The Center for Medicare and Medicaid Services' Quiet Coziness with Wall Street

Here is the introduction and the example most relevant to health care:

Nearly a dozen senior staff at the Centers for Medicare and Medicaid Services (CMS), the giant agency that administers hundreds of billions in federal health care dollars, had been called to a meeting. After a discussion with five Wall Street professionals that lasted nearly two hours, one senior CMS analyst filed an ethics complaint that later went to the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS).

His beef: that a handful of deep-pocketed investors had won a private hearing to probe whether the agency would allow Medicare reimbursement for specific medical devices manufactured by companies in which they already held a stake or might put new money. The market for one device, already approved for Medicare, was rapidly heading toward $1 billion annually; the agency’s impending decision to reimburse competing devices could have major market impact, a shift potentially worth hundreds of millions of dollars.

'This meeting forced agency staff to redirect their attention toward a select group from Wall Street, when neither competing investors nor patient-oriented stakeholders were present,' the whistleblower told the Project On Government Oversight (POGO). 'They got to probe us for hours in private about what we planned to do and how we approached procedures for reimbursing medical devices, the mechanics and psychology of CMS decision-making, in general and with respect to these specific devices.'

The meeting was set up by a former CMS employee working for the Marwood Group, an asset manager that counsels big health-care industry investors, the whistleblower says. The firm’s president is Edward 'Ted' Kennedy Jr., son of the late Massachusetts senator and a major supporter of President Obama’s health care reforms, and includes Kennedy cousins Robert F. Kennedy, Jr. and Stephen E. Smith, Jr., as senior advisors. The firm’s website highlights its staff recruitment among Congressional aides, the Executive Office of the President and CMS. One CMS veteran who joined Marwood after the 2009 meeting with Wall Streeters is Barry Straub, the agency's former Chief Medical Officer, who is also an expert on Medicare reimbursement, the website says. A company spokesman had no comment.

A supervisor at CMS’s Coverage Advisory Group, which decides which services the agency will pay for, also helped organize the session with investors. The whistleblower says he was told by a supervisor that such get-togethers are 'a routine practice at CMS.' At the time, in 2009, CMS’s top administrator had an aide with the title, 'capital markets advisor,' tasked with tracking investment community activity in Washington and elsewhere.

At the investor meeting, Wall Streeters asked a range of questions 'about confidential CMS information.' The whistle blower says he does not believe they received illegal disclosures, though they peppered CMS analysts with queries about the agency’s decision-making process and other sensitive matters which, if answered, could have violated the law or related regulations that bar the sharing of internal deliberations and decisions.

The whistleblower first filed his complaint in April 2009. He was terminated in 2011 for being disloyal to the agency mission after he made a series of internal protests, including the objection to what he calls a pattern and practice of unfettered access to CMS staff by Wall Street investors. He says he is currently fighting his dismissal through all available legal and administrative channels.

Implications and Summary

As the POGO article put it,

CMS does have a set of 'Open Door' policies and affords a variety of avenues for public access. The disclosure of payments to physicians and teaching hospitals by pharmaceutical companies and other interests are required under President Obama’s health reform. In practice, however, the public, not to mention competing investors and stakeholders, rarely get the kind of information and insight available in meetings like the whistleblower described.

In general,

A balance is necessary between the danger of too much insider access, and imposing excessive limitations. Indeed, the biggest problem with special access for Wall Street insiders is not just that they seem to get meetings and acquire information that may be privileged and non-public, but that others, including other investors, do not get a crack at the same material.

The activities above have all the usual elements of excess corporate - government coziness.  These include enhanced access for corporate leaders beyond what any ordinary members of the public might achieve; the revolving door between government service and corporate leadership; the participation of well-connected inside the beltway types, etc, etc. 

It also includes the apparent formalization of representation of corporate interests, e.g., the "Capital Markets Advisor," with no parallel formalization of the public's or patients' interests.  Even more worrisome is that an effort to make this all less anechoic resulted in alleged intimidation of a whistle-blower.

