Diabetes Cost Continues to Rise

Preventing complications of diabetes is a very important issue. Preventing diabetes is much more important. Worker productivity certainly may be a concern but should rank at the bottom of the list.

Prevention would be the focus. Newer drugs should be limited in use and older, less costly yet more effective drugs should be used when at all possible.

Big Ag should be banned from its control at the USDA in regard to food processing and food ingredients that promote the disease.

Aspartame and sucralose should be banned as the FDA does know of the devastation these chemicals pose. High fructose corn syrup should be included as well in the ban.

Natural therapies that are available to help prevent neuropathy are available. Other natural therapies to reduce blood sugar levels should be established as options.

Thorough endocrine evaluations should be offered because diabetes can be associated with low adrenal and low thyroid function.

And the US health care system can do better to improve the low raking it has in regard to improving health of those with chronic disease.

Study puts a total on diabetes cost: $218 billion
By LINDA A. JOHNSON, AP Business Writer
Tue Nov 18, 2008

TRENTON, N.J. – As diabetes is rapidly becoming one of the world's most common diseases, its financial cost is mounting, too, to well over $200 billion a year in the U.S. alone.

A new study, released Tuesday exclusively to The Associated Press, puts the total at $218 billion last year — the first comprehensive estimate of the financial toll diabetes takes, according to Danish pharmaceutical company Novo Nordisk A/S, which paid for the study.

That figure includes direct medical care costs, from insulin and pills for controlling patients' blood sugar to amputations and hospitalizations, plus indirect costs such as lost productivity, disability and early retirement.

The study, conducted by the Lewin Group consultants, estimates costs to society for people known to have Type 1 or Type 2 diabetes at $174.4 billion combined, a total previously reported by Novo Nordisk, the world's top producer of insulin and the maker of diabetes pills such as NovoNorm and Prandin. That study was done with the American Diabetes Association.

The new study adds estimates for people who haven't been diagnosed yet ($18 billion), women who develop diabetes temporarily during pregnancy ($636 million) and those on track to develop diabetes, an increasingly common condition called pre-diabetes ($25 billion).

"Diabetes has not seen a decline or even a plateauing, and the death rate from diabetes continues to rise," said Dana Haza, senior director of the National Changing Diabetes Program, an effort Novo Nordisk began in 2005 to improve diabetes care and prevention in the U.S.

"The numbers just keep going higher and higher, and what we want to say is, 'It's time for government and businesses to focus on it,'" said Haza, who believes diabetes will be the country's biggest health problem in the future, worsened by the obesity epidemic.

Novo Nordisk is to present the data Tuesday at a health care conference for corporate executives and then plans to publish a full report in a professional journal. The calculations are based on numbers from sources including databases on treatment of people with commercial insurance, Medicare and Medicaid, federal public health surveys and other sources.

Andrew Webber, president and chief executive of the National Business Coalition on Health, said the study is the first he's seen estimating diabetes costs. He praised its inclusion of indirect costs, which "add up and create such a powerful argument as to why employers need to take this challenge on."

"This study gives a very persuasive argument to employers to invest in a culture of health in their workforce," Webber said, calling the worsening diabetes epidemic "the tsunami that is coming."

Among people known to have diabetes, the new study estimated $10.5 billion in medical costs and $4.4 billion in indirect costs, or a total of $14.9 billion, for people with Type 1 diabetes, which generally begins in youth and can have a genetic link. Nearly 6 percent of the 17.5 million Americans diagnosed with diabetes have Type 1.

The study estimated $105.7 billion in medical costs and $53.8 billion in indirect costs, totaling $159.5 billion, for people with Type 2 diabetes, previously called adult-onset diabetes because of its link to the bigger waistlines and sedentary lifestyles.

The National Changing Diabetes Program, which includes medical partners such as the American Academy of Family Physicians and American Diabetes Association, wants more Americans at risk of diabetes to know their blood sugar level and control it. It also wants the White House to appoint a coordinator for diabetes prevention and education.

Meanwhile, plenty of companies have started their own efforts, said Webber, whose group includes 61 business coalitions with about 7,000 employers and 35 million employees and dependents.

Webber said six of those coalitions are running programs giving participating employees diabetes medicines without a co-pay, six more give doctors extra money for helping patients get their diabetes under control, and one coalition offers both types of programs.

"My guess is we need to do both," to prevent complications and improve worker productivity, Weber said.
___

On the Net: National Changing Diabetes Program, http://www.ncdp.com
Copyright © 2008 The Associated Press.

Bone Loss Problematic, Bone Drugs Risky

In January 2008 the FDA issued warnings regarding the class of drugs developed to allegedly help people with osteopenia and osteoporosis.

Numerous problems are associated with these drugs, including bone frailty and increased fracture rates.

Now chemotherapy for cancer seems to be opening a new window to ply these drugs on patients who already are health compromised because of the cancer and chemotherapy drug treatments.

It is interesting to note that there does exist a safe and effective approach to maintaining storng, healthy and flexible bones with vitamins and other natural supplements.

Some other physicians express concern -"

Bisphosphonates, like Fosamax and Actonel, are taken up by osteoclasts with resulting loss of osteoclast activity and inhibition of bone resorption, and bone remodeling (link). Although DEXA scanning confirms increased bone density and studies such as the FIT suggest reduced fracture rate, Susan Ott, MD raises questions about the long term safety of bisphosphonates. Although the bisphosphonates appear to have short term benefits, she speculates that after 5 years of use, there is severe suppression of bone formation with negative effects such as microdamage and brittleness.

Jennifer P. Schneider, MD, PhD reports a 59-year old previously healthy woman on long-term alendronate. While on a subway train in New York City one morning, the train jolted, and the woman shifted all her weight to one leg, felt a bone snap, and fell to the floor, suffering a spontaneous mid -femur fracture (see image). In the months following, it became clear that the fracture was not uniting. Schneider speculates that increased bone density from the bisphosphonate drug does not necessarily equate with good bone quality. By decreasing osteoclast activity and bone resorption, and therefore bone formation as well, microdamage, and brittle bone may result in fractures.

Odvina reports on 9 cases of spontanous fracture while on alendonate. Five of the nine cases were spontaneous mid femur fractures. Two had bilateral mid femur fractures same as Toulouse Lautrec. Six cases had delayed or absent fracture healing. Histomorphometric analysis of the cancellous bone showed markedly suppressed bone formation, and Odvina raised the possibility that severe suppression of bone turnover could develop during long-term alendronate therapy, resulting in increased susceptibility to, and delayed healing of, nonspinal fractures.

Dimitrakopoulos reports on 11 patients presenting with necrosis of the jaw, claiming this to be a new complication of bisphosphonate therapy administration, i.e. osteonecrosis of jaws. He advised clinicians to reconsider the merits of the rampant use of bisphosphonates. Osteonecrosis of the jaw is a common finding in pycnodysostosis. The bisphosphonates recreate the same clinical p rofile of spontaneous mid femur fractures, failure of bone healing and jaw necrosis which tormented Toulouse Lautrec.

In spite of this well known information, there are four more drugs in clinical trials which are specifically designed to inhibit cathepsin K, the enzyme defect in Lautrec's genetic bone disease. FDA approval for use in osteoporosis treatment is expected. Excuse me here, but perhaps this thinking needs re-evaluation. In essence we are creating a population of women with Toulouse Lautrec's bone disease. Ironically, women who sustain fractures while on Fosamax are told by their docs that the fractures are due to the underlying osteoporosis, not the drug. "

Cancer Treatment May Result In Bone Loss, Study Finds

ScienceDaily (2008-11-17) -- A new cross-Canada study has found that breast and prostate cancer treatment can foster bone loss. Scientists explain how loss of bone mass might affect 46,000 people diagnosed with breast and prostate cancer each year and place them at increased risk for osteoporosis and fractures. ... > read full article

FDA Issues Alert on Bone Drugs
By Elizabeth Trotta
The FDA posted an alert on Monday regarding possible severe, sometimes incapacitating bone, joint, and/or muscle pain in patients taking a class of bone-density drugs called bisphosphonates.
The possibility of such pain is listed in the drugs' prescribing information, but the FDA warned that doctors may overlook it to the point that it's prolonged or results in impairment, possibly requiring analgesics. This pain can occur days, months or years after initial use, and the risk factors for and incidence of severe musculoskeletal pain associated with the class are still unknown, according to the agency.

"Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug," noted the health regulator in a Med Watch post on Monday.

The class of bone drugs in question include:

Proctor & Gamble's(PG Quote - Cramer on PG - Stock Picks) Actonel, Actonel +Ca, and Didronel

Novartis'(NVS Quote - Cramer on NVS - Stock Picks) Aredia, Reclast and Zometa

Roche and GlaxoSmithKline's(GSK Quote - Cramer on GSK - Stock Picks) Boniva

Merck's(MRK Quote - Cramer on MRK - Stock Picks) Foxamax, Fosamax + D

Sanofi Aventis'(SNY Quote - Cramer on SNY - Stock Picks) Skelid.

Drug companies downplay risks of bone-strengthening drugs for women
18.01.2008 Source: URL: http://english.pravda.ru/science/103518-bone_strengthening_drugs -0

Drug companies exaggerate the benefits and downplay the risks of prescribing bone-strengthening drugs for women whose bones are weakened but who do not have osteoporosis, a new report claims.

Drugs such as alendronate and risedronate do reduce the risk of fractures of women with osteoporosis, according to the article in the Jan. 19 issue of BMJ.

Alendronate is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 U and 5600 U, under the name Fosamax+D). Merck's U.S. patent on alendronate is set to expire in 2008 and Merck has lost a series of appeals to block a generic version of the drug from being certified by the U.S. Food and Drug Administration.

Risedronate sodium is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone. It is produced and marketed by Procter & Gamble and Sanofi-Aventis.

