Thursday 22 March 2018

A Vaccine for Alzheimer's?

An article appeared in the science section of The Telegraph (21st March 2018) claiming that drugs to vaccinate over-50s against Alzheimer’s could be here in a decade. 
New analysis commissioned by Alzheimer’s Research UK found that drugs to halt, slow or reverse the disease could be available in as little as three years with major vaccine and screening programmes possible within a decade.
This would be a huge money-spinner for Big Pharma so my suspicions are immediately aroused and so I sought to find out a little more about Alzheimer's Research UK. Is it just another facade to mask the machinations of the pharmaceutical industry? On it's website it claims:
We believe in the power of research to change the future and we’re funding a unique Research Network of over 700 dementia researchers across 15 Centres in the UK – bringing together the best minds to defeat dementia.
Some funding comes from donations but it would be interesting to see how much comes from Big Pharma. In its 2018 Annual Review it states that:
It’s been a record year. In 2016/17 our income rose to £30.5 million, fuelled by a 44% increase in donations, allowing us to power more dementia research than ever before.
 

Of course, this still doesn't give us any idea of the relative contributions by individuals and pharmaceutical companies. In the Annual Report for 2017, it states that:
Total income rose strongly to £30.5m, up 38% on 2016 (£22m). This growth was underpinned by donations and legacies delivering £29.1m, an increase of 44% from 2016 (£20.2m). Legacy income delivered an extra £1.7m whilst donations increased by £7.2m from 2016. Investment income performed well, with an increase of 12% to £731,035 (2016: £655,520), and the portfolio remains strong, generating net gains of £787,448 (2016: £1,470,033) in the year. Alzheimer’s Research UK receives no income from government sources for our research. 
An increase in funding of 44% is quite a lot and most of it has come from donations. I'm doubtful whether donations from individuals would have increased significantly from 2016 to 2017. The organisation makes it clear that no income is derived from government sources so it would seem that corporate sponsors have been largely responsible for the increase in donations. However, how do we find out who these corporate sponsors are? There's much mention made of the organisation's corporate partners and this is made up of organisations that have made Alzheimer's Research UK their favourite charity and things of this sort. These organisations carry out fund-raising activities and support various initiatives but don't apparently make direct donations.

There is no indication of any support from the pharmaceutical industry. I'm not criticising such support but if there are significant financial contributions from the industry then why is it not transparent? Of relevance here is this news (posted on 8th January 2018) from Alzheimer's Research UK's website that it is:
calling for a recommitment from pharmaceutical companies to continue efforts to fund research into dementia, the leading cause of death in the UK. Recent news that Pfizer will refocus efforts away from dementia research is a reminder of one of the barriers that stands in the way of bringing about the first life-changing treatment for dementia. 
Clearly then Pfizer has been helping out financially but is now reducing its investment. However, donations are up 44%. So what's going on? Well, the 2017 corporate donations would been determined late in 2016 and Pfizer's announcement that it is abandoning research to find new drugs aimed at treating Alzheimer’s and Parkinson’s disease was fairly recent (Saturday 6th January 2018). So while the company may have spent money in 2017, it clearly won't be doing so in 2018.  Perhaps other big pharmaceutical companies are of a similar mind and so donations may plummet for 2018.

