Gardasil, Cervarix Update: “Unacceptable Pharma Collateral Damage”!
Every Vaccine is going to kill someone. Every Vaccine is going to destroy a life, maim and cripple someone for life consigning them to life-long anguish. That is “The State Of The Art”.
Think before you spin the cylinder and pull the trigger on “The Russian Roulette Pharma Gun”.
More often than not these days’ claims and fear-laden hype bear no relation to the truth.
Pharmaceutical Company bottom lines may well spell a bottom line for you of a grave or a life a crippling pain and suffering. Think, Think, Think, question, question, question…please.
Lives Changed By Cervarix: Stacey From The UK
Stacey, and her family, are wishing they never heard of Cervarix.
Before Cervarix, Stacy was a happy-go-lucky girl who went out of her way to help others. In addition to her busy school schedule, she had a part-time job at the local market. She also did volunteer work two days each week at a school where the children loved her. Now all of that is over.
Stacey had no history of medical problems, according to her physician. She was a normal, happy and healthy girl until after she completed the three recommended doses of Cervarix, the same HPV vaccine offered to all school girls age 12 to 18 in the United Kingdom.
Stacey received Carvarix injections in November 2008, January 2009 and the 16th of May 2009. When she became increasingly emotional after the first two injections, her parents thought their easy-going, 17-year old daughter had finally succumbed to adolescent mood swings. They were mistaken.
Immediately after her third injection, Stacey had a much more violent reaction. Four days later, Stacey suffered her first epileptic seizure, followed by 17 more in the following week.
The seizures continued for months, while she became increasingly disturbed and psychotic. She began hearing voices and making murderous threats. At times, Stacey was so aggressive her parents and younger sister were afraid to be in the same home.
Stacey's frequent seizures damaged her brain to the point she has had to undergo substantial rehabilitative therapy to re-learn simple tasks, like how to make a sandwich.
Her original diagnosis was epilepsy caused by swelling of the brain; cause of swelling unknown. Since the original diagnosis, her neurologist has determined Stacey has a very rare form of encephalitis, called anti-NMDA-receptor encephalitis, which in effect is an antibody attacking the brain.
According to an excerpt from her medical records:
This type [of epilepsy] in Stacey's case was not caused by an infection........symptoms began on 16 May 2009 (date of third vaccination). This was in the context of having recently received the third in a series of vaccinations for cervical cancer.
The eight months following her last Cervarix injection, Stacey spent between hospitals, brain injury treatment facilities and rehabilitation facilities. At one time, she was admitted to a psychiatric hospital. In 24 hours, they determined her problems were medical, not mental and released her immediately.
She was finally allowed to go home around Christmas 2009. Stacy is making slow progress and is still under the care of three specialists. Her parents are anxiously awaiting the results of recent blood tests that were run to see if the brain inflammation (encephalitis) is subsiding. Her next appointment with her neurologist is scheduled for July 2010.
Stacey's parents are angry. They feel the government and pharmaceutical company have used their daughter as a guinea pig. They not only want to make sure this happens to no one else; they want justice.
More About: HPV Vaccines · Cervarix
Meet The Gardasil Girls: Alexis From New Mexico
Alexis was scheduled to visit her grandparents in Germany, but her parents were reluctant because of the diabetes. Her doctors assured her parents that Alexis was handling everything so responsibly that it should be perfectly safe for her to go. Everything looked good for Alexis.
Alexis had two of the three recommended Gardasil shots before she went to Germany to visit her grandparents. While she was in Europe, most everything went well. Her grandparents said she acted a little out of character, but nothing they thought serious.
After returning, her mother started noticing odd behavior. Alexis didn't suffer from jet lag after her trip like they all had after their last trip to Germany. She had always been a very sensitive child, but she didn't cry when their 12 year old dog died. Little changes that sometimes only a mother notices began to show up.
As time went on, her behavior became more bizarre. She was getting in trouble in school. Alexis was not able to concentrate or retain anything she learned. She went to every kind of doctor imaginable, but all tests came back "normal.'
