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On July 2, 2008 an FDA panel suggested that diabetes drugs should face stricter standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. FDA advisers voted 14-2 on July 2, 2008 that all new diabetes drugs must undergo longer studies to assure they don’t increase risks of heart problems.

The agency currently doesn’t screen for heart risks associated with diabetes drugs. The opinions from diabetes experts, cardiologists and statisticians come less than a year after the FDA was criticized for it’s handling of heart risks connected with a widely used GlaxoSmithKline pill.

The drug was approved in 1999 but the agency didn’t add a warning about potential heart risks until last November. The majority of the panel said drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market. The testing would take an estimated five to seven years to complete, and likely cost tens of millions of dollars.

At least one panelist doubted whether the proposed studies would actually uncover heart risks, and added they could delay important medical breakthroughs.

“If you wait this amount of time for testing you’re going to be preventing certain drugs from getting out there that may be better than what we already have,” said Dr. Eric Felner, a pediatric specialist at Emory University School of Medicine.

The FDA is not required to follow the panel’s advice, though it often does.

GlaxoSmithKline PLC, AstraZeneca and Novartis AG are among the companies developing diabetes treatments to compete in the domestic market, which grew to more than $6 billion last year, according to pharmaceutical research firm IMS Heath.

Takeda Pharmaceuticals’ Actos, GlaxoSmithKline’s Avandia, and Eli Lilly and Amylin Pharmaceutical’s Byetta currently dominate the U.S. market.

An estimated 24 million Americans have Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.

The FDA was pressured to reconsider how it approves diabetes medications after an analysis released last year showed GlaxoSmithKline’s blockbuster drug Avandia may increase patients’ risk of heart attack.

The agency currently approves diabetes drugs based on their ability to lower blood sugar. But Dr. Steven Nissen, who authored the analysis on Avandia, said that criterion has little value if drugs also increase heart problems.

Nissen, the chairman of cardiology at the Cleveland Clinic, said the FDA is operating under “the irrational belief that lowering blood sugar using virtually any pharmacological means will produce” better results for patients.

He recommended the FDA require drug companies to prove their drugs do not have significant heart risks before granting approval.

“The fallacy here is that we will never know everything we’d like to about a drug before it goes on the market,” Dr. Ray Woosley, president of the Critical Path Institute in Tucson, Ariz., said in a phone interview. “If we held up drugs until we did know everything a lot of people would die.”

The institute is a nonprofit partnership with the FDA that aims to speed up the development of new drugs.

Approving drugs based on biological measurements, like blood sugar levels in diabetics, is thought to be a promising method for speeding-up drug development because the results can be gathered relatively quickly.

But that approach is under scrutiny, as some lawmakers and medical experts believe the FDA should not approve drugs without evidence they improve more meaningful measures like patients’ life span.

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On June 30, 2008, an 11-year-old Topanga Canyon girl informed a Malibu jury that she can barely remember what it’s like to see, since she was left near-blind and suffering from a painful condition that her parents and doctors claim was caused by a rare, severe allergic reaction to Children’s Motrin.

“It’s hard to remember what seeing is like, when you haven’t been able to see for a long time,” Sabrina Johnson testified during the trial of her family’s lawsuit against Children’s Motrin manufacturer Johnson & Johnson and its subsidiaries.

She and her father testified that Sabrina’s eyes were so painful in any dim light that she once chose to spend several weeks inside a box at her grandparents’ house, near a Florida eye clinic. “It was not a very fun Christmas,” Sabrina said. “Since I was in a box, I was one of the presents.”

The girl suffered chemical burns in her eyes and every orifice of her body after her parents gave her three doses of Children’s Motrin for a slight fever in 2003, when she had come home from Topanga Elementary School with a fever. The reaction sent her to Cedars-Sinai Medical Center, where even doctors did not know about medical links between the active ingredient in Motrin ibuprofen and the severe reaction called Stevens-Johnson Syndrome (SJS)

A lack of warnings to consumers, and the fact that physicians were not given warnings about the remote possibility of such a violent reaction until 2005, is at the heart of the five-week-long trial of the lawsuit.

The suit accuses Johnson & Johnson and its family of subsidiary companies of putting sales of its ibuprofen painkiller worth $1 billion in profits per year ahead of the extremely rare possibility that a person can be blinded, or killed, as a result of an allergic reaction that is not mentioned on the product’s label.

Johnson & Johnson lawyers have contended that the product is safe, and that warning labels on the box and inside the packaging adequately warned caregivers that they should consult doctors if any change of medical condition occurs after giving a young person Children’s Motrin. During opening statements last week, company attorneys said they will prove that the drug did not cause Sabrina Johnson’s illness.

