Monday, August 10, 2009
sober companion alert: Taking drugs make you forget about how much you drink
dr. sober companion wants to ask you about your drunk driving:
Taking drugs sometimes make you forget how much you have been drinking. Are you an alcoholic? Do you have a problem with alcohol? Have you been in a DUI incident once or more? All this talk about drug addiction makes people forget that drinking while driving may not only kill your children driving, but it may kill someone elses children as well.
dr. sober companion can save the lives of your children, and the children who might be killed by the DUI.
Wednesday, July 22, 2009
How far and how long have the jackson family hid michael jackson drug addiction?
Stressful situations make a drug addict turn towards drugs as a way to deal and cope with their situation. Sometimes the situation turns towards suicide. Could the family have stopped the suicide? Is it suicide if the drugs are supplied to the victim?
1. how long have the jackson family known of michael jacsons addiction problem?
In December of 2003, a doctor said to a British newspaper that the jackson family knew of michael jackson's addiction to morphine. He also said the drug was injected.
Referring to handwritten notes he made at the time, the doctor, who asked not to be named, said: ‘I’d been treating Michael’s brother Randy for several months when I was awakened by a phone call from him at 1.51am. I was told someone wasn’t well and that they couldn’t call 911 [the US emergency services number] for security reasons.’
If they called 911 and the world knew of michael jackson's drug addiction, could this have helped keep him alive?
2. how did the younger brother of Michael Jackson, Steven Randall "Randy" Jackson become such an expert on drug addiction?
Steven Randall "Randy" Jackson (born October 29, 1961 in Gary, Indiana)
A. Randy is the youngest son in the Jackson family.
B. Randy is the eighth out of nine Jackson children to be born.
C. Randy has 3 children: Steveanna, Randy Jr., Genevieve
In 1980 Randy was in a huge car accident. Is that where the drug addiction started for Randy, or was it much before, as part of the Jackson 5? This could have been the origination of pain medication addiction.
The next part of Randy's life was full of weird situations, incarceration (1 month prison term) for beating up his first wife Eliza Shaffe and daughter Steveanna. (this would explain why michael jackson would not want to leave his children with Randy, a convicted child abuser and wife beater) Having a child (Genevieve Olaza) with another women (Alejandra Genevieve Olaza) while still married to Eliza. Randy followed up the prison term with a trip to a psychatric facility for 1 month. He had 1 more children Randy Jr. with the lady he cheated with during his first marriage.
Ok, now that we cleared things up on why an enabling brother was giving advice to Michael Jackson, and trying to say he offered help, advice and tried to get Michael committed just as he was. In the end, you can say this was a failure as not even the most trusted and loved family member (besides Michaels mother) could help him.
Steven Randall "Randy" Jackson on October 29, 1961 in Gary, Indiana) is an African-American singer and musician, a member of the Jacksons, and is the youngest son in the Jackson family. He is the eighth out of nine Jackson children to be born.
Early career
He joined his older brothers in The Jackson 5 at age 11 (1972) playing the conga. Randy did not sing until he and his family began performing their act in Las Vegas. Randy often sung with younger sister Janet, and the duo won fame on Dinah Shore's show in 1975 after performing Mickey & Sylvia's "Love is Strange" for the first time on national television.
Enter the Jacksons
In 1976, after moving to CBS Records and changing their name to The Jacksons, Randy was named as the newest member of the group after Jermaine left to have a solo career in the group's former label, Motown. In 1978, Randy helped the Jacksons return back to fame after co-producing the album, "Destiny". One of the songs, "Shake Your Body (Down to the Ground)", was co-written by Randy and Michael, and went on to sell over 2 million copies becoming the group's biggest-selling single to date.
Randy was prepping for his own solo album around that time and one of his singles, "How Can I Be Sure?", featured the first recording of sister Janet, on the b-side of the song, titled "Love Song For Kids". Randy never got to release the album as he suffered injuries from a car crash around 1979. He would eventually recover from the accident. In 1984, he was thrust into the forefront of his brothers' Victory tour after Jackie's leg injury forced him to the sidelines. Afterwards, Randy and his brothers Jackie and Tito became renowned session musicians for other acts during this time. The trio recorded the title track to the Whoopi Goldberg film, "The Burglar", in 1987.
After the Jacksons
After one last album with the Jacksons, the group split up for good in 1990. After this split, Randy formed his own band, Randy & the Gypsys. The group only lasted one album and for the most part afterwards, like most of his siblings, with the exceptions of Michael and Janet, laid low. During his brother Michael's trial on child molestation, alcohol and conspiracy charges, Randy served as one of his consultants. Randy is often mistaken for American Idol judge Randy Jackson.
‘Randy said Michael had been under severe stress because of the television program which had aired that night.
‘I recall him saying that an earlier TV documentary had caused all manner of problems and that Michael had worked himself into a frenzy of anxiety over this one.’
The first documentary was Living With Michael Jackson, in which British journalist Martin Bashir interviewed the singer over eight months, from May 2002 to January 2003.
2 questions of this post:
1. how long have the jackson family known of michael jacsons addiction problem?
In December of 2003, a doctor said to a British newspaper that the jackson family knew of michael jackson's addiction to morphine. He also said the drug was injected.
Referring to handwritten notes he made at the time, the doctor, who asked not to be named, said: ‘I’d been treating Michael’s brother Randy for several months when I was awakened by a phone call from him at 1.51am. I was told someone wasn’t well and that they couldn’t call 911 [the US emergency services number] for security reasons.’
If they called 911 and the world knew of michael jackson's drug addiction, could this have helped keep him alive?
2. how did the younger brother of Michael Jackson, Steven Randall "Randy" Jackson become such an expert on drug addiction?
Steven Randall "Randy" Jackson (born October 29, 1961 in Gary, Indiana)
A. Randy is the youngest son in the Jackson family.
B. Randy is the eighth out of nine Jackson children to be born.
C. Randy has 3 children: Steveanna, Randy Jr., Genevieve
In 1980 Randy was in a huge car accident. Is that where the drug addiction started for Randy, or was it much before, as part of the Jackson 5? This could have been the origination of pain medication addiction.
The next part of Randy's life was full of weird situations, incarceration (1 month prison term) for beating up his first wife Eliza Shaffe and daughter Steveanna. (this would explain why michael jackson would not want to leave his children with Randy, a convicted child abuser and wife beater) Having a child (Genevieve Olaza) with another women (Alejandra Genevieve Olaza) while still married to Eliza. Randy followed up the prison term with a trip to a psychatric facility for 1 month. He had 1 more children Randy Jr. with the lady he cheated with during his first marriage.
Ok, now that we cleared things up on why an enabling brother was giving advice to Michael Jackson, and trying to say he offered help, advice and tried to get Michael committed just as he was. In the end, you can say this was a failure as not even the most trusted and loved family member (besides Michaels mother) could help him.
