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    Sunday, May 31, 2009


    We have reviewed antibiotic associated diarrheas [AAD] in a previous article.

    We have also reviewed the bacterial resistance that evolves with the use of antibiotics-especially the resistant C.difficle arising from the (over) use of fluoroquinolones.

    Levaquin (levofloxacin) is an antibiotic that is part of a group of drugs known as fluoroquinolones. Approved by the FDA in December 2006, Levaquin has become one of the more commonly prescribed antibiotics. In 2005, annual sales exceeded $2.3 billion. The use of Levaquin, however, has been associated with an increased risk of tendon ruptures, tendon damage and tendonitis, which has left some users permanently disabled after taking the drug.

    The risk of tendon ruptures has been associated with all fluroquinolone antibiotics, but the risk appears to be greater with Levaquin. According to reports received by the FDA, tendon ruptures, tendon damage and tendonitis accounted for 61% of all fluoroquinolone-associated ruptures between November 1997 and December 2005.A tendon rupture is a very painful injury that often requires surgery to repair the tendon damage. Symptoms associated with a Levaquin induced tendon rupture could include swelling, inflammation or pain.

    The most frequent rupture is the Achilles tendon found in the heel. However, reports have also indicate Levaquin side effects could cause tendon ruptures of the shoulder, biceps, hand and thumb.

    The risk of Levaquin tendon rupture side effects is said to be higher among those who are 60 years of age or older
    In August 2006, the consumer advocacy group Public Citizen filed a petition with the FDA requesting that these stronger warnings be provided, but the drug makers and FDA failed to take steps at that time to warn users.

    In July 2008, the FDA announced that the makers of all fluoroquinolone antibiotics, including Levaquin, will add more prominent language about this risk. In addition, the manufacturers will provide a medication guide which better informs users about the potential side effects of the drugs, and that they should consult with a doctor at the first sign of tendon pain. Meanwhile as with all antibiotics-the rule is do not use unless necessary. Doctors are placed under a lot of pressure by patients for antibiotics to knock out a cold or flu. A cold or viral upper respiratory infection or allergy does not warrant antibiotics. Do not pressure your medical provider to supply antibiotics –especially fluoroquinolones. Take his advice when he tells you antibiotics are not indicated for your “infection,”

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Saturday, May 30, 2009

    Do Doctors Get Disciplined?

    I hear comments all the time that doctors don’t really get disciplined by their peers.

    But, that’s not true. State medical boards across the country took 60 more disciplinary actions against physicians in 2008 than they did in 2007 reports K. B. O'Reilly, [AMNews], and nationwide, there were 5,379 disciplinary actions against physicians in 2008.

    “That increase -- less than 1% -- was not enough, however, to silence critics,” says O’Reilly. These critics argue the medical discipline boards are not doing enough to protect patients from bad doctors.

    There may be some truth to this. An analysis of disciplinary data by Public Citizen, a consumer advocacy group, said "there is considerable evidence that most boards are under-disciplining physicians."

    State medical boards maintain that staffing levels and funding affect a medical board's ability to address complaints against physicians quickly and fairly.” One example Kansas, an 11% budget increase last year helped the state board begin to address a case backlog resulted in more than double the number of disciplinary actions.

    As we’ve seen in another of my articles on this subject only about 5% of doctors are responsible for about 50% of medical malpractice cases in the US. Enough money must be found to fully staff Medical boards to do their job. In the meantime the suggestions from consumer advocacy groups that medical malpractice insurance premiums should be markedly increased for medical malpractice recidivists.

    On another front Physicians can expect to see more information about their malpractice payments, disciplinary actions and other identifying data being made easily accessible online, because Medical boards now push transparency as reported also by AMNews

    More than a decade ago, Massachusetts became the first state to mandate its medical board to post physician profiles online. With the click of a mouse, patients could find a physician's hospital affiliations, hospital and medical board disciplinary actions, medical malpractice payments and other data. Many physicians were skeptical in the beginning. "But it has worked out reasonably well," says the Massachusetts Medical Society.

    "It is an opportunity for patients to step up and see information such as where a physician has received training, whether they are board certified, whether they have malpractice suits against them and whether or not the suit falls in what one might expect in that specialty. A spokesman for the Massachusetts Board of Registration in Medicine, said the program has been a success from the board's perspective as well. There are about 6.5 million visits to the 31,000 physician profiles in a given year.
    65 of the 70 U.S. medical boards post physician profiles online.

