Tuesday, December 4, 2012

Branded Vs Generic Drugs


Branded vs Generic: The Saga Continues

The Pharmacist Perspective

Laurie Scudder, DNP, NP
  Nov 29, 2012 Authors & Disclosures
 

Brand-Name vs Generic Agents: The Pharmacist Experience

Pharmacists, prescribers, and patients often voice concerns about the safety and efficacy of generic drugs that are substituted for brand-name drug products. No matter where they fall on the spectrum, most clinicians, however, acknowledge that they are here to stay. The US Food and Drug Administration (FDA) approves a generic substitute if it has proven to be "identical, or bioequivalent, to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use." [1]
The FDA's Orange Book provides the latest information on generic approvals. Approved generic agents have been demonstrated to have therapeutic equivalence -- although many clinicians have questioned whether that equivalence extends to all patients and all clinical scenarios. Jenny Van Amburgh, PharmD, an Associate Clinical Professor of Pharmacy at Northeastern University in Boston, Massachusetts, reminded readers in a previous discussion on Medscape that generic products are only compared with their brand-name products and not with generics made by other manufacturers.
Drugs that are known to exhibit a narrow therapeutic index (NTI), including levothyroxine, warfarin, phenytoin, and digoxin, are of greatest concern. Switching between generic NTI products made by different manufacturers may require particular vigilance to recommended monitoring.
James Lindon, PharmD, PhD, JD, in an earlier article on Medscape discussing pharmacist liability in the selection of generic agents, noted that the product liability law applied to prescription drug products usually only requires the manufacturer to disclose "adequate warning and instruction" to the prescriber or dispenser. There may be no duty for the drug product manufacturer to warn the patient. [2] In contrast, both the pharmacist and the prescriber may have a duty to counsel the patient when a particular generic product is prescribed or selected by the pharmacy. Laws regarding substitution vary by state.
What if the generic substitution is required by a patient's insurance carrier? Or the switch to a generic drug from a different manufacturer is made at the pharmacy and the prescriber is not aware of it? Is the pharmacist liable?
We asked our readers to participate in a survey describing their experience with generic agents and their opinions on the appropriateness of their use. Here is what the pharmacists had to say.

How Frequent Are Generic Substitutions?

We asked whether respondents had been required to make a generic substitution by an insurance carrier in the previous 6 months. Over 80% of respondents indicated that they had indeed been required to make a substitution. Most reported that that substitution was made without notification of the prescriber. Less than a third (28%) agreed that they had an obligation to notify a prescriber if a substitution was made.
Dr. Lindon notes that there are pragmatic concerns in implementing prescriber notification about medication substitutions, particularly when changing between generic manufacturers. Multiple pharmacist calls to clinician practices could be cumbersome for both the pharmacy and the prescriber and potentially disruptive and intrusive. He questions how often a prescriber would find such information useful, object to a change in manufacturer, or request more information about the manufacturer or generic product.
One pharmacist wrote that a change from a brand-name drug to a generic was as often made because of patient requests as because of insurance requirements, with patients citing higher out-of-pocket costs for brand-name medications.

The Generic Experience: The Safety Question

We posed the question: Are generics usually just as safe and effective as the corresponding brand-name product? An overwhelming majority of pharmacists (85%) agreed. This is in contrast to only 55% of prescribers who agreed with this statement. While over a quarter (27%) of prescribers disagreed with this statement, only 5% of pharmacists reported that they thought generics were less safe or effective and 10% of pharmacists vs 18% of prescribers were neutral.
A question about poor patient outcomes that were perceived to be due to a brand/generic interchange yielded somewhat conflicting results. Just under half (49%) of respondents believed the substitution had caused a bad outcome in a patient; in contrast, only 31% indicated that their patients had not had a negative experience. These percentages are virtually identical to the evaluation of patient outcomes provided by prescribers.

