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November 15, 2008
Confronting the Racial Barriers Between Doctors and Patients
The New York Times reports that the election of the nation’s first African-American president raises questions about racial disparities in health care. Pauline W. Chen, M.D. provides an account of her experiences,
Last Tuesday, like most of the country, I stayed up too late watching the election results come in and then became emotional when it was clear that Barack Obama, an African-American, was going to be our next president. Wednesday morning’s New York Times captured the most salient part of the moment for me in its headlines: “Racial Barrier Falls in Decisive Victory.”
But a few days later, as I thought more about racial barriers, I started to question my election euphoria. In politics, the racial barriers might have fallen, I thought, but what about in health care?
There is no question that racial barriers still exist in many parts of this society. The first time I remember having a frank conversation about racial barriers in medicine was during my residency.
Of all the surgical residents I trained with, “Eric” was easily one of the smartest. He possessed a great bedside manner, brilliant clinical skills and plenty of that Obama cool. Eric was African-American, and one night, when we were both on call together, he told me something I have never forgotten.
“You know, Pauline,” he said, “there are a lot of times when I go to a patient’s room for the first time and they ask me, 'Are you transport? Are you here to wheel me to radiology?’” I can remember Eric shaking his head as he spoke. “They never assume I’m one of the doctors.”
Most of the research over the last 30 years has focused on the racial inequalities that affect patients; and the findings have been dismal. In 2002, the Institute of Medicine published a report that cited multiple examples of disparities across a wide range of health care and disease settings. African-Americans, for instance, were more likely to undergo less desirable procedures like amputation of all or part of a limb, while minorities with some forms of lung cancer had higher mortality rates because they were less likely to have surgery.
While there are probably multiple factors involved, researchers over the past decade have looked at how patients’ and doctors’ race and ethnicity might contribute to these disparities. One of the leading researchers in this area is Dr. Somnath Saha at the Oregon Health and Science University in Portland. Dr. Saha and his colleagues have shown that minority patients and white patients report better health care experiences when their doctors are of the same race or ethnicity .
But as my residency colleague, Eric, could attest, race and ethnicity can also influence the experiences of minority physicians. A recent study by Dr. Irena Stepanikova from the University of South Carolina notes that white patients who had non-white physicians were more likely to report a medical error than white patients with white doctors.
After reading through these study results, I decided to give Dr. Saha a call. I thought I would initially ask a couple of questions about his research, but I could not help starting with the election.
“On the one hand,” Dr. Saha said, “Obama’s election really provides some hope for people who thought it was impossible. But his election doesn’t automatically change what happens on the ground floor. Part of the downside of this historical event is that we may no longer believe that race can create a disadvantage. We may forget that we still do look at certain racial and ethnic minorities in a different way — not consciously but unconsciously.”
“I think the first step in addressing the disparities,“ Dr. Saha continued, “is really acknowledging that certain things affect the way we deliver care — our own stereotypes, our own cultural upbringing, our own ‘anxiety meters’ when we are interacting with people who aren’t like the people we grew up with.”
I never forgot my conversation with Eric because I, as an Asian-American woman, have had similar experiences. When working on consults with a white medical student or resident, I have watched physicians from other departments in the hospital look past me in order to speak to them. When preparing to operate on organ donor patients in other hospitals, I have had nurses and scrub technicians walk by me to help my assistants first, assuming that they were the lead surgeons.
But my own experiences were not the only reason I remembered Eric this past week. I remembered because our frank discussion was deeply unsettling. In order to empathize with my colleague and friend, I had to do the very thing Dr. Saha was talking about: I had to acknowledge my own biases and stereotypes first. And that was not easy.
I have prided myself on being as fair and as compassionate a doctor as I could be. But I am also very much the daughter of Taiwanese immigrants; and when, for example, I see patients or colleagues who come from a similar background, empathy comes almost automatically.
However, when I meet individuals whose race or ethnicity differs from mine — individuals who, for instance, are black, white, Hispanic or American Indian — there are fewer shared experiences. So I, like others, unconsciously tap into past experiences in order to bolster the connection and bring a greater sense of familiarity to the interaction. And it’s difficult to acknowledge that what I have tapped into may not always be fair.
“I think the key is getting to know each patient’s story and to treat each patient as an individual,” Dr. Saha said. “In doing so, you can really begin to understand where he or she is coming from. Empathy is really walking in their shoes, getting to know them, and putting your own biases aside.”
“It takes time to do that, Pauline,” Dr. Saha reflected. “But when it happens, it can really be a powerful thing.”
November 15, 2008 | Permalink
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Rule Allows More Time Off For Families of Injured Troops
The Washington Post reports that the Labor Department released a new regulation yesterday allowing workers to take up to 26 weeks off each year to care for family members seriously injured in the military. Michael A. Fletcher writes,
The new rule grew out of a recommendation by the President's Commission on Care for America's Returning Wounded Warriors that was incorporated into legislation signed into law in January. The change will also allow relatives of active-duty National Guard members and military reservists to take off for up to 12 weeks to look after their affairs.
"We made sure we were as generous as we could be on this leave," said Victoria Lipnic, an assistant secretary of labor.
While they generally applauded the new leave provisions for military families, labor and family advocates were critical of other changes to the law, including rules on how employees must notify their bosses that they are taking leave.
The liberalized military leave entitlements are part of a series of modifications to the 15-year-old Family and Medical Leave Act that have been finalized by the Labor Department. The changes come after a nearly two-year review in which the department received more than 20,000 comments from worker advocates and employers. The rules will go into effect 60 days after their official publication on Monday.