It is important to establish the extent of the financial support from the pharmaceutical industry because then it possible to gauge the degree of control they have over the direction of research. It turns out that Alzheimer's Research UK recently acquired a new director of research. Her career path is described in an article taken from this site (24th May 2017):
My original interest in neuroscience was purely due to a brilliant neuroscience lecturer who taught me during my degree, and so when a PhD advert in neuroscience popped up on a board, I applied.  The technology I developed during my PhD then enabled me to take a role in a Pharmaceutical company out in California setting up this technology and supporting the expansion of neuroscience within the company.
After five years in California, I began to miss England and so took a role back in the UK again working in preclinical neuroscience. This led to a role in SmithKline Beecham and it was here that I really took a keen interest in the more translational side of neuroscience, progressing potential new medicines from the lab bench towards patients. After several industry and Biotech positions within translational medicine, I took a slight change in career to join the new Dementia Discovery Fund, a fund focussed around the development of new treatments for dementia, before finally joining Alzheimer’s Research UK. Whilst I remain a strong supporter of the Dementia Discovery Fund, the philanthropic approach of Alzheimer’s research UK, and the focus on basic research and translational medicine are more strongly aligned to my aspirations.
Her allegiance is clearly to the pharmaceutical industry and this is not necessarily a criticism but it does suggest that the direction of any research she approves will be drug-oriented. It's unlikely that she would incline toward research of the following type:
New research from Lund University in Sweden has shown that intestinal bacteria can accelerate the development of Alzheimer's disease. According to the researchers behind the study, the results open up the door to new opportunities for preventing and treating the disease. Source
The reason is there's probably not much money to be made in regulating intestinal bacteria. It might even be possible to do it for free! This leads back to the article cited at the start of this post that goes on to say that the new drugs being trialled could come with a £9 billion price tag. The article continues:
Already 12 Alzheimer’s drugs are in late Phase III trials, the final hurdle before licensing ... the 12 drugs coming through the pharma pipeline could provide a lifeline for patients. Most of the clinical trials involve drugs which target sticky clumps of beta-amyloid, which accumulate in the brain and stop neurones from communicating. Several vaccine-like treatments - which work more like a ‘statin for the brain’ than a traditional jab - are currently at an earlier stage of development, undergoing Phase I and II trials, said the experts. The report estimates that a vaccine could prevent around 70 per cent of Alzheimer’s cases. Speaking at a news briefing in London, report co-author Professor Jonathan Schott, from University College London's Dementia Research Centre, said: "The availability of new treatments for Alzheimer's disease is a when and not an if. "Our patients are desperate for new treatments. When the media reports any hint of a new treatment for Alzheimer's disease our clinics are inundated. “When we have a successful trial, and I say when, this will be headline news around the world and the demand will be instant and huge."
Statins for the brain sounds scary and statins of course are scary drugs (visit this site). It's not clear how the new treatments work but they promise to make a lot of money for the pharmaceutical companies with successful marketing. That's why it's surprising that Pfizer is reducing its involvement, given the tone of the Telegraph article. However, it seems that some of the new drugs that are being trialled are not living up to the hype and are proving disappointing. For example, this article from The Guardian (10th January 2018) reveals:
The quest to develop drugs to treat Alzheimer’s disease has experienced a new setback, with a promising medication failing to show benefits in the latest series of clinical trials. Earlier trials had suggested that the drug idalopirdine, from the Danish international pharmaceutical company Lundbeck, might improve cognition in those with Alzheimer’s disease when taken alongside existing drugs – known as cholinesterase inhibitors – acting to improve symptoms rather than stopping the disease from developing. But the latest trials have dashed such hopes.
The Telegraph article seems like an attempt on the part of Alzheimer's Research UK to maintain the marketing hype surrounding these "promising" new drugs in the face of declining interest from Big Pharma. The prospects of Big Pharma defeating Alzheimer's Disease anytime soon seem unlikely and this makes the Telegraph article simply a ploy to stem a likely drying of corporate donations.

Sunday 4 March 2018

GIVE LOVE NOT HPV


An article in today's Brisbane Times trumpets the following headline: Queensland researcher sets Australia up to be first country to eliminate cervical cancer. The article then begins with:
Experts predict Australia is likely to become the first country to effectively eliminate cervical cancer, with the eradication expected in the next 40 years.
Professor Ian Frazer, who is attached to the University of Queensland, created Gardasil, the vaccine for Human Papillomavirus (HPV) which causes about 99.9 per cent of cervical cancers.
The mention of the word "experts" arouses suspicion. Who are these experts? Are 99.9% of cervical cancers really caused by HPV? Mention is made of some recent research:
According to research recently published in the Journal of Infectious Diseases, there's been a dramatic decline in the rates of HPV, which has been attributed to the effectiveness of Gardasil. 
The research paper is not identified in the news article that then goes on to mention that the International Papillomavirus Society (IPVS) had issued a statement saying that it believed cervical cancer could soon be eliminated as a public health problem. The IPVS is described as being made up of the world's leading cervical cancer and HPV researchers, including Professor Suzanne Garland from Victoria's Royal Women's Hospital and the University of Melbourne, who advises the WHO and global policymakers on cervical cancer prevention and screening. It is Garland who makes the claim that:
Australia would likely be the first country to achieve the milestone of cervical cancer eradication. "We are forecasting that over the next 30-40 years, rates of cervical cancer will drop from around the current 1000 cases a year in Australia to just a few".
So what exactly are the facts? An unnamed research article claims that somewhere in the world a study had indicated that there's been a dramatic decline in the rates of HPV. It's a bit of a stretch to forecast on the basis of that research that cervical cancer rates will drop dramatically in the next 30 to 40 years. Of course, Garland hastens to add that this will only happen if vaccinations continue.

The statistic is quoted that among Australian women aged 18 to 24, the HPV rate dropped from 22.7 per cent to just 1.1 per cent during the past 10 years. Before the vaccinations, almost all sexually active people had contracted HPV.

This of course means that only a little more than 22.7% of Australian women aged 18 to 24 were sexually active ten years ago because almost all sexually active people had contracted HIV. This is an absurd statistic but it's quoted by an expert so you'd better believe it. Of course, the old line is trotted out that the benefits of the vaccine far outweigh any dangers.

