Friday, March 12, 2010

Human Sacrifice for Science

Sacrifice in the Name of Scientific Progress

No one doubts the importance of testing new drugs before they come to market. Much of the early testing involves mice, and we don’t usually care when participating mice meet untimely deaths. Rarely do we even hear about the mice that sacrifice their lives for the good of scientific progress.

But it’s a whole different story when human participants begin losing their lives. That’s what happened to nine out of more than 350 people participating in clinical studies aimed at testing the effectiveness of a new drug to treat Alzheimer’s disease.

The fate of ELND005

The potential new weapon in the fight against Alzheimer’s is referred to as ELND005, or scyllo-inositol. After the U.S. FDA awarded the experimental drug Fast Track classification back in April, 2009, testing of 3 different dosages began. The highest dosage studied is 2,000 mg, administered twice a day. The second-highest dosage studied is 1,000 mg, also administered twice a day. A third and much lower dosage of 250 mg administered twice daily is also being studied. Some participants received a placebo.

After nine deaths and the development of other adverse reactions deemed serious, developers of the experimental drug made the decision in December to halt study of the two highest dosages. They did this even though no direct connection between the higher doses and the complications had been established. They cited their commitment to patient safety as the reason.

The two companies have decided, along with the Independent Safety Monitoring Committee, to continue unchanged their studies on the lowest-dose ELND005. All parties involved feel confident the progress that’s been made so far combined with the known safety and tolerability issues associated with the lower dosage warrants continued study.


This got me thinking

That decision made me think about the remaining participants and how they’re reacting to news of these deaths.

• Are they scared to continue?
• Do they cross their fingers each night and hope that they’re receiving the placebo?
• Have they been given the option of opting out?
• How much of what’s going on do they even comprehend?

I don’t know about you, but the idea of participating in clinical studies to test an experimental drug’s effectiveness scares me. It got me wondering whether I’d ever knowingly put my health at risk in that way. So far I haven’t been willing to do this and I wonder, does this mean I’m weak? Selfish? Uncaring?

And what about people who do participate? Do they do so because they have no other options and nothing to lose? Does this make them heroes? Do they receive any special acknowledgment?

There probably are people that participate for the money. But maybe people do it for no other reason than the satisfaction they get from helping find cures that will one day eliminate the suffering of millions.

And now I want to know

Have you ever participated in a clinical study?

If so, what was your motivation?

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Friday, February 26, 2010

E-Cigarette Update

E-Cigarette Import Ban Lifted

Is the FDA protecting public health, or is it protecting Uncle Sam’s wallet? Like most spicy conspiracy theories, to get to the bottom of this one, you have to follow the money.

On January 14, 2009, U.S. District Judge Richard J. Leon decided that the U.S. FDA could no longer block the importation of electronic, or e-cigarettes, those battery-operated cigarette look-alikes that produce no smoke or carcinogens.

For years, the FDA has justified the importation ban because in its view, e-cigarettes are unapproved gadgets designed to deliver drugs. But the judge didn’t agree. Instead, his decision sided with e-cigarette manufacturers who claim they’re no different than a pack of regular cigarettes and should be regulated in the same way.

They’re also the parties that brought suit against the FDA’s importation ban. The federal judge even went as far as saying that this case is “another example of F.D.A.'s aggressive efforts to regulate recreational tobacco products as drugs or devices."

The FDA’s reaction

Needless to say, the FDA was not happy with Judge Leon’s decision. The regulatory agency stands firm on its belief that e-cigarettes are a public safety threat. It’s so concerned that the Administration is using public safety as the basis for crafting an appropriate response to Judge Leon’s decision.

Which is actually kind of funny in a way. Seems to me if the FDA really was concerned about public safety, they would have done something about real cigarettes long ago. Cigarettes are addictive and they cause cancer. If anything should be banned, it seems cigarettes should be. But they aren’t.


E-cigarettes are—or at least the were—until the federal judge got involved.

And that’s what got me thinking about the money trail and what is more likely behind the FDA’s hesitation to give e-cigarettes the thorough regulatory review they’re due. If e-cigarettes really are a safer alternative to cigarettes, the FDA should let the world know about it. And if they aren’t any better, the world should know that, too.

So why has the FDA been hesitant to conduct more tests on e-cigarettes?

Judge Leon may have taken away any excuses the Administration might have. In another part of his decision, he reminded the FDA that because of the sweeping tobacco legislation passed last year, it has the power to regulate all marketing claims made by e-cigarettes manufacturers. And it has the power to regulate e-cigarette contents. But will it exercise that power?

