More Junque Science

The first question I have to pose is, "Who paid for this study?"

The second issue is the one that perhaps is much more important, stomach cancer.

It may be considered 'safe' to use these very mas marketed drugs if you have a concern for the health of your heart. And it may not, over longterm use. Of course no one is telling.

And what else they are not telling you, is something very important, and something we've addressed in other posts on this BLOG.

Nexium and Prilosec block what is called the P450 Cytochrome Pathway.

The P450 Cytochrome Pathway is critical to detoxification physiology that occurs in your liver.

When you use these drugs consistently your body incurs a risk of severe toxicity and the degelopment of stomach cancer, or cancers in corresponding organs such as the liver, pancreas, et al.

Now, when you have 'heartburn' one of the reasons is that you have TOO LITTLE hydrochloric acid in your stomach and you don't digest protein very well. Another is that you do not chew your food thoroughly, because, in case you did not know, digestion starts in the mouth.

It's that gulp and go process that dogs do all the time, but they are geared up for it by their physiology.

Another concern, especially if you are very, very young or over 35, is that you do not have adequate digestive enzymes to help you with proper digestion and assimilation of nutrients.

Then you could try a teaspoon of raw organic apple cider vinegar in a glass of water about 15 minutes before you eat, or a lick of celtic or Nine Times Taoist salt.

20 mg Prilosec Rx costs $360.97, active ingredients cost $0.52, profit is 69,417%.

And for your additional consideration -

Long term side effect of stomach acid blockers such as Pepcid, Tagamet, Zantac, Prilosec.
Potentially harmful acidity develops in the tissues of the body when the system's ability to eliminate the acids that are produced (metabolic waste, acid forming foods, and the system's various stress mechanisms) is reduced. The stomach is one of the primary venting mechanisms for this build up of hydrogen ions (acids are typified by an abundance of such ions) and when our stomach's acid producing mechanisms are pharmaceutically inhibited, the hydrogen ion concentrations become too abundant to be efficiently eliminated by other pathways of elimination. Consequently, the acids build up in the tissues and fluid compartments of the body, where they greatly interfere with the normal cellular functions. The overly acidic condition of the intercellular fluid compartment makes it an ideal breeding ground for harmful micro-organisms, creating an enormous burden on the immune system. This build-up can lead to fatigue, poor mental and emotional health and eventual chronic degenerative illness.

Stomach Acid Suppression and Increased Risk of Pneumonia -
The normal acidity of the stomach via hydrochloric acid production acts as a natural protective barrier against bacteria and viruses. Apparently, chronic use of acid suppressing medications increases risk for pneumonia. Normally the gastric pH is below 4, an environment that kills most pathogens. However, the dispensing of antacids can interfere with this natural barrier and lead to increased colonization of ingested pathogens.
Risk of Community-Acquired Pneumonia and Use of Gastric Acid-Suppressive Drugs. Laheij, RJF, et al. JAMA 292,16, 2004

Nutrient Depletion caused by acid blocking drugs -
Lansoprazole: 1) Omeprazole, a drug closely related to lansoprazole, taken for seven days led to a near-total loss of stomach acid in healthy people and interfered with the absorption of a single administration of 120 mg of beta-carotene.1 It is unknown whether repeated administration of beta-carotene would overcome this problem or if absorption of carotenoids from food would be impaired. Persons taking omeprazole and related acid-blocking drugs for long periods may want to have carotenoid blood levels checked, eat plenty of fruits and vegetables, and consider supplementing with carotenoids. 2) Folic acid is needed by the body to utilize vitamin B12. Antacids, including lansoprazole, inhibit folic acid absorption.2 People taking antacids are advised to supplement with folic acid. 3) Omeprazole, a drug closely related to lansoprazole, has interfered with the absorption of vitamin B12 from food (though not supplements) in some,3 4 but not all, studies.5 6 This interaction has not yet been reported with lansoprazole. However, a fall in vitamin B12 status may result from decreased stomach acid caused by acid blocking drugs, including lansoprazole.

Omeprazole: 1) Folic acid is needed by the body to utilize vitamin B12. Antacids, including omeprazole, inhibit folic acid absorption.1 People taking antacids are advised to supplement with folic acid. 2) Omeprazole interferes with the absorption of vitamin B12 from food (though not from supplements) in some2 3 4 5 but not all6 7 studies. A true deficiency state, resulting in vitamin B12-deficiency anemia, has only been reported in one case.8 The fall in vitamin B12 status may result from the decrease in stomach acid required for vitamin B12 absorption from food caused by the drug. This problem may possibly be averted by drinking acidic juices when eating foods containing vitamin B12. However, all people taking omeprazole need to either supplement with vitamin B12 or have their vitamin B12 status checked on a yearly basis. Even relatively small amounts of vitamin B12 such as 10–50 mcg per day, are likely to protect against drug induced vitamin depletion.