So, let's see, CMS, the Center for Medicare and Medicaid Services, the US Department of Health and Human Services (DHHS) branch which controls the Medicare and Medicaid programs, the government run single-payer programs for the elderly, the disabled, and the poor, does not seem to be able to afford to figure out in-house how to pay physicians for specific services.  Instead, it has effectively farmed out this task to a private committee, the American Medical Association's RBRVS Update Committee (RUC).  As we have discussed many times, this obscure and secretive committee likely had a major role in structuring the financial incentives that favor procedures and disfavor primary care. leading to excess costs, declining access, and degrading quality.  However, CMS can afford to have a "Capital Markets Adviser" and to use up staff time briefing wealthy investors and hedge fund types.  What is wrong with this picture?

In my humble opinion, government health care agencies ought to put the public's and patient's health first. They should not give special consideration to the rich, the powerful, the well-connected, whom some now call the one percent. Yet in the US we seem to have an increasingly corporatist state in which government and the plutocrats work together for their mutual interests, regulatory capture writ large.

We need to restore government, and our health care agencies to being of the people, by the people, and for the people.  Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders.

Large, Vertically Integrated Health Care Systems (Redux)

Amid enormous pressure to cut costs, improve care and prepare for changes tied to the federal health-care overhaul, major players in the industry are staking out new ground, often blurring the lines between businesses that have traditionally been separate.

Hospitals are bulking up into huge systems, merging with one another and building extensive new doctor work forces. They are exploring insurance-like setups, including direct approaches to employers that cut out the health-plan middleman.

On the other side, insurers are buying health-care providers, or seeking to work with them on new cooperative deals and payment models that share the risks of health coverage. And employers are starting to take a far more active role in their workers' care.
This ongoing consolidation is being discussed as inevitable.

'We're seeing a marketplace reacting to an economic imperative,' says Michael O. Leavitt, a former U.S. Secretary of Health and Human Services who is now chairman of a health-information company. 'The new delivery models are far more integrated.'

The ongoing consolidation is also being proclaimed as leading to a brave new world of health care. For example,

Jim Taylor, the chief executive of the University of Louisville Hospital, says his institution's future depends on an ambitious statewide merger with two other hospital systems. Now, he has to persuade others that he's right.

These mergers often are meant to lead to the creation of large, vertically integrated health systems which may include hospitals, physicians and other health professionals (sometimes as hired help), and an insurance function.

It's All Been Done Before

"Large, vertically-integrated health care systems," of course, were all the rage in the 1990s.  In fact, the WSJ also published a companion article by Anna Wilde Mathews that suggested "it has all been done before," it did not necessarily work then, and therefore, it may not work now.

One example used in the latter article :

Perhaps the most dramatic flameout was the Allegheny Health, Education, and Research Foundation. Starting in the mid-1980s, it was built from a Pittsburgh hospital into a statewide system through hospital and doctor-practice acquisitions. In 1998, AHERF, as it was called, became the U.S.'s largest health-care nonprofit bankruptcy. Its debts became unsustainable after it piled on too many money-losing assets, failed to manage the new primary-care physicians successfully, and lost money on capitated business, according to an account published in Health Affairs in 2000.

The hospitals' moves in the 1990s 'did not improve quality, they did not reduce costs. In fact they increased everyone's spending,' partly because some hospitals eventually used their bulked-up leverage to push for higher rates, says Lawton Robert Burns, a Wharton School professor and the AHERF history's lead author. 'Nobody's showed me we're going to do it a whole lot better this time....To expect that with one piece of legislation, everyone's going to sit around the campfire and sing kumbaya, forget about it.'

However, the Mathews article showed that even people who ought to have been familiar with this case seemed to think that this time things would be different. For example, it included this quote from the CEO of Humana which had problems with the integrated model in the 1990s:

'It's not like we don't understand what we are getting back into here,' said Michael B. McCallister, Humana's CEO, at an investor conference. 'But things have changed.'

Maybe so, but maybe if the enthusiasts of the resurrected vertically integrated health system model realized how badly things went in the past they would not be so optimistic.

