The passage of the Patient Protection and Affordable Care Act, (often called “Obamacare,” by those who oppose the Act) is leading to a fundamental restructuring of how we Americans pay for our health care. The law itself is long and complex. Here’s a 907 page legal summary, if you’re ready for a challenge. I’ll just wait here while you study up…

Didn’t get far? You’re not alone.  There is a lot of “legalese” to wade through, and the courts will be busy untangling much of the meaning for many years to come. But many of the essential aspects of the program are reasonably straightforward, including several provisions that have already been enacted as the law of the land. This includes parts of the Act that address preexisting conditions and the availability of health insurance.

Since September 2010, parents who purchase or renew insurance plans can obtain coverage for their children up to age 26.

Pre-existing health conditions cannot be excluded from coverage for children less than 19 years old.

Insurers are now prohibited from dropping policyholders if they get sick and make claims.

Other key provisions of the Patient Protection and Affordable Care Act (ACA) include:

• Insurers will be prohibited from establishing yearly and lifetime spending caps, and will be required to spend a certain percentage of collected premiums on actual health care rather than marketing, advertising and executive compensation Imagine!
• Insurers will no longer be allowed to deny coverage for adult consumers because of pre-existing conditions or raise their premiums if they develop problems.
• Coverage options will expand. An expansion of Medicaid will bring coverage to an estimated 16 million new enrollees and 40 percent of them will be under 30 years old.
• Individuals can also seek coverage from state-run exchanges — a new competitive marketplace for private health insurance that’s designed to give individuals and small businesses access to affordable coverage.
• Essential mental health and substance use disorder services must be covered as part of the benefits package by all insurance policies offered through the exchanges and Medicaid.
• ACA eliminates lifetime caps on benefits and restricts insurers’ use of annual caps for all new plans issued after December 2010. So if you have chronic conditions that are expensive, you can seek your services and not lose your insurance.
• ACA also puts a stop to rescission — the practice of dropping patients from coverage, usually when their medical expenses are high — except in cases of misrepresentation or fraud.
• ACA also focuses on preventive health, which means that consumers purchasing new plans will no longer have to face copayments or other forms of cost-sharing for preventive services, such as depression screening, drug and alcohol misuse screening and smoking cessation efforts.
• A report by the Center for Medicare Advocacy, Inc. states that, with the reform bill, Medicare savings will be about $130 billion over 10 years, by reducing overpayments to private Medicare Advantage plans.

The most controversial part of the Act is the universal mandate. This is the requirement that all Americans have some kind of approved health coverage (either as part of a commercial insurance plan or government program) or be subjected to a yearly penalty.

Currently, legal challenges to the mandate are winding through the courts, with some jurisdictions upholding and some striking down this provision. In all likelihood, the issue will ultimately be decided by the US Supreme Court. However the issue of a universal mandate is decided, other parts of the legislation will likely remain unaffected. The Constitutional challenge is not about whether the mandate is a reasonable economic decision, but whether the government is legally empowered to enforce the issue.

Once the entirety of the legislation goes into effect, health insurers will be required to offer plans with premiums based only on age and geographic location.  This is extremely important to consumers because it levels the playing field for those with more-complex health conditions.

Over the past year, there has been conflicting and misleading information about the Patient Protection and Affordable Care Act (ACA), led mostly by insurance industry lobbyists and special interest groups. This has led to some astonishing levels of confusion amongst consumers.

National Public Radio reported that among those lacking insurance, 41 percent incorrectly think the law lacks provisions to help those with modest means pay for health insurance (7 percent said they didn’t know) and 37 percent incorrectly said the law doesn’t include an expansion of the Medicaid program to low-income, able-bodied adults (16 percent weren’t sure).

According to a new Kaiser Family Foundation monthly tracking poll, a full 50 percent of uninsured people have no clue what health insurance benefits are to come with full implementation. Fewer than 31 percent say they think the law will help them obtain health insurance, although the ACA is projected to insure 32 million people who currently do not have coverage.

On the political side, as reported by the Henry J. Kaiser Family Foundation, consumers identifying themselves as Republicans and reported having a favorable view of the Affordable Care Act has reached its highest level in August, 2011; with 24% having that opinion since the law was passed last year,  At the same time, support among consumers identifying themselves as Democrats was at its lowest level, 60%, according to the most recent data from the monthly Kaiser Health Tracking Poll. Among independents, 33% expressed a favorable opinion toward the ACA in August, down from 38% the month before.