The statistic that struck me was that there only 1000 cases of cervical cancer a year in Australia. Considering that there are about 12.2 million females, that's a ratio of 1:12,200. Of course females younger than 15 are not likely to be at risk of this type of cancer. In 2017, the under-15s comprised 18.8% of the population and so that leaves a little under 10 million females aged 15 and above. That's still only a ratio of 1:10,000 and yet there's a determined effort to get every adolescent girl in Australia vaccinated. That's over 2 million girls based on 2017 figures. Of course, adolescent boys are encouraged to get vaccinated as well and together this cohort would total around 4 million.

That's requires a lot of Gardasil and a lot of money for Big Pharma. Let's forget screening. Garland wants increasing screening rates as well as increased vaccination rates for millions of females in Australia alone, regardless of the rest of the world. HPV is a cash cow for the medical and pharmaceutical industry and looks set to remain so as the fear-mongering about HPV shows no sign of abating.

So what are the facts about HPV? This 2005 article from The Body sheds some light on the matter:
There may be more than 100 kinds of HPV variants, with a few strongly linked to the development of cervical and anal cancer. Because the transmission of these worrisome kinds of HPV are associated with sex, the fight against the virus is becoming increasingly fraught with all of the fears, myths and misinformation that now accompanies any public health response to sexual issues in the United States. With two new vaccines against HPV on the horizon, there are emerging concerns that these weapons may not be effectively deployed due to moral and political objections. HPV infection is the most common sexually transmitted disease in the United States. Over 5 million cases are thought to occur each year, with half of all women between the ages 18 to 22 having vaginal infections at some point. The anal infection rate in young gay men is higher still. Infection occurs through skin-to-skin contact -- including areas not covered by condoms -- and warts need not be present for transmission to occur. Most infections are transient and are cleared by the immune system. Of the 40 or so types of HPV that infect the genital and anal regions, those that cause genital warts are deemed "low-risk" whereas those linked to cancer of the cervix or anus are termed "high risk." Types 16 and 18 are the most common high-risk varieties. Most HIV-negative people -- and 90 percent of women -- clear HPV infections within two years, but infections with types 16 and 18 seem to last longer. Studies have consistently found that persistent infection with varieties such as 16 and 18 are a necessary precondition for the development of precancerous lesions. Those who clear the virus are out of danger.
The same article explains that there are two vaccines available: Gardasil from Merck and Cervarix from GlaxoSmithKline (GSK). However, as of 2016 GSK seems to have ceded the market to Merck and its 9-valent human papillomavirus vaccine (Gardasil 9), which protects against infection from HPV types 16, 18, 31, 33, 45, 52, and 58. It is recommended that children and adolescents between 9 and 14 years receive two doses of this vaccine and in 2015, about 63% of US girls and about 50% of boys received at least one dose. Not surprisingly, Merck initiated a direct-to-consumer ad campaign to encourage parents to have their children vaccinated (article). Current price of a dose is US $116.22 (link). Merck has no competitors in the HPV vaccine marketplace, it has both a monopoly and the endorsement of all the officially sanctioned oncological organisations in the world. In Australia, if all the two million females on their way to adulthood have two doses, that would represent over US $450 billion dollars in sales. If the boys could be signed on as well, that's getting close to a trillion dollars. Some governments will offset the cost of the vaccinations for children and adolescents (at taxpayers expense) but Merck will still reap the rewards.

If potential sales in a small country like Australia can total close to a trillion dollars then the potential sales worldwide are nothing short of staggering. The resulting influence that Merck can exert on the medical establishment and governments around the world is terrifying and explains why Gardasil will not be disappearing from the marketplace anytime soon. In the United States at least, lawmakers have granted the pharmaceutical industry immunity from prosecution for any ill-effects of vaccines so in the case of Gardasil Merck does not even have to worry about litigation from those harmed by it. The government quietly takes care of that side of things (at taxpayers expense) and often does make payment to the victims of vaccinations (on condition that they keep their mouths shut).

Merck as a company is not concerned with the future health of adolescents. However, the parents of these adolescents are concerned with the future health of their children and preying on this concern is the key to a successful marketing campaign. Firstly, identify a virus such as HPV that has been implicated in the development of a life threatening illness (in this case, the adult onset of cervical cancer, possibly acquired in late adolescence via sexual activity). Secondly, exaggerate the threat that this virus poses to the health of adolescents who become infected. The formula HPV = CERVICAL CANCER works just fine in the same way that HIV = AIDS once used to. Thirdly, develop a vaccine and then get the Medical Mafia and Big Government to endorse it (usually a formality). Lastly, aggressively promote the benefits of the vaccine to brain-washed medical professionals and, via advertising, to brain-dead sheeple. If some parents are reluctant to subject their children to the vaccine, then a stick must be used in place of the carrot. Some countries now are punishing parents financially by withdrawing child support benefits and excluding the children from school if they don't vaccinate their children. This hasn't happened yet with Gardasil but it might.

Here is a link to the Australian Standard Vaccination Schedule with an excerpt shown below: