Headin' for pharmageddon - by crook or hook.

[Guest guest]

"WC Douglass" <realhealthDaily Dose - Headin' for pharmageddon - by crook or hookSun, 28 May 2006 12:59:02 -0400 A Leader CrookedI've got a confession to make: I've been sitting on a big story formore than a month.I normally wouldn't do something like this, but in this case I justhad to. I wanted to see what the mainstream media would do about thisstory before I broke it in this forum. I hoped it would make headlinesfor weeks and cause ripples that would shake the very columns of thebrand-new Food and Drug Administration building...But since the story looks poorly on both the FDA leadership and on thepolitical machine which greases the corrupt agency's axles

with shadyback-room deals, it caused no more than a momentary blip - nothingmore than barebones obligatory reporting so that the mainstream mediacan say it did its job.It's a shame, too. It's a blockbuster story. On with it...A New York Times investigative report from April 29th (picked up bythe AP and a few other news services and papers) claims that therecently resigned head of the FDA is being investigated criminally forfalse statements to Congress and for financial improprieties involvinga company overseen by the agency.According to the Associated Press report and other sources, former FDAhead Lester Crawford and his wife liquidated more than 50,000 sharesof personally held stock in companies directly regulated by the agency(drug companies, I assume) - stock they held for weeks even AFTERCrawford's confirmation last June. This constitutes a blatant conflictof interest, especially since Crawford had

been acting head of theagency since mid-2004.Less than three months after his confirmation, Crawford suddenlystepped down from his post in September of 2005. One can only assumeit was due to the impending investigation into his finances.But this securities conflict isn't the only problem brewing for theformer FDA head. He's also accused, as part of a lawsuit against theFDA, of holding up the approval of the over-the-counter version of RU486 (the "morning after" birth control pill) for purely politicalreasons - remember, this is a Republican presidential administrationwith a fiercely pro-life stance...Regardless of how you feel about oral contraceptives or prescriptiondrugs in general (I've got some strong opinions on both these thingsmyself), this kind of interference in what's supposed to be anobjective approval process violates everything the Food and DrugAdministration is supposed to stand for.

vTHAT'S what I was hoping would make national news.But what's even more disturbing than the alleged securities fraud ormanipulation of drug approvals (at least to me) is the politicalwheeling-and-dealing that got Crawford confirmed as FDA head to beginwith. You won't believe the details in the next Daily Dose...**************************************************A World HookedSpeaking of drug approvals, here are a few interesting tidbits aboutthe worldwide rise of pharmaceuticals from a recent Forbes.com article: * In 2005, prescription drug sales broke the $600 billion mark forthe first time in history - a leap of 7% over the year before. * Sales in the nine biggest markets (the U.S. included) grew by5.7%, while sales in developing nations like Russia, Mexico, China andSouth Korea averaged a blistering 81% growth year over

year! * Approximately 2,300 purely experimental drugs are currentlybeing tested on humans worldwide, while 212 more are in late-stagehuman trials. * So-called "biotech" drugs (protein-based, injected) grew 17% tomore than $50 billion in sales.Think drugs are taking over medicine, or what?No wonder control of the FDA is such a pivotal advantage for eitherpolitical party. Holding the reins to the domestic approvals oftomorrow's prescription medications spells hundreds of billions ofdollars into the pockets of drug companies - and into the government'scoffers...Only one thing is missing: Any kind of objective oversight oraccountability.Welcome to the prelude of "pharmageddon."Thinking globally, acting vocally,William Campbell Douglass II, MD************************* "Our ideal is not the spirituality that withdraws from life but the conquest of life by the power of the spirit." - Aurobindo.

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[Guest guest]

We did it

Part two.

Not only did we create AIDS but we created circa

1970,s MRSA – All as related by an orthodox Director

of Pharmacology. This “flesh eating bug “ as it

has been nicknamed was first recognised in Australian

Hospitals. As per the following item.

