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U.S. health regulators have warned Pfizer Inc over a series of failures that led to the overdosing of at least 13 children in a clinical trial of its antipsychotic drug Geodon, according to a letter made public on Tuesday.
The FDA, in an April 9 warning letter to the world’s largest drugmaker, said Pfizer “failed to ensure proper monitoring” of the trial in which several children given overdoses experienced tremors, restless legs and other complications.
The company is seeking to market the drug to children with bipolar disorder and has received cautious support from a U.S. advisory panel. While the study in question ended in 2007, the FDA is concerned Pfizer has not done enough to ensure the problem does not happen again.
Its concerns come amid continuous unease over the use of powerful drugs to treat depression, schizophrenia, bipolar disorder and other mental illness in youth. Many experts are concerned that such medications — widely used to treat adults — may not work the same in children and teenagers whose brains are still developing.
Geodon, first approved in 2001 for adults with schizophrenia, is already cleared for adults with bipolar disorder. Companies which study approved drugs in children can not only seek approval of pediatric use of their therapies, but also an added 6 months of patent protection under U.S. law.
In its letter, the FDA said the company did not properly monitor the study and “as a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner.”
Pfizer said it recognizes the issue’s seriousness and is committed to addressing the concerns, adding it reported many items cited in the letter as long as four years ago.
Since then it “has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators,” it said.
None of the children in question suffered long-term side effects or injuries because of the overdosing, Pfizer added, and just two of the patients were removed from the study.
The FDA said the letter follows repeated violations that the agency had notified Pfizer about in 2005. Seven children were found to have been overdosed, and an internal Pfizer document pointed to six others, it said.
The letter released on Tuesday comes after a 2009 agency inspection. A June 2009 response from Pfizer acknowledged the problems, but did not include a detailed list of the drugmaker’s plans to prevent future problems, the FDA said in its letter, posted online at http://link.reuters.com/waf68j.
At the same time, FDA was also seeking advice on the use of such drugs in younger patients.
Last June, an FDA panel of outside advisers cautiously backed Geodon along with two other similar drugs — AstraZeneca Plc’s Seroquel and Eli Lilly and Co’s Zyprexa — saying they appeared safe and effective in children, although concerns remained over their long-term impact.
Pfizer shares fell 3 cents to close at $16.76 on the New York Stock Exchange, roughly in line with the overall drug sector.
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The system for conducting cancer clinical trials in the United States is “at a breaking point” and needs a major overhaul, a panel of experts said on Thursday.
The Institute of Medicine panel said inefficient management, complicated government oversight and inadequate funding hamper the ability of the National Cancer Institute’s Clinical Trials Cooperative Group Program to design and run studies that answer important questions about new therapies.
“Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point,” John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston, who chaired the panel, said in a statement.
He said the program’s effectiveness is threatened just as biomedical research is making rapid advances in more personalized cancer treatments.
“A few isolated or partial measures won’t suffice,” Mendelsohn said.
“The program urgently needs changes across the board if it is going to continue producing the kind of studies necessary to answer crucial and fundamental questions about how to successfully treat and prevent cancer, which can’t be answered through other means.”
The Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year.
For these trials to be successful, they require a significant investment of time by busy doctors and other healthcare workers to manage patients’ care during the studies, according to the report by the 17-member panel appointed by the IOM, one of the National Academies of Sciences.
But doctors are less willing to take part because they are not reimbursed adequately, the panel said in the report.
LESS MONEY FOR TRIALS
Doctors and their clinics must pay for as much as half of the cost of clinical trials and nearly all must seek support from outside sources such as drug companies.
And trials are getting more expensive as researchers develop more personalized cancer treatments, including the use of so-called biomarkers to see how a treatment is working.
When inflation is taken into account, there is less money for the trials now than in 1999 — meaning researchers will be unable to conduct increasingly complex clinical trials that focus on developing drugs tailored to a person’s genetic makeup.
One major problem is that the system of designing a clinical trial is lengthy and redundant, and can take an average of two years to complete.
