AstraZeneca's weight gain and diabetes side effect cover up, and the sleazy Seroquel sex scandal
In the staid world of drug research, this is about as scandalous as it gets. The antipsychotic drug quetiapine, or Seroquel, is coming under fire.
As MedPage Today reports, damning e-mails from the past are resurfacing, implicating the drug maker for "burying" studies linking the drug to weight gain and diabetes.But here's where it gets juicy.AstraZeneca's former US medical director has admitted prior sexual relationships with both a researcher involved with the Seroquel studies, as well as with a ghost-writer who helped write journal articles involving the drug.
Psychiatrist Daniel Carlat comments further, and points to public court documents, which say the relationships with the women were "relevant and highly probative evidence of one high level AstraZeneca employee's determination to exploit his sexual relationships with these women in order to elevate Seroquel's status in the prescribing medical community through supposedly 'independent' publications of Seroquel safety and efficacy data .
Moreover, the mere existence of these relationships calls into question the integrity of the scientific work product of those involved. "Sex for positive drug spin? That's a first, and I'm sure we haven't heard the last of this scandal.
Wednesday, March 4, 2009
MRI and needless mastectomies: Perfect Together!
MRI Scans as Overtreatment for Breast Cancer
Yesterday, while scouring KevinMD, I stumbled across a post from “Respectful Insolence,” a blog authored by an academic surgeon/scientist who dubs himself “Orac.” In the post, Orac reports that this Wednesday at the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting,researchers from the Mayo Clinic will be reporting on a disturbing correlation between the use of breast magnetic resonance imaging (MRI) and a rise in the number of women having mastectomies.
In this context, Orac offers a cogent, compelling perspective on why too much cancer screening can harm patients. Orac’s worries specifically relate to using MRI scans to detect breast cancer. Advocates of the procedure rightly claim that MRI scans can detect more growths than other techniques, including mammography [i.e. an x-ray] and a clinical examination.
The MRI technology detects so much that, as the New York Times put it last year, the scans reveal “all sorts of suspicious growths in the breast, leading to many repeat scans and biopsies for things that turn out to be benign.”
In other words, breast MRI scans are so sensitive that if you have breast cancer, there’s an almost 100 percent chance that they’ll detect it; but the technology produces many false positives because it’s not as good at distinguishing between malignant and benign growths. As Orac puts it: “…MRI [scans] now routinely "section" people into "slices" much thinner than 1 cm, making our imaging sensitivity considerably higher than it was 14 years ago.
The problem is that while many people undergo malignant changes in various organs as they grow older than most will never actually develop “clinically apparent cancer.” In fact, some studies have shown that MRI scans accurately detect breast cancer just 30 percent of the time. Though most studies place this rate at a higher level, they also show that mammographies (using x-rays to examine the breast) lead to fewer false positives than MRI scans.
Yesterday, while scouring KevinMD, I stumbled across a post from “Respectful Insolence,” a blog authored by an academic surgeon/scientist who dubs himself “Orac.” In the post, Orac reports that this Wednesday at the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting,researchers from the Mayo Clinic will be reporting on a disturbing correlation between the use of breast magnetic resonance imaging (MRI) and a rise in the number of women having mastectomies.
In this context, Orac offers a cogent, compelling perspective on why too much cancer screening can harm patients. Orac’s worries specifically relate to using MRI scans to detect breast cancer. Advocates of the procedure rightly claim that MRI scans can detect more growths than other techniques, including mammography [i.e. an x-ray] and a clinical examination.
The MRI technology detects so much that, as the New York Times put it last year, the scans reveal “all sorts of suspicious growths in the breast, leading to many repeat scans and biopsies for things that turn out to be benign.”
In other words, breast MRI scans are so sensitive that if you have breast cancer, there’s an almost 100 percent chance that they’ll detect it; but the technology produces many false positives because it’s not as good at distinguishing between malignant and benign growths. As Orac puts it: “…MRI [scans] now routinely "section" people into "slices" much thinner than 1 cm, making our imaging sensitivity considerably higher than it was 14 years ago.
The problem is that while many people undergo malignant changes in various organs as they grow older than most will never actually develop “clinically apparent cancer.” In fact, some studies have shown that MRI scans accurately detect breast cancer just 30 percent of the time. Though most studies place this rate at a higher level, they also show that mammographies (using x-rays to examine the breast) lead to fewer false positives than MRI scans.
