Johnson & Johnson Recalls Yet More Tylenol Products
Strange Odor Caused by Chemical Leads to Another Recall
By KIM CAROLLO, ABC News Medical Unit
Oct. 19, 2010
The trouble continues for Johnson & Johnson, the makers of Tylenol. More of its adult pain relievers have been recalled voluntarily because of complaints about a strange, musty odor. It's the ninth time in a year that Johnson & Johnson's products have been taken from store shelves.
In a statement, Johnson & Johnson's McNeil Consumer Health division announced it is recalling one product lot of 50-count bottles of Tylenol 8 Hour Caplets. That's about 128,000 bottles.
"McNeil is taking this acdtion following a small number of complaints of a musty or moldy odor," McNeil said in the statement. The company said it believes the odor is caused by a chemical called 2,4,6-tribromoanisole (TBA).
It's not the first time this chemical has caused a Tylenol recall. In December and January, McNeil recalled nearly 60 million bottles of Tylenol Arthritis Relief Caplets and a number of other products after consumers complained of stomach problems linked to the same chemical. TBA comes from the breakdown of a chemical in wood pallets used to transport and store the packaging materials for the bottles.
According to ABC News Senior Medical Editor Dr. Richard Besser, the stomach problems some people experienced are not serious.
"They're not that severe - we're talking about vomiting, diarrhea," Besser said after news of the December recall.
When asked whether more product could be recalled as a result of contamination with TBA, a Johnson & Johnson spokeswoman would not comment. She did say that it's a different recall, but related to the same issue as the one in December.
The spokeswoman also said no other lots containing TBA have been identified and the company will continue surveillance for the chemical.
Back in July, McNeil announced a recall of 21 different product lots, including Children's Tylenol, Benadryl and Motrin.
And in the largest recall of children's medicine in history, Johnson & Johnson pulled more than 136 million bottles of Tylenol, Motrin, Zyrtec and Benadryl -- more than 40 products in all -- in April.
There have also been accusations of shady practices by the drug giant, including a "phantom recall," during which employees of a company hired by Johnson & Johnson were allegedly sent to buy affected Motrin off store shelves in lieu of a product recall. In September, a deputy commissioner at the U.S. Food and Drug Administration testified before Congress that the agency did not act quickly enough to stop the phantom recall.
http://abcnews.go.com/Health/PainManagement/tylenol-recall-hour-caplets-recalled-johnson-johnson-ninth/story?id=11917374
www.wellness4lifechiro.com
Friday, October 29, 2010
Monday, October 18, 2010
When medications cause problems they are supposed to prevent
News Analysis
When Drugs Cause Problems They Are Supposed to Prevent
By GINA KOLATA
Published: October 16, 2010 New York Times
In the past month, the Food and Drug Administration has concluded that in some cases two types of drugs that were supposed to be preventing serious medical problems were, in fact, causing them.
One is bisphosphonates, which is widely used to prevent the fractures, especially of the hip and spine, that are common in people with osteoporosis. Those drugs, like Fosamax, Actonel and Boniva, will now have to carry labels saying they can lead to rare fractures of the thigh bone, a surprising new discovery that came after another surprise — that they can cause a rare degeneration of the jawbone.
The other is Avandia, which is widely prescribed for diabetics, whose disease puts them at risk for heart attacks and heart failure. Two-thirds of diabetics die of heart problems, and a main reason for taking drugs like Avandia is to protect them from that.
But now the F.D.A. and drug regulators in Europe are restricting Avandia’s use because it appears to increase heart risks.
In the case of bisphosphonates, the benefits for people with osteoporosis still outweigh the risk, bone experts say. And no one has restricted their use.
But the fact remains that with decades of using drugs to treat chronic diseases, the unexpected can occur.
Something new is happening, said Daniel Carpenter, a government professor at Harvard who is an expert on the drug agency. The population is aging, many have chronic diseases. And companies are going after giant markets, huge parts of the population, heavily advertising drugs that are to be taken for a lifetime.
And the way drugs are evaluated, with the emphasis on shorter-term studies before marketing, is not helping, Dr. Carpenter said.
“Here is a wide-scale institutional failure,” he said. “We have placed far more resources and requirements upon premarket assessment of drugs than on postmarket.”
Dr. Jason Karlawish, a University of Pennsylvania ethicist who studies the ways new treatments are developed and disseminated, expressed a similar concern.
