HIV/AIDS Skepticism

Pointing to evidence that HIV is not the necessary and sufficient cause of AIDS

Posts Tagged ‘tenofovir toxicity’

Manslaughter by PreEposure Prophylaxis

Posted by Henry Bauer on 2014/07/13

The HIV/AIDS Establishment — Big Pharma, NIAID, etc. etc. — is assiduously promulgating the idea that healthy individuals who engage in sex should imbibe highly toxic substances so that they will be less likely to become “HIV-positive”.

This illustrates how true believers and those with vested interests are able to bias clinical trials to deliver desired results even when much earlier data already established that the desired results cannot have been obtained honestly:  for example, several trials of tenofovir to prevent “HIV infection” managed to report that serious adverse events from tenofovir were no more common than from placebo, even as it has long been established that tenofovir causes kidney failure and other harm.

Since this illustrates general flaws in medicine and science, I posted the full analysis on my scimedskeptic blog rather than here; see When prophecy fails.

Posted in antiretroviral drugs, clinical trials, experts, HIV absurdities, HIV risk groups, HIV transmission, sexual transmission, uncritical media | Tagged: , , , | 5 Comments »

Poisonous “prophylaxis”: PrEP (Pre-Exposure Prevention)

Posted by Henry Bauer on 2014/04/08

The Centers for Disease Control & Prevention has ballyhoo-ed “PrEP: A New Tool for HIV Prevention”  because Truvada has been approved by the Food and Drug Administration for preventing HIV infection. Truvada — tenofovir (TDF) plus emtricitabine (FTC) — had been earlier approved (in 2004) for treating HIV infection.

The 4-page CDC Fact Sheet contains no adequate warning of toxicity; the closest is this recommendation: “Disclose to women that safety for infants exposed during pregnancy is not fully assessed but no harm has been reported”.

Media coverage included “Gay men divided over use of HIV prevention drug”; but the reported division was not over the feeding of toxic drugs to healthy people but over whether such prophylaxis might induce people not to use condoms. The story said nothing about the toxicity of Truvada.

But the official Treatment Guidelines, freely available from the National Institutes of Health, have much to say about toxicity:

Adverse Effects of Antiretroviral Agents (Last updated February 12, 2013; last reviewed
February 12, 2013)
Adverse effects have been reported with use of all antiretroviral (ARV) drugs; they are among the most common reasons for switching or discontinuing therapy and for medication nonadherence. . . . However, because most clinical trials have a relatively short follow-up duration, the longer term complications of ART can be underestimated. In the Swiss Cohort study, during 6 years of follow-up, the presence of laboratory adverse events was associated with higher rates of mortality, which highlights the importance of adverse events in overall patient management (page K-7). [In clearer language: these are deadly drugs that can and do kill]

TDF may cause kidney injury in some patients, particularly in those who have pre-existing renal disease or are receiving concomitant nephrotoxic drugs. In addition, TDF induces a greater decline in bone mineral density than other ARV drugs (page F-2).

Renal impairment, manifested by increases in serum creatinine, proteinuria, glycosuria, hypophosphatemia, proximal renal tubulopathy, and acute tubular necrosis, has been associated with TDF use. . . .
participants receiving TDF/FTC experienced a significantly greater decline in bone mineral density than ABC/3TC-treated participants page (F-14).
TDF/FTC — Potential for renal impairment, including proximal tubulopathy and acute or chronic renal insufficiency (Table 6)

[TDF and FTC are both NRTIs (nucleoside reverse transcriptase inhibitors)]
Table 13. Antiretroviral Therapy-Associated Common and/or Severe Adverse Effects
Hepatic effects — reported for most NRTIs
Lactic acidosis —NRTIs
Nephrotoxicity/urolithiasis — TDF: ↑ serum creatinine, proteinuria, hypophosphatemia, urinary phosphate wasting, glycosuria, hypokalemia, non-anion gap metabolic acidosis
Osteopenia/osteoporosis — TDF: Associated with greater loss of BMD than with ZDV, d4T, and ABC.

