Month: April 2008

by Gardiner Harris

WASHINGTON — After a contaminated medicine from China was linked to as many as 17 deaths in the United States, members of Congress clamored for changes while regulators defended their actions.

The drug was a common antibiotic, and the year was 1999. But in recent weeks, the Food and Drug Administration has faced an almost identical crisis.

Nineteen deaths have been linked to contaminated heparin, a crucial blood thinner manufactured in China. Again the drug agency became aware of the problem only after hundreds were sickened. Again Congress is investigating.

The F.D.A. admitted that it violated its own policies by failing to inspect the China plant, and on Friday it said it had alerted border agents to detain suspect heparin shipments.

“This heparin problem has happened before with other drugs,” said William Hubbard, a former F.D.A. deputy commissioner, “and it’s going to keep happening until Congress fixes this problem.”

The Institute of Medicine, the Government Accountability Office and the F.D.A.’s own Science Board have all issued reports saying poor management and scientific inadequacies make the agency incapable of protecting the country against unsafe drugs, medical devices and food.

Indeed, in the years since the last China drug scandal, the share of drugs coming from that country has soared while the F.D.A.’s inspections of overseas drug plants have dropped. There are 566 plants in China that export drugs to the United States, but the agency inspected just 13 of them last year.

The agency does not have the money to inspect many more, and the Bush administration has no plans to fix this most basic of problems. The administration’s budget calls for a 3 percent increase in allocated funds next year, not enough even to keep up with rising costs.

Congress, though, may finally heed the calls of Mr. Hubbard and others and allocate far more money. The Senate passed a budget resolution on Friday to give the F.D.A. an additional $375 million, a 20 percent increase over this year.

“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the F.D.A.,” said Senator Edward M. Kennedy, Democrat of Massachusetts, who pushed for the new financing.

Several top legislators in the Senate and House said they supported the increase.

“F.D.A. needs a serious infusion of resources and strong leadership dedicated to reforming the agency,” said Representative Henry A. Waxman, Democrat of California, who is chairman of the House oversight committee.

Representatives John D. Dingell and Bart Stupak, powerful Democrats from Michigan, said they would fight to support the increase in the agency’s budget.

But the new money is far from assured. President Bush has threatened to veto appropriations that go beyond his requests, and there are powerful interests in Congress that are skeptical of increased agency financing.

Among the skeptics is Representative Rosa DeLauro, Democrat of Connecticut, who leads the House appropriations subcommittee with authority over the agency. Ms. DeLauro said that although the F.D.A. was in crisis, “I don’t want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.”

Some top agency officials are simply “incompetent,” she added, and real change can occur only with a new administration.

An F.D.A. spokeswoman, Julie Zawisza, said the agency was “looking at a number of options in addition to more foreign inspections to increase our presence abroad and our ability to detect problems.” For instance, the agency is opening an office in China to conduct audits and inspections.

The uncertain prospects of the increased financing have led many in Congress to consider a user-fee system to pay for foreign inspections. The agency already relies heavily on user fees to pay for new drug reviews. Mr. Stupak said such a system might be the only way to pay for the necessary inspections of an industry rapidly moving to places like China.

“Why should the taxpayer pay for these inspections so that you can close a plant here and open it over there to ship it back?” Mr. Stupak said. “It will be sustainable income so that we don’t have to get into these budget battles every year.”

Eighty percent of the active pharmaceutical ingredients of drugs consumed in the United States are manufactured abroad; 40 percent are made in China and India. Meanwhile, the F.D.A. has cut back on its foreign drug inspections, which declined to 341 in 2006 from 391 in 2000.

Among the only foreign inspections that the F.D.A. still conducts are those done before a drug’s approval. Spot foreign inspections are rare. For logistical reasons, the agency warns foreign plants when its inspectors intend to visit, something not done domestically. All of this needs to change, said Mr. Stupak, who wants the oversight of foreign plants to be as strict as those governing domestic ones.

Dr. Sidney Wolfe, director of Public Citizen’s health research group, said a fee-based inspection system was “a terrible idea” because it would lead the agency to become more lax with those who pay their salaries.

