Silver Buzz Cafe

The Health Care Hypocrites

hypocrite Recently we wrote about the hypocrisy of politicians who voted against a bill and then clamored to reap benefits from it, most notable those who voted against the Recovery Act and then turned up at ribbon cutting ceremonies for projects funded by it. Unfortunately, the whole health care reform debate has been clouded by misrepresentations, distortions and outright lies. What’s now emerging is a clear pattern of “What I say and what I’ve done are two different things.” We’ll cover a few recent examples and will leave it to you to reach your own conclusions.

First though, it’s worth mentioning a few of the recent lies. At the recent health care “summit”, House Minority Leader John Boehner (R-OH) claimed that Democratic healthcare reform proposals fund abortion coverage. They don’t. Although the language in the Senate bill is a little looser than that in the House bill, both bills uphold the Hyde Amendment, which strictly limits federal funding for abortion. At the same meeting, Rep. Dave Camp (R-MI) echoed the GOP storyline that the bills contain Medicare cuts for seniors. According to the Congressional Budget Office (CBO), there are waste reduction measures, but no cuts in benefits to seniors.

Last Thursday, March 4, Representatives Alan Grayson (D-FL) and Michele Bachmann (R-MN), debated a few points on the health care reform bill on Larry King’s show. Rep. Bachmann claimed that – “President Obama’s bill won’t bring down the costs (of health care) for average Americans — or really for very few Americans, if any.” The official CBO figures have been available for some time and they show that she has no basis for her claim. Politifact rated her statement as “False.”

Public option opponent would have voted for Medicare and Social Security
Last Friday, March 5, Lawrence O’Donnell interviewed Rep. John Culberson (R-Texas) on MSNBC’s “Hardball”, asking him why he is not in favor of a public option but refuses to vote for cuts to Medicare and Social Security. Rep. Culberson eventually admitted that he would have voted for the establishment of both Social Security and Medicare, despite the fact that they are government-run health-care systems.

Strangely, Culberson, who calls himself a “Jeffersonian Republican,” said he supports Medicare and Social Security but denied that they’re socialistic. O’Donnell asked him: “If Medicare is not socialism, why don’t we just delete the over-65 part of Medicare and make it available to everyone? What’s your argument against that?” Culberson refused to give a straight answer, but did agree that he knows that Medicare is a completely government-run health care system and that, even so, he would have voted for it.

O’Donnell closed, with some exasperation, by accusing Culberson of hypocrisy and more: “You lie to America about the evils of government-run health care because you people, not one of you liars about government health care is willing to repeal Medicare, to stand up and be consistent… ‘I hate government health care so I want to repeal Medicare’… That is a lie that you perpetrate every day.”

Public option opponent Sarah Palin used to abuse socialized medical treatment in Canada
Then, former Alaska Gov. Sarah Palin candidate for the Vice Presidency, admitted over the weekend that she used to get her treatment in Canada’s single-payer health care system, probably for free. Palin has been extremely critical of the supposed nightmares of the Canadian government-run system. In an extension of her “death-panel” lying, she used Canada as an example of where it is already happening, when, in fact, it clearly does not.

Her hypocrisy isn’t the end of the story, though. When she spoke in Skagway, where she had once lived, about an incident involving her brother, who had burned his foot, she told the audience that they had traveled on the ferry to Juneau for treatment. In Canada last weekend, she told the same story, but this time they’d traveled from Skagway, AK to Whitehorse, Canada on the famous train that goes over the pass. She either has a bad memory, or her brother burnt his feet multiple times, or she’s lying. If she lied in Skagway, why? Maybe she didn’t want to mention that health care is far more affordable in Canada, which, like all other industrialized nations, has socialized health care.

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Battling Hospital Acquired Infections

sbug The Centers for Disease Control and Prevention (CDC) estimates that 1.7 million people contract Hospital Acquired Infections (HAIs), and 99,000 patients die from HAIs annually in the United States. Many people believe that the problem is under-reported, so the real figures may be several times higher. The cost associated with HAIs is immense. A patient who obtains an infection while in the hospital costs an additional $15,000 to treat, on average. A recent study¹ calculated that HAIs cost the US and United Kingdom healthcare systems combined more than $8 billion annually.

The entire focus while a patient is in hospital should be around treatment of and recovery from the condition that put them there, but an increasing number of patients are being harmed and often die from HAIs. The problem has become so bad that the U.S. Center for Medicare and Medicaid Services (CMS) has stopped reimbursing hospitals for costs related to treating patients who are diagnosed with a HAI. The rationale is that the hospitals have no incentive to prevent the problem when they are making extra money as a result of it.

The Superbugs
It has long been known that overuse of antibiotics is leading to a situation where organisms that are immune to them, colloquially known as “Superbugs”, thrive and become very hard to fight. One of them, methicillin resistant Staphylococcus aureus (MRSA), or “Mersah,” has become the fastest spreading cause of HIAs. In 1993 fewer than 2,000 MRSA infections were reported by U.S. hospitals. In 2007, the Association of Professionals in Infection Control (APIC) conducted the largest ever survey of hospitals in the U.S. They found that 2.4% of patients, a total of 880,000, with MRSA infections had contracted it in the hospital.

The two strains of MRSA that are most prevalent in the U.S. have been associated with skin and soft tissue infections. The most common antibiotic resistant pathogens include:

Acinetobacter baumannii: A bloodstream infection first noted in patients at military medical facilities trating service members injured in Iraq and Afghanistan.
Clostridium difficile: a pathogen that causes diarrheal disease in hospitals world wide.
E. coli and Salmonella: these come directly from contaminated food and are a problem in all catering facilities.
Enterococcus: Strains can cause urinary tract infections, bacteremia, bacterial endocarditis, diverticulitis, and meningitis.
Pseudomonas aeruginosa: The symptoms of infections from it are are generalised inflammation and sepsis. If infections occur in critical body organs such as the lungs, the urinary tract, and kidneys, the results can be fatal. It thrives on most surfaces, so this bacterium is also found on and in medical equipment, causing cross infections in hospitals and clinics.
Streptococcus: The source of many diseases, ranging from mild superficial skin infections to life-threatening systemic diseases. Infections typically begin in the throat or skin. Examples include pharyngitis (”strep throat”) and localized skin infection (”impetigo”).

Battling HAIs
Many campaigns and resources, such as those from the Institute for Healthcare Improvement (IHI), are focused on helping hospitals promote better hand hygiene, and single use devices are also helping. However, these solutions are having little impact on the estimated 20% of HAIs that are transmitted through the air. Other approaches being taken include:

UV purification lamps: Philips, based in The Netherlands, has helped to pioneer a technological solution using ultra-violet (UV) purification lamps. These have the power to disinfect air and surfaces, protecting against airborne infections, viruses, and other micro organisms. The UV destroys the DNA structure of these unwanted invaders in such a way that the cells can no longer multiply, minimizing the risk of infection.
Silver nanoparticles: Another approach involves the use of silver nanoparticle coatings to create surfaces that are toxic to microorganisms, but not to humans. However, there are some concerns about the introduction of more silver, which is highly toxic, into the environment.
Vaccines: There are some anti-staphylococcal vaccines, but they have shown limited efficacy, mainly because of immunological variation between Staphylococcus species and the limited duration of effectiveness of the antibodies produced. Development and testing of more effective vaccines is under way.

Unfortunately, at the moment, the best thing you can do to avoid an HAI is to stay out of hospital, especially as a patient. That means taking care of your body and mind by eating healthily, exercising regularly and socializing.

References:
¹ “The financials of hospital-acquired infections.” (PDF file – takes a while to load) – Market research prepared by the Brookeside Group for Philips Medical Systems Nederland B.V.

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Everyone's Guide to Medical Equipment - Part 14 - Advanced Surgical Instruments

Lumenis Acublade®

In this series of articles we’ve looked at: the simple and advanced instruments that you would expect your physician or clinic to have on hand; medical monitors, such as electrocardiograms; laboratory equipment and advanced medical diagnostic equipment. In the previous article we looked at basic surgical instruments.

If you ask a layman which instrument they associate with surgery they will most likely think of the scalpel, a sharp bladed instrument used for cutting tissue. There is a surprisingly wide variety of scalpels, so we’ll look at conventional ones before covering more advanced instruments that use heat, lasers or particle beams. Some of these instruments are computer controlled and a whole new field of robotic surgery has opened up in the past twenty five years, starting with very simple procedures and leading to recently successful kidney transplant operations.

Surgical scalpels consist of two parts, a reusable handle and a replaceable blade and a handle. In surgical procedures, each blade is only used once, even if it was just for a single, small cut. This is in order to reduce the risk of infection. If the blade is double sided the instrument is called a lancet. Medical blades are almost always made of stainless steel, but ceramic, diamond, obsidian and titanium knives are commercially available. Obsidian is a naturally occurring volcanic glass that was used by early Egyptian surgeons. The non-magnetic materials can be used in the presence of strong magnetic fields, such as those produced by Magnetic Resonance Imaging (MRI) equipment.

Simple and Advanced Scalpels

Scalpels	Laser Scalpel

Laser Scalpels
Most of us will remember the ominous scene in the movie “Goldfinger” where the maniacal villain has the hero, James Bond (OO7) tied to the bed of an industrial metal cutting laser machine:
James Bond: “Do you expect me to talk?”
Auric Goldfinger: “No, Mr. Bond. I expect you to die.”

Although laser beams can now be made strong enough to cut through metal, they were only gradually introduced into medical procedures. Apart from the obvious concerns about safety, the laser beam produces an instantaneous heating effect at the point where it is focused. In effect, it both destroys or cuts the target and cauterizes the surrounding tissue. If wielded correctly this could be very useful, as bleeding would, theoretically, stop immediately. However, early experiments weren’t always successful, as very precise control of the beam is needed and a minor slip, where a surgeon would automatically retract the scalpel if he had any concern about the area being cut, moving the beam without cutting it off might well damage other tissue or organs. In other cases, permanent damage to tissue outweighed the perceived advantages of using the laser beam.

