WASHINGTON (AFP) – The risks of taking anti-inflammatory drug Vioxx could have been detected nearly four years before the drug was pulled from the market, according to analysis of nearly 30 clinical trials.
The findings, published in the Archives of Internal Medicine on Monday, analyzed 30 Vioxx trials involving around 20,000 individuals and fund evidence of the drug’s risks from as early as 2000.
The Merck-made drug was pulled in 2004 after it was linked with serious cardiovascular problems, including heart attacks.
Much of trial data used in the meta-study has only become available because of litigation against the firm.
The study’s authors, including Joseph Ross of the Mount Sinai School of Medicine in New York, said the results showed the need for the open publication of clinical trials.
“Physicians and the public deserve to be in a position to make informed choices about risk and benefits (of pharmaceutical products),” the authors said.
Merck voluntarily withdrew Vioxx from sale in September 2004 after a company internal study in 2001 showed the drug doubled the risks of heart attack in patients who took it for 18 months or longer.
The company has since faced a slew of lawsuits and was forced to pay billions of dollars in damages.
THURSDAY, Nov. 19 (HealthDay News) — People’s genetic makeup has been shown to affect how they respond to asthma medications, but a new study finds that many people respond well to a particular combination treatment regardless of their genes.
However, the study did find a difference in response among blacks.
The drug combo in question combines the long-acting beta-agonist salmeterol (Serevent) and moderate doses of an inhaled corticosteroid. The genes in question relate to a receptor in the body that is crucial to the effectiveness of asthma bronchodilators.
Some research has suggested that a variation in these genes can affect how people respond to the drugs. The researchers tested that theory in 87 people who had two types of the genetic variation — B16 Arg/Arg or B16 Gly/Gly.
They found that lung function did not differ overall in the groups, although there was some difference in blacks. The results are reported online Nov. 19 in The Lancet.
“These findings provide reassurance that, in the general population, patients should continue to be treated with long-acting beta-agonists plus moderate-dose inhaled corticosteroids irrespective of B16 genotype,” the researchers wrote.
However, there are still questions to be answered, particularly involving blacks’ response to salmeterol, they said.
Women with asthma may notice that their asthma symptoms get worse at certain times of the month. Now, a new study confirms that fluctuating female hormone levels appear to affect airway inflammation, but oral contraceptives might help ease those changes.
In women who were not using birth control pills, the study found that increased levels of estrogen were associated with decreased levels of exhaled nitric oxide — indicating decreased airway inflammation. In these same women, increased levels of progesterone were associated with increased levels of exhaled nitric oxide, indicating increased airway inflammation.
However, birth control pills lessen dramatic hormone fluctuations, and researchers didn’t find differences in asthma symptoms throughout the month for women who took them.
“This study is a first step in looking at the relationship between hormones and asthma,” said the study’s lead author, Dr. Piush Mandhane, an assistant professor of pediatric pulmonology at the University of Alberta in Canada. The findings might be of use in managing asthma among premenopausal women, the researchers said.
“Among women not on oral contraceptives, we did have changes in exhaled nitric oxide that were related to estrogen and progesterone levels. We didn’t have an association with estrogen and progesterone in women on oral contraceptives,” said Mandhane.
Results of the study are published in the November issue of the journal Chest.
Mandhane said that because many women report a change in asthma symptoms related to menstrual cycles, it’s often assumed that there is an association. But, he said, the relationship between hormonal fluctuations and asthma symptoms hasn’t been well-studied.
The current study included 17 women. Eight were on birth control pills that contained estrogen and progesterone. The average age of the women using oral contraceptives was 25.5, while the average age of the women not taking birth control pills was 37.5.
Three of the women in the group not on birth control reported experiencing menstrual-cycle related asthma prior to the study, while just one woman in the birth control group did.
The researchers gathered daily information about symptoms and conducted blood tests to measure estrogen and progesterone levels, performed spirometry (a lung function test) and took measurements of exhaled nitric oxide. They also conducted allergy tests, via skin pricks every other day.
They found that women who didn’t take birth control pills had an average exhaled nitric oxide level of 48.2 parts per billion (ppb), while those on oral contraceptives had an average level of 27 ppb. In women who weren’t taking oral contraceptives, each increase in estrogen levels was associated with a decrease in exhaled nitric oxide, while each increase in progesterone was associated with an increase in exhaled nitric oxide. That means when progesterone levels are elevated (before menstruation), asthma symptoms are likely to be worse.
Progesterone increases also aggravated allergy symptoms, with more severe allergic reactions evident on skin prick tests when progesterone levels were elevated.