 

DRUG RESISTANT germs spreading through Britain's

Hospitals are being blamed ï·“ for the

deaths of dozens of patients Doctors, are,

alarmed because, the germ is resistant to virtually

all common antibiotics. It has been identified in at

least 32 London hospitals, and, outbreaks have

occurred in Nottinghamshire, Yorkshire, and East

Anglia. "

Infected hospitals have had to close wards and

intensive care units and isolate patients' who are

carriers

Dr. Richard Smith assistant editor of the " British.

Medical Journal said the potential is frightening the

Bacteria are' only susceptible to one antibiotic,

vancomycin and could eventually become resistant to

that too, "

The strain the methicillin resistant staphylococcus a

aureus, 'bacteria I (MRSA), known, as

Super Staph " was First identified in an Essex

hospital in 1981

Patients particularly at risk include the, elderly,

those with open wounds, and people

undergoing ï·“ transplant, surgery, heart operations

and kidney dialysis. Complications caused by the

infection are believed to have contributed to, at,

least 30 deaths since, April.

Dr Jean Bradley, chairman of working party, examining,

the problem in the North East Thames Region said “

It, has caused deaths in people who were basically

well before they came into hospital. They have had an

operation and died from the infection.

The germ, which usually lives harmlessly or up

the nose, is easily spread from patient to patient on

the hands of medical or nursing staff

Although it is the same bacteria that often causes

wounds to become infected, the dangerous, antibiotic

resistant strain can lead to fatal blood poisoning as

it fails to respond to ordinary treatment

Scientists have' been warning for decades that

overï·“use of antibiotics could lead, to the emergence

of resistant strains

A similar epidemic has been wreaking havoc in

hospitals in Eastern Australia since the Iate, 1970s

and has caused the deaths of hundreds of patients " .

One new London hospital the Homerton in’

Hackney was` forced to set aside an entire ward for

MRSA infected when it opened in July.

Dr. Ken Grant district general manager for the City

and. Hackney Health Authority said there was a

significant increase in the number of people

identified as carriers in. June and July

.. We have been screening patients as they come in and,

put carriers in a separate ward in the hope of

'eradicating the infection. Staff with the bacteria

have, been I given antiï·“microbial shampoo and nasal

spray' " Basically problems arise when: staff and

patients move from one hospital to another.

Virtually all the major London hospitals have been

affected, greatly adding to the cost of treatment.

Guidelines for the control of outbreak have been drawn

up, by a working party of the Hospital Infection

Society, and the British Society for Antimicrobial,

Chemotherapy. .

Its report warns:' Effective' treatment of, serious

infections has often proved difficult. The

antimicrobial agents available are, often potentially

toxic, limited in number, difficult to administer and

expensive. Isolationï·“ facilities are essential

'once an outbreak, ha & occurred.' The cost of an

epidemic of MRSA is high and the onus should be on

prevention rather than cure.

Dr Paul Noone, consultant microbiologist at, the

Royal. Free Hospital, North London, said: " Hand

washing` is, probably the single most important step

to take. But nurses have to work under intense

pressure because of the cuts. Where people are

overworked, ï·“these hygiene measures tend to go.

.. The germ flourishes in hospitals because of the

widespread use of antibiotics, which kill' competing

bacteria and allow MRSA to, get a foothold.

Experts have blamed the indiscriminate use of

antibiotics for the, emergence, of resistant strains

of bacteria, a phenomenon, first noticed. In the

1950s when some types of infection that could no

longer be treated " with penicillin were, identified.

.. There are a number of different strains of. Super

Staph and all are vulnerable to treatment with

vancomycin. Although other rarely used antibiotics can

kill individual strains, treatment depends on rapid

identification but doctors warn that all the remaining

treatments are expensive and potentially toxic. They

fear that if the bacteria also becomes resistant to

vancomycm, medicine could be put back 50 years to the

days when even minor infections could kill.

Dr Ken Harvey. director of. Microbiology at the Royal

Melbourne Hospital in Australia, where a particularly

virulent strain of MRSA bacteria swept through the

wards, said recently: 'We may, look back at the

antibiotic era as just a passing phase in the history

of medicine, an era in which a great, natural resource

was squandered and where the bugs proved smarter than

the scientists

He is especially critical of 'doctors who constantly

use broadï·“spectrum antibiotics an indiscriminate

drug which kills a wide range of bugs in circumstances

where they are unnecessary.