Her personality changed 100%--Alexis was no longer herself. She would go into fits of rage, screaming and calling names. She swore she hated her family. She wanted to be taken to an orphanage and be adopted by another family. Sound and movement bothered her. She said people's faces made her sick to her stomach, even faces on the television. Doctors and school officials said she was just "testing her boundaries." Her mother knew something was seriously wrong.
Soon, she was not sleeping at all. She would spend her night time hours sitting up writing notes about things that never made sense. She became obsessed with food, eating anything she could get her hands on while the family slept. One day she stuck her tongue out and her mom noticed it looked almost like she had bitten off a chunk of it.
More visits to the doctor with no abnormal test results. Not knowing what else to test for, someone suggests a psychologist, thinking she may be having trouble accepting the diabetes. No one in the family thought that was the problem, but they agreed to try. After only two visits, the psychologist decided she was traumatized while on her trip to Europe. Alexis was put on antipsychotic drugs. They only made the problems worse. She began to vomit up everything she ate, and then couldn't wait to eat more.
January 2008, she received her third shot of Gardasil. Then the nightmare really began. Things got much worse. She was still not sleeping at all, vomiting up everything, binge eating, not to mention acting like a complete stranger to her family and friends.
Two weeks after the third shot, she was admitted to the hospital for a complete battery of tests. Still no diagnosis. No one knew what was wrong with this once healthy, happy girl. Not knowing what else to do, the doctors referred her to a Behavioral Unit.
While there, she was not allowed to be around any of the other children. She could only be in her room, or walk up and down a short hall. The staff had to be constantly instructed on how to handle her diabetic medication. She was given a bucket to vomit in. If she vomited, she was allowed no additional food. On the fourth day there, two nurses witnessed her eating the vomit from her bucket. After the fifth day, they said she was 'stable' and sent her home.
Alexis finally ended up in a Children's Psychiatric Hospital. Nothing they gave her made her sleep; nothing they gave her could stop the vomiting. Finally, one morning when mom was visiting Alexis had an unusual episode that mom witnessed. She told the staff and an EEG was done. They discovered she was in fact having seizures that were all concentrated in her frontal lobe, the part of her brain that controls personality. All of this time, she had been having seizures and no one had noticed.
The next six months were spent going back and forth between two hospitals. Each ran every test they could possibly think of; tissue and fluid samples were sent all over the country. Everything came back normal. It was finally determined that Alexis had been exposed to a virus and her system created antibodies to attack the virus. These antibodies were now attacking her.
She had not been sick and had not shown any symptoms of a viral infection--not even a runny nose. The only virus she had been exposed to was in the Gardasil shots.
They also determined she had suffered brain damage from the seizures. This once proud honors student now tests at about a 4th grade level. To this day, she is unable to attend school. Her seizure activity remains almost constant, day and night.
Every day, new symptoms seem to pop up. She has numbness in her arms and legs, headaches, horrible pain, no bladder control, constipation, vision problems, memory loss, brain fog, chronic fatigue, leg cramps dizzyness, and on, and on, and on.......
This beautiful little girl who showed so much promise may never be the same again. Her family is at the end of its rope. They know there is no explanation other than Gardasil.
This family is living a nightmare they desperately wish they could wake up from---unfortunately, it is real--very real.
http://www.examiner.com/examiner/examinerslideshow.html?entryid=1228316
Meet The Gardasil Girls: Raquel From Spain
Raquel was 14 when she got her first shot of Gardasil in November of 2008. In February of 2009, she received her second shot. Five minutes later, she was dizzy; ten minutes later, she was experiencing tachycardia (rapid heart beat) and seizures. A few hours later, she is in intensive care unable to breathe. Raquel is in a coma.
For the next two months, Raquel remains in the intensive care unit battling between coma and convulsions. When she is released from intensive care to a regular ward, Raquel can no longer walk.