A More Complete Version of the AHERF Story

In fact, Professor Burns' take on the AHERF bankruptcy above did not seem to reflect all that went on then. A somewhat more pointed summary of that massive failure had appeared in 2008. Then, Moody's Investor Service issued a report on the 10 year anniversary of the fall of the house of AHERF. Per an article again by Steve Twedt in the Pittsburgh Post-Gazette, who also wrote a significant series in the same newspaper summarizing the collapse of AHERF,

From the distance of 10 years, the historic bankruptcy of Allegheny General Hospital's then-parent organization still offers valuable lessons for today's health-care industry, says a new report by Moody's Investor Service.

'AHERF left such a stain, such an indelible mark on hospital management teams, they realized that if one of the big systems can fail, no one is immune,' said Lisa Goldstein, leader of the Moody's health-care team that produced the report.

On July 21, 1998, Allegheny Health and Education Research Foundation (AHERF) defaulted, resulting in what is still the largest bankruptcy ever among the 560 Moody's-rated not-for-profit health-care entities. At the time, AHERF had $2 billion in revenue and $555 million in outstanding debt, according to the Moody's report.

Analyst Lisa Martin, who wrote the report, says industrywide forces converged with 'the organization's own management and governance failures' to cause the foundation's failure.

The external forces included Medicare reimbursement cuts -- still an issue a decade later -- and highly competitive markets in both Pittsburgh and Philadelphia.

But, she added, 'we believe its ultimate downfall was driven more by decisions of the organization itself -- weak governance, poorly executed strategies, lack of refined leadership, and absence of methodical execution.'

Even that version seems too polite.

Although the AHERF bankruptcy appears to be the largest failure of a not-for-profit health care corporation in US history, its story has produced remarkably few echoes for doctors, other health care professionals, health care researchers, and health policy makers. I often use the fall of AHERF as major example in talks, at least the few talks I am allowed to give on such unpleasant subjects. Rarely have more than a few people in the audience heard of AHERF prior to my discussion of it. The only scholarly article I could locate on the topic that discussed the case in any detail, albeit incompletely since it was written before Abdelhak's guilty plea, was written by Professor Burns, who was quoted above, and colleagues [Burns LR, Cacciamani J, Clement J, Aquino W. The fall of the house of AHERF: the Allegheny bankruptcy. Health Aff (Millwood) 2000; 19: 7-41.] I doubt the case is used for teaching in most medical or public health schools. The lack of discussion of such a significant case is a prime example of the anechoic effect.

Therefore, let me repeat my 2008 summary of some of important points about AHERF not found above (see also this more detailed narrative, starting on page 5):

• AHERF, one of the largest health care systems of its day, was built by the poster-boy for health care  CEOs at the time, Sherif Abdelhak.
• Abdelhak, who started as food services purchasing manager at Allegeheny General Hospital, was repeatedly hailed as a "visionary" (in the March, 1997, ACP Observer) a "genius," and the like. His plans to create a huge integrated health care system were part of the wave of the future. Abdelhak was even invited to give the prestigious John D Cooper lecture at the annual meeting of the American Association of Medical Colleges (AAMC), which was published in Academic Medicine [Abdelhak SS. How one academic health center is successfully facing the future. Acad Med 1996; 71: 329-336.] He proclaimed then that "we will need to create new forms of organization that are more flexible, more adaptive, and more agile than ever before." And he announced that "my aim as chief executive has been to unleash the creativity and productive potential of every individual and to provide an environment that encourages teamwork"
• While Abdelhak was making these grandiose promises, he paid himself and his associates very well. For example, he received $1.2 million in the mid-1990s, more than three times the average then for a hospital system CEO. He lived in a hospital supplied mansion worth almost $900,000 in 1989. Five of AHERF's top executives were in the top 10 best paid hospital executives in Philadelphia.
• Although Abdelhak talked of teamwork, he warned the combined faculty of the new Allegheny University of the Health Sciences (AUHS): "Don’t cross me or you will live to regret it."
• As AHERF was hemorrhaging money, Abdelhak continued to pay himself and his cronies lavishly.
• After the AHERF bankruptcy, which was at the time the second largest bankruptcy recorded in the US, Abdelhak was charged with numerous felonies involving receiving charitable assets. In a plea bargain, he pleaded no contest to misusing charitable funds, a misdemeanor, and was sentenced to more than 11 months in county prison.

