Gardasil and the Sad State of Present-Day Medical Practices

A common albeit bowdlerized statement of the Hippocratic Oath is, “First, do no harm”.
In modern parlance, one might put it that any medical treatment should have a very high ratio of benefits compared to risks.
Present-day practices do not conform to that.

Some friends call me cynical, other friends call me naïve. I suppose it was my latter aspect that was stunned by the recommendation by the Centers for Disease Control and Prevention that males be vaccinated by Gardasil against the Human Papilloma Virus (HPV) in order to guard against genital warts and anal cancer. But even my cynical side was surprised that the supposed guardians of public health have sunk to such depths of incompetence — bearing in mind a favorite saying,

NEVER ATTRIBUTE TO MALICE
WHAT CAN BE EXPLAINED BY INCOMPETENCE

because incompetence really is so much more common than deliberate malice.

Several years ago,  I pointed out that there is no evidence at all that HPV causes cancer or anything else. About 6.2 million Americans contract HPV annually; fewer than 6000 women contract supposedly HPV-related cancers, and about 1300 men. Another 5000 men and women contract anal cancer, which was not then mentioned as HPV-related but has been recently alleged to be so. Take all of those together: Fewer than 15,000 annual cases of allegedly HPV-related cancers for 6.2 million annual infections: 1 chance in 40 that an infection will be associated with a cancer.
That doesn’t make HPV seem like an agent that actually causes those cancers, does it?

The only evidence ever offered for a link between HPV and any cancer is statistical association. The first law of statistics, the first thing taught to students about statistics, is that it seeks to estimate correlations, associations: and  CORRELATION NEVER PROVES CAUSATION.
Yet present-day medical practices routinely confuse correlation with causation, indeed assert that associations prove causation. “Risk factors” are treated as though they were actually risks, and many drugs are prescribed in order to modify risk factors, which amounts to treating symptoms instead of causes.

The reasons for this sorry state of affairs are too numerous to discuss in a blog post, but the state of affairs is obvious enough; rhetorical questions like “How could this have happened? Isn’t medicine evidence-based?” are beside the point. This is how it is.

With respect to Gardasil, one gains an inkling of the reasons for the scandalous situation by noting a few facts:
Judicial Watch, an independent group, has found through Freedom of Information filings that Gardasil has been associated with a significant number of deaths, for example
“Judicial Watch uncovers FDA Gardasil records detailing 26 new reported deaths — Other adverse reactions include: seizures, paralysis, blindness, pancreatitis, speech problems and short term memory loss” (press release, 19 October 2011). The Judicial Watch website has information about scores of earlier deaths  and other adverse events.
On the other hand, the Centers for Disease Control and Prevention (CDC) seek to play down the demonstrated lack of safety of this vaccine by stating,
“As of September 15, 2011, approximately 40 million doses of Gardasil® were distributed in the U.S. and VAERS received a total of 20,096 reports of adverse events following Gardasil® vaccination: . . . . 92% were considered to be non-serious, and 8% were considered serious. . . .
Deaths
As of September 15, 2011, there have been a total 71 VAERS reports of death among those who have received Gardasil®. . . . In the 34 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination”.
Note that while CDC is prepared to accept statistical association as evidence of causation when it come to HPV causing cancer, it is not prepared to accept reports of death associated with Gardasil as proving causation.

Bear in mind that there is no system for monitoring adverse events. It depends on initiative being taken by individual doctors. They may report to the drug company rather than the Food and Drug Administration or CDC, and drug companies use their own judgment as to when enough adverse events have come in to warrant informing the federal agencies. Many qualified observers have estimated that only about 1 in 10 of all adverse events comes to the attention of CDC or FDA. (For many discussions of this and other flaws in drug approving and monitoring, see the books listed under “!What’sWrongWithMedicine”.)
Bureaucracy and conflicts of interest have much to do with the current state of affairs. Have a look at the membership of the CDC’s Advisory Committee on Immunization Practices, with its 13 members, 9 “ex officio” members, and some 33 “Liaison Representatives” as well as the Chair and the Executive Secretary, the latter an official at CDC.
Anyone who has had anything to do with such groups knows that the actual work is done by staff members who bring the data and analyses to the Committee. That staff has prime influence on the proceedings. One suspects that some of the Liaison people do as well, for example the representative of the Pharmaceutical Research and Manufacturers of America (PhRMA).