Even Truvada’s own website acknowledges the serious risks of taking this drug:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TRUVADA?
TRUVADA can cause serious side effects:
Too much lactic acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, nausea, vomiting, stomach-area pain, cold or blue hands and feet, feeling dizzy or lightheaded, and/or fast or abnormal heartbeats.
Serious liver problems. Your liver may become large and tender, and you may develop fat in your liver. Symptoms of liver problems include your skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, and/or stomach-area pain.
You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking TRUVADA for a long time [emphasis added. PrEP implies extended use, but the CDC Fact Sheet says nothing about long-term use increasing the risk of iatrogenic harm]. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
Worsening of hepatitis B (HBV) infection. If you also have HBV and take TRUVADA, your hepatitis may become worse if you stop taking TRUVADA. Do not stop taking TRUVADA without first talking to your healthcare provider. If your healthcare provider tells you to stop taking TRUVADA, they will need to watch you closely for several months to monitor your health. TRUVADA is not approved for the treatment of HBV.”

Serious side effects of TRUVADA may also include:
New or worsening kidney problems, including kidney failure. Your healthcare provider may do blood tests to check your kidneys before and during treatment with TRUVADA. If you develop kidney problems, your healthcare provider may tell you to take TRUVADA less often, or to stop taking TRUVADA. [But the CDC Fact Sheet warns that failure to take Truvada consistently may vitiate its PrEP benefit]
Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.
Changes in body fat can happen in people taking HIV-1 medicines.
Changes in your immune system. If you have HIV-1 infection and start taking HIV-1 medicines, your immune system may get stronger and begin to fight infections. This may cause minor symptoms such as fever, but can also lead to serious problems. Tell your healthcare provider if you have any new symptoms after you start taking TRUVADA.
The most common side effects of TRUVADA are:
In people taking TRUVADA with other HIV-1 medicines to treat HIV-1 infection, common side effects include: diarrhea, nausea, tiredness, headache, dizziness, depression, problems sleeping, abnormal dreams, and rash.
In people taking TRUVADA to reduce the risk of getting HIV-1 infection, common side effects include: headache, stomach-area (abdomen) pain, and decreased weight.
Tell your healthcare provider if you have any side effects that bother you or don’t go away”.

And of course there is the usual
“You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch, or call 1-800-FDA-1088”.
The ultimate purpose of this statement is to safeguard a drug’s manufacturer against lawsuits stemming from the drug’s toxicity, by pretending concern for patients.

Summary:

A drug with known serious toxic effects,
which become more serious over time,
is being recommended for continuous use
and unlimited use in healthy people.

This would be bad enough

if HIV were actually an infectious agent causing serious illness,
which however it isn’t (see The Case against HIV

Posted in Alternative AIDS treatments, clinical trials, experts, HIV absurdities, HIV risk groups, Legal aspects, sexual transmission, uncritical media | Tagged: , , , , | 22 Comments »

Kidney-disease denialism (a special case of HAART denialism)