Computers have been used since the early 1960s to controlled advanced cutting machines. The technology, known as computer numerical control (CNC) can control cutting blades to machine surfaces to accuracies of 1/10,000th of an inch, or even higher precision in some cases. It soon became obvious that medical cutting lasers might be more safely manipulated using a computer than by even the most skilled surgeon. The most common kind of surgical laser device in use today, the Lasik® eye surgery device, actually vaporizes the targeted tissue without damaging adjacent tissue. The more powerful carbon dioxide (CO2) lasers that are used for cutting tissue can be either manually or robotically controlled. They aren’t often used as a generic replacement for regular scalpels, but for manipulation and cutting in areas where extreme precision is required, such as the larynx. They can also be used in the ears and nose, internally, for removing polyps or taking biopsies, and for neurosurgery.

Robotic Surgery
Once the advantages of computer control of medical equipment was realized, it was natural to start exploring its use in more advanced procedures. Modern robotic surgical assistance equipment is guided by the surgeon, but can achieve extreme accuracy. Many standard sequences, such as changing the kind of tool to be used, can be preprogrammed, leaving the surgeon free to focus on the details of the operation. The system has multiple “arms”, so it is possible to move tissue aside, view the area with a video camera, drain fluids and perform cutting or cauterizing operations simultaneously. The da Vinci® robotic surgery system can be used to carry out both open and minimally invasive laparoscopy procedures. The manufacturer lists many possible circumstances where it can help, including:

Bladder Cancer
Colorectal Cancer
Coronary Artery Disease
Endometriosis
Gynecologic Cancer

Heavy Uterine Bleeding
Kidney Disorders
Kidney Cancer
Mitral Valve Prolapse

Obesity
Prostate Cancer
Uterine Fibroids
Uterine Prolapse

The Federal Drug Administration (FDA) has currently cleared two systems for use in the United States. The da Vinci Surgical System was cleared to perform surgery, such as cutting and suturing (sewing), under the direction of a surgeon. The ZEUS® Robotic Surgical System has been cleared to assist surgeons in grasping, holding, and moving things out of the way, but isn’t yet cleared for cutting or suturing. As the robotic surgery systems become more capable and less expensive, it is likely that they will be usable in telehealth systems. Highly complex procedures could be directed by specialists working remotely over a dedicated, fail-safe communications link.

“The da Vinci system can control several endoscopic instruments, including rigid endoscopes, blunt and sharp dissectors, scissors, scalpels, and forceps. Tissue can be grasped, cut, dissected and sutured. In the simplest setup, the surgeon sits at a console several feet away from the operating table and manipulates the robot’s surgical instruments. The robot has three hands attached to a free-standing cart. One arm holds a camera (endoscope) that has been passed into the patient through small openings. The surgeon then operates the other two hands by inserting fingers into rings. The arms use a technology called EndoWrist — flexible wrists that surgeons can bend and twist like human wrists. The surgeon uses hand movements and foot pedals to control the camera, adjust focus, and reposition the robotic arms. The da Vinci has a three-dimensional lens system, which magnifies the surgical field up to 15 times. Another surgeon stays beside the patient, adjusting the camera and instruments if needed.

ZEUS differs from the da Vinci system in that the AESOP part of ZEUS responds to voice commands. For example, a surgeon might say: “AESOP move right.” The positioning arm then would move right until the “stop” command was given. Like the da Vinci system, the other two arms of ZEUS are the extension of the left and right arms of the surgeon. Surgeons sit at a console and wear special glasses that create a three-dimensional image. It also has flexible “wrists.” – FDA.

Robotic Surgery Systems

da Vinci Robotic Surgery System	ZEUS Robotic Surgery Assistant

The Cyberknife® and similar systems
The CyberKnife is a robotic radiosurgery system that delivers very accurately targeted radiotherapy for treating benign tumors, malignant tumors and other medical conditions. Its main elements are:

The radiation produced from a small linear particle accelerator.
A robotic arm which allows the energy to be directed at any part of the body from any direction.
An instantaneous image guidance system that uses X-ray imaging cameras located on supports around the patient.
A robotic six degree of freedom patient treatment couch called RoboCouch®. It provides the capability for significantly improving patient positioning options for treatment.

Unlike the mechanically more complex da Vinci and Zeus systems, the Cyberknife uses a standard industrial robot arm to position and direct the particle beam onto the area to be treated. In conventional frame-based radiosurgery, the accuracy of treatment delivery is determined solely by connecting a rigid frame to the patient. It is anchored to the patient’s skull with invasive aluminum or titanium screws. The CyberKnife, with its Robocouch, was the first radiosurgery device that does not require a frame for precise targeting.

The frameless nature of the CyberKnife also increases the clinical efficiency. A Computed Tomography (CT) scan can be carried out on any convenient day prior to treatment. The planners can preprogram the course of treatment, so that the patient need only be positioned on a treatment table and the predetermined plan delivered. While a patient is being treated, another clinician can be considering treatment options and plans, and another can be conducting CT scans. It also allows young patients, or patients with fragile heads because of prior brain surgery to efficiently re-treat the same patient without repeating the preparation steps that a frame-based system would require. The delivery of a radiation treatment over several days or even weeks (referred to as fractionation) can also be beneficial from a therapeutic point of view. Tumor cells typically have poor repair mechanisms compared to healthy tissue, so by dividing the radiation dose into fractions the healthy tissue has time to repair itself between treatments. This can allow a larger dose to be delivered to the tumor compared to a single treatment.” – Wikipedia.

The Gamma Knife® system uses several hundred Cobalt-60 sources located in a ring around a central treatment point to create and direct the radiotherapy (gamma ray) beams. It does, however, require a head frame to be bolted onto the skull of the patient, and is only capable of treating cranial lesions. As a result of frame placement, treatment with Gamma Knife does not require real time imaging capability as the frame does not allow movement during treatment.

The Novalis® radiosurgery system utilizes a small computer controlled micro Multi Leaf Collimator (mMLC), that can produce many complicated beam shapes, allowing a considerable range of tumors to be treated. It also has X-ray imaging that is used in conjunction with a planning CT scan to quickly and correctly position the patient. Because of its flexibility, the Novalis has become a leading instrument in the world of neurosurgery.

Robotic Radiotherapy Systems

CyberKnife	Gamma Knife

What’s next?
In the next and final article on surgical instruments we’ll look at the Lasik device, which is used for correcting some kinds of eyesight problem.

Related articles: Series

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New Insights Into The Possible Cause of Prostate Cancer

Prostate Cancer Awareness

Prostate cancer is the most common malignancy in men in the Western world, affecting one in six men. The rate of deaths per 100,000 American men is in the low 20s, but rises to over 50 for African-Americans. The cancer cells may spread from the prostate to other parts of the body, particularly the bones and lymph nodes, organs that are important to the functioning of the immune system.

“A man’s risk of developing prostate cancer is related to his age, genetics, race, diet, lifestyle, medications, and other factors. The primary risk factor is age. Prostate cancer is very uncommon in men younger than 45, but becomes more common with advancing age. The average age at the time of diagnosis is 70. Prostate cancer is the ninth-most-common cancer in the world, but is the number-one non-skin cancer in United States men.

Prostate cancer can be treated or managed using a variety of techniques, including: monitoring for tumor progress or symptoms; surgery; radiation therapy; external beam radiation therapy; high-intensity focused ultrasound; chemotherapy; oral chemotherapeutic drugs; positron emission tomography (PET); cryosurgery; hormonal therapy or some combination of them.” – Wikipedia. However, if the cancer spreads out of the prostate, treatment becomes more complex and the prognosis worsens. As with many cancers, early diagnosis generally improves the outcome.

New findings
Research¹ reported in February at the annual meeting of the American Association for the Advancement of Science (AAAS) suggests that some self-renewing stem cells may be a prime culprit in prostate cancer, and that a particular gene in these cells contributes to prostate cancer’s malignancy. Study coauthor Owen Witte, a Howard Hughes Medical Institute (HHMI) investigator at the University of California, Los Angeles (UCLA) said: “Think about cancer as a disease of stem cells. Mutations in these cells can cause “normal stem cells to lose their regularized behavior and instead turn into an incipient cancer.” He added that, in all cases the team has looked at, the basal stem cells are what drive the cancer, regardless of the type of mutation.

Prostate tissue is made up of several different kinds of cell, including a class called basal stem cells. These cells divide to replenish aging or damaged prostate tissue, but sometimes, instead of producing normal cells, they become cancerous, leading to tumors. Witte and his colleagues separated mouse prostate cells into different groups based on type. They then introduced mutations often found in prostate cancers and implanted the cells back into mice one type at a time. Basal stem cells were found to be far more likely to lead to cancerous changes. Earlier research suggests that this process might also be a factor in the formation of human prostate cancers.

Can the mutations be stopped?
Previous research has shown that a gene called Bmi-1 is important for the renewal of many kinds of stem cells’ self-renewal and may also play a role in malignancy. Witte and his coleagues found that when Bmi-1 activity was suppressed in basal stem cells, the cells were no longer able to self-renew, nor did they form tumors.

“We get a dramatic change in the rate of growth and the tumor outcome by blocking this one single pathway,” Witte said. “I don’t think this will be a magic bullet to cure prostate cancer by any means, but it’s certainly a pathway that should be explored.”

The screening controversy
The American Cancer Society (ACS) recently republished its guidelines on prostate cancer screening. The new guideline has a more pronounced emphasis on informed decision-making (IDM) than in the past. The document recommends that men should only be screened “after they receive information about the uncertainties, risks, and potential benefits associated with prostate cancer screening.”

The ACS points for inclusion in the informed decision-making process for patients who may be candidates for screening include:

Screening with the PSA blood test detects cancer at an earlier stage than if no screening is performed.
Prostate cancer screening might be associated with a reduction in the risk of dying from prostate cancer; however, evidence is conflicting.
For men whose prostate cancer is detected by screening, it is not currently possible to predict which men are likely to benefit from treatment.
Treatment for prostate cancer can lead to urinary, bowel, sexual, and other health problems that can be significant or minimal, permanent or temporary.
The PSA and Digital Rectal Examination (DRE) can produce false-positive or false-negative results.
Abnormal results from screening with PSA and DRE require prostate biopsies, which can be painful and lead to complications like infection or bleeding.
Not all men whose prostate cancer is detected through screening require immediate treatment. Some require periodic blood tests and prostate biopsies to determine the need for future treatment.

