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Federal health regulators are investigating hundreds of consumer complaints involving children’s medicines recalled by Johnson & Johnson last month, according to a congressional memo.
The Food and Drug Administration has not directly linked any of the reports to flaws with the company’s products.
J&J recalled more than 40 varieties of children’s cold medicines last month after FDA inspectors discovered a slew of manufacturing problems at a Pennsylvania facility. The company’s third recall in the past year triggered a flurry of criticism from Washington lawmakers, who will question company management at a hearing Thursday.
A spokeswoman for J&J declined Wednesday to comment on the congressional memo. Late Tuesday the company posted a statement on its Web site saying it would restore its public image by restructuring management and overhauling manufacturing operations.
“McNeil is taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies, and that the public rightly expects of us,” read the statement.
Since the April 30 recall, the FDA has received hundreds of reports of complications with J&J products, including seven deaths, according to a memo distributed to congressional staffers. The memo was obtained Wednesday by the Associated Press.
FDA is investigating whether the problems are linked to flaws in J&J products, which include infant Tylenol, Benadryl and Motrin.
“At this time, FDA is not aware of any child being harmed by taking one of the recalled products,” states the congressional memo.
FDA deputy commissioner Joshua Sharfstein is scheduled to testify. Sharfstein is expected to provide new detail on problems uncovered at J&J’s Fort Washington, Penn. plant.
FDA inspectors found that J&J failed to investigate medications that had potentially unsafe potency levels, according to FDA documents cited in the memo. While J&J rejected three batches of Infant Tylenol found to be overly potent, the company failed to check seven other batches at risk for the problem.
In another instance, FDA found that J&J did not recall a batch of products potentially infected with bacteria. The products were in distribution last fall and could still be on store shelves, according to FDA.
Colleen Goggins, J&J’s president for McNeil consumer products, will testify before the House Committee on Oversight and Government on J&J’s handling of the recall.
J&J, which is based in New Brunswick, N.J., has long enjoyed a sterling public image, even taking first place last year in a poll of corporate reputations.
That positive image is due in part to J&J’s handling of past product recalls.
The company’s response to a 1982 cyanide tampering scare in Chicago that killed seven people is considered a textbook example of how to deal with a brand crisis. J&J had its sales force remove 264,000 Tylenol bottles from store shelves and consumers were urged to return any Tylenol they had for a safe bottle.
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Creativity often goes hand-in-hand with mental illness, such as schizophrenia. Now scientists think they know why: The brain responds differently to the “feel good” chemical dopamine in both schizophrenics and the highly creative, a new study suggests.
The results showed similarities between the brains in healthy, highly creative people and those with schizophrenia. The findings suggest that creative types might not be able to filter information in their heads as well as “normal” folks, leaving them better able to make novel connections and generate unique ideas.
“Thinking outside the box might be facilitated by having a somewhat less intact box,” said study researcher Fredrik Ullen, of the Karolinska Institutet in Stockholm, Sweden.
Studies have found that creative skills are more common in people who have mental illness in their families, and are associated with a higher risk of schizophrenia and bipolar disorder. Also, certain psychological traits, such as the ability to make unusual or bizarre associations are shared by schizophrenics and healthy, highly creative people.
Some research has also found an association between creative abilities and the brain’s dopamine system – the network of neurons set up to respond to dopamine. (Dopamine is a neurotransmitter that, amongst other things, is involved in the reward response to everything from chocolate to cocaine.) However, the mechanism behind the dopamine-creativity link was largely a mystery.
Ullen and his colleagues administered psychological tests to 14 participants with no history of mental illness. The tests were designed to measure creativity, asking the subjects to find many different solutions to a problem.
Those who did well on this test, and were deemed “highly creative,” had a lower density of specific receptors in their brains for dopamine, called D2 receptors, in a region called the thalamus, than did less creative people, according to Ullen.
“Schizophrenics are also known to have low D2 density in this part of the brain, suggesting a cause of the link between mental illness and creativity,” he said.
The thalamus serves as a kind of relay center, filtering information before it reaches areas of the cortex, which is responsible, amongst other things, for cognition and reasoning.
“Fewer D2 receptors in the thalamus probably means a lower degree of signal filtering, and thus a higher flow of information from the thalamus,” Ullen said, and explains that this could a possible mechanism behind the ability of healthy highly creative people to see numerous uncommon connections in a problem-solving situation and the bizarre associations found in the mentally ill.
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Colorectal cancer patients who continued treatment with Roche Holding AG’s Avastin even after their cancer worsened lived longer than those who went off the drug, according to an “observational analysis” released on Thursday.
The findings came from follow-up of a trial involving more than 1,000 patients with advanced colorectal cancer who initially received Avastin in combination with chemotherapy.
The analysis showed that patients who continued an Avastin-based regimen after their cancer worsened had a 59 percent decrease in the risk of death compared to those who stopped therapy or switched to a regimen that did not include Avastin.
Median survival after the first disease progression was 16.3 months for patients who continued an Avastin regimen, 8.5 months for those who received a regimen without Avastin, and 5.2 months for those who stopped therapy altogether.
Adverse side effects associated with Avastin included gastrointestinal perforations (0.2 percent), arteriothromboembolic events (1.9 percent) and bleeding (3.7 percent).
