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Re: A follow up to the Times blog post earlier...

quiact — Tue, 07 Apr 2009 22:15:05 -0000

There exists potential and needed benefits with the utiliziation of EMRs, if they contain the 32 functionalities, and are well maintained, with a qualified and legitimate vendor.

However, an EMR vendor is exonerated from any liablility if the EMR fails in some way once installed. This could pose a danger to patients. The staff at the medical institution location will be liable, and not the EMR manufacturer. This may decrease the quality of EMRs made available to clinics and institutions.

Also, the EMRs, in large part, are designed to maximize the implementation of the various ICD-9 codes that could possibly be applied to a particular patient in order to maximize profits for the owners of the EMR system. This opens a door to health care fraud, and false claims act violations.

Finally, the health care provider should have and demand that this provider dictates progress notes on their patients, and offers the diagnosis based on the assessment or impression determined by the provider. EMRs can and do these things. EMRs are not health care providers.

So the quality, and standards, need to be created and inforced before they provide complete benefit for the health care of others.

Re: Electronic Medical Records: Advice For Physicians

quiact — Wed, 25 Mar 2009 07:46:02 -0000

Computerized Medicine
Electronic Medical Records (EMRs) are essentially digital treatment platforms that contain significant patient variables, such as their own medical history. This and relevant knowledge and data relevant to the individual patient assure to a higher degree that the treatment they receive from their health care provider when it is needed is reasonable and necessary.
EMRs have the potential to prevent medical errors that occur, unfortunately. Such errors are believed to cause nearly 100 thousand deaths every year.
Present medical records on documents are digitized and integrated into the EMR easily. And EMRs are desirable in the medical community for a number of reasons that fill unmet needs to restore the health of others. These health care provider assets provide evidence-based clinical information contained in this knowledge system.
In addition, EMRs provide additional patient safety, regulatory and reporting needs. These needs, as well as confirming reimbursement requirements, provide a strong ROI for those medical facilities that have quality EMRs at their location.
The first large demonstration of the effectiveness of EMRs was with the VA Hospital’s Vista System. The code was written by doctors for doctors, and has about 18000 pages within Vista. Author Phillip Longman wrote a book about this system and the quality it allowed for superior health care, which was entitled, “Best Care Anywhere.” The Vista is the largest EMR in the United States
In addition to EMRs storing patients’ medical history and present treatment regimens, EMRs make others aware when ordering ancillary testing for patients. The awareness is to make sure the testing ordered is not repeated, or does not already exist. In addition, and of particular importance to the health care provider, the need for transcription of patient notes is eliminated.
With some debate, there seems to be a good possibility for the development of increased profits for both health care providers and medical institutions. This is due to EMRs offering the most appropriate and accurate codes. These are diagnostic and procedural codes allowable for a particular patient as they are determined to be needed for this patient. These codes are used to seek reimbursement from health care payers, and are required for reimbursement from third party payers for certain patients.
The continuity of patient care improves the care of patients and reduces the need of additional patient staff that was needed before EMRs arrived at the medical facility. Historically, there is often a lack of needed staff at medical institutions due to the shortages of professions that exist in the health care field, such as nurses.
The EMR provides flexibility of architecture to meet individual workflow requirements at each location. Preventative medicine and compliance with treatment regimens are more assured with EMR utilization as well.
Again, evidence-based medicine as well as a higher degree of patient-centered healthcare is now possible and improved by EMRs. The many benefits perceived by others that are based on fact has resulted in the utilization of EMRs by various managed care companies and pharmacy benefit management companies.
However, health care providers who are in solo practice are understandably reluctant to acquire an EMRs because of cost. The cost of an EMR may approach 40 thousand dollars, as well as several thousands of dollars paid annually to maintain the EMR. A complete EMR package would include hardware, software, installation, maintenance, and training.
One of the primary functions of EMRs often includes electronic prescribing, which is more reliable in reducing prescription errors, which are believed to cause over 5 thousand deaths a year. Electronic prescribing also lets the health care provider know if there is a generic version of the drug available, and if the patient’s pharmacy insurance benefit covers the drug chosen by the health care provider.
Additional functions of EMRs would include the ordering diagnostic tests, and retaining the results of these tests. Also, the documentation from the health care provider about the health and well-being of their patient after a visit with such a provider is placed directly upon direction from the provider into the EMR. This thankfully improves patient data availability for other health care professionals may have a need to retrieve regarding these patients.
Aside from having great ability to store information and data, as well as the EMR having user-friendly navigation, the EMR should have the following core functionalities: Health information and data about disease states and patients that have been treated, the, ability to manage results, the features to allow order entry, the ability to provide decision support, and the EMR should have good communication with other devices.
As far as the plan of implementing EMRs within a medical facility, this would involve the EMR’s hardware, software, EMR installation, maintenance of the EMRs as determined, and training of the medical staff.
Additional patient benefits because of the ability and function of EMRs is the reduction in mortality, according to some studies. Mortality has been concluded to be reduced by around 40 percent. Equally impressive is that the EMR makes patient care much more efficient, including where efficiency may be needed the most. That would be those many patients who have at least one chronic disease. Chronic diseases consume around 80 percent of health care spending. The EMR facilitates a medical home for those patients who are chronically ill..
Surveys have shown that most people surveyed favor EMRs more than they do a health care provider visit. The EMRs allow and encourage written dialogue between the health care provider and their patients. When this is done, visits between these patients and their providers are significantly decreased.
Presently, those who have access to EMRs range in ages of those in their late teens, to those in their early 90s. Utilization of EMRs by others is not limited because these records are very user-friendly for most people. And utilizing EMRs may also be used to enhance one’s medical knowledge regarding a particular topic or disease state. With those who are with medical problems, this knowledge often will improve their health and their medical issues because the patient is now an advocate in their own treatment of their medical problem.
EMRs are certainly not flawless, and there are those that oppose the integration of this digital advance into the U.S. Health Care System. There are privacy concerns, as well as more valid concerns about EMRs becoming dysfunctional without notice. Presently, those who make EMRs in this 20 billion dollar a year industry are not regulated, and no uniform standards regarding their durability have been established. So likely, some EBMs are overall better than others,

