E-Articles - Health and Fitness

“Smoking kills. If you're killed, you've lost a very important part of your life.”

Brooke Shields (American actress)

Cigarette smoking is the number one preventable cause of premature deaths in the United States. In the year 2000, it is estimated that 8.6 million Americans had 12.7 million medical conditions that were caused by cigarette s

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

moking. For current smokers, the most prevalent were chronic bronchitis (49%), followed by emphysema (24%). For former smokers, the three most prevalent conditions were chronic bronchitis (26%), emphysema (24%), and previous heart attack (24%). Lung cancer accounted for 1% of all cigarette smoking-attributable illnesses Each year in the Unit

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

d States, approximately 440,000 persons die of a cigarette smoking-attributable illness. This results in 5.6 million years of potential life lost, $75 billion in direct medical costs, and $82 billion in lost productivity.. Smoking is responsible for 30% of all coronary heart disease deaths. Smoking however remains very prevalent, with almost

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

1 million men and 18 million women continue to smoke. The sad part is that a significant percentage of children continue to take up smoking each year.

“I smoke ten to fifteen cigars a day. At my age I have to hold on to something.” George F. Burns (American comedian 1896-1996). Geoge Burns may have been genetically blessed or just plain luck

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

. Most people who smoke will see the risk of dying from heart disease go up by almost three times. The risk of stroke will double. Smoking increases blood pressure, accelerates the progression of arteriosclerosis, decreases the good HDL cholesterol, and increases the tendency for the blood to clot. Even after heart bypass surgery, continuin

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

smoking increases the risk of recurrent cardiovascular events. Smokers also suffer from more peripheral arterial disease and aneurysms. Women who smoke and use oral contraceptives increase their risk of heart attack ten fold and increase their risk of strokes and blood clots in the legs

Second hand or passive smoke is also associated with

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ealth risks in both children and adults. This environmental tobacco smoke contains a complex mixture of over 4000 chemicals, many toxic and about 40 proven to cause cancer in humans. The EPA estimates that environmental tobaccos smoke causes approximately 3,000 lung cancer and about 37,000 coronary heart disease deaths in nonsmokers each yea

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

. Children, exposed to secondhand smoke before and after birth, are at a greater risk of developing high blood pressure, cleft pallets and lips, childhood leukemia, attention deficit disorder and childhood wheezing. Besides Sudden Infant Death Syndrome (SIDS), second hand smoke is also associated with an increase in acute lower respiratory tr

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ct infections, asthma, chronic respiratory symptoms and middle ear infections in children. Adults experience an increased risk of lung cancer, nasal sinus cancer, heart disease mortality, acute and chronic coronary heart disease morbidity and eye and nasal irritation, when exposed to second hand smoke. It also greatly increases the risk of de

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

eloping metabolic syndrome, both in children and adults. No wonder Indiana Governor Mitch Daniels noted, “Every citizen who stops smoking, or loses a few pounds, or starts managing his chronic disease with real diligence, is caulking a crack for the benefit of us all. “

“Smoking is related to practically every terrible thing that can happen

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

o you. “ Actress Loni Anderson. Smoking does not just damage the cardiovascular system. It can make men infertile and reduce their potency. It causes chronic lung disease like bronchitis and emphysema, and also the irritating chronic cough and increased phlegm production. It increases susceptibility to the flu and increases wrinkling. It has

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

een linked to hearing loss, cataracts, rheumatoid arthritis and many cancers. Pregnant women who smoke face the danger of spontaneous abortion, still birth and sudden infant death syndrome after childbirth.

If you stop smoking, the benefits start almost immediately. The body begins to repair itself almost immediately. Several clinical studie

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

have shown the cessation of smoking results in a substantial decrease in recurrent heart attacks, sudden cardiac death, total coronary heart disease mortality, and ischemic stroke. People who quit smoking cut their risk of abdominal aortic aneurysm in half. Within a few days or weeks, exercise endurance and cardiovascular capacity improve,

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

and the good high density lipoprotein cholesterol increases. Within a year, the risk for most cardiovascular diseases will be cut in half. Within 5 to 15 years after stopping smoking, the risk of having a stroke decreases to the same level as that of someone who never smoked. After 15 smoke free years, the cardiovascular system will be as he

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

lthy as of somebody who had never smoked. And the incidence of all smoking related cancers--of the mouth, larynx, esophagus, bladder, kidney and pancreas--decreases.

“The best way to stop smoking is to just stop - no ifs, ands or butts. ”Groucho Marx (American Comedian, Actor and Singer, 1890-1977). Once you are ready to quit smoking, set a

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

quit date. Inform and gather support from friends and relatives. Change your environment that encourages you to smoke. Get rid of all cigarettes and ashtrays in your home, car, and place of work. Do not let people smoke around you or in your home. Learn new skills and behavior and distract yourself from the urge to smoke. Drink lots of water

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

and other fluids. You may also want to join a smoking support group. If you feel like the actress Loni Anderson, who unfortunately experienced, “Once you are hooked, smoking is harder to quit then heroin, “ then you may want to seek professional help. There are several prescription and non-prescription medicines available. Nicotine replacemen

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

therapy is available as nicotine patch, gum, nasal spray or inhaler. Non-nicotine therapy includes prescription drugs Zyban and Chantix. Four out of five people who quit smoking may gain an average of about five pounds in weight. The good news is that this usually goes away within a few weeks or months after quitting.

Smokeless tobacco sh

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

uld not be used as an alternative to cigarettes. It is highly addictive and often more difficult to give up. This is because of its high nicotine content. Using smokeless tobacco also increases the risk of high blood pressure, cardiovascular disease and stroke.

So quit today. You will not only look younger but smell better. You will also liv

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

a better and longer life. And save a lot of money. It has also been said that cancer cures smoking. Perhaps I can add that premature death will definitely cure your smoking. So do not be like Mark Twain (American Humorist, Writer and Lecturer. 1835-1910) “It's easy to quit smoking. I've done it hundreds of times.” Quit once and quit forever

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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