Saturday, February 21, 2009
As our Blog title states:
Man in Coma Has 'Miracle' Recovery
Wakes Up After Doctors Decided to Pull Plug
(Feb. 18) - A California man astounded his family and doctor alike when he awoke from a coma 96 hours after suffering a heart stoppage -- and just after the decision was made to take him off life support.
Mike Connolly, 56, , developed an arrhythmia on Jan. 31, California's North County Times reported. His heart stopped beating, and his wife, Loris, called 911.
Paramedics worked on Connolly for 35 minutes, performing CPR and shocking him with a defibrillator, before his heart re-started. Pulmonary physician Martin Nielsen told the North County Times that it's likely Connolly went without oxygen for at least 10 minutes -- which usually causes severe brain damage.
Doctors had deemed his condition hopeless, and his family decided to disconnect life support. Then he woke up.
"When we get a guy like Mike Connolly, it's almost like a miracle," pulmonary physician Martin Nielsen said. "I've never seen anybody come back like he has."
(Yeah-I bet they couldn't wait to get their greedy little hands on all those nice, fresh organs for expensive organ transplants! I bet the Docs are actually pissed-off! The perfect candidate....too bad they didn't get to the plug fast enough. Who is guarding YOUR plug??)
Wakes Up After Doctors Decided to Pull Plug
(Feb. 18) - A California man astounded his family and doctor alike when he awoke from a coma 96 hours after suffering a heart stoppage -- and just after the decision was made to take him off life support.
Mike Connolly, 56, , developed an arrhythmia on Jan. 31, California's North County Times reported. His heart stopped beating, and his wife, Loris, called 911.
Paramedics worked on Connolly for 35 minutes, performing CPR and shocking him with a defibrillator, before his heart re-started. Pulmonary physician Martin Nielsen told the North County Times that it's likely Connolly went without oxygen for at least 10 minutes -- which usually causes severe brain damage.
Doctors had deemed his condition hopeless, and his family decided to disconnect life support. Then he woke up.
"When we get a guy like Mike Connolly, it's almost like a miracle," pulmonary physician Martin Nielsen said. "I've never seen anybody come back like he has."
(Yeah-I bet they couldn't wait to get their greedy little hands on all those nice, fresh organs for expensive organ transplants! I bet the Docs are actually pissed-off! The perfect candidate....too bad they didn't get to the plug fast enough. Who is guarding YOUR plug??)
Friday, December 12, 2008
Some Asthma Drugs Too Risky, FDA Told
WASHINGTON (Dec. 11) - Government health advisers Thursday called for restrictions on some long-acting asthma drugs, but spared Advair, a top-selling medication used by millions of patients.
Outside experts advising the Food and Drug Administration recommended that Foradil and Serevent no longer be used for asthma. But they said the benefits of Advair and Symbicort clearly outweigh the risks.
All the medications contain an ingredient that relaxes muscles around stressed airways. But that may mask symptoms that can trigger life-threatening asthma attacks. Advair and Symbicort contain a second ingredient that reduces inflammation inside breathing passages and may help patients avoid such problems.
The FDA's own drug safety experts had recommended restrictions on all four drugs, including that none of them be used to treat asthmatic children. But the agency's respiratory specialists said the risks were manageable and no curbs were needed.
With its own experts deadlocked, the FDA called in an unusually large panel of 27 outside advisers. The medical and scientific experts said Advair and Symbicort should continue to be used with all patients, including children. The vote on Advair was 27-0; on Symbicort it was 26-0. On Foradil nine voted "yes" and 18 said "no," with a "no" vote meaning the risks were greater than the benefits. For Serevent the vote was 10-17.
The FDA usually follows the recommendations of its outside experts.
About 22 million people in the United States suffer from asthma, which claims nearly 3,600 lives. Children account for nearly one out of every three patients. An FDA analysis showed that the risks of long-acting asthma medications were greater in children.
The four medications contain a kind of drug called a long-acting beta agonist, or LABA. It relaxes the muscles around stressed airways to help patients breathe.
In recent years, millions of asthma patients have turned to the long-acting drugs to help them breathe more normally, allowing adults to get nights of uninterrupted sleep, and kids, for instance, to join a soccer team. Advair dominates the market, with almost 4 million patients.
