Reuters (3/22) reported that the Food and Drug Administration (FDA) has “recommended updating the prescribing instructions for a Baxter International anesthesia drug,” Suprane (desflurane), “after three reports of cardiac arrest in children,” according to agency documents. The drug’s label “already carries warnings about other cardiac problems including heart attacks, irregular heart beats, and unstable blood pressure.”
NY Times, 3/24/08:
Those precautions had mixed results, and an estimated 675,000 Americans died during that outbreak, according to the Centers for Disease Control and Prevention in Atlanta.
Today, New Jersey, Connecticut and New York are much more prepared than they were 90 years ago in the event that an influenza outbreak turns into a pandemic. But five years after an avian flu outbreak in Asia made pandemic flu planning a priority, some experts are concerned that states have not been equally vigilant about preparing, and as attention and federal financing begin to decrease, they fear that preparedness efforts will slacken.
“There is a worry that there was a lot more attention to the issue two or three years ago,” said Richard Hamburg, government relations director for Trust for America’s Health, a Washington-based nonprofit health watchdog. “The fact is that it’s still spreading. There are still cases throughout the world. Preparedness is not a one-shot deal. You don’t know if this will hit this year, next year, five years, 10 years from now.”
Federal officials are tracking the flu worldwide, but it is up to cities and states to prepare their own public health plans. So in 2002, when fears of a new pandemic began to escalate, the federal government agreed to send the states billions of dollars to prepare for a pandemic. The health and human services secretary, Michael O. Leavitt, warned states in 2005 that if they expected the federal government to bail them out when a pandemic hit, they would be “tragically wrong.”
Trust for America’s Health released a report late last year examining how states were preparing for public health emergencies. The report graded the states on their efforts to protect against a pandemic. Over half of the states received a score of 5 or less for their health emergency preparedness capabilities, with 10 being the highest score.
In this region, Connecticut received a score of 8; the state lost points for failing to buy enough antivirals and failing to use a disease surveillance system that is compatible with the federal system to track the progress of an outbreak as it moves across the country. New York scored a 9 — for failing to increase public health financing as quickly as inflation, though state officials said financing has since risen — and New Jersey received a 10.
Pandemics occur when the flu virus mutates into a more deadly form and begins to spread easily from person to person. Health officials are worried about pandemic flu now because they fear the avian flu that has spread to Asia and Europe could mutate into a more deadly and transmissible form.
During the 1918 flu pandemic, which killed about 50 million worldwide, the federal government did not ask states to report their flu tallies until weeks or months after the disease had begun to spread. This time around, the government has been tracking the flu for years.
And in 1918, scientists were unable to make an effective vaccine; in an outbreak today, a vaccine could most likely be created within six months.
Connecticut, New Jersey and New York expect to use two basic methods to keep the flu under control before the vaccine is ready: antiviral drugs and a kind of mass crowd control. The federal government has bought 50 million courses of antiviral drugs that federal officials said could limit the severity of flu infections and possibly serve to protect uninfected people from the disease.
The Department of Health and Human Services has urged states to buy antivirals through a discount program that offers a federal subsidy, cutting the cost of a course of drugs (enough for one person) to $20 from $80, said Dr. William F. Raub, science adviser to Secretary Leavitt. The eventual goal is to have enough antiviral medication to cover at least one-fourth of the population.
In the region, the states have taken different approaches to stockpiling antivirals. Connecticut decided not to buy its full share of antivirals, though it has bought about 11,000 courses with federal money and sent a letter to the federal government indicating it wants to buy 8,465 more. Even after including the 520,000 courses in the federal stockpile designated for Connecticut, the state would still have only enough antivirals for about one-sixth of its population.
William Gerrish, a spokesman for the Connecticut Department of Public Health, said state officials haven’t put as much emphasis or money into antivirals as other states because they have “limited utility and limited shelf life.”
Indeed, federal officials are uncertain just how effective antivirals would be in the event of a pandemic and whether they could serve some prophylactic purpose. And because antivirals currently have a five-year shelf life, states are spending millions of dollars on medicine they may have to throw away in the next few years. But other state officials said they weren’t willing to take chances.