“The F.D.A. is too important to be left to the industry to fund it,” Dr. Wolfe said.

Manufacturers would support a user-fee system in hopes of making medicines safer and competition fairer, said Guy Villax, chief executive of Hovione, a drug maker based in Portugal with plants in Europe, the United States, China and Macao.

Plants in China and India are rarely inspected by Western governments, which can reduce costs dramatically, Mr. Villax said. Even the Chinese did not inspect the plant making contaminated heparin because, regulators there said, everything made at the plant was shipped overseas.

“The globalization of active pharmaceutical ingredients has happened very quickly,” Mr. Villax said, “and the government agencies are very slow at adapting to changing circumstances.”

by Will Dunham

WASHINGTON (Reuters) – Bystanders who see someone suddenly collapse should quickly give the person chest compressions even if they are not trained in cardiopulmonary resuscitation, the American Heart Association said on Monday.
The association urged people not to stand idly by because they do not think they know how to administer CPR while an adult stricken with sudden cardiac arrest is dying in front of them.

In recommendations published in its journal Circulation, the group emphasized "hands-only" CPR — a simple procedure that bystanders can perform without worrying about doing the mouth-to-mouth resuscitation part of CPR.

"The thing that's killing people is inaction," said Dr. Michael Sayre of Ohio State University, who headed the association's team that drafted the new recommendations.

Sayre said people not trained in CPR should do two things when they encounter an adult who has suddenly collapsed: first, call emergency services; and second, begin pushing "hard and fast" in the center of the person's chest.

This is necessary to maintain vital blood flow, according to experts. Chest compressions should continue until emergency medical services responders arrive, Sayre said.

"Today in the United States, less than a third of victims of sudden cardiac arrest get any form of CPR. Anything that would increase that is bound to save lives," Sayre said in a telephone interview.

"We want the general public to know that even if they've never been trained, they can help victims of sudden cardiac arrest."

In the minutes after an adult collapses, hands-only CPR — without mouth-to-mouth rescue efforts — is equivalent to conventional CPR in its life-saving value, Sayre said.

All too often, no one at the scene does anything to help the victim of sudden cardiac arrest — often because there is no one trained in CPR and other people are scared that they will do something to make the victim's condition worse.

But considering the person's condition, Sayre said, "You can't make them any worse."

The heart association said that about 310,000 adults in the United States die annually from sudden cardiac arrest that takes place away from a hospital setting. It said that CPR administered by a bystander can double or triple a person's chance of surviving.

About 94 percent of sudden cardiac arrest victims die before reaching a hospital, the group said. Up to 80 percent of sudden cardiac arrests occur at home, it added. Brain death begins four to six minutes after a person suffers sudden cardiac arrest if no CPR or defibrillation is given.

"Hands-only" CPR is not advised for babies and children or for adults whose cardiac arrest is due to respiratory causes such as a drowning scenario or drug overdose, the group said.

The new recommendations update the group's 2005 advice that had asked bystanders to do chest compressions only if they were unable or unwilling to provide mouth-to-mouth efforts.

Conventional CPR is still an crucial skill to know and medical personnel should still perform it, the group said.

by Ben Wasserman

TUESDAY April 1, 2008 — Organs from a 15-year old teen who died a year ago from what doctors said was bacterial meningitis spread a rare lymphoma to four recipients, injuryboard.com reported today.

WCBS-TV was cited as reporting that two organ recipients have already died from the undiagnosed lymphoma and two others are still fighting the deadly disease.

Jim and Lisa Koehne, the teen's parents who live in Sag Harbor, New York, requested an autopsy for their son and only found he actually died from a rare lymphoma. Doctors’ misdiagnosis caused lots of stress to the couple.

Doctors and hospitals are cleared of any responsibility for the spreading of cancer, but New York University and the University of Minnesota which transplanted one of the organs have now changed their policies to make sure the organ is safe.

Spreading of cancer through organ donation is not common as news media and the industry claim.  Theoretically, however, both organs and blood from a cancer patient can potentially spread cancer to the recipients.  

