FLU Shot and the Elderly: Nothing New

You will have heard in recent days that the spin on the recent flu vaccine failure, especially with the elderly, is making the rounds on almost all media outlets.  When I first heard this I thought where have these people been and why aren't they reporting with real facts and connected reporting of the same issue for many years past.

February 21, 2013

ATLANTA (AP) — It turns out this year's flu shot is doing a startlingly dismal job of protecting senior citizens, the most vulnerable age group.

The vaccine is proving only 9 percent effective in people 65 and older against the harsh strain of the flu that is predominant this season, the Centers for Disease Control and Prevention said Thursday. SOURCE

I guess it is the continuation of the promotion of confusion or just plain not wanting you to know. 

In general the issue of vaccinating Elders and getting poor results is not new.  And if it is well established that the effectiveness is  just not there then why continue the practice?

"... the vaccine's ability to keep the elderly alive was, "if present at all...very small and statistically non-significant and may simply be a healthy- user artifact that they were unable to identify".

" If an elderly person is not in good health, flu vaccination does little to help ward off lung infections, Dutch investigators report."

" In a review of 64 studies in 98 flu seasons, For elderly living in nursing homes, flu shots were non-significant for preventing the flu. For elderly living in the community, vaccines were not (significantly) effective against influenza, ILI or pneumonia.

Reference: “Vaccines for preventing influenza in the elderly.” The Cochrane Database of Systematic Reviews. 3(2006)."

NB: Also note that water fluoridation suppresses immunity and is having the effect of limiting vaccine effectiveness at an average rate of 50%.  Funny how this number is similar to the reported diminished effectiveness in the 2012 vaccine.

From the top 30+ posts on this topic from Natural Health News...

Natural Health News: FLU SHOT UPDATE

Feb 22, 2005

It will come as no surprise to vaccine critics that flu vaccination does not result in a decreased incidence of deaths in the elderly. In my book The Vaccine Guide (North Atlantic Books, 2002) I stated that, "The primary targeted ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Reverberating Issues with Flu Vaccine

Mar 25, 2010

In a review of 64 studies in 98 flu seasons, For elderly living in nursing homes, flu shots were non-significant for preventing the flu. For elderly living in the community, vaccines were not (significantly) effective against influenza, ...

http://naturalhealthnews.blogspot.com/

Natural Health News: More Vaccine Failure Reported

Oct 12, 2006

If an elderly person is not in good health, flu vaccination does little to help ward off lung infections, Dutch investigators report. They found that annual flu shots appear to reduce the risk of developing lower respiratory tract ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Comment on Flu Data Double Speak

Nov 05, 2009

They split 704 elderly patients into two groups, one of which had gotten a flu shot and one had not. They adjusted for criteria that had been ignored in other studies – like education, income and social status – and concluded ...

Worried About Heat? Hot Weather Help

Elders and others need to pay close attention in hot weather

This news article has some good information about being older and the current hot heat throughout most of the US.

By LINDSEY TANNER - AP Medical Writer 

Here is another cooling drink that should be considered -

Enjoy now while fresh mint is plentiful -

To make it: Place several sprigs fresh mint in a heat-safe container. Pour 1 cup of freshly boiled water over the mint and let it steep.  Then add 3 cups fresh water (not heated), stir and refrigerate 1 to 2 hours. Remove mint before serving.

More recipes in articles listed below for hot times of the year.

CHICAGO (AP) — This week's heat wave may be uncomfortable, but you're healthy, active and feel just fine. So what if you're over 65? Think again. Feeling good doesn't mean you're safe.

There are changes in an older person that raise the risk for heat stroke and other problems. An older body contains far less water than a younger one. Older brains can't sense temperature changes as well, and they don't recognize thirst as easily.


Blistering summer heat is an underappreciated killer, claiming by some estimates as many as 1,000 U.S. lives each year — more than any other type of weather.


One federal study found 40 percent of heat-related deaths were in people 65 and older. Those numbers could be lower if more heeded heat warnings aimed at seniors. Yet research has shown many people over 65 don't think the warnings apply to them — because they don't think they're "old."


