Archive for the ‘Uncategorized’ Category

Testicular Cancer – Facts Men Should Know and Do Something About!

Monday, November 1st, 2010

Last week, I posted a brief blog about prostate cancer. One of our Facebook fans pointed out that if a man lives long enough, he will get prostate cancer. She noted that a more concerning cancer is testicular cancer, a condition that affects men at a much younger age when perhaps they are unsuspecting of serious  medical problems. The reader is right on the mark. Did you know that testicular cancer is the most common cancer in men between the ages of 20 and 35? I certainly didn’t.

Testicular cancer is carcinoma of one or both testicles. It is a disease process whereby malignant or cancerous cells invade the healthy tissue of the testicle. The testicles are a set of glands, which produce and store sperm. These gland are a primary source of testosterone in men, a hormone that triggers the development of the male reproductive system as well as other male characteristics (e.g., facial hair).

Here are some other noteworthy facts about testicular cancer that men should know about:

  • There are about 7,500 new cases yearly, with approximately 350 deaths per year in the US.
  • Testicular cancer is more common in white men than black or Asian.
  • Although it accounts for only about 1 percent of all cancers in men, it is the number one cancer killer among men in their 20′s and 30′s.
  • Most testicular cancers are self-discovered by patients as a painless or uncomfortable lump in the testicle. About 1-3% of testicular neoplasms are bilateral.
  • Pure seminomas constitute roughly 40% of all testicular cancer cases. Forty percent of the testicular cancers have mixture of histology.
  • The cancer risk for boys with a history of undescended testicles is about 10-40 times higher than normal individuals. The risk of developing the disease was estimated at 1 out of 20 for a testis retained in the abdomen and 1 out of 80 if it was within the inguinal canal. The risk remains elevated after surgical correction. Both testis are at higher risk, not just the undescended one.
  • If found early, testicular cancer is almost always curable.
  • Early stage testicular cancer can be treated with surgery and radiation therapy. Late stage testicular cancer can be treated with the combination of surgery, radiation therapy and/or chemotherapy.
  • The prognosis for men with testicular cancer is very good, even with late stage disease. The chances of recovery are excellent with surgery and radiotherapy for early stage disease. Combined modality is used for treatment of late stage disease with good results.
  • More than 90% of testicular cancer patients are cured by their initial treatment, and many of those who have recurrent disease can also be cured with chemotherapy or radiation.

There are two basic types of testicular cancer: seminomas and nonseminomas. There are additional sub classifications under each type of testicular cancer. Both types can be present at the same time. Seminoma describes a testicular cancer of the germ cell, which is slow-growing. Germ cells are cells that develop into reproductive cells (e.g., sperm and ova). Nonseminoma describes a more rapidly growing/spreading testicular cancer that originates in the germ cells.

Some of the signs and symptoms of testicular cancer include:

  • A painless lump or swelling in a testicle
  • Pain or discomfort in a testicle or in the scrotum
  • Any enlargement of a testicle or change in the way it feels
  • A feeling of heaviness in the scrotum
  • A dull ache in the lower abdomen, back, or groin
  • A sudden collection of fluid in the scrotum

If you have one or more of the risk factors mentioned above and are manifesting signs and symptoms consistent with testicular cancer, talk to a doctor as soon as possible. Don’t ignore your symptoms and don’t wait for them to simply go away. Talk to your doctor about testicular cancer and the various tests, which can be used to rule it out. These generally include: blood tests, ultrasound, and tissue biopsy.

Again, don’t try to run and hide if you have these symptoms. Remember Lance Armstrong, who was diagnosed with stage 3 testicular cancer, which had spread to his lungs and brain by the time of his diagnosis.

Who’s Hawking Rx Drugs? Is It Really an Effective Medication or Just Effective Marketing?

