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Offline Satyagraha

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Developing the Sentinel System —
A National Resource for Evidence Development
NEJM | January 12, 2011 | Topics: Drugs, Devices, and the FDA

Rachel E. Behrman, M.D., M.P.H., Joshua S. Benner, Pharm.D., Sc.D., Jeffrey S. Brown, Ph.D., Mark McClellan, M.D., Ph.D., Janet Woodcock, M.D., and Richard Platt, M.D.

The Food and Drug Administration (FDA) now has the capacity to “query” the electronic health information of more than 60 million people, posing specific questions in order to monitor the safety of approved medical products. This pilot program, called Mini-Sentinel, uses a distributed data network (rather than a centralized database) that allows participating health plans and other organizations to create data files in a standard format and to maintain possession of those files. These organizations perform most analyses of their own data by running computer programs distributed by a coordinating center, and they provide consistent summarized results for the FDA’s review.1 The principles and practices involved in this effort to improve the safety of medical products can inform other uses of electronic health information to answer additional important questions about health and health care.

When the FDA announced the Sentinel Initiative in May 2008, it established a vision and objectives for the program, including the development of
the Sentinel System, which will eventually be able to search the
electronic health data of a minimum of 100 million patients.

Laying the groundwork for that system has required an extraordinary range of input from public and private organizations. Under a cooperative agreement with the FDA, the Engelberg Center for Health Care Reform at the Brookings Institution has been convening an ongoing series of discussions among stakeholders to address the near- and long-term challenges inherent in implementing the Sentinel System.3 In 2009, the FDA gave the Harvard Pilgrim Health Care Institute the lead role in fulfilling a 5-year contract to establish a system — the Mini-Sentinel — for developing and testing approaches and methods that could be used to inform the structure and operations of the full Sentinel System. The institute is now leading a diverse partnership of approximately 200 epidemiologists, clinical content experts, statisticians, and data specialists from 27 institutions that are participating in this pilot system (

Through the Mini-Sentinel, capabilities are being developed for actively monitoring the safety of approved medical products using the electronic health information in claims systems, inpatient and outpatient medical records, and patient registries. The Mini-Sentinel builds on the work of the Vaccine Safety Datalink project (managed by the Centers for Disease Control and Prevention), the HMO Research Network, the Population Medicine Distributed Research Network (PopMedNet, funded by the Agency for Healthcare Research and Quality), and the Observational Medical Outcomes Partnership, among others.4

In the first year of the Mini-Sentinel project, its leaders established a network of data partners and a system with robust patient-privacy policies that could be used in querying the network’s databases. The initiative’s distributed data network allows each data partner to maintain physical and operational control over its own patient-level data, while providing the aggregated information needed to address the FDA’s questions. Source data reside behind the data partners’ institutional firewalls, where they are transformed into a standard format. This approach allows each data partner to answer the FDA’s queries by executing standardized computer programs distributed by the Mini-Sentinel Operations Center. A typical result might include the number of new users of a product who experience a particular outcome, grouped according to age, sex, other treatments, and health status. This use of distributed analysis — whenever possible — eliminates or greatly reduces the exchange of protected health information. The data partners can obtain full-text medical records when necessary to confirm diagnoses or exposures and to determine the existence or severity of risk factors.

The initial focus of Mini-Sentinel has been on developing the ability to use claims data. In the next year, laboratory-test results and vital signs, derived from electronic health records and clinical laboratory records, will be added. The partnership is also evaluating procedures whereby Mini-Sentinel data partners will be able to link to data held by other organizations, such as state immunization registries and device registries.

The FDA will soon begin to actively monitor the data, seeking answers to specific questions about the performance of medical products, such as the frequency of myocardial infarction among users of oral hypoglycemic agents (a topic selected because it has been difficult to identify drug-induced myocardial infarction through existing prospective surveillance mechanisms). The FDA will also monitor the occurrence of adverse events associated with select routinely administered vaccines. Using the Mini-Sentinel system, the FDA will also be able to obtain rapid responses to new questions about medical products and, eventually, to evaluate the health effects of its regulatory actions. This monitoring portfolio will expand as the FDA and its collaborators acquire experience and develop operational efficiencies and as additional data resources become available.

The distributed-database-and-analysis model and the infrastructure of the Mini-Sentinel data network can be extended to other forms of evidence development. Provisions in the economic stimulus and health care reform legislation, and a recent report from the President’s Council of Advisors on Science and Technology,5 envision expanded use of electronic health information for other types of public health surveillance, quality measurement, comparative effectiveness research, and biomedical research — all of which are essential to improving the country’s health and health care delivery system.

Issues relevant to other secondary uses of electronic health information include recruitment of appropriate data partners, development and refinement of analytic methods, implementation of standards to ensure that analytic methods are consistent across the data sources, and above all, protection for the rights and privacy of patients. Data privacy and security are top priorities that were key considerations in the decision to build Mini-Sentinel as a system that uses a distributed data system and distributed analysis whenever possible. The committed collaboration among representatives of patients and consumers, health care professionals, Mini-Sentinel’s data partners and safety scientists, and the medical-products industry has been essential to the Sentinel Initiative’s progress.

It is particularly challenging to establish appropriate governance for a distributed data network that can support multiple secondary uses for health information. The current infrastructure is supported by a single federal agency, the FDA, and all the data are provided by private organizations, yet potential users of such a system reside not only broadly in government but also in academia, the private sector, and other user communities. To facilitate the development of this infrastructure into a national resource, this distributed system may ultimately be best managed by a consortium of interested parties operating as a public–private partnership. For example, specialized network-coordinating centers might rely on a consistent infrastructure to use the same sources of health information for various purposes, including public health uses, effectiveness research, quality measurement, and health services research.

The envisioned Sentinel System will build on the knowledge, partnerships, data resources, privacy protections, and technical capabilities that are being developed in the Mini-Sentinel program. Success in the form of improved safety of medical products will depend on the continued engagement of all concerned stakeholders and on ensuring that patients, consumers, and health care providers understand that all medical products pose risks and that postmarketing surveillance is critical to expanding the limited evidence base that exists when products are approved. Success also depends on the continued development of surveillance methods and on increasing the workforce of scientists who are trained to develop and interpret this evidence effectively.

Health care data represent a precious resource that must be used to the fullest possible extent to promote the public health, while the rights of patients and consumers are protected. As an early working model for secondary uses of data produced in the routine delivery of health care, the Sentinel System can and should become a national resource for evidence development and a cornerstone of a learning health care system.

This article (10.1056/NEJMp1014427) was published on January 12, 2011, at

Disclosure forms provided by the authors are available with the full text of this article at
Source Information

From the Food and Drug Administration, Silver Spring, MD (R.E.B., J.W.); the Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC (J.S. Benner, M.M.); and the Department of Population Medicine, Harvard Pilgrim Health Care Institute, and Harvard Medical School — both in Boston (J.S. Brown, R.P.).

   1. Platt R, Wilson M, Chan KA, Benner JS, Marchibroda J, McClellan M. The new Sentinel Network — improving the evidence of medical-product safety. N Engl J Med 2009;361:645-647Full Text | Web of Science | Medline

   2. The Sentinel Initiative: national strategy for monitoring medical product safety. Silver Spring, MD: Food and Drug Administration, May 2008. (

   3. Summaries of Brookings events on active medical product surveillance. Washington, DC: Brookings Institution. (

   4. Brown JS, Holmes JH, Shah K, Hall K, Lazarus R, Platt R. Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care. Med Care 2010;48:Suppl:S45-S51CrossRef | Web of Science | Medline

   5. Realizing the full potential of health information technology to improve healthcare for Americans: the path forward. Washington, DC: Executive Office of the President, December 2010. (

And  the King shall answer and say unto them, Verily I say unto you, 
Inasmuch as ye have done it unto one of the least of these my brethren,  ye have done it unto me.

Matthew 25:40


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« Reply #1 on: January 13, 2011, 03:02:44 pm »
Great information Pilikia, thanks
FDA is so full of crap for pharmaceutical CEO's
No privacy laws what about Hippa? (Sarcasm)

Offline larsonstdoc

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« Reply #2 on: January 14, 2011, 09:12:26 am »

  The FDA wouldn't compromise our records, would they?   ---sarcasm

Offline Dig

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Gary Hart's Anti-Government Violent Fundamentalist Trilateral Terrorist Handbook

We Are Change Colorado confronts Senator Gary Hart

Former Senator Gary Hart decided to kick off his book tour in his home state of Colorado at the Tattered Cover bookstore in downtown Denver.Bad idea.After actually reading his new book “Under the Eagle’s Wing:A National Security Strategy of the United States for 2009″ several members of WeAreChangeColorado assisted by Truthalliance and Colorado911visibility were on hand to ask him a few hard questions.

This book is a masterpiece of newspeak and doublethink and is clearly a plan to put into motion a New World Order system called the “Global Democracy Security Organization”consisting of 4 branches with a permanent command structure,headquarters,and command staff,presumably unelected as in the EU model.

The first branch would be”an integrated intelligence service that operates a common database on individual and group threats and a common communications system shared by memeber nations”.

A second branch should be dedicated to “The excision of financial sources from terrorist organizations”.