Dan Abshear

Re: Achaogen takes in $5.6M to fight bacterial infections

quiact — Wed, 04 Mar 2009 14:51:16 -0000

Sometimes, Death Is Good….. For A Vicious Unicellular Microorganism.

There are a variety of different types of foreign bacterial infections one can get from many different sources, yet some are more common than others.

If they are not beneficial for your physiology, they all should die in order to restore your health.

Bacteria are a simple life form, yet are incredibly productive and efficient. As with other life forms, it exists to reproduce, and does so about every hour, and evolves and adapts to its environment as needed.

To do this, it fully utilizes all available resources and energy to develop the protein that is essential for its survival, and bacteria have the ability to adapt as needed to assure this happens.

It needs exactly 7 genes to produce the essential ribosomes for this to occur. Any more or less genes than 7, the bacteria is not maximizing its efficiency to survive and reproduce. Amazing.

Strept infections are caused by what are called gram positive bacteria, and are the most common bacteria that infect others.

Staph bacterial invasions are gram positive as well, yet it is the MRSA, Methicillin Resistant Staff Aureous bacteria of this type often are very difficult to treat normally when a patient suffers from their damage from being invaded by these bacteria.

Another difficult situation is when a patient is infected by VRE, Vancomycin Resistant Enterococci, as well.

These MRSA and VRE pathogenic or disease causing bacteria are the ones that are the most clinically concerning for the health care provider.

In most cases, such bacteria invade a resident of a medical institution, and have proved to result in very dangerous infections.

If so, they are called nosocomial infections, and such infections are not limited to resistant strains of bacteria.

Greater than 5 percent of nosocomial infections are determined to be MRSA infections, others have determined. This results in about 100,000 serious hospital infections, as well as about 20,000 deaths from MRSA infections annually.

Group A strep infections can cause diseases such as strep throat and pneumonia.

Since there are several types of bacteria, a diagnostic test called a culture and sensitivity is usually performed to assure the correct antibiotic is selected for treatment, as the bacteria are identified with this method.

Typically, fluid from the area suspected of being infected is obtained from the patient suspected to have an infection and smeared on what is called a petrie dish. And then these dishes are incubated for 2 to 3 days.

Gram positive bacteria stain during this process a dark violet or blue. Gram negative bacteria would be pink in color, and are capable of harm as well to a human being.

When the culture is complete, technology offers recommendations on the appropriate class or brand of antibiotic for this bacteria present in another person- presuming the bacteria will not be resistant to the antibiotic recommended, as this happens on occasion.

Usually, classes of antibiotics that are used to treat gram positive strep infections that are not VRE or MRSA are cephalosporins, macrolides, or general penicillins.

If the microbe that is causing the infection is resistant to the antibiotic from such classes that are administered to the infected patient, other options should be considered.