But in rare cases, the drugs can increase the risk of serious asthma complications and send patients to the emergency room gasping for air.
Some experts believe that using a LABA alone can mask developing symptoms, and unexpectedly get patients in trouble. That's why treatment guidelines call for LABA medications to be used with a steroid. Asthma patients also carry a "rescue" inhaler for emergencies.
Bottom line: Unless it is ABSOLUTELY NECESSARY, do not pump your body full of drugs, especially steroids, as they can kill you.
If you suffer from severe asthma, emergecy inhalers are far safer and more efffective than prophylactic steroids.
Outside experts advising the Food and Drug Administration recommended that Foradil and Serevent no longer be used for asthma. But they said the benefits of Advair and Symbicort clearly outweigh the risks.
All the medications contain an ingredient that relaxes muscles around stressed airways. But that may mask symptoms that can trigger life-threatening asthma attacks. Advair and Symbicort contain a second ingredient that reduces inflammation inside breathing passages and may help patients avoid such problems.
The FDA's own drug safety experts had recommended restrictions on all four drugs, including that none of them be used to treat asthmatic children. But the agency's respiratory specialists said the risks were manageable and no curbs were needed.
With its own experts deadlocked, the FDA called in an unusually large panel of 27 outside advisers. The medical and scientific experts said Advair and Symbicort should continue to be used with all patients, including children. The vote on Advair was 27-0; on Symbicort it was 26-0. On Foradil nine voted "yes" and 18 said "no," with a "no" vote meaning the risks were greater than the benefits. For Serevent the vote was 10-17.
The FDA usually follows the recommendations of its outside experts.
About 22 million people in the United States suffer from asthma, which claims nearly 3,600 lives. Children account for nearly one out of every three patients. An FDA analysis showed that the risks of long-acting asthma medications were greater in children.
The four medications contain a kind of drug called a long-acting beta agonist, or LABA. It relaxes the muscles around stressed airways to help patients breathe.
In recent years, millions of asthma patients have turned to the long-acting drugs to help them breathe more normally, allowing adults to get nights of uninterrupted sleep, and kids, for instance, to join a soccer team. Advair dominates the market, with almost 4 million patients.
But in rare cases, the drugs can increase the risk of serious asthma complications and send patients to the emergency room gasping for air.
Some experts believe that using a LABA alone can mask developing symptoms, and unexpectedly get patients in trouble. That's why treatment guidelines call for LABA medications to be used with a steroid. Asthma patients also carry a "rescue" inhaler for emergencies.
Bottom line: Unless it is ABSOLUTELY NECESSARY, do not pump your body full of drugs, especially steroids, as they can kill you.
If you suffer from severe asthma, emergecy inhalers are far safer and more efffective than prophylactic steroids.
Wednesday, November 12, 2008
FLU VACCINE FOUND "INEFFECTIVE" by CDC
(WebMD) This year's flu shot was only 44% effective, a new study suggests - the least effective flu vaccine in a decade.
The findings come from a study of 616 Wisconsin residents who came down with flu-like illnesses during the peak of the flu season. Study findings appear in today's issue of the CDC's Morbidity and Mortality Weekly Report.
In good years, flu vaccines are 70% to 90% effective in preventing confirmed cases of flu bad enough to cause a person to seek medical attention. This year's vaccine appears to be the least effective since the 1997-1998 flu season, when the vaccine was about 50% effective. Two of the 2007-2008 flu vaccine's three components didn't match most of the flu viruses circulating this flu season.
This season's predominant flu bugs have been the mismatched type A H3N2 and type B H3N2 strains. The H3/N2 component was only a partial mismatch, cutting the vaccine's effectiveness against type A flu to 58%. The type B flu component did not match at all - and the vaccine seems to have had no effect against this bug.
In a commentary on the studies in the same journal, Paul Glezen of Baylor College of Medicine in Houston pointed out that in spite of the leap in vaccination rates among older people from 30% to 67% between 1989 and 1997, "mortality and hospitalisation rates continued to increase rather than decline".
Yet, despite the fact that the flu vaccine is less than half effective when given, even for the proper strains of flu, we are sold a bill of goods that our children need the vaccine as preschoolers.
In all of 2007, only 6 children in the U.S. died of flu-related illnesses, and most had other additional life threatening illnesses to boot. Compare that to the 50,000,000 vaccines given and the possible side effects, it gives credence to the segment of society that believes flu vaccines in children are unnecessary, dangerous, and just another example where the drug companies are forcing public policy.
