RE: Archived messages

[Guest guest]

Just wanted to let everyone know that my second e-bay ad ended this morning

with 1,345 hits on the counter. The new listing for that ad is 5594665519.

Total hits on the two ads this week 2361! Plus 250 on my newly placed ad.

Lana

>From: Rogene S <saxony01@...>

>Reply-

>

>Subject: Archived messages

>Date: Thu, 30 Jun 2005 20:12:21 -0700 (PDT)

>

>

[Guest guest]

Tell what you think about this letter to the FDA so far. I could probabbly

use some help with it. Lana

ASSURING SAFETY IN A RISKY WORLD

Let me thank you in advance for giving me a chance to speak with you about a

matter that requires your urgent attention. The FDA is considering placing

silicone breast implants back on the market. This is an atrocity! There has

not been enough research done to prove the safety of these " cosmetic

devices " . The proper technology to monitor these devices for rupture and or

gel migration are inadequate, to say the least. Because the silicone gel is

so minuet, it is extremely difficult, if not impossible in a large number of

cases, to detect the migrated silicone gel once it has migrated out of the

implant site and moved into other areas of the body. There is no one single

piece of radiology equipment in existence today that can adequately map out

the migrated silicone gel and or clearly show the residual gel once it's

moved outside of the implant site.

It is a well-known fact that the silicone gel implants have a high rate of

rupture. Knowing this and verifying the high rupture rate through their own

study, it would be completely irresponsible for the FDA to allow the

silicone gel implants to be sold to the general public.

It is the FDA's fundamental responsibility to assure the safety of the many

products it regulates-everything from drugs for humans; drugs and feed for

animals--those you consume or those that you adore; biologics such as gene

therapy, blood and vaccines; medical devices, cosmetic devices, from tongue

blades to pacemakers; to foods and food additives; cosmetics, diagnostics;

and some things you may not realize, like microwave ovens and other

radiation-emitting devices. In assuring the safety of medical products, the

agency must weigh their benefits against their risks. And there are inherent

risks associated with nearly all of the products they regulate.

People go about their day-buying and preparing food, undergoing medical

diagnosis and treatment, filling a drug prescription or checking out the

latest over-the-counter remedy for baldness, trying out a new shade of

lipstick, or using laser pointers in their latest lectures. So as you can

see we depend on the FDA to their job, which is to make sure that the

products they approve for sale are indeed SAFE! When considering whether to

allow or approve silicone breast implants again you MUST place the safety of

the consumer first and foremost.

The FDA must remember the problems that the medical industry has had in the

past with the silicone gel. First it was silicone injections, stopped

because the free floating silicone gel cause serious health problems. After

that horrific lesson, we began using the silicone breast implants, same gel

only now inside a silicone bag. Those implants were taken off the open

market as well, but only after thousands of Med-Watch forms were filed and

thousands of lawsuits were filed with the courts from women claiming that

they were injured by the gel that was either leaking or had leaked out of

the breast implants. For the past several years the FDA has ALLOWED (NOT

APPROVED) the silicone gel breast implants to be sold under a research study

that was completely inadequate.

The FDA's own study showed a high percentage rupture rate. Sadly, what their

study does not show is the most important question of all. Where does the

silicone gel migrate to once the implant ruptures. The other major flaw in

the FDA's study was the lack of research done in the area of secondary

silicone exposure. The FDA must insist that any and all women involved in

their studies that are planning on having children after implantation

consent to having the placenta sent in for testing and analysis.

The manufacturer claims that the MRI will show the migrated gel, it does not

show the migrated gel. In fact, once the silicone-gel particles spread out

into the body, they become to minuet to detect with todays current radiology

equipment. How can anyone say that the FDA's research or the manufacturers

research for that matter is adequate? Until the FDA's studies and the

manufacturers studies include the answers as to where the migrated gel is

going, they should not even consider placing the silicone implants back on

the market. The FDA must take the health of the American people into

consideration when making their up coming decision. It is time for the FDA

to not only refuse to permit Mentor to sell silicone breast implants, it is

time for the FDA to insist on some answers as to what happens to the gel

once it enters the body.

Throughout its nearly 100 year history, the FDA has enjoyed a high level of

trust by the American people, which continues to the present. But trust is a

fragile thing. For trust once lost is difficult to regain, as our

counterpart regulatory bodies in Europe have experienced in recent years.