With two antibiotics in particular, which are methicillin and vancomycin, which is the case with VRE and MRSA bacteria, then there are other more aggressive antibiotics that will be chosen for this patient.

Such brands and types of antibiotics for MRSA and VRE bacteria include Zyvox, which has both IV and oral dosage options. There are also other antibiotics, such as Cubicin.

However these antibiotics for antibiotic resistant bacteria are given usually due to infections that have progressed to a more serious nature within a patient infected in such a way.

Progressive medical conditions include sepsis, or blood infection, osteomyelitis, or bone infection, or Pneumonia, which is a serious lung infection.

A hospital stay is normally required with such patients, as the last antibiotics mentioned for MRSA and VRE bacterial infections are given by IV administration initially for several days, if not several weeks.

There are numerous classes and types of antibiotics available, yet bacterial resistance to most of these antibiotics constantly remains serious concern for the health care provider, and the infected patient.

With MRSA at the top of the list of concerns for the health care providers, this concern continues to progress, unfortunately.

Medical institutions should possibly consider quarantine for those patients at their locations that have been determined to be infected with the MRSA bacteria.

Dan Abshear

http://www.cdc.gov/ncidod/d...

Re: New influenza antiviral drugs

quiact — Wed, 28 Jan 2009 09:43:36 -0000

Historical Facts Believed To Be Associated With Influenza:

The last influenza pandemic that occurred in the United States was nearly 100 years ago, and this deadly outbreak resulted in about 50 million deaths worldwide. The pandemic that occurred before this one happened about thirty years before the 1918 flu. Influenza epidemics typically occur about every 8 months or so. Influenza is caused by a virus, which is a parasite that needs a host to survive and reproduce.
It was called the Spanish Flu because the first human case was identified there. The pandemic ended up killing more than those that died during WWI. Understandably there was panic among people worldwide, as influenza was not discovered until 1933, so the mystery was rather frightening of what was happening.
Those who survived have allowed others to obtain antibodies from them to develop other antibodies for future viral outbreaks that may occur with this type of virus. This last influenza pandemic also allowed others to obtain this virus from those who died as a result to facilitate effective treatments and vaccines for viral outbreaks that may happen in the future as well.
The virus responsible for the 1918 pandemic was an avian influenza. Nearly 700,000 people in the U.S. died as the result of the Spanish Flu- and those that did die was due often to a bacterial pneumonia that followed the viral invasion and damage. Ultimately, this pandemic killed nearly 3 percent of humans infected. Normally, an influenza strain may kill less than one percent of those infected. The Spanish Flu caused an unusually severe immune response in the human host which made it very deadly due to overkill of the cells of this host.
The influenza viruses are categorized as A, B, and C. The Influenza A virus is the one that historically has caused pandemics that have developed-, such as the Spanish Flu Pandemic. The other influenza pandemics primarily have occurred in countries in Asia.
With influenza, it is understood that the disease influenza is a disease caused by a RNA virus that can infect both mammals and birds. In fact, this particular virus can mutate to where it can be shared between the two life forms and multiply within each one of them. Unlike coryza, influenza expresses symptoms more severely, and usually lasts two weeks until one recovers who has the flu. Influenza, however, poses a danger to some with compromised immune systems, such as the chronically ill, so the recommendation is greater in such populations, along with women who may be pregnant during the flu season, residents of nursing homes or chronic care facilities. Health care personnel are encouraged to get the flu vaccine as well. Such populations allow influenza to progress to deadly pneumonia.
Symptoms of influenza usually start to express themselves symptomatically about two days or so after being infected with the virus. Over 10 percent of the population is infected with this virus every year- resulting in about 200,000 hospitalizations and nearly 40,000 deaths. This season’s first influenza case was identified in Delaware in November of 2008, and it was a type B influenza strain.

