Friday, August 29, 2008

WISDOM FROM THE PAST

Here is an interview with Dr. David Graham (senior drug safety researcher at the FDA) that was held exactly 3 years ago. Seems things haven't changed much from then. Lets hope that as the dead lines for preemption approach some real change will begin to get traction.
As you read this interview you will be impress with Dr. Graham's wisdom, honesty and bravery in the face of the FDA bureaucracy.

The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower

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Monday, August 25, 2008

Petition Against Preemption - Make Your Voice Heard

May the word about Preemption be heard from Cost to Cost and ring in the halls of Congress. We will not stand for this loss of our Constitutional Right to be heard in a Court of Law. No organization public, private, political or judicial will stand in the way of the rights of America’s citizens.

We must get the word out to our friends and families.

Go to this site and sign the petition against preemption.

http://www.ipetitions.com/petition/fdapreemptionbadmedicine?e

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Saturday, August 16, 2008

COMING OUT AGAINST PREEMPTION

See the attached article from Pharmalot.
The Right To Sue: A Case Against Preemption

As we approach the end of the year we see some very strong language from some very learned folks. The issue of preemption and the corporate stance is exposed to the light of common sense.

For example:
From The New England Journal of Medicine, 359:1, July 3, 2008

"Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA's regulatory actions and enhance patient safety...
In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people."

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Monday, July 21, 2008

Preemption Under Attack

See this post from Pharmalot - Ed Silverman

http://www.pharmalot.com/2008/07/judge-reverses-preemption-ruling-in-paxil-case/

In the courts opinion:

Glaxo “has acknowledged that the regulations give it the responsibility for proper labeling of Paxil, and that it had the ability to make changes to Paxil’s label when there was “reasonable association” between a serious hazard and a patient’s ingestion of the drug.

“…The FDA’s current position on preemption is not ‘long standing’ but is in fact a ‘180-degree reversal’ from its earlier stance…the court, on reconsideration, gives relatively little weight to the FDA’s opinion on the preemptive effects of its regulations…Drug manufacturers have the authority to strengthen warnings without the advance permission of the FDA.

“[F]ailure to warn litigation can serve to reinforce the FDA’s regulations, which already place the obligation to strengthen the warnings on a drug’s label squarely on the shoulders of the drug’s manufacturer…

“The FDA’s statement, made several years after the fact, that it would not have approved a warning change that was never actually proposed, is speculative and will not serve as the basis for a finding of a preemptive conflict.”

Thanks Ed

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Wednesday, June 25, 2008

Why Doctors Should Worry about Preemption


From The New England Journal of Medicine
http://content.nejm.org/cgi/content/full/359/1/1
Volume 359:1-3
July 3, 2008
Number 1