“If you had a novel strain causing a pandemic that was responsive to antivirals and your state had no stockpile, I could predict that the public would be pretty upset,” said Dr. Eddy Bresnitz, the state epidemiologist in New Jersey, which has bought 850,000 of the 900,000 courses available under the federal cost-sharing program. He acknowledged, however, that if the antivirals expire, “that’s a lot of dollars flushed down the drain.”
Similarly, New York has gone so far as to buy supplies of antiviral medications that were initially designated for other states that decided not to buy them.
The bulk of the planning, however, has focused on other methods to keep people from getting sick during a pandemic, ranging from surveillance to shutting down public gatherings and schools to quarantining people who are exposed to the flu and isolating those who have it.
The states have held drills for public health and safety workers to determine what to do when the flu hits, and they have developed increasingly sophisticated reporting systems that make doctors pick up the telephone immediately after seeing signs of certain diseases.
New Jersey has been particularly diligent: the state compiles analyses of school absenteeism and flu diagnoses each week and links to its pandemic flu plans from the top of its Web site. The challenge, state officials say, is keeping their plans current and local officials up to date on flu preparedness.
Meanwhile, state officials said they have received less money for outreach to local communities that they have done in the past. Congress turned down the president’s request for $870 million in this year’s budget for flu preparedness, and state officials said they expected future grants to be much more competitive.
“It means the system is a little bit thinner,” said Dr. Gus Birkhead, New York’s deputy commissioner for public health.
NBC News, 3/22/08: (3/22, story 12, 2:25, Holt) reported, “Public hospitals like San Francisco General make up two percent of America’s hospitals,” yet they “take care of 25 percent of patients with little or no medical coverage.” However, they are “disappearing at an alarming rate, down almost 22 percent since 1990.” According to Larry Gage, of the National Association of general hospitals, these closures are due to “a combination of budget cuts at almost every level of government, increased numbers of uninsured, [and] increased demand on the emergency” department “and the trauma systems.”
San Diego Union Tribune, 3/22/08: Patients with the most lethal type of heart attack are receiving lifesaving care in half the time as before 2007 under a cardiac-response system launched early last year, county officials said yesterday.
EDUARDO CONTRERAS / Union-Tribune
Dr. David Spiegel explained a procedure yesterday to patient Eleanor Kendall at Tri-City Medical Center in Oceanside. Kendall underwent angioplasty and stent placement.
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Now, paramedic ambulances carry special equipment that allows them to diagnose these heart attacks in the field. The paramedics then call any of 13 designated hospitals’ heart attack teams to let them know a patient will soon arrive so they can be prepared, said Dr. Bruce Haynes, medical director of the county’s Emergency Medical Services.In the years before the Cardiac System of Care was created, patients would arrive at the emergency room and have to wait 125 to 140 minutes before they could go into a cardiac catheterization lab and have their artery blockages cleared, Haynes said.
That time was reduced to 62 minutes during the first year of the program, which was launched in January 2007. “Medical research shows this saves lives and is truly a great benefit,” Haynes said.
He said 330 patients benefited from the new system in 2007.
Haynes, hospital cardiologists, paramedics and county officials held a news conference yesterday to announce its success. County officials said they don’t know how many deaths the program prevented or how many patients had less damage to their heart muscle because blood flow was restored faster.
But county Supervisor Greg Cox said he is sure the system has made a lifesaving impact. “Today, heart attack victims have a much better chance to survive and recover,” he said.
One of the first patients to benefit from the cardiac system was Ron Rosenbaum of San Marcos, who experienced pain in his arm a year ago and went to a Carlsbad fire station to get checked out.
The station hooked him up to an electrocardiogram machine and immediately determined he was having a type of heart attack called ST-segment elevation myocardial infarction, or STEMI. He was promptly transported to a hospital where heart specialists awaited.
“It was no time at all before I was in the cath lab . . . and had two stents put in,” Rosenbaum said. “I didn’t realize then, but I do now, how lucky I was with this system. If they didn’t have their specialized team there . . . . I might not be lucky enough to be standing here.”
One reason for delays in the old system is that paramedics would routinely take symptomatic patients to the nearest hospital, regardless of whether it had a cath lab team ready to go, seven days a week, 24 hours a day. Paramedics didn’t know which patients were having a true heart attack.