Another branch should “Coordinate the activities of multinational law enforcement and public safety organizations in isolating and planning the elimination of terrorist cells once they have been identified”.

And a fourth branch should jointly train and exercise the special forces of these member nations to undertake the suppression of these cells”.

These are quotes people.Right out of this Rockefeller backed scumbag’s book.Our intelligence says that Gary Hart is definitely seeking a cabinet position in the new adminstration and with all these delightful ideas that advance the cause of global government he will look extremely attractive to the powers that be.He must be stopped!He must be confronted on this global vision of his that would make even the most hawklike neocon proud to endorse it.The left/right paradigm is false folks.It is just another divide and conquer control mechanism that works like a charm on the dumbed down mass of humanity that has been trained that what is truly important is who’s gonna win “American Idol”.Wake up!The game is staged.Gary Hart is supposedly a democrat.Think about it.So you’ve never heard of the North American Union ,Gary?Really?Even though you are a prominent member of the Council on Foreign Relations and dedicated globalist?You’re a liar.

Everybody should read his book(hopefully without actually buying it and supporting this traitor) and see for themselves this nightmare New World Order vision he has in store for us and then this man should be confronted ruthlessly and relentlessly until this thing is exposed into full view to be seen by everybody, everywhere, for what it actually is:A new plan being implemented by the elite to fully usher in the New World Order.
Posted on: Saturday, March 29, 2008

Gary Hart warns of new False Flag
10 min - 29 Apr 2008
Uploaded by wearechange

Wearechange Confronts Gary Hart
10 min - 30 Apr 2010
Uploaded by SilentRepublicWTC

All eyes are opened, or opening, to the rights of man. The general spread of the light of science has already laid open to every view the palpable truth, that the mass of mankind has not been born with saddles on their backs, nor a favored few booted and spurred, ready to ride them legitimately

Offline donnay

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« Reply #4 on: January 14, 2011, 11:11:34 am »

  The FDA wouldn't compromise our records, would they?   ---sarcasm

Only if Big Pharma tells them so!
Please visit my website:

Offline Mr Grinch

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From "Seeds of deception" pg 101

Former FDA Commissioner Dr. Herbert Ley said in 1969, "The thing that bugs me is that people think the FDA is protecting them. It isn't. What the FDA is doing and what the public thinks it's doing are as different as night and day"

SF Chronicle 1/2/70
The History Of Political Correctness or: Why have things gotten so crazy?

Common sense is not so common.

I do not agree with what you have to say, but I'll defend to the death your right to say it.

Offline Satyagraha

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... the Sentinel System, which will eventually be able to search the
electronic health data of a minimum of 100 million patients.


We know the FDA agenda: they are the watchdogs for pharma and agri-business. They are not concerned with protecting the American people from harmful food and drugs: they are a stasi agency with a mission to ensure the will of pharma and agri-business is carried out: no health food, supplements, natural healing and holistic medicine is allowed. It's about profits for pharma and companies like Monsanto, but more importantly - it's about EUGENICS.

Look at the REAL HISTORY of the FDA below, then consider they will now have access to the medical records of 100 million people. They will know if you're taking your Prozac, or NOT. They will know if you've taken your vaccines, or NOT. They will know what medical problems you have, and if and how you are treating them. They will have access to your personal medical history, not because they want to protect you - but because they want to make sure YOU ARE TAKING YOUR MEDICINE: and EATING THE RIGHT FOODS. (Don't take my word for it - just check out Michael Taylor, former Monsanto lobbyist, now in charge of the FDA).


Tyranny in the USA: The true history of FDA raids
on healers, vitamin shops and supplement companies
Thursday, April 12, 2007
by Mike Adams, the Health Ranger

Here's a brief overview of some of the campaigns of terror the FDA has initiated against natural healers, nutritional supplement companies and other organizations. Many were conducted using armed agents wielding assault rifles and automatic weapons, dressed in body armor. All of them were intended to destroy natural medicine, thereby protecting the profits of drug companies and conventional medicine practitioners.

This is the true history of the FDA that the FDA doesn't wan't you to know!

(This timeline is excerpted from my book Natural Health Solutions and the Conspiracy to Keep You From Knowing About Them)

1987: The Life Extension Raids

The Life Extension Foundation ( has long been targeted by the FDA. It is a non-profit organization that publishes information about the healing power of nutritional supplements and genuine anti-aging breakthroughs from the world of natural health.

On February 26, 1987, approximately 25 armed FDA agents and U.S. Marshals burst through the glass doors of the Ft. Lauderdale offices of the Life Extension Foundation with guns drawn. A second group of FDA agents simultaneously attacked the LEF warehouse, where they detained LEF founder William Faloon at gunpoint.

Employees were lined up against the wall and searched. Agents rifled through the personal belonging of the employees and confiscated many items. Over the next 12 hours, they seized thousands of items, including nutritional products, files, and documents, including 5,000 newsletters that were about to be mailed to subscribers. Computers and telephones were reportedly, "…ripped from the wall," and agents seized anything they could find regardless of whether such items were actually named in the search warrant. Later analysis revealed that 80 percent of the seized items were never named in the warrant.

Not surprisingly, the entire legal basis for the raid was fraudulent to begin with. The search warrant, issued by Magistrate Lurana S. Snow, was based on perjured testimony by FDA agent Martin Katz. But the intent to terrorize the Life Extension Foundation worked: Employees suffered nightmares and many were afraid to come to work.

Rather than giving in to the tyranny of the FDA, Bill Faloon and the Life Extension Foundation chose to fight for their First Amendment rights. As explained by Saul Kent of the Life Extension Foundation at

Everyone we consulted, including attorneys who were FDA "experts", told us we had to submit to the FDA's authority to have any chance of surviving. We ignored all this advice and instead decided to wage all-out war against the FDA. We did this knowing that we would not only risk our livelihood, but our personal freedom as well
We were told again and again that the FDA had the unlimited resources of the federal government at its disposal, and that an organization with fewer than 5,000 members had no chance of winning an all-out war with them.

To further terrorize the Life Extension Foundation and its founders, the FDA, with the help of various corrupt law enforcement bodies, filed 56 criminal charges against Foundation officers Saul Kent and William Faloon. After an 11-year reign of terror in which the FDA spent millions of taxpayer dollars attempting to prosecute them, Kent and Faloon prevailed. In November, 1995, Federal Judge Daniel Hurley dismissed 55 of the 56 charges, and in February, 1996, the final charge was dismissed.

And thus ended the FDA's campaign of terror against the Life Extension Foundation. It was the first time in 88 years that the FDA had been forced to give up its prosecution efforts and throw in the towel.

As Saul Kent says, "The FDA's dismissal of the charges against me (and Bill Faloon) is an unprecedented victory against FDA tyranny that goes far beyond winning in court. The FDA's historic defeat is a victory for everyone who cherishes freedom in healthcare."

In 1994, the Life Extension Foundation established the FDA Holocaust Museum to document the decades-long reign of terror the FDA has perpetrated against the American people.

1990 - The El Cajon pet food store raid

In 1990, FDA agents raided the pet food store of Sissy Harrington-McGill, a 57-year-old pet lover who was guilty of the "crime" of claiming that vitamins would help keep pets healthy. Without a search warrant, FDA agents ransacked her store, confiscating products and literature.

She was later tried and convicted of violating the Health Claims Law, a law that did not exist at the time of the raid and was never passed by the U.S. Congress. Nonetheless, likely due to FDA pressure on the presiding judge, she was sentenced to 179 days in prison and fined $10,000 for daring to say that vitamins are good for puppy dogs!

1990 - The Highland Laboratories raid

In 1990, Ken Scott ran a vitamin business in Mt. Angel, Oregon, a small rural town. He was selling nutritional supplements containing coenzyme Q10, a vital nutrient for cellular energy that has received tremendous praise from the scientific community for boosting cardiovascular health, preventing congestive heart failure, improving blood pressure and cholesterol profiles, as well as many other benefits. To help educate customers about the healing power of CoQ10, he offered to send reprints of magazine and newspaper articles describing some of the scientific findings about the nutrient.

This public education effort, of course, would not be tolerated by the FDA Gestapo. So the FDA organized an armed raid comprised of nine FDA agents, 11 U.S. Marshals and eight Oregon state police. With guns drawn, they kicked in the doors to Ken Scott's business and conducted one of the most terror-driven "vitamin" raids in U.S. history.

For the next 11 hours, agents confiscated nearly everything they could find at Highland Laboratories. Ken Scott and his employees were threatened with violence if they tried to set foot in the office, and his daughter, who was located miles away, was illegally detained and held in "house arrest" for 12 hours.

The FDA, you see, would not tolerate Ken Scott mailing scientific literature or articles to his customers. So in order to comply with the FDA, Scott later hired an outside mailing service owned by his daughter to run the article mailing operations.

The FDA's response to that? They illegally raided the mailing service company and threatened to confiscate the checkbook and cash of its owner. Out of fear (terrorism works, you see?), that owner subsequently closed her business and refused to file charges against the FDA.

Ken Scott was ultimately forced to cut a deal with prosecutors, and eventually served five years on probation for his "crime" of telling the truth about CoQ10.

The message from the FDA to other vitamin companies couldn't be more clear: Don't you dare tell your customers the truth about vitamins, or we'll shut you down and prosecute you!

