Dr TJ talking about the flu shot

http://www.digitaljournal.com/article/288946#tab=comments&sc=0&contribute=&local=

Two separate reviews of medical data on the effectiveness of vaccinating people to prevent influenza showed there were no benefits to being vaccinated for the flu.

Epidemiologist Dr. Tom Jefferson, who is with theCochrane Vaccines Field, participated in two different reviews of medical studies related to influenza vaccines. Both reviews were published by theCochrane Collaboration. Dr. Jefferson summarized the conclusions of the reviews in a podcast.

"... The reviews are very different in their content but not in their conclusions. Both ... highlight serious problems with the current evidence base.

... The implausible results of the studies are that the vaccines appear effective against those outcomes least likely to be caused by influenza viruses; such as influenza-like illness, hospitalization and death from all causes. In contrast they show only modest or no effect against influenza and hospitalization from pneumonia.

... our reviews include a number of studies funded by industry. An early systematic review of all influenza vaccine studies published between 1948 and 2007 found that industry-funded studies were published in more prestigious journals and were cited more than other studies but their methodological quality and size were the same as the other studies. Studies funded from public sources were significantly less likely to report conclusions favourable to the vaccines.

In conclusion we have no reliable evidence on the effects of influenza vaccines on the elderly and health care workers who work with the elderly. What we do have evidence of is widespread manipulation of conclusions and spurious notoriety of the studies."

While the doctors did not look at the outcome of the H1N1 vaccine, the conclusions reached imply, when extrapolated to the H1N1 vaccine, that many countries may have thrown away millions of dollars on the vaccine in 2009, when less money could have been spent promoting more effective preventative measures, such as hand-washing, wearing masks and wearing gloves.

In Vaccines for preventing influenza in the elderly, Doctors Jefferson, Di Pietrantonj, Al-Ansary, Ferroi, Thorning and Thomas reviewed 40 years worth of gathered records on influenza shots given to adults 65 years and older, which included 75 studies. The reviewers concluded more testing was required before anyone could say flu shots are effective.

"The available evidence is of poor quality and provides no guidance regarding the safety, efficacy or effectiveness of influenza vaccines for people aged 65 years or older. To resolve the uncertainty, an adequately powered publicly-funded randomised, placebo-controlled trial run over several seasons should be undertaken."

In the second review, called Influenza vaccination for healthcare workers who work with the elderly, Doctors Thomas, Jefferson and Lasserson looked at five available studies for the identified population group and concluded

"... there is no evidence that vaccinating HCWs prevents influenza in elderly residents in LTCFs. High quality RCTs are required to avoid risks of bias in methodology and conduct, and to test these interventions in combination."

A False Pandemic?

Recently, the Council of Europe held a panel discussion on the influence of pharmaceutical companies on the World Health Organization after Dr. Wolfgang Wodarg called the H1N1 pandemic a "false pandemic. Dr. Wodarg asserted

"... pharmaceutical companies have influenced scientists and official agencies, responsible for public health standards, to alarm governments worldwide. They have made them squander tight health care resources for inefficient vaccine strategies and needlessly exposed millions of healthy people to the risk of unknown side-effects of insufficiently tested vaccines."

A report is being prepared for the Council of Europe and is anticipated to be ready later this year.

Dr. Jefferson has been critical of the WHO's response to the H1N1 outbreak. In a 2009 interview withMaryann Napoli in 2009, Dr. Jefferson noted

"... in the WHO pandemic preparedness document, which is 62 pages long, you see in the citation count only 2 references for hand washing, 3 for masks, 1 for gloves, 23 for vaccines and 18 for anti-viral drugs. What WHO should be pushing worldwide, especially for poor countries, are these public health interventions; instead, it’s pushing pharmacologic interventions"

The WHO pre-approved nine different H1N1 vaccinations from a total of 17 submitted. The WHO has determined which companies the United Nations can purchase H1N1 vaccine from. Those pharmaceutical companies include Novartis, Sanofi Pasteur, MedImmune, GlaxoSmithKline, and CSL.

Follow the Money

It might be a sticky bit of business to prove that the WHO was influenced by pharmaceutical companies. However, it is readily evident that those pharmaceutical companies that had their H1N1 vaccines pre-approved by the WHO have benefitted.

Novartis has three different swine flu vaccines, and all were pre-approved by the WHO. Sales of its swine flu vaccines boosted company revenues by 8% in 2009.

