Wednesday, April 25, 2012

The Cervical Cancer Vaccine – Global Concerns


The Cervical Cancer Vaccine – Global Concerns
- Jagannath Chatterjee

When you visit your doctor these days you may come across a placard extolling the virtues of a vaccine that supposedly protects against cancer. This cancer affects the lower parts of the uterus or the uterine cervix in women and is known as cervical cancer. As this cancer may be caused by a virus called the Human Papilloma Virus or the HPV, the vaccine is also called the HPV vaccine. This cancer, states the placard, kills 200 women in India every day.

There are actually two vaccines, the Cervarix produced by GSK and Gardasil by Merck. When these vaccines appeared, Gardasil in 2006 and Cervarix in 2007, there was a flutter in the vaccine market. After all here was a vaccine against cancer! This is supposed to be a great medical achievement and the shareholders of these two vaccine manufacturers congratulated themselves and expected a windfall profit from the sales they would generate.

The IAP recommended the vaccine in 2008. “This vaccine has a favorable tolerability profile and the IAP-COI recommends offering HPV vaccine to all females as per label. The recommended age for initiation of vaccination is 10-12 years and catch up vaccination is permitted up to the age of 26 years. It is recommended to be given in three doses at 0, 2 and 6 months.” This was after the Drugs-Controller of India gave permission to market the two vaccines.

However the vaccine ran into heavy weather worldwide almost from the word go. At first the objections stemmed from ethical and moral perspectives. The HPV is acquired through sexual contact and the mothers of the girls the vaccines targeted wondered if they would encourage their wards to embrace a promiscous life emboldened by the knowledge that they were protected from a sexually transmitted illness. Another factor was the price. When the vaccines were introduced the required three doses cost a whopping Rs. 40,000/-.

But as the vaccines started to be administered to young girls and women there was a sense of alarm. Deaths and adverse effects necessitating hospitalisations began to be reported from across countries where such events are recorded and not neglected unlike as in India. The death toll in the US alone has crossed 89 with more that 21000 cases of serious adverse events as recorded in the Vaccine Adverse Effect Reporting System (VAERS) as on Nov 23, 2010. The most common adverse effects reported besides deaths are autoimmune disorders, blindness, epilepsy, convulsions and seizures, thrombocytopenic purpura, appendicitis and Acute Disseminated Encephalomyelitis (ADEM). However recording in the VAERS is passive that is, it is not compulsory. It has been observed that only 1 to 10% of cases are reported. The CDC studied these cases and came to the conclusion that they were not vaccine related though the vaccine package inserts do mention various systemic disorders found in both boys and girls administered the vaccine during clinical trials.

The latest damage statistics of the HPV cervical cancer vaccine from the VAERS database is;

Disabled = 760 children
Deaths = 103 
Did Not Recover = 4,616
Abnormal Pap Smear = 387
Cervical Dysplasia = 144
Cervical Cancer = 41
Life Threatening = 440
Emergency Room Visit = 8,926
Hospitalized = 23,388
Ext. Hospital Stay = 199
Adverse Events = 23,338

Please note this is data from the USA database only and ranges from 1 to 10% of the actual figures.

But yet the sales of the vaccine dipped. The manufacturers responded by reducing the vaccines costs almost by half. Today the three doses cost Rs 9000/- in India. But that too did not ensure a good uptake. In the USA around 35% of the eligible population has received the vaccine. It was noticed that of these almost 73% did not report for the subsequent booster doses. This was attributed to the high reactogenicity of the vaccine.

The scientific community responded by describing the vaccine to be "safe and trustworthy", a claim that the parents refused to acknowledge. The manufacturers began donating to the election funds of Presidential candidates and soon Rick Perry decided to mandate the vaccine for every girl child in Texas, an US state. There was a furore but the industry never let go of their efforts to mandate the vaccine and waive parental consent before administering the vaccine to children which continue to this day. They now recommend the vaccine for boys too for genital warts. The subject cancer is no longer restricted to cervical cancer alone but has embraced anal and even throat cancer. Though it would take over six decades to know whether the vaccine was effective, scientific studies claim that the vaccine is a major success and that cervical cancer rates had fallen!

Critics and concerned doctors then warned the population that the claims of the manufacturers that the vaccine protected against cervical cancer was in itself doubtful as the vaccine included only two to four strains from a possible hundred strains of HPV that could cause cancer, 15 being the number called the high risk strains. They pointed out that as nature abhors a vaccum, it was likely that targeting a few strains could make the other strains more virulent.

They warned that the Gardasil vaccine contained a neurotoxic metal, aluminum, as adjuvant and of the presence of Polysorbate 80 or Tween 80, observed in a European clinical study to cause infertility in rats, and a chemical that causes the blood brain barrier to become porous. The Cervarix vaccine too has been in the news for the use of a novel aluminum and oil based (squalene) adjuvant called AS04 that has never been tested either in children or adolescents.

