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Hepatitis b is a liver disease caused by a virus with the same name. The infection may be acute or chronic and symptoms can include fever, malaise, fatigue, jaundice, abdominal tenderness, and elevated liver enzymes. While a person can be quite ill with thi

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

s infection, the treatment is supportive and aimed at providing comfort. The vast majority of patients recover within eight weeks of an acute episode of the infection without any long term complications.

Parents are told that hepatitis b is a potentially l

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

Examples of combination products may in

fe-threatening illness. What they are not told is the real risk of serious complications from the disease and that it is very unlikely their child will contract hepatitis b.

The virus is spread by coming in contact with the blood of an infected pers

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

n. The vast majority of hepatitis b infections occur in persons considered to be in “high risk groups.” These groups include adults who inject illicit drugs or are chronic alcoholics; individuals who have been diagnosed with a sexually transmitted disease;

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

nd men who have sex with men. Only 1.25 percent of infected individuals may develop liver cancer 30 years after being diagnosed as a chronic carrier.(1) Despite the low incidence of cancer, the hepatitis b vaccine has been called the first “anti-cancer vac

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

Combination pro

ine.” Considering the risk factors of those who contract hepatitis b, it could well be the alcohol or the drugs that cause the cancer, not the virus.

The number reported cases of acute hepatitis b infection have steadily declined, from 18,003 cases in 1991

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

to 8,036 cases in 2000.(2) Of all persons who are exposed to the hepatitis b virus, 50 percent will develop no symptoms and 30 percent develop only mild flu-like symptoms. In both circumstances, the person will acquire life-time immunity to the virus.

App

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

roximately 20 percent of persons who contract hepatitis b will develop fever, abdominal tenderness and the telltale sign of the infection: jaundice. In this subset of patients, more than 95 percent recover fully and will be immune for life. That means of al

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

persons who are both exposed to the virus and become measurably ill, only 5 percent have the potential to become chronic carriers of the hepatitis b infection.(3)

So, let’s do the math: If 8,000 persons were diagnosed in the U.S. with hepatitis b in 2000,

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

and 5 percent of those became chronic carriers, that would be 400 persons. If approximately 1 percent of chronic carriers go on to develop liver cancer, 4 adults might be prevented from contracting liver cancer by massive vaccination of more than four milli

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

n newborns born each year.

Why babies?
In 1991, the Advisory Committee of Immunization Practices (ACIP) began recommending the hepatitis b vaccine for newborns within the first 48 hours of life. Between 30-50% of children who develop ade

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

Following aspects would a

uate antibody after three doses of vaccine will loose detectable antibody within 7 years.(4) That means that many children vaccinated as babies will not have a measurable level of antibodies by the time they are seven years of age; most will not retain ant

dd to the challenges in developing combination products:

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

bodies into adulthood.

The government pushed hepatitis b vaccination on infants as part of a strategy to eliminate the hepatitis b virus from the general population. Vaccination programs that targeted high-risk groups did not work because many adults refus

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

d the vaccine. Finding it difficult to vaccinate high risk groups with three doses of the vaccine, the government advisors decided the only way to control the problem was to vaccinate the entire population, starting at birth.

Newborns have been targeted fo

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

r vaccination because they are accessible. Ask any parent who has tried to refuse this vaccine before leaving the hospital and you will hear horror stories of unrelenting pressure placed on them by nurses and doctors wanting to vaccinate their precious newb

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

rn.

If the hepatitis b vaccine is avoided at birth, then it is administered during the routine two month office visit…along with five other vaccines: polio (three strains), the Hib (H. influenza), Prevnar (seven strains of streptococcus), DTaP (diphtheria,

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

Professional from academic institutions, pharmaceutical industries, health care indust

tetanus, pertussis) and now, the new Rotateque (four strains of rotavirus). That is a total of 19 vaccine antigens and multiple doses of chemicals injected on the same visit into an eight week old baby.

Clearly, the universal vaccination of all newborns wi

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

h hepatitis b vaccine is a policy that is based on convenience and opportunity, not need. Parents would be wise to investigate the risks of hepatitis b infection long before they are forced to make the decision about the vaccine.

_____________________

.

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

___________
(1) Hyams, K.C. Risks of chronicity following acute hepatitis B virus infection: A review. Clin. Infect. Dis. 20, 992-1000. 1995.
(2) Acute hepatitis B infection and hepatitis B surface antigen positivity reported in the Department o

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

Companies that provide selfless information through particip

Veterans Affairs: Occurrence in a population seeking medical assistance.
(3) Ibid. Hyams, K.C. (1995)
(4) Protection against viral hepatitis. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1990 Feb 9;39(RR02):1-26

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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