The Moral of the Story

The story of AHERF was not merely that of an unlucky bankruptcy. It shows what can go wrong when health care adopts business practices such as jumping on the latest management band-wagons and genuflecting before imperial CEOs.

Yet since the fall of AHERF, we are still hearing breathless stories about the latest wonderful plans to save health care (think about, for example, electronic medical records, pay for performance schemes, etc), and the the need to genuflect to brilliant CEOs who may turn out to be not so brilliant (think about, for example, Dr William McGuire, the former CEO of UnitedHealth, and his back-dated stock options).

We health care professionals need to stop falling for this hype and spin. Saving health care will take clear thinking and hard work by a lot of people. The "visionaries," if we let them, are likely to depart with a huge cache of money, leaving us and health care worse off. If it is just "not done" to talk about cases such as that of AHERF, and other examples of "recent unpleasantness," how will be learn not to fall for the propaganda?

Of course, it is those who benefit from the propaganda who do not want us catching on to their game.

If physicians, health professionals, health care researchers, and health policy makers do not learn the lessons of the fall of AHERF, they will be doomed to see its repetitions.

Some time ago, I'd written an eight part (later expanded to nine part) series on health IT mission hostile user interfaces and experiences

I am writing to report a problem in the design of the cerner powerchart computer provider order entry (cpoe) product. As i will describe below, these design flaws are largely responsible for approximately 100 medication errors per day in our 240 bed hosp. The (b)(6) hosp in (b)(6) is a 240 bed teaching hosp. We are owned by the (b)(6). We have to be one of the only hospitals in the country to fully implement cpoe with two entirely different electronic medical records (emr).

In 2007, we completed a comprehensive cpoe implementation using idx 3. 1 (which was later purchased by general electric). Our self-reported medication error rate was <2 error reports per day. In (b)(6) of 2010, we transitioned our emr to cerner millennium - powerchart (b)(4). This implementation was done as a first step to converge onto a single electronic medical record across the (b)(6) enterprise.

Despite extensive nursing informatics support (approx. 7000 hrs per month for the first six months after implementation), our error rate went from approx. 176 medication errors per day one month after implementation to approx. 100 medication errors per day currently. It has been stable at this level for at least the past 3 months. Many of these errors involve high risk medications (e. G. Heparin, morphine). In order to understand the etiology of the errors, i need to explain how cerner processes cpoe orders.

With cerner, orders are grouped into plans ("powerplans"). These plans can include sub-plans ("phases") and sub-sub-plans ("sub phases"). A typical orders display screen appears as follows: (b)(4). Under the plans is an order tab which displays other orders.

This design allows two distinct sources of error.

First, there is no consistent way to view orders for medications. A medication order can display either in a plan, sub-plan, or under the orders tab. In order to find a given medication, cerner mandates that you click through each and every plan. This facilitates duplication of both medication and non-medication orders (there is a medication checker which is so poorly designed and does little to aid the pharmacists in detecting duplicate medications).

Second and more dangerous, high risk intravenous medications can be run either inside or outside of the plan. Cerner programming [i.e., the user interface design -ed.] does not keep high risk medications in a consistent spot. It is very easy to stop monitoring for heparin (which is included in the heparin plan) while continuing the heparin (which is outside the plan) or vice-versa.

As you can probably guess, we formed multiple interdisciplinary teams to address these deficiencies. [Workarounds - ed.]

I was the lead physician on the orders team. Although we were unable to reduce the error rate, it is not close to an acceptable level. Again, i believe this is because of the design of the cerner product which is why i chose to bring this to your attention. With issues this complex, i am a firm believer that "seeing is believing. " if desired, i would be happy to arrange a web conference to demonstrate my concerns.