Our advice - ask what the risks are versus benefit before you accept a drug.

Ask what options are available, starting with sound nutrition and lifestyle changes.

FDA: Heartburn drugs seem OK for heart

9 August 2007

The popular heartburn drugs Prilosec and Nexium don't appear to spur heart problems, say preliminary U.S. and Canadian probes announced Thursday.

The Food and Drug Administration and its Canadian counterpart began reviewing the drugs, used by tens of millions of people, back in May, when manufacturer AstraZeneca provided them an early analysis of two small studies that suggested the possibility of a risk.

Those studies compared treating the chronic heartburn known as gastroesophageal reflux disease, or GERD, with either of the two drugs or with surgery, and tracked patients for five to 14 years. The company's initial analysis counted more patients treated with drugs who had had heart attacks, heart failure or heart-related sudden death.

The FDA followed up on those studies, and found that they seemed skewed: Patients who underwent surgery were younger and healthier than those treated by drugs, suggesting the heart link was a coincidence.

While the studies' designs make safety assessments difficult, many of the participants who developed heart problems had risk factors before starting the drugs, Health Canada said Thursday.

The FDA then looked at 14 additional studies of the drugs, and found no evidence of heart risks. In fact, in a few studies where patients received either medication or a dummy pill, those who took the heartburn drugs actually had a lower incidence of heart problems.

The FDA plans to complete its probe within three months, but issued a public notice Thursday that it "does not believe that health care providers or patients should change either their prescribing practices or their use of these products at this time."

Health Canada reached the same initial conclusion. It also urged doctors and patients to make no changes until its own probe is finished by year's end, noting that untreated GERD can lead to serious complications.

The drugs are among a family of acid-reducers known as proton pump inhibitors. FDA's Dr. Paul Seligman said Thursday that while the agency's focus is on Nexium and Prilosec, it is "interested in the data from all similar products" as it looks for all available evidence to settle the heart question.

Nexium is the world's No. 2 selling drug, with 2006 sales of $6.7 billion, according to health care research firm IMS Health.

More on Natural Cancer Therapies

Dr Tullio Simoncini believes that cancer doesn’t depend on mysterious causes (genetic, immunological or auto immunological) as the official oncology proposes, but it comes down from a simple fungal infection, whose destroying power in the deep tissues is actually under estimated.

His Premise -

The present work is based on the conviction, supported by many years of observations, comparisons and experiences, that the necessary and sufficient cause of the tumour is to be sought in the vast world of the fungi, the most adaptable, aggressive and evolved micro-organisms known in nature.

I have tried many times to explain this theory to leading institutions involved in cancer issues (the Ministry of Health, the Italian Medical Oncological Association, etc.) elaborating on my thinking, but I have been brushed aside because of the impossibility of setting my idea in a conventional context.

A different, international audience represents the possibility of sharing a view about health, which differs, from what is widely accepted by today's medical community, either officially or from the sidelines.

There is an opposition between the allopathic and the Hippocratic medical ideal. The former has the disadvantage of its inability to consider the individual as a whole. Therefore it brings with it all the distortions and aberrations which such a point of view entails (excessive specialisation, therapeutic aggressiveness, superficiality, harmfulness etc.). The latter approach instead tends in the direction of being too generic, non-scientific, and devoid of therapeutic incisiveness.

The position that I promote represents instead a meeting point of these two conceptions of health, since, from the conceptual point of view, it sublimates and adds value to both, while highlighting how they both are victims of a common conformist language.

The hypothesis of a fungal aetiology in chronic-degenerative illness, able to connect the ethical qualities of the individual with the development of specific pathologies, reconciles the two orientations (allopathic and holistic) of medicine. The hypothesis is a strong candidate for being that missing element of psychosomatics that has been sought but never found by one of the fathers of psychosomatics, Wiktor Von Weiszäcker.

In considering the biological dimensions of the fungi, for instance, it is possible to compare the different degrees of pathogenicity in relation to the condition of organs, tissues and cells of a guest organism, which in turn also and especially depend on the behaviour of the individual.

Each time the recuperative abilities of a known psycho-physic structure are exceeded, there is an inevitable exposure, even considering possible accidental cofounders, to the aggression -- even at the smallest dimensions -- of those external agents that otherwise would be harmless.

