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Wed, 5 Mar 2003 11:40:01 -0500

HSI - Jenny Thompson

Pot, Meet Kettle

 

POT, MEET KETTLE

 

Health Sciences Institute e-Alert

 

March 5, 2003

 

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

 

Dear Reader,

 

I've just come across what may be the most astonishing

comment I've ever seen in defense of a drug company. I have

read and reread this comment, and I still find it hard to

believe.

 

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

From the mouths of litigators

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

 

Bayer, the German based pharmaceutical giant, is being sued

by more than 10,000 patients who have reported serious

health problems as the result of taking Bayer's cholesterol

lowering drug called Baycol (which was taken off the market

in 2001). Some of those lawsuits have been brought by

families of patients who have died from kidney failure

caused by Baycol.

 

Bayer representatives deny the allegations that Baycol has

caused death and permanent health damage. Nevertheless, the

company has already settled almost half of the cases, with

some payouts reportedly up to $1.2 million.

 

But not all of the lawsuits have been settled out of court,

and the first of them to reach the litigation stage began

its trial two weeks ago in Corpus Christi, Texas. And that's

where we hear the comment that stopped me in my tracks,

straight from one of the attorneys for Bayer.

 

According to the New York Times, he stated that Baycol was

taken off the market because physicians had not been

prescribing the drug as directed.

 

Amazing, but true. That's the best defense the Bayor legal

team could come up with. They actually want us to believe

that Baycol is not to blame for those deaths and for

hundreds of patients who will spend the rest of their lives

receiving dialysis treatments. In fact, (as the statement

implies) Baycol might still be on the market if only doctors

could be trusted to read the label and correctly prescribe

the drug. It's not Baycol's fault - it's all those negligent

doctors! (They must have missed the presentation (given over

a $1,500 dinner or a free round of golf) on the proper way

to prescribe the drug.)

 

But even if there was some misunderstanding on the part of

physicians, Bayer executives were apparently well aware that

their product was more dangerous than other statin drugs

throughout the entire period Baycol was available. Let's

have a look.

 

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

Telling timeline

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

 

The statin drug market is huge - one of the largest

moneymakers for international drug companies. In the year it

was taken off the market, Bayer had projected $600 million

in annual sales of Baycol. There was just one problem.

Baycol created a dangerous side effect called rhabdomyolysis

(known more simply as rhabdo), which causes muscle cells to

deteriorate and enter the blood stream. Muscle weakness and

pain are the obvious symptoms, with the most serious cases

leading to kidney failure, paralysis and death.

 

A quick timeline of the life of Baycol reveals just about

everything you need to know about how the dangers of this

drug were balanced against its market value:

 

* June 26, 1997 - Baycol approved by the FDA.

* June 27, 1997 - " Simple and safe no longer appears to be a

viable marketing platform, " states an executive of a Bayer

marketing partner in a memo in which he expresses concerns

that Baycol is known to cause adverse drug interactions

that, " could be magnified at higher doses. "

* Early 1998 - Bayer begins marketing Baycol.

* Summer 1998 - Doctors begin reporting serious side effects

with Baycol usage.

* May 1999 - The FDA approves a stronger dosage of Baycol.

* October 1999 - The FDA warns Bayer that sales materials of

Baycol are " false, lacking in fair balance or otherwise

misleading. "

* July 2000 - The FDA approves yet another higher dosage of

Baycol

* November 2000 - An analysis by Bayer shows that Baycol

users have 5 to 10 times greater chance of developing

rhabdo than those using other statin drugs.

* July 2001 - Having received increasing reports of deaths

attributed to Baycol use, the FDA expresses concerns to

Bayer executives.

* August 2001 - Bayer removes Baycol from the market.

 

All of this information was revealed as the Corpus Christi

trial got underway and Bayer company memos were made public

for the first time.

 

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

The tradeoff

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

 

As I've mentioned many times in previous e-Alerts (most

recently in " Rolling Back the Red " 11/25/02) the mainstream

medical establishment has done a wonderful job of selling

the idea that lower cholesterol levels are the end-all and

be-all of cardiovascular health. Unfortunately, that fact

simply isn't true. But that doesn't stop people from

continuing to risk the side effects of statin drugs in order

to get that dreaded LDL level down. And it certainly doesn't

stop the drug companies from continuing to look for

cholesterol-lowering stars.

 

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

 

....and another thing

 

I wouldn't normally report on a study from a school of

veterinary medicine (in this case, from Purdue University),

but a recent study of dogs helps confirm the cancer fighting

value of an essential nutrient that we've told you about in

many e-Alerts and Members Alerts.

 

The canine is the only species that shares an unfortunate

trait with humans: prostate cancer is common, occurs

spontaneously, and is complicated by the aging process.

 

Knowing this, Purdue researchers tested the effects of a

selenium-enriched diet on elderly beagle dogs, and then

examined their prostate cells to determine age related DNA

damage. Results showed that the dogs receiving selenium

experienced significantly less damage to prostate cells.

 

In a recent e-Alert ( " Most Valuable Mineral " 12/4/02), I

told you about a study that showed how selenium may activate

an important tumor-suppressing gene that is mutated in a

large majority of all cancers. In addition to prostate

cancer, selenium may lower the risk of breast, colorectal

and lung cancers.

 

Purdue scientists believe that their results with dogs

indicate a promising possibility that an increased intake of

selenium may provide protection from DNA damage to the

prostate cells of older men.

 

Protein rich foods such as meats and fish contain good

amounts of selenium. But the most potent dietary source of

selenium is the Brazil nut. One ounce of Brazil nuts

contains more than 800 mcg of selenium - well above the

recommended daily intake of 50 mcg.

 

As I mentioned in the December e-Alert, too much selenium

can be toxic, but that would require an intake of more than

2,500 mcg per day for an extended period of time. So while

the chances of getting a dangerous dose are very slim, the

chances of helping prevent and fight cancer with a generous

daily intake of selenium appear to be very good.

 

To Your Good Health,

 

Jenny Thompson

Health Sciences Institute

 

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

 

 

Sources:

" Papers Indicate Bayer Knew of Dangers of Cholesterol Drug "

Melody Peterson and Alex Berenson, The New York Times,

2/22/03

" Bayer: Cannot Forecast Litigation Outcome " Sitaraman

Shankar, Reuters, 2/26/03

" Investors Dropping Bayer's Stock for Fear of Baycol

Lawsuits " Mark Landler, The New York Times, 2/27/03

" Selenium May Fight Prostate Damage / Supplementation May

Reduce Prostate Cancer Risk " Jennifer Warner, WebMD Medical

News, 2/4/03

 

Copyright ©1997-2003 by www.hsibaltimore.com, L.L.C.

The e-Alert may not be posted on commercial sites without

written permission.

 

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

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

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

 

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

To learn more about HSI, call (203) 699-4416 or visit

http://www.agora-inc.com/reports/HSI/WHSIC313/home.cfm.

 

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

 

 

 

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