Brand Name CERNER POWERCHART COMPUTER
Type of Device NONE
Manufacturer (Section F) CERNER
Manufacturer (Section D) CERNER
Device Event Key 2081342
MDR Report Key 2045867
Event Key 1942844
Report NumberMW5020161
Device Sequence Number 1
Product Code LNX
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 04/03/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?
Page Last Updated: 11/30/2011

I will let the FDA report speak for itself, with only one question:

When will the designers, developers, purchasers and implementers of medical devices like this start to be held criminally liable for patient injuries that occur from the risk these devices pose to patient safety?

criminal negligence - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences)

It's not as if the issues related to good user interface design are a mystery, nor have those issues been a mystery for at least a few decades.

An EHR design as described, if accurate, while perhaps "nifty" in some way from the computer-techie perspective, would require significant recklessness to design and to actually implement in a life-critical setting.

Those who try to point out these issues internally are sometimes subject to retaliation (for not being a "team player", of course, which in today's parlance means someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness). An example is here. We at Healthcare Renewal simply refuse membership on that team.

(Did I mention this deterministic miracle-making technology is slated via the HITECH Act for rollout in the U.S., unless the medical professional or organization is willing to accept progressive cuts to their Medicare reimbursement?)

Problems with New Sweetener

A reader comments on Erythritol as not causing her any problems as noted in our researcher's report. Just like all substances, the ingestion of a substance needs to be in the right form, the right amount, et al, and the effect and outcomes are individual. Please realize that our researcher is a former FDA investigator who has an indepth background in the sciences necessary to make such statements. Please note that the artificial sweeteners referred to, Truvia (Cargill) and PureVia(Whole Earth Sweeteners) are manufactured by these agribusness corporations with an extract of stevia (rebiana)and erythritol and are NOT whole leaf stevia or pure(whole leaf)stevia extract.

UPDATE 2, 22 December 08: Please note that contrary to other reports you may be reading, the FDA DID NOT APPROVE STEVIA. The FDA, in cahoots with Cargill and Coke, approved a synthesized product - as reported originally in this article - manufactured with rebiana (an extract from Stevia) and erythritol (a sugar alcohol).

As Dr. Evangelista states (quoted below): "DO NOT CONFUSE REBIANA (TRUVIA) WITH STEVIA"

Zerose is the Cargill synthesized artificial sweetener made from stevia and erythritol. Zsweet is a similar product in UK and EU. There are numerous scientific studies presenting that this, and related products such as Truvia, may lead to calcium, potassium and phosphate loss with calcification (and lesions) in the kidneys (just like Splenda) and bowel alterations. Please read more.

As to Zevia soda, it seems to me to be quite irresponsible on the part of the company CEO (an attorney)to make the following quote, "Why not supplement a steady breast milk diet with some refreshing ZEVIA?" This quote is associated with a photo of an infant being fed soda by the mother on the company blog. I would suggest the mother is irresponsible as well. While the company web site does not state that Zerose is the sweetener used in their products it does mention that eryrithritol is an ingredient.

I am sure this fellow was not in my 'Social Responsibility of Business' class in grad school.

We suggest Just Like Sugar, unaltered Stevia (order the extract via the Starwest link on this page) and Agave.

We do not endorse the use aspartame or sucralose or any forms of these chemicals, first developed as inseticides, or any products containing them, as they are known toxins to human health, nor do we endorse the use of acesulfame K.

The news this morning on NPR seems to be focused on helping you be in the spin on 'rebiana'(Truvia) and how it is "just stevia".

Coke (using Truvia) and Pepsi (using PureVia) are marketing this new artificial sweetener in their beverages but apparently aren't open to presenting both sides of the story.

Even the one TV ad I saw recently for "Truvia" would lead you to believe that this is a safe and natural additive.

Zevia(a soda), because it contains erythritol, may also have similar problems.

The problem is that is may come from natural sources but it is an extracted and modified chemical when it comes out the other end.