"Everybody knew this was coming," said David W. James, a Labor Department spokesman. "There is no way it can be confabulated into being a last-minute regulatory change" by the outgoing Bush administration.
The changes also include a new requirement that workers notify employers before they miss work to care for family members or tend to their own health concerns. Currently, department officials say, the act is interpreted to allow people to take off and inform their employers as many as two days after the fact -- a provision that was protested by business owners.
"Lack of advance notice for unscheduled absences is one of the biggest disruptions employers point to as an unintended consequence of the current regulations," the department said in a fact sheet.
Also under the new rules, a worker with a chronic health condition is required to certify doctor visits at least twice a year for that condition.
The Family and Medical Leave Act allows workers to take up to 12 weeks of unpaid leave to care for family members or to recover from their own medical conditions. The act guarantees the leave and a continuation of health benefits, allowing workers to deal with family emergencies without risking losing their jobs.
Since the law's enactment, workers have used it 100 million times, according to family advocates, who had wanted changes that would make it easier for employees to take off under the law.
"The new FMLA regulations for workers take us in the wrong direction and are harmful and unnecessary," said Debra L. Ness, president of the National Partnership for Women & Families. "They will restrict access to protections that workers have relied on for 15 years."
AFL-CIO President John Sweeney also was critical of the changes to the law for nonmilitary workers. "Given the worsening economic situation facing families, we should be talking about how to expand successful laws like the FMLA to provide workers more job security and flexibility to deal with urgent family situations, not less," he said.
November 15, 2008 | Permalink
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November 14, 2008
FDA Blocks Chinese Milk Products
The Washington Post reports on the largest effort to date to keep products tainted with the industrial chemical melamine from reaching U.S. consumers. Annys Shin writes,
Federal food safety officials yesterday began holding up shipments of food from China that contain milk or milk-derived ingredients in the largest effort to date to keep products tainted with the industrial chemical melamine from reaching U.S. consumers.
The Food and Drug Administration is requiring importers of the halted shipments to test for the chemical, which is used to make plastic and fertilizer but has been added to human and animal food to boost protein readings. The types of products likely to be waylaid are cookies, candies, and other goods made with milk or milk powder.
If an importer can prove his product is not tainted, FDA will release it, said Steve Solomon, the agency's deputy associate commissioner for compliance and policy. The agency also will step up its testing of products already on the market.
FDA Commissioner Andrew von Eschenbach and Health and Human Services Secretary Mike Leavitt are scheduled to travel to China next week to meet with food safety officials there about melamine and other issues, and to open FDA offices in three Chinese cities.
Since September, FDA officials have recalled several products -- sold mainly in ethnic grocery stores -- due to possible melamine contamination. They chose to take broader measures yesterday based on the results of product testing and on information from food safety officials in other countries.
"We're taking regulatory action to make sure we're controlling these products," Solomon said. Consuming large amounts can lead to kidney stones and even death.
FDA officials said they were taking action despite the small likelihood that melamine in processed foods is harmful, as was the case with infant formula in China. At least four infants have died and tens of thousands more have become sick. "The finished product is not going to cause the same adverse affects," Solomon said.
The FDA recently did a risk assessment of melamine and concluded that for products other than infant formula, levels of melamine below 2.5 parts per million do not raise public health concerns.
Consumer advocates had a mixed reaction to the FDA's action. "Given the revelations of the extent of the problem in China, this step is both precautionary and appropriate," said Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest, a Washington-based advocacy group. "The question is, did FDA wait too long to stop the spigot?"
Concern over the scope of melamine contamination in the global food supply has been growing since Chinese officials first acknowledged the infant formula problem. Since then, melamine has been found in frozen yogurt, instant coffee, and chocolates sold in countries such as Singapore, New Zealand, South Korea, Spain, Yemen, Canada and the United States. In recent weeks, the chemical has also turned up on Chinese eggs and in fish feed.
Rep. Rosa DeLauro (D-Conn.), who chairs the appropriations subcommittee with jurisdiction over the FDA, said the agency should have acted sooner and included egg and fish products. "Clearly, the problems involving melamine in China are significantly deeper than FDA would have us believe," she said.
Melamine is officially banned from human and animal food in China. The prohibition was put in place after last year's recalls of melamine-tainted pet food and the deaths of thousands of pets in the United States. Chinese officials have made arrests in the infant formula scandal and vowed to step up regulation.
November 14, 2008 | Permalink
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Obama Urged to Overhaul Healthcare, Stat
The Los Angeles Times reports that four leading adovcacy groups representing business, labor, and reitrees retirees are calling for comprehensive healthcare reform in the new administration's first 100 days. Noam N. Levey writes,
Reporting from Washington -- Four leading advocacy groups representing business, labor and retirees are starting a campaign today to press Barack Obama to enact comprehensive healthcare reform, upping the pressure on the president-elect to tackle the issue quickly after he takes office.
In a letter to Obama, the Business Roundtable, the National Federation of Independent Businesses, AARP and the Service Employees International Union urge that a healthcare overhaul be a priority in the administration's first 100 days.
The groups plan to spend nearly $1 million to publicize their cause in newspaper and television advertising in coming weeks.
"What we are doing is reminding not just the president but the Congress as well that . . . this remains one of the most important issues facing the country," said Business Roundtable President John Castellani. "We need to now follow through."
In their letter, the groups link healthcare reform with the nation's bleak economic conditions.