Steven Randall "Randy" Jackson on October 29, 1961 in Gary, Indiana) is an African-American singer and musician, a member of the Jacksons, and is the youngest son in the Jackson family. He is the eighth out of nine Jackson children to be born.
Early career
He joined his older brothers in The Jackson 5 at age 11 (1972) playing the conga. Randy did not sing until he and his family began performing their act in Las Vegas. Randy often sung with younger sister Janet, and the duo won fame on Dinah Shore's show in 1975 after performing Mickey & Sylvia's "Love is Strange" for the first time on national television.
Enter the Jacksons
In 1976, after moving to CBS Records and changing their name to The Jacksons, Randy was named as the newest member of the group after Jermaine left to have a solo career in the group's former label, Motown. In 1978, Randy helped the Jacksons return back to fame after co-producing the album, "Destiny". One of the songs, "Shake Your Body (Down to the Ground)", was co-written by Randy and Michael, and went on to sell over 2 million copies becoming the group's biggest-selling single to date.
Randy was prepping for his own solo album around that time and one of his singles, "How Can I Be Sure?", featured the first recording of sister Janet, on the b-side of the song, titled "Love Song For Kids". Randy never got to release the album as he suffered injuries from a car crash around 1979. He would eventually recover from the accident. In 1984, he was thrust into the forefront of his brothers' Victory tour after Jackie's leg injury forced him to the sidelines. Afterwards, Randy and his brothers Jackie and Tito became renowned session musicians for other acts during this time. The trio recorded the title track to the Whoopi Goldberg film, "The Burglar", in 1987.
After the Jacksons
After one last album with the Jacksons, the group split up for good in 1990. After this split, Randy formed his own band, Randy & the Gypsys. The group only lasted one album and for the most part afterwards, like most of his siblings, with the exceptions of Michael and Janet, laid low. During his brother Michael's trial on child molestation, alcohol and conspiracy charges, Randy served as one of his consultants. Randy is often mistaken for American Idol judge Randy Jackson.
Dr. Howard Samuels is a recovering drug addict
dr. howard samuels psyd
Wonderland Rehab
get help from a recovering addict of cocaine and heroin?
break the bonds and choose an independent sober companionWonderland Rehab
get help from a recovering addict of cocaine and heroin?
Michael Jackson's family sought the help of Dr. Howard C. Samuels. Who is he?
Howard C. Samuels, PsyD is the co-founder and Executive Director of the Wonderland Treatment Center. Dr. Samuels opened Wonderland in the spring of 2006
dr. howard samuels psyd
Wonderland Rehab
get help from a recovering addict of cocaine and heroin?
dr. howard samuels psydWonderland Rehab
get help from a recovering addict of cocaine and heroin?
Dr. Howard Samuels psyd is known as Doc Hollywood, is said to be a favorite of celebrities because of his unconventional treatment methods at wonderland center. Don't be fooled by these methods when it is really the willingness of the addict to seek help. The more willing the addict of drugs or alcohol, the more able Dr. Samuels is of helping the addict become sober.
In very sharp contrast to Dr. samuels and wonderland rehab, Dr. sober companion is against the 12 step and group methods because of the gross affects of being in the environment of potential enablers. Just being in a room full of drug addicts is very harmful, because you can't think of anything else besides drugs, when you are in that kind of environment. Its the same for alcoholics. They are in the group with only one subject to talk about.
While the addict is in the safe haven, this is not the moment of volatility, but when they leave Wonderland Rehab and are on their own. This is when the sober companion is most important to keeping the addict sober and even more important, is keeping the addict alive. (unless we believe so called experts like Dr. drew pinsky whose own rehab facility has said, wherever you have addicts you have drugs. Dr. Sober Companion feels that rehab centers are different only in the amount of supervision given)
While dr. sober companion does not differentiate between a recovering addict or a person getting high daily, it may be another form of denial on the addicts part to hide their continued dependency.
The difference between the people in the sober business and the different forms of sober coach, sober companion, sober escort, sober driver and personal recovery assistant and whatever else people are calling themselves is that they were and are all addicts of drugs and alcohol or both, that need to constantly be drug tested and watched for relapses of their own.
dr-sober-companion is different. dr. sober companion is made up of licensed doctors who were never drug addicts or alcoholics. Peer pressure or for whatever the reason in life, they were not cursed with the problems of addiction and don't need the supervision that all other sober companions require.
Another difference of opinion is that Dr. Samuels tries to get the celebrity to feel less important, when he said: "Really getting the individual to have an understanding that it's not about them, that they are not the center of the universe. It's not about "don't you know who I am?"
While Dr. Sober companion feels that an addict can learn very destructive techniques from fellow addicts in the setting of rehab centers, they might not to return for their willingness to become sober, but instead gain new suppliers, learn about new drugs, best pill pushing doctors, and other unsaviory techniques of denial.
Dr. Samuels said of Lindsay Lohan "She's becoming a professional, unfortunately," Samuels said on The Early Show Thursday. "There are many people that we work with at wonderland that go in and out of treatment. We have so many people that have been to all the treatment centers. And that's part of the process. So you can go at them harder because they've already been in so many treatment centers that you can start to identify their arrogance and their entitlement much more."
While Dr. Samuels has said of famous addicts like lindsay lohan: "Lohan will likely participate in group therapy, individual therapy and 12-step meetings." He follows the treatment plan of group therapy and 12 step amongst his wonderland rehab methods.
In very sharp contrast to Dr. samuels and wonderland rehab, Dr. sober companion is against the 12 step and group methods because of the gross affects of being in the environment of potential enablers. Just being in a room full of drug addicts is very harmful, because you can't think of anything else besides drugs, when you are in that kind of environment. Its the same for alcoholics. They are in the group with only one subject to talk about.
While the addict is in the safe haven, this is not the moment of volatility, but when they leave Wonderland Rehab and are on their own. This is when the sober companion is most important to keeping the addict sober and even more important, is keeping the addict alive. (unless we believe so called experts like Dr. drew pinsky whose own rehab facility has said, wherever you have addicts you have drugs. Dr. Sober Companion feels that rehab centers are different only in the amount of supervision given)
While dr. sober companion does not differentiate between a recovering addict or a person getting high daily, it may be another form of denial on the addicts part to hide their continued dependency.
The difference between the people in the sober business and the different forms of sober coach, sober companion, sober escort, sober driver and personal recovery assistant and whatever else people are calling themselves is that they were and are all addicts of drugs and alcohol or both, that need to constantly be drug tested and watched for relapses of their own.
dr-sober-companion is different. dr. sober companion is made up of licensed doctors who were never drug addicts or alcoholics. Peer pressure or for whatever the reason in life, they were not cursed with the problems of addiction and don't need the supervision that all other sober companions require.
DENIAL
Because of denial, most addicts refuse rehab so that is why a sober companion is of most importance. Its like going to rehab, because you get many of the same benefits, without learning from other addicts on how to become a greater addict.Another difference of opinion is that Dr. Samuels tries to get the celebrity to feel less important, when he said: "Really getting the individual to have an understanding that it's not about them, that they are not the center of the universe. It's not about "don't you know who I am?"