    Today, 65 of 70 boards in the United States put physician profiles online, according to the Federation of State Medical Boards. But what is included in those profiles varies. Most states post licensure status and disciplinary history on the Web sites. The more detailed sites, though, include items such as medical malpractice information and criminal convictions, with only 16 and 17 boards, respectively, posting that information.

    It makes online physician profiles an evolving arena, especially as consumers continue to demand more and more about doctors.In many states, before information was posted online, physicians were concerned that patients would not be able to put material such as medical malpractice data into context. As physicians have worked with many state medical boards and legislatures to make sure that the postings were fair, accurate and in context, their earlier fears have not been realized. In South Carolina, the board made disciplinary actions public.

    In New Jersey, the state board's Web site tells a visitor how many malpractice payments the physician has made, how many physicians are in that physician's specialty, and how many physicians in that specialty made malpractice payments in the past five years. It also shows how many total malpractice payments there were in the specialty and whether the physician is below average, average or above average compared with other physicians in the specialty. A report by consumer advocacy group Public Citizen ranked how state boards' Web sites fared in disclosing physician information in eight categories, including board disciplinary action, malpractice data and criminal convictions. The median score for state MD and DO boards was 42.2 of a possible 100. New Jersey scored the highest at 83.7 points.

    The trend toward transparency is expected to continue."People expect transparency," said the CEO of the Washington, D.C.-based Citizen Advocacy Center, which offers training and research for members of health care regulatory, credentialing and governing boards.

    In summary among the 70 state medical boards authorized to regulate allopathic and osteopathic physicians:
    65 have online physician profiles
    62 include licensure information
    56 include disciplinary history
    34 include medical education information
    24 include medical specialty information
    17 include criminal convictions
    16 include information on medical liability cases

    Source: "State of the states: Physician regulation 2007," Federation of State Medical Boards, April 2007 ( 2007 state of states report.pdf)

    Friday, May 29, 2009

    For A Responsible National System Of Balanced, Evidence-Based, And User-Friendly Drug Information

    In a health care system that rewards quantity over quality, rushed clinical encounters with physicians and pharmacists leave too little time to review drug risks and benefits says Jerry Avorn [Communicating Drug Benefits and Risks Effectively: There Must Be a Better Way. Jerry Avorn, MD, and William H. Shrank, MD, MSHS 21 April 2009 | Volume 150 Issue 8 | Pages 563-564]

    This is not to mention a problematic mix of overpromotion, undercommunication, and inadequate regulation which has left many patients bewildered and mistrustful of prescriptions.

    Avorn makes the case that as lay people and physicians increase their demands for coherent, evidence-based, unbiased drug information, we would all be well served by a comprehensive program to replace our current patchwork of bad communication and excessive promotion with a responsible national system of balanced, evidence-based, and user-friendly drug information.

    Neither the package inserts nor the container labels offer as much help as they should says Avorn. Much discussion about drug information for lay people has focused on the package inserts; however, these documents are primarily written for physicians, not patients, and they are rarely inserted in the packages patients actually receive. Another source is the label affixed to the medication bottle. These communicate the name of the pharmacy in large type but vary greatly in their reporting of warnings (3) and instructions (4). When communicating essential safety information, container labels often use a font too small for many patients to read, and they often emphasize information more relevant to the pharmacist than the patient.

    This reappraisal should not stop with evaluating patient-directed materials. Physicians need to learn about benefit and safety data through sources that are more useful than the tiny-print overkill that now constitutes these official documents (12–14). But as the work of Schwartz and colleagues points out, more than reformatting will be needed to create educational materials that guide physicians and patients in the right direction.

    Using a Drug Facts Box to Communicate Drug Benefits and Harms-Two Randomized Trials Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS; and H. Gilbert Welch, MD, MPH 21 April 2009 | Volume 150 Issue 8 | Pages 516-527

    Two randomized, controlled trials were conducted between October 2006 and April 2007 by Lisa M. Schwartz et al. This was a symptom drug box trial using direct-to-consumer ads for a histamine-2 blocker and a proton-pump inhibitor to treat heartburn, and a prevention drug box trial using direct-to-consumer ads for a statin and clopidogrel to prevent cardiovascular events.

    In the symptom drug box trial, 70% of the drug box group and 8% of the control group correctly identified the PPI as being "a lot more effective" than the histamine-2 blocker (P < 0.001), and 80% and 38% correctly recognized that the side effects of the 2 drugs were similar (P < 0.001).

