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Intensive Corticosteroid Treatment May be Best in Treating Severe Lupus

Kristina Michel — Wed, 28 Jul 2010 19:00:00 GMT

Large doses of corticosteroids given repeatedly over several weeks may be the best method of treatment for people with severe lupus, according to researchers at the UT Southwestern Medical Center in Dallas.

Lupus is an autoimmune disease in which the immune system attacks the body’s connective tissue cells, causing inflammation in the joints, heart, skin, kidneys, lungs and blood cells. In severe cases of lupus, patients are given corticosteroids (such as hydrocortisone, cortisone and prednisone) to control inflammation, usually for a few days intravenously. They are later given gradually smaller doses of oral corticosteroids. According to the researchers, however, a different, more intensive form of treatment—known as pulse treatment—where the patient is given high doses of corticosteroids intravenously over several weeks, is more effective and causes fewer side effects.

“By giving the very high dose early and frequently in the course of the disease, we could actually end up using much less steroids in the long run,” said Dr. Marilynn Punaro, professor of pediatrics at UT Southwestern and co-author of the study, in a news release. “This finding suggests that by doing so, we might be able to get the disease under control more quickly and patients might experience fewer long-term side effects.”

The researchers studied human and animal cells containing lupus and evaluated how different doses of corticosteroids affected cells called plasmacytoid dendritic cells. Plasmacytoid dendritic cells produce interferon alpha, which promotes the inflammation seen in lupus. According to their research, high doses of corticosteroids administered by IV were more effective in killing the plasmacytoid dentritic cells. In fact, oral corticosteroids failed to produce the same effect.

Although highly effective, corticosteroids have many severe side effects associated with long term use, including weight gain, severe acne, hyperglycemia, anxiety and osteoporosis. Punaro says their study proves why pulse treatment is more beneficial, minimizes side effects of corticosteroids and reduces the amount of corticosteroids needed to be used overall.

“If the patient receives very high doses of pulse steroids during the induction period, when steroid-sparing long-term drugs--which take a while to work--are being ramped up to an effective level, then our experience has been that we end up using fewer steroids overall,” Punaro said.

1.5 million Americans suffer from Lupus, according to the Lupus Foundation of America, and more than 16,000 new cases are reported each year across the country. Punaro said the next step in research will be to hold a clinical trial that compares the pulse treatment with standard therapy. While corticosteroids will always be a treatment option only for the most severe cases of lupus, Punaro also hopes that this research will enable doctors to use less corticosteroids more effectively.

The UT study is available online in Nature magazine.

28-Jul-10 2:00 PM

FDA Suspends Enrollment in Avandia Clinical Trial

Kristina Michel — Tue, 27 Jul 2010 17:00:00 GMT

The FDA told GlaxoSmithKline last week to temporarily suspend enrollment of new participants in a mandated clinical trial to study the effects of diabetes drug Avandia on the heart.

The FDA originally ordered Avandia’s manufacturer GlaxoSmithKline to conduct the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial to definitively decide if Avandia poses any greater risk for heart complications than similar diabetes drug Actos, manufactured by Takeda Pharmaceuticals. However, concerned health officials have criticized the trial, saying that it is unethical to enroll participants in a trial with little to no perceived benefits. U.S. senators are also concerned not enough is being done to inform participants in the trial of recent studies on Avandia, according to a letter to the FDA from the Senate Finance Committee sent back in February.

“After reading these documents, we would like to know what steps the FDA has taken to protect patients in the TIDE trial, and why this trial is allowed to continue,” the Senate Finance Committee wrote in the letter addressed to FDA commissioner Margaret Hamburg.

An advisory panel to the FDA decided in a meeting held July 13-14 that while it agrees (in a 24-4 vote) that Avandia may pose a greater risk of heart complications than Actos, no definitive proof exists to warrant removing Avandia from the market (by a 20-12 vote). The panel did recommend that more warnings and stricter guidelines about the risks of heart complications be issued on the drug. It also recommended that the TIDE trial should continue if the FDA decides to keep Avandia on the market in a 19-11 vote.

GlaxoSmithKline said in a statement released on its website that it will cooperate with the FDA’s decision to suspend enrollment. Ellen Strahlman, the company’s chief medical officer, also said it will use the time the FDA takes to decide if Avandia should remain on the market to provide patients and researchers participating in TIDE with information on the drug that was presented to the FDA advisory panel.

“This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the Committee’s recommendations,” Strahlman said. “We are committed to working with the FDA in the best interest of diabetic patients.”

Currently enrolled participants in the TIDE trial can still continue with the trial. The FDA has mandated that GlaxoSmithKline update officials involved in the TIDE trial on the new information presented at the advisory panel meeting and to update consent forms for current participants.

Avandia (rosiglitazone) and Actos (pioglitazone) are both part of the thiazolidinedione class of drugs that treat diabetes by reducing glucose, insulin blood concentrations and fatty acids by making the body more sensitive to insulin. Health professionals have been concerned about Avandia since a controversial meta-analysis report by Cleveland Clinic researchers Dr. Steven E. Nissen, MD and Kathy Wolski, MPH in the New England Journal of Medicine found that patients taking Avandia had a 43 percent increased risk of heart attack or other cardiovascular problems compared with patients taking a placebo.

