Re: Re: interesting - - My Rant on the Arava Petition

[Guest guest]

Hi, Lucy. Don't apologize for voicing your opinion, no matter the

length, here. We welcome all points of view.

I can understand that it is disheartening for those, like you, who have

found relief with Arava (leflunomide) to hear calls for its withdrawal

from the market. Yet, I do believe an inquiry into the product's safety

is necessary. The data we have so far on leflunomide are disturbing,

especially since its effectiveness in most (of course, there are

exceptions) patients is hardly astonishing.

Although the relative numbers of deaths and hospitalizations are small,

leflunomide is also a relatively new drug (approved by the FDA in

September of 1998 in the US). What does the future hold for long-time

leflunomide users?

On the one hand, not all adverse reactions are reported. Have more

people been harmed by Arava than we know about? Undoubtedly. Some

estimates are that less than 10% of adverse drug reactions are reported

to the FDA:

http://my.webmd.com/content/article/1728.55257

http://depts.washington.edu/druginfo/DTT/2001_Vol30_Files/V30N4.pdf

http://www.sma.org/smj2001/aprsmj01/brown.pdf

On the other hand, when adverse reactions are reported, they are hard to

sort out, especially when they relate to drugs used to treat a disease

like RA (where it is likely that other drugs are being used as well and

comorbid conditions exist). The question becomes: is the adverse

reaction truly due to Arava or something else? Hard to say in all cases;

however, even with that in mind, the results to date are highly

suspicious.

As I see it, arguments can be made on both sides, but isn't it safer to

err on the side of caution?

What would Dr. Yocum, director of the Arizona Arthritis Center,

who previously headed an FDA advisory panel that reviews arthritis

drugs, have to gain by recommending that Arava be pulled from the

market?

Aside from legitimate worry about future possible deaths and injury

directly due to leflunomide use, the legal ramifications are also worth

considering. We keep it on the market and we run the risk of creating

new, big business for some lawyers. We all pay for those multi-million

dollar suits in one way or another. Crude, but true.

I agree, resentment is a valid feeling when others try to control our

decisions, our lives, but I don't believe that Public Citizen is

motivated by anything but a desire to do what is best for the majority

and to give the public a voice against powerful special-interest groups

and those who are influenced by them. The FDA's and Aventis' motivations

for what they do may be quite different. We need watchdog groups to

question the actions of those who may at times be influenced by money

more than by concern for what is best for public health.

In addition, what is extremely sad in this realm is that insurers

pressure physicians to try less expensive drugs first, without letting

safety or efficacy enter the equation; Arava over Enbrel or Remicade,

for example. How many physicians have prescribed Arava for their

patients because it's cheaper than either Enbrel or Remicade, not

because it works better or is safer?

In March of 2001, after less than two years on the European market,

the European Medicines Evaluation Agency (EMEA) issued its own cautions

regarding leflunomide:

http://www.who.int/medicines/library/qsm/drugalert/alert101.html

From the Australian Adverse Drug Reactions Bulletin, Volume 20, Number

2, June 2001:

http://www.health.gov.au/tga/docs/html/aadrbltn/aadr0106.htm#leflu

The American College of Rheumatology (ACR) has issued guidelines for

monitoring leflunomide:

http://www.rheumatology.org/research/hotline/0801leflunomide.html

How many physicians adhere to those guidelines? Is your physician

following them? I don't think we can count on physician and patient

education to keep people from being harmed by unsafe prescription drugs.

Study after study shows that both groups fall far short of the

knowledge, investigation, vigilance, and compliance required when it

comes to following the rules and recommendations regarding prescription

medications.

In my experience with our own group, I am flabbergasted every time I

hear of someone being started on a DMARD without the precautionary

baseline laboratory tests done. It happens much too frequently.

I do understand your frustration, Lucy, but we need to know that the

drugs approved by the FDA for the treatment of rheumatoid arthritis

are reasonably safe. Could leflunomide be safe for some individuals?

Yes. But what if is it is unsafe for most individuals though and, on top

of that, not as effective as methotrexate? Is it worth risking lives

over?