"Addressing skyrocketing healthcare costs is a critical component of stabilizing household, national and global economies," the letter said. "Inaction undermines the economic security of our families; limits the productivity of our workforce; stagnates job creation and wage growth; and threatens to crowd out investments in energy, education and infrastructure."
Obama made healthcare reform a central plank of his presidential campaign, pledging a sweeping effort to expand coverage and lower costs.
But since his victory, he has not indicated how he plans to proceed with an overhaul that could cost hundreds of billions of dollars and spark an intense political battle.
In a national radio address Saturday, Obama made a general reference to healthcare reform, listing it with energy, education and tax relief as "key priorities."
Several senior House Democrats have indicated they are uneasy about tackling broad healthcare legislation in the first months of the new Congress.
House Speaker Nancy Pelosi (D-San Francisco) has talked about an effort to expand the popular State Children's Health Insurance Program, a more limited initiative that President Bush vetoed last year.
But there are growing calls elsewhere in the Democratic Party for swift action.
Sens. Edward M. Kennedy (D-Mass.) and Max Baucus (D-Mont.), who chair the committees that would probably put together any healthcare legislation, have urged Obama to move quickly.
On Wednesday, Baucus plans to unveil a plan for universal health insurance coverage.
The Service Employees International Union, or SEIU, one of the nation's most powerful unions and an Obama supporter, is mobilizing millions of people nationwide to press Washington for aggressive action on healthcare.
"We are going to run this like it is a presidential campaign, but our candidate will be healthcare reform," said Dennis Rivera, chairman of SEIU Healthcare. "It will be very disheartening if there is no action."
Castellani of the Business Roundtable said he hoped a comprehensive overhaul bill could be on the floor of the House and Senate within 100 days of Obama's inauguration on Jan. 20.
In 2007, the four advocacy groups lobbying Obama formed the Divided We Fail coalition to raise the profile of the healthcare issue in the presidential campaign.
The unusual partnership -- linking labor and business groups with the politically potent AARP -- secured pledges from Obama and more than two-thirds of the members of the new Congress to work across the aisles on the issue.
"We can't allow campaign promises of bipartisanship and action to fall apart simply because the election is over," said Nancy LeaMond, AARP's executive vice president. "Millions of Americans are still struggling to find affordable healthcare."
November 14, 2008 | Permalink
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November 13, 2008
Subsidized Insurance Backed
The Washington Post reports that Maryland health advocates unveiled a $15.5 billion proposal yesterday for universal health care that would subsidize insurance coverage for low-income residents with a payroll tax and increases to cigarette and alcohol taxes. Lisa Rein writes,
The Maryland Citizens Health Initiative also calls for mandated coverage for those who do not get it through their employer. The group pledged that the policies would be more affordable than they are now.
The coalition of labor groups, churches, businesses and community organizations consulted with health policy experts from the University of Maryland, Johns Hopkins University and the Robert Wood Johnson Foundation.
The plan aims to build on two programs the General Assembly passed last year, an expansion of the federal-state Medicaid program for the poor and subsidies to some small businesses to help them afford insurance.
But lawmakers and even the advocates acknowledged that the plan has no chance for passage soon.
"We don't expect it to pass in 2009," said Vincent DeMarco, president of the nonprofit Baltimore-based group. "This is the beginning of a campaign."
DeMarco called the plan a way to "make quality health care affordable to all, especially small businesses" and said his group will focus in coming months on building public support for it.
Del. James W. Hubbard (D-Prince George's) is expected to introduce a bill in the 90-day legislative session that begins in January.
Del. Peter A. Hammen (D-Baltimore), chairman of the House health committee, said the General Assembly has little appetite for costly programs in the current economy. But he said the plan "gives energy" to efforts to pass ambitious health-care legislation in a state with an estimated 700,000 uninsured residents.
The plan would allow small businesses and individuals to join an insurance pool, giving them leverage to negotiate lower rates for policies than on their own. Maryland would go into the insurance business, covering the costs of catastrophic care to lower premiums. To contain costs, patients would face higher co-payments for less effective and more expensive procedures.
A 2 percent payroll tax would be levied on all businesses, and the tax on cigarettes would jump to $2.75 a pack from $2 and alcohol by a dime.
The National Federation of Independent Business, a lobbying group representing small companies, said in a statement that higher payroll taxes would drive businesses out of Maryland.
November 13, 2008 | Permalink
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More Countries Make Spreading HIV a Crime
The Washington Post reports that an increasing number of countries worldwide are making spreading HIV a crime, according to a new report from the International Planned Parenthood Federation. Thirty-two states in the US have alerady criminalized HIV transmission. Maria Cheng writes,
Health officials fear the trend could undermine gains made in fighting the AIDS pandemic and provoke a surge in cases. Globally, about 33 million people are thought to have HIV and nearly 3 million people are newly infected every year.
"If the law is applied badly, this could set us back and do incredible damage," said Paul de Lay, an AIDS expert at UNAIDS, who was not involved in the report.
De Lay said the laws could result in forced testing and drive the epidemic underground as people hide their HIV status, allowing the virus to spread unnoticed.
According to Planned Parenthood, 58 countries worldwide have laws that criminalize HIV or use existing laws to prosecute people for transmitting the virus. Another 33 countries are considering similar legislation.
Since 2005, seven countries in West Africa have passed HIV laws. In Benin, simply exposing others to HIV is a crime, even if transmission doesn't occur. And in Tanzania, intentional transmission of the virus can lead to life imprisonment.
Many of the laws in Africa were passed after a meeting in Chad in 2004 sponsored by the U.S. Agency for International Development, the world's biggest funder of AIDS programs, and attended by U.N. officials.