Why Doctors Should Worry about Preemption -->
Gregory D. Curfman, M.D.,
Stephen Morrissey, Ph.D., and
Jeffrey M. Drazen, M.D.
-->A leading drug company may be poised to win a landmark legal victory next fall. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the U.S. Supreme Court (Wyeth v. Levine),1 drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective.
A medical-device company won such a victory in April. In Riegel v. Medtronic,2 the Supreme Court determined that a product-liability lawsuit against Medtronic in a state court was preempted because the device had received FDA approval. Preemption is a legal doctrine based on the supremacy clause of the U.S. Constitution, which states that when federal and state laws are at odds, federal law takes precedence. Its application to state tort litigation is a radical extension of its original meaning.
Medtronic won its case because the 1976 law that grants the FDA authority to regulate medical devices contains a clause asserting that state requirements with regard to medical devices are preempted by federal requirements. Although the preemption clause is silent on common-law tort actions, the Supreme Court (with Justice Antonin Scalia writing for the Court) interpreted the preemption clause broadly to include such actions.
Unlike the law governing medical devices, the Food, Drug, and Cosmetic Act, which provides the statutory framework for the regulation of drugs by the FDA, contains no such preemption clause. Thus, in Wyeth v. Levine — which concerns a patient who lost her arm after an injection of Wyeth's antiemetic drug Phenergan — the Court will decide whether preemption of state tort litigation is implied by the law, even though it is not explicitly stated.
Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA's regulatory actions and enhance patient safety. Margaret Jane Porter, former chief counsel of the FDA, wrote, "FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."3 Persons who are harmed have the right to seek legal redress. Preemption would erase that right.
But in the past few years, the government's views have shifted, and the FDA has reversed its position, now claiming that common-law tort actions are preempted. The FDA argues that tort liability stifles innovation in product development and delays the approval process, and that lay juries are incapable of making determinations about product safety. It has been argued, however, that Congress, not unelected appointees of a federal agency, has the power to decide whether preemption should apply.
Drug and device companies have chosen an inauspicious moment to attack the right of patients to seek redress. A series of pivotal reports on patient safety from the Institute of Medicine, as well as numerous articles in scholarly journals, has put the issue of patient safety in the national spotlight. Although frivolous lawsuits should not be condoned, product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it. Through the process of legal discovery, litigation may also uncover information about drug toxicity that would otherwise not be known. Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety.
Owing in part to a lack of resources, approval of a new drug by the FDA is not a guarantee of its safety (see timeline).4 As the Institute of Medicine has reported, FDA approval is usually based on short-term efficacy studies, not long-term safety studies.5 Despite the diligent attention of the FDA, serious safety issues often come to light only after a drug has entered the market. The FDA, which — unlike most other federal agencies — has no subpoena power, knows only what manufacturers reveal.

View larger version (41K):[in this window][in a new window]
Four Drugs with Safety Problems Discovered after FDA Approval.
Why should doctors be concerned about preemption? In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere.
In May, a Congressional hearing on preemption was held by Representative Henry Waxman (D-CA) and the House Committee on Oversight and Government Reform. As we stated in our testimony to the committee, to ensure the safety of medical devices, we urge Congress to act quickly to reverse the Riegel decision. Congressman Waxman and Congressman Frank Pallone, Jr. (D-NJ), are poised to introduce legislation that would unambiguously eliminate the possibility of preemption of common-law tort actions for medical devices. And if the Supreme Court rules for preemption in Wyeth v. Levine, which we hope it will not, Congress should consider similar legislation for drugs. Such legislation is in the best interest of the health and safety of the American public.
Source Information
Dr. Curfman is the executive editor, Dr. Morrissey the managing editor, and Dr. Drazen the editor-in-chief of the Journal. An interactive timeline is available with the full text of this article at www.nejm.org.
References

Wyeth v. Levine, cert. granted, 128 S. Ct. 1118 (2008).
Riegel v. Medtronic, 128 S. Ct. 999 (2008).
Porter MJ. The Lohr decision: FDA perspective and position. Food Drug Law J 1997;52:7-11. [ISI][Medline]
Kessler DA, Vladeck DC. A critical examination of the FDA's efforts to preempt failure-to-warn claims. Georgetown Law J 2008;96(2). (Accessed June 13, 2008, at http://lsr.nellco.org/georgetown/ois/papers/2/.)
Baciu A, Stratton K, Burke SP, eds. The future of drug safety: promoting and protecting the health of the public. Washington, DC: National Academies Press, 2007.

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Friday, May 9, 2008

Drug Safety: FDA Can Not, Drug Companies Will Not, Supreme Court Doesn’t Care

Three extremely important issues that everyone needs to investigate. Please review these issues for your health safety. Unfortunately it’s up to you these days.

1. The FDA commissioned an independent study titled - FDA Science and Mission at Risk - Report of the Subcommittee on Science and Technology. Nov 2007
18 negative findings were reveled, three of which are:
• The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
• The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
• The FDA cannot fulfill its mission because its information technology infrastructure is inadequate.
See report at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf

2. The current state of pharmaceutical industry affairs is alarming and getting worse. Some topics:
• Imported ingredient in Herapin contaminated and caused 19 deaths.
• Merk’s drug Vioxx - FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal.

