January 22, 2010
By Leah Voigt*
Medical Care Still "Challenging" as Haitian Hospitals Start Comeback
Doctors at Haiti's largest hospital Monday delivered their first baby and carried out their first pediatric surgery since last week's devastating earthquake, according to a spokesman for the Pan-American Health Organization (PAHO). The national university hospital is in fair condition, and surgery is being carried out there--and at three other institutions also rated as in fair shape--by doctors from nongovernmental agencies and international organizations, said Jon Andrus, MD, deputy director of PAHO, part of the World Health Organization (WHO).
Elsewhere in Port-au-Prince, medical care remains challenging, he told a press briefing from Washington. "Surgeries are being done in the open air under incredibly difficult circumstances," he said. But there has been progress in getting supplies into the shattered capital, Andrus said. Roads are beginning to be passable and--in a sign of resilience--a few supermarkets are open, he said.
Despite the progress, backlogs and shortages remain. Andrus said organizations and people intending to come to Haiti to help in the rescue effort must be logistically self-sufficient. He said some supplies have been off-loaded from aircraft but remain at the airport because their donors had not found a way to get them where they are needed. WHO medical kits, with supplies for 10,000 people for three months, are being distributed, according to Tim Callahan, leader of the U.S. Disaster Assistance Response Team in the country. And a range of other nonfood items is now available, ranging from water containers to plastic sheeting, Callahan told reporters in a telephone briefing from Port-au-Prince. Helicopters are being used to deliver food and water, he added.
Some critical medical supplies are still lacking, Andrus said, including blood, which he characterized as "one of the most urgent health needs." PAHO managed to bring in fifty units Monday and has been given an additional 300 units of blood and 600 of plasma by Bolivia and the Dominican Republic, Andrus said. He said he had no exact figure on how much blood is needed in total.
Another issue is that Haiti has high tuberculosis and HIV rates. "This also makes blood donation difficult," Andrus said. The earthquake struck last Tuesday afternoon, with its epicenter about ten miles southwest of Port-au-Prince, near the town of Léogâne, which was between 80% and 90% destroyed. Other towns in the region also suffered severe damage.
Michael Smith, Medical Care Still "Challenging" as Haitian Hospitals Start Comeback, MedPage Today (Jan. 19, 2010).
FDA Gives Approval to New Heart Device
The U.S. Food and Drug Administration (FDA) recently granted pre-market approval to a second left ventricular assist system, the HeartMate II. The device can now be used as destination cardiac support for patients with advanced-stage heart failure who are ineligible for transplantation. It was previously approved as an interim device for those awaiting transplantation. The device's small size allows it to be implanted in smaller patients, including many women.
The approval was based on data from a two-year cohort study of 200, which randomized patients to the HeartMate II or the HeartMate XVE, the only other device approved for destination therapy, on a two-to-one basis, according to a statement from device manufacturer Thoratec.
Endpoints included survival at two years, free of debilitating stroke, and reoperation to repair or replace the device. The new device showed a 58% versus 24% two-year survival rate. Patients also experienced shorter hospital stays, lower rates of re-hospitalization, and fewer reoperations annually. Patients with the HeartMate II noted an 80% increase in quality of life based on a 0% baseline. The device also showed a lower rate of infection, renal failure, right heart and respiratory failure, and cardiovascular arrhythmia than its predecessor.
As part of the pre-market approval, Thoratec must complete a post-market study and measure adverse effects, functional status, and quality-of-life data. The company also agreed to a second study to gather data on the relationship between bleeding, thrombosis, von Willebrand syndrome, and anticoagulation in left ventricular assist system patients.
Cole Petrochko, FDA Gives Approval to New Heart Device, MedPage Today (Jan. 21, 1010).
Obama Weighs Paring Goals for Healthcare Bill
President Barack Obama signaled on Wednesday that he might be willing to scale back his proposed healthcare overhaul to a version that could attract bipartisan support, as the White House and Congressional Democrats grappled with a political landscape transformed by the Republican victory in the Massachusetts Senate race.
"I would advise that we try to move quickly to coalesce around those elements of the package that people agree on," President Obama said in an interview on ABC News, notably leaving near-universal insurance coverage off his list of core goals. But it was not clear that even a stripped-down bill could get through Congress anytime soon. Throughout the day, White House officials and Democratic Congressional leaders struggled to find a viable way forward for the healthcare bill and to digest the reality that much of their agenda, including an energy measure and an overhaul of banking regulations, had been derailed by the Massachusetts outcome.
Inside the White House, top aides to the president said President Obama had made no decision on how to proceed and insisted that his preference was still to win passage of a far-reaching healthcare measure, like the House and Senate bills, which would extend coverage to more than thirty million people by 2019. On Capitol Hill, Democratic leaders said that they were weighing several options. But some lawmakers in both parties began calling for a scaled-back bill that could be adopted quickly with bipartisan support, and President Obama seemed to suggest that if he could not pass an ambitious healthcare bill, he would be willing to settle for what he could get. In the ABC interview, he cited two specific goals: cracking down on insurance industry practices that hurt consumers and reining in healthcare costs.
