The Inside Story of Nexium

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http://www.mercola.com/2002/dec/18/nexium.htm

 

How the Drug Companies Deceive You -- The Inside Story of Nexium

 

 

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The heartburn drug Nexium, the object of a half-billion-dollar marketing

campaign to move people off the prescription medications predecessor,

Prilosec.Top 10 Pharmaceuticals

Prilosec slipped from the number-one to the number-two selling prescription drug

last year after its patent was about to expire and maker AstraZeneca shifted its

promotional muscle to the " new Purple Pill, " Nexium.

DrugTreatmentU.S. Sales1LipitorCholesterol

$5.22b2PrilosecHeartburn$4.61b3ZocorCholesterol$3.68b4PrevacidHeartburn$3.55b5Ce\

lebrexArthritis$2.61b6EpogenAnemia$2.56b7ProcritAnemia$2.55b8ZyprexaSchizophreni\

a$2.51b9ZoloftDepression$2.27b10PaxilDepression$2.15bThe Life Cycle of the

Purple Pill

Worldwide earnings from the Purple Pill grew annually from the time it was

introduced in 1988 until just before its patent expired last year.

By Neil Swidey

 

Part 1 of 2 (Continued next issue)

 

 

Gertrude was sitting with her husband in their Lowell living room, watching the

nightly news, when the man on the moving cliff found her during a commercial

break. " I'm every man, " the serious, gray-haired guy said, nodding confidently.

" And every woman, " continued a blonde standing on the adjacent cliff, " whoever

suffered from frequent, persistent heartburn. " Over the course of 60 seconds,

waves crashed, sunlight pushed through an overcast sky, and rock formations

reconnected hydraulically. A dozen cliff-top baby boomers of every race spread

the word about Nexium, as capsules of " the new Purple Pill " rained from the

heavens.

 

Like most of the TV commercials for prescription drugs that keep Brokaw, Rather,

and Jennings on the air every night, the Nexium spot ended with the suggestion

" Talk to your doctor. " But Gertrude didn't have to. Her primary care physician

had already brought up Nexium with her at her last visit. " Hey, that's the drug

my doctor just switched me to, " she told her husband. " It must be pretty good. "

 

The 79-year-old, who didn't want her last name used, is a longtime sufferer of

serious heartburn. So she's among the many who hail the miracle powers of the

original Purple Pill, Prilosec. That drug stripped misery from the lives of

millions and became the world's best-selling prescription drug - and the number

one medication prescribed for seniors - taking in $6 billion a year. Prilosec is

so good, and patients so attached to it, that doctors jokingly call it " purple

crack. "

 

It's an expensive habit, about $4 for each daily pill, or $1,500 a year. General

Motors alone spent $55 million on Prilosec for its workers last year. The drug

has been the ultimate cash cow for its maker, AstraZeneca.

 

But by now the cow should have run dry. The main patent on Prilosec expired more

than a year ago. Under normal circumstances, that would have triggered the

arrival of a generic version on the market, followed by a host of generic

rivals. With so much low-cost competition, we would all be enjoying lower drug

costs. But that didn't happen.

 

Through lawsuits, the makers of Prilosec have managed to keep the generics at

bay while unleashing a half-a-billion-dollar marketing blitz to move people off

Prilosec and onto Nexium, their costly, patent-protected new Purple Pill, which

even their own studies show to be barely more effective than the original.

 

How and why AstraZeneca has been able to keep the purple profits flowing sheds

more light on the nation's prescription drug crisis than reams of policy papers

and congressional testimony. The same tactics are being used by just about all

the big pharmaceutical companies, which are under intense shareholder pressure

to maintain their best-in-business profits as the patents on about 20

blockbuster drugs expire over the next couple of years.

 

That explains the ads for the new drug Clarinex that are everywhere, right down

to the white CVS bag your last prescription came in. Schering-Plough has been

feverishly working to move the itchy-eyed onto Clarinex and off its omnipresent

Claritin, whose patent expires this month. Ditto for Forest Laboratories' new

antidepressant, Lexapro, the spawn of Celexa, whose patent is set to expire at

the beginning of 2004.