“ Broad﷓spectrum, antibiotics, are the refuge of

the diagnostically 'destituteâ€. he said.

The British Medical Journal is shortly to publish

advice to GPs and hospitals on the best, way to

control outbreaks of MRSA. [Mrsa is also known as the

“flesh-eating bugâ€]

 

 

Latest reports on “Clostridium Dificile†[CD]

indicate that modern drugs have created another

‘monster’ from an innocuous microorganism, by the

use of Antibiotics.

 

 

In addition to the above we have the

“â€unsolvedâ€â€ cases of SID or

“â€inexplicableâ€â€ cot deaths . Unsolved and

inexplicable because the orthodox medicine field

refuses to credit the evidence that these deaths are

due to VACCINATION.

 

Then of course there is the items you are all familiar

with - the effects of the Mercury preparation

included in VACCINES . These include AUTISM , ASTHMA

and ECZEMA.

It should be pointed out that Asthma – whilst it may

have many irritants that cause an attack -- is a sign

of a DEPLETED IMMUNE SYSTEM!!.

 

While we are dealing with these matters it should be

appreciated that the current wave of violence and

indiscriminate attacks on the public by “mentalâ€

patients is due to the fact that Psychologists are NO

LONGER following the wisdom of Jung , Freud and Adler.

Putting in long laborious hours of hard work sorting

out the problems of the mentally disturbed.

Why take this hard labor on when the Psychotropic

Drugs produced by the Pharmaceutical Industry and

given a “Hard†sell to Doctors in the Psychology

area .They can drug up the patients who go away and

stop being a problem!!.

The trouble is that these drugs –like ALL drugs –

have “side effectsâ€. These side effects all

resemble the problems suffered by the ELI LILLY drug

“Halcion†which caused various patients to murder

their closest relatives , one of whom was a police

chief!. It was rapidly withdrawn.

The salient fact is that when you suppress ANY symptom

, it is similar to shutting down the safety valve on a

pressure cooker . The pressure-problem goes some place

else in the mind-body axis and creates fresh problems

that only surface later . As the Medicine man will

point out - this is a different problem and has

nothing to do with the other problem I “cured†a

year ago.

If those words sound vaguely familiar I plead guilty

to lifting them from the “Organum†of Sam

Hahnemann!!. Who wrote them some 200 years ago!!! Does

NOTHING EVER CHANGE??-

 

 

 

 

 

 

 

 

 

 

 

 

[Guest guest]

Big Pharm in trouble again

 

From today's New York Times (link for those who can

use it:

http://www.nytimes.com/2006/06/02/he...=2 & _r=1 & th & emc

Drug for Bones Is Newly Linked to Jaw Disease

 

 

By GINA KOLATA

Published: June 2, 2006

In the last 10 years, millions of patients have taken

a class of drugs that

can prevent agonizing broken and deteriorating bones.

The drugs once seemed

perfectly safe and have transformed life for patients

with cancer or

osteoporosis.

 

[Graphic removed: Top-Selling Bisphosphonates]

 

But recently there have been reports of a serious side

effect: death of

areas of bone in the jaw.

Everyone agrees that the condition, osteonecrosis of

the jaw, is an uncommon

complication, but that its true incidence is not

known. It is estimated that

among the 500,000 American cancer patients who take

the drugs because their

disease is affecting their bones, 1 to 10 percent may

develop the problem.

As for the millions of osteoporosis patients, who take

lower doses, the

condition seems less common. But no one knows how much

less. Some oral

surgeons have as many as a couple of dozen cases, but

their clinics have

become centers to which patients elsewhere are

referred. Among people with

osteoporosis, only 15 cases of the new ailment have

been reported in the

medical literature.

So for now, doctors and dentists are perplexed. Firm

data are scarce to

nonexistent, studies that may provide answers are only

about to begin, and

medical organizations and drug companies are

scrambling to provide guidance,

often based only on hunches. Some dentists are

refusing to treat patients

taking the drugs, fearful that the dental work will

induce a case of

osteonecrosis, and lawyers are lining up to sue the

drugs' makers, saying

they failed to give patients adequate warning.