3. Supreme Court Supports Preemption (Reigle v. Medtronic)
• Preemption explanation - a Medical Device that has been approved by the FDA is exempt from product liability law suits. Drug ruling follows this fall.

In conclusion – The FDA does not have the resources to do an adequate job of protecting the American public from dangerous products. The pharmaceutical companies compound the FDA’s failure by purposeful deception. The Supreme Court has ruled against due process of law to protect pharmaceuticals companies.

Seriously, be very careful before taking a new drug or medical device. There are many of us that can attest to the fact that unfortunately you may not know the real side affects or adverse reactions until it’s too late.

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Sunday, April 27, 2008

FDA Failing Public | Courts Covering Up

FDA-approved Lawsuit Preemption
planetc1.com-news@8:40 pm PST By Darrel Crain, DC

Everyone seems to be picking on the poor Food and Drug Administration (FDA) these days, but for vastly different reasons. To the hundreds of thousands of victims (including dead ones) of adverse prescription drug reactions each year, and their families, the FDA is failing to protect the public. These people believe the agency should spend more time and effort making sure drugs are safe and effective before approval. Meanwhile, the pharmaceutical companies feel the FDA is a nuisance, way too fussy about drug safety details and terribly slow with approval. This, they say, deprives consumers of the latest drugs, not to mention delaying company profits.
Drug companies have long insisted that going to all the trouble and expense of obtaining FDA approval for their drugs and medical devices should entitle them to complete immunity from all product liability lawsuits. In other words, if FDA-approved drugs destroy your health or kill a loved one, get over it.
A few years ago Dr. Allen Roses, an executive vice president with drug maker GlaxoSmithKline admitted in an interview that prescription drugs are irrelevant to the health of most people, most of the time. "The vast majority of drugs - more than 90 per cent - only work in 30 or 50 percent of the people," he said.
A much different story is relentlessly beaten into the minds of the public every day by aggressive, multi-billion-dollar-a-year drug marketing. That story tells us that every human illness is a drug deficiency disease that can only be "cured" by taking the latest drug every single day for the rest of one"s life.
Imagine if those billions were instead spent on a massive public education campaign teaching the two basic, unchanging principles of human life and health: 1) Lifestyle and environmental factors account for the vast majority of health disorders, and 2) For most people the body is perfectly capable of healing itself when underlying nutritional deficiencies are corrected, toxins are cleared and lifestyle improved. But I digress.
President Bush has long pushed for preemption of lawsuits for drug companies, arguing that the expert doctors at the FDA are the only people in the country smart enough to understand these complicated matters, and the courts should not try and second-guess the all-wise FDA.
Gee, did someone forget to tell the president that the experts over at the FDA have already given notice that the agency is completely incompetent? The FDA's science board spent a year studying problems at the agency, and concluded that a lack of resources and personnel "is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public."
The new protocol for public safety seems pretty obvious: Avoid taking anything approved by the FDA.
As if things weren"t bad enough already, the U.S. Supreme Court is poised to rule in favor of drug-maker Wyeth in a case that will likely usher in total preemption of lawsuits for all products approved by the FDA.
Johnson and Johnson is only one of the drug giants salivating at the enormous windfall in store once the courtroom doors are locked to drug-injured parties. J&J lawyers are already using the preemption argument to defend the company from 3,000 women suing for serious health problems caused by its birth control patch. Injuries to women who have used the patch include heart attacks, strokes and at least 40 deaths.
One scientist within Johnson and Johnson urged the company to conduct a formal evidence-based review following FDA approval because of "an abnormally high number of 'spontaneous cases' of clotting disorders, as well as death," associated with the patch. The company never performed such a study.
To its credit, Johnson and Johnson does admit that initial drug safety data on the patch was altered using a "correction factor." This is another way of saying "we made up the numbers." But J&J lawyers swear this kind of monkey business is normal and standard procedure for safety trials, and I believe them.
