Quality Control: Johnson & Johnson, dealing with the fallout from a series of product recalls, is creating a new quality-control executive slot and is instituting a reorganization of its manufacturing side, CEO William Weldon told the WSJ in an interview. The revamp is designed to unify quality standards across the company’s range of business units — including McNeil Consumer Healthcare, where the manufacturing problems have occurred, the WSJ reports.

Health Care Worries: Despite the passage of health-care overhaul legislation, Americans still worry about whether they’ll be able to afford and access care, the Associated Press reports, citing a Robert Wood Johnson Foundation study due out today. The index used by the RWJF is intended to track attitudes over time, the AP says; its baseline of 100 was set last spring and has now slipped to 97.5 after ticking up when the legislation was passed, the AP says.

FDA News: Two quick FDA items: the agency is giving priority review to Bristol-Myers Squibb’s experimental immune-boosting treatment for metastatic melanoma, ipilimumab, the WSJ reports. (Positive data for the drug were reported at this year’s ASCO oncology confab.) Separately, the FDA is raising concerns about the safety of a proposed fibromyalgia treatment made by Jazz Pharmaceuticals, the WSJ reports. An FDA advisory committee meets tomorrow to discuss the drug, which is currently marketed for use against narcolepsy. The agency agreed that the drug helps control pain but is concerned about its potential for abuse, the paper says.

Treating Symptoms: In other news on fibromyalgia, a NEJM study finds tai chi can improve symptoms — including pain and fatigue — better than a general wellness and stretching program, the New York Times reports. The 66-patient study also found that those in the tai chi arm were more likely to feel better even after the 12-week program was over, the paper says.

Source: The Wall Street Journal

Popularity: 2% [?]

If you were planning a quick jaunt to Walgreens to find out your genetic risk for breast cancer or whether you’re likely to respond well to a statin, save yourself the trip. The drugstore chain is holding off on its plans to sell a mail-in DNA testing kit at 6,000 stores, pending a resolution of discussions between the test’s developer and the FDA.

As the WSJ reports, the FDA has contacted Pathway Genomics and suggested the company’s Insight test needs its clearance. For its part, Pathway tells the WSJ it believes the test complies with FDA rules but is “communicating” with the agency.

Putting this immediate issue aside, we were interested in one of the big concerns about this test and direct-to-consumer genetic testing in general: giving people often-vague information about their risks for certain diseases might cause worry and distress, especially if there’s no sure way to reduce those risks.

But that’s not how Thomas Goetz, a Wired editor and author of “The Decision Tree: Taking Control of Your Health in the New Era of Personalized Medicine,” sees it. He’s been active on Twitter all week, noting that the arguments against providing genetic information directly to consumers echo the old attitude — now seen as paternalistic — that doctors shouldn’t necessarily be straight with their patients about a diagnosis of cancer.

Moreover, even disturbing genetic information doesn’t lead to significant distress, he says, citing a NEJM study that found receiving the results of a genetic test for Alzheimer’s risk didn’t “result in significant short-term psychological risks.”

Of course, there are plenty of other concerns about getting your DNA information as easily as you’d buy toothpaste; following up on results might lead to unnecessary tests and procedures, for one. But Goetz’s notion that, as he says, “we don’t need the FDA or docs as info gatekeepers,” is an interesting one. Readers, what do you think?

Source: The Wall Street Journal

Popularity: 2% [?]

A trio of new studies has underscored both the distinct therapeutic advantages as well as the blockbuster market potential of two new oral drugs for multiple sclerosis. But while the studies demonstrated a reduction in the number of relapses and a slowing of disease progression–while beating an established interferon therapy after 12 months of treatment–the drugs’ ability to suppress the human immune system also triggered a higher rate of infections.

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The news in the NEJM articles was a clear plus for Novartis and Merck KGaA, which have both been advancing oral MS drugs through the pipeline. Novartis recently applied for approval of FTY720 in Europe and the U.S. Merck KGaA, meanwhile, recently ran into an unexpected hurdle at the FDA when regulators handed back its application for cladribine, calling it incomplete and delaying any U.S. launch. That leaves Novartis clearly in the lead for a groundbreaking approval.