    When asked what they would do if they had bothersome heartburn and could have either drug for free, 68% of the drug box group and 31% of the control group chose the proton-pump inhibitor, the superior drug (P < 0.001).

    In the prevention drug box trial, the drug box improved consumers' knowledge of the benefits and side effects of a statin and clopidogrel. For example, 72% of the drug box group and 9% of the control group correctly quantified the benefit (absolute risk reduction) of the statin (P < 0.001). Most of the control participants overestimated this benefit, and 65% did so by a factor of 10 or more.

    A drug facts box improved U.S. consumers' knowledge of prescription drug benefits and side effects. It resulted in better choices between drugs for current symptoms and corrected the overestimation of benefit in the setting of prevention.

    Thursday, May 28, 2009

    Drug Deals with Medical Insurance Carriers Tie Prices to How Well Patients Do.

    So What’s in it for us?
    Pressed by insurance companies, some drug makers are beginning to adjust what they charge for their drugs, based on how well the medicines improve patients’ health, reports A. Pollack. “Think of it as product guarantees by the drug industry.”

    Traditionally, discounts and rebates that drug companies offer insurers have been based on how much drug is used, not how well patients do. But the emerging, outcomes-based contracts would — in theory — better align the incentives of insurers, drug companies and the employers that provide health coverage toward improving people’s health. Johnson & Johnson set what is considered the prototype deal in 2007 with Britain’s national health system, which had tentatively decided not to pay for the cancer drug Velcade. To avert that decision, the company offered essentially a money-back guarantee. If Velcade did not shrink a patient’s tumors after a trial treatment, the company would reimburse the health system for the cost of that patient’s drug.

    In a current deal Merck will agree to peg what the insurer Cigna pays for the diabetes drugs Januvia and Janumet to how well Type 2 diabetes patients are able to control their blood sugar. Also the two companies that jointly sell the osteoporosis drug Actonel agreed to reimburse the insurer Health Alliance for the costs of treating fractures suffered by patients taking that medicine. “We’re standing behind our product,” said Dan Hecht, general manager of the North American pharmaceutical business of Procter & Gamble, which sells Actonel with Sanofi-Aventis. “We’re willing to put our money where our mouth is.” Under the Actonel deal, if a patient insured by Health Alliance suffers a nonspinal fracture despite faithfully taking Actonel, the drug makers will help pay for the medical care — spending $30,000 for a hip fracture, for instance, and $6,000 for a wrist fracture.

    This clearly lowers the cost of the drug to Health Alliance, a small insurer in Illinois and Iowa. But Procter & Gamble and Sanofi-Aventis might benefit as well. The deal could reduce the pressure on the insurance company to move patients off Actonel, which costs about $100 a month, to less-expensive generic versions of Fosamax. And the insurer has kept Actonel in a tier of its drug list that requires a smaller co-payment than for a competing brand-name drug, Boniva.

    Some experts hail such arrangements as a welcome step toward health care that rewards good outcomes for patients. “We’re going to see a growth in outcomes guarantees for pharmaceuticals, and it’s very healthy,” said Robert Seidman, a consultant who was formerly the chief pharmacy officer for WellPoint, an insurance company.

    Such contracts started to take hold a few years ago in countries with national health systems, in which the government could effectively block a drug from being used if it was too costly. In the United States, where insurance companies do not have national monopolies — and where Medicare, by law, is precluded from negotiating drug prices — insurers have less leverage with drug makers. Even so, they can give favorable treatment to certain drugs, by reducing the required co-payments, for example.
    The deal between Cigna and Merck is more complex.

    Rather than getting paid more for good results, Merck will actually give Cigna bigger discounts on Januvia and Janumet. Some discounts will be granted if more people diligently take the drugs as prescribed. This helps both Cigna, because people who take their pills are likely to have fewer complications from the disease, and Merck, because it sells more pills. The assumption is that Cigna will push for patient-compliance programs that urge people to take their medicine at the right times and in the proper doses.

    Moreover, in an unusual move, Merck will offer even greater discounts to Cigna on Januvia and Janumet if patients’ blood sugar is better controlled — regardless of whether the improvement comes through Merck’s drugs or other medications. In effect, though, Merck is betting not only that its drugs prove superior but that Cigna’s incentives to reap the benefits of the deeper Januvia and Janumet discounts will prompt the insurer to try to keep patients on those drugs. Januvia, approved in 2006, costs about $150 a month. Janumet, approved a year later, is a combination of Januvia and metformin, a widely used generic drug.

