SPECIAL REPORT: Breast Cancer

I have avoided writing about this subject for a long time. It’s a scary area, especially when so many of the people I love are women, and breast cancer is pretty common. There is also a sense in which as a doctor I often wonder whether anything I do really does make a difference, or are the successes just cancers that would not have spread anyway?

I have the impression from my research that in general there are three kinds of breast cancers. The one kind is a systemic disease and is not just localised in the breast. When the breast lump is removed, other areas of cancer begin to appear. Positive lymph nodes are often present in these cases.

The other kind of breast cancer is a local lesion, which if removed in time is cured and does not need chemotherapy or radiotherapy, which may be overkill and even stimulate other breast cells to become cancerous. I will look at this story later in the article.

And then there is inflammatory breast cancer, probably the worse kind of cancer, as it is difficult to detect and spreads rapidly. Prognosis is very poor for this cancer.

Clearly there is a great deal of confusion around breast cancer despite the rhetoric from oncologists that everything is under control. Today breast cancer is an industry making money for a lot of people who don’t want the status quo changed, and who present results in a way that support their point of view.

From the conventional perspective, metastatic breast cancer remains essentially incurable, and goals of therapy include the palliation of symptoms, delay of disease progression, and prolongation of overall survival without negatively impacting quality of life. This is the best that can be contemplated at present, but the complexity of each cancer in a unique individual makes this ideal outcome not at all straightforward.

O’Shaughnessy J.  Extending survival with chemotherapy in metastatic breast cancer. The Oncologist 2005;10(3):20-29

Breast cancer management has gone through a number of major shifts, and while most doctors like to point to the way science works in slowly pinpointing the best options, the fact is that the best science is not driving protocols; dogma and self-interest are the drivers. What else would account for the fact that there was a premature abandonment of “no-treatment” control groups in trials of cytotoxic chemotherapy in the 1980s? It suddenly became “unethical” to do such a study, long before it was even clear that chemotherapy in fact was better than doing nothing. Today all the trials compare one chemotherapy against another. In fact there had already been a number of trials showing no benefit to adjuvant drug treatment. So without trials comparing chemotherapy to no treatment apart from surgery, there can never be any clarity around the whole issue of chemotherapy, and whether women are better off or not having cytotoxic drugs and even radiation therapy. Both of these invasive approaches have long-term consequences.

To my mind it is unethical to offer chemotherapy until there are sufficient studies showing the superiority of chemotherapy over no treatment.

Breast Cancer Incidence

Breast cancer is the most frequently diagnosed cancer in women in the USA and in South Africa. While the incidence continues to increase, the mortality rate appears to decrease slightly.

An American Women has a 12% chance (1 in 8) of developing breast cancer during her lifetime afflicting one out of every three older women. In South Africa one out of 29 women will be diagnosed with breast cancer (one in 81 in African women, similar to Japan, and one in 13 among white women, similar to Western countries).

The CONTROVERSY AROUND THE HPV VACCINE

Because I have so many questions coming up around the HPV vaccine I decided to review the article I wrote a year ago and check whether there is anything new I need to know. What I realise again is that the constant and repeated statements by pharmaceutical companies and specialists tends to dissipate the controversy over time, so that eventually doctors and the public tend to only remember the one prevailing viewpoint. That viewpoint is often the one that has the most money to back the effort to disseminate the preferred information, and is not necessary the one that has the best science to it.

So what facts can one glean from the literature?

1. Up to 80% of women will suffer from an HPV infection in their lifetime. It is the most common sexually transmitted infection in the US; an estimated 6,2 million people are infected every year.

2. 11 100 new cases of cervical cancer will be diagnosed every year and 3 700 women will die from this cancer in the US.

3. There are more than a 100 strains of HPV, a virus akin to the common cold virus. A small number of these strains cause cancer in very limited circumstances. The two main cancer-causing strains are HPV-16 and -18.

4. Two vaccines are available, Cervarix (GlaxoSmithKline) which covers 4 strains and Gardasil (Merck) which covers 2 strains, including the above two strains.

5. Most infections with HPV clear up (just like a flu). Persistent HPV infection may precede cervical cancer by many decades. Pre-cancerous changes can be detected with a pap smear.