Overall support among all Americans dropped from 42% in July to 39% in August, the lowest level since the ACA was passed. Overall, 44% of Americans expressed an unfavorable view of health reform and 17% said that they didn’t know or declined to express an opinion.

Despite the ongoing controversy and pending legislation, it is important to note that the ACA doesn’t just impact the uninsured; it strengthens the coverage for people who are already insured.

CardioGen-82: Is it business as usual winning over Safety?

Between February 17^th and February 21^st, 2011, two heart patients, one from Sarasota, Florida and the second from Nevada underwent nuclear PET (Positron Emission Tomography) scans to diagnose possible heart malfunctions.  After having undergone CardioGen-82 PET scans, the two patients and at least one other had a lingering problem, residual high level radiation. And if it were not for heightened vigilance from Homeland Security personnel, those patients might never have learned that they were walking radiation repositories.

After the March earthquake that devastated Japan and wreaked havoc on its nuclear facilities, Homeland Security began screening international travelers to detect any possible abnormal radiation levels. On June 3, 2011 while going through a Canadian checkpoint on his way to Buffalo, New York, the first CardioGen patient lit up Homeland Security’s gamma radiation detector. Homeland Security personnel then detained that individual, and he became marooned in Canada for an indefinite period. As a result, he called Heart Specialists of Sarasota, where he had undergone the CardioGen diagnostic PET scan to determine if personnel there could help him to obtain permission to go home.

CardioGen-82 is a device that generates Rubidium-82 tracer, which is currently the only radioactive material available to perform cardiac PET scans. Bracco Diagnostics distributes the CardioGen-82, which makes rubidium-82 from Strontium-82 on location. Because of its very short, 75 second half-life, Rubidium needs to be made “fresh” and on location for it to be an effective tracer. Rubidium’s short half-life is what makes it a relatively safe radioactive tracer, because residual radioactivity disappears within a very short time and is much less likely to cause side effects.

The CardioGen-82 makes tracer in the following way. The daughter element, Rubidium-82 (half-life, 76 seconds) is made within the CardioGen itself from a parent element called Strontium-82 (half-life approximately 4 weeks). Bracco obtains the heart of the CardioGen, a Strontium-Rubidium generator, from Nordion, a Canadian company and one of a few companies in the world that is capable of producing the Strontium-Rubidium generator.

The Strontium-Rubidium generator itself is made of a tube containing a substrate of tin oxide. Nordion then impregnates the tin oxide substrate with the more radioactive Strontium-82. Over a period of about a month, the impregnated Strontium-82 decays and continuously produces the less radioactive Rubidium-82 as a by-product. The CardioGen, equipped with a series of valves, syringes and a dosimeter then manages the collection of Rubidium-82 within the CardioGen-82 device, by using a saline solution. The saline is eventually sent through the tube, and it collects the Rubidium, while attempting to avoid collecting the more radioactive Strontium-82.

If Strontium-82 manages to slip into the final solution in a greater than permissible (trace) amount, that contamination is termed “breakthrough.” Obviously, breakthrough is not permissible because the highly radioactive Strontium-82, having a half-life over 1,000 times as much as Rubidium, might cause unwanted health risks for a patient undergoing a diagnostic cardiac PET scan.

As mentioned, very few facilities in the world can make enough Strontium-82 to manufacture the Strontium-Rubidium generator. As a result, Bracco Diagnostics, Inc. partnered with MDS-Nordion to develop a new dedicated manufacturing facility in Ottawa, Canada to produce CardioGen-82.

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“Quid pro quo” happens in business all the time. You scratch my back, I’ll scratch yours.

Usually, the exchange is relatively even and the result doesn’t really cause any harm to anyone… or at least any harm of real consequence.

But, give me a million dollars for my “quo” and your “quid” must be huge!

That is what is happening between doctors and medical device manufacturers. Both drug companies and medical device manufacturers have been playing this game for decades. Whether it is a case in which the doctor gets paid for putting their name on an article they did not write and supporting the latest, greatest drug or they are paid for “consulting fees” that result in the doctor’s support of a particular new medical device. The result is the same – a respected name gets attached to the latest, greatest widget and sales rise.

The Chicago Tribune reports that “orthopedic surgeons have received hundreds of millions of dollars from joint implant manufacturers…” Yes. You read that correctly – hundreds with six 0’s following them.