Doctors say worried patients hearing about the ailment

are starting to

besiege them. The patients want to know whether they

should stop taking the

drugs, called bisphosphonates. They want to know

whether they should shun

invasive dental procedures, like tooth extractions and

implants, which

appear to set off the condition. They want to know

whether osteonecrosis of

the jaw can be treated and, if so, how likely it is

that a person will

recover.

Some patients who have not developed osteonecrosis

have decided to stop

taking the drugs until more is known.

" I'm giving myself a little holiday, " said Judy

Langley, 63, of Anacortes,

Wash., who because of osteoporosis has been taking a

bisphosphonate for

seven years.

Doctors also say the level of alarm among patients, as

well as some

physicians and dentists, is itself alarming. " The

whole thing has spun out

of control, " said Dr. Ethel Siris, director of the

Toni Stabile Osteoporosis

Center at Columbia University.

The Food and Drug Administration is aware of the

issue, said Laura Alvey, a

spokeswoman, and has required that all bisphosphonate

labels disclose the

link to osteonecrosis of the jaw. The problem is that

patients cannot easily

abandon the drugs.

Cancer patients, mostly those with multiple myeloma

and breast cancer whose

disease has spread to their bones, generally take one

of two

bisphosphonates, Zometa or the older Aredia,

intravenously. The drugs,

doctors say, largely prevent excruciating bone pain

and fragile bones that

break like kindling.

Osteoporosis patients, on the other hand, usually take

bisphosphonates as

pills, in much lower doses. Those drugs - Fosamax,

Actonel and Boniva -

reduce the risk of fractures of the spine or hip,

injuries that can create a

steady downward spiral in patients' condition.

Even if patients stop taking the drugs, they are not

free of them.

Bisphosphonates remain in bone for years, and no one

knows how long the

osteonecrosis risk remains. Some doctors and dentists

suggest stopping the

drugs for a few months before and after an invasive

dental procedure. Others

say six months to a year may be better.

As for what happened to patients who developed the

condition, oral surgeons

say some got better but many did not. It now appears

that the best treatment

is with antibiotic rinses; cutting away the dead bone

just made things

worse.

So little is known, said Dr. Bruce L. Pihlstrom,

acting director of the

division of clinical research at the National

Institute of Dental and

Craniofacial Research, that the most fundamental

questions lack answers.

The institute is starting studies, but for now " we

have to be careful that

we're not too alarmist about this, " Dr. Pihlstrom

said. " We just don't have

the information we need. "

The story of bisphosphonates (pronounced

bis-FOS-fo-nates) began in 2003

with a letter in The Journal of Oral Maxillofacial

Surgery calling

osteonecrosis of the jaw " a growing epidemic. "

Its author, Dr. Robert E. Marx, chief of oral and

maxillofacial surgery at

the University of Miami, reported on 36 patients who

had received

intravenous bisphosphonates. All had " painful bone

exposure, " as is typical

with the condition, and " were unresponsive to surgical

or medical

treatments, " Dr. Marx wrote.

" The common denominator, " he said in a telephone

interview, " was that they

all had cancer. Then we started looking at their

treatment. The one common

thread was bisphosphonates. "

But not everyone was convinced.

" My first reaction was that maybe there is an

association but this wasn't

enough, " said Dr. Regina Landesberg, an oral and

maxillofacial surgeon at

Columbia University. " I wanted to see more data. "

Meanwhile, another oral and maxillofacial surgeon, Dr.

Salvatore Ruggiero of

Long Island Jewish Hospital, was gathering his own

data. At first he saw

patients with breast cancer or multiple myeloma who

arrived with exposed

bone in their mouths.

 

" It looks like a piece of ivory with little tiny holes

in it, " Dr. Ruggiero

said. " The one drug they were all on was

bisphosphonates. "

 

He tried scraping away the dead bone and letting it

heal, but that only made

things worse.

 

" We were creating a larger bone wound that didn't

heal, " Dr. Ruggiero said.

 

He called local cancer specialists, but " they said

they did not have any

experience with this kind of complication. "

 

He contacted Novartis, which makes Zometa and Aredia,

the intravenous drugs.