During her stay in the hospital, doctors rule out the possibility of encephalitis, viral infection, and bacterial inflammation. Left scratching their heads as to a cause, they say it is a pseudocrisis and release her without further treatment. Raquel had to be transported home in an ambulance because she could not yet sit in a wheelchair, although one was provided for her. She and her family were left trying to deal with convulsions and paralysis on their own.
Raquel's parents take her to a private neurologist who determines she suffers from demyelination, a loss of the myelin that insulates her nerve endings. She is given a prescription for anticonvulsive treatment and a myelin rebuilder.
In May, she is released to rehabilitation. By the end of July, she can finally walk again.
In October, her doctor decides to gradually decrease her medications because she has been seizure free for several months. In November, the nightmare begins again. Raquel is once more confined to a wheelchair and has to try to fight her way back to a somewhat normal existence.
Raquel has missed a lot in the last year:
- She remembers very little about her two month stay in the Intensive Care Unit.
- She missed the touch of her parents for months, while they could only view her though a window and communicate via blackboard.
- She could not wish her brother "Happy Birthday," she was intubated that day.
- She could not celebrate Easter with her family, she was in the hospital.
- She could not celebrate her 15th birthday with family and friends, she was in the hospital.
- She missed five months of school.
- She can no longer enjoy many of her favorite foods, Raquel is on a special diet.
- She misses participating in normal everyday activities with her friends.
From the day she received her second shot of Gardasil, her life has been totally changed. She spent a lot of time wondering if she would survive at all.
Instead of looking forward to growing up and making plans for her future, Raquel has but one thought on her mind, "I do not want one more girl to suffer what I have suffered!"
For more information about HPV vaccines, visit the Truth About Gardasil website.
More About: Gardasil Girls · Gardasil
Meet The Gardasil Girls: Brittney From Ohio
Brittney has been suffering for almost three years; she wishes to dedicate her story to those who have been injured, or passed away, around the world after receiving HPV vaccinations.
Brittney was born a warm, caring people person. As a child, she would try to help other children, rushing to their aid when they cried, or passing out hugs when they were lonely. She was full of life, vibrant and entertaining from the day she could talk.
She loved school so much, she completed her junior and senior year of high school in a single year with an excellent grade point average to boot. She loved drama and music, actively participating in both. She was affectionately called the "hostess of the classroom," because she was always baking or cooking for her friends and classmates.
When she got to college, she added physical activities to her list of things to do. She began lifting weights, running wind sprints and doing cardio workouts. By the time she was 21, she was hiking up to seven miles at a time, swimming regularly and keeping up with a multitude of social activities with her friends.
In June 2007, at 21 years of age, Brittney was told by her family doctor that she needed to take the Gardasil vaccine to protect her against picking up an HPV infection via accident at the college lab. The doctor assured her there were no complications with this vaccine, so she gave in for fear the doctor may be right.
For the next six weeks, Brittney began to have sporadic health problems. She experienced fainting, hammering leg pain that would come and go, and most frightening -- seizures. She had never experienced seizures, nor was there any family history of seizures.
Despite these odd incidents, Brittney refused to slow down even a little. Pushing on, she remained quite active physically and mentally.
At least until August, when she got her second injection of Gardasil. Ten days later, her life changed forever. Pressure in her head and jaw started building, followed by excruciating leg pain, muscle weakness, rubbery sensations and burning prickles in her limbs and head. Finally, she lost the ability to walk.
She was taken to several specialists, an ER visit, and admitted to a well-known research hospital. All kinds of tests were run with no conclusion other than ruling out conversion disorder. Neither she, her parents, nor her doctors knew what was happening to her.
Luckily, a friend sent Brittney some information about other girls who had taken Gardasil and were suffering similar mysterious symptoms. Because of her nausea, blurred vision and dizziness, Brittney could not read, much less sit at a computer. So, her mother began to research the effects of this new vaccine. A couple of weeks later, mom had enough information about Gardasil to convince Brittney not to get the third injection.