"The U.N. was definitely remiss to allow this to happen," said Kevin Osborne, a senior HIV adviser at IPPF and one of the report's authors.
De Lay said UNAIDS found out about the meeting only after it happened.
But poor countries aren't the only ones using these laws.
In the U.S., 32 states have laws criminalizing HIV transmission. Experts estimate that thousands of people have been charged across the country with spreading HIV.
Since 2001, 16 people in the United Kingdom have been prosecuted for spreading HIV.
Continue reading "More Countries Make Spreading HIV a Crime"
November 13, 2008 | Permalink
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November 12, 2008
Senators Hurry to Keep Health Care in Forefront
The Washington Post reports on Senator Max Baucus and Senator Edward Kennedy's different plans of reforming American health care. Ceci Connolly writes,
Two of the Senate's most influential leaders are working separately behind the scenes on legislation that would dramatically alter the way Americans get health care, hoping their early efforts -- including the release today of a position paper -- will push President-elect Barack Obama to move rapidly on the issue and spare the incoming administration some of the missteps that killed Bill Clinton's health reform initiative in 1994.
Senate Finance Committee Chairman Max Baucus (D-Mont.) is unveiling a 104-page blueprint today that serves as the opening move in a fierce competition in the Senate to frame the debate. Sen. Edward M. Kennedy (D-Mass.), who is battling a life-threatening brain cancer, has directed aides over the past several months to convene negotiating sessions with a diverse group of stakeholders, including physicians, patient advocates, small-business owners and insurers. He intends to have legislation drafted by Inauguration Day.
The first promise Obama made as a presidential candidate was to enact a universal health-care plan by the end of his first term, but since his victory a week ago, he has focused on repairing the economy. Health reform advocates fear that just as Clinton was sidetracked in early 1993 by debates over the North American Free Trade Agreement and gays in the military, Obama's urgency about taking on health care may wane.
"President Clinton came in determined to do something significant on health-care reform" but did not submit a bill until 10 months after taking office, noted Ron Pollack, executive director of the pro-consumer health group Families USA. "A president's leadership is most effective before he expends much of his political capital."
The Senate maneuvering, combined with an unprecedented level of post-election lobbying by outside interest groups, is intended to hold Obama to his pledge.
Yesterday, Divided We Fail, a coalition of business executives, consumer advocates and unions with 53 million members, announced a $1 million ad campaign to keep the pressure on Obama.
In a letter, the group offered the president-elect a deal: "If you will commit to taking action on this critical issue early in your administration, we will commit to engaging our members by hosting a health care reform summit, working with you to develop a proposal as part of your agenda for the first 100 days and educating our members about the challenges and trade-offs reform entails." A similar coalition led by Families USA is preparing its own ad blitz.
Though not as public, Kennedy's efforts will carry enormous weight, given his lifelong focus on the issue, his early endorsement of Obama over Sen. Hillary Rodham Clinton (D-N.Y.) and his own health status.
"We're doing all we can today to unite Congress around a single, unified bill for early action next year," he said through an aide.
The release of Baucus's white paper, entitled "Call to Action, Health Reform 2009," is striking in both its timing and scope. Rarely, if ever, has a lawmaker with his clout moved so early -- eight days after the election of a new president -- to press for such an enormous undertaking.
"We're at one of those rare moments that come every 15 years when you have a chance" to accomplish major change, said Drew E. Altman, president of the nonprofit Henry J. Kaiser Family Foundation, which researches health policy issues. "But a lot of things have to break right for it to happen."
The Baucus plan outlines an ambitious path for providing health coverage to every American in less than 10 years. Eventually, his approach would impose a mandate on every individual and large employer to participate in the system.
Continue reading "Senators Hurry to Keep Health Care in Forefront"
November 12, 2008 | Permalink
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Senator Takes Initiative on Health Care
The New York Times reports more on Senator Max Baucus' plan to guarantee health insurance for all Americans by facilitating sales of private insurance, expanding Medicais and Medicare, and requiring most employers to provide or pay for health benefits. Robert Pear writes,
Without waiting for President-elect Barack Obama, Senator Max Baucus, the chairman of the Finance Committee, will unveil a detailed blueprint on Wednesday to guarantee health insurance for all Americans by facilitating sales of private insurance, expanding Medicaid and Medicare, and requiring most employers to provide or pay for health benefits.
Aides to Mr. Obama said they welcomed the Congressional efforts, had encouraged Congress to take the lead and still considered health care a top priority, despite the urgent need to address huge problems afflicting the economy.
The plan proposed by Mr. Baucus, Democrat of Montana, would eventually require everyone to have health insurance coverage, with federal subsidies for those who could not otherwise afford it.
Other Democrats with deep experience in health care are also drafting proposals to expand coverage and slow the growth of health costs. These lawmakers include Senator Edward M. Kennedy of Massachusetts and Representatives John D. Dingell of Michigan and Pete Stark of California.
The proposals are all broadly compatible with Mr. Obama’s campaign promises. But Mr. Baucus’s 35,000-word plan would go further than Mr. Obama’s in one respect, eventually requiring all people — not just children — to have coverage.
“Every American has a right to affordable, high-quality health care,” Mr. Baucus said. “Americans cannot wait any longer.” Far from being a distraction from efforts to revive the economy, he said, “health reform is an essential part of restoring America’s economy and maintaining our competitiveness.”
Mr. Baucus would create a nationwide marketplace, a “health insurance exchange,” where people could compare and buy insurance policies. The options would include private insurance policies and a new public plan similar to Medicare. Insurers could no longer deny coverage to people who had been sick. Congress would also limit insurers’ ability to charge higher premiums because of a person’s age or prior illness.