“The point is not that the drugs are bad, but that drugs for these chronic diseases present a novel set of challenges about how to assess their safety,” he said.
But such discussions make Dr. Ethel Siris, an osteoporosis expert at Columbia-Presbyterian Medical Center, nervous. Bisphosphonates have been extensively studied, she said, and the thigh fractures from bisphosphonates — while surprising — are very rare. Dr. Siris’s fear is that people who really need the drugs will turn away from them.
It is not clear how the nation should respond to the new era of widespread drug use for chronic diseases.
“The basic underlying theme is that we don’t have good long-term safety indices for common chronic diseases that we are treating with major drugs,” said Dr. Clifford J. Rosen, director of the Maine Center for Osteoporosis Research. Dr. Rosen, in addition to studying osteoporosis, was on an advisory committee of the drug agency that examined the evidence that Avandia was linked to heart risks.
The difficulty is in figuring out how to assess the safety of drugs that will be taken for decades, when the clinical trials last at most a few years.
Today’s system, which largely consists of asking doctors to report adverse reactions and of researchers’ attempts to look at patient experiences in a variety of diverse databases, like records of large health plans, is ineffective, medical experts agree.
“There has to be a better system,” Dr. Rosen said.
Congress recently gave the drug agency the power to require studies after drug approval, but the agency has used it sparingly.
Some, like Dr. Rosen and Dr. Carpenter, would like large clinical trials after a drug is approved and continuing for years, even for drugs that met all the premarket requirements.
Dr. Karlawish questions whether this is practical. Once a drug is approved, it can be difficult to persuade doctors to assign their patients randomly to one approved treatment or another, and the sort of studies being suggested would go on for many years, making them difficult.
He favors something different — the development of a national electronic drug database that would reveal drug use and complications. In the meantime, Dr. Karlawish said, he could not help marveling at the paradox of drugs causing what they were supposed to prevent.
“This is priceless,” he said.
http://www.nytimes.com/2010/10/17/health/policy/17drug.html?_r=2&hpw
www.wellness4lifechiro.com
When Drugs Cause Problems They Are Supposed to Prevent
By GINA KOLATA
Published: October 16, 2010 New York Times
In the past month, the Food and Drug Administration has concluded that in some cases two types of drugs that were supposed to be preventing serious medical problems were, in fact, causing them.
One is bisphosphonates, which is widely used to prevent the fractures, especially of the hip and spine, that are common in people with osteoporosis. Those drugs, like Fosamax, Actonel and Boniva, will now have to carry labels saying they can lead to rare fractures of the thigh bone, a surprising new discovery that came after another surprise — that they can cause a rare degeneration of the jawbone.
The other is Avandia, which is widely prescribed for diabetics, whose disease puts them at risk for heart attacks and heart failure. Two-thirds of diabetics die of heart problems, and a main reason for taking drugs like Avandia is to protect them from that.
But now the F.D.A. and drug regulators in Europe are restricting Avandia’s use because it appears to increase heart risks.
In the case of bisphosphonates, the benefits for people with osteoporosis still outweigh the risk, bone experts say. And no one has restricted their use.
But the fact remains that with decades of using drugs to treat chronic diseases, the unexpected can occur.
Something new is happening, said Daniel Carpenter, a government professor at Harvard who is an expert on the drug agency. The population is aging, many have chronic diseases. And companies are going after giant markets, huge parts of the population, heavily advertising drugs that are to be taken for a lifetime.
And the way drugs are evaluated, with the emphasis on shorter-term studies before marketing, is not helping, Dr. Carpenter said.
“Here is a wide-scale institutional failure,” he said. “We have placed far more resources and requirements upon premarket assessment of drugs than on postmarket.”
Dr. Jason Karlawish, a University of Pennsylvania ethicist who studies the ways new treatments are developed and disseminated, expressed a similar concern.
“The point is not that the drugs are bad, but that drugs for these chronic diseases present a novel set of challenges about how to assess their safety,” he said.
But such discussions make Dr. Ethel Siris, an osteoporosis expert at Columbia-Presbyterian Medical Center, nervous. Bisphosphonates have been extensively studied, she said, and the thigh fractures from bisphosphonates — while surprising — are very rare. Dr. Siris’s fear is that people who really need the drugs will turn away from them.
It is not clear how the nation should respond to the new era of widespread drug use for chronic diseases.