In January 2006 P&G and its marketing partner Sanofi-Aventis filed a Lanham Act false claims lawsuit against rival drugmakers Roche and GlaxoSmithKline claiming false advertising about Boniva. The manufacturers of Boniva, a rival bisphosphonate, were accused in the suit of causing a "serious public health risk" through misrepresentation of scientific findings. In a ruling on on September 7 2006 U.S. District Judge Paul A. Crotty rejected P&G's attempted injunction. P&G was criticized for attempting to "preserve its market share by denigrating Boniva". Judge Crotty wrote that "Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented".

Source: «PRAVDA.Ru».

No Difference in Psych Drugs for Depression

SSRI group of anti-depressant pharmaceuticals have been problematic ever since Prozac was introduced some decades ago. The list of side effects and untoward behavior related to fluoride containing drugs also creates other concerns.

If it all boils down to looking at the issues of side effects, cost and response then I would suggest that better evaluation of the person's state of general health, especially endocrine health, and nutritional status be addressed before prescribing any of these drugs.

For example, I learned that a friend was taking Chantix in an effort to stop smoking. My knowledge of this person's situation is that he was smoking to cover up a deep seated emotionally painful life event.

After he started on Chantix, and while he was taking endocrine system altering drugs for prostate cancer, he became depressed.

He was just written an Rx for Lexapro, however, no effort was taken to evaluate his history and symptoms or look at drug side effects and related issues.

I can't quite get the current ethic to overlook this basic health care function, but perhaps it is why I gave up on my work in mainstream medicine 15 years ago after I was attacked by a young girl taking Zoloft, and seriously injured.

Internist Group Finds No Efficacy Difference Among Modern Antidepressants
By John Gever, Senior Editor, MedPage Today
Published: November 17, 2008

Practice Guidelines


PHILADELPHIA, Nov. 17 -- Second-generation antidepressants all have similar efficacy, so physicians should base their medication choices for depressed patients on side effects, cost, and patient response, according to a new practice guideline from the American College of Physicians.

Clinicians should also begin monitoring patients for adverse effects and clinical response within one to two weeks of starting antidepressant therapy, recommended Amir Qaseem, M.D., Ph.D., M.H.A., of the American College of Physicians, and the other authors of the guideline, published in the Nov. 18 issue of Annals of Internal Medicine.

"The current evidence did not show any clinically significant differences between efficacy, effectiveness, or quality of life between various second-generation antidepressants," said Dr. Qaseem.
Action Points

* Explain to interested patients that a treatment guideline from the American College of Physicians recommends that second-generation antidepressant choices be made on the basis of side effects, cost, and patient preference, since efficacy of these drugs is equivalent.

* Explain that individual patient factors should always guide treatment decisions.

* Note that the guidelines do not address use of older medications that are still available and may be appropriate for some patients.

The findings do not differ markedly from the American Psychiatric Association's current practice guideline on major depressive disorder, last updated in 2005.

"The effectiveness of antidepressant medications is generally comparable between classes and within classes of medications," according to the APA guideline. "Therefore, the initial selection of an antidepressant medication will largely be based on the anticipated side effects, the safety or tolerability of these side effects for individual patients, patient preference, quantity and quality of clinical trial data regarding the medication, and its cost."

The ACP's recommendations were based on a review of more than 200 published studies of a dozen antidepressants, conducted by a separate group of researchers led by Gerald Gartlehner, M.D., of Danube University in Krems, Austria.

Drugs covered in the review included:

* Fluoxetine (Prozac)
* Sertraline (Zoloft)
* Paroxetine (Paxil)
* Bupropion (Wellbutrin)
* Citolapram (Celexa)
* Escitolapram (Lexapro)
* Duloxetine (Cymbalta)
* Fluvoxamine (Luvox)
* Mirtazapine (Remeron)
* Trazodone (Desyrel)
* Nefazodone (Serzone)
* Venlafaxine (Effexor)

The guideline also calls for physicians to modify treatment if patients fail to respond adequately within six to eight weeks.

Drugs that show adequate symptom relief should be maintained for four to nine months after a major depressive episode, or longer in the case of recurrent episodes.

The review and guidelines do not address more traditional medications such as tricyclic antidepressants and monoamine oxidase inhibitors.

Dr. Qaseem and colleagues said these agents are no longer in common use because newer drugs have similar effectiveness with less toxicity.

Among the newer drugs, the review disclosed no efficacy differences among patient subgroups defined by age, sex, race-ethnicity, or comorbid conditions.

A few studies identified certain agents as better than others in patients with other neuropsychiatric symptoms besides depression, such as insomnia or anxiety. But these studies were mostly not of the highest quality, and others found little or no difference.

Those findings stand in contrast to the APA's depression guideline, which suggests that some subgroups may benefit more than others from particular agents, although with no specifics.

The ACP review found relatively few clear differences between second-generation drugs in side effects.

"Most of the second-generation antidepressants had similar adverse events, with some differences in the incidence of specific adverse events," according to the guideline authors.

Nausea and vomiting were more common with venlafaxine than with other agents, they noted, whereas sertraline appeared especially prone to cause diarrhea.

Weight gain was more frequent with mirtazapine and paroxetine, and drowsiness was relatively common with trazodone compared with several other drugs.

Sexual adverse effects were another area where drugs have different profiles.

For example, bupropion was less likely to have sexual adverse effects than fluoxetine and sertraline, whereas paroxetine had relatively high rates.

The ACP review found little difference between agents in suicidality, although non-fatal suicide attempts appeared to be more common with SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine) than with other drug classes.

Few data were available on other severe adverse effects such as seizures, cardiovascular problems, liver toxicity, hyponatremia, or serotonergic abnormalities, the researchers said.

The guideline graded the evidence and recommendations by using the American College of Physicians clinical practice guidelines grading system.

All four recommendations were considered to be strong with moderate quality evidence.

The American College of Physicians funded the review underlying the recommendations.

Authors of the guideline reported relationships with Atlantic Philanthropies, Novo Nordisk, Boehringer Ingelheim, Sanofi Pasteur, and Endo.

Authors of the literature review reported relationships with GlaxoSmithKline, Pfizer, Wyeth-Ayerst, Shire Pharmaceutical, Phillips Lytle, Bristol-Myers Squibb, Novartis, Robert Wood Johnson Foundation, and M-3 Corporation.

Primary source: Annals of Internal Medicine
Source reference: Qaseem A, et al "Using second-generation antidepressants to treat depressive disorders: a clinical practice guideline from the American College of Physicians" Ann Intern Med 2008; 149: 725-33.

Additional source: Annals of Internal Medicine
Source reference: Gartlehner G, et al "Comparative benefits and harms of second-generation antidepressants: background paper for the American College of Physicians" Ann Intern Med 2008; 149: 734-50.

And as an additional consideration, it has been suggested that more than 85% of physicians are unaware that Serotonin Syndrome even exists.

How Common or Significant Is Serotonin Syndrome?

Joel Lamoure, RPh, BSP, FASCP
Medscape Pharmacists. 11/10/2008 ©2008 Medscape

Question
We are seeing more patients who are taking multiple antidepressants of different classes. All drug interaction programs cite drug-drug interactions leading to the potentially severe toxicity known as serotonin syndrome. Just how common and clinically significant is serotonin syndrome?

Response from Joel Lamoure, RPh, BSP, FASCP
Assistant Professor, Department of Psychiatry, University of Western Ontario, London, Ontario, Canada; Mental Health Pharmacist, London Health Sciences Centre, London, Ontario, Canada

The Toxic Exposure Surveillance System reviewed cases from office-based practices, inpatient settings, and emergency departments and found that during 2004, selective serotonin reuptake inhibitors (SSRIs) caused significant toxic effects in 8187 persons, leading to 103 deaths.[1] The true incidence of serotonin syndrome and associated morbidity are likely to be much greater. This syndrome may be underdiagnosed given the fact that SSRIs are not the only contributing class of agents. Moreover, it has been suggested that more than 85% of physicians are unaware that the syndrome even exists.[2]

Serotonin syndrome is a condition caused most often by the concurrent use of 2 or more agents that enhance synaptic serotonin levels.[3] A triad of clinical changes -- cognitive, neuromuscular, and autonomic -- characterizes this syndrome. Specific changes may include confusion, delirium, agitation, restlessness, muscular spasms, hyperpyrexia, diaphoresis, tachycardia, blood pressure fluctuations, mydriasis, nausea, or diarrhea.[4,5] Symptoms often develop within 2 hours of the increase in the synaptic level of serotonin.[6] The clinician must be proactive to identify the early symptoms, such as cognitive changes, when they occur.

Confusion about symptoms may be responsible for the difficulty in assessing the actual incidence of serotonin syndrome.[2] Agitation, a cardinal symptom of serotonin syndrome, is clinically similar to activation, an adverse effect associated with SSRI use.[7]

Polypharmacy is pandemic, and the incidence of serotonin syndrome may be on the rise. Both drug factors and patient factors can contribute to the toxicity of SSRIs in some individuals. A wide range of medications can increase serotonin levels in the body. When these agents are combined, the risk of serotonin syndrome increases. Drug classes implicated include anti-migraine agents (eg, triptans); antidepressants (eg, SSRIs, serotonin-norepinephrine reuptake inhibitors, buspirone, tricyclic antidepressants, monoamine oxidase inhibitors); antipsychotics; anticonvulsants; anti-Parkinsonian agents; analgesics (eg, meperidine, tramadol); over-the-counter products (eg, medications containing dextromethorphan); herbal products (eg, St. John's Wort); and antibiotics (eg, linezolid).[6,8-14]

Concurrent use of medications that interact with serotonergic drugs through the inhibition of the cytochrome P450 pathway can also contribute to serotonin syndrome.[15] For example, extra caution should be observed if a patient is taking an SSRI in addition to a cytochrome P450 2D6 (CYP2D6) inhibitor because SSRIs are extensively hepatically metabolized by this isozyme.