In 2007, device manufacturers were told they were going to be required to disclose payments made like this; so, since then the total amounts in tribute paid has dropped, while the amount of individual payments has gone up. So, manufacturers are simply being more selective in choosing “which” doctor and agreeable to paying a 40 % higher amount of “tribute” to each. The average payments per doctor have risen from $212,740 to $233,108; with some individual payments being as high as $1 million according to an analysis of statistics by Dr. Robert Steinbrook from Yale University School of Medicine.

Dr. Steinbrook notes that conflicts of interest continue as recently reported in The Spine Journal, in connection with a Medtronic clinical trial for recombinant bone morphogenetic protein:

“Financial information was available for 12 of the 13 original studies: “the median-known financial associations between the authors and Medtronic Inc were found to be approximately $12,000,000 to $16,000,000 per study (range, $560 000-$23 500 000). An editorial noted ‘a rising, if not malignant, doubt about the spine field’s ability to honestly assess and report on clinical practice and new technologies.”

Only 4% of physicians ever are treated with these bonuses by medical device manufacturers; so is it really a problem?

Yes.

The way your physician makes decisions about recommending drugs and medical devices is by reading about them in journals, going to conferences, and hearing about them from manufacturer sales representatives. The sales reps are a given that the information is slanted in favor of the manufacturer.

So, that leaves articles and conferences.

If the respected men and women in a given field are willing to receive payment for supporting a particular medical device or drug by making speeches at conferences or by talking to fellow physicians at them, then we are down to journal articles. We have already read the reports about articles being ghost written by marketing professionals and “experts” being paid to add their names as authors.

Who can your physician trust? Your physician who is simply trying to provide the best care he or she can – how do they make the best judgments of which device is the best and which new drug is the most effective? They read. They listen. The problem is…who are they listening to?

There are growing safety concerns over the anti-arrhythmia drug Multaq, (dronedarone), which is manufactured and marketed by Sanofi-Aventis and has generated a great deal of controversy and concern in just a few short years.

Multaq was first approved by the Food & Drug Administration (“FDA”) in 2009 for use as an anti-arrhythmic drug in heart patients with paroxysmal or persistent atrial fibrillation.  Atrial fibrillation is essentially an irregular heartbeat that may be a sign of an asymptomatic problem or may be a sign of a significant and life threatening problem. People with atrial fibrillation are exposed to things such as fainting, congestive heart failure, and stroke. Paroxymal refers to patients with symptoms that resolve in less than (7) days and persistent to patients with symptoms resolving in over (7) days.

The drug, Multaq, was prescribed in particular for patients with severe heart disease, including those who were elderly, had other serious medical conditions such as hypertension or diabetes, a history of a previous stroke or cerebrovascular accident, or had evidence of serious heart disease or heart failure based up on their EKG and echocardiogram findings. The drug carries a “black box warning” (the strongest level of warning on a prescription drug) informing physicians that Multaq should not be prescribed for patients with severe congestive heart failure because of  concerns that use of the drug might worsen patients’ heart failure symptoms or increase their chances of dying.

Here is just a glimpse into the questionable history of Multaq:

• July 1, 2009 – Multaq, (dronedarone hydrochloride), was approved by the FDA for sale in the United States.  The drug was subject to a Risk Evaluation and Mitigation Strategy (REMS), which essentially means that the drug had been identified as one that would require special care in its prescription and use. As such, it was accompanied by special patient materials and warning labels not distributed with other drugs that are evaluated as posing less risk to patients.
• Early 2010 – FDA warned of possible problems with congestive heart failure in patients taking Multaq.
• Spring 2010 – FDA warned of a possible link between Multaq and a potentially fatal ventricular arrhythmia known as torsades de pointes.  Other drugs, such as Propulsid, have been recalled due to links to this same life-threatening arrhythmia as well as an electrical conduction problem in the heart known as “long QT syndrome.”
• September 2010 – FDA includes Multaq in a report entitled “Potential Signals of Serious Risks/New Safety Information Indentified by Adverse Event Reporting System (AERS) between July – September 2010,” which was part of a new initiative by the FDA to alert the public and medical community about potential, emerging drug-related safety issues.  This same report included some other drugs that remain under a cloud of suspicion and/or are the subject of current litigation efforts, including Epogen and Procrit (possible contamination with lamellae); Gemzar (liver toxicity); Keppra (linked to Stevens Johnson Syndrome and Toxic Epidermal Necrolysis); and Actos (rhabdomyolysis).
• January 14, 2011 – The FDA issued a Drug Safety Communication directed to patients and healthcare professionals regarding its receipt of numerous adverse event reports (also known as AERs) relating to liver toxicity, serious liver injuries, and acute liver failure requiring a liver transplant in patients taking Multaq.  At that time, it was estimated that more than 147,000 patients had taken the drug in the 18 months since it was approved.

