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Recently in Consumer Rights Category
The United States Supreme Court reduced the amount of
punitive damages Exxon Mobile will
have to pay for its destruction of the Alaska coastline from $5 billion to $500
million. This gift of funds
comes on the heels of a reported $40 billion profit by the oil giant for the
year 2007. This is the largest
annual profit for a corporation in history.
Originally a jury awarded the victims of the Exxon Valdez spill $5 billion in punitive
damages. Later an Appellate Court
to $2.5 billion reduced that. The
Supreme Court showing they are more generous than any appellate jurisdiction
reduced it to just $500 million.
The Exxon Valdez oil
spill occurred in 1989 and the original jury verdict was made in 1994. The giant oil corporation, by balking
at paying the jury's award, was able to save $4.5 billion in penalties, plus
the cost of money over 14 years. If Exxon had put the original award of $5
billion into a certificate of deposit at 7%, it would have earned $500 million
in interest in less than two years.
That's Exxon's punishment
for its reckless misconduct in spilling 10.8 million gallons into Prince
William Sound. It remains one of
the greatest environmental disasters in our history.
But the real story is the
Court's decimation of the important role of punitive damages to punish outlaws and hold them publicly accountable.
Corporations and the
corporate controlled media like to perpetuate the mythology that punitive
damages awards are excessive.
Punitive damages are only used against a defendant when a jury has
determined an egregious wrong was committed. The jury in the Exxon Valdez found that the company
knew that the Captain of the vessel was an alcoholic and that he had been
drinking on the ship. They also
found that compensatory damages to commercial fisherman would never be
sufficient for their loss.
In addition, the court
found Exxon was slow to act to clean-up the disaster and executives of the
company had little remorse for the actions of the company that led to the
disaster.
The 33,000 plaintiffs in
the case would have received $150,000 after the jury award, $75,000 after the
reduction by the Appellate Court and $15,000 after the today's ruling. Fifteen thousand dollars is the
equivalent of $7,000 placed in a bank in 1994 at five percent interest.
The Court's ruling is a
travesty for protecting the environment.
Scientists have concluded it will take over 30 years for the coastline
to recover. There is no reason,
given the new guidelines for punitive damages, that giant corporations should
fear be deterred from reckless or intentional misconduct, as long as they have
correctly calculated their economic risks.
Environmental
destruction, contaminated foods, toxic products, and dangerous toys for
children will not be detrrred as a result of this decision.
There's other lesson from
the Exxon Valdez case.
Corporations now are assured that if they stretch litigation out and get
to a very friendly Supreme Court they can maximize their profit and limit their
liability. The only real danger
they face is from a qualified attorney in front of a jury who can justly
determine the damages.
That's why corporations
are supporting John McCain for president.
With four right-wingers just waiting for one more vote, the election of
McCain guarantees a decade of corporate protection at the U.S. Supreme Court.
Across the board the
right-wing minority on the Supreme Court relishes its power to eviscerate the
rights of consumers whenever it can scare up one more vote. Check the recent history on prescription
drugs and medical devices.
We need the Supremes to
sing a different tune. That will
only be possible if we elect a candidate for change in November. He's not the old white guy riding in a
golf cart with President Bush.
Onward,
Richard Alexander
There is no doubt the "good hands" people have been using
them to pick Californian pockets.
Allstate
Insurance Company was ordered to reduce their homeowner's rates by $255 million
statewide by the California Department of Insurance. Now the question remains whether it
will issue the refunds owed their customers.
More than 850,000 customers will see their insurance rates
reduced by about $250 as a result of the order. The order represents a 28.5% reduction in the cost of
homeowner's insurance premiums.
Incredulously, Allstate initially sought a 9.3% increase in premiums.
This is the second time in less than a year that Allstate
was found to be overcharging its customers. In
March, the Department of Insurance ordered the company to reduce its auto rates
by 15.9%, saving Allstate auto customers $124 per car.
The real story is that Allstate has taken its sweet time in
reducing these excessive rates.
Allstate initially sued the Department of Insurance for reducing their
rates, but later dropped its appeal.
The acrimony between Allstate and the California Department
of Insurance has been going on for three years. Lt. Governor, and former Insurance Commissioner John
Garamendi, rightfully called for the company to issue refunds to consumers for
the last three years. That's how
long Allstate has been overcharging customers while it fought the Department.
