Why The New Cervical Cancer Drug “Cervarix” by GlaxoSmithKline Should Not Be Used To Treat Cervical Cancer In USA and Other Countries Abroad, Research Paper Example

Abstract

The pharmaceutical companies are presenting a new drug called Cervarix. The drug has documented some fantastic reviews concerning the research studies and effectiveness of preventing cervical cancer in women. At first glance the research appears to be well researched; however the rave reviews are just propaganda coming from the pharmaceutical company GlaxoSmithKline.  GlaxoSmithKline has deep pocket that allows the company to spend millions or marketing dollars spreading the word to the world on the Internet. This paper will show that Cervarix is a drug that has detrimental side effects, studies were skewed and there is not enough solid research in the United States proving its effectiveness.

Introduction

The pharmaceutical industry brings many effective drugs to the market each year that saves lives. However, the lines have become blurred between profit and saving human lives. We have relied on the medical advances to help us live longer and healthier, but at what price are we paying for the medical advances?  GlaxoSmithKline has figure out how to out maneuver the FDA rules and regulations by shifting the cervical cancer clinical testing to outside of the United States. There are selling a cervical cancer drug that is not preventing cervical cancer in women.

Cervarix is a vaccine that has been presented to the world as a drug that can prevent cervical cancer. However, this drug does not meet the standard as the best drug treatment. The drug is called Cervarix which has been label by the pharmaceutical company not the medical community a preventive drug. Cervical cancer is caused by the human papillomavirus (HPV) which is transmitted by sexual activities.  HPV may be present in any man or women without any symptoms or signs that they have the disease. GlaxoSmithKline has paid millions of marketing dollars to flood the market touting GlaxoSmithKline as the leader in treating certain cancers specifically cervical cancer. The Cervarix drug is a vaccination that contains purified proteins to treat two types of human papillomarvirus which are types 16 and 18. The drug can be injected using the vials or using a prefilled syringe with the dosage already measured for single treatments. The drug companies depend on research done in other countries to determine the effectiveness of their drug. They will complete research, double placebo studies in a country that has non-existent FDA regulations.

Today, we have so many clinical medical advances that have brought a plethora of drugs into the market that claim to be the most effective treatment for cervical cancer. In reality, the pharmaceutical companies do not have any full-proof safe treatments because every drug has some kind of debilitating or damaging side effect. Recently, the pharmaceutical organizations delivery the drugs to the entire world before they have proven the drug can help a person with cervical cancer. The consumer needs to be aware because Cervarix is a drug that has not shown to deliver the best treatment for women in the United States or any other country abroad. The pharmaceutical company will boast the success of the drug in a third world country because they have fewer restrictions from the government.

Skewed Studies

The GlaxoSmithKline studies were based on over 60 percent of the white population leaving 40 percent of the diverse cultures unaccounted for in these studies. This is not a negative towards the testing but a larger percentage of diverse cultures have cervical cancer yet on a small percentage was tested. According to KaiserEdu.org (2012), “These studies were conducted in North America, Latin America, Europe, Asia, and Australia. Overall, the majority of subjects were white (59.5%), followed by Asian (25.9%), Hispanic (8.5%), black (3.4%), and other racial/ethnic groups (2.7%)”. This demographic chart clears shows that Whites have only 8.8% of women in 100,000 cases that get cervical cancer. The black women at 11.7% and Hispanic women 10.0%. This clearly shows that the ethnic races are not represented very well in the GlaxoSmithKline studies. (Appendix 1)

The marketing materials from GlaxoSmithKline conveniently leave out the location of the population of these studies. The information that GlaxoSmithKline was sharing a firm proof that the Cervarix drug was the best treatment for cervical cancer came from an ongoing study in Japan and Australia, Canada, Singapore and Switzerland. The overseas drug regulatory bodies are not as stringent as the protocols for bringing a new drug to the United States population. The pharmaceutical companies have been doing their research abroad for many years. It must cheaper for the pharmaceutical giants to completing the testing in countries Japan, Brazil, India and China. These countries are so hungry for the United States business that the drug regulations for testing overseas are weak to non-existent.

Common Side Effects

The side effect of Cervarix does not fall into the minor category. These are some major side effects such as the Blood and Lymphatic System Disorders or Lymphadenopathy. The second side effect is the Cervarix drug destroys the immune system. It appears the drug is curing one disease but the chances are high that you will develop an immune deficiency disease that will shorten your life. The side effect is called the Immune System Disorders that caused allergic reactions such as anaphylactic and anaphylactic serious reactions especially for a child. The third serious side effect is the Cervarix drug impacts the nervous system. The side effect is called the Nervous System Disorders such as syncope. In reality, every drug on the market has some kind of side effect but Cervarix has life threatening side effects. The warnings directly from Cervarix is frightening: Fainting can happen after getting Cervarix, some people who faint might shake or become stiff, side effects include pain, redness, and swelling at the injection site, fatigue, headache, muscle pain, upset stomach,  join pain and Cervarix may not fully protect everyone.

To ensure the Cervarix is protected they have the pre-stated warnings from Cervarix (2012). Cervarix leadership is so arrogant that they listed all the potential damaging side effects as if the chances of contracting any of these diseases are slim to null. The following list of information is directly from the label of Cervarix including the Internet documented research reports that clearly state what Cervarix does not do for the women that is suffering from cervical cancer:

What Cervarix does not do:

• You should continue to get routine cervical cancer screening (such as a Pap smear).
• Cervarix may not fully protect everyone who gets the vaccine.
• Not all cervical cancers are caused by the HPV types CERVARIX protects against.
• Cervarix will not protect against diseases from all HPV types.
• Cervarix will not protect against HPV types that you already have.
• Cervarix does not provide protection against disease due to all HPV types [see Clinical Studies (14.3)].
• Cervarix has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity [see Clinical Studies (14.2)
• Females should continue to adhere to recommended cervical cancer screening procedures
• Vaccination with Cervarix may not result in protection in all vaccine recipients.