Often, the potential for a new drug to cause liver failure is not identified until the drug is given to a large number of patients after the drug is placed on the market, and these patients, sadly, unknowingly serve as real world guinea pigs for new drugs that are tested on too few and under aggressively-controlled study protocol, such that study participants are often pulled from the pre-marketing clinical studies at the first signs of any toxicity and before it is possible to detect potential liver problems.  Drug-induced liver problems are a serious health issue in the United States, with more than 400 prescription and over-the-counter drugs being linked to hepatoxicity, with only a fraction of these drugs being recalled due to liver-related safety issues.

• February 11, 2011 – Drug warning label enhanced to include the risks of acute liver failure or hepatic toxicity.  The symptoms associated with acute liver failure include jaundice, abdominal pain, dark urine, itching, fever, malaise, anorexia, vomiting, and nausea.  Patients may also have abnormal blood tests slowing elevated liver enzymes.
• March 11, 2011 – Drug warning label further changed to discuss the potential for drug interactions, especially with warfarin (also known as Coumadin).
• June 21, 2011 – Multaq’s warning label was changed yet again to note that some patients who had taken the drug had developed serious pulmonary and respiratory problems, including interstitial lung disease, pneumonitis, and pulmonary fibrosis.  These serious lung problems had not been noted in the limited clinical trials completed to evaluate the safety of Multaq prior to FDA approval.
• July 21, 2011 – The FDA issued a “Drug Safety Communication” to doctors and patients regarding the increased risk of death and serious cardiovascular adverse events noted in an ongoing clinical trial involving patients taking Multaq (or dronedarone) for permanent atrial fibrillation (an indication for use of the drug that had not yet been approved by the FDA).  This clinical study is known as the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) Study.  The July of 2011 safety alert indicated that from July of 2009 through June of 2011 approximately 241,000 patients had ingested Multaq.  At that time, patients were urged to consult with their physicians regarding whether they should discontinue the medication, and were encouraged to report adverse events to the FDA and Sanofi-Aventis.  Physicians were also urged not to prescribe Multaq to patients with permanent atrial fibrillation, an off-label use of the drug. At that time, the FDA indicated that the data showing potential safety issues in the PALLAS clinical trial was preliminary, and that the Agency would be conducting a more thorough review to determine whether the same increased risk of cardiovascular death or serious heart-related side effects noted in study patients with permanent atrial fibrillation might also be seen in patients taking Multaq for paroxysmal or persistent atrial fibrillation or atrial flutter, conditions for which the drug had been approved by the FDA in 2009.
• August 5, 2011 – The Food & Drug Administrator and the manufacturer of Multaq updated the “Risk Evaluation and Mitigation Strategy (REMS)” plan, in order to further outline efforts to be undertaken to provide better information to patients and prescribing physicians in hopes of preventing future injuries and death to patients using Multaq.  In addition, patients who have suffered serious adverse reactions were urged to report them to the Food & Drug Administration at 1-800-FDA-1088 or at www.fda.gov/medwatch.  Patients have also been cautioned to consult with their physicians prior to discontinuing Multaq, as there are serious potential side effects if patients abruptly stop taking this medication.
• August 22, 2011 – The warning label was again modified to reflect that patients may experience changes in their kidney function while taking Multaq.  Adverse event reports have noted that patients experienced elevations in their creatinine and blood urea nitrogen (BUN) levels while taking Multaq.
• September 22, 2011 – The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), the drug safety organization similar to the FDA that oversees drug safety in the European Union, met to discuss safety concerns over Multaq and whether the drug should continue to be prescribed in Europe.

In the past, the EMA has shown that it is more inclined to move swiftly to recall dangerous drugs and to put the welfare of patients before the interests of the pharmaceutical industry, unlike the FDA which has shown a tendency to move at a much slower pace while it studies safety issues relating to drugs (and, sadly, to give the drug manufacturers a few more months or years for last-ditch efforts to peddle unsafe pills).  The EMA committee recommended that use of Multaq be limited in light of evidence that the drug was associated with serious adverse effects on the liver, heart, and lungs.

Meanwhile, patients in the United States are faced, yet again, with a difficult situation.  So, what should Multaq patients do?  Patients should consult with their physician now and on a regular basis to determine whether continued use of Multaq, in the face of growing safety concerns, is warranted given their particular medical history and personal risk factors.