Why do addicts try different rehab centers besides wonderland?
While Dr. Sober companion feels that an addict can learn very destructive techniques from fellow addicts in the setting of rehab centers, they might not to return for their willingness to become sober, but instead gain new suppliers, learn about new drugs, best pill pushing doctors, and other unsaviory techniques of denial.
Dr. Samuels said of Lindsay Lohan "She's becoming a professional, unfortunately," Samuels said on The Early Show Thursday. "There are many people that we work with at wonderland that go in and out of treatment. We have so many people that have been to all the treatment centers. And that's part of the process. So you can go at them harder because they've already been in so many treatment centers that you can start to identify their arrogance and their entitlement much more."
if you had enough of the rehab facility when you left or were asked to leave, then break your bonds of addiction to them and try dr. sober companion.
dr. sober companion is not controlled by the rehab facility and does not give kickbacks for continuing to keep people addicted to them.
Is replacemt therapy the immedate cure?
The main ingredient that some rehab centers and sober companions that work with the rehab centers use for an immediate cure for a drug and alcohol addict is to feed them another prescription to replace the original addiction. this is known as the replacement therapy
dr. sober companion, what do you mean: "replace my addiction with another addiction?"
For instance, if you are addicted to drugs and alcohol, there is a technique used called replacement therapy, which simply means replace one addiction with a pharmaceutical replacement, that is every bit as addictive as the original.
Some of these replacement medications are:
- Suboxone
- Naltrexone
The rehab center or sober companion associated with a rehab center and its medical physician will place you on these replacement therapies to control your addiction, ease discomfort from cravings during withdrawal and other psychiatric medications where indicated for treatment of co-occurring disorders.
(They are every bit as addictive as what they are replacing.)
why begin the cycle of addiction again?
This is not really a cure for your addiction, nor is it recommended if you really want to end your addiction to pharmaceuticals, medications, or drugs or even alcohol. The pharmaceutical versions that control your cravings are every bit as strong and works on the same part of your brain as the drugs you became addicted to originally. Its no cure, its just a replacement.
how is dr. sober companion different?
dr. sober companion is not interested in replacing one addiction with another addiction, that may be worse than the original, and much easier to get.
why is dr. sober companion's approach unpredictable?
dr. sober companion uses a different approach that is more realistic to a natural reaction that might cause you to seek your drugs or alcohol, but you don't. Its this real life experience, that dr. sober works on. its the unpredictable life experience that dr. sober companion prepares you for.
How is dr. sober companion going to stop me from my addictions?
dr. sober companion teaches how to react to an unpredictable lifestyle, that could be filled with stress and psychological trauma. Its how you react and are taught to react to these situations, that cure you of them. This is how dr. sober gets you through your life one day at a time.
note: while dr. sober companion cannot go into details on how he preforms the unpredictable method in this blog, because this is the secret dr. sober companion's method. This method is reserved for dr. sober companion clients only.
The difference between the different forms of sober coach, sober companion, sober escort, sober driver and personal recovery assistant and whatever else people are calling themselves is that they were and are all addicts of drugs and alcohol or both, that need to constantly be drug tested and watched for relapses of their own.
dr-sober-companion is different. dr. sober companion is made up of licensed doctors who were never drug addicts or alcoholics. Peer pressure or for whatever the reason in life, they were not cursed with the problems of addiction and don't need the supervision that all other sober companions require.
The following is actual experts from sober companion websites:
Why do so many drug addicts and alcoholics think they make great sober companions?
Why do so many drug addicts and alcoholics think they make great sober coach?
Why do so many drug addicts and alcoholics think they make great sober escorts?
Why do so many drug addicts and alcoholics think they make great sober drivers?
Why do so many drug addicts and alcoholics think they make great personal recovery assistant and whatever else these people are calling themselves?
But a bigger question is: Why are you choosing them?
Another drug addict and alcoholic went into the business and is calling his brand sober soldiers.
The following is a so called experts from his sober companion website:
Paris Cronin of sober soldiers
"Paris was born in Los Angeles, California and is the son of famed REO Speedwagon lead singer Kevin Cronin. Being raised on the road and exposed to the Rock N’ Roll lifestyle at an early age contributed to his struggle with drug addiction and alcoholism. At the age of 29 Paris grew tired of the way his life was going and finally decided to take control of his future and get sober. Paris began traveling all over the world working with touring bands as a Sober Companion."
The difference between paris cronin is that he is an addict of drugs and alcohol, that need to constantly be drug tested and watched for relapses of his own. (using the teachings of alcoholics anonymous: once you are an alcoholic or drug addict, you are always a drug addict and always a alcoholic)
dr. rob tencer of dr-sober-companion, also grew up in the household of a famous rock n roll group that toured the world, and also had excessive amounts of drugs and alcohol around him, except his family would not allow him to be in the same room when this excessive behavior was going on, and would not allow anyone around him to even swear or cuss around him.
Kevin Cronin failed his son and made him into the drug addict alcoholic that he is today.
dr-sober-companion is different.
dr. sober companion is made up of licensed doctors who were never drug addicts or alcoholics. Peer pressure or for whatever the reason in life, they were not cursed with the problems of addiction and don't need the supervision that all other sober companions require.
The worst fear that the families of my patients have, is that the enablers can get into the lives of their children. At sober soldiers They are letting addicts into the lives of their clients.
The list of addicts with experience as an alcoholic and drug user are endless.
* Is that the kind of 24 hour 7 day a week supervision you want for your son?
* Is that the kind of 24 hour 7 day a week supervision you want for your daughter?
* Is that the kind of 24 hour 7 day a week supervision you want for your loved one?
* Is that the kind of 24 hour 7 day a week supervision you want for your client?
dr. sober companion is unlike the rest, we aren't addicts now and never were.
dr. sober companion is different. dr. sober companion is not an alcoholic and was never an alcoholic.
dr. sober companion starts by removing enablers from your life, including addicts that now call themselves sober companions.
contact dr. sober companion here: dr.sober@gmail.com
michael jackson death could have been prevented with sober companion.
michael jackson's death could have been prevented.
Dr. sober companion could have saved michael jackson's life. It is not to late to save the life of your son or daughter!
Here is a few techniques to prove how dr. sober companion could have saved michael jackson's life.
1. remove ALL enablers.
2. remove ALL drugs
3. remove ALL reasons for WANTING drugs
4. 24 hour supervision (to insure total compliance)
2. remove ALL drugs
3. remove ALL reasons for WANTING drugs
4. 24 hour supervision (to insure total compliance)
5. other proprietary method's
A typically Hollywood invention, a 'sober companion' aka 'sober coach', is a trained professional who accompanies a patient full-time to ensure they stay off drugs. They administer random drug tests and liaise with psychiatrists and other doctors to keep the patient DRUG FREE and sober.
dr. sober companion could have saved michael jackson's life!
