Medical & Business Ethics and Gorillas

[Guest guest]

Medical & Business Ethics and Gorillas

http://www.redflagsweekly.com/articles/2004_dec03.html

 

Thomas A. Braun RPh

 

In my business career as a pharmaceutical buyer and later as a Drug

Marketing executive, I had nothing but the highest respect for Merck. They

had an image of impeccable business and medical ethics and they ran their

own show. This image was confirmed by trade surveys year after year.

Somewhere along the way, they started to lose focus on healthcare and the

focus shifted to the bottom line.

 

When Clinton was running for the presidency, he often showed up in the

company of Merck. This week, Arianna Huffington wrote a biting article

about Merck’s fall from grace titled “You want a Moral Issue? How about

drugs that don’t kill”. The theme is that the Democrats should come

together and open the medicine chest and clean up the hidden mess that is

inside.

 

The problem is that the Democratic Party has long shared in the money dole

from the pharmaceutical manufacturers. It’s somewhere around a 60-40

split, with the Republicans getting the bigger piece of the donation pie.

Big Pharma has always hedged their bets and it doesn’t matter which party

is running this country because they have seduced most of the Congressmen

with money and junkets and the like. Phil Crane from Illinois, one of Big

Pharma’s champions was not re-elected this fall. Abbott Laboratories, in

his former district, has paid over 100 million dollars in fines for not

following Good Manufacturing Practices. Total fines and judgments have

been over one billion dollars in the last five years for Abbott, the

Champion fine payer. [1] Another 7 Pharmaceutical manufacturers accounted

for an additional one Billion plus dollars in fines and penalties paid for

fraudulent business practices over the last five years. The only way you

recoup these losses is to raise your prices.

 

A 300-pound Gorilla has been let out of the cage called Vioxx. There is

another Gorilla rocking his cage called Statin. Back in the early 1980’s,

time-release Niacin (which is a vitamin) was beginning to gain acceptance

by physicians as a way to control high cholesterol. It appeared to work in

many cases. Was not expensive and if you didn’t overdose on it, you were

in great shape.

 

I remember reading a Clinical paper, when it was first published, about a

10 patient study from the St. Louis VA hospital that claimed that Niacin

caused liver damage. No one confirmed that the liver of these 10 VA

patients was normal before the study began. Mysteriously, this small study

got nation wide press and Niacin was discredited.

 

Within 90 days of the nationwide negative publicity on Niacin, the first

prescription statin drug was marketed by none other than Merck. All those

who were worried about their cholesterol levels were saved. The drug was

called Mevacor. Would anyone suggest that Merck primed the pump for their

new drug by discrediting Niacin? This was the first of a long line of

cholesterol-lowering drugs called Statins. Today, the most popular ones

are Merck’s Mevacor and Pfizer’s Lipitor. Baycol from Bayer was removed

from the market due to its deadly side effects. Class Action law suits

continue to this day. Crestor is under attack for its high side effect

profile and may be the next drug to be removed from the market. In the

meantime, Statin drugs produce about $20 billion dollars in sales for the

manufacturers and everyday these drugs remain on the market they provide a

power house of profit.

 

It still is an open question today whether high cholesterol causes Heart

disease. Is it the cause or an effect? Some medical researchers theorize

that inflammation of the artery walls which is caused by unknown pathogens

& /or immune system responses causes the body to send out cholesterol to

repair the weakening wall of the artery. [2]

 

More of a Band-Aid response rather than a cause. This is why statin drugs

that suppress the liver’s cholesterol production is prescribed. All the

consumer ads for these Statin drugs warn that there is a danger of liver

damage. Sound Familiar?

 

In the process of creating the first statin drug, Merck discovered that an

essential enzyme called Co Enzyme Q 10 is reduced in the body if you take

a statin drug that suppresses your cholesterol. Cells in your body require

Co Enzyme Q 10 as well as cholesterol, but medical researchers pushed on

with the concept that high cholesterol is bad for you and ignored the

consequences of too little cholesterol or Q 10 in the body. Over the years

the manufacturers have convinced physicians that lower and lower values of

cholesterol should be the norm. Early on 220 was considered the upper

limit of normal. Now, Pfizer has been promoting that 150 is the max.

Profit motives surpass realistic medical guidelines.