Here’s what I think

Maybe the FDA doesn’t want to find a safer alternative to cigarettes because of the impact a discovery like this might have on the U.S. economy. Imagine how many jobs would be lost or affected if cigarette demand declined because of competition—farmers, tobacco pickers, tobacco processors, packagers, convenience store owners—the list goes on and on. Now think how much less revenue the U.S. government would take in from taxes and regulatory measures. This could cripple the economy.
And maybe that’s the real problem with e-cigarettes. It’s just a thought.

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Wednesday, February 24, 2010

H1N1 Scorecard

H1N1 Update

I don’t know about you, but I hardly hear anything about the H1N1 virus anymore. Not very long ago I couldn’t go anywhere, read anything, or watch anything without hearing about school closings, vaccine shortages, more deaths, and forecasts of a third wave projected to be more serious and more widespread than either of the previous two.

But today, hardly a word.

Gone are the guidelines regarding who should be given higher priority to limited vaccinations. That’s because rather than a shortage, there’s now so much H1N1 vaccine available that outlets don’t know what to do with it all. Health officials are perplexed by the lack of urgency people now seem to have about getting the vaccine. A recent survey of unvaccinated individuals reveals that only 11% of the responders have definite plans to get vaccinated.

Hopefully, all of this is a sign that what quickly turned into a fearsome global pandemic in the spring of 2009 is today little more than new strain of easily treatable flu virus. Health officials however, are not so sure.

Since there’s no way to predict the future, let’s take a look at the past and how much of an impact the H1N1 virus has had on the lives of Americans.


Between April and mid-December, 2009:

• Estimates put the number of Americans infected by the H1N1 virus between 55 and 80 million. That’s a lot of people and it’s probably also why H1N1 was regularly in the news.

• It’s also estimated that as few as 8,000 but perhaps as many as 20,000 people have died as a result of the H1N1 virus. Of particular concern to health officials is the number of children and younger adults that have succumbed to this strain. Normal seasonal flu mainly claims seniors as victims, but the H1N1 virus caused the most deaths in adults under age 65 (approximately 8,600). Children and teenagers were the second hardest hit group, accounting for approximately 1,200 deaths within this segment of the population.

• And that’s not all. Estimates of the number of Americans admitted into hospital as a result of an H1N1 infection is up to 362,000.

Vaccination update

The good news is that so far, nearly 61 million people have received the H1N1 vaccination, which is about 20% of the total population. Of those in the highest risk groups, nearly 1 in 3 has been vaccinated. While the numbers are encouraging, a big part of the American population remains unvaccinated.

Health officials hope this number increases because they believe vaccination really is the best protection. They report that although news of H1N1 has died down, people are still dying from the virus. They remind us although H1N1 activity has declined we’re still in the midst of the flu season and warn that the worst may not yet be over.

And that means there’s still plenty of time for that third wave to come crashing down around us.

Will you be caught unprotected?

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Charla Nash Denied Transplant

If You Think You’ve Got Problems

You definitely need to read this story. Then when you’re done, your problems might not seem as hopeless.

The story is about an unfortunate woman named Charla Nash. Charla wasn’t always unfortunate. Before last year she was happy and loving, and had what most people would consider a pretty unusual job. Little did she know though, that her job would nearly kill her—literally.

Maybe you’re familiar with Charla and her horrendous story. It was all over the news, and she told it to millions of viewers watching the Oprah Winfrey show.

Here’s what happened

In February, 2009 Charla was at the home of her friend and employer, Sandra Herold. Charla’s job was caring for Sandra’s 200 pound chimpanzee, a job she liked—most of the time. One afternoon, Sandra and Charla were trying to get the chimpanzee to go back in the house. That’s when the chimpanzee unexpectedly and violently attacked Charla, mauled her, and left her for dead.

Paramedics quickly arrived and found Charla face down on the ground. Upon closer examination, all they saw was ground up flesh where her face and hands used to be. Missing were her eyelids, lips, nose, part of her scalp, and most of her fingers. Uncertain of her chances for survival, Charla was rushed to the hospital, and miraculously, she lived.

For the past year, Charla’s focus has been on getting better, regaining her independence, and getting much-needed face and hand transplants. Since the accident, she’s been a patient at the Cleveland Clinic, the same facility that made history in 2008 when doctors performed a successful face transplant. Naturally she assumed she would be next. But recently, hospital representatives said no—not the news she expected to hear.





Transplant denied

• Did the hospital lack the necessary resources and skills for two very complicated procedures?
• Were the procedures too risky?
• Were the procedures too expensive?

Without a doubt the transplant procedures are complicated, and risky. Charla’s had a lot of surgery already. But she’s blind, eats through a straw, can’t breathe through her nose, and is seriously disfigured. Her face requires considerable reconstruction.

While not admitting to complications or risk or cost, in their denial, all hospital representatives stated was that both transplants would have to be performed simultaneously, and the same donor would have to provide all necessary organs. They haven’t ruled out collaborating with other medical facilities. Still though, the hospital hasn’t made a commitment, which is what Charla needs most. The hospital’s stance has forced Charla’s family to search for alternate solutions, including approaching other medical facilities that may be able to help.

