On MedRants, a commentator expressed this "managed care" view of the Vioxx mess:
Payers are frustrated that MDs are prescribing drugs patients don’t need, driving up short term costs with no attendant benefit to patients. Meanwhile, these decisions may very well lead to additional costs, as patients suffering cardiovascular events who also took COX-2s for WC injuries seek compensation from their WC payer.
The net - payers see MD prescribing behavior as abdicating responsibility, and increasing payer costs. Frustration is rampant.
I think there is plenty of blame to spread around for the Vioxx debacle. Physicians' enthuisiasm for Vioxx and other Cox-2 inhibitors clearly went beyond the evidence. And I think some physicians believed that Cox-2 inhibitors are actually more effective than regular non-steroidal anti-inflammatory drugs (NSAIDS), without evidence to support this belief.
However, before 2004, it would have taken some digging to find evidence that suggested Cox-2 inhibitors were actually dangerous. The published VIGOR trial data did show heart attack risk was higher in the Vioxx group, but this could have been due to chance alone.[1] Although the most evidence-based discussions of Cox-2 inhibitors did raise questions about cardiac risk, they offered no definitive conlusions (see the Cochrane Review[2] and ACP Journal Club[3] from 2002.)
Furthermore, even the most evidence-based physician would have had a hard time discouraging a patient absolutely determined to get a Cox-2 inhibitor before 2004, especially in the context of the typical 15 minute visit during which Cox-2 may have been only one of many issues raised. Such patients were not rare, due to vigorous direct to consumer (DTC) advertisements.
Managed care, of course, has to accept some blame for deluging physicians with paper-work and bureaucracy, while cutting reimbursements for office visits, thus making it financially disadvantageous for physicians to spend enough time with patients to discuss benefits and harms of treatments. Managed care, of course, likes to talk about "evidence-based medicine," but has provided little real support for clinical trials, systematic reviews, or educating physicians about evidence-based medicine. And managed care did nothing to counter all those fancy pharamaceutical DTC advertising campaigns that down-played the adverse effects of drugs, including Cox-2 inhibitors.
If managed care organizations really want patients to get the best possible care based on the best possible evidence, they should provide support and incentives for physicians to take enough time with patients, and for physicians to understand, have access to, and be able to use the tools of evidence-based medicine.
References
[1] Bombardier C et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520-8.
[2] Garner S et al. Rofecoxib for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev 2002; CD003685.
[3] Meyerhoff J. Rofecoxib, 25 md/d, was more effective than rofecoxib, 12.5 md/d, or acetaminophen in osteoarthritis of the knee. ACP Journal Club 2002; 137: 26.
Thursday, January 24, 2008
The Doppler Effect on the Fate of NIH Whistle-Blowers
See The Doppler Effect for an expanded discussion of the firing by the NIH of Dr. Fishbein after he raised questions about the Ugandan site of the nevaripine HIV prevention trial. (My discussion of this recent case of whistle-blowing with an unfortunate outcome for the whistle-blower is here.)
Sex Dreams Equal 8% of Adults' Dreams
Antonio Zadra, PhD, asked 109 women and 64 men to keep a dream diary for two to four weeks. Participants were about 30 years old, on average.
According to Zadra, only two other studies have probed the frequency and content of sexual dreams, and both of those studies were done more than 40 years ago.
In Zadra's study, participants jotted down every dream they had, whether it was sexual or not. All in all, they noted 3,564 dreams. Of those dreams, 292 included sexual content.
"Sexual intercourse was the most common type of sexual content, followed by sexual propositions, kissing, and fantasies," Zadra writes.
For men and women alike, sexual dreams accounted for 8% of all reported dreams. Zadra also notes that "masturbation accounted for approximately 6% of both male and female sexual dreams and an orgasm was experienced in approximately 4% of all sexual dreams."
However, there were some gender differences in sex dreams.
By Miranda Hitti
"Men's sexual dreams were more likely to take place in public or unknown settings, to have the dreamer initiate sexual contact, and to involve unknown characters or multiple partners," Zadra writes, adding that "gender differences in the content of everyday sexual dreams may reflect people's waking needs, experiences, attitudes, and concerns with respect to sexuality."
His findings were presented today in Minneapolis at Sleep 2007, a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society.
According to Zadra, only two other studies have probed the frequency and content of sexual dreams, and both of those studies were done more than 40 years ago.
In Zadra's study, participants jotted down every dream they had, whether it was sexual or not. All in all, they noted 3,564 dreams. Of those dreams, 292 included sexual content.
