Accident & Injury Law in Texas

Posts Tagged ‘study’

A federal drug official dealt a severe blow Friday to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.

The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to have serious heart problems that were not counted in the study’s tally of adverse events.

Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” Marciniak wrote.

The detailed report could prove crucial next week, when a panel of experts meets to consider whether to recommend to the FDA that the manufacturer, GlaxoSmithKline, withdraw Avandia from the market or restrict its sale.

The panel’s decision will have broad consequences for the company, the FDA and perhaps even the entire process by which medical products are approved. The agency rarely does clinical trials on its own, depending on drug companies to conduct them appropriately.

Avandia, which helps patients get better control of their blood sugar levels, has already come under intense criticism. It has been shown to increase the risks of bone fractures and to cause swelling that can lead to heart failure and eye problems. And a number of studies, including some by GlaxoSmithKline, suggest that it could increase the risks of heart attack, stroke, and death.

GlaxoSmithKline has relied heavily on the major clinical trial, named Record, to demonstrate that those risks are exaggerated.

Marciniak’s review of the Record study calls that assertion into question. He found one case in which a seizure patient was hospitalized for bleeding in the brain, but all mention of the episode was deleted from records. Another patient was hospitalized for 67 days after a severe stroke, but the study record showed no sign of a cardiovascular problem.

Another patient died after being hospitalized for a serious heart problem, but the death was listed as arising from an unknown cause and not as being heart-related.

Correctly interpreted, he concluded, the study actually supports critics’ contentions that Avandia may cause heart attacks and strokes.

“One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes, heart attacks.

Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, said, “The Record study was conducted according to good clinical practices, and the data are reliable.”

Marciniak’s review is part of a reassessment of Avandia’s safety by FDA medical officers to educate the panel meeting Tuesday and Wednesday.
Debate about Avandia’s safety and how to handle reports of its dangers has split the food and drug agency and led to fierce recriminations, staff departures and questions from Congress.

It was the FDA’s delay in issuing stronger warnings about Avandia that led Congress in 2007 to give the agency greater powers over drug makers.

Within the FDA, some officials insist that the evidence is mixed and others say it is strong enough to merit the drug’s withdrawal. An advisory meeting in 2007 concluded that Avandia did increase heart attack risks but that it should stay on the market.

Although endocrinologists have advised against its use, Avandia remains popular with nearly 2 million prescriptions last year. If the drug were to be withdrawn, GlaxoSmithKline — already facing lawsuits claiming Avandia caused injuries — would likely see its liability soar.

(Except of course, in Texas, where pain and suffering is capped at $250,000)

Drivers know that green means go, red means stop and yellow often means “Can I make it?” Although the law is clear that yellow means slow down and prepare to stop, many drivers do not. New research sheds light on what factors come into play when a driver decides to run those yellows, and it turns out it’s not just a matter of speed.

Researchers from the University of Cincinnati, funded by the Ohio Department of Transportation, monitored four intersections in suburban areas of Ohio, using video cameras to track more than 1,500 drivers.

They found that cars traveling in right-hand lanes tended to go through yellow lights, while those on the left did not. Truckers also tended to
speed through yellows, as did drivers on streets with higher posted speed limits.

Not surprisingly, how long the light remains yellow also matters. (Yellow-light times vary but typically last about three to five, seconds. Traffic engineers base the time on the average speed of the vehicles passing through the intersection.)

The longer the yellow persists, the more likely it is that drivers will not stop, said Zhixia Li, an engineering doctoral student who worked on the study with his professor, Heng Wei.

In fact, Li said, with a long yellow, “stopping is more dangerous,” because other drivers are likely to keep going through the yellow, and someone who opts to stop runs a greater risk of getting hit from behind.

New research into front air bags in automobiles is raising troubling questions about their effectiveness for drivers wearing seat belts.

The research suggests that when compared with the versions they replaced, the newest air bags, required in all vehicles beginning in 2008 and in some as early as 2004, might not do as good a job of protecting belted drivers.