DO NOT CONFUSE REBIANA (TRUVIA) WITH STEVIA

Do not confuse this with pure stevia, it is a combination of chemicals with a dab of the stevia plant. Stevia itself is a sweetener and yet they are using Erythritol which is a sugar alcohol known to cause such things as bloating, diarrhea and cramps. That tells you they are not using much stevia. Nor are they removing the poisonous aspartame from Diet Coke and Diet Pepsi. They are simply trying to satisfy a part of the population that knows how deadly aspartame is and wants to use something else.

Notice this sentence: "Stevia was not approved as a food additive by U.S. regulators, but the U.S. Food and Drug Administration issued letters to the companies on Wednesday saying it had no objections to their sweeteners, which are derived from the plant." The FDA has made themselves clear. Industry can do anything they please but they have no intention of approving something safe for the general public. They don't want to displease the aspartame industry who is powerful and takes care of those who defend their poison. Make sure you understand this is a combination of sweeteners and chemicals and not real stevia. The pop companies feel "a dab will do you, so just buy our product regardless of how its made". The public again will be the guinea pigs and lab rats. Also, see the admission that Pepsi's Purevia is being developed with Merisant, an aspartame manufacturer. Nobody should use these products until they are analyzed. Industry is constantly adding small amounts of aspartame because its addictive. If they do this to these products aspartame victims will react because aspartame is so poisonous it causes chemical hypersensitization.

Transvaginal Mesh and Women’s Health

C.R. Bard (NYSE:BCR) may have beaten The Street with its third-quarter results, but Wall Street investors are beating it back today, sending shares down nearly 4 percent.

The medical device maker reported its Q3 earnings and its $250 million acquisition of Medivance after the market closed yesterday. Bard posted profits of $130.1 million, or $1.46 per diluted share, on sales of $719.2 million for the three months ended Sept. 30.

That's 2.0 percent more profit and 6.0 percent more revenues than during the same period last year, when Murray Hill, N.J.-based Bard reported profits of $127.5 million, or $1.34 diluted EPS, on sales of $678.4 million.

Boston Scientific and other transvaginal mesh makers defend their devices amid FDA probe

Boston Scientific urges the FDA to maintain a class II device status on transvaginal mesh amid calls from public advocates for product recalls and FDA warnings that the devices may do more harm than good.

Johnson & Johnson vaginal mesh lawsuits another blow to the FDA's device review process

October 20, 2011 by Arezu Sarvestani

With high profile recalls in hip implants and defibrillators in the recent past, the FDA's medical device review process takes another hit it doesn't need as health care giant Johnson & Johnson weathers a storm of transvaginal mesh complaints.

FDA's medical device review process is again under scrutiny as lawsuits pile up against health care leviathan Johnson & Johnson (NYSE:JNJ) for transvaginal mesh devices that may do more harm than good.

Lawsuits claiming negligence against mesh-makers have also implicated the FDA's review system for continuing to clear new mesh products under the 510(k) system, despite the predicate device being pulled from U.S. shelves.

Boston Scientific Corp.'s (NYSE:BSX) ProteGen mesh, cleared in 1996 and pulled from the shelves a year later, was used as a predicate device for clearing subsequent mesh products, despite more than 120 adverse event reports on the original design at the time, Bloomberg reported.

Several years ago I was commissioned by a consumer injury law firm to write a series of articles. One of those articles, http://naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html addressed issues with the transvaginal mesh device. This article is also found on our other websites, simply4health.org and leaflady.org.

In the past several months I have noticed an increasing number of TV ads for this device from consumer injury law firms. I have also noticed a viral spread of this article which has booted the reader ship of my blog, Natural Health News, by thousands of readers daily.

This tells me that many women must be very interested in this topic, either because they have had this surgery and are facing problems, or they have been advised to have this operation.

Alternatives to the surgery are available options. I hope to educate you about an important one that can do a great deal to prevent and correct this condition.

Should you wish a copy of this new article please email us and request it.

Please consider a donation to help us continue this important work.

