I read these and just thought I would share them. Take what you want from them. I also supplied the links since the Michael Moore has an interview as well as the article.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.aarp.org/bulletin/yourlife/sicko.html
">http://www.aarp.org/bulletin/yourlife/sicko.html
</a>
Read an extended interview with "Sicko" director Michael Moore
After taking on General Motors, the U.S. gun culture and the Iraq war, Oscar-winning director Michael Moore has found a target designed to connect with all political affiliations: America's ailing health care system.
His new documentary, Sicko, goes straight for the heart, recounting the stories of people who were unable to get needed medical care for themselves or their families.
Moore, 53, says that Sicko is a departure from his past take-no-prisoners works. "I made this film in hopes of reaching across the great divide in this country, so I made it in a nonpartisan way," he told the AARP Bulletin. "I started with the premise that illness knows no political stripe."
In the movie, Moore visits Canada, England and France, where medical care is free - or at least taxpayer-funded. He takes 9/11 rescue workers suffering from various illnesses to the U.S. Naval Station in Guantanamo Bay, Cuba, for medical attention; they are ultimately treated in a Havana hospital. Because of that stunt, he's now under federal investigation for allegedly violating the Cuban trade and travel embargo.
Moore says he is buoyed by the early response to the film: "I've had Republicans come up to me after a screening and shake my hand and thank me."
After all, he says, Sicko "isn't just about health care - it's about how we treat ourselves as human beings."
<a target=_blank class=ftalternatingbarlinklarge href="http://www.aarp.org/bulletin/yourlife/edletter_july07.html
">http://www.aarp.org/bulletin/y.../edletter_july07.html
</a>
We've come a long way from the days of Warner's Safe Cure for Diabetes.
Warner's was an elixir peddled at the turn of the last century, typical of a generation of potions that were heavy on promotion and light on actual benefit. After decades of debate and a timely push from Teddy Roosevelt, Congress passed the Food and Drug Act of 1906. But like that law, every effort to regulate the industry since has faced stiff resistance from the drug industry. Granted, the pharmaceutical industry has helped make the nation healthier, kept us out of hospitals and nursing homes and extended our lives. As a nation, we depend on drugmakers' research skills and creativity. Still, the industry continues to mix a potent brew of financial largess and political influence that at times has stymied public officials and overwhelmed lawmakers.
Let's follow the money: Approval money. The Food and Drug Administration expects $400 million from the drug industry to finance the approval process of brand-name drugs next year. That distorts the FDA's drug approval process by accelerating availability of high-cost drugs at the expense of a growing backlog of low-cost generics whose approval depends on scarce federal funds.
Campaign money. The drug and health products industry has directed $93 million to congressional and presidential candidates since 2000, according to the nonpartisan Center for Responsive Politics.
Lobbying money. An army of 1,100 lawyers and arm-twisters has spent over $1 billion since 1998, more than any other industry, to influence public officials and shape drug legislation.
These three financial trails converged with a new Congress this spring and deflected efforts to secure greater FDA scrutiny, to let the secretary of health and human services bargain for lower drug prices and to reduce drug costs by legalizing imports from Canada. Over the last four years, industry lobbyists effectively blocked at least six separate bills approving importation. In May they did it again. The Senate also rejected a partial advertising ban for new drugs and the addition of another step to the approval process that would have added an independent voice in post-market assessments. That amendment failed by one vote.
The one constant in these debates was the pharmaceutical lobbying money and campaign contributions. This is not to suggest that the senators were bought off by campaign contributions. That's illegal, and it's not how the system works. But campaign contributions do provide special interests greater access to lawmakers.
And where does that leave consumers? Americans pay almost twice as much per capita for their medical care as people in other industrialized nations, yet our longevity rate is lower and our child mortality rate higher. The drugs we take are a major factor in those inflated numbers for medical care. A recent study by the management consulting firm McKinsey & Co. calculated that each American pays $728 a year for prescriptions, nearly twice the average cost for the industrial world. The pharmaceutical industry is fond of saying that as a share of the total health bill, Americans pay no more for their drugs than they did in 1960. That ignores the fact that the cost of health care today is three times what it was in 1960.
Warner's Safe Cure is long gone - except at antique shows. It was banned in the 1930s. In its wake are higher prices and a regulatory system that is vastly underfinanced and overwhelmed and remains too close to the pharmaceutical industry it is supposed to regulate.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.aarp.org/bulletin/yourhealth/is_the_fda_doing_its_job.html
">http://www.aarp.org/bulletin/y...da_doing_its_job.html
</a>
Is the FDA Doing Its Job?
Avandia scare raises more questions about safety.
By Patricia Barry
July-August 2007
First Vioxx, now Avandia. The news that this widely prescribed drug for type 2 diabetes might boost the risk of heart attack in some patients - though not yet scientifically confirmed - sent patients into a panic and once again raised questions on how well the Food and Drug Administration is doing as the country's watchdog on drug safety.
Some of those questions have been stinging. "We need to know if this is another Vioxx, where the FDA sat on its hands and endangered lives," thundered Sen. Chuck Grassley, R-Iowa, who began a congressional investigation.
The storm over Avandia, currently used by about 1 million Americans, broke on May 21 when the New England Journal of Medicine published a report by the Cleveland Clinic's Steven Nissen, M.D., former president of the American College of Cardiology. His analysis of 42 clinical trials suggested that the drug could cause a 43 percent increase in heart attack risk.
Avandia's manufacturer, GlaxoSmithKline, strongly disagrees with the findings, citing other, unpublished studies. Nissen himself acknowledges his analysis was "limited by a lack of access to original source data." Other experts say the issue is far from settled. "We don't know whether there's a small increased risk for everyone [on Avandia] or a very high risk for a few or no added risk at all," says Richard Hellman, M.D., president of the American Association of Clinical Endocrinologists. Even so, he adds, there was "absolutely a panic" among patients who called their doctors "within 24 hours of hearing it on the evening news."
FDA Commissioner Andrew von Eschenbach, M.D., defended the agency against accusations that it hadn't issued earlier alerts, telling reporters in May: "I believe we did it right in regard to Avandia." But in early June he announced that he had asked Glaxo and Takeda, which makes another diabetes drug, Actos, to place "black box" warnings - the strongest warning - about heart failure risks on their labels.
The incident has again raised the wider issue of how the FDA handles drug safety and to what extent Congress gives it the funds and regulatory teeth to do its job.
Fifteen years ago, faced with complaints from the drug industry that the FDA was taking too long to approve new drugs, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing drug companies to help fund the process. That shortened the review time but also resulted, critics say, in the agency losing its scientific independence. Over time, the FDA has become "more focused on the industry and less on what the science is telling us and what is in the best interest of public health," says Susan Wood, a former FDA official and now a professor at George Washington University's School of Public Health.
Wood and 21 other leading scientists and physicians recently sent a letter to Congress asking it to rethink PDUFA. Drug approvals completed too quickly, they said, are often associated with later safety problems. In 1999 the eight priority new drugs the FDA approved in only six months or less included Vioxx - the painkiller withdrawn in 2004 - and Avandia and Actos.
Next year the drug industry will likely pay the FDA's Center for Drug Evaluation and Research $400 million in user fees. "When you're getting paid directly from an industry you're supposed to be regulating, it takes quite a bit of edge out of the regulating," says Sidney Wolfe, M.D., director of health research for the consumer advocacy group Public Citizen, which often asks the FDA to withdraw drugs it considers risky. The group's publication Worst Pills, Best Pills currently lists 181 drugs it says "you should not use." Several of the brand-name drugs have been withdrawn from the market.
In February four former FDA heads said they'd prefer drug reviews to be funded by Congress rather than by user fees. Now, Grassley says of the drug companies' offer to pay for reviews, "We were suckers to take them up on it."