    As part of the agreement, too, Merck will get better placement for Januvia and Janumet on Cigna’s formulary, meaning a lower co-payment for patients than for some other branded drugs. The deal was made with the pharmacy benefit management division of Cigna, which manages prescriptions for 7.1 million people.

    So what’s in it for us patients?
    If this does not translate to our pocketbooks there will be problems.
    We’ll wait and see if and how much this will save we patients.

    Wednesday, May 27, 2009

    Ultrasound Alternative To Mammograms

    Radiologists can now suspend a patient's breast in water, and then send sound waves through the water in order to image breast tissue. The device uses 256 ultrasonic sensors to assemble 50 to 70 two dimensional slices into a three dimensional image of the breast that reveals cancers larger than five millimeters in diameter.

    Each year more than 18-million women get a mammogram. But up to 15% of mammograms miss tell-tale signs of cancer. Now, a new technology that may be better at finding cancer and saving lives could be available.

    So far it's been able to see almost all the cancers that are above five millimeters.
    Developed by physicists and radiologists, the new technology, called computed ultrasound risk evaluation device -- or CURE -- does not use radiation, lasts one minute and is pain-free. While the woman's breast is suspended in water, ultrasound sensors transmit sound waves through the water. The device measures how the sound waves travel through the breast tissue. Computer images help doctors better pinpoint cancerous tissue.
    "Based on the more limited trials it remains to be proven that it is more accurate than mammography.


    Ultrasound is a medical imaging technique that uses high-frequency sound waves and their echoes. It is similar to how bats navigate in the dark, and the SONAR used by submarines underwater. The machine transmits high-frequency sound pulses into the body using a probe. The sound waves travel through the body and bounce off any boundaries, such as between fluid and soft tissue, tissue and bone. Some of the sound waves are reflected back to the probe, while others travel further through until they bounce off another boundary. All the reflected waves are recorded by the machine, which then calculates the distance each sound wave traveled based on how long it took the sound wave's echo to return. This data is used to form a two-dimensional image based on the distances and intensities of those echoes.

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Tuesday, May 26, 2009


    This “Swine Flu epidemic has so far been milder than originally expected –at least it has receded from the headlines. Still, by Friday, 5/22/09 the New York Times reported 12,022 cases of swine flu, including 86 deaths, had been reported to the World Health Organization from 43 countries. More than half of the cases were from the United States. Of the deaths, 75 were reported by Mexico.

    Health officials continued to stress that anyone with underlying health conditions — like diabetes, asthma, emphysema or a compromised immune system — who is exposed to flu should seek medical attention.

    But an "odd feature" of this H1N1 virus is — about one third of infected patients at two Mexican hospitals did not have fever when screened. Given that, many experts consider fever "the most important sign of the disease, its absence could increase the difficulty of identifying and controlling the epidemic,” say experts.
    Moreover, the MMWR Dispatch advises pregnant women "in close contact" with those who have confirmed, probable, or suspected swine-origin influenza A (H1N1) infection should receive a 10-day course of zanamivir or oseltamivir, according to an MMWR Dispatch report on three pregnant women with H1N1, one of whom died. The report recommends that pregnant women with confirmed, probable, or suspected disease should receive antivirals for 5 days. Oseltamivir is "normally not recommended for use during pregnancy," according to its label, but the CDC says the drug is the preferred treatment for pregnant women during this outbreak. Oseltamivir should be started within 48 hours of symptom onset.


    Adverse pregnancy outcomes have been reported following previous influenza pandemics, with increased rates of spontaneous abortion and preterm birth reported, especially among women with pneumonia. Case reports and several epidemiologic studies conducted during inter-pandemic periods also indicate that pregnancy increases the risk for influenza complications for the mother and might increase the risk for adverse perinatal outcomes or delivery complications.

    The currently circulating novel influenza A (H1N1) virus is sensitive to the neuraminidase inhibitor antiviral medications zanamivir (Relenza®) and oseltamivir (Tamiflu®), but is resistant to the adamantane antiviral medications, amantadine (Symmetrel®) and rimantadine (Flumadine®).


    Pregnancy should not be considered a contraindication to oseltamivir or zanamivir use.

