Re: If it Works Use It I just like to provide education and research for all..

January 21, 2005

and all~

I am not sure that I could take something if I didn't know the long

term affects. I was given neurontin to take when I was first

diagnosed. It scared me to death when I read about this drug. I

don't think it helped me at all but they put me on so many drugs

those first few years that who knows what caused any of the side

affects that I had...

Plus, I trusted my doctors to prescribe the best medicines available

for me. Now, I am not so trusting. I research and find out how

many tests have been done on the drugs I am on. I watch myself for

any adverse side affects. I also won't take a drug more then 3

months if I don't see something good from it.

At the time I took neurontin, I developed headaches - terrible - I

started stuttering, I became scared of my own shadow...worried all

the time about and thinking others were after me...

I was on a lot of drugs at that time and we don't know which ones

caused my problems but now I watch and check everything. I hope

that everyone can take the time to do this and has the capability of

questioning their doctors. I was told by one doctor he wouldn't

treat me anymore because I wouldn't take any -2 inhibitors - or

anti-depressants...I told him fine - that I could find another

doctor and wrote him up to his superiors(he was a military doctor).

I am glad now that I didn't continue taking celebrex, vioxx and

bextra, nerontin, ultram, flexeril, and ambien etc.... I think to

many times I have just done what the doctor tells me to do and it

was no help. Now, at least I have my memory back, the headaches are

minimal, and I don't stutter anymore...I have a lot of pain and my

body is deteriorating but I am okay anyway.

God bless,

Althea

> Dear Friends in Pain,

>

> If it works use it, but keep abreast of what it's all about...

>

> Peace!!

>

> Drugmaker admitted fraud, but sales flourish

> By Schmit, USA TODAY

> What happens to drug companies that commit federal crimes? For the

nation's

> No. 1 drug company, the answer is: some pain, more gain.

> In mid-May, Pfizer's (PFE) Warner-Lambert division pleaded guilty

to

> illegally marketing a drug called Neurontin to treat ailments for

which it was not

> approved. Pfizer, which did not own Warner-Lambert when the

government said the

> wrongdoing happened, paid a $430 million fine to settle charges

that included

> defrauding Medicaid.

> Pfizer's confession that the success of one of its top drugs was

built partly

> on fraud may have been humbling, but it isn't hurting the bottom

line.

> Neurontin sales last quarter rose 32% from a year ago, and 2004

sales should pass

> last year's $2.7 billion. With few exceptions, state Medicaid

programs pay for

> Neurontin just as before and so do major insurers. (Related story:

Pfizer

> poised to fight off generics with new drug)

> Other drug penalties

>

> Other government civil and criminal settlements involving drug

companies:

>

> Schering-Plough in July agreed to pay $345 million to settle

charges that it

> didn't give Medicaid its best price for the allergy drug Claritin.

> AstraZeneca Pharmaceuticals in 2003 paid $355 million to settle

charges that

> it gave doctors kickbacks by providing free samples of its

prostate drug

> Zoladex knowing that they would bill Medicaid and Medicare.

> Bayer in 2003 paid $257 million to settle charges that it

concealed some

> drug discounts to avoid paying Medicaid enough in rebates.

> TAP Pharmaceuticals in 2001 paid $875 million to settle charges

similar to

> AstraZeneca's involving its prostate cancer drug Lupron.

>

> By Schmit

>

> The tale of Neurontin shows how hard it is to stop the momentum of

a

> blockbuster drug, absent evidence that it is unsafe, and to

control health care costs.

> " They (Warner-Lambert) made their money, and they got off cheap, "

says Larry

> Sasich, a doctor of pharmacy at the consumer-oriented Public

Citizen Health

> Research Group based in Washington, D.C. Without prosecution of

Warner-Lambert

> executives, he says, the $430 million fine is an inexpensive " cost

of doing

> business. " (Related story: Whistle-blower started scrutiny)

> In addition to the fine, Pfizer agreed to tighter rules to ensure

compliance

> with drug-marketing laws. It will also contribute millions of

dollars to

> states to educate doctors about Neurontin.