Our uniquely American way of representative government has society's

expectations--for matters ranging from national defense to public health and

safety--reflected in law. A regulatory body is then expected to make these

laws operative.

The benefits of a strong regulatory agency such as the FDA are many. The

most important benefits are enjoyed by patients and consumers who need safe

and effective products. But benefits are also realized from an economic

standpoint, for a high-quality, science-based regulatory agency attains

credibility and respect on a global scale, stimulating innovation, enhancing

U.S. competitiveness abroad, providing a predictable and level playing field

for industry, and encouraging increased foreign investment in this country.

What are some of the challenges the FDA faces today? First and foremost are

the tremendous advancements in science and technology. Both government and

the private sector have invested enormous resources in biomedical research

and biotechnology. The result of this investment is, and will continue to

be, a wealth of new products and technologies that will be presented to the

FDA for thier review and approval before they are introduced into the

marketplace.

In order for the FDA to make these judgements, it is essential that they

have the scientific talent to adequately assess the safety and effectiveness

of these novel products and technologies. Their scientists must be current

in their fields of expertise, quick learners in new areas, and have the

creativity and ability to collaborate with other scientists in the FDA and

outside the agency. They must be able to anticipate and access the

cutting-edge science that will be needed to regulate the products of future

technology.

Their scientist's help to establish standards for product performance and

potency, provide data to support regulatory decisions on product safety and

information to consumers for the safe use of products, and provide the basis

for science-based regulatory policies. The safety of vaccines, acceptable

levels of mycotoxins such as fumonisin B1 in corn products, more rapid

methods of detecting pathogens in food, better understanding of the

significance of antibiotic resistance, are all examples of the products of

research from within FDA laboratories. A high quality staff and robust

regulatory research program are critical for supporting, in a scientifically

sound fashion, the review and regulatory decisions we make every day.

The interaction between their researchers and their regulatory, review and

enforcement scientists are becoming increasingly critical, given the rapid

pace of advancements in science and medicine.

Enhancing the agency's science base has been one of their highest

priorities. The FDA must have the strongest possible scientific acumen-the

most capable scientists and the most current and reliable scientific

information to support their decisions. Clearly, having a less than the

excellent scientific capability to adequately determine the outcome of

medical complications cause by one or more products whether cosmetic or

otherwise, is not an option for the FDA!

While they must be scientifically sound, consistent, and predictable in

their review of products and issues that surround product approvals, it is

equally vital to maintaining credibility that thier decision-making be open

and transparent to the lay public, health professionals, the regulated

industry, and any party who depends on the outcome of FDA's decisions.

Let's talk just for a moment about the judgements that are rendered as they

make decisions about which products are safe and effective and ready to move

to the market place. Calling a product " safe " does not mean that there is no

risk associated with its use. In reviewing drugs, biologics, and devices,

the FDA spends a considerable part of the review weighing the benefits of a

particular product against its risks. There is a continuum of uncertainty

that is tolerated, depending on the seriousness of the illness. For a drug

that is intended to treat a life-threatening illness, and for which there is

no other available treatment, more uncertainty would be tolerated. As a

medical oncologist, I am well aware that patients faced with grave diseases

are willing to assume great risks.

On the other end of the spectrum, little or no uncertainty would be

tolerated for remedies for alleviating minor symptoms of the common cold,

nor should they be tolerated in the areas of cosmetic surgery!

I want to assure you that uncertainties about risk do not prevent the FDA

from making decisions. An increasing number of drugs, biologics, and devices

are being approved every year, many of which are new molecular entities and

represent significant advances over those that were available previously.

The U.S. now leads the world in terms of timeliness of review of new drugs

and biologics without compromising a very high standard of safety. The

average review time for drugs is less than 12 months and for drugs for

serious and life-threatening conditions less than 6 months. But at the time

of any review it is not feasible, indeed, possible, for the agency to

identify every potential risk associated with the use-and abuse-of a medical

product. A key question is how extensively drugs and or medical device

should be studied to uncover adverse reactions before approval of a product.

It should be obvious that there is less certainty with a study of 500 people

than one with 5,000 or 50,000 people. Still, there are risks that the FDA

doesn't discover during clinical trials because some adverse events are very

rare or may be only associated with a subset of the population that is

unusually sensitive compared to everyone else.

Determining the risk in a population does not necessarily predict the risk

for the next individual. And from a practical standpoint, having to include

150,000 human subjects in a study would often be a major obstacle to getting

drugs and medical devices on the market in a timely fashion, especially for

rare diseases.