In the presence of an indubitable connection between patient morale and disease it is no longer legitimate to separate the two domains (allopathic and naturopathic) which are both indispensable for improving the health of individuals.

The Platonic separation of the human mind from the human body, responsible for the present mechanistic and materialistic character of today's medicine, is outdated. So is the pessimistic Kantian position concerning integration of the rational and emotional sides of man ("the starred sky above me, the moral law within me"), which generates the present myopia of today's medical epistemology. With such outdated cognitive frameworks inevitably come all the mindsets that carry similar restrictive and limiting presuppositions.

There's More to IVC for Cancer Than Doctors Admit

Biochemical individuality based nutritional therapy is the core of health. I work from this model every day and see great results. I too wish more people had this knowledge and therapy available to them. I also with that more medical people would open their minds to this process.

Dr. Gayle

INTRAVENOUS VITAMIN C and CANCER, from the orthomolecular perspective

"...it takes much more than logic and clear-cut demonstrations to overcome the inertia and dogma of established thought." — Irving Stone

Irving Stone was an early thinker and writer about vitamin C (its scientific name is ascorbic acid). He knew it would be an uphill battle to change the way the medical profession viewed vitamin C. While most doctors accept that scurvy is a vitamin C deficiency illness, few have made the rather humongous jump to seeing high dose intravenous vitamin C as a major player in the management of cancer.

There is actually a wide spectrum of medical uses for vitamin C. Evidence exists documenting it as the best antiviral agent now available ... IF used at the proper dose. Vitamin C can neutralize and eliminate a wide range of toxins. Vitamin C will enhance host resistance, greatly augmenting the immune system's ability to neutralize bacterial and fungal infections. Now the National Institutes of Health has published evidence demonstrating vitamin C's anti-cancer properties. With so many medical benefits, why do so few doctors know of them?

One explanation stems from ascorbic acid's designation as a "vitamin." Consider Dorland's Illustrated Medical Dictionary's definition of vitamin: A general term for a number of unrelated organic substances that occur in many foods in small amounts that are necessary in trace amounts for the normal metabolic functioning of the body. As a vitamin, only a minuscule 60 mg of ascorbic acid is needed to prevent the emergence of scurvy symptoms. As a medical treatment for cancer and life-threatening infections and toxic exposures, tens of thousands of milligrams of ascorbic acid must be administered, often by the intravenous (IV) as well as the oral route.

The Center's founder, Dr. Hugh Riordan, was a true scientist who believed in the power of scientific measurement over dogma. With the establishment of The Center in 1975, he routinely checked plasma vitamin C levels in chronically ill patients. He found these sick patients to be consistently low in their plasma C levels. Interestingly enough, the cancer patients he was seeing had VERY LOW vitamin C reserves. This matched scientific literature documenting low vitamin C levels in cancer patients. Cancer cells were actively taking up vitamin C in a way that depleted tissue reserves of C.

PET scans are commonly ordered by oncologists to evaluate their cancer patients for metastases (cancer spread to other organs). What is actually injected into the patient at the start of the scan is radioactive glucose. Cancer cells are anaerobic obligates, which means they depend upon glucose as their primary source of metabolic fuel. Cancer cells employ transport mechanisms called glucose transporters to actively pull in glucose.

In the vast majority of animals, vitamin C is synthesized from glucose in only four metabolic steps. Hence, the molecular shape of vitamin C is remarkably similar to glucose. (Figure 1) Cancer cells will actively transport vitamin C into themselves, possibly because they mistake it for glucose. Another plausible explanation is that they are using the vitamin C as an antioxidant. Regardless, the vitamin C accumulates in cancer cells.

If large amounts of vitamin C are presented to cancer cells, large amounts will be absorbed. In these unusually large concentrations, the antioxidant vitamin C will start behaving as a pro-oxidant as it interacts with intracellular copper and iron. This chemical interaction produces small amounts of hydrogen peroxide.

Because cancer cells are relatively low in an intracellular anti-oxidant enzyme called catalase, the high dose vitamin C induction of peroxide will continue to build up until it eventually lyses the cancer cell from the inside out! This effectively makes high dose IVC a non-toxic chemotherapeutic agent that can be given in conjunction with conventional cancer treatments. Based on the work of several vitamin C pioneers before him, Dr. Riordan was able to prove that vitamin C was selectively toxic to cancer cells if given intravenously. This research was recently reproduced and published by Dr. Mark Levine at the National Institutes of Health.

As feared by many oncologists, small doses may actually help the cancer cells because small amounts of vitamin C may help the cancer cells arm themselves against the free-radical induced damage caused by chemotherapy and radiation. Only markedly higher doses of vitamin C will selectively build up as peroxide in the cancer cells to the point of acting in a manner similar to chemotherapy. These tumor-toxic dosages can only be obtained by intravenous administration.