    Recommendations for use of antivirals for pregnant women might change as data on antiviral susceptibilities become available. Nevertheless, as of now pregnant women who meet current case-definitions --should receive empiric antiviral treatment.
    • Pregnant women who are close contacts with persons with suspected, probable, or confirmed cases of novel influenza A (H1N1) should receive chemoprophylaxis.
    • Recommended duration of treatment is five days, and for chemoprophylaxis is 10 days.
    • Oseltamivir and zanamivir treatment and chemoprophylaxis regimens recommended for pregnant women are the same as those recommended for adults who have seasonal influenza.


    Antiviral medication treatment or prophylaxis is not a contraindication for breastfeeding.
    • Infants who are not breastfeeding are particularly vulnerable to infection and hospitalization for severe respiratory illness.
    • Women who deliver should be encouraged to initiate breastfeeding early and feed frequently.
    • Ideally, babies should receive most of their nutrition from breast milk.
    • Eliminate unnecessary formula supplementation, so the infant can receive as much maternal antibodies as possible.

    If a woman is ill, she should continue breastfeeding and increase feeding frequency. If maternal illness prevents safe feeding at the breast, but she can still pump, encourage her to do so. The risk for novel influenza A (H1N1) transmission through breast milk is unknown. However, reports of viremia with seasonal influenza infection are rare. Expressed milk should be used for infants too ill to feed at the breast.

    In certain situations, infants may be able to use donor human milk from a HMBANA-certified milk bank.

    Instruct parent and caretakers on how to protect their infant from the spread of germs that cause respiratory illnesses like novel influenza A (H1N1):
    • Wash adults and infants’ hands frequently with soap and water, especially after infants place their hands in their mouths.
    • Keep infants and mothers as close together as possible and encourage early and frequent skin-to-skin contact between mothers and their infants.
    • Limit sharing of toys and other items that have been in infants' mouths. Wash thoroughly with soap and water any items that have been in infants' mouths.
    • Keep pacifiers (including the pacifier ring/handle) and other items out of adults' or other infants' mouths prior to giving to the infant.
    • Practice cough and sneeze etiquette.

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Monday, May 25, 2009

    Could Doctors Today Have Saved Lincoln's Life?

    Could Doctors Today Have Saved Lincoln's Life?
    Memorial Day is a United States federal holiday observed on the last Monday of May (May 25 in 2009). Formerly known as Decoration Day, it commemorates U.S. men and women who died while in the military service. First enacted to honor Union soldiers of the Civil War (it is celebrated near the day of reunification after the civil war), it was expanded after World War I to include American casualties of any war or military action. Memorial Day, prior to the rest of the wars, was a day celebrated by Civil War veterans as a day special for them.

    The most important casualty of the Civil War was Abraham Lincoln.On April 14, 1865, Lincoln was shot in the back of the head by John Wilkes Booth at Ford's Theatre in Washington, D.C. The bullet from Booth's derringer stopped behind Lincoln's left eye. Army assistant surgeon Charles Leale, who was at the theater, cared for Lincoln and found a blood clot at the back of the president's head.

    Physicians used brain decompression, but within 10 hours, Lincoln was dead.

    "The state of the art that they offered him was brandy, water and probing the wound," said a physician who reviewed medical records from Lincoln's physicians.

    He added that Lincoln's frontal lobes were spared, preserving sections that handle emotions, language and problem-solving. Thus with rehabilitation, the president would have improved and may have been able to communicate.

    If the shooting happened now, Lincoln would be airlifted to a trauma center for a CT scan and medications to reduce effects of brain swelling.

    Surgery would be done to lessen pressure and remove accumulated blood.

    Doctors also would work to prevent additional brain damage.

    But Lincoln would have had a difficult time returning to a normal presidency."If Lincoln had survived, he would have been in such bad shape, says one doctor, that there would have been a long, long rehabilitation."

    At the time, it should be noted; there was no provision for replacing a disabled president. It wasn't until 1967 that the 25th Amendment was ratified to address transfer of power from the president.

    He would have had a long recovery and would have had to endure a long rehabilitation while in office to regain some of his abilities. Experts say Lincoln would be left with residual dyslexia and vision problems.

    Could crucial post Civil War America survived the long rehabilitative period without a strong hand at the helm?


    But look what they got instead.