A less obvious reason that risks unseen in clinical trials appear when the

drugs are used in the real world is that in clinical trials, the drugs and

or medical devices are only studied for the condition for which the drug or

device was developed, and with all other factors carefully controlled. Once

the drug or medical devise is on the market, it may be prescribed for a

condition other than that for which it was approved, may be given using a

different dosing regimen, or it may be used in conjunction with a variety of

other drugs, foods or dietary supplements that could interact with the drug

and or product. And the product will be used in numbers of people much

greater than were used in the clinical trials, potentially uncovering side

effects not previously seen.

These factors must all be taken into account as we work with sponsors of new

products to make sure they are safe and effective, and available to patients

in a timely manner...yet be alert to new findings after a product is on the

market.

The FDA monitors the adverse reactions of drugs for both predictable and

unexpected side effects. This requires effort on the part of scientists and

medical officers in FDA; physicians and other healthcare professionals in

the community; drug manufacturers; and the patients themselves to report any

side effects, particularly previously unknown side effects associated with

the use of a product. The FDA's MED-WATCH reporting pollicies are now being

questioned for accuracy, due to the fact that the FDA's MED-WATCH reporting

forms are voluntary and not mandatory, which could lead to a lack of quality

assurance and inept reporting practices.

The recent report from the Institute of Medicine entitled " To Err is Human "

has brought renewed attention to the issue of risk management to everyone in

the health care delivery system. This IOM report indicates that medical

mistakes are responsible for the deaths of about 98,000 people every year.

An important point made in the IOM report is that the majority of injuries

and deaths in the U.S. that are attributable to medical products are from

known side effects, and not from unexpected ones.

The findings of this study confirmed what the FDA said in its earlier report

issued last May, " Managing the Risks from Medical Product Use: Creating a

Risk Management Framework " .

Since most medical products have some inherent risks associated with their

use, some greater than others, as these products enter or are in the market

place it remains the FDA's responsibility to identify the risks, and

communicate that information effectively to physicians, nurses, pharmacists,

patients, consumers, and anyone else who may be affected by those risks or

their management. Risks involving specific subpopulations of people, for

example, children or pregnant women and or women considering pregnancy, must

be clearly conveyed.

The entire health care delivery system must have adequate safeguards in

place. This begins with the development, manufacture, and approval of a

product, and continues with physician prescribing practices, pharmacy

dispensing, and proper administration of the product to patients in a

hospital setting, or at home by the patients themselves.

Communication, feedback and correction-throughout the entire system--about

the benefits and risks of a drug or other product for a particular use, is

critical to the health care system's effort to reduce the incidence of

medical errors. Communication, feedback and correction needs to take place

between drug companies and physicians, between physicians and patients,

between pharmacists and patients, on the product label and package insert,

and in any advertisements promoting a particular product.

The FDA is also responsible for ensuring that foods for humans and animals

are safe and truthfully labeled. In the case of food additives, safety means

that there is a reasonable certainty, in the minds of competent scientists,

that the substance is not harmful under the intended conditions of use. Our

current laws prohibit the use of food additives that are carcinogenic in

animals or humans.

Testing every chemical that may contact foods, for example, in food wrap

substances, for its potential to cause cancer in humans or animals would be

prohibitive. Instead, risk assessment principles are used to determine if

animal carcinogenesis tests are needed. For example, using a procedure known

as the " threshold of regulation " , a chemical whose use in food contact

articles results in a dietary concentration of one half part per billion or

less would be exempt from the process for a food additive petition approval.

Under another procedure known as the " constituents policy " , a carcinogenic

contaminant of a non-carcinogenic food additive is permitted if the lifetime

cancer risk is negligible.

Thus, the rule of " reasonable certainty of no harm " assures the safety of

food without unreasonably restricting the use of chemical substances that

may contribute to the safety of foods.

I would like to conclude with a few final thoughts, It is vital that the FDA

have adequate research to assure that no more consumers will be injured by

these ELECTIVE surgery products. It is important to keep the agency's

mission uppermost in your minds-allowing consumers to have confidence in the

safety, quality, and effectiveness of the FDA-regulated products they buy

and use. It is your responsibility to safeguard the health of Americans,

recognizing that in today's marketplace, any decision made by the FDA truly

has global implications.