Vaccination, lead by the Flu Vaccine in children, rakes in over 100 billion dollars for Big Pharma yearly
The findings come from a study of 616 Wisconsin residents who came down with flu-like illnesses during the peak of the flu season. Study findings appear in today's issue of the CDC's Morbidity and Mortality Weekly Report.
In good years, flu vaccines are 70% to 90% effective in preventing confirmed cases of flu bad enough to cause a person to seek medical attention. This year's vaccine appears to be the least effective since the 1997-1998 flu season, when the vaccine was about 50% effective. Two of the 2007-2008 flu vaccine's three components didn't match most of the flu viruses circulating this flu season.
This season's predominant flu bugs have been the mismatched type A H3N2 and type B H3N2 strains. The H3/N2 component was only a partial mismatch, cutting the vaccine's effectiveness against type A flu to 58%. The type B flu component did not match at all - and the vaccine seems to have had no effect against this bug.
In a commentary on the studies in the same journal, Paul Glezen of Baylor College of Medicine in Houston pointed out that in spite of the leap in vaccination rates among older people from 30% to 67% between 1989 and 1997, "mortality and hospitalisation rates continued to increase rather than decline".
Yet, despite the fact that the flu vaccine is less than half effective when given, even for the proper strains of flu, we are sold a bill of goods that our children need the vaccine as preschoolers.
In all of 2007, only 6 children in the U.S. died of flu-related illnesses, and most had other additional life threatening illnesses to boot. Compare that to the 50,000,000 vaccines given and the possible side effects, it gives credence to the segment of society that believes flu vaccines in children are unnecessary, dangerous, and just another example where the drug companies are forcing public policy.
Vaccination, lead by the Flu Vaccine in children, rakes in over 100 billion dollars for Big Pharma yearly
Friday, October 17, 2008
Vaccine Foes Rally for Bill
Four-month-old Gianna DiFiglia died only two days after being injected with four different vaccines at a routine doctor visit.
Thursday, her mother, Patricia DiFiglia of Hackettstown, stood on the State House steps with a picture of her daughter in the air, underlined by the words "Murder," protesting mandatory children vaccinations.
The issue has come to a head since New Jersey became the first in the nation to require annual flu shots for preschoolers last month. DiFiglia said she is scared to let her two other children get the mandatory shots, but the decision is difficult because schools mandate the vaccinations.
"I really want the choice without fail to be able to say no, especially with the flu shot," said DiFiglia, 41. "It's just ludicrous that they are mandating it in New Jersey."
DiFiglia was one parent in a passionate crowd of 200 adults and children rallying for the passage of a bill allowing for conscientious objection exemptions to mandatory vaccinations. Many in the crowd held up signs saying "Our Kids, Our Choice," or "Mother Knows Best."
Those opposing the mandatory vaccinations say parents should have ultimate say on what shots their children get and that chemicals in the vaccines can cause serious neurological disorders, such as autism.
Health officials strongly oppose such exemptions, saying they would open the door for widespread disease. They view vaccines as a great advancement in medicine that has eliminated diseases such as polio.
"Vaccines have really changed the face of medicine," said Lawrence Frenkel, a physician at the Children's Hospital at St. Peter's University Hospital in New Brunswick. "It has saved millions of lives and prevented countless epidemics of horrible, deadly disease."
New Jersey last month became the first state to require annual flu shots for preschoolers and approved three additional required vaccinations. All told, children need 11 disease-related vaccinations, some requiring multiple doses, to enter day care or preschool in the state, state Department of Health and Senior Services spokeswoman Marilyn Riley said.
While 19 states have conscientious-objection laws on the books, New Jersey currently allows for exemptions only for medical or religious reasons. A hearing on the proposal was held in June, but the bill still has not been acted upon.
Thursday, her mother, Patricia DiFiglia of Hackettstown, stood on the State House steps with a picture of her daughter in the air, underlined by the words "Murder," protesting mandatory children vaccinations.
The issue has come to a head since New Jersey became the first in the nation to require annual flu shots for preschoolers last month. DiFiglia said she is scared to let her two other children get the mandatory shots, but the decision is difficult because schools mandate the vaccinations.