The flu vaccination is trivalent- meaning it contains three viral strains of suspected viruses for flu outbreaks during a particular winter season, as determined by the World Health Organization, as well as the Centers for Disease Control, and other organizations. Unfortunately, the influenza vaccine administered last flu season was largely ineffective due to unsuspected strains of the virus infecting others, although about 140 million injections of this vaccine were administered.
After giving the vaccination dose to one, it takes about 10 days for that person to build up the immunity for the disease of influenza. The months of October to December are recommended to receive this vaccine. And the vaccine is about 50 percent effective in offering protection from influenza, according to others. Vaccines are a catalyst for antibody production in humans, which protect them against the virus. Influenza vaccines can be given by injection or nasally.
Anti-virals, on the other hand, decrease greatly the ability for viruses to reproduce once established in a human.
The Avian influenza that many have heard of is potentially the next flu pandemic- as humans have no immunity to what is called the H5N1 virus- on of about 1 strains of avian Influenza. For an Influenza pandemic to occur, which means a global disease existence, the virus must emerge from another species to humans without immunity, as well as the ability to make more humans ill than normal. Also, the virus must be highly contagious for a pandemic to occur. The H5N1 virus appears to replicate in the human GI tract and also has a longer incubation period in humans, one to two weeks, compared with other influenza strains. The H5N1 Avian influenza virus seems to have become progressively more pathogenic in the past decade, according to others.
With the Avian Influenza existing with the H5N1 strain, millions of birds have been slaughtered due to the danger and unpredictability of this strain. The first human case infected with this strain occurred in China in 1997. The first human avian flu case outside of China was identified in 2003 in the Netherlands. The first recorded incidence of human-to-human transmission of the H5N1 virus was in Thailand in 2004. In 2006, it was discovered that the H5N1 had split into two separate strains. There have been outbreaks of Avian flu in about 15 countries in the world so far- with Indonesia being the worst. Migratory birds spread this influenza virus between continents.
The pathogenic strength of the H5N1 strain varies due to constant re-assortment or switching of genetic material between the viruses- essentially creating a hybrid of what it was before this occurs. So far, about 300 people worldwide have been infected with this strain- and about half have died from the infection. Vaccinations are being developed and reformulated constantly at this time due to the pandemic threat of the H5N1 Influenza virus.
Yet, the normal flu season that is now occurring was supplied with 150 million vaccines in the United States. However, some studies have shown that this vaccine is rather ineffective based on incidences of the acquisition of the influenza virus by others anyway.
The influenza season peaks between the months of January and March. The vaccine for this influenza season is manufactured by 6 different companies. Yet the strains chosen are speculated influenza viruses, as this does not eliminate the chance of a new and dominant influenza viral strain that possibly could cause a pandemic. It takes manufacturers about 6 months to make and formulate the influenza vaccination. There is a vaccine for this illness that is produced every year according to which type of virus may be prevalent during a particular flu season. If influenza occurs in a human host, the results may be the patient acquiring pneumonia or meningitis.
The presence of influenza can be widespread in certain states, yet not others. The vaccination is recommended to be administered to those who are at high risk, such as the chronically ill. Also, it is recommended that those under 18 years of age get the vaccine, as well as those people over the age of 50. Furthermore, those people who regularly take aspirin should receive the vaccine, as the influenza disease can become a catalyst for what is called Reye’s Syndrome. Pregnant women should receive the vaccine as well- as there are many other vaccines available to fortunately prevent other diseases, perhaps.
http://www.cdc.gov/flu/weekly/
Dan Abshear