The Generic Experience: The Cost Question

A large majority (80%) of pharmacists agreed that after all costs are considered, generic drug products probably save money or reduce expenditures when they are used. However, 10% disagreed and 10% voiced no opinion.
A 2010 article in U.S. Pharmacist described generics as "the best bargain in health care" and asserts that implementation of the Affordable Care Act is likely to lead to an increase in their use. [3] The author of this article, John Coster, PhD, RPh, Senior Vice President for Government Affairs with the National Community Pharmacists Association (NCPA), cites an analysis of Medicaid claims data conducted by NCPA that concluded that the average price of a generic prescription was $20.61, a mere fraction of the average price of a branded product, which was $195.54, a difference that translates to almost $2000 per year for chronic medications. John Bishel, PharmD, a community pharmacist, points out that, given that the median hourly wage in the United States in 2011 was just under $17, [4] the average patient would have to work an additional 10 hours per month to make up that cost difference. He argues that, in many cases, there is little evidence to support the use of a branded product in place of an acceptable generic alternative and believes that if "prescribers were aware that some medications could cost the patient an additional $2000 per year with marginal potential benefit, it may alter prescribing habits, given that half of working Americans live on an hourly wage that equates to about $35,000 per year."

What About Liability?

Given the murky legal waters regarding potential liability with the use of generics, we asked clinicians whether they believed that allowing the use of generic drug products for their patients increased their legal liability. Opinions were split: Just over half (56%) of respondents indicated that they did not feel they were at increased risk while almost a third (31%) voiced no opinion. A small percentage (12%) was concerned about increased legal liability.

The Bottom Line?

Prescribers in this survey pointed out that, ultimately, their patients often were more concerned about the use of generics than the healthcare professionals. The FDA provides extensive information aboutgenerics for patients that can be an important resource for clinicians in educating their patients about generic medications.

Autonomy & Patient’s Rights to Die


'You MUST Let My Bedsores Kill Me. You MUST!'

