There is a theory and a very strong probability that AEG, more or less murdered Michael Jackson! The love of my life, the man that saved me in just about every way a person can be saved (No I'm not trying to quote Titanic...It's true!) If AEG killed a man for sheer profit then here is what they took from the world for a soless thing like money: (In just what he was to me and what he did for me, there really is no way to measure the good a man like Michael can do) he helped me to get over a fear I had had for ten years, he was the Knight and shining Armor that I always knew a child like me would need...a knight and shining armor that would fight for the lives and happyness of children like me, he inspiored me in more ways than I can count, he proved to me that there can stilll be good in the heart of a simple man, he was alive and just that one simple thing did more for me than anyone else could do because he was my solemate and though I never even got the chance to give him the kiss (I had been saving for him since the very last day I was by his side and dreaming of the day I could give it to him. I refused to give it to anyone else, mind you) I feel as though I've lost the only man I will ever wish to call my husband and that's not even everything he was...no, is to me. Let's not also forget that the children who I will never get to raise, will never see thier father again, I only whish I could somhow absorbe the pain that those children felt...that Michael might have felt. Was it really all for money? could AEG have really killed the man I have loved since time began and the father of the children I love (Because he loves them...and thier children) for a few shards of green paper? the same few shards of green paper that put him in jail twice! (he was never a pedophile, if he was I would have known) and yet he was arested under a simple lie, no proof needed, because of money, because the police get money for thier arests and court appearences and because some fat cow somewhere wanted a new car! It was so easy to kill him with drugs because the pharaphutical company cuts corners and makes drugs that are deadly and addictive rather that trying to be as safe and natural as possible and why? MONEY! The other half to my sole is never going to recieve that first kiss as long as I live because he was tortured and killed for money! I swear if this is true than AEG, Big Pharma, and the Police Dep are going to wish I was never born!!!!!!!!!!!!!!!
By the way, do you all want to know the standerd prociedure of putting a person under arrest? I'll tell you they first bully you like big pompus hot shots, then they somtimes physicely assalt you if they think they have the slightest excuse, then they cuff you and put you in thier car (You feel rediculouse) then they take you to thier little station where they strip you naked and search the holes in your body (Including your anus) for drugs, once you are pronounced clean they put you in a tiney little cell to await your triel (You don't know if you'll be out in days,weeks, months, or years) or if you are lucky untill you post bail, but wail you are there they treat you like an animal! like a filth of the earth! untill you leave. This is all done befoure the triel (Innocent until proven guilty are we?) and then if you are found innocent, like my innocent, lovie, dovie, Mikey Mikey Boo Boo! you don't even get an oppology.
To the things that need to change Pharmaphutical niglect and Medical mal-practice, Coperate greed and espionage and Police brutality, heck we are a government of the people and for the people not of greed and for greed let's make the whole government good again we can do it if enough people speak out! Please speak out! If not for my sweet Angel than for yourself, for the children, for animals, for freedom...for good. My heart belongs to Michael and I will never stop screaming for him, I just wish more people would join me.
Monday, June 28, 2010
Sunday, June 20, 2010
Happy Fathersday to my Father and brothers
Once again I know this has nothing to do with pharmasuticals, but I just wanted to say that this Fathersday...on the day it's self I would like to take the time to honor my real father and my real brothers the one who has always been there for me even though I sometimes forget it. I'm talking about God, Jesus and the Holy Ghost, it's true I don't have any biological brothers an my biological Ftather, well, lests just say he was never there (My life would have been better if this was true) but God has been the only thing that has ever made me happy, I would see him in Children, Animals, and my friends and family whenever they would shine his glory to to the world and that was a gift he gave me as my father, it's the gift he gives you as your Father, and let us not forget the sacrifice our brother Jesus Christ made for us, he died to save us from our sins, if that is not a good Brother I don't know what is and last but not least the Holy Ghost who makes it possible to speak to the spirit of God, whithout him I would be much sadder and much more clueless, though somtimes it is so easy to question them or forget they are there, I find I am much more happier when I can believe, I know they are there and that they are with me, I have proven this in my own life, but dispare is a powerful thing and we (I) must remember to never forget.
Friday, June 18, 2010
Happy Fathersday to my Grandpa
Yes, I know this has nothing whatsoever to do with medicine but I just wanted to give my Grandfather a Fathersday thing, so I just wanted to say in a blog, as I recently descoverev I don't want my poetry on blogs so I'll just say that my Grandfather, Edward, though he was my Mothers Stepfather, I will always consider him my Grandfather, In the short time I knew him I knew he was a very good man and he loved me as his Grandaughter. I love you Grandpa Ed.
Monday, June 14, 2010
Vioxx
here is an essay I found on http://www.yourlawyer.com/topics/overview/vioxx
Information
FDA Drug Information Facts
VIOXX (Rofecoxib) FDA INFORMATION
The FDA issued several warnings concerning Vioxx related side effects before the drug was removed from the market.. The links below will redirect you to these warnings on the FDA website.
■2001 Merck Vioxx VIGOR Study
■2001 Vioxx Advertising Warning Letter
■2002 FDA Vioxx Talk Paper
■2002 Merck Vioxx Dear Doctor Letter
■2002 Vioxx Safety Label Update
■2004 FDA Vioxx Recall Advisory
■2004 FDA Vioxx COX II Q&A
■2004 FDA Statement on Vioxx
■2004 FDA Vioxx David Graham Statement
■2004 Vioxx- Drug Safety Controversy
■2005 FDA Vioxx Timeline
■2005 FDA-Vioxx Cardiovascular Safety
Quick Facts
Vioxx Reference Guide
Generic Name
Rofecoxib
Date Approved
May 20, 1999
Manufacturer
Merck & Co.
Status
Withdrawn 9/30/04
Approved Uses
Arthritis
Muscle pain
Off Label Uses
Bone pain
Muscle pain
General pain
Serious Side Effects
Heart attacks
Blood clots
Stroke
Related Topics
Bextra
Celebrex
Mobic
Blood Clots
Heart Attacks
Stroke
Defective Drugs
Diseases
Home » Topics » Defective Drugs » Vioxx
Injured by Vioxx?
Parker Waichman Alonso LLP Has Been Representing Vioxx Heart Attack & Stroke Victims Nationwide Since 2001. Merck & Co. removed its blockbuster arthritis drug Vioxx (Generic: Rofecoxib) from the market worldwide because new data from a clinical trial found an increased risk of heart attack and stroke. Merck decided to remove the drug from the market on September 30, 2004, after data from the trial showed an increased risk of heart attack, stroke, blood clots and other cardiovascular complications. Parker & Waichman has been the choice for Vioxx victims in need of a pharmaceutical liability lawyer since 2001.
Vioxx Recall Timeline
Lancet Says Vioxx Should Have Been Recalled in 2000
Documents May Show Merck Knew About Vioxx Side Effects
The data comes from a three-year study aimed at showing that Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. The trial was stopped after Merck discovered the higher heart risk compared to patients taking dummy pills.
Before the withdrawal of Vioxx, the FDA announced that patients taking Vioxx have a 50 percent greater chance of heart attacks and sudden cardiac death. he study, presented at an epidemiologists conference, also found patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.
The popular and heavily advertised arthritis drugs Vioxx and Celebrex have been linked by researchers to an increase in the risk of blood clots, heart attacks and strokes.The study from the Cleveland Clinic appeared in the Journal of the American Medical Association and was based on an analysis of previous clinical trials. Celebrex and Vioxx are projected to produce U.S. sales greater than $6 billion this year.
