The FDA is largely responsible for governing the way in which tobacco firms are allowed to market and advertise their products. The use of FDA consulting firms is commonplace within the tobacco industry because without their expert assistance the propensity for falling foul of watchdog guidelines is exceptionally high.

FDA consulting companies will advise tobacco companies of what they can and can’t do in relation to the manufacture and marketing of their tobacco products. This is increasingly important since the FDA significantly tightened the reins on tobacco firms in terms of their advertising endeavours. There were fears that tobacco companies were pandering to teenagers with their advertising but the FDA have clamped down on this with a new set of regulations.

Looking at the New Regulations

The FDA made no secret of the fact they were unhappy with the way tobacco companies were marketing their products to children and have announced a new set of regulations to help make this a thing of the past. It is quite likely that many of the large tobacco production companies will now seek out the services of FDA consulting firms because they will be able to advise them on what is now expected of them in respect to the manufacture and marketing of cigarettes. 

According to a report in the Washington Post, the new FDA regulations have provided them with much more leeway for dictating the ingredients that go into cigarettes and this is something that they hope will yield great health dividends. Using FDA consulting firms is likely to be the best means of ensuring that no issues arise in relation to the new regulations. Speaking about the potential positives of the new regulations, assistant secretary for health, Howard Koh, stated to the Washington Post, “This is truly a historic announcement in our country’s public health history. This is designed to prevent our children from becoming the next generation of Americans to die early from tobacco-related illnesses.”

FDA consulting will be a valuable undertaking for any tobacco company in light of the new regulations which have been put in place. The FDA are frequently altering and modifying their regulations of the various different sectors that they regulate and can often prove quite difficult for manufacturers to keep up to date with the latest legislations. Pharmaceutical consultants are the ideal solution insomuch as they have vast industry experience and are invariably one step ahead when it comes to ensuring FDA compliance.

If you’re after a leading FDA consulting company, look no further than NSF-DBA. They are delighted to be considered one of the world’s best pharmaceutical consultancy firms and offer everything from GMP training to FDA consulting. 

Once in my lifetime I would like to hear the truth told about anything the government does or supports. The very closest is our military being second to none, the best equipped, the best prepared. I do believe that is true, but it depends upon which person is in command when it is said. Clinton almost disarmed us, Bush did not go quite far enough and Oh! Mama, Obama does not respect our military at all, so look out soldiers, don’t throw those shovels away yet.

With that said and now the super colossal disaster poised to universalize our health program. I hurt for those who are without health care insurance, the worker that is, who cannot afford half his wages to buy a none performing package. Check this out. I totaled a truck from which I walked away–bruised left hand, a bad bruised right hand pinkie knuckle with split skin requiring three stitches, a scrap mark on my forehead. Mind you I walked away from a truck that was totaled and I should have been dead. People at the scene encouraged me to go to the hospital just to be safe. One thousand dollars for an ambulance to carry me seven miles. Twelve hours on an emergency bed waiting for a doctor to finish up another gruesome emergency so I could get the finger stitched up. He ordered X-Rays for my neck without seeing me, for the hand and this only cost my insurance $4500.00 less the $500.00 deductible I had to pay. And your president wants us all to have that type of care.

Greed

I know greed when I see it and I know that for $5500.00 dollars I could have at least gotten a hot juicy hamburger and felt a lot better. Or let me sleep in that nice bed you had me sitting on for twelve hours. Or come on, one thousand dollars for a ride, just there in case, the real world is not at your door steps. Doctors notoriously over charge due to insurance. By the way, on an itemized statement the three stitches cost five hundred and not that pretty at that. An aspirin I could not afford, thank goodness I did not need one and I was afraid to ask for a bottle of water, oop! There went a kidney. The president wants to redistribute wealth, he could take lessons from the doctors. If they receive federal funds, a certain percentage of their services must be to those who cannot afford to pay, so they over charge the insured so that cost, for the poor, is also covered. That is they take extra money from me through my insurance so some poor and none working government slave can have free medical service.

First sign of greed is when a few doctors form an incorporated clinic or hospital. The important feature is their attention goes from patient to bottom line(profit). Say! Fellow doctors, we will be short this month if we don’t amputate an arm, leg or a foot, or a good needless knee operation will cover it. Can we slough some of those poor people down the street to that bleeding heart facility so we have time for those who pay. Then internally, they receive samples from the pharmaceutical firms but charge the patient full price (meaning the hospital’s full price) or they insist upon a Cat Scan so they get at least a $400.00 rebate from the maker. But the worst form of greed is practicing medicine without knowing what the heck health is all about. We should do as the Chinese do, pay them to keep us healthy, and when we are sick it is free. Follow the money, if it makes money, do not touch it, and friends ‘cures’ do not make money.