In laboratory, it is a common practice that cancer cells are injected in healthy animals to grow the cancer in them for a study purpose.

by Corey Binns

More than just a pretty smile, clean teeth and gums are a sign of total body health. And those painful sessions with the dental hygienist could save your life, new findings suggest.Most people know that the tedium of good oral hygiene — regular brushing, flossing and trips to the dentist's office — reduces  tartar, plaque, cavities, gingivitis and bone loss and helps the breath smell like roses.

But recent research shows that diabetes, low birth weight babies and heart disease are also linked to gum and bone disease in the mouth that can be prevented by teeth cleanings. Treating gum disease might even prevent heart attacks, a new study suggests.

"Systemically, visits to the dentist and hygienist may reduce the risk of cardiovascular disease, stroke and possibly heart attack, and can decrease the likelihood of tooth loss for diabetics," said Gwen Cohen-Brown, a dentist and lecturer for the New York State Department of Health.

The tooth-heart link
When people neglect to brush their teeth or floss, bacteria accumulate between the teeth. These bacteria can make their way into the blood stream.

"Certain bacteria present in the mouth may be related to clogging up the arteries by contributing to the plaque that builds on the walls of the arteries," said New York University oral microbiologist Walter Bretz.

And treating gum disease, or periodontal disease, can improve the long-term function of endothelial cells that line blood vessel walls, according to a study conducted by researchers at the University of Connecticut Health Center. With better performing endothelial cells, plaques that cause heart disease will decrease, diminishing the risk of triggering a heart attack.

The authors of the study, detailed in the March 1 issue of the New England Journal of Medicine, estimate that severe periodontitis affects up to 1 percent of adults in the U.S., and as many as 80 percent of American adults have some form of periodontal disease.

Unclear pregnancy results
Periodontal disease is also quite common among pregnant women. Expectant mothers' gums react differently to the bacteria due to their increased levels of estrogen and progesterone. Women may experience swelling, bleeding or tenderness in the gum tissue.

Several studies have linked gum disease to an increased risk of giving birth to a premature and underweight baby.

Yet, an article published in a 2006 issue of the New England Journal of Medicine reported that, although treatment of gum disease in pregnant women is safe and improves periodontal health, preterm birth and low birth-weight babies were unaffected by the treatment.

The jury is still out on whether a mother's unhealthy gums can affect her unborn baby, but scientists are learning more from a large clinical trial currently under way at the University of Minnesota, focusing on whether treating periodontal diseases in pregnant women may prevent preterm and low birth-weight babies.

Diabetes and dental health
Unlike the case for pregnancy, researchers have found direct links between gum disease and diabetes. Gum disease is known to increase the risk of diabetes, and vice versa.

Studies show that inflammatory periodontal diseases may increase insulin in the same way that obesity increases insulin.

Meanwhile, doctors recognize diabetes as an important risk factor for severe gum disease and infection that may result in the destruction of tissues and bone surrounding the tooth.

by Judith Graham

Adding to a vigorous debate over how to control drug-resistant bacteria, researchers at Evanston Northwestern Healthcare reported Monday that screening all hospital patients for MRSA can sharply reduce hospital-acquired infections.

The study in the Annals of Internal Medicine comes a week after a well-publicized study in the Journal of the American Medical Association that concluded screening of surgical patients for methicillin-resistant Staphyloccocus aureus isn't especially effective.

Although the two reports might seem contradictory, some experts suggest they are in fact complementary. The take-home message is that "a very comprehensive, aggressive MRSA screening program can significantly reduce the number of infections," said Dr. Lance Peterson, founder of Evanston Northwestern's MRSA screening program.

"Testing high-risk groups isn't enough," he said. "You stop some [of the bacteria's] spread, but not enough" to really make a difference in hospital-acquired infections.

The Evanston Northwestern study describes a three-stage rollout of MRSA screening across Evanston Hospital, Glenbrook Hospital and Highland Park Hospital. First, epidemiologists tested all hospital patients to estimate the number of people who carry the drug-resistant bacteria on their bodies. That was 8.5 percent.

