June 2008 Archives

The late Congressman Tom Lantos in November 2007 lambasted Yahoo CEO Jerry Yang for outing a Chinese journalist who was arrested as a result of information provided to the communist government by Yahoo.  Lantos called Yang a "moral pigmy" for caving in to a request of the Chinese government for disclosure of evidence used to prosecute a journalist and send him to prison.

Now, the House of Representatives by a vote of 293-129 has capitulated on a major civil liberty by indemnifying telecommunications companies for committing the same act in this country.   If these changes to the Foreign Intelligence Surveillance Act pass the Senate it will insulate telecommunications companies from lawsuits for the Bush Administration's warrantless eavesdropping on phone and computer lines.

Some will argue there is a big difference between the totalitarian government of the Chinese and the current Bush Administration.

The current Bush administration is decidedly authoritarian and acts very much like the Chinese government in many ways.

The Chinese torture political prisoners; the Bush Administration tortures political prisoners.

The Chinese are not bound by Constitutional principles; the Bush Administration does not see itself bound by Constitutional principles.  

The Chinese run an oppressive political machine that squelches free speech; the Bush-Rove operation has attempted to do likewise.  

The Chinese spy on their citizens; the Bush Administration spies on its citizens and supports the wholesale investigation of telephone records, without a warrant or respecting existing statutory safeguards. 

Both governments use the ruse of national security to justify their actions.  If you have been thinking about boycotting the Chinese Olympics advertisers, which is a very good idea, we need equivalent action in the U.S. against the U.S. government.

To allow communications companies to give up confidential telephone records to the government on request is an outrageous erosion of civil liberties.  It is the same as Yahoo executives declaring they must follow the law in China.  The despicable acts our government have asked of the telecom companies are headed towards becoming sanctified by law.

Benjamin Franklin said, "Those who give up essential liberty to obtain a little temporary safety deserve neither liberty nor safety."

This administration, using 9/11 as a bloody shirt, have continually worked to erode the Constitution and basic liberties.  What Bush and a previous Republican majority in Congress have done is so outrageous that even a fundamentally conservative court struck down the statute they enacted to suspend the constitutional right of habeas corpus. 

In Boumediene v. Bush, decided June 2008 the Supreme Court held that individuals on American soil at Guantanamo Bay could not be denied access to the courts protected by via a writ of habeas corpus.   The 5-4 decision has been heavily criticized by John McCain.  Mr. McCain believes that people held in American prisons at Guantanamo should not have the right to have our courts decide if their imprisonment for years is legal.

Since when is it OK for a free nation to arrest any person, for any conduct, and then pass a law to prohibit them from asking a court to decide if their imprisonment is legal?  This is the United States of America, not the 20^th century Soviet Union.  

Professor Richard Epstein, University of Chicago Law School, wrote an amicus brief for the prisoners.  He got it right in an op-ed to the New York Times: "Boumediene v. Bush is not a license to allow hardened terrorists to go free. It is a rejection of the alarmist view that our fragile geopolitical position requires abandoning our commitment to preventing Star Chamber proceedings that result in arbitrary incarceration."

Our four arch-conserative justices were just one vote away from holding that allowing the writ of habeas corpus would constitute reckless judicial intervention in military matters.  I call them the TSARs [Thomas, Scalia, Alito and Roberts] because thats what we would have for a Supreme Court if McCain gets elected and gives them one more vote.

But for the intercession of a Democratic Congress in 2006, the foundations of a totalitarian state were underway, which is why this most recent vote to endorse surveillance of the telecoms is a total outrage.  Spying on citizens, locking up people and denying them the writ of habeas corpus and condoning torture are not the hallmarks of a free society or a public morality worth emulating.   I have written about the Bush Administrations wholesale abuse of the Constitution before.

The bill approved on June 20, 2008 allows for mass, untargeted and unwarranted surveillance of all communications coming in to and out of the United States.  The courts' role is that of a rubber stamp and it is useless;  the government can continue spying on our communications even after the FISA court has objected.  293 "representatives" [a classic oxymoron] approved a wholesale giveaway of our Fourth Amendment rights.

Tom Lantos must be rolling over in his grave.  His own beloved country is advocating a national policy to legalize the very immoral acts that he condemned Yahoo for committing in communist China.

Those who forget history are condemned to relive it. 

