Tuesday, March 30, 2010

Crestor and the Jupiter Trial

A main steam news article talks about absolute risk reduction, this is almost unheard of!

So here's what the Jupiter trial showed, if you have an elevated CRP and have 1 risk factor for heart disease (what we formerly called "low risk") and you take Crestor for 2 years you might be the one person out of 500 taking the pill that had a heart attack prevented. Doesn't that sound less glamourous than "50% reduction"?

The problem with that, among many, is that statins in general seem to raise the diabetes rate. This was shown in the Jupiter trial but that study was pretty short-lived. Other studies of statins show that taking the pill for 4 years will give you the chance of being the one person out of 250 that gets diabetes from taking the pill. Now maybe Crestor is a little lower or a little higher (it IS more potent that other statins so it's probably worse than 1 in 250 but no proof on that yet).

And this is just interesting with all the Vitamin D tests we're ordering now.

Again this all boils down to a highly lucrative experiment. We have no idea what taking Crestor for 3 years , 4 years or 20 years does to someone with a low risk of heart attacks. It's kind of despicable for a study that's supposed to be about heart attack prevention in relatively young healthy people to just run for 2 years. But it's par for the course.

It's really amazing to see the media talking about the down sides to these fads. The world is a changing my friends.

Sunday, March 28, 2010

Quitting smoking


  • Research shows that two-thirds to three-quarters of ex-smokers stop unaided. In contrast, the increasing medicalisation of smoking cessation implies that cessation need be pharmacologically or professionally mediated.

  • Most published papers of smoking cessation interventions are studies or reviews of assisted cessation; very few describe the cessation impact of policies or campaigns in which cessation is not assisted at the individual level.

  • Many assisted cessation studies, but few if any unassisted cessation studies, are funded by pharmaceutical companies manufacturing cessation products.

  • Health authorities should emphasise the positive message that the most successful method used by most ex-smokers is unassisted cessation.

    Oh my goodness! So let me get this straight. Most people who quit smoking, do it without using ANY pharmaceutical products or "professional" help.

    So when folks want to quit smoking, we should tell them the best thing for it is for them to just do it. We can charge you some money but it is your efforts that will determine success.

    Change all the ads for Chantix to ads stating "most ex-smokers quit without paying a dime to the medical system"

    I guess that'd be bad for business.

Framingham Risk


This is the starting point for anyone considering cholesterol lowering medications. It gives us the 10 year risk of having a heart attack. When the risk is in the single digits, usually you can stop thinking about cholesterol lowering drugs.

I've had family members placed on cholesterol lowering drugs or combinations of cholesterol lowering drugs inappropriately. We live in a medical culture that encourages "doing something". But the evidence of harms usually outweighs the evidence of benefit in the general, healthy , symptom-free population. We have to be very careful when doing things to the symptom free , general population. We have to have solid proof of benefit > harm before we start doing tests, procedures and prescribing preventive pharmaceuticals to healthy people.

Otherwise we will continue to do more harm than good.

Trans Fat


Interesting stuff about the history of the chemistry of diet, marketing of a byproduct of industrial soy bean production, and health effects of lab manufactured fat.

Makes me want to eat a cup of crisco, yummy

My pal over at the Skeptic's Health Journal is to blame for this post :)

Saturday, March 27, 2010

Drug Companies Funding Patient Advocacy Groups


Ever since Lenzer’s investigative report, I’ve come to realize that many patient support groups, which often claim to provide “independent” or “impartial” advice, have very deep ties with drug companies—ties that present real or perceived conflicts of interest.

Thursday, March 25, 2010

Getting It Right: Being Smarter about Clinical Trials


The PSA test provides some important object lessons. It can detect a broad spectrum of prostate cancers. However, prostate cancers are a heterogeneous group—ranging from rapidly progressing and aggressive to slowly progressive or nonprogressive. Treating the last group may lead to the erroneous conclusion that these patients were “cured” by screening and treatment. If unscreened and untreated, these same men might simply have gone on to die from other causes—at the same point in time. Early diagnosis based on screening may also lead to the erroneous assumption that screening increases true survival time, since survival is measured from the time of diagnosis—longer in the case of the screening diagnosis compared with the time when the patient becomes symptomatic (the “lead time” bias).

Movie Night

The Business of Being Born

I'm about 20 minutes into this and it's right on the money.

No pun

This shows my experience being trained to deliver babies and practicing Obstetrics on my own for 3 years in the hospital. It really IS a fight to fend off the cascade of interventions from the culture of the OB floor.