Arthur L. Caplan, PhD
  Nov 29, 2012 Authors & DisclosuresI am Art Caplan, from the Division of Medical Ethics at the NYU Langone Medical Center in New York, New York. I want to discuss an interesting, and in some ways disturbing, ethics consultation [I had not so long ago].
When we get into issues about stopping care for people, normally we move toward discussions about turning off the ventilator, withdrawing dialysis, or pulling the feeding tube, and we are usually caught up in considerations about how to manage life support when they involve technologies. This case had none of that, but it raises some very interesting and tough moral questions.
An older gentleman, in his eighties, was doing pretty well living by himself but sadly suffered a series of small strokes and wound up in the hospital. He was told that he was going to have to be transferred to a nursing home and his days of independent living in his home were over. He had only 1 daughter who lived about 30 or 40 miles away. This man had been independent. He was a World War II veteran, had distinguished himself in that conflict, and had lived by himself and enjoyed his life since that time, but in hearing that he was going to long-term care, he wanted none of that.
The nurses and people who were caring for him while he was in the hospital said, "One of the things we have to do is turn you because you are in bed and at great risk of developing bad skin ulcers." We all know that it doesn't take much to set that off, particularly in a man in his late eighties with aging and fragile skin. They turned him, but he began to develop small skin ulcers. They [then decided to provide him with] a special air mattress, but then this man began to think about his situation and he said to the doctors and nurses, "I don't want you to turn me anymore; stop turning me." They told him that they could not do that. They explained that these ulcers would become painful and he would develop infections and die. He answered that this is what he wanted to happen. And he refused to give permission to turn him in bed.
This set off quite a controversy at the hospital. Many of the nursing staff said they would not deal with this patient. It is standard of care to turn [immobilized patients]. Others warned that the administration and state authorities would be "all over us" if this man died of skin ulcers, saying that [developing infected skin ulcers] is an adverse event that could basically result in no reimbursement for this man's care and all kinds of penalties because we are not following basic standards that JCAHO and other organizations would expect. Some doctors said he must be depressed, he must be crazy. After evaluating him, the consulting psychiatrist said that he absolutely knows what's going on. He has decided that this is the way he wants to end his life. I cannot give you the excuse that he is somehow less than competent.
This went on for a while. His ulcers got worse. Some began to be infected, and the nurses complained even more loudly, saying that they did not want to care for him in this situation. The hospital was in a small rural area. They asked whether any long-term care facility would take this man. At this point the long-term care facility that was available said no. There was a small hospice program that consisted of volunteers in the community, but they could not deal with him. Ultimately he died in the hospital, with huge ulcers. Basically, his body fell apart, the nursing staff was in an uproar, doctors fighting about whether or not it was right to let this happen. It was quite divisive for the staff morale, and indeed they were investigated about how a person in their hospital could die from infected skin ulcers.
What are the lessons to be learned from this refusal-to-be-turned request? For one thing, we need to be sensitive to the idea that it is as likely that someone may say "don't turn me" as they may say "I don't want any more dialysis" or "I want you to shut off my ventilator" or "take out my feeding tube." Institutions may want to establish policies such as: "We always turn people and we do not shut off the heat in a patient's room. There are certain things we are not going to do, and as soon as someone says they do not want that, we need to talk about moving them home or moving them elsewhere because there are some steps that we will not take here." Patients need to know that. Hospital staff, ethics committees, and others may want to think about developing policies concerning requests that will not be honored.
At the end of the day, I think this man did have the right to say "don't touch me." I think he had the right to say "don't turn me." But if his decision started to affect nursing and staff morale and began to become a problem in the delivery of care for others, then I believe that is a factor that has to be considered when deciding whether to honor what he says. The nurses cannot work if the unit becomes a smelly, untenable mess, and although this man had his rights, other people have their rights too. If I thought the care of others was being compromised by these morale issues and staff problems, I might override a patient's wishes. I might not honor his request in the name of other people's rights. In my opinion, there may be limits to what you can request when it affects the care that others can receive. That is a tradeoff that has to be weighed at all times.
As tough as this case was, it provides lessons to take home. Autonomy and patient rights may have some limits when they begin to affect others and the care that others can get. It may be important to think about this kind of dilemma in advance, and be ready to say as soon as a request comes that this is the patient's right, but it is not something we can accept at this facility. I am Art Caplan at the Division of Medical Ethics at the NYU Langone Medical Center in New York. Thanks for watching.