Experts say that the way complex new drugs are tested before approval - on relatively small groups of usually young and healthy people taking the test pill or a placebo - can't accurately forecast how safe they'll be over time for millions of patients who are older and may take several medications.
Yet the FDA devotes far more of its limited resources to approving new drugs than monitoring safety after they're on the market, according to two scathing reports from the Government Accountability Office and the Institute of Medicine in 2006. The IOM called on the agency to track the risks and benefits during a drug's entire lifetime on the market.
Congress has not yet given the FDA the authority to require drug companies to carry out post-marketing studies, and those conducted voluntarily are frequently not completed, the GAO says. In disputes over what action should be taken when safety problems arise, it is the FDA's approval office, which has closer ties to the industry, rather than the safety office that typically has the final say.
A Senate bill to reauthorize PDUFA, passed in early May, gives the FDA more ammunition to insist on follow-up studies. But an amendment giving the office of safety equal authority with the approvals office was defeated by one vote. The Avandia issue could push the provision into a House bill, Grassley says, but he doesn't underestimate drug industry opposition. "They don't want this sort of independence for post-marketing surveillance."
With increased use of prescription drugs, the FDA's workload has increased considerably in recent years, prompting AARP and many lawmakers to call for more funding for the agency.
There's also the issue of "transparency" - publishing all drug studies so scientists outside the FDA can review them and making the reasons for FDA decisions public. "Sometimes [drug safety] is complex, and there are pros and cons, and the data are not very solid," Wood says. "But at least we'd be able to see what's happening and why...and restore confidence in what FDA does."
What to do if you take Avandia:
Don't just stop taking medicine. If your blood sugar isn't controlled, the risk of heart disease increases along with other risks.
Ask your doctor: "What do you think is my risk on Avandia at this time?" That's because the medical condition of your heart may have changed since you began taking it.
If you're not considered at risk but are uncomfortable with Avandia, ask about alternatives such as the older drug metformin.
Consider insulin injections. Many people with type 2 diabetes become insulin-deficient with age. When used properly, insulin is safe and effective.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.aarp.org/bulletin/yourlife/sicko.html
">http://www.aarp.org/bulletin/yourlife/sicko.html
</a>
Read an extended interview with "Sicko" director Michael Moore
After taking on General Motors, the U.S. gun culture and the Iraq war, Oscar-winning director Michael Moore has found a target designed to connect with all political affiliations: America's ailing health care system.
His new documentary, Sicko, goes straight for the heart, recounting the stories of people who were unable to get needed medical care for themselves or their families.
Moore, 53, says that Sicko is a departure from his past take-no-prisoners works. "I made this film in hopes of reaching across the great divide in this country, so I made it in a nonpartisan way," he told the AARP Bulletin. "I started with the premise that illness knows no political stripe."
In the movie, Moore visits Canada, England and France, where medical care is free - or at least taxpayer-funded. He takes 9/11 rescue workers suffering from various illnesses to the U.S. Naval Station in Guantanamo Bay, Cuba, for medical attention; they are ultimately treated in a Havana hospital. Because of that stunt, he's now under federal investigation for allegedly violating the Cuban trade and travel embargo.
Moore says he is buoyed by the early response to the film: "I've had Republicans come up to me after a screening and shake my hand and thank me."
After all, he says, Sicko "isn't just about health care - it's about how we treat ourselves as human beings."
<a target=_blank class=ftalternatingbarlinklarge href="http://www.aarp.org/bulletin/yourlife/edletter_july07.html
">http://www.aarp.org/bulletin/y.../edletter_july07.html
</a>
We've come a long way from the days of Warner's Safe Cure for Diabetes.
Warner's was an elixir peddled at the turn of the last century, typical of a generation of potions that were heavy on promotion and light on actual benefit. After decades of debate and a timely push from Teddy Roosevelt, Congress passed the Food and Drug Act of 1906. But like that law, every effort to regulate the industry since has faced stiff resistance from the drug industry. Granted, the pharmaceutical industry has helped make the nation healthier, kept us out of hospitals and nursing homes and extended our lives. As a nation, we depend on drugmakers' research skills and creativity. Still, the industry continues to mix a potent brew of financial largess and political influence that at times has stymied public officials and overwhelmed lawmakers.