The results “provide a new horizon for patients with relapsing-remitting multiple sclerosis and a welcome increase in the range of treatment options,” neurologist William Carroll wrote in the New England Journal of Medicine.

Novartis’ chief of global drug development told Bloomberg that the sales of FTY720 could “absolutely” surge past the billion-dollar mark to achieve blockbuster status. The drug, he added, is a “potentially game-changing therapy.”

While news of the higher infection rate may spur some caution around the drugs, analysts also note that Tysabri has been very successful in the MS market despite several deaths linked to a rare brain infection. That demonstrates that patients are willing to accept considerable risk when the therapy helps them to manage the disease.

Source: FierceBiotech

Popularity: 4% [?]

We know that directions for some medications can be confusing, but a letter from two doctors and other two health-care professionals to the New England Journal of Medicine warns that the instructions for giving children the flu medication Tamiflu could result in serious dosing errors.

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One of the letter writers is the parent of a 6-year-old for whom Tamiflu, made by Roche Holding, was prescribed. The parents — the other is a primary-care physician — said they had “great difficulty” determining the correct dose to give their child despite their training.

That’s because a syringe in the Tamiflu package comes with markings in milligrams, while the measurement dictated by the physician in this case used milliliters. The parents eventually figured out the correct dose by way of a mathematical formula they came up with to convert the measurements on the label to the markings on the syringe.

“Most families and caregivers would not be able to identify or perform the cumbersome calculations required to administer Tamiflu safely to children,” the authors warn in the letter appearing in the NEJM. They say there is a high chance for dosing errors, compromised treatment or toxic effects. The authors call for an immediate change to the instructions and packaging.

The CDC, in a nod to the possible confusion, posted a note on its flu Web site today warning health-care professionals of the issue.

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A spokeswoman for Roche said it is working with the FDA to alert physicians to the prescribing issue.

Source: The Wall Street Journal

Popularity: 3% [?]

Results from a small study published in the NEJM showed that Roche’s Avastin (bevacizumab) decreased the size of benign tumours in most patients with neurofibromatosis type 2 (NF2) and alleviated other complications associated with the rare genetic condition that can lead to hearing loss. Lead author Scott Plotkin commented that “our study is the first to provide evidence that a drug can shrink vestibular schwannomas – benign tumours on the balance and hearing nerves – and the first to show that patients’ hearing can be improved.”

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In the study, 10 patients with progressive NF2 and progressive vestibular schwannomas who were not candidates for standard treatment with surgery or radiation were administered Avastin intravenously every two weeks for a median duration of 12 months. Researchers found that treatment resulted in tumour shrinkage in nine patients. Six individuals achieved a decrease in tumour volume of at least 20 percent from baseline, with four maintaining the response during 11 to 16 months of follow-up, investigators noted.

Additionally, the study found that of the seven patients who began losing their hearing prior to the start of the trial, four regained some hearing, which was maintained for up to 16 months, while two had stable hearing and one experienced progressive hearing loss.

Plotkin indicated that based on the study’s results, researchers have started recruiting patients for a clinical trial of PTC Therapeutics’ VEGF inhibitor, PTC299, as a potential treatment for NF2. The oral compound, Plotkin said, may be easier to administer than Avastin and may also cause fewer side effects.

Source: FirstWord

Popularity: 3% [?]

One thing health-care practitioners know about treating the elderly is that they don’t know enough about treating the elderly.

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The point is underscored today by Richard C. Frank, a doctor who writes in a WSJ.com guest column about a 83-year-old patient with heart problems seeking aggressive treatment to fight non-Hodgkin’s lymphoma. The cancer is often curable but there is precious little information about how much an elderly patient with a weak heart — or other serious conditions, for that matter — can handle the normal rigors of anti-cancer treatment. Frank writes:

Clinical trials for cancer treatments usually enroll patients with few if any major health problems besides cancer. And patients in their 70s, 80s and 90s are notoriously underrepresented in trials, even though cancer is much more common in the elderly.