Patients should also urge the drug manufacturers and the FDA to be more proactive in removing dangerous drugs from the market rather than continuing to issue press releases and revised warning labels which, obviously, are failing to protect patients from drug-induced injuries.

For additional resources related to Multaq, please visit these sites:

Manufacturer’s web site

Medication Guide for Patients

REMS

July 2009 label

February 2011 label

March 2011 label

June 2011 label

August 2011 label

FDA summary memo regarding review of the new drug application for Multaq

FDA drug approval package

7/21/2011 Safety Alert

1/14/2011 Safety Alert

January 2011 – FDA podcast on liver toxicity

I want to tell you about a man called Jack the Bike Man. His given name is Jack Hairston and while he tells his own story on his website, I want to illustrate what Jack does.

Jack the Bike Man understands about kids and bikes. More importantly, Jack the Bike Man understands about hearts and kids and bikes. Jack the Bike Man understands the difference that can be made in the lives of children with things like bikes and compassion.

I remember my first bike.

I remember my first bike because I built it from a frame I found in a creek near my home, the chain and sprocket came from someone else’s old bike, and some wheels and tires I was able to get by cleaning shelves for the discount store downtown for several weeks. It was my very own Huffy-Schwinn-American bike.

I remember my first ride on my first bike. It was better than my first car because it represented to me, as an 11 year old boy, the ultimate freedom. For the first time I could actually get blocks from home in a relatively short period and I could feel the freedom of the wind blowing on my face. I also could decorate the bike to conform to my very own personality.

A boy’s bike defines him. It says to the world, “I am here and I am unique!”

Much to the shock of my mother, I could build daredevil ramps and launch through the air or fly along dirt paths and leap off gullies. I could be free to skin my elbows or, in one occasion, knock out a couple teeth.

But, mostly, my first bike was about responsibility. Of course, no one told me that and it is only now when I must hide that little boy in my middle-aged body that I realize this lesson. That bike taught me about paying for my own mistakes and about being responsible for my own actions – as painful as both those things can be.

Jack the Bike Man gives all this to kids – to boys and to girls. He provides them with this little piece of heaven and the memories that will provide a lifetime of lessons about responsibility and compassion.

And, Jack the Bike Man has been doing this all for years with little help. He has begged and pleaded for old bikes; for pieces and parts of bikes; and for help getting these old bikes repaired. Jack fixes them, puts them all back together and once Jack has the bikes in a safe condition, he gives them out to kids in need of some dreams and children in need of a little hope.

Jack the Bike Man is like the Santa Claus of bikes. I wish I could someday do something even as remotely important as Jack has been doing now for years.

Sadly, there are many more kids than there are bikes. I challenge everyone to donate to this worthy cause by going to Jack the Bike Man’s website; or buy a bike and drop it off to Jack at his shop located at 4401 Broadway in West Palm Beach, Florida.

I challenge you to help Jack The Bike Man make a difference in the life and future of a child.

What are “lawyer referral services”?

To accurately answer that question in any given case, you must look at something that consumers seldom know – who owns the referral service? Is the service owned by physicians, chiropractors, or physical therapists? Is the referral service simply a handy way to funnel injured victims toward a specific medical clinic or chiropractor’s office?

What is a “lawyer referral service” supposed to accomplish?

An appropriate service should help consumers by providing information about what consumers can and should do in the event of a tragic accident. The service should provide information about highly qualified attorneys in the consumer’s geographical area who practice in the legal specialty needed by the consumer. Finally, the service should provide a way for consumers to get in contact with the service’s attorney member of the consumer’s choice.

What have some lawyer referral services become?

Lawyer referral services are not regulated by the Florida Bar Association. In fact, other than the state attorney general or Better Business Bureau, there is little regulation and no oversight.

Some “lawyer referral services” have sadly evolved into nothing more than “medical referral services” and particularly in the area of motor vehicle accidents. Many of the services are reportedly steering accident victims to “medical clinics” who rapidly institute treatment of the injured person’s injuries and charge that treatment against PIP (personal injury protection) limits under the victims auto policy. Typically the policy limits for PIP are $10,000 and theses services quickly eat up the available limits with medical charges.

What these referral services fail to tell patients is that PIP can also be applied to things like loss of wages and incidental expenses incurred in the course of medical treatment. As a result, medical expenses rapidly eat up available PIP amounts before the injured victim can take advantage of lost wage compensation.