For each of the issues that I've mentioned tonight that relate to product

safety and risk considerations-of the silicone gel breast implants, I urge

you to keep the silicone implants off the market and I insist that the FDA

improve and expand their silicone breast implant study to include better

quality radiology and to immediately create a research study to research the

secondary effects of the migrating silicone gel. Including but not limited

to non-invasive, testing of the placentas of the women involved in the FDA's

study. The FDA must have the best science brought to bear for

decision-making so that all of us can feel safe in this risky world.

Thank you for the opportunity to share my views with you I would appreciate

your cooperation in seeing to it that the silicone implants are NOT placed

back on the open market! .

Recent Speeches | FDA Home Page | Back Issues

(Hypertext created by mn 2000-MAY-25)

>From: Rogene S <saxony01@...>

>Reply-

>

>Subject: Archived messages

>Date: Thu, 30 Jun 2005 20:12:21 -0700 (PDT)

>

>

[Guest guest]

please see attachment.

Lana

>From: Rogene S <saxony01@...>

>Reply-

>

>Subject: Archived messages

>Date: Thu, 30 Jun 2005 20:12:21 -0700 (PDT)

>

>

[Guest guest]

Lana,

Your message is great! I hope they take the time to

carefully consider everything you've said!

The way it looked, you posted it somewhere. . . On an

FDA webpage?

Keep up the good work . . . Let's make these

government officials (employees of OURS!) do the job

they are supposed to do - For the citizens of this

country!

Hugs,

Rogene

[Guest guest]

Lana,

It looks good . . . maybe a little wordy, but the

ideas are all there!

If you'd like me to do some editing, it will probably

be a week before I have time. We're going to Tulsa

(plan to meet Kenda while there), then when I get

home, I'm going to DFW to visit family.

Hugs,

Rogene

[Guest guest]

No, I didn't write this letter! This is a ruff draft of a letter that the

head of the FDA wrote. I re-wrote the letter using ALL of their own facts

and research, included the parts about medical devices and implants then I

exclude all the stuff about the internet. That's why it so wordy and goes

into so many different areas. The FDA wrote this because they are trying to

make it illeagl to buy any medication off of the internet. I am just simply

using their own facts to support our cause. In the end I will write " A good

number of the statments made in this letter are dircetly quoted from

......... The name is listed at the top of the origanial paper.

What do ya think? Lana

>From: Rogene S <saxony01@...>

>Reply-

>

>Subject: RE: Archived messages

>Date: Fri, 1 Jul 2005 17:32:25 -0700 (PDT)

>

>Lana,

>

>Your message is great! I hope they take the time to

>carefully consider everything you've said!

>

>The way it looked, you posted it somewhere. . . On an

>FDA webpage?

>

>Keep up the good work . . . Let's make these

>government officials (employees of OURS!) do the job

>they are supposed to do - For the citizens of this

>country!

>

>Hugs,

>

>Rogene

[Guest guest]

Lana,

You're one sharp cookie! . . . Now, how do we cram

their own words down their throats?

Hugs,

Rogene

--- Lana Transue <lanadearest@...> wrote:

> No, I didn't write this letter! This is a ruff draft

> of a letter that the

> head of the FDA wrote. I re-wrote the letter using

> ALL of their own facts

> and research, included the parts about medical

> devices and implants then I

> exclude all the stuff about the internet. That's why

> it so wordy and goes

> into so many different areas. The FDA wrote this

> because they are trying to

> make it illeagl to buy any medication off of the

> internet. I am just simply

> using their own facts to support our cause. In the

> end I will write " A good

> number of the statments made in this letter are

> dircetly quoted from

> ........ The name is listed at the top of the

> origanial paper.

> What do ya think? Lana

> >From: Rogene S <saxony01@...>

> >Reply-

> >

> >Subject: RE: Archived messages

> >Date: Fri, 1 Jul 2005 17:32:25 -0700 (PDT)

> >

> >Lana,

> >

> >Your message is great! I hope they take the time to

> >carefully consider everything you've said!

> >

> >The way it looked, you posted it somewhere. . . On

> an

> >FDA webpage?

> >

> >Keep up the good work . . . Let's make these

> >government officials (employees of OURS!) do the

> job

> >they are supposed to do - For the citizens of this

> >country!