> Approved for two conditions

> Warner-Lambert's offense was marketing Neurontin to doctors for

purposes

> other than as a supplemental anti-seizure medication for

epileptics. That was the

> only use approved by the Food and Drug Administration during

Neurontin's early

> years, when prosecutors say Warner-Lambert's illegal marketing

took place.

> In 2002, the FDA said Neurontin also could be used for nerve pain

related to

> shingles.

> Doctors can prescribe FDA-approved drugs for other purposes, so-

called

> off-label uses. But federal law forbids pharmaceutical companies

to market drugs for

> treatments not FDA-approved.

> The Justice Department says that's what Warner-Lambert did from

shortly after

> introducing Neurontin in 1994 until 2000. Prosecutors alleged that

> Warner-Lambert lied to doctors about the drug's effectiveness,

paid doctors to allow a

> sales representative to sit in on sessions with patients and paid

doctors, some

> up to $250,000, to unethically talk up Neurontin to other doctors.

> In fact, the list of ailments that Warner-Lambert claimed

Neurontin

> alleviated was so long â€ " covering pain, headaches, bipolar

disorder, attention deficit

> disorder, alcohol detoxification â€ " that some Warner-Lambert

employees dubbed

> it the " snake oil " list, government documents say.

> The strategy worked. In 2002, 94% of Neurontin's sales were for

off-label

> uses, up from40% in 1995, the government estimates, citing company

documents and

> independent market research. Wall Street firm Lehman Bros.

estimates that 90%

> of Neurontin sales are currently off-label.

> Doctors consider the drug relatively safe with few side effects.

But

> prosecutors said Warner-Lambert's actions caused Medicaid to pay

for prescriptions it

> should not have. They also said patients could have been harmed by

taking a

> drug not proved safe and effective for their condition.

> " The aggressive marketing campaign by Warner-Lambert resulted in

real

> increased costs to the states, insurers and consumers, " Vermont

Attorney General

> Sorrell said the day of the settlement. He noted a 30-day

supply of

> Neurontin at a common dose costs $205.

> Angry at the company

> Steve Borcherding, 42, is a former Neurontin user. The father of

three runs a

> home-repair business in Portland, Ore. He has bipolar disorder, an

illness

> often called manic depression. People who have the disorder often

cycle from

> euphoria to deep depression. Borcherding has hit psychotic states.

If not on

> medication, he says, he might do things such as try to drive

through a brick wall

> because he believes he'll pass through.

> In 2001, his psychiatrist suggested he try Neurontin. He knew it

wasn't

> FDA-approved for his illness. That didn't worry him, because many

drugs for his

> condition are not FDA-approved.

> He says he didn't know that two studies published in 2000 â€ "

including one

> sponsored partly by Warner-Lambert â€ " had shown Neurontin was no

more effective

> than a placebo for his disorder.

> He says he began taking Neurontin along with another drug he'd

been taking

> before. His wife, Karla Wolf, says Neurontin didn't seem to make a

difference

> for her husband at first. She recalls his mania then increased,

and he was

> hospitalized for five days.

> Borcherding was then taken off Neurontin.

> He isn't suing anyone. Since the government's settlement, the New

York-based

> law firm of Finkelstein & Partners has filed at least five

lawsuits alleging

> Neurontin caused suicides or attempted suicides. Borcherding says

there's no

> way to prove that Neurontin caused his downward spiral. He'd had

similar spirals

> before taking Neurontin and had been hospitalized while on other

drugs.

> He considers drug researchers " heroes " and trusts the doctor who

prescribed

> Neurontin for him.

> But he's angry at the company's promotion of the drug for his

illness. " They

> had the data that this was not an effective drug, and they ignored

that data, "

> he says. " I really have faith in the scientific process and

Western medicine

> and empirical evidence, and they hijacked that process. They

betrayed it. "

> Pfizer says that the company will vigorously defend itself against

all

> lawsuits and that it knows of no individual harmed by Neurontin.

It also says that

> many drugs are used off-label, including cancer drugs, and that

the government

> did not allege illegal conduct after Pfizer bought Warner-Lambert

in 2000.