Great movie for perspective on the medical system.

Digging up More old Prevnar data


So here's where the original study that got prevnar approved had some pneumonia data and 2 years after the vaccine has been approved based on this study (without this data included) 2 years after prevnar has been standard of care for the nation's infants.

In per protocol follow-up of children given PCV, first episodes of all clinically diagnosed pneumonia were reduced by 4.3% [95% confidence interval (CI), -3.5, 11.5%, P = 0.27]

That stuff after 4.3% says "we don't know when adjusting for random chance if the vaccine prevents all cause clinically diagnosed pneumonia or not. "

Then they go on to talk about how that number exploded to 17% as they continued the study. I'll get the original and see what's in there. This is only the abstract.

Of course there's other studies of the effectiveness and longer term effects on children ( see Invasive Pneumococcal Disease Caused by Nonvaccine Serotypes Among Alaska Native Children With High Levels of 7-Valent Pneumococcal Conjugate Vaccine Coverage)

Where the levels of IPD dropped 67% then rebounded with replacement serotypes with 19A being the most common. The overall rate of IPD was still lower at the end of this longer study but there was replacement disease and the serotype 19A has gone on to develop quite a reputation for causing multi-drug resistant infections in children.

But the original study in California got the stuff approved, so let's see what was going on down there.

Tuesday, March 23, 2010

Dr TJ talking about the flu shot


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.

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

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?




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.


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.

Monday, March 22, 2010

Health Care Reform: Who are the big winners?


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.

Sunday, March 21, 2010

Nanotech successfully used in melanoma


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.


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

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 :)

Saturday, March 20, 2010

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.
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.
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."

Friday, March 19, 2010


So tomorrow, saturday march 20th, this friend of mine who happens to be a PA student is going to give a lecture to whoever randomly shows up at the North Town Coffee shop downstairs at 1 in the afternoon. The talk is on Gardasil


Like the risks and benefits and what the clinical trials show. Stuff that would be important parts of being properly consented before taking the vaccine.

It's free and I'll be there chiming in randomly and possibly talking too much and ruining his required public service gig.

He put up a couple fliers today and he doesn't think anyone will show up. So help me put my friend on the spot, ask a bunch of angry questions. To him, not me.

Thank you

Prevnar 13


The L.A. Times notes that Prevnar was the world's top-selling vaccine in 2008 with sales of $2.7 billion and was considered a key product in Pfizer's decision to purchase its rival Wyeth. And Matthew Herper of Forbes' health blog predicts that the vaccine could be Pfizer's top seller after Lipitor loses patent protection.

Pfizer expects to start selling Prevnar 13 in the U.S. during the first quarter. Already approved for infants and young children in 38 other countries, Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected later in the year, according to a Pfizer statement. Earlier this year, the company said that Prevnar 13 sales in adults older than 50 could account for $1.5 billion in sales.

Pfizer's stock jumped 1.5 percent to $17.94 yesterday following the approval, according the Financial Times.

It's Prevnar day


Ladies and gentlemen, thank you for being here tonight. I believe we are here to recognize not only Dr. Graham and myself, but all individuals who summon the faith and courage to challenge unethical
and unlawful practices. I want to share with you the story regarding my attempt to change the dysfunctional regulatory compliance culture of a pharmaceutical manufacturing plant in the years 2000-2002.

- I was hired in 2000 by Wyeth Pharmaceuticals to help in the introduction of Prevnar, a new vaccine designed to fight pneumoccocal pneumonia and meningitis in babies. The North Carolina facility where I worked is the sole production site for this pediatric vaccine which is taken in a four-dose regimen by every infant in the United States at 2, 4, 6, and 12 months. One of my key responsibilities was to assure compliant manufacturing through quality training and continuous improvement systems.


Pneumococcal Vaccine and Otitis Media

by Dr. Erdem Cantekin

Transcibed by and made available by Families for Natural Living

Dr. Erdem Cantekin, Ph.D., is Professor of Otolaryngology, University of Pittsburgh. An internationally recognized authority on otitis media and has studied causes and treatments for ear infection and sinusitis in his 25 year career. An early, outspoken critic of the overuse of antibiotics to treat ear infections, Dr. Cantekin has published more than 150 articles and abstracts in the medical literature on eustachian tube function, ear tube surgery, antibiotic resistance and conflicts of interest in biomedical research and manufacturer sponsored medicine.