Even if they didn’t admit it, the transplants will be risky and expensive. If performed, she’ll still need years of continual care and there’s no way to rule out complications. Perhaps the biggest unknown is how much she’d improve.

Incredibly, in a situation that seems hopeless, Charla is full of hope; something no chimpanzee or hospital representative can ever take away from her.

It’s a reminder to us all that no matter how bleak the future may seem, there’s always hope.

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Wednesday, February 3, 2010

Texas Ordered to Destroy Thousands of Blood Samples

Infant Blood Taken Without Consent

This sounds like the plot of a horror movie, but it actually happened in real life.
Not long ago, a group of Texas parents discovered that blood samples drawn from their infants were being stored indefinitely without their consent. They thought the blood samples were being destroyed after they were screened for various disorders and birth defects. But that wasn’t the case. Some were used for “unspecified research projects.”

So the group filed a federal lawsuit against the Texas Department of State Health Services as well as the Texas A&M University System. Federal court determined this was a violation of the plaintiffs’ 4th amendment rights against unlawful search and seizures.

When I think of unreasonable search and seizure, I think of arbitrary intrusions of homes, cars, or persons by law enforcement officers or government officials. I don’t think of hospital personnel unlawfully taking and using someone else’s blood, especially an infant’s. That’s kind of creepy.

The background

There isn’t necessarily anything wrong with collecting blood samples from newborn babies. The state of Texas has done this for decades. Most parents appreciate the comfort that comes from knowing the results of early screening of their newborn babies’ DNA.

But what some parents didn’t appreciate was finding out that stored infant blood could be used without their knowledge or consent for research. What’s worse, they were concerned that personal information associated with the blood samples could be misused.

As a parent, I don’t think I’d be comfortable knowing my baby’s blood was sitting on a shelf somewhere, accessible to anybody with the right credentials.


Millions will be destroyed

Only 5 plaintiffs were involved in the lawsuit. However, over 5 million blood samples will be destroyed. That might seem like a waste of valuable research material, especially when the blood may have played a role in the discovery of some new disease or treatment. But if the blood samples shouldn’t have been there in the first place, destroying them really can’t be considered a waste.

Whether or not the millions of blood samples should have been there is the heart of the lawsuit. Stricter laws were passed recently giving parents a choice of opting out of the blood storage situation. The laws also strengthened patient privacy rights. But the parents that gave birth prior to the law’s passage didn’t have any of these rights.

That’s why millions of blood samples obtained and stored prior to the implementation of these new laws were also ordered destroyed.

Who’s right?

Obviously in this case, the federal government felt there was a clear-cut violation of constitutional rights. And I tend to agree with that.

But what about the people who could have benefitted from medical advancements that might have been discovered had that blood samples been made available for study? Do they have any rights?

I don’t know the answer. But I do know that if anyone wants my blood or my child’s, they’ll have to ask me for it. That way I can decide its fate.

What do you think?

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Sunday, January 31, 2010

Haiti - Update # 2

Haiti Health Update #2

It’s been nearly 3 weeks since an earthquake devastated Haiti’s capital, and survivors are hungry. It’s far from normal in the city’s streets, and many places residents used to go for food remain buried under the rubble. So they eat what they can find.

Aid from abroad is arriving

Rice, water, ready-to-eat meals, beans and other staples have begun pouring in to the capital city’s airport. But distribution is a problem and much of the supplies aren’t making it to the neediest people. Obstructed roadways, logistics, too few vehicles, and too many unscrupulous thugs all cause delivery delays.

Patient Haitians spend hours waiting for deliveries of food and water. When it finally arrives, they sometimes have to fight to get their fair share. Food riots and outbreaks are frequent, and supplies often are unfairly distributed with the strongest taking the lion’s share. Then they turn around and charge outrageous fees for food that was distributed for free moments ago. Some pay, but many can’t afford to so hunger persists.

People need food to survive, and to heal. They also need it for strength. There’s a lot of clearing and rebuilding to do and the work won’t be easy. In situations like Haiti’s, the most vulnerable usually are the most taken advantage of. It’s already happening with food, and it’s also happening to orphans.

No one knows how many there are, only that there are a lot. Efforts are being made to gather newly parent-less and homeless children of all ages, and take them to safety. Otherwise they risk being taken and sold into slavery, or prostitution.


United States food aid waits to be delivered outside a U.S camp.

Airlifts cease

Wounds are still being treated and the demand for medical help remains great. But resources at Haitian hospitals are stretched thin. Some of the most critically-injured Haitians were lucky enough to be airlifted out of the country, but it’s difficult to say how much longer this will go on. Airlifts were suspended after Florida, which had received hundreds of the injured Haitians, made an urgent plea to cease transports into the state, claiming it didn’t have the resources to care for so many.