About 80 percent of all drivers wear seat belts, according to federal estimates, but government standards for air bags are intended to maximize protection for unbelted drivers.

The researchers found that belted drivers had a 21 percent greater chance of dying in cars equipped with the latest model of air bags than those in vehicles with the previous model. The risk for unbelted drivers was unchanged.

“The fact is that we’re not getting optimal protection for belted drivers,” said David Zuby, senior vice president for vehicle research at the Insurance Institute for Highway Safety, which did the study. “The study does not suggest that people should turn off their air bags, nor does it suggest that people should unbuckle their seat belts. It says that government regulations and air bag designers could do a better job of protecting belted drivers.”

A study of Medicare patients shows that costlier, more complex spinal fusion surgeries are on the rise — and sometimes done unnecessarily — for a common lower back condition caused by aging and arthritis.

What’s more alarming is that the findings suggest these more challenging operations are riskier, leading to more complications and even deaths.

“This is exactly what the health care debate has been dancing around,” said Dr. Eugene Carragee of Stanford University Medical Center. “You have one kind of operation that could cost $20,000 and another that could cost $80,000, and there’s not good evidence the expensive one is being used appropriately in the majority of cases.”
Add to that the expense for patients with problems after surgery, and “that’s not a trivial amount of money” for Medicare, said Carragee. He wrote an editorial in the Journal of the American Medical Association, where the federally funded study appears today.

All the patients in the study had stenosis in their lower backs, a painful squeezing in the spine that’s most common in people over 50. The researchers compared the risks for three different, types of surgery for the condition: decompression, simple fusion and complex fusion.

“It s not necessarily true that the more aggressive surgery is better, at least in terms of safety,” said the lead author, Dr. Richard Deyo of Oregon Health and Science University in Portland.

Patients should ask their doctors about alternatives to complicated operations, Deyo said. Could steroid injections and physical therapy be tried? Would a simple decompression procedure be as helpful as a spinal fusion?

In a decompression procedure, the simplest method studied, a surgeon cuts away part of the bone that’s pressing on nerves. It can cost about $30,000 in hospital and surgeon fees.

For a fusion, a surgeon binds two or more vertebrae together using a bone graft, with or without plates and screws. The researchers defined a complex fusion as one involving three or more vertebrae or more than one side of the spine. Fusions cost $60,000 to $90,000.

The researchers analyzed data on more than 32,000 Medicare patients who had one of the surgeries. About 5 in 100 who had simple or Complex fusions suffered major complications such as stroke, compared with 2 in 100 with decompressions. The risk of death after surgery was different, too: 6 in 1,000 for complex fusions, 5 in 1,000 for simple fusions and 3 in 1,000 for decompressions.

Aggressive marketing of devices used in complex fusions is probably playing a role in the increase, Deyo said.

Allegations of questionable financial arrangements involving doctors have plagued the industry. Medtronic Inc. reached a $40 million settlement in a federal case that included allegations that the company paid doctors to use , its spine surgery products.

The company denied any wrongdoing.

A treatment that uses medical cement to fix cracks in the spinal bones of elderly people worked no better than a sham treatment, the first rigorous studies of the popular procedure show.

Pain and disability were about the same up to six months later.

The treatment is so widely thought to work that the researchers had a hard time getting patients to take part when it was explained that half of them would not get the real thing.

“All of us who do the procedure have seen apparently miraculous cures,” said Dr. David Kallmes, a radiologist at the Mayo Clinic who led one of the studies. But he said there were also “miraculous cures” among those who got the fake treatments.

The researchers said it is yet another example of a medical procedure coming into wide use before good studies are done to show that it is safe and effective.

About 750,000 Americans suffer painful compression fractures in the spine each year. Bone-thinning osteoporosis is the most common cause. There are about 80,000 bone cement procedures done in the United States each year, Kallmes said.