As originally written in 2009, in cooperation with Eric Chaffin, this article has created an internet storm -

Thinking About PSA and the Latest News

I live where it is a good 90 minute drive to any city of real size. When I moved to this area almost ten years ago I was trying to teach the communities about the fact that the PSA test was ineffective. Of course the closed minds so common in small towns ruled and no one would even try to listen. Now we know that even the medical profession has decided that PSA can be a real issue leading to over treatment to many who do not even need it.

One forward thinking doctor told me years ago that the acid fast bacteria lab test was much more effective in screening for real cancer cases in men when it came to prostate care.

Like the story my long time colleague tells below, I lost a friend to this dis-ease because of a doctor who always said he would use natural care but it took too much time to tell his patients.

What cost health?

PSA test DOA

by David Christopher, M.H.

You have probably read the news about prostate screening for cancer, which appeared on the front page of many newspapers across the country. On Thursday October 13, 2011 an Associated Press article by Marilynn Marchione basically blasted PSA tests. It related that this test is only a measure of inflammation which can be elevated for many reasons including bike riding, recent sex, or normal enlargement of the prostate due to age. She also debunks the claims that the screening saves lives. She makes these claims by drawing from a very large, well done American study, that\ showed that annual screening did not lower the chances of dying from prostate cancer. Many men believe the screening saved their lives because their urologist erroneously told them it did. These men and urologists become very vocal in promoting prostate cancer screening.

Less visible are the unfortunate men who test high for PSA and are then subjected to invasive testing that can harm or spread cancer. One such case as reported in the article is, "... Donald Weaver who was a healthy 74 year old Kansas farmer until doctors went looking for prostate cancer. A PSA test led to a biopsy and surgery, then a heart attack, organ failure and a coma. His grief stricken wife took him off life support. 'He died of unnecessary preventive medicine,' said his nephew, Dr. Jay Siwek, vice chairman of family medicine at Georgetown University. Blood tests can kill you ..."

The United States Preventive Task Force does not recommend the use of this test, and doctors have been warned by the AMA to leave slow-growing prostate cancer alone; that interference may spread the cancer.

What should we do to prevent prostate cancer? Well first, grow up and eat like an adult. Stop eating those sugary breakfast cereals. Stop drinking milk, it contains hormones that stimulate growth of prostate tissue. The hormones found in meat can also negatively effect prostate health. Do eat plenty of fresh fruits and vegetables, sprouted grains and legumes, and include nuts and seeds in your diet. This program is preventive for not just prostate cancer, but all cancers. If prevention is too late, then do the extended herbal cleanse as explained in the Dr. Christopher Three Day Cleanse booklet.

Next eat the seeds highest in cancer preventing nitrilosides; which are apricot seeds. They are extremely bitter, but buck up and eat six seeds a day to start and work up to as many as 30 per day. These simple seeds are natures' chemo therapy.

Cyanide and benzaldehyde are the chemicals in the seed that destroy cancer cells. These two chemicals are bound to two glucose molecules and are inert until activated at the actual cancer site. This is accomplished enzymatically. The chemicals are released with beta-glucosidase which is found at cancer sites. Healthy cells are surrounded by the enzyme rhodanese, which in the presence of sulfur, converts the cyanide into thiocyanate, which then converts to cyanocobalamin (vitamin B12). The Benzaldehyde, in the presence of oxygen is converted to benzoic acid, an analgesic.

In conclusion, I ask "Why would anyone want to go through risky medical procedures to look for possible prostate cancer, when nature provides a safe and natural chemotherapy, specific to cancer cells and at the same time is nutritive to healthy cells?"

NOTICE: All information in this newsletter is given out as information only and is not intended to diagnose or prescribe. For our official Disclaimer, Biological Individuality, Important Notice-Terms of Use please see: http://www.herballegacy.com/Disclaimer.html

Statins appear to harm about as many people as they help

When I was at medical school I remember being lectured on the wonders of hormone replacement therapy (HRT). I was distinctly taught, and without reservation, that women taking HRT had a lower risk of heart disease compared to women ‘going without’. This ‘fact’ turned out to be complete rubbish. Subsequent evidence revealed that HRT actually has the capacity to increase risk of heart disease.