The noticeable effects of amputated limbs are all around. Estimates put the number of limbs amputated because of irreparable injury or infection at around 2,000. Entire wards have been set aside for amputees who need time and a safe place to heal. Upon their release, all will face difficulties adapting to life without a limb, without a job, without family, and without so much. The lucky ones will enroll in rehabilitation programs, and receive after care and prosthetics. But the magnitude of the problem and the number or people requiring help will likely overwhelm many organizations.

Money won’t fix this problem

As news crews pack up and leave, the spotlight on Haiti and its suffering will dim. Countries will still send money, and lots of it. But like the food, most will end up in the wrong hands and never help those who truly need it most.

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Monday, January 4, 2010

Uninsured ER Patients

Are Uninsured ER Patients at Higher Risk of Death? 

Here’s something else to worry about if you don’t have health insurance. Your visit to the Emergency Room could kill you!

That’s according to research of nearly 690,000 patients in the United States covering the period 2002 through 2006. A group of researchers from Harvard University headed up the study, the results of which were published recently in the Archives of Surgery.

The study focused on ER patients who had suffered traumatic types of injuries, like those resulting from vehicle accidents, gunshots, and falls. The study did not include any patient that was declared dead on arrival, or that was treated then released, or that had been admitted for burns.

The numbers tell a scary story

When comparing the results, researchers found that the death rate among all patients was 4.7%. While they were pleased to see that most ER patients lived, they were displeased when they compared death rates of the uninsured with those who had health insurance. They found a 3.3% rate of death among insured ER patients. But among the uninsured, the death rate rose over 2 percentage points to 5.7%.

Researchers even made adjustments to the data based on factors including age, gender and how serious the patient’s injuries. And still, they calculated an 80% greater chance of dying in the ER if you don’t have health insurance. 

The group’s findings are sure to factor into the heated debate over efforts to create a national health insurance program that promises to insure up to 94% of Americans. But even if 94% coverage could be attained, I’d sure hate to be part of the 6% without insurance, especially after learning of this research!


The group was not able to attribute a reason for the difference in death rates among insured and uninsured ER patients. However, they did have a few ideas.

Why is this happening?

One reason may have to do with transferring the uninsured to facilities that are more likely to treat the uninsured. Laws state that no one admitted to the ER can be denied medical assistance. But there is a bit of a loophole. The law indicates that medical care must be given only until the patient is stable. Once stabilized, the patient can be transferred elsewhere. And they believe this happens a lot.

The problem is, transfers delay the rest of the medical care the patient may need. And delayed treatment could be causing patients to die when, had they been given further medical care sooner, they may not have.

Another potential reason is the facilities themselves. Private medical centers are typically better funded so they usually have more staff, and more highly skilled specialists. Facilities that accept patients without insurance tend to be less modern, not as adequately staffed, not as financially stable, and usually have fewer resources overall. Other potential problems include communication difficulties, and differences in the type of care given to the insured versus the uninsured.

It’s frightening to know that you could needlessly die in a place where the whole purpose is to save lives!

Do you have private health insurance?

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Monday, December 28, 2009

Obesity – A Growing Problem

Obesity is a growing problem, in more ways than most people realize. Even if you are not obese, it’s quite possible this epidemic will have an effect on your life.

Perhaps what’s most frightening is how the obesity rate has grown just in the past 2 decades. The rate of U.S. adults classified as obese has doubled since 1985 and there’s no sign of it slowing down. Assuming current trends continue, by the year 2018, over 40% of the adults living in the U.S. will be classified as obese. That’s just 9 years away!

When people think of obesity, most think of an individual they know who is too big to fit in an airplane seat. Or they think of the star attraction at carnivals and state fairs. No doubt these individuals are obese, perhaps morbidly obese even. But it surprises many when they realize what it means to be obese.

Obesity is defined as a BMI or Body Mass Index of 30 or higher. BMI is a calculation of a person’s weight and height. To make obesity easier to envision, someone who is 5’9” tall and weighs 203 pounds or more is usually considered obese. (I say usually because there are exceptions to this rule.)

Obesity is also causing unprecedented growth in health care costs. If current trends continue, the costs associated with treating not only obesity, but the 50 or more other health issues caused by obesity will reach $344 billion by the year 2018.


Obesity defined

Among these other health issues are cancer, degenerative arthritis, diabetes, heart disease, high blood pressure, high cholesterol, breathing problems, infertility, skin infections, ulcers, sleep apnea, stress, urinary incontinence, as well as problems with self-esteem which could lead to depression.