A useful earlier criticism (February 2009) of Gardasil was by Herb Newborg, “The Tragic Truth behind the Gardasil Nightmare”. Sharp but documented, evidence-based critiques of the recent Gardasil recommendation come from Anthony Gucciardi  and Ethan Huff at Infowars.com; Huff cites among others Christian Fiala, who successfully campaigned against approving Gardasil for use in Austria.

We have a medical system in which good people combine to achieve tragically harmful outcomes for far too many other people. Hippocrates is spinning in his grave.

RA 2011 to be re-scheduled

The proposed meeting in Washington DC beginning of December has had to be postponed:

 

Rethinking AIDS regrets to inform you that RA 2011 will not be held on December 1-3, 2011. Many Rethinkers experienced difficulty raising adequate travel and lodging funds in these tough economic times and, in some cases, were unable to obtain visas in time. Without access to support from governments, foundations and corporations, Rethinking AIDS has decided to postpone the conference and to consider alternative formats that can involve more rethinkers at less cost.

We appreciate the support provided by both our volunteer speakers and by those of you who did register. All registrants will be contacted soon to arrange a refund. We apologize for any inconvenience this may cause.

– David Crowe, Conference Chair and President, Rethinking AIDS
mailto:David.Crowe@rethinkingaids.com

Deniers, Skeptics, Dogmatists, Scientists

AIDS Rethinking has implications far beyond specific issues concerning HIV and AIDS.

A common, natural, naïve objection to AIDS Rethinking is, “How could science be so wrong?” This stems from the conventional wisdom that science is objective and self-correcting because it deploys the scientific method.
A logical fallacy is that the self-correction wouldn’t be needed if the scientific method really made science objective. A practical fallacy is that science is done by humans. There has never been an objective and self-correcting human being, no matter the methodology being used; and there has never been a group of human beings who were objective and self-correcting through being guided by an infallible methodology.
The first sociologist of science, Robert Merton, identified the norms of science as communalism, universalism, skepticism, disinterestedness; and John Ziman later added “originality”. But human beings don’t practice communalism — uninhibited free sharing — and human beings are not very good at being skeptical about their pet theories, and there is no such thing as a universally disinterested human being. As to the scientific method, it is a construct by philosophers trying to explain why science had apparently been so successful at gaining authentic understanding of the material world; scientists don’t actually work by the so-called scientific method.

AIDS Rethinkers have become aware of much of this in the particular case of HIV/AIDS. The hypothesis that HIV causes AIDS is not an outcome of disinterested, skeptical research freely and openly shared. Instead, it exemplifies how science and its applications are subject to the psychological and social influences that pervade all human activities. Self-interested careerists were able to capitalize on particular social and political circumstances to have their views entrenched as mainstream consensus, and the usual sociopolitical inertia against drastic change has kept it there as more and more sectors of society came to have vested interests in the status quo. So the mainstream hardened into dogma, and dissenting voices have been dubbed “deniers” and treated as heretics.

But AIDS Rethinking is not the only nexus displaying these aberrations. As I pointed out at the Oakland Conference in my talk, “HIV/AIDS blunder is far from unique in the annals of science and medicine”, dogmatism and the suppression of minority views is quite widespread.

I was just alerted to a fine essay by David Deming, “Why I deny global warming”, which brings out the difference between skepticism and denying. Since science is a matter of attending to evidence and not a matter of belief, there can be no such thing as denying or denialism if science is being practiced properly. Such things as “belief” and “denying” pertain to matters of religion, not matters of science.
Deming’s essay has a link to an earlier piece, “Doubting Darwin”,  which is similarly instructive. Accepting that evolution has occurred does not entail accepting that natural selection was sufficient to bring it about.

Highly recommended reading.

Are the best things free?