There are also several new recommendations for men who choose to be tested:

Prostate-specific antigen (PSA) testing is now recommended with or without the digital rectal exam. It is more important when the PSA is in the borderline range.
The ACS continues to recommend that the PSA value of 4.0 ng/mL be used as a “reasonable threshold” to trigger further evaluation.
They have added a recommendation that physicians consider an individualized risk assessment for men with PSA values between 2.5 and 4.0 ng/mL. This is because approximately 25% of those men may already harbor prostate cancer.
An individual assessment should take into account non-PSA risk factors, such as race, family history, results of previous biopsies and DRE results.
The ACS also now recommends that the PSA testing interval be reduced to every other year for men whose PSA level is under 2.5 ng/mL. They believe that this will lead to significantly reduced false positives, unnecessary biopsies, and overdiagnosis, with only a negligible increase in missed cancers.

It’s worth noting that the American Urological Association (AUA) differs with the ACS on PSA values. “The AUA feels there is no single PSA standard that applies to all men, nor should there be,” they write in a press release issued soon after the guideline was made public.

As always, you should consult with your doctor on matters concerning your health, rather than trying to make a judgement on your own.

¹ “Basal epithelial stem cells are efficient targets for prostate cancer initiation” – Devon A. Lawson, Yang Zong, Sanaz Memarzadeh, Li Xin, Jiaoti Huang, and Owen N. Witte – Proceedings of the National Academy of Sciences of the United States – PNAS 2010 107:2610-2615; published online before print January 25, 2010, doi:10.1073/pnas.0913873107.

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Delays In Referral Longer for Older Ovarian Cancer Patients

Ovarian Cancer Awareness A few days ago we wrote about a study that found that the most frequent error in medicine seems to occur nearly one out of three times a patient is referred to a specialist. Nearly a third of those patients are not scheduled for appointments and therefore do not receive the treatment their primary care doctor intended them to receive, primarily due to human error. That’s disturbing, but what if the doctors are also delaying referring older patients to specialists?

That’s what researchers at the Brighton and Sussex Medical School in the United Kingdom (UK) have found. They studied records from the General Practice Research Database (GPRD) and compared recorded diagnoses of ovarian cancer against rates in the UK cancer registries to see whether there was a difference in how older patients are managed by their General Practitioner (GP). Despite significant advances in cancer treatment, data from the World Health Organization registry database suggests that there has been little or no improvement in cancer mortality rates (among the lowest in Europe) for the UK’s elderly during the last decade.

Findings
The researchers looked at data for the period 2002-2006 and noted that:

GPs were less likely to refer patients for gynaecological investigation when they were older.

82% of women under the age of fifty-five years had received at least one relevant investigation in the year before their diagnosis.
This figure fell to 75% for women aged between fifty-five and sixty-nine years, and 66% for women aged over seventy years.

GPs were slower to refer elderly patients than their middle-aged counterparts:

Women aged between forty-five and sixty-nine years tended to be referred for gynaecological investigation within ten weeks of presenting to their GP with their first symptom.
This figure steadily increases, peaking at twenty weeks for women aged seventy-five to seventy-nine years.

The rates of recorded diagnoses of ovarian cancer in the GPRD were lower than those recorded in UK cancer registries for all age groups.These differences were much larger for patients over sixty:

For women aged forty-five to fifty, the difference was only 5%.
For those between seventy-five and eighty, the difference was 22%.

Comments on the study
Sara Hiom, Director of Health Information at Cancer Research UK, said: “Ovarian cancer is more common in older women, with four out of five cases in women over 50, so it’s concerning if these older women are indeed less likely to be investigated.”

The researchers are not sure why there are discrepancies between the GP database and the UK cancer registry. It may be explained in part by how and when data is recorded. It may also be possible that GPs are less motivated to record cancer diagnoses in older people if they have other serious illnesses, or they may investigate them for other problems first.

Professor Jackie Cassell, Honorary Clinical Research Fellow in epidemiology and public health at Brighton and Sussex Medical School, explained that: “Electronic patient records provide a valuable opportunity for disease surveillance and for monitoring and improving. It is important that we understand why there is a discrepancy between rates in the GP databases compared to cancer registries. This will help ensure that the information available to our health services is accurate and fit for purpose.”

Dr. Rosemary Tate, lead author of the study emphasized the main findings: “Ovarian cancer is a relatively rare disease but, as with all cancers, early diagnosis is important for improving the chances of successful treatment. Our research suggests that age plays a role in how quickly diagnosis and referral occurs – the older the patient, the later this appears to happen.” She went on to say that: “As we only looked at one type of cancer, we don’t know if our results will generalise to other cancers. However, if this is the case, then such delays could be an important cause of avoidable illness and mortality, and could contribute to the lower survival rates and higher mortality rates experienced in the UK compared with other European countries.”

The situation in the United States
It’s not clear if the situation is similar in the United States, where cervical screenings tend to start earlier than in the UK. Overall, the prognosis of ovarian cancer remains poor, with a 45% 5-year survival rate. The rate of occurrence of ovarian cancer per 100,000 population is 7.9 in the USA versus 9.8 in the UK. As with most cancers, the prognosis of ovarian cancer is closely related to the stage it has reached when first diagnosed. Other facts:

Approximately 22,430 new cases of ovarian cancer are diagnosed annually.
Approximately 15,280 women die every year in the United States from ovarian cancer.
Estimates indicate that 1 in 70 women will develop ovarian cancer in her lifetime
Ovarian cancer accounts for 3.3% of all new cases of cancer.
The 5-year survival rate for ovarian cancer has improved significantly in the last 30 years.
The overall survival rate in 1975-1977 was 36%, compared to 45% in 1995-2002.
The disease is uncommon in patients younger than 40 years, after which incidence increases.
Most cases are diagnosed in the seventh decade of life.
The incidence of ovarian cancer in women over 65 has increased by more than 40% in the past few decades.
Worldwide, there are more than 204,000 new cases of ovarian cancer diagnosed each year.
The incidence of ovarian cancer is highest in the USA and Northern Europe and lowest in Africa and Asia.

Reference:
¹ “Are GPs under-investigating older patients presenting with symptoms of ovarian cancer? Observational study using General Practice Research Database.” – A R Tate, A Nicholson, J A Cassell – British Journal of Cancer – 2 March 2010 doi:10.1038/sj.bjc.6605593.

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Migraine Relief Device Undergoing Trials

sTMS If we’d seen this device advertised in the back pages of Popular Science magazine we’d have immediately discounted it as quackery, but it’s based on solid research¹ done at the highly regarded Albert Einstein College of Medicine in New York. The inventors claim that it relieves pain, for at least two hours and sometimes as long as two days, in 40% of migraine patients without serious side effects.

Migraines are severe headaches that affect about 18% of women and 6% of men in the USA and Western Europe, but they are the least publicly funded of all neurological conditions. About 20-30% of patients experience sensory or visual disturbances before a migraine headache sets in. The symptoms, known as auras, include visual phenomena, such as seeing spots of light and zigzag lines. Other physical symptoms can include numbness, tingling and difficulties with speaking. Some migraine attacks can be treated with drugs, but there is no universal cure.

Special magnetic pulse seems to prevent painful attacks
The new hand-held device delivers a special kind of magnetic pulse to the back of the head. The technique, known as single-pulse transcranial magnetic stimulation (sTMS), seems to disrupt the electrical events in the brain which cause the preliminary symptoms of migraines with aura. The technique has been tried in clinics, using large, expensive devices, but this is the first attempt to produce am sTMS device that can be safely used anywhere. A related technique, repetitive transcranial magnetic stimulation (rTMS) that repeatedly applies short magnetic pulses, has been used in researching ways of combatting migraine, stroke, Parkinson’s disease, dystonia, tinnitus and some classes of psychiatric disorder.

The three month trial, conducted by researchers at the Albert Einstein College of Medicine, was designed to assess the safety and effectiveness of the device. They asked two hundred patients to use the device to treat migraines with aura. Half of the patients were given placebo treatment. They found that the real magnetic pulse from the device was significantly more effective than placebo treatment. More patients were pain free 2, 24 and 48 hours afterwards.

Cautionary note
The device is still under trial and it’s not known if it, or something similar, could also prevent the painful, non-aura, migraine attacks that 70-80% of sufferers experience. It also relies on a specially tuned (”shaped”) magnetic pulse. This is completely different from the huge variety of quack magnetic devices that are claimed to cure chronic pain, rheumatism and a wide range of other currently incurable diseases. Almost all of those devices use ordinary permanent magnets that produce a steady, generally weak field. The vast body of scientific evidence to date has shown them to be completely worthless, other than as placebos. The new, portable sTMS device is based on scientific research done at a major biomedical and clinical research facility, so we’ll keep an eye on developments in this area.

¹ “Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial.” – Richard B Lipton MD et al. – The Lancet Neurology, Early Online Publication, 4 March 2010doi:10.1016/S1474-4422(10)70054-5.

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Avoiding The Most Frequent Error In Health Care

herror2 The Institute of Medicine defines a medical error in its groundbreaking report “To Err is Human” as a “wrong plan”, or a failure of a planned action to be completed. Researchers from the Regenstrief Institute and the Indiana University School of Medicine followed 6,785 primary care patients seen at an urban medical institution. All of them were over age 65, with a mean age of 72 and ninety one percent of the patients were covered by Medicare.

The researchers found that the most frequent error in medicine seems to occur nearly one out of three times a patient is referred to a specialist. Nearly a third of those patients are not scheduled for appointments and therefore do not receive the treatment their primary care doctor intended them to receive, primarily due to human error.

The detailed findings of the study¹, which was supported by the National Institute on Aging, were that:

Only 71 percent of patients age 65 or older who were referred to a specialist were actually scheduled to be seen by that physician.
Only 70 percent of those with an appointment actually went to the specialist’s office.
So, only 50 percent (70 percent of 71 percent) of those referred to a specialist had the opportunity to receive the treatment their primary care doctor intended them to have.

Human errors cause the problem
Michael Weiner M.D., M.P.H.², lead author of the study, said: “Patients fail to complete referrals with specialists for a variety of reasons, including those that the health care system can correct, such as:

Failure of the primary care doctor’s office to make the appointment.
Failure of the specialist’s office to receive the request for a consultation – which can be caused by something as simple as a fax machine without paper
Or a failure to confirm availability with the patient.”

He went on to say: “There will always be reasons – health issues or lack of transportation, for example – why a referred patient cannot make it to the specialist he or she needs, but there are many problems we found to be correctable using health information technology to provide more coordinated and patient-focused care. Using electronic medical records and other health IT to address the malfunction of the referral process, we were able to reduce the 50 percent lack of completion of referrals rate to less than 20 percent, a significant decrease in the medical error rate.”