Tom Lantos was all too aware of the slippery slope that leads to totalitarianism, having survived the Nazi regime.  To say that it cannot happen in this country is to ignore history. It can happen anywhere. To say that it is not happening in this country is to ignore reality. 

If we are to preserve "liberty and justice for all" we must be resoundingly say "no" to giving up rights here, and then there, and then everywhere.   Freedom is nonnegotiable.  That must apply to the Bush administration, to telecom companies, and to corporate executives.  If freedom is to flourish good men and women cannot be idle.  This 293-129 vote is a bad idea.

As Dante said, "the hottest places in hell are reserved for those who in times of moral crisis preserve their neutrality."

My views of the Surveillance Bill were best expressed by Rep. Zoe Lofgren, a leading voice of reason on the House Judiciary Committee.  On the floor of the House she said: " Mr. Speaker, this bill goes far beyond  what is necessary and what was agreed to by the Director of National Intelligence. All of us agree that foreign-to-foreign communications need to be available for surveillance. However, this bill would grant the Attorney General the ability to wiretap anybody, anyplace, anytime, without court review, without any checks and balances. This unwarranted, unprecedented measure would simply eviscerate the fourth amendment that protects the privacy not of terrorists, but of Americans. I strongly oppose this warrantless surveillance measure."

Well said Representative Lofgren. Thank you.

The Senate must kill this bill.  

Filibuster if they must, but they must kill it for the sake of "liberty and justice for all."

It is a lesson Congressman Tom Lantos knew well.

Onward, 

Richard Alexander

For those of us who cherish civil liberties, the last thing we need is Sen. John McCain in the Oval Office.   What many people don't think about when pulling the lever in the voting booth is that the president appoints judges that control their lives - not only appointments to the U.S. Supreme Court, but up and down the federal judiciary.

Senator McCain's "positions are nearly identical to the president's on abortion and the types of judges he says he would appoint to the courts,"  "How Close McCain Is to Bush Depends on the Issue," New York Times, June 17, 2008.

President Bush's arch-conservative choices for the Supreme Court are one vote away from a majority.  One more appointment by either President Bush or Mr. McCain, if elected president, would mean a stunning reversal for human rights.

On June 12, 2008 the Supreme Court by just a 5-4 vote held that terror suspects held at the U.S. Naval Base at Guantanamo Bay could not be denied the right to file a habeas corpus petition to challenge why they were being held.

The news stories of the day claimed a great triumph for democracy. The linked piece is just one example of many television, radio and press stories that totally missed the point.  

To anyone who claimed this was a "great triumph" or the like, that's a frightening conclusion.

This decision was a near disaster. 

Habeas corpus should be protected by a 9-0 vote.  

This 5-4 decision mirrors the U.S. criminal justice system, which has the highest number of people behind bars in the world.  Even more than in China.  That is a stunning indictment of a "sink or swim" society and raises serious questions about the law that your courts are enforcing and just how uncivilized a society we have allowed the United States to have become.  Law and order is fine, but for all the law, we don't have much order.

The statute denying the historic protection of habeas corpus with the purpose of taking away the supervisory function of the courts was drafted and supported by John McCain. And his favorite judges - the kind he would appoint - voted against this necessary constitutional restraint on illegal government actions.

Chief Justice John Roberts, and associate justices Samuel Alito, Antonin Scalia and Clarence Thomas - whom Bush senior lied about when he said Thomas was the most qualified person he could appoint - all were the dissenters. 

Thomas, Scalia, Alito and Roberts, our TSARs in waiting, would love to have just one more reactionary vote to chisel away more of the underpinnings of our Constitution and put an end to individual rights.

Here's how it works for the TSARs:  Business and government uber alles. Personal rights last.  

In March a 4-4 split court in Warner-Lambert v. Kent didn't have the five votes needed to take on the question whether a product liability claim could be brought be against a manufacturer of an FDA approved drug. 

You were one vote away from losing your personal right to sue for personal injuries caused by dangerous drugs: Trasylol which causes kidney failure, Ortho Evra that causes stroke and heart attacks, MRI contrast solutions with gadolinium that are lethal for kidney patients, Zyprexa that causes diabetes and Vioxx the pain killer that kills. And those are just a few of the currently dangerous drugs without opening the archives.

With one more vote the United States Supreme Court could have granted legal immunity to pharmaceutical manufacturers on the legal theory that once a defective drugs had been approval by the FDA, even though proven to be unsafe and dangerous, no further questions can be asked in a court of law.  