Prior to the enrollment freeze, the recruitment goal for the trial was 16,000 participants. GlaxoSmithKline had enrolled 1,324 participants spread around 353 medical centers in 23 countries prior to the FDA mandate to suspend enrollment, according to a story on CNN Health.

The FDA is still considering whether or not to remove Avandia from the market. FDA spokesman Joshua Sharfstein said in an NPR news story that the agency hopes to finish its review by the end of the summer. Doctors have advised patients taking Avandia to discuss any concerns they have about the recent controversy with their primary care physician before they decide to stop using the drug.

27-Jul-10 12:00 PM

New Painless Flu Patch Could Change How People Receive Vaccines

Kristina Michel — Wed, 21 Jul 2010 18:00:00 GMT

In addition to providing a painless way to deliver the influenza vaccine, a new patch consisting of tiny, microscopic needles that dissolve into the skin developed by researchers at Emory University and the Georgia Institute of Technology could allow patients to administer the vaccine on their own.

The patch is made of a freeze-dried form of the vaccine mixed with a polymer material and arranged into an array of 100 microscopic needles along a backing the size of an adult fingertip. The needles are so small, they can’t be felt, and they quickly dissolve as they get absorbed into the skin. The backing of the patch is also water-soluble and can be discarded in ordinary waste bins after use. Researchers at Georgia Tech and Emory ultimately hope that the patch can adapted for use with several common immunizations that patients can pick up or have mailed from a pharmacy and then self-administer at home.

“We envision people getting the patch in the mail or at a pharmacy and then self administering it at home,” Sullivan said in a news release from Emory and Georgia Tech. “Because the microneedles on the patch dissolve away into the skin, there would be no dangerous sharp needles left over.”

The scientists compared the patch with administering the vaccine through a syringe in different groups of mice. According to the study, both methods proved equally effective in protecting one group of mice from infection from the seasonal flu virus 30 days later. However, after a second group of mice was infected three months after vaccination, scientists discovered the mice vaccinated with the patch were able to clear the virus more effectively from their lungs than the ones vaccinated via syringe. Richard Compans, a professor of microbiology and immunology at Emory, believes that the mirconeedle patch was more effective because the vaccine is absorbed through the skin instead of through the muscle as it would be from a syringe.

“The skin is a particularly attractive site for immunization because it contains an abundance of the types of calls that are important in generating immune responses to vaccines,” Compans said.

The patch still requires further clinical study. According to an article in the Houston Chronicle, it could be available in only five years. Researchers hope that the patch’s ease and efficiency of delivery will also help people in poorer nations, where poorer medical conditions can prompt the re-use of syringes and increase the risk of contracting diseases like HIV and hepatitis. They also see it simplifying vaccination programs in schools and assisted living facilities.

The study on the patch was published in the July 18 issue of Nature Medicine online.

21-Jul-10 1:00 PM

FDA Warns of Stolen Advair

Kristina Michel — Tue, 20 Jul 2010 14:00:00 GMT

The FDA has issued a warning for pharmacy professionals, doctors and patients to watch out for stolen Advair diskus inhalers being sold in pharmacies.

FDA investigators discovered that the inhalers, which Advair’s manufacturer GlaxoSmithKline reported stolen in 2009, have found their way into pharmacies and may have been inadvertently sold to patients. The FDA is concerned that the stolen medications may have been tampered with or improperly stored before they made it to pharmacies and could cause adverse reactions in patients. Pharmacy professionals and consumers should check their Advair supplies for the following lot numbers:

Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose, Exp: Sep 2010
Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose, Exp: Sep 2010

Advair medications containing these lot numbers should be immediately removed from the pharmacy supply and reported to the FDA Office of Criminal Investigations. Patients with inhalers containing these lot numbers should stop using them immediately and contact GlaxoSmithKline’s Customer Response Center and follow up with their physician or pharmacist to get a replacement inhaler.

More information on the warning on Advair medications is available on the FDA news release and on the GlaxoSmithKline news release.

20-Jul-10 9:00 AM

FDA Advisory Panel Reviews Avandia

Kristina Michel — Thu, 15 Jul 2010 15:00:00 GMT

An FDA advisory panel of medical experts that met on Tuesday has decided by a 20-12 majority that the diabetes drug Avandia will remain on the market but with stricter guidelines and warnings about the risks of heart complications.

The panel’s decision is the latest in a string of controversy that has surrounded Avandia (also known by the generic name rosiglitazone) ever since a 2007 report in the New England Journal of Medicine suggested that use of the drug could increase the risk of heart attack and other cardiovascular complications. According to news reports from the Associated Press, the panel voted in favor of leaving the drug on the market due to conflicting and inconclusive evidence on both sides of the issue.

"I didn't want to take away a drug without definitive evidence that it was bad for those few patients who need it," said Lamont Weide to the Associated Press, one of the panelists who voted to leave the drug on the market with new restrictions.

The controversy surrounding Avandia started in 2007. Cleveland Clinic researchers Dr. Steven E. Nissen, MD and Kathy Wolski, MPH, published a meta-analysis report in the New England Journal of Medicine that found patients taking Avandia had a 43 percent increased risk of heart attack or other cardiovascular problems compared with patients taking a placebo. This prompted the FDA to call a meeting that same year to decide whether or not to pull Avandia off the market. As it did this week, the panel voted to let Avandia remain on the market but with a safety alert and a black box warning.