The study highlights how enormous a problem this is for patients who are not getting the specialized care they need. Although the findings would likely differ among institutions, Dr. Weiner and his colleagues believe it very likely that overall trends are similar in other parts of the country.

Avoiding the error
If your doctor says that you need follow up action you should try to confirm the appointment with the administrative staff before leaving the facility. It’s always worth checking with the patient care manager a few days after an appointment to see if any follow up action was required and if so, when and where it will occur. Then make sure that you get there.

Thankfully, improving electronic health care records is an area that the current administration is very focused on. Reducing human errors will save Medicare money, in addition to improving patient care.

Footnotes:
¹ “Errors in completion of referrals among older urban adults in ambulatory care (p 76-81)” – Michael Weiner, Anthony J. Perkins, Christopher M. Callahan – Published Online: Feb 12 2010 6:55AM – DOI: 10.1111/j.1365-2753.2008.01117.x
² Dr. Weiner is Director of the Regenstrief Institute’s Health Services Research Program, Director of the Indiana University Center for Health Services and Outcomes Research, and Director of the VA Health Services Research and Development Center of Excellence on Implementing Evidence-Based Practice at the Roudebush VA Medical Center.

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Medicare Advantage Heading Towards Becoming Medicare Disadvantage

oldambulance A study¹ by consulting firm Avalere Health LLC. found that premiums for Medicare Advantage plans offering medical and prescription drug coverage has jumped by 14.2 percent on average in 2010, after an increase of only 5.2 percent in 2009. That’s peculiarly close to the 14% that the government claims they overpay the private health insurance companies that administer Medicare Advantage plans each year and that health care reformers want to stop paying them.

In 1997 a new Act of congress allowed the private insurance companies to offer policies equivalent to the standard Medicare Part A (hospital insurance) and Part B (medical insurance, or outpatient) benefits. The new program was known as Medicare+Choice, or Part C. In 2003 the Medicare Prescription Drug, Improvement, and Modernization Act allowed the insurers to add prescription drug coverage to their equivalents of Parts A & B and Part C became known as “Medicare Advantage” (MA). About 8.5 million elderly and disabled Americans are in the Medicare Advantage plans, which often provide more comprehensive coverage than traditional Medicare. Overall costs may be lower than the standard coverage if extra benefits, such as access to fitness facilities, are included

The government overpays the health insurers but customers don’t benefit
Nonpartisan technical advisers to Congress say that Medicare Advantage plans are being overpaid because of a flawed formula. The proposed health reform bill would indeed reduce the overpayments to the private health insurers, most of which goes to their profit margins, rather than better care. However, it would also reinforce Medicare Parts A and B by improving preventive benefits and narrowing the prescription coverage gap. Nevertheless, Republicans and other opponents of health care reform, determined to derail the initiative, have misrepresented the cuts and have succeeded in scaring seniors into believing that Medicare benefits will be cut. That’s simply not true.

Pre-emptive strike
The health insurance companies, faced with a possible cut in their income, could wait and see if it actually happens, then decide whether to increase premiums, cut profits, reduce costs, or reduce benefits. They’ve chosen to move preemptively and penalize patients now by increasing premiums. Seniors who did not shop around for lower-priced coverage during open enrollment in the fall got hit with some of the biggest increases, averaging 22 percent. If previous behavior is an indicator of future behavior, they’ll probably start dropping customers and raising prices by a further 14% if the health care bill passes. They’re already dropping patients across the spectrum of policies at the rate of 14,000 a day.

The Avalere study found that Medicare Advantage is becoming less of a bargain. The average premium for 2010 is $39.61, representing an increase of nearly $5 a month, versus the $1.75 increase in 2009. The averages are adjusted based on enrollment levels in particular plans that offer medical and prescription coverage. The Medicare Advantage rate increases coincide with rate hikes for individuals who buy their own private insurance. They have been hit with increases between 10% and 70% in the past month by companies such as Wellpoint, United Healthcare and Aetna.

Prognosis
Lindsey Spindle, a Vice President of Avalere Health, the data analysis firm that produced the statistical study said – “These premium increases fit within a broader trend of increased financial pressure on the insured. We see very large premium increases and a continued upward creep in how much out-of-pocket expenses beneficiaries are expected to pay, such as copayments.” Medicare spokesman Peter Ashkenaz said – “The [private insurer] plans need to explain why these increases are necessary.” Good luck on that one!

¹ “Avalere Analysis Finds Medicare Advantage Enrollees Face Higher Premiums in 2010” – 02/19/2010.

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FDA Insists That Misleading TV Ads for Aricept Be Withdrawn

aric The Federal Drug Administration (FDA) approved product labeling for the prescription drug Aricept® is indicated for “the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild to moderate Alzheimer’s Disease, as well as in patients with severe Alzheimer’s Disease.” In early February, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the FDA wrote to Eisai Medical Research Inc. informing them that two of their adverts for Aricept are misleading¹ because they overstate the efficacy of the drug.

The letter, from Sharon M. Watson, PharmD LCDR, USPHS, Regulatory Review Officer at the DDMAC to Gary Wieczorek, Associate Director, Regulatory Affairs at Eisai Medical Research Inc., goes on to describe the relevant clinical trials and their results. It then focuses on the content and assertions made in two adverts for Aricept, starting by saying, under the heading “Overstatement of Efficacy”, that “Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience.”

The adverts are then described in some detail and summarized as follows – ” The beginning segment of each ad presents patients with Alzheimer’s disease looking blank, confused, distant, and walking off apart from their family members. However, after talking to their doctors about treatment with Aricept, the patients are seen interacting and communicating with their family members, happily and actively involved in activities with them. These presentations imply that, as a result of Aricept treatment, patients’ cognitive and daily functioning, specifically aspects of attention and focus, orientation, communication, and social interaction and engagement, will be restored to normal.”

FDA claims misrepresentation of Aricept’s benefits and requests action
The FDA letter then says – “The totality of the above claims and presentations misleadingly overstates the efficacy of Aricept, implying a greater benefit than has been supported by substantial evidence or substantial clinical experience.”

The letter writer requests that Eisai immediately cease the dissemination of violative promotional materials for Aricept and that the company submit a written response to the letter on or before February 18, 2010, stating whether or not it intends to comply with the request. It also asks (perhaps somewhat hopefully) that the response also list other adverts that contain similarly misleading claims.

The FDA site doesn’t yet cite any response from the company, but there has been a noticeable absence of Aricept adverts on television recently. Perhaps the warning worked. It does make one wonder how many of the countless other drug adverts on television are similarly misleading. The Aricept advert below, which is not cited in the DDMAC letter, nevertheless seems to over emphasize the benefits of Aricept and make its side effects, which the FDA regards as “serious risks”, seem quite trivial.

References:
¹ The FDA claims that the TV ads misbrand Aricept in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), and FDA implementing regulations. 21 CFR 202.1(e)(5)(i) & (e)(6)(i).

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British Medical Association Concerned About Ethical Trading

UNESCO

The British Medical Association (BMA) has launched a campaign to put pressure on the United Kingdom’s National Health Service (NHS) to investigate where its medical equipment comes from. The campaign, called Fair Medical Trade, is aimed to make NHS staff aware of ethical issues and to push for a change in buying policy to ensure that workers in developing countries receive fairer pay and better working conditions. The BMA claims that at least a fifth of surgical instruments are made in northern Pakistan, where workers produce goods in dangerous sweatshop conditions and child labour is common.

The BMA wants the NHS, which operates most medical facilities in the United Kingdom, to use more Fairtrade and ethically-sourced kit. Fairtrade, which is known as Fair Trade Certified in the United States and Canada, is a product certification system designed to allow people to identify products that meet agreed environmental, labour and developmental standards. The campaign was started after the BMA conducted a survey of 383 doctors on the topic of fair and ethical trading. It found that, although only one in 10 was previously aware of ethically-sourced goods, eight in ten doctors were supportive of the suggested NHS purchasing policy.

Dr. Mahmood Bhutta, a surgeon and adviser on the BMA’s Medical Fair and Ethical Trade Group, said more needed to be done to raise awareness. Workers in Pakistan often toil for twelve hours a day, seven days a week. Ironically, they don’t, of course, receive medical benefits. Dr. Bhutta said – “Some of the workers in the developing world making medical supplies bound for the NHS are exposed to hazardous working conditions where they risk serious injury and even death.”

Government Ministers said “exploitation of any kind was unacceptable” and that the Department of Health was working with the BMA to develop practical guidance. A Department of Health spokesperson said – “We welcome the BMA’s initiative to raise awareness of ethical trade issues across the medical profession. We are working hard with procurers to make sure they seek assurance and evidence that international labour standards are being maintained.”

The NHS already buys some supplies, such as bed linen and cotton gauze, from Fairtrade suppliers such as The Organic Medical Clothing Company (OMCC). Their spokesman, Nik Powell, said that the company helps farmers in developing countries provide freshwater wells, schools and healthcare. The BMA Fair Medical Trade Campaign is advising NHS personnel that there are four important things that they can do to improve the situation:

Ask your Chief Executive to adopt ethical procurement into your institution’s policy.
Ask healthcare suppliers where they produce their goods and under what labour conditions.
Collaborate with colleagues to form an ethical trade “interest group” in your institution.
Tell others – Could you involve local patient groups or local media?

The NHS has already made some moves to improve the situation. Its Purchasing and Supply Agency has produced “Ethical Procurement for Health”, a step-by-step guide to assist NHS institutions in achieving this. The NHS Supply Chain also has a Code of Conduct that is based upon International Labour Organization (ILO) standards. The NHS also published a report¹ on the UK Government’s strategy on healthcare in a global environment.

The BMA has launched a new website that provides information on the ethical procurement of medical supplies and how doctors can get involved. You can also view their video and hear Dr. Bhutta’s podcast on our Audio and Video page.

¹ Health is global: a UK Government strategy 2008-13.