Over a span of 15 years of vitamin C research, Dr. Riordan's RECNAC (cancer spelled backwards) research team generated 20 published papers on vitamin C and cancer. RECNAC even inspired its second cancer research institute, known as RECNAC II, at the University of Puerto Rico. This group recently published an excellent paper in Integrative Cancer Therapies, titled "Orthomolecular Oncology Review: Ascorbic Acid and Cancer 25 Years Later." RECNAC data has shown that vitamin C is toxic to tumor cells without sacrificing the performance of chemotherapy.

Intravenous vitamin C also does more than just kill cancer cells. It boosts immunity. It can stimulate collagen formation to help the body wall off the tumor. It inhibits hyaluronidase, an enzyme that tumors use to metastasize and invade other organs throughout the body. It induces apoptosis to help program cancer cells into dying early. It corrects the almost universal scurvy in cancer patients. Cancer patients are tired, listless, bruise easily, and have a poor appetite. They don't sleep well and have a low threshold for pain. This adds up to a very classic picture of scurvy that generally goes unrecognized by their conventional physicians.

When Center cancer patients receive IVC, they report that their pain level goes down, and that they are better able to tolerate their chemotherapy. They bounce back quicker since the IVC reduces the toxicity of the chemotherapy and radiation without compromising their cancer cell killing effects. IVC is complementary to oncologic care. IVC is not "either/or" - it's a good "both/and" proposition. IVC can help cancer patients withstand the effects of their traditional therapies, heal faster, be more resilient to infection, develop a better appetite, and remain more active overall. These things promote a better response to their cancer therapy.

IVC has been used for three decades here at The Center. There have been no serious complications, but there are a couple of potential complications that need to be screened for. Because vitamin C enhances iron absorption, iron overload must be ruled out. The high sodium load of IVC can create a fluid overload in a patient with congestive heart failure, renal insufficiency or failure. We also check our patients for G6PD deficiency (an enzyme used to maintain stability of the red blood cell membranes). Although many physicians worry that large doses of vitamin C may cause kidney stones, we have rarely seen the phenomenon, and several huge clinical trials in the medical literature refute this misconception.

To summarize, most organisms make their own vitamin C. When they are under stress, either by illness or injury, Mother Nature has provided them with a means to facilitate healing: they synthesize more ascorbic acid. As a result, they are in less pain, they remain active, they can sleep, and they have a better appetite: all functions which promote healing.

Dr. Riordan once said that here at The Center, we don't treat cancer... we treat people who happen to have cancer. IVC is a tool that allows our Center physicians to harness a healing mechanism that our human ancestors lost long ago: the ability to dramatically increase tissue levels of vitamin C. Research shows that the astonishingly high levels achievable only by IVC not only help fight the risk of infection and the pain of metastases, they actually aid in the defeat of the cancer cells themselves, through a very elegant mechanism that does no harm to healthy cells. It's a discovery that the medical world is only beginning to discover.

Ron Hunninghake, M.D.,
Chief Medical Officer, Olive W. Garvey Center for Healing Arts

About Loss

Our deepest sympathy goes out to the families of those lost in the Minnesota bridge tragedy.

These same sentiments go daily to those lost in the terrible conflict in the mid-east, loved ones and families...

May peace be with you all.

Here's What's Up

The people's hero, David Graham, MD, a drug safety officer at the F.D.A., called for Avandia’s withdrawal. Dr. Graham estimated that its toxic effects on the heart had caused as many as 205,000 heart attacks, strokes and death from 1999 to 2006. For every month that Avandia is sold, he said, another 1,600 to 2,200 patients are likely to suffer from heart attacks and strokes, some of them fatal.

Meanwhile, back at 'the ranch'- depending on whether you define this as the Oval Office which benefits from millions in Pharma Cartel money, the new 'faster track' fast-track drug approval for money scheme, thousands paid in lobbying efforts to senators and representatives to pass the recent drug bill originally brought to you by Teddy Kennedy, or the failure to pass a Medicare drug bill allowing price negotiation (a Bush giveaway) - the people have been had. Especially any one with diabetes.

We reported over four years ago to all the people with diabetes on our news service alert plan the cardiac risks of Avandia. Readers of our most recent newsletter learned more.

This is not unlike how more than fifteen years ago we began warning women NOT to submit to mammography because it DOES cause cancer. Today you read this same news again because someone did a new study. yet when do you see that there has been a change to thermography or ultrasound for diagnosis in all these years. You don't. And you don't because of the $$$.