Medicare pays $1,500 to $2,100 for the procedure.

The findings were published in today’s New England Journal of Medicine.

The first study of drivers texting inside their vehicles shows that the risk sharply exceeds previous estimates based on laboratory research and far surpasses the dangers of other driving distractions.

The new study, which entailed outfitting the cabs of long-haul trucks with video cameras over 18 months, found that when the drivers texted, their collision risk was 23 times greater than when not texting.

The Virginia Tech Transportation Institute, which compiled the research and plans to release its findings today, also measured the time that drivers take their eyes from the road to send or receive texts.

In the moments before a crash or near-crash, drivers typically spent nearly five seconds looking at their devices enough time at typical highway speeds to cover more than the length of a football field.

Even though trucks take longer to stop and are less maneuverable than cars, the findings generally applied to all drivers, who tend to exhibit the same behaviors as the more than 100 truckers studied, researchers said.

Compared with other sources of driver distraction, “texting is in its own universe of risk,” said Rich Hanowski, who oversaw the study at the institute.

Hanowski said the texting analysis was financed by $300,000 from the Federal Motor Carrier Safety Administration, which has the mission of improving safety in trucks and buses. The final analysis of the data is undergoing peer review before formal publication.

Tom Dingus, director of the Virginia Tech institute, one of the world’s largest vehicle safety research organizations, said the study’s message was clear.

“You should never do this,” he said of texting while driving. “It should be illegal.” Thirty-six states do not ban texting while driving; 14 do, including Alaska, California, Louisiana and New Jersey. In Austin, City Council Member Mike Martinez is pushing to ban texting while driving and require the use of hands-free devices for those who talk on the phone while they drive.

One difficulty in measuring crashes caused by texting drivers — and by drivers talking on phones — is that many police agencies do not collect this data or have not compiled long-term studies. Texting also is a relatively new phenomenon.

Overall, texting has soared. In December, phone users in the United States sent 110 billion messages, a tenfold increase in just three years, according to the cellular phone industry’s trade group, CTIA.

By comparison, several field and laboratory studies show that drivers talking on cell phones are four times more likely to cause a crash than other drivers. A previous Virginia institute study videotaping car drivers found that they were three times more likely to crash or come close to a crash when dialing a phone and 1.3 times more likely when talking on it.

Bottom line – don’t text and drive.

Allstate America’s fifth annual ranking of U.S. cities for safe driving puts Austin in a familiar position – far behind almost everyone else.

According to the study, Austin finished 179th out of 193 cities ranked.

On average, the Austin-area driver will have an accident once every seven years.  In 2005, the study’s first year, Austin ranked 176th of 196 cities, with a wreck every 7.5 years for the average driver.

The national average, based on accident claims made in 2006 and 2007 against Allstate insurance policies in which there was property damage, was an accident about once in 10.1 years.

Scrawl on the patient with a permanent marker to show where the surgeon should cut. Ask the person’s name to make sure you have the’ right patient. Count sponges to make sure you didn’t leave any in the body.

Doctors worldwide who followed a checklist of such steps cut the death rate from surgery almost in half and reduced complications by more than a third in a large international study of how to avoid blatant operating room mistakes.

The results most dramatic in developing countries — startled the researchers. “I was blown away,” said Dr. Atul Gawande, a Harvard surgeon and medical journalist who led the year-long, eight-nation study, published in today’s New England Journal of Medicine.

U.S. hospitals have been required since 2004 to take some of these precautions. But the 19-item checklist used in the study was far more detailed than what is required or what many institutions do: The researchers estimated that implementing the longer checklist in all U.S. operating rooms would save between $15 billion and $25 billion a year in the costs of treating avoidable complications.

“Most of these things happen most of the time for most patients, but we need to make it so that all these things happen all the time for all patients, because each slip represents an opportunity for harm,” said Dr. Alex Haynes of the Harvard School of Public Health, one of the study’s co-authors.