1990: The Century Clinic "chelation" raids

In Reno, Nev., 1990, the Century Clinic was raided by the FDA and Postal Service inspectors. Agents seized large quantities of items from the clinic, virtually wiping it out of computers and equipment, as well as patient records and files. No charges were filed.

After Century Clinic rebuilt and sued the FDA for the return of its property, the FDA raided it again and conducted a search of the persons and homes of the owners and employees. Patients at the clinic were reportedly interrogated and not allowed to leave without turning over their names and addresses. No charges were ever filed against the clinic or its owners.

1991: The Tijuana cancer clinic kidnapping

Jimmy Keller cured his own cancer through the use of natural medicine therapies. Encouraged by success with his own cancer, he pursued a career in natural medicine and later moved to Mexico and opened a clinic that could legally treat U.S. patients with the disease (treating cancer naturally is illegal in the United States, so the best practitioners are forced to open clinics in Mexico or other countries). The success of this clinic caught the eye of health authorities in the United States, and they decided to put a stop to it.

In March 1991, armed Mexican police officers, with no warrants or charges whatsoever, kidnapped Keller from the St. Jude Hospital and delivered him to U.S. Justice Department bounty hunters who, against his will, drove him across the border to the USA. There, the FBI arrested him and charged him with wire fraud (Keller had used the telephone to hold conversations with prospective patients). Keller was later convicted of wire fraud and sent to a North Dakota prison for two years. His kidnapping and arrest are blatantly illegal under international law.

1992 - Raid on Nature's Way

In 1992 in Utah; the FDA seized bulk primrose oil from Nature's Way, a manufacturer that offers some of the highest-quality supplements in the business. Nature's Way filed a lawsuit to get their product returned, but was forced to remove the natural Vitamin E from the formulation, as the FDA insisted that Vitamin E had not been approved as an additive for primrose oil.

1992 - The Tahoma Clinic FDA Raid

On May 6, 1992, FDA agents joined armed King County police officers in an armed raid against the clinic of Dr. Jonathan Wright, an M.D. and natural health practitioner. His crime? He was treating patients with injectable high-dose B vitamins -- a safe, natural treatment -- and in doing so was actually helping patients heal.

The armed agents smashed down the door, rushed into the clinic like a SWAT team with guns drawn, terrorizing the patients and shouting at them to put their hands in the air. Over the next fourteen hours, agents rifled through Dr. Wright's clinic, seizing patient records, computers, vitamin supplies, and various natural therapy products. The FDA illegally held on to confiscated items, including the computers needed to run his clinic, for three years.

But was Dr. Wright really so dangerous as to justify an armed raid? He's a graduate of Harvard and the University of Michigan Medical School. He's a book author, a prolific public speaker, and served as the nutrition editor of Prevention magazine for more than ten years. The purpose of the FDA raid was clearly not to arrest Dr. Wright, who was never charged. Rather, the purpose appears to be conducting a campaign of terror: sending a message to the alternative medicine community that anyone engaged in nutritional treatments could be raided and shut down, with no legal justification.

It was all part of the FDA's campaign against natural health treatments, a campaign that continues to this day.

1992: The Texas vitamin store raids

In 1992, the FDA prompted the Texas Department of Health (TDH) and the Texas Department of Food and Drug to conduct raids on more than 12 health food stores. Agents seized flaxseed oil, aloe vera, zinc supplements, vitamin C, and even Sleepytime Tea. One health food store owner was reportedly threatened by TDH with, "Don't talk to the press, or we'll come down on you twice as hard!"

None of the confiscated products were ever returned to the store owners, no charges were filed, and no reason for the raids was ever given. The raids were simply a campaign of terror designed to destroy the inventory and disrupt business operations of stores selling natural health products.

1993: The health food store raids

In 1993, the war against health freedom reached its peak in Texas, where combined forces of the FDA, DEA, IRS, U.S. Customs, and U.S. Postal Services conducted commando-style raids on nearly 40 different health food stores, vitamin companies, and natural health clinics from May through September. The homes of company owners and employees were also raided, and some raids were conducted with SWAT teams brandishing assault weapons and flak jackets.

In one home, a mother who was breast feeding her infant was reportedly "roughed up and handcuffed for 11 hours while FDA agents ransacked her home." Items seized in the raids included vitamins, minerals, herbs, and nutritional supplements. IRS officials also seized computers, automobiles, and bank accounts. The U.S. Postal Service illegally blocked the mail of some of the targeted companies, denying them the ability to conduct business or even organize a legal defense.

Targeted products included Dr. Kurt Donsbach's nutritional products and Dr. Hans Neiper's German-made health products.

The 1963 Church of Scientology raid

In the early 1960s, the FDA got word of something it didn't like: The Church of Scientology was helping its members overcome mental problems with the use of a simple biofeedback device called the E-meter. With the market for psychotropic drugs so consistently profitable, and with Scientology gaining momentum in helping millions of people overcome severe emotional and mental problems, this E-meter had to be taken out of play… and fast!

To do so, the FDA filed a "libel of information" with a U.S. District Court, after which Judge William B. Jones ordered a warrant authorizing the arrest of the E-meters. Yes, the meters themselves were to be arrested. The warrant also authorized the arrest of "an undetermined number of items of written, printed or graphic matter."

With the warrant issued, armed U.S. Marshals and FDA agents launched a military-style raid on the church. According to sworn affidavits of eyewitnesses, the agents "…burst into the church offices… and loudly demanded and threatened all in sight; observed absolutely no courtesies except for not actually shooting the guns they carried, and denied to the Church administrators any opportunity to arrange that students and Church members not be disturbed, upset or terrorized.

"Showing no legal warrant, the agents and … deputies pounded their way up stairways, bursting into confessional and pastoral counseling sessions, causing disruption and violently preventing the quiet pursuit of the normal practice of religious philosophy.

"They seized all the publications and all the confessional aids called E-meters they could find in desks, in ladies' handbags, in students' briefcases and in the session rooms.

"… the agents removed from the church to the waiting vans some tens of thousands of copies of over twenty Church books, texts, recorded sermons; even the Church archives were sacked. The confiscated material was handled roughly, and when ministers of the Church asked that their property be handled more carefully, the 'deputies' from Baltimore gave only sneering illiteracies for answer."

In all, three tons of materials were seized. In clear violation of both the First and Fourth Amendments, the FDA had illegally used its powers to spread yet more fear and terror through the world -- this time, to raid a church.

All religions have healing tools

Of course, Scientology is not as mainstream as Christianity, Buddhism, or Catholicism, but since when did religions have to be popular to enjoy equal protection under the U.S. Constitution? Besides, various churches have always attributed special healing powers to their particular tools. Roman Catholic churches have Holy Water and other healing elements (Easter wafers, Saint Glaize Candles, Scapulars, and so on). Other religions use prayer clothes, prayer oils, and various pieces of string for which healing benefits are commonly prescribed. Nearly all churches recognize prayer as an effective form of healing. Yet the FDA chose to single out Scientology's E-meter machine, likely because it perceived the device as presenting a genuine threat to psychiatry's monopoly over mental health treatment.

The FDA, you see, believes it not only regulates foods, drugs, and cosmetics, but also religions. Only "mainstream" religious practices will be allowed, and any such religions that use alternative symbols, rituals, or scriptures will be prosecuted, regardless of what the Constitution says. The rule of law never interferes with the FDA's campaigns of terror.

The history of the U.S. government's persecution of the Church of Scientology is long and complex, and it is a sad demonstration of true religious intolerance right here in the United States. The First Amendment, which protects both Free Speech and Religion, offers no real protection against the criminals at the FDA, who have for decades attempted to suppress alternative philosophies that actually help people heal.

After nine years of protracted legal battles, and the expenditure of countless millions in taxpayer dollars that funded the prosecution efforts, the Church of Scientology achieved a victory in the courts, and the FDA was forced to return the E-meters. Yet, just to inflict a little more pain and punishment upon the Church, the court ordered the Church of Scientology to pay for all the warehousing costs of the confiscated items held over the previous nine years, plus all the legal fees of the government's prosecution efforts. The courts also ruled that all Scientology literature describing the E-meter must carry a warning message written by the FDA, and that the church must pay the salaries and travel expenses of FDA agents who would, from time to time, visit the church to ensure compliance with the courts. (Source: The Hidden Story of Scientology, Omar V. Garrison, page 143.)

In other words, the Church of Scientology was to be severely punished for daring to oppose the tyranny of the FDA. Just as a factory-working Jewish prisoner who talked back to his Nazi captors in 1942 would be beaten and shot, the FDA made sure that the Church of Scientology would pay a dear price for daring to question the authority of this all-powerful federal agency, an agency that could summon the aid of firearms-brandishing law enforcement officials at any time, for apparently any reason, regardless of its legality.

Other FDA raids

1991, San Leandro, Calif.: A nutritional supplement company, NutriCology, is raided by 12 FDA agents. All FDA injunctions were eventually thrown out of court.