The TSARs wants to turn over total control of regulating drugs to the FDA, a proven administrative disaster, and allow drug companies to profit by selling highly questionable, and sometimes known dangerous drugs, without allowing victims a chance to hold them responsible in front of a judge and jury.

Don't doubt for a minute that isn't likely to happen.

That's why we need a Democratic president.

Voters should stand proud of the voice they gave to Obama and Clinton. It was an historic race.  Sen. Clinton made a spectacular run against a culture of misogyny and Sen. Obama proved it was the person, and not the color, that counted.

But it can be even more.

An Obama-Clinton ticket means more than the vote's of18 million Clinton supporters and it's more than merely seeking women to support the Democratic ticket.  It would show Obama's commitment to real change at two levels.  

First, at a very personal level, Obama could show that to change the country he is willing to change himself.  

Secondly, that leadership action would cement his position as the most committed Democratic leader since Franklin Roosevelt.

USA Today on June 10 2008 described on page one the changes on abortion, job bias, and campaign finance and racial polices that have occurred since the retirement of Sandra Day O'Connor from the Supreme Court in January 2006.  

In short, Justice O'Connor's legacy has faded. 

Imagine how bad it would be with the next Supreme Court justice appointed by McCain, giving the TSARs a solid Supreme Court majority.

We are on the cusp.  

A Democrat in the White House is a must.  

An Obama-Clinton ticket guarantees a Democratic win - a win that we must have to protect ourselves against right-wing abuse on the Supreme Court and to preserve human rights.

This is not the time for risk. There is way too much to lose.  There is so much to protect.

Onward.

Richard Alexander

Two members of the Tongan Royal Family, visiting the San Francisco area to discuss political reforms in their tiny South Pacific nation, stepped into a Ford Explorer for a short ride to a meeting with the Tongan community. Instead, because of decisions made by Ford executives, the Explorer gave the royals a ride to their deaths.

A teenage driver in a 1998 Ford Mustang on U.S. 101 in Menlo Park, California cut off the 1998 Explorer in which Prince Uluvala Tu'ipelehake and Princess Kaimana Tu'ipelehake were passengers.  The Mustang was going no more than 10 miles hour faster than the Explorer when it moved left into the Explorer's lane and struck the bumper.  The Explorer swerved to the right, and the driver over-corrected, causing the Explorer to trip and roll, killing both passengers and their driver. 

The teen driver, Edith Delgado, was found guilty of misdemeanor vehicular manslaughter, and was sentenced to two years in county jail, but the Explorer was the real culprit. 

Ford executives deserve jail time for the deaths of the Tongan visitors and the deaths of hundreds of others whose fates were sealed in Explorers.

Delgado cut off the Explorer and caused it to make a swerve to the right.  Then, as expected, the driver lost control of the Explorer when she jerked the wheel back to the left and the Explorer did what it was designed to do. It rolled on a flat level road. 

The real proof of the Explorer's instability is Delgado's Mustang. 

The Mustang suffered minor damage.  I bought it and had it driven to my warehouse for storage as evidence in the lawsuit I filed against Ford on behalf of the Prince's two sons.

Ford's management knew that the Explorer would roll and kill people when they first marketed it in 1990. The Explorer was a replacement for the equally dangerous Bronco II, and Ford's decision to sell a new model that was certain to cause deaths and horrific injuries continued a pattern of behavior that went back at least 20 years to the Pinto and its exploding gas tank.

Ford engineers told management the Explorer was unstable and had major handling flaws long before the first Explorer came off the assembly line, but Ford's decision makers smelled big profits from the "First Mover" market position that the Explorer would give them.

As the executives hoped, they made their huge profits. As expected, Explorers rolled, people died, and continue to die.

In California alone, from 1990 to 2000, the Explorer earned Ford more than $2 billion in profits, and Dr. Alan Goedde, an expert witness, calculated the First Mover portion of the profits at between $383 million and $442 million.

Rollover problems began with the Explorer as soon as it hit the streets. Its center of gravity was too high and its wheelbase was too narrow. Every extra passenger raised the center of gravity even higher, making the vehicle even more unstable and the roof was not nearly strong enough to protect passengers when rollovers did occur.

Defective Firestone tires were a major contributing factor in many Explorer rollovers. Those tires frequently separated and caused Explorers to spin wildly out of control.  Disintegrating tires caused severe personal injuries and deaths, but when Ford became aware of problems with tires, it approved replacement tires from other manufacturers that made the Explorer even more dangerous.