 

But given the sheer numbers involved and its still-evolving nature, the Purple

Pill may be our best case study of the forces driving up prescription drug

costs. It's the story of a wondrous medical advance that brought relief to

millions and significantly reduced the need for surgery. But it's also the story

of the steroid-injected marketing muscle that has ensnared, among others,

Boston's most respected hospitals and the exhaustive legal maneuvers that have

delayed competition, helping to drive up costs for you, me, and Gertrude.

 

" This is a locomotive that's barreling down the tracks, and you either get out

of the way, get on board, or get squished, " says Dr. James Richter, a Boston

gastroenterologist.

 

First things first: This prescription drug crisis you hear everyone squawking

about - it's really so avoidable. We Americans are on pace to spend nearly $200

billion on our meds this year. That's more than the federal government paid last

year for education, agriculture, transportation, and the environment combined.

 

It matches the highest prediction of what it would cost to topple Saddam Hussein

with a full-scale attack on Iraq. Talk about a war on drugs. In any rational

world, that sum would not just cover our current pill habit but would also allow

us to pick up the drugstore tab for all those senior citizens paying out of

pocket for their high blood pressure and arthritis pills. We could spare them

the indignity of those Greyhound-bus narc-runs to Canada to score their cut-rate

Cardizem and Celebrex.

 

Who's responsible for the fact that prescription drug spending continues to rise

15 to 20 percent a year, doubling every five years?

 

The big pharmaceuticals have certainly lost much of their " best and the

brightest - making life better for you " luster. That's perhaps inevitable when

you pour more money into peddling your newest product than Nike does its

sneakers. But there's plenty of blame to go around. The government allows drug

companies to control the testing of new drugs, designing trials to suit their

interests, not the consumers'.

 

HMOs and hospitals, under their own bottom-line pressures, make deals that help

the drug manufacturers move patients to new, expensive drugs when cheaper, older

ones might do fine. Doctors operate in a world where drug maker freebies like

Red Sox tickets, Four Seasons dinners, and Arizona golf outings somehow seem

normal instead of the outrageous graft they are.

 

Now go to your bathroom and look in the mirror. There's a good chance that

you're one of those shareholders demanding higher profits from the

pharmaceutical companies, even if you don't know it. (Think about those

pharmaceutical-dense mutual funds you're counting on to pay your kid's college

tuition.) Now open the medicine cabinet.

 

Do you see a bottle of Clarinex? Or maybe there's a vial of Vioxx, the new drug

you pressed your doctor to prescribe for your arthritis, because it did wonders

for Dorothy Hamill. ( " Look how easily she can lace up her skates now! " ) Forget

the fact that several studies have questioned whether it's any more effective

than over-the-counter Advil. Or maybe there's some Viagra on the shelf. And

let's just say you're half Bob Dole's age and haven't been treated for prostate

cancer.

 

" We're in this perfect storm of forces that conspire to make it a very expensive

time, " says Dr. Thomas Lee, medical director for Partners Community HealthCare,

the largest physician network in Massachusetts. He ticks off some of the factors

driving up costs.

 

First, all that research after World War II didn't begin to bear fruit until the

1980s and 1990s. Now we have effective medicines for all kinds of conditions,

including ways to treat impotence and depression that don't involve a couch.

 

Second, we've got all these baby boomers passing through middle age and either

getting chronic disease or doing everything to avoid it. " Baby boomers don't

want to accept that they will ever die, " says Lee. Just since 1995, his Partners

group has seen a nearly one-fifth increase in the number of patients taking

medication regularly. And last, we've got pharmaceutical companies trying to get

the maximum market for the drugs they spent so much to develop. " They're not

interested in fine-tuning to make sure the people who get the new expensive

drugs are those who will really benefit from it, " Lee says. " They want everyone

for whom there is a reasonable justification. "

 

This is how it used to be: The boss would keep four bottles of Maalox in his

desk. Every three hours, he'd grab one from his bottom drawer and take a swig.