Cantekin discussed the new Prevnar vaccine for pneumococcal, as endorsed by the American Academy of Pediatrics. "The alleged benefits for this new vaccine are greatly exaggerated and the risks are significant," said Cantekin. "The bacteria pneumococcus, with more than 90 serotypes, is a common pathogen. Though pneumococcus causes various diseases the carriage rate and serotype distribution rates in different groups are not know. Also, it is not known how pneumococcus transmutes itself into a pathogen. The role of pneumococcus in the microbiological balance is not known. It does contribute to 3,000 cases a year of meningitis, 50,000 a year of bacteremia, 500,000 cases of pneumonia, and seven million cases of otitis media or ear infections."

"With all of these unknowns, the vaccination of newborns with seven pneumococcal serotypes and possible eradication of those serotypes, is an uninformed experiment at best," said Cantekin.

"Unfortunately, our public health officials have no good estimates of these carriage rates in common populations. The rates of healthy newborns contracting these diseases are not well documented and yet to be determined.

Yet in February 2000 Prevnar, a seven-valent, conjugate vaccine was approved for infants and toddlers. The FDA did not approve pneumococcal for pneumonia or otitis media. This approval was limited and paradoxical because three years earlier the New England Journal of Medicine the scientists had concluded that 'bacterial meningitis in the US is now a disease predominately of adults rather than infants and young children.'"

Cantekin pointed out that the study on Prevnar violated rules of internationally accepted methods of reporting clinical trials by publishing the results when they were incomplete. For example, regarding pneumonia there was no information at all. All the results were presented in a "confusing nonstandard format." Also, the control group for the study did not receive a placebo, but another meningitis vaccine.

Other questions remained unanswered: "If this HMO trial was going to be the only foundation to vaccinate every newborn in the United States, why were those findings, involving 38,000 captive HMO children, not published in a leading medical journal? The results were instead published in a journal well known to be the mouthpiece of drug manufacturers. It is also troubling that, prior to the publication of primary results, the medical economic analysis was rushed to publication in the Journal of the American Medical Association. Then a string of publications appeared in print - this was a well-organized effort to capture the newborn population as quickly as possible. Prevnar is not effective for otitis media or pneumonia and the prevention of meningitis data are inconclusive. Why does the American Academy of Pediatrics want our children to be immunized using Prevnar? Why are all those experts excited about this new vaccine? I'm afraid the answer does not lie in the scientific realm. Endorsements by experts become more puzzling if we examine the adverse or peculiar effects of the vaccine in the HMO trial. As shown here, Prevnar had four times more seizures, four times more gastritis than the control group, significantly more developed asthma, one death in the Prevnar group. Strangely, there were twice as many SIDS in the control group, but remember the control group was receiving another experimental vaccine.

"The big push for Prevnar came from its supposed prevention of otitis media, even though it had not been approved for this use. The promise of saving children from this common, self-limiting disease now turned into persistent childhood pest, is an excellent strategy, for marketing. Every parent knows and abhors otitis media.

"Simple facts about otitis media is that 60 percent of the cases are viral, less than 40 percent are bacterial, and perhaps 25 percent of all otitis media is due to pneumococcus. In two days, 90 percent of the otitis cases resolve by itself without treatment. Regardless of these facts our experts for two decades have been recommending aggressive interventions, such as long duration antibiotic therapy and designer drugs, antibiotic prophylaxis and then followed by aggressive surgery. This clinical practice, not supported by existing scientific based evidence, fuels our $5 billion a year otitis media medical economics. So if Prevnar could stop the cycle of drug and slash, it would have been a great public benefit. But that is not the case.

The FDA data both from Finland and the HMO trial show that the prevention benefit is less than four percent. Despite this, the economic spin goes on." When the JAMA rushed to publish the economic analysis deployment of Prevnar in the US prior to the publication of the HMO trial results, Cantekin wrote a letter to the editor. In this letter he pointed out that all of the money the vaccine was supposed to save health care consumers would be saved without the vaccine if health care providers would stick to the clinical guidelines for the treatment of otitis media. His letter to the editor was rejected.