Re: How to Blog, by Merlin Mann

quiact — Mon, 15 Dec 2008 00:58:02 -0000

Recently published on: www.beforeyoutakethatpill.com
The Prevention of Ignorance

Historically, information sources provided to American citizens were limited due to the few methods available to the public, such as radio, TV, or news print. And also this information was subject to being filtered and, in some cases, delayed. This occurred for a number of reasons, which included political ones.
Now, and with arguably great elation, there is the internet, which can be rather beneficial for the average citizen.
Soon after the advent of the internet well over a decade ago, web logs were created, that are now termed ‘blogs’. At that time the blogs were referred to as personal journals or diaries visible on line. As time passed, blogs became a media medium, and blog communities evolved into addressing topics that often were not often addressed in mainstream media, as they crossed previously existing political and social lines. In addition, blogs provide immediate contributions by others, the readers of the posts of the blog authors, instead of the cumbersomeness of opinion and editorial pieces historically and not always presented in such media forms as newspapers or magazines.
The authors of blogs vary as far as their backgrounds and intent of what they choose to address on their blogs exactly, just as with other media forms. Some are employed by the very media sources that existed before them. Furthermore, they are not exonerated from the legalities of what is written, such as cases of libel. While we can presume that bloggers like to write, they may not be quality writers, yet several are in fact journalists, as well as doctors and lawyers, for example. But to write is to think, which I believe is a good quality one should have. Regardless, a type of Socratic learning seems to be occurring due to the advent of blogs.
Yet presently, blogs have become quite a driving force for those with objectives and issues often opposed by others, and therefore have become a serious threat to others. These others may be politicians, our government, or corporations- all of which have been known to monitor the content of certain blogs of concern to them for their potential to negatively affect their image or their activities previously undisclosed. This is why blogs, on occasion, have become a media medium for whistleblowers, which will be addressed further in a moment.
While one disadvantage of blogs is the potential lack of reliability, blogs however do allow in addition to the comments of its readers the posting of authentic internal or confidential documents that typically are not created to be viewed by the public, yet are acquired by certain bloggers. For example, blogger Dr. Peter Rost, a whistleblower himself, not long ago posted a newsletter published by pharmaceutical company AstraZeneca on his blog site, and this newsletter was given to him by AstraZeneca's employees who called themselves the ‘AZ Group of Seven’- with the intent of this group being to bring to the attention of others the illegal activity of off-label promotion of one of AZ’s cancer drugs promoted by their employer. Yet this particular concern by AZ seven, by surprise, is not what caught the attention of so many who viewed the posted newsletter by Dr. Rost and was read with great interest by others. It was instead a comment included in this newsletter that was stated by former regional AZ manager Mike Zubalagga, who was being interviewed by a district manager in this newsletter. Mr. Zubalagga, who in this newsletter posted on Dr Rost's blog site, referred to doctors’ offices as ‘buckets of money’, which caught the attention of several readers. This and other statements by this man were in fact published in this newsletter clearly not reviewed before its publication. . Again, the statement and the newsletter created by AZ was indeed authentic and further validated due to the content being in the written word, which added credibility.
Mr. Zubalagga was fired the next day due to this ‘buckets of money’ comment due to the effect it had on the image of his employer. His manager resigned soon afterwards from AZ.
Blogs, one can safely conclude, reveal secrets.
And there have been other whistleblower cases on various blogs in addition to this one described a moment ago, which illustrates the power of blogs as being a very powerful and threatening media medium of valid information disclosure that others cannot prevent from occurring.
This, in my opinion, is true freedom of information- largely free of embellishments or selective omissions. It’s a step towards communication utopia, perhaps, yet a force that has the ability to both harm and protect many others.
Yet again, the information on these blogs should not be taken as absolute truth without proof to verify claims that may be made, as with other media sources. Of course, documents that are authentic is an example of a good validation source. And this, in my opinion, is the blog’s greatest value, combined with the comments on blogs from the growing number of readers who are allowed to contribute to the subject matter so quickly, which fuels the objectives of the blogs, which may be a type of Socratic learning.
Like other written statements, some on such internet sites are composed with respect of the written word. Others are not. It's the freedom that may be most appealing of this new medium which has the ability to convert citizens into journalists who want to contribute to an issue of their concern they share with the blogger often with great conviction and accuracy.
Because we, the public, have a right to know what we are entitled to know and what we want to know. This is especially true if the information disclosed on blogs could potentially be adverse to our well-being.
Ignorance is bliss, but knowledge is power.
“Information is the seed of an idea, and only grows when it’s watered.” --- Heinz V. Berger
Dan Abshear

Re: Nurses May Not Fill The Primary Care Shortage: “We’re Not Suckers”

quiact — Fri, 07 Nov 2008 15:34:35 -0000

So, You Want To Be A Doctor…..

Lately in the media, others have said and appear to express concern about the apparent shortage of primary care doctors in particular- both now and in the speculated future. Typically, the main reason believed and speculated by others for this decline of this health care profession specialty that historically has been the apex of our health care system is lack of pay of this specialty when compared with other specialties chosen by potential physicians while in training, as the annual salary of a PCP is around 130 thousand a year on average, others have concluded may be the national average and factors in payers both of a private and public nature.

Yet considering the additional attention of shortages of students in some medical schools as well, as conceived by others, one could posit hat this professional vocation that has been one viewed in the not so distant past in the U.S .

Viewed as one with great esteem and respect may not be desired as a vocation by many, that demands commitment and dedication, as reflected in their training regimen in the U.S. that consumes about a third of their lifespan. Such reasons for this paradigm shift may include:

Primary Care Doctors perhaps more than other physician specialties seem to be choosing to practice medicine under the direction and financial security of one of the many and newly created health care systems These regional and nationally created systems are typically composed of numerous hospitals and clinics under combined ownership- frequently of a private nature that is not dependent upon their beliefs as it is perhaps on their profit motives and intentions. Yet their approach and etiology of their views regarding the restoration of the health of others are usually similar with such mergers of multiple medical facilities, which are presently preferred to save costs, it has been said, and therefore these systems have not been protested by a largely uninformed public.