The researchers didn’t find any statistically significant differences in allergic reactions during the month for women on birth control pills.
Mandhane said that “birth control works by flattening out the fluctuations in hormone levels,” and that’s likely why there weren’t many differences in asthma symptoms for women taking birth control pills.
“Hormones do play a role,” said Mandhane, “and women need to be aware that there’s a potential relationship between their asthma symptoms and their menstrual cycles.”
Dr. Jennifer Appleyard, chief of allergy and immunology at St. John Hospital and Medical Center in Detroit, said that this study “lends credence to the fact that asthma is affected by hormones. This is definitely not something women should just write off. It’s not just all in their minds.”
But she also pointed out that this was a small study, and that the women in each group were very different from each other. “There were a lot of older women in one group who took more asthma medication. It’s not really comparing apples to apples,” she said.
Because birth control pills can have some serious side effects, Appleyard said she would not advise someone to go on oral contraceptives just to help their asthma. However, if a woman notices a difference in her symptoms throughout her menstrual cycle, she may want to talk to her doctor about increasing her asthma medications during that particular time in her cycle, she said.
LONDON (AFP) – British health professionals have called for a change in the treatment of dementia patients after an official report warned that wrongly prescribed anti-psychotic medicines are causing the deaths of an estimated 1,800 each year.
As many as 144,000 out of an estimated 180,000 people suffering from the disease are unnecessarily given powerful “chemical cosh” drugs, the Department of Health-ordered review revealed.
The report also linked a significant number of strokes among elderly patients due to over prescription of the medication.
“We need to be sure that only the people who benefit from these drugs get them, and they get them at the lowest possible dose for the shortest period of time,” Sube Banerjee, the report’s author and professor of mental health at King?s College London Institute of Psychiatry, said in the report.
“It is clear that these medications are being prescribed to deal with behaviour and psychological symptoms in dementia rather than just for psychosis,” he added.
Banerjee urged social care services to develop a “different mindset” in tackling the issue.
There are presently 700,000 people in the country with the condition, but the numbers are expected to rise to one million in the next decade because of an ageing population.
“We know there are situations where anti-psychotic drug use is necessary - we’re not calling for a ban, but we do want to see a significant reduction in use,” said care services minister Phil Hope.
Neil Hunt, chief executive of Britain’s Alzheimer’s Society, welcomed the review saying the recognition of the scale of the problem was long overdue.
“This goes beyond quality of care. It is a fundamental rights issue. Our members tell us of enormous worry and distress over what is happening to their loved ones,” he added.
Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed.
According to the report, when a company-funded study’s primary finding wasn’t favorable, that result was usually buried and something else positive was highlighted, without disclosing the switch.
The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers. The lawyers, who are seeking class action status for the cases, claim Pfizer concealed evidence the epilepsy drug Neurontin didn’t work for those unapproved uses, including nerve pain, migraines and bipolar disorder.
One of the report’s authors is an expert witness for the plaintiffs; another has received fees from the lawyers.
Pfizer disputes the report’s conclusions, saying the company never “attempted to mislead the medical community about the effectiveness” of the drug for certain uses.
“We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research,” Pfizer said in a statement.
The report, by researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public Health, comes two months after Pfizer was fined a record $2.3 billion — including an unprecedented $1.2 billion criminal fine — for illegally marketing other blockbuster drugs.
The report appears in Thursday’s New England Journal of Medicine.
Dr. Sidney Wolfe, head of health research at consumer group Public Citizen, called it the first comprehensive look “at studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was.”
“In every instance, the published article made the drug look better than it would have,” said Wolfe, a member of the Food and Drug Administration’s drug safety advisory committee. “This results in harm.”
Neurontin was approved by the FDA a decade ago for treating seizures and later for pain caused by shingles — but not for other conditions. Its potential side effects include suicidal tendencies and depression.
While doctors can prescribe drugs for unapproved, or off-label uses, drug companies are legally barred from promoting their products for such uses. Drugmakers often test drugs for additional conditions and publicize the results. But they don’t always seek approval for those new uses, particularly if the new findings aren’t convincing.
Experts believe most Neurontin sales were for off-label uses — the ones in the reviewed studies. Sales peaked at $2.7 billion in 2004, when Pfizer paid $430 million in government fines to settle allegations it improperly marketed the epilepsy drug for unapproved uses. By last year, Neurontin sales fell to $387 million due to cheaper generic versions sold as gabapentin.