Susceptibility to the serotonin syndrome can also be conferred by patient factors, such as the capacity to metabolize certain drugs. One of the key enzymes related to adverse drug reactions, the CYP2D6 system, has a high degree of genetic polymorphism.[16] An example of this was reported in a study of 4 elderly patients who ostensibly developed serotonin syndrome as a result of an interaction between tramadol and mirtazapine.[17] The patients had auditory and visual hallucinations, myoclonus, hypertension, and changes in behavior. Tramadol may be subject to genetic polymorphism; about 7% of whites are poor metabolizers of CYP2D6.[18,19] Consequently, these patients would have higher serum levels of tramadol and be at increased risk for serotonin syndrome when a second serotonergic agent is added.[18]

Although rare in monotherapy, serotonin syndrome is more prevalent with polypharmacy, even across medication classes. When a computer flags this interaction, the clinician should consider the whole patient: What medications has the patient taken previously? What adverse reactions have previously been experienced? When making an evidence-based recommendation, it is essential to apply the therapeutic thought process and carry out a sound risk-benefit assessment. Awareness of serotonin syndrome and education about its effects are vital. All of these factors must be considered, lest all the "holes in the Swiss cheese line up" and the patient comes to harm.[20]

The author acknowledges Jessica Stovel, pharmacist, and Katherine Bateman, pharmacy resident at London Health Sciences Centre, for their research and contributions to this article.

References
Watson WA, Litovitz TL, Rodgers GC, et al. 2004 Annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2005;23:589-666. Abstract
Boyer EW, Shannon M. The serotonin syndrome. N Engl J Med. 2005;352:1112-1120. Abstract
Dunkley EJ, Isbister GK, Sibbritt D, Dawson AH, Whyte IM. The Hunter Serotonin Toxicity Criteria: simple and accurate diagnostic decision rules for serotonin toxicity. Q J Med. 2003;96:635-642.
Lane R, Baldwin D. Selective serotonin reuptake inhibitor-induced serotonin syndrome: review. J Clin Psychopharmacol. 1997;17:208-221. Abstract
Isbister GK, Bowe SJ, Dawson A, Whyte IM. Relative toxicity of selective serotonin reuptake inhibitors (SSRIs) in overdose. J Toxicol Clin Toxicol. 2004;42:277-285. Abstract
Turner EH, Loftis JM, Blackwell AD. Serotonin a la carte: supplementation with the serotonin precursor 5-hydroxytryptophan. Pharmacol Ther. 2006;109:325-338. Abstract
Vorstman J, Lahuis B, Buitelaar JK. SSRIs associated with behavioral activation and suicidal ideation. (letter) J Am Acad Child Adolesc Psychiatry. 2001; 40:1364-1365.
Mills K. Serotonin syndrome. A clinical update. Crit Care Clin. 1997;13:763-783. Abstract
Mitchell, PB. Drug interactions of clinical significance with selective serotonin reuptake inhibitors. Drug Sa.f 1997;17:390-406.
Egberts AC, ter Borgh J, Brodie-Meijer CC. Serotonin syndrome attributed to tramadol addition to paroxetine therapy. Int Clin Psychopharmacol. 1997;12:181-182. Abstract
Manos G. Possible serotonin syndrome associated with buspirone added to fluoxetine. Ann Pharmacother. 2000;34: 871-874. Abstract
Sclar DA , Robison LM , Skaer TL. Concomitant triptan and SSRI or SNRI use: a risk for serotonin syndrome. Headache. 2008;48:126-129. Abstract
Lavery S, Ravi H, McDaniel WW, Pushkin YR. Linezolid and serotonin syndrome. Psychosomatics. 2001;42:432-434. Abstract
Gardner DM, Lynd LD. Sumatriptan contraindications and the serotonin syndrome. Ann Pharmacother. 1998;32:33-38. Abstract
Looper KJ. Potential medical and surgical complications of serotonergic antidepressant medications. Psychosomatics. 2007;48:1-19. Abstract
Ingelman-Sundberg M, Genetic polymorphisms of cytochrome P450 2D6 (CYP2D6): clinical consequences, evolutionary aspects and functional diversity. Pharmacogenomics J. 2005;5: 6–13.
Gnanadesigan N, Espinoza RT, Smith R, Israel M, Reuben DB. Interaction of serotonergic antidepressants and opiod analgesics: Is serotonin syndrome going undetected? J Am Med Dir Assoc. 2005;6:265-269.
Gan SH, Ismail R, Wan Adnan WA, Wan Z. Correlation of tramadol pharmacokinetics and CYP2D6*10 genotype in Malaysian subjects. J Pharm Biomed Anal. 2002;30:189-195. Abstract
Enggaard TP, Poulsen L, Arendt-Nielsen L, Brosen K, Ossig J, Sindrup SH. The analgesic effect of tramadol after intravenous injection in healthy volunteers in relation to CYP2D6. Anesth Analg. 2006;102:146-150. Abstract
Reason J. Human error: models and management. BMJ. 2000;320:768-770. Abstract

Suggested Readings: Evans RW. The FDA alert on serotonin syndrome with combined use of SSRIs or SNRIs and triptans: an analysis of the 29 case reports. Medscape General Medicine. 2007;9:48. Available at: http://www.medscape.com/viewarticle/561741 Accessed October 31, 2008.

Doctors to Quit

To me this is no surprise. It is, in effect, a wake up call to everyone that the health care system in the US is in much worse shape than you've been told.

One problem is the shift that started back in the 1980s toward limits to exactly what is the definition of 'a doctor visit'.

When the managed care model came into vogue patient care really started a down hill slide. I notice things like this more easily than a person who hasn't been in the health care industry, perhaps more so because I've been both a provide and an administrator.

Today you can see your doctor for one issue only. That means if you happen to have a headache and a sore knee you have to make two appointments. This of course increases billable hours and the bottom line. It also fragments care.

If you are in an HMO or similar managed care you might not always get the same doctor so continuity of care is out the window.

Insurance regulations contribute to this. Pharmaceutical control and restrictive licensing issues are factors.

And then there is the factor relating to the inability to provide high quality care to people with chronic health problems, and a focus on prevention and cure.

Perhaps we need to get on a track to lead health care to a system as if people mattered.

Another way of looking at this is to get on a train to education so you can learn what measures you can take to improve your health and increase the use of natural care in your health maintenance options.

Certainly we need to overhaul USDA and FDA controls on health care options. We also need to have a level approach to health care where everyone gets the same basic coverage.

Now everyone in Congress, everyone employed or corporate fat cats will all get the same services.

In the mean time I am going to continue taking my vitamins and other herbs and supplements, in spite of news reports saying otherwise.

This protects my health. It can protect yours too!

Many doctors plan to quit or cut back Tue Nov 18, 2008

WASHINGTON (Reuters) – Primary care doctors in the United States feel overworked and nearly half plan to either cut back on how many patients they see or quit medicine entirely, according to a survey released on Tuesday.

And 60 percent of 12,000 general practice physicians found they would not recommend medicine as a career.

"The whole thing has spun out of control. I plan to retire early even though I still love seeing patients. The process has just become too burdensome," the Physicians' Foundation, which conducted the survey, quoted one of the doctors as saying.

The survey adds to building evidence that not enough internal medicine or family practice doctors are trained or practicing in the United States, although there are plenty of specialist physicians.

Health care reform is near the top of the list of priorities for both Congress and president-elect Barack Obama, and doctor's groups are lobbying for action to reduce their workload and hold the line on payments for treating Medicare, Medicaid and other patients with federal or state health insurance.

The Physicians' Foundation, founded in 2003 as part of a settlement in an anti-racketeering lawsuit among physicians, medical societies, and insurer Aetna, Inc., mailed surveys to 270,000 primary care doctors and 50,000 practicing specialists.

The 12,000 answers are considered representative of doctors as a whole, the group said, with a margin of error of about 1 percent. It found that 78 percent of those who answered believe there is a shortage of primary care doctors.

More than 90 percent said the time they devote to non-clinical paperwork has increased in the last three years and 63 percent said this has caused them to spend less time with each patient.

Eleven percent said they plan to retire and 13 percent said they plan to seek a job that removes them from active patient care. Twenty percent said they will cut back on patients seen and 10 percent plan to move to part-time work.

Seventy six percent of physicians said they are working at "full capacity" or "overextended and overworked".

Many of the health plans proposed by members of Congress, insurers and employers's groups, as well as Obama's, suggest that electronic medical records would go a long way to saving time and reducing costs.

(Reporting by Maggie Fox; editing by Chris Wilson)
Copyright © 2008 Reuters Limited.

U.S. Trails Other Nations in Chronic Illness Care
By Will Dunham

WASHINGTON (Reuters) Nov 13 - Chronically ill Americans are more likely to forgo medical care because of high costs or experience medical errors than patients in other affluent countries, according to a study released on Thursday.

The study comparing the experiences of patients in eight nations reflected poorly on the U.S. health care system as President-elect Barack Obama and his allies work on plans to rein in health costs and extend insurance to more people.

The researchers questioned 7,500 adults in Australia, Canada, France, Germany, Netherlands, New Zealand, Britain and the United States. Each had at least one of seven chronic conditions: high blood pressure, heart disease, lung disease, diabetes, cancer, arthritis and depression.

Dutch patients had the fewest complaints, while the Americans had plenty, according to the study by the Commonwealth Fund, a New York-based health policy research group.

Fifty-four percent of Americans surveyed said high costs prevented them at some point from getting recommended medical care, filling prescriptions or seeing a doctor when ill. Seven percent of the Dutch cited cost as a barrier to treatment.