People would have a duty to obtain coverage when affordable options were available to all through employers or through the insurance exchange. This obligation “would be enforced, possibly through the tax system,” the plan says.
In an interview with CNN just four days before the election, Mr. Obama said his top priorities would be fixing the economy and promoting energy independence. But he added: “Priority No. 3 would be health care reform. I think the time is right to do it.”
Advisers to Mr. Obama said they expected him to take swift action on two fronts. First, they said, he will probably revoke a Bush administration directive that sharply restricted states’ ability to expand the State Children’s Health Insurance Program. In addition, they said, he will support Congressional efforts to expand the program before March 31, 2009, when at least 42 states are projected to exhaust their allotments of federal money.
Ronald F. Pollack, the executive director of Families USA, a liberal-leaning consumer group that has worked closely with Congress and the Obama team, said, “The prospects for meaningful health care reform have never looked better.” Among Mr. Obama’s health care strategists, Mr. Pollack said, are former Senator Tom Daschle; Jeanne M. Lambrew, a former Clinton aide; Neera Tanden, who was director of domestic policy for the Obama campaign; and Representative Rahm Emanuel, who will be White House chief of staff.
In his plan, Mr. Baucus makes these proposals:
People age 55 to 64 should be able to buy Medicare coverage if they do not have access to a public insurance program or a group health plan. More than four million people in this age group are uninsured.
Medicaid would be available to everyone below the poverty level, providing at least seven million more people with access to the program. In many states, adults with incomes well below the poverty level — $17,600 for a family of three — are ineligible for Medicaid.
The State Children’s Health Insurance Program would be expanded to cover all uninsured youngsters in families with incomes at or below 250 percent of the poverty level ($44,000 for a family of three). This would raise the income limit in about half the states.
Mr. Baucus would also make it easier for many legal immigrants to qualify for Medicaid and the children’s health program. Under current law, such immigrants are generally barred from the programs in their first five years in the United States. He would lift that ban.
More than half of all Americans receive coverage through employers, and Mr. Baucus said he wanted to halt the erosion of such coverage. He would offer tax credits to small businesses to help them defray the costs of providing health benefits to employees.
To make insurance more affordable for those who buy coverage on their own, Mr. Baucus would offer tax credits to individuals and families with incomes at or below four times the poverty level ($70,400 for a family of three). Only 10 percent of the uninsured have incomes above that level, he said.
November 12, 2008 | Permalink
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November 11, 2008
The Promise and Power of RNA
The New York Times reports that RNA interference, discovered only about 10 years ago, is attracting huge interest for its seeming ability to knock out disease-causing genes. Andrew Pollack writes,
People whose bodies make an unusually active form of a certain protein tend to have dangerously high levels of cholesterol. Those with an inactive form of the protein have low cholesterol and a low risk of heart attacks.
Needless to say, pharmaceutical companies would love to find a drug that can attach itself to the protein and block its activity. That might be difficult for this protein, which is called PCSK9.
But a powerful new approach, called RNA interference, may surmount that obstacle. Instead of mopping up a protein after it has been produced, as a conventional drug would do, RNA interference turns off the faucet, halting production of a protein by silencing the gene that contains its recipe.
In monkeys, a single injection of a drug to induce RNA interference against PCSK9 lowered levels of bad cholesterol by about 60 percent, an effect that lasted up to three weeks. Alnylam Pharmaceuticals, the biotechnology company that developed the drug, hopes to begin testing it in people next year.
The drug is a practical application of scientific discoveries that are showing that RNA, once considered a mere messenger boy for DNA, actually helps to run the show. The classic, protein-making genes are still there on the double helix, but RNA seems to play a powerful role in how genes function.
“This is potentially the biggest change in our understanding of biology since the discovery of the double helix,” said John S. Mattick, a professor of molecular biology at the University of Queensland in Australia.
And the practical impact may be enormous.
RNA interference, or RNAi, discovered only about 10 years ago, is attracting huge interest for its seeming ability to knock out disease-causing genes. There are already at least six RNAi drugs being tested in people, for illnesses including cancer and an eye disease.
And while there are still huge challenges to surmount, that number could easily double in the coming year.
“I’ve never found a gene that couldn’t be down-regulated by RNAi,” said Tod Woolf, president of RXi Pharmaceuticals, one of the many companies that have sprung up in the last few years to pursue RNA-based medicines.
The two scientists credited with discovering the basic mechanism of RNA interference won the Nobel Prize in Physiology or Medicine in 2006, only eight years after publishing their seminal paper. And three scientists credited with discovering the closely related micro-RNA in the 1990s won Lasker Awards for medical research this year.
RNA and DNA are strands made up of the chemical units that represent the letters of the genetic code. Each letter pairs with only one other letter, its complement. So two strands can bind to each other if their sequences are complementary.
Genes, which contain the recipes for proteins, are made of DNA. When a protein is to be made, the genetic code for that protein is transcribed from the DNA onto a single strand of RNA, called messenger RNA, which carries the recipe to the cell’s protein-making machinery. Proteins then perform most functions of a cell, including activating other genes.
But scientists are now finding that a lot of DNA is transcribed into RNA without leading to protein production. Rather, the RNA itself appears to be playing a role in determining which genes are active and which proteins are produced.
Much attention has focused on micro-RNAs, which are short stretches of RNA, about 20 to 25 letters long. They interfere with messenger RNA, reducing protein production.
