated
FDA asks maker of tainted wipes to stop production
Senators question FDA's response to tainted wipes
Wipe-maker shuts doors after U.S. Marshals arrive
Feds seize $6 million in products from wipe-maker
FDA admits weak oversight in tainted wipes review
Feds seek injunction against maker of tainted wipes
More potentially tainted medical products recalled
Suspect wipes used at VA medical centers
FDA admits weak oversight in tainted wipes review
Feds seek injunction against maker of tainted wipes
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The first death report that cites Bacillus cereus infection was submitted on behalf of
Harrison Kothari, a Houston toddler whose case sparked investigation into whether Triad products included in a massive January recall were responsible for serious infections. The 2-year-old's parents have filed a lawsuitclaiming that contaminated Triad wipes led to the child’s fatal case of meningitis last year. Both that death and the 66-year-old man's death are part of an ongoing review, the FDA said.
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Six other death reports submitted by patients’ family members or their
doctors question the role of Triad medical products without citing specific bacteria, according to a review of reports from Jan. 6 to June 28. Such reports are difficult to confirm because they don’t include enough information to guide investigators, said Shelly Burgess, an FDA spokeswoman.
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Officials with the Triad Group and H&P Industries Inc. have repeatedly said that no deaths or injuries have been confirmed to be caused by their products. Christy Maginn, a spokeswoman for the firm, said that the company hadn't seen the FDA reports and couldn't comment on the specific cases.
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Last month, federal officials
filed a permanent injunction barring the Wisconsin sister firms from manufacturing or distributing any products because of the potential of life-threatening bacterial contamination.
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The records show that the FDA has received reports of 11 non-fatal infections tied to Triad alcohol prep wipes. They include eight related to the alcohol prep products; among those are five that specifically cite Bacillus cereus. In one instance, a hemophiliac patient developed a Bacillus cereus infection and the wipes tested positive for the bacteria, records show. The three other reports cite different pathogens.
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In addition, the FDA received one report of an infection caused by the bacteria that forced the March recall of hundreds of thousands of povidone iodine prep pads manufactured and distributed by the Wisconsin firms. The rare bacterium Elizabethkingia meningoseptica was detected in the blood of an infant with a central venous catheter. A Triad povidone iodine swab stick had been used to
clean the skin before the line was inserted, the report said.
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The agency also received two reports of infections related to recalled sterile lubricating jelly used in medical exams.
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In addition, the FDA received nearly 250 reports of other minor problems such as swelling at the injection site, redness, nausea and vomiting.
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An ongoing msnbc.com investigation revealed that the
FDA knew about problems with contamination and sterilization of the alcohol prep pads and other products dating back to at least 2009. It’s not clear how long the agency has suspected problems with Bacillus cereus because FDA heavily redacts inspection documents. However,
redactions challenged by the Milwaukee Journal Sentinel newspaper showed that FDA documented the bacterium in a multi-week inspection that began Nov. 29, 2010.
Under pressure,
FDA officials told two U.S. senators that the agency should have issued a warning letter to H&P Industries Inc. and the Triad Group last summer instead of allowing the company to voluntarily comply.
. Drives Down Costs by an Average $13,000 Per Patient
FRANKLIN LAKES, N.J.,
July 5, 2011 /PRNewswire/ -- Accredo Health Group Inc., the specialty pharmacy of Medco Health Solutions, Inc. (NYSE:
MHS), has developed a unique ability to manage the costs of treating hepatitis C (HCV), while keeping patients adherent to a complex medication regimen for a sometimes lethal disease that can lead to liver cirrhosis and certain cancers. The introduction of two new HCV medications that hold tremendous promise but also add even a greater degree of complexity to treatment will require this "high touch" approach to help increase patient adherence.
Patients must be at least 80-85 percent adherent to therapy for the HCV treatment to be effective, and Accredo has results demonstrating that patients who receive therapy from Accredo's nurses and specialist pharmacists are nearly 10 percent more adherent than those who get their therapy from another provider. Accredo has also been successful in using genotype information to identify patients who may need only 24 weeks of therapy, resulting in drug cost savings up to
$13,000.
Accredo's high-touch care model helps educate patients about their treatment and the necessity to adhere to it. This includes patient instruction about using their medications, communicating with doctors about treatment programs and assisting patients to manage side effects. This, in turn, helps to improve patient outcomes and reduce costly hospitalizations or the wastage of expensive medications that are not being properly taken.
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As Accredo has improved care for HCV patients, boceprevir and teleprevir will likely improve patients' odds for beating the condition that affects 3.2 million Americans, sparing thousands of patients from liver failure, potential transplants or cancer.
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"These new drugs will likely be game-changers for HCV patients, but patients are going to need help adhering to treatment," said
Richard Faris, vice president and national practice leader for Medco's Rare and SpecialtyTherapeuticsResourceCenter. "Medco's enhanced clinical oversight and expertise in gene-based medicine enables us to help patients get the right treatment and stay on therapy."