> As part of the settlement, Warner-Lambert pleaded guilty to

conduct before

> Aug. 21, 1996, only, even though prosecutors alleged illegal

actions occurred

> later, too. The settlement made it possible for the company to

continue to

> participate in federal health care programs such as Medicaid,

despite an Aug. 21,

> 1996, health care fraud law that might have led to its exclusion.

Pfizer would

> not make an executive available to be interviewed for this story.

> Used by millions

> Almost 12 million people have used Neurontin since 1994, Pfizer

says. Sixty

> countries allow it to treat pain. Even though the U.S. has

approved it for only

> two conditions, Neurontin's popularity has snowballed. For the

past three

> years, it has been the third-biggest drug cost for Oregon's

Medicaid program.

> That occurred despite a lack of strong scientific support for its

off-label uses.

> In 2003, the Journal of Managed Care Pharmacy published a

literature review

> of Neurontin studies. The author, Mack, a doctor of

pharmacy, concluded

> Neurontin was not the " optimal " treatment for the majority of off-

label uses

> except nerve pain related to diabetes and for frequent migraines.

> One rigorous study published in 2002 dubbed it an expensive anti-

migraine

> option: $138 per migraine prevented.

> Assistant U.S. Attorney Kanwit in Boston, one of the chief

prosecutors

> on the Neurontin case, says his biggest hope is that the case

changes drug

> industry marketing practices.

> As far as affecting Neurontin's momentum, Kanwit acknowledges the

case may

> have little impact. Among the reasons:

> â€¢Insurers have a hard time controlling drug prescriptions.

Insurance

> companies and Medicaid programs can require doctors to get their

approval before

> prescribing a specific drug. But it's rarely done with Neurontin,

even though the

> allegations about fraudulent marketing became public in 2000.

> Only four of 50 state Medicaid programs require preapproval of

Neurontin

> prescriptions, USA TODAY found when it surveyed all of them after

Pfizer's

> government settlement. Among major health insurers, only Aetna

says it's considering

> preapproval.

> Preapproval can hurt sales. Florida expects its July 1 decision to

require

> preapproval for Neurontin will save more than $7 million in its

$2.1 billion

> Medicaid drug program. Neurontin prescriptions in Maine's Medicaid

program

> dropped 19% â€ " despite a 9% increase in eligible Medicaid clients

â€ " after

> preapproval took hold in October. Massachusetts and Oregon also

started requiring

> preapproval last year.

> Other states and insurers are wary because restricting Neurontin's

> availability could hurt consumers who really need it. Preapproval

rules are also costly

> and time consuming to administer. What's more, lower-cost generic

competitors

> may become available in the USA as soon as next year. To require

preapproval

> for Neurontin prescriptions now may cost more than it saves, says

> Seidman, chief pharmacy officer for WellPoint Health Networks,

parent of Blue Cross

> of California.

> " We have to make sure the payoff is worth the hassle factor, "

agrees

> Nesser, pharmacy director of the Oklahoma Health Care Authority.

> The authority decided it wasn't in 2002 after its own study

suggested that

> fewer than 10% of its clients on Neurontin suffered from epilepsy

or shingles,

> Neurontin's two FDA-approved uses. " You don't want to put a

roadblock on an

> epilepsy drug, " Nesser says.

> Oklahoma's Neurontin costs surpassed $5 million in 2003, up from

$4.2 million

> the year before.

> â€¢Medicaid laws fuel off-label prescribing. To ensure that

Medicaid patients

> had good access to drugs, Congress in the early 1990s decreed

Medicaid should

> pay for a drug for a use that is FDA-approved or supported by

citations in one

> of three medical directories.

> One directory, Drugdex Information System, owned by Canada's

Thomson Corp.,

> says Neurontin is effective or possibly effective in treating 46

ailments.

> Often, that judgment is based on case studies of a small number of

patients or

> studies in which patients knew they were taking the drug, which

can skew results.

> The FDA requires more rigorous testing for approval.

> The other directories cite Neurontin for FDA-approved conditions

and six pain

> conditions.

> Nicotine withdrawal is one condition Drugdex says Neurontin

is " possibly

> effective " in treating. That is based on the 2001 case of a 54-

year-old man who

> had also been alcohol-dependent and who was being treated for

depression. While

> on a daily dosage of 2,400 milligrams a day, costing about $8 to

$12 a day

> based on today's online prices, he abstained from nicotine for 10

weeks. The

> study's author suggested further study.

