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Showing posts with label pharmaceutical. Show all posts
Showing posts with label pharmaceutical. Show all posts

Saturday, June 25, 2011

supreme court places blame on parents for generic drugs killing your children

dr. sober companion interpreted the recent supreme courts decision on generic drugs as placing the blame on parents for generic drugs killing your children.

If you agree with dr. sober companion, we welcome your comments.
If you disagree with dr. sober companion, we still want to hear from you.



If the supreme court says there is no blame on the pharmaceutical manufacturers generics killing your children, then the interpretation of dr. sober companion is that parents killed their children, because they ignored:

  • addiction properties of the generic medication
  • side effects of the generic pharmaceutical
  • warnings and dangers of generic drug use

The United States Supreme Court justices ruled 5-4 that generic drug companies do not share the same level of responsibility as makers of brand-name equivalents, to update their warning labels when significant new risks emerge. (even though most drugs bought are generic)

Your children's killers include:
  • Sonia Sotomayor
  • Stephen G. Breyer
  • Samuel A. Alito
  • Elena Kagan
  • Clarence Thomas
  • Antonin Scalia
  • Chief Justice John G. Roberts
  • Anthony Kennedy
  • Ruth Bader Ginsburg

The U.S. supreme court were split along political lines.

"It is beyond dispute that the federal statutes and regulations that apply to brand-name drug manufacturers are meaningfully different than those that apply to generic drug manufacturers," said Justice Clarence Thomas. "Indeed it is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing drugs more quickly and cheaply to the public."

In dissent, Justice Sonia Sotomayor countered, "These divergent liability rules threaten to reduce consumer demand for generics... Nothing in the court's opinion convinces me that, in enacting the requirement that generic labels match their corresponding brand-name labels, Congress intended these results."

Justices Ruth Bader Ginsburg, Stephen Breyer, and Elena Kagan supported Sotomayor.


If a generic drug for the simple condition of acid reflux, causes permanent damage to the nervous system, how much more will the damage be to your children's brain functions from the poison's you consent to giving them?

What is at stake?
How about the life of your children?

The claim is that inadequate warnings were provided about the long-term risks of taking the medicine. It was also alleged there was growing evidence of the dangers posed by the drug, but that the companies took no steps to change the warning labels.

Parents need to take responsibility for the damage and the deaths to their children, for the mood altering generic medications that they keep refilling for their children. Dr. Sober companion stresses over and over again, of the importance to seek alternatives to drug use and alternatives from medical treatments heavily biased approach to helping your children. When money is involved, the only ones who win are the pharmaceutical companies that produce the generic drugs.

Reduced price of generics is behind high use:

If a generic drug costs less than half the price of the real medication it copies, than the demand will never drop, despite the fact that the generic may kill your children faster.

If more than 70% of all drugs prescribed in the United States are filled with generics, than you should understand how big of a problem we are facing.

There are no adequate warnings or dangers that you need to be made aware of, to keep your children out of danger.

Parents must stop consenting to their children swallowing poison:


Barack Obama is to blame for cheap drug epidemic:

Obama's health care reform bill encourages greater use of generics, because of their low cost, and shows a reckless behavior of having no concern for safety.

If a lawsuit against a doctor, pharmaceutical manufacturer or even the pharmacist is diluted or abolished, by the supreme court, there is nothing to stop the epidemic of your children's death, by consenting to your children's future drug addiction, one pill at a time.

The U.S. supreme court shines light on the fact that this is not only about drug addiction, but is about the lack of dangers and warnings that the pills will cause damage.

Obama is fueling the drug epidemic:

The Obama administration is backing the pharmaceutical manufacturer's, concerned that if state lawsuits are pre-empted by federal law, that will reduce the incentive for generic drug makers to provide the most current safety information to the FDA.

dr. sober companion does not change his point of view, nor will he back down to peer pressures, when it comes to saving the lives of your children.

You must now begin to understand, that dr. sober companion was right, when he attacked the parents, who have the ultimate consent over their children as to what medications, drugs, pills, are going into the mouths or entering the body through shots.

If you, the parent have the ultimate consent, then not even the family doctor, nor the pharmacist, nor the manufacturer of the medications/poisons should be to blame.

Stop putting yourself first, and make your children your priority.

Dr. Sober Companion is available 24 hours a day and 7 days a week to help you save the life of your children.

Friday, August 20, 2010

TMZ goes easy on drug pushing medical doctor criminals

Adderall and Ritalin for your children

This post is in response to the TMZ article "ADDERALL may have unhinged.."