Brittney was later informed by one of her physicians, that had she received the third injection she probably would not have survived.
Brittney has seen over 40 specialists in various fields. Some dismiss her symptoms as conversion disorder as soon as they hear Gardasil may be involved. Some medical facilities have husstled her out the door as soon as they hear an HPV vaccine could be to blame.
However, at least five different physicians have diagnosed the following disorders: peripheral neurological disorder, abnormal pupillary function and dilation, peripheral neuropathy in both legs, decreased endocrine activity and function, idiopathic epilepsy, liver function suppression, GI tract disorders, chronic Guillain-Barre-like symptoms, and hormone problems. All five attributed her problems to the Gardasil injections she received. At least once, she was told with time and treatment all of the damage could be reversed.
Today, it's almost three years later and Brittney is seeing some improvement. Many times, those improvements are marred by setbacks. She is for the moment, content to take life one day at a time. Both she and her family are hopeful that one day Britt will get an opportunity to live a long and ordinary life.
http://www.examiner.com/examiner/examinerslideshow.html?entryid=1225531
Friend Ruth in Australia sent me The Link To The Gary Null Show - I was one of the guest speakers on Friday last. I have checked it out and once you press download eventually you will get the bar and press the play button - that was the second on the left. I come after the first lady speaker Cindy Bevington - after the first half hour. Hope you enjoy if you get the time to listen!!! Was quite a nervous lady at this end but think I don’t sound it - not that I have listened to myself. Freda
Today's guest is Cindy Bevington and she is an investigative reporter for the KPC Media Group and she broke the story of a lead researcher in Merck's Gardisil trials.
Also, we have Marian Green and she is the co-founder and Chairperson for the organization, TruthAboutGardisil.org.
Also, we have Freda Birrel and she is a long time political activist living in Scotland who ius devoted to alerting politicians about the medical risks of the Gardisil and Cervarix vaccines.
Also, we have Alan Phillips and he is one of the few lawyers in America practicing vaccine exemption and waiver law and individual and legal rights on vaccination policies.
At 12 years old, Shania's dream was to represent Australia and compete for the Olympic Gold. Being a junior State Champion for three years in a row definitely put her on the right track.
She broke many records in her young career, including one that had been standing for 22 years and another that had remained unbroken for 17 years. She was accustomed to being a Champion.
It was not at all unusual for her to return from a swim meet with 8 gold medals and a couple of silvers. Her medals and trophies line the shelves in her proud parents' living room. There were many who thought she just might make it to the Australian Olympic swim team. After all, Shania "the Flyer" was unbeatable in most events, especially the butterfly.
By the tender age of 12, she had already been selected for the state swim team and handpicked by Swimming W.A. to join a special training squad for the State's elite junior swimmers. Everything she did led her closer to her dream.
All of that came to an abrupt halt on August 9, 2009, 9 days after her second injection of Gardasil, when she collapsed in front of hundreds of spectators during a swimming competition. Shania was rushed to the hospital and had to be wheeled in because she was unable to walk. She felt nauseous, had a headache and blurred vision. She complained of being dizzy and hovered on the edge of consciousness. Her asthma, which had been under control for so long that she had forgotten about it, came back with a vengeance. She could hardly breath and was coughing a lot. She had no reflexes and could not stand on her own, much less walk. Shania said her arms and legs "felt dead."
Six hours later, after various doctors had performed every test they could imagine and were still shaking their heads, Shania was allowed to go home with the understanding she would be seen by her own doctor the next day.
As it turns out, August 9 was not the beginning of Shania's nightmare. She had been suffering many symptoms since her first Gardasil shot, but like the champion she was, she toughed it out and kept going until she completely collapsed.
Her symptoms have included extremely high fever, headache, aching heavy limbs and extreme tiredness. She seemed nauseous and had a difficult time concentrating. Her parents noticed she was losing her hair. Where her menstrual cycle had always been as regular as clockwork, now it was not. Shania began to constantly complain of numbness, or a "pins and needles" sensation in her limbs. She developed a severe rash that extends over most of her body. The slightest physical exertion causes her to spend several days recovering.