"Prevnar will have the same effect that antibiotic abuse currently has because, by changing serotype, it will exert selective pressure on the microbial ecology. This vaccine is the perfect example of a profit driven health care with no checks and balances. In our $1 trillion health care system the public health for people's interest are supposedly in the hands of three government agencies: the FDA, the CDC, and the NIH. These three pillars of our public health system are more and more in the hand of expert panels and advisory committees with ad hoc appointed outsiders. Such experts dictate policies, control the complex biomedical information system, and directly influence the taxpayers' health and wealth. Those experts are frequently in the state of conflict of interest because they also serve those special interest groups who profit from their expert decisions. Most experts are in financial relationships with these special interest groups and are usually registered with the speaker offices of various manufacturers. In other words, they are paid lobbyist. The perils of such interlocking conflicts are dangerous to public health. With increasing frequency we witness the media exposures of these white coat crimes. I think it is time that a reform act was in order and the people demand better controls from the government to protect their health and their pocket books."

Wednesday, March 17, 2010




Sunlight is by far the world's largest energy resource. A 1993 report by the DOE found that available domestic resources from solar represented 586,687 Quadrillion BTUs (Quads), out of a total of 667,597 Quads, with coal representing the second largest resource, a distant 38,147 Quads.[2] By comparison, the total annual energy consumption of the United States in 2007 was approximately 100 Quads,[3] less than 0.5% of that available from sunlight.

Tuesday, March 16, 2010

Awesome blog post on osteoporosis


here's the opening paragraph

A recent story on NPR accused the drug manufacturer Merck of inventing a disease, osteopenia, in order to sell its drug Fosamax. It showed how the definition of what constitutes a disease evolves, and the role that drug companies can play in that evolution.

Long article detailing the low points of the psychopharma era

As mental illness has become profitable, we are seeing more of it

Date Published: 2007-11-01 05:00

Author: Bruce E. Levine, PhD

The U.S. Psycho-Pharmaceutical-Industrial Complex

In Eugene Jarecki's documentary film Why We Fight, about the U.S. military-industrial complex, U.S. foreign policy critic Chalmers Johnson states: "I guarantee you when war becomes that profitable, you are going to see more of it." Similarly, as mental illness has become extremely profitable, we are seeing more of it. On September 4, 2007, The New York Times reported, "The number of American children and adolescents treated for bipolar disorder increased 40-fold from 1994 to 2003. . . .Drug makers and company-sponsored psychiatrists have been encouraging doctors to look for the disorder" ("Bipolar Illness Soars as a Diagnosis for the Young"). Not too long ago, a child who was irritable, moody, and distractible and who at times sounded grandiose or acted without regard for consequences was considered a "handful." In the U.S. by the 1980s, that child was labeled with a "behavioral disorder" and today that child is being diagnosed as "bipolar" and "psychotic"--and prescribed expensive antipsychotic drugs. Bloomberg News, also on September 4, 2007, reported, "The expanded use of bipolar as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion U.S. market for antipsychotic drugs." Psychopathologizing young people is not the only reason for the dramatic rise in sales of such antipsychotics as Eli Lilly's Zyprexa and Johnson & Johnson's's Risperdal (each, in recent years, grossing annually from $3 to $4 billion). Much of Big Pharma's antipsychotic boon is attributable to generous U.S. government agencies, especially Medicaid. The Medicaid gravy train has been fueled by Big Pharma corruption so over-the-top that it has been the subject of recent media exposures. The Associated Press, on August 21, 2007, reported, "A groundbreaking Minnesota law is shining a rare light into the big money that drug companies spend on members of state advisory panels who help select which drugs are used in Medicaid programs for the poor and disabled." Those advisory panels--dominated by physicians--have great influence over the $28 billion spent by Medicaid on drugs, but only Minnesota, Vermont, and Maine require drug companies to report monies paid to physicians. The AP article focused on John E. Simon, a psychiatrist on the Minnesota advisory panel since 2004, who received $489,000 from Eli Lilly between 1998 and 2006. The top drugs paid for by Minnesota Medicaid, according to the AP article, have been antipsychotic drugs, especially Eli Lilly's Zyprexa.