More than 400 micro-RNAs have been found in the human genome, and a single micro-RNA can regulate the activity of hundreds of genes, said David P. Bartel, a biologist at the Whitehead Institute in Cambridge, Mass., and at the Massachusetts Institute of Technology.
As a result, Dr. Bartel said, the activity of more than half the genes in the human genome is affected by micro-RNA.
“It’s going to be very difficult to find a developmental process or a disease that isn’t influenced by micro-RNAs,” he said.
Indeed, scientists have found that some micro-RNAs contribute to the formation of cancer and others help block it.
Other studies have found micro-RNAs important for the proper formation and functioning of the heart and blood cells.
Scientists are also finding other types of RNA, some of which may work differently from micro-RNA. By now, there are so many types of RNA that one needs a scorecard to keep track.
Besides micro-RNA (miRNA), the new ones include small interfering RNA (siRNA), piwi-interacting RNAs (piRNA), chimeric RNA, and promoter-associated and termini- associated long and short RNAs. They join an existing stable that included messenger RNA (mRNA), transfer RNA (tRNA), and small nucleolar RNA (snoRNA), which all play roles in protein production.
Scientists do not know what all the newly discovered RNA is doing. Some of it may be just a nonfunctional byproduct of other cellular processes.
And there is still uncertainty over how big a role RNA plays. Some scientists say proteins are like a light switch, turning genes on and off, while RNA usually does fine tuning, like a dimmer.
Continue reading "The Promise and Power of RNA"
November 11, 2008 | Permalink
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AMA Acts Against Trans Fats and Texting While Driving
The Washington Post reports that the American Medical Association on Monday took a stand against two unhealthy habits: eating foods made with artificial trans fats and text-messaging while driving. The Washington Post writes,
At its semiannual policy meeting, the nation's largest physicians' group agreed to support any state and federal efforts to ban the use of artificial trans fats in U.S. restaurants and bakeries. And it agreed to lobby for more state legislation banning text-messaging while driving or operating machinery.
Several cities and fast-food chains already have shunned trans fats, which can increase artery-clogging of "bad" cholesterol, and decrease levels of "good" cholesterol.
Numerous bans on texting while driving also are in effect.
Delegates at the meeting in Orlando, Fla., also rejected establishing ethical guidelines for hospitals and doctors offices that use "secret shopper" patients. Many hospitals, clinics and doctors' offices hire these fake patients to evaluate things like waiting times, staff behavior and even doctors' bedside manner.
Opponents called the practice devious and unethical.
The measure was first proposed at an AMA meeting in Chicago in June but was referred for a vote at the Orlando meeting.
In their adopted resolution, the delegates called trans fats "one of the most dangerous fats" Americans consume.
"By supporting a ban on the use of artificial trans fats in restaurants and bakeries, we can help improve the quality of the food Americans eat and may ultimately save lives," Dr. Mary Anne McCaffree, an AMA board member, said in a statement.
The Chicago-based AMA's vote on text-messaging follows a warning earlier this year from the American College of Emergency Physicians, which said its members had seen severe injuries and even deaths linked to texting while driving.
Several states and cities have adopted bans on texting while driving, and meeting delegates agreed that the AMA should lobby for more laws.
AMA board member Dr. Peter Carmel said in a statement that a recent study showed that texting while driving "causes a 400 percent increase in time spent with eyes off the road. No one should have to worry that other drivers are focused on texting instead of traffic."
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November 11, 2008 | Permalink
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November 10, 2008
Obama Weighs Quick Undoing of Bush Policy
The New York Times reports that President-elect Barack Obama is poised to move swiftly to reverse actions that President Bush took using executive authority, and his transition team is reviewing limits on stem cell research and the expansion of oil and gas drilling, among other issues, members of the team said Sunday. Jeff Zeleny writes,
As Mr. Obama prepared to make his first post-election visit to the White House on Monday, his advisers were compiling a list of policies that could be reversed by the executive powers of the new president. The assessment is under way, aides said, but a full list of policies to be overturned will not be announced by Mr. Obama until he confers with new members of his cabinet.
“There’s a lot that the president can do using his executive authority without waiting for Congressional action, and I think we’ll see the president do that,” John D. Podesta, a top transition leader, said Sunday. “He feels like he has a real mandate for change. We need to get off the course that the Bush administration has set.”
Throughout his presidency, Mr. Bush has made liberal use of his executive authority, using it to put his stamp on a range of hot-button policy issues.
In January 2001, on his first full day in office, Mr. Bush reinstated the so-called global gag rule, initiated during the Reagan administration and overturned by President Bill Clinton, which prohibited taxpayer dollars from being given to international family planning groups that perform abortions and provide abortion counseling. After Mr. Obama’s victory last week, the Center for Reproductive Rights delivered a 23-page memorandum to his transition team, calling for “bold policy change,” including a repeal of the gag rule.
On Sunday, in a sign that the presidential campaign had definitively ended and that the fast-forming administration had become the focal point, the faces of Mr. Obama’s new team appeared across the spectrum of Sunday talk shows, a changing of the guard more than two months before he officially assumes power.
Mr. Obama’s new chief of staff, Representative Rahm Emanuel, Democrat of Illinois, said the federal government should provide aid to the automobile industry to help the major automakers and their suppliers survive the financial crisis. General Motors, the largest American automaker, said last week that it had been losing more than $2 billion a month recently from its cash cushion and could face bankruptcy.
Mr. Emanuel told the CBS News program “Face the Nation” that the industry was “an essential part of the economy,” echoing remarks that Mr. Obama made at his first post-election news conference last week.
