Darin BrownDrug peddlers’ ads ignore FDA
Posted by Henry Bauer on 2009/11/05
Advertising of prescription drugs direct to consumers is permitted, in the developed world, only in the United States and New Zealand (Marcia Angell, The Truth About the Drug Companies: How They Deceive Us and What To Do About It, Random House, 2004, p. 125). Anyone who watches TV or reads magazines knows how attractive these ads can make their medications seem: radiantly satisfied users are shown, and the “side” effects are hidden in the finest print in magazine ads while on TV or radio they are described in cheery, lighthearted tones and words intended to make them seem ignorable, mild inconveniences at worst. My favorite illustration of that is in the ads for sexual stimulants, where one is advised to consult one’s doctor if experiencing “changes in hearing or vision”, which doesn’t quite acknowledge the occasional cases of irreversible deafness or blindness.
The overwhelming majority of HIV-positive people who have taken antiretroviral drugs have found the “side” effects extremely debilitating. On a number of occasions I’ve cited the gruesome descriptions from the NIH Treatment Guidelines, including that people on HAART suffer more “non-AIDS” events than “AIDS” events, chiefly heart, kidney, or liver failure. A backhanded official acknowledgment of these awful “side” effects is the prominence given to the problem of ensuring “compliance” by patients to taking the pills. An actual demonstration is that in clinical trials in an orphanage, the children found the side effects of the drugs so painful that “compliance” had to be ensured by surgically implanting tubes direct into their stomachs (www.guineapigkids.com, accessed 13 May 2009) for ready insertion of the drugs. Another illustration is that AIDS clinics report a 40% drop-out rate from medication [Drug non-adherence, imaginary epidemics, and sexual nonsense, 30 August 2009].
The drug peddlers nevertheless like to illustrate their advertisements for antiretroviral drugs with photos of radiant men in the pink of condition. This has been so egregious that “In a strongly worded letter, FDA marketing division chief Thomas Abrams ordered pharmaceutical companies to create ads that are more ‘representative’ of the realities of HIV . . . . The ad for Crixivan features three athletic men and one woman who have just scaled a dramatic mountain peak, an athletic feat that many perfectly healthy people probably couldn’t do. Meanwhile, the ad for Combivir shows a muscular and attractive African-American with a towel over his shoulder, hinting that he has just completed a rugged workout. The text tells us he’s ‘living proof’ of the power of Combivir. . . . [T]he HIV drug ads . . . fail to spell out the potentially deadly kidney and liver problems, diarrhea, nausea and other side effects that are endemic to anti-retroviral treatments” (Daryl Lindsey, 8 May 2001, “The ‘Joe Camel’ ads of AIDS?”).
Despite that “strongly worded” admonishment from the FDA, 3 years later the FDA had to actually ban two advertisements by Abbott Laboratories.
Another 3 years on, and the drug pushers had still not mended their ways:
”Certain omissions in these ads do not technically violate current FDA regulations, but they do violate those regulations’ intent. . . . Current ads [fail to] . . . highlight life-threatening side effects” [Kallen et al., “Direct-to-consumer advertisements for HIV antiretroviral medications: A progress report”, Health Affairs, 26 #5 (2007): 1392-8].
Another two years on, and the apparently toothless tiger of the FDA overlooks or ignores such ads as this one, which appeared recently as a full page on the inside cover in both gay publications in Washington DC, Washington Blade and Metro Weekly.
Perhaps the FDA could insist that photos in such ads always be of people who have been compliantly on the advertised drugs for at least a year?
HIV/AIDS Skepticism 
MacDonald said
This from The Body is supposed to be a sober article:
The headline is “13th CROI Surprise: Antiretrovirals Are Good for You”
“Antiretrovirals Are Good for You” was also printed on the cover.
If you click on the Lexiva ads, there are patient testimonials to the fact that “I have HIV, I am Loved, Needed and Cherished”.
Disclaimers tell us that the patients are not actual patients but “Models used for illustrative purposes only”, and even that the patient testimonials are “Not actual patient testimonials”(!)
Was it really impossible to find anyone who was willing to BS for money, or are the peddlers so disdainful of the bimbos they are targeting that they can’t be bothered going for the merest fig of authenticity?