The risk of cardiovascular problems associated with Avandia was further evaluated in the RECORD trial, which was conducted by Avandia’s manufacturer GlaxoSmithKline. In the trial, Avandia was compared against another popular diabetes medication, metformin. The trial, published in 2009, concluded that Avandia posed no greater risk for heart complications than metformin. However, the trial has received criticism from medical experts and politicians, and it divided officials within the FDA itself, such as Dr. Thomas Marciniak of the FDA division of cardiovascular products, who in the New York Times accused GlaxoSmithKline of inadequately conducting the trial. The controversy reached its climax on Tuesday, when the new FDA advisory panel met to review the RECORD trial and other clinical studies that have been published since the first panel review.

In a statement by GlaxoSmithKline, the company held that Avandia is safe and effective when used by the correct patient in accordance with product labeling. It also said that when the clinical trials held since 2007 are judged as a whole, Avandia poses no greater risk for heart complications than other diabetes drugs on the market.

“Results from six controlled clinical trials have been reported since the FDA last reviewed questions about the cardiovascular safety of Avandia in 2007,” the company statement said. “Together, these trials show that Avandia does not increase the overall risk of heart attack, stroke or death.”

Avandia was originally approved in 1999 for the treatment of type 2 diabetes. The drug is a part of the thiazolidinedione class of drugs that reduces glucose, insulin blood concentrations and fatty acids by making the body more sensitive to insulin. Critics of Avandia have suggested that Avandia be removed and patients taking the drug should instead use Actos (pioglitazone), manufactured by Takeda Pharmaceuticals, another thiazolidinedione that works much like Avandia without the associated heart risks. Although the panel voted to let Avandia remain on the market, it seemed to agree with critics, voting 21-4 that Avandia is more likely to cause heart problems than Actos. Actos, however, has also been found to increase the risk of bone fractures in women.

The advisory panel’s decision is not binding, and the FDA intends to review the risks associated with Avandia further, but it may be months before the agency comes to a final decision. As part of its review, which began in February, the FDA mandated that GlaxoSmithKline hold a clinical trial to decide definitively whether or not Avandia poses any greater risk of heart problems than Actos. GlaxoSmithKline is still recruiting patients worldwide, but it has experienced some trouble recruiting participants. The government of India placed a hold on studies going on in trial sites in its country due to the controversy surrounding Avandia. GlaxoSmithKline still hopes to recruit 16,000 participants with an expected completion date in 2015.

A similar study led by Dr. David J. Graham from the FDA's Center for Drug Evaluation and Research and published in the Journal of the American Medical Association found that Avandia posed a 25 percent higher risk of heart attack and a 27 percent higher risk of stroke than Actos did in elderly patients.

Physicans have cautioned that patients who are currently taking Avandia should not stop using it in spite of the scrutiny the drug has received. In a joint-statement issued by the Endocrine Society, the American Diabetes Association and the American Association of Clinical Endocrinologists, doctors representing all three organizations said patients should discuss any concerns they have about the news surrounding Avandia with their primary care physician before they decide to stop taking it.

"Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider," said Dr. Robert A. Vigersky, past president of the Endocrine Society. "Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short term health problems and could increase the risk of diabetes-related complications in the long term."

15-Jul-10 10:00 AM

Scientists Discover Potent HIV Antibodies That Could Boost Vaccine Research

Kristina Michel — Wed, 14 Jul 2010 17:00:00 GMT

Scientists at the National Institute of Allergy and Infectious Diseases (NIAID) have discovered three important human antibodies, two of which were able to neutralize 91 percent of known strains of HIV, that could play a significant role in HIV/AIDS vaccine research.

The antibodies, referred to as VRC01, VRC02 and VRC03, were discovered through a special molecular device that examines specific cells that make antibodies against HIV. According to the team, which was led by Drs. Peter D. Kwong, Ph.D., John R. Mascola, M.D. and Gary J. Nabel, M.D., Ph.D. at the NIAID Vaccine Research Center, VRC01 and VRC02 neutralized 91 percent of HIV strains while VRC03 neutralized 57 percent.

"The antibodies attach to a virtually unchanging part of the virus, and this explains why they can neutralize such an extraordinary range of HIV strains," said Mascola, who is also the deputy director of the NIAID Vaccine Research Center, in a news release.

In addition to discovering the three antibodies, the team was able to map the atomic structure of VRC01 and learn exactly where it attaches to HIV strains. Researchers have been trying to find and use HIV antibodies for years to create a vaccine. The problem is that the disease is already at an advanced stage by the time people begin producing antibodies, rendering most antibodies ineffective. Also, HIV varies by several different subtypes and is highly mutable. However, by identifying VRC01, VRC02 and VRC03 and understanding how they work, scientists hope to design a vaccine that can prevent HIV before people can even get infected.

“The discovery of these exceptionally broadly neutralizing antibodies to HIV and the structural analysis that explains how they work are exciting advances that will accelerate our efforts to find a preventive HIV vaccine for global use,” said NIAID director Dr. Anthony S. Fauci, M.D.

Manipulating the antibodies to create an effective vaccine will still take years of research and development. For now, scientists are content with the fact that this research has brought them one step closer to understanding how the body fights HIV and how to use that knowledge to develop a cure. Fauci also hopes that the technique the NIAID team used to identify the antibodies can be used to find effective antibodies for other infectious diseases.