Isn’t it amazing that in the eighty years plus while the pharmaceutical companies got bigger and richer not one cure of any disease has ever been found or developed. More about the drug companies later. Billions of dollars are spent each year on research which by definition is conducted to fine the cure for multiple diseases. Obviously, the American Heart Association, the Association for Diabetes, the American MSM Association and the hundreds more. It is not important whether I got the names right or not, what is important is for you to realize these organization house the most talented, and the most expensive technicians money can buy. And money has bought them, time and again. Not one laboratory, not one single or group has ever found a cure for any disease.

What we hear in their sob story is we are close, please help us find the cure for this dreadful disease. It is as if with just a bit more money, we can make a miracle happen, your boy or your girl will not have to suffer this disease, so please help. So like puppets, we reach in our pockets for we have bought their malarkey once again, they are so close. Gosh! I hate to burst your bubble but in 1914 Popular Science ran an article that Selenium, a simple mineral, would cure type two diabetes. Now the alternative medicine people add Chromium Picolinate and Vernadium minerals to the mix and it either cures or arrest diabetes. In 1928, Dr. Otto Warburger proved he could cause and cure cancer, later he received the Nobel Prize for his work. Did I see cure used with two of the most dreaded diseases? Type I diabetes has no cure, only type II.

Did you know that not one cure has been found by the laboratories who beg for your money to continue their operation. Did you know there is no money in cures, the money is in the sickness and the continued treatment of those sicknesses. Did you know that a few rabbles have found cures of certain devastating diseases and they are quickly shut up. It is almost a death wish to find a cure for any disease, to much money to be lost. Take a small laboratory, say forty employees. Each making say $100,000 per year, then there are the support staff, the facility cost and perks. A small firm costing about $6,000,000 dollars to do research for the cure of x-disease. They find a cure for x-disease. If they do not replace the x-disease with another one there are 40 researchers out on the street looking for another $100,000 job. Who wants them, no one, for the money is in the research and treatment, not in the cure.

Greed Champion

You may be under the assumption that the FDA is managed and ran by the Federal Government of the United States. Friend that is just what they want you to think. You also probably think they control the pharmaceutical companies and are there to protect the public from false claims concerning drugs and their application. For a rude awakening, did you know the FDA requires each drug that is applying to be licensed to be thoroughly tested in competent labs. Sounds great on the surface, does it not? To save dollars and staff, they often allow the pharmaceutical company to do the test and submit a report of the results. Did I mentioned how many drugs are recalled after the public screams about the side effects, some times even death. Now you know the why, the why of the license, not the why of the greed. By the way, before I complete leave the FDA behind, not even Congress controls the FDA. Nor does the pharmaceuticals, they are a self sustaining entity subject to ‘NO ONE’.

Hey, the pharmaceuticals provide us with all these wonderful drugs that make us feel better. Sure they do, and quite frankly I have been happy to use their products for many aches and pain until I discovered alternative medicine. Now they want to keep quiet those who do practice alternative medicine, it works without the side effects. No drug, that I am aware of out of the many, does not cause side effects. When the side effect occurs, a new disease is found, and a new drug and with that new drug billions of dollars are raked in by the greedy paws of those in the drug business. Do you realize that the pharmaceutical companies have no obligation to find cures for diseases. Their one and only obligation is to make money for their stockholders, just like the doctor owned clinics, hospitals, the research labs and all drug maker. You cannot make money with cures, but you can amass a fortune in making drugs that mask the symptoms and make us feel better.

Fight National Health Care

Every related program to health the federal government has put into action has cost the taxpayers ten times what they estimated it would cost. The primary reason is the greed of the unpoliced administrators of the programs at the grass root level. Doctors billing for services or drugs not administered and similar tactics. We need to fight the national health care package for one major reason. We the taxpayers already support the majority of those who do not have medical care, and that does not work. We need a program that puts these people to work so they purchase the health care they need. Even if it is made up jobs like beautifying our national parks with paths, small bridges and paths with signs identifying trees passed. Maybe we have them work part time for groceries in operations similar to Will Allen’s Growing Power in Milwaukee, Wi. The idea of giving a helping hand to help someone rise above his current low status makes more sense than a handout that leaves them behind but makes me feel good. I don’t need to feel good when I help someone, what I need to see is they feel good about themselves, by receiving my help up. They would know it is just a make up job, but as they gain skills and self esteem, they too will reach down to help someone up, one step at a time.

Folks, you ought to be tired by now of neighbors who are poor due to lack of incentive and or opportunity. They are not proud of their situation, not normally anyway, and given a choice of starve or work, I believe they would do the right thing. Then who distributes the wealth, they would by paying taxes, buying what they need, and maybe become what God intended them to be what they were created to be. Did you know not one poor person has ever made himself all he could be poor, it takes money, it takes training, it take self effort, it takes hope, it take courage, and it takes a dream to rise above poverty. The national health care program is just another stone weighting a person down into the drudgery of a modern form of slavery. It is not for me, it is not for anyone I know, are will one day know. Those I meet in life, I want the best for, not another weight to carry. Speak up and let us beat this new burden, kill national health care.