There have also been reports of improprieties in the way injured people are referred to attorneys. In some cases, it has been reported that:

• Some referral services have used advertising to disguise direct solicitations to physicians and lawyers.
• A patient injured in an accident calls the referral service number and is sent to a clinic. Although the patient had not requested a lawyer, he or she is met at the clinic by a lawyer or representative of a lawyer before seeing the doctor.
• The patient, in filling out paperwork, unknowingly signs a retainer for a law firm included with the medical paperwork, which is not explained.
• Patients showing up at the clinic after a referral are told they must see an attorney first, provided by the referral service, before they will be treated, even though they had not requested a lawyer.
• Some patients, unhappy with their treatment at the clinic, have gone to their designated lawyer for help, only to be told the lawyer cannot help them because he or she also represents the clinic, perhaps in seeking PIP benefits from the insurance company.

It is bad enough to be the victim of an accident that causes injuries, loss of income and medical costs. Consumers should arm themselves with information to protect themselves in the event of an accident and consumers should not blindly sign documents without fully understanding them.

Here are some common sense things a consumer can do to avoid being taken advantage of:

• Know that you do not need to contact an attorney or a lawyer referral service from the scene of the accident. In fact, that may be the very worst place to make this type of decision.
• If you need an attorney, do your homework or ask a trusted loved one to do the research for you. Look at lawyer websites, call and talk to law firms, and request all the information that will allow you to make an informed decision. Much of that information should be readily available on the law firm website.
• Ask your family physician for a referral to a trusted medical provider or; ask friends and family for the name of a physician you would want to see.
• Do not sign any documents you do not fully understand. Do not be intimidated. Ask questions about every aspect of documents you are being asked to sign until you fully appreciate what you are signing.
• Consult a trusted attorney, whether you ultimately hire one or not.
• Understand that reputable attorneys do not undertake representation of people who do not need a lawyer.

So, in the event of an accident, take care of yourself, your loved ones and your injuries first. Guard your legal rights and do not sign documents unless you know what you are signing. Know who you are hiring and for what purpose.

Know that ethical lawyers do not send lawyers or investigators to you unless you have contacted them first. If you are visited by someone representing a law firm, be sure they are someone you contacted first.

As depicted in the following video, over the years, cardiologists have relied upon invasive catheterization to diagnose cardiac-related blood flow problems and muscle wall damage. However, placing a catheter into blood vessels and guiding it into the heart is technique-sensitive, and is far more invasive and less diagnostic than the use of Positron Emission Tomography (PET).

[youtube]http://www.youtube.com/watch?v=xwh3tlFaVm0[/youtube]

This is true because instead of using a mechanical, wire-like catheter, cardiologists can inject a less intrusive “Rubidium-82 saline liquid” into patients’ blood vessels  The short span radioactive liquid (having a very short 76 second half life) then combines with the blood that usually flows through the blood vessels. The Rubidium-82 liquid, also called a tracer, acts just like potassium. Rubidium-82 substitutes itself in place of potassium in the cells.

If the physician injects a potassium analogue tracer into a patient, the patient’s heart muscle cells will absorb the tracer. Note that blood vessels carry the tracer to the heart muscle, but while the tracer disappears in the blood, it collects in the heart muscle, providing a sharp contrast when viewed via a PET scanner that can photograph the emitting radiation.

Several minutes after the Rubidium-82 tracer injection, a PET image will show a concentrated, retained tracer in the heart, which contrasts with the low activity in the blood (because newly circulating blood is carrying away the excess tracer).

Since Rubidium-82 has a relatively short, 76 second half-life, after six half-lives (450 seconds or 7.5 minutes), investigators treat the tracer as completely decayed  – because only a mere 1.6% of original radioactivity remains. This brevity of activity means that the tracer cannot be stored and transported between facilities. Instead, it must be produced on-site.

The usual way to produce tracers is by using an expensive cyclotron. Because the cyclotron is expensive and cumbersome, researchers investigated alternative ways to produce tracers with less expensive equipment that could be used on-site in the offices of cardiologists or other healthcare providers. The Cardiogen-82 Strontium-82 to Rubidium-82 generator, which General Electric manufactures and distributes for Bracco Diagnostics, Inc., is a relatively inexpensive piece of equipment that can produce Rubidium-82 from Strontium-82 (which has a longer half-life of 24 days). Strontium-82 is produced from Strontium-85 (having a half-life of about 65 days). Given the much longer half-lives, strontium isotopes would be too toxic for use as tracers in humans.