In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib Vioxx) with the traditional NSAID naproxen, the risk of cardiovascular problems, including heart attack,chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib group than in the naproxen group.
Vioxx, like Celebrex, is classified as a COX-2 inhibitor, or coxib. COX-2 inhibitors, like older drugs such as ibuprofen and naproxen, are nonsteroidal anti-inflammatory drugs, or NSAIDs. Older NSAIDs reduce inflammation by blocking an enzyme called COX-2, but they also block another enzyme called COX-1. This enzyme helps protect the lining of the stomach, so blocking COX-2 can cause stomach irritation. COX-2 inhibitors only block COX-2, leaving the stomach-protecting COX-1 alone.
In 2000, Merck spent $160.8 million on direct to consumer Vioxx marketing. Many people are familiar with Vioxx television advertisements featuring the famous figure skater Dorothy Hamill. Sid Wolfe, a physician and director of the Health Research Group of the advocacy group Public Citizen in Washington, D.C. said "Dorothy Hamill doesn't tell people they have a four times higher risk of a heart attack on Vioxx."
If you or a loved one took Vioxx and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
VioxxRSS FeedMerck Loses Australian Vioxx LawsuitMar 5, 2010 | Parker Waichman Alonso LLPWe just wrote that Merck & Co. made a final $4.1 billion payment to its Vioxx settlement fund. According to a recent Associated Press (AP) report, final payouts to former Vioxx users or their survivors should be made by the end of June. Now, Bloomberg News is reporting that Merck & Co.’s Australian unit neglected to warn a physician about cardiac risks associated with the controversial painkiller, citing the findings of a Melbourne court. The drug giant could be...
Merck Loses Australian Vioxx Lawsuit »
Merck & Co. Makes Final Payment to Vioxx Settlement FundMar 2, 2010 | Parker Waichman Alonso LLPMerck & Co. has almost wrapped up its Vioxx settlement, having recently made its final $4.1 billion payment to the settlement fund. According to the Associated Press, all Vioxx heart attack claims have already been paid or denied. Nearly 18,000 Vioxx stroke claims are in process, and about 7,400 of those resulted in initial payments. The fund should be finished paying all claims by the end of June. The Associated Press is also reporting about 355 plaintiff groups did not...
Merck & Co. Makes Final Payment to Vioxx Settlement Fund »
Doctor Accused of Falsifying Drug Studies Pleads GuiltyFeb 23, 2010 | Parker Waichman Alonso LLPDr. Scott S. Reuben, former chief of acute pain at the Bay State Hospital in Springfield, Massachusetts, has pleaded guilty to one count of health care fraud. As we’ve reported previously, Reuben was charged in federal court last month with falsifying studies involving the post-surgical benefits of drugs like Vioxx, Bextra, Celebrex, Effexor and Lyrica. According to the Associated Press, federal prosecutors in Massachusetts had alleged that Reuben sought and received research grants from...
Doctor Accused of Falsifying Drug Studies Pleads Guilty »
Merck Loses Australian Vioxx LawsuitJan 1, 2010 We just wrote that Merck & Co. made a final $4.1 billion payment to its Vioxx settlement fund. According to a recent Associated Press (AP) report, final payouts to former Vioxx users or their survivors should be made by the end of June. Now, Bloomberg News is reporting that Merck & Co.’s Australian unit neglected to warn a physician about cardiac risks associated with the controversial painkiller, citing the findings of a Melbourne court. The drug giant could be...
Merck Loses Australian Vioxx Lawsuit »
Vioxx Scandal Didn't Lead To Changes At FDADec 9, 2009 | Parker Waichman Alonso LLPThe Vioxx scandal, and the Food & Drug Administration's (FDA) role in it, has not brought about much change at the agency, according to a new government report.Vioxx was approved for use in 1999, and quickly became a bestseller for Merck, with annual sales of $2.5 billion; however, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003....
Vioxx Scandal Didn't Lead To Changes At FDA »
Information
FDA Drug Information Facts
VIOXX (Rofecoxib) FDA INFORMATION
The FDA issued several warnings concerning Vioxx related side effects before the drug was removed from the market.. The links below will redirect you to these warnings on the FDA website.
■2001 Merck Vioxx VIGOR Study
■2001 Vioxx Advertising Warning Letter
■2002 FDA Vioxx Talk Paper
■2002 Merck Vioxx Dear Doctor Letter
■2002 Vioxx Safety Label Update
■2004 FDA Vioxx Recall Advisory
■2004 FDA Vioxx COX II Q&A
■2004 FDA Statement on Vioxx
■2004 FDA Vioxx David Graham Statement
■2004 Vioxx- Drug Safety Controversy
■2005 FDA Vioxx Timeline
■2005 FDA-Vioxx Cardiovascular Safety
Quick Facts
Vioxx Reference Guide
Generic Name
Rofecoxib
Date Approved
May 20, 1999
Manufacturer
Merck & Co.
Status
Withdrawn 9/30/04
Approved Uses
Arthritis
Muscle pain
Off Label Uses
Bone pain
Muscle pain
General pain
Serious Side Effects
Heart attacks
Blood clots
Stroke
Related Topics
Bextra
Celebrex
Mobic
Blood Clots
Heart Attacks
Stroke
Defective Drugs
Diseases
Home » Topics » Defective Drugs » Vioxx
Injured by Vioxx?
Parker Waichman Alonso LLP Has Been Representing Vioxx Heart Attack & Stroke Victims Nationwide Since 2001. Merck & Co. removed its blockbuster arthritis drug Vioxx (Generic: Rofecoxib) from the market worldwide because new data from a clinical trial found an increased risk of heart attack and stroke. Merck decided to remove the drug from the market on September 30, 2004, after data from the trial showed an increased risk of heart attack, stroke, blood clots and other cardiovascular complications. Parker & Waichman has been the choice for Vioxx victims in need of a pharmaceutical liability lawyer since 2001.
Vioxx Recall Timeline
Lancet Says Vioxx Should Have Been Recalled in 2000
Documents May Show Merck Knew About Vioxx Side Effects
The data comes from a three-year study aimed at showing that Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. The trial was stopped after Merck discovered the higher heart risk compared to patients taking dummy pills.
Before the withdrawal of Vioxx, the FDA announced that patients taking Vioxx have a 50 percent greater chance of heart attacks and sudden cardiac death. he study, presented at an epidemiologists conference, also found patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.
The popular and heavily advertised arthritis drugs Vioxx and Celebrex have been linked by researchers to an increase in the risk of blood clots, heart attacks and strokes.The study from the Cleveland Clinic appeared in the Journal of the American Medical Association and was based on an analysis of previous clinical trials. Celebrex and Vioxx are projected to produce U.S. sales greater than $6 billion this year.
In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib Vioxx) with the traditional NSAID naproxen, the risk of cardiovascular problems, including heart attack,chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib group than in the naproxen group.
Vioxx, like Celebrex, is classified as a COX-2 inhibitor, or coxib. COX-2 inhibitors, like older drugs such as ibuprofen and naproxen, are nonsteroidal anti-inflammatory drugs, or NSAIDs. Older NSAIDs reduce inflammation by blocking an enzyme called COX-2, but they also block another enzyme called COX-1. This enzyme helps protect the lining of the stomach, so blocking COX-2 can cause stomach irritation. COX-2 inhibitors only block COX-2, leaving the stomach-protecting COX-1 alone.