> Medicaid could refuse to pay for Neurontin for nicotine

withdrawal, says

> Barbara Dean, head of Texas' Medicaid drug program. But it " would

be taking its

> chances, " she says, because drug companies can argue that Medicaid

laws

> stipulate it pay.

> Drugdex editor Soares says Drugdex hasn't changed its

criteria for

> what it includes in decades. Drugdex became one of the three

directories in

> 1997. " I realize there's implications for (Medicaid)

reimbursements, " he says.

> But Drugdex's No. 1 goal is to inform pharmacists and doctors

about a drug's

> use and how it works, he says. The nicotine study was published in

a reputable

> medical journal, and Drugdex's review board, which includes

doctors, included

> it because " people might be talking about it. " Drugdex notes

support for

> Neurontin for nicotine withdrawal is poorly documented.

> â€¢Doctors want to help patients. They'll try drugs if they think

they might

> work, even if the FDA hasn't sanctioned them for a particular

treatment.

> Jim Moorman, CEO of Taxpayers Against Fraud, spends his life

working on ways

> to reduce fraud, thus taxes. He applauds the Justice Department's

action

> against Pfizer.

> Yet he also takes Neurontin because " it seems to work " in

alleviating his

> restless-leg syndrome. Neurontin is not FDA-approved to treat RLS,

in which legs

> inadvertently jerk. No drugs are, but there is some evidence that

Neurontin

> can help RLS patients.

> " Let's recognize this: There are off-label uses for Neurontin that

are

> valid, " Moorman says. " But (Warner's) marketing department didn't

care if the uses

> were valid or not. "

> Turek, medical director of the Oregon Health Plan, also

says a drug

> that may not work for many may work for an individual, even if it

has only a

> placebo effect.

> Should onus be on doctors?

> Despite Pfizer's fraud settlement, psychiatrist Suzanne Vogel-

Scibilia

> remains sold on Neurontin. She has 1,000 patients in her

Pennsylvania practice. A

> board member for the National Alliance for the Mentally Ill, she

says the

> bipolar studies on Neurontin are not exhaustive enough.

> She prescribes Neurontin, always with another drug, to ease

anxiety and sleep

> disorders in mild bipolar cases. As a bipolar patient, she takes

it, too. " As

> a doctor, I want the freedom to prescribe what I think works, " she

says.

> She says doctors should check the validity of drug studies and

decide

> prescriptions case by case.

> But Jerome Avorn, author of an upcoming book, Powerful Medicines,

says

> time-pressed doctors turn most often to drug representatives for

drug information.

> Avorn, a doctor with Harvard Medical School and Brigham and

Women's Hospital,

> also says doctors too often attempt to learn whether a drug works

for a patient

> by trying it. " We ought to have a better system than that. " He

advocates more

> studies and easier access to data.

> Even Oregon, with new preapproval rules, will continue to pay for

Neurontin

> for existing bipolar users. " It doesn't fit with the science ...

but people

> aren't machines, so we have to use some of the art (of medicine)

as well as the

> science, " Turek says.

> Janet Marquez, 25, doesn't pay much mind to studies. She looks at

her life.

> Several years ago, Marquez spent four months in a psychiatric

hospital.

> Diagnosed as bipolar, she tried other drugs. They didn't work, she

says. About four

> years ago, she started Neurontin. She's now in college, living on

her own and

> volunteering at a local library.

> When Oregon last year threatened not to pay for her Neurontin, her

doctor

> wrote a letter for her.

> Oregon still pays for Marquez's Neurontin. " If it doesn't work,

then why do I

> feel better? " she says.

> Contributing: Darryl Haralson, Ankner

>

> Hallenbeck~Sikorsky~ BS,RN,UM,QC

> Owner-Moderator

> " AnGeLsInPain "

> " OneVoiceInPain "

> Interqual Certified

> Published Psychiatric Researcher

> Advocate for those in CIP, HIV, Psychologic Pain

> " The Lord Will NEVER push us beyond what we can endure. "

>

January 21, 2005