“We used to fly blind, without knowing the true condition of the patient,” said Paul Maxwell, a county paramedic.
The improvement brings the county to a speed – called a door-to-balloon time – that is even faster than the national target of 90 minutes. Hospitals across the country have been dramatically reducing their times as well. Two years ago, the national goal was 120 minutes.
Part of the success of the new system is that every ambulance with a paramedic in the county now carries a 12-lead electrocardiogram machine, county officials said. These devices can identify STEMI heart attacks.
In a STEMI, the artery is completely occluded, causing heart muscle downstream to die rapidly, said Dr. Paul Phillips, a cardiologist at Scripps Mercy Hospital in Hillcrest and one of the first to advocate the new system.
STEMIs are also called “tombstones” in part because of the heart waves’ appearance on a printout. About one in every three heart attacks is classified as a STEMI.
The blockages almost always occur in the left ventricle, and they’re far more likely to cause death more quickly than most other kinds of heart attacks.
Each year, about 400,000 people in the nation suffer a STEMI, according to the American Heart Association. Many of them die without reaching the hospital.
Non-STEMI heart attacks are less urgent because they are usually caused by clots or blockages that haven’t blocked blood flow entirely.
“You could say that other kinds of heart attacks, your kitchen sink is draining slowly, but it’s still draining. But with a STEMI, there’s no flow at all,” said Ori Ben-Yehuda, director of the Coronary Care Unit at UCSD Medical Center in Hillcrest.
The most effective way to treat a STEMI is prompt catheterization. Of the nearly 5,000 acute-care hospitals in the United States, less than half have catheterization labs and only 1,200 have equipment and specialized teams ready to do such procedures.
In San Diego County, paramedics don’t automatically route non-STEMI patients to one of the 13 hospitals participating in the cardiac-response program.
Non-STEMI heart attacks are tougher to identify. Their symptoms can resemble those of indigestion, anxiety or other problems. That’s why health experts say that people who suspect they’re having a heart attack should call 911 instead of going to the hospital themselves.
The countywide cardiac-response system was made possible in large part because of a $536,000 gift to the city of San Diego from La Jolla stock adviser Jack White, who suffered a STEMI heart attack in 2004. When paramedics arrived at his home, they couldn’t diagnose him because they lacked the 12-lead equipment, he recalled.
“They told me the city hadn’t been able to fund them to buy it, and how important it was to get this equipment because every second after a heart attack, a little more muscle is destroyed,” White said in a 2006 interview. “So I asked them how much money it would take.”
Ambulance companies, hospitals and fire departments have provided most of the remaining financial support.
Hospital officials around the county are delighted with the system.
“There’s no question that the quality of care given to people having heart attacks in this county has improved,” said Dr. Jerrold Glassman, a cardiologist and chief of staff at Scripps Mercy Hospital in Hillcrest.
Palomar Pomerado Health pioneered the STEMI-response concept in San Diego County in November 2003. Its ambulances were the first to have the 12-lead electrocardiogram machines.
Before November 2003, the average door-to-balloon time for patients using the 911 system was 136 minutes. Today, the time is 72 minutes, said Andy Hoang, a spokesman for Palomar Pomerado Health.
“That’s a huge difference,” Hoang said.
Chicago Tribune, 3/22/08: The pursuit of a synthetic version of heparin, free of animal materials and made with stricter quality controls, is gaining more attention as awareness grows that the blood thinner can be sourced from an unregulated supply chain that starts with hog lots in rural China.
The U.S. Food and Drug Administration this week disclosed that low-cost animal cartilage made its way into Baxter International Inc.’s heparin, raising fears conventional quality-control procedures do not adequately protect American consumers. Baxter’s product, recalled in the U.S. last month, has been linked to hundreds of potentially dangerous allergic reactions and at least four deaths. On Friday, the FDA said another American heparin-maker, B. Braun Medical Inc., recalled, as a precaution, more than 20 lots made by the same Chinese plant that supplied Baxter.
“The reason we are pushing for the synthetic is that you can completely control the production process,” said Jian Liu, associate professor of medicinal chemistry and natural products at the University of North Carolina School of Pharmacy, who is developing a synthetic heparin that is years from the U.S. market. “For the time being, we are stuck with the pig stuff. It has served us well for 50 years, but it was only a matter of time until something like this happened. It is too easy for the heparin extraction process to be contaminated if strict controls are not maintained.”
