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Tue, 25 May 2004 08:50:13 -0500

HSI - Jenny Thompson

Easy as O.T.C.

 

Easy as O.T.C.

 

Health Sciences Institute e-Alert

 

May 25, 2004

 

************************************************************

 

Dear Reader,

 

When the needs of a government are in sync with the needs of

one of the largest drug companies in the world, it's a win-

win situation for everyone.

 

Well, not exactly everyone. Can you guess who gets the short

end of the stick in this situation? You don't have to be a

brain surgeon to figure out that consumers are going to

lose. And while the average Joe may end up opening his

wallet (as the drug companies and government prosper), the

real problem here is all about health.

 

-----------------------------

Goodbye, middleman

-----------------------------

 

Just days ago, Dr. John Reid, the UK Health Secretary made

it official: Backed by the Committee on Safety of Medicines,

the cholesterol-lowering statin drug Zocor will soon be

available over-the-counter (OTC) in 10 mg doses. The UK will

be the only country in the world where a statin drug is

available without a prescription.

 

Last year, the UK patent for Zocor ran out, so going OTC

will provide a huge boost for Merck & Co., the manufacturer

of the drug. And this idea apparently wasn't a hard sell to

the UK government bean counters. If enough patients purchase

the OTC statin, eventually OTC may become the norm for

statins. And when doctors stop writing statin prescriptions,

the National Health Service (NHS) will save hundreds of

millions by not having to foot the bill.

 

According to Reuters Health, 1.5 million Britons are

currently taking statin drugs, at a cost to the NHS of about

750 million pounds each year.

 

All of this is just a matter of doing business, of course.

Drug companies, just like all companies, work situations to

their advantage to turn a profit. But in this case, the

bottom-line interests of corporations and the government

will reveal the potential dangers of statin drugs by cutting

out the middlemen: doctors.

 

-----------------------------

Miracle mirage

-----------------------------

 

Zocor may cause muscle pain or weakness, as well as liver

problems, according to the Zocor web site (zocor.com). The

site also notes that, " Your doctor may do blood tests before

and during treatment with Zocor to check for liver problems.

To avoid serious side effects, discuss with your doctor

medicine or food you should avoid while on Zocor. "

 

But when Zocor Heart-Pro (the OTC brand name) becomes

available this summer, there will be no doctor standing

between the drug and the patient. According to the UK

newspaper The Independent, pharmacists will ask questions of

prospective customers, but no blood tests or cholesterol

tests will be performed.

 

Of course, all responsible patients will tell their doctors

if they're using Zocor Heart-Pro, and all responsible

doctors will carefully monitor their patients accordingly.

But it's pretty obvious that this best-case scenario won't

be followed in 1.5 million cases.

 

And, if the ephedra " crisis " was any indication, people

won't stop at the recommended dosage. " If 10 mg will lower

my cholesterol 10%, just imagine how quickly my heart will

be healthier if I take 50 mg! "

 

Meanwhile, the mainstream press in the UK has mostly

embraced the idea of statins as a safe wonder-drug. An April

headline in The Independent read: " A New Pill for All Ills. "

And the accompanying article described statins as a " cure-

all to rival aspirin. " When an influential paper like The

Independent compares statins to aspirin, there's a good

chance that consumers will assume that this miracle drug is

as safe as aspirin too.

 

So a great number of Zocor Heart-Pro users will actually be

signing on to participate in a long-term study to find out

what happens when statin use is not monitored by a

physician.

 

-----------------------------

Man overboard

-----------------------------

 

When the official word was announced about the OTC decision

for Zocor, The Independent Health Editor Jeremy Laurance

stated that statins have saved " tens of thousands of lives, "

and, " are thought to save between 6,000 and 7,000 lives a

year. "

 

This is the familiar myth offered by statin supporters. In

fact, a 2003 study reported in the Journal of the American

Medical Association showed a quite different outcome.

 

Over a period of four years, researchers compared the use of

the statin Pravachol to " usual care " (maintaining proper

body weight, no smoking, regular exercise, etc.) in 10,000

subjects who participated in the Antihypertensive and Lipid-

Lowering Treatment to Prevent Heart Attack Trial - better

known as ALLHAT.

 

Of those in the group that received 40 mg of Pravachol

daily, 28% lowered their LDL cholesterol significantly. In

the usual care group, about 11% had a similar drop in LDL.