Dr. Sober Companion wants to know: Why is TMZ going easy on drug pushing MD's who make their prescription pad available to celebrity and wealthy addicts?

Instead of coming right out to just say that MD's who prescribe ADDERALL for the catch all attention deficit hyperactivty disorder (ADHD), which makes addicts out of children, who are required to be using to attend school, they only used the celebrity tie in, which makes the epidemic seem isolated to the rich and famous.


If Medical Doctor and teacher across the United States order it, they must know whats right for your children? Right?

WRONG !!!

While MD's keep a waiting room full of newly addicted children, the teachers just want an easy teaching job, where children are doped up on drugs, and made into young addicted zombies (yaz)

Now back to TMZ, who went lightly on the mention of MD's misdiagnosing ADDERALL drug addict celebrity convict lindsay lohan.

When situations like this arise, where the spotlight is shining on information that you are not supposed to know about; about the pharmaceutical industry coming up with ingenius fake diagnosis to push their drugs and make billions while addicting new customers every day.

Its not a misdiagnosis, but it is a fraud on the American public.

A fraud and negligence that turns your children into drug addicts while you pay for the doctor visit and the prescription that addicts your children.

Snap out of the spell that makes you think that medical doctors and teachers know whats right for your children.

The harshest reality that TMZ points out, and makes little use of, is that medical doctors know that ADDERALL is just a prescription version of coccaine or methamphetamine.

TMZ continues to point out that medical doctors also prescribe AMBIEN, so the drug addicts high on ADDERALL can get to sleep.

TMZ, you got it all wrong. Its not just an isolated bad medical diagnosis, its fraud against the american public.

Some idiots still believe that marijuana is the gateway drug.

Dear mom and dad,
Open your eyes to this fraud against you and your children. Stop the pharmaceutical companies and medical doctors from dumping drugs into your childrens mouths. You must put your foot down, once and for all.

You may have gotten the message in time to save your children before its to late.

Dr. Sober Companion is mad as hell, and needs your support against the pharmaceutical industry.

While the medical doctors are the pushers in this fraudulent scheme, and very much complicent, its the makers of these drugs that need to be stopped.

The fraud does not stop with drug makers and medical doctors.

The FDA also needs a severe scrubbing and investigation into how the deep pocketed pharmaceutical industry bribed and paid the FDA to look the other way to allowing pharmaceutical coccaine and methamphetamine
into your local Walmart, Target and Costco pharmacies?

Teachers unions as well as individual teachers are also part of the fraudulent scheme of bringing drugs into the school.

Questions for teachers:
Have you no shame?
How can you sleep at night, knowing what you did to the children?
You gave them an education in drug addiction that will stick with them for the rest of their lives.

The media has kept quiet as well, because the pharmaceutical industry is so important to their budgets. Biased media is part of the fraudulent scheme against you and your children.


Now think about scenarios like this:

Yes, the pilot who crashed the plane tested positive for drug use, but he had a prescription.

Yes, the driver that killed dozens was a drug addict, but he also had a prescription.

Yes, the children who killed their classmates and then killed themselves were on medications, but they did have a prescription.

Do you get the point that Dr. Sober Companion is trying to make? Dr. Sober Companion is trying to save your childrens life, and you from grief and guilt.

While TMZ's article only discussed ADDERALL and AMBIEN, there are drugs like ritalin that also are being prescribed to your children, and have the same effects in making your children addicted.

Dr. Sober Companion is here when you need us.

Friday, July 9, 2010

Lindsay Lohan - prescription drug user for as long as she can remember

Lindsay Lohan - prescription drug user for as long as she can remember

Its not every day that dr. sober companion has access to a random drug test of a celebrity, unless of course they are clients of dr. sober companion. It is really unbelievable the access that the press and public have to peoples private information. Then again, you lose your rights if you are arrested and convicted.

Isn't that reason enough to hire a sober companion, to keep your name out of the press, and to keep your ass out of jail? We think you will agree, that the information that websites like TMZ got on Lyndsay Lohan is way to much.

We used to rely on drug addicts to supply us with the names of the current medications of choice, but now we know that celebrities like Lyndsay Lohan are being prescribed Ambien and Adderall, and Dilaudid -- an extremely powerful painkiller ... often compared to morphine ... and even heroin.