It’s estimated that health care spending to treat obesity and the problems it can trigger may add up to 21% of all health care costs by 2018. That’s a lot of money spent to treat health problems that are largely preventive. And if health care reform passes, that means you, me and everyone else will be paying to treat other people’s obesity issues.

These obesity trend projections are the result of research conducted by health care economist Dr. Ken Thorpe of Emory University. His research was sponsored by a number of foundations and associations concerned by the alarming rise in obesity in the U.S. Dr. Thorpe sees a turnaround in the current obesity crisis as the only hope for reining in health care costs.

But health care costs aren’t the only costs escalating

Nowadays, emergency response personnel must carry specially-designed equipment to help deal with situations involving obese individuals. Some of this equipment was used just recently to extract a man stuck in a chair, and who ultimately died there.

He was 900 pounds and could no longer walk because of a knee injury. He spent the last 9 months of his life sitting in a chair inside his home, too embarrassed to go outside, too large even to make it to his bathroom.

That’s no way to live and it’s certainly no way to die, either. Do you think that we will get this problem under control?


Authorities say this obese South Carolina man stayed in his recliner without moving for nine months until shortly before his death.

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Tuesday, December 1, 2009

Swine Flu Affecting the Young

Swine Flu Affecting the Young More Than Any Other Age Group

That’s what statistics compiled by the CDC during a 40-day period beginning on September 1st and ending on October 10th show. And that is what has officials so concerned.

In general, the young are supposed to be healthier and therefore better able to fight off the flu. That’s the way it’s been with the seasonal flu, with the majority of people requiring hospitalization falling into the age 65 and older category.

However, during the reporting period mentioned above, a whopping 53% of the confirmed cases of swine flu comprise males and females 25 years old and younger.

When it comes to swine flu fatalities, we are seeing the same type of trend. So far, nearly a quarter of laboratory-confirmed cases of swine flu that resulted in death involved individuals aged 25 and younger. Sixty-five percent of the fatalities involved the 25 – 64 age group. This is in stark contrast to the seasonal flu in which nearly all of the fatalities, a whopping 90%, involve people age 65 and older.

“A disease of the young”

This is how one high-ranking CDC official described the swine flu outbreak on October 21st after reviewing the latest data. When asked why she believes the swine flu virus is taking a bigger toll on younger individuals, her comments reminded us that this is not the first time we’ve seen a swine flu-like virus. Since it hit years before anyone in the age group being hardest hit was even born, the official suggested that the younger population has not had an opportunity to build up immunity whereas older individuals may have.

Other late breaking swine flu news

Swine flu activity is still on the rise with 46 of the 50 states recently reporting widespread flu activity. This is another issue that is differentiating swine flu from the seasonal flu. Normally we wouldn’t be seeing so many cases of regular flu this early in the season.

The first of the vaccinations are out, and priority is being given to people in high-risk groups like children and pregnant women. Even though there’s controversy, people are getting vaccinated. My pregnant cousin eagerly got her swine flu vaccination, but my daughter didn’t, even though vaccines were offered right at her school. She’s healthy so I’ve decided to wait a little longer.


Swine flu strikes close to home

I recently had a swine flu scare when I found out that two of my nieces became infected just last week. One is 13 and the other is 15. They were infected after an outbreak hit their school. It affected so many students that their school was shut down for a week. I’m happy to say they’ve fully recovered and are anxious to get back to school.

And this same scenario is being played out all over the place. Kids get sick, kids infect other kids and schools shut down. So far, it really does seem to be a disease of the young.

Are you or your children getting vaccinated? Why or why not?

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Wednesday, November 11, 2009

Health Care Reform Bill

Landmark Health Care Bill Narrowly Passes House

Saturday night was a late night on Capitol Hill. But lawmakers were not there to welcome some head of states while feasting on an extravagant 5-course meal.
The only thing these lawmakers were nibbling on were their fingernails as they anxiously awaited the excruciatingly slow vote on health care reform.

Prior to the vote, the president took advantage of an opportunity to appear in person and urge passage of a bill that he reminded legislators will have historical significance. Apparently, many were swayed by the president’s last-minute cheering because, much to everyone’s surprise, the bill passed, although just barely. 220 votes were in favor of the bill, and 215 votes, including 39 votes cast by Democrats, opposed the bill.

That slim victory was enough for most democrats, as well as President Obama himself, to do a quick little happy dance to celebrate the hard-won victory.

And quick that little dance was. Moments after House approval of the bill was announced, Senate Republicans vowed to mount an even bigger battle against the House version while pushing their own version of health care reform.