Shania has been tested for everything under the sun, to no avail. Her doctors are still calling it a "mystery condition." They can find no answer other than Gardasil, yet they can not seem to prove the connection.
Two of her specialists told her parents not to expect doctors to be 'helpful' with trying to make the connection to Gardasil, regardless of the evidence, because the moment one of them admits it was Gardasil, it would open them up to lawsuits.
Meanwhile, over 8 months later, Shania is still trying to recover some semblance of her normal self. She is a long way from back to normal, but she is experiencing some improvements.
Her parents know she will probably never be able to return to the pool. They hope and pray their daughter will someday have the energy to participate in some of the things she used to enjoy. They wonder how you compensate someone for a lost dream.
Everything Shania lived for and trained for was aimed at reaching her dream of the Olympic Swim Team. She had one goal, one dream --- a dream that was turned into a nightmare by Gardasil.
For more information on HPV vaccines, visit the Truth About Gardasil Website.
If you suspect you have been adversely affected by any vaccine, file a report with VAERS online.
The Guardian Angels are a group of volunteers that are here to help, whether it be to answer questions or just provide some emotional support. We all understand how difficult it is to have a family member dealing with the effects of Gardasil. We would eventually like to have a Guardian Angel in every state, and every country across the globe, especially as more and more people realize that they or their loved one is ill, due to a reaction from the Gardasil vaccine.
If you would like to become a Guardian Angel, please email us with Guardian Angel in the subject line, at moderator@truthaboutgardasil.org
http://www.google.com/search?client=gmail&rls=gm&q=birrell_df%40btopenworld.com
HPV Vaccines And Emily Tarsell: A Mother's Quest For Truth
Emily Tarsell is a practicing mental health therapist who works with adults, adolescents, families and children, especially children with special needs. Two years ago, her biggest concern was paying for one more year of tuition for her only child, Christina. Her greatest joy in life was watching Chris blossom at Bard, a college she loved.
Her daughter was the child every parent dreams of having: an honors student, active in sports and her community, and a talented artist. She was a wholesome, healthy and happy girl; a beautiful person inside and out. Chris was the light of her mother's life.
Two years ago, aggressive marketing on television, newspapers and magazines was telling middle class families everywhere to have their daughters, between the ages of 9 and 26, vaccinated against cervical cancer. Their mantra was "Be one less." Gardasil was touted by doctors and professional medical associations as being safe and effective for preventing cervical cancer. Nothing was mentioned about any potential serious adverse side effects.
When Chris had her first gynecological appointment, the doctor suggested she have this "safe" vaccine. There seemed to be no reason to refuse it.
Chris began to experience various unusual symptoms, but not having been told of any possible serious adverse reactions, her parents viewed each symptom on its own. 18 days after her third injection, Chris became "one less." The cause of death is still undetermined.
No one connected it to the vaccine until several weeks after her death when her father heard on television that there were deaths possibly related to Gardasil. They began to investigate and discovered the things Chris experienced were not unusual. Many other families had similar stories.
Now, Emily is on a mission. She merged the grief from losing her only child with her scientific skills to become an expert on Gardasil. She spends every waking moment trying to get the word out through TV and radio interviews, speaking at churches and schools, and testifying before any legislative body that will take the time to listen.
The best way to relate Emily's message is via exerpts from the testimony she presented to the Health and Government Operations Committee, Maryland General Assembly in February of this year.
Here is part of her testimony:
Families need the opportunity to be heard in public hearings because we have not been given adequate information to make informed decisions. The truths about Gardasil and cervical cancer are suppressed. I am not just talking about the controversial adverse reports of embolisms, strokes, motor neuron degeneration, numbness, muscle weakness, paralysis, heart disorders, skin disorders, extreme fatigue, debilitating headaches, recurring dizziness, seizures, and death. I am talking about the plain, unequivocal truth about cervical cancer and the HPV vaccine, Gardasil.