Restating Mr. Obama’s points, Mr. Emanuel said the Bush administration should accelerate $25 billion in federal loans provided by a recent law to help automakers and suppliers retool to build more energy-efficient vehicles. He said that the Bush administration had the power to do more and that Mr. Obama’s economic team, once chosen, would devise options for helping the industry in ways that had the added benefit of being “part of an energy policy, going forward, where America is less dependent on foreign oil.”
The idea of turning the auto industry’s crisis into a chance to enact changes with energy and environmental benefits is one that Mr. Emanuel has promoted in Congress. But he said that Mr. Obama had yet to settle on his proposals or whether he would announce them before he was sworn in.
“Rule one: Never allow a crisis to go to waste,” Mr. Emanuel said in an interview on Sunday. “They are opportunities to do big things.”
Mr. Podesta, who for months has been preparing for the transition, said in an appearance on “Fox News Sunday” that Mr. Obama was considering Democrats, Republicans and independents for key cabinet positions. While previous presidents have not announced such appointments until December, Mr. Podesta suggested that officials with responsibility for the economy, national security, health care and energy portfolios could be named sooner.
“I think he intends to move very quickly,” Mr. Podesta said. “And you know, he’s beaten a lot of records during the course of the campaign.”
Mr. Obama does not intend to name any cabinet officials this week, aides said Sunday, but could announce additional White House decisions on senior staff members as early as Tuesday as he begins building his administration, from the Oval Office to other positions in the West Wing and other parts of the government.
Mr. Emanuel said Congress needed to extend unemployment insurance benefits and offer states a lift in paying for health care bills. When the new Democratic Congress convenes in January, he said, it should tackle a wider economic stimulus package that includes the middle-class tax cut that was a centerpiece of Mr. Obama’s presidential campaign.
“You cannot have a strong and resilient economy that does not have a strong and resilient middle class,” Mr. Emanuel said on “This Week” on ABC. “They have been squeezed over the last number of years, and it is essential to have an economic strategy that strengthens them going forward.”
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November 10, 2008 | Permalink
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African Researchers Plan Malaria Vaccine Trial
The Washington Post reports on a medical trial hoping to develop the first malaria vaccine. Donna Bryson writes,
A medical trial involving 16,000 children across Africa will be a challenge to human, scientific and communications resources on the world's poorest continent, three researchers hoping to develop the first malaria vaccine said Monday.
Joe Cohen and Drs. Christian Loucq and Eusebio Macete said in an interview in Johannesburg that much of the groundwork already has been laid in preliminary trials involving 4,000 children since 2003. They said that even if their vaccine does not succeed, Africa will be left with better communications, research and other infrastructure that could be used in the search for vaccines against AIDS and other diseases.
Malaria, caused by parasites and spread by mosquitoes, kills nearly 1 million people every year, most of them children in Africa. The massive trial of a vaccine that could cut those numbers may start as early as next month, and should be well under way by January, said Cohen, a top vaccine researcher for the international pharmaceutical giant GSK.
GSK is working with the PATH Malaria Vaccine Initiative, which is an anti-malaria charity funded by the Bill & Melinda Gates Foundation, and clinics and research centers in Africa. While the researchers were optimistic, it will be several years before they know whether their vaccine candidate is safe and effective enough for wide use.
The massive vaccine trials will be conducted in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. Loucq, director of the Malaria Vaccine Initiative, said the project has been working over the past year to upgrade laboratory, computer and other equipment in those countries, train technicians, and even help develop local equivalents of the U.S. Food and Drug Administration to ensure the trials are properly monitored.
The Malaria Vaccine Initiative has so far spent $107 million on the project and has not yet calculated how much more it will spend. GSK has spent $300 so far, and estimates it will spend up to $100 million more.
The initial trials showed the vaccine was likely to be at least 30 percent effective against mild malaria cases and about 50 percent against severe malaria. That may sound low compared to, for example, the injectable polio vaccine that is at least 90 percent effective. But researchers have found it difficult to pin down a vaccine for parasites, and further tests may show the GSK candidate is more effective, Cohen said.
Dr. Michel Van Herp, a Medecins Sans Frontieres epidemiologist, said a vaccine might have to be more effective than the GSK candidate has been shown to be so far to be worth the effort of putting it in use. But he acknowledged that matching the effectiveness of the polio vaccine has proven difficult, and said a partially effective vaccine "at least will reduce the workload on the health sector."
Medecins Sans Frontieres, also known as Doctors Without Borders, is not involved in vaccine research, but is at the forefront of treating malaria among the poor in Africa and elsewhere.
The vaccine would have to be used along with preventive measures like mosquito nets and insecticides to save lives.
Macete, who is director of the Manhica Research Centre in Mozambique and was involved in some of the early field trials, said stopping any percentage of the disease would be welcomed in areas "where people are dying every day of malaria."
"It's a huge, huge burden, this disease," Macete said. "Whatever percentage we can get will be useful in reducing the impact of the disease."
November 10, 2008 | Permalink
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November 9, 2008
Seven Things Obama's Win Could Mean for Women's Health
US News reports on some of the policies put in place by Bush that women's health activists are hoping Obama will reverse. Deborah Kotz writes,
Women's health activists are fist-bumping each other over Obama's slam-dunk win, and they're hoping that he'll reverse some of the policies put in place by Bush. Yesterday, I had a chance to catch up with Planned Parenthood President Cecile Richards in between her strategy meetings and blogging for the Huffington Post. She predicted seven things that would change in the new administration.