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Everyone's Guide to Medical Equipment - Part 13 - Basic Surgical Instruments

surgicalinstruments I’ll never forget the awe and apprehension I felt as a child when I heard that my friend was in hospital and required surgery after an accident on his bike. We ran down to the hospital for the latest news, only to find him coming out of the door with his arm in a sling. It was a while before we could see and marvel at the amazing arc of stitches on his forearm. Until then, I’d always equated “surgery” with the cosy, Edwardian style waiting room of our doctor. He was a cheerful Irishman with a shock of tousled red hair and an ever present smell of something medicinal (Jameson’s Irish Whiskey, I was to learn later) about him. He held surgery twice a day and went out on his rounds the rest of the day, visiting the hospital and people who were ill or due for a regular visit at home. On that particular day he’d been called to the hospital, just down the road from his home and practice, to perform some real, albeit simple, surgery on our friend.

Every doctor’s bag has a few basic surgical instruments in it, but today we’ll look at the mainstays of any operating theater. We’ll look at more advanced equipment in a second episode. Let’s start by looking back at some of the earliest known surgical instruments. We can surmise that early man found it necessary to patch up fellow hunters after an encounter with a mastodon, saber toothed tiger or other potential meal. They’d at least have needed something to stop the bleeding and a means to stitch up wounds. Animal hides, leaves, poultices and catgut (natural fibers pulled from the intestines of animals) would probably have done the job. Even minor wounds could have proven lethal because of the risk of untreatable infections. We’ve come a long way since then.

Progressive development
It’s not known exactly when the first surgical instruments were invented but: “Rough trephines (cylindrical blades) for performing round craniotomies have been discovered in many neolithic sites. It is believed that they were used by shamans to release evil spirits and alleviate headaches and head traumas caused by war-inflicted wounds.” – Wikipedia. Other historical records from many countries reveal the early use of quite sophisticated instruments and techniques. Here’s an approximate timeline:

India: Sushruta Samhita (circa 500 BC) described over 120 surgical instruments, 300 surgical procedures and classified human surgery into 8 categories.
Hua Tuo (110-207 AD) was a famous Chinese physician during the Han and Three Kingdoms era. He was the first person to perform surgery with the aid of anesthesia, some 1600 years before the practice was adopted by Europeans.
Greece and Rome: Surgeons developed many ingenious instruments manufactured from bronze, iron and silver that are very well preserved in medical museums around the world. Most of these instruments, manufactured to greater precision, continued to be used in Medieval times.
Moorish Spain (Andalusia): Abu al-Qasim al-Zahrawi, known in the West as Abulcasis, and considered the “father of modern surgery” wrote a seminal book on surgery in 1000 AD. It was translated into the thirty volume medical encyclopedia “The Method of Medicine” and was aimed to establish the general guidelines in the practical medicine by emphasising the “do” and “don’t” in almost every issue encountered and recommended techniques and treatments. Al-Zahrawi ended his encyclopedia with a treatise in which he describes his collection of more than 200 surgical tools.
Renaissance period: Many new instruments were invented and designed in this period, largely due to the increased severity of war-inflicted wounds resulting from the use of firearms and cannons.
19th and early 20th centuries: The discovery of anesthesia and surgical asepsis lead to the development of tools for penetrating the skull, thorax and abdomen. Hundreds of new surgical procedures were developed in the 19th century and first decades of the 20th century.
Modern times: In the second half of the 20th century, energy-based instruments were developed, such as electrocauteries, ultrasound and electric scalpels, surgical tools for endoscopic surgery, and finally, surgical robots.

Types of instrument
Unlike earlier articles, we don’t intend to cover every type of instrument in detail, only the most frequently used ones and the latest developments. Here’s a summary of the kinds of instrument available to a modern surgeon.

Mechanical support/positioning devices:
- Measurement devices, such as rulers and calipers.
- Graspers, such as forceps.
- Clamps (hemostats) and occluders for blood vessels and other organs.
- Retractors, used to spread open skin, ribs and other tissue.
- Distractors, positioners and stereotactic devices.
- Dilators and specula, for access to narrow passages (e.g. during gynecology) and guiding incisions.
- Carriers and appliers for optical, electronic and mechanical devices.
- Cutting laser guides.
Cutting tools:

Mechanical cutters (scalpels, lancets, drill and rasp bits, trocars and ligasure instruments,used for fusing blood vessels and saws.
Cauterizers and laser cutters.
Powered devices, such as drills and dermatomes (for cutting skin).

Diagnostic and observational aids:

Scopes and probes, including fiber optic endoscopes and tactile probes.
Ultrasound tissue disruptors and cryotomes (used for freezing and slicing tissue sections).
Many others were covered in earlier articles on diagnostic equipment.

Hygiene and healing aids:

Sealing devices, such as surgical staplers.
Suction tips and tubes, for removing bodily fluids.
Irrigation ( flushing and washing out anything with water or another liquid) and injection needles, tips and tubes for introducing fluid.

What’s next?
In the second article on surgical instruments we’ll take a closer look at scalpels and some of the modern versions of them, including laser and robotic surgery devices.

Footnote:
The surgical saw at top left was used by Surgeon James Powell, of the British Ordnance Medical Department, at the Battle of Waterloo in 1815 to amputate the leg of Lieutenant General Henry Paget, Earl of Uxbridge.

Related Articles: Part 1 – Basics | Series

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Minority Rule

bullsnose When is a majority not a majority? That’s simple, of course. It’s when you’re talking about the way that the US Senate works. Forty one of the one hundred Senators can block the wishes of the majority under filibuster rules. “In the United States Senate, the Senate rules permit a senator, or a series of senators, to speak for as long as they wish and on any topic they choose, unless 3/5 of the Senate (60 out of 100 Senators “duly chosen and sworn”) brings debate to a close by invoking cloture. According to the Supreme Court ruling in U.S. v. Ballin (1892), changes to Senate rules could however be achieved by a simple majority.” – Wikipedia.

In effect, the need to have 60 people vote in favor of a bill can put the minority in control, particularly with the current Senate makeup, where there are 57 Democrats, 41 Republicans and 2 Independents. It is, however, possible to use a process called “reconciliation” to push a bill through. It requires a simple majority of the votes, i.e. 51 to 49 at present. We did some math on the topic of the reconciliation process in the Senate. The total number of voters that each party represents, computed from the actual numbers in the 2004, 2006 and 2008 Senate elections is:

Democrats: 112,960,147

Independents: 1,065,263

Republicans: 96,324,270

Reconciliation still represents the wishes of the majority
So, the Democrats in the Senate represent 14.7% more voters than the Republicans. If you average out the number of voters per Senator and then assume that the Democrats pass a bill by reconciliation, which requires 51 Senators to vote for it, those Senators represent about 101 million voters. The Republican minority represents a total of just over 96 million voters and even with the two Independents voting with them, the opposition would still only represent slightly over 97 million voters.

Even when using reconciliation, the Democrats would be representing more voters than the opposition. However you look at it, 51 out of 100 votes is a majority and representing the wishes of 101 million people against those of 97 million also gives the Democrats a legitimate majority. That’s how a democracy is supposed to work. The majority gets to decide what happens. The 60:40 filibuster rule needs to go. It’s making the Senate dysfunctional.

The reconciliation mechanism has been used to pass major revisions to Medicare, Medicaid and other government health programs (there are seven of them) in the past. It’s worth noting, that despite the bleating of the Republicans on this occasion, they jammed through four major, unfunded bills using reconciliation during their most recent term in power. The Republicans just don’t seem to like taking their own medicine.

This is how the situation could look if reconciliation were used.

100 Senate votes with 51 for a bill.	Proportion of voters represented.

Passing health care reform
The Democrats should just get on with it and use reconciliation to pass the badly needed health care reforms that we thought we were voting for at the last election. Then they should set about changing the filibuster rules. It’s legally possible – ” The current Senate rules state that affirmative votes from two-thirds of the Senators present and voting are required for future rule changes. Despite this written requirement, the possibility exists that the filibuster could be changed by majority vote, using the so-called nuclear option, also called the ‘constitutional option’ for political reasons and because of its roots in constitutional majoritarianism; that is, the Ballin decision.” – Wikipedia.

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Study Finds That Many People Don't Have Advance Medical Directives

A report¹ by researchers at the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health covers the findings of a telephone survey that asked people questions about advance medical directives. We’ve covered the importance of having an advance medical directive in earlier articles. An advance directive is an end-of-life planning tool that provides instructions for types of medical treatment that are desired and/or who can make decisions about medical care should someone be unable to do so for him or herself. Some also designate power of attorney over financial matters.

Research has shown that the benefits of advance directives include: improved quality near the end-of-life; fewer burdens on the patient’s family and health care providers; and a reduced need for, sometimes controversial, life-sustaining treatment.

Lead study author Keshia Pollack, PhD, MPH, an assistant professor at the Johns Hopkins Bloomberg School and her colleagues ran a population-based cross-sectional telephone survey of 1,195 adult Maryland residents. They were asked whether they have an advance directive, where they had received information on them, and where they would like to receive such information.

The key findings of the survey were that:

Only 34 percent of respondents had advance medical directives in place.
61 percent indicated they have preferences about medical care in the event they are unable to make such decisions.
Younger adults and blacks were less likely than older adults and whites, respectively, to report having an advance directive.
The primary reasons reported for not having an advance directive include:

Being unfamiliar with them.
Feeling too healthy to need one, or,
For the younger adults, being too young to need one.

Forty percent of adults surveyed reported that they would like to obtain information on advance medical directives from a physician.
Only 12 percent of the respondents with advance directives reported obtaining it from their doctor.

Prof. Pollack said – “These findings suggest a disconnect between what people want in the event they are unable to make medical decisions for themselves, and their actions to ensure their preferences are actually carried out.” She also pointed out that – “While these results are specific to Maryland, they are relevant to other areas of the country with the factors that lead to or hinder completion of advance directives.”

The research project was initiated by Dan Morhaim, MD in order to better understand the public’s perception regarding advance directives and to identify potential policy solutions. Morhaim, an adjunct professor with the Department of Health Policy and Management and a member of the Maryland House of Delegates, said – “These results support a need for legislative and regulatory changes to increase the number of people with advance directives. Advance medical directives cost nothing to complete and are readily available from many sources. We need to make sure that people know where to get them and why it’s important to complete them.”

¹ “The public’s perspectives on advance directives: Implications for state legislative and regulatory policy.” – Health Policy – Available online 27 January 2010 – Keshia M. Pollack, Dan Morhaim, Michael A. Williams. The research was funded by a grant from CareFirst BlueCross BlueShield.