Serotonin Deficiency and WMDs

With the advent of Eli Lilly's serotonin-enhancer Prozac at the end of 1987, the general public and doctors began receiving a multi-billion dollar marketing blitz proclaiming that depression is caused by a deficiency of serotonin, and that this deficiency could be corrected by Prozac (and, later, other serotonin-enhancer antidepressants such as Zoloft, Paxil, Celexa, Lexapro, and Luvox). Between 1987 and 1997, the percentage of Americans in outpatient treatment for depression more than tripled. Of those in treatment, the percentage prescribed medication almost doubled. In 1985 the total annual sales for all antidepressants in the U.S. was approximately $240 million, while today it is approximately $12 billion. In 2006, the American Journal of Psychiatry reported that the percentage of American adults with major depression in 1991 was 3.33 percent, but by 2001, the percentage had more than doubled to 7.06 percent.The serotonin-deficiency theory of depression was so successfully marketed that it was news to many Americans when Newsweek's February 26, 2007 cover story, "Men and Depression," mentioned that scientists now reject the theory that depression is caused by low levels of neurotransmitters such as serotonin. Thomas Insel, director of the National Institute of Mental Health, told Newsweek that "a depressed brain is not necessarily underproducing something."The demise of the serotonin-deficiency theory of depression should not be considered news in 2007 because in 1998 The American Medical Association Essential Guide to Depression was already stating: "The link between low levels of serotonin and depressive illness is unclear, as some depressed people have too much serotonin." That same year Elliot Valenstein, professor emeritus of psychology and neuroscience at the University of Michigan, in his book Blaming the Brain pointed out, "Furthermore, there is no convincing evidence that depressed people have a serotonin or norepinephrine deficiency." (Antidepressants that increase the neurotransmitter norepinephrine as well as serotonin include Effexor and Cymbalta). In 2002 The New York Times reported: "Researchers knew that antidepressants seemed to raise the brain's levels of messenger chemicals called neurotransmitters, so they theorized that depression must result from a deficiency of these chemicals. Yet a multitude of studies failed to prove this precept." Unfortunately, that fact was buried under more than fifty preceding paragraphs.Similar to the Bush administration, which knew it is was far easier to sell a war when Americans believed they were threatened by weapons of mass destruction, antidepressant manufacturers know it is much easier to sell serotonin-enhancer drugs when people believe depression is caused by a deficiency of serotonin. The Bush Administration and the mental health establishment (including the National Institute of Mental Health) have retreated from their respective theories, but neither has spent a great deal of time or energy getting the word out. Since each officialdom's earlier claims were so loudly trumpeted and their later retractions so quietly whispered, many Americans continue to believe in mistaken rationales for policies and treatments that continue to affect millions of lives.The reality is that when patients report Prozac, Paxil, or Zoloft as "working," it is not because these drugs are correcting any kind of chemical imbalance. These drugs can temporarily "take the edge off"--as is the case with many psychotropic drugs, legal or illegal. But for a significant number of people, these drugs produce extremely unpleasant side effects, while for many others, these drugs have little or no effect. So, overall, the difference in effectiveness between antidepressants and a sugar-pill placebo is "clinically negligible." This was the conclusion of University of Connecticut professor of psychology Irving Kirsch, who used the Freedom of Information Act to gain access to 47 antidepressant studies sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone that had been submitted to the U.S. Food and Drug Administration (but many of which had not been published). Kirsch discovered that in the majority of the trials, the antidepressant failed to outperform a sugar-pill placebo (Prevention & Treatment, "The Emperor's New Drugs," 2002).Why now are we hearing more from the corporate media about the demise of the serotonin-deficiency theory of depression? Perhaps it is because the blockbuster serontin-enhancer drugs have either lost their patent protection or are soon to lose it and drug companies are preparing us for the next wave of patent-protected drugs and biochemical justifications for them. The Newsweek article on "Men and Depression" went on to state, "Instead of focusing on boosting neurotransmitters (the function of the antidepressants in the popular SSRI category such as Prozac and Zoloft), scientists are developing medications that block the production of excess stress chemicals."