“That’s my little girl, every day,” Sabrina’s father, Kenneth Johnson, testified earlier as he pointed to a large photo of his daughter clasping blankets tightly to her head as she sat in a dark room. Sabrina endured a two-week hospital stay in which she was in excruciating pain or a morphine haze, her father said.

“I thought we were going to lose her,” Kenneth Johnson said.

Kenneth Johnson, an engineering manager at a top-secret Raytheon government electronics project, said he read the Motrin label before buying it and before dispensing it, and was given no warning that it could cause the severe ibuprofen reaction known as Stevens-Johnson Syndrome (SJS).

“I’m scared to death now that my daughter will end up in some apartment in some city, on a government subsistence check and that scares me to death,” Johnson said, choking back tears.

Johnson & Johnson lawyers agreed today with the family’s attorneys that the girls medical bills over the last five years totaled $534,000.

On the witness stand a former company executive testified that the firm and its subsidiary, McNeil, knew that as many as 20 people had been blinded, killed or seriously injured by Children’s Motrin between the time it was put on the over-the-counter market in the 1990s, and when Sabrina Johnson was given three doses of it in 2003.

Anthony R. Temple, who was executive medical director for Johnson & Johnson’s McNeil Consumer Products subsidiary, said he was also aware that more than 40 cases of Stevens-Johnson Syndrome (SJS) occurred in the years after doctors at Cedars-Sinai Medical Center told the Topanga Canyon family that Motrin had caused Sabrina’s hospitalization, and near-death, and continued terrible pain.

Temple also said the company did not add warnings to the product label after an extensive clinical trial found that it could cause a severe allergic shock similar to a violent bee sting reaction in more than 5 out of every 100,000 children given the drug.

The label warnings were made more severe after doctors petitioned the federal government to add tougher language in 2005. Language about the symptoms of Stevens-Johnson Syndrome (SJS) was added to Children’s Motrin sold via prescriptions, but not the same drug sold over-the-counter, Temple said.

Attorneys from the drug company had no questions for their former employee, who has now retired, but said they may recall Temple when they put on their rebuttal case.

Sabrina Johnson tried to watch on television as her lawyer played videotape of her testimony before a FDA advisory committee in Washington, where the little girl implored rulemakers to “please do something so other children don’t get hurt by Stevens-Johnson Syndrome (SJS) like me. People really need to know about that.”

Sabrina said she is learning Braille and hopes to become a pediatrician or a veterinarian. At her lawyer’s request, she sang a song with the chorus “It’s possible, anything is possible.”

Johnson & Johnson’s attorneys had no questions.

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On June 17, 2008, the FDA announced that Chattem Inc. failed to inform officials about new warnings added to its Icy Hot heat therapy patches after getting more than 168 complaints, according to a recently released letter.

In a warning letter to the company, the U.S. Food and Drug Administration said Chattem did not tell the FDA it was changing the wording on the product’s label to help consumers avoid burns and other skin irritations after it received the complaints, the agency said in the letter dated June 6.

The company also did not report some complaints to the agency within the time period required by law, it said. It was not immediately clear how many consumers were seriously injured or otherwise harmed by the patch. FDA and Chattem officials did not return calls seeking comment.

Icy Hot is one of the companies biggest-selling brands, according to its 2007 annual report, which did not break down sales for specific products. The product line aims to help prevent muscle pain through the use of menthol a mint extract that produces a cooling sensation. The patches come in different shapes to adhere to the back and other sore body parts.

The FDA said Chattem did not have proper procedures in place to handle complaints and other problems.

It also said the product’s label did not properly explain its warnings or caution that certain users such as children should not use the patches.

“The duration of use of ‘up to 8 hours’ raises significant clinical concerns as this duration exceeds the established time at which a 2nd degree burn has been shown to occur on human skin at the target temperature of the patch,” the letter also said.

“The labeling needs to provide adequate directions for use with respect to the duration the device is to be applied to the patient’s skin,” it added.

The FDA’s letter follows an inspection of the company’s Chattanooga, Tennessee, plant Feb. 5 through Feb 8. Chattem recalled a variety of Icy Hot heat therapy products on Feb. 8, saying it had received consumer reports of burns and skin irritation.

FDA officials issue dozens of warning letters a year and can impose fines, product seizures and other penalties, although most are resolved without such measures.

The FDA said Chattem has 15 days to notify the agency about steps it was taking to correct problems. The agency acknowledged the company had sent an earlier response about some problems but said it was inadequate.

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