Let's follow the money: Approval money. The Food and Drug Administration expects $400 million from the drug industry to finance the approval process of brand-name drugs next year. That distorts the FDA's drug approval process by accelerating availability of high-cost drugs at the expense of a growing backlog of low-cost generics whose approval depends on scarce federal funds.
Campaign money. The drug and health products industry has directed $93 million to congressional and presidential candidates since 2000, according to the nonpartisan Center for Responsive Politics.
Lobbying money. An army of 1,100 lawyers and arm-twisters has spent over $1 billion since 1998, more than any other industry, to influence public officials and shape drug legislation.
These three financial trails converged with a new Congress this spring and deflected efforts to secure greater FDA scrutiny, to let the secretary of health and human services bargain for lower drug prices and to reduce drug costs by legalizing imports from Canada. Over the last four years, industry lobbyists effectively blocked at least six separate bills approving importation. In May they did it again. The Senate also rejected a partial advertising ban for new drugs and the addition of another step to the approval process that would have added an independent voice in post-market assessments. That amendment failed by one vote.
The one constant in these debates was the pharmaceutical lobbying money and campaign contributions. This is not to suggest that the senators were bought off by campaign contributions. That's illegal, and it's not how the system works. But campaign contributions do provide special interests greater access to lawmakers.
And where does that leave consumers? Americans pay almost twice as much per capita for their medical care as people in other industrialized nations, yet our longevity rate is lower and our child mortality rate higher. The drugs we take are a major factor in those inflated numbers for medical care. A recent study by the management consulting firm McKinsey & Co. calculated that each American pays $728 a year for prescriptions, nearly twice the average cost for the industrial world. The pharmaceutical industry is fond of saying that as a share of the total health bill, Americans pay no more for their drugs than they did in 1960. That ignores the fact that the cost of health care today is three times what it was in 1960.
Warner's Safe Cure is long gone - except at antique shows. It was banned in the 1930s. In its wake are higher prices and a regulatory system that is vastly underfinanced and overwhelmed and remains too close to the pharmaceutical industry it is supposed to regulate.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.aarp.org/bulletin/yourhealth/is_the_fda_doing_its_job.html
">http://www.aarp.org/bulletin/y...da_doing_its_job.html
</a>
Is the FDA Doing Its Job?
Avandia scare raises more questions about safety.
By Patricia Barry
July-August 2007
First Vioxx, now Avandia. The news that this widely prescribed drug for type 2 diabetes might boost the risk of heart attack in some patients - though not yet scientifically confirmed - sent patients into a panic and once again raised questions on how well the Food and Drug Administration is doing as the country's watchdog on drug safety.
Some of those questions have been stinging. "We need to know if this is another Vioxx, where the FDA sat on its hands and endangered lives," thundered Sen. Chuck Grassley, R-Iowa, who began a congressional investigation.
The storm over Avandia, currently used by about 1 million Americans, broke on May 21 when the New England Journal of Medicine published a report by the Cleveland Clinic's Steven Nissen, M.D., former president of the American College of Cardiology. His analysis of 42 clinical trials suggested that the drug could cause a 43 percent increase in heart attack risk.
Avandia's manufacturer, GlaxoSmithKline, strongly disagrees with the findings, citing other, unpublished studies. Nissen himself acknowledges his analysis was "limited by a lack of access to original source data." Other experts say the issue is far from settled. "We don't know whether there's a small increased risk for everyone [on Avandia] or a very high risk for a few or no added risk at all," says Richard Hellman, M.D., president of the American Association of Clinical Endocrinologists. Even so, he adds, there was "absolutely a panic" among patients who called their doctors "within 24 hours of hearing it on the evening news."