According to the American Cancer Society, the facts about cervical cancer are:
- Mortality rates have declined 75% since the Pap test was widely implemented 50 years ago.
- There is less than a 1% lifetime risk of developing cervical cancer and less than one quarter of 1% lifetime risk of dying of cervical cancer. This means 3 out of every 100,000 women die from cervical cancer in the U.S. annually.
- There are dozens of HPVs that can cause cervical cancer. In 90% of women, HPVs clear up on their own within two years. Of the remaining 10% of HPV infections, only half will develop into cervical cancer. It is only when the HPV virus lingers for many years that abnormal cells could turn into cancer.
- The length of time required to develop invasive cervical cancer after identification of precursor lesions averages between 8.1 and 12.6 years, and may take up to 40 years.
- Nearly all cervical cancer deaths are preventable by a simple Pap screening and appropriate follow-up.
Had we, as consumers, just been given this factual information when we were told about Gardasil, we would certainly have declined the injections. Why would you get an inoculation you don't need to prevent something you will most likely never get, which is very treatable if you do get it?
Add to this the unequivocal facts they do not tell you about Gardasil:
- The goal of the vaccine is to induce the body to create antibodies for two HPV viruses known to cause cervical cancer, and two HPV viruses that cause genital warts. However, it appears the antibodies drop below therapeutic levels after five years; and therefore, the vaccine would be ineffective without a booster shot.
- Gardasil ony addresses two of the dozens of viruses that cause cervical cancer; therefore it is essential to continue to have annual Pap screens to test for cervical cancer.
- Gardasil does not cure cervical cancer. Its effectiveness in preventing cervical cancer will not be known for decades.
- The rate of reported serious adverse events following shots of Gardasil is greater than the incidence rate of cervical cancer.
- The vaccine was fast-tracked by the FDA and was approved in just six months. Because it was fast-tracked, there are no long term safety studies, no studies about the interaction with other vaccines given concomitantly, and no studies about the interaction with birth control pills.
- The effect on a fetus, or reproduction is unknown.
- The vaccine has not been evaluated for potential to cause carcinogenicity or genotoxicity.
My daughter died from being talked into getting a vaccine she did not need; a vaccine we would have declined if we had been told the truth about risks and benefits.
Last week, India called a halt to HPV vaccinations in their country due to citizens' concerns about death, injury and allegations of unethical practices by Merck, GlaxoSmithKline and Path International. They will allow no further HPV vaccinations until the concerns and allegations are completely investigated.
Emily believes nothing less should happen in the United States.
If you, or someone you know, is considering an HPV vaccine, please visit The Truth About Gardasil, before you decide. Educate before you Vaccinate.
From Peter Tucker:
A group of us who are opposed to DC's mandate that sixth grade girls receive the controversial
HPV vaccine testified at the DC Council before the Health Committee on Wednesday morning
at a hearing on the DC Department of Health budget. The Chairman of the Committee, David Catania, who is responsible for creating the mandate, could not respond to Emily Tarsell's testimony.
Ms. Tarsell lost her daughter, Christina, 18 days after Chris was vaccinated with her third dose
of Gardasil. Chris had shown signs of complications after the second dose, but since doctors don't always forewarn those receiving the HPV vaccine about the possible side effects, Ms. Tarsell had
no idea that it was Gardasil that was causing the complications and that futher vaccination could make things worse for her daughter.