Australia-based CSL is the only company in the Southern Hemisphere cleared by WHO to produce a swine flu vaccine, and the company experienced a 23% increase in 2009 profits, which the company attributed to sales of its swine flu vaccine.

MedImmune, a company owned by AstraZeneca, landed a contract from the United States for a swine flu vaccine in the same month the WHO declared the pandemic. The U.S. also awarded contracts to GlaxoSmithKline, Novartis and Sanofi Pasteur. AstraZeneca saw a 23% increase in its 2009 profits, which it also attributed to its swine flu vaccine. The company announced it is cutting 8,000 jobs this year.

Sanofi Pasteur said it's last quarter of 2009 saw a 10% increase in profits due to swine flu vaccine sales.

The biggest winner was GlaxoSmithKline, which reported a 66% increase in profits in the 4th quarter of 2009. The gain was attributed to sales of the swine flu vaccine. The Dutch government is trying to recoupsome of the money spent on the H1N1 vaccine by selling it back to GlaxoSmithKline.

Baxter, which produced a swine flu vaccine approved for use in Europe, but not pre-approved by the WHO, only netted a 1% increase in profits for its 4th quarter, 2009.

Lessons Learned

While the WHO has toned down its approach to the pandemic since last year, it has not declared thepandemic over. Because the pandemic is still sweeping through many countries, the WHO is coordinating the distribution of H1N1 vaccines.

Until the studies Dr. Jefferson and his colleagues have called for have been conducted by credible public agencies, people should be asking questions about recommendations for influenza vaccinations of all varieties. Consumers should question reports on the effectiveness of flu vaccines, such as one just issued by Baxter, just as they should be cautious about new recommendations on flu vaccinations. Smart consumers will ask who funded the study, and who will profit from the recommendation.

And then, just to be sure, perhaps the public should remain calm in the face of warnings about pandemics while Dr. Jefferson and his colleagues vet the credible studies that prove flu vaccines provide protection.

Am I just talking Gibber Jabber?

So maybe I'm not being clear.

Gardasil was tested and showed in 2 studies to prevent abnormal pap smears in women age 20 (ranged from age 16-24). Well it lowers the risk.

http://content.nejm.org/content/vol356/issue19/images/large/06f2.jpeg

You can see how it lowers the risk of an abnormal pap like from 15% to 12%.

http://content.nejm.org/cgi/content/full/356/19/1928

Well how important is an abnormal pap at age 20 or younger?

Not very it turns out. We're told to wait for abnormal paps to resolve in women 20 or younger because they will clear the infection without us doing a thing and cancer almost never happens at that age. In other words, if we continue to freeze and cut on cervixes with pap smear abnormalities in women 20 or younger we'll do more harm than good. The new guidelines in fact say do not do a pap smear on women under 21.

The population studied was older than the target group to get the vaccine by 10 years and the duration of protection is thought to be 5 years according to the makers of the vaccine.

We don't know what gardasil will do but there's no reason to think adding 5 years of HPV protection to an age group that is inherently capable of killing the infection naturally nearly 100% of the time will somehow prevent cervical cancer.

Maybe we'll end up doing boosters every 5-10 years in the end. Then all we have to worry about is this deal called serotype replacement.

There's like 11 other HPV types that cause cancer. Gardasil covers the 2 most common types seen but we're going to find out what those other 11 are like possibly since they'll have less competition with the 2 most common types out of the picture.

But we could get lucky and get only benign types doing the replacing. There are many more benign types than cancer causing.

But shouldn't we know if we're going to make matters worse BEFORE mass vaccinating all the children in america?

I don't know, maybe it's too complicated?

Shingles

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1177968/?tool=pmcentrez

http://www.ncbi.nlm.nih.gov/pubmed/18999945

Just wanted to save these studies where I knew I could find them later.

This doesn't PROVE the chickenpox vaccine has caused a spike in shingles cases (what I refer to as the shingles tsunami) but there's a chance that's exactly what we've done.

Turns out the natural exposure to children with chickenpox probably acted as a booster for adults and older children and teens and prevented shingles.

The chickenpox vaccines got rid of that natural boosting.

But that's ok, the pharmaceutical industry has made a shingles shot.

Sheesh

BEFORE we introduce mass vaccination, these issues should be teased out. When we figure out what's going to happen on a population level AFTER mass vaccination, well that's an experiment.

An experiment done without consent.