1991, Texas: The anti-cancer clinic of Dr. Stanislaw Burzynski, a brilliant researcher from Poland, is raided by the FDA and the Texas Department of Health. Just before the raids, the National Cancer Institute had announced they would evaluate the pioneering work of Dr. Burzynski, which involved cancer treatment using antineoplastons. With the help of health freedom champions like Dr. Julian Whitaker, Dr. Burzynski fought FDA oppression and went on to save the lives of countless cancer patients, some of which are profiled on his clinic website today:

1992, San Diego, Calif.: The heads of three European vitamin companies, along with their U.S. marketing professional David Halpern, are arrested and charged with 198 counts of conspiracy, smuggling, and violation of the Food, Drug and Cosmetic Act for importing simple nutritional supplements that are freely available in Britain, Germany, and other European countries. The indictments reportedly carried combined prison terms of 990 years.

And this report, by the way, doesn't even cover the FDA's terror-style tactics against a company called Lane Labs, which developed and marketed anti-cancer supplements that really worked.

As you can see from this report, it is quite clear that the FDA
has the intention of destroying natural medicine using any means necessary,
including terrorism tactics.

And who supports the FDA? Pharmaceutical companies, medical associations, doctors, medical journals, hospitals and numerous corrupt Congresspeople and Senators. By supporting the FDA, they condone the use of terrorism tactics against the American people and, ultimately, support the continued use of police state tactics against innocents.

You can learn more about the true history of the FDA and Big Pharma in my tell-all book, Natural Health Solutions and the Conspiracy to Keep You From Knowing About Them.

Learn more:
And  the King shall answer and say unto them, Verily I say unto you, 
Inasmuch as ye have done it unto one of the least of these my brethren,  ye have done it unto me.

Matthew 25:40

Offline Dig

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« Reply #7 on: January 15, 2011, 08:35:02 am »
The FDA and HCFA (Part I):
Unconstitutional Regulatory Agencies
James A. Albright, MD


The accumulation of all powers, legislative, executive and judiciary, in the same hands whether of one, a few or many, and whether hereditary, self-appointed or elective, may justly be pronounced the very definition of tyranny.

James Madison, 1787
Federalist Papers #47

Executive Agencies with the Power of Legislation

Many of the current problems in this country can be traced to the growth of the regulatory agencies, some of which have become independent fiefdoms with legislative as well as executive and judicial powers. This has indirectly led to disaffection of the population, which in general believes that the government no longer represents their interests. It is a justifiable conclusion, because a high percent of our "laws" are now written by the regulatory agencies in the form of "regulations." The bureaucrats of the regulatory agencies do not answer to the people, as do the congressional legislators. However, the legislators are willing to approve such a system because it serves their interests. It allows them to write general, benevolent sounding laws without taking responsibility for the "nasty" details because these are written by the regulatory agencies. There is little question that the laws would have a different bent if legislators were responsible for the details. Yet, there is a light at the end of the tunnel: Regulations written by the regulatory agencies are unconstitutional, other than those which are procedural recommendations, not binding extensions of the law itself.

The U.S. Constitution

One of the settled maxims in constitutional law is, that the power conferred upon the legislature to make laws cannot be delegated by that department to any other body or authority. Where the sovereign power of the State has located the authority, there it must remain...until the Constitution itself is changed.
-Thomas M. Cooley, 1883(1)

Article I, Section 1, of the Constitution states: "All legislative Powers herein granted shall be vested in a Congress..." But does this statement mean what it says? In actuality, the evidence that it does is overwhelming, beginning with the intent of the Founding Fathers, as well as comments and arguments in speeches and publications during ratification, plus actions of the court, particularly those decisions closer in time to the constitutional period.

The individual whose ideas had the greatest influence on the Founding Fathers was Baron Charles Louis de Montesquieu (1689-1755) from France. He was the first modern writer during the constitutional period to promote the concept of three separate, but equal, powers: Executive, Legislative, and Judicial. The contribution of Montesquieu to our system of government cannot be overemphasized, a fact that has often been overlooked in the past. In 1940, P.M. Spurlin recognized the critical role of Montesquieu, and he quoted numerous authorities who emphasized his importance.(2) This conclusion was documented in a recent study of citations between 1760 and 1805.(3) This study found that, "If there was one man read and reacted to by American political writers of all factions during all stages of the founding era, it was probably not Locke but Montesquieu." Even so, John Locke's (1632-1704) views supported similar concepts, as indicated by his statement in 1690: "The legislature neither must nor can transfer the power of making law to anybody else, or place it anywhere but where the people have."(4)

Montesquieu's concepts captured the imagination of the Founding Fathers who immediately recognized the wisdom of his warning that freedom is abolished and totalitarian powers prevail whenever any individual or group controls any two of the three powers. Montesquieu's, as well as Locke's, influence on James Madison (1751-1836) is evident in Federalist Paper #47 which states that the lack of the separation of powers is "the very definition of tyranny."(5) The wide circulation of Montesquieu's concepts in this country can be appreciated by Spurlin's statement that if Montesquieu's book The Spirit of Laws(6) were suddenly blotted out of existence, a goodly portion of it, certainly the important parts, could be reconstructed accurately from American newspapers of the 18th century. In fact, Madison himself gives Montesquieu full credit.

John Marshall (1755-1835), the 4th Chief Justice of the Supreme Court (January 27, 1801-July 6, 1835), recognized the importance of Montesquieu's writings.(7) Marshall has been called the definer of our nation, the expounder of the Constitution, and the greatest jurist in our history. After ratification of the Constitution, the role of the court was ill-defined. In fact, when the government moved from Philadelphia to Washington, D.C., in 1800, no provision was made to fund or house the court, and for many years it convened in one room in the Capital. At that time, it was questioned whether the court had a significant role to play. Yet, by the end of Marshall's tenure the court had assumed the role it has today: It is a critical pillar supporting our tripartite system of governance.

Marshall's most famous case, Marbury vs Madison, firmly established the power of the court to rule on the constitutionality of legislative acts by Congress. Marshall had purchased Montesquieu's book, The Spirit of Laws, which focuses on the necessity of a tripartite system if liberty is to be protected. This was clearly expressed in the Majority decision written by Marshall: "It is a proposition too plain to be contested that the Constitution controls any legislative act repugnant to it." Moreover, "courts as well as other departments are bound by that instrument."(8)

In 1975, Sotirios Barber stated: "From the early years of the Republic the courts have found implicit in the Constitution a rule restricting the degree to which Congress may delegate its powers to others."(9) Barber called this principle: "The rule of nondelegation."(10) This rule defines a crucial principle for the effective function of a tripartite system (i.e., Executive, Legislative, and Judicial), where each body has specified powers. However, since the 1930s, the Supreme Court has permitted the regulatory agencies to write laws. Technically, these laws are called regulations, but in reality, they are treated as laws by the government, including all three branches, even the judiciary. Anyone who argues that regulations are not laws can easily test this supposition by purposely creating an infraction of a "regulation." The response thereby engendered will be more than that stimulated by a "recommendation"; it will be indistinguishable from a "law."(11) This creates two fascinating constitutional issues: 1) The Constitution gives Congress, and only Congress, the power to write laws; 2) Only the Legislative branch is authorized to write laws; yet, the regulatory agencies are part of the Executive branch which is authorized to enforce the law, not to make law.

Furthermore, the power of the regulatory agencies extends beyond the creation of laws de novo. Their actions can turn a constitutionally enacted law by Congress on its head --- i.e., the law is reinterpreted to serve the interests of the bureaucrats.(12)

Clearly, it is destructive to constitutional government when an executive agency promulgates its own rules, and then interprets and executes those rules, prosecutes alleged violations, imposes penalties, and even adjudicates challenges to its authority. Congressional delegation of legislative powers can also be, and has been, challenged because it encroaches on the civil liberties of citizens without due process of law."(13) It also encroaches on First Amendment rights.

In short, the Supreme Court has avoided the constitutional issue itself, indicating it is aware of the underlying problem but refuses to address it. Even more startling is the fact that under our current system the courts can overturn the decisions of Congress and of the president, but decisions by the FDA and HCFA seem not to be subject to any higher authority.(14) It is not possible for the non-legal mind to grasp the reasons for this bizarre twist of logic. It is a situation where the Judiciary, that branch of government most responsible for upholding citizens' rights, has been inactivated by what appear to be self-imposed restrictions.(15)

This stance of the court presumably stems from a doctrine known as stare decisis which honors precedent as determined by previous court decisions. In a legal sense this may hold true for laws, but it cannot be applied to constitutional principles which do not change except by Amendment. Schoenbrod states that the doctrine of stare decisis has three major purposes:

1. To appraise accurately the intention of those who wrote the text being interpreted. The Supreme Court did not depart from this interpretation until the end of the 19th century.

2. To maintain public faith in the judiciary as a source of impersonal and reasoned judgments.

3. To protect expectations based on precedent so that people can rely on prior judicial decisions.(16)

This doctrine, therefore, requires judges to examine the Constitution itself, together with the framers' opinion of the Constitution, as well as that of judges who lived closest in time to the Founding Fathers who wrote the constitutional provision in question. Nevertheless, there is considerable disagreement on this issue. Some believe that supporting evidence is crucial, and some believe that the words themselves take precedence. Fortunately, on the question of delegation there is no conflict. The intent of the Founders, and the opinion of the courts during the first two-thirds of the country's existence, are synonymous with the words themselves, which even a layman can understand: "All legislative Powers herein granted shall be vested in a Congress...."