How could we have got it so wrong?

The initial ‘evidence’ on HRT was epidemiological in nature, which meant that it looked at the relationship between HRT/non-HRT use in a population and risk of cardiovascular disease. One fundamental potential problem with these studies relates to what is known as the ‘healthy user’ effect. In short, what this means is that healthier individuals are more likely to be prescribed a drug than sicker people who may already be on multiple medications and prone to side-effects and interactions. So, any ‘benefit’ seen to be associated with a drug may have nothing to do with the drug, and everything to do with the fact that people taking it are inherently healthier.

To untangle all of this, what we need is randomised controlled trials. These trials give essentially equivalent groups the treatment or placebo to assess any potential benefits or harms of the treatment. It’s when these studies were done that we realised that HRT actually increased the risk of heart disease.

The healthy-user effect, though, has not gone away, and is still alive and well in medical research. Here’s another apparent example that concerns cholesterol-reducing drugs known as statins…

In the past, statins have said to help prevent pneumonia (infection in the lung) on the basis of epidemiological studies. However, it is generally the case that frail, elderly individuals, with perhaps complicated health histories are less likely to be prescribed or take statins than healthier individuals. Because of this, when we see lower incidence of infection in those taking statins, we have no idea if it’s the statins, or the fact that these people are generally healthier, or both, that accounts for the reduced infection risk.

One way to get clarity here is to attempt to take into account health status of individuals when performing this sort of analysis. That’s exactly what a team of doctors based in the US did when analysing the relationship between statin use and risk of pneumonia in a study published in 2009 [1]. This more careful analysis revealed that statin use was actually associated with a 26 per cent increased risk of pneumonia. For pneumonia severe enough to require hospitalisation, statin use was associated with a 61 per cent increased risk.

Now, we should not forget that these studies are epidemiological in nature, and cannot be used to prove that statins cause enhanced susceptibility to pneumonia. However, the evidence as it stands is incriminating nonetheless. Further suspicion is raised in the form of evidence which shows that statins have the ability to directly impair the immune system and its ability to resist bacteria [2].

The most comprehensive account of statin side-effects I can find was published last year in the British Medical Journal [3]. Known side-effects of statins include muscle weakness and/or pain (myopathy), liver damage , kidney failure and cataracts. Here, in summary, are the findings of this review:

For every 10,000 women at high risk of CVD [cardiovascular disease] treated with statins, we would expect approximately 271 fewer cases of cardiovascular disease, 8 fewer cases of oesophageal cancer, 23 extra patients with kidney failure, 307 extra patients with cataracts; 74 extra patients with liver dysfunction; and 39 extra patients with myopathy.

For every 10,000 men at high risk of CVD treated with statins, we would expect approximately 301 fewer cases of cardiovascular disease, 9 fewer cases of oesophageal cancer, 29 extra patients with kidney failure, 191 extra patients with cataracts; 71 extra patients with liver dysfunction; and 110 extra patients with myopathy.

This study focused specifically on data relating to individuals deemed to be at high risk of cardiovascular disease. Many individuals who take statins are actually not at high risk of cardiovascular disease. For these, benefits are likely to be significantly lower than those elucidated in this study (while risks are likely to be about the same).

But look at those figures for a moment. Two things jump out to me:

Of 10,000 high-risk individuals, only about 300 will benefit – that’s 3 per cent. That means, of course, 97 per cent will not benefit. The number of people who benefit is roughly matched by those who will get a serious adverse effect. Hands up who wants to take a statin now?

References:1. Dublin S, et al. Statin use and risk of community acquired pneumonia in older people: population based case-control study. BMJ 2009;338:b2137

2. Benati D, et al. Opposite effects of simvastatin on the bactericidal and inflammatory response of macrophages to opsonized S. aureus. J Leukoc Biol. 2010;87(3):433-42

3. Hippisley-Cox J, et al. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database BMJ 2011;340:c2197

by Dr. John Briffa