"The
company has pocketed far more of the policyholders' money than was warranted,"
Garmendi said. "But, frankly, they must in my view provide a rebate for
the three years in which they charged an illegal amount."
Now it will be up
to a Republican, Insurance Commissioner Steve Poizner, to see those past
illicit gains are not kept by the rogue company and that refunds are issued in
a timely manner to the victims of Allstates' excesses.
But the real heroes of this story are
the folks at Consumer Watchdog, a group led by Harvey Rosenfield, Doug Heller,
Jamie Court and Pam Pressley.
Rosenfield, especially,
deserves credit for crafting Proposition 103.
Proposition 103
provided for an elected Insurance Commissioner in the State of California. More importantly, it gave the Commissioner
the power to lower rates when they were excessive.
So
far, Proposition 103 has saved California Consumers over $62 Billion. In addition, Consumer Watchdog and
their folks will take the lead in holding the current Commissioner accountable
for making sure that Allstate refunds its illegal overcharges.
This should not
be difficult. The current
Republican Commissioner has been outspoken in his desire to seek refunds from
the company and he has seen, first hand, the arrogance and intransigence
Allstate has demonstrated since he took office.
Further, Consumer
Watchdog is already leading the charge to get these refunds for victims of
Allstate. Initially, the group had
put the issue of refunds on hold until the California Department of Insurance
determined the excessive rate issue. Now they are free to pursue claims against the company
because of the provisions of Proposition 103. Allstate is sure
to fight back. They take a no-hold
barred approach to their fight.
Earlier this year Allstate made good on its pledge to pull out of the
property insurance business in California altogether. A move that was designed to scare Californians into meeting
Allstate's demand for excessive rates.
But the numbers
don't lie. In 2006 Allstate took
in over $5 billion. The total
shareholder return from 1994-2006 was a whopping 590%. It is noteworthy that Allstate
can give-up the California market and still make billions of dollars.
"Allstate
boasted of record profits to Wall Street, then came to California claiming it's
not making enough money in order to charge its policyholders higher premiums.
Proposition 103's prohibition on excessive rates protected California consumers
with home and auto insurance policies from Allstate's price gouging and saved
them over half a billion dollars this year," said Pamela Pressley,
litigation director at Consumer Watchdog.
But Allstate,
incredulously, still claims
increases are necessary. And
there are troubling signs at the Department of Insurance that the current
Commissioner is tacking right in an effort to please his Republican breathren
in order to position himself for Governor. Poizner, who came
to the office as a moderate and promised to run the department in a nonpartisan
manner, recently has looked increasingly like the old Republican model -- including taking a position as Co-chair
of the John McCain Campaign Committee and putting part of his vast personal fortune into
rightwing Republican registration efforts.
But the most
disturbing signs of trouble come in the recent reorganization of his executive
staff, as two major consumer advocates have left the department. Moreover, there are troubling
signs that he has left the day to day operations in the hands of a longtime
Republican idealogue, Jim Richardson, who is the former chief of staff to
archconservative and former Republican minority leader Jim Brulte, while
Poizner campaigns for Governor.
But one can only
assess a politician's record by results and, so far, Poizner's actions in
recovering excessive claims from thieves like Allstate have been good, but it
is not over by a longshot. So we need to be
vigilant in helping Consumer Watchdog in its quest to get the current
Commissioner to fulfill the promises of his campaign. If he does so, he just might become Governor.
In the meantime,
next time you see the your friends with the "good hands"--keep yours in your
pocket, lest they pick them clean again.
Onward,
Richard Alexander
Losing your house in a fire
is devastating, but having your Insurance Company renege on their promise to
cover your loss is beyond the pale.
But that is exactly what is happening all over California as increasing
firestorms destroy happy lives.
From Lake Tahoe to San
Diego, from Santa Cruz to Malibu the insurance industry is ducking and weaving
in an attempt to deny homeowners the full replacement value of their home.
It is these Insurers who set
the replacement value of your home in the first place.
The scam starts by insurance
companies offering low premiums to homeowners as a marketing tool to get their
business. To do so, the agents
and/or companies undervalue the cost of the dwelling. Then, when the catastrophe hits, the company refuses to pay the full replacement value of
the home, much to the surprise of the victimized homeowner.
