Missouri Injury Lawyer Blog

Two more studies published in yet another prominent medical journal have raised questions about the safety of Avandia, a once-popular diabetes medicine. One study found that Avandia, made by GlaxoSmithKline, doubled the risks of heart failure and raised the risks of heart attack by 42 percent. A second study found that Actos, a similar drug made by Takeda, actually lowered the risks of heart attacks, strokes and death but, like Avandia, also raised risks of heart failure.

Taken together, some of the authors said, the two studies in The Journal of the American Medical Association confirm what doctors and patients using Avandia have already done in great numbers, that is, switch to another drug. Sales of Avandia have plunged.

GlaxoSmithKline said in a written statement that the studies were flawed and “offered no new information on the safety of Avandia.” The company “continues to support Avandia as safe and effective when used appropriately,” the statement said. In July, a federal advisory panel voted overwhelmingly that Avandia should remain on the market even though it raised the risks of heart attacks. In June, the Food and Drug Administration said it would place its strictest warnings on the labels of both Avandia and Actos because of heart failure risks.

Riven by internal disagreements, the drug agency is still pondering further regulatory actions regarding Avandia. Some in the agency say that the drug should be withdrawn, while others say that all diabetes drugs have risks and that doctors need a variety of options.

The controversy began in May when The New England Journal of Medicine published a combined analysis of more than 40 studies of Avandia that found that it significantly raised the risks of heart attacks. The study attracted wide attention, but it was also criticized by the company and some on Capitol Hill as flawed.

In the study’s aftermath, the drug agency said that it had been told in 2005 of a similar study conducted by GlaxoSmithKline that came to a similar conclusion. Critics denounced the agency’s delay in alerting patients.

Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists, said that the new studies were “more evidence that we should have a very high level of caution” regarding the use of Avandia. The drug agency should further strengthen the warnings on Avandia’s label to make it clear that the drug should be used very sparingly.

In the first study, researchers from Wake Forest University did yet another combined analysis of Avandia studies, this time limiting themselves to four long-term studies. The authors’ hope was that, by focusing on such a select set, their analysis would avoid some of the limitations of the May analysis.

The redo came to a conclusion almost identical to that of the study published in May. Dr. Sonal Singh, an assistant professor of internal medicine at the Wake Forest School of Medicine and a co-author of the study, said the drug agency should consider withdrawing Avandia from the market.

In addition to its deleterious effects on the heart, Avandia can cause blindness, and it doubles the risks of bone fractures in women, Dr. Singh said in an interview. “If you use Avandia to treat patients with Type 2 diabetes,” he said, “their chance of getting heart failure due to Avandia is one in 30 and their risk of getting a heart attack is one in 220. All due to the drug.” Dr. Singh added, “There are older and cheaper drugs that are far better to treat diabetes.”

In the second study, researchers at the Cleveland Clinic combined data from 19 trials of Actos and found that the drug seemed to lower the risks of heart attack, stroke and death by about 20 percent. The study confirmed that Actos increased the risks of heart failure, but this problem is mostly reversible.

“I think this shows that these drugs aren’t the same,” said Dr. A. Michael Lincoff, vice chairman for research in the department of cardiovascular medicine at the Cleveland Clinic. Dr. Lincoff said that Actos not only appeared to be safer than Avandia, but also offered some protection to the heart. Most diabetics die of heart disease. In an accompanying editorial, two doctors from Brigham and Women’s Hospital in Boston wrote that Avandia would probably not have been approved in 1999 had its heart risks been known.

In an interview, Dr. Daniel H. Solomon, a co-author of the editorial, called Avandia “a drug of last resort.” Dr. Solomon wrote that the Avandia situation should be used to improve the nation’s drug-safety system. Among his proposals is that when several drugs are available to treat a condition, new drugs must prove that they improve or extend people’s lives before they are approved. Now, many drugs are approved only after they improve laboratory results, like blood sugar or cholesterol levels.

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Posted In: Drug Safety

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Car crashes in Missouri and Illinois are common. Cars are designed to protect you if you are wearing a seat belt. You hear it all the time, wear your seat belt and your chances of surviving a crash are much higher. In fact, statistics show you have a 60 percent chance of making it out of an accident alive if you buckle up.

But this weekend alone three people died on roads in southeast Missouri and police say they were not wearing seat belts. Five people who died in Kentucky last week also did not have their seat belts on. Emergency responders say they see a lot of gruesome sights at deadly accidents where people didn't buckle up, so they always tell their loved ones not to leave their driveway without buckling up first.

"When they're not restrained they're a little more bloodier, there are more injuries," Paramedic Meg Cooper said. She became an emergency responder, working at Cape County Private Ambulance, to help save lives. But she says it's often too late when people don't take the time to buckle up.

"A lot of times people are ejected through a window. In a rollover, there can be partial ejection, where the vehicle rolls on top of them. If you're fully ejected, you run the risk of the vehicle following you or running over," Cooper said.