Marshall's stance was that of professional objectivity. He was determined that the Court not be made an instrument of partisan politics. He believed that political issues were within the purview of the Executive, and legal issues were within the jurisdiction of the court, i.e., checks and balances rather than reliance on official and citizen virtue as the primary method for maintaining constitutional order.

Debate at the Constitutional Convention proceeded on the premise that Congress could not delegate its legislative powers to the Executive. Furthermore, the framers' claim that Article I of the U.S. Constitution protects the people from elected officials would have been inconsistent with delegated authority that permitted officers to make law outside of the Article I process.(17,18)

A basic premise of the delegates was that a written constitution to establish specific guidelines was essential in order to prevent gradual corruption. Therefore, they felt a sense of accomplishment, even exhilaration after completing what they claimed to be the world's first written constitution.

In short, abundant evidence from the constitutional period indicates that the words in the constitutional text mean exactly what they say.

In Part II of this essay, we will explore, explain, and provide evidence that the FDA and HCFA have abused their regulatory power to interfere in the practice of medicine in America.


1. Cooley TM. A Treatise on the Constitutional Limitations which Rest Upon the Legislative Power of the United States of the American Union. 5th Edition, Little, Brown & Co., Boston, 1883.
2. Spurlin PM. Montesquieu in America: 1760-1801. Baton Rouge, LSU Press, 1940.
3. Lutz DS. The Relative Influence of European Writers on late Eighteenth-Century American Political Thought. Am Political Sci Review, March 1984, pp. 189-197.
4. Locke J. Second Treatise of Government. 1690. Reprinted 1980. Hackett Publishing Co, Inc., Indianapolis, Cambridge, 141, pp. 74-75. "The legislature cannot transfer the power of making laws to any other hands: for it being but a delegated power from the people, they who have it cannot pass it over to others...and when the people have said, We will submit to rules, and be governed by laws made by such men, and in such forms, no body else can say other men shall make laws for them; nor can the people be bound by any laws, but such as are enacted by those whom they have chosen, and authorized to make laws for them. The power of the legislative being derived from the people by a positive voluntary grant and institution, can be no other than what that positive grant conveyed, which being only to make laws, and not to make legislators, the legislative can have no power to transfer their authority of making laws, and place it in other hands."
5. Madison J. Federalist Paper #47.
6. Montesquieu Baron Charles Louis de. The Spirit of Laws. Thomas Nugent's translation (London, Nourse, 1750). Reprinted 1977, David Wallace Carruthers (ed.). University of California Press, Berkeley, Los Angeles, London. Book XI, Chapter 6, p. 201.
7. Smith JE. John Marshall: Definer of a Nation. Henry Holt & Co, NY, 1996.
8. Marbury vs Madison. 5 U.S. (I cranch) 137,2 L.Ed. (1803).
9. Barber SA. The Constitution and the Delegation of Congressional Power. University of Chicago Press, Chicago, 1975, p. 1.
10. Ibid., p. 11. Barber also stated that the "Rule of Nondelegation" has been called an import into constitutional law from the common law of agency where an ancient maxim prohibits the redelegation of delegated power (delegata potestas non potest delegari).
11. Crews CW. Kerrigan K. Here's a winning issue. Wall Street Journal, March 7, 1996.
12. DiIulio JJ. How bureaucrats rewrite laws. Wall Street Journal, October 2, 1996.
13. Barber, op. cit., pp. 31-34.
14. Driscoll JA. Cure for FDA-induced pain. Wall Street Journal, February 2, 1996. Regulatory gridlock should not be compared with the much ballyhooed "government gridlock" which is actually the system of checks and balances the framers created to prevent runaway government.
15. Murphy WE, Fleming JE, Barber SA. American Constitutional Interpretation, 2nd Ed. The Donation Press, Inc., Westbury, NY, 1995, p. 427. Prior to the New Deal, the court had ruled that the president did not have to seek the Senate's approval to remove a postmaster from office (Myers vs U.S., 1926). That case suggested that Congress could place no limitations on the president's removal power. However, later on the court decided that Congress could insulate some administrators from presidential control, specifically commissioners of the independent regulatory agencies, such as the Interstate Commerce Commission, the Federal Trade Commission, and the Federal Power Commission. These individuals could serve for specific terms, rather than at the pleasure of the president. In effect, the court established independent fiefdoms, which in actuality constitute a fourth branch of government controlled by unelected officials who wield power equal to the other three branches. This action not only fits, it exceeds, James Madison's definition of tyranny.
16. Schoenbrod D. Power Without Responsibility: How Congress Abuses the People Through Regulation. Yale University Press, New Haven, 1993.
17. Madison J. Notes of Debates in the Federal Convention of 1787. W.W. Norton and Co., New York, 1966, pp. 326-327. Mr. Madison: "If it be a fundamental principle of free government that the Legislative, Executive and Judiciary powers should be separately exercised, it is equally so that they be independently exercised. There is the same and perhaps greater reason why the Executive should be independent of the Legislature, than why the Judiciary should: A coalition of the two former powers would be more immediately and certainly dangerous to public liberty."
18. Ibid., p. 339. Mr. Gov Morris: "...expositors of laws ought to have no hand in making them.

Dr. Albright is Professor and Chairman of the Department of Orthopedic Surgery at Louisiana State University Medical Center in Shreveport, Louisiana. His e-mail is [email protected].

Originally published in the Medical Sentinel 2000;5(5):169-171. Copyright © 2000 Association of American Physicians and Surgeons (AAPS).

The FDA and HCFA (Part II):
Unconstitutional Regulatory Agencies
James A. Albright, MD

In regard to the deleterious changes that have taken place in the field of medicine, the regulatory agencies that have had the most damaging effect on the Constitution are the FDA and HCFA. Indeed, the history of the government's involvement in medical care provides a textbook example of the natural history of a command (a managed or collective) economy. In a command economy, power is centralized, which means it is an authoritarian system. Furthermore, when power is centralized, rules and regulations to control the system, particularly costs, inevitably become increasingly oppressive, due to the lack of incentives for self-control that exist in a market economy. For example, most physicians know that the measures implemented by the government (HCFA) to control Medicare have become more onerous each year. In fact, it has reached the point where most physicians know that severe penalties, even imprisonment, can be imposed if they bill too much and, as incredible as it may seem, even if they bill too little.(1) It is no surprise that few physicians actually know the details of what is and is not permitted, nor what the penalty might be for any given infraction.

Most physicians are well aware of the day to day agitations which result from government policies, and many have heard about some of the more sensational problems which occur.(2) The basic issue concerns the regulatory agencies in general. For example, in 1994, the estimated cost of economic, social, and environmental regulation topped $647 billion (as much as $6,457 per family), according to the General Accounting Office.(3) The FDA is one of these regulatory agencies and, in fact, it may be the most unaccountable of them all. Over the past 30 years, the FDA has inflated its powers so much that regulatory gridlock is now a greater menace to public health than thalidomide ever was.(4) The presumed "protection" provided by the system is illusory.

The misadventures of the device section of the FDA are well-known.(5) Some of the more memorable cases include the Bjork-Shiley heart valve implanted in 86,000 patients between 1979 and 1986, with a success rate of 99.5 percent. But it was pilloried by the government because it fractured in 0.5 percent. In other words, it saved the lives of 191 individuals for every valve that fractured. This raises the question of whether perfection is a reasonable standard for any mechanical device, a standard that the 51,000 patients who were still alive in 1992 might question.

Other infamous cases include a defibrillator made by Physio Control, which functioned properly more than 99.995 percent of the time. This product was the victim of scurrilous reporting by the news media, combined with heavy-handed tactics from Congress and the FDA.

The most recent, widely reported fiasco was that of breast implants. In spite of multiple epidemiological studies showing no relationship between breast implants and either connective tissue disease or carcinoma of the breast, FDA Commissioner David Kessler precipitated actions which resulted in a $43 billion legal settlement in 1994. Then, in the absence of data showing any link between breast implants and the alleged ailments, an FDA spokesman, Bruce Burlington, head of the Center for Devices and Radiological Health (CDRH), said the agency would maintain the same course it had set before the studies were reported. A Wall Street Journal editorial stated, "This, after billions of dollars have been put up to pay off the Plaintiffs' lawyers, after mastectomy patients have been terrorized, and after companies and careers associated with the implants have needlessly washed over the falls."(6)

Orthopaedic surgeons received an overnight education on the FDA from pedicle screws. Numerous research studies have shown that pedicle screws provide the strongest possible fixation in the spine. In fact, a non-medical observer, even an astute school child, could look at a vertebra and immediately recognize where the strongest part is. This explains why pedicle screws are often used clinically for certain problems.(7,8) Clearly, they provide optimum treatment for certain conditions. Yet, for many years, the FDA refused to approve pedicle screws. Because there was no logical explanation for this position, a neutral observer might conclude that the underlying purpose was to transfer funds into the hands of plaintiffs' lawyers since the actions of the FDA precipitated a massive class-action lawsuit.(9) The defendants included physicians and professional organizations such as the American Academy of Orthopaedic Surgeons, the Scoliosis Research Society, the North American Spine Society, the Orthopaedic Trauma Society, the Orthopaedic Research and Educational Foundation, the American Association of Neurological Surgeons, and the Congress of Neurological Surgeons, as well as countless individual physicians and major companies that manufacture the devices. (One company, Sofamore Danek, had approximately 3,000 lawsuits filed against it.) The professional societies and their members were accused of fraud and illegal collusion with orthopaedic companies by sponsoring academic meetings where scientific papers on pedicle screw devices were presented. Ironically, the companies that manufacture pedicle screws and the physicians who use them should be commended, not condemned.