Monday, July 20, 2009
Michael Jackson agreed to have a Sober Companion right before his death. Was it with dr. sober companion?
The bombshell that NBC Today show missed, was that dr. sober companion was hired to be the sober companion for Michael Jackson London tour
Because dr. sober companion respects the request for privacy for his clients, he would not confirm or deny the report to NBC today show reporters, when he was interviewed.
NBC Today show missed the boat with their segment with Dr. Rob Tencer, by instead following a drug addict as he went undercover to a medical doctors office, and deleted all but one sentence of Dr. Rob Tencer's interview. "They told me they had their agenda, and that the work of a sober companion was unimportant to them. They only wanted to know about drug use of celebrities." said Dr. Rob Tencer of dr. sober companion.
dr. sober companion dr. rob tencer dc, bswas he hired by Jackson family?
While the examiner mentioned rehab and other forms of replacement therapies, it seemed to veer away from the usefulness of a sober companion.
While most families that are part of the entourages are enabling the drug addict, they are all in denial. Dr. Sober Companion has mentioned this many times before and last discussed denial while mentioning the high functioning drug addict and the high functioning alcoholic.
Dr. Rob Tencer wrote about Ms. Sarah Allen Benton's book: Understanding the High-Functioning Alcoholic: Professional Views and Personal Insights
which covers denial very clearly as a main reason for avoiding the help that the addicts really need, to stay alive.
Dr. Sober Companion was featured 7/10/2009 on the #1 morning show in the USA, NBC The Today Show, in a special story called: "Undercover: Prescription meds in Hollywood". The video is available online from NBC entitled: "Undercover: getting drugs in Hollywood". The description of the segment on the NBC site is "Video: TODAY examines how easy it is for people with cash to get drugs."
Shamed reality starmedical Dr. Drew Pinsky
of Celebrity Rehab
The real Michael Jackson bombshell story was that Michael Jackson was in complete denial. To the end he remained adamant that he did not have a drug problem. Sources report that although he continued to deny any drug abuse, he did agree to honor the wishes of his family that he bring a “sober companion” with him for the London tour.
What could a sober companion do to keep michael jackson alive that other methods could not?
This was and is the true bombshell that while it is to late to hire a dr. sober companion for Michael Jackson, it is not to late to hire a dr. sober companion for your son or daughter. Are you in denial?
Sunday, July 19, 2009
michael jackson bombshell discovery is a warning to pharmaceutical companies
many drugs are not safe and effectiveIn march 2009, it was discovered that the FDA has changed its position on state tort law, which may mean that pharmaceutical companies can now be sued without being able to hide behind federal law.
While the blame game continues, and nobody except dr. sober companion points finger at pharmaceutical companies, it has been discovered that the pharmaceutical companies can no longer hide behind FDA warning labels, which made them teflon coated until Wyeth v. Levine appeared in the supreme court of the united states.
Michael Jackson, Heath ledger, Anna Nicole Smith and millions of non famous people may now point a dead finger at pharmaceutical companies because we are not talking about street drugs like heroine and cocaine, but instead their pharmaceutical counterparts, which are as easily available as ordering a pizza and commonly available at your nearest pharmacy.
While Levine also went after the doctors for malpractice, it did not stop with them.
3Respondent sued her physician, physician’s assistant, and hospital for malpractice. After the parties settled that suit for an undisclosed sum, respondent’s physician sent her a letter in which he admitted “responsibility” for her injury and expressed his “profoun[d] regre[t]” and “remors[e]” for his actions. 1 Tr. 178–179 (Mar. 8, 2004) (testimonyof Dr. John Matthew); see also App. 102–103 (testimony of physician’sassistant Jessica Fisch) (noting that her “sense of grief” was so “great” that she “would have gladly cut off [her own] arm” and given it torespondent). Thereafter, both the physician and the physician’s assistant agreed to testify on respondent’s behalf in her suit against Wyeth.
The significance of the supreme court ruling is that the blame game can now include pharmaceutical companies and not just the doctors who administered the drugs. I think the only reason people never thought of this before was that pharmaceutical companies were largely untouchables.
Wyeth (a pharmaceutical company), filed a motion for summary judgment, arguing that Levine’s failure-to-warn claims were pre-empted by federal law.
Just because a drug is FDA approved, and has a federal law approved warning label, this does not mean the drug won't kill you.
If a drug kills enough people, it is taken off the market, however if it is because of overdose, it is blamed on the person taking it. If a drug causes distinct negative side effects, those are added to the micro sized small print. Is this adequate to save lives? Dr. sober companion says this is not adequate to save lives.
The following is exerted from Wyeth v. Levine
Petitioner Wyeth manufactures the antinausea drug Phenergan. After a clinician injected respondent Levine with Phenergan by the “IV-push” method, whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state-law damages action, alleging, inter alia, that Wyeth had failed to provide an ade-quate warning about the significant risks of administering Phener-gan by the IV-push method. The Vermont jury determined that Le-vine’s injury would not have occurred if Phenergan’s label includedan adequate warning, and it awarded damages for her pain and suf-fering, substantial medical expenses, and loss of her livelihood as aprofessional musician. Declining to overturn the verdict, the trial court rejected Wyeth’s argument that Levine’s failure-to-warn claimswere pre-empted by federal law because Phenergan’s labeling hadbeen approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.
Wyeth’s argument that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions is meritless because it relies on an untenable interpretation of con-gressional intent and an overbroad view of an agency’s power to pre-empt state law. The history of the FDCA shows that Congress didnot intend to pre-empt state-law failure-to-warn actions. In advanc-ing the argument that the FDA must be presumed to have estab-lished a specific labeling standard that leaves no room for different state-law judgments, Wyeth relies not on any statement by Congress but on the preamble to a 2006 FDA regulation declaring that state-law failure-to-warn claims threaten the FDA’s statutorily prescribed role.
The warnings on Phenergan’s label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth’s new drug application in 1955 and when it later approved changes inthe drug’s labeling. The question we must decide is whether the FDA’s approvals provide Wyeth with a com-plete defense to Levine’s tort claims. We conclude that they do not.
---------------------------
I don't know if you understand the significance of this supreme court ruling, so let me try to explain in more detail.
Wyeth lawyers made it clear the blame game has changed when it argued that recognition of Levine’s state tort action creates an unacceptable “obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” Hines v. Davidowitz, 312 U. S. 52, 67 (1941), because it substitutes a lay jury’s decision about drug labeling for the expert judgment of the FDA.
Do you now begin to see the layers of government protection that was afforded the pharmaceutical companies? Do you begin to see lobbying efforts, and the billions of dollars that went into paying off congress for their votes. The government protection afforded them is now unravelling before our eyes.