The CardioGen-82 generator employs a long tin oxide tube that contains the more toxic Strontium-82 (parent), and normal saline is pumped through the tin oxide tube, which results in the manufacture of the less toxic Rubidium-82 tracer. Of course, it is paramount that physicians prevent an occurrence called “breakthrough,” which happens when Strontium-82 is carried along with Rubidium-82 in the tracer liquid in larger than permissible amounts. Injecting Strontium along with Rubidium into a patient increases the risks of radiation poisoning.

The relatively short half-life of Rubidium-82 is both an advantage and a disadvantage. On the positive side, quick decay means shorter patient exposure to radiation. And, physicians can perform repeated PET scans every 10 minutes, because the radiation from the previous dose has disappeared by that time. However, fast decay shortens the maximum scan time and reduces the quality of the scans. That is the reason why on-site Rubidium-82 tracer manufacture and direct tracer injection into a patient, within a really brief period, is so necessary.

The information, above, makes it clear that both catheterization and Rubidium PET scanning have diagnostic pros and cons. While Rubidium PET is less mechanically invasive, and more diagnostic than catheterization, Rubidium PET is, nonetheless, invasive because of the use of radiation in patients and the complexity of technique required in order to use the product safely. If Strontium-82 were to break through during a procedure, it could be disastrous to a patient.

Each year, Americans observe National Hispanic Heritage Month from September 15 to October 15, by celebrating the histories, cultures and contributions of American citizens whose ancestors came from Spain, Mexico, the Caribbean and Central and South America.

The observation started in 1968 as Hispanic Heritage Week under President Lyndon Johnson and was expanded by President Ronald Reagan in 1988 to cover a 30-day period starting on September 15 and ending on October 15. It was enacted into law on August 17, 1988, on the approval of Public Law 100-402.

The day of September 15 is significant because it is the anniversary of independence for Latin American countries Costa Rica, El Salvador, Guatemala, Honduras and Nicaragua. In addition, Mexico and Chile celebrate their independence days on September 16 and September18, respectively. Also, Columbus Day or Día de la Raza, which is October 12, falls within this 30 day period.”

Notable Latino “Firsts” include:

Antonia Novello, First Hispanic US Surgeon General

Mario Molina, First Hispanic Nobel Prize-Chemistry

Ellen Ochoa, First Hispanic Female Astronaut

[youtube]http://www.youtube.com/watch?v=kaLYtH_2jR0[/youtube]

Roberto Clemente, First Hispanic Baseball Hall of Fame Inductee

Sonia Sotomayor, First Hispanic US Supreme Court Justice

Carlos Santana, First Hispanic First Hispanic Rock and Roll Hall of Fame Inductee

[youtube]http://www.youtube.com/watch?v=b84ZOi4lQsE[/youtube]

Nancy Lopez, First Hispanic LPGA Hall of Fame Inductee

John Ruiz, First Hispanic Heavyweight Champion

Rita Moreno, First Hispanic Female Supporting actress Oscar Winner

[youtube]http://www.youtube.com/watch?v=jb-Soa3kN-g[/youtube]

For 35 years, our firm has represented a broad spectrum of clients because we believe that “justice for all” is what makes the fabric of our democracy strong.  That’s why the law firm of Searcy Denney Scarola Barnhart & Shipley is especially proud to commemorate Hispanic Heritage Month 2011 with the launch of its Spanish language website www.VozParaLaJusticia.com.

Many physical, social, and chemical changes happen to a woman both before and after her pregnancy.  These changes can lead to women suffering from a number of symptoms including depression.  In fact, it has been said that one out of every five women has symptoms of depression during their pregnancy.

Naturally, women seek help to battle these illnesses and often resort to medicine to prevent adverse effects to themselves and their child.  However, using medications containing sertraline hydrochloride, such as Zoloft, to combat depression can lead to serious issues for a developing child.

Zoloft was approved by the FDA in 1991 and is currently manufactured by Pfizer, Inc.  Zoloft is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs) and works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance.  Zoloft has proven to be a large source of revenue for Pfizer and in 2010, brought in $532 million in revenue, a 3% increase in sales from 2009; nearly a billion dollars in sales in just two years.