FDA Commissioner Andrew von Eschenbach, M.D., defended the agency against accusations that it hadn't issued earlier alerts, telling reporters in May: "I believe we did it right in regard to Avandia." But in early June he announced that he had asked Glaxo and Takeda, which makes another diabetes drug, Actos, to place "black box" warnings - the strongest warning - about heart failure risks on their labels.
The incident has again raised the wider issue of how the FDA handles drug safety and to what extent Congress gives it the funds and regulatory teeth to do its job.
Fifteen years ago, faced with complaints from the drug industry that the FDA was taking too long to approve new drugs, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing drug companies to help fund the process. That shortened the review time but also resulted, critics say, in the agency losing its scientific independence. Over time, the FDA has become "more focused on the industry and less on what the science is telling us and what is in the best interest of public health," says Susan Wood, a former FDA official and now a professor at George Washington University's School of Public Health.
Wood and 21 other leading scientists and physicians recently sent a letter to Congress asking it to rethink PDUFA. Drug approvals completed too quickly, they said, are often associated with later safety problems. In 1999 the eight priority new drugs the FDA approved in only six months or less included Vioxx - the painkiller withdrawn in 2004 - and Avandia and Actos.
Next year the drug industry will likely pay the FDA's Center for Drug Evaluation and Research $400 million in user fees. "When you're getting paid directly from an industry you're supposed to be regulating, it takes quite a bit of edge out of the regulating," says Sidney Wolfe, M.D., director of health research for the consumer advocacy group Public Citizen, which often asks the FDA to withdraw drugs it considers risky. The group's publication Worst Pills, Best Pills currently lists 181 drugs it says "you should not use." Several of the brand-name drugs have been withdrawn from the market.
In February four former FDA heads said they'd prefer drug reviews to be funded by Congress rather than by user fees. Now, Grassley says of the drug companies' offer to pay for reviews, "We were suckers to take them up on it."
Experts say that the way complex new drugs are tested before approval - on relatively small groups of usually young and healthy people taking the test pill or a placebo - can't accurately forecast how safe they'll be over time for millions of patients who are older and may take several medications.
Yet the FDA devotes far more of its limited resources to approving new drugs than monitoring safety after they're on the market, according to two scathing reports from the Government Accountability Office and the Institute of Medicine in 2006. The IOM called on the agency to track the risks and benefits during a drug's entire lifetime on the market.
Congress has not yet given the FDA the authority to require drug companies to carry out post-marketing studies, and those conducted voluntarily are frequently not completed, the GAO says. In disputes over what action should be taken when safety problems arise, it is the FDA's approval office, which has closer ties to the industry, rather than the safety office that typically has the final say.
A Senate bill to reauthorize PDUFA, passed in early May, gives the FDA more ammunition to insist on follow-up studies. But an amendment giving the office of safety equal authority with the approvals office was defeated by one vote. The Avandia issue could push the provision into a House bill, Grassley says, but he doesn't underestimate drug industry opposition. "They don't want this sort of independence for post-marketing surveillance."
With increased use of prescription drugs, the FDA's workload has increased considerably in recent years, prompting AARP and many lawmakers to call for more funding for the agency.
There's also the issue of "transparency" - publishing all drug studies so scientists outside the FDA can review them and making the reasons for FDA decisions public. "Sometimes [drug safety] is complex, and there are pros and cons, and the data are not very solid," Wood says. "But at least we'd be able to see what's happening and why...and restore confidence in what FDA does."
What to do if you take Avandia:
Don't just stop taking medicine. If your blood sugar isn't controlled, the risk of heart disease increases along with other risks.
Ask your doctor: "What do you think is my risk on Avandia at this time?" That's because the medical condition of your heart may have changed since you began taking it.
If you're not considered at risk but are uncomfortable with Avandia, ask about alternatives such as the older drug metformin.
Consider insulin injections. Many people with type 2 diabetes become insulin-deficient with age. When used properly, insulin is safe and effective.