In fact, only about 60 percent of National Cancer Institute-sponsored late-stage clinical trials are completed, a waste of human and financial resources, the committee said.
The group urged the National Cancer Institute, one of the National Institutes of Health, to devote more of its research budget to the program. If not, groups should take on fewer NCI-funded trials, the panel said.
The American Society of Clinical Oncology applauded the IOM report and urged the National Cancer Institute to double its support for the network within five years.
An ACSO-sponsored survey of more than 500 U.S. and Canadian groups found as many as a third plan to reduce their participation in NCI-sponsored trials.
ASCO said NCI devotes about $145 million a year to the program, representing just 1.2 percent of the institute’s 2009 fiscal year budget of about $5 billion.
“Considering the program’s vital importance to the nation’s fight against cancer, it is clearly not in the public interest that it receives such a small fraction of NCI’s overall budget,” Dr. Richard Schilsky, past president of the ASCO, said in a statement.
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Many Spanish-speaking people in the United States receive prescription instructions from the pharmacy so poorly translated that the medications are potentially hazardous to their health, a new study shows.
The errors occur largely because of deficiencies in computer programs that most pharmacies rely on to translate medication information from English to Spanish, said lead researcher Dr. Iman Sharif, chief of the division of general pediatrics at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del.
“The technologies that are currently available to produce instructions in the patient’s language are inadequate,” Sharif said.
Half of the Spanish-language prescription labels reviewed for the study contained errors, and some of those errors could result in life-threatening situations if misinterpreted by the patient, Sharif said.
The study is published in the May issue of Pediatrics.
Of the New York City pharmacies surveyed that provide Spanish-language labels, more than four of every five used a computer program to translate their labels from English to Spanish. Nearly all the pharmacies said they had someone doublecheck the labels for errors, but researchers found dozens of examples of poorly translated instructions.
A common problem was “Spanglish,” Sharif said. The programs produced a mix of English and Spanish on the labels, creating confusing and difficult-to-read instructions.
The use of “Spanglish” also created some potentially dangerous situations. For example, the word “once” means “eleven” in Spanish. “You mean to say ‘once,’ as in ‘take once a day,’ and a Spanish-speaking person could interpret that to mean ‘eleven,’” Sharif said. Such a mistake could result in an overdose.
Other phrases that weren’t accurately translated include “dropperfuls,” “apply topically,” “for seven days,” “for 30 days,” “apply to affected areas,” “with juice” and “take with food.”
Misspellings also created errors. Incorrect use of the word “poca” for the word “boca” meant patients were told “by the little” instead of “by the mouth.” One set of instructions included “dos besos,” which means “two kisses”; the intended instructions likely were “dos veces,” which means “two times.”
Poor translations specifically cited in the study included:
Dr. David Flockhart, director of the division of clinical pharmacology at the Indiana University School of Medicine in Indianapolis, said it’s not surprising that these computer-generated errors are occurring.
“Word-for-word, you probably could get it right, but you can’t get the entire sense of what’s being communicated through a computer program,” Flockhart said.
The sheer amount of information that a pharmacist must provide day-to-day also makes it difficult for people with a shaky grasp of Spanish to catch errors. “It’s a particular issue because the PDR [Physicians Desk Reference] is so huge,” Flockhart said. For pharmacists who don’t speak Spanish, to translate it is nearly impossible. There’s too much information.”
Sharif believes these errors help explain why non-English speakers tend to receive poorer health care in the United States.
“This is something that is a critical contribution to disparities in care,” she said. “Many people who don’t speak English can’t understand how to use their medications. This is one piece of that puzzle.”
Noting that New York City requires prescription labeling in six other common languages, the authors said more research is needed to identify labeling hazards and safeguard non-English-speaking patients.
Also, software firms need to create better programs if patients are to be better served, since it’s unlikely that every pharmacy in the United States will be able to find and hire qualified live interpreters to produce labels and instructions, Sharif said.
