Saturday, March 17, 2012

Medical societies fight CMS efforts to make CME funding more transparent

On February 9, 2012, I wrote about how Merck manages to evade FDA regulations on advertising by funneling money through third party intermediaries: educational institutions and education/PR companies.  These third parties then pay doctors to provide advertising to other professionals in the form of continuing medical education.  Merck can then have the doctors speak about off-label uses of its drugs and vaccines, a discussion which is prohibited by FDA if conducted by (direct) employees of Merck.

Doctors are required to obtain at least 50 hours of continuing medical education yearly in order to maintain their licenses.  A common way to do so is to attend professional meetings, which have individual talks or even whole sessions sponsored by pharmaceutical companies.  This is said to keep the cost of attending down, and additionally funnels money to the professional organizations that put on the meetings. Professional organization can earn huge fees from this type of sponsorship.

The Centers for Mericare and Medicaid Services (CMS) have proposed regulations that would make the process of using third parties to obscure who is funding educational programs for medical professionals more transparent.  Speaking fees and other "transfers of value" from industry would be published on the internet for all medical practitioners.  Using third parties would not exempt the information from publication.

The information provided would come from the pharmaceutical companies.

But the professional societies are balking.

According to Medscape,
CMS proposes requiring drug and device makers to report not only direct transfers of value to physicians but also indirect transfers through a third party when the manufacturer knows whom the ultimate recipients are. An example would be a grant given to CME faculty by an industry-funded CME provider. Organized medicine has cried foul about this, saying that CMS is going beyond the intent of Congress.
In their letter to CMS, the AMA and its allies contended that accredited CME does not need to be policed for influence peddling, as it is structured to prevent industry funders from controlling its content, speakers, or attendees. [Give me a break--Nass]  According to organized medicine, following these dollars would further burden CME providers, manufacturers, and physicians, who would have to track "any activity that could conceivably have any indirect transfer of value." That task contributes greatly to the 80 hours of annual paperwork that the regulation would impose on physicians, stated the medical societies. Accordingly, they urged CMS to exclude CME from the reporting requirements.
The ACC also asked CMS to exempt CME. Otherwise, drug and device makers would be less likely to fund CME events, and physicians would be less likely to attend.
"Better educated physicians furnish higher quality care," the ACC stated. "Reducing available CME activities certainly does not assist in achieving that goal."  [The problem is that our CME are currently so tainted, they can often not be believed.--Nass]


Monday, March 5, 2012

Bradley Manning revealed information of major international import/ Bill Blum

Bradley Manning spent nearly a year in solitary, being tortured with ploys like forced nakedness (perfected in Iraq as a torture method?).  He is unlikely to ever be free.   Julian Assange got the honeypot treatment and is likely to spend much of his remaining life incarcerated.

Yet we were told those leaked cables had little of value, except for their embarrassment potential.  I certainly didn't have the time to read them.  I accepted the received wisdom from the NYT etc.

Now Bill Blum says we got it wrong.  There was big stuff in those cables, and they helped bring on the Arab spring and with it the Occupiers.  Hmmm.  What was revealed?  "Here is a sample of some of the other Wikileaks revelations that make the people of the world wiser:
  • In 2009 Japanese diplomat Yukiya Amano became the new head of the International Atomic Energy Agency, which plays the leading role in the investigation of whether Iran is developing nuclear weapons or is working only on peaceful civilian nuclear energy projects. A US embassy cable of October 2009 said Amano "took pains to emphasize his support for U.S. strategic objectives for the Agency. Amano reminded the [American] ambassador on several occasions that ... he was solidly in the U.S. court on every key strategic decision, from high-level personnel appointments to the handling of Iran's alleged nuclear weapons program."
  • Russia refuted US claims that Iran has missiles that could target Europe.
  • The British government's official inquiry into how it got involved in the Iraq War was deeply compromised by the government's pledge to protect the Bush administration in the course of the inquiry.
  • A discussion between Yemeni President Ali Abdullah Saleh and American Gen. David H. Petraeus in which Saleh indicated he would cover up the US role in missile strikes against al-Qaeda's affiliate in Yemen. "We'll continue saying the bombs are ours, not yours," Saleh told Petraeus."
There is plenty more.  Read Blum's piece.

