Mylotarg won approval under abbreviated process help bring
Medicines cleared in that way must pass follow-up tests to confirm they work.
The Food and Drug Administration said on Monday it asked Pfizer to withdraw the drug after a recent clinical trial raised new concerns about the products safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
Mylotargs first-quarter sales were 8.8 million, making it a small product for the worlds largest drugmaker. The company reported first quarter revenue of 16.8 billion. Pfizer acquired Mylotarg when it bought Wyeth in October 2009.
Pfizer said it was voluntarily withdrawing the drug after a study showed adding Mylotarg to chemotherapy did not extend survival for patients with previously untreated acute myeloid leukemia AML, an aggressive bone marrow cancer.
We are disappointed that the study did not confirm the clinical benefit of Mylotarg, Dr. Mace Rothenberg, a Pfizer senior vice president, said in a statement.
The trial also showed more deaths in the first couple months of treatment. The fatality rate was 5.7 percent for Mylotarg patients, compared with 1.4 percent without the drug, Pfizer said.
Mylotarg is the first drug approved under the FDAs abbreviated process to be withdrawn for failing to show effectiveness, agency officials said.
The injectable drug was approved for treating certain patients age 60 and older with recurrent AML who were not candidates for other chemotherapy. Patients with AML have few treatment options and may die within months of a diagnosis.
The FDA cleared Mylotarg for sale in 2000 on the basis of trials involving 142 AML patients. About one-quarter of patients saw their disease go into remission.
The agency required a follow-up study to confirm Mylotarg helped patients live longer. The trial started in 2004 and was stopped ahead of schedule last year when researchers saw no benefit and the higher death rate.
AML affects about 13,000 new patients in the United States each year. Fewer than 2,500 are treated with Mylotarg annually, Pfizer estimated.
The drug will be withdrawn October 15, but Pfizer recommends that no new patients be prescribed it in the meantime.
People already taking Mylotarg may continue their course of therapy after consulting with their doctors, the company said. Mylotarg is given in two doses typically two weeks apart.
After the withdrawal, new patients can only be treated under an FDA process for testing of experimental drugs.
Mylotarg is sold in nine other countries. Pfizer will work with authorities there to determine the best action forward, Rothenberg said in an interview.
The drug was designed to be less toxic than other drugs by delivering cancer-killing effects straight to tumors, thereby minimizing damage to other cells and tissues.
There are no other medicines approved for treating relapsed AML. The number one option for people with relapsed disease is a clinical trial of an experimental medicine or a drug already sold for treating another disease, said Dr. Alison Walker, a hematologist and oncologist at The Ohio State University.
Mylotargs withdrawal is an example of the need to support the scientifically-rigorous post-marketing capability of the FDA for long-term study of risks and benefits from medicines, said Ryan Hohman, a spokesman for Friends of Cancer Research.
Pfizer shares fell 0.7 percent to close at 15.10 Monday on the New York Stock Exchange.
Reporting by Lisa Richwine editing by John Wallace and Tim Dobbyn source
They said raising price can soda percent cut soft drink
Obesity adds an estimated 147 billion a year in costs to the U.S. health care system and several states, including New York and California, have weighed a tax on sweetened soft drinks to defray the cost of obesity-related diseases.
Obesity is at epidemic levels. Its an incredibly difficult and complicated problem, said Dr. Jason Block of Harvard University in Boston, whose study appears in the American Journal of Public Health.
He said soft drinks have been increasingly recognized as a major contributor to the countrys growing obesity epidemic.
First Lady Michelle Obama last month unveiled a 70-point plan to reduce childhood obesity which called for an analysis of the impact of local sales taxes on consumption of less healthy foods.
Too much sugar not only makes people fatter, but is also a key culprit in diabetes, heart disease and stroke, according to the American Heart Association.
Regular soft drinks make up about 7 percent of all calories consumed in the United States, Block said in a telephone interview, adding that they are a major driver of obesity in the United States.
For the study, Block and colleagues raised the price of a can of soda by 45 cents or 35 percent in the cafeteria at the Harvard-affiliated Brigham and Womens Hospital in Boston and then measured the effect on sales.
The price increase applied to sugary soft drinks, which they defined as carbonated beverages with calories.
What we found is that a price increase of 35 percent on regular soda led to a 26 percent decline in regular soda sales, Block said.
Instead of reaching for an energy drink or fruit juice, people tended to increase their consumption of diet drinks or coffee during the study period, he said.
The team compared the effect of a price increase to an educational campaign, in which the team posted signs and information about weight loss and the need to cut back on sweetened beverages.