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This presentation was based on a data from an occurrence survey conduced by the United States Geological Survey in New Jersey. The USGS wanted to measure the trace contamination of drinking water and compare that data between the various districts of New Jersey. The team headed out to the water treatment facility and measured the water that’s going in and the “cleaned” water that is released by the facility. Both waters were tested positive for the presence of pharmaceutical products (1/3 of the contamination in waste water), metabolites, detergents, plasticizers, flame retardants, fragrances, cosmetics, solvents, other drugs (OTC etc.) and trace elements of pesticides.

These contaminants survived not only the basic sewage treatment process but it also survived the advanced treatment procedures as well. The implications of the presence of these chemicals in the drinking water is not known as there are no studies done on the long term effects of such chemicals or possible biomagnifications of these chemical compounds through the aquatic life – and eventually leading the contaminated food source to humans. Of course the short term effects are negligible and hardly any effects since these compounds are in such low quantity in the drinking water. After the water was treated the presences of these chemicals were hard to detect and some of them were shown to be “not there” but in reality, it may have been simply the fact that we do not have the capability to measure them.

The easiest way to deal with this problem is to raise public awareness to proper disposal of drugs, chemicals, and items that may contaminate water. It is in the general public interest to make sure that they do not dispose things into the drinking water system as it only ends up in their own bodies.

The Dalkon Shield was the first venture into contraceptives for A. H. Robins. In the late 1960s and early 1970s, much controversy surrounded the use of the birth control pill, so there was a large market for a safe and effective method of contraception. A. H. Robins responded to this demand by purchasing the rights to the Shield on June 12, 1970, from the Dalkon Corporation, a small company that had shared ownership between the two creators of the Dalkon Shield, Hugh Davis and Irwin Lerner, and a Connecticut attorney, Robert Cohn. Issues with the research conducted on the Shield by its creators surfaced quickly. Features of the device’s design, including pronged edges and a multifilament string that was thought to “wick” bacteria into the uterus, were claimed to be the cause of thousands of injuries and illnesses.

Despite these early issues, the Shield was aggressively marketed to physicians and women in the United States and worldwide. From the time the device hit the market in 1971 and was pulled in 1974, an estimated 4.5 to 5 million Shields were distributed around the world. Despite the Shield’s success in its first few years on the market, reports of injuries in Shield users were quick to surface, and the first lawsuit against Robins was filed in 1972. The first Dalkon Shield verdict was reached in the case of a Kansas woman, Connie Deemer, who became pregnant, suffered a perforated uterus, and was subjected to emergency surgery to remove the Shield, which had lodged itself in her abdominal cavity. She was awarded $10,000 in actual (compensatory) damages and $75,000 in punitive damages in what was to be the first of many lawsuits to yield awards to Shield users.

By 1985, Robins and its insurer, Aetna Life & Casualty Company, had already paid out $380 million in Shield-related lawsuits, the number of complaints and actions being filed were steadily increasing, and a class-action lawsuit was filed on behalf of nearly two thousand Shield users. Even with Robins reporting its highest-ever operations earnings of $128 million in 1984 (up 21 percent from the previous year) and its stock holding reasonably well, the Shield-related litigations proved to be too costly for the company. In March 1985, Robins announced that it was setting up a reserve fund to pay out Shield claims totaling $615 million, yielding a nearly $1 billion payout level for the company thus far. Creating the fund, however, left Robins with an over $4 million net loss for the year. In addition, records were being set on the amount of damages being awarded to Shield litigants, with a May 1985 decision awarding Loretta Tetuan, a Shield-user who had lost her uterus and ovaries, $7.5 million in punitive damages and $1.1 million in compensatory damages. In an attempt to protect the company and those who had a vested interest from the potentially devastating cost of more multimilliondollar Shield-related awards, Robins filed to seek reorganization under Chapter 11 of the Bankruptcy Code in August 1985.

This froze all monetary claims against the company and caused the company’s stock to plummet to a third of its value. In 1989, The American Home Products Corporation acquired A. H. Robins as part of the reorganization plan from bankruptcy. The consummation of the bankruptcy reorganization made it so that Robins had immunity from any further Shield-related civil litigation. Instead, as part of the deal, American Home agreed to finance a court-ordered trust to fund Shield claimants, putting $2.3 billion into the trust and additional moneys to the company’s shareholders.

The trust was responsible for paying claimants against the Shield for the following 20 years. Those persons who claimed injury from the Shield submitted the claim to the Trust, who then decided the amount to be settled based on adjusted historic settlement values. The reorganization also meant that Robins’s shareholders received American Home Products stock, resulting in large financial gains, since the American Home Products stock was worth four times the price of the Robins stock before bankruptcy was settled.