After inflicting such enormous costs on society, both monetarily in legal costs and professionally in patient care, in 1998 the FDA reversed course and reclassified pedicle screw spinal systems from Class III to Class II for certain indications,(10) i.e., after countless years of resisting undeniable evidence, the FDA reluctantly admitted a serious error. Whatever the reasons, there is little question that the effect of the FDA's actions had an adverse effect on patients in this country.

Although this discussion has focused on actions of the device section, the drug section has a similar, if not more alarming history.(11)

Potential Solutions

It is now obvious the basic structure of the regulatory system needs to be changed or abolished. To simply put on the brakes by restructuring HCFA and the FDA either by reordering their priorities or by legislation, might work for awhile. However, as long as these agencies continue to exercise unconstitutional legislative and/or judicial power, the current problems and dangers to society will persist. The reason is that the history of authoritarian systems is well-known.(12-14) Examples of such systems have been repeatedly demonstrated over the past 60 years, not only in Nazi Germany and the former Soviet Union, but also in most of the underdeveloped countries in the world. There is little question that the FDA and HCFA are exhibiting the same dangerous attributes that are inherent in authoritarian systems.

The current question is: "What can be done to change the FDA and HCFA into organizations that have a positive, rather than a negative, effect on society?" There are several possibilities.

Constructive change could come from Congress, but we should not expect a revolution because Republicans now face the same political incentives and restraints previously faced by the Democrats and, unfortunately, they are beginning to act similarly. Thus, the most desirable solution would be for the United States Supreme Court to take the lead and re-establish the authority of the Constitution as the Supreme Law of the Land.

Numerous proposals have been offered to change the structure of the FDA. These range from a plan to provide funding strictly from royalties derived from products approved by the agency, to limiting its function to the determination of safety. One of the more sensible suggestions would alter its mission to that of product certification. No longer would it engage in excruciatingly detailed rule-making and law enforcement. Consumers, therefore, would be free to purchase products lacking FDA certification, and sellers would be free to sell uncertified products without government interference.(15)

Defenders of the current system claim that such a "drastic" change would be too dangerous because charlatans and imposters would flood the market with ill-devised and harmful "remedies." But such a response is irrational, because the evidence suggests otherwise. The prime example presented by defenders of the status quo is thalidomide. Yet, it is now known that the market had already solved that problem prior to the government-imposed sanctions. In effect, the government simply provided another example of what Professor E.G. West termed the "galloping horse" phenomenon.(16) In reality, market forces and their ramifications, including our legal system, provide the most effective methods of protecting the public from harmful drugs and devices. Enforcement of the Constitution, together with more sensible guidelines, would unleash the most effective controls.

In the final analysis, as stated by Ludwig von Mises in 1927, "The ultimate outcome in the struggle between libertarianism and totalitarianism will not be decided by arms, but by ideas. It is ideas that group men into fighting factions, that press the weapons into their hands, and that determine against whom and for whom the weapons shall be used. It is they alone, and not arms, that, in the last analysis, turn the scales."(17) It is ideas that led to the fall of the Soviet Union. Although some state that it was predetermined and that it was merely a matter of time before it fell, nothing is predetermined. The course of events is influenced by unexpected forces and directed by men of vision and resolve.

In the recent past, for example, the determination and wisdom of Ronald Reagan set the course in world affairs, which led to an outcome which was nothing less than the fall of the "Evil Empire." We can benefit from this lesson if we set our sights on the ultimate triumph of individual rights over totalitarian forces, whatever form they may take. We must attack this issue on a philosophical basis, while at the same time maintain pressure at every level. Therefore, it is imperative that we look beyond our next transaction and not lose sight of the ultimate goal, which is the triumph of liberty. If we remain steadfast in this resolve, the future is clear. By choosing this path, we cast our lot with those who would preserve high quality medical care, together with those who would guarantee liberty for every citizen.

It is one thing to claim that the function of government is to determine whether or not a given product is safe or not safe for citizens to use. But in a free society, there is no justification for forcing people to do what the government states is best for them. To do so is tyranny. Peter McWilliams succinctly calls it, "The absurdity of consensual crimes in a Free Society."(18) The absurdity hits home with the realization that any adult with a terminal illness who is given up as a hopeless case by the medical establishment can be put in jail for trying certain alternative therapies because the FDA has determined that such treatment might prove harmful.

The historic and continuing struggle of citizens against government oppression must be fought at several levels. Vigilance in opposing specific actions that infringe on citizens' rights is critical. However, the battle will not be won at that level alone. Our major focus must address the philosophic issue by concentrating on the concept of Constitutional Supremacy and the rule of nondelegation to expose the unconstitutional structure and actions of the FDA and HCFA (and other regulatory agencies). Equally important, we must pressure our "public servants" at all levels of government to simply adhere to the vows they take when sworn into office. At that time, they promise to uphold the Constitution. It is a travesty that most of them break this vow immediately after swearing to uphold it. Justice Joseph Story had strong opinions on this issue. He felt that if a judge departs from the original meaning of the Constitution, he acts on his own personal opinion of the public good or wise policy --- i.e., he usurps powers not given to him by the people through their Constitution. Therefore, he is no longer interpreting the Constitution, but amending it in a manner contrary to what the document itself permits.(19)

Justice John Marshall's driving interest was to establish the Constitution as the supreme law of a tripartite system. What does this mean in practical terms? Is it relevant or is it simply a concept of theoretical interest only? For much of the 20th century, we failed to honor constitutional principles and the executive branch has increasingly exercised legislative powers. However, in recent decisions the court has begun to address this issue, so we, as Benjamin Franklin, may be viewing a rising, not a setting, sun.(20)

Most dramatic was the recent case where the court firmly declared that the line item veto was unconstitutional.(21,22) The decision was based on the separation of powers. It was emphasized that Congress has no authority to delegate legislative power to the executive branch. Indeed, Alexander Hamilton in rejecting the idea that Congress could delegate its authority to any other power stated: "There is no question which depends on clearer principles than that every act of a delegated authority, contrary to the tenor of the commission under which it is exercised, is void. No legislative act, therefore, contrary to the Constitution can be valid."(23)

More recently, in Washington Legal Foundation v. Friedman, Federal District Court Judge Royce C. Lamberth ruled that the FDA could not prevent pharmaceutical companies from informing physicians of valuable off-label (not FDA approved) actions of drugs.(24) The decision was based on First Amendment rights. This decision was followed by an Act of Congress on November 21, 1998: The FDA Modernization Act (FDAMA) which attempted to overrule the Friedman court decision by legalizing the FDA's unconstitutional regulations.(25) This law was enacted to amend the Federal Food, Drug and Cosmetic Act.(26) In response to an appeal by the government, the court reconsidered its decision made in July 1998, with an opinion on July 28, 1999.(27) The court stated that the FDA's claims were "preposterous" and akin to "constitutional blackmail." The decision firmly upheld the court's decision in 1998 and the FDAMA was ruled unconstitutional. The ruling states that the "Defendants shall not in any way prohibit, restrict, sanction or otherwise seek to limit any pharmaceutical or medical device manufacturer or any other person" ...from publicizing any information on off-label uses of drugs or devices "...previously published in a bona fide peer-reviewed professional journal." It would be reasonable to expand these same criteria for the initial approval of a drug or device.

Most recently, the Supreme Court ruled that the FDA's attempt to regulate tobacco was unconstitutional.(28) It was a bold and much needed, if belated, decision. More serious is the court's continuing failure to recognize that many and probably most "laws" (regulations) written by regulatory agencies are unconstitutional.

The recent decisions of the Supreme Court, together with the fact that the unconstitutional actions of the FDA and HCFA have deprived American citizens of optimum medical care, point toward the next logical step: A constitutional challenge must be made in the form of a legal case. To have standing in court, the plaintiff must be an individual, or a body, who was damaged by an unconstitutional action of either HCFA or the FDA. This could either be a physician, or a patient, or even an institution. The recent announcement that the Association of American Physicians and Surgeons (AAPS) is considering such a case is very encouraging. For maximum benefit, the case must be one which not only will receive a favorable opinion from a District Court, but one which the Supreme Court will elect to accept for consideration, rather than simply accepting the District Court's opinion.

In recent years, the Supreme Court has accepted far fewer cases than in previous years. Yet, this fact should in no way discourage the development of such a case, because the court's powers are limited and it may simply be waiting for a suitable case (or series of cases). The court has no legislative power, so it can only make decisions on cases presented to it. There is a real possibility that a suitable case has never appeared.


The unique value of our Constitution is the balance of power it establishes between three equal branches of government. Once discovered by our Founding Fathers, this concept immediately captured their imagination, and it became the central driving issue during the Constitutional Convention in 1787. The Founders understood the danger that results when any two of the three powers are exercised by a single branch: When the lawmaker also becomes the enforcer, or the accuser becomes the executioner. As a result, the Founding Fathers specifically created a Constitution that separated these three powers between three equal divisions of government.