We know that older, sicker people are at higher risk of harmful side effects from cancer treatments, but we don’t know how best to vary those treatments to accommodate the wide range of health problems common in the elderly.

Of course, the fact that the elderly are underrepresented in much research has been well-known for a long time. In a 1997 analysis published in BMJ, researchers looked at a group of published studies and concluded that more than a third excluded elderly people without justification.

A 1999 study in the New England Journal of Medicine found those 65 years and older represented 63% of the population with cancer in the U.S. but they accounted for only 25% of people in cancer-treatment trials. There are some signs of change, however; an NEJM study published earlier this year looked only at women 65 and above who were at risk for a recurrence of breast cancer.

As for Frank’s lymphoma patient, the doctor came up with a treatment plan and the cancer has been in remission for two years. But Frank says of the patient: “Knowing that he received less-than-ideal therapy, I continue to worry about his cancer returning.”

Source: The Wall Street Journal

Popularity: 3% [?]

Findings from a study published in the NEJM demonstrated that standard adjuvant chemotherapy is superior to Roche’s Xeloda (capecitabine) in women 65 years of age and over who have early-stage breast cancer. Women who took Roche’s drug were twice as likely to have a relapse and almost twice as likely to die as patients in the chemotherapy arm, researchers noted.

In the study, 600 women aged 65 years and over with stage I, II, IIIA or IIIB breast cancer were randomised to receive standard chemotherapy or Xeloda. Data at three years showed the rate of relapse-free survival was 68 percent for those who took Xeloda, compared with a rate of 85 percent for women who were given standard chemotherapy.

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Lead researcher Hyman Muss noted that “this study is important because it is among the first several trials specifically targeted to older women with early-stage breast cancer and shows that chemotherapy can make a difference.” He remarked: “In this trial, we had hoped that [Xeloda] would be as good as standard therapy, so we would have a pill treatment with [fewer] side effects, but it turned out it wasn’t as good.” Muss suggested that “women who fit the criteria for the trial should be considered for standard chemotherapy or even more aggressive newer chemotherapy depending on their general health and risks for breast cancer recurrence.”

In response to the news, Roche spokeswoman Virginia Valenze said the findings were unexpected based on previous studies that showed Xeloda benefited women with more advanced cancer. She stated that no single drug has yet proven superior to combination therapy after surgery. In addition, Nancy Davidson, director of the University of Pittsburgh Cancer Institute, commented that “this trial does not say that capecitabine is an inactive drug — rather its routine use should be limited to women with advanced breast cancer,” adding that “it is also very useful in other cancers like colon cancer.”

Source: FirstWord

Popularity: 4% [?]

Data from two studies published in the NEJM showed that GlaxoSmithKline’s experimental drug mepolizumab produced positive results in patients suffering from severe and difficult-to-treat forms of asthma involving eosinophilic inflammation.

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In a study involving 20 patients with persistent sputum eosinophilia and symptoms despite treatment with prednisone, nine patients were randomised to receive mepolizumab in five monthly infusions, and 11 patients were administered placebo. Patients had been taking prednisone for around nine years, plus other asthma medications. Results demonstrated that “mepolizumab reduced the number of blood and sputum eosinophils and allowed prednisone sparing,” researchers concluded.

Senior author Paul O’Byrne commented that by preventing the production of eosinophils, a type of white blood cell that can trigger asthma symptoms, “we were able to improve asthma and reduce the need for prednisone by close to 90 percent.” In comparison, patients on placebo experienced flare ups in their asthma as prednisone was reduced, he explained. The researcher added that mepolizumab is only appropriate for patients with the eosinophilic form of asthma, and that larger studies are needed. O’Byrne stated that he is “optimistic” that trials in larger populations of this patient group will show the same benefits.

In addition, in a separate study of 61 patients with refractory eosinophilic asthma and a history of recurrent severe exacerbations, 29 patients were randomised to receive a monthly infusion of the anti-interleukin-5 monoclonal antibody for one year, while 32 patients received placebo. Regarding the primary outcome measure, findings indicated that mepolizumab “was associated with significantly fewer severe exacerbations than placebo” over the course of the 50-week treatment period, the study authors noted.