“The basic underlying theme is that we don’t have good long-term safety indices for common chronic diseases that we are treating with major drugs,” said Dr. Clifford J. Rosen, director of the Maine Center for Osteoporosis Research. Dr. Rosen, in addition to studying osteoporosis, was on an advisory committee of the drug agency that examined the evidence that Avandia was linked to heart risks.
The difficulty is in figuring out how to assess the safety of drugs that will be taken for decades, when the clinical trials last at most a few years.
Today’s system, which largely consists of asking doctors to report adverse reactions and of researchers’ attempts to look at patient experiences in a variety of diverse databases, like records of large health plans, is ineffective, medical experts agree.
“There has to be a better system,” Dr. Rosen said.
Congress recently gave the drug agency the power to require studies after drug approval, but the agency has used it sparingly.
Some, like Dr. Rosen and Dr. Carpenter, would like large clinical trials after a drug is approved and continuing for years, even for drugs that met all the premarket requirements.
Dr. Karlawish questions whether this is practical. Once a drug is approved, it can be difficult to persuade doctors to assign their patients randomly to one approved treatment or another, and the sort of studies being suggested would go on for many years, making them difficult.
He favors something different — the development of a national electronic drug database that would reveal drug use and complications. In the meantime, Dr. Karlawish said, he could not help marveling at the paradox of drugs causing what they were supposed to prevent.
“This is priceless,” he said.
http://www.nytimes.com/2010/10/17/health/policy/17drug.html?_r=2&hpw
www.wellness4lifechiro.com
Vaccinated People getting Whooping Cough
Vaccinated People Getting Whooping Cough In SD
By Joanne Faryon
September 7, 2010
SAN DIEGO — A KPBS investigation has raised questions about how effective the whooping cough vaccine is in preventing people from getting sick. Nearly two out of three people diagnosed with whooping cough in San Diego County this year, were fully immunized.
California is in the midst of the worst whooping cough epidemic in 50 years. Thirty six hundred people in the state have been diagnosed with the disease. Eight babies have died since January.
KPBS examined data from San Diego County’s Health and Human Services Agency. Of the 332 confirmed cases of whooping cough in the county so far this year, 197 of the people who got sick were up to date with their immunizations. That's nearly 2 out of 3 cases.
Dean Sidelinger is the county’s deputy health officer.
“It’s a little higher then we expected, but certainly we do still feel the vaccine provides protection and it’s an important health tool to try and prevent this disease.”
Research in the Netherlands suggests the bacterium which causes whooping cough, or pertussis, may be mutating and contributing to whooping cough outbreaks worldwide.
http://www.kpbs.org/news/2010/sep/07/vaccinated-people-getting-whooping-cough-sd/
www.Wellness4lifechiro.com
By Joanne Faryon
September 7, 2010
SAN DIEGO — A KPBS investigation has raised questions about how effective the whooping cough vaccine is in preventing people from getting sick. Nearly two out of three people diagnosed with whooping cough in San Diego County this year, were fully immunized.
California is in the midst of the worst whooping cough epidemic in 50 years. Thirty six hundred people in the state have been diagnosed with the disease. Eight babies have died since January.
KPBS examined data from San Diego County’s Health and Human Services Agency. Of the 332 confirmed cases of whooping cough in the county so far this year, 197 of the people who got sick were up to date with their immunizations. That's nearly 2 out of 3 cases.
Dean Sidelinger is the county’s deputy health officer.
“It’s a little higher then we expected, but certainly we do still feel the vaccine provides protection and it’s an important health tool to try and prevent this disease.”
Research in the Netherlands suggests the bacterium which causes whooping cough, or pertussis, may be mutating and contributing to whooping cough outbreaks worldwide.
http://www.kpbs.org/news/2010/sep/07/vaccinated-people-getting-whooping-cough-sd/
www.Wellness4lifechiro.com
Monday, October 11, 2010
How to Brand a disease
How to brand a disease -- and sell a cure
By Carl Elliott, Special to CNN
October 11, 2010 7:38 a.m. EDT
Editor's note: Dr. Carl Elliott, an M.D. and Ph.D., is the author of "White Coat, Black Hat: Adventures on the Dark Side of Medicine" (Beacon Press, 2010).
(CNN) -- If you want to understand the way prescription drugs are marketed today, have a look at the 1928 book, "Propaganda," by Edward Bernays, the father of public relations in America.