The U.S. Food and Drug Administration (FDA) approved the medications in May to supplement treatments of pegylated interferon and ribavirin in patients with HCV genotype 1, the most common type of the virus. The new treatments improve efficacy to approximately 75 percent from 50 percent when pegylated interferon and ribavirin, the standard of care for HCV since 2001, are used together for 48 weeks. At the same time, the new drugs can shorten the duration of treatment to 24 weeks in most patients. Despite being oral drugs, the new treatments that prevent HCV from replicating add a layer of complexity to an already complex treatment program
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The Accredo Model
The Hepatitis C Therapeutic Resource Center at Accredo has been successful in helping patients, physicians and payers with this difficult therapeutic regimen. Accredo's approach is to maximize clinical effectiveness for patients and benefits plan sponsors by reducing the potential for waste. Failure to properly monitor the therapy, genotype and viral load can cost up to
$64,000 in unnecessary drug costs for treating an HCV patient. Pegylated interferons are dosed in precise increments based on a patient's weight.
Patient adherence to these therapies is crucial to achieving a successful course of therapy, but made difficult given their significant side effects and intensive drug regimen. Accredo's Hepatitis C Therapeutic Resource Center services include patient training, preventing drug waste, coordination of care, genetic screening, and patient monitoring and counseling to overcome barriers to treatment adherence.
Hepatitis C and its costs
HCV – and subsequent liver cirrhosis – is the leading cause of liver transplant and it is estimated that 30 percent of the 17,000 people on the liver transplant list are infected with HCV. The initial cost for a liver transplant is
$315,000 with follow-up care costing
$22,000 annually. HCV is also a leading cause of liver cancer. HCV patients also can have significant co-morbidities that require complex care from specialty pharmacy. For example, in
the United States up to 8 percent of those with chronic HCV may be HIV co-infected. Overall, an estimated 6,200 persons with bleeding disorders are affected by HCV, representing 44 percent of all persons with hemophilia and 5 percent of all persons with von Willebrand disease. Persons above the age of 21 have the highest rates of infection, since they were most likely to get human blood products as treatment.
About Medco
Medco Health Solutions, Inc. (NYSE:
MHS) is pioneering
the world's most advanced pharmacy® and its clinical research and innovations are part of
Medco making medicine smarter™ for more than 65 million members.
With more than 24,000 employees worldwide dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2010 revenues of
$66 billion, Medco ranks 34th on the 2011
Fortune 500 list and is named among the world's most innovative, most admired and most trustworthy companies. Accredo Health Group, Inc., is a wholly-owned subsidiary of Medco.
For more information, go to
http://www.medcohealth.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-looking statements are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about the business and future financial results of the pharmacy benefit management ("PBM") and specialty pharmacy industries, and other legal, regulatory and economic developments.
SOURCE Medco Health Solutions, Inc.
RELATED LINKS
http://www.medcohealth.com
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Written By: Nigel Roberts 7/4/11 Categorized in: DeKalb News
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Hepatitis C was “the missing piece of the puzzle” that explained Quinton Moore’s weight loss and fatigue. A routine blood test to refill a prescription revealed abnormal liver function. Upon further examination, his doctor found that Moore was in the final stages of liver disease and would need a transplant if the disease progressed.
After weighing his options, Moore decided to participate in a clinical drug trial of Incivek (also known as Telaprevir), which offered a better chance than the standard treatment of curing the disease. The side effects were uncomfortable, but he persevered with the six-month drug trial. He was among the more than 2,200 people in the trial that led the U.S. Food and Drug Administration in May to approve Incivek for treatment of chronic hepatitis C.
Today, Moore is completely cured of the disease. “I feel wonderful,” said the 62-year-old Decatur resident. “I’m optimistic about living many more decades.”
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Hepatitis C cases in region on the rise
Federal, state and local health officials are trying to figure out why the number of hepatitis C cases in six central and northern Wisconsin counties has increased.
The Centers for Disease Control and Prevention and state Department of Health Services are working with health departments in Wood, Portage, Marathon, Langlade, Lincoln and Oneida counties to figure out the reason the number of new cases among people younger than 30 more than doubled in 2009 and 2010, said Joanie Kuennen, Wood County public health nurse. From 2004 through 2008, the six-county area had a combined average of 12.2 cases a year. In 2009 and 2010, they averaged 27 cases annually.
Hepatitis C, a viral disease, causes inflammation of the liver, which can lead to a variety of health problems, including liver cancer and death, Kuennen said. Unlike with hepatitis A and B, there is no prevention vaccine.