"Sexual intercourse was the most common type of sexual content, followed by sexual propositions, kissing, and fantasies," Zadra writes.
For men and women alike, sexual dreams accounted for 8% of all reported dreams. Zadra also notes that "masturbation accounted for approximately 6% of both male and female sexual dreams and an orgasm was experienced in approximately 4% of all sexual dreams."
However, there were some gender differences in sex dreams.
By Miranda Hitti
"Men's sexual dreams were more likely to take place in public or unknown settings, to have the dreamer initiate sexual contact, and to involve unknown characters or multiple partners," Zadra writes, adding that "gender differences in the content of everyday sexual dreams may reflect people's waking needs, experiences, attitudes, and concerns with respect to sexuality."
His findings were presented today in Minneapolis at Sleep 2007, a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society.
Any Type of Alcohol Drink Raises Breast Cancer Risk, New Study
A large US study suggests that it did not matter whether women drank beer, wine or spirits, they all raised the risk of breast cancer to the same extent. And more than three alcoholic drinks a day raised breast cancer risk by 30 per cent, compared to women who had less than one drink a day, said the researchers.
The study, one of the largest of its kind, was presented yesterday, Thursday, at the European Cancer Conference (ECCO 14) in Barcelona, Spain, and is the work of Dr Arthur Klatsky, adjunct investigator in the Division of Research, Kaiser Permanente Medical Care Program, Oakland, US, and colleagues.
Klatsky and colleagues showed that it made no difference what type of alcoholic drink the women had, it was the fact they contained ethyl alcohol that mattered, and how much was consumed.
The increase in breast cancer risk due to three or more alcoholic drinks a day is similar to that posed by smoking a pack of cigarettes or more a day said Klatsky. It is also similar to the risk posed by taking oestrogenic hormones he added.
Speaking at a news briefing, Klatsky explained that:
"Population studies have consistently linked drinking alcohol to an increased risk of female breast cancer."
"But there has been little data, most of it conflicting, about an independent role played by the choice of beverage type," said Klatsky.
The researchers studied the drinking habits of 70,033 women of different ethnic origin who underwent health exams during the period 1978 to 1985 and looked at the breast cancer incidence in the cohort in subsequent years.
They found that 2,829 of the women had been diagnosed with breast cancer by 2004.
The results showed that:
There was no difference in breast cancer risk between wine, beer and spirit consumption.
Even between red and white wine, the impact was the same.
In terms of overall alcohol intake, women who had between one and two drinks a day had a 10 per cent higher breast cancer risk compared to those who had one drink a day.
The risk went up to 30 per cent for women who had more than three drinks a day.
The results were the same for all age and ethnic groups.
Commenting on the results, Klatsky said that:
"Statistical analyses limited to strata of wine preferrers, beer preferrers, spririts preferrers or non-preferrers each showed that heavier drinking, compared to light drinking, was related to breast cancer risk in each group."
"This strongly confirms the relation of ethyl alcohol per se to increased risk," he added.
Although only a small proportion of women are heavy drinkers, and the risk of breast cancer varies among different groups, a 30 per cent increase in relative risk from drinking heavily probably translates to 5 per cent of all breast cancers being due to this habit.
Klatsky and colleagues have previously linked red wine to reduced heart attack incidence, and he said that different biological mechanisms probably explain the different effects.
The protective effect on the heart from red wine is probably due to increased HDL ("good") cholesterol, reduced blood clotting and reduced diabetes. But none of these has been shown to have anything to do with breast cancer, he said.
"The coronary benefit from drinking red wine may also be related to favourable drinking patterns common among wine drinkers or to the favourable traits of wine drinkers, as evidenced by US and Danish studies," said Klatsky.
Emphasizing that all medical advice should be tailored to the individual patient, Klatsky added that the only general statement that could be made from the findings was that it showed more reasons why "heavy drinkers should quit or cut down".
Klatsky concluded his conference presentation:
"This has been fascinating research. Our group has been involved in studies of alcohol drinking and health for more than three decades, including in the area of heart disease. We are fortunate to have data available about a large, multi-ethnic population with a variety of drinking habits."
According to a report in WebMD, Dr Shumin Zhang, associate professor of medicine at Brigham and Women's Hospital and Harvard Medical School, said the findings were "generally consistent with previous research".