Conversely and in addition, this system of increasing popularity is not necessarily a desired method to practice medicine as a primary care physician, often stated by them as members of their employer that has the power to limit and dictate how they practice medicine. This is because, among other reasons, such doctors have largely unexpected and unanticipated limitations regarding their patients’ heath provided by them. This is further aggravated by possible and unreasonable expectations of their employer, such as mandating that doctors they employ are required to see as many patients as theycan in a day, and there have been cases of physicians being fired by a health care system- along with financial rewards for seeing more patients a day than what is determined as average visits by others. Such requirements likely and potentially affect or alter the clinical judgment determined by physicians employed in what may be viewed as authoritarian employers, which would limit the medical care they provide to their patients, as well as the quality of this care. Also, such health care systems may have their own managed health care system that may be determined by factors not in the best interest of the patients of doctors employed by the health care system.

The primary etiology and stimulus for a doctor to practice medicine in this way is due to their frequent inability to provide and employ ancillary staff, combined with the increasing premiums for their mandatory malpractice insurance, which may make doctors financially unable to work independently.

Malpractice laws and premiums, which is determined in large part on a state level, are an issue with those required to have this adverse aspect of their professions. Also, these premiums become more expensive for doctors, depending on the perceived risk of their chosen specialty. For example, the premiums of an OB/GYN doctor are usually higher than one of a specialty viewed less risky for lawsuits, such as Dermatology, perhaps. Plaintiffs win about 25 percent of the time on average a half a million dollars. 95 percent of these cases are settled out of court.

In addition, the issue of medical malpractice is also frequently a catalyst for a doctor to practice what has been called defensive medicine, which basically means that the health care provider is prohibited from relying upon their subjective factors in their assessment of their patients, which in itself raises the question of what the point was of all of their training in the first place. Because if a doctor practices medicine in such a way, it typically involves what may be considered as unnecessary diagnostic testing for their patients to rule out what may be unlikely disease states of their patients’ medical conditions. This waste of medical resources is further validated by the legality reflected in the tone of the notes a doctor usually annotates or dictates with their patients.

Such restrictions and limitations imposed on today’s primary health care provider are usually not fully illustrated during their training for this profession, which is one that has been viewed as one that is quite noble and of great responsibility on a societal level. It seems that this perception and vocation that now is greatly misperceived due possibly to being deformed by others who may have profit as their motive for the health care they may dictate to doctors they may employ in some way, which often and likely is in conflict with their motives as doctors and how they wish to deliver needed health care to others. This may be why this medical profession may no longer be viewed as distinct from other vocations, in large part, as it seems that presently the profession of a doctor has been reduced to one dependent on the financial stability and growth of its employer, which may alter how the doctors perceive what is expected of them as well, which may affect the importance of how they view their profession, as it has been said that overall, doctors are somewhat understandably more cynical and demoralized, which may be replacing the pride they historically have viewed their callings as doctors, as well as the perceptions of patients in the U.S. Health Care System.

Further complicating and vexing to these restrictions is the usual financial state of the individual physician, as they normally have to pay off the debt acquired from attending medical school and training, which averages well over 100,000 dollars today after their training is completed, it has been estimated, along with this debt amount presently is about 5 times higher than it was only a few decades ago.

Conversely, there are some who believe that doctors in the U.S. are over-paid and are compared with some corporate monster, who behaves based upon the premise of greed. In spite of how they are judged, physicians are likely not absent of financial concerns- which may be of more of an issue than many other professions, comparatively speaking, in addition of taking on more responsibility that is of greater importance compared with other vocations. Such realistic variables should be factored in when one chooses to judge the profession of a physician. On the other hand, no physician should view their jobs as no different from any other venture capitalist when rationalizing their income and motives related to this exceptional vocation as a physician, as others are more dependent on their judgment.

It has been determined by others, and suggested often and lately, that many of today’s physicians practicing medicine in the United State do not recommend or speak favorably of their professions compared with their typical views of their profession in the not so distant past. While this self-perception physicians may have of a negative nature may be somewhat understandable it is also and potentially unfortunate for the health of the public in the future, and the nature normally associated with the medical profession which could deter ideal medical care for others

There have been cases where doctors do in fact change careers, and get into vocational fields such as medical communications or corporate medical companies. Also, expert witnessing is another consideration for those who choose to leave their profession.

Finally, other choices considered include consulting and research. The training of doctors fortunately leaves them with options not involved directly with the flaws of medical care, but this is bad for us as citizens, overall. The etiology of their departure from their designed profession is largely due to the negative state perceived by themselves as well as others of their profession as medical doctors.