> >

> >Hugs,

> >

> >Rogene

>

>

>

[Guest guest]

Thank you for the complement, I like to be creative. I'm a little on the

onery side too. Ok Here goes. First we need to fine tune it a little. I

think that some of the ladies should read it very carefully...ie ilena,

lynda and so on and then see if there is anything they feel should be added

or removed from the letter. I was hesitent to remove to much of its contents

because when the FDA was trying to present thier argument to the

univercities they felt that all of these facts were neccassary. so I felt

that maybe I should just leave them in. I think after we fine tune it that

we should ask people to sign it and send copies to the FDA, to their local

politicians, to thier local news paper columnists and to any news stations

and or media sources that we can reach. I don't know if it will help but

it's worth a try. IF WE ALL WORK TOGETHER AND UNITED WE CAN DO ANYTHING. I

KNOW IT FOR A FACT AND FROM EXPERIENCE. Besides, they have given us all the

ammo that we need to fight them with. WERE MAD AS HELL AND WERE NOT GONNA

TAKE IT ANYMORE !!

The only way we can make a difference, is if we take a stand together. These

guys and their money are a pretty powerful entity alright, but HELL HATH NO

FURRy LIKE THOUSANDS OF WOMEN SCORNED " and working together!! " Lana

Rogene S <saxony01@...>

>Reply-

>

>Subject: RE: Archived messages

>Date: Fri, 1 Jul 2005 18:00:54 -0700 (PDT)

>

>Lana,

>

>You're one sharp cookie! . . . Now, how do we cram

>their own words down their throats?

>

>Hugs,

>

>Rogene

>

>

>

>--- Lana Transue <lanadearest@...> wrote:

>

> > No, I didn't write this letter! This is a ruff draft

> > of a letter that the

> > head of the FDA wrote. I re-wrote the letter using

> > ALL of their own facts

> > and research, included the parts about medical

> > devices and implants then I

> > exclude all the stuff about the internet. That's why

> > it so wordy and goes

> > into so many different areas. The FDA wrote this

> > because they are trying to

> > make it illeagl to buy any medication off of the

> > internet. I am just simply

> > using their own facts to support our cause. In the

> > end I will write " A good

> > number of the statments made in this letter are

> > dircetly quoted from

> > ........ The name is listed at the top of the

> > origanial paper.

> > What do ya think? Lana

> > >From: Rogene S <saxony01@...>

> > >Reply-

> > >

> > >Subject: RE: Archived messages

> > >Date: Fri, 1 Jul 2005 17:32:25 -0700 (PDT)

> > >

> > >Lana,

> > >

> > >Your message is great! I hope they take the time to

> > >carefully consider everything you've said!

> > >

> > >The way it looked, you posted it somewhere. . . On

> > an

> > >FDA webpage?

> > >

> > >Keep up the good work . . . Let's make these

> > >government officials (employees of OURS!) do the

> > job

> > >they are supposed to do - For the citizens of this

> > >country!

> > >

> > >Hugs,

> > >

> > >Rogene

> >

> >

> >

>

[Guest guest]

You know whats so cool. When I first started running my ad there were at

least six young girls selling nude pics of them sellves and begging for

money for breast implants. Slowly but surley, and one at a time, they have

stopped placing those ads. They may relist them soon but for now, there

gone. Maybe just maybe they read my ad and read my ad and decided to change

their minds. I doubt it but one can always hope. Thanks for your support

with my e-bay ad. You gals are great! Lana

>From: Rogene S <saxony01@...>

>Reply-

>

>Subject: RE: Archived messages

>Date: Fri, 1 Jul 2005 18:00:54 -0700 (PDT)

>

>>

>

>

>---

[Guest guest]

Lana,

You go girl!!! That is great! I hope that it is because they read the ad that they decided that Breast Augmentation isnt the answer........Let's all say our Prayers for that!

DianeLana Transue <lanadearest@...> wrote:

You know whats so cool. When I first started running my ad there were at least six young girls selling nude pics of them sellves and begging for money for breast implants. Slowly but surley, and one at a time, they have stopped placing those ads. They may relist them soon but for now, there gone. Maybe just maybe they read my ad and read my ad and decided to change their minds. I doubt it but one can always hope. Thanks for your support with my e-bay ad. You gals are great! Lana>From: Rogene S <saxony01@...>>Reply- > >Subject: RE: Archived messages>Date: Fri, 1 Jul 2005 18:00:54 -0700 (PDT)>>>>>>---Opinions expressed are NOT meant to take the place of

advice given by licensed health care professionals. Consult your physician or licensed health care professional before commencing any medical treatment. "Do not let either the medical authorities or the politicians mislead you. Find out what the facts are, and make your own decisions about how to live a happy life and how to work for a better world." - Linus ing, two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)