Thursday, November 1, 2012

Physical Exercise and Brain Health


Healthy Seniors
Have you heard of or read John Ratey’s book “Spark: The Rev­o­lu­tion­ary New Sci­ence of Exer­cise and The Brain”? Accord­ing to Har­vard Psy­chi­a­try Pro­fes­sor John Ratey noth­ing beats exer­cise for pro­mot­ing brain heath.
I am sure you have also heard that exer­cis­ing your mind pro­motes brain health.
What is the con­nec­tion between phys­i­cal and men­tal exer­cises? Do they have addi­tive effects on brain health? Are they redundant?
Let’s start by review­ing what we know about the effects of phys­i­cal exer­cise on the brain.
The effect of phys­i­cal exer­cise on cog­ni­tive performance
Early stud­ies com­pared groups of peo­ple who exer­cised to groups of peo­ple who did not exer­cise much. Results showed that peo­ple who exer­cised usu­ally had bet­ter per­for­mance in a range of cog­ni­tive tasks com­pared to non-exercisers.
Lau­rin and col­leagues (2001) even sug­gested that mod­er­ate and high lev­els of phys­i­cal activ­ity were asso­ci­ated with lower risk for Alzheimer’s dis­ease and other dementias.
The prob­lem with these stud­ies is that the exer­cis­ers and the non-exercisers may dif­fer on other fac­tors than just exer­cise. The advan­tage that exer­ciser show may not come from exer­cis­ing but from other fac­tors such as more resources, bet­ter brain health to start with, bet­ter diet, etc.
The solu­tion to this prob­lem is to ran­domly assigned peo­ple to either an aer­o­bic train­ing group or a con­trol group. If the exer­ciser group and the non-exerciser group are very sim­i­lar to start with and if the exer­ciser group shows less decline or bet­ter per­for­mance over time than the non-exerciser group, then one can con­clude that phys­i­cal exer­cise is ben­e­fi­cial for brain health.
In 2003, Col­combe and Kramer, ana­lyzed the results of 18 sci­en­tific stud­ies pub­lished between 2000 and 2001 that were con­ducted in the way described above.
The results of this meta-analysis clearly showed that fit­ness train­ing increases cog­ni­tive per­for­mance in healthy adults between the ages of 55 and 80.
Another meta-analysis pub­lished in 2004 by Heyn and col­leagues shows sim­i­lar ben­e­fi­cial effects of fit­ness train­ing on peo­ple over 65 years old who had cog­ni­tive impair­ment or dementia.
What is the effect of fit­ness train­ing on the brain itself?
Research with ani­mals has shown that in mice, increased aer­o­bic fit­ness (run­ning) can increase the num­ber of new cells formed in the hip­pocam­pus (the hip­pocam­pus is cru­cial for learn­ing and mem­ory). Increased exer­cise also has a ben­e­fi­cial effect on mice’s vas­cu­lar system.
Only one study has used brain imag­ing to look at the effect of fit­ness on the human brain. In 2006, Col­combe and col­leagues ran­domly assigned 59 older adults to either a car­dio­vas­cu­lar exer­cise group, or a non­aer­o­bic exer­cise con­trol group (stretch­ing and ton­ing exer­cise). Par­tic­i­pants exer­cised 3h per week for 6 months. Col­combe et al. scanned the par­tic­i­pants’ brains before and after the train­ing period.
After 6 months, the brain vol­ume of the aer­o­bic exer­cis­ing group increased in sev­eral areas com­pared to the other group. Vol­ume increase occurred prin­ci­pally in frontal and tem­po­ral areas of the brain involved in exec­u­tive con­trol and mem­ory processes. The authors do not know what under­ly­ing cel­lu­lar changes might have caused these vol­ume changes. How­ever they sus­pect, based on ani­mal research, that vol­ume changes may be due to an increased num­ber of blood ves­sels and an increased num­ber of con­nec­tions between neurons.
How does phys­i­cal exer­cise com­pare to men­tal exercise?
Very few stud­ies have tried to com­pare the effect of phys­i­cal exer­cise and men­tal exer­cise on cog­ni­tive performance.brain books
When look­ing at each domain of research one notices the fol­low­ing differences:
- The effects of cog­ni­tive or men­tal exer­cise on per­for­mance seem to be very task spe­cific, that is trained tasks ben­e­fit from train­ing but the ben­e­fits do not trans­fer very well to tasks in which one was not trained.
- The effects of phys­i­cal exer­cise on per­for­mance seem broader. How­ever they do not gen­er­al­ize to all tasks. They ben­e­fit mostly tasks that involve executive-control com­po­nents (that is, tasks that require plan­ning, work­ing mem­ory, mul­ti­task­ing, resis­tance to distraction).
To my knowl­edge only one study tried to directly com­pare cog­ni­tive and fit­ness training:
Fabre and col­leagues, in 1999, ran­domly assigned sub­jects to 4 groups: an aer­o­bic train­ing group (walk­ing or run­ning for 2 h per week for 2 months), a mem­ory train­ing group (one 90 min ses­sion a week for 2 months), a com­bined aer­o­bic and men­tal train­ing group, or a con­trol group (no training).
Results showed that com­pared to the con­trol group, the mem­ory per­for­mance of all 3 groups increased. The com­bined group showed greater increase than the other 2 train­ing groups.
This sug­gests that the effects of cog­ni­tive and fit­ness train­ing may be addi­tive. How­ever this study involved only 8 par­tic­i­pants per group! More research is clearly needed before any­thing can be safely concluded.
In the mean­time let’s play it safe and com­bine fit­ness and cog­ni­tive train­ing for bet­ter brain health.