Then, the hospitals began testing every patient being admitted to intensive care units for MRSA. Those with the bacteria were placed in isolation, and special precautions were taken, including gowns and gloves for providers and rubdowns with disinfectants.

This is the regimen now required in Illinois for all hospitals under legislation passed last year.

To their surprise, scientists at Evanston Northwestern found this level of intervention didn't make a dent in the rate of hospital-acquired MRSA infections.

Peterson suspected the screening had been insufficient. Epidemiologists had found that patients colonized by MRSA were dispersed across the hospitals, not concentrated in a few units. And MRSA had begun circulating widely in the community, making it difficult for a targeted hospital-based effort to snuff it out.

To Peterson, the trends argued that testing should be expanded to all patients, not just intensive-care patients, and Evanston Northwestern became the first hospital group in the country to screen universally for MRSA in August 2005.

This time, the intervention worked, and hospital-acquired MRSA infections plummeted by 70 percent.

Given those findings, Peterson argues that the results of the JAMA study are not surprising. In that case, only half of the patients in a Swiss hospital's surgical wards were tested for colonization with MRSA. The other half were subject to normal infection control practices, and there's no evidence that patients elsewhere in the hospital were tested.

A reasonable conclusion is that perhaps 30 percent of the Swiss hospital's patients were screened for bacteria, Peterson said.

This wasn't universal screening, in other words. "I think their data says you can't just test certain units in the hospital and make an impact," Peterson said.

Proponents of universal screening will seize on the new article's findings to support their cause. But an accompanying editorial in the Annals of Internal Medicine sounds a note of caution.

It's still not clear which part of Evanston Northwestern's universal screening intervention worked, said Dr. Ebbing Lautenbach of the University of Pennsylvania School of Medicine. Was it the isolation of colonized patients and other precautions? Was it the use of antibiotic ointments to eliminate MRSA in patients who tested positive? Was it ongoing feedback to medical units with elevated infection rates?

Until further evidence comes in, "each institution may need to tailor its intervention to its unique needs and resources," Lautenbach concludes.

by Anna Boyd

The Massachusetts Department of Public Health confirmed the fourth flu-related death of a child this year. Massachusetts health officials informed that a 12-year-old girl from Worcester County died Sunday from flu complications, two days after a 15-year-old boy died in Newton from flu-related pneumonia, the Boston Globe reported.

The Massachusetts DPH announced last week that the state first confirmed pediatric death associated with influenza involving a 6-year-old child from Suffolk County. The child died on March 2 after he had suffered from a number of health problems that likely contributed to complications from the flu.

The second confirmed case involved a 14-year-old child from Middlesex County who died on March 1, and also had a number of health problems that likely contributed to complications from the flu.

None of the children was identified because of patient confidentiality laws.

This flu season seems to have been wilder than the past two winters. Forty-four states reported widespread flu outbreaks last month. About 10 children had died from the flu nationwide as of February.

“This has been a very difficult flu season for the residents of Massachusetts. While flu-related deaths of children are rare, tragically they do occur. These deaths are a reminder that flu is a serious illness that can result in severe consequences fro children, particularly those with underlying medical problems,” Dr. Alfred DeMaria, DPH’s Director of Communicable Disease Control said, according to the same source.

Flu activity peaked in the state during the week of Feb. 17, but will remain active through April. According to officials, people with chronic health conditions are at high risk of bad outcomes from influenza.

Health officials are urging Massachusetts residents to follow some steps, which can prevent flu from spreading including: being vaccinated, staying home when sick, frequently washing hands with soap and warm water and coughing into a tissue and not into hands.

This year’s flu shot did not match some of the flu strains circulating this year, which also worsened the situation. However, health officials said people should get vaccinated no mater the flaws of the vaccine. The specialists also recommended that in future flu season, all children should be vaccinated, except those younger than 6 months.

by Courtney Humphries

Researchers use unique molecular signatures to visualize the body.Although scientists understand much about diseases like cancer on a molecular level, imaging diseases still relies largely on anatomy–the outline and shape of a tumor or a clot, for instance. Researchers have been working on ways to visualize molecular changes that take place inside the body, and a new method may offer some advantages over existing anatomical and molecular imaging technologies. In a study published online this week in the Proceedings of the National Academies of Sciences, a team of researchers at Stanford University used Raman spectroscopy, a technique common in chemical analysis, paired with specialized nanoparticles to noninvasively visualize organs and tumors in living mice. The technique could be useful for studying complex disease processes in animals, and, if found to be safe in humans, it could help clinicians view multiple molecular changes in certain cancers and other diseases.