Cytotalker said
The last thing they would care to portray in their ads would be a “Crix belly” or other forms of lipodystrophy, a disfigurement so common within the gay community that it is used in the STOP AIDS campaign to promote safe sex. Lamentably, according to these activists, those poisoned to the point of disfigurement have no choice but to stay alive taking these drugs.
MacDonald said
The URL:
http://www.thebody.com/content/art12279.html
mo79uk said
I see a bit of a parallel with statin drugs. I apologise that this comment is going a tad off topic.
Though in England there isn’t direct consumer marketing of prescription drugs, various printed articles or TV ads (for supermarket cholesterol lowering foods) extol the benefits of these wonder drugs, convincing people to see their doctor and get their cholesterol tested.
Most people would qualify for the drug as the population average is more than the recommended amount of total cholesterol.
But there isn’t much talk of the debilitating side effects that more than a minority face. And of course there is also no clear link between cholesterol and heart disease, as for example the French on average have higher cholesterol than the British but less heart disease.
Aboriginal people have the least cholesterol and higher incidence.
These are based on WHO stats, but conveniently glossed over (a British GP called Michael Kendrick unearthed these in his book ‘The Great Cholesterol Con’).
Statins in all their years of prescription have not erased heart disease and their benefits are small or negligible for many.
All you need is a smiling face above a brand and a ‘condition’ and you become a drug marketing genius. And it’s not the peoples fault; so many people desperately love the idea of a simple solution that for those suffering – genuinely or not – it’s just irresistible, in the same way that no one desperate for a loan really cares about the small print.
One last note, that brings some connection to the original post, is I see that Lexiva (aka Fosamprenavir) can cause a rise in HDL (aka ‘good’) cholesterol. HDL often rises in response to fish oil and/or vitamin D which have anti-inflammatory properties.
So if there are any measurable benefits at all in Lexiva it may be due to the fact that any form of inflammation control, even if very minimal, is resultantly causing a decrease in so-called HIV markers.
(http://www.nelm.nhs.uk/en/NeLM-Area/News/477994/477995/478007/) But of course fish oil (at a valid dose) or any other natural anti-inflammatory wouldn’t batter your body in the way HIV drugs in general do.
Cytotalker said
Your point is one that HIV dissidence does tend to overlook, which is that unscientific nonsense in the med-pharma industry is hardly limited to HIV. You cite cholesterol, but the list of other scientifically unsustainable dogma within the discipline is staggering. HIV dissidents are swatting at a single fly in a swarm.
mo79uk said
Most definitely. I could speculate that both the HIV/AIDS hypothesis and the lipid hypothesis are being kept alive primarily for financial gain (atorvastatin, or Lipitor as it’s commonly known, is a statin that’s the top-selling drug in the world), but really it boils down to poor science and acceptance of this that keeps erroneous dogma alive.
The money side isn’t so much down to greed than apathy.
The great pity is that it’s become shameful to question things.
Cytotalker said
The depicted ad is disturbing in the manner in which it outright designates HIV diagnosis as a cause of shame which is cleansed away with lifelong ARV treatment. There is much that troubles me about the symbols in this ad, and I hope you will forgive my getting these impressions off my chest.
Visually, the cleanliness of the treated is here conveyed by the raised arms, exposing armpits, implying freshness, as in a deodorant commercial. The African American market is once again targeted with another very light-complected model who symbolizes transcendence from a disease that is increasingly correlated with blackness. ARV treatment is no longer even addressed as a health issue in this ad but instead is portrayed as sterilizing, rendering the otherwise unclean perhaps even touchable. Drug advertising has totally abandoned well-being concerns here, and has entered the realm of selling desirability normally touted in shampoo or teeth whitening commercials, and it does so by attributing shame to non-compliance to their prescribed protocol, shame for walking around with unsuppressed retroviral expression, and shame from the assumed socially unacceptable behavior which led to this condition. Perhaps I read too much into this ad, but the symbols to me are blatant, and I cannot fathom another meaning behind their use of the word “shame.”
MacDonald said
There is one person still living in “shame”, and the AIDStruth Death Squad have now set their sights on her after having danced on Christine Maggiore’s grave until exhaustion.