Updated efficacy and safety data, including results for progression-free survival and overall survival, will be reported at the annual meeting of the American Society of Clinical Oncology in early June.
Roche has just completed enrollment in a Phase III trial evaluating the continued use of an Avastin regimen, compared to chemotherapy alone, after progression following first-line use of Avastin plus chemotherapy.
Avastin, which is designed to block a tumor’s blood vessel supply, is not currently approved for use as such a “maintenance” therapy.
Sandra Horning, global head of clinical oncology development at Roche’s Genentech unit, said the observational findings support the idea that Avastin is effective in multiple lines of therapy.
“The hypothesis needs to be tested in a rigorous clinical trial,” she said.
Initial treatment with Avastin for colorectal cancer costs about $48,000, with annual costs capped at $56,000 by Roche.
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The erectile dysfunction drug Viagra, and possibly other similar medications, may prompt long-term hearing loss among users, a new study suggests.
In the May 18 issue of the Archives of Otolaryngology — Head and Neck Surgery, researchers from the University of Alabama at Birmingham discuss evidence supporting an association between the onset of hearing problems and Viagra. The medication is one of the so-called class of phosphodiesterase type 5 inhibitors (PDE-5i), which also includes Cialis and Levitra.
The finding follows the 2007 decision by the U.S. Food and Drug Administration to adjust labeling for such medications to more prominently display warnings about hearing loss risks. The move stemmed from reports that year regarding sudden hearing loss among users of these drugs.
“It appears from these findings that the current government warning regarding hearing loss and the use of PDE-5i medications is warranted,” study author Gerald McGwin, a professor of epidemiology in the University of Alabama at Birmingham School of Public Health, said in a news release. “Though there are limitations to this study, it is prudent that patients using these medications be warned about the signs and symptoms of hearing impairment and be encouraged to seek immediate medical attention to potentially forestall permanent damage.”
The finding stems from an analysis of survey data concerning more than 11,500 men over the age of 40 that had been collected by the federal Agency for Healthcare Research and Quality between 2003 and 2006.
McGwin and his team found that men who said they used PDE-5i drugs had twice the risk for developing hearing loss as those who did not.
The authors stressed that more research is needed, while suggesting that one possible explanation could lie in the original purpose of these medications. They note that although now used mainly for erectile dysfunction, this class of drugs was initially prescribed for the treatment of pulmonary high blood pressure.
“PDE-5i medications work in erectile dysfunction patients by their ability to increase blood flow to certain tissues in the body,” said McGwin. “It has been hypothesized that they may have a similar effect on similar tissues in the ear, where an increase of blood flow could potentially cause damage leading to hearing loss.”
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Patients suffering from depression may find relief from treatments using electromagnetic stimulation, offering a possible alternative to mood-altering medications, a new study found.
The research, which was released on Monday, tested 190 patients who had previously failed to respond to antidepressant drugs.
Patients were given at least three weeks of magnetic stimulation. Scientists found that the treatment led to remissions for 14 percent of them, and that most remained in remission for several months.
The treatment, known as repetitive transcranial magnetic stimulation (rTMS) offers future hope of a non-drug treatment for depression sufferers, although researchers said additional studies are needed.
“This study should help settle the debate about whether rTMS works for depression,” said Mark George of the Medical University of South Carolina in Charleston, who led the research team.
“We can now follow up clues suggesting ways to improve its effectiveness, and hopefully further develop a potential new class of stimulation treatments for other brain disorders.”
The treatment aims to jump-start the brain’s mood-regulating circuitry by jolting the top left front section with an electromagnetic coil emitting 3,000 pulses over a 37-minute session.
Researchers said the treatments can be safely administered in a doctor’s office with few side effects, unlike more invasive brain stimulation treatments, such as electroconvulsive therapy (ECT).
The US National Institute of Mental Health-funded research showed that although the treatment “has not yet lived up to early hopes that it might replace more invasive therapies, this study suggests that the treatment may be effective in at least some treatment-resistant patients,” center director Thomas Insel said.
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Suicidal behavior in adults taking anti-depressants does not vary depending on what medication they are on, according to a study released Monday.
“There was no clinically meaningful difference in risk among individuals taking different classes of discount medications,” said researchers from Brigham and Women’s Hospital and Harvard Medical School in the study published in the May issue of Archives of General Psychiatry.
“Our finding of equal event rates across anti-depressant agents supports the US Food and Drug Administration’s (FDA) decision to treat all anti-depressants alike in their advisory,” it said.
“Treatment decisions should be based on efficacy, and clinicians should be vigilant in monitoring after initiating therapy with any anti-depressant agent.”
For the study, researchers examined the medical data of 287,543 adults in British Columbia, Canada, who began anti-depressant therapy between 1997 and 2005. During the first year of treatment, 751 people in the study attempted to commit suicide and 104 people carried it out.
“Despite the widespread use of antidepressant medications… there is inconsistent evidence that growth in anti-depressant use has reduced the prevalence of suicidal ideation or suicide attempts during the past decade,” said the study.
In October 2004, the researchers said, the FDA warned of potentially increased risk of suicidal thoughts and behaviors among children and adolescents taking anti-depressants, but subsequent research found no increased risk for adult anti-depressant users.
“Treatment decisions should be based on efficacy, and clinicians should be vigilant in monitoring after initiating therapy with any anti-depressant agent,” they said.
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