We agree with Dr. Graham. In the mean time, so should you.

We also agree that everyone should force this issue with their elected officials, especially if they are ones who voted for this FDA bill (see a recent post about being screwed by Congress). And we strongly agree that there should be NO drug on the market with any serious health risk as a side effect. For the FDA, to do less is unconscionable.

Read here about drugs: http://Rxlist.com (skip the patient information, because that's just fluff).

And if you want to know healthful and safe approaches to prevent and care for diabetes, let us know. The VA has proven it is reversible, so the facts are in.

There is help for Type I too.

Advisers: Avandia should stay on market

By ANDREW BRIDGES, Associated Press Writer Mon Jul 30, 6:41 PM ET

The widely used diabetes drug Avandia should remain on the market, government health advisers overwhelmingly recommended Monday, saying evidence of an increased risk of heart attack doesn't merit removal.

The nonbinding recommendation to the Food and Drug Administration came on a 22-1 vote by the panel.

"We're being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision," said Rebecca Killion, a diabetic from Bowie, Md., and the panel's patient representative.

However, in an earlier 20-3 vote, the panelists said that available data show the drug does increase heart risks.

Panelists said the drug's label should include a so-called "black-box" warning, the most severe the FDA can require, to flag that risk. Some suggested the label caution against using the drug together with insulin because doing so may elevate heart risks. That joint use is currently FDA-approved. The experts also asked that the drug be studied further.

The FDA isn't required to follow the advice of its advisory committees but usually does.

The manufacturer, GlaxoSmithKline PLC, earlier recommended continuing long-term studies of the drug and updating the label to inform doctors and patients of what's known so far about any heart risks. FDA scientist Dr. David Graham said waiting for more results could subject as many as 2,200 people a month to serious side effects from the drug.

Graham also told the joint panel of experts that the drug's heart risks, combined with its lack of unique short-term benefits in helping diabetics control blood sugar, meant continued sales were not justified.

But Glaxo contended there is no increased risk, citing its own analyses of studies of Avandia, also called rosiglitazone.

"The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents," said Dr. Ronald Krall, the company's senior vice president and chief medical officer.

Previously, the FDA had said information from dozens of studies pointed to an increased risk of heart attack.

That conclusion swayed the panel but apparently did not rise to the level of requiring any regulatory action more dire than beefed-up warnings and continued scrutiny.

"It's suggestive but by no means conclusive," said Dr. Thomas Pickering, an assistant professor of medicine at Columbia University Medical Center.

The lone dissenting panel member on the main vote, Arthur Levin, said there was a strong suggestion of a safety signal. That, along with widely shared doubts that further study would settle the issue and the enormity of the potential risk to the public health, moved him to vote "no."

"I logically can't find any way to leave this drug on the market," said Levin, director of the Center for Medical Consumers in New York.

About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.

Graham's boss, Dr. Gerald Dal Pan, also said the balance between the risks and benefits of Avandia didn't favor the drug. But the FDA isn't of one mind on the drug: the issue exposed a rift between agency officials charged with approving new medicines and those who monitor their safety once on the market.

"It is important that the committee understand there is a fundamental disagreement within (the FDA's drugs office) on the scientific conclusions that should be drawn," said Dr. Robert Meyer, head of the FDA office that reviews new diabetes drugs.

The FDA moved up the date of Monday's meeting after the May publication of a study in The New England Journal of Medicine that generated new concerns about Avandia's safety. The analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

Separately, the FDA is working to add so-called "black box" warnings to the labels of both Avandia and a second oral diabetes drug, Actos, to caution patients about the increased risk of heart failure associated with the drugs. That risk is separate from those discussed Monday.

The diabetes epidemic affects more than 18 million Americans. Most have Type 2, where the body makes too little insulin or cannot use what it does produce.

Each day, there are 4,100 new cases of diabetes in the United States, and 810 deaths, said Dr. Robert Ratner, vice president of medical affairs at the MedStar Research Institute. Of those deaths, 60 percent are due to heart disease, Ratner told the panel.

Congress has pointed to Avandia as evidence of FDA's fumbling of safety problems that emerge long after drugs win agency approval. The House and Senate are at work on legislation to overhaul the FDA.
___

On the Net:
http://www.nytimes.com/2007/07/30/health/30cnd-avandia.html?ei=5090&en=99cebe0695132539&ex=1343448000&adxnnl=1&partner=rssuserland&emc=rss&adxnnlx=1185915836-9+YCcKa2QolwI3fgltYfOA&pagewanted=print
Avandia: http://www.avandia.com/
Food and Drug Administration: http://www.fda.gov/

July 30, 2007
F.D.A. Panel Votes to Keep Diabetes Drug on Market
By GARDINER HARRIS

GAITHERSBURG, Md., July 30 — A federal drug advisory committee voted 20 to 3 late this afternoon that Avandia, a controversial diabetes drug made by GlaxoSmithKline, raises the risks of heart attacks, but it then voted 22 to 1 that the drug should nonetheless remain on the market.