Indeed, prior to 2007, the FDA lacked the authority toorder manufacturers to revise their labels. See 121 Stat. 924–926. When Congress granted the FDA this authority,it reaffirmed the manufacturer’s obligations and referred specifically to the CBE regulation, which both reflects the manufacturer’s ultimate responsibility for its label and provides a mechanism for adding safety information to the label prior to FDA approval. See id., at 925–926 (stating that a manufacturer retains the responsibility “to main-tain its label in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and
601.12 of title 21, Code of Federal Regulations
We also learn from this case that the pharmaceutical companies try to blame the doctor as noted here: Nevertheless, the jury rejected Wyeth’s argument that the clinician’s conduct was an intervening cause that absolved it of liability. See App.234 (jury verdict), 252–254. In finding Wyeth negligent as well as strictly liable,
federal law and FDA labeling
In order to identify the “purpose of Congress,” it is ap-propriate to briefly review the history of federal regulation of drugs and drug labeling. In 1906, Congress enacted itsfirst significant public health law, the Federal Food andDrugs Act, ch. 3915, 34 Stat. 768. The Act, which prohib-ited the manufacture or interstate shipment of adulter-ated or misbranded drugs, supplemented the protection for consumers already provided by state regulation and common-law liability. In the 1930’s, Congress becameincreasingly concerned about unsafe drugs and fraudulent marketing, and it enacted the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended,21 U. S. C. §301 et seq. The Act’s most substantial innova-tion was its provision for premarket approval of new drugs. It required every manufacturer to submit a newdrug application, including reports of investigations and specimens of proposed labeling, to the FDA for review.Until its application became effective, a manufacturer was prohibited from distributing a drug. The FDA could reject an application if it determined that the drug was not safe for use as labeled, though if the agency failed to act, anapplication became effective 60 days after the filing. FDCA, §505(c), 52 Stat. 1052.
In 1962, Congress amended the FDCA and shifted the burden of proof from the FDA to the manufacturer. Before 1962, the agency had to prove harm to keep a drug out of the market, but the amendments required the manufac-turer to demonstrate that its drug was “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling” before it could distribute the drug. §§102(d), 104(b), 76 Stat. 781, 784. In addition, the amendments required the manufacturer to prove thedrug’s effectiveness by introducing “substantial evidencethat the drug will have the effect it purports or is repre-sented to have under the conditions of use prescribed,recommended, or suggested in the proposed labeling.” §102(d), id., at 781.
As it enlarged the FDA’s powers to “protect the public health” and “assure the safety, effectiveness, and reliabil-ity of drugs,” id., at 780, Congress took care to preserve state law. The 1962 amendments added a saving clause,indicating that a provision of state law would only be invalidated upon a “direct and positive conflict” with theFDCA. §202, id., at 793. Consistent with that provision,state common-law suits “continued unabated despite . . . FDA regulation.” Riegel v. Medtronic, Inc., 552 U. S. ___, ___ (2008) (slip op., at 8) (GINSBURG, J., dissenting); see ibid., n. 11 (collecting state cases). And when Congressenacted an express pre-emption provision for medicaldevices in 1976, see §521, 90 Stat. 574 (codified at 21
U. S. C. §360k(a)), it declined to enact such a provision for prescription drugs.
In 2007, after Levine’s injury and lawsuit, Congressagain amended the FDCA. 121 Stat. 823. For the first time, it granted the FDA statutory authority to require amanufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval. §901(a), id., at 924–926. In doing so, however,Congress did not enact a provision in the Senate bill thatwould have required the FDA to preapprove all changes todrug labels. See S. 1082, 110th Cong., 1st Sess., §208, pp. 107–114 (2007) (as passed) (proposing new §506D).Instead, it adopted a rule of construction to make it clearthat manufacturers remain responsible for updating their labels. See 121 Stat. 925–926.
See De la Cuesta, 458 U. S., at
153. The FDA’s premarket approval of a new drug appli-cation includes the approval of the exact text in the pro-posed label. See 21 U. S. C. §355; 21 CFR §314.105(b) (2008). Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemen-tal application. There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency’s approval. Among otherthings, this “changes being effected” (CBE) regulation provides that if a manufacturer is changing a label to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instructionabout dosage and administration that is intended to in-crease the safe use of the drug product,” it may make thelabeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval. §§314.70(c)(6)(iii)(A), (C).
As the FDA ex-plained in its notice of the final rule, “‘newly acquired information’” is not limited to new data, but also encom-passes “new analyses of previously submitted data.” Id., at 49604. The rule accounts for the fact that risk informa-tion accumulates over time and that the same data maytake on a different meaning in light of subsequent devel-opments: “[I]f the sponsor submits adverse event informa-tion to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severityor frequency than did reports previously submitted toFDA, the sponsor meets the requirement for ‘newly ac-quired information.’” Id., at 49607; see also id., at 49606.
Wyeth suggests that the FDA, rather than the manufacturer, bears primary re-sponsibility for drug labeling. Yet through many amend-ments to the FDCA and to FDA regulations, it has re-mained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of itslabel at all times. It is charged both with crafting anadequate label and with ensuring that its warnings re-main adequate as long as the drug is on the market.
why can't FDA adopt the same warning labels as required by tobacco industry?
In 1962, Congress amended the FDCA and shifted the burden of proof from the FDA to the manufacturer. Before 1962, the agency had to prove harm to keep a drug out of the market, but the amendments required the manufac-turer to demonstrate that its drug was “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling” before it could distribute the drug. §§102(d), 104(b), 76 Stat. 781, 784. In addition, the amendments required the manufacturer to prove thedrug’s effectiveness by introducing “substantial evidencethat the drug will have the effect it purports or is repre-sented to have under the conditions of use prescribed,recommended, or suggested in the proposed labeling.” §102(d), id., at 781.
As it enlarged the FDA’s powers to “protect the public health” and “assure the safety, effectiveness, and reliabil-ity of drugs,” id., at 780, Congress took care to preserve state law. The 1962 amendments added a saving clause,indicating that a provision of state law would only be invalidated upon a “direct and positive conflict” with theFDCA. §202, id., at 793. Consistent with that provision,state common-law suits “continued unabated despite . . . FDA regulation.” Riegel v. Medtronic, Inc., 552 U. S. ___, ___ (2008) (slip op., at 8) (GINSBURG, J., dissenting); see ibid., n. 11 (collecting state cases). And when Congressenacted an express pre-emption provision for medicaldevices in 1976, see §521, 90 Stat. 574 (codified at 21
U. S. C. §360k(a)), it declined to enact such a provision for prescription drugs.
In 2007, after Levine’s injury and lawsuit, Congressagain amended the FDCA. 121 Stat. 823. For the first time, it granted the FDA statutory authority to require amanufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval. §901(a), id., at 924–926. In doing so, however,Congress did not enact a provision in the Senate bill thatwould have required the FDA to preapprove all changes todrug labels. See S. 1082, 110th Cong., 1st Sess., §208, pp. 107–114 (2007) (as passed) (proposing new §506D).Instead, it adopted a rule of construction to make it clearthat manufacturers remain responsible for updating their labels. See 121 Stat. 925–926.