In 2000, Merck spent $160.8 million on direct to consumer Vioxx marketing. Many people are familiar with Vioxx television advertisements featuring the famous figure skater Dorothy Hamill. Sid Wolfe, a physician and director of the Health Research Group of the advocacy group Public Citizen in Washington, D.C. said "Dorothy Hamill doesn't tell people they have a four times higher risk of a heart attack on Vioxx."
If you or a loved one took Vioxx and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
VioxxRSS FeedMerck Loses Australian Vioxx LawsuitMar 5, 2010 | Parker Waichman Alonso LLPWe just wrote that Merck & Co. made a final $4.1 billion payment to its Vioxx settlement fund. According to a recent Associated Press (AP) report, final payouts to former Vioxx users or their survivors should be made by the end of June. Now, Bloomberg News is reporting that Merck & Co.’s Australian unit neglected to warn a physician about cardiac risks associated with the controversial painkiller, citing the findings of a Melbourne court. The drug giant could be...
Merck Loses Australian Vioxx Lawsuit »
Merck & Co. Makes Final Payment to Vioxx Settlement FundMar 2, 2010 | Parker Waichman Alonso LLPMerck & Co. has almost wrapped up its Vioxx settlement, having recently made its final $4.1 billion payment to the settlement fund. According to the Associated Press, all Vioxx heart attack claims have already been paid or denied. Nearly 18,000 Vioxx stroke claims are in process, and about 7,400 of those resulted in initial payments. The fund should be finished paying all claims by the end of June. The Associated Press is also reporting about 355 plaintiff groups did not...
Merck & Co. Makes Final Payment to Vioxx Settlement Fund »
Doctor Accused of Falsifying Drug Studies Pleads GuiltyFeb 23, 2010 | Parker Waichman Alonso LLPDr. Scott S. Reuben, former chief of acute pain at the Bay State Hospital in Springfield, Massachusetts, has pleaded guilty to one count of health care fraud. As we’ve reported previously, Reuben was charged in federal court last month with falsifying studies involving the post-surgical benefits of drugs like Vioxx, Bextra, Celebrex, Effexor and Lyrica. According to the Associated Press, federal prosecutors in Massachusetts had alleged that Reuben sought and received research grants from...
Doctor Accused of Falsifying Drug Studies Pleads Guilty »
Merck Loses Australian Vioxx LawsuitJan 1, 2010 We just wrote that Merck & Co. made a final $4.1 billion payment to its Vioxx settlement fund. According to a recent Associated Press (AP) report, final payouts to former Vioxx users or their survivors should be made by the end of June. Now, Bloomberg News is reporting that Merck & Co.’s Australian unit neglected to warn a physician about cardiac risks associated with the controversial painkiller, citing the findings of a Melbourne court. The drug giant could be...
Merck Loses Australian Vioxx Lawsuit »
Vioxx Scandal Didn't Lead To Changes At FDADec 9, 2009 | Parker Waichman Alonso LLPThe Vioxx scandal, and the Food & Drug Administration's (FDA) role in it, has not brought about much change at the agency, according to a new government report.Vioxx was approved for use in 1999, and quickly became a bestseller for Merck, with annual sales of $2.5 billion; however, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003....
Vioxx Scandal Didn't Lead To Changes At FDA »
Thursday, June 10, 2010
Happy fathers day Michael Jackson
Happy fathers day, my husband (In my heart) dear.
Happy fathers day, my husband dear.
Never mine on paper, but always mine in my heart.
I'll give you my life, my heart and never fear.
I give it willingly, no chains bind, nor desires distract.
Everyday I tell you I love you, every day you'll hear.
I'll be yours forever if you me and God three
would have it be.
Happy fathers day, my husband dear.
You raised our children to be as beauieful as you.
I pray twards the light they will continue to stear.
For you have tought them well, my one and only.
My love, my solemate, my big teady bear.
It's no secret that we love you and will be yours forever, if you, we and God three would have it be.
Happy Fathers day Michael Joseph Jackson.
Happy fathers day, my husband dear.
Never mine on paper, but always mine in my heart.
I'll give you my life, my heart and never fear.
I give it willingly, no chains bind, nor desires distract.
Everyday I tell you I love you, every day you'll hear.
I'll be yours forever if you me and God three
would have it be.
Happy fathers day, my husband dear.
You raised our children to be as beauieful as you.
I pray twards the light they will continue to stear.
For you have tought them well, my one and only.
My love, my solemate, my big teady bear.
It's no secret that we love you and will be yours forever, if you, we and God three would have it be.
Happy Fathers day Michael Joseph Jackson.
Tuesday, June 8, 2010
the legal side of things
here is an essay I found on http://www.lawyersandsettlements.com/articles/00118/fda.html
FDA Shields Drug Companies From Lawsuits
February 27, 2006. By Evelyn Pringle
Last month, the FDA revealed its latest protective policy for drug companies in a statement that said people who believe they have been injured by drugs approved by the FDA should not be allowed to sue drug companies in state courts.
"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
The agency's assertion of "federal preemption" was included as a preamble to its new drug labeling guidelines.
The claim of preemption was quickly attacked by trial lawyers and members of Congress as another effort by the Bush administration to limit the public's ability to bring and win lawsuits, according to the January 19, 2006 Washington Post.
"Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America.
"The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process," Mr Suggs told the Post.
In response to the FDA's announcement, Senator Kennedy issued a statement that said: "It's a typical abuse by the Bush Administration - take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."
The National Conference of State Legislatures, a bipartisan group that represents state lawmakers, accused the FDA of trying to seize authority that it did not have.
Over the past several years, lawmakers have been turning up the heat on both the FDA and the pharmaceutical industry in response to their combined failure to reveal problems found during studies conducted on top selling drugs like Vioxx.
At one point, Senator Charles Grassley (R-Iowa), Chairman of the Senate Finance Committee, came right out and accused the FDA of suppressing studies in order to protect pharmaceutical industry profits and the careers of certain FDA officials.
"The Vioxx example showed that the FDA and Merck were too close for comfort," Senator Grassely told Health News on March 12, 2005. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck," he said.
Based on a trial that took place in 2000, both the FDA and Merck were aware that heart attacks were five times more likely in patients taking Vioxx than among those taking a similar drug, Sen Grassley pointed out, but the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed its product on nightly TV.
Back on November 18, 2004, he generated enormous media attention when he held hearings on Vioxx, and FDA scientist, Dr David Graham, who works in the FDA Office of Drug Safety, testified that Vioxx may have been responsible for tens of thousands of heart attacks and strokes but that his superiors had pressured him to keep silent about his findings.
"The estimates range from 88,000 to 139,000 Americans," Dr Graham told the committee. "Of these, 30 to 40 percent probably died," he advised.
"For the survivors," he added, "their lives were changed forever."
To put this large number of injuries into perspective, Dr Graham told members of the committee that instead of a serious side-effect of a prescription drug, to think of it as if they were talking about jetliners.
"If there were an average of 150 to 200 people on an aircraft," he said, "this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky."
"This translates to 2-4 aircraft every week," he noted, "week in and week out, for the past 5 years."