Ms. Tarsell is a psychologist and she has merged her grief from losing her only child with her scientific skills and has become an expert on Gardasil. Among other things, she has started a
website in honor of Chris (www.gardasilandunexplaineddeaths.com). After giving her amazing testimony, as she was riding in a car to Union Station to catch a train back to Baltimore on her
way home to northern Maryland, I got to interview her (attached). The interview aired Wednesday evening on Spectrum Today on WPFW 89.3 FM
She is truly an amazing woman. Please spread this far and wide.
best, Pete 202 365 6118
Note: These attachments will expire in 30.00 days. View All
http://drop.io/pagub5q/asset/emily-tarsell-4-21-10-mp3
http://drop.io/hidden/jz2gfanhrlyndn/asset/ZW1pbHktdGFyc2VsbC00LTIxLTEwLW1wMw%253D%253D
Do You Have Low T? Circadian Dysrhythmia? Pharma Hopes So
By Martha Rosenberg
Since direct-to-consumer drug advertising debuted in 1997, pharma's credo has been When The Medication Is Ready, The Disease (and Patients) Will Appear. Who knew so many people suffered from seasonal allergies, GERD, erectile dysfunction, restless legs and bipolar disorder?
But pharma's recent plan to move from mass-market molecules into more lucrative vaccines and biologics did not see the anti-vaxer movement coming: millions of Americans saying You Want to Vaccinate Me -- and My Child -- with WHAT?? and condemning vials of H1N1, rotavirus, MMR vaccines and Gardasil and Cervarix to sit, well, way past their expiration dates. Nor were fears of an international vaccine conspiracy helped by former CDC Director Julie Gerberding resurfacing as President of Merck Vaccines in December. (Nice revolving door if you can catch it.)
Now pharma is back to creating new diseases, patients, risks and "awareness campaigns" faster than you can say thimerosal (the vaccine preservative that started the backlash.)
SERM deficiency
A pill to prevent postmenopausal osteoporosis packs the "magic three" of drug sales -- fear, forever and faith -- since you never know if it's working or if you need it, but fear stopping. But 15 years after women began swallowing bisphosphonates like Fosamax and Boniva because pharma-planted bone density machines in medical offices revealed they had "osteopenia,"* bisphosphonates are linked to jaw bone death, esophageal cancer and causing the fractures they were supposed to prevent. Sorry about that. Now pharma is hawking Selective Estrogen Receptor Modulators (SERMs) like Evista and Tamoxifen to prevent osteoporosis and even some cancers. Unfortunately they can cause others"
Statin Deficiency
If it seems like the whole world is on statins, it's not your imagination. Last year the FDA approved AstraZeneca's Crestor for children as young as 10 and in March it approved Crestor for 6.5 million people who have no cholesterol or heart problems at all! (See: fear, forever and faith.) Many say, since lead investigator of the Justification for the Use of Statins in Primary Prevention study Paul Ridker of Brigham and Women's Hospital in Boston is co-patent holder/inventor of the C-reactive protein (CRP) test which "proves" Crestor's effectiveness, there's a conflict of interest. Others say, since CRP isn't necessarily even a marker for heart disease and statins can cause Type 2 diabetes, it's bad science along with a conflict of interest.
Circadian Dysrhythmia
Insomnia is a gold mine for pharma because everyone sleeps -- or watches TV when they can't. But Ambien, Lunesta, Sonata and Rozerem have reached market saturation, so pharma is rolling out subcategories like middle-of-the-night (MOTN) insomnia, sleep eating, sleep walking and sleep sweating (yes sweating) and "non-restful sleep" to boost the franchise. Meanwhile another demo is swelling Circadian Dysrhythmia numbers: Thanks to restless legs syndrome, sleep apnea, shift work sleep disorder, people who skimp on sleep and of course insomnia meds themselves, there's an epidemic of excessive sleepiness! Enter Provigil, "a mood-brightening and memory-enhancing psychostimulant which enhances wakefulness and vigilance," and Adderall and Vyvanse -- known in the days of Lenny Bruce as speed. Bruce had "excessive sleepiness" too.