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The Public Option Fiasco

circuscircus The public option, an optional health insurance plan offered via a government program, rather than directly from private companies, has been hotly debated over the past year. The House’s reform bill included a mechanism to provide something similar to a public option, with the aim of making affordable coverage available to all Americans. The Senate reform bill doesn’t include a public option. It has been widely criticized, not just by liberal or progressive democrats, but by independent voters too. The Senate bill was so bad that many people who voted for a Democrat last time said that they would vote for somebody else next time.

President Obama seemed to be in favor of a public option during his election campaign. However, the White House has been ambivalent in its support of the public option over the past year. They aren’t against it, but they seem afraid of going out of their way to push for something that has been resisted by more conservative members of the Senate Democrats, such as the Blue Dog coalition. Congressional Republicans have totally opposed the idea of a public option, claiming, without any evidence whatsoever to support their views, that the private insurance industry would collapse.

Some facts
Before looking at the positions that congress and the White House are taking, it’s worth looking at some of the facts:

There are currently more than 46 million Americans without any form of health insurance.
It is estimated that an average of 114 Americans die every day as a result of having no health insurance.
1.6 million Americans are forced into bankruptcy every year as a result of health care debts.
The insurance companies are currently dropping coverage for over 14,000 people a day.
Here’s how we get our coverage:

Half of Americans are covered by private insurance plans, mostly provided via their employer.
One third of Americans are covered by one or more of the seven government health insurance plans.
One sixth of Americans have no health insurance.

Health care costs individual Americans twice as much as comparable or better care in other developed countries.
The United States ranked 24, 37 and 72 in three independent studies of the effectiveness of healthcare systems worldwide.
Many states have no regulatory control over health insurance companies and even where they do, they don’t seem able to influence the cost of premiums.
Health insurers raised rates by an average of around 35% last year, whereas their costs rose by around 5% and inflation was 3.8%.
Health insurers are already threatening to raise rates by between 10 and 39% in 2010. Their costs will probably rise by no more than 5%.
Health insurers are hitting individuals who buy their own health insurance particularly hard by raising their rates disproportionately.
Health insurers are dropping coverage for individuals who cost them more than their average client and applying increasingly stringent pre-existing condition rules to deny coverage to people changing jobs or who try to switch insurers.
Health insurers cannot operate across state borders. However, they are allowed to collude behind closed doors in order to align policies and fix prices, effectively removing real competition.
Recent polls show that two out of every three Americans want to see a public option in the health care reform bill.
The health care and insurance industry donates huge amounts of money to political campaigns and has spent almost a billion Dollars opposing reform.
Every politician who has opposed key aspects of health care reform, especially the public option, has received substantial campaign funding from the insurance industry.

Lying for a living
When people in most trades and professions are caught lying they are likely to be reprimanded, fired or taken to court. Unfortunately, lying seems to have become a way of life for the politicians and lobbyists in Washington, DC. The Republicans are particularly adept at taking a fact and reversing it to make the White House and the Democrats look like the bad guys. If they can’t find a fact, they’ll invent something, such as Sarah Palin’s invocation of the mythical “Death Panels” and Jim Towey’s “Death Book“, designed to scare seniors into turning against the reform bills. Yesterday, Rep. Joe Wilson (R-SC), of “You Lie” infamy, said that he believes that the U.S. has the best health care system in the world. All of the published facts prove otherwise.

We could pick almost any statement by Republican leaders over the past year and disprove most of it, but when House Minority Leader John Boehner (R-OH), House Republican Whip Eric Cantor (R-VA) and Senate Minority Leader Mitch McConnell (R-KY) all claimed during the past week that voters are overwhelmingly opposed to the public option, when all recent polls prove that the opposite is true, it’s clear that they regard lying as an acceptable tactic. It’s not.

Weakness in leadership
It would be wrong of us to throw rocks at the Republicans without also going after the Democrats, who are even more to blame for the current situation regarding health care reform. Most Democratic Party Senators should be ashamed of themselves for the poor job they’ve done since coming to power. Their indecisiveness and poor organization are bad enough, but their ridiculous attempts at bipartisanship look like attempts to tie ribbons on a werewolf. One has to ask “why bother?” We didn’t elect them to get rolled over by the minority party.

Robert Gibbs, White House Press Secretary, put his foot in his mouth yesterday when he seemed to be giving up on the public option “because there aren’t enough votes for it” in the Senate. Hasn’t he been reading the polls? It’s good to see the President taking a leadership position over health care reform, but that should have happened a year ago.

Why are the politicians struggling with the notion of a public option?
Given that voters are 2:1 in favor of a public option, why not just get on with creating a viable one, using reconciliation to drive the legislation through? There’s only one plausible explanation – they’ve been bought by private interests. Fearful of losing health sector campaign funding and, even worse, the devastating effect that unfettered corporate campaign advertising could have in future elections, they’re trying to get something passed without annoying their corporate puppet masters.

It’s odd that the people who are against “big government” don’t mind their lives being controlled by big businesses that are motivated only by profit. This may be one of the clearest indicators ever that our political system is broken. It’s a corpocracy, not a democracy.

Tomorrow’s debate
President Obama will be holding a bipartisan meeting to discuss health care reform tomorrow. It will be televised on C-SPAN and some other channels. He has put forward an 11 page document¹ summarizing his proposals. It seems to want something similar to the public option, but without spelling out all of the details. The Republicans immediately dismissed his document, saying that it’s way too short for such a complex and important subject. Their own list² is one page long, so it’s hard to understand their logic. This could be very interesting.

References:
¹ The President’s 02/22/10 proposal on health care reform.
¹ The GOP proposals for health care reform.

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Long-Term Care Hospitals Are Poorly Regulated

bedrace Long-term acute care hospitals now treat about 200,000 patients a year, including 130,000 Medicare patients — at a projected cost of $4.8 billion to the government this year, up from $400 million in 1993. However, a spate of lawsuits, negative inspection reports and analysis of federal statistics have raised concerns about the level of care they provide, particularly when they are run for profit. It’s particularly troubling to find that Medicare has never closely examined the quality of care they provide and that they are not penalized financially if they fail to submit quality data.

Fewer than 10 hospitals dedicated to long-term care existed in the early 1980s, but over 400 have opened since then, driven by Medicare rules that offer high payments for hospitals that treat patients for an average of 25 days or more. Long-term care hospitals, typically averaging about 60 beds, do not treat specific types of patients or offer services unavailable in regular hospitals. They are defined solely by the fact that they keep patients longer than other hospitals. They generally provide services beyond those of a nursing home, but most do not have doctors on the premises. Patients who need surgery or suffer serious medical emergencies are usually transferred back to general hospitals.

The financial incentive
Long-term acute care hospitals treat patients who are too sick for nursing homes but are also not improving at traditional hospitals. Hospital intensive care units are not intended to treat patients for weeks or months. Hospitals can move patients to regular medical wards, but Medicare payment rules often cause facilities to lose money on patients who have to be treated for extended periods, so they have an incentive to move them to a long-term hospital. Medicare then pays the long-term hospital for taking in a new patient and the regular hospital gets paid as soon as it refills the bed, so both hospitals benefit financially. In 2007, regular hospitals lost an average of 6 percent on Medicare patients, whereas long-term hospitals made a 6% profit on them.

Unfortunately, it seems that the rapid rise in the number of long-term hospitals has been for purely financial reasons, rather than because patients benefit. Dr. Jeremy M. Kahn of the University of Pennsylvania, who has received a federal grant to study the hospitals, says -“The U.S. health care system allows unintentional financial incentives to drive sweeping changes.” Long-term care hospitals do not have emergency rooms, so they can choose which patients to admit. Although Medicare tries to prevent them from admitting patients who could be treated less expensively at nursing homes, many lucrative patients slip through the net.

A hospital is certified as a long-term care hospital and receives high Medicare reimbursements if most patients stay at least 25 days. Medicare pays the hospital a fixed amount for each patient, meaning that patients who stay longer than 25 days become less profitable. This is evident in the case of Select Medical Corporation, the subject of the incidents we’ll cite in this article. It adheres closely to this formula, with an average length of stay at its hospitals of about 24 days, according to public filings. In 2007, an inspector for Medicare found that a case manager at a Select hospital in Kansas refused to discharge a patient despite the wishes of his physician and family. The hospital had calculated that it would lose $3,853.52 if it discharged the patient when the family wanted.

Oddly, nearly half of long-term care hospitals, and almost all of Select’s, are actually “hospitals within hospitals.” They occupy a floor or two of an existing hospital, contracting most services from the host hospital, so they can be opened quickly and cheaply. Under Medicare rules, because they have different owners, the two hospitals are considered separate for payment purposes. This means there can be a second reimbursement when a patient is simply transferred between floors.

Warning signs
Incidents that occurred in the for-profit side of the industry, centered on Select and Kindred Healthcare, raised alarm bells about the state of the long-term care hospital system. The first involved a 46 year old diabetic who was hospitalized at Select in Kansas City for five weeks in 2007. She died after a series of very elementary mistakes. Medicare inspectors found that the hospital did not have enough nurses on the night she died and that the volume on her monitor was turned down. The inspectors noted that, although staff members “recognized the need to report the death” because she had been in restraints, “they stated the corporate legal department advised the hospital not to report the death” to Medicare. Select claimed that the company’s lawyers did not think that the death needed to be reported to Medicare. The hospital, which is insured separately from the parent company, settled a legal suit against it in June 2009 by paying the patient’s family $800,000, while denying wrongdoing.

The second incident, also at Select’s Kansas City hospital, involved a 69 year old patient recovering from an amputation. He died of a heart attack there in October 2004. The hospital’s director of quality, later told the patient’s sister that a nurse had turned off the patient’s heart monitor “because the nurse was tired of listening to the monitor beep.”

The family sued, but the case was dropped in 2006 after Select paid them $195,000. The company also fired the nurse involved. Select did not admit liability in the settlement, saying that its “monitoring policy in place at that time met the prevailing standard of care” and that the death resulted from “human error and a failure to comply” with the company’s policy. The director of quality at the time said that she believed that Select’s failure to spend adequately put patients at risk. The company now claims to have hired a clerk to watch over the heart monitors.