Thursday, October 28th, 2010

We have all seen the non-stop drug ads on TV – a pill or injection that will cure whatever it is that ails us. Public advertising, however, is just one way that pharmaceutical companies get their drugs into the market place. Behind the scenes, there is a full-blown marketing campaign that the public never sees in which drug companies hire doctors (tens of thousands of doctors) to spread the word on their drugs, primarily by giving talks to other doctors.  An ongoing investigation by ProPublica reveals that some of these doctors have significant disciplinary actions in their past:

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.  More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

There is no doubt that the pharmaceutical industry (sometimes referred to as Big Pharma) is a huge industry.  According to IMS Health,a healthcare information and consulting company, prescription drugs generate $300 billion in sales in the United States alone.  Therefore, the pressure on drug companies to market their products is immense. For the doctors out there, doing free-lance work for drug companies can be a very lucrative side-business, with some physicians earning as much as $1,500 to $2,000 for giving a single talk to a group of doctors. While there is nothing wrong with marketing a legal product, the public must be assured that the marketing is honest and that the drugs in question are being prescribed because they are effective drugs, not simply because the drug companies have an effective marketing campaign.

“Without question the public should care,” said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

Big Pharma appears to be turning a relatively blind eye to the situation. As part of its investigation, ProPublica compiled a database of physicians who work for the drug companies, and then cross-checked these doctors’ credentials and state disciplinary records.  The drug companies themselves could have taken this approach in vetting their doctors, but most do not bother to do so. Most companies “rely on self-reporting and checks of federal databases.”  However, it is the state disciplinary records that typically contain the relevant data on doctors who have been disciplined (and even state authorities do not always post such infractions on their websites). Lisa Bero, a pharmacy professor at University of California, San Francisco, questions the way that Big Pharma checks on its doctors:

Did they not do background checks on these people?  Why did they pick them? If they did things in their background that are questionable, what about the information they’re giving to me now?

In addition to disciplinary actions, ProPublica also raises questions as to these doctors’ credentials, e.g. medical research, academic appointments and professional society involvement, that would make them especially qualified to speak on medical conditions and ways to treat them. The investigation highlights a Las Vegas endocrinologist who has earned over $300,000 from Big Pharma. However, ProPublica contends that it was unable to locate any credentials on this doctor other than his schooling and some 20-year-old research articles. Furthermore, an online brochure from a recent presentation given by this doctor indicated that he was the chief of endocrinology at a local hospital, but “an official there said he hasn’t held that title since 2008.” Such stories only add to the serious questions as to how Big Pharma is selecting its doctors.

Certainly, a lot of good can come from honest marketing of effective new drugs. Especially in out-of-the way places, a talk by a knowledgeable physician can be a great source of information on new treatments available for a certain disease. If a new drug is truly effective, then by all means the word needs to get out on that drug because such drugs allow us to live longer and to live more comfortably with what were once debilitating diseases.  However, the public must demand honest assessment of these drugs. When drug companies allow unscrupulous doctors to hawk their wares, it raises legitimate suspicion as to whether these drugs are so popular because they are truly effective or simply because they had a good marketing blitz.

If you are curious about a specific doctor, ProPublica has a searchable database of doctors who do work for drug companies. Also, ProPublica has published several follow-up and/or related articles which can be found here.

Actavis issues voluntary recall of fentanyl transdermal system C-11 patches.

Monday, October 25th, 2010

Eighteen lots of fentanyl transdermal system C-11 patches have been recalled by Actavis. The fear leading to the recall relates to concerns that the active ingredient could release into the patient’s system at “an accelerated rate,” potentially leading to hypoventilation, respiratory depression and stoppage of breathing.

For more information, you can find the manufacturer’s voluntary recall notification information on the FDA’s website.

AED (Automated External Defibrillators): A Reader’s Comment Raises More Concerns About The Recent Recall

Monday, August 9th, 2010

At the end of last week, one of the firm’s medical specialists, Sharon Stabile, wrote a piece on a large recall of AED’s – automated external defibrillators. As I was editing and finalizing the piece for publication on the firm’s blog, I couldn’t help but wonder just how many people are aware of exactly what these ubiquitous devices do and how to use them should the need ever arise.

Every day I enter our office, I see an AED hanging from the wall in the common area of our building. I admit that until about a year or so ago when I began investigating the death of a young boy at one of our area school’s (an AED was used to no avail in an attempt to save his life), I personally didn’t know what this was or how to use one if I ever had to do so.