Adult Autism, ADHD and Refusal to Play Nicey
Having marketed adult diseases like depression, bipolar disorder and schizophrenia in 4-year-olds to death, pharma is now finding childhood diseases in adults. Adults with ADHD have hyperactivity, impulsivity, "executive function deficits" and "difficulty with organization and time management," says Harvard Medical School's Joseph Biederman, in a 2004 JAMA. The disease, found in most people's brother-in-laws, requires "lifelong" medication says Biederman, who was accused of pushing Risperdal and hiding pharma income by Congress in 2008. Adults may suffer from autism too says a 2008 article in Psychiatric News, if they're "unsociable, extremely rigid, given to angry outbursts" and "acutely sensitive to light, heat, and pain." Luckily, in two studies "SSRI antidepressants led to a decrease in repetitive behaviors and to somewhat more socializing," in adults with autism says the Psychiatric News.
Asthma That Requires "Two Drugs"
Leave it to pharma to develop an asthma drug -- the long-acting beta2-agonists (LABAs) -- that triples the rate of asthma deaths, especially in African-Americans. And leave it to the FDA to approve LABA's on the basis of a trial, the 2003 SMART trial (Salmeterol Multicenter Asthma Research Trial), that was stopped early because of so many deaths. In March, after more deaths, especially in children, a sheepish FDA recast LABAs as a last resort medication with or without use of a concomitant inhaled steroid. But AstraZeneca doesn't want to stop selling its LABA with a steroid, Symbicort -- and GSK its LABA with a steroid, Advair -- just because they're correlated with death. So the LABA drugs are being billed as safe and having "two drugs" to treat asthma (see: Vytorin) and projected to earn billions this year.
"Treatment Resistant" Conditions
If an engine additive or laundry product didn't work, who would chase it with another product --or two-- because the manufacturer told them to? Who would pay $300 to $900 a month out of their pocket for antidepressants, antipsychotics, mood stabilizers and mood brighteners some of which don't work? (see: fear, forever, faith.) Increasingly, pharma is billing drugs as add on or "adjunctive therapy" like the antipsychotic Abilify in whose ads a patient says, "I'm taking an antidepressant but think I might need more help." Last year, the FDA approved AstraZeneca's antipsychotic Seroquel* for patients who "failed to respond adequately to an antidepressant alone" and Eli Lilly's Symbyax, a combination of antidepressant Prozac and antipsychotic Zyprexa (do patients gain 100 pounds but feel great?) for "treatment resistant depression." Why are diseases "treatment resistant" instead of the drugs "ineffective" or diagnoses "wrong"?
Low T
Men are you feeling run down and over the hill? Is your hair falling out, skin wrinkling and abdomen developing its own zip code? Have you lost interest in sex or worse, has your partner? (With you?) Do you need reading glasses, dental implants and heel splints? You're not getting old, you just have Low T and are ready for the aging-is-really-just-low-hormones con that women have lived with for 60 years: hormone replacement therapy. Like 50 million women before you, you can be Forever Masculine even though, to (quote hormone giant Wyeth) you have outlived your testes if you start replacing your lost testosterone. You'll get both kinds of zips back in your life, and it won't change your prostate-specific antigens. Pharma promises.
"Spectrum" Disorders
Nothing proves pharma's when-the-medication-is-ready credo better than the legions of people who have fibromyaglia now that Cymbalta, Savella and Lyrica are available to treat it. Still, a "grassroots" pharma front group is conducting a Fibromyalgia Is Real awareness campaign like it did for depression and bipolar disorder, just to make sure. Pharma has also rolled out the term "depression spectrum disorder" for fibromyalgia to make sure patients who have some but not all of the symptoms seek treatment. And speaking of spectrums, "Epilepsy Spectrum Disorder" was rolled out in January's JAMA -- a disorder which is not just about seizures anymore but has "shared mechanisms" with "depression, autism"and other cognitive comorbidities." Spectrum disorders are Real--which is pharma for Reimbursable.
* a pharma contrivance like "perimenopause" to widen the patient pool
**this week AstraZeneca agreed to pay $520 million to settle Justice Department allegations it illegally marketed Seroquel and paid physicians to act as authors for ghostwritten articles. Don't the FDA and Justice Department talk to each other?
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