Select Medical cited for serious violations of Medicare rules
The Kansas City hospital is part of a chain called the Select Medical Corporation, a publicly traded Pennsylvania company that runs 89 long-term hospitals, more than any other company. In a presentation to investors in January, the company reported that it improved its margins by monitoring staffing levels and lowering supply costs. That’s nice for the investors. However, unfortunately for the patients, Medicare inspection reports describe preventable patient injuries and deaths and portray Select’s hospitals as understaffed and with high turnover.

In 2007 and 2008, Select’s hospitals were cited at a rate almost four times that of regular hospitals and twice that of other long-term hospitals for serious violations of Medicare rules. Long-term care hospitals also had a higher incidence of bedsores and infections than regular hospitals in 2006, the most recent year covered in federal data. In the last three years, inspectors found 22 violations of care standards at 12 Select hospitals which were so serious that, if left uncorrected, could lead Medicare to ban those hospitals from admitting Medicare patients. Select strongly defends its care, pointing out that its patients, like those at other hospitals, are seen by physicians at least once a day and that they perform better than other hospitals at some aspects of care.

Select has 23,000 employees and provided care to 42,000 patients in 2009. Select Medical Corporation has no physicians on its board or in management. In 2007, it hired a physician for a new position, National Medical Director. The physician estimates that he spends only 10 hours a week working for Select Medical. The company says that it has several corporate-level employees responsible for ensuring safe care and that each hospital has a full-time quality manager.

A widespread problem
Many other Select hospitals have problems, according to Medicare inspectors, but their facilities aren’t the only long-care hospitals with problems. A March 2009 report from the Medicare Payment Advisory Commission found that, in 2006, nine out of 1,000 Medicare patients developed serious infections in long-term care hospitals. The federal Agency for Healthcare Research and Quality reported that fewer than three out of 1,000 (predominantly Medicare) patients over 65 developed infections while in traditional hospitals that year.

Surprisingly, Medicare cannot impose fines or reduce payments to long-term care hospitals, or any hospitals, when problems are found. Hospitals merely have to submit plans to correct the problems that inspectors find. The hospitals could be forced out of the program, but because that penalty would probably cause a hospital to close, the agency almost never uses it. When Medicare tried to force out the Select hospital in St. Louis in 2009, the company sued. A federal judge found that the case did not directly harm patients and ruled in favor of the company. The hospital eventually agreed to hire outside experts to help correct the problems.

A moratorium was imposed but is about to expire
Medicare adjusted its rules in 2007 to slow the industry’s growth and contain its own costs. The agency limited the number of patients that hospitals-within-hospitals could admit from their hosts. It refused to pay multiple reimbursements when patients were admitted to a long-term care hospital and then rapidly returned to a regular hospital. The industry continued to grow rapidly until December 2007, when Medicare instituted a three-year moratorium on new long-term care hospitals. The freeze slowed, but didn’t stop, the industry’s growth. The moratorium did halt soaring Medicare costs though. After a rapid decade-long growth, Medicare spending on long-term care hospitals has been flat for the last two years.

The moratorium expires in December of this year. With or without it, existing long-term hospitals will continue to admit nearly 200,000 Medicare, Medicaid and private insurance patients a year, without any proof that they match the quality of traditional hospitals. An industry that was founded as a result of a loophole in Medicare regulations looks as if it will continue to thrive, no matter how badly they care for patients.

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Everyone's Guide to Medical Equipment - Part 12 - More Diagnostic Equipment

Taronga Western Plains Zoo

In this series of articles we’ve looked at: the simple and advanced instruments that you would expect your physician or clinic to have on hand; medical monitors, such as electrocardiograms; and laboratory equipment. This is the last of the group of four articles on advanced medical diagnostic equipment, ranging from X-ray machines through devices that exploit highly advanced nuclear physics to look inside our bodies.

One of the principal techniques that most of the advanced imaging equipment uses is tomography. A computer program uses a mathematical algorithm to combine sectional images into a two or three-dimensional view of the part of the patient being examined. Radiography, CAT, MRI and PET scanning can all use tomography to give the physician or other specialist a more useful view of the body than than individual images would provide. The same technique is used in a wide range of other instruments that use light, sound, heat, electricity, or combinations of them, to generate the individual images.

In this article we’ll cover:

Endoscopy, sigmoidoscopy, colonoscopy and videocolonoscopy.
Electron microscopy.
Scanning laser ophthalmoscopy.
Ultrasound.
Elastography.
Optoacoustic imaging.
Photoacoustic imaging.
Thermography.
Electrical impedance tomography (EIT).

Endoscopy, sigmoidoscopy, colonoscopy and videocolonoscopy
“Endoscopy is an invasive diagnostic medical procedure that is used to assess the interior surfaces of an organ by inserting a tube into the body. The instrument may have a rigid or flexible tube and not only provides an image for visual inspection and photography, but also enables the taking of biopsies and retrieval of foreign objects. ” – Wikipedia. It can be employed in a wide range of diagnostic situations, including:

The ear (otoscopy)
The gastrointestinal tract (GI tract) – esophagogastroduodenoscopy, enteroscopy, colonoscopy,sigmoidoscopy, endoscopic retrograde cholangiopancreatography (ERCP), duodenoscope-assisted cholangiopancreatoscopy, intraoperative cholangioscopy and proctoscopy (rectoscopy and anoscopy)
Hand Surgery, such as endoscopic carpal tunnel release surgery
Normally closed body cavities (through a small incision) – arthroscopy, laparoscopy, mediastinoscopy and thoracoscopy.
Panendoscopy (or triple endoscopy) – Combines laryngoscopy, esophagoscopy, and bronchoscopy
Plastic Surgery
During pregnancy – colposcopy, falloscopy and hysteroscopy.
The respiratory tract – rhinoscopy and bronchoscopy.
The urinary tract (cystoscopy).

That’s a lot of “oscopies”, many of which we’d hardly heard of! There’ll be a test later. Some of these are much more commonly deployed than others. Sigmoidoscopy is the minimally invasive medical examination of the large intestine from the rectum through the last part of the colon. We most commonly encounter it as a part of colonoscopy examinations and procedures, which use a video camera (videocolonoscopy) or a fiber optic camera on a flexible tube. It can provide a visual diagnosis (e.g. recognizing polyps or ulceration) and it can also be used to take a biopsy, or to remove polyps and repair lesions.

Various Endoscopy Instruments and Procedures

Sigmoidoscope	Colonoscope	Bronchoscopy

Electron Microscopy
Regular microscopes shine light through or onto a subject and then bend the light rays in glass lenses, magnifying the scene as much as a 1500 times. The same principle is used in electron microscopes. They use electrons as the source of illumination and bend the rays using permanent or electromagnets, magnifying small details as many as 2,000,000 times. There are three kinds of electron microscope:

Scanning electron microscope (SEM): this type looks at the surface of bulk objects by scanning the surface with a fine electron beam and measuring reflection. It can also be used for spectroscopy.
Transmission electron microscope (TEM): this type passes electrons completely through the sample, in the same way as a regular microscope.
Scanning Tunneling Microscope (STM): this instrument can image surfaces at the atomic level, something that was once thought impossible.

Scanning laser ophthalmoscopy
This instrument uses a low power laser beam to scan the retina or cornea of the human eye. “The key feature of confocal microscopy is its ability to acquire in-focus images from selected depths, a process known as optical sectioning. Images are acquired point-by-point and reconstructed with a computer, allowing three-dimensional reconstructions [i.e. by using tomography]. – Wikipedia.

Scanning laser opthalmoscopy is important in diagnosing diseases and problems in the eye, such as glaucoma and cataracts. It is also becoming an extremely useful tool in the early diagnosis of the risk of strokes.

Electron Microscopy and Scanning Laser Ophthalmoscopy

Scanning Electron Microscope (SEM)	SEM Image of a Nerve Ending

Scanning Laser Opthalmoscope (SLO)	SLO image of the Retina

Ultrasound
Ultrasonic diagnostic machines use high frequency, broadband sound waves that are reflected by tissue to varying degrees to produce 2D or 3D images. Strong, short electrical pulses from the ultrasound machine make a transducer “ring” at the desired frequency (usually between 2 and 18 MHz). The sound is focused either by the shape of the transducer, a lens in front of the transducer, or a complex set of control pulses from the ultrasound scanner machine, producing an arc-shaped sound wave from the face of the transducer. The wave travels into the body and comes into focus at a desired depth. Sound reflections are detected by sensors and converted into signals that are combined into single or moving images.

The technique has been in use in various forms since the 1940s and is generally regarded as safe. It is widely used in fetal examinations during pregnancy, but it has many other medical diagnosis uses as well, including imaging: the abdominal organs, heart, breast, muscles, tendons, arteries and veins. Although it provides less anatomical detail than techniques such as Computed (X-ray) Tomography (CT) or Magnetic Resonance Imaging (MRI), it can be used to study the function of moving structures in real-time. It also emits no ionizing (dangerous) radiation and contains additional information (”speckle”) that can be used in elastography.

Elastography
Elastography is a non-invasive method in which stiffness or strain images of soft tissue are used to detect or classify anomalies, such as tumors. A tumor, or a suspicious cancerous growth, is normally 5 to 28 times stiffer than the background of normal soft tissue. When a mechanical compression or vibration is applied, the tumor deforms less than the surrounding tissue. i.e. the strain in the tumor is less than the surrounding tissue. It can also be used to detect fibrosis in the liver and other organs. Elastography is usually performed using standard ultrasonic equipment with computer programs that can recognize and measure the degree of stiffness of the objects in the area being examined.

Ultrasound Equipment and Applications

Ultrasound Machine	Sonogram	Elastogram

Optoacoustic/Photoacoustic and Thermoacoustic imaging
These are imaging technology based on the photoacoustic and thermoacoustic effects. They can be used for obtaining images of structures in turbid environments, such as the stomach. The technique combines the accuracy of spectroscopy with the depth resolution of ultrasound. Although optoacoustic imaging is still in its infancy, it is already being used for breast cancer detection and in equipment for measuring blood oxygenation levels.

Low power optical laser or radio frequency pulses are directed into the tissues to be examined. Some of the delivered energy will be absorbed and converted into heat, leading to minute and temporary expansion material in the area, which itself results in faint ultrasonic emissions. The generated ultrasonic waves are detected by transducers and are used to form images. If lasers are used then the technique is known as optoacoustic imaging. If electromagnetic (radio frequency) pulses are used then it is known as thermoacoustic imaging.