The plain truth is even Cervarix is not sure of the benefits of their cervical cancer drug. The labels read as if Cervarix expects to be sued by patients because of the deadly and debilitating effects of the Cervarix. Cervarix has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity (GlaxoSmithKline, 2011).

This drug will have a devastating effect on patients and families because it is apparent GlaxoSmithKline is already bracing and anticipating the serious lawsuits to be filed in the United States courts. The side effects warnings should raise the eyebrows of any governmental agency. The warnings read in such a disturbing way to suggest any legal battles will be nearly futile because the warning labels specially makes all its legal claims disguised as label warnings. The large conglomerates in the pharmaceutical industry use the risk factor. The risk factor determines how much profit the drug makes versus how much is the potential liabilities in they were sued. GlaxoSmithKline already knows the outcome before pushing the Cervarix drug to the market.

Pros

There are some positives concerning the Cervarix drug in the market. The drug has helped children have a fighting chance with the Cervarix drug that did not exist years ago. Many parents will appreciate any type of drug that can give their child better odds of having a healthy life well into the future.  Cervarix is used in women and girls from nine years old to protect against precancerous lesions (abnormal cell growth) in the cervix (the neck of the womb) and cancer of the cervix that are caused by infection with certain cancer-causing types of the human papillomavirus (HPV) (EMA,2012). There are some good studies that support the use of Cervarix such as one study by Cervarix which included the population sample of over 20,000 women between the ages of 15 and 25 years of age. The study did utilize a source of comparison using the vaccine hepatitis-A virus.

The study looked at how many women, who in the vast majority had no current infection with HPV types 16 or 18 at the start of the study, went on to develop precancerous lesions in the cervix linked to infection with these types of HPV(Williams & Wilkins,(2008). The basis of the cervical cancer study was calculating the effectiveness of the drug over long periods of time to determine the real impact of the drug. The Cervarix research study was tracked and documented for four years, after the patient’s initial dosage. One of the immediate successes that are helping researchers understanding the cervical cancer is the Cervarix can be effective stopping the malformed cell growth within the cervix.

In the main study, after an average of 39 months, four of the more than 7,000 women who received Cervarix and who had not been infected with HPV types 16 or 18 before, developed precancerous lesions in the cervix linked to these HPV types (Williams & Wilkins, (2008). However, with the positives effects of the Cervarix drugs do not outweigh the cost of human lives while the drug has been prematurely touted as the cure for cervical cancer.

Cons

The pharmaceutical conglomerates should be held accountable for their lack of consideration of the human life. The overseas countries are targeted because they already lack medical resources necessary to take care of the unhealthy population. Specially, GlaxoSmithKline is one the conglomerates that is driving their clinical testing abroad because they know third world counties will jump at the opportunity to try a potentially lifesaving cervical cancer drug.  The opposition will say” we have our foreign constitutes that are participating with the clinical trials to sign a consent form that they understand all the dangers and potential problem with the drug”.

How can a cervical cancer drug that has not been tested for more than five years produce enough results for the FDA to approve this drug in 2009? The answer is GlaxoSmithKline pay the cost to get the product approved by the government. GlaxoSmithKline has a history of being scandalous and will do anything to increase drug profits.  The Europeans have often stated that the Cervarix drug has been marketing with slick play on words and advertising that clearly deceives the women into thinking the Cervarix prevents cervical cancer. This has not been proven that this drug works not even in the third world countries.

Conclusion

One can intelligently argue the benefits of the Cervarix drug preventing cancer in young and older women is a breakthrough. But, GlaxoSmithKline has not proven that the Cervarix prevents patients from getting cervical cancer. The actions of the pharmaceutical companies are clearly endangering the lives of patients just for a profit. The unethical marketing tactics preying on the emotional desperation of sick women should be criminal. The research is skewed because they have completed the clinical in foreign countries using distressed populations to complete dangerous clinical test.  The Cervarix drug has documented some great medical reviews concerning the research studies and effectiveness of preventing cervical cancer in women. At first glance the research appears to be well researched; however the rave reviews are just propaganda coming from the pharmaceutical company GlaxoSmithKline.  GlaxoSmithKline has deep pocket that allows the company to spend millions of marketing dollars spreading the false promises of Cervarix.

Reference

Cervarix.com. (2012).Cervarix. Retrieved from www.cervarix.com

European Medicine Agency(EMA).(2012).Cervarix. Retrieved from http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000721/human_med_000694.jsp&mid=WC0b01ac058001d124 GlaxcoSmithKline. (2012).

GSK.com(2012). Effects of Cervarix. Retrieved from us.gsk.com/products/assets/us_cervarix.pdf

KaiserEdu.org(2012). Florida: Women’s health status: Women’s health status. Retrieved from

http://www.statehealthfacts.org/profileind.jsp?cat=10&sub=112&rgn=11

Williams, L. & Wilkins. (Oct.2008). Uses for Gardasil expanded to include prevention of certain vulvar & vaginal cancers.Oncology Times. Volume 30 – Issue 19 – p 45 doi: 10.1097/01.COT.0000340755.32951.eb

Appendix  1