All that's left of 38-year-old Gilbert Marler's truck is a mass of crumpled metal. Police say he lost control of the truck and overturned on a Stoddard County road on Sunday. Investigators say the impact tossed Marler out into a field. Marler died and he was not wearing a seat belt.

"It still surprises me that people don't wear seat belts and they think nothing is going to happen to them," said Lt. John Davis with the Cape Girardeau Police Department. He reconstructed accidents for many years.

"Anytime you're behind the wheel of a car, your body's in motion too. If your car stops suddenly, your body continues on at the same speed, and if you're unrestrained, then you're going to hit the steering wheel, the dash or the windshield," he said.

That's the kind of logic emergency crews hope you take into account when you get behind a wheel. Something else to think about, the only survivor from this weekend's deadly crashes in Southeast Missouri had her seat belt on.

Posted by Jeff Lowe | Permalink | Email This Post

Posted In: Traffic Safety

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Missouri drivers are dying in automobile accidents at increased rate because of their failure to wear seat belts. According to a recently published Missouri Department of Transportation press release, a recent survey released by the Missouri Coalition for Roadway Safety showed that only 77 percent of Missouri residents wear their seat belts whenever they're in a car. This number is well below the 2006 national average of 81 percent.

According to the director of the Missouri Department of Transportation's Highway Safety Division, "The survey shows that Missourians have not changed their seat belt usage significantly over the last five years, and that's disturbing. People are dying needlessly by failing to simply buckle up." Seat belt percentages have ranged from 73 percent to 77 percent in the past several years.

As I have previously written, Missouri has been contemplating a seat belt law that would allow police to pull a driver over and ticket them just for a seat belt violation. The current law only allows police officers to ticket someone for a seat belt violation if they pull the person over for some other infraction. If the new law is enacted, it is estimated based on the increases in seat belt usage in states with similar laws seat belt belt use in Missouri could increase by roughly 11 percent and save approximately 90 lives each year in the Missouri.

Every time I read the paper about a automobile accident fatality in Missouri, Illinois or any other state I look to see it the deceased was wearing a seat belt. I know as a personal injury lawyer that modern cars are designed to have safety features for persons wearing seat belts. These safety features include front, side, and side curtain air bags, pillars designed to keep the roof from crushing in a roll over accident, and most of all wearing a seat belt will keep occupants from being ejected from cars.

Statistics in Missouri revealed that approximately 69 percent of the 1,096 people that died in Missouri car crashes last year were not wearing a seat belt. Based on an analysis of traffic accidents, anyone involved in a traffic accident has a 1 in 31 chance of dying if they were not wearing a seat belt, however, if the passenger was wearing a a seat belt the chance of dying decreases 1 chance in 1,300.
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As for the dividing line between genders, the study showed that 82 percent of women wear their seat belts while only 76 percent of men wear theirs. Teens and pickup truck drivers tend to wear their seat belts the least. Pickup truck drivers only wear theirs 66 percent of the time while only 61 percent of teens buckle up. Within past years, teens have been the group to be least likely to buckle up when either driving or being in a car at all.

On a better note, the numbers of people wearing their seat belts has gone up in general. Back in 1998, only about 60 percent of drivers did not wear their seat belts while the current number is number is up to 77 percent this year.

Source: MDOT. "Missouri Seatbelt Use Remains Below National Average." http://www.modot.org/newsandinfo/District0News.shtml?action=displaySSI&newsId=12984

Posted by Jeff Lowe | Permalink | Email This Post

Posted In: Traffic Safety

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A $1.5 million settlement was reached in a car crash for a teen who were seriously injured in a car accident following a party at an equestrian center where alcohol was served to minors. The state Act had taken effect 29 days before the accident under the Illinois Drug or Alcohol Impaired Minor Responsibility Act.

At the party, free kegs of beer were available to all guests and minors were not required to provide identification. After the girls left the party, the driver made an illegal left turn and
crossed the two southbound lanes where the car was hit by a tractor-trailer truck. The injured teen who was in the back seat, was thrown out of the car and suffered serious neurological injuries. The injury is permanent, restricts use of her left hand and leg. None of the other girls was injured.

This law imposes civil liability against persons over 18 who allow minors to drink, if a minor becomes impaired and injures or kills another. Prior to this law neither Missouri nor Illinois recognized what is know as social host liability. This law is a good step toward imposing civil liability on persons who serve alcohol to minors who then injure other people.

I practice law in both Illinois and Missouri and many clients are shocked to find out that they did not have a cause of action under Illinois or Missouri law against someone who provides alcohol to minors who then injure them. The law is based on the assumption that serving alcohol is not the proximate cause of the accident, but the person who caused the accident was the proximate cause. This new law in Illinois serves a good purpose and should be more broadly adopted in other states including Missouri.

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Posted In: Settlements

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