Short of surgery, there wasn't much else he could do to treat his heartburn,

which is the main symptom of gastroesophageal reflux disease.

 

Food travels from the mouth, down the esophagus, and through a sphincter muscle

to get into the stomach. Because the stomach is filled with acid potent enough

to take the rust off your car, the sphincter is supposed to relax only to let

food and drink in. But for the 25 million Americans who suffer chronic

heartburn, the muscle relaxes way too often.

 

So the acid regularly flows up into the esophagus, causing a noxious burning in

the upper abdomen and lower chest, especially after eating that third slice of

deep-dish pepperoni pizza.

 

In 1977, the Tagamet revolution began. Whereas the common antacids like Maalox

and Tums neutralized acid, prescription Tagamet blocked it. It made a huge

difference. Still, there was a group of people who needed something more

powerful than Tagamet and its successors, included in a class of drugs that came

to be known as H2 blockers.

 

In 1989, that power came in spades and in the unforgettable shade of purple.

Prilosec was the first proton pump inhibitor, or PPI. H2 blockers stop acid at

one of three possible sites in the cells of the stomach, but PPIs block it at

the final site of production. They're a fail-safe means of turning off the

stomach-juice spigot before it backs up into the esophagus. " Prilosec gave

physicians a sense of power, a sense that we can cure you, " recalls Dr. James

Reichheld, an Andover gastroenterologist.

 

Still, Prilosec was really just a niche drug when the Swedish company Astra AB

(it later merged with the British firm Zeneca) teamed up with the US firm Merck

to launch it in the United States. The US Food and Drug Administration approved

it for just two indications, or uses, for which there was a particularly limited

pool of customers. Heartburn wasn't one of them. And there were fears, later

shown to be unfounded, that the drug might have cancer risks.

 

As most drug manufacturers do, Astra continued clinical trials to win approval

for new indications to put on the Prilosec label - it eventually reached eight -

and increase its customer base. (Remember, Viagra was originally developed to

treat angina; that whole erection thing was just a pleasant surprise.)

 

Prilosec continued to grow. Then, in 1997, the FDA tied a bow on a big fat gift

to the pharmaceutical industry: relaxed rules for drug advertising. It's not

that direct-to-consumer advertising was a new phenomenon.

 

Back in 1708, Boston apothecary Nicholas Boone bought the first patent-medicine

ad, announcing in the News-Letter that he would be selling Daffy's Elixir

Salutis for four shillings and sixpence a bottle. It's just that, prior to 1997,

drug makers were required to disclose so many side effects on their ads as to

make TV spots unworkable. The new FDA rules allowed them to make their claims

unimpeded, as long as they offered a phone number or Web site or referenced a

magazine ad where consumers could get the fine print.

 

Prilosec was the perfect drug to market on TV. Millions of people have gastric

problems, and many were no doubt feeling the pain right as the commercial

flashed on the screen in front of them. Here was this incredibly effective new

medication waiting to change their lives. And when they later found themselves

sitting on a doctor's padded exam table, they didn't even have to recall the

drug's name. All they had to remember was its color.

 

Soon, Purple Pill ads were everywhere - on TV, on the Web, even on the floor of

New York's bus terminals. Hall of Fame pitcher Jim Palmer was telling anyone who

would listen how the drug had saved his broadcasting career. All those forces

helped catapult Prilosec to the top. In 1998, it became the first drug ever to

hit $5 billion a year in worldwide sales, and it didn't stop there.

 

Here's the thing: Unlike many hyped drugs, Prilosec is a wonder drug that

actually deserves its title. In dozens of interviews for this article, even

critics of the purple juggernaut got around to saying: " It's a very good drug. "

But that doesn't mean a slew of people couldn't do fine on something much

cheaper.