The information that we are getting is from TMZ, who has various sources, including Lindsay Lohan's probation officer, who made a report that lists 5 drugs Lindsay Lohan is allowed to take, under the terms of probation.

The 5 drugs are:
Zoloft (antidepressant)
Trazodone (antidepressant)
Adderall (amphetamine stimulant to control ADHD)
Nexium (acid reflux)
Dilaudid (opiate pain killer) DENTAL PAIN?

Judge Marsha Revel appointed Dr. Kaushal Sharma to evaluate Lindsay Lohan, and then make recommendations to the court.

If you compare the drugs Lyndsay Lohan is allowed, to celebrities who overdosed, or just plain common drug addicts, the thing that sets them apart is access to prescriptions, ability to buy them or have someone buy for them, and ability to try and fool the public.

Enablers of celebrities, like parents and friends, will not try and stop the addict if they want to continue receiving their allowances or whatever else they get in return for looking the other way. If you consider the statement "The defendant indicates she has been on the same prescription medication for as long as she can remember.", and you consider the fact that Lyndsay is still very young and in her twenties, it must have been her mother that originally helped her obtain the prescriptions and medical care. Any minor, must have their parents permission to be treated. Why would a parent allow their child amphetamines and opiates?

Dr. sober companion will help our clients to test negative for opiates and amphetamines because we remove all drugs and alcohol and remove all replacement drugs which have the same properties as street drugs, but are much more potent. A parent must be fooling themselves if they are talked into accepting replacement therapy drugs as a way to help their children, by medical doctors. READ THE DRUG TEST! POSITIVE FOR AMPHETAMINES AND POSITIVE FOR OPIATES!

Stop being so gullible to a medical doctors recommendations that you are helping your children. The only way to test negative for drug and alcohol use is to remove everything and totally abstain.

Medical proof for prescription drug use, is a lie perpetrated by the medical industry, which is largely funded by the pharmaceutical industry.

Submitting your children to random drug tests that you know damn well beforehand that the test will be positive, is a cruel joke played on your children. Dear Parents, are you that cruel to your children?

Are you that stupid?

Sunday, December 13, 2009

does tiger woods have a drug addiction after knee surgery?

Tiger Woods Press Conference

Tiger Woods will soon need to make a press conferencce to explain the misdirection and silence for lies and deceit to the public and his family. Tiger Woods cannot have a very private life and be a famous celebrity at the same time. Does tiger woods need dr. sober companion to keep an eye on him and remove the enablers from his life? Does dr. sober companion need to go on suicide watch for tiger woods?

Tiger Woods Knee Injury caused drug addiction to painkillers

Tiger woods maybe a drug addict of pain killer pharmaceuticals, prescribed by another drug pushing medical doctor, who can't say no to a celebrity. Before and After the painful knee surgery, tiger woods may have never stopped taking the pain killers. dr. sober companion could have been called upon to help.
tiger woods leads a very private life, when he is not being televised golfing, or endorsing a product. Now, the cat is out of the bag, and he must start coming clean to his addiction to pharmaceutical drugs and pain he has caused his family because of the drugs and bad decision making.

(please note: not all of the images of knee surgery are tiger woods, but are used as an artistic explanation of how serious and painful knee surgery is. knee surgery could have lead to the primary drug addiction of tiger woods)

How did tiger woods really injure his knee?

The new york daily news first brought to the publics attention, the possibility that tiger woods might have been covering up for how is knee injury really happened, when they wrote:
"There is not a lot known about ACL injuries in golf, because it isn't common," Altchek said.
tiger woods claims to have injured himself while jogging in 2007, but experts say there could be more to the story. "You wouldn't normally hurt your ACL just jogging," said Dr. Rich D'Agostino, chief of orthopedic surgery at St. Francis Hospital and a Yankees assistant physician. "You would have to have a fall or twist."

Was tiger woods lying about his knee injury? What really happened in this cover up? How long has tiger woods been taking pain medication for the knee pain?

Mark Steinberg is an enabler

One thing is certain, and that is tiger woods agent at IMG Mark Steinberg is an enabler, who became one of the tiger woods entourage. Could Mark Steinberg, who saw his golden boy client struggle to walk and grimace with pain have taken charge and advise his client against continuing to play in pain? Thats when Mark Steinberg became an enabler, however it could have started much earlier.
The PGA are enablers

It is a known fact, that without tiger woods competing, more than half the audience won't watch. "Tiger Woods is an enormous attraction, there's no denying that". The PGA's decision to keep tiger woods playing, was the wrong decision for their super star. The PGA knew that this was tiger woods third surgery in five years on his left knee. The whole world watched tiger woods in the PGA tournaments. Tiger Woods revealed he has been playing for at least 10 months with a torn ligament in his left knee, and that he suffered a double stress fracture in his left leg two weeks before the U.S. Open. Tiger Woods didn't say anything about the torn ACL or the stress fractures, even though we all watched him limp and in clear pain. Tiger Woods wouldn't say how he was treating it, only that it was more sore as the week went on. Could this have been an indication that he was treating the pain with pharmaceutical pain killers?