Speaker Nancy Pelosi, center, is joined by (L-R) Majority Whip James Clyburn, and Rep. George Miller, D-Calif. during a press conference at the U.S. Capitol, Saturday, Nov. 7, 2009 in Washington after the passage in the house of the health care reform bill. (AP Photo/Alex Brandon)

Highlights of the 1,990 page House bill:

• Provides affordable access to health care
• Most Americans would be required to carry health insurance
• Large companies would be required to offer employees health insurance
• Penalties would be imposed for failure to carry/offer health insurance
• No more denials based on pre-existing medical conditions
• The practice of charging higher premiums based on gender and health history would end
• Coverage for abortions significantly restricted
• Establishment of federally overseen insurance co-ops or exchanges (public option) offering health insurance plans for consumers
• Total cost estimated at $1.2 trillion over 10 years
• A 5.4% tax surcharge on individuals earning more than $500,000 and families earning more than $1 million, combined with a decade of cuts to Medicaid, is the proposed method of paying for expanded health coverage.

Even with the Senate promising fierce opposition, the president is confidently predicting passage of health care reform legislation. The president and democrats want to keep the momentum going and pass some form of health care reform before the end of this year.

A short-lived victory?

“Dead on arrival” is the way one republican Senator characterized the House version of health reform legislation. Senators are opposed to much of what is included in the House version. The public option may be a deal killer. In addition, the cost of reform, while still greatly unknown, is believed to be too great for Americans to bear, especially with the economy still in flux. Also causing much controversy is the last minute inclusion of tighter restrictions on abortion. Including the wording helped gain the necessary House votes, but it also enraged pro-choice advocates.

No doubt the battle over health care reform will rage on. If nothing else, the coming months are sure to be some of the most exciting Capitol Hill has experienced in a very long time!

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Sunday, November 8, 2009

The Shortage of Children's Tamiflu

How Some Pharmacists Overcome the Shortage of Children's Tamiflu

If you don’t already know it, Tamiflu is one of two prescription antiviral medicines used to treat and prevent flu symptoms, including the H1N1 influenza. Available in adult and children’s dosages, Tamiflu is already being widely prescribed as this year’s flu season kicks into high gear sooner than many had anticipated. One group that’s getting hit particularly hard: Children.

A report produced by the CDC titled: Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season found that:

During April to August 2009 hospitalization rates for laboratory-confirmed 2009 H1N1 influenza among children younger than 2 years old were 2.5 times higher than rates for children 2 year to 4 years old. Children 2 years to 4 years old had slightly (20%) higher rates of hospitalization compared with children 5 years to 17 years old. In studies of seasonal influenza, the risk for hospitalization is also highest for infants, with the risk decreasing as age increases.

Although antiviral drugs are not meant as a substitute for the flu vaccine, the CDC has approved its use in higher priority cases, including children. According to the FDA, Tamiflu is safe for use in children aged 1 year and older. Infants younger than 1 year can be prescribed Tamiflu as long as such use complies with the FDA’s Emergency Use Authorization guidelines. And that’s good news since both the normal seasonal flu and the H1N1 flu are showing up in schools at alarming rates.

The bad news is that concern over preventing the spread of these viruses and timely treatment of symptoms once exposed has parents and caregivers running to their doctors for children’s Tamiflu prescriptions. Add to that the manufacturers’ decision to concentrate their production efforts on adult dosages that are easier and quicker to manufacture, and we’re now faced with a shortage of Tamiflu for children.

Pharmacists get creative

To keep up with demand, pharmacists are finding it necessary to be creative in filling children’s Tamiflu prescriptions.

Some pharmacists are taking adult-strength pills and compounding a dose suitable for children. This involves diluting a pill until it’s safe enough for a child and then mixing into a flavored liquid. The child’s weight determines a suitable dose.


To better protect infants that qualify for Tamiflu under the guidelines of the Emergency Use Authorization, many pharmacists prescribe the liquid form of Tamiflu. But special care must be taken when dispensing the liquid form.

Pharmacists must ensure that a proper measuring device is substituted since the one included from the manufacturer is not suitable for infants. If they don’t substitute the manufacturer’s dropper which measures in milligrams with a dropper that measures in teaspoons (the more common infant measurement), caregivers will find themselves having to figure out complicated unit measurement conversions. And that can lead to problems.

Rather not take a chance with your child?

We don’t blame you. That’s why we want to remind you that you can still get the real thing right here at PharmacyEscrow.com. Call us today to speak to one of qualified sales agents.

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Monday, November 2, 2009

Prescription Drug Corporations

Are Drug Companies Defrauding our Most Vulnerable?

We often hear how tough economic times are taking a toll on families, with many wage earners losing their jobs or having their hours reduced. But people aren’t the only ones being affected. State budgets are being hard hit, too, with some teetering on the brink of bankruptcy. This has caused leaders to come up with some pretty creative ways to balance their budgets.

Even states that aren’t about to go bust are taking steps to trim budgets to the bone, starting with payroll, one of state government’s biggest expenses. However, payroll cuts have not been enough to create balance. More is needed.