Apparently it has also become normal to delete negative drug reactions from safety reports submitted to the FDA, and lie about who wrote the reports, as we discovered with the Vioxx debacle. Since the FDA does not carry out drug safety research itself, its decisions are based on whatever selective and biased reporting the companies decide to hand in.
Before being pulled from the market, Merck & Company's drug Vioxx, a pain medication described as no more effective than over-the-counter pain relievers, caused more than 100,000 heart attacks and at least 50,000 deaths in the United States, according to senior FDA researcher Dr. David Graham. The public did not learn details about Merck"s massive data doctoring until forced to open up its cooked books in courtroom proceedings.
Even when lawsuits force some companies to come clean on their dirty secrets, we must remember that the gold standard of clinical science itself, the placebo-controlled randomized trial, has been downgraded to a fool's gold standard. Over recent decades, drug companies have "streamlined" standard clinical procedures to improve chances for FDA approval.
Randomization of patient selection has been replaced with "run-up" and "pre-trial adjustment" periods, in which test subjects are removed from the study whose responses make placebos look too good or the drug too toxic. This prevents the data from being "skewed" by real-world responses.
Many of today's placebos are also fakes, doctored with chemicals that mimic the side effects caused by the drug being tested. Obviously, if the "placebo" causes adverse reactions similar to the tested drug, the drug looks much better.
In modern vaccine trials, so-called placebos can contain toxic chemical cocktails that are part of the tested vaccine, including aluminum. The adverse reactions people have to such neurotoxins are then counted as placebo responses.
As any first year student of science can tell you, a scientifically valid clinical trial demands the use of a control group receiving a placebo with zero active ingredients, without exception.
In any other industry, these kinds of creative "improvements" to established scientific protocol would be called "cheating." Drug companies have their own word for drug safety trials that violate basic rules of science, "profitable."
Lawsuits have traditionally served as the only check and balance available to shore up the shortcomings of the FDA. As things stand, if preemption wins the day and lawsuits are forbidden, the drug companies will be free to get away with murder more than ever because they will never be forced to disclose exactly how the numbers were fudged or what data was withheld to gain approval.
While preemption is a spiffy idea for the drug companies, it is grossly unfair to the rest of us and violates the constitutional right of citizens to due process of law. Perhaps there is another, more equitable strategy to pull us out of the regulatory quagmire at the FDA.
What about leaving it up to the free market? As Thomas Jefferson once pointed out, "It is error alone which needs the support of government. Truth can stand by itself."
An absolutely free, unfettered, lassieze-faire market may be the most suitable solution for the business of making and selling prescription drugs. Why not completely dismantle the entire regulatory process of the FDA? What good are lengthy and expensive drug safety trials when they get falsified in the end anyway?
Dispense with the corrupt approval process and the money saved from the trials can be reallocated to pay for courtroom expenses and settlements. This is the kind of feedback that forces companies to make safer products.
Let the pharmaceutical companies quit their whining and swallow their own bitter pill of legal accountability. Let every drug company large or small concoct whatever chemical drug it wants to, advertise whatever miraculous benefits sound good, and then leave it to the marketplace to decide what really works, what harms and what kills.
If a company profits from a drug that turns human liver to a quivering glob of goo, or kills a few hundred or a few thousand people, that company deserves to be righteously sued in a court of law. Directors at the top of any company selling deadly goods should be held criminally liable for damages. Why should dangerous and deadly medical products be treated differently than dangerous and deadly tires, toasters, tainted food, or anything else?
To the drug lords hiding in the boardrooms of the pharmaceutical houses, I say if you are afraid to stand up for the integrity of your products and face your victims in the courtroom, then switch to the pesticide business where chemicals for sale are fully intended to cause death and disability.
The time has come to unleash the free market on the pharmaceutical industry and leave it to the invisible hand of supply and demand to sort things out. But first let's make sure we preserve the time-honored tradition of due process in a court of law for those consumers harmed by bad goods.

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