“In addition, the technique the teams used to find the new antibodies represents a novel strategy that could be applied to vaccine design for many other infectious diseases,” Fauci said.

The NIAID research is now available online in the July edition of Science magazine.

14-Jul-10 12:00 PM

Study Ties Gene in Fat Cells to Type 2 Diabetes

Kristina Michel — Fri, 09 Jul 2010 15:00:00 GMT

A new study by researchers at the University of Cincinnati (UC) suggests that a specific gene in found in the fat cells could play a major role in the development of Type 2 Diabetes.

According to the UC study, led by Dr. Jorge Moscat, Ph.D., chair of the University of Cincinnati cancer cell and biology department, fat cells are regulated by a gene known as protein kinase C-zeta (PKC-zeta). Obesity, however, can cause the fat cells to become inflamed, which causes PKC-zeta to release a substance called IL-6. IL-6 travels to the liver, eventually causing the insulin resistance that leads to Type 2 Diabetes.

Moscat says this research is unique in that earlier studies had said a different gene called JNK1, known to regulate immune cells, also regulated fat cells and therefore was behind the inflammation in fat cells that could ultimately lead to Type 2 Diabetes.

"This finding is quite novel because current drug development efforts target immune cells to eliminate this hyperinflammation. Our research suggests obesity-related glucose intolerance has nothing to do with the immune system. It may be more effective to target adipocytes (fat cells),” said Moscat in a UC press release.

Type 2 Diabetes affects more than 23 million Americans, according to the CDC. According to Moscat, drug developers are currently working on treatments for Type 2 Diabetes that target JNK1, so these treatments could affect the both fat cells and immune cells. However, if PKC-zeta is what is really causing fat cells to become inflamed, drug developers will be able to produce pharmaceuticals that can treat Type 2 Diabetes without compromising the immune system.

Moscat and his colleagues are currently working with the University of Cincinnati’s Drug Discovery Department to develop compounds that regulate PKC-zeta for further research. In addition to treating Type 2 Diabetes, Moscat hopes that this research can help explain the role PKC-zeta plays in tumor growth and help researchers develop new drugs to prevent certain cancers.

“We believe a similar mechanism of action is at play in malignant tumor development,” Moscat said. “Now we are trying to understand how PKC-zeta regulates IL-6 to better determine how we can manipulate the protein to help prevent diabetes and cancer.”

The study is available online in the July issue of Cell Metabolism.

9-Jul-10 10:00 AM

International Study to Examine Benefits of Aspirin in the Elderly

Kristina Michel — Thu, 08 Jul 2010 17:00:00 GMT

United States and Australia researchers are collaborating to assess the health benefits of aspirin in the elderly in the largest international trial ever sponsored by the U.S.National Institute on Aging (NIA).

Led by researchers from Monash University in Australia and the Minneapolis Medical Research Foundation in Minnesota, the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial will recruit 19,000 participants from the U.S. and Australia to determine whether taking an aspirin a day can help prolong life and reduce the risk of disability or dementia in people over 70. NIA awarded $50 million last year to help fund the ASPREE trial, one of the largest contributions it has ever awarded an international study.

“ASPREE is unprecedented in that it’s the largest trial and the first international trial the NIA has ever done,” said Dr. Richard Grimm, Medical Director of the Berman Center for Outcomes and Clinical Research and the lead researcher of the ASPREE trial in the U.S, in a press release. “What we learn from this study will help determine whether physicians recommend aspirin as preventative medicine to their older patients.”

Participants in the trial will be randomly assigned either a low-dose aspirin or a placebo to take daily. Researchers will evaluate their progress over a period of five years. According to John McNeil, the head of the Monash School of Public Health and Preventative Medicine and lead researcher of the ASPREE trial in Australia, a daily dose of aspirin is known to help prevent heart attacks and some forms of stroke, and it may also help prevent mental decline and some forms of cancer. However, he said, aspirin is also known to have side effects such as bleeding, that may offset its benefits, especially in people over 70.

“We want to look at the potential of aspirin to improve the health of older (people) something that is increasingly important as the population ages,” McNeil said. “This age group has not previously been studied in sufficient numbers to inform health guidelines.”

Other sponsors include the National Health and Medical Research Council in Australia and Bayer, which is supplying the aspirin for the trial. Enrollment in the United States still ongoing in clinics across 11 states including Minnesota, Texas, Florida and North Carolina. The U.S will enroll 6,500 participants over the next two years.

More information is available at www.ASPREE.org or at the Minneapolis Medical Research Foundation website.

8-Jul-10 12:00 PM

First Ever Generic Version of Effexor XR FDA-Approved

Kristina Michel — Wed, 30 Jun 2010 18:00:00 GMT

The FDA has approved the first ever generic version of Effexor XR (venlafaxine hydrochloride) to treat major depressive disorder.

Teva Pharmaceuticals is expected to begin shipping the generic this week. It will be available as extended-release capsules in 37.5 mg, 75 mg and 150 mg strengths. Teva was also granted exclusive marketing rights for the generic for a period of 180 days.

“The approval of this widely used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs,” said Keith Webber, Ph.D., deputy director of the FDA Office of Pharmaceutical Science in the FDA news release. “Access to treatments for depression is important because depression can interfere with a person’s daily life and routine, which can significantly affect relationships with family and friends.”