The synthetic process purifies the drug and its ingredients every step of the way in laboratories, in contrast to the need for scrutiny of village workshops and farms in China that are now under investigation by U.S. and Chinese health officials.
The FDA on Wednesday said as much as 50 percent of Baxter’s heparin tested from suspect lots recalled showed that the raw ingredient used to make the drug contained oversulfated chondroitin sulfate, an unapproved dietary supplement taken orally to treat joint pain.
Synthetic heparin has its own drawbacks, however. It is complex to make and development costs could push the price up between five and 40 times the $1 per-vial cost of the decades-old heparin, researchers and analysts said.
“It’s been inexpensive to derive heparin from animal sources so that there has been little incentive to consider a synthetic version of this particular heparin,” said FDA spokeswoman Karen Riley.
Indeed, Wisconsin-based Scientific Protein Laboratories four years ago opened a manufacturing plant in Changzhou, China, to keep its heparin costs low. Scientific Protein, which supplied active ingredients used to make heparin for both Baxter and B. Braun, made the move to China after supplies of pigs were inadequate in the U.S. and Canada.
Currently, there is no FDA-approved synthetically derived heparin with the broad indications awarded Baxter’s heparin, which is used for dialysis and before heart surgery. The synthetics that are available are approved for specific uses, the FDA and researchers said.
The push for synthetic heparin also comes as some industry experts wonder whether there could one day be supply issues with pigs just like there were concerns decades ago from international health officials about shortages of cow and pig pancreases that had been used for decades to make insulin.
Such concerns in the 1980s forced insulin-makers like Eli Lilly & Co. to begin to move to synthetic versions as the world’s diabetes epidemic began to take off. In 2005, the Indianapolis-based drug giant produced its last insulin derived from pigs. “If we did not think of better ways to produce it, we could be facing a potential problem because the diabetes epidemic was starting,” Lilly spokesman Scott MacGregor said.
Synthetics are being pursued in other areas. This spring, biotech company Discovery Laboratories Inc. of Warrington, Pa., expects to win FDA approval to market a synthetic lung treatment, Surfaxin, for respiratory diseases in premature babies. It hopes to compete with North Chicago-based Abbott Laboratories‘ cow-derived product known as Survanta.
Proponents of synthetics claim they’re safer. “Animal-derived products carry the risk of developing an immune response,” said Thomas Miller, senior vice president of commercial operations for Discovery.
Analysts said Surfaxin, once it’s approved by the FDA, could be $200 to $400 a vial more expensive than Abbott’s product, and Discovery will have to convince insurance companies the expense is worth it. But Miller believes doctors and hospitals will find it as a long-overdue alternative.
“If it was my child, this would be my choice,” Miller said. “I don’t think cost would be at the top of my mind in my decision analysis.”
Abbott, however, said “there is no evidence that synthetic sources are inherently safer or more efficacious than naturally derived ones.”
AP, 3/11/08: Two sets of parents in Belgium were recently sentenced to five months in prison for failing to vaccinate their children against polio. Each was also fined $8,000. The polio vaccine is the only vaccination required by Belgian law, unlike the United States, where immunizations against many other diseases are required. And unlike the United States, where many state laws allow children to opt out if their parents have religious or philosophical objections, Belgium allows exemptions only if parents prove their child might have a bad reaction to the vaccine. Reaction from some ethicists and public health experts backs the hard-line stance. “At the end of the day, the law must be respected,” said Dr. Victor Lusayu, head of Belgium’s international vaccine center. John Harris, a professor of bioethics at the University of Manchester, had a similar view: “Nobody has the right to unfettered liberty, and people do not have a right to endanger their kids. The parents in this case do not have any rights they can appeal to. They have obligations they are not fulfilling.” Polio is highly infectious, and despite a 99 percent drop in cases since a World Health Organization (WHO) eradication effort began in 1988, the virus is still endemic in Afghanistan, India, Nigeria, and Pakistan. “It is up to individual countries to decide their own policies, but we do not feel that imprisonment would help,” said Dr. David Heymann, WHO’s top polio official.
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