Zhang, who did not take part in the research conducted by Klatsky and colleagues, has also found a link between frequent alcohol consumption and elevated breast cancer risk, said WebMD
The study, one of the largest of its kind, was presented yesterday, Thursday, at the European Cancer Conference (ECCO 14) in Barcelona, Spain, and is the work of Dr Arthur Klatsky, adjunct investigator in the Division of Research, Kaiser Permanente Medical Care Program, Oakland, US, and colleagues.
Klatsky and colleagues showed that it made no difference what type of alcoholic drink the women had, it was the fact they contained ethyl alcohol that mattered, and how much was consumed.
The increase in breast cancer risk due to three or more alcoholic drinks a day is similar to that posed by smoking a pack of cigarettes or more a day said Klatsky. It is also similar to the risk posed by taking oestrogenic hormones he added.
Speaking at a news briefing, Klatsky explained that:
"Population studies have consistently linked drinking alcohol to an increased risk of female breast cancer."
"But there has been little data, most of it conflicting, about an independent role played by the choice of beverage type," said Klatsky.
The researchers studied the drinking habits of 70,033 women of different ethnic origin who underwent health exams during the period 1978 to 1985 and looked at the breast cancer incidence in the cohort in subsequent years.
They found that 2,829 of the women had been diagnosed with breast cancer by 2004.
The results showed that:
There was no difference in breast cancer risk between wine, beer and spirit consumption.
Even between red and white wine, the impact was the same.
In terms of overall alcohol intake, women who had between one and two drinks a day had a 10 per cent higher breast cancer risk compared to those who had one drink a day.
The risk went up to 30 per cent for women who had more than three drinks a day.
The results were the same for all age and ethnic groups.
Commenting on the results, Klatsky said that:
"Statistical analyses limited to strata of wine preferrers, beer preferrers, spririts preferrers or non-preferrers each showed that heavier drinking, compared to light drinking, was related to breast cancer risk in each group."
"This strongly confirms the relation of ethyl alcohol per se to increased risk," he added.
Although only a small proportion of women are heavy drinkers, and the risk of breast cancer varies among different groups, a 30 per cent increase in relative risk from drinking heavily probably translates to 5 per cent of all breast cancers being due to this habit.
Klatsky and colleagues have previously linked red wine to reduced heart attack incidence, and he said that different biological mechanisms probably explain the different effects.
The protective effect on the heart from red wine is probably due to increased HDL ("good") cholesterol, reduced blood clotting and reduced diabetes. But none of these has been shown to have anything to do with breast cancer, he said.
"The coronary benefit from drinking red wine may also be related to favourable drinking patterns common among wine drinkers or to the favourable traits of wine drinkers, as evidenced by US and Danish studies," said Klatsky.
Emphasizing that all medical advice should be tailored to the individual patient, Klatsky added that the only general statement that could be made from the findings was that it showed more reasons why "heavy drinkers should quit or cut down".
Klatsky concluded his conference presentation:
"This has been fascinating research. Our group has been involved in studies of alcohol drinking and health for more than three decades, including in the area of heart disease. We are fortunate to have data available about a large, multi-ethnic population with a variety of drinking habits."
According to a report in WebMD, Dr Shumin Zhang, associate professor of medicine at Brigham and Women's Hospital and Harvard Medical School, said the findings were "generally consistent with previous research".
Zhang, who did not take part in the research conducted by Klatsky and colleagues, has also found a link between frequent alcohol consumption and elevated breast cancer risk, said WebMD
Even 1 drink a day may raise risk of breast cancer
BARCELONA, Spain -- All types of alcohol -- wine, beer and liquor -- add equally to the risk of women developing breast cancer, U.S. researchers said Thursday.
Previous studies have shown a link between alcohol consumption and breast cancer, but there have been conflicting messages about whether some kinds of alcohol were more dangerous than others.
The researchers, led by Dr. Arthur Klatsky of the Kaiser Permanente Medical Care Program in Oakland, Calif., revealed their findings at a conference in Barcelona.
Researchers analyzed the drinking habits of 70,033 women of various races from 1978 to 1985. By 2004, 2,829 had been diagnosed with breast cancer. Klatsky and his colleagues looked at which types of alcohol the women drank and their total alcohol intake. They compared it with that of women who had less than one drink a day.
They found no difference in the risk of developing breast cancer among women who drank wine, beer or liquor. Compared with light drinkers -- those who had less than one drink a day -- women who had one or two drinks a day increased their risk by 10 percent. Women who had more than three drinks a day raised their risk by 30 percent.
It is not clear how alcohol contributes to breast cancer, but some think it raises hormone levels in the blood to levels that could cause cancer.
Previous studies have shown a link between alcohol consumption and breast cancer, but there have been conflicting messages about whether some kinds of alcohol were more dangerous than others.