This appeared to have no effect on buying habits of regular soda, Block said.
He said the study suggests a price increase should be part of the conversation policymakers have among themselves as they weigh options to address obesity in the United States.
There are a number of proposals out there to levy taxes on soda. I think its an important discussion. We see from this study there is some evidence that it could work to reduce consumption rates, Block said.
The American Beverage Association, a trade group whose members include Coca-Cola Co, Pepsico Inc, and Dr Pepper Snapple Group, strongly opposes such taxes and says sugar-sweetened drinks are not a unique risk factor for obesity or heart disease.
SOURCE here. 175687v1
American Journal of Public Health, online June 17, 2010. source
Emergency department visits involving nonmedical use pain
We urgently need to take action, CDC Director Dr. Thomas Frieden said in a statement, noting that trips to the emergency department for nonmedical use of prescription pain drugs are now as common as those for use of illicit drugs.
These prescriptions medicines help many people, but we need to be sure they are used properly and safely.
SAMHSA Administrator Pamela Hyde said the increase in emergency department visits is straining the health care system.
This public health threat requires an all-out effort to raise awareness of the public about proper use, storage, and disposal of these powerful drugs, Hyde said in a statement.
The spike in emergency department visits associated with nonmedical use of these drugs occurred among men and women, as well as among those younger than age 21 and those 21 and older.
Abuse of other drugs, such as morphine, fentanyl and hydromorphone, resulted in fewer visits to the emergency room. But they, too, have increased sharply, according to the study published in the CDCs weekly report on death and disease.
Part of the increase reflects higher prescription rates among doctors in the United States, researchers said.
The top three most abused prescription pain drugs between 2004 and 2008 were
Oxycodone, in which emergency room visits for nonmedical use rose 152 percent to 105,214.
Hydrocodone, in which emergency visits rose 123 percent to 89,051.
Methadone, in which emergency visits rose 73 percent to 63,629.
The study was based on 2004 to 2008 data from SAMHSAs Drug Abuse Warning Network, a public health information system that monitors drug-related emergency hospital visits across the United States.
Last August King Pharmaceuticals won approval for its morphine-based drug Embeda, a pain medicine meant to help thwart abuse by those who crush or chew long-acting opioid drugs to get a dangerous high.
But in April FDA advisers urged the agency to reject an experimental painkiller from King and Acura Pharmaceuticals called Acurox pill.
U.S. government statistics show more than 13,000 fatal overdoses involving opioids occur each year.
Reporting by Julie Steenhuysen Editing by Xavier Briand source
Scientists international agency for research cancer iarc
Scientists at the International Agency for Research on Cancer IARC said that although they had not found a causal link, the results may be a clue to why some smokers never get lung cancer and some non-smokers or former smokers do.
Lung cancer is the most common form of the disease in the world and 90 percent of all cases are caused by cigarette smoking. It kills 1.2 million people a year.
About 10 to 15 percent of smokers develop lung canceralthough they often die of other smoking-related causes like heart disease, stroke or emphysema. Lung cancer is also known to kill people who never smoked or who gave up years ago.
The IARC study, which looked at around 900 people with lung cancer, found a link to low levels of vitamin B6 and an amino acid called methionine, found in protein like meat, fish and nuts. B6 is also found in meat, nuts, vegetables and bananas.
What we have found is that these two things are strong markers of lung cancer risk, but we have not shown they are causing that rise in risk, said Paul Brennan of the Lyon-based IARC, who led the study and published its findings in the Journal of the American Medical Association JAMA on Tuesday.
This indicates that diet may have an important role in lung cancer development, but its still a little premature to say simply that if you change your diet and eat more foods with these vitamins then youll change your future lung cancer risk.
NUTRIENTS KEY TO DNA HEALTH
Brennans team studied around 900 lung cancer patients, mostly smokers but also including about 100 who never smoked and 260 who had quit.
Brennan said the change in risk of lung cancer linked to B6 and methionine levels was the same for all three groups, although of course the overall risk of getting the disease was much higher in the smokers to start with.
For the two nutrients together, the risk reduction was about 60 percent, he said. Obviously if you had a very high risk because you smoke, then a 60 percent reduction of that is quite important, although not as important as quitting smoking.
Brennan said his findings appeared to reinforce previous research which suggested deficiencies in B vitamins may increase the probability of DNA damage and subsequent gene mutations.
A Swedish study in 2005 found that women with high levels of vitamin B6 had a lower risk of developing colorectal cancer.
Basically, these B vitamins and nutrients are all involved in the pathway which is responsible for the creation and maintenance of DNA, Brennan said. So obviously you would want that pathway to work as well as possible.