That person is Noreen Martin, who has committed the sin of kicking the HIV drugs and not immediately dropping dead, struck by a thunderbolt from above.
AIDStruth luminaries like John Moore and Nick Bennett have long remote-diagnosed and predicted (wished for) Noreen’s death on Tara Smith’s Aetiology blog, among other places, and she is now top on their Death Watch list. To wit this sick exchange at Kalichman’s:
“Anonymous said…
Any word on Noreen Martin?
November 10, 2009 9:44 AM
Seth Kalichman said…
No word from Noreen.
My sources tell me she was not at the RA Conference in Oakland…But that has not been confirmed. I am waiting for more info from Joe’s Brother.”
Seth Kalichman is of course well known for his silly cloak-and-dagger methods. After a career as Field Officer Joe Newton, he has now risen, at least in his own and fellow “Truthers'” imagination, to the position of managing an intelligence-gathering network entrusted with vital national security tasks, such as discovering the whereabouts of Noreen Martin.
Noreen has had a long history with health problems before she tested HIV-positive. She is a cancer survivor, among other things, so they obviously reckon it’s a good bet she will get sick again at some point, affirming the doctrine that the Virus always wins in the end.
Henry Bauer said
MacDonald: Doesn’t AIDStruth know that there are thousands of officially recognized HIV+ people who have lived in good health for decades while — or because of — avoiding ARVs? (the so-called “elite controllers” or “long-term non-progressors”; and when I recover and catch up after my 2-week absence, a planned blog will delineate how much larger the actual number of healthy HIV+ people is as well as how widespread is the damage done by ARV “side” effects).
As to “Intelligence” work by Kalichman, he is so inept and ignorant about Internet matters that he himself informed me unwittingly as to who his “contact” is at Virginia Tech (who also disappointed SK by telling him that my reputation here is good and sound).
MacDonald said
I guess it’s sort of OK for HIV-positives to not die from AIDS, as long as they don’t write books about it or rub AIDStruth’s nose in it in other ways. But Noreen Martin has stuck her neck out, as did Christine, and that attracts the witch hunters.
Sadun Kal said
See here for a related discussion on the twisted mentality of truthers: http://forums.aidsmythexposed.com/main-forum/5524-extreme-absurdity.html
It’s a matter of self-defense, I guess. Even if your experience contradicts their commandments, it’s OK as long as you’re not aware of it or at least you don’t try to raise awareness through it.
Philip said
“Disclaimers tell us that the patients are not actual patients but ‘Models used for illustrative purposes only”, and even that the patient testimonials are “Not actual patient testimonials'”
Don’t you love it when Big Pharma uses “fake” testimonials to claim the efficacy of their products while thumbing down real testimonials from real people for so-called “alternative” meds?
Noreen Martin said
MacDonald, you are correct in your statement that I had numerous health issues before AIDS came onto the scene. I hate to disappoint them, but I am still here and not on the HAART. As I wasn’t buying into the HIV theory, I had some non-traditional immune tests performed and discovered that I have the XMRV(mouse virus), RNASE-L Dysfunction, and high Elastase. So, there are many reasons for my health issues, excluding HIV.
It’s a great time for the rethinking movement thanks to the The House of Numbers, The LOTTI study, quotes from DeCock, the recent article by Etienne de Harven (Human Endogenous Retroviruses and AIDS Research..)etc.
AIDS patients aren’t manily dying from opportunistic diseases, but from Grade 4 Events, probably due to the side effects of the toxic drugs.
Yes, many of us are proving them wrong. And more and more of the general public are seeing through this AIDS scam, thanks to rethinker sites, talk radio,YouTube, etc.
Pellegri said
People on ARVs, HAART, and any of these other toxic drugs should be flooding the FDA’s adverse event reporting system.
Just sayin’.
Henry Bauer said
Pellegri:
Well, when I checked that website, I found already
“# Kaletra (lopinavir/ritonavir): Label Change — Serious Health Problems in Premature Babies New Warning about serious heart, kidney, or breathing problems which can be fatal. Posted 03/08/2011”
“# Abacavir — Ongoing Safety Review: Possible Increased Risk of Heart Attack8 FDA meta-analysis of clinical trials did not show an increased risk of MI associated with the use of abacavir. Posted 03/01/2011”