They also warned that examination of uterine pap smears was still an effective tool for controlling cervical cancer and not the vaccine which was a long way from being proven. So even if the girls were administered all the required doses of the vaccine, they would still require to go in for regular pap smear tests to check for pre-cancerous or otherwise caused lesions as per Dr Neerja Bhatia of AIIMS, New Delhi.

According to Dr Diane Harper, one of the leading developers of the vaccines, in a statement made on Oct 2, 2009, 70% of HPV virus infections resolve themselves without treatment within one year. After two years this rate climbs to 90%. Of the remaining 10% of HPV infections only half coincide with the development of cervical cancer. She also said, “With the use of Gardasil, there will be no decrease in cervical cancer until at least 70% of the population is vaccinated, and in that case, the decrease will be very minimal. The highest amount of minimal decrease will appear in 60 years”. Also according to her, “there have been no efficacy trials in girls under 15 years”. The American Cancer Society notes that “between 1955 and 1992 the cervical cancer death rate declined by 74%” and that “the death rate from cervical cancer continues to decline by nearly 4% each year”.  The society ranks deaths from cervical cancer as the 12th leading cause of carcinoma related deaths.

In September 2011 an NGO investigations into 13 vials of the HPV vaccine Gardasil from 13 different vials from 13 different lots of the vaccine from around the world revealed that the vaccine was contaminated with HPV recombinant DNA. This is despite the vaccine package insert claiming that it contained no viral DNA. All DNA residue discovered was firmly attached to the insoluble aluminum adjuvant in the vaccine, requiring a new protocol for detection, according to the report.

According to researchers such rDNA was a problem even in laboratory conditions and that whenever such an entity was handled for research there were always fears that they would escape from laboratory conditions. And here was this vaccine that was injecting rDNA into childrens bodies! This in itself could cause cancer besides autoimmune disorders and the vaccine package insert also stated that the vaccine was never tested for carcinogenicity! It listed a series of extremely serious conditions including death that were observed both during clinical trials and after the vaccine was administered.

Faced with stiff opposition in developing nations the industry had already turned its attention to developing nations. In India the vaccine was tried in 2007 on tribal girls in the states of Andhra Pradesh and Gujarat. Studies of the clinical trial revealed gross irregularities as required parental consent was not taken or manipulated and the civil society here protested widely and vociferously. On April 7, 2010, the MoHFW ordered a probe and the ICMR distanced itself from the trial. Nine tribal girls died during the trial and the trial was hurriedly stopped. Though the government claimed that the deaths were not due to the vaccine but the exact details were not made available to the public.

The mothers of some of these tribal girls who could be contacted claimed that their children were hale and hearty before taking the vaccine and they blamed the vaccine for the deaths.Experiments on tribal girls in India is itself an unethical task. In India too doctors from Kerala have reported that cervical cancer cases are already in the decline without the vaccine due to the growing awareness about uterine pap smears.

Right now the manufacturers have devised a strategy to penetrate the developing countries. GSK has donated 1 million doses of the vaccine to the Pink Ribbon Red Ribbon alliance and Merck has donated $ 3 million to the alliance. The idea is to draw girls and ladies to the clinic with the noble intention of conducting Pap smear tests and then offer to them the vaccine. Efforts are also being made, by tweaking the scientific community again, to reduce the required doses of the vaccine and hence make it more affordable.

Let us see where these efforts lead to. The European Medical Association has called for a reassessment of the vaccine in light of the rDNA contamination being found, the American Association of Physicians and Surgeons have questioned the safety of the vaccine and so also the Scientific American, a journal devoted to science. Parents from all over the world are up against the vaccine led by parents of girls who have died from or been disabled/injured by the vaccine. It is difficult to predict what the future holds but with forces like the WHO, BMGF, GAVI, PATH, CDC and AAP backing the vaccine, it is definitely not going to fade away. In fact the GAVI is now planning to arrange HPV vaccines for the developing countries at $5 per dose.

Already there are powerful voices advocating the vaccination of infants to boost compliance and ensure a steady market despite Dr Diane Harper’s comments that “if you vaccinate a child, she won’t keep immunity in puberty and you do nothing to prevent cervical cancer”. She also says that the rates of serious adverse events from the vaccine are greater than the incidence of the disease, at least in the USA. It will be of interest to know that 15 deaths occurred during the trial of the Gardasil vaccine.  

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Note: The writer has prepared this note from memory and internet searches and is not responsible for any errors that might have crept in despite due diligence. There is no conflict of interest. This note is prepared in public interest.

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