Then again, not all doctors are deities. Like others, some are greedy and corrupt, which complicates others in this profession in relation to how their vocation is viewed by others and based on limited judgment and analysis. Yet citizens overall should determine what sort of health care they desire, and it seems that often they fail to voice this right as a citizen.

For perhaps Primary Care Physicians in particular, the medical profession and those who provide medical care clearly needed by others to some degree appears to be absent as a desired path of today’s careerist. The authentic reasons for what many believe to be a negative perception of possibly the entire health care system may never be known, yet many would agree that most U.S. citizens are understandably concerned with the state of this system of great importance to society. Yet need to be active more in assuring this necessity is more aseptic.

“In nothing do men more nearly approach the Gods then in giving health to men.” --- Cicero

Dan Abshear
Author’s note: What has been written has been based upon information and belief of a layperson, yet also the assessments of a patient.

Re: Who Should Determine Drug Labeling Language: Juries Or The FDA?

quiact — Fri, 07 Nov 2008 15:30:21 -0000

The Conversion of Our Protector

The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States in regards to what they consume, primarily. The one person who became the catalyst for the formation of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in this book. While the author intended with composing this book, “The Jungle”, to address and focus for the benefit of the readers the effects of capitalism, the issue regarding food safety is what ultimately captured the attention of everyone, including the president, so the FDA began during this time.

However, their purpose and function seems to have changed the past few decades, as the FDA appears to have decided to ensure the health of certain industries instead of the public health.

One example is the large amounts of money the industry gives the FDA for various reasons created recently- amounts so large that this accounts, according to some, for about half of the FDA’s total income, although it is by definition a governmental administration. An example of stated reason for receiving such funds is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and is now required to pay the FDA for faster approval of their pending medications after pharmaceutical companies submit a new drug application to the FDA.

The FDA also accepts over a million dollars from the pharmaceutical industry to give their pending new drug a priority review of 6 months instead of a year, along with a created etiology for this urgency often.

Results of this relationship, which some have called collusive and intimate, between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs as demonstrated by their removal of, or the labeling change requiring what is known as a black box warning of such drugs, which means that the drug is basically on probation. The lack of regulation and monitoring required by the FDA of such industries as the pharmaceutical one may be why there is this progressive safety concern of medications prescribed to many in the United States. In addition, perhaps, the FDA continues to validate what has been surmised through their known financial support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public.

Yet, the presumed intimacy between these two organizations does in fact seem to continue to worsen. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales representatives to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval and presumed elation to possibly create harm to patients with this proposal due to the obvious uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional if not absurd, to say the least.

A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically and legally, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity that deviates from the product insert that illustrates the medication’s indications. In fact, it is a federal offense for such representatives to speak off-label about the drugs they promote, and more pharmaceutical companies are and have been penalized for this activity in the form of large settlements in the past as determined to some degree by the department of justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, rarely admit guilt as part of such settlement agreements, which include agreements where the corporation is not prosecuted. Off-Label activities are only some of the federal laws that have been frequently fractured in a progressive manner as well.

This off-label FDA protocol for drug representatives that has been described and proposed by our FDA is called, “Good Reprint Practices.” This would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials that aseptic and without bias, when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug representatives, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the medications involved in such trials- often by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol suggested by the FDA, yet possibly a protocol influenced by others. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration when they did suggest this ridiculous and frightening authorization.
Furthermore, this proposal is flawed in that most pharmaceutical representatives lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug representatives have little medical or clinical training in any objective way. So this seems to further complicate the idea of this off-label concept due to the ignorance of the representatives In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for representatives of the pharmaceutical industry to embellish statements to prescribers for their own benefit in regards to their promoted medications they present to them. In fact recently, a study by Sermo concluded that 90 percent of doctors want clinical evidence based medicine from educated and trained professionals instead of pharmaceutical sales representatives, which according to this study, 80 percent of doctors do not wish to interact with these reps, yet will accept samples and literature related to of their products

So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices that aggravate the existing situation with the lack of efficacy of the FDA.lth, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of any benefit to patient health. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.

However, there is freedom of speech, but in the amendment should certainly be restrictions in regards to public health, as speech should be accurate and objective when conducting dialogues with prescribers. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval.

Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interest, and I believe we as public citizens demand that the FDA be reconstituted.