According to the National Institute of Mental Health, major depressive disorder is the most common form of depression in the United States, affecting about 14.8 American adults in 2005. It is the leading cause of disability for Americans ages 15 to 44. A 2004 CDC study found that antidepressants are the most commonly prescribed drugs in the U.S.

Effexor is manufactured by Wyeth Pharmaceuticals, which merged with Pfizer last year. According to a press release from Teva, Effexor generated about $2.75 billion in sales in the U.S. last year.

30-Jun-10 1:00 PM

P&G Recalls Nasal Spray

Kristina Michel — Wed, 30 Jun 2010 15:00:00 GMT

Procter & Gamble is recalling its Vicks VapoSpray 4-Hour Nasal Spray after it found that some of the sprays may not meet the expiration dates listed on the packaging.

P&G said in a press release that the recall is voluntary, and it has not heard any consumer complaints about the nasal spray. It also advised consumers who have the recalled nasal spray with an expiration date prior to June 2013 to simply discard the product and talk to a health care professional if they feel they may have experienced any adverse reactions to the recalled product. Consumers can also report any adverse reactions they feel they may have experienced with the nasal spray through the FDA MedWatch Program.

More details about the recall for both consumers and health care professionals are available on the P&G website and an FDA news release. Consumers who have purchased the recalled nasal spray should contact P&G with any questions they have or to request a replacement coupon or refund.

VapoSpray was also sold under the names Sinex Nasal Spray and Sinex Ultra Fine Mist before June 2009.

30-Jun-10 10:00 AM

MIT and University of Delaware Researchers Develop Easier Way to Develop Longer-Lasting Drugs

Kristina Michel — Mon, 28 Jun 2010 16:00:00 GMT

A team of scientists from MIT and the University of Delaware has discovered a new chemical synthesis method that could help pharmaceutical manufacturers develop longer-lasting, more stable medicines.

The research team discovered an easier way to incorporate fluorine atoms into organic chemical molecules in drugs. Pharmaceutical manufacturers often try to attach fluorine atoms to the chemical structure of new drugs to enable them to last longer in the body, thus improving their effectiveness. However, the current chemical process requires harsh laboratory conditions and only works in a small number of cases. David MacMillan, a Princeton University chemistry professor who commented on the new chemical process, hopes it will make it much easier to synthesize new, more effective drugs at a reduced cost.

“Overnight, people are going to start using this chemistry,” MacMillan said in a news article by MIT . “Every single person in the pharmaceutical industry who makes molecules that incorporate fluorine to test as drugs has needed this reaction for a very long time.”

The process developed by the MIT and University of Delaware research team uses a soluble form of a precious metal called palladium as a catalyst to add a chemical compound called trifluoromethyl (CF₃), which contains one carbon and three fluorine atoms, to a drug’s overall chemical structure. CF₃ is tougher for the liver to break down, so a drug with CF₃ stays in a patient’s body longer. Some current drugs with the CF₃group include the arthritis medication Celebrex and the antidepressant Prozac.

The new process still needs some fine-tuning to be cost-effective for pharmaceutical manufacturers to use it on drugs currently on the market, but the researchers believe it will help reduce the overall cost to synthesize brand new drugs. Donald Watson, a chemistry professor at the University of Delaware who was a part of the research team, adds that since the synthesis method is simple and can work under mild lab conditions, it will become less expensive to reproduce further down the line. In addition to pharmaceutical applications, Watson also says the new synthesis method will have applications in agricultural chemical research and in alternative energy.

“In my lab we do basic science that has the potential for real-world applications,” Watson said in an article from the University of Delaware. “It's exhilarating to do research that will impact the way chemists build molecules.”

The research paper on the new synthesis method is now available online in the June 25 edition of Science. The research team was led by Stephen Buchwald, a chemistry professor at MIT. Other scientists on the research team included Eun Jin Cho, the lead author of the research paper, MIT postdoctoral associates Tom Kinzel and Yong Zhang, and Todd Senecal, an MIT graduate student.

28-Jun-10 11:00 AM

Mylotarg to be Pulled off the Market

Kristina Michel — Tue, 22 Jun 2010 16:00:00 GMT

Pfizer has decided to withdraw the leukemia treatment Mylotarg from the market after a post-approval clinical trial raised questions about the drug’s safety and effectiveness.

Mylotarg was originally approved by the FDA back in 2000 to treat patients over 60 who suffer from a rare form of cancer called acute myeloid leukemia (AML)--in particular patients suffering from relapse AML that are not considered candidates for standard chemotherapy regimens. The drug was approved under the FDA’s accelerated approval program, which requires a post-approval trial to evaluate the drug’s effectiveness on the market.

The post-approval trial, which began in 2004, was done to determine whether or not Mylotarg improved the survival time in patients when paired with a standard chemotherapy treatment. The trial had to be concluded in August last year, seven months ahead of its scheduled completion date in March, after preliminary results found no measurable benefits in participants taking Mylotarg. The study also found a higher death rate in participants taking the Mylotarg/chemotherapy combination when compared with participants taking chemotherapy by itself.