"If you were confronted by this situation," Dr Graham asked the committee, "what would be your reaction, what would you want to know and what would you do about it?"
He condemned the FDA's failure to acknowledge the risks that Vioxx posed to millions of people in the 5 years it was allowed to remain on the market. "I strongly believe that this should have been, and largely could have been, avoided," Dr Graham told the committee.
The Vioxx matter caught the attention of the Senate Finance Committee basically because of the Vioxx related costs to government programs like Medicaid and Medicare. The committee is responsible for oversight of the two programs. At the November 18, 2004 hearing, Senator Max Baucus said:
"In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug."
"And Medicaid bears the cost of any additional medical care necessary when drugs cause injury," he pointed out.
The hearings followed a study that estimated between 28,000 and 160,000 deaths may have been caused by the Vioxx since it gained FDA approval in 1999.
By far, the Vioxx debacle is the most serious public health failure to occur since the FDA took on the authority for safety oversight of medical products in 1938.
On September 3, 2005, Shane Ellison, M.Sc, a former pharmaceutical chemist turned whistleblower and author of the book, "Health Myths Exposed," gave an interview to Crusador Magazine and discussed Vioxx and some of the problems within the FDA.
His book which was published before Vioxx began making headlines, referred to Vioxx as the "silent killer."
According to Mr Ellison, the FDA and Merck knew about the dangers associated with Vioxx for at least 4 years before it was taken off the market. "Instead of removing the drug immediately," he said, "they kept it on the drug market for matters of wealth not health."
Mr Ellison says pharmaceutically compliant politicians have "democratized" the drug industry. "This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary," he reports. "Science and choice no longer prevail at the FDA or at pharmaceutical companies," he added.
"To go against the 51% means losing your career," Mr Ellison said. "Therefore, the majority of scientists choose to please drug companies, not the general public."
To substantiate this claim, Dr Ellison pointed to Dr Curt Furberg, a member of the FDA's drug safety advisory committee.
In the wake of the Vioxx revelations, Dr Furberg went public with findings that Pfizer's drug Bextra also caused heart attacks and strokes and said studies "showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," in the British Medical Journal.
"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that was responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."
"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes - not science," he told Crusador.
A little-mentioned fact is that many FDA employees end up working for the pharmaceutical industry. "The old joke is that the FDA is sort of like a showcase for a future job in the drug industry," Robert Whitaker, author of Mad In America, said in an August 2005 interview with Street Spirit.
"You go there, you work awhile, then you go off into the drug industry," he said, "the progression that people make, in essence they're making good old boy network connections, so they're not going to be so harsh on the drug companies."
Critic say the passage of the Prescription Drug User Fee Act in 1992 contributed to the current problems within the FDA. The Act allows the agency to collect a fee from a drug company seeking approval for a new drug. In return, the FDA is expected complete the review process within 12 months.
User fees now account for about 40% of the approval process, which means the FDA is dependent on drug companies for nearly half of its funding.
This situation is the root of a major conflict of interest according to Dr Graham: "This culture (at the FDA) views the pharmaceutical industry it is supposed to regulate as its client. It overvalues the benefits of the drugs it approves, and seriously undervalues, disregards and disrespects drug safety," he told members of Congress.
Another problem he cited is that even when the FDA does try to take measures to limit harm, the agency lacks the enforcement authority to force drug companies to comply. In the case of Vioxx, Dr Graham said it took more than 2 years to get Merck to add the increased risk of heart attack and stroke to its label.
Then there are the conflicts of interests involving the FDA panels that advise the agency on matters such as which drugs should be approved, what their warning labels should say, and how studies should be conducted.
The 300 experts on the 18 committees make decisions that affect billions of dollars in sales and with few exceptions the FDA follows their recommendations.
Members of the panels are supposed to be free of conflicts of interest relating to products they consider. But the FDA can grant a waiver if a member's expertise is deemed to outweigh the risk of a conflict or if the financial interest is minimal. Waivers are liberally granted all the time.
For instance, in February 2005, when the highly publicized hearings were held to determine whether the COX-2 inhibitors, manufactured by Merck and Pfizer, should be permitted to remain on the market, an advisory committee that was mired with conflicts of interest was exposed. Out of the 32 advisers voting on the issue, ten had served as consultants to Merck and Pfizer in recent years.
This revelation prompted Senator Mike Enzi, (R-WY), the chairman of the Health, Education, Labor and Pensions Committee, along with Senators, Edward Kennedy (D-MA), and Richard Durbin (D-IL), to ask the General Accounting Office to look into the FDA's practice of letting scientists serve on panels when they have conflicts of interest.
"We are concerned about the process that supports FDA's decisions to waive conflicts of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors," said a letter to the GAO, signed by Senators in September 2005.
"These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees," they wrote. The Senators specifically noted the conflicts among the panels that studied the Cox-2 inhibitors like Vioxx.
According to the Associated Press on January 24, 2006, Merck currently faces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and the rest in state courts. Without state product liability laws, drug companies like Merck will be able to escape liability for injuries and deaths caused by drugs like Vioxx.
FDA Shields Drug Companies From Lawsuits
February 27, 2006. By Evelyn Pringle
Last month, the FDA revealed its latest protective policy for drug companies in a statement that said people who believe they have been injured by drugs approved by the FDA should not be allowed to sue drug companies in state courts.
"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
The agency's assertion of "federal preemption" was included as a preamble to its new drug labeling guidelines.
The claim of preemption was quickly attacked by trial lawyers and members of Congress as another effort by the Bush administration to limit the public's ability to bring and win lawsuits, according to the January 19, 2006 Washington Post.
"Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America.
"The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process," Mr Suggs told the Post.
In response to the FDA's announcement, Senator Kennedy issued a statement that said: "It's a typical abuse by the Bush Administration - take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."
The National Conference of State Legislatures, a bipartisan group that represents state lawmakers, accused the FDA of trying to seize authority that it did not have.
Over the past several years, lawmakers have been turning up the heat on both the FDA and the pharmaceutical industry in response to their combined failure to reveal problems found during studies conducted on top selling drugs like Vioxx.
At one point, Senator Charles Grassley (R-Iowa), Chairman of the Senate Finance Committee, came right out and accused the FDA of suppressing studies in order to protect pharmaceutical industry profits and the careers of certain FDA officials.
"The Vioxx example showed that the FDA and Merck were too close for comfort," Senator Grassely told Health News on March 12, 2005. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck," he said.
Based on a trial that took place in 2000, both the FDA and Merck were aware that heart attacks were five times more likely in patients taking Vioxx than among those taking a similar drug, Sen Grassley pointed out, but the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed its product on nightly TV.
Back on November 18, 2004, he generated enormous media attention when he held hearings on Vioxx, and FDA scientist, Dr David Graham, who works in the FDA Office of Drug Safety, testified that Vioxx may have been responsible for tens of thousands of heart attacks and strokes but that his superiors had pressured him to keep silent about his findings.
"The estimates range from 88,000 to 139,000 Americans," Dr Graham told the committee. "Of these, 30 to 40 percent probably died," he advised.
"For the survivors," he added, "their lives were changed forever."
To put this large number of injuries into perspective, Dr Graham told members of the committee that instead of a serious side-effect of a prescription drug, to think of it as if they were talking about jetliners.
"If there were an average of 150 to 200 people on an aircraft," he said, "this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky."
"This translates to 2-4 aircraft every week," he noted, "week in and week out, for the past 5 years."