In addition, 41 percent of the U.S. patients said they spent more than $1,000 over the past year on out-of-pocket medical costs. That compared to lows of 4 percent in Britain and 5 percent in France.

A third of U.S. patients said they were given the wrong medication or dosage, experienced a medical error, received incorrect test results or faced delays in hearing about test results, more than any of the other countries.

WASTED TIME

Almost half of the U.S. patients said their time had been wasted because of poorly organized care or had received care of little or no value during the past two years. These views were lowest in the Netherlands and Britain.

Only Canadians reported visiting an emergency room at higher rates in the past two years than the Americans.

The Commonwealth Fund's Cathy Schoen, who worked on the study, said the United States spends twice as much on health care as the others, with the current economic woes putting more people at risk of losing employer-provided health insurance.

"Overall, the United States stands out for chronically ill adults reporting the most negative experiences," Schoen said in a conference call with reporters.

"In short, the U.S. patients are telling us about inefficient, unsafe and often wasteful care. The lack of access, combined with poorly coordinated care, is putting these patients at very high health risk and driving up costs of care."

The U.S. Census Bureau has reported that 15 percent of Americans, 45.7 million people, had no public or private health insurance last year.

The study, published in the journal Health Affairs, was the latest to show the U.S. health care system is performing worse than those in comparable countries. Unlike many rich nations, the United States does not have universal health care.

(Editing by Maggie Fox)

Test Panel Checks for 12 Viruses

In January 2008 the FDA approved a new lab test for a panel of viruses.

In early November, the Wall Street Journal reported on the test as

" A new cold and flu test can precisely diagnose a dozen winter ailments and reduce unneeded use of antibiotics, says the company that sells it. Physicians say the test is accurate and the most comprehensive available, but some say its long processing time limits usefulness in emergency rooms. "

Health News Review today ranks this article with 5 Stars and says

"This story does a good job of presenting accurate, comprehensive information - a balanced approach in presenting the evidence supporting the pros and cons of the test."

More on the evaluation of the story can be found on their web site.

FDA Clears Test to Identify 12 Respiratory VirusesFDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses.

The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001.

The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, specific beads, or microspheres, bind to the amplified viral genetic material. The beads are then sorted so that the specific virus can be identified.

The xTAG panel is the first FDA-cleared test for infectious respiratory disease viruses that uses a multiplex platform, allowing several tests to be processed using the same sample.

"Nucleic acid tests such as the xTAG Respiratory Viral Panel utilize small amounts of genetic material, and then replicate it many times," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

"This speeds up the usual process of detecting and identifying respiratory viruses, which can take up to a week," said Schultz. "And, because this multiplex viral panel tests for 12 viruses at once, it uses less of a patient's test specimen."

Other viruses identified by the xTAG Respiratory Viral Panel:

influenza B - one of three types of human influenza, less severe than influenza A respiratory syncytial virus subtype A and B - both are leading causes of infant pneumonia and bronchiolitis (an infection of the airways leading to the lungs) and often contribute to the development of long-term pulmonary disease

parainfluenza 1, 2 and 3 - all are leading factors in the croup and the common cold

rhinovirus - the most common viral infective agent in humans and a cause of the common cold

adenovirus - a cause of respiratory tract infections often similar to strep throat or tonsillitis

While the test is faster than conventional tests, it is specific to the dozen viruses listed and should be used with other diagnostics such as patient data, bacterial or viral cultures and X-rays. Positive results do not rule out other infection or co-infection and the virus detected may not be the specific cause of the disease or patient symptoms.

The xTAG Respiratory Viral Panel is manufactured by Toronto-based Luminex Molecular Diagnostics.

SOURCE: FDA Press Release, January 3, 2008

© 2008 MedicineNet, Inc. All rights reserved.
MedicineNet does not provide medical advice, diagnosis or treatment.

The American Cancer Society Has It All Wrong

A new news report from the American Cancer Society (ACS) cites The Physicians Health Study headed up by Howard Sesso of Harvard-affiliated Brigham and Women's Hospital in Boston as "proof" vitamin C and vitamin E don't protect doctors from cancer.

The ACS conclusion also promulgates the concept that diet is the best source of vitamins.

In the study vitamin E was offered at 400 international units every other day; vitamin C was 500 milligrams daily.

At this low level of supplementation it would be difficult to reach therapeutic dose levels. It is the therapeutic dose level that protects and prevents.

It certainly is a vested interest of the ACS to dissuade the public from using vitamins because their survival relies on the fraudulent "Race for the Cure", no support for prevention and little or no inclusion of natural therapies that may be better alone or better augment the current strategies. The current strategies are linked to drugs and radiation with little to show for true long term survival in significant numbers.

It is sad to say that a Harvard affiliated institution is so remiss in its research approach that it has failed to uncover well established research that shows the effectiveness of the two vitamins for cancer prevention (such as colon cancer and vitamin E) or preventing hair loss with vitamin E provided at therapeutic dose level two days preceding chemo treatments. The therapeutic dose level of vitamin E in the very famous Drs. Schute Brothers study showing it reversed cardiovascular disease was 800 IU daily.

We also do not know if The Doctors Study used soy based vitamin E or the synthetic dl form which makes it half as effective as natural vitamin E products.

We don't know the form of vitamin C utilized either, and to say the least, the real daily minimum dose of vitamin C for adult humans is 3000 mg. Its hard to believe that 500 mg a day would do much at all, but 500 mg daily is eight times more than the USDA RDA!

As far as food sources of vitamins, yes there are some. The higher amounts are found in organically grown food. Most people can't afford organic fruits and vegetables. Commercial products are usually heavily sprayed with herbicides, pesticides and fungicides that effectively eliminate most vitamin content.

Vitamin C for instance, in therapeutic doses, can bring about dramatic recovery for blood based cancer. It has great effectiveness for hepatitis C recovery as well.

I've taken therapeutic doses of vitamin C for decades. I take no prescription drugs, don't wear glasses, don't have arthritis, kidney or gall stones, and have mostly dark brown hair. I'm told I don't look any where close to my age. And I'm not the only one I know who is a supplement supporter with similar results.

Resources for a primer of supportive information on the benefits of E and C.

Of course the choice is yours, but recall that in the late 1970s a Seattle area doctor told me that people in his practice recovered from standard cancer treatment much faster and with less problem when using the vitamin-mineral protocol I provided for him.

Perhaps, had they taken the vitamins before the diagnosis, they might never have experienced cancer.

Vaccine Comment

"Our main concern is with the pertussis (whooping cough) vaccine. One in 3000 doses cause permanent injury to a child."

James Strain, MD (American Academy of Pediatrics)

as quoted in the United Press.

In 1926, according to historical evidence and the AMA, the pertussis vaccine was known to be associated with neurological damage to children.

It appears little has changed except for more vaccines and more problems.

Safe Disposal of Rx Drugs

Water treatment facilities are burdened because people often dispose of drugs by throwing them into a toilet and flushing then down the drain.

Because water treatment facilities cannot remove the chemicals from the water supply all of us are inundated with drug metabolites including hormones to chemotherapy.

Be wise and incinerate. Check with a local pharmacy or hospital in your area for resources. Be Wise.

How Do You Dispose of Unused Meds?

Unwanted Drugs Pollute Waterways, But One City Has Come Up With A Solution to Keep Them Out of the Water Supply

Studies have shown the presence of a wide range of over-the-counter and prescription drugs in our waterways due to the flushing of old or unwanted meds and human waste.

In addition, farms provide a runoff problem, and an ongoing AP investigation found that millions of pounds of unused pharmaceuticals are flushed by hospitals and long-term care facilities in the US.

But how else can people dispose of these drugs?

Chicago has come up with a solution. According to the Environmental News Service, the Windy City has set up drop boxes at five police stations where people can deposit expired or unused prescription drugs. The meds will then be packaged and sent to a state-authorized incinerator for destruction.

The program is funded by the EPA and the Illinois EPA.

Mayor Richard Daley is quoted in the article: "Many people may not be aware that improperly disposing of prescription or over-the-counter drugs, such as flushing them down the toilet, contributes to pharmaceuticals found in our waterways."

In March, according to the article, the Illinois EPA tested the drinking water of five public water supplies in Illinois, and identified 16 pharmaceuticals, including caffeine, nicotine, aspirin and the insect repellent DEET, prescription drugs such as the antibiotic penicillin, the anti-convulsant Dilantin and the thyroid hormone replacement Levothyroxine.

While this is a step in the right direction, the article says the majority of trace pharmaceuticals found in the city's waterways are the result of human and livestock excretion.

Find this article at: http://www.thedailygreen.com/environmental-news/latest/chicago-meds-drop-boxes-44111208

'Old treatments' better

Two of the most effective treatments I have ever used with clients experiencing GI problems have been peppermint oil (and tea) as well as fiber or a favorite fiber blend.

A Novartis drug taken off the market recently made me want to pull my hair out because it had such offensive ads. Women were targeted and I think the tome was that IBS was one of those "hypochondriac" and imaginary illnesses.

I guess no one at Novartis knew, or cared, that IBS and other issues like diverticulitis often were from a lack of fiber in the diet.

I like to use peppermint oil. Generally these come in coated capsules but I have had clients use peppermint tea and essential oil effectively. Peppermint oil does soothe and relax, but can fight bacteria as well.

Not to overlook the stress related GI problems, herbs such as marshmallow root for reducing inflammation along with scullcap or similar herbs, and selected flower essences can do quite a remarkable job.

'Old treatments' better for IBS
Older "overlooked" treatments for irritable bowel syndrome may end up being the best option for patients, research suggests.

Fibre, anti-spasmodic drugs and peppermint oil were all found to be effective in a review of the evidence.

Guidelines on IBS should be updated in light of the findings, the researchers say in the British Medical Journal.