Ian Pavord, a study investigator, commented that GlaxoSmithKline’s drug made “quite a difference” for patients, and he suggested that the main challenge will be to provide screening to determine which patients have this form of asthma and can benefit from the treatment, if it is approved.

Source: FirstWord

Popularity: 3% [?]

As part of an ongoing investigation into the safety and efficacy of Merck & Co.’s and Schering-Plough’s Vytorin (ezetimibe/simvastatin), the US House Energy and Commerce Committee sent a letter to the companies asking for information related to the unblinding of two trials on the cholesterol drug prior to the conclusion of the studies.

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The letter, signed by Henry Waxman and Bart Stupak, specified that the committee wants information about decisions made by the data safety monitoring boards (DSMB) of the SHARP and IMPROVE-IT trials regarding the unblinding of their studies. The boards of the SHARP and IMPROVE-IT trials agreed to release their study data before the trials concluded, following a request in January 2008 from the DSMB of the SEAS trial.

Among the details being sought are the names, affiliations and contact information for the safety boards of the three trials, in addition to all documents related to an article published last year in the NEJM. The article dealt with the ongoing SEAS study and said that risks of cancer related to Vytorin were not credible, while an editorial in the same issue noted that it was premature to ignore concerns about the risks of cancer.

In response to the requests, a spokesman for Merck stated that “we are aware of a new letter from the House Energy and Commerce Committee and we plan to cooperate with [its] requests for information.” Waxman and Stupak have asked for the documents by March 6. Merck’s and Schering-Plough’s handling of data on Vytorin has been questioned by politicians and advocates since shortly after results from the ENHANCE trial, comparing Vytorin to Zocor (simvastatin), were released last year.

Source: FirstWord

Popularity: 3% [?]

Research findings published in the current issue of the NEJM suggest that US drugmakers are increasingly opting to perform late-stage clinical studies in developing countries, which in turn is raising serious concerns about the efficacy, ethics and economics of drug development. Lead author Seth Glickman indicated that “there are powerful forces luring clinical trials overseas, including the lower cost of doing business and access to larger study populations.”

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As part of the study, researchers examined government registries of Phase III trials and studies of industry-sponsored trials in 2007, as well as 300 articles reporting trial data published in the NEJM, JAMA and Lancet in 1995 and 2005. They found that, as of November 2007, about one-third of trials conducted by the 20 largest US-based drugmakers were being performed entirely abroad, and that 13 521 of 24 206 study sites were outside the country. In addition, the findings showed that from 1995 to 2005, the number of clinical trial sites in the US and Western Europe decreased, while the number conducted overseas doubled.

Researchers noted that regulatory hurdles faced by drugmakers in the US are partly responsible for the trend. The different regulatory standards abroad may make doing trials in the countries more enticing, but as study co-author Charles Cairns commented, the practice means relying on another regulatory system’s method of “test[ing] drugs to make sure they are safe and effective…Across the globe there are different standards and no uniform approach to conducting clinical trials.” Commenting on the news, Ken Johnson, senior vice-president of PhRMA, said that “regardless of location…companies seeking US approval must maintain the FDA’s high standards for conducting the trial…in addition to meeting the requirements mandated in these…emerging markets.”

Regarding the standards in the US, Glickman said: “many of the policies in regards to the regulatory framework are well intentioned…They have the unintended effect of being very onerous from the administrative standpoint.” The study authors recommended that regulations governing drug studies be reduced, while at the same time ensuring ethical standards, and that “key strategies for clinical trials should be outlined in formal clinical-development plans, publicly vetted, and submitted to regulatory agencies.”

PhRMA’s vice president for scientific and regulatory affairs, Alan Goldhammer, said the industry will review the suggestions made by the study’s authors and will consider whether they should be implemented. Meanwhile, an unnamed FDA spokesperson noted that the agency has started training regulators in countries where clinical trials are conducted for pharmaceutical manufacturers seeking drug approvals in the US.

Source: FirstWord

Popularity: 3% [?]