"If you were confronted by this situation," Dr Graham asked the committee, "what would be your reaction, what would you want to know and what would you do about it?"
He condemned the FDA's failure to acknowledge the risks that Vioxx posed to millions of people in the 5 years it was allowed to remain on the market. "I strongly believe that this should have been, and largely could have been, avoided," Dr Graham told the committee.
The Vioxx matter caught the attention of the Senate Finance Committee basically because of the Vioxx related costs to government programs like Medicaid and Medicare. The committee is responsible for oversight of the two programs. At the November 18, 2004 hearing, Senator Max Baucus said:
"In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug."
"And Medicaid bears the cost of any additional medical care necessary when drugs cause injury," he pointed out.
The hearings followed a study that estimated between 28,000 and 160,000 deaths may have been caused by the Vioxx since it gained FDA approval in 1999.
By far, the Vioxx debacle is the most serious public health failure to occur since the FDA took on the authority for safety oversight of medical products in 1938.
On September 3, 2005, Shane Ellison, M.Sc, a former pharmaceutical chemist turned whistleblower and author of the book, "Health Myths Exposed," gave an interview to Crusador Magazine and discussed Vioxx and some of the problems within the FDA.
His book which was published before Vioxx began making headlines, referred to Vioxx as the "silent killer."
According to Mr Ellison, the FDA and Merck knew about the dangers associated with Vioxx for at least 4 years before it was taken off the market. "Instead of removing the drug immediately," he said, "they kept it on the drug market for matters of wealth not health."
Mr Ellison says pharmaceutically compliant politicians have "democratized" the drug industry. "This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary," he reports. "Science and choice no longer prevail at the FDA or at pharmaceutical companies," he added.
"To go against the 51% means losing your career," Mr Ellison said. "Therefore, the majority of scientists choose to please drug companies, not the general public."
To substantiate this claim, Dr Ellison pointed to Dr Curt Furberg, a member of the FDA's drug safety advisory committee.
In the wake of the Vioxx revelations, Dr Furberg went public with findings that Pfizer's drug Bextra also caused heart attacks and strokes and said studies "showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," in the British Medical Journal.
"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that was responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."
"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes - not science," he told Crusador.
A little-mentioned fact is that many FDA employees end up working for the pharmaceutical industry. "The old joke is that the FDA is sort of like a showcase for a future job in the drug industry," Robert Whitaker, author of Mad In America, said in an August 2005 interview with Street Spirit.
"You go there, you work awhile, then you go off into the drug industry," he said, "the progression that people make, in essence they're making good old boy network connections, so they're not going to be so harsh on the drug companies."
Critic say the passage of the Prescription Drug User Fee Act in 1992 contributed to the current problems within the FDA. The Act allows the agency to collect a fee from a drug company seeking approval for a new drug. In return, the FDA is expected complete the review process within 12 months.
User fees now account for about 40% of the approval process, which means the FDA is dependent on drug companies for nearly half of its funding.
This situation is the root of a major conflict of interest according to Dr Graham: "This culture (at the FDA) views the pharmaceutical industry it is supposed to regulate as its client. It overvalues the benefits of the drugs it approves, and seriously undervalues, disregards and disrespects drug safety," he told members of Congress.
Another problem he cited is that even when the FDA does try to take measures to limit harm, the agency lacks the enforcement authority to force drug companies to comply. In the case of Vioxx, Dr Graham said it took more than 2 years to get Merck to add the increased risk of heart attack and stroke to its label.
Then there are the conflicts of interests involving the FDA panels that advise the agency on matters such as which drugs should be approved, what their warning labels should say, and how studies should be conducted.
The 300 experts on the 18 committees make decisions that affect billions of dollars in sales and with few exceptions the FDA follows their recommendations.
Members of the panels are supposed to be free of conflicts of interest relating to products they consider. But the FDA can grant a waiver if a member's expertise is deemed to outweigh the risk of a conflict or if the financial interest is minimal. Waivers are liberally granted all the time.
For instance, in February 2005, when the highly publicized hearings were held to determine whether the COX-2 inhibitors, manufactured by Merck and Pfizer, should be permitted to remain on the market, an advisory committee that was mired with conflicts of interest was exposed. Out of the 32 advisers voting on the issue, ten had served as consultants to Merck and Pfizer in recent years.
This revelation prompted Senator Mike Enzi, (R-WY), the chairman of the Health, Education, Labor and Pensions Committee, along with Senators, Edward Kennedy (D-MA), and Richard Durbin (D-IL), to ask the General Accounting Office to look into the FDA's practice of letting scientists serve on panels when they have conflicts of interest.
"We are concerned about the process that supports FDA's decisions to waive conflicts of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors," said a letter to the GAO, signed by Senators in September 2005.
"These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees," they wrote. The Senators specifically noted the conflicts among the panels that studied the Cox-2 inhibitors like Vioxx.
According to the Associated Press on January 24, 2006, Merck currently faces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and the rest in state courts. Without state product liability laws, drug companies like Merck will be able to escape liability for injuries and deaths caused by drugs like Vioxx.
Here's another good book on the subject.
I hear that this book is pretty good for the subject, everyone should check it out and see if it works for you, as far as I understand this book is about the pharmaphutical companys impact on what we know about curing diseases and what we can do to cure things naturaly.
Monday, June 7, 2010
Here's one recomendation
I would highly recomend reading this book. I only read a few short essays inspired by this and I was shocked at what I saw. I really do recomend reading this befoure you base everyother aspect of your life on the Pharmasutical industry and the medical system.
nullI have been doing some reaserch on the
nullI have been doing some reaserch on the
Sunday, June 6, 2010
Lets get spacific
June 6, 2010 - Sunday
Let's get spacific
Here is a blog I found on http://humanrights.foreignpolicyblogs.com/2009/09/27/yaz-birth-control-controversy-pharmaceutical-profits-unnecessary-risks-and-the-gendered-distribution-of-family-planning/
Yaz Birth Control Controversy: Pharmaceutical Profits, Unnecessary Risks, and the Gendered Distribution of Family Planning
By Jessica Corsi
Sunday, September 27 5:23 pm EST
The current Yaz birth control controversy illustrates the continued tension between what pharmaceutical companies and the doctors that they pay claim is safe for consumption, and contrary scientific evidence. Natasha Singer of the New York Times is reporting that Yaz, a birth control pill manufactured and marketed by Bayer, is under fire as an inappropriately advertised, improperly made, more dangerous pill. Two new studies out of Denmark and Holland and published in the British Medical Journal indicate that Yaz creates a higher risk of blood clots and strokes than other birth control pills. A large group (at this time 74) of women in the U.S. are suing for blood clots and resultant health injuries that they have endured as a result of using Yaz. The U.S. Food and Drug Administration (FDA) has been investigating Bayer and Yaz for some time, and Switzerland’s medicines supervisor is investigating this pill because it contributed to a lung clot that killed a woman earlier this month, and left a 16 year old girl permanently disabled last May. The evidence has mounted around the globe that Yaz is an unsafe option, that the advertisements used by Bayer to promote Yaz obscured the health risks, and even that the manufacturing plants producing Yaz are not properly producing the drug.