Before making generalizations about vaccines, learn some facts

One particularly obnoxious quality of mine is that I do not suffer fools gladly.  I get mad;  I get contemptuous;  and I want to get even.  So when I read this uneducated paean to VACCINES I was forced to respond.  When the newspaper would not publish my response and instead sent a little box that said "Oops" I got madder.  Here is the result:

A vaccine is something designed to stimulate the immune system.  (Actually some drugs do that too.)  Most vaccines get injected, but some get swallowed.  Most drugs get swallowed, but some get injected.  When medical practitioners have to know that every drug does not have a positive benefit/risk ratio for every patient, how can some medical practitioners believe that every vaccine's benefits overwhelmingly outweigh its risks?

The authors of this article lump all vaccines together.  For example: 
  1. "Vaccines have been saving our children, our pets and us from the ravages of countless bacteria and viruses. 
  2. The science of vaccines has come a long way, over the 200 years since Edward Jenner coined the term vaccination...
  3. Vaccines are the seat belts against many infections..."
Yet the authors wouldn't think of lumping all drugs together and claiming uniform effectiveness.  Nor would they claim for drugs (as a class) as they do for vaccines: "The risks of any side effects are far outweighed by the benefits of vaccines..."

In fact, each vaccine is different from every other, and each has its unique benefits and risks.  Many vaccines (for both humans and animals) have been taken off the market because they increased susceptibility to the disease they were intended to prevent, or caused severe adverse reactions. (I have blogged on this issue previously, with examples.)

Vaccines that recently caused more problems than they solved (and were taken off the market) include Rotashield and Lymerix.  Pandemrix use has been stopped for certain demographic groups.  Pandemrix was estimated to have saved 6 lives in Sweden, but caused 170 cases of narcolepsy in Swedish children.

If anything, the effect of Pandemrix was "public health in reverse" -- at least in Scandinavia and Finland, where most of the studies have been done.

Vaccines have been made from the pus of calves' bellies (smallpox), monkey kidneys (polio), fetal cells (Hepatitis A, Rabies, Varicella and Zostavax (shingles) vaccines), insect proteins (Cervarix), mouse proteins (Japanese Encephalitis vaccine) -- need I say more? -- and have included many known and unknown extraneous viruses and other unwanted material.  Vaccines commonly contain heavy metals and potentially dangerous adjuvants that were deliberately added as immune boosters or to suppress microbial growth (we are speaking of unwanted microbes that should not even be in the vaccines and are not mentioned in the label, but require growth suppression nonetheless:  thus the addition of mercury).

There is no reason to glorify every product that comes under the rubric 'vaccine'.   To a great extent, the value of a vaccine is a function of the reliability of its manufacture and its testing.   Testing before licensure is entirely paid for by the manufacturer, and all data are owned by the manufacturer.  FDA approves every vaccine (or drug) and crafts a label (along with the manufacturer) describing the safety and efficacy of every vaccine (or drug), based only on these data. 

In general, vaccine manufacturers are protected against product liability lawsuits.  That protection is absolute in the US for some vaccines, like US swine flu vaccine in 2009 only, and anthrax and smallpox through 2015,  and it was granted overseas for the 2009 Pandemrix and other swine flu vaccines.

I can assure the article's authors that no evidence exists that anthrax vaccine is effective for inhaled anthrax in humans.  Anthrax has never been used against soldiers, and therefore has not protected any soldiers from anthrax, despite the authors' claims.  But it has led to serious illnesses in 1-2% of recipients, according to the CDC and General Accounting Office. See pages 3-4.

For vaccines, as much else in life, the devil is in the details.  And public access to those details (especially regarding safety) remains constrained.  Why the data are hidden should concern you.