“Unlimited power is apt to corrupt the minds of those who possess it.” --- William Pitt

Dan Abshear (author’s note: what has been written was based on information and belief)

Re: Trusera launches social network for health advice

quiact — Wed, 22 Oct 2008 09:28:12 -0000

Recently published on: www.beforeyoutakethatpill.com

The Prevention of Ignorance

Historically, information sources provided to American citizens were limited due to the few methods available to the public, such as radio, TV, or news print. And also this information was subject to being filtered and, in some cases, delayed. This occurred for a number of reasons, which included political ones.
Now, and with arguably great elation, there is the internet, which can be rather beneficial for the average citizen.
Soon after the advent of the internet well over a decade ago, web logs were created, that are now termed ‘blogs’. At that time the blogs were referred to as personal journals or diaries visible on line. As time passed, blogs became a media medium, and blog communities evolved into addressing topics that often were not often addressed in mainstream media, as they crossed previously existing political and social lines. In addition, blogs provide immediate contributions by others, the readers of the posts of the blog authors, instead of the cumbersomeness of opinion and editorial pieces historically and not always presented in such media forms as newspapers or magazines.
The authors of blogs vary as far as their backgrounds and intent of what they choose to address on their blogs exactly, just as with other media forms. Some are employed by the very media sources that existed before them. Furthermore, they are not exonerated from the legalities of what is written, such as cases of libel. While we can presume that bloggers like to write, they may not be quality writers, yet several are in fact journalists, as well as doctors and lawyers, for example. But to write is to think, which I believe is a good quality one should have.
Yet presently, blogs have become quite a driving force for those with objectives and issues often opposed by others, and therefore have become a serious threat to others. These others may be politicians, our government, or corporations- all of which have been known to monitor the content of certain blogs of concern to them for their potential to negatively affect their image or their activities previously undisclosed. This is why blogs, on occasion, have become a media medium for whistleblowers, which will be addressed further in a moment.
While one disadvantage of blogs is the potential lack of reliability, blogs however do allow in addition to the comments of its readers the posting of authentic internal or confidential documents that typically are not created to be viewed by the public, yet are acquired by certain bloggers. For example, blogger Dr. Peter Rost, a whistleblower himself, not long ago posted a newsletter published by pharmaceutical company AstraZeneca on his blog site, and this newsletter was given to him by AstraZeneca's employees who called themselves the ‘AZ Group of Seven’- with the intent of this group being to bring to the attention of others the illegal activity of off-label promotion of one of AZ’s cancer drugs promoted by their employer. Yet this particular concern by AZ seven, by surprise, is not what caught the attention of so many who viewed the posted newsletter by Dr. Rost and was read with great interest by others. It was instead a comment included in this newsletter that was stated by former regional AZ manager Mike Zubalagga, who was being interviewed by a district manager in this newsletter. Mr. Zubalagga, who in this newsletter posted on Dr Rost's blog site, referred to doctors’ offices as ‘buckets of money’, which caught the attention of several readers. This and other statements by this man were in fact published in this newsletter clearly not reviewed before its publication. . Again, the statement and the newsletter created by AZ was indeed authentic and further validated due to the content being in the written word, which added credibility.
Mr. Zubalagga was fired the next day due to this ‘buckets of money’ comment due to the effect it had on the image of his employer. His manager resigned soon afterwards from AZ.
Blogs, one can safely conclude, reveal secrets.
And there have been other whistleblower cases on various blogs in addition to this one described a moment ago, which illustrates the power of blogs as being a very powerful and threatening media medium of valid information disclosure that others cannot prevent from occurring.
This, in my opinion, is true freedom of information- largely free of embellishments or selective omissions. It’s a step towards communication utopia, perhaps, yet a force that has the ability to both harm and protect many others.
Yet again, the information on these blogs should not be taken as absolute truth without proof to verify claims that may be made, as with other media sources. Of course, documents that are authentic is an example of a good validation source. And this, in my opinion, is the blog’s greatest value, combined with the comments on blogs from the growing number of readers who are allowed to contribute to the subject matter so quickly, which fuels the objectives of the blogs, which may be a type of Socratic learning.
Like other written statements, some on such internet sites are composed with respect of the written word. Others are not. It's the freedom that may be most appealing of this new medium which has the ability to convert citizens into journalists who want to contribute to an issue of their concern they share with the blogger often with great conviction and accuracy.
Because we, the public, have a right to know what we are entitled to know and what we want to know. This is especially true if the information disclosed on blogs could potentially be adverse to our well-being.
Ignorance is bliss, but knowledge is power.
“Information is the seed of an idea, and only grows when it’s watered.” --- Heinz V. Berger
Dan Abshear