Health Care Reform: Who are the big winners?

http://www.msnbc.msn.com/id/35984164/ns/business-the_new_york_times//

With a sweeping overhaul of the nation’s health care system, Congress would be giving the health care industry as many as 32 million additional paying customers in the next few years.

That would mean millions more Americans buying private health insurance and better able to pay for their hospital stays, doctors’ visits, prescription drugs and medical devices.

And some analysts said as the vote neared that the final legislation was shaping up as much kinder to the industry than many initially feared. Hospitals and drug makers, which supported the final legislation, would be clear beneficiaries, analysts say, even if the outlook for insurers was less certain.

...

To help spread the costs and risks of insurance, the legislation would eventually require most Americans to have insurance or pay a federal penalty

...

Hospitals have little to fear. The number of newly insured is expected to decrease significantly the amount that hospitals now lose each year when they provide care to people with no means to pay.

...

Doctors are another group likely to benefit from more paying customers, which is a reason that the American Medical Association last week began publicly supporting the legislation.

Yet doctors must still wait for Congress to handle the sharp payment cuts they perennially face under Medicare as a result of the formula the government uses to pay doctors. In recent years, Congress has annually stepped in with a so-called doc fix to stave off those cuts.

Well doctors, IF the congress sticks to the budget they presented to the CBO you'll be keeping the Medicare cuts next year. Of course, with people ready in November to vote in a bunch of Republicans out of anger over the lack of hope and change (eyeroll) , there's a good chance the Medicare budget projections will change.

Drug makers, meanwhile, may have the most clear reason to celebrate the legislation. Pharmaceutical companies are going to be asked to contribute $85 billion toward the cost of the bill in the form of industry fees and lower prices paid under governmentprograms over 10 years. But they can look forward to tens of billions of dollars in additional revenue as more people with insurance visit doctors and fill prescriptions.

"Nom nom nom" says the pharmaceutical industry. "All our lobbying paid off!"

As a result, the pharmaceutical industry has been a significant proponent of the legislation, in sharp contrast to its behavior when the Clinton administration tried to pass a similar overhaul. The industry spent an estimated $100 million in TV advertising, grass-roots organizing and other marketing efforts to promote reform.

The legislation will also eventually close the gap in Medicare drug coverage, known as the doughnut hole, in which elderly patients must pay for prescription drugs rather than having them covered by the government. Many chose to stop taking their medicine or switched to lower-price generics.

Eventually? Eventually?! Why not do that this year big O? Come on! I thought this was for the people. Historic just like civil rights legislation and Medicare? What happened?

Sorry, I watched them vote the bill in on cspan yesterday and it kinda poisoned my brain cells a little.

Historic indeed.

Nanotech successfully used in melanoma

http://news.yahoo.com/s/nm/us_cancer_rnai

U.S. researchers have developed tiny nanoparticle robots that can travel through a patient's blood and into tumors where they deliver a therapy that turns off an important cancer gene.

Noncompliance

At the briefing, the CDC reported that 155 million doses of H1N1 vaccine had been shipped for distribution throughout the U.S. and about 70 million doses had been administered

http://www.cdc.gov/media/transcripts/2010/t100205.htm

So around 23% of the population in the US decided to participate in the H1N1 vaccination program. The government purchased around 200 million doses, shipped 155 million and the vast majority of people despite the unprecedented media bombardment decided to say "no thanks".

If that doesn't make you proud of people, then I got nothing for ya :)

That's awesome. The best marketing and scaremongering the medical industrial complex could muster resulted in a big whopping 23% compliance with the untested vaccine.

Bravo Americans.

This is a perfect example of the loss of legitimacy suffered by the health care system. People aren't even "buying" the "free" vaccine.

Someone ask the CDC if we can get a refund for those 130 million doses they purchased but didn't use. We could use the cash to bail out california :)

Prevnar and such as

Let’s look critically at what is known about Prevnar starting with the 2 prelicensure trials. Here is the main one http://tinyurl.com/ybnc3xp

Look at the study design first of all. What are they measuring and does it make sense clinically? The primary outcome is IPD caused by the serotypes in the vaccine. Secondary outcomes include all cause IPD, but wouldn’t it more relevant to include all invasive bacterial diseases? Would it be a success if we replaced IPD with other pneumonias, ear infections, bacteremia etc? Notice how after 3 years and 17 cases of IPD the randomization period was stopped by design and then less than a year later there were 56 cases to review.