"I really want the choice without fail to be able to say no, especially with the flu shot," said DiFiglia, 41. "It's just ludicrous that they are mandating it in New Jersey."
DiFiglia was one parent in a passionate crowd of 200 adults and children rallying for the passage of a bill allowing for conscientious objection exemptions to mandatory vaccinations. Many in the crowd held up signs saying "Our Kids, Our Choice," or "Mother Knows Best."
Those opposing the mandatory vaccinations say parents should have ultimate say on what shots their children get and that chemicals in the vaccines can cause serious neurological disorders, such as autism.
Health officials strongly oppose such exemptions, saying they would open the door for widespread disease. They view vaccines as a great advancement in medicine that has eliminated diseases such as polio.
"Vaccines have really changed the face of medicine," said Lawrence Frenkel, a physician at the Children's Hospital at St. Peter's University Hospital in New Brunswick. "It has saved millions of lives and prevented countless epidemics of horrible, deadly disease."
New Jersey last month became the first state to require annual flu shots for preschoolers and approved three additional required vaccinations. All told, children need 11 disease-related vaccinations, some requiring multiple doses, to enter day care or preschool in the state, state Department of Health and Senior Services spokeswoman Marilyn Riley said.
While 19 states have conscientious-objection laws on the books, New Jersey currently allows for exemptions only for medical or religious reasons. A hearing on the proposal was held in June, but the bill still has not been acted upon.
Wednesday, October 15, 2008
Object to Forced Injection of Toxins in your Baby??
Here it is, folks!!
The first attempt to allow you freedom of choice in NJ-THE MOST HEAVILY VACCINATED SPOT ON THE PLANET!
Call the legislators and voice your support!
ASSEMBLY, No. 260
STATE OF NEW JERSEY
213th LEGISLATURE
PRE-FILED FOR INTRODUCTION IN THE 2008 SESSION
Sponsored by:
Assemblywoman CHARLOTTE VANDERVALK
District 39 (Bergen)
Assemblyman PETER J. BIONDI
District 16 (Morris and Somerset)
Assemblyman GARY S. SCHAER
District 36 (Bergen, Essex and Passaic)
Assemblyman PATRICK J. DIEGNAN, JR.
District 18 (Middlesex)
Assemblyman JON M. BRAMNICK
District 21 (Essex, Morris, Somerset and Union)
Co-Sponsored by:
Assemblyman McKeon, Assemblywomen Oliver, Voss, Wagner, Assemblyman Rooney, Assemblywoman Stender, Assemblymen Doherty, Vas, Chiappone, Greenwald, Merkt, Assemblywoman Cruz-Perez, Assemblyman Rudder, Assemblywoman Handlin, Assemblymen Prieto, Rumana, Chiusano and Assemblywoman McHose
SYNOPSIS
Provides for conscientious exemption to mandatory immunizations.
CURRENT VERSION OF TEXT
Introduced Pending Technical Review by Legislative Counsel
The first attempt to allow you freedom of choice in NJ-THE MOST HEAVILY VACCINATED SPOT ON THE PLANET!
Call the legislators and voice your support!
ASSEMBLY, No. 260
STATE OF NEW JERSEY
213th LEGISLATURE
PRE-FILED FOR INTRODUCTION IN THE 2008 SESSION
Sponsored by:
Assemblywoman CHARLOTTE VANDERVALK
District 39 (Bergen)
Assemblyman PETER J. BIONDI
District 16 (Morris and Somerset)
Assemblyman GARY S. SCHAER
District 36 (Bergen, Essex and Passaic)
Assemblyman PATRICK J. DIEGNAN, JR.
District 18 (Middlesex)
Assemblyman JON M. BRAMNICK
District 21 (Essex, Morris, Somerset and Union)
Co-Sponsored by:
Assemblyman McKeon, Assemblywomen Oliver, Voss, Wagner, Assemblyman Rooney, Assemblywoman Stender, Assemblymen Doherty, Vas, Chiappone, Greenwald, Merkt, Assemblywoman Cruz-Perez, Assemblyman Rudder, Assemblywoman Handlin, Assemblymen Prieto, Rumana, Chiusano and Assemblywoman McHose
SYNOPSIS
Provides for conscientious exemption to mandatory immunizations.
CURRENT VERSION OF TEXT
Introduced Pending Technical Review by Legislative Counsel
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