“The best things in life are free” applies, like all other such generalizations, in some cases but not in others.
When it comes to information about HIV/AIDS, the best information is available from AIDS Rethinkers, and much of it is available entirely free over the Internet. Some in professional journals may require the help of Interlibrary Loan, and some books may need to be borrowed or bought, but none of this is particularly expensive.
One point of considerable importance is the mainstream-asserted HIV/AIDS epidemic in sub-Saharan Africa. That the official UNAIDS and WHO numbers are greatly exaggerated has been asserted authoritatively by the former WHO epidemiologist, James Chin, in The AIDS Pandemic (2007). The fact had been noted years earlier by the South African journalist Rian Malan: “AIDS in Africa: In search of the truth”, Rolling Stone Magazine, 22 November 2001; “Africa isn’t dying of Aids”, The Spectator (London), 14 December 2003.
Despite that, Chigwedere et al. published the absurd claim, based on the highly exaggerated UNAIDS estimates, that failure to provide antiretroviral drugs had caused ~300,000 unnecessary deaths (“Estimating the lost benefits of antiretroviral drug use in South Africa”, JAIDS 49 [2008] 410-5). Duesberg et al. pointed out that the official government agency, Statistics South Africa, reported deaths from AIDS that were 1/25 of the UNAIDS estimate, ~12,000 annually rather than ~300,000, but JAIDS refused to publish the correction. It was later accepted by Medical Hypotheses, published on-line, but later withdrawn by Elsevier Publishers at the behest of mainstream vigilantes (Elsevier-Gate). The same facts were later published by Galletti and Bauer (“Safety issues in didactic anatomical dissection in regions of high HIV prevalence”, Italian Journal of Anatomy and Embryology, 114 #4 [2009] 179-92).

Rethinkers were pleased, then, that recognition of these facts appeared to have become common knowledge, as indicated by a press release trumpeting a new report, “Where are the bodies? — HIV/AIDS statistics in South Africa —— New report recalculates AIDS-related death estimates with powerful policy implications”:
“•    Pharmaceutical companies investing $300 million into developing HIV/AIDS drugs while anticipating a global market of 40+ million people will be competing for a market only a fraction of the size.
•    AIDS/HIV research consumes 42% of government, corporate, and philanthropic research funding while the two largest killers in the third-world (pneumonia and diarrhea) receive less than 6 per cent combined; tuberculosis remains the biggest killer in the third world.
•    Only a tiny fraction of the 5.6 million people in Africa who are receiving anti-retroviral drugs actually have HIV infection.  Not only are the anti-retroviral drugs potentially toxic, ‘the frightening scenario looms that widespread, but curable, diseases are wrongly classified as AIDS-related complex, thereby foregoing appropriate treatment. . . .
UNAIDS estimated that the Republic of South Africa had 360,000 HIV/AIDS deaths in 1997.  However, after tabulating all deaths for 1997, South Africa attributed only 6,635 deaths to HIV/AIDS. . . .
The supposed HIV seroprevalence rates in the Republic of South Africa exceed all plausible limits of heterosexual HIV transmission’”.

We were naturally interested to learn more about where this report originated. The press release mentioned that HIV/AIDS Statistics in the Republic of South Africa could be ordered from http://www.MarketResearch.com and http://www.ResearchandMarkets.com. We couldn’t find it there, though an earlier report was listed, Redefining the Size, Scope, and Scale of the AIDS Epidemic
by Forensic Review of the Medical Literature. The press release had been issued by Health Alert Communications, and its website  does offer both reports. Each is offered at the same price of $5,995 for Online Download or $14,995 for a Global Site License.

“You get what you pay for” is another of those common generalizations whose opposite is often the case. For just under $6000, information is available from Health Alert Communications that was earlier available for free in several places.

These Reports illustrate how huge and lucrative has become the HIV/AIDS BUSINESS, the HIV/AIDS INDUSTRY. Tens of billions of dollars are expended annually on research, treatment and associated social activities, so it becomes feasible for entrepreneurs to attempt to market publicly available information in dressed-up format in a manner that seems to offer commercial benefit: “Pharmaceutical companies investing $300 million into developing HIV/AIDS drugs while anticipating a global market of 40+ million people will be competing for a market only a fraction of the size”.

We face a dilemma:
Is it worth investing $5995 in order to determine whether Health Alert Communications could be sued for plagiarism or for violating the copyrights of the journals and books that have previously published these analyses?
Or perhaps Rethinkers should no longer cast valuable pearls freely before the unappreciative public and instead offer their services, at modest fees, to Health Alert Communications.