[ ] Re: interesting - - My Rant on the Arava Petition

< -- rant on -- >

This has been out for several days and I did some checking into

the " Private Citizen " website and other information. I am truely

concerned that this watchdog group has petitioned for the ban on

Arava. Lets see, 22 deaths, that may or may not be totally

attributable to Arava, out of how many thousands of prescriptions

that have helped a lot of RA sufferes when there was nothing else

that works for them. RA itself is a risk and so are many of the other

treatments we take so we can lead more normal lives.

I have recently read and been involved in other discussions on this

topic on other groups. A lot of those I have spoken with do

NOT want Arava banned, neither do I. Besides, I don't like some

watchdog group founded by Ralph Nader deciding for me that I do not

have the right to make my own decisions on what risks I can or can't

take. " Public Citizen is a national, nonprofit consumer advocacy

organization founded by Ralph Nader in 1971 to represent consumer

interests in Congress, the executive branch and the courts. " You can

check out the " Private Citizen " web site at: http://www.citizen.org

The full text of the petition can be seen in PDF format at:

http://www.citizen.org/documents/1614.pdf

Myself and others have sent letters and e-mails to the head of

the 'Dept of Health and Human Resources' asking that Arava not be

banned based on this petition. Below is the letter that I wrote:

=======================================

Mr. Tommy G.

Department of Health and Human Services

200 Independence Avenue, SW

Washington, DC 20201

Mr. ;

Please do NOT remove Arava from the market. An organization called

Public Citizen has taken it upon themselves to petition the FDA to

take Arava away from those of us that need it. Their petition is at:

http://www.citizen.org/documents/1614.pdf .

Myself, like so many others with Rheumatoid Arthritis, are in need of

the Arthritis Drug Arava, also known as leflunomide and produced by

Aventis. There are those that have been on many of the other Disease

Modifying Rheumatoid Arthritis Drugs but find ourselves still trying

to find a treatment that will help us to lead more normal and

productive lives. Those of us that live with this disease everyday

know the risks involved in the medications we must take. We also

know what our lives would be like if we had no more options available

and all other treatments have either failed or have produced side

effects that may be even more life threatening to some of us.

I question whether the group Public Citizen and the individuals that

would like to make this treatment no longer available have ever

experienced the disabling pain, fatigue and disfigurement that is the

future of those with this disease, Rheumatoid Arthritis? For those

who suffer with RA, the availability or Arava has finally given them

a chance to live a life closer to what the healthy consider normal

lives. Their comparison to Methotrexate may or may not be

legitimate, but does no good for those like myself who have had other

severe side effects or who no longer find relief from Methotrexate.

I believe that strong education to Doctors and Rheumatologists that

would prescribe the drug should be considered and implemented before

such drastic action, such as banning it, takes place. It is possible

to more closely monitor patients for possible liver complications and

stop it's use if necessary. Please do NOT eliminate the last

recourse for many Rheumatoid Arthritis patients based on a public

advocacy group that may or may not even understand what we and our

families must live with every day, for the rest of our lives.

Sincerely,

Lucy Summers

=======================================

Ok, I have said my piece. I hope every RA sufferer will take a long

look at both sides of this situation and make up their own minds. If

you, like myself decide that you do NOT want Arava banned, your are

more than welcome to use my letter. You can use it as or modify it as

you choose. The regular snail mail address is in the letter. The e-

mail address for Mr. is: HHS.Mail@... I also sent a

copy my letter to the " Private Citizen " group at: hrg1@...

< -- rant off -- >

I apologize, I know this is somewhat of a long rant, but I feel I

have to do what I can to at least help make sure the FDA gives all

sides of this issue equal time to be heard. Also, I hope others will

give consideration to this response and maybe send their own letter

to Mr. .