After Sharon’s blog was posted, which had dozens of readers as soon as it was posted, one of the readers, Denise Maier, posted a thought-provoking comment. It turns out the Ms. Maier has a website, www.defibillator.net, which is a retail site for certain brands of defibrillators. Having elected to review all comments before they are approved (mainly to avoid spammers – of which there are many), I initially wondered if this was just another piece of spam by someone trying to promote their product or website. After getting over my initial reaction and investigating her site more closely,  I realized that Ms. Maier’s site had a lot more to offer than just a product. I navigated on the home page to tabs entitled Articles and Blog and started to pay attention to the content of these postings. I was more than pleasantly surprised to find that this site offers some very valuable information regarding AED’s, policies, procedures, recommendations and news releases concerning matters such as the recall about which Sharon Stabile had written.

In her comment on our blog, Ms. Maier wrote in pertinent part:

I am an American Heart Instructor. I have been posting updates on the website http://www.defibrillator.net concerning the mandatory field updates released by Cardiac Science. One more problem that must be addressed regarding the update. If the AED’s battery does not have sufficient energy to complete the field upgrade, the unit may fail and the AED user must order a new battery. There is no test to determine whether the battery installed will perform through the upgrade. At the very least Cardiac Science should be supplying free batteries to AED owners to complete their upgrade. But the fact remains that only those end users specified as more likely to use their AED will be sent a new unit. There is a school district that has 22 units in our area. All units need the upgrade. None of their units are being replaced by the recall. What type of training will be provided by Cardiac Science in the event one of their AEDs fail? Recent reports indicate that schools are considered among the best places to have a Sudden Cardiac Arrest in the country since most have AEDs with trained responders. Cardiac Science distributed thousands of AEDs throughout the Ohio Schools subsequent to being awarded the AED Grant a few years ago. Without a replacement on those AEDs, how safe are the Ohio Schools?

These observations and commentary by Ms. Maier are exactly the reason I found Sharon’s blog posting important to publish. I truly didn’t know the depth of the problem with these devices or the recall and its limitations, but I certainly was aware of my own misgivings about the devices and the risks associated with their use by someone such as myself.

While I don’t usually post blogs about comments, I feel that Ms. Maier’s was precisely the kind of first-hand information from which our readers could benefit. How many schools, restaurants, office buildings, malls and the like which have AED’s available to the public for use are even aware of the recall? How many of these public locations have a policy of training responders to use these devices, or other complimentary policies in effect (e.g. periodic maintenance)?

In one of the site’s postings entitled Every School Needs AED Program Management, the author (I don’t know if it’s Ms. Maier or not) makes the following observations:

A panel of medical experts gathered by the National Athletic Trainer Association recommended the school guidelines below for anyplace where emergency medical services treatment isn’t assured within five minutes.

  • Establish an emergency communication system so help can be summoned quickly.
  • Coordinate their plans with local emergency medical services.
  • Ensure that an AED is handy and they establish a short response time – 3 to 5 minutes from anywhere at the site.
  • Train staff and students to respond, perform CPR and use the AED.
  • Practice their response to a cardiac arrest at least once a year.
  • Assume immediately that if an athlete collapses, it’s cardiac arrest.

The article concludes with the following recommendations that should not be overlooked in this whole discussion.

[S]chools should have comprehensive policies that authorize use by any willing rescuer, procedures to check the AED frequently, and signs along with accessibility.

Although it is thought that an untrained person can use an AED within about 90 seconds, training increases the comfort level with using the device and thus increases the likelihood that someone will do so when needed. The chief of the Division of Pediatric Cardiology at The Children’s Hospital of Philadelphia states “Schools have to have plans. Unless people are trained and go over it and over it, you are not ready to act.”

While these observations and recommendations are made in the context of schools, are they not equally valid and significant for all businesses and locations that have these devices accessible for use? It’s one thing to have a device available, it’s a totally different matter to have devices that are functional, non-defective and usable by those who may find themselves called upon to save the life of someone who has suffered a potentially fatal arrhythmia.