Thursday, August 23, 2012

Optimal Temperature for Indoor Exercise


Is there an optimal temperature for working out and does it reduce the calories we burn if the room is too cold (or not hot enough)?

Several factors should be taken into consideration when trying to set room temperature: what activity is being done there, the outside temperature AND outside humidity level.
The American College of Sports Medicine’s recommended temperature for exercising indoors is  68-72 o F  (20 – 22.2 o C).  This range keeps most exercisers comfortable, whether they're on the treadmill, taking a step class or pumping iron.

The International Fitness Association has developed these guidelines:
 Aerobics, cardio, weight training and Pilates areas should be at about 65 to 680F
Yoga areas should be somewhat warmer at about 800F
Pool areas should be in the 70 to 800F  range.
Humidity levels for all areas should be around 40% to 60%.

According to the "European Journal of Applied Physiology," sports performance gets worse in the heat - very hot or cold environments affects performance and safety during cardio workouts.
Although hot temperatures burn the most fat, they can also cut your workout short.
As evidenced in the 1997 study, cyclists who were able to withstand the longest workouts were those exercising in moderate to warm, not hot weather.

Increasing your body temperature
The false belief is that you increase your metabolism, sweat more and burn more calories. For years, wrestlers ran around in sweatsuits in overheated conditions to shed pounds before a match in order to fit into their weight category.  Well, the lost pounds were mostly water weight and they were dehydrating themselves - the wrong way to drop pounds and outright dangerous.

Sweating is not necessarily an accurate measure of a good workout or an indicator that calorie burning is in high gear.
1. Everyone doesn't sweat the same amount or under the same circumstances. 
2. Some people sweat just sitting at their desks
3. Others don't until they're midway through a high-impact aerobics class.
4. If it's hot and humid outside, you could break a sweat just walking out the door.
"You don't have to sweat to get a good workout, and exercising in higher temperatures and humidity can be dangerous," says Endress an exercise physiologist and fitness director at the Duke University Diet and Fitness Center in Durham, N.C.
Heat and humidity interfere with the body's natural cooling process.
While sweating is your body's natural cooling process, sweating is not always harmless.
Risks increase when the humidity is above 70% and the temperature is 70 0F or above.  (Malaysia 82 – 930F  (28 – 340C humidity >84%) Beauty works studio ?350C)

Exercising in warm and humid conditions can be hard on your heart.
When performing aerobic exercise in the heat, blood vessels of the skin dilate to facilitate cooling. This reduces blood flow to the respiratory system which causes the heart rate to go up.
The problem is made worse because the heart is trying to deliver blood and oxygen to your working muscles while your body is trying to cool off by sweating.
If you sweat too much, you lose fluid. This decreases your total blood volume.  That means your heart has to pump even harder to get the smaller volume of blood to your working muscles, skin and the other body parts.
When you lose too much fluid, your body temperature rises and your nervous system doesn't work properly.
Extreme fluid loss can lead to brain and heart damage (heat stroke).
Hot temperatures can also be dangerous, leading to heat exhaustion and dehydration unless you are prepared and know when to stop.
Warning signs include dizziness, sudden fatigue and nausea as well as leg cramps from depleted electrolytes
Here are some tips for exercising SAFELY in heat and humidity:
·      Drink plenty of fluids. Dehydration caused by excessive sweating can lead to heat exhaustion and heat stroke. Drink fluids before, during, and after exercise even if if you do not feel thirsty. Water replenishes your body's water content and sports drinks to replace electrolytes.
·      Dress for the heat. Wear loose-fitting, light-colored, and lightweight clothes.                  Cotton is best when sweat-soaked because it has a cooling effect.
·      Use common sense. As a rule, the higher the air temperature, the lower the humidity  must be to avoid risk of heat injury. For example, when air temperature > 800F, you are at risk if the humidity exceeds 50%. During very hot and humid spells, exercise in the cool indoors or go swimming.
·      Take time to adjust. The body needs time to acclimatize to hot weather. It takes 7 to 14 days to fully acclimatize, so gradually increase your exercise time.
Be especially careful if heat comes with high humidity, a perfect combination for heat exhaustion.