Don Worden is 79 and an avid tennis buff who prefers playing doubles on outdoor courts along Chicago's lakefront — even in oppressive 90-degree temperatures like those hitting the Midwest this week.


"I don't pay too much attention to those" warnings, Worden said. "I stay in pretty good shape, and I don't feel they apply to me."


Worden said he drinks a lot of water and would stop a match if he started feeling effects from the heat, "but that hasn't happened."


Scott Sheridan, who studies the effects of heat and climate on health at Kent State University, researched how people over 65 view heat warnings. In his 2006 study of more than 900 people, he found about 70 percent knew about advice to drink plenty of water on very hot days, avoid outdoor activities and stay inside with air conditioning. But only about half said they followed the advice.


"People well into their 70s would say old people should watch out but not them," he said. "People just didn't want to be thought of in that same category."


Dr. David Zich, an emergency medicine specialist at Northwestern Memorial Hospital, said he has colleagues in medicine that age who shun being thought of as "elderly." But those heat warnings apply to them, too.


As Dr. William Dale, geriatrics chief at the University of Chicago Medical Center explains it, "Any older adult has less reserve and is more likely to become dehydrated than others, just because their overall body water goes down with age no matter how healthy you are."


The amount of water in the body declines with aging, from about 80 percent in young adulthood to about 55 to 60 percent for people in their 80s, Dale said.


Temperature sensors in the brain become less sensitive as people age, so the body doesn't get the same signals to drink water in hot weather, and older people often don't feel thirsty even when they need to replenish, Dale said.


They also may not feel the typical symptoms of dehydration, such as headache or dizziness. Some complain of just feeling "bad" and think they're getting sick, he said.


Conditions were ripe for those types of complaints Tuesday as a dense dome of hot air remained parked over much of the nation's midsection, raising temperatures into the mid- to upper-90s from the Texas Gulf Coast to the Rockies and the northern Plains. Tropical-level humidity raised the heat index in many places to nearly 120 degrees.


In South Dakota, up to 1,500 head of cattle died across the state from the heat. And in eastern Iowa, the scorching sun caused a portion of Interstate 380 to buckle. The weather also sent dozens of people to hospitals, canceled outdoor sporting events and caused sporadic power outages.


In such conditions, dehydration can lead to heat exhaustion and potentially deadly heat stroke. During a heat wave, that can happen in a matter of hours in older people if they over-exert themselves, don't drink enough water or are frail and don't get out of uncooled homes, said Dr. Chris Carpenter, an emergency medicine physician at Washington University School of Medicine in St. Louis.


Heat exhaustion can cause muscle cramps, low blood pressure, rapid pulse and nausea. It can be treated at home, by drinking water, getting into an air-conditioned room or sitting in front of a fan and misting the body with cool water.


But affected people should be monitored for mental changes and to make sure their temperature does not rise above 102 because the condition can quickly lead to heat stroke. A medical emergency, heat stroke involves temperatures of 104 or higher and can cause seizures, loss of consciousness and death.


Medicines many older people take also may make them more vulnerable to the heat. These include diuretics for high blood pressure, which increase urination — and make it more important to drink plenty of water, Dale said.


Some types of drugs can interfere with sweating and raise body temperature, including some medicines for insomnia, nausea, prostate conditions, Parkinson's disease and even Benadryl. Many list "dry mouth" as a side effect — a tip-off to drink more water, Zich said.


There aren't specific guidelines on how much water older people should drink in a heat wave.


Dale said he generally tells his older patients to drink a quart of water throughout the day, and to drink even if they don't feel thirsty.


Doctors also advise older patients to avoid alcohol and coffee during extreme heat because they can cause the body to lose fluid and contribute to dehydration.

Selections from Natural Health News

Natural Health News: Cooling Down in Hot Climates

Jun 11, 2011

“Cool Wave” towel is a must for all of your warm weather activities! Order Now! . Large 16” x 26” towel . Keeps you cool without getting you wet . Will remain10 to 20 degrees cooler than current air temperature for 4 to ...