A recent survey by United
Policyholders found that 75% of homes were undervalued by an average of
$240,000 in the recent fires in San
Diego and San Bernardino Counties.
And only 46% of the victims had received offers eight months after the
fire.
This is not a new
problem. Insurance companies have
been trying to get away with this fraud for years.
When Katrina hit New Orleans
most, if not all, of the victims found they were underinsured. Moreover, the insurance companies began
to utilize the small print in their adhesive contracts to avoid paying claims.
An "adhesive" contract is
one in which the terms are dictated by one side and are not the subject of
mutual negotiation. In other
words, the companies "stick" you with their terms.
Fortunately the law is on
the side of the victims.
Gigantic State Farm was held liable for $2.5 million for its bad faith in handling the
losses of its insured. State Farm
claimed that its contract provided protection against wind, but not water and
it did not have to pay the homeowners claim.
A federal judge ruled that
State Farm was liable for the damages and a jury awarded punitive damages to
the victims for the bad faith actions of State Farm.
But was this insurance
company contrite? Did it do the
right thing for other victims?
No. Here is State Farm's response:
Robert Hartwig,
chief economist for the Insurance Information Institute in New York, said
before the jury announced its decision that a punitive damage award would be
"distressing" for insurers. "It adds even more cost and more
uncertainty to the other problems that already exist in the Mississippi
homeowners insurance market," he said.
Note to Mr.
Hartwig: There is no uncertainty
if you pay the rightful claims owed to people who acted in good faith. Nonetheless State Farm continues to
argue that the result of this case will make it harder for them to "settle"
future claims.
State Farm
customers should not be settling for anything less than what they are
rightfully owed.
The actions of the
Insurance Industry have been so heinous that it forced one former U.S. Senator
to see the light. Trent Lott a
one-time political beneficiary of these companies lost his own house and vowed to fight the Industry to his dying day. It is unfortunate that it took a
personal calamity to change the Senator's views, but he joins the thousands of
victims who must continue to fight their insurance company, even as much of
their life remains in ruins.
There are several
ways to get help. The California
Department of Insurance will help investigate disputes with the companies. http://www.insurance.ca.gov/
Consumer Advocates
such as United Policyholders http://unitedpolicyholders.org will advocate for consumers and have a wealth of
information regarding how to deal with your insurance company.
In addition, all
consumers should research how different companies handle these catastrophes
before buying insurance. There are
actually some companies who pay their claims in a timely manner. You should probably avoid the mass advertisers
who claim to be a "good neighbor" or will put you in "good hands."
But the best way to
fight these corporations is to have a strong advocate, your own personal lawyer
to deal with these companies for you. Victims should not have to fight for their own money. The insurance industry is in a position
of power and many victims walk away with less than their due, simply because
the process seems hard. And given
the complete destruction of their lives many victims are often not mentally or
physically able to take on their insurance company.
So, if you are ever
the victim of a fire, fight back.
Don't get burned after the fire.
Hire qualified legal counsel and insure your rights are protected.
As we know well,
your insurance company is only a "good neighbor" if you never make a claim.
Onward, Richard Alexander
It is unconscionable for the
Mercury News to devote its editorial page to the mythology that citizens who
sue wrongdoers who have ruined their lives should give up their rights to aid
the economy. The Mercury is guilty
of publishing the propaganda of Lawrence McQuillan, the darling of right-wing
crazies, without a shred of fact or reality checking. Even in the opinion section of the newspaper, lying should
be discouraged and certainly not perpetuated without an appropriate
warning. But, that's to be expected
after the Mercury lost its corporate memory when it fired nearly all of its
experienced writers and reformulated itself to compete with the National
Enquirer in supermarket checkout lanes.
The Mercury op-ed throws
around alleged statistics and studies that have absolutely no relevance to
reality.
Th3 Mercury's bogus views of
our tort system fly in the face of the truth. A report recently released by the
Department of Justice's Bureau of
Justice Statistics deflates the myths that so-called "tort reformers"
use to condemn our civil justice system.
But you wouldn't know that
from reading the Mercury News.
The Mercury is right there with the Republican scream
machine using tort reform to justify the criminal acts of corporate and
government leaders. What an embarrassing patsy.