Solution: The safest and effective training method involves wearing loose-fitting clothing (shorts, T-shirt and sneakers) in comfortable temperatures (ideally 68 to 72F) and doing high-intensity cardio for at least 20 minutes. You'll perspire and efficiently burn both calories and fat, and your metabolism will increase as mentioned above, allowing you to continue burning fat and calories well after the workout.

REFERENCES
7 Cardiovascular Training Mistakes http://au.askmen.com/sports/bodybuilding

Wednesday, August 22, 2012

Egg Yolk Consumption and Heart


From Heartwire

Debate Over Dangers of Egg-Yolk Consumption Continues With New Study

Reed Miller
 
 
August 20, 2012 (London, Ontario) — Researchers who have long argued that egg-yolk consumption contributes to cardiovascular disease have now published a study showing that lifelong consumption of egg yolks is correlated to development of carotid artery plaques and therefore should be avoided by anyone at risk for cardiovascular disease.
Dr J David Spence (Robarts Research Institute, London, ON) publish the results of a study of 1262 consecutive patients attending vascular prevention clinics in Canada online August 1, 2012 in Atherosclerosis. All of the subjects had baseline measurement of total carotid plaque area by ultrasound and filled out questionnaires about their diet and lifestyle, including medications they take, smoking, and the number of egg yolks they've eaten per week times the number of years they've kept that dietary pattern (egg-yolk years).
The results show that carotid plaque area increased linearly with age after age 40 and increased exponentially with both pack-years of smoking and egg-yolk years. The average plaque area in subjects claiming to consume fewer than two eggs a week (n=388) was 125 mm2 vs 132 mmin subjects eating three or more egg yolks per week (n=603) (p<0.0001 after adjustment for age). 
Multiple regression analysis found that egg-yolk years were a significant predictor of disease after adjustment for other coronary risk factors.
Spence is a long-time critic of the egg industry and believes the industry's lobbyists have confused the public by convincing government dietary guideline writers to downplay the dangers of dietary cholesterol. He often points out that a single egg yolk contains approximately 215 mg to 275 mg of cholesterol, more than the 200-mg daily limit recommended by the American Heart Association (AHA) and National Cholesterol Education Program.
"We've known that [dietary cholesterol is a cardiovascular risk factor] for 50 years, but the egg marketing people have been so successful with their propaganda that in Canada there are no longer recommendations against consuming dietary cholesterol," he told heartwire .
He argues that the defense of eggs as part of a healthy diet depends largely on a study in the 1990s based on the Health Professionals Follow-up Study and Nurse's Health Study [2]. Together, these studies found that consumption of up to one egg per day had little or no impact on cardiovascular risk. But Spence maintains that "the reason they failed to show harm in the people who remained healthy was that they were too young and they weren't followed long enough."
That study found a link between cardiovascular risk and egg consumption in diabetics, and a 2006 study in Greece found that increased consumption of eggs and saturated fat was associated with a significant increase in mortality among diabetics [3], Spence stresses. Also, a 2009 study of data the Women's Health Study andPhysicians' Health Study showed that high levels of egg consumption are associated with an increased risk of type 2 diabetes [4].
Bad Diet vs Bad Foods
In an interview with heartwire , nutritionist Dr Susan Racette (Washington University School of Medicine, St Louis) pointed out that cholesterol is certainly not the only dietary factor that can contribute to the development of cardiovascular disease, yet the study by Spence et al provides no other dietary information. "Cholesterol itself may not be the biggest player, but cholesterol is included in foods with saturated fats," she said.