SUN Safety

Jun 06, 2010

As summer in the northern hemisphere arrives in a few weeks, this can be helpful information for everyone, including your animal companions. New article - SUN SENSE. more information and article links here. Sun Safety Hot Weather Tip ...

Natural Health News: Forward Thinking

Apr 06, 2008

"These include heat stress, other heat-related illness events (affecting the heart, blood vessels and lungs), trauma from extreme weather events, and more allergic diseases." Meanwhile, greater air pollution would ...

Overprescribing the Healthy Elderly

As far as I know my mother was not prescribed statins during the last - highly drugged and controlled - years of her life.  She was over prescribed unnecessary psychiatric drugs.  None of the prescribed drugs were relevant to her closed head injury.  She was never referred to a neurologist in spite of my many requests, and she never received speech therapy for the expressive aphasia that kept her even more imprisoned.  My brother, a salesman for MetLife, ignored my requests for proper care  and later claimed I refused to collaborate on my mother's care.

Bentley Care Center threatened my brother if my mother was taken off the half dozen+ drugs, telling him she would be forced to move.  And most likely Medicare picked up the high priced tab for these drugs, a fraud in itself.

Elders aren't the only people who are over prescribed drugs by people who are not paying attention to the risks and hazards over time.  Health Forensics helps prevent this.

Why Funding Research and Drug Safety is Paramount

By Laura Newman | Jun 30, 2011 

My frail, 92-year-old mother was prescribed 80 mgs of the cholesterol-lowering drug, or statin, simvastatin for years. She fell four times in the last four years of her life: the last fall was the least forgiving. Doctors diagnosed her with rhabdomyolysis, a life-threatening condition, and acute kidney failure; she was dead within 8 weeks.

Source: Laura Newman

The MedlinePlus encyclopedia defines rhabdomyolysis as "the breakdown of muscle fibers and release of their contents (myoglobin) into the bloodstream." In severe case, "the myoglobin breaks down into potentially harmful compounds, blocking the kidneys, causing damage such as acute tubular necrosis or kidney failure. Dead muscle tissue may be caused by any condition that results in damage to skeletal muscle, especially trauma."

The FDA Safety Alert states that symptoms to watch for are: "muscle pain, tenderness or weakness, dark or red-colored urine, and unexplained fatigue" and should be brought to the attention of a health professional. Further, it advises doctors to inform patients taking that dose that they are at risk for rhabdomyolysis.

Rhabdomyolysis is a medical emergency. It is not uncommon after crush injuries, falls, and athletic feats. FDA’s safety warning that 80 mg simvastatin is linked to myopathy, issued on June 8, 2011, struck a chord in me because the 80 mg dose of simvastatin was the same given my mother.

An article in the Nov. 13, 2010 Lancet sounded an alarm that high-dose simvastatin could be hazardous. In a blinded randomized trial of more than 12,000 survivors of acute myocardial infarction, investigators found two (0.03%) cases of myopathy in patients taking 20 mg simvastatin daily, compared with 53 (0.9%) cases in the 80 mg group.

This finding could not be ignored. FDA pressed forward in further analyses. Even as my mother was in crisis, doctors told me that they were astounded that such a high-dose statin was given to a low-risk, frail, elderly women. By low-risk, she had no history of cardiovascular disease and she met the widely used and time-testedFramingham Risk Factor criteria. She did not smoke, had low-level, well-controlled hypertension, but a high cholesterol. I sensed deterioration months before she was diagnosed with rhabdomyolysis. Before she developed life-threatening rhabdomyolysis, she walked everywhere.

The Author and her mother in Canadian Rockies celebrating her 90th birthday. Source: Laura Newman

She called me, saying: "All of a sudden I feel exhausted, like my legs won’t support me, and I keep stopping and sitting down. I just don’t think I can do it anymore." Who knew whether it was normal aging? Her doctor did not think much of these changes.