The battle over prescription drug prices

That’s why several state legislators have set their sights on bigger and better targets: prescription drug groups. Claiming they are manipulating the price that Medicaid recipients pay for drugs, some state governments hope to pump up their bottom lines by forcing drug companies to repay hundreds of millions of dollars they claim they overspent on Medicaid reimbursements.

That type of budget-balancer is easy enough for most of us to support, especially when you consider that the prescription drug market is a multi-billion dollar industry. It’s difficult to feel any sympathy towards these seemingly greedy groups that charge crazy prices for drugs that already cash-strapped governments and individuals have no choice but to pay.

Just the facts, please

But fortunately for the drug groups, that’s not the way the judicial system works. Feelings and emotions have no place in decisions. When in court, only the facts are considered. A perfect example occurred recently with a ruling by the Alabama Supreme Court.

Prior to hearing the case, it appeared the state of Alabama had scored a major victory against three big pharmaceutical giants AstraZeneca, Novartis and GlaxoSmithKline when a jury awarded the state $274 million in repayment.
The decision allowed the state to conduct its own research when deciding how much to pay pharmacists for Medicaid recipients’ prescription drugs. The decision meant that Alabama did not have to rely on information provided by drug companies when calculating payment. By conducting its own research to determine pricing, the state would be freed from overpaying for the drugs to which poor and elderly citizens are entitled under Medicaid.

But when the Alabama Supreme Court heard the case, it didn’t agree with the previous jury decision and overturned the ruling. As you’d imagine, drug company representatives were pleased with the outcome, fiercely defending their pricing practices and benchmark data used to set those prices.

This decision doesn’t mean the battle is over. In fact, it’s just beginning and Alabama isn’t the only state taking on pharmacy group giants.


Who will be the winners?

Will the ultimate winners be the states and their constituents? Or will be the side that has the most money to spend on legal fees be the victor? If history is a good predictor of the future, there’s a good chance states will have to find some other way to fund their budgets.

Please give us your opinion on this topic.

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Saturday, October 31, 2009

The Bill Gates Foundation

Bill and Melinda Gates – All That Money and They’re Doing the Right Thing!

William Henry "Bill" Gates III; the man so many people love to hate. Well not hate, maybe, but certainly envy. And what’s not to envy? His is the consummate rags to riches story. In the right place at the right time, Bill turned a passing opportunity into what is arguably the most successful company on the planet.

First, a brief history

Follow his meteoric rise to fame from geeky programmer in 1975 who co-founded a small software company originally named Micro-Soft, to CEO of Microsoft until he stepped down in January 2000, and you see a driven man who has the skills and savvy to capture the PC marketplace and hold it hostage with the only operating system most PC users have ever known.

Here’s a man that reportedly earns more than $300 per second who wakes up one day to the realization that he has reached the pinnacle of his career and can’t possibly buy enough toys to drain his bank account. So what does one of the world’s most wealthy men do when he grows tired of running the multi-national company he built from the ground up?

Now, the history-making foundation

He and his bride took the lion’s share of their wealth and created The Bill & Melinda Gates Foundation (B&MGF or the Gates Foundation). The primary purpose of one of the world’s largest privately-owned philanthropic organizations is “to enhance healthcare and reduce extreme poverty, globally and in America, and to expand educational opportunities and access to information technology.”

And that’s just what Mr. and Mrs. Gates are busy doing. On October 20th, it was announced that the Foundation recently awarded 76 grants, each in the amount of $100,000 with the goal of finding newer and better ways to improve global health. While this in itself is newsworthy, something else that caught people’s attention during this year’s award was the recipients.


Many of the $100,000 grants were awarded to “young” researchers; graduate students and post docs. And this points to a major shift. Historically, the people that are awarded grants are the ones with the most experience in their fields. These tend to be professors and associate professors. Of the 3,000 grant applications submitted to the Bill and Melinda Gates Foundation for consideration, the majority were submitted by the groups with more life and work experience; in other words, the older folks.

But when you take a closer look at the applications that were ultimately chosen after not one but three rounds of consideration, a noticeable percentage was awarded to younger applicants.

Why the shift?

Is this an effort by Bill Gates to relive his youth by giving a hand, or in this case, $100,000 to so many younger applicants? Or do the Gateses think it’s time to let a younger, more innovative generation take a chance at solving the world’s problems? Or is something else going on?

What do you think?

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Monday, October 26, 2009

U.S. and Canadian Drug Markets

As the United States government struggles to devise a better way to provide health care coverage to its citizens, comparisons to the Canadian-run system are common. What’s also common is the wide range of opinions offered by patients and physicians alike.

Depending on whom you believe, the Canadian government-run plan is either far superior to or far more limiting than the privately run U.S. system.