For Bernays, the public relations business was less about selling things than about creating the conditions for things to sell themselves. When Bernays was working as a salesman for Mozart pianos, for example, he did not simply place advertisements for pianos in newspapers. That would have been too obvious.
Instead, Bernays persuaded reporters to write about a new trend: Sophisticated people were putting aside a special room in the home for playing music. Once a person had a music room, Bernays believed, he would naturally think of buying a piano. As Bernays wrote, "It will come to him as his own idea."
Just as Bernays sold pianos by selling the music room, pharmaceutical marketers now sell drugs by selling the diseases that they treat. The buzzword is "disease branding."
To brand a disease is to shape its public perception in order to make it more palatable to potential patients. Panic disorder, reflux disease, erectile dysfunction, restless legs syndrome, bipolar disorder, overactive bladder, ADHD, premenstrual dysphoric disorder, even clinical depression: All these conditions were once regarded as rare until a marketing campaign transformed the brand.
Once a branded disease has achieved a degree of cultural legitimacy, there is no need to convince anyone that a drug to treat it is necessary. It will come to him as his own idea.
Disease branding works especially well for two kinds of conditions. The first is the shameful condition that can be destigmatized. For instance, when Pharmacia launched Detrol in the late 1990s, the condition the drug treated was known to doctors as "urge incontinence." Patients called it "accidentally peeing in my pants" and were embarrassed to bring it up with their physicians.
Pharmacia fixed the problem by rebranding the condition as "overactive bladder." Whereas "incontinence" suggested weakness and was associated mainly with elderly women, the phrase "overactive bladder" evoked a supercharged organ frantically working overtime.
To qualify for a diagnosis of "overactive bladder," patients did not actually have to lose bladder control." They simply needed to go to the bathroom a lot.
The vice president of Pharmacia, Neil Wolf, explained the branding strategy in a 2002 presentation called "Positioning Detrol: Creating a Disease." By creating the disease of "overactive bladder," Wolf claimed, Pharmacia created a market of 21 million potential patients.
Another good candidate for branding is a condition that can be plausibly portrayed as under-diagnosed. Branding such a condition assures potential patients that they are part of a large and credible community of sufferers. For example, in 1999, the FDA approved the antidepressant Paxil for the treatment of "social anxiety disorder," a condition previously known as "shyness."
In order to convince shy people they had social anxiety disorder, GlaxoSmithKline, the maker of Paxil, hired a PR firm called Cohn and Wolfe. Cohn and Wolfe put together a public awareness campaign called "Imagine being allergic to people," which was allegedly sponsored by a group called the "Social Anxiety Disorders Coalition."
GlaxoSmithKline also recruited celebrities like Ricky Williams, the NFL running back, and paid them to give interviews to the press about their own social anxiety disorder. Finally, they hired academic psychiatrists working on social anxiety disorder and sent them out on the lecture circuit in the top 25 media markets.
The results were remarkable. In the two years before Paxil was approved for social anxiety, there were only about 50 references to social anxiety disorder in the press. But in 1999, during the PR campaign, there were over a billion references.
Within two years Paxil had become the seventh most profitable drug in America, and Cohn and Wolfe had picked up an award for the best PR campaign of 1999. Today, social anxiety disorder, far from being rare, is often described as the third most common mental illness in the world.
It is hard to brand a disease without the help of physicians, of course. So drug companies typically recruit academic "thought leaders" to write and speak about any new conditions they are trying to introduce. It also helps if the physicians believe the branded condition is dangerous.
When AstraZeneca introduced Prilosec (and later Nexium) for heartburn, for example, it famously repositioned heartburn as "gastroesophageal reflux disease," or GERD. But it also commissioned research to demonstrate the devastating consequences of failing to treat it.
If all drugs were harmless, disease branding would be relatively harmless, too. But no drug is completely benign.
For example, Detrol can make elderly people delirious and may cause memory problems. Paxil is associated with sexual dysfunction and dependence. It also carries a black-box warning for suicide in children and adolescents. Side effects like these are a part of every drug. But they are never part of the brand.
The opinions expressed in this commentary are solely those of Carl Elliott.
http://www.cnn.com/2010/OPINION/10/11/elliott.branding.disease/index.html?hpt=C2
www.Wellness4LifeChiro.com
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