MomBom - <©¿©>

[Guest guest]

E. Yocum, MD, receives grant/research support from Centocor, Inc.,

Boehringer Ingelheim, Searle, and Merck. In addition, Dr. Yocum acts as a

consultant for Boehringer Ingelheim and participates in the Speakers Bureau for

Centocor and Boehringer Ingelheim.

http://216.239.33.100/search?q=cache:ErUo3mQs244C:www.medscape.com/CMECircle/rhe\

umatology/2001/CME01/public/author.html+Dr.++Yocum & hl=en & ie=utf-8

Unfortunately I don't have much faith in the FDA to be watchdogs for us. The

fact that Aspartame / Nutrasweet is still on the market after thousands of

adverse reactions being reported doesn't sit to well with me. So many of these

inquiries into different treatments are a result of competitive companies

complaining about each other to get the edge in the market.

I agree 100% that this drug has to be closely monitored and the patients must

know the risks involved in taking it. As you say, so many doctors do not do the

recommended testing. I hope that this article from Public Citizen will educate

the patients as to the risks and also the doctors so that they will perform the

recommended testing. I will be curious to see Aventis' response to this

article.

The first 3 months that Celebrex was on the market, it was linked to 10 deaths

and 11 cases of gastrointestinal hemorrhages.

http://www.ethicalinvesting.com/monsanto/news/10046.htm

One study estimated that 20,000 hospitalizations and 2,600 deaths each year

could be linked to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) in

rheumatoid patients. According to the FDA, " 200,000 cases of gastrointestinal

bleeding, with 10,000 to 20,000 deaths, occur each year due to the 68 million

prescriptions of NSAIDs, used for arthritis.

So where does this leave us?

a

[ ] Re: interesting - - My Rant on the Arava Petition

< -- rant on -- >

This has been out for several days and I did some checking into

the " Private Citizen " website and other information. I am truely

concerned that this watchdog group has petitioned for the ban on

Arava. Lets see, 22 deaths, that may or may not be totally

attributable to Arava, out of how many thousands of prescriptions

that have helped a lot of RA sufferes when there was nothing else

that works for them. RA itself is a risk and so are many of the other

treatments we take so we can lead more normal lives.

I have recently read and been involved in other discussions on this

topic on other groups. A lot of those I have spoken with do

NOT want Arava banned, neither do I. Besides, I don't like some

watchdog group founded by Ralph Nader deciding for me that I do not

have the right to make my own decisions on what risks I can or can't

take. " Public Citizen is a national, nonprofit consumer advocacy

organization founded by Ralph Nader in 1971 to represent consumer

interests in Congress, the executive branch and the courts. " You can

check out the " Private Citizen " web site at: http://www.citizen.org

The full text of the petition can be seen in PDF format at:

http://www.citizen.org/documents/1614.pdf

Myself and others have sent letters and e-mails to the head of

the 'Dept of Health and Human Resources' asking that Arava not be

banned based on this petition. Below is the letter that I wrote:

=======================================

Mr. Tommy G.

Department of Health and Human Services

200 Independence Avenue, SW

Washington, DC 20201

Mr. ;

Please do NOT remove Arava from the market. An organization called

Public Citizen has taken it upon themselves to petition the FDA to

take Arava away from those of us that need it. Their petition is at:

http://www.citizen.org/documents/1614.pdf .

Myself, like so many others with Rheumatoid Arthritis, are in need of

the Arthritis Drug Arava, also known as leflunomide and produced by

Aventis. There are those that have been on many of the other Disease

Modifying Rheumatoid Arthritis Drugs but find ourselves still trying

to find a treatment that will help us to lead more normal and

productive lives. Those of us that live with this disease everyday

know the risks involved in the medications we must take. We also

know what our lives would be like if we had no more options available

and all other treatments have either failed or have produced side

effects that may be even more life threatening to some of us.

I question whether the group Public Citizen and the individuals that

would like to make this treatment no longer available have ever

experienced the disabling pain, fatigue and disfigurement that is the

future of those with this disease, Rheumatoid Arthritis? For those

who suffer with RA, the availability or Arava has finally given them

a chance to live a life closer to what the healthy consider normal

lives. Their comparison to Methotrexate may or may not be

legitimate, but does no good for those like myself who have had other

severe side effects or who no longer find relief from Methotrexate.

I believe that strong education to Doctors and Rheumatologists that

would prescribe the drug should be considered and implemented before

such drastic action, such as banning it, takes place. It is possible

to more closely monitor patients for possible liver complications and

stop it's use if necessary. Please do NOT eliminate the last

recourse for many Rheumatoid Arthritis patients based on a public

advocacy group that may or may not even understand what we and our

families must live with every day, for the rest of our lives.

Sincerely,

Lucy Summers

=======================================

Ok, I have said my piece. I hope every RA sufferer will take a long

look at both sides of this situation and make up their own minds. If

you, like myself decide that you do NOT want Arava banned, your are

more than welcome to use my letter. You can use it as or modify it as

you choose. The regular snail mail address is in the letter. The e-

mail address for Mr. is: HHS.Mail@... I also sent a

copy my letter to the " Private Citizen " group at: hrg1@...

< -- rant off -- >

I apologize, I know this is somewhat of a long rant, but I feel I

have to do what I can to at least help make sure the FDA gives all

sides of this issue equal time to be heard. Also, I hope others will

give consideration to this response and maybe send their own letter

to Mr. .

MomBom - <©¿©>

[Guest guest]

a,

This nearly slipped into my ancient history file - sorry!

I agree that Dr. Yocum receives grant money from a variety of sources.

Since he is heavily involved in research and clinical trials at the

University of Arizona, that is to be expected. He had previous

involvement with at least one trial of leflunomide, too, so I believe

it's possible that he or his institution also received Aventis money at

some time or another:

Yocum DE, Nordensson K and Strand V (1998)

" Effect of leflunomide(LEF), methotrexate(MTX) and placebo(PL) on

peripheral blood mononuclear cell (PBMC) phenotypes and in vitro

proliferation to mitogens/recall antigens. "

Furthermore, even though Centocor is in his recent list of

contributors/sponsors, I don't think Remicade has serious competition

from Arava. And Boehringer Ingelheim manufactures Enbrel in Europe; they

make Mobic, too. Merck produces Vioxx. Searle markets Celebrex. This

guy's all over the map. I don't believe there is a conflict of interest

associated with his opinion that Arava should be withdrawn from the

market. He doesn't seem to be leaning toward any one drug or company,

and I don't see that Arava is head-to-head with any of the

above-mentioned drugs.

Yocum is internationally known and respected, well-published, and has

received many awards of various kinds. Would he find financial rewards

so attractive that he would risk his reputation? I hope not, and I

really don't think so.

Wouldn't it be smarter, if he were only after the money, to keep his

mouth shut? He wouldn't want to scare off a potential benefactor by

trashing a drug unfairly, would he? Also, he was prescribing Arava for

some of his patients. If he had strict loyalties elsewhere, wouldn't he

be using those other drugs instead?

It's nearly impossible for any physician to do research without

accepting those big pharmaceutical dollars at some time in his career.

Unfortunately, the drug makers have the upper hand, that's for sure.

Money drives these investigations, and the pharmaceutical companies have

lots of it. I do view all of the research studies with a healthy dose of

skepticism, but I don't believe all of the physicians involved are in it

just for the money or that every researcher has lost all objectivity.

Are the results biased sometimes? Sure. Are there some researchers who

are making a fortune off of these trials in one way or another? I think

so. But I don't think that's what's going on here.

I would like to believe that Yocum was upset that one of his patients on

Arava died and wanted to do something about it. He also has experience

as a former arthritis drug evaluator with the FDA. He was involved in at

least one clinical trial with leflunomide and knows a lot more about

this drug and how the FDA works than the average rheumatologist. He

probably feels a responsibility to act. (By the way, I don't know Dr.

Yocum and am not related to him, LOL!)

No drug is absolutely safe. The FDA cannot guarantee that there will be

no deaths. Their job is to try to make sure that the benefit of a

particular medication outweighs the risk. In the case of Arava, Public

Citizen's major beef is that Arava doesn't seem to be significantly more

effective than methotrexate yet seems to have a much, much higher

toxicity profile.

If these numbers are accurate, the following, claimed by Public Citizen,

is quite disturbing:

" In a comparison between Arava and methotrexate, which is an equally or

more effective drug for treatment of rheumatoid arthritis, Public

Citizen found that over the three-year period it has been on the market,

Arava was linked to six times more cases of fatal liver toxicity and 13

times more reports of hypertension than methotrexate, although there

were 6.8 million (5.5 times) more prescriptions filled for methotrexate

than Arava during that time. Additionally, Arava has been associated

with 12 cases of the life-threatening autoimmune disease s-

Syndrome, and methotrexate with none. "

If this is true, Arava should be reevaluated.

The NSAID issue: I agree that, tragically, we have many, many

NSAID-related deaths each year. No doubt about that. That's why the

COX-2s were developed. COX-2s aren't supposed to be more effective than

the older NSAIDs (although that has been unfairly implied!), they are

supposed to be safer. The jury's still out on the safety question, but

it seems to be generally true.

When we compare the number of alleged Arava-related deaths to those from

Celebrex, we have to keep in mind that, since approval in 1999, there

have been approximately 17 million Celebrex prescriptions - far more

users of it than Arava. Also, how many people would have died if they

had continued to take their previous NSAIDs instead of Celebrex? Maybe

Celebrex has actually saved lives. Given the numbers you found - maybe

as many as 20,000 per year on all NSAIDs in 68 million prescriptions -

the few possibly Celebrex-related deaths that there have been to date

out of 17 million prescriptions is statistically not bad.

I'm with you that aspartame is not a good choice to include in one's

diet in any form, especially on a regular basis! And it's not safe to

use many OTC products (like those NSAIDs!) in the fashion some

individuals choose to. But people do have some responsibility, too, to

look into these things and make the best choice they can about what they

put into their bodies.

I know what you're saying. The FDA is far from perfect and so is the way

we run trials and allow products to enter the market (and stay when

maybe they shouldn't), but it's a pretty good system considering what an

enormous task it is.

Re: [ ] Re: interesting - - My Rant on the Arava

Petition

E. Yocum, MD, receives grant/research support from Centocor, Inc.,

Boehringer Ingelheim, Searle, and Merck. In addition, Dr. Yocum acts as

a consultant for Boehringer Ingelheim and participates in the Speakers

Bureau for Centocor and Boehringer Ingelheim.

http://216.239.33.100/search?q=cache:ErUo3mQs244C:www.medscape.com/CMECi

rcle/rheumatology/2001/CME01/public/author.html+Dr.++Yocum & hl=en & ie

=utf-8

Unfortunately I don't have much faith in the FDA to be watchdogs for us.

The fact that Aspartame / Nutrasweet is still on the market after

thousands of adverse reactions being reported doesn't sit to well with

me. So many of these inquiries into different treatments are a result

of competitive companies complaining about each other to get the edge in

the market.

I agree 100% that this drug has to be closely monitored and the patients

must know the risks involved in taking it. As you say, so many doctors

do not do the recommended testing. I hope that this article from

Public Citizen will educate the patients as to the risks and also the

doctors so that they will perform the recommended testing. I will be

curious to see Aventis' response to this article.

The first 3 months that Celebrex was on the market, it was linked to 10

deaths and 11 cases of gastrointestinal hemorrhages.

http://www.ethicalinvesting.com/monsanto/news/10046.htm

One study estimated that 20,000 hospitalizations and 2,600 deaths each

year could be linked to a group of nonsteroidal anti-inflammatory drugs

(NSAIDs) in rheumatoid patients. According to the FDA, " 200,000 cases of

gastrointestinal bleeding, with 10,000 to 20,000 deaths, occur each year

due to the 68 million prescriptions of NSAIDs, used for arthritis.