How can this be? And who should you believe? As the heated arguments rage on, both sides seem willing to agree on this: Neither system is perfect.

Today, we’ll take a closer look at one of the biggest dilemmas both U.S. and Canadian citizens face: Access to affordable prescription drugs.

Price regulation

The United States and Canada are two of the biggest pharmaceutical drug markets in the world. Unlike in the U.S., the Canadian government determines the price Canadians pay by regulating drug prices. While this helps “cap” drug prices, Canada’s numerous provincial drug benefits plans creates inconsistencies in drug benefits, drug prices, and drug coverage.

In the U.S., insurance companies and other large drug purchasers negotiate prices with drug manufacturers directly. Since the U.S. government does not regulate prescription drug pricing (except in certain government-run programs like Medicaid), the free market reigns, making drugs a very lucrative market. The driving force behind U.S. pricing strategy is maximizing profitability, which is why drugs in the U.S. cost so much more than they do in other industrialized countries like Canada.

In exchange for the higher price they pay though, U.S. citizens don’t get superior drugs. Aside from the occasional name change, the ingredients in same drugs purchased in the U.S. and in Canada are usually identical. Most often they’re manufactured at the same facilities in an effort to control manufacturing costs then distributed around the world.

It doesn’t take long for anyone searching the Internet to realize that purchasing drugs from non-U.S. dispensaries can save a considerable amount of money. Naturally, attempts to stop this practice are frequent, but so far, unsuccessful.


A Closer Look at the U.S. and Canadian Drug Markets
Use of generic brands

Another notable feature of the Canadian drug market is use of generic brands. Just over 50% of 2008 total drug sales in Canada were for generic drugs. Generic drugs come to market much more quickly than they do in the U.S. so Canadians have greater access to them.

Drug manufacturers aren’t allowed to saturate Canadian television advertising like they do in the U.S. so there isn’t the same demand for name-brand drugs. However, today’s tough economic climate is changing this, as U.S. citizens already struggling with higher costs for health care and basic necessities are switching to generics as a way to save money.

One similarity

Interestingly, there is one similarity in both drug markets that affects millions: Newer drugs and specialty drugs are still out of reach for many of the people that need them either because they lack insurance or because their insurance plans doesn’t cover 100% of the costs.

And that is a problem both governments need to fix.

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Thursday, October 1, 2009

President’s Obama's Proposed Health Reform

Why All the Opposition to the President’s Proposed Health Reform?

You’d think health reform that provided affordable coverage for everyone would be a good thing. But if it’s so good, why is there so much controversy surrounding Obama’s plan to reform health care?

I could make this a short post and say that the controversy stems from society’s fear of change. Rather than take a chance on the unknown, people would rather live with (and complain about!) what they already know. It’s easier that way. However, people want change, and they need change. So there has to be something more behind all the controversy. Let’s take a closer look at some of the issues.

The price tag

One of the biggest problems with the proposed plan is the price tag. Here, fear of the unknown is fueling the controversy. People already know the cost of their current health insurance plan. But most don’t know how much the plan being proposed will cost.

Government-subsidized health care sounds like a terrific bargain for American citizens. However, the people Obama says will benefit from it most are the very same people that will be paying for it in the form of huge tax increases. Whether the total cost of the plan is $8 billion or $28 billion a year for the next two decades, both are mind-boggling numbers. Until everyone sees a final and realistic price tag, controversy will continue.



Who’s covered, who’s not, and at what cost

Another very real problem is the prospect that non-taxpaying individuals may be able to take advantage of the new plan. No doubt you’ve heard about the recent outburst by one senator regarding the current plan’s failure to require proof of citizenship in order to receive subsidized health care. It’s the belief of many hard-working middle class Americans that if you’re going to benefit from the system, you should be paying into the system. Until it’s clear who’s entitled to receive benefits, controversy will continue.

A requirement that all customers be offered the same rate regardless of the risk they pose is not sitting well with people either. This means that someone that’s been a 2-pack-a-day smoker for the last 20 years pays the same amount as a young active adult with no underlying health issues. Evening out the rate scales by lowering one person’s cost and raising another’s gives an advantage to some while penalizing others. Until this matter is resolved, controversy will continue.

Public options

Inclusion of a public option plan all by itself is creating quite a bit of controversy. Public option plans will compete with privately offered insurance plans, and many experts believe, will eventually drive most private insurers out of business. Not only that, government subsidized public option plans may lead to rationing of services since more people will take advantage of services they previously were unable to afford and/or that they may not need. Until the public option mess is cleared up, controversy will continue.

Plenty of other provisions in the 700+ page proposal are generating heated controversy. And until the all the details are clearly laid out, controversy will continue.

What do you think about the president’s health care reform plan, is it good or bad?

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