The recall, though highly questionable in terms of its scope, is only of value if those who have such devices are (1) aware of the recall and (2) check their devices to see if they are subject to the recall and take corrective action.

If any of you have other information to share about these devices, the recall, policies and procedures at your institutions or enterprises, it would be a great public service to share your information and thoughts with others. These devices are intended to save lives. If the word doesn’t get out about their limitations, defects and proper use, they may just serve to cause someone’s death. Help get the word out. If you have something important to share, we will certainly publish it and make sure the word gets out.

Would you use an AED if called upon to do so? Would you have a clue how to use it? Is the one you pull down for use really working right? How does training in the use of the device get done? Does your school, gym or office have trained responders? Do you even know if they do? Lot’s of questions, let’s start getting some answers.

$8 Million Verdict in Fosamax trial – Jawbone Destroyed By Drug

Thursday, July 22nd, 2010

A landmark verdict against the pharmaceutical giant Merck was recently rendered in a Fort Walton Beach Florida courtroom.  It should raise wide-spead public concern over the safety of drugs called bisphosphonates prescribed for mostly women as treatment for osteoporosis and osteopenia.  Bisphosphonates  are a drug classification that includes Fosamax, Fosamax + D, Aredia, Boniva, Didronil, Actonel, Actonel + Ca, Reclast, Skelid,  and Zometa.

Limited news reports tell the story of Shirley Boles, a 72 year old great grandmother and retired sheriff’s deputy, who was taking the drug Fosamax for osteopenia.  The condition of osteopenia is a normal thinning of the bones as a person ages.  It does not typically result in bone fractures unless it progresses to the disease osteoporosis. Current medical practices recommend treatment to prevent the development of osteoporosis.

Ms.  Boles also had a history of periodontal disease and smoking. She began experiencing jaw problems after taking Fosamax over a 10 year period of time.  She ultimately needed extraction of two teeth. Following the extraction, a very serious  condition called osteonecrosis of her jaw was diagnosed. In essence, the bone in her jaw disintegrated and died.  Jurors witnessed the physical decaying bone matter and infection seen from two drains in her chin. They heard how Ms.  Bales only eats soft food and will need to undergo repeated surgeries to replace her dead jawbone.

How the condition osteopenia went from a research term to an actual disease classification for some people and not others, and how Merck advanced their money-losing drug Fosamax to treat the new disease is a fascinating read.

NPR broke the story during Christmas 2009.  That same month, it was also reported that 10 million people in the United States had osteoporosis and most were women.  That same year,  45 million bisphosphonate prescriptions were written in the US generating $4.9 billion. Given the holiday season, one must wonder how many people actually became aware of this story.

The tale actually begins with the publication of an article released by the Wall Street Journal in December 8, 2004.  The story noted that in 2001, the Chief of Oral Surgery at the Long Island Jewish Medical Center, Dr. Salvatore Ruggiero, began recognizing a distinct pattern of osteonecrosis and jawbone death in 8 cancer patients taking the drug Aredia to combat bone loss.  He reported his cases to the FDA. He continued to track 90 of his subsequent patients, who developed jawbone osteonecrosis while taking Aredia and Zometa.  During this period, other oral surgeons were also reporting the same findings, including the Chief of Oral and Maxillofacial Surgery at the University of Miami’s Miller School of Medicine, Dr. Robert Marx.

The drug company Novartis, which makes Aredia and Zometa, first reported the side effect of osteonecrosis of the jaw (ONJ) on drug inserts in 2003.  By 2004, Novartis had received 500 reported cases in cancer patients taking Aredia and Zometa.  In September 2004, the FDA issued their first warning associated with intravenous bisphosphonates. In June 2006, the National Osteoporosis Foundation put out a Scientific Statement that ONJ associated with bisphosphonate therapy was seen 95% of the time in cancer patients and only rarely in the general osteoporosis patient population.

Ms. Boles did not have cancer.