FDA’s Simvastatin 80 mg Warning

FDA’s Drug Safety Communication: New Restrictions, Contraindications, and Dose Limitations for Simvastatin to reduce the risk of muscle injury state:

- Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drugs.

- Patients taking simvastatin 80 mg have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class.

- Muscle problems typically occur in the first year of use.

FDA is taking a major step to improve the public’s health. Whether it is far enough is debatable.

The consumer health advocacy group, Public Citizen considers 80 mg simvastatin unsafe and wants it off the market to protect the public. On its Worst Pills, Best Pillswebsite (subscribers only), it presses for a recall of 80 mg dose and urges consumers, no matter how long they have been on it, to ask their doctor for an alternative that is weaker.

According to FDA’s Safety Communication, approximately 2.1 million patients in the US were prescribed a product containing 80 mg simvastatin in 2010.

Prescribing Simvastin in the Elderly

Rodney Hayward, professor of public health and internal medicine at the University of Michigan, told me that sometimes, fatigue and muscle weakness are attributed to aging, when the culprit might be excess dosing. He said: "Unfortunately, people don’t realize that an excessive dose might be causing loss of appetite, muscle problems, and not eating enough. The most common adverse event with the high-dose statins are the myopathies, pain in the muscles." And if the old are not doing well, the sensible thing is to taper down."

Also, of critical importance, "as people age, the risks and benefits of people being on medicine change," said Hayward. "Processing through the kidneys especially is increasingly less effective. You want to be aware of how many medications, and how many doses people are on, and reconcile that with the amount of benefit and risk."

I thought that my mother had an eating disorder. She ate very little; it was all low fat, low cholesterol, and low salt. She ate like that for decades. She was 5’ 1" and weighed about 105 pounds. Her refrigerator was pretty empty.

Rita Redberg, MD, director of women’s cardiovascular services, the University of California San Francisco, points out that many trials of hyperlipidemia have not included enough women to determine gender-specific benefits and harms. Therefore, meta-analyses and systematic reviews become imperative. But particularly glaring is the reality that most studies have never demonstrated a survival benefit for statins at all for low-risk women like my mother, yet some doctors go so far as to put them on high-dose statins.

So one could argue that the benefit-risk ratio shifts towards harm in such women, particularly when they are given high-dose statins. Both Redberg and Hayward said that they know of no studies showing that low-risk people taken off statins are at increased risk for cardiac events. Hayward, Redberg, and many other physicians argue that doctors should be far more cautious in prescribing medications for the elderly.

"High-dose statins should almost never be used in the elderly," said Hayward. "In fact," he added: "I almost always use low doses of statins in people over 75 unless they have known heart disease, since most of the benefit of statins is achieved with low doses and there are good reasons to be concerned about the safety and tolerance of higher doses of statins in the elderly." People over age 75 are under-represented in clinical trials, leaving physicians in the dark as to safety.

Moreover, said Hayward: "With stepped-up dosing, the risk for harm escalates disproportionally. Most of the benefit from the simvastatin is in the initial dose. "

Factors in Overtreatment

Another issue of concern is whether overtreatment with high-dose statins has become widespread because of how heavy marketing, according to Hayward. Marketing of some statins promised achieving very low levels of low-density lipoprotein (LDL) cholesterol (a.k.a. "bad cholesterol"). It proved a valuable selling point. Setting targets this low may be inappropriate for the elderly, according to numerous pharmacoepidemiologists.

Also adding to the problem of overmedication are pay for performance (P4P) programs, which set specific targets in cholesterol-lowering to payment. Target setting is controversial because they may be too low for many individuals, yet they are widely used for assessing quality of care. One notable exception that may actually help keep the healthy elderly is that in HEDIS performance measures, people over age 75 are excluded from lipid-lowering targets.