Profit Motive Pushes Companies to Encourage Women to Take Unnecessary Risks
As is often the case in a pharmaceutical controversy, the doctors paid by Bayer are rushing to downplay the risk presented, while independent doctors take the approach you might expect from a health care practitioner: advising that, even if increased risk of blood clots and stroke is low, why not switch to any one of the multiple birth control pills that present a lower risk? If you find the latter approach more sensible, congratulations; you are thinking like a person who would rather manage health risks than engage in unnecessary ones. It seems too much of a coincidence that the only people who keep pushing the risk of Yaz are the only ones profiting monetarily from it.
Why Are Less Safe Birth Control Options Still on the Market?
Birth control pills present a unique pharmaceutical situation, for several reasons, one of which is that there are safer pills available and yet the less-safe pills remain on the market. There are many different formulations of the hormones that go into the myriad birth control pills for sale, and not every combination of hormone is equally safe. Dutch research shows that, while taking the pill generally increases a woman’s risk of blood clot, the extent of the risk depends on the exact type of hormones in the pill. This research demonstrates that many women taking the pill are not taking the safest pill available to them. Drug developers have been recalibrating the combination of hormones in birth control pills since the 1960s with the intent to reduce the risk of blood clots and thus make it safer for the women and girls that take it, which begs the question-why are we still marketed pills that are not at the optimum safety level? How can companies such as Bayer continue to justify their manufacture of these less safe option? It also raises the question of whether governments will allow them to advertise as “just as safe” as other oral contraceptive pills now that research shows that they are not “just as safe” as the other oral contraceptive options.
Birth Control: A Gendered Burden
Because only women and girls take birth control pills and other forms of hormonal contraception, this particular pharmaceutical controversy takes on a gendered dimension. Yaz’s ads attempt a Sex and the City vibe that the New York Times describes as having succeeded in making it and its sister drug “the go-to brands for women under 35.” The FDA has criticized Yaz’s advertisements-which feature young, attractive women chatting about Yaz at a chic rooftop party; ensconced on a plush sofa, they discuss the pill as servers stroll by with cocktails-for misleading women about the non-pregnancy related uses of this pill. If ever a TV spot tried to make a pill seem trendy and fashionable, this is it. It is this marketing of the pill as if it were a handbag or car that raises additional ethical questions. Of course the pill is not some sort of fashion accessory, and of course the young women that it targets, such as the now permanently disabled 16 year old in Switzerland, should have it presented to them as a contraceptive and not a “lifestyle” drug. In response to FDA demands, Bayer released a “follow-up” Yaz advertisement to clarify the previous one; and yet here is the same young, beautiful doctor, strolling through a party in a great outfit to tell you about these “clarifications.” Not much has changed, nor do the ads reveal that this particular type of hormone combination presents a higher risk than others.
Hortense writes on Jezebel.com that flippant and non-medical advertising is a feature of all pharmaceuticals, not just birth control:
This is a problem that extends to all ads for medication; the consumer is told to go to the doctor and demand a certain brand name, without even knowing, exactly, what the medication really does to the body. Someone always does a voice over about diarrhea and blood clots and death, but all the audience seems to pick up on are the scenes of horses frolicking or women laughing or couples holding hands in the sun.
And yet contraception is a uniquely female issue; men are less likely to engage in or worry about shopping for or using birth control. They have fewer options, and a daily pill is not currently available to them, in part because pharmaceutical companies have chosen not to produce one. Because women and men share unequally in the child bearing process-obviously the burden (or, if you like, the privilege and the joy) of actually bearing the child falls on women, and so, they more readily accept the risks, including stroke and death, associated with pregnancy prevention in order to simply prevent the pregnancy. Men can don a condom or have a vasectomy, but if a girl or a woman wants to take matters into her own hands, she can take a pill, use a patch, get a shot, etc. As Lisa Campo-Engelstein writes in Science Progress, this creates an unequal burden that has women and girls using more of their time and money, and encountering more stress and stigma, for finding, using, and dealing with the repercussions-negative health effects; failed contraception-of birth control.
The Yaz controversy highlights the serious health risks associated with female birth control methods. While these are often presented as minimal, Campo-Engelstein points out that the gravity of these side effects is not only important to consider in its own right, but becomes more problematic when compared to the side effects of current male options. The comparison reveals the unequal burden:
The side effects of female hormonal contraceptives can include cardiovascular complications, depression, hepatic adenomas, pathologic weight gain, and possible bone loss. The two available male forms of contraception also carry fewer risks than their corresponding female contraceptives, female barrier methods and tubal ligation, respectively. Some dismiss women’s side effects as “minor”; however, to the women who experience them, they often are far from benign. Women most commonly discontinue contraceptives due to side effects and most forms of contraception have discontinuation rates approaching 50 percent after one year of use.
The fact that women discontinue their use of birth control pills at “rates approaching 50 percent after one year of use” is immensely telling about the health risks these pills present.
Big Pharmas Shut Down Male Contraception Options
Seeing birth control as a uniquely female issue means that most research dollars are targeted to creating new forms of female birth control vs. new forms of male birth control. Time Magazine reported in August 2008 that the reason we don’t have male birth control options that mirror female options is that pharmaceutical companies-including Bayer, which led the market in halting the research, inspiring others to abandon it as well-decided in 2006 that there was not a large enough market for male contraception. This despite the fact that they were reportedly on the verge of successful breakthroughs and that global surveys indicate male interest in birth control pills or injections. Doctors researching male contraception cite the “knee-jerk” reaction of pharmaceutical companies that men aren’t interested, despite evidence to the contrary. The Time article notes that “if even a small percentage of sexually active men agreed to try a new method of birth control, that would amount to a colossal number of potential consumers,” meaning, there should be profit incentive for developing the product. The fact that there is insufficient corporate interest indicates that other barriers, such as gendered and cultural assumptions about male sexuality, are getting in the way of research and development.
To close the gap, the World Health Organization has led the charge in pushing for new male contraception options as part of their family planning programme. It says something about the stakes involved and the integral role male birth control could play that the WHO has gotten behind it, especially in the face of disinterest by for-profit health related companies. Until other options are available, however, and even when they are, governments must hold Bayer and other companies accountable for the preventable health risks presented by their products and for the way that these products are marketed.
9 Comments So Far»
Zainab Jeewanjee on 27/09/2009 in 18:08
wow. This is an excellent piece. Excellent information and insight. The past ten years has seen a sharp rise in direct consumer advertising on behalf of the pharmaceutical industry and you couple that with teh way the drugs are marketed and then pushed by physicians and it becomes a little much.
Thanks for such an interesting article.
Cynthia on 28/09/2009 in 22:27
The contraceptive pill, Yaz, has been linked to life-threatening side effects such as strokes, blood clots, and heart attacks. Since 2004, at least 50 deaths have been reported in women taking Yaz and birth control pills containing similar ingredients. There’s more information on this disturbing problem at http://www.yaz-may-cause-strokes.com/
birthcontroloptions on 02/10/2009 in 08:58
There are many birth control options out there available to women and men (condoms), The important point is that more options is always better than fewer and that couples understand the risks associated with each one.
Hormones for men or women will carry some side effects for many of them and since the Pill and other hormone treatments have been by far the most popular choices outside of the condom we will hear about more incidents of these effects as time moves on.
Unplanned pregnancies are at epidemic levels and most are avoidable with some planning.
We can all spread the information as you are doing in this piece about options other than hormones.
Thanks so much for the article.