So where does this leave us?

a

[Guest guest]

Scientists are accepting large sums of money from drug companies to put their

names to articles endorsing new medicines that they have not written - a growing

practice that some fear is putting scientific integrity in jeopardy.

http://www.guardian.co.uk/medicine/story/0,11381,646078,00.html

Major drug companies and their related financial interests direct medical

research. These interests fund the major medical schools and have extremely

powerful allies in the government. The medical companies and the FDA board

routinely rotate staff to make sure the interests of the drug companies are

protected. Considering that the FDA is supposed to be a consumer watchdog, this

practice undermines the integrity of the FDA. Research is ONLY done on

patentable drugs that are potential money makers, while any natural products,

effective or not, are attacked. These natural products pose to much competition

to drug companies. In my eyes, if the FDA was truly a watchdog protecting our

interests, ALL avenues of research, despite the profit potential, would be done.

They say there is no money, but take a look at how much money is donated to

organizations that are supposed to be researching cancer and arthritis. Look at

how much money the FDA spends on shutting down alternative practices. That

money alone would fund studies to prove or disprove various herbs, therapies

etc. but as long and drug company employees are on the FDA board, we will never

get the truth anyway. Why is it that St 's Wort is the FIRST line of

treatment for depression in Germany, yet the last here? Depression used to be

considered rare, but now is a multi-billion dollar industry, and everyone has

it!

Have you ever read about the scientist Royal R. Rife? Inventor of the Universal

Microscope, it's interesting that he cured cancer with the use of electricity

back in the 30's, was considered a hero, but read what happened to him.

http://www.rense.com/health/rife_new.htm

Is it truth? We will never know because our watchdog has better things to spend

our money on.

I'm not implying that all scientists are working for drug companies or have only

money motivations behind their research, but having drug company employees on

the board of the FDA surely doesn't make me feel to comfortable with unbiased

results. The FDA is the best we've got, so we're kind of stuck with them. I

think in time, with the power of the internet, people are getting educated to

all available treatments and will be able to make educated decisions about their

health.

I too would like to believe that Dr. Yokum's motivations are purely out of

concern for our health and safety. Arava should definitely be re-evaluated with

statistics as bad as they are.

I just wish someone could explain to me why the Nabisco corporation would have

to pull packages off the shelf if they were labeled 16 ounces and only had 15

ounces, and we hear so much about products being recalled for undeclared

ingredients, yet supplement companies can mislabel supplements. Where is the

FDA? Aren't supplements considered a food?

I'd better get off my rant. Maybe you wish you kept this in your ancient

history file LOL!

I've been reading to many health care conspiracy theories this week, so please

excuse me.

a

Re: [ ] Re: interesting - - My Rant on the Arava

Petition

E. Yocum, MD, receives grant/research support from Centocor, Inc.,

Boehringer Ingelheim, Searle, and Merck. In addition, Dr. Yocum acts as

a consultant for Boehringer Ingelheim and participates in the Speakers

Bureau for Centocor and Boehringer Ingelheim.

http://216.239.33.100/search?q=cache:ErUo3mQs244C:www.medscape.com/CMECi

rcle/rheumatology/2001/CME01/public/author.html+Dr.++Yocum & hl=en & ie

=utf-8

Unfortunately I don't have much faith in the FDA to be watchdogs for us.

The fact that Aspartame / Nutrasweet is still on the market after

thousands of adverse reactions being reported doesn't sit to well with

me. So many of these inquiries into different treatments are a result

of competitive companies complaining about each other to get the edge in

the market.

I agree 100% that this drug has to be closely monitored and the patients

must know the risks involved in taking it. As you say, so many doctors

do not do the recommended testing. I hope that this article from

Public Citizen will educate the patients as to the risks and also the

doctors so that they will perform the recommended testing. I will be

curious to see Aventis' response to this article.

The first 3 months that Celebrex was on the market, it was linked to 10

deaths and 11 cases of gastrointestinal hemorrhages.

http://www.ethicalinvesting.com/monsanto/news/10046.htm

One study estimated that 20,000 hospitalizations and 2,600 deaths each

year could be linked to a group of nonsteroidal anti-inflammatory drugs

(NSAIDs) in rheumatoid patients. According to the FDA, " 200,000 cases of

gastrointestinal bleeding, with 10,000 to 20,000 deaths, occur each year

due to the 68 million prescriptions of NSAIDs, used for arthritis.

So where does this leave us?

a