    Sunday, May 24, 2009


    CT scans is associated with significant radiation exposure in some patients; the risks should be considered carefully when imaging for chronic disease and when screening asymptomatic individuals .It is estimated that 1.5-2.0% of US population cancers may be caused by CT radiation exposure. A retrospective, cohort study at a tertiary academic medical center identified 31,462 patients undergoing diagnostic CT during 2007; and 190,712 CTs over 22 years. Estimated lifetime attributable risk (LAR) for cancer was calculated. In this cohort, baseline cancer rates predicted 13,214 cancers and 6,292 fatal cancers; 98 additional cancers (62 fatal) were predicted from CT.

    “Recurrent CT, Cumulative Radiation Exposure and Associated Radiation-Induced Cancer Risks from CT of Adults” by Sodickson A et al. Radiology 2009;251:175-184 Colonoscopy Prevents 15,000 Cancer Cases

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Saturday, May 23, 2009

    Should End Of Life Patients Smoke?

    I’m in complete sympathy with Peter A. Ubell, MD ,director of the Center for Behavioral and Decision Sciences in Medicine at the University of Michigan who writes that “Eighteen years out of training, and I still find myself struggling to understand the moral imperatives of medical practice.”

    “Not long ago,” he relates, “as part of my hospital duties, I cared for a man who could no longer swallow. This dysphagia was his only medical complaint, one that had sneaked up on him over the course of a month. He simply couldn’t find the muscular strength to propel food and liquid down to his stomach. After some investigation, the medical team discovered he had metastatic lung cancer. That explained the dysphagia: cancer had stimulated his immune system to attack his swallowing muscles.

    While the cancer was incurable, we hoped we could slow its progression and give him a few extra months of life — small solace for a man in his mid-50s with a loving wife and several children ready to start new families, but the best we could offer. On rounds the morning after he received a feeding tube, I stopped by to see how he was doing — checking his abdomen for signs of infection and, more important, assessing his fragile mood. I tried to keep things upbeat, making small talk while examining his belly. But something about his response, and the look he gave his wife, was troubling.

    I looked up and asked him how he was feeling, keeping purposely vague about whether I was posing a medical, or a social question. His wife replied— angrily. She lashed out at her husband for having sneaked off that morning for a cigarette. He glared back and told her to mind her own business. She looked toward me for support — I was the physician, after all — and I found myself in a common medical quandary.

    According to this new paradigm of preference-sensitive decision-making, doctors like me shouldn’t tell patients what to do (Take your pills! Stop smoking!), but rather should educate our patients about the risks and benefits of their options. So going by the book, I should have informed my patient about the pros and cons of tobacco. But I couldn’t stand by, in the role of a dispassionate educator, and let this man hurt himself. Instead, I felt compelled to give him advice that would promote his best interests.

    I advised him to smoke. Then I turned to his wife. “I know that you are trying to keep your husband from smoking because you love him and don’t want him to get sicker, but those cigarettes aren’t going to hurt him now. If anything, they’ll help him relax.”

    Medical decisions these days are increasingly recognized as being more than simply medical, with the right choice depending in part on the patient’s preferences. My duty as a physician, says Ubell is to improve my patients’ lives. And if I can do that by sharing my perspective with them, however strange or uncomfortable it may sound, then that is what I must do. Even if it means encouraging them to smoke.

    This anecdote brought me back a few decades when my father was also at his end of life. He was in his room at Johns Hopkins Hospital for several weeks suffering from Chronic Obstructive Lung Disease [COPD]-after a lifetime of cigarette smoking-Lucky Strikes, unfiltered to keep the taste strong. Every breath was an effort. But he managed to breathe “better” while smoking, he said.

    I was a resident physician at the hospital which made it easier to visit with him 3-4 times per day. Oxygen tanks for his oxygen treatments every 2 hours were in his room- so smoking and matches in his hospital room were out of the question.

    My father understood this.

    So when no one was looking-or he thought no one was looking-- he wheeled his chair into the visitors lounge. His engaging good nature always managed to get him a cigarette- from either a patient or guest. Today smoking is banned in offices and workplaces and even banned in many bars but those were the days when smoking was not banned even from hospitals.

    He smoked in the hospital visitors’ lounge-but quickly put it out and hid it when nurses were close. One nurse whispered to me about his secret violations of the medical regimen and insisted that I stop his smoking or she would tell his pulmonologist who happened to be my boss.