1. No more federal funds for abstinence-only education. Two years ago Obama told a conservative Christianaudience that abstinence-only education was not enough to prevent teen pregnancy and that he "respectfully but unequivocally" disagrees with those who oppose condom distribution to prevent HIV transmission, according to the reproductive health blog Reality Check. He's also an original co-sponsor of the Prevention First Act, which mandates that all federal sex-education programs be medically accurate and include information about contraception. That legislation could be resurrected in the new Congress.
2. No more global gag rule. On Bush's first day in office in 2001, he reinstituted the "global gag rule" that restricted federally funded health clinics in foreign countries from performing abortions or even providing referrals or medical counseling on abortion. "We think there's going to be a change in that approach and that these clinics will be allowed once again to offer a full range of family planning services," Richards says.
3. Better coverage for contraception and pregnancy. While Richards says women's health activists had to "battle the current administration to get emergency contraception approved over the counter," they're now hoping that Obama's proposed health plan will make contraception more affordable to women. It could force drug plans to cover birth control pills as they would any other drug. (Many still do not.) And it could include more comprehensive prenatal coverage; some women shell out $5,000 or more to have a baby. I'm also curious to see whether Obama reverses a Medicaid rule that last year stopped allowing discounted birth control pills to be dispensed on college campuses.
4. Reversal of the "conscience" regulation that threatens women's access to birth control. Obama will probably reverse a new rule, opposed by most medical organizations including the American Medical Association and the American College of Obstetricians and Gynecologists, that's slated to be enacted in the next few weeks by the Department of Health and Human Services. It allows doctors and other healthcare workers to opt out of certain practices that some of them find morally objectionable—like prescribing birth control pills, inserting IUDs, or dispensing emergency contraception (a.k.a. the morning-after pill) to rape victims—without fear of losing their jobs. Read more about this here.
5. Increases in funding for reproductive health clinics serving uninsured. While Title X federal funds were recently increased for Planned Parenthood and other family planning clinics, Richards hopes an Obama administration will provide further increases. "We're currently meeting the needs of 3 million women," she says, "but an additional 14 million who need our services aren't getting them."
6. Fixing gender disparities in health insurance premiums. While Obama's proposed health plan is probably a pipedream in this economic climate, it could (if ever enacted) ensure that women who buy individual policies aren't discriminated against because of their gender. A recent analysis of 3,500 health plans from the National Women's Law Center found that insurers charged 40-year-old women anywhere from 4 percent to 48 percent more than they charged men of the same age. "The average woman uses healthcare more because she spends an average of 5 years getting pregnant and 30 years trying not to," explains Richards. "It's certainly not fair that she pays more, and this is the kind of issue that Obama wants to address."
7. Improved access to morning after pills and abortions for U.S. military women serving overseas. Women who become pregnant while serving overseas are immediately shipped home. They aren't allowed to get surgical abortions in military hospitals, nor do they have access to medical abortions early in the pregnancy using Mifeprex, a combination of two medications. Obama's health plan includes coverage for abortions, and he could join with the Democrat-led Congress to enact legislation that ensures that soldiers get the same health benefits as the rest of us.
November 9, 2008 | Permalink
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Vitamin Pills Don't Prevent Heart Disease, Study Says
Contrary to what most would think, the Washington Post reports that a study funded by the National Institutes of Health and several vitamin makers suggests that Vitamins C and E do nothing to prevent heart disease in men, and instead may aid cancer and raise the risk of bleeding strokes. Marilynn Marchione writes,
Vitamins C and E, pills taken by millions of Americans, do nothing to prevent heart disease in men, one of the largest and longest studies of these supplements has found.
Vitamin E even appeared to raise the risk of bleeding strokes, a danger seen in at least one earlier study.
Besides questioning whether vitamins help, "we have to worry about potential harm," said Barbara Howard, a nutrition scientist at MedStar Research Institute of Hyattsville, Md.
She has no role in the research but reviewed and discussed it Sunday at an American Heart Association conference. Results also were published online by the Journal of the American Medical Association.
About 12 percent of Americans take supplements of C and E despite growing evidence that these antioxidants do not prevent heart disease and may even be harmful.
Male smokers taking vitamin E had a higher rate of bleeding strokes in a previous study, and several others found no benefit for heart health.
As for vitamin C, some research suggests it may aid cancer, not fight it. A previous study in women at high risk of heart problems found it did not prevent heart attacks.
Few long-term studies have been done. The new one is the Physicians Health Study, led by Drs. Howard Sesso and J. Michael Gaziano of Harvard-affiliated Brigham and Women's Hospital in Boston.
It involved 14,641 male doctors, 50 or older, including 5 percent who had heart disease at the time the study started in 1997. They were put into four groups and given either vitamin E, vitamin C, both, or dummy pills. The dose of E was 400 international units every other day; C was 500 milligrams daily.
After an average of eight years, no difference was seen in the rates of heart attack, stroke or heart-related deaths among the groups.
However, 39 men taking E suffered bleeding strokes versus only 23 of the others, which works out to a 74 percent greater risk for vitamin-takers.
The study was funded by the National Institutes of Health and several vitamin makers. Results were so clear that they would be unlikely to change if the study were done in women, minorities, or with different formulations of the vitamins, Howard said.
"In these hard economic times, maybe we can save some money by not buying these supplements," she said.
A second study found that vitamins B-12 and B-9 (folic acid) did not prevent heart disease either, supporting the results of previous trials. That study involved more than 12,000 heart attack survivors and was led by Dr. Jane Armitage of the University of Oxford in England.
November 9, 2008 | Permalink
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