A UK expert said there had been a general feeling among doctors that the therapies "didn't work".

Between 5% and 20% of the population is estimated to suffer from IBS which is characterised by abdominal pain and an irregular bowel habit.


This puts these simple remedies back on the agenda
Professor Roger Jones, King's College London

The exact cause of the condition is unknown and recommendations for treatment include dietary advice, antidepressants and alternative therapies.

Fibre, antispasmodics and peppermint oil are used to treat IBS, but evidence of their effectiveness is unclear because of conflicting results from studies, the researchers said.

They have also been overlooked because of the focus on newer more expensive drugs which ended up being withdrawn due to lack of efficacy and safety concerns, they added.

Benefits

By trawling through all the studies comparing the therapies with dummy pills or no treatment, the researchers were able to look at data from 2,500 adult patients with IBS.

Fibre, antispasmodics and peppermint oil were all found to be effective, with doctors needing to treat 11, 5 and 2.5 patients, respectively for one patient to benefit.

Insoluble fibre such as bran was not beneficial; only isphaghula husk - a soluble form of fibre - significantly reduced symptoms.

Hyoscine - extracted from the cork wood tree - was the most successful antispasmodic drug looked at and should be the first choice, the researchers said.

Out of all three treatments, peppermint oil seemed to come out on top.

Both peppermint oil and hyoscine - an antispasmodic not currently widely prescribed in the UK - are available from the pharmacy.

Study leader Dr Alex Jones, a gastroenterologist who has recently moved from Canada - where he did the research to St James University Hospital in Leeds - said the treatments were cheap, safe and had been in use for 15 to 20 years.

"They fell out of favour with the development of new drugs.

"This is good news for patients."

Professor Roger Jones, head of the Department of General Practice at Kings College London, and founding president of the Primary Care Society for Gastroenterology, said: "There is a general feeling that they don't work very well.

"With all of the treatments for IBS, there is a huge placebo effect so it is easy to imagine your treatment is working then the trials come along and suggest they don't.

"This puts these simple remedies back on the agenda."

He added that the study did not pick out which patients would benefit from which treatment but as they are safe and cheap, patients can test what works best for them.

Story from BBC NEWS: http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7727459.stm
Published: 2008/11/14
© BBC MMVIII

Taking Deatiled Health History Better Than Tests

I know of many situations where people suffering heart attacks were given post-event stress EKG (ECG), passed with flying colors, returned to work, then died in weeks to a month or three.

In the early to mid 1970s I used to teach physical diagnosis to other health professionals who were studying for the early critical care certification exams. Interviewing technique was also stressed in my NP classes and in my college nursing curriculum.

Somewhere along the way this very important diagnostic tool seems to have fallen by the wayside in exchange for lab tests or other diagnostic testing such as an EKG. Often, especially in health care settings where women, disabled or people of color, complaints of symptoms may be dismissed.

While EKG can be helpful in many situations, interpreting the results may be another story.

Heart test 'cannot predict risk'
Heart tests offered to many patients with chest pain are of little value in predicting future heart disease, say researchers.

Instead of electrocardiagram (ECG) tests, doctors should spend more time quizzing patients about their symptoms and examining them, they said.

The British Medical Journal study, by the London Chest Hospital, followed 8,176 suspected angina patients.

A heart charity stressed that the test was useful in other circumstances.

"Better risk assessment of patients with angina is needed to help identify those most at risk of heart attack or death."
Dr Mike Knapton, British Heart Foundation

Approximately two in 100 people in the UK experience angina, which is the most common symptoms of heart disease.

Reporting chest pain to a doctor generally means referral to a rapid access clinic, where ECGs taken to predict whether a patient needs further attention.

An ECG monitors the electrical activity of the heart over a period of time, looking for evidence of weakness in the heart muscle, or abnormal rhythms.

Often the patient will be asked to undergo the test while exercising, which can help highlight these problems.

The study compared the progress of the patients, 60% of whom who had an exercise ECG performed.

Among the 60%, 1,422 not only had the basic "summary" results recorded, but had detailed data from the ECG used to help make a diagnosis.

All the patients were then followed up for the next few years.

History call

However, almost half of all coronary "events", such as heart attacks, that happened during this period, happened in patients whose ECG results had not shown any sign of problems.

A routine clinical assessment, which involved taking a detailed "history" from the patient, and examining them thoroughly, was almost as good in predicting future heart disease as the exercise ECG.

The researchers concluded that the tests were "of limited value" to doctors faced by patients with no prior heart disease.

Dr Mike Knapton, from the British Heart Foundation said that while early diagnosis of angina was important, the study showed that the best way to achieve that was to talk to the patient.

"Tests such as resting or exercise ECGs can be helpful when patients present with unusual symptoms or suffer from chest pain following a heart bypass.

"But exercise ECG is not very good at assessing future risk. Better risk assessment of patients with angina is needed to help identify those most at risk of heart attack or death.

"Any results for ECGs should be in addition to consultation with your Doctor to properly monitor your condition."

Story from BBC NEWS: http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7728817.stm
Published: 2008/11/14
© BBC MMVIII

How Crazy Was This?

Journal of Medical Ethics 1992;18:94-98; doi:10.1136/jme.18.2.94
Copyright © 1992 by the BMJ Publishing Group Ltd & Institute of Medical Ethics.
Articles by Bentall, R P

A proposal to classify happiness as a psychiatric disorder.
Department of Clinical Psychology, Liverpool University.

It is proposed that happiness be classified as a psychiatric disorder and be included in future editions of the major diagnostic manuals under the new name: major affective disorder, pleasant type. In a review of the relevant literature it is shown that happiness is statistically abnormal, consists of a discrete cluster of symptoms, is associated with a range of cognitive abnormalities, and probably reflects the abnormal functioning of the central nervous system. One possible objection to this proposal remains--that happiness is not negatively valued. However, this objection is dismissed as scientifically irrelevant.

Vitamin C Effective in Reducing Inflammation

Inflammation is involved in numerous health issues from allergy to post-op surgical reactions. Life Extension provides this chart -

Allergy: Inflammatory cytokines induce autoimmune reactions

Alzheimer's: Chronic inflammation destroys brain cells

Anemia: Inflammatory cytokines attack erythropoietin production

Aortic valve stenosis: Chronic inflammation damages heart valves

Arthritis: Inflammatory cytokines destroy joint cartilage and synovial fluid

Cancer: Chronic inflammation causes many cancers

Congestive heart failure: Chronic inflammation contributes to heart muscle wasting

Fibromyalgia: Inflammatory cytokines are elevated

Fibrosis: Inflammatory cytokines attack traumatized tissue

Heart attack: Chronic inflammation contributes to coronary atherosclerosis

Kidney failure: Inflammatory cytokines restrict circulation and damage nephrons

Lupus: Inflammatory cytokines induce an autoimmune attack

Pancreatitis: Inflammatory cytokines induce pancreatic cell injury

Psoriasis: Inflammatory cytokines induce dermatitis

Stroke: Chronic inflammation promoted thromboembolic events

Surgical complications: Inflammatory cytokines prevent healing

The more vitamin C you take the less inflammation you will experience.

The important information about anti-oxidant vitamins is certainly something you aren't reading in the mainstream press or hearing on TV or radio.

Certainly vitamin C is much less expensive than a statin drug and isn't replete with serious side effects or death. The important concern is to purchase a mineral bound ascorbate form of the vitamin, or those with food based formulas. The vitamin C blend we have been offering our our clients for the last decade or more contains both food and mineral-ascorbate sources and is organic as well(C5 or C5+).

The USDA-RDA dose of sixty milligrams of vitamin C daily will prevent scurvy but it is not therapeutic enough to prevent or reverse health problems.

Outside the issue of CRP, adequate vitamin C intake daily is one of the best preventive measures against macular degeneration you can use.

Of course the choice is yours, but there is quite enough information I've posted about CRP and related issues here on Natural Health News to get your brain cells itching for relief of inquiring mind syndrome.

An article scheduled to appear in the January 1, 2009 issue of Free Radical Biology and Medicine reports the finding of researchers at the University of California, Berkeley that supplementing with vitamin C reduces C-reactive protein (CRP), a marker of inflammation linked with an increased risk of cardiovascular disease and diabetes.

Berkeley professor emeritus of epidemiology and public health nutrition Gladys Block and her associates randomized 396 nonsmokers to receive 1000 milligrams vitamin C, 800 international units vitamin E, or a placebo for two months. Serum C-reactive protein levels were measured before and after the treatment period.

Although no effects for vitamin E were observable, and no effect for vitamin C was noted among those with desirable CRP levels, for participants with elevated C-reactive protein (defined as 1 milligram per liter or higher), vitamin C lowered CRP by 0.25 milligrams per liter compared to the placebo, a reduction similar to that associated with statin drug treatment.

"This is an important distinction; treatment with vitamin C is ineffective in persons whose levels of CRP are less than 1 milligram per liter, but very effective for those with higher levels," stated Dr Block. "Grouping people with elevated CRP levels with those who have lower levels can mask the effects of vitamin C. Common sense suggests, and our study confirms, that biomarkers are only likely to be reduced if they are not already low."

Dr Block noted that a trial reported earlier this week in the Journal of the American Medical Association, which found no association between supplementation with vitamins C and E and the risk of stroke or heart attack, failed to screen participants for CRP elevation, which is important in the determination of who might benefit from vitamin C.

In another recently reported study ( the Jupiter trial), Harvard Medical School researchers showed that statin drugs reduced cardiovascular disease and cardiovascular mortality in individuals with normal lipids and elevated CRP. The trial found a 37 percent reduction in CRP associated with statins compared to treatment with a placebo. "One of the strengths of the Jupiter trial is that only persons with CRP levels greater than 2 milligrams per liter were enrolled," Dr Block remarked. "Researchers found very important effects of lowering CRP in people who had high levels to begin with."