" They had no record of the problem, " Dr. Ruggiero

said.

 

Dr. John A. Hohneker, vice president for oncology

medical affairs and

services at Novartis, said the company got its first

patient report in

December 2002.

 

" We did a literature search looking for osteonecrosis

of the jaw, " Dr.

Hohneker said. " There are a lot of unknowns there.

There really isn't even a

consistent definition of what osteonecrosis of the jaw

is, and the true

incidence is unknown. "

 

But as case reports began to trickle in, Novartis put

a warning of the

condition on the drugs' labels, even before the F.D.A.

required it, and

appointed an advisory board, which included Dr.

Ruggiero.

 

In the meantime, Dr. Ruggiero and others had noticed

something new:

osteoporosis patients taking bisphosphonate pills who

had developed

osteonecrosis of the jaw. In 2004, he published a

report on 63 patients - 56

with cancer, the rest with osteoporosis.

 

Still, the number of reported cases remains tiny. A

recent article in The

Annals of Internal Medicine reviews the published

papers. They include

reports of osteonecrosis in 388 cancer patients; 3

patients with Paget's

disease, a degenerative bone disorder treated with

oral bisphosphonates; and

15 with osteoporosis.

 

The authors of that article, led by Dr. Sook-Bin Woo

of the School of Dental

Medicine at Harvard, estimated the risk for cancer

patients taking

intravenous drugs at 6 to 10 percent. The risk for

osteoporosis patients,

taking the lower doses, is unknown, they said.

 

But Dr. Catherine H. Van Poznak, a breast cancer

specialist at the

University of Michigan, said it was very hard to get

good estimates of risk

from the sort of data, mostly case reports, that have

been published so far.

 

" The case definition in one report can be different

from the case definition

in another, " Dr. Van Poznak said.

 

And not every case has been published or reported.

" We've seen about 20

patients at Columbia, " Dr. Landesberg says. " But it's

so impossible to get a

handle on what the incidence is. You just don't know. "

 

Lawyers, though, are advertising for plaintiffs and

beginning to file suits.

 

Novartis says it does not comment on litigation.

Merck, which makes Fosamax,

a bisphosphonate for osteoporosis, says 15 suits have

been filed against it,

while Roche, which makes Boniva, used for

osteoporosis, reports none. Two

suits have been filed against Procter & Gamble, which

makes Actonel, for

osteoporosis, and Didronel, for Paget's disease. All

the companies say

osteonecrosis never emerged in their clinical trials,

involving tens of

thousands of patients.

 

As professional medical and dental societies formulate

guidelines,

scientists say that what they really need are some

good studies, which are

only about to begin, as to what advice is helpful.

 

Drug holidays, for example. Should cancer patients

stop taking

bisphosphonates for a year or so and then start again?

Should osteoporosis

patients stop periodically?

 

" The pharmaceutical industry has every desire that a

patient who starts on a

bisphosphonate would take it for life, " said Dr.

Robert Gagel of the M. D.

Anderson Cancer Center in Houston. " The bone

community, of which I am a

member, has always been a bit suspicious of that

viewpoint. "

 

Some patients say they are left unsure of the medical

advice they have

already been given.

 

Joan McDevitt, 53, of Franklin, Me., took steroids for

an eye problem, a

treatment that may increase the risk of osteonecrosis.

Then, with low bone

density, she began taking an oral bisphosphonate. A

year and a half later,

this February, she had an infected tooth extracted.

The hole would not heal,

and pieces of bone from her jaw kept splintering and

coming out.

 

Her oral surgeon, Ms. McDevitt said, " cut into the jaw

- he cut and filed

the bone down. "

 

It did not help.

 

" I had horrible sores back there, " she said, " ungodly

painful sores. I was

in agony. I had never had anything like that in my

life. "

 

Ms. McDevitt is now no better.

 

" I still can't eat on that side of my mouth, " she

said. " The skin is really

thin, and it's still sore. "

 

Her oral surgeon never mentioned osteonecrosis, but

her doctor's partner

figured it out. She stopped taking the bisphosphonate.

 

" Hopefully it will heal, " Ms. McDevitt said. " It's

pretty scary. "