Accident & Injury Law in Texas

Archive for the ‘Medicine’ Category

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)

A new study led by a federal drug safety expert ties the diabetes drug Avandia to a higher risk of heart problems, strokes and deaths in older adults and says it is more dangerous than a rival drug, Actos.

The study, a huge review of Medicare records, comes two weeks ahead of a Food and Drug Administration hearing on Avandia’s safety.

The lead author, Dr. David Graham, is an FDA scientist who wants the pill banned.

As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999, Graham said.

The Johnson & Johnson unit that recalled millions of bottles of liquid children’s Tylenol and other pediatric medicines last month may face criminal penalties, product seizures or other sanctions, an official from the Food and Drug Administration said last Thursday.

The agency is considering further actions against McNeil Consumer Healthcare, the Johnson & Johnson unit, said Dr. Joshua M. Sharfstein, the FDA’s principal deputy comissioner, at a congressional hearing Thursday.

On April 30, McNeil voluntarily recalled more than 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec because they may have contained too much of the active ingredient of the drug, metal specks or inactive ingredients that failed testing requirements, the agency said. But McNeil’s problems go beyond those related to last month’s recall, including other forms of contamination, dating back two years.

Sharfstein noted lengthy delays by the company in reporting problems to the agency. And in one case, in 2008, he said, McNeil hired a contractor to quietly remove packages of Motrin from retailers for suspected quality problems — which he suggested was essentially an unannounced recall that was not reported to the FDA.

Sharfstein said the FDA was “considering additional enforcement actions against the company for its pattern of noncompliance. which may include seizures, injunction or criminal penalties.”

“I have become deeply concerned about your company,” Rep. Edolphus Towns, chairman of House Committee on Oversight and Government Reform, told the Johnson &. Johnson executive who testified. “It paints a picture of a company that is deceptive, dishonest and that has risked the health of many of our citizens.”

Hundreds of doctors in Texas are dropping out of the federal health care program for senior citizens as physician reimbursements for Medicare decline.

More than 300 Texas doctors have dropped the program in the past two years, including 50 in the first three months of 2010, the Houston Chronicle reported Tuesday.

The Texas Medical Association did a survey in 2008 that found 42 percent of Texas doctors surveyed said they were no longer accepting all new Medicare patients. Among primary care doctors, the percentage was 62 percent.

The dropoffs follow years of declining Medicare reimbursements, which led to a looming 21 percent cut in 2010. Congress has voted three times to postpone the cut, which is set to begin June 1.

Anxious parents are scouring the Internet for information after an enormous recall of over-the-counter medications for infants and children that was announced last week.

The recall affects all unexpired lots of liquid Tylenol, Motrin, Zyrtec and Benadryl formulated for youngsters more than 43 products overall.

The U.S. Food and Drug Administration advised families to stop using the products, noting some may contain “tiny particles” while others have too much of the active ingredients or inactive ingredients that don’t meet specifications. McNeil Consumer Healthcare, the manufacturer, and federal officials said the prospect of serious medical problems was “remote.”

For its part, McNeil did little to calm parents’ fears with a hot line (888-222-6036) that featured a verbal rendition of the company’s news release. That release, including a list of all affected products and their lot numbers, is available at www.mcneilproductrecall.com.

McNeil is a unit of Johnson and Johnson.

Families should feel comfortable using generic versions of the drugs, said Dr. Saul Weiner, an associate professor of pediatrics and internal medicine at the University of Illinois at Chicago Medical Center.

If you have given a child one of the medications being recalled, watch out for nausea, vomiting, diarrhea, a rash or “any symptoms that seem out of the ordinary,” said. Jenny Elhadary, pharmacy administrator for Children’s Memorial Hospital.

Call a doctor immediately if the symptoms appear.

Meanwhile, a conressional committee has aunched an investigation into the problems, with lawmakers pledging to crutinize the performance of both the drug maker and federal regulators.