Posted by Henry Bauer on 2010/11/20

Mainstreamers have perfected the ART of explaining away the toxicities of HAART even as they publish illustrations of its statistically significant toxicities. They find  that HAART causes oxidative stress even “during apparently successful HAART”, which “underline[s] HAART associated toxicity”; yet they practice HAART denialism by calling it “life-saving”.
They know that protease inhibitors cause lipodystrophy, but practice denialism by calling it “HIV-associated” lipodystrophy.
They know that HAART causes kidney disease, but practice denialism by calling it “HIV-associated nephropathy”, underscoring how well established this is supposed to be by giving it an acronym, HIVAN (Mocroft et al., “Estimated glomerular filtration rate, chronic kidney disease and antiretroviral drug use in HIV-positive patients”, AIDS, 24 [2010] 1667-78):
“increasing exposure to tenofovir was associated with a higher incidence of CKD [chronic kidney disease] . . . .
Nephrolithiasis was seen in up to 27% of patients treated with indinavir [23,24] and there are numerous studies [25–29] demonstrating that tenofovir is associated with impaired kidney function . . . .”
After 24 months, 1.5% of patients on HAART had developed kidney disease, and 3% had after 36 months. Two other methods of assessing the results gave similar numbers, 0.95 and 0.88 respectively as incidence of kidney disease per year ( = 1.8-1.9% after 24 months, 2.7-3% after 35 months).
Now how could one practice denialism in the face of these statistically significant findings?
Here’s how:
“This study has demonstrated a relatively low proportion of patients developing CKD and that in addition to the traditional risk factors for renal disease, increasing exposure to tenofovir, indinavir, atazanavir and lopinavir was associated with an increased incidence of CKD” [emphasis added] —
A few percent is indeed a low percentage, though one doubts whether properly informed patients would willingly accept that high a probability of losing their kidney function.
The insertion of “in addition to the traditional risk factors” has only one purpose, to defuse the following admission that HAART kills kidneys. Those “traditional” factors include age, hypertension, and diabetes; but they are entirely irrelevant, since HAART independently kills kidneys.
The abstract practices this denialist obfuscation in its first sentence: “Chronic kidney disease (CKD) in HIV-positive persons might be caused by both HIV and traditional or non-HIV-related factors”. What the article fails to say, though, is that the work proves that HAART causes kidney disease but offers absolutely no evidence that “HIV” does.
Admittedly, some patients “at baseline” already had early signs of kidney disease; but given that “HIV” tests react poz to a wide range of disease conditions, it may well be that those individuals tested “HIV-positive” only because they already suffered from some sort of kidney problems — which “treatment” then promptly made worse.
The article’s “Introduction” lays HIV/AIDS belief on the line at once:
“HIV infection is associated with renal dysfunction, including HIV-associated nephropathy (HIVAN), immune complex kidney disease and acute renal failure [1,2], which may be associated with progression to AIDS and death [3,4]. There is increasing evidence that HIV infection of the kidneys is involved with HIVAN [5], whereas other disorders include nephropathy resulting from coinfection with hepatitis B, hepatitis C or syphilis [6,7]; diabetes or hypertension [8] and immune complex glomerulonephritis [9]”.
This is followed by remarkable claims:
“The incidence and occurrence of renal disease has decreased since the widespread introduction of combination antiretroviral therapy (cART) [10,11], with studies suggesting that cART reduces the incidence of HIVAN [12], possibly by slowing the decline in renal function [13,14]”.
I’m awaiting delivery of copies of those references 10-14, but it is curious indeed that Mocroft et al. should cite them in this manner but then, in their abstract and conclusions, point only to kidney damage done by HAART. Evidently their work has superseded and contradicted those earlier claims, yet they cite them here and do not anywhere discuss the conflict with their own findings. To have done so would, of course, have made kidney-disease denialism and HAART denialism more difficult.
The article’s final paragraph seeks to give the impression that kidney damage comes only from tenofovir:
“increasing exposure to tenofovir was associated with a higher incidence of CKD independently of other antiretroviral drugs and traditional CKD risk factors. The increase in risk of CKD was also true for indinavir and atazanavir, whereas the results for lopinavir/ r were less clear. There may be some reversibility in CKD after discontinuation of the antiretroviral drugs, but this requires confirmation in larger studies with longer follow-up”.
While the large effect of tenofovir could not be denied, the attempt to make it seem that there is some doubt about damage from the others is disingenuous, for the incidence-over-time trend is reported as positive in all of these cases, at very high statistical significance, p<0.0001 (Figure 2).
Furthermore, the suggested hope that HAART-caused kidney damage might be reversible is not supported by the earlier observation of “high risk of CKD in the group of people within 12 months of stopping tenofovir”.
The call for more research is routine, of course, and demonstrates the willingness of HIV/AIDS researchers to continue to observe, for the good of science and medicine and humanity, what happens to people who are being slowly poisoned by their “treatment”.
As of January 2009, there were well over 100 clinical trials of tenofovir (Tenofovir and the ethics of clinical trials), including as prophylaxis (Prophylaxis via organ failure and bankruptcy) against contracting “HIV”, some of them using tenofovir in a microbicide (More clinical trials in Africa; Reading HIV/AIDS numbers) despite the horrendous “side” effects that had long been known (To avoid HIV later, damage your kidneys and liver now, 19 January 2008).

Tuskegee and Guatemala were not the last examples
of Mengele-type human experimentation
by doubtless-well-intentioned medical researchers.

Posted in antiretroviral drugs, clinical trials, experts, HIV risk groups, HIV skepticism, HIV tests | Tagged: , | 7 Comments »