Raptiva is being withdrawn from the U.S. market, California-based drug maker Genentech announced Wednesday.
The move comes almost two months after U.S. health officials issued a public health advisory on the drug after confirming a link to a rare, sometimes fatal brain infection.
2,000 patients in the United States may currently be using Raptiva for chronic psoriasis. Since it was approved by the U.S. FDA in 2003, 46,000 patients worldwide have been treated with Raptiva, the Genentech said.
In February, an FDA advisory cited three deaths in people taking Raptiva. Two involved people with progressive multifocal leukoencephalopathy (PML). The third death was a person believed to have contracted the brain infection. All had been treated with Raptiva for at least three years, and none was taking other immune suppressants, which would make the body more susceptible to such infections.
Raptiva works by affecting T-cells in the immune system. The effects of Raptiva also decrease the function of the immune system and increase susceptibility to infections. Raptiva was approved for the treatment of moderate to severe plaque psoriasis in 2003.
According to the FDA; there were no cases of PML seen in the clinical trials that supported the approval of Raptiva. At the time of approval, a total of 2,764 patients had been treated with Raptiva. Of those 2,764 patients, 2400 had been treated for three months, 904 for six months, and 218 for one year or more. In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML.
So there was a boxed warning of potential death with Raptiva, yet they continued to sell it because the risks at the time did not outweigh the benefits of the treatment of psoriasis. While Genentech is protecting patients (and ultimately is reputation, but not so much its wallet), those who have severe psoriasis are likely NOT going to want to stop taking the medication, even if they are risking serious infection.
New Medical & Public Health Search Engine!
Thursday, April 9, 2009
Monday, April 6, 2009
Today starts National Public Health Week
Yes there is a week devoted to public health. NYS health commissioner Richard Daines is celebrating by visiting 8 separate counties to commend them for their work. Organizations like APHA, the AMA, and public health schools throughout the country have a bunch of activities. I wont be partaking in any, because I dont take the time to celebrate my work...ok just kidding I just want to enjoy my vacation which happens to be this week. So if you know a public health worker, time to pat them on the back for all they do, cause Lord knows they aren't compensated for what their worth!
One in five 4 Year Olds OBESE!
Sesame Street Must Be Up In Arms! Years of public education and goverment sponsored nutrition programs just cant keep up with the alarming rise in obesity. We focus efforts one place, make an improvement, and in three other places we have new problems. How then can we possibly target interventions, or distribute public program dollars? Well given this new study, I argue that we need life long nutrition education, not just during certain periods of our lives.
We have all heard that obesity is up 30% in the last 2 decades, and that older children and teens are the fastest growing subpopulation, no pun intended....
Now we have to worry about our toddlers more so than ever before. This study backs up the need for programs like Women Infants & Children (WIC) and Food Stamps, both which supplement food costs and offer education, particularly WIC.
Out of Chicago: this new study says almost 1 in 5 American 4-year-olds is obese, and the rate is alarmingly higher among American Indian children, with nearly a third of them obese. Researchers were surprised to see differences by race at so early an age.
Overall, more than half a million 4-year-olds are obese, the study suggests.
Obesity is more common in Hispanic and black youngsters, too, but the disparity is most startling in American Indians, whose rate is almost double that of whites.
"The cumulative evidence is alarming because within just a few decades, America will become a 'minority majority' nation," he said. Without interventions, the next generation "will be at very high risk" for heart disease, high blood pressure, cancers, joint diseases and other problems connected with obesity, said Flores, who was not involved in the new research.
This is a real problem, and NEEDS to be funded to be corrected!
More on this story can be found at: http://news.yahoo.com/s/ap/20090406/ap_on_re_us/med_obese_preschoolers;_ylt=AgldHAhAi5hkXf6QLCmSfMCISbYF
We have all heard that obesity is up 30% in the last 2 decades, and that older children and teens are the fastest growing subpopulation, no pun intended....
Now we have to worry about our toddlers more so than ever before. This study backs up the need for programs like Women Infants & Children (WIC) and Food Stamps, both which supplement food costs and offer education, particularly WIC.
Out of Chicago: this new study says almost 1 in 5 American 4-year-olds is obese, and the rate is alarmingly higher among American Indian children, with nearly a third of them obese. Researchers were surprised to see differences by race at so early an age.
Overall, more than half a million 4-year-olds are obese, the study suggests.