Health officials are in the middle of an investigation into the problem, said Melanie Behr, nursing supervisor for Portage County Community Health. Although it's listed as one of the six counties, Portage County hasn't seen the same increase as the other five counties, she said. However, Behr wants to wait for the results of the investigation before making any assumptions about the situation.
"I think anytime you have an increase in hepatitis C, it is concerning," Behr said.
The state and federal agencies gave the counties a survey to use when talking with people to determine a commonality for what people were doing when they were infected with hepatitis C, Kuennen said.
The six counties aren't alone in the problem, Kuennen said.
"It's happening nationwide; it's not just Wisconsin, or the northern region," she said.
One of the potential causes for the trend is an increase in intravenous drug use, Kuennen said. Illegal drugs, such as heroin, can be purchased for less money than some of the prescription drugs that get abused, such as oxycodone.
The one new case of hepatitis C seen in Portage County in 2010 involved intravenous drug use, Behr said.
Heroin use is becoming more socially accepted, Wood County Investigator-Sgt. Scott Saeger said. Nationally, health department officials think 35 to 70 percent of drug users who inject are infected with hepatitis C, Saeger said.
To avoid contracting the disease, people should make sure they use clean needles every time and never share a needle, Kuennen said. People can become part of a clean needle exchange program by contacting their local health department.
"I never ask their names," Kuennen said. "I'll be happy to give the contact information to them; this disease needs to stop."
Kuennen also recommends people who are getting tattoos or piercings check to make sure the provider is state certified and inspected.
Tattoo artists need to check their sanitizing equipment monthly and provide the records to county officials during inspections, said Kate Carlson, Wood County environmental health specialist. This protects the health of clients.
Kuennen recommends that anyone who has ever shared a needle get tested for hepatitis C. One of the problems with the disease is that it usually doesn't have any visible symptoms until the person who has it becomes very sick. Eventually, the disease will cause the skin and eyes to turn orange.
If hepatitis C is caught early, doctors can help patients live a long life with a good
quality of life, Kuennen said.
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Medicare proposes change in anemia drug usage
LOS ANGELES (Reuters) - The Medicare federal health insurance program has proposed removing its requirement that kidney dialysis providers keep patient hemoglobin levels above a set minimum, which could lead to lower use of Epogen, the anemia drug sold by Amgen.The government health plan said last month that it had no plans to change its reimbursement terms for anemia drugs used to treat kidney patients.
But in a statement on its website on Friday, the agency proposed retiring a requirement that patients' hemoglobin, or red blood cell, levels be kept above 10 milligrams per deciliter.
It said such an action would be "consistent with revised U.S. Food and Drug Administration guidelines."
Last week, the FDA changed the labels for Amgen's Epogen and Johnson and Johnson's Procrit to call for lower dosing of the anemia drugs, which have been linked in recent years to safety concerns such as increased risk of heart problems.
"Clinicians should use the lowest dose of ESA (erythropoiesis stimulating agent) sufficient to reduce the need for red blood cell transfusions," Patrick Conway, chief medical officer at the Centers for Medicare and Medicaid (CMS) said in the statement.
Amgen said it recognizes that the labeling for ESAs has changed, but is concerned that the proposal would remove an important safeguard designed to protect dialysis patients from being undertreated.
The Medicare guidelines "should have a measure that protects patients from hemoglobin levels that fall too low," the biotechnology company said in an emailed statement.
Sales of the anemia drugs have declined steeply in recent years, but Amgen's Epogen, along with its second-generation drug Aranesp, and J&J's Procrit are still expected to generate around $6 billion in 2011 sales, according to data from Thomson Reuters Pharma.
The proposed change would apply under Medicare's quality performance standards for "bundled" payments to dialysis providers and would affect payment years 2013 and 2014, the agency said.
CMS projected that its payment rates for dialysis treatments would increase by 1.8 percent in 2012, representing projected inflation of 3 percent less a projected productivity adjustment of 1.2 percent. It also estimated that federal payments to dialysis facilities in 2012 would total $8.3 billion.
While Medicare traditionally covers just elderly and disabled Americans, kidney disease patients are an exception. The program covers all those with end stage renal disease under a decades-old law.
Medicare said it would accept comments on the proposed rule until the end of August and will respond to them in a final rule to be issued by November 1.
(Reporting by Deena Beasley)
Pharmaceutical
FDA Inspects Half A Dozen Plants In India
NEW DELHI: The US drug regulator has inspected the manufacturing plants of at least half-a-dozen Indian drugmakers, raising hopes that these companies will be able to export medicines to the world's largest drug market, reports Khomba Singh from New Delhi. Several industry executives said teams of inspectors from the US Food and Drug Administration (FDA) did not find any major deficiency during their inspection of facilities of
Ranbaxy Laboratories , Orchid Chemicals, Emcure Pharma,
Nectar LifeSciences and Ind Swift Laboratories. But this could not be officially confirmed from the FDA.