More importantly, however, both groups showed the same rates

of death, heart attack and heart disease.

 

So the statin group lowered its LDL more than twice as

effectively as the usual care group, but didn't experience

any fewer heart attacks or deaths than the usual care

subjects. Given the length of this study and the number of

participants, the results don't support the idea that

statins save " tens of thousands of lives. " And this is

certainly less than a ringing endorsement when you consider

that the drugs carry unpleasant side effects, but are

only " significantly " effective in about one in four people.

 

-----------------------------

Back stateside

-----------------------------

 

The FDA has so far rejected several attempts by drug

companies to introduce OTC statins in the U.S. So no doubt,

drug executives and FDA officials will be paying close

attention to how things go in the UK. And you can be sure

that Merck and other statin makers will be putting a feel-

good spin on the outcome, tempting the U.S. to climb on

board the statin express.

 

Meanwhile, the UK has taken a huge step toward turning

Britain into a drug company's dream come true: a statin

nation.

 

**************************************************************

To start receiving your own copy of the HSI e-Alert, visit:

http://www.hsibaltimore.com/ealert/freecopy.html

Or forward this e-mail to a friend so they can sign-up to

receive their own copy of the HSI e-Alert.

 

**************************************************************

 

... and another thing

 

Remember when you had to actually get off the couch to

change the channel on your TV set? Or get out of the car to,

dare I say it, open the garage door by hand? I thought about

both these things when I came across an item about the

exercise habits of Americans. According to a study in the

International Journal of Behavioral Nutrition, most

Americans spend much more time in their cars or watching TV

than they spend exercising.

 

In a survey of more than 7,500 adults, the data showed that

the average American devotes nearly 3 hours per day to TV

viewing - 9 times the amount they apply to exercise.

 

Maybe technological advances like remotes and garage door

openers are a big part of the problem. Remember how Fred

Flintstone tooled around Bedrock in a car powered by " Fred's

two feet " ? Just think: If we all drove Flintstone cars, we'd

get plenty of exercise while we zip frantically from here to

there. Fred never seemed to shake off that pear shape, but I

bet his heart was as strong as a brontosaurus.

 

The television/driving/exercise study comes on the heels of

a new report from the Department of Health and Human

Services that doubles the previous estimate of the number of

people in the U.S. who are pre-diabetic. The HHS report puts

the new figure at 41 million. That's the population of

California and New Jersey combined, who are driving or

watching TV instead of exercising.

 

Obviously, it's time to pull over, park the car and hook the

television up to a generator that's powered by a treadmill

or an exercise bike.

 

All those in favor say, " Yabba dabba do! "

 

To Your Good Health,

 

Jenny Thompson

Health Sciences Institute

 

**************************************************************

To start receiving your own copy of the HSI e-Alert, visit:

http://www.hsibaltimore.com/ealert/freecopya.html

Or forward this e-mail to a friend so they can sign-up to

receive their own copy of the HSI e-Alert.

 

**************************************************************

 

Sources:

" Merck Heart Drug Set to go Over Counter in Britain " Reuters

Health, 5/10/04, forbes.com

" A New Pill for All Ills " Roger Dobson, The Independent,

4/26/04, news.independent.co.uk

" Heart Drug Will be Sold by Chemists Without Prescription "

Jeremy Laurance, The Independent, 5/13/04,

news.independent.co.uk

" Major Outcomes in Moderately Hypercholesterolemic,

Hypertensive Patients Randomized to Pravastatin vs Usual Care "

Journal of the American Medical Association, Vol. 288,

No. 23, 2998-3007, 12/18/02, jama.ama-assn.org

" Common Cholesterol Drug Lowers Cholesterol but Not Death

Rate " Dr. Joseph Mercola, 1/4/03, mercola.com

" Americans Drive, Watch TV More Than Exercise - Study "

Reuters Health, 3/11/04, reutershealth.com

" Millions Estimated to be Pre-Diabetic " Associated Press,

4/29/04, cnn.com

 

************************************************************

Before you hit reply to send us a question or request,

please visit here http://www.hsibaltimore.com/ealert/questions.html

 

************************************************************

If you'd like to participate in the HSI Forum, search past

e-Alerts and products or you're an HSI member and would like

to search past articles, visit http://www.hsibaltimore.com

 

************************************************************

 

 

 

 

 

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