For the new review, the researchers examined 20 patient studies funded by New York-based Pfizer and its Parke-Davis unit on use of Neurontin for preventing migraines or treating nerve pain or bipolar disorder. The studies were published in medical journals or presented at conferences, mostly over the last decade.
In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn’t disclosed at all.
The authors cited some limitations to their review, including not knowing who made the changes.
“We cannot be certain that selective reporting was a decision made by employees of Pfizer and Parke-Davis, since the authors of the published reports included nonemployees,” the researchers wrote.
Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report “one of the most ethically disturbing papers I’ve read in some time” and “an indication that people have been playing fast and loose with studies,” particularly industry ones.
Caplan said the FDA should have the power to audit industry drug studies. Wolfe said there should be bigger fines and jail terms for manipulating study data, plus tougher rules for studies being published in journals.
Medical journals in recent years have required that studies be listed on a federal Web site, http://www.clinicaltrials.gov, to be eligible for publication. That move was made partly to make it harder for industry to hide studies on products that don’t pan out and only publish those with good results. The study descriptions also list their primary and secondary outcomes.
Pfizer said it now has 1,245 company-sponsored studies listed on the Web site.
Men who regularly get moderate exercise may have a lower risk of developing prostate cancer — including aggressive, fast-growing tumors, a new study finds.
Researchers found that among 190 men who underwent biopsies for possible prostate cancer, those who exercised moderately — the equivalent of three to six hours of walking per week — were less likely to be diagnosed with the disease.
Compared with their sedentary counterparts, these men were two-thirds less likely to have a biopsy positive for prostate cancer. In addition, men who got the equivalent of one to three hours of walking each week had an 86 percent lower chance of having an aggressive form of the cancer.
The findings, which appear in the current issue of the Journal of Urology, do not prove that exercise helps prevent prostate cancer. But they could offer men yet more incentive to get active.
“If you need one more reason to exercise, this could be one,” said senior researcher Dr. Stephen J. Freedland, of the Duke University Prostate Center and the VA Medical Center in Durham, North Carolina.
A number of studies have looked at the relationship between exercise and prostate cancer, and while most have pointed to a protective effect, about one-third have found no association, Freedland told Reuters Health.
One question has been whether the positive findings reflect a greater tendency of health-conscious exercisers to get screened for prostate cancer. This study avoided that issue, Freedland said, by focusing on men who were sent for biopsies after concerning findings from prostate specific antigen (PSA) testing or a digital rectal exam.
He and his colleagues found that among the 111 sedentary men in the study, half were diagnosed with cancer after biopsy. That compared with 27 percent of those men who got the equivalent of three to six hours of walking each week.
And among men diagnosed with prostate cancer, 51 percent of sedentary patients had more-aggressive cancer, versus 22 percent of those who had been mildly active — getting the equivalent of one to three hours of moderate walking per week.
Exercise itself remained linked to a lower risk of prostate cancer after the researchers accounted for a number of other factors, like age, weight and race.
Along with studies finding a relationship between exercise habits and lower prostate cancer risk, there is also research showing that the connection is biologically plausible, Freedland said.
For one, he noted, exercise has been shown to lower blood levels of testosterone and other hormones that may stimulate prostate tumor growth. Exercise is also believed to stimulate the immune system and the body’s natural antioxidant mechanisms, both of which may help prevent the development of prostate cancer.
The US food and drug safety watchdog warned Thursday that an over-the-counter men’s sex aid, labeled as all-natural, contains a chemical similar to the active ingredient in Viagra and could be dangerous.
“‘Stiff Nights’, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal,” the Food and Drug Administration (FDA) said in a statement.
The FDA began probing Stiff Nights after receiving a customer complaint about the product. The agency did not reveal the nature of the complaint.
The investigation found that rather than being all-natural, Stiff Nights contains sulfoaildenafil, a chemical similar to the ingredient in Viagra.
“Because this product is labeled as an all-natural dietary supplement, consumers may assume it is harmless and poses no health risk,” said Deborah Autor, director of the FDA?s Center for Drug Evaluation and Research Office of Compliance.
“In fact, this product is illegally marketed and can cause serious complications,” she said.
Sulfoaildenafil could interact with prescription drugs known as nitrates and cause dangerously low blood pressure.
Stiff Nights is sold online and at retail stores in bottles or blister packs containing red capsules.
A bottle of 12 Stiff Nights capsules was being offered Thursday on Amazon for around 27 dollars.
Another website — mystiffnights.com — said the product is made with “only the finest herbs and greens.”
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The Merck-made drug was pulled in 2004 after it was linked with serious cardiovascular problems, including heart attacks.