"Major studies have found that the level of CRP in the body predicts future risk of cardiovascular disease, including myocardial infarction, stroke and peripheral artery disease, as well as diabetes," Dr Block stated. "Some believe CRP to be as important a predictor of future heart problems as high levels of LDL and low levels of HDL cholesterol."

"This is clearly a line of research worth pursuing," she added. "It has recently been suggested by some researchers that people with elevated CRP should be put on statins as a preventive measure. For people who have elevated CRP but not elevated LDL cholesterol, our data suggest that vitamin C should be investigated as an alternative to statins, or as something to be used to delay the time when statin use becomes necessary."

Cholesterol and Statins: Another physician reviews the Jupiter study

UPDATE: 21 April, 2010 -
Cholesterol Drugs May Lower Men's Sex Drive
Some new studies believe that low testosterone is associated with prostate cancer.
Eating your way to lower cholesterol Note that we do not support the use of plant sterols as they are mainly sourced from GMO soy and canola oil

ORIGINAL POST
In addition to the many posts (136) here on Natural Health News, there is a selection of related articles on our main website.

Statins reduce cardiovascular disease in healthy people, and why this study is a poke in the eye for the cholesterol hypothesis

By Dr John Briffa On November 10, 2008

It’s been going this way for a while: even healthy people should be on the cholesterol-reducing drugs known as statins. That, in a nutshell, is the verdict of a study published over the weekend which found that even in people deemed to be at low risk of cardiovascular disease, treatment with rosuvastatin (Crestor) at a dose of 20 mg per day almost halved the risk of ‘vascular events’ (such as heart attack, stroke, and death from these conditions) in middle-aged and elderly men and women. Overall risk of death was down too in those taking the rosuvastatin, to the tune of 20 per cent. Average length of treatment was a shade under two years.

These results look impressive, but it does need to be borne in mind that the study population were essentially healthy. And, because of this, the risk of things like heart attacks and strokes is generally low in this population. Just to put this in perspective, the risk of vascular events was 2.2 per cent in the group taking the statin, but 2.8 per cent in those on placebo. In other words, what is known as the absolute risk reduction (as opposed to the relative risk reduction) was a little over half a percent.

It is perhaps also worth reflecting on the fact that treatment with rosuvastatin was associated, compared with placebo, with a significantly increased risk of developing diabetes. Curiously, the authors of the study say this effect could “reflect the play of chance.” In other words, even though there was a statistically significant enhanced risk of diabetes in those taking the statin, it may have nothing to do with the statin, and everything to do with bad luck. Curiously, the authors are not similarly circumspect about the positive effects of statins seen in this study.

But the reason for writing about this study is not so much to put the results in this context, but more to explore what these results say about the widely accepted context that cholesterol causes cardiovascular disease. On the face of it, this study strengthens this concept. But I’m not so sure.

You see this study was done in individuals whose cholesterol levels were not deemed to be risky. Individuals had to have LDL cholesterol levels of less than 130 mg/L (3.37 mmol/L) to qualify. However, to qualify for the study individuals did have to have elevated levels of a substance known as C-reactive protein (CRP). CRP is a marker for inflammation in the body, and inflammation is believed to be a key underlying process in the development of cardiovascular conditions such as heart disease and stroke.

Significant benefits were seen individuals who had elevated CRP levels, but no other major risk factors for cardiovascular disease (and LDL cholesterol levels of 100 mg/L or less). This inevitably throws up the possibility that in this study, the benefits of rosuvastatin came, at least in part, through its ability to reduce CRP levels. CRP levels actually dropped by 37 per cent on average in this study.

Cholesterol levels dropped too (LDL levels actually halved), but as the authors point out, the clinical benefit associated with this was much larger than expected. This finding also adds weight to the idea that rosuvastatin’s benefits may have been less to do with bringing cholesterol levels down, and more to do with an anti-inflammatory and/or other actions.

Previously on this site I have cited a 2006 review of the evidence regarding the relationship between cholesterol and cardiovascular outcomes such as heart attacks and strokes [2]. Having reviewed a broad range of available evidence, the authors of this review stated that: ‘…no clinical trial subgroup analyses or valid cohort case control analyses suggesting that the degree to which LDL cholesterol responds to statin independently predicts the cardiovascular risk reduction.” In other words, there is no robust relationship between cholesterol levels and degree of risk of cardiovascular disease.

This is not the only review that has found this. In another from the same year, researchers reviewed 13 studies in which statins were used in individuals who had suffered from ‘acute coronary syndrome’ (i.e. heart attack and angina). Statin therapy was found to reduce risk of cardiovascular disease, but this was independent of LDL cholesterol reduction. The authors concluded that there is no significant evidence that reduction in LDL cholesterol level explains the clinical benefits seen with statin therapy on cardiovascular disease risk [3].

And what of studies that have assessed the relationship between CRP and cardiovascular outcomes? The lead author of the recent NEJM paper was also the lead author of a paper published in 2005 that assessed data from another large statin study (the so-called ‘PROVE-IT’ study) [4]. The study concluded: “Patients who have low CRP levels after statin therapy have better clinical outcomes than those with higher CRP levels, regardless of the resultant level of LDL cholesterol.”

From the same year, comes another study in which the relationship between LDL cholesterol and CRP levels and development of the process which narrows the coronary blood vessels in heart disease (atherosclerosis) in individuals treated with a statin. Atherosclerosis actually regressed in patients with the greatest reduction in CRP levels, but not in those with the greatest reduction in LDL cholesterol levels [5].

Another way of unpicking the role of cholesterol in health would be to go beyond statins, and look at the effectiveness of other cholesterol reducing drugs or strategies on overall risk of death. This latest study, and others (particularly in those at high risk of cardiovascular disease) found statin therapy is associated with a reduced risk of death. A review from 2005 assessing the impact of cholesterol reducing therapy on overall mortality. Here are the results:

Statins – statistically significant reduction in risk of overall mortality

Fibrates – NO statistically significant reduction in risk of overall mortality

Resins – NO statistically significant reduction in risk of overall mortality

Niacin – NO statistically significant reduction in risk of overall mortality

Diet – NO statistically significant reduction in risk of overall mortality

Some people argue that the failure of other cholesterol-reducing strategies is because they don’t reduce cholesterol enough. I suppose that’s one potential explanation. Here’s another: cholesterol reduction doesn’t have broad benefits for health.

References:

1. [1] Ridker PM, et al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. New England Journal of Medicine. Epub 9th November 2008.

2. Hayward RA, et al. Narrative review: lack of evidence for recommended low-density lipoprotein treatment targets: a solvable problem. Ann Int Med 2006;145:520-530

3. Hulten E, et al. The effect of early, intensive statin therapy on acute coronary syndrome: a meta-analysis of randomized controlled trials. Archives of Internal Medicine. 2008;166:1814-1821

4. Ridker PM, et al. C-reactive protein levels and outcomes after statin therapy. New Engl J Med 2005;352:20-8.

5. Nissen SE, et al. Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease. N Engl J Med 2005;352: 29-38
--------------------------------------------------------------------------------
Article printed from Dr Briffa’s Blog: http://www.drbriffa.com
URL to article: http://www.drbriffa.com/blog/2008/11/10/statins-reduce-cardiovascular-disease-in-health-people-and-why-this-study-is-a-poke-in-the-eye-for-the-cholesterol-hypothesis/
URLs in this post:
[1] Ridker PM, et al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. New England Journal of Medicine. Epub 9th November 2008.: http://content.nejm.org/cgi/content/full/NEJMoa0807646

Much Ado About Merck Marketing

I'd suggest the money spent on this fiasco be put to nutrition education in an effort to prevent and reverse diabetes rather than promote drug sales.

A group of labor unions is launching a campaign that accuses CVS Caremark Corp. of violating patient privacy and improperly pushing doctors to prescribe a costly prescription drug.

Change to Win, a group of unions that represents about six million workers, said CVS's pharmacy benefits management business has been urging doctors via a letter to add Merck & Co. diabetes drug Januvia to specific patients' treatments. The letter, obtained by the union group, said CVS identified the diabetes patients through a review of prescription-drug claims processed by its Caremark unit.

A line at the bottom of the letter says Merck paid for the mailing. Neither Merck nor CVS would say how much Merck paid, and the drug maker also declined to say whether the mailing boosted Januvia sales.

CVS said the union group's actions are rooted in a dispute about workplace rules. The unions represent several thousand CVS workers. The Woonsocket, R.I., company said the unions have been attacking CVS for more than a year, including objecting to two recent acquisitions.

Januvia is as much as eight times more expensive than many other diabetes treatments, according to a recent study. Some medical experts say patients may not need the drug and may respond just as well to older, cheaper treatments.

The CVS letter was previously reported by Phoenix Business Journal.

Change to Win says the Januvia letter is an example of CVS putting its interests ahead of the businesses that pay it to manage employee prescription-drug benefits. CVS became a big player in the pharmacy-benefits business when it acquired Caremark, then the nation's second-largest PBM, for about $27 billion in 2007.

A Merck spokeswoman said the Whitehouse Station, N.J., company paid for the mailing "to help inform physicians about additional treatment options." She added that "no personal information about patient participants in the plan are provided to Merck." The letters were sent by CVS Caremark, not Merck.

CVS said it does not improperly try to switch patients to more expensive drugs and protects the privacy of plan participants' health information. As for the Januvia mailing, CVS said it was part of a program to provide information to physicians and that doctors make the ultimate decision about prescribing a drug.

Employers and insurers hire PBMs with the goal of keeping costs low while providing access to a wide range of treatments.

In recent years, PBMs have been accused of favoring drugs that generate rebates and high profit margins. Six years ago, some patients complained about a letter from Longs Drug Stores urging the patients to switch to a new version of the osteoporosis treatment Fosamax. That mailing also was paid for by Merck.