The American Society of Oral and Maxillofacial Surgeons (ASOMS) put out a clinical position paper in September 2006. Their clinical research found increased risk factors for ONJ in those receiving both intravenous AND oral bisphosphonates.  There was a definite risk increase in patients taking the drugs for more then 3 years, but ASOMS concluded more study was needed. In addition, ASOMS noted a seven-fold increase in patients who had a history of periodontal disease and oral abscess. Diabetes, smoking, and alcohol also increased risk.

Current drug inserts and patient information do not list (ONJ) in drug contraindications or warnings.  However, under general precautions the inserts say ONJ can “occur spontaneously in association with tooth extractions, dental implants, and bony surgery.  It can also occur in cancer patients receiving cancer treatments.  Persons at risk include those with poor oral hygiene, periodontal disease, pre-existing dental disease, anemia, coagulopathy, and ill-fitting dentures.”

In 2009, an article was published in the Journal of the American Dental Association involving the University of Southern California dental clinics.  The results were even more alarming.  The researchers found out of 208 patients taking the drug Alendronate, also known as Fosamax and sold by Merck, nine had active ONJ.  This represented 1 in 23 patients, 4% of the general dental clinic population.  The researchers concluded the incidence may be much higher then previously reported, and the risk appears great even in short term users.  The study author noted there was a 10 year half-life of the drug remaining in bone tissue.  So dentists and patients need to be alerted to the risk remaining over a period of time.

Faulty drug design was the basis for Mrs. Boles $8 million dollar verdict.  Merck plans to appeal.  In the meantime, how many woman taking bisphosphonates remain uninformed of this potential risk?

Debate about Color Vision -Are you seeing red?

Friday, June 25th, 2010

Theories behind color perception have been a topic of debate, for many years. But new studies suggest several possible reasons for the perception of shades of colors.

CNN News recently reported that among scientists, it is a popular belief that color vision is generally consistent within many cultures and populations. It is further believed that evolutionary reasons are responsible for such consistencies.

Within the human retina lie six to seven million photoreceptors known as cones, which allow us to see colors corresponding to short, medium and long light wavelengths. Hues of purple and blue are located at the short end, while hues of red correspond to the long ends. Some estimates claim that these cones allow the naked eye to distinguish between one and ten million variations of colors.

But some people really don’t see the color red in the way that most do. About 8 percent of men have trouble differentiating between certain colors; less than 0.5 percent of women have this problem, according to the American Academy of Ophthalmology.

In most cases of color blindness, the cone systems for either medium or long wavelengths do not work properly, resulting in reds, greens and perhaps yellows appearing very similar. But different people experience this to varying degrees. In rarer cases, people have trouble telling blue and yellow apart; the rarest of all make people see the world in grayscale.

Mark Changizi, a cognitive scientist at the Rensselaer Polytechnic Institute located in Troy, Ney York, states that:

“Color vision is all about emotions and moods, and it has much deeper and richer connections to the rest of our perceptual worlds…”

But Stephen Palmer, professor of cognitive science at the University of California, Berkeley has a different theory:

“I don’t think that we have a pure sensory experience of the color. I think it’s overlaid with how much we like things…”

Some theories suggest that color visuals have only evolved to serve as a survival skill for animals. Although cats and dogs are colorblind, they have better developed peripheral vision. Pigeons and goldfish are able to see ultraviolet light which is invisible to the human eye. Color perception is believed to have developed within the human ancestry to distinguish between red berries and green foliage.

Despite various theories regarding development and evolution, Mr. Changizi’s research suggests that the cones in our retinas are optimized to recognize changes within the hemoglobin located in our bloodstream. Simply, when physiological changes occur, the human eye is able to detect and recognize them in consistency with the color spectrum. His research further suggests that color perception must be consistent, considering the mode of the eye’s cone’s ability to detect subtle skin tone changes.

However, Mr. Palmer’s research suggests differently – that color perception is related to one’s likes and dislikes. For example, the research showed that people tend to associate colors with preferences and meaning such as blues which are characterized as symbolizing things that are good for us, and others which are associated with bad things. Blue is often associated with blue skies and clear water, both of which are good for human health; whereas yellow-green tones are associated with toxins and poisons which are detrimental to the body.