 

In 1990, Merck received a patent for the combination drug of lovastatin

and Co Enzyme Q 10. (Patent#’s 4929437 & 4933165). They have never

marketed this combination drug. Today, 14 years later, neither the NIH nor

FDA nor any other medical authority has demanded that the way Statins are

prescribed and patients are treated has to be changed to include the

supplement Co Enzyme Q 10. I would have thought that if they were not

going to market this combination of drug, at least they would have told

the prescribing physicians that a Q 10 supplement should be taken along

with the statin drug. So much for patient concerns and medical ethics.

Medical Ethics has been relegated to the rear of the classroom and in many

cases has never left academia. How else can you explain the lack of outcry

from physicians for being convinced to prescribe a class of drugs that may

do harm not only to the liver but also the heart that requires adequate Co

Enzyme Q 10 to function properly. [3]

 

When this 1000-pound Gorilla called Statin comes out of his cage and his

rampaging is heard, then maybe the Democrats and the Republicans will

learn how to spell the word “Bipartisanship”.

 

US Healthcare ranks 37th in the World and, at almost 15% GDP, costs the

majority of the citizens twice what it does in the other countries that

deliver better healthcare to their citizens. There are 45 million

Americans who can’t afford healthcare at all. I can’t understand why the

physicians of this country don’t demand complete and honest medical

information and take back their profession from special interests.

 

Restoring Medical & Business Ethics to the Pharmaceutical Arena would go

along way in improving Healthcare in the US and reducing costs.

 

President Bush is proposing Selfcare as part of the solution, which is

what 45 million Americans practice because they can’t afford Healthcare.

Congress does not want to act to reduce medical costs because of their

dependence on Campaign Contributions from medical sources for 100’s of

millions of dollars in campaign funds. Their attitude, while 100’s of

thousands die from avoidable medical events, seems to be. “Let’s not stop

the medical carpetbaggers; it may be bad for politics.”

 

 

 

Copyright,2004 Thomas Braun RPh

 

 

 

1. HHS Semiannual Report to Congress 10/1/03 to 3/31/2004, Top 100

False Claims Act Cases

2. The Inflammation Syndrome, 2003 Jack Challem

3. Peter H. Langsjoen, MD., F.A.C.C. presentation to FDA

 

Thomas A. Braun RPh

 

In my business career as a pharmaceutical buyer and later as a Drug

Marketing executive, I had nothing but the highest respect for Merck. They

had an image of impeccable business and medical ethics and they ran their

own show. This image was confirmed by trade surveys year after year.

Somewhere along the way, they started to lose focus on healthcare and the

focus shifted to the bottom line.

 

When Clinton was running for the presidency, he often showed up in the

company of Merck. This week, Arianna Huffington wrote a biting article

about Merck’s fall from grace titled “You want a Moral Issue? How about

drugs that don’t kill”. The theme is that the Democrats should come

together and open the medicine chest and clean up the hidden mess that is

inside.

 

The problem is that the Democratic Party has long shared in the money dole

from the pharmaceutical manufacturers. It’s somewhere around a 60-40

split, with the Republicans getting the bigger piece of the donation pie.

Big Pharma has always hedged their bets and it doesn’t matter which party

is running this country because they have seduced most of the Congressmen

with money and junkets and the like. Phil Crane from Illinois, one of Big

Pharma’s champions was not re-elected this fall. Abbott Laboratories, in

his former district, has paid over 100 million dollars in fines for not

following Good Manufacturing Practices. Total fines and judgments have

been over one billion dollars in the last five years for Abbott, the

Champion fine payer. [1] Another 7 Pharmaceutical manufacturers accounted

for an additional one Billion plus dollars in fines and penalties paid for

fraudulent business practices over the last five years. The only way you

recoup these losses is to raise your prices.

 

A 300-pound Gorilla has been let out of the cage called Vioxx. There is

another Gorilla rocking his cage called Statin. Back in the early 1980’s,

time-release Niacin (which is a vitamin) was beginning to gain acceptance

by physicians as a way to control high cholesterol. It appeared to work in

many cases. Was not expensive and if you didn’t overdose on it, you were

in great shape.