Big Pharma, FDA, NIMH, and Congress

There are other parallels between the military-industrial complex and the psychopharmaceutical-industrial complex. Vital to the profits of both are supportive U.S. government regulatory, research, and purchasing agencies. There is nothing more important for a drug manufacturer than FDA approval and so it is common sense that a pharmaceutical company will spend whatever it takes to ensure FDA approval. In 2000 an article in USA Today, "FDA Advisors Tied to Industry," reported that in 55 percent of the FDA advisory meetings on drug approvals, half or more of the FDA advisers had financial connections to the interested drug company; and in 92 percent of these advisory meetings, at least one FDA adviser had a financial conflict of interest. Joseph Glenmullen, in Prozac Backlash (2000), notes that Paul Leber, director of the FDA's division of neuropharmacological drug products, left the FDA in the late 1990s to direct a consulting firm that specializes in advising pharmaceutical companies attempting to gain FDA approval for new psychiatric drugs.The revolving door of employment is also used by Big Pharma to maintain influence over the National Institute of Mental Health. In Talking Back to Prozac (1994), Peter and Ginger Breggin report that in 1993 Steven Paul, scientific director of NIMH, resigned to become vice president of Eli Lilly (maker of Prozac and Zyprexa). In 2001 Roche Pharmaceutical (manufacturer of Valium, Klonopin, and other psychiatric drugs) proudly announced that Lewis Judd, a former NIMH director, had joined its scientific advisory board. To the delight of Big Pharma, NIMH uses taxpayer monies to fund researchers who are financially connected to pharmaceutical companies. One important example is the "Sequential Treatment Alternatives to Relieve Depression (STAR*D)," a $35 million U.S. taxpayer-funded study that proclaimed the effectiveness of antidepressant treatment. The results of STAR*D were widely reported by the corporate media. Unfortunately, the NIMH press release about STAR*D excluded the fact that STAR*D researchers received consulting and speaker fees from the pharmaceutical companies that manufacture the antidepressants studied in STAR*D--and this fact went unreported by the corporate media. Also not in the press release and unreported is the fact that STAR*D researchers failed to include a placebo control and failed to incorporate relapse rates in the overall results. So in reality, STAR*D antidepressant results were no better than the customary placebo results or the results of no treatment at all--this also unreported by the corporate media. The corruption by Big Pharma of the FDA and NIMH is not difficult when these agencies' overseer, the U.S. Congress, has also been corrupted by Big Pharma. Billy Tauzin, a former Republican congressperson from Louisiana, is one example. Tauzin, as chairman of the House Energy and Commerce Committee, helped shepherd passage of the Medicare prescription drug law --a bonanza for Big Pharma. Soon after this favor to Big Pharma, Tauzin became head of Pharmaceutical Research and Manufacturers of America (PhRMA), Big Pharma's trade organization. Tauzin's annual salary as head of PhRMA (as reported on April 1, 2007 by "60 Minutes") is $2 million.

Psychiatry's Officialdom

Robert Whitaker, in his book Mad in America (2001), summarized the beginnings of Big Pharma's corruption of America's psychiatrists and their professional organization, the American Psychiatric Association (APA): By the early 1970s, all of psychiatry was in the process of being transformed by the influence of drug money. Pill-oriented shrinks could earn much more than those who relied primarily on psychotherapy (prescribing a pill takes a lot less time than talk therapy); drug-company sales representatives who came to their offices often plied them with little gifts (dinners, tickets to entertainment, and the like); and their trade organization, the APA, had become ever more fiscally dependent on drug companies. 30 percent of the APA's annual budget came from drug advertisements to its journals."Whitaker also reported that the APA relied on drug company grants to fund its "educational" programs. Such grants have continued and in the first quarter of 2007, Eli Lilly reported providing grants of over $412,000 for two APA programs: "Improving Depression Treatments" and "Understanding the Complexity of Bipolar Mixed Episodes."Drug companies have also been successful hijacking university psychiatry departments. In 2005 the Boston Globe reported that Harvard Medical School's psychiatry department at Massachusetts General Hospital received $6.5 million from four drug companies. Marcia Angell, physician and former editor-in-chief of the New England Journal of Medicine and author of The Truth About the Drug Companies (2004), reported that the head of the psychiatry department at Brown University Medical School made over $500,000 in one year consulting for drug companies that make antidepressants. Angell remarked, "When the New England Journal of Medicine, under my editorship, published a study by him and his colleagues of an antidepressant agent, there wasn't enough room to print all the authors' conflict-of-interest disclosures. The full list had to be put on the website."Drug companies also provide major funding for so-called "mental health consumer organizations," the most well-known of which is the National Alliance for the Mentally Ill (NAMI). NAMI received $11.72 million from drug companies between 1996 and mid-1999, according to Mother Jones in 1999, which also reported that Eli Lilly was NAMI's leading drug company funder and that "in the case of Lilly, at least, 'funding' takes more than one form. Jerry Radke, a Lilly executive, is 'on loan' to NAMI, working out of the organization's headquarters." Exposés of Big Pharma methods of influencing NAMI have not stopped the practice. In the first quarter of 2007, Eli Lilly's "Grant Office 2007" posted that Lilly provided NAMI with a grant of $450,000 for NAMI's "Campaign for the Mind of America 2007." For those troubled by the success of the psycho-pharmaceutical-industrial complex at manufacturing consent in the United States, the title "Campaign for the Mind of America 2007" is a chilling one.

ZBruce E. Levine, Ph.D., is a clinical psychologist and author of Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy (Chelsea Green, 2007). www.brucelevine.net