Pfizer plans to withdraw the drug effective October 15. After that, physicians wanting to prescribe the drug to new patients will have to submit an investigational new drug (IND) application to the FDA. Patients who are currently taking Mylotarg have been advised to consult with their primary health care provider before continuing their treatment. Until the drug is taken off the market, Pfizer has also recommended that physicians do not prescribe Mylotarg to new patients.

Acute myeloid leukemia is a form of leukemia characterized by the rapid growth of abnormal white blood cells that interfere with normal blood cell production in the bone marrow. Although a relatively rare cancer, AML is the most common type of leukemia to be diagnosed in adults over the age of 60. According to the American Cancer Society, the average age of a patient with AML was 67 in 2009. Few treatment options are available for patients with relapsed AML. Other than high dose chemotherapy regimens, the only other alternative treatment aside from Mylotarg is a stem cell transplant.

22-Jun-10 11:00 AM

Counterfeit Tamiflu Could Cause Adverse Reaction in Patients Allergic to Penicillin

Kristina Michel — Thu, 17 Jun 2010 21:00:00 GMT

The FDA has released a warning for consumers and health care providers about a fraudulent version of the antiretroviral drug Tamiflu marketed online as “generic Tamiflu.”

FDA investigators were able to purchase the fraudulent Tamiflu without a prescription from a fake Internet pharmacy. Then, they performed tests on it. According to the FDA news release, the product contains cloxacillin in place of Tamiflu’s active ingredient oseltamivir. Cloxacillin is an antibiotic in the same class as penicillin. The FDA is concerned that patients who are allergic to penicillin may experience similar adverse reactions to the fraudulent Tamiflu.

This is not the first time counterfeit Tamiflu has been found being sold in illegitimate Internet pharmacies. In 2009, during the height of the H1N1 swine flu pandemic, “generic Tamiflu” was one of many illegal, counterfeit products being marketed as treatments to the H1N1 flu virus. In 2005, customs agents seized over 50 shipments of counterfeit Tamiflu at a time when health officials were concerned about a global outbreak of the H5N1 bird flu virus.

The counterfeit Tamiflu was sent to FDA investigators in an envelope postmarked from India containing two foil-backed blister packages. The capsules were described as yellow- and tan-colored containing white powder. The foil backing is labeled in part, “Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules” and “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.”

Health care professionals who encounter the fake capsules should report them to the FDA Office of Criminal Investigations. Consumers should remain vigilant and protect themselves when purchasing drugs from an online pharmacy. All legitimate online pharmacies are licensed by the appropriate state board of pharmacy. The National Association of Boards of Pharmacy also gives a seal of approval to all state-licensed online pharmacies called the Verified Internet Pharmacy Practice Sites (VIPPS) Seal. Health care professionals and consumers may also report adverse events associated with use of the fraudulent Tamiflu to the FDA MedWatch Program.

Tamiflu is manufactured by Roche Pharmaceuticals. No FDA-approved generic version of Tamiflu currently exists on the U.S. market.

17-Jun-10 4:00 PM

Medicare to Review ESA Anemia Drug Coverage

Kristina Michel — Thu, 17 Jun 2010 16:00:00 GMT

The U.S. Centers for Medicare and Medicaid Services (CMS) will be reviewing its coverage of erythropoiesis-stimulating agents (ESAs), a type of drug used to treat anemia in patients with cancer and kidney disease.

The decision was made based on the testimony of an advisory panel back in March and on several studies indicating increased risk of cardiovascular problems associated with the long term use of ESAs in certain patients, the most notable being the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT), which was published in 2009. According to TREAT, patients who took the ESA Aranesp were at an increased risk of heart attack, stroke and blood clots than those who took a placebo. The FDA has been requiring all ESAs to be prescribed under a risk evaluation and mitigation strategy (REMS) since February to help ensure proper use of ESAs on patients who truly need them.

ESAs, marketed under the names Epogen, Procrit and Aranesp, are FDA-approved for the treatment of anemia resulting from chronic kidney failure, chemotherapy, certain treatments for HIV and to reduce the number of blood transfusions during and after certain major surgeries. The drugs work by stimulating the bone marrow to produce red blood cells. Amgen Inc. manufactures Epogen and Procrit while Johnson & Johnson manufactures Aranesp. Epogen is primarily marketed for use in patients with kidney disease while Procrit and Aranesp are primarily marketed for cancer patients.

According to an article in Reuters, Medicare covers the cost of about 90 percent of all U.S. citizens with end-stage renal disease. The CMS will be taking comments and documents from companies, the medical community, advocacy groups and others on the safety of ESAs until July 16.

17-Jun-10 11:00 AM

Claris Lifesciences Recalls IV Antibiotics, Nausea Medications

Kristina Michel — Mon, 07 Jun 2010 14:00:00 GMT

Claris Lifesciences has issued a voluntary recall of the IV antibiotics metronidazole and ciprofloxacin and the anti-nausea medication ondansetron after floating matter was discovered in some of the packages.

Ondansetron is used to treat nausea in patients undergoing chemotherapy, and metronidazole and ciprofloxacin are used to treat infection. The recalled products are all administered to patients intravenously. The concern is that if the products are indeed compromised and are administered to immune-compromised patients, it could result in dangerous and potentially lethal infection. Health care workers with the recalled products should not use them and should remove them immediately from their inventory.