Knowing the risks that the Explorer presented, Ford never slowed its marketing efforts. Suburban housewives and city residents who thought they were driving the equivalent of a station wagon were placing their families in trucks that didn't meet federal automobile safety standards.  And when evidence showed that Explorers were killing and maiming people, Ford sent out its lawyers and PR people to attempt to cover up its misdeeds.

Despite all the deaths, injuries, and lawsuits, the Explorer is still on on a roll - literally. In government tests on the 2008 Explorer, it received only a 3 (of a possible 5) in rollover safety. 

Henry Ford wouldn't be happy with the profits-before-lives approach that his company has taken. Mr. Ford was a pacifist who once faced a lawsuit from his own shareholders because he was more interested in the welfare of his workers than in maximizing his profits.

Henry Ford was a socially responsible manager with a conscience.  We know what Henry would say about the Explorer if he were alive today.  Too bad his conscience is no longer at the helm.

Onward.

Richard Alexander

Kudos to Evelyn Pringle of the Media Monitors Network for an excellent case study of how drug companies promote profits by paying for research supporting off-label uses for their products.  "Just What Kids Need - Sparlon - Another ADHD Drug" (March 2006).

The report features DuBose Ravenel, MD, a pediatrician with 25 years experience with ADHD children, who testified for the International Center for the Study of Psychiatry and Psychology at the FDA's March 23, 2006 meeting of the Psychopharmacologic Drugs Advisory Committee and blew the whistle on Joseph Biederman's conflict of interest in his research supporting an off-label use for an ADHD drug.

Together Evelyn Pringle and Dr. Ravenel raised ethical questions of Dr. Biederman relationships to a drug companies.  Add that to the recent revelations by the New York Times'  "Researchers Fail to Reveal Drug Pay" June 8, 2008 and you will see why I recommended in my previous article on this topic that Harvard make a public example of their "payola" faculty by firing them.  

Here is what Ms. Pringle wrote in March 2006.

"The pharmaceutical company, Cephalon Inc, is going through the motions of legitimizing the sale of Sparlon for the treatment of ADHD even though its active ingredient, modafinil, has been heavily promoted and sold under the name Provigil, for off-label treatment of ADHD by Cephalon for years.

"Last October, the FDA sent an "approvable" letter to Cephalon for the pediatric use of Sparlon pending a March 23, 2006, meeting of the Psychopharmacologic Drugs Advisory Committee to review the drug's approval.

"Modafinil-based Provigil is currently only approved for narcolepsy, sleep apnea and shift work sleep disorder, according to the FDA. However, it is estimated that half of all Provigil prescriptions are written for off-label use.

"Doctors now prescribe it to treat everything from attention deficit hyperactivity disorder (ADHD) to fatigue associated with multiple sclerosis and depression," according to the November 1, 2004 Business Week Online.

"Cephalon gets nearly half of its $1.2 billion in annual sales from modafinil.

* * *

"With Sparlon's application to FDA approval, Cephalon claimed 3 studies involving more than 600 children aged 6 to 17, found the drug to be more effective than a placebo.

 * * *

"Dr DuBose Ravenel, MD, who will testify on behalf of the International Center for the Study of Psychiatry and Psychology at the advisory committee hearing on March 23, makes the point that although "48% of drug treated subjects at final follow-up were "much" or "very much" improved clinically, 52% were not."

"This is a substantially lower response rate than has been reported for traditional stimulants," the doctor notes.

Dr Dubose Ravenel is a pediatrician with 25 years experience in private practice with a heavy emphasis upon behavioral issues, including diagnosing and managing ADHD.

"In addition, she notes, with regard to potential conflicts of interest, itemized conflicts for each of the Pediatric study's authors are numerous.

"For instance, "Dr. Biederman received research support from 10 companies, serves on speakers' bureaus for 4 companies, and is on advisory boards of 6 companies,"" Dr Dubose Ravenel reveals.

"Other authors have numerous listed conflicts as well she notes.

"In light of recent widely publicized articles showing widespread deceptive practices engaged in by pharmaceutical companies in designing, selective reporting, and interpreting studies," she says, "the large number of pharmaceutical company ties with the authors of the study do not lend confidence to the reader even beyond the aforementioned concerns."

And "thank you" to Dr. Ravenel for reporting on conflicts of interest in drug research investigations.  Good job.