Editing by Peter Graff source
In page warning letter pfizer chief executive jeffrey
In a 12-page warning letter to Pfizer Chief Executive Jeffrey Kindler, the FDA cited numerous examples involving some of the companys top-known brands, including impotence drug Viagra, cholesterol pill Lipitor and seizure medicine Lyrica.
The delays in reporting side effects date back as far as 2004 and have grown in recent years, according to the FDAs letter that was released by Pfizer on Wednesday.
Ronald Pace, director of the FDAs New York office, told Pfizer in the letter dated May 26 that it had not properly documented or investigated reported problems in patients after the drugs were approved for use.
FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated, Pace wrote.
Pace asked Kindler to arrange a meeting between the company and the agency over the violations. Pfizer said it received the letter June 3.
The FDA conducted a 6-week inspection of Pfizers New York headquarters in July and August of 2009, where agency inspectors found system-wide lapses at the worlds largest drugmaker.
The patient reports contained serious and unexpected adverse events… that were not submitted until they were identified during the FDA inspection, Pace wrote. Efforts to fix the problem have been shown to be ineffective, he added.
In a statement, Pfizer said it would work with the FDA to satisfy the agency and to assure optimal surveillance and reporting of post-marketing adverse events.
But it also said that such individual reports are just one part of its overall monitoring of the drugs it sells and that it believes we provide complete and accurate data to determine the benefit and risk profile for all of our medicines, and to enable their safe and appropriate use.
In its letter, the FDA cited multiple examples of reporting lapses.
For example, while Viagra and similar medications are known to cause serious visual problems, including blindness, Pfizer failed to report cases related to its drug within the agencys 15-day deadline by misclassifying and/or downgrading reports to non-serious without reasonable justification.
And with Pfizers now withdrawn painkiller Bextra, FDA granted the company a waiver allowing 60 days to forward any complaints, a window of time the drugmaker still missed.
The FDA said Pfizer initially blamed the problems on a new computerized system to handle the reports, saying staff were not properly trained. In a September 2009 response to the agency, Pfizer told the agency it would update user manuals, better train its staff in the computerized reporting system and take other action.
Despite those steps, the FDA said in its letter that the companys actions were inadequate.
Pfizer told the FDA that its reporting improved after May 2009, but did not include any data backing up that claim, the FDA said. Additionally, the company did not prove to the FDA that it trained all the employees it said it would.
According to the FDA, the companys delays in telling the agency about reported complaints have only grown. About 4 percent of Pfizers 80,560 reports were sent late from March 2006 through December 2008 compared with 9 percent from December 2008 to June 2009, the letter said.
Additionally, the FDA cited Pfizer for not immediately telling the FDA about thefts and significant losses of its medications.
FDAs Pace requested an immediate meeting and asked for the problems to be fixed within 15 days, or an explanation provided if it would take longer. He also called for Pfizer to submit a revised plan to fix the problems.
Failure to fix the problems could result in legal action without notice and the FDA could delay action in approving the companys pending drugs, among other penalties, Pace said in the letter.
Reporting by Susan Heavey, additional reporting by Lisa Richwine Editing by Tim Dobbyn source
Dairy foods are a major source of saturated fat in diet
However, theres some evidence that dairy foods could actually benefit heart health, for example by lowering blood pressure or reducing cholesterol levels, Dr. Eva Warensjo of Uppsala University and her colleagues note in the American Journal of Clinical Nutrition.
To get a clearer sense of peoples intake of fat from dairy and heart disease risk, Warensjo and her team measured blood levels of two biomarkers of milk fat in 444 heart attack patients and 556 healthy controls. The substances, pentadecanoic acid and heptadecanoic acid, indicate how much dairy fat a person has been eating.
The researchers found that people with the highest levels of milk fat biomarkers, suggesting they consumed the most dairy fat, were actually at lower risk of heart attack for women, the risk was reduced by 26 percent, while for men risk was 9 percent lower.
Based on the American Heart Associations Heart Attack Risk Calculator, a normal-weight 60-year-old man with no risk factors for heart disease such as smoking or diabetes has a 6 percent risk of dying over the next 10 years the current study suggests, therefore, that if this hypothetical man ate lots of dairy food, he would reduce his risk by about half a percent. For a woman, or someone at higher risk of a heart attack, the benefit would be larger.
Dairy foods contain a number of potentially beneficial substances, such as calcium, vitamin D, and potassium, Warensjo and her team note. They have also been shown to increase peoples levels of good HDL cholesterol.
