Monday, March 22, 2010

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.



Sunday, March 21, 2010

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


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.
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.
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

FYI

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

http://www.yelp.com/biz/northtown-coffeehouse-yakima

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

http://www.fiercevaccines.com/story/prevnar-13-pfizers-next-lipitor/2010-02-24

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

http://www.vaccinetruth.org/mark_livingston.htm

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.