Onward.

Richard Alexander

Drug company money influences and corrupts research.  That is a given.

What is less understood is why drug manufacturers spend billions for research on off-label uses for their products - uses that were never cleared with the FDA when the drug was submitted for approval.

Off-label use allows drug companies to get "through the back door" what they could never, and I mean never, get away with by going directly to the FDA for approval for a new use of a product - what is known today as an off-label use.  

You would hope that researchers wouldn't corrupt the commercial experimentation of a new, or off-label, use of a drug to treat children by covering up their consulting fees from Big Pharma.  But that's what happened.

More important than what happened is why it happened and at the bottom of all this is a terrible mistake the U.S. has made in allowing the exploitation of off-label use.

The devil is in the details, so here is the story as it has unfolded.

Leading Harvard professors studying off-label uses, the gold mine of the drug industry, have violated National Institute of Health reporting requirements when more than $10,000 has been received from a subject company, according to the New York Times, "Researchers Fail to Reveal Drug Pay" June 8, 2008.  

Johnson & Johnson, Eli Lilly, Merck and the other big time operators, the leading exploiters of junk science, thrive on talking the FDA into approving a drug for one use and then encouraging research so doctors will use it for other purposes. Everybody knows the FDA can't stop toxic food from being unloaded on Americans.  Yet few realize that the drug companies have hired off the FDA's most seasoned researchers, leaving juniors guarding our public health. 

So it is easy to wing a drug application past the FDA's lap dogs and once that occurs, off-label use can exploited by the manufacturers. 

Off-label use is allowed under our law on the theory that the doctor knows best, and once a drug is approved by FDA for one purpose, a physician can prescribe the medication for other uses.  That's where the big money is in pharmaceuticals.  Off-label drug use accounted for more than 20 percent of drug sales in 2006, according to the Annals of Internal Medicine, which provides an excellent overview of who's in charge of safeguarding patient welfare and FDA off-label policies.  

Drug companies cannot directly market off-label use.  That's against the law and major companies such as Eli Lilly, Pfizer and Astrazenica have been prosecuted for doing so and causing serious personal injuries and deaths.  

In many cases the harm caused by off-label continues for years.  That's the case with Wyeth's Pondimin® and Redux®, better known as Fen-Phen, an off-label use for weight loss that is responsible for primary pulmonary hypertension. Fen-Phen continues to devastate lives with tragic and deadly personal injuries a decade after its marketing demise.  I know.  These innocent victims are my clients.

But what the FDA takes away from drug manufacturers on one hand it gives back on the other.  Today there is a loophole in prohibitions against marketing off-label use big enough to drive a train through.  Our FDA watch-kittens have eased the rules which allow drug companies to republish and distribute scientific articles on the topic. 

It's a bad policy that has been blasted by a leading Stanford researcher, Dr. Randall Stafford who said so in an editorial in the New England Journal of Medicine in April 2008. 

The drug companies know the trick is to get someone else to talk about new ways to use their drugs and then pass on copies of the research articles they cannot publish themselves to every doctor in the western world under the companies' First Amendment right to free speech.  That's why Merck wrote drug studies for doctors.  

Drug companies need to have researchers finding new off-label uses.  Since pushing research for off-label use is a key to profitability, that is what drug companies do and to the extent that it promotes scientific discovery that's good, but it has to be above board. 

Turns out that Dr. Joseph Biederman, a world-renowned Harvard child psychiatrist and his Harvard sidekick Dr. Timothy Wilens have been operating below the board.  They either cannot count over $10,000, or they have willfully violated NIH mandates and federal reporting requirements.

The duo collected $1.6 million in unreported consulting fees from drug makers since 2000 to experiment with antipsychotic medicines in children, but nary a disclosure.

They are not the only ones.

Dr. Thomas Spencer, another Harvard professor, pulled down at least $1 million in unreported drug money and reporting also slipped his mind.

So there must be more.

Thank you Senator Charles Grassley for forcing them to disclose.  Good work.

Harvard needs to end this skullduggery by requiring their big league faculty to annually turn in their tax returns with the W-2s and 1099s attached to guarantee full disclosure and compliance with ethical research requirements.  Then post it on a website.  Let them complain.  If they want the Harvard imprimatur, that's the price.

Other major research institutions also need to make sure that disclosure requirements are mandatory, not merely "ethical" expectations.  If the public and regulators are to have any confidence in research, the source of funds and the amounts must be publicly disclosed.