Obesity is more common in Hispanic and black youngsters, too, but the disparity is most startling in American Indians, whose rate is almost double that of whites.
"The cumulative evidence is alarming because within just a few decades, America will become a 'minority majority' nation," he said. Without interventions, the next generation "will be at very high risk" for heart disease, high blood pressure, cancers, joint diseases and other problems connected with obesity, said Flores, who was not involved in the new research.
This is a real problem, and NEEDS to be funded to be corrected!
More on this story can be found at: http://news.yahoo.com/s/ap/20090406/ap_on_re_us/med_obese_preschoolers;_ylt=AgldHAhAi5hkXf6QLCmSfMCISbYF
Friday, April 3, 2009
The Tragedy In Binghamton
At an immigration center in Binghamton, NY, a nut-job opened fire on a peaceful group of immigrants taking a United States Citizenship Exam. At least 13 people are dead, and dozens more injured. He ended his rampage before taking his own life. The community is in shock. I am in shock. There is no reason for this, let alone no known motive. Someone just seemingly taking their aggression out on the world. This madness has got to end! Nearby students were removed from their dwellings for safe keeping, businesses closed their doors for protection. Just an absolute living nightmare for this town. Our prayers are with the family members of the victims.
Wednesday, April 1, 2009
Manhattan Anesthesiologist License Revoked
The New York State Department of Health has determined that Dr. Brian Goldweber, 62, violated appropriate infection control practices and used the medication Propofol in an inappropriate manner. He also failed to take an infection control and barrier precaution course as mandated by Public Health Law.
"Dr. Goldweber's reuse of syringes while injecting patients with anesthetics is an inappropriate and unacceptable practice that could have led to the spread of bloodborne diseases, including hepatitis B, hepatitis C and HIV," said State Health Commissioner Richard F. Daines, M.D.
The Board found Brian Goldweber, M.D., guilty of gross negligence, negligence on more than one occasion, gross incompetence, incompetence on more than one occasion, and failure to comply with provisions governing the practice of medicine.
Commissioner Daines cited Governor Paterson's signing of the 2008 Patient Safety Law, which enhanced the State's authority to take action against physicians, helping to prevent future infection control and other violations.
He had a history of violations:
Dr. Goldweber was disciplined in 1999 after he incorrectly administered anesthesia in several patients, and falsified records in one case. As part of his penalty he underwent a medical competency evaluation and more medical training.
In 2002, Dr. Goldweber was again disciplined after he admitted to the charge of violating state Public Health Law by fraudulently answering questions related to the disciplinary action taken against him by the Department on an application he submitted to Ellenville Regional Hospital.
In 2007, authorities notified 4,500 people who were patients of Dr. Goldweber, between December 2003 and May 2007, about his careless infection control methods.
This is the second physician to lose their license in a week.
"Dr. Goldweber's reuse of syringes while injecting patients with anesthetics is an inappropriate and unacceptable practice that could have led to the spread of bloodborne diseases, including hepatitis B, hepatitis C and HIV," said State Health Commissioner Richard F. Daines, M.D.
The Board found Brian Goldweber, M.D., guilty of gross negligence, negligence on more than one occasion, gross incompetence, incompetence on more than one occasion, and failure to comply with provisions governing the practice of medicine.
Commissioner Daines cited Governor Paterson's signing of the 2008 Patient Safety Law, which enhanced the State's authority to take action against physicians, helping to prevent future infection control and other violations.
He had a history of violations:
Dr. Goldweber was disciplined in 1999 after he incorrectly administered anesthesia in several patients, and falsified records in one case. As part of his penalty he underwent a medical competency evaluation and more medical training.
In 2002, Dr. Goldweber was again disciplined after he admitted to the charge of violating state Public Health Law by fraudulently answering questions related to the disciplinary action taken against him by the Department on an application he submitted to Ellenville Regional Hospital.
In 2007, authorities notified 4,500 people who were patients of Dr. Goldweber, between December 2003 and May 2007, about his careless infection control methods.
This is the second physician to lose their license in a week.
Follow-Up to Pistachios-Salmonella
A few days ago I spoke about the tainted pistachio products. They may contain salmonella. FDA has issued warning to avoid all pistachio products until they determine which products are actually tainted, which may take weeks to months. I stand by my original statement that roasted nuts and ice cream products are safe, given the process used to make these products.
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