The PGA could have stopped tiger woods from playing injured. But the pain intensified through the Masters, where he finished second, and Woods said the cartilage damage developed from the ACL injury. He bypassed surgery on the torn ligament April 15, hopeful that by cleaning out the cartilage he could make it through the year. What he didn't anticipate were the stress fractures as he tried to get ready for the Memorial.

What kind of medication was tiger woods on, to play with ligament damage, cartilage fragments and several fractures to his knees? The PGA could have stopped the insanity of seeing their golden boy in pain, but continued to allow him to play.

(I suddenly remember the rule of not allowing players to ride in golf carts, and how some players with disabilities sued the PGA.)

Tiger Woods Knee Surgery


June 18, 2008: On his website, Tiger Woods announced that he would undergo ACL surgery and would miss the remainder of the PGA Tour season.1
Tiger Woods Knee Surgery

Tiger Woods Knee Surgery

Tiger Woods had arthroscopic surgery on his left knee on april 15, 2008. The procedure was performed at Healthsouth Medical Center in Park City, Utah.




Tiger Woods public and private life is ruined

All drug addicts and their families know, when they are under the influence of narcotics, lives are ruined. tiger woods is no exception, and may have succumbed just as michael jackson and countless others to something that started off small, as a result of an injury, and escalated to the destruction of a career and family, let alone all the endorsement money for keeping such an apparently clean lifestyle.

tiger woods can rebound

tiger woods is young enough to bounce back, and continue his golf career. tiger woods is young enough to learn from his mistakes, before it consumes his life, and he can once again become a role model and idol to the millions of fans he has all over the world.

tiger woods must remove the enablers

tiger woods must begin by removing the enablers in his life, that let things slide because they continued to benefit from him, and did not want to rock the boat. Those people in tiger woods life enabled him by keeping silent, and this may have included his wife elin, his manager mark steinberg, the PGA, and even his caddy, who walked with tiger and saw him in discomfort and pain.
Will tiger woods lose his family?

At what cost will the fiasco end? Will the fiasco cost tiger woods his beautiful wife and children?
tiger woods beautiful wife elin

what other problems arose in tiger woods personal life as a result of the pain medication that tiger woods might have become addicted to?

tiger woods leads a very private life, when he is not being televised golfing, or endorsing a product. Now, the cat is out of the bag, and he must start coming clean to his addiction to pharmaceutical drugs and pain he has caused his family because of the drugs and bad decision making.


Will tiger woods lose his children? How much has this painkiller drug addiction affected the tiger woods family of a beautiful wife and children?


Will tiger woods save his marriage, and save his children? How much has this painkiller drug addiction affected the tiger woods family of a beautiful wife and children?

Will tiger woods push his wife elin away, or return to her? How much has this painkiller drug addiction affected the tiger woods family of a beautiful wife and children?

Is tiger woods mother an enabler? How much has this painkiller drug addiction affected the tiger woods family of a beautiful wife and children?

How beautiful is this baby of tiger woods? How much has this painkiller drug addiction affected the tiger woods family of a beautiful wife and children?

How much has this painkiller drug addiction affected the tiger woods family of a beautiful wife and children?


gratuitous topless photo of tiger woods

How much has this painkiller drug addiction affected the tiger woods family of a beautiful wife and children?

tiger woods crying on the golf course

Did tiger woods life become chaotic because of the knee pain? How much has this painkiller drug addiction affected the tiger woods family of a beautiful wife and children? Does tiger woods need dr. sober companion? DO you need dr. sober companion, before your life gets out of hand?

Sunday, July 19, 2009

michael jackson bombshell discovery is a warning to pharmaceutical companies

many drugs are not safe and effective

michael jackson bombshell warning to pharmaceutical companies - you can no longer hide behind federal laws of "safe and effective".

In 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?



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.

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.

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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.

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 Kerlikowske
United States Office of National Drug Control policy


The 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.