 

Prilosec's success prompted several competitors to come forward with their own

PPIs: Prevacid (TAP/Abbott), Aciphex (Eisai/Johnson & Johnson), and Protonix

(Wyeth). And, of course, Prilosec me-too'ed itself last year with the launch of

Nexium.

 

It's probably not surprising that me-toos have become so irresistible. Trying to

come up with genuine breakthroughs is a lot harder, riskier, and more expensive.

A recent study from Tufts University's Center for Drug Development found that it

costs an average of $802 million to develop and win approval to bring a new drug

to market in the United States.

 

Why so much? Take a drive out to Waltham to AstraZeneca R & D Boston, the

company's new three-winged structure of Minnesota limestone. Throughout four

floors of bright, impeccable labs, sneaker-clad scientists in white coats are on

the hunt for genuinely novel medicines - not me-toos - to treat cancer and

infection. In a field that has come to be dominated by talk of profits and

patents, the vital work going on behind these glass walls - testing and

retesting compounds, replicating DNA - puts some of the inspiring sheen back on

the pharmaceutical industry.

 

I ask Hans Nilsson, the Swedish native who oversees the Waltham site, why it's

so hard to hatch a new drug. He walks up to the white board in his office and

makes a series of drawings: enzyme, membrane, cell, tissue, organ, mouse, cat,

dog, monkey, human, cluster of humans.

 

Drug discovery, he says, is the attempt to make a series of increasingly complex

connections to get to the finish line. If the connection works from, say, cell

to tissue, you can move on. More often than not, it won't, so you have to return

to an earlier step. Even at the end, when you've shown a compound to be

effective and safe in thousands of humans, you might get one whose liver fails

because of toxicity caused by the drug. So you start again.

 

The vast majority of attempts will never get to the approval stage. The trick is

knowing how long to stick with it or when to pack it in. Research on omeprazole,

the generic name for Prilosec, " started in the late 1960s, " Nilsson says. " It

was launched 20 years later. Twenty years. You never know how close you might

be. "

 

[ Continued next issue ]

 

Boston Globe November 17, 2002

 

 

 

 

DR. MERCOLA'S COMMENT:

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As I said earlier this year:

 

I can assure you the number of people who actually need this drug is less than

one in 100 of those taking it. In other words, people are being prescribed drugs

for heartburn when it is one of the easiest medical problems to treat. Most

people ignore that heartburn is an important clue from their body and rely on a

drug to suppress the symptoms.

 

This is the equivalent of driving your car and ignoring the engine light that

comes on on your dashboard to warn you of a problem. Using a Band-Aid like

Prilosec to cover the light allows you to ignore the problem and, although it

may solve the problem in the short-term, the implications for ignoring this

important clue are quite obvious. You could be looking at more costly repairs by

not acknowledging the symptom.

 

So what is the solution for heartburn?

 

There are several key points:

 

1. Drink adequate amounts of clean water.

2. Follow the nutrition plan being careful to avoid sugar.

3. Use one to two cloves of raw fresh garlic per day to eradicate H. pylori,

which is a factor for many with heartburn.

4. Use high-quality probiotics.

 

And what is the solution for not getting burned by the pharmaceutical companies

any more?

 

Knowledge.

 

You can start with some of the " Related Articles " below, and I also strongly

recommend you read " Trust Us, We're Experts. " This accessible and often

startling book blows the lid right off the industries who manipulate " scientific

fact " to ridiculous (but, sadly, effective) ends to sell gobs of their harmful

products. It truly belongs on every American's bookshelf.

 

Related Articles:

 

Why Inhibiting Acid Production With Prilosec and Prevacid Could Make Ulcers

Worse

 

Prilosec and Prevacid Natural Alternatives

 

How to Cure Your Heartburn Now That Prilosec Will Go Over the Counter (OTC)

 

Dissatisfaction with Heartburn Drugs Common

 

 

 

Return to Table of Contents #386

 

 

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