All three recalled products are manufactured by India-based Claris Lifesciences. Claris has already stopped manufacturing the products as it investigates the circumstances surrounding the recall, and it has asked distributors to stop distributing the products and to quarantine them. So far neither Claris nor the FDA has received reports of adverse effects associated with using the medications. The FDA has not released word on whether or not it will investigate the recall.

Metronidazole, ciprofloxacin and ondansetron are distributed in the U.S. through Pfizer. Hospitals, wholesalers and distributors may contact Claris, Pfizer or the FDA for more information about the recall. Information about the recall, including a full list of the recalled lots, is also available on the FDA MedWatch website and the Claris and Pfizer websites.

7-Jun-10 9:00 AM

New FDA Warnings on Asthma Medications Now in Effect

Kristina Michel — Mon, 07 Jun 2010 13:00:00 GMT

The FDA’s new warnings for the use of long-acting beta-agonist (LABA) asthma medications officially went into effect last week.

Manufacturers of LABAs are now required to attach additional warning labels and recommendations regarding the use of LABAs in asthma and chronic obstructive pulmonary disease (COPD) patients. The agency is also adopting a risk evaluation and minimization strategy (REMS) to ensure that only patients who truly need LABAs should be allowed to use them. Under the new FDA guidelines:

Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
LABAs should be used for the shortest amount time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
Children who need a LABA in addition to their inhaled corticosteroid to control asthma should use a combination product containing both a corticosteroid and a LABA.

The FDA began looking into the safety of LABAs after the release of the Salmeterol Multi-center Asthma Research Trial (SMART) by GlaxoSmithKline, which manufactures salmeterol, back in 2003. According to the trial results, patients receiving salmeterol were at an increased risk for asthma-related death compared to patients receiving a placebo. After years of researching and data analysis, the FDA made its final recommendations on the usage of LABAs in February of this year. The agency also ordered LABA manufacturers to conduct studies on the risk associated with LABAs when used in combination with an asthma controller medication.

LABAs are prescribed to treat moderate to severe persistent asthma and COPD. They are usually available by themselves or in a combination with corticosteroids, which treat lung inflammation. The most commonly-prescribed single-ingredient LABAs include Serevent (salmeterol), manufactured by GlaxoSmithKline, and Foradil (formoterol fumarate), manufactured by Novartis. The most commonly-prescribed combination corticosteroid and LABA medications include GlaxoSmithKline’s Advair (fluticasone propionate) and AstraZeneca's Symbicort (budesonide and formoterol).

More information on the new regulations is available on the FDA website. The FDA also released a drug safety podcast in February for patients and health care workers when the new guidelines were made public. The podcast and transcript are available on the FDA Drug Safety page.

7-Jun-10 8:00 AM

New FDA/NIH Site Allows Veterinary Pharmacies to Report Safety Issues

Kristina Michel — Wed, 26 May 2010 15:00:00 GMT

Veterinary pharmacies and veterinary drug manufacturers have a new place to report product safety issues with the launch of the FDA and National Institutes of Health’s new Safety Reporting Portal.

The new site is part of a combined effort on the part of the FDA and the National Institutes of Health (NIH) to create a common, one-stop shop electronic reporting system. Instead of having to file multiple reports with different agencies, health care professionals, manufacturers, industry leaders and citizens may file a single report that will be forwarded to all agencies and parties concerned.

“The portal will be a key detection tool in improving the country’s nationwide surveillance system and will strengthen our ability to protect the nation’s health,” said Commissioner of Food and Drugs Margaret A. Hamburg the joint FDA-NIH-issued release. “We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public.”

In addition to the veterinary drugs, the Safety Reporting Portal also has a place where pet owners and veterinarians can report on problems with pet foods and treats, a reportable food registry that collects mandatory reports from the food industry and public health officials regarding problems with human and animal food products and a place where biomedical researchers can report adverse events in clinical trials involving human genetics.

Neither the FDA nor the NIH has released a statement on when the Safety Reporting Portal will be complete and ready for safety reporting on all agency-regulated products. Until completion, the portal redirects users who want to report on other products regulated by the FDA, the U.S. Department of Agriculture, Environmental Protection Agency or the Consumer Product Safety Commission to the appropriate web site location. Veterinary pharmacy workers may review the Safety Reporting Portal at http://www.safetyreporting.hhs.gov.

26-May-10 10:00 AM

New Drug Could Become another Treatment Option for Recurring Breast Cancer

Kristina Michel — Mon, 24 May 2010 16:00:00 GMT

Patients suffering from recurring breast cancer despite several rounds of chemotherapy could have another treatment option in Tokyo-based Eisai Pharmaceuticals’ new drug eribulin.

Recent studies on the drug, which Eisai will present at the American Society of Clinical Oncology (ASCO)’s 46th Annual Meeting in June, show that the drug’s unique mechanism of action could make it a potential third line of defense against recurring or metastatic breast cancer in patients who had previously received at least two rounds of chemotherapy treatment with common chemotherapy drugs anthracycline and taxane.

Eribulin’s unique mechanism of action is derived from Halichondrin B, a compound found in sea sponges. Like most chemotherapies, Halichondrin B acts as a mitotic inhibitor, meaning that it prevents cancer cells from growing and spreading by disrupting cellular division. What makes eribulin unique to other chemotherapy treatments is that it also programs the cancer cells to destroy themselves in a process called apoptosis. Also like most chemotherapy treatments, eribulin is infused intravenously and has much of the same side effects including depression of the immune system and lower blood cell count.