    What was I to do? Smoking is contra-indicated in everybody-especially those ravaged by the terrible effects of tobacco in the lungs. But was cessation of smoking now going to help him after 50 years of the habit resulting in death approaching in weeks if not days?

    My duty as a physician is to improve patients’ lives. Moreover, like Ubell strange as it may sound, even if it means enabling them to smoke.

    I made the same decision. In fact, I aided and abetted him by getting him an occasional cigarette and wheeling him to the outside deck of the Marburg floor where he could privately smoke in peace in the early Baltimore Spring.

    He understood and was grateful. His eyes told me even though he would not say it for fear of incriminating me in the crime.

    His pulmonologist also understood. He never mentioned anything about it to me.

    My father died later that spring.

    Friday, May 22, 2009

    Going to Starbucks for an enema?

    Can Colon Cleansing with Coffee and Other Colon "Detoxification" Methods Leads To Better Health?

    You have heard the claims--that regular colon or liver cleansing and other methods of “detoxification gets rid of auto-intoxication in our body.

    Claims are that it rids us of pollutants, aids in weight loss, prevents cancer, causes a beautiful skin, fosters potency, strengthens the immune system, reduces stress, improves circulation, improves sleep, enhances mental focus, relieves headaches and arthritis pain, as well as provides relief from indigestion, diarrhea, constipation, weight loss, body odor, Candida, acne, mucus colitis, gas, food cravings, fatigue, obesity, Diverticulosis, bad breath, parasitic infections, premenstrual syndrome and whatever else.

    What is Autointoxication?

    Autointoxication is an ancient theory based on the belief that intestinal waste products can poison the body and are a major contributor to many, if not all, diseases.

    Ancient Egyptians associated feces with decay and used enemas and laxatives liberally. In more recent times, this concern has been embodied in the concept of "autointoxication" and has been promoted by warnings against "irregularity." The theory of "autointoxication" states that stagnation of the large intestine (colon) causes toxins to form that are absorbed and poison the body.

    Some proponents of colon cleansing depict the large intestine as a "sewage system" that becomes a "cesspool" if neglected. Other proponents state that constipation causes hardened feces to accumulate for months (or even years) on the walls of the large intestine and block it from absorbing or eliminating properly. This, they say, causes food to remain undigested and wastes from the blood to be reabsorbed by the body.

    In the 19th century, it was the ruling doctrine of medicine and led "colonic quackery" in various guises. By the turn of the 20th century, it had received some apparent backing from science. When it became clear that the scientific rationale was wrong and colonic irrigation was not merely useless but potentially dangerous, it was exposed as quackery and subsequently went into a decline.

    Today we are witnessing a resurgence of colonic irrigation based on little less than the old bogus claims and the impressive power of vested interests.

    Even today's experts on colonic irrigation can only provide theories and anecdotes in its support. It seems, therefore, that ignorance is celebrating a triumph over science.

    Colonic irrigation is performed by passing a rubber tube through the rectum.

    Some proponents have advocated that the tube be inserted as much as 30 inches. Warm water—often 20 gallons or more—is pumped in and out through the tube, a few pints at a time, to wash out the contents of the large intestine. (An ordinary enema uses about a quart of fluid.)
    Some practitioners add herbs, coffee, enzymes, wheat or grass extract, or other substances to the enema solution.

    Colonic irrigation, which can be expensive, has considerable potential for harm.

    The process can be very uncomfortable, since the presence of the tube can induce severe cramps and pain. If the equipment is not adequately sterilized between treatments, disease germs from one person's large intestine can be transmitted to others. Several outbreaks of serious infections have been reported, including one in which contaminated equipment caused amebiasis in 36 people, some of whom died following bowel perforation.

    There are also claims of detoxification through special footpads. But when held over a pot of boiling water the steam caused the pad to turn black, indicating that the dark color that results from wearing a pad is caused not by toxins attracted to the pad but by a chemical in the pad that reacts to moisture. Sweat glands in the feet can excrete water and some dissolved substances. However, its minor role in ridding the body of unwanted substances is not changed by applying footpads. All such products should be regarded as fakes, and the proposed mechanisms should be regarded as nonsensical.

    Colon cleansing is based on the same theory --that your body accumulates harmful toxins such as metals, pesticides, bad bacteria, bad whatever, etc. Without any real medical evidence except personal anecdotes proponents believe special treatments including herbals or supplements given orally or as enemas, or special diets are needed to remove these toxins from the body. There is NO proof to support any of these theories...or that any special product or method will rid the body of toxins.