Zoloft has been used to treat illnesses such as:

• depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over)
• panic attacks, (sudden, unexpected attacks of extreme fear and worry about these attacks)
• post-traumatic stress disorder (psychological symptoms that develop after a frightening experience)
• social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life)

Research has demonstrated that Zoloft can cause adverse effects in babies that include: heart problems, low birth weight, and high blood pressure in the arteries that supply blood to the lungs (pulmonary hypertension).  These side effects have been so serious that the FDA has released warnings of Zoloft’s danger like this one posted in July 2006:

“The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) was recently published in a medical journal. Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies.  Babies with PPHN can be very sick and may die.  The study results showed that babies born to mothers who took selective serotonin reuptake inhibitors (SSRIs), the family of medicines Zoloft® belongs to, 20 weeks or later in their pregnancies had a higher chance (were 6 times as likely) to have PPHN than babies born to mothers who did not take antidepressants during pregnancy (6-12 per 1000 births versus 1-2 per 1000 births). The FDA plans to further look at the role of SSRIs in babies with PPHN.”

Additionally, doctors such as Peter R. Breggin, MD, who published a study on the topic, concluded:

“Pregnant mothers should avoid taking SSRI antidepressants—they are hazardous to the developing fetus, cause withdrawal symptoms in the newborn baby, and induce biochemical and morphological abnormalities in the brain. If pregnant mothers need help with sad or anxious feelings, they should seek counseling or psychotherapy, especially family therapy involving the child’s father, as well as other sources of emotional support.”

As Dr. Breggin has recommended, depression can be treated in several ways. Support groups may help.  But most importantly, if you know a woman that is taking an antidepressant and wants to get pregnant, make sure that she talks to her health care provider beforehand. Together, they will decide whether she should keep taking the medication, change the medication, gradually reduce the dose, or stop taking it all together.

A study released in the journal Pediatrics found that children driven by their grandparents are less likely to suffer from a serious injury if involved in a crash. Dr. Fred Henretig, an emergency medicine specialist at Children’s Hospital of Philadelphia and lead author of the study said that the study was inspired by his own experiences with his first grandchild: “I found myself being very nervous on the occasions that we drove our grand-daughter around and really wondered if anyone had ever looked at this before.”   Acknowledging that car crashes are more common in drivers above age 65, the study instead focused on the injuries involved in crashes rather than the number of crashes.

Surprisingly, a child’s risk of injury was lower when riding with grandparents than with parents. The study analyzed State Farm insurance claims from 2003-2007 of car crashes in 15 states as well as interviews with the drivers. The data included over 11,000 children under age 15. Although children driven by grandparents made up about 9.5% of the sample, children driven by grandparents resulted in only 6.6% of the total injuries.  Overall, 1.05% of children were injured when they were riding with their parents, but only 0.70% of that group was injured when riding with their grandparents. Thus, a child had almost a 33% lower risk of injury when driven by their grandparent.

Additionally, the study found that there was little difference in the type of injury for children while driving with grandparents versus parent drivers. Head injuries accounted for about 63% of the injuries, injuries to extremities at 16.6%, chest and abdomen at 13.5%, face at 5.7% and spinal column at 1.2%.

Unfortunately, grandparents did fail one aspect of the study: best-practice recommendations for optimal child restraint. Grandparents were less likely to follow the recommended practices (rear-facing backseat car seats for infants, seat belts, etc.) that parent drivers. However, this failure did not seem to affect the injury rates published in the study.

There are some drawbacks to the study: failure to include information on the types of car trips involved (busy city traffic versus road trips in the country) and other circumstantial factors that may have influenced the results (i.e. grandparents may be less distracted spending their leisure time with children than parents that are rushing to work or dropping kids off at school). However, all-in-all, children seem to be safer with grandparents.

Both parents and grandparents are advised to follow the most current child-restraint guidelines found in an article by Dennis Durbin, MD; to make sure your child is safe when you are driving:

1. All infants and toddlers should ride in a rear-facing car safety seat (CSS) until they are 2 years of age or until they reach the highest weight or height allowed by the manufacturer of their CSS.
2. All children 2 years or older, or those younger than 2 years who have outgrown the rear-facing weight or height limit for their CSS, should use a forward-facing CSS with a harness for as long as possible, up to the highest weight or height allowed by the manufacturer of their CSS.
3. All children whose weight or height is above the forward-facing limit for their CSS should use a belt-positioning booster seat until the vehicle lap-and-shoulder seat belt fits properly, typically when they have reached 4 feet 9 inches in height and are between 8 and 12 years of age.
4. When children are old enough and large enough to use the vehicle seat belt alone, they should always use lap-and-shoulder seat belts for optimal protection.
5. All children younger than 13 years should be restrained in the rear seats of vehicles for optimal protection.