 

I remember reading a Clinical paper, when it was first published, about a

10 patient study from the St. Louis VA hospital that claimed that Niacin

caused liver damage. No one confirmed that the liver of these 10 VA

patients was normal before the study began. Mysteriously, this small study

got nation wide press and Niacin was discredited.

 

Within 90 days of the nationwide negative publicity on Niacin, the first

prescription statin drug was marketed by none other than Merck. All those

who were worried about their cholesterol levels were saved. The drug was

called Mevacor. Would anyone suggest that Merck primed the pump for their

new drug by discrediting Niacin? This was the first of a long line of

cholesterol-lowering drugs called Statins. Today, the most popular ones

are Merck’s Mevacor and Pfizer’s Lipitor. Baycol from Bayer was removed

from the market due to its deadly side effects. Class Action law suits

continue to this day. Crestor is under attack for its high side effect

profile and may be the next drug to be removed from the market. In the

meantime, Statin drugs produce about $20 billion dollars in sales for the

manufacturers and everyday these drugs remain on the market they provide a

power house of profit.

 

It still is an open question today whether high cholesterol causes Heart

disease. Is it the cause or an effect? Some medical researchers theorize

that inflammation of the artery walls which is caused by unknown pathogens

& /or immune system responses causes the body to send out cholesterol to

repair the weakening wall of the artery. [2]

 

More of a Band-Aid response rather than a cause. This is why statin drugs

that suppress the liver’s cholesterol production is prescribed. All the

consumer ads for these Statin drugs warn that there is a danger of liver

damage. Sound Familiar?

 

In the process of creating the first statin drug, Merck discovered that an

essential enzyme called Co Enzyme Q 10 is reduced in the body if you take

a statin drug that suppresses your cholesterol. Cells in your body require

Co Enzyme Q 10 as well as cholesterol, but medical researchers pushed on

with the concept that high cholesterol is bad for you and ignored the

consequences of too little cholesterol or Q 10 in the body. Over the years

the manufacturers have convinced physicians that lower and lower values of

cholesterol should be the norm. Early on 220 was considered the upper

limit of normal. Now, Pfizer has been promoting that 150 is the max.

Profit motives surpass realistic medical guidelines.

 

In 1990, Merck received a patent for the combination drug of lovastatin

and Co Enzyme Q 10. (Patent#’s 4929437 & 4933165). They have never

marketed this combination drug. Today, 14 years later, neither the NIH nor

FDA nor any other medical authority has demanded that the way Statins are

prescribed and patients are treated has to be changed to include the

supplement Co Enzyme Q 10. I would have thought that if they were not

going to market this combination of drug, at least they would have told

the prescribing physicians that a Q 10 supplement should be taken along

with the statin drug. So much for patient concerns and medical ethics.

Medical Ethics has been relegated to the rear of the classroom and in many

cases has never left academia. How else can you explain the lack of outcry

from physicians for being convinced to prescribe a class of drugs that may

do harm not only to the liver but also the heart that requires adequate Co

Enzyme Q 10 to function properly. [3]

 

When this 1000-pound Gorilla called Statin comes out of his cage and his

rampaging is heard, then maybe the Democrats and the Republicans will

learn how to spell the word “Bipartisanship”.

 

US Healthcare ranks 37th in the World and, at almost 15% GDP, costs the

majority of the citizens twice what it does in the other countries that

deliver better healthcare to their citizens. There are 45 million

Americans who can’t afford healthcare at all. I can’t understand why the

physicians of this country don’t demand complete and honest medical

information and take back their profession from special interests.

 

Restoring Medical & Business Ethics to the Pharmaceutical Arena would go

along way in improving Healthcare in the US and reducing costs.

 

President Bush is proposing Selfcare as part of the solution, which is

what 45 million Americans practice because they can’t afford Healthcare.

Congress does not want to act to reduce medical costs because of their

dependence on Campaign Contributions from medical sources for 100’s of

millions of dollars in campaign funds. Their attitude, while 100’s of

thousands die from avoidable medical events, seems to be. “Let’s not stop

the medical carpetbaggers; it may be bad for politics.”

 

1. HHS Semiannual Report to Congress 10/1/03 to 3/31/2004, Top 100

False Claims Act Cases

2. The Inflammation Syndrome, 2003 Jack Challem

3. Peter H. Langsjoen, MD., F.A.C.C. presentation to FDA