See De la Cuesta, 458 U. S., at
153. The FDA’s premarket approval of a new drug appli-cation includes the approval of the exact text in the pro-posed label. See 21 U. S. C. §355; 21 CFR §314.105(b) (2008). Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemen-tal application. There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency’s approval. Among otherthings, this “changes being effected” (CBE) regulation provides that if a manufacturer is changing a label to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instructionabout dosage and administration that is intended to in-crease the safe use of the drug product,” it may make thelabeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval. §§314.70(c)(6)(iii)(A), (C).
As the FDA ex-plained in its notice of the final rule, “‘newly acquired information’” is not limited to new data, but also encom-passes “new analyses of previously submitted data.” Id., at 49604. The rule accounts for the fact that risk informa-tion accumulates over time and that the same data maytake on a different meaning in light of subsequent devel-opments: “[I]f the sponsor submits adverse event informa-tion to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severityor frequency than did reports previously submitted toFDA, the sponsor meets the requirement for ‘newly ac-quired information.’” Id., at 49607; see also id., at 49606.
Wyeth suggests that the FDA, rather than the manufacturer, bears primary re-sponsibility for drug labeling. Yet through many amend-ments to the FDCA and to FDA regulations, it has re-mained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of itslabel at all times. It is charged both with crafting anadequate label and with ensuring that its warnings re-main adequate as long as the drug is on the market.
why can't FDA adopt the same warning labels as required by tobacco industry?
But the trial court and the Vermont SupremeCourt found that the 1988 warning did not differ in any materialrespect from the FDA-approved warning. See ___ Vt. ___, ___, 944
A. 2d 179, 189 (2006) (“Simply stated, the proposed warning was different, but not stronger. It was also no longer or more prominent than the original warning . . .”); App. 248–250. Indeed, the United States concedes that the FDA did not regard the proposed warning as substantively different: “[I]t appears the FDA viewed the change as non-substantive and rejected it for formatting reasons.” Brief for United States as Amicus Curiae 25; see also ___ Vt., at ___, 944 A. 2d, at 189.
A. 2d 179, 189 (2006) (“Simply stated, the proposed warning was different, but not stronger. It was also no longer or more prominent than the original warning . . .”); App. 248–250. Indeed, the United States concedes that the FDA did not regard the proposed warning as substantively different: “[I]t appears the FDA viewed the change as non-substantive and rejected it for formatting reasons.” Brief for United States as Amicus Curiae 25; see also ___ Vt., at ___, 944 A. 2d, at 189.
what does this mean as far as the blame game?
7Although the first version of the bill that became the FDCA would have provided a federal cause of action for damages for injured consum-ers, see H. R. 6110, 73d Cong., 1st Sess., §25 (1933) (as introduced), witnesses testified that such a right of action was unnecessary because common-law claims were already available under state law. See Hearings on S. 1944 before a Subcommittee of the Senate Committee on Commerce, 73d Cong., 2d Sess., 400 (1933) (statement of W. A. Hines); see id., at 403 (statement of J. A. Ladds) (“This act should not attempt to modify or restate the common law with respect to personalinjuries”). 8In 1997, Congress pre-empted certain state requirements concerningover-the-counter medications and cosmetics but expressly preservedproduct liability actions. See 21 U. S. C. §§379r(e), 379s(d) (“Nothing inthis section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of anyState”).
additional notes:
during his closing argument, respondent’s attorney told the jury, “Thank God we don’t rely on the FDA to . . . make the safe[ty] decision.You will make the decision. . . . The FDA doesn’t make the decision, you do,” id., at 211–212.2
Alito commented: Federal law, however, does rely on the FDA to make safety determinations like the one it made here.
But turning a common-law tort suitinto a “frontal assault” on the FDA’s regulatory regime for drug labeling upsets the well-settled meaning of the Supremacy Clause and our conflict pre-emption jurisprudence. Brief for United States as Amicus Curiae 21.
---------------
more notes:
They try to solve that problem with helpful politicians doing by executive fiat at an agency what they could not do in Congress; for example, by placing a corporate immunity clause in the preamble of an FDA rule that says if a drug is FDA approved, you can't sue. Thus, drug companies ask the courts to imply that preemption exists even though it was not expressly legislated.
Next up is from the Center for Justice and Democracy, a consumer rights group dedicated to preserving the civil justice system. They issued a report today: THE BITTEREST PILL -- How Drug Companies Fail To Protect Women and How Lawsuits Save Their Lives. The report, according to the authors, "tells the story of the hyped marketing to women of a disproportionate number of unsafe drugs and devices resulting in countless deaths and injuries." As you may guess, they aren't too keen on immunity being granted to a company that was negligent, and whose negligence injured people. It's part of that whole personal responsibility thing that conservatives usually talk about, except when it comes to big business.
In piecing together the emails from the FOIAs, AAJ uncovered the cozy relationship between federal officials and the industries they regulate. For example, the pharmaceutical industry intensified its efforts to influence the FDA in the months leading up to the physician labeling rule's release on January 24, 2006. Much of the lobbying efforts were aimed at Sheldon Bradshaw, who had succeeded Daniel Troy as FDA chief counsel in April 2005.
AAJ obtained emails that list attendees of a meeting between Bradshaw and the Pharmaceutical Research and Manufacturers of America (PhRMA) revealing the FDA chief counsel met with legal representatives from Pfizer, Wyeth, Eli Lilly, Berlex, Organon, Abbott Laboratories, Takeda, Sanofi-Aventis, Serono, AstraZeneca, Cephalon, Millenium, Eisai, Amgen, Astellas, GlaxoSmithKline, Bristol Myers Squibb, Johnson & Johnson, Novartis, Merck, and 3M.
Less than six months after this meeting, the agency would release its final physician labeling rule with complete immunity preemption language in the preamble, a complete about-face from the language in the proposed rule that specifically said the agency did not intend to preempt state law with the rule.
"Big business lobbyists have been on a crusade to destroy state consumer protection laws, and further stack the deck against American consumers," said Weisbrod.
Saturday, July 18, 2009
corrections in the michael jackson functioning drug addict story
Sarah Allen Benton, the author of "Understanding the High-Functioning Alcoholic: Professional Views and Personal Insights" wrote us with some corrections of an earlier post, which we agreed to correct on this blog.
Sarah Allen Benton describes high-functioning alcoholics as people who are able to maintain respectable, even high-profile lives. That balancing act continues until something dreadful happens that reveals the truth and forces the person to enter a treatment program or lose everything that means anything. (Including their life. Think michael jackson or heath ledger).
While Ms. Benton agreed that there are similarities between high functioning alcoholics and a high functioning drug addict, she never implied anything about michael jackson, his drug addiction, or symptoms of a functioning drug addict nor the way a drug addict reveals their addiction to their friends, family or the public, nor anything to do with michael jackson molestation charges.
Ms. Benton did say that the functioning alcoholic sometimes reveals their addiction or gets exposed for having made inappropriate sexual advances. (dr. sober companion drew a conclusion from this statement to try to connect the two together.)