One expert at the University of Illinois still maintains that the majority of scientists believe that red is the constant color, unchanging between humans in hue perception. But the question remains, why is red the only indifferent color?

Contributing Author: Caitlynn Gillyard

“Hospital Delirium” – a true concern for our society!

Friday, June 25th, 2010

There is a concerning report posted today by JusticeNewsFlash.com regarding “hospital delirium” in elderly patients. While it has long been recognized that elderly patients in hospitals are many times confused during their hospital stays, “contemporary resarch has indicated that such episodes may be accompanied by significant negative consequences” – longer hospitalizations, delayed procedures, increasing health costs, dementia later in life and a sginifciant rise inpremature death.

The American Geriatrics Society estimated that approximately one-third of patients over the age of 70, experience hospital delirium. Intensive-care and post-surgical patients also have an increased tendency to endure such cognitive lapses.

Though the cause of hospital delirium, more often reported as “confusion,” remains unknown, doctors have become more aware of its potential triggers. These included infections, surgery, pneumonia, medical procedures such as catheter insertions, among others.

All of these cases and procedures have a tendency to incite apprehension in many elderly patients. Certain medications have also been linked to hospital delirium.

McKnight’s, an online source for long-term care and assisted living, reports in a posting on June 24th:

A study has been underway by researchers at Indiana University. The report’s author, Dr. Malaz A. Boustani, referred to delirium among elderly patients as “more dangerous than a fall.”

On June 20, 2010, Pam Belluck, a reporter for the New York Times wrote a piece entitled “Hallucinations in Hospital Pose Risk to Elderly.” She recounts a chilling story of exactly how an 84 year old patient, Justin Kaplan, a Pulitzer Prize-winning historian with a razor intellect … became profoundly delirious while hospitalized for pneumonia last year. For hours in the hospital, he said, he imagined despotic aliens, and he struck a nurse and threatened to kill his wife and daughter.”

Doctors once dismissed it as a “reversible transient phenomenon,” thinking “it’s O.K. for someone, if they’re elderly, to become confused in the hospital,” said Dr. Sharon Inouye, a Harvard Medical School professor.

This thinking is now becoming significantly modified.

Some hospitals are adopting delirium-prevention programs, including one developed by Dr. Inouye, which adjusts schedules, light and noise to help patients sleep, ensures that patients have their eyeglasses and hearing aids, and has them walk, exercise and do cognitive activities like word games.

On a personal note, a very close relative of mine had undergone a knee replacement operation. Within a day of surgery, this elderly woman became so disoriented that she was convinced that she was being attacked by a strange man entering her room in the middle of the night. Fearing for her life, she picked up the nearest ‘weapon’ she could find – the bedside telephone – and struck the ‘intruder’ with the phone. It turned out that this ‘intruder’ was a male nurse coming to take her vitals. Hearing of this incident and shocked that this woman – my mother – would ever do such a thing (since she was the embodiment of the description -”wouldn’t hurt a fly”), my sister and I asked the hospital to check her electrolytes. It turned out that they were wildly abnormal. She was administered the necessary replacement therapy and returned to her normal, sweet self – having absolutely no memory of this incident whatsoever.

It is no secret that as the Baby Boomer population ages, the number of people in our country over the age of 70 will soon be very significant. We can only hope that physicians such as Dr. Sharon Inouye and Dr. Malaz Boustani will continue their research and efforts to learn what can be done to minimize the incidence rate of “hospital delirium.” It is good to see recognition of this problem now exists and that the concept of “it’s OK – it will pass; they’re just confused” is becoming a thinking process of the past.

Stent Wars – The Decade Begins

Tuesday, June 22nd, 2010

On June 10th, we did the first in a series of articles regarding the basic medical issues involved in the St. Joseph Medical Center/Dr. Mark Midei stent scandal. This second installment begins in the year 2000 – a period in time the cardiology industry calls the STENT WARS.