Republican Congressional aides said a compromise bill could include new insurance industry regulations, including a ban on denying coverage based on preexisting medical conditions, aid for small businesses for healthcare costs, and possible steps to restrict malpractice lawsuits. But as President Obama noted on ABC, a pared-down package imposing restrictions on insurers might make coverage unaffordable, which is one reason why he prefers a broad overhaul.
As the full Congress returned to Washington to start a new legislative year on the first anniversary of President Obama's inauguration, options were limited and there were signs of a divide between the White House and Democrats on Capitol Hill. House leaders signaled that they had effectively ruled out the idea of adopting the Senate bill, which would send it directly to the president for his signature. Yet close advisers to the president said such a move was still on the table.
Brown's victory in Massachusetts on Tuesday denies Democrats the sixtieth vote that they need to surmount filibusters and advance a revised healthcare measure. Senate leaders said they would not risk antagonizing voters by trying to rush a bill through before Brown could be sworn in, and President Obama agreed. "People in Massachusetts spoke," the president told ABC. "He's got to be part of that process."
Another option considered by Democrats would be to use the procedural maneuver known as reconciliation to pass chunks of the healthcare bill attached to a budget measure, which requires only a simple majority. But there appeared to be little appetite for such a move on Capitol Hill.
Sheryl Gay Stolberg and David Herszenhorn, Obama Weighs Paring Goals for Healthcare Bill, N.Y. TIMES (Jan. 10, 2010).
Officials Debate Merits of Medical Marijuana as Coping Tool in Pain Fight
As access to medical marijuana becomes more widespread, officials are debating its use as a pain-coping treatment and are easing rules for the sick to use the drug, The Wall Street Journal reports. "The U.S. Department of Justice has said it will not generally prosecute ill people under doctors' care whose use of the drug complies with state rules. New Jersey will become the 14th state to allow therapeutic use of marijuana, and the number is likely to grow. Illinois and New York, among others, are considering new laws." But there are not many clinical trials to show solid data on how successful such use of the plant is to helping patients.
"A recent American Medical Association review found fewer than 20 randomized, controlled clinical trials of smoked marijuana for all possible uses. These involved around 300 people in all--well short of the evidence typically required for a pharmaceutical to be marketed in the U.S. . . . Though states have been legalizing medical use of marijuana since 1996, when California passed a ballot initiative, the idea remains controversial."
The New York Times reports that the federal government still "discourages research into the medicinal uses of smoked marijuana. . . . Lyle E. Craker, a professor of plant sciences at the University of Massachusetts, has been trying to get permission from federal authorities for nearly nine years to grow a supply of the plant that he could study and provide to researchers for clinical trials." The Drug Enforcement Administration has refused.
"But there is no good evidence that legalizing the smoking of marijuana is needed to provide these effects. The Food and Drug Administration in 1985 approved Marinol, a prescription pill of marijuana's active ingredient, T.H.C. Although a few small-scale studies done decades ago suggest that smoked marijuana may prove effective when Marinol does not, no conclusive research has confirmed this finding." The University of Mississippi has the nation's only federally approved marijuana-growing operation that supplies to researchers.
Kaiser Health News' Daily Report, Officials Debate Merits of Medical Marijuana as Coping Tool in Pain Fight (Jan. 19, 2010).
Big Benefits are Seen from Eating Less Salt
In a report that may bolster public policy efforts to get Americans to reduce the amount of salt in their diets, scientists writing in The New England Journal of Medicine conclude that lowering the amount of salt people eat by even a small amount could reduce cases of heart disease, stroke, and heart attacks as much as reductions in smoking, obesity, and cholesterol levels. If everyone consumed one-half-a-teaspoon less salt per day, there would be from 54,000-99,000 fewer heart attacks each year and from 44,000-92,000 fewer deaths, according to the study.
The report comes as health authorities at federal, state, and municipal levels are considering policies that would have the effect of pressuring food companies to reduce salt in processed foods, which are considered to be the source of much of the salt Americans eat.
Last week, New York City announced an initiative to urge food manufacturers and restaurant chains to reduce salt in their products nationwide by 25% percent over the next five years. California, according to the author's study Kirsten Bibbins-Domingo, an associate professor of medicine and epidemiology at University of California, San Francisco, is considering setting salt limits on food the state purchase for schools, prisons, and other public institutions.
A panel appointed by the Institute of Medicine, the widely respected independent research arm of the National Academies of Science, is close to issuing a report that will make recommendations about reducing salt intake, including actions government and manufacturers can take.
Dr. Bibbins-Domingo also said that FDA was considering whether to change the designation of salt from a food additive that is generally considered safe to a category that would require companies to give consumers more information alerting them to high levels of salt in food. A FDA spokesman was unable to say Wednesday whether such discussions were taking place.
Pam Belluck, Big Benefits are Seen from Eating Less Salt, N.Y. TIMES (Jan. 20, 2010).
*We would like to thank Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.