Differences in the Elderly, in Women

Arguments pressing for treating the elderly differently have been commonplace for decades because the elderly have been under-represented in clinical trials; hence, guidance on practice are not science based (Zulman, Sussman, Chen, Cigalle et al., 2010; McMurd, Witham, Gillespie, 2005; Scott and Guyatt, ).

We are really in new terrain now, with an aging boom and more pills available for any symptom than could ever have been fathomed America’s shifting demographics in the United States, as evidenced by the most recent US Census Bureau report (Table left). The number of people in the oldest age group, namely age 85 and over, is rising, projected to grow from 5.8 million in 2010, to 8.7 million in 2030, and 19 million by 2050, according to the US Census Bureau. Not only have people age 75 and over been largely excluded from clinical trials, subgroup analyses in the aged have barely begun.

These should be compelling reasons for FDA, the Centers for Medicare and Medicaid Services, and Congress to back drug safety initiatives in the elderly. Many health researchers are also urging further study of potentially inappropriate medications (called PIMs) in elderly patients. Archives of Internal Medicine highlighted the problem in its June 13, 2011 issue, and there is a growing literature on it.

A recent study of elderly ICU survivors found that 85 percent were discharged with 1 or more potentially inappropriate medicines, with more than 50 percent in that group discharged with medications deemed more harmful than beneficial (Morandi et al, 2011). The authors press for more attention to appropriateness reviews, with the rationale for starting each therapy in the ICU, and discussion of when it can be stopped.

Brian Strom, MD, professor of public health and pharmacology, University of Pennsylvania, describes the issues this way: "The problem is Congress and our research agencies. They fund so little work on the pharmacology of the aged and other demographic subgroups, and their risk of drug interactions. And, there is phenomenally small, and shrinking by 60% (down to $5.1 million/year), amount of money being spent supporting the Centers for Education and Research and Therapeutics, who are charged with doing studies that industry would not fund, and with changing prescribing to be more rational."

Caregiver Remorse

The entire experience of trying to find quality care for my mother was made especially difficult because of the dearth of good clinical practice guidelines and science guiding chronic care for the elderly. I think it is way too much to ask family and caregivers to take this on. Now both my parents are dead. I see friends and family struggle under impossible odds, yet physicians who care for the elderly have little science to guide them.

This is where Congress, the Centers for Medicare and Medicaid Services, and the FDA must step up, expand funding, and beef up post-marketing drug surveillance. FDA has a treasure trove of safety data that has been deemed proprietary, some of it preferentially published, that could improve the public’s health. "No one has the right to respect this data except the FDA,"said Hayward. "Most of the trials data is industry-supported and the industry can hide safety data," he said, "but with public pressure, ineffectiveness and harm may be detected."

Without well-funded research and analyses of subgroups of the aged (age 85-100), and postmarketing surveillance, the US is operating in too much darkness and uncertainty for the public’s health. Many generations of Americans will continue to suffer.

The aged take disproportionally more drugs than every group, and as a result are more at risk for drug-drug interactions. It will take a significant commitment from the federal government to marshall science and surveillance of drugs in this population.

References:

Rhabdomyolysis. Accessed on June 27, 2011.

FDA Simvastatin 80 mg drug safety. Accessed on June 27, 2011.

Armitage et al. (2010) Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial, Lancet: 376(9753):1658-69. Epub 2010 Nov 8.

Morandi et al. Inappropriate Medications in Elderly ICU Survivors: Where to Intervene? Arch Intern Med.2011; 171: 1032-1034.

Risk Assessment Tool for Estimating Your 10-year Risk of Having a Heart Attack Ten-Year Cardiovascular Disease Risk Calculator. Third report from the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol. Downloaded on June 27, 2011.

Walsh JME, Pignone M. Drug treatment of hyperlipidemia in women. JAMA 2004; 291(18):2243-2252. Abstract

Scott IA, Guyatt GH. Cautionary tales in the interpretation of clinical studies involving older persons.Arch Intern Med. 2010 Jun 14;170(11):927.