There are other concerns with the study design. Since pneumococcus is normal flora in children, addressing long term effects of altering the normal flora is critical. Again, are there other bacteria replacing the infections prevented from these few serotypes of pneumococcus? What about the remaining 80 something serotypes of pneumococcus? Are we getting more or less virulent bacteria in the normal flora because of prevnar? What about the antibiotic resistance of these replacement serotypes? The initial 2 studies didn’t look at this but post after mass vaccination, we do have some studies looking into what happened.
http://www.ncbi.nlm.nih.gov/pubmed/17456820
Initially we have this:
(from 403.2 per 100,000 in 1995-2000 to 134.3 per 100,000 per year in 2001-2003, P<.001)

Then after the initial dramatic decrease in IPD, the replacement serotypes fill the partial void:
"However, between 2001-2003 and 2004-2006, there was an 82% increase in invasive disease in Alaska Native children younger than 2 years to 244.6/100,000 (P = .02). Since 2004, the invasive pneumococcal disease rate caused by nonvaccine serotypes has increased 140% compared with the prevaccine period (from 95.1 per 100,000 in 1995-2000 to 228.6 in 2004-2006, P = .001)"

What other bacteria are replacing the vaccine specific serotypes?
JAMA 2004 Aug 11;292(6):716-20
"CONCLUSIONS: Streptococcus pneumoniae carriage, specifically of vaccine-type strains, is negatively associated with S aureus carriage in children. The implications of these findings in the pneumococcal vaccine era require further investigation"
Lancet 2004 Jun 5;363(9424):1871-2
"These findings suggest a natural competition between colonisation with vaccine-type pneumococci and S aureus, which might explain the increase in S aureus-related otitis media after vaccination."

Anyone in clinical practice recall an explosion of MRSA in children since 2000? It's no fun holding down a 3 month old to drain an abscess.

There seems to be an accepted causal relationship between prevnar's eradication of its 7 serotypes and the emergence of serotype 19A as the dominant pathogen of IPD. Serotype 19A which is responsible for multidrug resistant IPD. Meaning children requiring quinolones to clear their ear infections.

The fact is, we don't know what effects Prevnar 13 will have any more than we knew what Prevnar 7 would do. If you want to look at the studies of clinical efficacy on Prevnar 13, we can; but it's rather disturbing seeing how the bulk of the research was done outside of the US and often on those living in extreme poverty. The new vaccine has been tested on populations which aren't intended to get the vaccine after licensure.

The mechanism for pneumococcus evading the antibodies from prevnar 7 , capsid switching, is a well accepted characteristic of the bacteria. Prevnar 13 will simply add another 6 antibodies and we have no reason to believe that this slightly enhanced selective pressure will give us anything other than a more robust version of 19A.

Prevnar has been the most lucrative pharmaceutical for Wyeth some of the years between 2000 and now. What benefit did we receive? Prevnar wasn't able to get an indication for preventing meningitis (bacterial meningitis in infants practically vanished in the years prior to prevnar's release). Maybe prevnar decreases IPD including pneumonia in older children and adults, but again all cause pneumonia and invasive bacterial infections would be a proper comparison AND the mothers who consented to have their infants vaccinated with prevnar weren't consenting to protect older children and adults.

Any benefit on ear infections would have to be looked at in the context of all cause ear infections and longitudinal serotype replacement phenomenon. Also the ear infection outcome has to be looked at in the context of more recent recommendations to allow the majority of clinical otitis presentations to resolve without antibiotic therapy.

http://www.news-medical.net/news/20100224/FDA-approves-Wyeth-Pharmaceuticals-Prevnar-13-pneumococcal-disease-vaccine.aspx

Look at how they compared prevnar 13 to prevnar 7 in the US trials and only looked at immunology not any clinical outcome.

Pretend Prevnar is a pill for a minute, a pill like Zetia. If it were a pill to be given to 2 month olds and the long term impact were uncertain would you recommend it to every 2 month old in the nation and "hey we'll figure out what went right and what went wrong a decade later"…..

Any preventive test or intervention is capable of doing more harm than good. We must be extremely careful mucking with the normal flora of children. The bright minds reading the articles on this site are capable of critical thinking. Now ask yourselves who has more to gain financially by manipulating people, the makers of homeopathic snake oil or Wyeth.

"Prevnar sales surged 24% in 2007 to $2.4 billion, making it the first vaccine to exceed $2 billion in annual sales."