The early part of this decade was a period when interventional cardiologists, such as Dr. Midei, were aggressively seeking to demonstrate a short and long term successful alternative to open cardiac bypass surgery for patients. While there is no doubt that these specialists were seeking better approaches for their patients by avoiding, if possible, open heart bypass surgery, it is also evident that these endovascular procedures were quite lucrative for interventional cardiologists as well.  It was reported that drug eluting stents generated a world market revenue of $5 billion annually in the early 2000′s.  In 2001, more then 500,000 procedures involving stents and balloon angioplasty were being performed in the United States annually. The “war” for market position was on. Who would win top position among manufacturers and grab this pot of gold?

The STENT WARS were also being fought around the globe and included familiar company names: Cordis, Boston Scientific, Medtronic, Abbott, Conor MedSystems, OrbusNeich, Biosensors, and Xtent.  Mergers, acquisitions, partnerships abounded.  As you can imagine, clinical trials were also proliferating throughout the medical world. Investment money was flowing. Interventional cardiologists invested in their own technology and made money on both the procedures and their investments. During this period of enormous expansion, Dr. Midei became co-founder of a large cardiology practice in the Baltimore metropolitan region. In the latter part of 2007, he was recruited away from his group practice and hired by St. Joseph Medical Center as its Director of Interventional Cardiology (Cardiac Catheterization).

So what was stent research showing?  What was the science that gave Dr. Midei an open door to placing numerous unnecessary stents at the cost of $10,000 – $15,000 a stent.

Early clinical trials were positive for the industry.  Data revealed drug-eluting stents (DES) reduced re-stenosis (i.e. re-narrowing of the cardiac blood vessel) from 20-30% to single digits and continued to show better outcomes than bare metal stents (BMS) and balloon angioplasty.  These favorable results led to the official FDA approval of two drug-eluting stents in 2003 and 2004 for use in the USA although clinical trials had been underway in major cardiac centers for several years. The stent type, coating of the stent with a particular drug, and key decisions made by the interventional cardiologist during stent placement were reportedly all factors necessary for favorable outcomes.  Using coronary angiography, the interventional cardiologist determined the proper stent length and diameter needed to repair a blocked artery and was able to ensure proper stent placement within the artery.  There was  enough new scientific research data for the American College of Cardiology and the American Heart Associated to update and publish clinical practice guidelines  for both hospitals and cardiologists in 2001.

Landmark studies during this time were also revealing more new information about progressive heart disease.  Research studies demonstrated coronary artery atherosclerosis usually affected more then one vessel and was, therefore, often a diffuse disease.

While these results led to the positive development of conjunctive drug therapies, they also opened the door for exploitation.

An interventional cardiologist, seeking to line his/her own pockets and/or gain a position of power within an organization for whom he/she worked could place many stents in multiple coronary vessels regardless of size or complexity. In other words, stents could be placed in symptomatic large blockages, and stents could also be placed in those small areas that MIGHT, in the so-called clinical judgment of the operator, develop into a blockage. Clinical practice guidelines were silent as to what should be done to lesser size lesions.  In the absence of data, the cardiologist could choose to be aggressive or conservative.  However, clearly an avenue for financial abuse and gain was opened for some interventional cardiologists to push acceptable judgment boundaries.

You might ask: weren’t there provisions and systems in hospitals to prevent such exploitation if it were to occur.  Unfortunately, nether the ACC nor AHA 2001 clinical practice guidelines contained any recommendations for peer review or oversight of this burgeoning stent industry. It was left to hospitals to establish their own monitoring guidelines to oversee the conduct of their physicians.

Join our next blog to learn more about the introduction of peer review guidelines that were finally published four years later in 2005.

In Memory of My Father – Happy Father’s Day, Dad!

Sunday, June 20th, 2010

I spend a good part of my week reading and writing about law, medicine and related topics. Then today came along and as I watched the Tweets fly-by wishing the world a Happy Father’s Day (which I just learned is in September in some parts of the world like Australia), I thought to myself, why not use this medium to tell some other people about the dad who raised me, my brother and sister – and the center of my universe.