Ms. Benton identifies herself as a recovering alcoholic with an addiction problem (not to drugs), while Dr. sober Companion is Dr. Rob Tencer DC, BS, whom never was a drug addict and never had problems with alcohol.
To our knowledge, Dr. Sober Companion is the only sober companion to have never been a drug addict or alcoholic, which also means he will never be an enabler to your son or daughter.
In retrospect, I was trying to hit people over the head with the similarities, and went a little to far to demonstrate the connections between high functioning alcoholics as described in "Understanding the High-Functioning Alcoholic: Professional Views and Personal Insights", and the Michael Jackson high functioning drug addiction. For that, I apologize.
This is a very emotional topic for me and my passion for speaking against enablers got the best of me. How could the michael jackson entourage of family, friends, doctors and staff not see the signs of drug addiction? That is why enablers must be completly removed from the lives of people you are trying to save.
" wrote us with some corrections of an earlier post, which we agreed to correct on this blog.Sarah Allen Benton describes high-functioning alcoholics as people who are able to maintain respectable, even high-profile lives. That balancing act continues until something dreadful happens that reveals the truth and forces the person to enter a treatment program or lose everything that means anything. (Including their life. Think michael jackson or heath ledger).
While Ms. Benton agreed that there are similarities between high functioning alcoholics and a high functioning drug addict, she never implied anything about michael jackson, his drug addiction, or symptoms of a functioning drug addict nor the way a drug addict reveals their addiction to their friends, family or the public, nor anything to do with michael jackson molestation charges.
Ms. Benton did say that the functioning alcoholic sometimes reveals their addiction or gets exposed for having made inappropriate sexual advances. (dr. sober companion drew a conclusion from this statement to try to connect the two together.)
Ms. Benton identifies herself as a recovering alcoholic with an addiction problem (not to drugs), while Dr. sober Companion is Dr. Rob Tencer DC, BS, whom never was a drug addict and never had problems with alcohol.
To our knowledge, Dr. Sober Companion is the only sober companion to have never been a drug addict or alcoholic, which also means he will never be an enabler to your son or daughter.
In retrospect, I was trying to hit people over the head with the similarities, and went a little to far to demonstrate the connections between high functioning alcoholics as described in "Understanding the High-Functioning Alcoholic: Professional Views and Personal Insights
", and the Michael Jackson high functioning drug addiction. For that, I apologize.This is a very emotional topic for me and my passion for speaking against enablers got the best of me. How could the michael jackson entourage of family, friends, doctors and staff not see the signs of drug addiction? That is why enablers must be completly removed from the lives of people you are trying to save.
michael jackson doctors like conrad murray must take fall for pharmaceutical companies to continue its drug addiction unfettered.
Michael Jackson's last doctor on record Dr. Conrad Murray
(unless you count the coroner Dr. Quincy)
Can someone please explain to the sober companion audience of this blog, why the michael jackson death is a wake up call that should put all blame (or most of it) on the pharmaceutical industry and government, and not on the doctor, and write it in simple english?
This can be answered in a simple answer. The pharmaceutical companies spend billions of dollars to bribe the government, that they are not to blame. So far it has been working!
If we were looking at a food chain we would start with phamaceutical industry at the top, then government, then doctor, then pharmacist, then you. Somewhere in there we should throw in massive marketing and lobbying campaign.
People injured by drugs are blocked from getting in justice by trial, because government blocks blame with FDA road blocks.
(unless you count the coroner Dr. Quincy)
When we last wrote about Michael Jackson's on call doctor, Dr. Conrad Murray, it looked as if he was off the hook because he was cooperating with the homicide investigation of Michael Jackson.
While there will be countless fake and real names found on the pill bottle prescriptions found at the homicide scene of michael jackson, the only real incriminating name is of doctors who supplied the pharmaceutical prescription drugs. This is a witch hunt of blame, where anyone of the entourage could be to blame as much as the doctors giving the prescriptions. (think howard k. stern)
Everyone wants to know which doctors names were uncovered in evidence during Michael Jackson child molestation supeonea of evidence on the premises of neverland ranch, which included syringes and pill bottles with prescription information on them which also included the doctor who prescribed them. Did Debbie Rowe say to much about the syringes and injections?
Everyone wants to know the following:
While there will be countless fake and real names found on the pill bottle prescriptions found at the homicide scene of michael jackson, the only real incriminating name is of doctors who supplied the pharmaceutical prescription drugs. This is a witch hunt of blame, where anyone of the entourage could be to blame as much as the doctors giving the prescriptions. (think howard k. stern)
Everyone wants to know which doctors names were uncovered in evidence during Michael Jackson child molestation supeonea of evidence on the premises of neverland ranch, which included syringes and pill bottles with prescription information on them which also included the doctor who prescribed them. Did Debbie Rowe say to much about the syringes and injections?
Dr. Sober Companion is Dr. Rob Tencer DC, BS. A licensed Doctor of Chiropractic who believes in abstinence of drugs from the perspective of a drug addict. You can not get abstinence from being around enablers, entourage, parents, friends. A good source to hang around is dr. sober companion.
The question I hope to answer:
Can someone please explain to the sober companion audience of this blog, why the michael jackson death is a wake up call that should put all blame (or most of it) on the pharmaceutical industry and government, and not on the doctor, and write it in simple english?
This can be answered in a simple answer. The pharmaceutical companies spend billions of dollars to bribe the government, that they are not to blame. So far it has been working!
If we were looking at a food chain we would start with phamaceutical industry at the top, then government, then doctor, then pharmacist, then you. Somewhere in there we should throw in massive marketing and lobbying campaign.
People injured by drugs are blocked from getting in justice by trial, because government blocks blame with FDA road blocks.
What does this all mean to the michael jackson homicide investigation and you?
If someone like Michael Jackson has a personality trait that is easily addicted to things like prescription pharmaceuticals (drug addiction), plastic surgery addiction, can you blame the doctor?
This addiction sounds very much like the argument against the tobacco industry and addictive qualities of nicotine. We know that the tobacco industry knew of the addiction and the death it caused and the eventual outcome of the battle that took at least twenty years to win.
The point is, stop pointing the finger at the doctor and go after the real criminal which is none other than the pharmaceutical industry.
Yes, a doctor can be negligent, but the risk of what they administer is in the small print.
(do you know what happened to the small print in tobacco?)
the small print became MUCH EASIER TO READ
Proper warning labels
Improper warning labelsThe argument against pharmaceutical and government (FDA)
Lawsuits, industry advocates say, can expose drug makers to a conflicting hodgepodge of jury decisions in multiple state courts that often contradict the expert judgment of the FDA when it decides what warnings belong on a drug label. The FDA-approved label, they argue, should trump the findings of juries who lack the same expertise. Wyeth and its supporters want the high court to rule that the FDA's powers pre-empt state court lawsuits that claim stricter drug warnings were needed.