"If people are consuming more eggs, then people might be consuming more saturated fat from other sources as well," she suggested. She pointed out that the preparation of eggs--fried vs boiled--makes a difference, but that wasn't specifically addressed in the study. Also, the subjects in the study were consuming a lot of eggs despite the professional recommendations to cut back because of their disease risk. "That implies that perhaps they weren't following other dietary recommendations, either. It might not just be the cholesterol, but part of a whole dietary pattern that may not be optimal, although that doesn't mean the cholesterol doesn't have potentially an important role."
Racette says she supports the AHA's recommendation that individuals concerned about their cardiovascular risk limit their egg-yolk intake "within the constellation of limiting saturated fats, trans fats, and cholesterol." She also pointed out that some dietary choices can offset the consumption of cholesterol. Plant sterols (phytosterols)have been shown to reduce the body's absorption of cholesterol. "But people who eat a lot of cholesterol are probably consuming fewer plant products," she said.
Egg Industry Is Not Impressed
Researchers aligned with egg producers are not persuaded by the study by Spence et al. Dr Mitch Kanter, executive director of the Egg Nutrition Center (ENC), in Park Ridge, IL told heartwire that the study "is just not that well done." He pointed out that the study included mostly older at-risk patients and relied entirely on their self-reports of egg consumption. "There are so many confounders just in a question like that," he said. "The people who were oldest were the people in the highest quintile, and that makes sense because if a guy is 75, even if he ate only one and half eggs per week, 75 times one-and-a-half per week is going to give you a high number. If these are the premises upon which these data were collected, then how do you put a lot of faith in the results that you get?"
The Egg Nutrition Center is funded by the American Egg Board, which is supported by egg farmers as a so-called "check-off" program overseen by the US Department of Agriculture.
As further evidence that eggs can be part of a heart-healthy diet, the ENC cites a study published in Risk Analysis that found that modifiable lifestyle risk factors account for less than 40% of coronary heart disease mortality and that for most adults, consuming one egg a day accounts for less than 1% of coronary disease risk [5]. The group also highlights a small randomized study in England that found that increased intake of dietary cholesterol from two eggs a day did not increase total plasma or LDL cholesterol when accompanied by moderate weight loss [6].
Dr Maria Luz-Fernandez (University of Connecticut, Storrs), who has received research funding from the ENC and has criticized Spence's position on eggs in the past, told heartwire in an email that the conclusions of Spence et al are "really overstated based on the data."
She points out that "the subjects under study were already sick and came to the clinic with high blood pressure, hyperlipidemia, and excess body weight, [and because] this is a cross-sectional study it is not possible to reach a causal conclusion."
She also questions the usefulness of measuring consumption in egg-years. "It is not surprising that the individuals with more egg-years (older) had higher plaque area. So a big problem is that they did not control their data with age, which as we all know is highly associated with heart disease and high lipid levels." Also, she argues that the questionnaire used in the study was biased because it only asked about egg intake and smoking and not other potentially relevant dietary factors such as saturated fat and high sugar intake.
Spence, however, anticipated this reaction in his interview with heartwire . "Every time a paper like this comes out the media come and . . . they ask what my study shows, and then they go ask what the egg marketers think and give equal weight to three of Canada's leading experts on stroke prevention nutrition and cholesterol and to the egg marketers," Spence said. "No wonder the public is confused."
This research was supported by the Stroke Prevention & Atherosclerosis Research Centre and the Heart & Stroke Foundation of Ontario. Disclosures for the authors were not provided. Luz-Fernandez has received research funding from the American Egg Board, the Egg Nutrition Center, and the National Dairy Council. Racette reports no potential conflicts.