Cynthia on 05/10/2009 in 22:47
The birth control pill. Yaz, has been linked to life-threatening side effects such as strokes, blood clots, and heart attacks. Since 2004, at least 50 deaths have been reported in women taking Yaz and contraceptives made with similar ingredients. There is more information on this disturbing problem at http://www.yaz-may-cause-strokes.com/.
Enlightened on 18/10/2009 in 03:54
I have been taking Yasmin for several years, and have experienced no side effects, it has only benefited me and my body.
If people experience problems, they should change immediately and not wait for the inevitable to occur.
Blood clots and blood pressure should be checked by the doctor prescribing ANY pill as it is a requirement!
This media frenzy on this contraceptive is uncalled for.
Look at other factors that may have contributed to the health problems those patients experienced:
1. Previous health problems.
2. Misuse of the contraceptive.
3. Failure to recognize the warnings provided by the pill, the doctors and research- eg: smoking and age are some of the factors that may cause such poblems. If you do not read the warnings, and risks in taking the pills, you have chosen to be ignorant and misuse the pill.
I am a smoker, but I acknowledge the risk I am taking by being on ANY contraceptive pill whilst smoking. If anyhing, the pill works wonders, and should not be blamed for misuse and utter ignorance. Doctors warn you, Yasmin and Yaz warn you and of course the internet warns you. And if you have other health problems, don’t use Yasmin as an excuse or way of getting sympathy.
Yes, there may be alot of media and skepticisim about this pill, but this type of media occurs with EVERY DRUG, EVERY type of pill.
Using any drug, whether it be a headache tablet or the pill, you will always be putting yourself at risk!
Cynthia on 02/11/2009 in 06:58
Be very careful if considering the birth control pill, Yaz. Yaz has been connected to stroke, heart attack, and other adverse events: http://www.yaz-may-cause-strokes.com/.
Cynthia on 23/12/2009 in 00:10
This bears repeating: The birth control pill, Yaz, has been linked to a number of adverse reactions, including strokes and lawsuits are growing over these issues. Here is some good information: http://www.yaz-may-cause-strokes.com/
Kate Meredith on 10/03/2010 in 14:17
This is such a great and thorough article. The ad campaigns for this product truly are misleading and women naturally trust their doctors and pharmaceutical companies to refer them to the right birth control. I mean if it’s backed by the FDA, then it has to be OK for me right? Wrong. I hope with the Yaz controversy becoming more public that more women will consider truly researching their options before putting it into their bodies.
Jessamyn on 10/03/2010 in 15:02
I just had a terrible ordeal that I believe was a result of Yaz.. Doctors found two bloodclots one in my right leg which I could have lost and one moving that they found in my groin area. It’s been a month and I’m still recovering from the surgery. I’ll have permanent damage from the surgery and in my opinion I wouldn’t advise anyone to use any Yaz products. Check ou this site http://www.yaztalk.com . When choosing a birthcontrol pill read all the packaging and discuss it fully with your doctor.
Let's get spacific
Here is a blog I found on http://humanrights.foreignpolicyblogs.com/2009/09/27/yaz-birth-control-controversy-pharmaceutical-profits-unnecessary-risks-and-the-gendered-distribution-of-family-planning/
Yaz Birth Control Controversy: Pharmaceutical Profits, Unnecessary Risks, and the Gendered Distribution of Family Planning
By Jessica Corsi
Sunday, September 27 5:23 pm EST
The current Yaz birth control controversy illustrates the continued tension between what pharmaceutical companies and the doctors that they pay claim is safe for consumption, and contrary scientific evidence. Natasha Singer of the New York Times is reporting that Yaz, a birth control pill manufactured and marketed by Bayer, is under fire as an inappropriately advertised, improperly made, more dangerous pill. Two new studies out of Denmark and Holland and published in the British Medical Journal indicate that Yaz creates a higher risk of blood clots and strokes than other birth control pills. A large group (at this time 74) of women in the U.S. are suing for blood clots and resultant health injuries that they have endured as a result of using Yaz. The U.S. Food and Drug Administration (FDA) has been investigating Bayer and Yaz for some time, and Switzerland’s medicines supervisor is investigating this pill because it contributed to a lung clot that killed a woman earlier this month, and left a 16 year old girl permanently disabled last May. The evidence has mounted around the globe that Yaz is an unsafe option, that the advertisements used by Bayer to promote Yaz obscured the health risks, and even that the manufacturing plants producing Yaz are not properly producing the drug.
Profit Motive Pushes Companies to Encourage Women to Take Unnecessary Risks
As is often the case in a pharmaceutical controversy, the doctors paid by Bayer are rushing to downplay the risk presented, while independent doctors take the approach you might expect from a health care practitioner: advising that, even if increased risk of blood clots and stroke is low, why not switch to any one of the multiple birth control pills that present a lower risk? If you find the latter approach more sensible, congratulations; you are thinking like a person who would rather manage health risks than engage in unnecessary ones. It seems too much of a coincidence that the only people who keep pushing the risk of Yaz are the only ones profiting monetarily from it.
Why Are Less Safe Birth Control Options Still on the Market?
Birth control pills present a unique pharmaceutical situation, for several reasons, one of which is that there are safer pills available and yet the less-safe pills remain on the market. There are many different formulations of the hormones that go into the myriad birth control pills for sale, and not every combination of hormone is equally safe. Dutch research shows that, while taking the pill generally increases a woman’s risk of blood clot, the extent of the risk depends on the exact type of hormones in the pill. This research demonstrates that many women taking the pill are not taking the safest pill available to them. Drug developers have been recalibrating the combination of hormones in birth control pills since the 1960s with the intent to reduce the risk of blood clots and thus make it safer for the women and girls that take it, which begs the question-why are we still marketed pills that are not at the optimum safety level? How can companies such as Bayer continue to justify their manufacture of these less safe option? It also raises the question of whether governments will allow them to advertise as “just as safe” as other oral contraceptive pills now that research shows that they are not “just as safe” as the other oral contraceptive options.
Birth Control: A Gendered Burden
Because only women and girls take birth control pills and other forms of hormonal contraception, this particular pharmaceutical controversy takes on a gendered dimension. Yaz’s ads attempt a Sex and the City vibe that the New York Times describes as having succeeded in making it and its sister drug “the go-to brands for women under 35.” The FDA has criticized Yaz’s advertisements-which feature young, attractive women chatting about Yaz at a chic rooftop party; ensconced on a plush sofa, they discuss the pill as servers stroll by with cocktails-for misleading women about the non-pregnancy related uses of this pill. If ever a TV spot tried to make a pill seem trendy and fashionable, this is it. It is this marketing of the pill as if it were a handbag or car that raises additional ethical questions. Of course the pill is not some sort of fashion accessory, and of course the young women that it targets, such as the now permanently disabled 16 year old in Switzerland, should have it presented to them as a contraceptive and not a “lifestyle” drug. In response to FDA demands, Bayer released a “follow-up” Yaz advertisement to clarify the previous one; and yet here is the same young, beautiful doctor, strolling through a party in a great outfit to tell you about these “clarifications.” Not much has changed, nor do the ads reveal that this particular type of hormone combination presents a higher risk than others.
Hortense writes on Jezebel.com that flippant and non-medical advertising is a feature of all pharmaceuticals, not just birth control:
This is a problem that extends to all ads for medication; the consumer is told to go to the doctor and demand a certain brand name, without even knowing, exactly, what the medication really does to the body. Someone always does a voice over about diarrhea and blood clots and death, but all the audience seems to pick up on are the scenes of horses frolicking or women laughing or couples holding hands in the sun.