The important point here is that the ability of the vaccine to actually prevent cervical cancer 10 to 20 years down the road has not, and probably cannot, be demonstrated. The end point that trials are measuring is cervical intra-epithelial neoplasia, which is a well recognised precancerous condition, and not cervical cancer. Cervical intraepithelial neoplasia can be detected with routine pap smears. The need for pap smears is not removed or even lessened by taking the vaccine, as the virus is only one cause for these changes.

6. Randomised, placebo-controlled trials indicate that the vaccine was effective in preventing grade-two cervical intraepithelial neoplasia (90% effective).

7. The development of these vaccines uses recombinant DNA technology (GM technology) plus an adjuvant (in Cerarix) such as ASO4, which is a combination of standard aluminium hydroxide and a new component, monophospholipid A (MLP). MLP is a derivative of the lipid A molecule found in gram negative bacteria and is considered one of the most potent immune system stimulants known. Gardasil on the other hand uses another adjuvant called Polysorbate-80. This is a surfactant used in pharmacology to deliver certain drugs or chemical agents across the blood-brain barrier. Research in mice has shown that this agent can cause infertility and decreases the weight of the ovaries and uterus. Garasil also contains L-histadine, a histamine- like chemical. The long-term effects of these vaccines are very difficult to assess.

8. The vaccines result in statistically significant reductions of HPV-associated genital diseases, such as warts and cervical dysplasia in young women who receive it, but not in women who already have an infection, or if the infection is not of the type vaccinated against.

9. The HPV vaccine also statistically significantly reduces pap-smear abnormalities, procedures such as colposcopy, and definitive cervical therapies, compared to placebo. The average follow up was 3,6 years for the 17 622 young women between 16 and 26 years. The results were better in women who had not been sexually active.

10. The potential benefit for older women (more than 40 years old) is low. New infections do not progress to grade 2 or 3 cervical intraepithelial neoplasia in older women.

11. Cervical cancer is not a disease of young women, and there is no evidence that Gardasil is effective after 5 years, yet the vaccine is targeted for use by the very young before they become sexually active.

12. Gardasil does not work once the person has been infected with the HPV strains in the vaccine.

13. There is no clinical proof, and no clinical trials that show that Gardasil protects against cancer in the long term. This means that the vaccine does not eliminate the necessity for pap smears.

So with all this evidence, why would any young women refuse the vaccination? Well, as always, there are downsides. This means that every young women needs to collect the data and make her own choice around this issue.

What are the downsides?

1. No vaccine is pure unadulterated material. Most vaccines, and these two are no exception, carry an adjuvant. The purpose of the adjuvant is to improve the immune response now that the virus has been attenuated by passage through various animal tissues.

Gardasil HPV vaccine has been found to be contaminated with recombinant DNA despite the fact that this is not noted in the information brochure. In other words, this is a genetically engineered form of HPV genetic code that is added to the vaccines during their manufacture. This was discovered when independent tests were done after an adolescent girl experienced ‘acute onset Juvenile Rheumatoid Arthritis within 24 hours’ of being injected with an HPV vaccine. According to Dr Lee who did this research, the rDNA was ‘firmly attached to the aluminium adjuvant’.

Are we asking the right questions about vaccinations?

By Dr Bernard Brom

MB ChB (UCT), CEDH (France), Dip Acup

This column is not so much about giving answers, as about asking questions. My sense is that no one likes to be asked too many questions because it quickly becomes obvious how complex these issues are and how difficult it is to establish absolute answers. The vaccination debate and controversy is clearly such a problem.

The conventional viewpoint is that vaccines may involve risks but the benefits far outweigh these, and while some children may even die because of this procedure many more lives are saved. The conventional viewpoint is that vaccines represent one of the most effective interventions in medicine and can protect whole populations from potentially dangerous diseases. However I don’t think any doctor would deny that vaccines can cause serious adverse reactions. Doctors are concerned that doubts about the safety of the vaccines cause parents to become confused, with some parents even deciding not to vaccinate their children.

WHAT EVERYONE SHOULD KNOW ABOUT INFLUENZA

1.The flu virus can linger in the air for a few hours. One infected person in a crowded space can infect a large number of people.

2. The  young and very old are most susceptible. Influenza is especially dangerous in the latter who should make sure that their immune system is functioning well.

3. Fever is not ‘the problem’.  The higher the fever the better the immune system is functioning and the more interferon is produced. Interferon is the body's own antibiotic. Bringing the fever down with aspirin or panado is interfering with  the body's own innate intelligence.