Likewise, there no longer is any doubt that the regulatory agencies, including the FDA and HCFA, now have legislative, as well as executive, powers. Such imbalance was defined by James Madison as tyranny, because power is transferred from the people to the government.

Thus, the concentration of power in the hands of regulatory agencies has resulted in an authoritarian system where power has been extracted from the people and centralized by the government.

The first step toward recovery is recognition of the problem.


1. Orient JM. Can "health care fraud" be ended? Medical Sentinel 1998;3(4):124-130.
2. Trasby TR. What has government done to our health care? Cato Institute, Washington, DC, 1992.
3. Crews CW, Kerrigan K. Here's a winning issue. Wall Street Journal, editorial page, March 7, 1996.
4. Driscoll JA. Cure for FDA-induced pain. Wall Street Journal, editorial page, February 8, 1996. Regulatory gridlock should not be compared with the much ballyhooed "government gridlock" which is actually the system of checks and balances the framers created to prevent runaway government.
5. Higgs R. Wrecking ball: FDA regulation of medical devices. Policy Analysis #235, Cato Institute, Washington, DC, August 7, 1995.
6. Higgs R. Hazardous to our Health? FDA Regulation of Health Care Products. Oakland, CA, The Independent Institute, 1995, pp. 64-66.
7. Dick, W. Internal fixation of thoracic and lumbar spine fractures. Lewiston, NY, Hans Huber Publication, 1989.
8. Berkman EF, Cruse RN, Mukherjee DP, Sadasivan KK, Albright JA. A comparative biomechanical evaluation of the thoracolumbar burst fracture in human and canine spine. Orthopaedic Transactions 1994;18(2):77.
9. White JS. The pedicle screw lawsuits: Can CME finally come out of the shadows? Medical Economics, September 1998, pp. 40-46.
10. Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems. Federal Register, July 27, 1998, Vol. 63, No. 143, pp. 40025-40041.
11. Higgs, Hazardous to our Health? op. cit., pp. 13-27.
12. Albright JA, Bleck, EE, Ricardo-Campbell R. Health care in the United States: What we should keep and what we should change. Essays in Public Policy, Hoover Institution, Stanford University, 1994, p. 9.
13. Hayek F. The Road to Serfdom. Chicago, IL., University of Chicago Press, 1944, p. 100.
14. Bastiat F. The Law. The Foundation for Economic Education, Irvington-on-Hudson, NY, 1950. Translation of 1850 Edition.
15. Higgs, Hazardous to our Health? op. cit., pp. 97-101.
16. Seldon A. Capitalism. Basil Blackwell Ltd, Oxford, UK, 1990, p. 258. When the solution to a problem is already in place, but not widely recognized, "the occupational disease of politicians is to succumb to the inducements of the political process to 'interfere' by putting themselves at the head of 'prospering systems' in order to win credit for their wisdom and public spirit but often to end by obstructing them. Professor West accused the politicians of jumping onto 'a galloping horse.' " Almost invariably, the outcome is a progressive deterioration of the program at issue.
17. Mises L. Liberalism: The Classical Tradition. The Foundation of Economic Education, Inc. Irvington-on-Hudson, NY, 1996. Translation of 1927 edition, translated by Ralph Raico, p. 51.
18. McWilliams P. Ain't Nobodies Business If You Do. Los Angeles, CA, Prelude Press, 1993.
19. Story J. A Familiar Exposition of The Constitution of the United States, 1840. Reprinted by Regency Books, Lake Bluff, IL, 1986, pp. 68-70. Forward by Edwin Meese III, p. 12.
20. Madison J. Notes of Delegates in the Federal Convention of 1787. Reissued by Norton & Co., NY and London, 1987, p. 659. At the conclusion of the Federal Convention in 1787, while the last members were signing the Constitution, Madison reported that Doctor Franklin looked toward the President's chair at the back of which a rising sun had been painted. He was heard to say that painters found it difficult to distinguish between a rising and a setting sun. He said he often looked at that sun but due to the "vicissitudes of his hopes and fears" during the convention, he was unable to tell whether it was rising or setting. But now, he said, "... I have the happiness to know that it is a rising and not a setting sun."
21. City of New York v. Clinton and Snake River Potato Growers v. Rubin, 985 F Supp. 168, p. 169. (D.D.C.) February 12, 1998. The court held that "...the Line Item Veto Act violates the procedural requirements ordained in Article I of the United States Constitution and impermissibly upsets the balance of powers so carefully prescribed by its Framers. The Line Item Veto Act therefore is unconstitutional."
22. Clinton v. City of New York, WL 333013 (U.S.) p. 14, 1998. Supreme Court of the United States, June 25, 1998. The court held that the Line Item Veto Act "...would authorize the President to create a different law - one whose text was not voted on by either House of Congress or presented to the President for signature." Furthermore, "such change must not come by legislation but through the amendment procedures set forth in Article I of the Constitution." Therefore "The judgment of the District Court is affirmed."
23. Hamilton A, Madison J, Jay J. The Federalist Papers. New York, New American Library, No. 78, p. 467.
24. Washington Legal Foundation v. Friedman, 13F. Suppl. 2d 51 (D.D.C.) July 30, 1998).
25. FDA Modernization Act. Dissemination of Information on New Uses. Public Law 105-115 (S. 830). Title IV, Section 401, November 21, 1998.
26. Federal Food, Drug, and Cosmetic Act Section 554(d), as amended 21 U.S.C.A. Section 360aaa-3(d), 1999.
27. Washington Legal Foundation v. Henney and Donna Shalala. 1999 WL 557679, *2, *6 (D.D.C.) July 28, 1999. The Court held that "...the FDAMA largely perpetuates the policies held unconstitutional by the court on July 30, 1998 and therefore may not be applied or enforced by FDA." The court held that the Central Hudson Test (447 U.S. 557, 1980) applied: "If the speech is truthful and nonmisleading, the government must demonstrate a substantial interest that is directly advanced by the regulation without burdening substantially more speech than necessary."
28. Food and Drug Administration, et al., v. Brown and Williamson Tobacco Corporation 153 F. 3d 155 (98-1152) USC, March 21, 2000.

Dr. Albright is Professor and Chairman of the Department of Orthopedic Surgery at Louisiana State University Medical Center in Shreveport, Louisiana. His e-mail is [email protected].
Dr. Albright does not have a conflict of interest with any of the products discussed in this article, although as an orthopedic surgeon, he has performed numerous laboratory studies on pedicle screws and associated implants.

Originally published in the Medical Sentinel 2000;5(6):205-208. Copyright © 2000 Association of American Physicians and Surgeons (AAPS).
All eyes are opened, or opening, to the rights of man. The general spread of the light of science has already laid open to every view the palpable truth, that the mass of mankind has not been born with saddles on their backs, nor a favored few booted and spurred, ready to ride them legitimately

Offline Dig

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« Reply #8 on: January 15, 2011, 08:44:46 am »
How many database systems will be combined into the PROMIS/INSLAW privatized offshore information gold mine based on the elimination of basic human rights? Here is just one example of a "Health Initiative" to dehumanize all native Americans via a "National Healthcare" plan that continually runs recon operations on the citizens and then implements behavioral modification projects. That system and some of the intelligence gathering projects described in the following pdf is less than 1% of the insanity that the CFR and Bilderberg plan on running throughout the US...

As CFR agent Joe Biden said when Barry Soetoro signed the seditious piece of crap: "It is a big f**king deal"

Yeah Joe, we know. It gives Bilderberg the ability to market American genocide to the highest bidders.
All eyes are opened, or opening, to the rights of man. The general spread of the light of science has already laid open to every view the palpable truth, that the mass of mankind has not been born with saddles on their backs, nor a favored few booted and spurred, ready to ride them legitimately

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« Reply #9 on: January 15, 2011, 09:12:41 am »
 Rapid Responses
Analysis: What can we learn from drug marketing efficiency?
David P Kao
BMJ 337:doi:10.1136/bmj.a2591 (Published 2 December 2008)

EU-ADR: a European multifaceted approach to improving postmarketing surveillance of drugs
Miriam C Sturkenboom, professor Miriam Sturkenboom, J. Kors, C. Díaz Acedo, S. Boyer, L. Cantarutti, A. Fourier, R. Gini, D.Gurwitz, R. Herings, J. Hippisley-Cox, M. Loza, G. Mazzaglia, M. Molokhia, Jose L. Oliveira, L. Pedersen, S. Romio, F. Sanz, G. Trifiro', J. vander Lei
Erasmus Univeristy Medical Center

Dr. Kao states in his analysis on the efficiency of marketing drugs that more efficient approval and marketing of drugs requires significant improvements in the available postmarketing surveillance tools to faster detect potential safety problems that may otherwise go unnoticed for a long time. As improvements to the system Dr. Kao describes the establishment of the FDA sentinel network under the FDA Amendment Act and suggests new methods to improve patient reporting of adverse events.