That logic is known as the pre-emption argument, which maintains that the federal government has the last word on drug labeling. And, therefore, government warnings override legal challenges after a drug has been approved. (Bernadette Tansey, San Francisco Chronicle)
Information obtained by Representative Henry Waxman (D., CA) show that neither FDA staffers nor FDA experts agree with the pre-emption position of the White House administration:
That logic is known as the pre-emption argument, which maintains that the federal government has the last word on drug labeling. And, therefore, government warnings override legal challenges after a drug has been approved. (Bernadette Tansey, San Francisco Chronicle)
Information obtained by Representative Henry Waxman (D., CA) show that neither FDA staffers nor FDA experts agree with the pre-emption position of the White House administration:
"We know that many currently approved drug labels are out of date and in many cases contain incorrect information," the committee report quoted top FDA official Dr. John Jenkins as saying in a 2003 internal policy memo.
What makes the whole thing especially outrageous is that the FDA now requires approval to change a warning label when new adverse event information becomes known to the manufacturer. In previous administrations the FDA actually encouraged drug makers to update their labels immediately.
A recent Supreme Court decision upheld federal pre-emption clauses in legislation for medical devices, but this language isn't in the same statutes concerning drugs. Nevertheless, Big Pharma and the white house administration argue it is "implied."
There is now a developing consensus, even amongst in the public health establishment that FDA is a broken agency. Thus to maintain that this hollow husk of a regulatory agency's warning labels is all we need to protect consumers is a very cruel joke.
Friday, July 17, 2009
how do prescription drugs get in your medicine cabinet?
How do prescription drugs get in your medicine cabinet?
Drug czar Richard Gil KerlikowskeThe drug czar Richard Gil Kerlikowske of the United States Office of National Drug Control policy, recently went on record by deflecting blame by pharmaceutical companies for drug addiction and over dose deaths and instead placing the blame solely on the parents.
Dear drug czar. Maybe you can answer these questions, if you really blame the parents?
How many millions of dollars are required to get a highly addictive drug FDA approved?
How many drugs show up in the pharmacy that are not FDA approved?
How do pharmaceutical drugs get to the pharmacy?
How many times have you heard the drugs side effect is more beneficial than what it was created for?
Drugs like viagra were not meant for erectile disfunction, but as a heart medication. The same for rogaine for hair growth, etc...
Is it possible that highly addictive drugs masqueraded as LIFE SAVING pharmaceuticals, but the SECRETLY KNOWN use was for very different reasons and the another secretly known side effect is to get people ADDICTED.
We now know that tobacco industry knew about addiction and increased levels of nicotine to keep people addicted. They also knew about the continued use causing cancer and painful deaths.
How many people will need to die of prescription drugs before our government puts an end to this?
The problem of prescription drugs might be blamed on parents, but not for the same reasons people think. (Read Dr. Sober's blog on what the parents are really to blame for.)
The real problem is thinking that pharmaceutical companies who spend billions to addict you are not to blame.
Another addiction people have:
Think of petrol / gas for your auto. The monopoly addiction is when you can't get from point A to point B without buying gas for your automobile. Can't the governments change to a different fuel that we are not so addicted to?
This is the same reason that pharmaceutical companies can't possibly be blamed.
They give to much money in their lobbying efforts to the politicians in government.
Another example is when you watched me on NBC today with my anti drug message, some of the commercials shown at the break were for pharmaceutical prescription drugs. Does NBC have any ethics at all?
The correction of prescription drugs starts when politicians and media stop taking blood money from pharmaceutical companies that addict and kill people by the millions.
A Sober Companion might be the answer to saving your childrens lives, if you don't really think the medicine cabinet is to blame.
Sunday, July 12, 2009
NBC deletes Michael Jackson drug addiction bombshell interview to risk actors life
Dr. Rob Tencer on NBC Today Show
July 10, 2009
July 10, 2009
Dr. Sober Companion was featured this morning on the #1 morning show in the USA, NBC The Today Show, in a special story called: "Undercover: Prescription meds in Hollywood". The video is available online from NBC entitled: "Undercover: getting drugs in Hollywood". The description of the segment on the NBC site is "Video: TODAY examines how easy it is for people with cash to get drugs."
The Truth behind the scenes of the NBC Today Show segment
After the media request from NBC today show producers, and on a very short notice, (within 1 hour) Dr. Sober Companion and his staff hurried to get media prepared in our own wardrobe, notes and rushed to the NBC studio in Burbank, California so they could record our segment and work on other segments that eventually people backed out of.(many people backed out in fear of their life and of their medical licenses for what they were going to reveal, which would have incriminated themselves on the highest rated morning TV show in the USA.)
Dr. Sober Companion and his intake specialist Logan, (now revealed to be an actual drug addict and alcoholic named david lerman) sat side by side and gave a riveting interview of bombshell after bombshell. The NBC producer, had us give individual interviews, and would not allow us to speak as a team, and would not allow us to speak about the Dr. Sober Companion work that saves lives. They didn't seem to even care about our Michael Jackson drug addiction bombshells, and had their own agenda and set of questions.
During the interview, dr. sober companion explained in detail our technique on how we have become such experts about latest drugs and trends.
Dr. Sober Companion explained exactly what we do and why for the segment. Dr. Sober Companion explained what we do is to go undercover as a patient to the dr. feelgood offices.
Dr. Sober Companion expertly trained staff also pose as patients at rehab centers, and 12 step meetings.
The person who interviewed Logan (now revealed to be an actual drug addict and alcoholic named david lerman) and myself was so interested in this technique, that they cut my entire interview bombshell and all, into 1 sentence.
NBC Today show also cut in its entirety the interview of Logan (whom I insisted sit next to me), who dropped bombshells and made several wake up calls, that were certain to expose the truth about drug addiction in the Michael Jackson death. (Logan, now revealed to be an actual drug addict and alcoholic named david lerman)
Dr. Rob Tencer on NBC Today Show
July 10, 2009
For NBC to get the undercover operation, they hired my employee's that I originally gave them access to, but I backed out because I feared that they were risking the lives of my staff for their own agenda.
Before I backed out of the NBC undercover operation, Logan was in charge of training my staff for the undercover operation, and the staff member who continued with NBC undercover operation against the stern wishes of Dr. Sober Companion, became unemployed. (It was now revealed that Logan is an actual drug addict and alcoholic named david lerman, and was never employed by dr. sober companion, regardless of his expertise in his own drug addiction)
NBC made many promises for dr. sober companion's involvement including featuring my staff and myself and the dr. sober blog that originally gained the interest of the NBC today show producers.
The NBC producers and the reporter of the segment, constantly assured me that the blog would be shown in screen shots with the address prominently featured. NBC was dishonest, and were full of deceit by not following through with their promises. They lied to get my full cooperation.
They completely negated the message that dr. Sober stands for and the message that we know will save the lives of people who hear it.
We only ask that in any future media requests for interviews, you allow us to help save lives by spreading the dr. sober message.
Dr. Sober is available for media interviews, and can be reached by clicking below.
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