The divided vote came after committee members said that studies concerning Avandia were too murky to merit drastic regulatory action and that other diabetes medicines might have similar risks.

“My feeling here is that we’re being asked to take a very draconian action based on studies that are very inadequate for us to make that kind of decision,” said Rebecca Killion, a patient representative and committee member from Bowie, Md.

Dr. Clifford J. Rosen, chairman of the committee who is from St. Joseph Hospital in Bangor, Me., said after the meeting that “there was enough concern on the advisory committee that virtually everybody felt there was risk” of heart attacks from taking Avandia.

Patients who have congestive heart failure or a history of cardiovascular disease, or those taking insulin or nitrates should not be given Avandia, Dr. Rosen said.

“There are going to be changes in the way this is promoted and certainly in how physicians use this drug,” Dr. Rosen predicted.

GlaxoSmithKline told the committee that it did not believe that Avandia increases the risks of heart attacks “and we still don’t,” said Christopher A. Viehbacher, president of the company’s American drug business, after the meeting ended.

He said that if the F.D.A. ordered a strong warning placed on Avandia’s label, some patients would take other medicines that might be more dangerous. “I don’t think it’s a slam dunk yet as to what the F.D.A. is going to do with this,” he said.

The votes came after an extraordinary meeting in which officials from the Food and Drug Administration, which brought the committee together, openly disagreed with one another about the right course to take.

Dr. David Graham, a drug safety officer at the F.D.A., called for the drug’s withdrawal and estimated that its toxic effects on the heart had caused as many as 205,000 heart attacks, strokes and death from 1999 to 2006. For every month that Avandia is sold, he said, another 1,600 to 2,200 patients are likely to suffer from heart attacks and strokes, some of them fatal.

Dr. Robert Meyer, director of the office within the F.D.A. that approved Avandia’s initial application, immediately disagreed with Dr. Graham.

“I think it’s important that the committee understand there’s a fundamental disagreement” within the agency, he said. Other diabetes drugs also have risks, Dr. Meyer said, and doctors and patients need a variety of treatment options.

Dr. Douglas C. Throckmorton, a deputy director of the F.D.A.’s center for drugs, explained at a news conference after the meeting that the split within the agency resulted from the “complexity” of the issue.

The F.D.A. usually follows the advice of its advisory committees, especially when the votes are so lopsided. Agency officials said they did not know when they would come to a decision and refused to characterize the form that any new Avandia warning might take.

The open disagreement within the F.D.A. reflects a fierce debate that has occurred among diabetes experts across the country since The New England Journal of Medicine published a study in May suggesting that Avandia increases the risks of heart attacks.

In the revelations since then, F.D.A. officials have said that GlaxoSmithKline told the agency about these risks nearly two years ago, but that because of fierce internal disagreements, the agency never warned patients about them. In Europe, regulators required that the drug’s label reflect some concerns about these risks.

The agency’s lack of action helped persuade some lawmakers to support legislation that has since passed both the House and Senate that provides the agency with more money and power to police drug safety issues. That legislation is expected to be sent to President Bush within days.

About a million patients in the United States took Avandia last year, and a nearly identical number took Actos, a similar pill made by Takeda that may be safer. Avandia’s global sales last year totaled $3.4 billion, but its sales have plunged since May.

The Avandia controversy largely revolves around whether several highly complex statistical analyses of dozens of studies show that Avandia increases the risks of heart attacks. Separate from this argument, there is considerable evidence that both Avandia and Actos worsen the condition of heart failure.

Dr. Murray Stewart, a GlaxoSmithKline vice president, said that in recent months the company has examined data from several large managed care companies in the United States that included 1.35 million patients with diabetes. The company’s analyses, he said, showed that patients who took Avandia suffered no greater risk of heart attack or death from heart problems.

The committee disagreed, with most members saying that while GlaxoSmithKline should continue to market Avandia, the F.D.A. should place strict warnings on its label.

“I also think there needs to be a stiffening of the warnings,” said Dr. Peter J. Savage, a committee member from the National Institutes of Health, echoing the comments of others.