If the Mercury truly wants
to help the economy it can focus his attention on the corporate criminals that
make daily headlines stealing with impunity from the American people.
Tort reform is a
"get-away-free" card for the most heinous criminals on our planet. If a criminal steals a loaf of bread
three times in the wrong way, he can get life. Corporate criminals, abuse the public, steal millions and
walk away with golden parachutes.
And where is our
government?
Does anybody really believe
the Food and Drug Administration will protect them? We have salmonella from our tomatoes or peppers, mad cow
disease from our cattle, and nobody knows what coming from China to poison our
children.
But don't offend
China. As of December 2007, China's Treasury securities holdings were $406
billion, accounting for 17.2% of total foreign ownership of U.S. Treasury
securities and making China the second largest foreign holder of U.S.
Treasuries after Japan, according to China's Holdings of U.S. Securities:
Implications for the U.S. Economy. CSR Report to Congress, February 28, 2008.
But what is especially galling about the Mercury's
op-ed page is that it attempts to correlate tort reform with loss of jobs in
California: "entrepreneurs opt for states with balanced tort systems that
discourage excessive litigation . . . ."
That's not the law. It doesn't work that way.
Anyone who puts his or her products into the stream
of commerce is subject to being sued for a defective product in the state where
it is sold. Ford cannot mandate
that you can only sue in Detroit for deaths or injuries caused by its
outrageously defective Explorer in Colorado.
Silicon Valley was built by entrepreneurs before
corporate plans to deny citizens the right to sue ever existed. The loss of business in California is
not because of our litigious nature, it is because corporations would rather
pay starvation wages by exporting production to China, Indonesia and Mexico,
where environmental controls don't exist, unions do not advocate for safe
working conditions, fair pay and an 8 hour day and the Occupational Safety
& Health Administration does not exist.
The Mercury even goes so far as to claim that
Volkswagen, Hitler's favorite car company, did not market its three-wheeled
green car that goes over 46 miles per gallon because of potential
lawsuits.
Obviously the Mercury has been living under a bushel
basket. Since 1969 U.S. Federal
Motor Safety Standards have mandated that gas tanks not leak in crashes,
passenger compartments doe not crush in expected crashes and that roofs of
passenger vehicles survive a rollover.
Many foreign cars cannot meet those standards. That is why, for example, you don't see new Peugeots on our roads.
By the way, a Prius gets 46 miles per gallon and it
has air bags.
We have seen the likes of the corporate criminals who
say "greed is good." They sell
tobacco to drag our youth into the pit of cancer, paint their toys with lead,
put asbestos in cribs, and formaldehyde in trailer homes.
They would prefer that families devastated by these
crimes have no recourse. The tort
system is the only chance for justice for many people.
When O.J. Simpson killed is wife, it was the tort
system that provided justice. When a child
suffered brain damage due to his mother being exposed to toxins, it was the
tort system that provided justice. When corporate criminals knowingly hurt
other people, it is the tort system that provides condemns the wrongdoing and
makes the bad buys pay.
Finally, the biggest and most positive changes in the
health care industry are the result of the tort system. The escalating cost of healthcare
is not because of litigation, it is because of the enormous greed by insurance
companies, HMOS, pharmaceutical companies and doctors.
Experts
agree that our health care system is riddled with inefficiencies, excessive
administrative expenses, inflated prices, poor management, and inappropriate
care, waste and fraud.
The next time the Mercury News gives up its opinion
page to a one sided diatribe it should not refuse to print opposing views. 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
Congress needs make Internet privacy a national priority.
The U.S. Supreme Court has done little to protecting individual privacy and since 1976 it routinely has sided with government over the rights of individuals.
In 1976 The U.S. Supreme Court held in Miller v. United States that the right to privacy does not protect checks written by individuals on their individual checking accounts. In short, every time a check is written in the United States, there is no expectation of privacy in what many believe are their personal bank records.
The Miller decision was startling because the Supreme Court ignored a mew approach to privacy it had recognized in 1965 and the subsequent strong support the concept has received from distinguished jurists who have recognized that respect for individual privacy must keep pace with the perils of new technology.
This page is a archive of recent entries in the Consumer Rights category.
Class Action is the previous category.
Dangerous Drugs is the next category.
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