And yet contraception is a uniquely female issue; men are less likely to engage in or worry about shopping for or using birth control. They have fewer options, and a daily pill is not currently available to them, in part because pharmaceutical companies have chosen not to produce one. Because women and men share unequally in the child bearing process-obviously the burden (or, if you like, the privilege and the joy) of actually bearing the child falls on women, and so, they more readily accept the risks, including stroke and death, associated with pregnancy prevention in order to simply prevent the pregnancy. Men can don a condom or have a vasectomy, but if a girl or a woman wants to take matters into her own hands, she can take a pill, use a patch, get a shot, etc. As Lisa Campo-Engelstein writes in Science Progress, this creates an unequal burden that has women and girls using more of their time and money, and encountering more stress and stigma, for finding, using, and dealing with the repercussions-negative health effects; failed contraception-of birth control.
The Yaz controversy highlights the serious health risks associated with female birth control methods. While these are often presented as minimal, Campo-Engelstein points out that the gravity of these side effects is not only important to consider in its own right, but becomes more problematic when compared to the side effects of current male options. The comparison reveals the unequal burden:
The side effects of female hormonal contraceptives can include cardiovascular complications, depression, hepatic adenomas, pathologic weight gain, and possible bone loss. The two available male forms of contraception also carry fewer risks than their corresponding female contraceptives, female barrier methods and tubal ligation, respectively. Some dismiss women’s side effects as “minor”; however, to the women who experience them, they often are far from benign. Women most commonly discontinue contraceptives due to side effects and most forms of contraception have discontinuation rates approaching 50 percent after one year of use.
The fact that women discontinue their use of birth control pills at “rates approaching 50 percent after one year of use” is immensely telling about the health risks these pills present.
Big Pharmas Shut Down Male Contraception Options
Seeing birth control as a uniquely female issue means that most research dollars are targeted to creating new forms of female birth control vs. new forms of male birth control. Time Magazine reported in August 2008 that the reason we don’t have male birth control options that mirror female options is that pharmaceutical companies-including Bayer, which led the market in halting the research, inspiring others to abandon it as well-decided in 2006 that there was not a large enough market for male contraception. This despite the fact that they were reportedly on the verge of successful breakthroughs and that global surveys indicate male interest in birth control pills or injections. Doctors researching male contraception cite the “knee-jerk” reaction of pharmaceutical companies that men aren’t interested, despite evidence to the contrary. The Time article notes that “if even a small percentage of sexually active men agreed to try a new method of birth control, that would amount to a colossal number of potential consumers,” meaning, there should be profit incentive for developing the product. The fact that there is insufficient corporate interest indicates that other barriers, such as gendered and cultural assumptions about male sexuality, are getting in the way of research and development.
To close the gap, the World Health Organization has led the charge in pushing for new male contraception options as part of their family planning programme. It says something about the stakes involved and the integral role male birth control could play that the WHO has gotten behind it, especially in the face of disinterest by for-profit health related companies. Until other options are available, however, and even when they are, governments must hold Bayer and other companies accountable for the preventable health risks presented by their products and for the way that these products are marketed.
9 Comments So Far»
Zainab Jeewanjee on 27/09/2009 in 18:08
wow. This is an excellent piece. Excellent information and insight. The past ten years has seen a sharp rise in direct consumer advertising on behalf of the pharmaceutical industry and you couple that with teh way the drugs are marketed and then pushed by physicians and it becomes a little much.
Thanks for such an interesting article.
Cynthia on 28/09/2009 in 22:27
The contraceptive pill, Yaz, has been linked to life-threatening side effects such as strokes, blood clots, and heart attacks. Since 2004, at least 50 deaths have been reported in women taking Yaz and birth control pills containing similar ingredients. There’s more information on this disturbing problem at http://www.yaz-may-cause-strokes.com/
birthcontroloptions on 02/10/2009 in 08:58
There are many birth control options out there available to women and men (condoms), The important point is that more options is always better than fewer and that couples understand the risks associated with each one.
Hormones for men or women will carry some side effects for many of them and since the Pill and other hormone treatments have been by far the most popular choices outside of the condom we will hear about more incidents of these effects as time moves on.
Unplanned pregnancies are at epidemic levels and most are avoidable with some planning.
We can all spread the information as you are doing in this piece about options other than hormones.
Thanks so much for the article.
Cynthia on 05/10/2009 in 22:47
The birth control pill. Yaz, has been linked to life-threatening side effects such as strokes, blood clots, and heart attacks. Since 2004, at least 50 deaths have been reported in women taking Yaz and contraceptives made with similar ingredients. There is more information on this disturbing problem at http://www.yaz-may-cause-strokes.com/.
Enlightened on 18/10/2009 in 03:54
I have been taking Yasmin for several years, and have experienced no side effects, it has only benefited me and my body.
If people experience problems, they should change immediately and not wait for the inevitable to occur.
Blood clots and blood pressure should be checked by the doctor prescribing ANY pill as it is a requirement!
This media frenzy on this contraceptive is uncalled for.
Look at other factors that may have contributed to the health problems those patients experienced:
1. Previous health problems.
2. Misuse of the contraceptive.
3. Failure to recognize the warnings provided by the pill, the doctors and research- eg: smoking and age are some of the factors that may cause such poblems. If you do not read the warnings, and risks in taking the pills, you have chosen to be ignorant and misuse the pill.
I am a smoker, but I acknowledge the risk I am taking by being on ANY contraceptive pill whilst smoking. If anyhing, the pill works wonders, and should not be blamed for misuse and utter ignorance. Doctors warn you, Yasmin and Yaz warn you and of course the internet warns you. And if you have other health problems, don’t use Yasmin as an excuse or way of getting sympathy.
Yes, there may be alot of media and skepticisim about this pill, but this type of media occurs with EVERY DRUG, EVERY type of pill.
Using any drug, whether it be a headache tablet or the pill, you will always be putting yourself at risk!
Cynthia on 02/11/2009 in 06:58
Be very careful if considering the birth control pill, Yaz. Yaz has been connected to stroke, heart attack, and other adverse events: http://www.yaz-may-cause-strokes.com/.
Cynthia on 23/12/2009 in 00:10
This bears repeating: The birth control pill, Yaz, has been linked to a number of adverse reactions, including strokes and lawsuits are growing over these issues. Here is some good information: http://www.yaz-may-cause-strokes.com/
Kate Meredith on 10/03/2010 in 14:17
This is such a great and thorough article. The ad campaigns for this product truly are misleading and women naturally trust their doctors and pharmaceutical companies to refer them to the right birth control. I mean if it’s backed by the FDA, then it has to be OK for me right? Wrong. I hope with the Yaz controversy becoming more public that more women will consider truly researching their options before putting it into their bodies.
Jessamyn on 10/03/2010 in 15:02
I just had a terrible ordeal that I believe was a result of Yaz.. Doctors found two bloodclots one in my right leg which I could have lost and one moving that they found in my groin area. It’s been a month and I’m still recovering from the surgery. I’ll have permanent damage from the surgery and in my opinion I wouldn’t advise anyone to use any Yaz products. Check ou this site http://www.yaztalk.com . When choosing a birthcontrol pill read all the packaging and discuss it fully with your doctor.
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