The US drug regulator has inspected manufacturing plants of at least half a dozen Indian drugmakers in the last few weeks, raising hopes among some of these companies that they will shortly be able to export medicines to the world's largest drug market.
Several industry executives said teams of inspectors of the US Food and Drugs Administration (FDA) did not find any major deficiency during inspection of facilities of Ranbaxy Laboratories,
Orchid Chemicals & Pharmaceuticals , Emcure Pharma, Nectar Lifesciences and Ind Swift Laboratories over the course of the last four weeks. But this could not be officially confirmed from FDA, which did not respond to an e-mail query sent last Thursday.
While in the case of Ranbaxy and Nectar, a go-ahead from the FDA will mean that they can begin exporting to the US from their units, in the case of other companies, an FDA approval will allow them to continue exporting. FDA conducts audit to ensure that Indian drugmakers meet US drug manufacturing norms so that the medicines made at these facilities are safe for American citizens, before they are allowed to be sold in the US market.
Senior industry executives said this was the first time that FDA had inspected so many manufacturing units in India during such a short span of time. "The US government may be trying to expedite approval of generic drugs to reduce healthcare cost, which is a welcome move," D G Shah, secretary-general of Indian Pharmaceutical Alliance , an association of big Indian drugmakers said.
An estimated $30-40 billion worth of drugs, including top-selling drugs like Lipitor (
Pfizer )), Nexium (Astra Zeneca) and Plavix ( Bristol Myers Squibb), will lose patent protect protection in the next 1-2 years. This means generic firms can launch their versions at one-tenth of the price of the original brand, if they have FDA approval. For the US consumer, sale of more generic drugs will result in greater competition and therefore, lower prices. Ranbaxy Laboratories, the country's largest drugmaker, stands to benefit the most from a favourable report from the FDA.
The US constitutes a fourth of Ranbaxy's total sales and a nod from the FDA will permit the Gurgaon-based firm to sell new drugs in the US from its Indian plants, nearly three years after FDA banned and halted marketing approval of new drugs from its two main plants for data fabrication. Two FDA officials spent about two weeks examining the drugmaker's new manufacturing facility at Mohali, Punjab and it is learnt that they have not pointed out any major flaw during the examination. A Ranbaxy spokesperson declined comment.
FDA officials carried out separate four-day inspections at the active pharmaceutical ingredient (API) plants of two Chandigarh-based firms, Nectar Lifesciences and Ind Swift, at their Dera Bassi plants. Nectar can begin exporting APIs to the US once it gets a formal approval from the American regulator. For Ind Swift, which already exports to the US, this was a re-inspection which concluded about a week back, said the company's managing director NR Munjal. The Nectar Lifesciences spokesman declined comment.
Chennai-based Orchid Chemicals said late last month that its cephalosporin API manufacturing facility in Alathur, Chennai has cleared a recent FDA inspection allowing it to continue supply of niche APIs to developed markets. For Pune-based Emcure, this was the third reinspection of its API plant in Kurkumbh, near Pune.
FDA officials also audited the facility of a Mumbai-based drugmaker's plant in Naroda, near Ahmedabad. Local industry executives said Indian firms are better prepared for scrutiny as top drugmakers such as Ranbaxy, Dr Reddy's,
Sun Pharma and Aurobindo have been penalised by FDA in the last two years.
While some executives were of the view that the FDA teams followed a more 'collaborative approach', others said the officials from the regulator stuck to their guidelines and did not show any leniency. According to the Pharmaceutical Exports Council of India, US accounts for about a quarter of the country's .`50,000-crore drug market. Despite increased pressure on margins, the US market remains highly profitable and a key growth driver for many Indian companies.
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P&G wins round in Fixodent cases
Procter & Gamble has won a big victory in its defense of dozens of lawsuits over its Fixodent products.
A federal judge in Miami threw out the lead case in a series of lawsuits that claimed using the denture cream caused nerve damage.
U.S. District Court Judge Cecilia Altonaga did not rule on the merits of the plaintiffs' claims. But she ruled that the expert witnesses the plaintiffs planned to call would not be permitted to testify.
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Roche drops plans to develop Chugai diabetes drug
TOKYO, July 5 | Tue Jul 5, 2011 2:20am EDT
TOKYO, July 5 (Reuters) - Swiss drugmaker Roche Holding AG has dropped its plans to develop and sell a diabetes treatment with Chugai Pharmaceutical and has handed back the overseas rights, the Japanese drugmaker said on Tuesday. The drug CSG452 was dropped after a review by Roche of its pipeline, Chugai said.
Chugai said it will consider other partners to help it develop the drug and has not changed its plans to submit it for approval to Japanese health authorities in 2013.
(Reporting by
Mayumi Negishi and
Edwina Gibbs; Editing by Edmund Klamann)