Reps. Edolphus Towns, D-N.Y., and Darrell Issa, R-Calif., the leaders of the House Committee on Oversight and Government Reform, said in a joint statement that they are “deeply concerned” about the recall, which affects an estimated 70 percent of the market for over-the-counter pediatric liquid medicines.

The investigation comes a day after the Food and Drug Administration released documents by federal inspectors who found widespread quality control problems at the Pennsylvania facility where the recalled medicines were manufactured.

Federal investigators found that raw materials had “known contamination” with unspecified bacteria and “were ap proved for use to manufacture several finished lots of Children’s and Infant’s Tylenol drug products.” FDA officials said they couldn’t identify the bacteria.

Samples of finished products tested negative for bacteria, however, and the risk to consumers was remote, agency officials said.

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.

Doctors in the United States wrote more than 4 million prescriptions last year for nitroglycerin tablets, heart drugs placed under the tongue to reduce the chest pain of angina or to stop a heart attack.

But the majority of the drugs sold had not been approved for sale or had their safety and effectiveness vetted by the Food and Drug Administration.

And many doctors, who discovered only last week that pharmacies were giving their patients unproven heart tablets, now say they have no way of knowing whether patients have suffered unnecessarily as a result.

The problem of the unapproved tablets stems from a longstanding ambiguity about the rules for drugs whose use predates the establishment of the FDA in 1938. Only one brand of nitroglycerin pills is federally approved: Nitrostat, made by Pfizer, on the market since 2000.

The FDA sent warning letters to two drugmakers ordering them to stop marketing unapproved nitroglycerin tablets. But the drugs are still being sold at pharmacies while the order takes effect.

The drugmakers said they would comply with the order but said that their tablets were safe.

The FDA said that it had not examined the quality of the products it was ordering off the market but that it had recorded problems with other unapproved nitroglycerin products in the past.

People who take unapproved nitroglycerin are advised to continue taking their tablets but to consult their doctors about replacement prescriptions.

Cardiologists regularly prescribe nitroglycerin to relieve chest pain associated with coronary artery disease. Placed under the tongue, the drug quickly dissolves into the blood, where it dilates the coronary artery, slightly decreasing blood pressure and reducing heart exertion.

When taken during an initial episode of chest pain, nitroglycerin can prevent a heart attack in 3 to 4 percent of patients, said Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic.
Many makers of various drugs, not only nitroglycerin tablets, have long contended that their medications did not require FDA review because they were grandfathered as pre-1938 drugs. But the agency is now disputing that interpretation.

Federal prosecutors in Boston announced Thursday that they have filed a health care fraud charge against a doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex.

Court documents indicate that anesthesiologist Scott Reuben has agreed to plead guilty in exchange for prosecutors recommending a sentence of up to 10 years in jail, a $250,000 fine and forfeiture of assets received for the research worth at least $50,000.

Prosecutors allege the former chief of acute pain at Baystate Medical Center in Springfield, Mass., received research grants from pharmaceutical companies but never performed the studies. He fabricated patient data and submitted information to anesthesiology journals that unwittingly published it, court documents allege.

Two of the drugs that Reuben reported favorable results for, Vioxx and Bextra, were pulled from the market amid evidence they raised the risk of heart attack, stroke and death.

How can someone who is supposed to be a healer and care for people show such callousness, knowing that his reports would affect drug use by thousands of patients?

Two popular heartburn medications can interfere with the blood thinner Plavix, a drugtaken by millions to reduce risks of heart attack and stroke.

The Food and Drug Administration said the stomach-soothing Prilosec and Nexium cut in half the blood-thinning effect of Plavix, or clopidogrel.

The Texas Medical Board fined Dr. Philip W. Caterbone of Pflugerville $1,000 for a record-keeping violation. He was among 75 doctors disciplined at the board’s meeting this month.

The board’s order said that Caterbone, who is engaged in family practice, failed to document the progress notes from a patient’s visit in September 2008.