However, complementary to the US initiatives there are important initiatives in Europe as well, which were not reported. The EU-ADR project of the European Commission 7th Framework Programme (previously known as ALERT which started in 2008 and will end in 2011) brings various important innovations to the current postmarketing surveillance system, which are necessary to quickly detect safety issues while avoiding biases from the spontaneous reporting systems (

Published 26 February 2009

The law lags behind the science
Andre R Menache, CEO
Antidote Europe Perpignan 66000France

At present, there is a legal requirement to submit animal data as proof of safety and efficacy of human medicines, but only a voluntary requirement to submit human data. For example, Annex I, part 3 of Directive 2001/83/EC on the community code relating to medicinal products for human use makes it a legal requirement for manufacturers to provide animal toxicity data. The submission of human toxicity data obtained from exposure of human cell lines to candidate prescription drugs is currently only a voluntary requirement. With the recognition of personalised medicine, surely the time has now come to make the submission of pre-clinical human data to the regulatory authorities a compulsory requirement.

Competing interests: None declared
Submit rapid response
Published 18 January 2009

Marketing is Harmful
David Egilman, Clinical Associate Prof. Brown University

The author states, “These techniques enable drug companies to reach more potential customers faster than ever before. In most cases, this is not harmful and can benefit many patients in need of new treatment options. Nevertheless, improved infrastructure for postmarketing surveillance will be crucial to minimise risk to users of these new products.”

This assertion that this marketing is “not-harmful” is not cited and not defined. Even worse the author asserts that this marketing "can benefit many patients." This is also un-cited and contradicts many FDA citations, DOJ criminal prosecutions, pharma industry guilty pleadings etc. These are well documented in any number of recent articles including those the author cites. (Krumholtz et al.) If "harmful" included illegal or non-transparent marketing then there is evidence to the contrary. The quote above will now be accepted as fact & authority - this is regrettable. For example: In August 2008 the FDA issued its first citation for misleading banner advertising. [Sangeeta Vaswani 2008] In a letter to Novartis the FDA said:

“Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The banners present various efficacy claims for Diovan, but fail to communicate any risk information. For example, the banners present the following efficacy claims for Diovan...[1]


Competing interests: Has consulted at the request of patients injured by drugs and devices.
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Published 5 January 2009

Drug Marketing Efficiency
Manthan D Janodia, Lecturer, D.Sreedhar, V.S.Ligade, N.Udupa
Manipal College of Pharmaceutical Sciences,Manipal University, Manipal 576104, India

The author has rightly identified the problems with drug safety during initial phase of its marketing as many of its side effects, adverse events or adverse effects come to the fore only when it is used by large number of patients. Moreover, the drugs that undergo priority review are not adjudged for their safety, efficacy and toxicity profiles as the USFDA staff has paucity of time to approve or reject the approval for marketing a drug. This poses a serious threat to the health of people.

Monitoring of adverse effects by healthcare professionals is very important and reporting of the adverse effects or side effects, when used by larger number of patient, need to be effectively implemented. What is surprising is, according to author, that despite the time reduced for approval of drugs, the number of drugs withdrawn from the market is not reduced. This may be attributed to the fact that adverse event reporting is voluntary and may involve bias on the part of healthcare professional by concealing the adverse event with use of drug.

What is required is a concrete approach with respect to adverse event monitoring and reporting. Healthcare professionals should be educated to identify and report and adverse effect. Further, a central point for reporting an adverse event would reduce the confusion associated with regard to reporting and adverse event.

BMJ 2008;337:a2591

Competing interests: None declared

Firstly (and in line with the FDA initiative) EU-ADR will federate clinical records and claims databases of at least 30 million Europeans in Denmark, Italy, the Netherlands, and the UK.

Secondly EU-ADR will directly use the clinical information and drug prescription in health care records to discover new drug safety signals, the information in the databases will be used to provide information on drug utilization, incidence of selected events and on drug-event associations.

Thirdly and at difference with the US initiatives, to substantiate signals, a number of novel methods are used in EU-ADR: causal reasoning based on Bradford-Hill criteria, semantic mining of the biomedical literature, and computational analysis of biological and chemical information (drugs, targets, anti-targets, pathways etc.). Signal substantiation should reduce false positive signals which would otherwise overflow the system. The integrated combination healthcare and biomedical knowledge should result in an automated system that can be used by various stakeholders. The ultimate aim of EU-ADR is to develop an innovative approach to the early detection of drug safety signals. We believe this system could be one of the multi-faceted innovations that Dr. Kao is asking for. The near future will show whether they indeed effective in quickly identifying new safety issues.

Competing interests: The work presented in this paper is funded by the Information and Communication Technologies (ICT) Area of the European Commission under the VII Framework Programme (Grant agreement number 215847).
All eyes are opened, or opening, to the rights of man. The general spread of the light of science has already laid open to every view the palpable truth, that the mass of mankind has not been born with saddles on their backs, nor a favored few booted and spurred, ready to ride them legitimately

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« Reply #10 on: January 15, 2011, 09:14:04 am »
They needed the deathcare bill to hold them harmless from illegal shit they were already doing...

News Release
Thursday, May 22, 2008

New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care

HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Secretary Leavitt said. “We are moving from reactive dependence on voluntary reporting of safety concerns -- to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.”

In a white paper released by the FDA today, the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events. That Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.

A CMS final regulation published today will make it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program (Part D) -- subject to protections for beneficiary privacy and commercially sensitive data -- for public health and safety research, quality initiatives, care coordination and other research and analysis.

The Sentinel System is an important example of how electronic health records and other electronic health information, such as the Medicare data, can help move the nation toward a system that delivers safer and better quality health care. President Bush has set the goal of most Americans having access to an interoperable electronic health record by 2014.

FDA’s Proposed Sentinel System Will Strengthen Safety Monitoring of Drugs and Other Medical Products

The new FDA white paper, titled “The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety,” describes the proposed Sentinel System and calls for a public-private collaboration to develop and implement it. The report is available at: The system would enable FDA to analyze significantly more information than it can today by tapping into vast databases of health information to detect early signs of emerging safety problems.

“With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people,” said FDA Commissioner Andrew C. von Eschenbach, M.D. “The era of ‘wait and see’ is going to become the era of ‘tell me right now.’ By harnessing the world’s most powerful information technologies, and by partnering with CMS, the VA and DoD, and an array of private health care organizations, we will have the ability to monitor a product’s performance in millions of patients in real time. The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface.”

Creating an active surveillance system such as the Sentinel System was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. The recently passed Food and Drug Administration Amendments Act of 2007 (FDAAA) includes provisions that call for the development of such a system. As planned, the Sentinel System will fulfill some requirements of FDAAA while also meeting additional FDA needs.

Access to CMS Data Will Facilitate Public Health and Safety Research and Quality Initiatives

“We look forward to working with the FDA on the Sentinel Initiative,” said CMS Acting Administrator Kerry Weems. “There’s a clear nexus between the data collected through Medicare’s prescription drug program and the FDA’s role in protecting the public from adverse events. The public health and safety benefits from this cooperative venture with the FDA will be substantial.”

Weems noted that CMS’s most recent survey of beneficiaries indicates that people with Medicare use more than twice as many medications in a year as do other Americans. Medicare beneficiaries use an average of 28 prescriptions in a year, while those who consider themselves in poor health have about 45 prescriptions in a year (source: Medicare current beneficiary survey, 2004). In contrast, other Americans use about 13 prescriptions a year, according to a 2007 study by the Agency for Healthcare Research and Quality ( Medicare beneficiaries’ high usage of medications, coupled with numerous chronic health conditions, puts this population segment at higher risk of adverse drug events than other Americans and makes them the group most likely to see benefits from the FDA’s new Sentinel Initiative.

The Medicare Prescription Drug Benefit data, linked to Medicare inpatient and outpatient claims data, will allow the creation of a highly robust HHS database as the prototype for the Sentinel System. Publication of the Medicare Part D Claims Data Rule enables the FDA to use Part D claims data as the FDA explores drug safety questions related to particular products. Medicare’s Part D prescription drug program, implemented in January 2006, has generated claims data on medications used by the more than 25 million beneficiaries with prescription drug coverage under the benefit. Linking these data on prescription drug use to other Medicare claims information, including diagnoses, medical treatments, hospitalizations, and physician services, will provide the FDA, other agencies, and researchers with a powerful new tool to investigate potential drug safety problems and questions about health outcomes. With approximately 1 billion claims per year, the Medicare Part D database is unprecedented in size and scope and will be a valuable resource for patient safety analyses that will benefit not only Medicare beneficiaries but the entire nation.

Publication of the final rule today will enable CMS to use Medicare Part D claims data for research, program oversight and evaluation, care coordination, quality improvement, and performance measurement initiatives. In compliance with beneficiary privacy protections, as required by the Federal Privacy Act and HIPAA regulations, and while protecting commercially sensitive data, Medicare drug claims will be linked to other Medicare information on patient care, such as hospitalizations and physician visits, and made available to other federal agencies, state Medicaid programs, researchers, and beneficiaries for their personal health records.

CMS will be developing guidelines and workshops to inform researchers on how they can request these data.

The CMS final rule and a related fact sheet may be viewed at
All eyes are opened, or opening, to the rights of man. The general spread of the light of science has already laid open to every view the palpable truth, that the mass of mankind has not been born with saddles on their backs, nor a favored few booted and spurred, ready to ride them legitimately