The union campaign, set to be announced Friday, comes as CVS's PBM business has struggled. In its most recent quarterly earnings report, announced last month, revenue in the PBM unit fell about 1% to $10.6 billion.

Change to Win's executive director, Chris Chafe, said the goal of the CVS campaign is to change state laws to force PBMs to disclose to customers all payments or rebates they receive from drug companies; limit the amount of patient information the PBMs can disclose; and require that any switching of drugs results in lower costs for PBM customers.

Mr. Chafe said CVS was targeted because of its large role in the retail drug business and the PBM industry, and because the company manages prescription benefits of many union members. Change to Win's members include the Teamsters and the Service Employees International Union.

Write to David Armstrong at david.armstrong@wsj.com
http://online.wsj.com/article/SB122663485690627711.html?mod=todays_us_marketplace

And Now for the Rest of the Story

Just this past Sunday (9 November, 2008) I posted this article on Natural Health News: Boosting Drug Sales with Studies.

I added one follow-up article earlier today, and now I am happy to give you something to think about in terms of why sound nutrition is a better option than wholesale use of drugs. Supplements certainly do edge out the pharmaceuticals in this study.

You'll also see how it is totally possible to fool a lot of the people a lot of the time -

Why treat nutritional deficiency with drugs?
(OMNS, November 13, 2008) A recent study suggested that statins might be used to avoid the effects of nutritional deficiency. Writing in the New England Journal of Medicine, the Jupiter group described a study of statin drugs in people with high C-reactive protein and low cholesterol. (1) High C-reactive protein levels are associated with inflammation and heart disease/stroke. The authors concluded that, in apparently healthy persons with elevated C-reactive protein levels, rosuvastatin (Crestor) significantly reduced the incidence of major cardiovascular events.

Their much-publicized claim, that this statin lowers the risk of heart attack by approximately one half, is technically correct though highly misleading. The reported annual incidence of coronary events was 37 people in 10,000 (controls) and 17 people in 10,000 (treated). Similar results were reported for risk of stroke. When expressed as a proportion, a 46% improvement (17/37) sounds large. However, an improvement of 20 events (37-17) in 10,000 people known to be at risk is less impressive. Such an improvement means that 500 people (10,000/20) with this increased risk would need to take the tablet daily for a year, to prevent one person suffering an event.

The paper does not explicitly report deaths. One reason for this may be that if a person on statins suffered a heart attack, that person was about three times more likely to die than a control who was not on statins.

The cost of rosuvastatin per person is approximately $1000 per year. So, treating enough people to prevent one heart attack costs $500,000 per year. Since about 70% of the heart attacks were not fatal, prevention of a single death from heart attack would cost even more, approximately $1,700,000. Giving the benefit of the doubt, we may allow for a similar reduction in stroke and say that "only" $250,000 is needed to protect one person from a stroke or heart attack. It is hardly surprising that Astra Zeneca's share price increased by $1.3 billion dollars on release of this paper and the corresponding media hype. (2)

The media suggested millions of healthy people could cut their risk of heart disease by taking statins. (3) They also claimed that statins could cut the risk of heart attack for "everyone". (4) This is inaccurate and incorrect. The study did not include normal healthy people, only a sample of a relatively small number of people, suffering from inflammation (increased C-reactive protein) - a known cause of heart disease and stroke. Out of 89,890 people considered for inclusion, 17,802 people (19.8%) met the specific criteria of poor health for the study. Widespread prescription of statins to healthy people is not supported by these findings.

The fact that statins produce a modest improvement is unsurprising, since they are known to lower inflammation, as do many nutritional supplements. It has pointed out that Crestor lowered C-reactive protein by 37%, but vitamin E lowers it (C Reactive Protein) by 32%, (5) and vitamin C by 25.3%. (6,7) These effects are similar to those of statins and would be expected to provide comparable benefits, without side effects and at a lower cost.

Crestor and other statin drugs have serious side effects. The incidence of established side-effects, such as rhabdomyolysis (0.3 per 10,000 per year), myopathy (1.1 per 10,000) and peripheral neuropathy (1.2 per 10,000 per year) seems low, (8) but may be underestimated as it takes time to establish long-term side-effects. (The depletion of coenzyme Q10 by statins is a particular concern.) The figures imply that for every ten people who avoid a cardiovascular event, at least one previously healthy person will suffer a non-trivial side effect of the statin drug.

The doctors reported a statistically significant increase (270) in diabetes in the statin group compared to the placebo group (216). Over the course of the study, this corresponds to an increased risk of approximately 61 in 10,000 people. So, the number of people on statins reported to become diabetic was greater than the number that avoided a heart attack! These people might have shorter lives and be at greater risk of heart disease in the long term.

Notably, the Jupiter study was stopped early, which the authors admit prevents assessment of how side-effects might outweigh reported benefits in the longer term. The study was to last 3-5 years and the criteria for stopping were not included in the original published design. (9) The paper claims that when the study was stopped "these [diabetic] events were not adjudicated by the end-point committee". The committee either knew about the diabetes in which case it was considered, or it did not and the committee was not doing its job properly.

The Jupiter name stands for Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; the reader might think this "justification" sounds more like a marketing plan than a scientific endeavor. The researchers did not address the underlying cause of the inflammation and increased C-reactive protein: they simply treated the condition with drugs. In many cases, raised C-reactive protein is a result of nutritional deficiency. (10)

It is worth mentioning that several nutritional supplements inhibit inflammation and lower C-reactive protein, without causing known side effects. Deficiency in vitamins A, (11) B6, C, E, A, folate, carotenoids and lycopene, (12) and selenium (for example) is associated with raised C-reactive protein. (13,14,15) We suggest that the $250,000 cost of preventing a single cardiovascular event with rosuvastatin might be better spent funding a study of such inexpensive alternatives the deficiency of which may be the cause of the problem.

The people at risk could be encouraged to supplement their diet and restore their health without using these expensive drugs to conceal their underlying sickness.

Stick with the supplements!

References:

(1) Ridker P.M. Danielson E. Fonseca F.A.H. Genest J. Gotto A.M. Kastelein J.J.P. Koenig W. Libby P. Lorenzatti A.J. MacFadyen J.G. Nordestgaard B.G. Shepherd J. Willerson J.T. Glynn R.J. for the JUPITER Study Group (2008) Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein, NEJM, 359(21), 2195-2207.

(2) Mail Online (2008) Crestor news helps AstraZeneca market value leap by more than £1.3bn, 9:25 PM, 10th Nov.

(3) Smith R. (2008) Millions could cut heart attack risk by taking statins, study finds, telegraph.co.uk, 7:55AM GMT, 10 Nov.

(4) Hope J. (2008) The new statin drug that cuts the risk of heart attacks and strokes for EVERYONE, Daily Mail, 11th Nov.

(5) Devaraj S. Tang R. Adams-Huet B. Harris A. Seenivasan T. de Lemos J.A. Jialal I. (2007) Effect of high-dose alpha-tocopherol supplementation on biomarkers of oxidative stress and inflammation and carotid atherosclerosis in patients with coronary artery disease, Am J Clin Nutr, 86(5), 1392-1398.

(6) Block G. Jensen C.D. Dalvi T.B. Norkus E.P. Hudes M. Crawford P.B. Holland N. Fung E.B. Schumacher L. Harmatz P. (2008) Vitamin C treatment reduces elevated C-reactive protein, Free Radic Biol Med, Oct 10. [Epub]

(7) Sardi B. (2008) The Headline You Should Be Reading: Statin Drugs Don't Save Lives And May Increase Your Risk For Diabetes, Knowledge of Health Report, Nov 11.

(8) Law M. Rudnicka A.R. Statin Safety: A Systematic Review, The American Journal of Cardiology, 97(8), Suppl 1, S52-S60.

(9) Ridker P.M. JUPITER Study Group (2003) Rosuvastatin in the primary prevention of cardiovascular disease among patients with low levels of low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: rationale and design of the JUPITER trial, Circulation, 108(19), 2292-2297.

(10) Ford E.S. Liu S. Mannino D.M. Giles W.H. Smith S.J. (2003) C-reactive protein concentration and concentrations of blood vitamins, carotenoids, and selenium among United States adults, European Journal of Clinical Nutrition, 57, 1157-1163.

(11) Root M.M. Hu J. Stephenson L.S. Parker R.S. Campbell T.C. (1999) Determinants of plasma retinol concentrations of middle-aged women in rural China. Nutrition 15, 101-107.

(12) Boosalis M.G. Snowdon D.A. Tully C.L. Gross M.D. (1996): Acute phase response and plasma carotenoid concentrations in older women: findings from the nun study, Nutrition, 12, 475-478.

(13) Friso S. Jacques P.F. Wilson P.W. Rosenberg I.H. Selhub J.(2001) Low circulating vitamin B(6) is associated with elevation of the inflammation marker C-reactive protein independently of plasma homocysteine levels, Circulation, 103(23), 2788-2791.

(14) Devaraja S. Jialal I. (2000) Alpha tocopherol supplementation decreases serum C-reactive protein and monocyte interleukin-6 levels in normal volunteers and type 2 diabetic patients, Free Radical Biology and Medicine, 29(8), 790-792.

(15) Upritchard J.E. Sutherland W.H. Mann J.I. (2000): Effect of supplementation with tomato juice, vitamin E, and vitamin C on LDL oxidation and products of inflammatory activity in type 2 diabetes, Diabetes Care, 23, 733-738.

Nutritional Medicine is Orthomolecular Medicine

Low Cholesterol Risks

Professionals only supplements resources that I rely on in my clinical work usually publish reports on studies of natural supplements that help health concerns.

While most hear about how high cholesterol is so bad and how many risky drugs you need, often you don't hear that low cholesterol can impair your immune function or defer review of other more risky markers. Triglycerides included.