Harvard needs to make a strong public statement by making a public example of these outlaws. Saying "sorry" isn't enough.  

If Harvard doesn't fire them, it will be complicit in the cover-up.  

Throw them off campus.  Ring the bell loud and clear that no matter how renown or stellar, if you don't play by the rules, you can't play at all.  And the NIH should forever ban them from receiving grants.

Don't throw out the baby with the bath water.  Once appropriate punishment has been served, give these researchers a chance to polish their tarnished reputations. Allow them to conduct research under the supervision of a responsible administrator who knows that "veritas," means truth, accuracy, honesty, and uprightness and that it's more than just a motto.

Onward. 

Richard Alexander 

Would you like to turn over control of your health and viability - possibly your very longevity - to an understaffed, underfunded government bureaucracy?  

Doesn't appeal to you, does it?   

The FDA (U.S. Food & Drug Administration), which if you think about it for a little while, has extraordinary power over your personal well-being - may gain even more dominance over your destiny.  The battle for world domination of your body will occur this fall in the august chambers of the U.S. Supreme Court.

The foundation of the legal fight is the Vermont Supreme Court decision in Levine v. Wyeth. 

Diana Levine, a professional musician, was treated, in April 2000, for a severe migraine headache and nausea.  Staff at the Vermont Health Center injected her with Phenergan, a nausea medication. They used her arm to administer the injection and the outcome was very disastrous: she lost her right arm below the elbow, and left the hospital an amputee.

Levine sued Wyeth, which sells Phenergan, on the basis that the warning label on Phenergan - although it complied with FDA requirements - was inadequate.  Levine won a jury trial and was awarded about $6.8 million.

Wyeth appealed the decision because it wants to hide behind the FDA. The case went to the Vermont Supreme Court which ruled against Wyeth, saying, in essence, the drug manufacturer had a duty under state law to strengthen the warning label on the drug, regardless of the FDA's confusing, and sometime conflicting, regulations on when, or if, warning labels should be revised.

The Politics of Pre-Emption

At the heart of the upcoming U.S. Supreme Court battle is the concept of pre-emption: that federal law pre-empts the right of victims such as Diana Levine to sue for the damages inflicted upon them in state courts. 

The [supposed] logic is this: if the FDA has approved the drug, or medical device, and the label, then drug manufacturers need only to comply with the FDA's requirements to be granted sweeping immunity against personal injury law suits filed in state court for damages based for failure to warn.  Or as the New York Times stated the drug companies are looking for  "a legal shield" against being held accountable.

Why is it that major corporations, and many of their Republican supporters, are always talking about accountability and responsibility, until it comes to them?

The whole thing is scary.

Here is an agency - the FDA - which is understaffed and not keeping up with technology - faced with the possibility of assuming even more control over our very being.   USA Today published a story - citing an independent panel review of the FDA - which revealed that the agency has about the same size staff as 15 years ago.  According to the article, Instead of being proactive, the agency (FDA) is often in "fire-fighting" mode.

If the U.S. Supreme Court rules in favor of Wyeth, upholding the pre-emption rule, it takes away one of the major legal remedies the average U.S. citizen has when events such as Diana Levine's nightmare occurs.  

And yes, politics, notably the Bush administration, is solidly evident. The Bush Administration has moved stealthily to prevent state common law claims. 

In January 2006, the FDA adopted new regulations, the ultimate purpose was to torpedo efforts to allow personal injury claims to be heard by state court juries. 

The FDA said "it is the expert federal public agency charged by Congress with insuring that drugs are safe and effective and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading."   Translation: "if we say it won't kill you, it won't kill you."

And since when is the FDA in the job of insuring anything?  These are the same folks who can even inspect imported food to make sure it is safe.

Take all the extremely technical legal argument out of this and there is still the factor of human error, of an understaffed agency monitoring an exponentially growing number of pharmaceutical products, and the potential for this agency to slam the door in a citizen's face should a medical catastrophe occur.

In May, the Congressional Committee on Oversight and Government Reform held hearings on the pre-emption issue. Chairman, Rep. Henry Waxman, said in his statement, that if the pharmaceutical managers, the FDA and the Bush Administration have their way in court, "...one of the most powerful incentives for safety, the threat of liability, would vanish."

Whose body is it anyway?  Yours, or the FDA's?

Onward.

Richard Alexander