Dr. Steven Nissen, a Cleveland Clinic cardiologist who authored the study in The New England Journal of Medicine in May, said in an interview after the hearing that he would have voted to remove Avandia from the market. But he said he was encouraged that the committee “affirmed the finding that there was an increased cardiovascular risk from the drug.”

He predicted that Avandia’s sales would plunge with the new warning.

The disagreements within the F.D.A. affected almost every aspect of the hearing. In their presentations, Dr. Graham and his boss, Dr. Gerald Dal Pan, both referred to studies that suggested that Actos is safer to the heart than Avandia. But the Actos studies have not been thoroughly reviewed by the F.D.A., and the underlying data from them were not given to committee members.

When asked why, Dr. Graham said that “we were promised that that would be done for this meeting.” Officials eventually explained that the agency did not enough resources to get the analysis done for the meeting, he said.

“So then I’m faced with a dilemma,” Dr. Graham said. “Do I keep silent about that and not breathe a word of it, or do I present it?”

Dr. John R. Teerlink, a committee member from the University of California in San Francisco, said that the agency should “either have the political will to either schedule the meeting when we had the data or not to present data that we couldn’t look at.”

The public debate about Avandia has brought about a remarkable number of independent examinations of the drug’s safety, and several researchers shared their findings with the committee during the hearing’s open public comment period.

Executives with both Tricare, a managed care company that serves active and retired military personnel, and WellPoint, a huge health insurer, said they had found no evidence in their records that patients given Avandia had suffered more heart attacks.

Dr. Sidney Wolfe of the drug safety advocacy group Public Citizen, said F.D.A. records show that Avandia has a lot more problems associated with it than just heart risks.

“If Avandia were up for approval today, based on what we know now, it would be rejected,” he said.

Multiple speakers reminded the committee that few diseases have a greater public health impact than diabetes. Each day in the United States, there are 4,100 new diabetes cases and 810 deaths from the disease, said Dr. Robert E. Ratner of the MedStar Research Institute in Washington. Also every day, about 230 diabetes patients suffer amputations, 120 suffer kidney failure and 55 go blind.

He said that while controlling blood sugar levels has proven health benefits in the short term, no study has proven that diabetes drugs extend lives.

“We’re not keeping people alive with our drug therapy because our drug therapy isn’t adequate,” he said. And he said that no diabetes medicine has conclusively proven that it helps protect the heart. He also noted that diabetes patients often fail to take their medicines properly, and that doctors often fail to treat the disease aggressively enough.

“Why do we need new therapies for type-two diabetes?” Dr. Ratner asked. “We have an epidemic of diabetes and its complication that will soon swamp our medical delivery system.”

Most diabetics die from heart disease, since the disease has severe effects on the heart. If Avandia actually increases the risks of heart attacks, that “denotes a serious limitation” of the drug’s usefulness, an F.D.A. reviewer concluded in a report before the meeting.

It's Drug Pushers and Junque Science Again...or Menstruation key to bone rebuilding

So with the mass marketing of Gardasil in timing with the push for a pill to stop your menstrual cycle, this report shows something close to normal human physiology.

Gee, maybe there is a way back to truth in labeling, or, as it were, scientific research without pre-determined outcomes.

My alarm went off with Gardasil, as readers of this BLOG well know. It also went off when the big ad campaign came out to get you to buy into how great life is without that part of being a woman that they want to deny you next.

One pill, no period.

Sounds easy, but did they forget to include in the ad all the problems you'll encounter because of the pill's nutrient depletions? Not!

And of course they probably forgot to mention that as you age, you just might be forced into a category of those swallowing TIDE.

Yes, bisphosphonates are made from by-products of laundry detergent. And, yes, they do destroy bone and increase your risk of developing esophageal cancer.

Aren't these baby boomers going to be a lucky bunch, while Merck, Pfizer, and P & G laugh all the way to the bank.

And then those natural types, like yours truly, will do what she can to educate others on the positive health benefits of menstruation.

This is also something your Taoist teacher will tell you if you listen.

Menstruation key to bone rebuilding in anorexics

Adequate nutrition can rebuild bone mass in women with anorexia, but the restoration of normal menstrual periods appears to be necessary for fully normal bone metabolism to be recovered, a new study shows.

"Our observations may be important to an understanding of the mechanism of possible reversal of osteoporosis in anorexia nervosa, for which there is as yet no effective treatment," Dr. Jennifer Dominguez of Columbia University Medical Center in New York City and her colleagues conclude.

Studies in which anorexic women have been given oral contraceptives or estrogen to help restore bone mass have had mixed results, Dominguez and her team note, while the process by which bone thinning occurs in these patients is not fully understood. Further, they add in the July issue of the American Journal of Clinical Nutrition, "the role of nutrition in the recovery of bone has been underestimated."