Jerry H. Gurwitz; Robert J. Goldberg. Age-Based Exclusions From Cardiovascular Clinical Trials: Implications for Elderly Individuals (and for All of Us): Comment on "The Persistent Exclusion of Older Patients From Ongoing Clinical Trials Regarding Heart Failure" Arch Intern Med, Mar 2011; 171: 557 - 558. doi:10.1001/archinternmed.2011.33

Cho S, Lau SWJ, ; Tandon,V; Kumi K, Pfuma A, Abernethy DR Geriatric Drug Evaluation. Where Are We Now and Where Should We Be in the Future? Arch Intern Med. 2011;171(10):937-940. doi:10.1001/archinternmed.2011.152

Vincent, Grayson K. and Victoria A. Velkoff, 2010, THE NEXT FOUR DECADES, The Older Population in the United States: 2010 to 2050, Current Population Reports, P25-1138, U.S. Census Bureau, Washington, DC.

Hamilton H, Gallagher P, Ryan C, Byrne S, O'Mahony D. Potentially Inappropriate Medications Defined by STOPP Criteria and the Risk of Adverse Drug Events in Older Hospitalized Patients. Arch Intern Med. 2011 Jun 13;171(11):1013-9

Schnipper J. Medication Safety: Are We There Yet?: Comment on "Potentially Inappropriate Medications Defined by STOPP Criteria and the Risk of Adverse Drug Events in Older Hospitalized Patients". Arch Int Med 2011 Jun 13;171(11):1019 

About the Author: Laura Newman writes about medicine, health policy, and clinical outcomes research. She has a long-term interest in healthcare reform and what matters to patients. She has written news in health and medicine in peer-review journals, on the web, and for newsletters. Laura blogs at Patient POV, is active on twitter at  @lauranewmanny, and she is especially interested in integrating patients into health reform efforts. The views expressed are those of the author and are not necessarily those of Scientific American.  SOURCE

Selections from Natural Health News 

Too many Drugs, Too High Doses: Too Much for Elders

Dec 23, 2009

Old heart patients 'over-drugged' Elderly patients are being treated too aggressively for high blood pressure, researchers claim. They say the "oldest olds", meaning patients aged 80 plus, are being given too many drugs and in too large ...

http://naturalhealthnews.blogspot.com/

Natural Health News: The Case of a Sequestered Mind

Dec 18, 2010

The drug interaction profile will tell you that many of these are NOT supposed to be given together, and the research tells you that Zyprexa is not for Elders, especially women. My younger brother, a MetLife salesman, ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Is CODEX for Killing the Elderly?

Jul 13, 2005

Remember that AARP supported the Bush drug plan for Elders. This plan is about the biggest corporate welfare plan to come along in years; it surely doesn't do much for health. I'm not sure why Bill Sardi no longer is the ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Bone Health and AntiAcid Drugs

May 26, 2010

Please note that these drugs are not good for babies and young children which is a common practice today. Elders may have more problems with the drugs because of delayed metabolism times. In the May 10 Archives of ...

Natural Health News: Adverse Drug Events in Seniors

Jun 14, 2011

A new set of criteria for identifying potentially hazardous medications in elderly patients accurately predicted serious adverse drug events, a prospective study found. from Natural Health News ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Drugs Slow Elders' Recovery

Mar 30, 2010

Sedating Drugs May Slow Elders' Recovery By Ed Susman, Contributing Writer, MedPage Today, January 15, 2010. Elderly patients sedated with morphine or haloperidol (Haldol) were less likely to to be discharged to their ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Call to end exclusion of elderly from drug trials

Feb 02, 2010

Zyprexa is questionable for the elderly, especially for use in elderly women, and it can precipitate diabetes. The case in point is that regardless of the number of drugs prescribed, and failure of the center to evaluate...

http://naturalhealthnews.blogspot.com/

Anti-convulsant Drugs Increase Suicide Risk in Elders

May 10, 2010

This article points out problems with anticonvulsant drugs. It is important to be because the gabapentin mentioned in the article showed suicide was increased with gabapentin and the increased risk was greater in Elders. ...