I've educated on triglyceride issues for so long it seems funny to me that its just hitting headlines. Still its not prominent in the media to equal the risk to your health.

The real warning should be that yes, high triglycerides will kill you.

The Deadly Truth about Low Cholesterol
It’s a common misconception with fatal consequences: Many people still believe that low total cholesterol levels mean you’re not at risk for stroke, heart attack, or any of the other deadly risks that come with cardiovascular disease.

But in reality, nothing could be further from the truth—and unless you’re paying close attention to one particular group of fats called triglycerides, your heart could be a ticking time bomb, no matter how healthy your cholesterol might look.

Triglycerides are naturally manufactured and stored by both your liver and fat cells. At normal levels, they’re a crucial source of energy for your body—but start producing more than you can store, and those excess triglycerides will be dumped into your bloodstream, where they can wreak havoc on your arteries, heart, pancreas, and liver.1

Studies have shown that abnormally high triglyceride levels raise your risk of heart attack threefold—and when accompanied by low levels of high-density lipoproteins (HDL, or “good” cholesterol), your risk jumps a staggering 16 times higher. In fact, this ratio is one of the single strongest predictors of heart attack risk, even more accurate than the better-known LDL (low-density lipoprotein, or “bad” cholesterol) to HDL ratio.2 And it isn’t just your heart that suffers. Studies show that risk of stroke, obesity, diabetes, and liver disease are all linked to these dangerous fats.3-5

Keeping triglycerides in check is absolutely critical to your health—and a simple combination of omega-3 fatty acids, niacin and a supplement blend™ can make all the difference. One recent trial showed that supplementing with fish oil daily slashed triglyceride levels by 46 percent in as little as eight weeks.6 And niacin boasts nearly five decades of research demonstrating that it not only reduces triglycerides and LDL cholesterol, but also increases HDL levels by up to 29 percent.7-8

Finally, be wary of your blood sugar: Numerous clinical trials have shown that refined carbs and sugar can actually double triglyceride production.9-10 Tossing sugary sodas and boosting protein intake can help.11 So can supplementing with natural blood sugar managing agents like bitter melon, goat’s rue and quercetin.12-13A comprehensive formulas like some we use in our work contain these ingredients along with several others, including cinnamon. Clinical trials reveal that this popular spice can reduce triglycerides by 23 to 30 percent.14

References:

1. Webster’s New World Medical Dictionary, 3rd edition, William Schiel, Jr, MD, Author, 2008, Webster publishing.

2. Gaziano, JM., Hennekens, CH. Fasting triglycerides, high-density lipoprotein, and the risk of myocardial infarction. Circulation. 1997 Oct 21; 96(8):2520-5.

3. Grundy, SM., Cleeman, JI., Merz, CN., Brewer, HB, Jr., Clark, LT., Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004 Jul 13; 110(2):227-39. Review. Erratum in: Circulation. 2004 Aug 10; 110 6):763.

4. Tanne, D., Koren-Morag, N., Graff, E. Blood lipids and first-ever ischemic stroke/transient ischemic attack in the Bezafibrate Infarction Prevention (BIP) Registry: high triglycerides constitute an independent risk factor. Circulation. 2001 Dec 11; 104(24):2892-7.

5. Kadikoylu G, Yavasoglu I, Bolaman Z. Plasma exchange in severe hypertriglyceridemia, a clinical study. Transfus Apher Sci. 2006 Jun; (3):253-7.

6. Vega GL, Chandalia M, Szczepaniak LS, Grundy SM. Effects of N-3 fatty acids on hepatic triglyceride content in humans. J Investig Med. 2008 Jun; 56(5):780-5.

7. Crouse, JR. 3rd. new developments in the use of niacin for treatment of hyperlipidemia: new considerations for use of an old drug. Coron Artery Dis. 1996 Apr; 7 (4):321-6.

8. Drexel H. Nicotinic acid in the treatment of hyperlipidaemia. Fundam Clin Pharmacol. 2007 Nov;21 Suppl 2:5-6.

9. Teff, KL., Elliott, SS., Tschop, M., Dietary fructose reduces circulating insulin and leptin, attenuates postprandial suppression of ghrelin, and increases in triglycerides in women. J Clin Endocrinol Metab. 2004 Jun;89(6):2963-72.

10. Furtado, JD., Campos, H., Appel, LJ., Miler, ER. Effects of protein, unsaturated fat, and carbohydrate intakes on plasma apolipoprotein B and VLDL and LDL containing apolipoprotein C-III: results from the OmniHeart Trial. Am J Clin Nutr. 2008 Jun;87 (6): 1623-30.

11. Parks, EJ., Skokan, LE. , Timlin., Dingfelder, CS. Dietary sugars stimulate fatty acid synthesis in adults. J. Nutr. 2008 Jun: 138 (6): 1039-46.

12. Sridhar MG, Vinayagamoorthi R, Arul Suyambunathan V, Bobby Z, Selvaraj N. Bitter gourd (Momordica charantia) improves insulin sensitivity by increasing skeletal muscle insulin-stimulated IRS-1 tyrosine phosphorylation in high-fat-fed rats. Br J Nutr. 2008 Apr;99(4):806-12.

13. Rivera L, Morón R, Sánchez M, Zarzuelo A, Galisteo M. Quercetin ameliorates metabolic syndrome and improves the inflammatory status in obese zucker rats. Obesity (Silver Spring). 2008 Sep;16(9):2081-7.

14. Anderson RA. Chromium and polyphenols from cinnamon improve insulin sensitivity. Proc Nutr Soc. 2008 Feb;67(1):48-53.

Unwarranted And Unwise: Mandatory HPV Vaccination

For well over a year we have been alerting readers of Natural Health News to the risks of the HPV vaccines, the problematic side effects, and the fact that for the most part it is unproven and that HPV more often than not clears on its own. We also believe it should not be mandatory, that there are no studies of long term effects, and several natural therapy approaches are available.

You can locate our prior posts on vaccines and Gardasil via the search function on Natural Health News.

Now we find that a number of experts agree.

Mandatory HPV Vaccination Is Unwarranted And Unwise, According to Experts

ScienceDaily (2008-11-12) -- A new article in the Journal of Law, Medicine & Ethics suggests that it is premature for states to currently mandate the HPV vaccine as a condition for school attendance. Gardasil is relatively new and long-term safety and effectiveness in the general population is unknown, experts point out. ... > read full article

Doctors: Disclose Off-label Prescribing To Patients

There exists a culture today in mainstream medicine, and sadly in the hybrid called naturopathic medicine, to treat patients like objects. Failing to explain medications or treatments is one of the missing links and a basic but forgotten ethic of health care practice.

There are just too many people who have not understanding of why they are given a drug for a symptom or what the drug or treatment might do or the adverse effects.

Arrogance fails to heal: Here take this drug, maybe it will make you sicker or kill you, but we're not telling.

Roulette anyone?

ScienceDaily (Nov. 11, 2008) — Doctors should be required to disclose when they are prescribing drugs off-label, argues a new article in this week's PLoS Medicine. Michael Wilkes and Margaret Johns from the University of California Davis argue that the ethics related to informed consent and shared decision-making provide an imperative for doctors to inform patients about the risks of a medical treatment when their use has not been approved by regulators.

Off-label prescriptions are those that do not comply with the use approved by the Food and Drug Administration (FDA) for the drug. While off-label prescribing is legal and accounts for roughly half of all prescriptions currently written in the US, it is often not supported by sound scientific evidence. Worse, say the authors, off-label prescribing can put patients at risk and drive up healthcare costs.

The public often assumes that all common uses of prescription drugs have been approved by the FDA, say the authors. But current law does not prevent doctors from prescribing a drug to any patient for any use whether it was approved for this use or not.

And while off-label prescribing is common and sometimes necessary (as in the area of paediatrics where many drugs have not been tested on children), Wilkes and Johns argue that off-label prescribing can also pose potentially serious risks. By definition no governmental body has conducted a review of the effectiveness or safety of the drug for the off-label use, they say. As a result, an off-label prescription may be ineffective or detrimental, and could be more costly than existing drugs.

Wilkes and Johns argue that the strict requirement that doctors obtain informed consent from patients before enrolling in a research study means they should obtain the same consent when a drug is being prescribed off-label as each such prescription is just like a mini research study. The contemporary expectation for shared decision-making between doctors and patients also supports full disclosure about off-label prescribing, leaving the option open for patients to opt for a drug which has received FDA approval for the condition in question.

"From an ethical perspective," say Wilkes and Johns, "[what is required is] open, honest discussions where doctors tell their patients that the use of the drug will be off-label and thus not approved for this indication, explain the risks, potential benefits, and alternatives, and then ask patients for their permission to proceed."

A recent PLoS Medicine paper (http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050210) described techniques by which drug companies covertly promote off-label use. Adriane Fugh-Berman (Georgetown University Medical Center, Washington DC) and Douglas Melnick (a preventive medicine physician working in North Hollywood, California) discussed the use of "decoy indications" and drug representatives to engage in illegal pharmaceutical marketing. Pharmaceutical marketing, they say, has "distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown."

"Companies that engage in off-label promotion should be heavily fined and their future marketing practices subject to increased scrutiny by regulatory agencies," say Fugh-Berman and Melnick.
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http://www.sciencedaily.com/releases/2008/11/081110223328.htm

Journal reference: Wilkes M, Johns M. Informed consent and shared decision-making: A requirement to disclose to patients off-label prescriptions. PLoS Med, 5(11): e223

Public Library of Science (2008, November 11). Doctors Should Disclose Off-label Prescribing To Their Patients, Experts Argue. ScienceDaily. Retrieved November 12, 2008, from http://www.sciencedaily.com? /releases/2008/11/081110223328.htm