To better understand bone loss and rebuilding in these patients, the researchers followed 28 women with anorexia nervosa who were undergoing treatment to help regain weight, comparing them to a control group of 11 healthy young women.

After just over two months on nutrition therapy, the anorexia nervosa patients showed significant increases in bone mineral density, the researchers found. Patients' levels of the protein osteocalcin, which is secreted by bone cells and is a key marker of bone formation, also rose. But levels of N-telopeptide, a marker for bone breakdown, remained abnormally high, except among eight women who began menstruating normally after recovering 90 percent of their ideal body weight.

The average bone mineral density among women who didn't begin menstruating after treatment was lower than the bone mineral density for the women who started menstruating and the healthy controls.

The findings suggest, Dominguez and her colleagues note, that women with anorexia have normal to increased rates of bone formation, but that bone breakdown outpaces bone building, resulting in loss of bone mineral density.

"Our data suggest that nutritional therapy is critical and necessary for optimal effect of other therapies," the researchers write. These drugs include antiresorptives -- drugs that block bone breakdown - and estrogen replacement therapy. In fact, they add, such treatment may not be effective until nutritional therapy has restored normal bone formation.

SOURCE: American Journal of Clinical Nutrition, July 2007.

Doctor Wants More Money to do Basic Legal Care

Confused older patients die sooner according to an article today from Reuters.

This doesn't surprise me because most patients are confused about drugs and how to use them for several reasons.

One reason it seems to affect people with Medicare of Medicaid coverage is the bias against the poor in MSMed today. This is related to dictates of Big Insurance to doctors and others in the health industry, all relying on reimbursement.

Secondly, US Codes do require that a physician, nurse practitioner or physician assistant specifically explain the risks and benefits of using a drug and how to properly use it. There's more than just giving the information in the communication process, or don't medics get that?

And now why, with a risk of higher health care costs, do arrogant doctors deem they should neglect patients unless they get more KA-CHING?

EFFECTIVE COMMUNICATION'

Cancer patients are more intensively managed by health-care staff and may not need to be as personally involved in their own care, which may explain why health literacy did not affect their fates.

Dr. Anne Fabiny, chief of geriatrics at Cambridge Health Alliance in Massachusetts, said one of her patients made repeated trips to the emergency room when she felt dizzy from taking her daily blood pressure pills in one sitting.

The solution itself was easy: space out the doses over each day. The challenge was making sure her patient understood.

Many doctors do not check that their elderly patients can see or hear instructions in the first place, she added.

"I write out all my instructions for all my patients now (and) have them read the instructions back. If they can read it, (I ask) does that make sense to you?" Fabiny said in a telephone interview.

"Until physicians are compensated for the time it requires to have this sort of effective communication, it will continue to be a problem."

and here is the first part of the article by Ishani Ganguli

Understanding doctors' orders can be a matter of life or death for senior citizens: those who had trouble comprehending their physicians died sooner than their more savvy peers, U.S. researchers said on Monday.

Medicare clients who were confused by pill bottles or appointment slips were 52 percent more likely to die over the six years of the study, especially from heart disease.

"Patients with inadequate literacy know less about their diseases ... They are much more likely to be hospitalized," said Dr. David Baker of Northwestern University, who led the research.

"It's not just higher hospital rates. It's significantly higher mortality."

Baker and colleagues followed 3,260 Medicare patients 65 and older in four U.S. cities. To test the volunteers' so-called health literacy, which drops with age, they quizzed them on how well they understood prescription bottles, appointment slips and insurance forms.

"(We provided) a prescription bottle that says 'take this medicine on an empty stomach one hour before meals or two hours after.' The question is, you're going to eat lunch at noon, what time are you going to take this medicine?" Baker said in a telephone interview.

In another example: "Normal blood sugar is 80 to 130. Your blood sugar today is 160. Is your blood sugar normal? A quarter of patients couldn't get this correct," Baker said.

The 25 percent of people who got 55 percent or fewer of the questions right were rated as having inadequate health literacy. Another 11 percent scored as marginally literate and had a 13 percent higher chance of dying in the six years.

The findings held regardless of factors such as income and education, the researchers reported in the Archives of Internal Medicine.

Baker said he was not surprised that less literate patients were more vulnerable to death from heart disease -- which puts more burden on the patient to maintain their health.

"If somebody has heart problems or they have diabetes or high blood pressure, there's a whole host of things they need to be able to do to have good health in the future -- take medicines correctly, eat a low salt diet, exercise regularly," he said.