The exact mechanism behind these associations cannot be deduced from the present study, but the range of bioactive components present in the food matrix of milk products as well as associated lifestyle factors may all have contributed to the observed associations, the researchers conclude.
The study was funded in part by the National Dairy Council/Dairy Management Inc., a trade group for the US dairy industry. Dr. Warensjo has been a paid speaker for the Swedish Dairy Association and the International Dairy Federation.
SOURCE here show=amphits=10ampRESULTFORMAT=ampfulltext=Warensjoampsearchid=1ampFIRSTINDEX=0ampresourcetype=HWCIT
American Journal of Clinical Nutrition, online May 19, 2010. source
With obamas schedule largely dominated since april gulf
Many Republicans, meanwhile, have been focusing on healthcare in campaigning ahead of November elections that could cut into the Democratic majorities in the U.S. Congress.
Obamas speech at a senior citizens center in the Washington suburb of Wheaton, Maryland, was one of many events around the country to tout the overhauls advantages for older Americans.
They are considered an essential voting bloc because they show up reliably at the polls on Election Day, and polls show many are nervous about what the new law will do to Medicare, their government health insurance.
Your guaranteed benefits will not change. Eligibility wont change. Medicare will continue to cover your costs the way it always has. If you like your doctor, you can keep your doctor, Obama told the crowd of about 200 retirees before taking questions at the event and by telephone.
Obama and his fellow Democrats in Congress pushed through healthcare reform, his White Houses biggest legislative success, in March, after months of bitter partisan wrangling with Republicans, who say the plan is too expensive and an unwarranted government intrusion into a private industry.
Senate Republican leader Mitch McConnell dismissed Obamas renewed health care push as this major P.R. campaign to try to make something thats immensely unpopular popular.
He said, And I assume all this is designed to occur before the November election.
REMEMBER THE DEATH PANELS
Obama took aim at the opposition, who he said have spread nasty rumors and misinformation to scare older Americans.
The death panels, remember those he asked, referring to charges from some Republicans during his push to pass the healthcare law that the program would include panels to determine whether the sick and elderly should receive care or be left to die.
You have an entire party out there that is running on a platform of repeal. They want to roll back all these reform efforts, Obama said.
The event was timed to come before the first mailing on Thursday of 250 rebate checks to help the elderly pay for medications, one of the most popular provisions of the plan, which Obama signed into law in March.
At least 20 of the 50 U.S. states have joined a lawsuit seeking to overturn the sweeping reform of the 2.5 trillion U.S. healthcare system.
The states behind the suit, most with Republican attorneys general, claim the healthcare overhaul violates state government rights in the U.S. Constitution and will force massive new spending on hard-pressed state governments.
Obama told the audience that his plan would cut costs and included provisions to cut wasteful spending, and would not bankrupt Medicare and Medicaid insurance programs.
Obama also announced new programs to fight Medicare fraud, in another effort to appeal to those older than 65.
Additional reporting by Thomas Ferraro, editing by Stacey Joyce source
Twenty three percent patients dose schedule once every
Twenty-three percent of patients on a dose schedule of once every three weeks saw substantial shrinkage in their tumors, and 38 percent saw a marked reduction in the ovarian cancer biomarker CA-125.
The overall clinical benefit rate of 48 percent included patients whose disease did not progress while on two different dose regimens in the study.
The results from the study of 68 patients were presented at a meeting of the American Society of Clinical Oncology in Chicago.
These results demonstrate that NKTR-102 holds great therapeutic potential for women battling ovarian cancer, said Dr. Ignace Vergote, head of obstetrics and gynecology and gynecologic oncology at the Catholic University of Leuven, Belgium, and the studys lead investigator.
About 230,000 women worldwide are diagnosed with ovarian cancer each year, and nearly 70 percent with advanced disease die within five years.
NKTR-102 is also being tested in two separate Phase 2 clinical trials in patients with metastatic breast cancer and colorectal cancer.
Reporting by Susan Kelly in Chicago Editing by Peter Cooney source
In an analysis of 21 studies published in past 13 years
The same relationship was not seen, however, among premenopausal women.
The findings, published in the American Journal of Clinical Nutrition, add to a conflicting body of research into the relationship between dietary phytoestrogens and breast cancer risk.
Phytoestrogens are plant-based compounds that are structurally similar to estrogen and may have weak estrogen-like, as well as anti-estrogen, activity in the body. Some studies have linked high phytoestrogen intake to a lower risk of breast cancer, but others have suggested that the compounds may help fuel breast cancer growthor have no significant effect on a womans risk of the cancer.
Lignans are one of the three main types of phytoestrogen. The new study focused on lignans, in part because they are the main phytoestrogen in the typical Western diet.