The researchers, led by Dr. Arthur Klatsky of the Kaiser Permanente Medical Care Program in Oakland, Calif., revealed their findings at a conference in Barcelona.
Researchers analyzed the drinking habits of 70,033 women of various races from 1978 to 1985. By 2004, 2,829 had been diagnosed with breast cancer. Klatsky and his colleagues looked at which types of alcohol the women drank and their total alcohol intake. They compared it with that of women who had less than one drink a day.
They found no difference in the risk of developing breast cancer among women who drank wine, beer or liquor. Compared with light drinkers -- those who had less than one drink a day -- women who had one or two drinks a day increased their risk by 10 percent. Women who had more than three drinks a day raised their risk by 30 percent.
It is not clear how alcohol contributes to breast cancer, but some think it raises hormone levels in the blood to levels that could cause cancer.
4 Foods To Fight Breast Cancer
As a woman, reading about an article related to a woman’s body as well as psychological aspect, interest me a lot. As I’ve read about this new article that I’me going to share, it makes me feel responsible to share this to all my readers. It’s something about what we can eat to cut cancer risk
Sometimes, some woman or mother rarely has time to cook because they are working. Figuring out on what to have for dinner is hard enough without having to factor in the latest news about food and cancer.
What to Eat
Fish: Fatty fish like salmon, sardines, and herring are high in omega-3 fatty acids, a healthy fat that's believed to have anticancer properties. Aim for two to three servings a week.
Cruciferous vegetables: Broccoli, cauliflower, and cabbage are powerful cancer fighters and appear to contain chemicals that turn on your body's natural detox enzymes. Eat them raw or slightly steamed (cooking breaks down the protective chemicals). Shoot for five servings a week.
Berries: The more colorful, the better! These fruits are rich in antioxidants, which protect cells from damage, and strawberries and raspberries contain ellagaic acid, which has been shown to protect against breast cancer in lab studies. Sneak these in wherever you can...toss some in your smoothie or even have some with dessert.
Whole grains: Lowfat sources of fiber, such as quinoa, unbuttered popcorn and cereals like All-Bran and Fiber One, may regulate your levels of estrogen and insulin, two hormones that both have been linked to breast cancer. Aim for 25 grams per day.
What to Watch
Red meat: You don't have to forgo the occasional burger (thank goodness!), but eating more than 1.5 servings of red meat per day can nearly double the chances of developing breast cancer. Limit your intake to three servings of lean cuts (such as filet mignon, flank steak or sirloin) a week or fewer.
Alcohol: As few as two drinks a day may increase breast cancer risk by 20 percent, possibly by raising estrogen levels. There's nothing wrong with having some wine with dinner, but it's safest to average no more than one drink a day. (Savor it! I mix soda water in my white wine to make one glass last through dinner.)
Sometimes, some woman or mother rarely has time to cook because they are working. Figuring out on what to have for dinner is hard enough without having to factor in the latest news about food and cancer.
What to Eat
Fish: Fatty fish like salmon, sardines, and herring are high in omega-3 fatty acids, a healthy fat that's believed to have anticancer properties. Aim for two to three servings a week.
Cruciferous vegetables: Broccoli, cauliflower, and cabbage are powerful cancer fighters and appear to contain chemicals that turn on your body's natural detox enzymes. Eat them raw or slightly steamed (cooking breaks down the protective chemicals). Shoot for five servings a week.
Berries: The more colorful, the better! These fruits are rich in antioxidants, which protect cells from damage, and strawberries and raspberries contain ellagaic acid, which has been shown to protect against breast cancer in lab studies. Sneak these in wherever you can...toss some in your smoothie or even have some with dessert.
Whole grains: Lowfat sources of fiber, such as quinoa, unbuttered popcorn and cereals like All-Bran and Fiber One, may regulate your levels of estrogen and insulin, two hormones that both have been linked to breast cancer. Aim for 25 grams per day.
What to Watch
Red meat: You don't have to forgo the occasional burger (thank goodness!), but eating more than 1.5 servings of red meat per day can nearly double the chances of developing breast cancer. Limit your intake to three servings of lean cuts (such as filet mignon, flank steak or sirloin) a week or fewer.
Alcohol: As few as two drinks a day may increase breast cancer risk by 20 percent, possibly by raising estrogen levels. There's nothing wrong with having some wine with dinner, but it's safest to average no more than one drink a day. (Savor it! I mix soda water in my white wine to make one glass last through dinner.)
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