Thermography
This technique uses special cameras to detect electromagnetic radiation in the infrared range and produce images (thermograms) of that radiation. The cameras are detecting temperatures, rather than reflected light. When viewed using a thermographic camera, warm objects stand out very well against cooler backgrounds; humans and other warm-blooded animals become easily visible against the environment, day or night.

“Its use in medical diagnosis, known as Digital Infrared Imaging (DII) Thermography, is based on the principle that metabolic activity and vascular circulation in both pre-cancerous tissue and the area surrounding a developing breast cancer is almost always higher than in normal breast tissue. Cancerous tumors require an ever-increasing supply of nutrients and therefore increase circulation to their cells by holding open existing blood vessels, opening dormant vessels, and creating new ones (neoangiogenesis). This process frequently results in an increase in regional surface temperatures of the breast.

Digital Infrared Imaging uses extremely sensitive medical infrared cameras and sophisticated computers to detect, analyze, and produce high-resolution diagnostic images of these temperature variations. Because of DII’s sensitivity, these temperature variations may be among the earliest signs of breast cancer and/or a pre-cancerous state of the breast.” – Wikipedia.

Electrical impedance tomography (EIT)
In this new, experimental technique, an image of the conductivity or permittivity of part of the body is computed from surface electrical measurements. The proposed applications of EIT include: the monitoring of lung function; the detection of cancer in the skin and breast; and location of epileptic foci.

Conducting electrodes are attached to the skin of the subject and small alternating currents are applied to some or all of the electrodes. The resulting electrical potentials are measured, and the process may be repeated for numerous different configurations of applied current and with the electrodes in different positions. The conductivity or permittivity of nearby parts of the body are then calculated from the surface electrical measurements.

Photoacoustic, Thermographic and Electrical Impedance Tomography Images

Photoacoustic Image	Thermogram	EIT image

Where from here?
That concludes the group of articles on medical diagnostic equipment. In the next article in this series we’ll be looking at surgical instruments, ranging from the most basic scalpels to modern robotics and the application of nanotechnology.

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Controversy Rages Over Safety Of Diabetes Drug Avandia

avandia Last week we reported¹ that some popular cholesterol-lowering drugs slightly increase the risk of diabetes, particularly in older patients. Now, in an almost inverse situation, there are serious concerns about the risk that a controversial diabetes-battling drug may cause heart problems. However, the public hasn’t been informed of the risk because of battles within the Federal Drug Administration (FDA) and pressure on whistle blowers from the manufacturer, GlaxoSmithKline (”Glaxo”), the company that withdrew an unrelated product² from the US market just last week. Unfortunately, the FDA has not seen fit to instruct the manufacturer to withdraw the drug.

Confidential government reports, obtained by the New York Times, recommend that the drug Avandia (rosiglitazone) be removed from the market. One of the reports claims that hundreds of people taking the diabetes medicine needlessly suffer heart attacks and heart failure each month. Avandia was designed to treat Type 2 diabetes. However, it was linked to 304 deaths during the third quarter of 2009. The report claims that switching diabetic patients to a similar drug, Actos (pioglitazone), would avert 500 heart attacks and 300 cases of heart failure every month.

Conflict within the FDA
Avandia was once one of the biggest-selling drugs in the world. A multimillion-dollar advertising campaign and other marketing pushed its sales to $3.2 billion in 2006. Then a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the FDA to issue a warning and sales plummeted. Another report, by Dr. David Graham and Dr. Kate Gelperin of the FDA, concluded that – “Rosiglitazone should be removed from the market.” Both of the authors recommended that Avandia be withdrawn. However, later in 2007 a committee of independent experts found that Avandia might increase the risk of heart attack but recommended that it remain on the market. An FDA oversight board voted 8 to 7 to accept that advice.

The internal FDA reports are part of a fierce debate within the agency over what to do about the drug. Some officials want it withdrawn because they believe there is a safer alternative, while others insist that studies of the drug provide contradictory information, so Avandia should continue to be an option for doctors and patients.

More studies have been done since 2007. Dr. Janet Woodcock, director of the FDA’s drug center, wrote in a December 2009 internal memorandum – “There are multiple conflicting opinions” about Avandia within the agency. She ordered FDA officials to assemble another advisory committee, expected to report this summer, to reconsider the situation.

The Senate, European governments and the World Health Organisation get involved A bipartisan multiyear Senate investigation that included looking into the Avandia situation, dug through more than 250,000 internal company documents, will release its results publicly on Monday. It sharply criticizes Glaxo, saying that the company failed to warn patients years earlier that Avandia was potentially deadly.

The report, which was overseen by Senator Max Baucus (D-MT) and Senator Charles E. Grassley (R-IO) concludes that – “Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.” Senator Baucus said – “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”

They cited a study, completed in November 2003 by Glaxo, in which diabetics given Avandia had far more heart problems than those given placebos. Just two months later, the World Health Organization (WHO) sent the company an alert linking Avandia to heart ailments. A June 2004 meeting of the company’s Global Safety Board recommended that a hard look be taken at all Avandia clinical trials for more signs of heart problems.

European regulators had also ordered Glaxo to conduct a study, called the Record trial, to examine Avandia’s heart risks because hints of these problems appeared in the company’s earliest trials. However, company executives were aware in 2004 that the Record trial was going so poorly that it would never be conclusive. So, they gathered dozens of Avandia studies and sifted their combined data. This meta-analysis found, first in 2005 and in an updated look in 2006, that Avandia increased the risks of serious heart problems by nearly a third. This was hugely worrying because two-thirds of diabetics die of heart problems. The executives revealed the results of their meta-analysis to the FDA in 2005 and in 2006 they provided the agency with the underlying data.

Glaxo, of course, disagreed with the Senate investigation’s conclusions. The company said that it could not comment on internal FDA documents but that “the official ruling from FDA is that Avandia remain on the market.” The company claims that it has studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks. Note that this is in sharp contrast to the findings of their own meta-analysis of the data, as revealed to the FDA in 2005.

Other studies, some ongoing, also raise concern
The results of two other large company-sponsored trials, called Dream and Adopt, were also published near the end of 2006. Each provided more hints that Avandia hurts the heart. In a March 2007 meeting of the company’s Diabetes Franchise Cardiology Advisory Board, advisers expressed disquiet about the safety worries found in these many studies.

Amongst all of the controversy, agency officials ordered Glaxo to undertake a new study, called TIDE, comparing how many heart attacks, strokes and heart-related deaths occur among patients given either Avandia, Actos or a placebo. The studies suggest that Actos, made by Takeda, lowers blood sugar as well as Avandia but without as much risk of damaging the heart.

Now the TIDE study itself is under fire from Dr. Graham and Dr. Gelperin, working in the FDA’s office of surveillance and epidemiology. They argued in two separate internal reports (dated October 2008) that the new Glaxo study, is “unethical and exploitative because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit.” They are alarmed because the trial may include patients who have had heart attacks or chest pains, even though some foreign drug authorities have warned against Avandia’s use on such patients. One of the FDA’s reports concludes – “Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable.”

The authors’ recommendations were later overruled by other agency officials and Glaxo is still enrolling patients in the TIDE trial. It is not expected to be completed until 2020, although the company is hoping to report some results to the FDA by 2014. Glaxo’s patent on Avandia expires in 2012 and generic versions may swallow most remaining profits.

In a letter sent Thursday to Dr. Margaret Hamburg, the Food and Drug Administration commissioner, Senators Baucus and Grassley asked “what steps the FDA has taken to protect patients in the TIDE trial” and said the trial’s patients had never been told about the concerns raised by the agency’s own safety officers.

Big Pharma threatens whistle blowers
The Senate inquiry also concludes that the company threatened doctors who publicly suggested that Avandia might have serious risks. According to the New York Times – “In 1999, Dr. John Buse, a Professor of Medicine at the University of North Carolina, gave presentations at scientific meetings suggesting that Avandia had heart risks. Glaxo executives complained to his supervisor and hinted of legal action against him, according to the Senate inquiry. Dr. Buse eventually signed a document provided by Glaxo agreeing not to discuss his worries about Avandia publicly.

Glaxo said that it “does not condone any effort to silence” scientific debate, and that it disagrees with allegations that it tried to silence Dr. Buse. Still, it said the situation “could have been handled differently.” The Senate report also cites a separate incident where the company intimidated investigators at the University of Pennsylvania.

Will anything actually be done?
The question of when and how to communicate possible drug risks is an ongoing problem. Thousands of drug injury reports pour into the FDA every week. For example, an analysis done by the Institute for Safe Medication Practice, a drug safety oversight group, ranked Avandia first among all prescribed drugs in the number of serious, disabling and fatal problems reported to the agency in the third quarter of 2009, when 304 people died from its effects. The Big Pharmas say that such reports do not offer proof of a problem and that highlighting them can scare patients away from needed treatment, so they want more certainty before alarms are raised. Glaxo also claims that most of the recent reports regarding Avandia are tied to litigation. That may be so, but when its own reports indicate that there were serious reasons for concern, one has to doubt the company’s motives.

Senator Grassley said that the internal agency battle showed that the FDA to be restructured to give more power to safety officials, like Dr. Graham and Dr. Gelperin, over their counterparts who approve medicines and deal more directly with drug makers. It’s worth noting that FDA employees have often been convicted of corruption in the past. Senator Grassley also said – “It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision. The Avandia case may be the most alarming example of the problem with this setup.”

It remains to be seen as to whether or not the FDA will erect an effective barrier between the regulators who authorize the release of a drug to the market and those who subsequently monitor its effects. Meanwhile, despite all of the warning signs, Glaxo continues to market and advertise Avandia aggressively. Hundreds of thousands of diabetic patients still take the medicine, although some top endocrinologists say they no longer prescribe the drug.

Related articles:
¹ “Cholesterol Lowering Drugs May Slightly Increase Risk of Diabetes.”
² “Glaxo To Stop Making Denture Creams Containing Zinc.”

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February 21st, 2010 | Verna & Leon | Print This Post | Visit the Silver Buzz Cafe Store | | | Tags: Conditions and Diseases, Health Studies, Medication, News for seniors, Senior blog, Senior Health | Category: Ailments, Health Studies, Medications, News, News for Care-Related Professionals, News for seniors, Senior Health | Leave a comment

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Everyone's Guide to Medical Equipment - Part 12 - More Diagnostic Equipment