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. . . .
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.