“We need help,” she said. “We need the technology industry to step up and improve the way pharmacy prescription software translates drug instructions.”
Flockhart takes a different view, saying the real solution is to hire more bilingual pharmacists. “I doubt you could improve the software to the point where it’s as good as a pharmacist who speaks Spanish,” he said.
In the meantime, Spanish-speaking patients need to protect themselves. “My recommendation would be make sure you ask for an interpreter who speaks your language to explain how to use the prescribed medicine,” Sharif said.
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U.S. health regulators on Monday called for flat government payments next year to private insurers offering Medicare health coverage to the elderly, in line with recently passed health care legislation.
So-called Medicare Advantage plans would see the same payment rates they saw in 2010, instead of a previously proposed increase of more than 1 percent, according to the Centers for Medicare and Medicaid Services (CMS).
The law requires payments to Medicare Advantage plans to remain steady in 2011 and for reductions to begin in 2012.
The move affects health insurers such as UnitedHealth Group Inc and Humana Inc, two of the largest Medicare Advantage providers, as well as HealthSpring Inc, Coventry Health Care and Universal American Corp, among others.
Before the health care reform bill passed, CMS had proposed a net 1.28 percent hike in February.
Several analysts had anticipated a flat or negative final rate as CMS officials factored in the new healthcare law, and shares of UnitedHealth, Humana and other providers were largely unchanged in after-hours trading following the CMS announcement.
Ipsita Smolinski, a Washington-based analyst for Capitol Street, said the flat update was as expected and that CMS’s rates held “no surprises” for next year.
“That just means that 2012 and beyond will be not pretty, but we already knew that from the legislation,” she told Reuters.
Medicare Advantage plans offer Americans age 65 and older an alternative to traditional, fee-for-service Medicare run by the federal government. Such plans tend to offer extras such as prescription drug coverage and coverage for vision or dental services.
The government also reimburses insurers that provide those plans at a higher rate, making it a target for cost cutting and potentially a less attractive business for insurers.
Health insurers have said the cuts called for under the bill signed into law last month go too far and could force seniors who opt for the plans to pay more out-of-pocket costs or see fewer benefits.
Under the bill, Medicare Advantage plans also must spend at least 85 cents of every dollar on actual medical care or face penalties. Additionally, those that earn high marks for quality would be eligible for bonuses.
Medicare Advantage has been a growing business for the industry as high unemployment dents enrollees in health insurance plans offered by employers.
Roughly 23 percent of the 45 million people enrolled in Medicare, or about 10.2 million, opt for the private alternatives, according to the Kaiser Family Foundation.
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Four anti-HIV drugs inhibit a retrovirus recently linked to prostate cancer and chronic fatigue syndrome (CFS), say U.S. researchers.
If further investigation proves that the retrovirus xenotropic murine leukemia virus-related virus (XMRV) causes prostate cancer or CFS, these HIV drugs may be an effective treatment for the two conditions.
In this study, researchers from the University of Utah and Emory University/Veterans Affair Medical Center tested how effectively 45 compounds used to treat HIV and other viral infections worked against XMRV. Raltegravir was the most effective, and three other drugs — L-00870812, zidovudine (ZDV or AZT), and tenofovir disoproxil fumarate (TDF) — also prevented XMRV replication.
“Our study showed that these drugs inhibited XMRV at lower concentrations when two of them were used together, suggesting that possible highly potent ‘cocktail’ therapies might inhibit the virus from replicating and spreading,” Raymond F. Schinazi, a professor of pediatrics and chemistry and an investigator with the Center for AIDS Research at the Emory University School of Medicine and the Atlanta VA, said in a news release.
“This combination of therapies might also have the added benefit of delaying or even preventing the virus from mutating into forms that are drug-resistant,” Schinazi added.
“These results offer hope to infected persons, but we are still at the early stages of our understanding of the potential link between XMRV and these diseases,” Dr. Ila R. Singh, an associate professor of pathology at the University of Utah Medical School, said in the news release.
The study was published April 1 in the journal PLoS One.
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