Flaxseed and sesame are particularly high in lignans, and the compounds are also found in whole grains, berries and some other fruits, a number of vegetables such as broccoli and kale, and green tea.
For this study, Dr. Jenny Chang-Claude and colleagues at the German Cancer Research Center in Heidelberg combined the results of 21 previous studies on lignan intake and breast cancer risk. In some of the studies, researchers also took blood or urine samples to measure participants levels of enterolignanscompounds created when intestinal bacteria interact with dietary lignans.
Overall, the researchers found no correlation between womens lignan intake and their risk of breast cancer. However, when they separated the women by menopause stage, they found that high lignan intake – which they did not define in the study – was related to a somewhat lower risk of breast cancer.
In one study of nearly 60,000 postmenopausal women in France, for example, the one-quarter of women with the highest lignan intake were 17 percent less likely to develop breast cancer during the study period compared with the one-quarter with the lowest intakeestimated based on dietary questionnaires the women completed at the outset.
Breast cancer is the most common cancer in women worldwide, accounting for around 16 percent of all female cancers. It kills around 519,000 people globally each year.
The researchers on the French study accounted for a number of other factors in breast cancer riskincluding the womens age, family history of breast cancer, weight and history of estrogen exposure from birth control pills or hormone replacement therapy. The relationship between lignan intake and breast cancer risk remained.
Still, the overall findings of the review show only an association between higher lignan intake and lower breast cancer riskand do not prove that the compounds themselves confer the protection.
The studies the researchers evaluated had various limitations, such as relying on dietary questionnaires to estimate lignan intake instead of measuring it or watching what subjects ate.
And many were case-control studies, where researchers compared the reported diet histories of women with breast cancer to those of women without the disease these types of studies are not as strong as prospective studieswhere, for example, researchers would collect diet information at the outset, then follow women over time to see which ones developed breast cancer.
If lignans do have an effect on breast cancer development, these findings suggest it is likely to be moderate, Chang-Claude told Reuters Health in an email.
Still, foods high in lignans are also generally healthy ones, the researcher noted. Therefore, it might be advisable for postmenopausal women to include some lignan-rich foods in their diets, she said.
In theory, lignans and other phytoestrogens might protect against breast cancer by inhibiting the bodys own estrogen activity, or through other pathways, such as the compounds antioxidant effects.
Its not clear why lignan intake would have different effects in pre- and postmenopausal women, according to Chang-Claude and her colleagues. One possibility, they note, is that any protective lignan activity is only effective when womens natural estrogen levels are relatively lower, as they would be after menopause.
SOURCE here American Journal of Clinical Nutrition, May 12, 2010. source
Finding new flu drugs essential flu viruses mutate
In a paper published in Nature Biotechnology, scientists from Hong Kong and Canada said they had found a chemical nucleozin, which fought off both seasonal flu viruses and the H5N1 in mice as well as in cell culture.
We have now brand-new weapons to combat influenza virus resistant to … antiviral drugs like oseltamivir and zanamivir, said microbiologist Richard Yao at the University of Hong Kong, who led the study.
Nearly all of the seasonal H1N1 viruses circulating in the United States in the 2008-2009 flu season were resistant to Roche AG and Gilead Sciences Incs Tamiflu, known generically as oseltamivir, according to the paper.
Adamantanes, an older class of drugs, was also powerless against seasonal H3N2 flu viruses in the United States during that same period.
Zanamivir is the generic name for Relenza, GlaxoSmithKline and Biota Incs flu drug
Nucleozin targeted a protein in flu viruses, called nucleoprotein, that was responsible for virus replication, Yao said in reply to questions from Reuters.
Yao said they selected nucleozin from a chemical library with more than 50,000 compounds, the same library which experts here used to study the SARS virus.
Nucleozin is highly potent in cell culture and also in mice infected with the highly pathogenic influenza virus H5N1 … it can stop the virus from replicating, Yao said.
The compound was effective against H1N1, H3N2, and H5N1 viruses and researchers can now target nucleoprotein to fight flu, Yao said.
Scientists could now use nucleoprotein as a target to develop antiviral therapeutics for the treatment of influenza infection, he said.
A cousin of the new H1N1 swine flu virus, the seasonal H1N1, has been circulating widely for a long time. SARS surfaced in southern China in 2003, killing about 800 people world-wide.
The H5N1, although mainly a disease in birds, has a mortality rate of 60 percent on the rare occasions when it infects people. It was first discovered in people in 1997.
Reporting by Tan Ee Lyn Editing by Ron Popeski source