He was a quiet, simple man of principle. Strong, religious, caring, loving in his own quiet but definite way. He was born and raised in Brooklyn in 1911 – a die-hard Brooklyn Dodgers fan until Da Bums had the nerve to move to California. He then would open his Rheingold beer and follow with whatever passion he could muster his new baseball love – the Marvelous Mets.

When people came to visit, it was my father who made sure they were welcomed guests in our home. Harry – the name he went by but not the one on his birth certificate – was the rock for all the wayward family souls needing strength, guidance or just a kindly smile.

He made the big trip in those days across the Hudson River and dated a girl from New Jersey (or “Jersey” as those of us on Exit 15W of the Turnpike refer to it). A lovely and loving young girl, who was not permitted to finish high school – because in those days education was a waste of time for girls. They married, had three kids and settled down in Jersey for the rest of their days. She was the center of his universe and the eternal love of his life.

What was my childhood like? The best…simple in all respects. A toy or two at Christmas – the best Christmases anyone could want. Baseball season (he loved baseball) - A glance from me, his son, into the stands during Little League and Babe Ruth baseball season – there he was. Not screaming at the umpire but omnipresent with an encouraging smile for his son.

Summer vacations – in a little hunter’s cabin in the middle of nowhere on the Delaware River in New York. Again – simple, fun and filled with love. Memories that will never fade.

He didn’t have to raise his voice when his kids were just being dumb kids. His “look” said whatever needed to be said. After a full day of work in New York and taking the DeCamp bus back and forth to Gotham City – there he was, at the kitchen table helping with homework or some goofy project we thought was the most important venture man or God could imagine. He made it seem that way too.

Having come from New York, he wasn’t the most patient driver the Lord ever placed behind a wheel. But rather than a string of curse words (I never in my entire life heard him curse), I would hear his famous – “Ya Bum, ya” when someone might cut him off on Route 3 leading into the City. Pass a church? – the tip of his hat was never, ever missed. No big show of religion, just a simple, quiet sign of respect that was not lost of me – ever!

When we lost my Dad in 1992 – a deep, dark hole in my life was created. It can never be filled. The quiet man of grace, humor, love and unending principle has been sorely missed these many years.

I’m glad I thought about writing this today. (My only regret is that I didn’t think about doing this last month for the sweet angel of my life – my Mom. Next year I will NOT forget).

If even one other person reads this – then my task is accomplished – one other person will know just a little bit about the man I loved and always will. Let’s tip our hats together and to all dads – but especially to mine – HAPPY FATHER’s DAY.

How can something so deadly be so beautiful?!

Wednesday, June 16th, 2010

This morning, one of my senior trial lawyers, Marian Hogan, brought to my attention a New York Times featured post called “Killer Art.”

If you look at Marian’s biography, you see that she “earned a graduate degree in anatomic pathology from the University of Maryland. In addition to completing that coursework at the University of Maryland School of Medicine, she performed hundreds of autopsies, examined thousands of surgical specimens, and also conducted original medical research.” Her office is adorned with photographs of surgical specimens, which in their own macabre way are fascinating, if not beautiful.

I started this post with a picture of one of the artist’s – Luke Jerram – pieces. What did you think when you first saw it? Was it beautiful, aesthetically pleasing, interesting, mystifying? If I now tell you it is a representation of the swine flu organism in transparent glass, what’s your reaction now?

Jerram’s website offers the following:

Jerram is exploring the tension between the artworks’ beauty, what they represent and their impact on humanity.

The sculptures were designed in consultation with virologists from the University of Bristol using a combination of different scientific photographs and models. They were made in collaboration with glassblowers Kim George, Brian Jones and Norman Veitch.

OK…so this isn’t one of our usual posts involving medicine, law, injuries and the like. That being said – the exhibit does fascinate me. How does it strike you?

Margaret Wolfe Hungerford: “Beauty is in the eye of the beholder.”

Then again – maybe the words of Virginia Woolf are more appropriate in this instance.
The beauty of the world has two edges, one of laughter, one of anguish, cutting the heart asunder.”

Maybe I’ll go take another look at Marian’s autopsy specimen pictures one more time….