Raman spectroscopy detects how objects scatter laser light, a phenomenon named after the Indian physicist Chandrasekhara Venkata Raman, who discovered the effect in the 1920s. Each type of molecule produces a unique Raman signature. There are several techniques that employ the Raman effect, but this study used SERS (surface enhanced Raman scattering), which relies on roughened surfaces of metal nanoparticles to greatly boost the Raman effect. To create Raman nanoparticles, scientists attach small dye molecules, which scatter light, to these molecular amplifiers. They can then affix molecules that allow them to target the particles to a location in the body, such as antibodies that bind to specific proteins in cells.

A study published last December in Nature Biotechnology, led by Shuming Nie at Emory University, used Raman nanoparticles to target and detect tumors in mice. In this study, the Stanford team used two kinds of Raman nanoparticles–a gold sphere and a carbon nanotube–as well as a specialized microscope to create images of the particles in living mice for the first time. The researchers imaged particles accumulating in the liver of the mouse, demonstrating that the technique could visualize structures within the body. They then used a tumor-specific nanoparticle to image tumors in mice.

The key advantage of this technique is that it allows for what imaging researchers call multiplexing: creating images of several different molecules at once. "One of the problems with imaging is, we tend to only be able to look at one or two things at a time," says Sanjiv Sam Gambhir, lead author of the study and codirector of the Molecular Imaging Program at Stanford. Multiplexing is important in complex diseases like cancer, in which several events occur within tumor cells, each of which could give information about the tumors' status and the likelihood that it will spread. As a first demonstration of multiplexing, Gambhir's team injected mice simultaneously with four kinds of Raman nanoparticles at different concentrations and showed that it is possible to locate the different particles and calculate their concentrations based on their Raman signal.

The most widely used molecular imaging technique in the lab is fluorescence. What makes Raman spectroscopy unique is that "you get a very sharp signal back, unlike [with] fluorescence, where you get a broad spectrum of energy," Gambhir says.

Claudio Vinegoni, an imaging specialist at the Center for Molecular Imaging Research at Harvard and at the Massachusetts General Hospital, who was not involved in the study, says that although scientists can use fluorescent molecules of different colors to see more than one molecule at a time, the ability to multiplex is limited because their signals quickly begin to overlap. In contrast, with Raman spectroscopy, "every molecule has its own Raman spectrum," Vinegoni says, so there is no possibility of the signals interfering. Because of their specificity, Raman nanoparticles can also be imaged at concentrations a thousand times lower than what can be detected using fluorescent quantum dots.

Although Raman spectroscopy could prove immediately useful in animal imaging, Gambhir ultimately hopes to bring it into the clinic. The best method for imaging biochemical events in humans is through PET imaging, in which a radioactive tracer injected into the body makes it possible to detect chemical activity. Gambhir's goal is to "develop the next generation of imaging technologies that wouldn't have to use radioactivity." In addition to its ability to image many things at once, Raman spectroscopy offers better sensitivity than PET and would be much less expensive.

One of the major shortcomings of this technique, as in all optical imaging methods, is the limited ability of light to penetrate deep into tissue. Although it can be used to visualize the internal organs of a mouse, Gambhir says that in humans, the technique would be more useful for visualizing tumors close to the surface of the skin, such as melanomas or even breast cancer. The technique could also be used in conjunction with endoscopes that probe inside the body. Gambhir's team is planning a clinical trial to test the use of Raman particles in conjunction with colonoscopies for detecting early-stage cancers. In this procedure, the nanoparticles could simply be sprayed onto the surface of the colon rather than injected into the body. But a key challenge for bringing this technique into the clinic will be determining the safety of nanoparticles as probes–studies that Gambhir's group is currently undertaking.