Eribulin’s effects were studied in three separate trials, including the Phase III clinical trial EMBRACE that will determine the drug’s approval for commercial use in Europe by the European Medicines Agency (EMA). According to a story in Reuters, Eisai has also filed for approval in the U.S. and in Japan. The FDA has not released word on whether or not it has begun evaluating eribulin for approval.

Eisai has also tested eribulin’s potential in treating several other cancers including colorectal cancer, ovarian cancer and urological cancer. The results of these trials will also be presented at the ASCO Annual Meeting in June.

Improving Safety While Advancing the Pharmacy Technician Profession

Kristina Michel — Wed, 12 May 2010 18:00:00 GMT

NPTA Launches New Certification Course: Safe Handling of Hazardous Drugs

HOUSTON—The National Pharmacy Technician Association (NPTA) is doing its part to improve the safety of pharmacy technicians with the launch of a new ACPE-accredited certification course on the safe handling of hazardous medications, also referred to as Chemo Certification.

The new course will teach pharmacy technicians the latest standards and recommendations on how to prepare, manipulate, store and dispose of hazardous drugs. NPTA’s Founder and CEO Mike Johnston said that he wanted to create a course that provided pharmacy professionals with quality education and valuable hands-on experience without faltering on convenience and affordability.

“It is a natural expansion for NPTA to launch a national certification course on the topic of safe handling hazardous drugs due to our extensive involvement with the National Institute for Occupational Safety and Health (NIOSH), the United States Pharmacopeia (USP) and the launch of Safe Handling Awareness Month,” said Johnston. “We want to ensure that pharmacy technicians have the validated practical experience to go along with a proper education on this topic.”

This course will be an extension of NPTA’s nationally recognized sterile products (IV) certification program. Due to the hazardous nature of the drugs being handled, pharmacy technicians must have successfully completed NPTA’s sterile products certification program or a similar ACPE-accredited program, or they must have documented significant work experience with aseptic technique.

Participants will be fully trained on the proper use of the Phaseal® system – the only clinically proven closed-system transfer device. Johnston hopes that this course will improve the safety of patients and health care workers by bringing well-educated and trained pharmacy technicians to the workforce.

“Employers are looking for individuals with accredited training and certification in preparing and handling hazardous drugs,” said Johnston. “Participants in this course will walk away with confidence in their ability to safely prepare and handle hazardous medications, protecting themselves, their co-workers and their patients.”

Registration for the course has already begun. Course dates, costs and enrollment information are available on the NPTA web site at www.pharmacytechnician.org/chemo.

About NPTA
The National Pharmacy Technician Association (NPTA), which was founded in 1999, is the largest non-profit trade association for pharmacy technicians in the world. The association represents over 30,000 individuals practicing in a variety of settings, such as retail pharmacy, health-system pharmacy, independent pharmacy, federal pharmacy services, purchasing, education and management. NPTA is the leading provider of accredited continuing education programs for Certified Pharmacy Technicians and offers advanced certifications in Sterile Products and Compounding. The association is committed to advancing the roles of pharmacy technicians to reduce medication errors and advocates for mandatory/standardized technician education, certification and registration. For more information on NPTA, call 888-247-8700 or visit http://www.pharmacytechnician.org

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12-May-10 1:00 PM

First Ever Cancer Vaccine FDA-Approved

Kristina Michel — Wed, 05 May 2010 19:00:00 GMT

Hailed as a milestone breakthrough in cancer treatment, the FDA has approved the first ever therapeutic vaccine to help treat prostate cancer.

The vaccine, called Provenge and produced by Seattle biotech company Dendreon, works by using the body’s own immune cells to target prostate cancer tumors and keep them from spreading. Doctors collect special blood cells from each patient that help the immune system recognize cancer as a threat. The cells are mixed with a protein found on most prostate cancer cells and another substance to build the immune system. The resulting "vaccine" is administered to the patient as three infusions two weeks apart. Provenge has been approved to treat prostate cancer types in patients who experienced few or no symptoms, are resistant to hormone treatment and have metastasized or spread to other areas of the body.

The FDA approval was based on the IMPACT study of 512 patients. According to the study, those receiving Provenge treatments lived, on average, about four months longer than those who did not receive the treatment. According to the FDA news release, almost all of the patients who received Provenge had some type of side effect including chills, fatigue, fever, back pain, nausea, joint ache and headache.

Prostate cancer is the second leading cause of cancer death in men in the U.S. after lung cancer. Over 27,000 men in the U.S. died from prostate cancer last year, and over 192,000 new cases were reported, according to the National Cancer Institute. Dr. Jonathan Simons, CEO of the Prostate Cancer Foundation in a statement made on the foundation's web site, called Provenge a validation of 16 years worth of funding the foundation has invested in cancer immunotherapy research. He hopes immunotherapeutic reseach will lead to a vaccine that can prevent prostate cancer altogether.

“Now the field gets to build upon and improve the micromanagement of the prostate cancer patient's immune system to fight their disease,” Simmons said. “Also, the concept that some day we could develop a preventative vaccine against developing prostate cancer in the first place gets a big scientific boost.”

5-May-10 2:00 PM