    How about Coffee enemas?

    Three deaths have been recorded associated with the use of coffee enemas from electrolyte imbalances and septicemia as reported by. Eisele JW, Reay DT. Deaths related to coffee enemas. JAMA 1980;244:1608; Ernst E. Colonic irrigation and the theory of autointoxication: A triumph of ignorance over science. J Clin Gastroenterol 1997;24:196.; Margolin KA, Green MR. Polymicrobial enteric septicemia from coffee enemas. West J Med 1984;140:460.

    The Facts

    Real detoxification of foreign substances takes place in the liver, which modifies their chemical structure so they can be excreted by the kidneys, which filter them from the blood into the urine.

    The truth is that our kidneys and liver are very efficient at filtering and eliminating toxins from the body. There are dangers associated with some of the practices that are being promoted especially those detoxification programs, which include laxatives. These laxatives can cause significant diarrhea, which then results in body fluid losses and electrolyte imbalances. Some laxatives can even worsen heart failure or cause kidney failure in people at risk. Other risks of enemas or colonics in addition to causing electrolyte imbalances can also cause a perforated rectum.

    One other caveat is that you must guard against strong colon cleansing agents. Acute phosphate nephropathy and renal failure have been reported associated with the use of oral sodium phosphate bowel cleansing products especially in the middle age and elderly people.

    The healthy way is to stick to standard measures...a good diet, regular exercise, using bulking agents (psyllium, etc) to stay regular if needed.

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Thursday, May 21, 2009


    The most appropriate management of a healthy patient with Barrett’s esophagus is nothing --except for regular monitoring by endoscopy.
    When and if nodularity or ulceration is discovered in a segment of Barrett’s esophagus, additional targeted biopsies should be obtained due to heightened suspicion for dysplasia or cancer.
    The most appropriate management of verified high-grade dysplasia within a nodule is surgical referral, in line with American College of Gastroenterology guidelines. Although the management of expert-verified, high-grade dysplasia (HGD) remains somewhat controversial -- in a relatively young, healthy patient with long-segment Barrett’s esophagus, surgical resection remains the only modality that ensures complete removal of all dysplastic tissue and provides definitive confirmation of the diagnosis (and absence of invasive cancer).
    In addition, the entire Barrett’s segment would theoretically be excised, eliminating potential future neoplastic risk.

    Other Options:

    Endoscopic mucosal resection (EMR) is a reasonable option but should still be considered experimental at this time and reserved for clinical trials, patients at high surgical risk, or for those who decline surgery.
    The long Barrett’s segment would remain and continue to require intensive surveillance.
    Similarly, photodynamic therapy, argon plasma coagulation, and Nd:YAG laser photoablation would all provide the potential for ablation of the nodular lesion, as well as mucosal reversal of the Barrett’s segment.
    But these options would not provide deep-tissue sampling for confirmation of the diagnosis and could leave “buried glands” under the reversed segment.
    As with EMR, these modalities should be reserved for research protocols and high risk patients.

    1. Sampliner, R. Updated guidelines for the diagnosis, surveillance, and therapy of Barrett's esophagus. Am J Gastroenterol. 2002;97:1888.
    2. Soetikno, R, Gotoda, T, Nakanishi, Y, et al. Endoscopic mucosal resection. Gastrointest Endosc. 2003;57:567.
    3. Scotiniotis, I, Kochman, M, Lewis J, et al. Accuracy of EUS in the evaluation of Barrett's esophagus and high-grade dysplasia or intramucosal carcinoma. Gastrointest Endosc. 2001;54:689.
    4. Collard, J. High-grade dysplasia in Barrett's esophagus. The case for esophagectomy. Chest Surg Clin N Am. 2002;12:77.

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Wednesday, May 20, 2009

    Plavix, Heartburn Drugs May Be Risky Combination

    Patients with coronary artery stents should discuss the use of these meds with their doctor

    Proton-pump inhibitors ( PPIs) are medications used for heartburn. These medications include esomeprazole (Nexium, AstraZeneca), omeprazole, pantoprazole (Protonix, Wyeth), lansoprazole, or rabeprazole (Aciphex, Eisai/Ortho-McNeil-Janssen Pharmaceuticals). Plavix anti-platelet therapy is given to patients to prevent clots especially those who have a history of or tendency for strokes or after getting a stent for coronary artery disease.

    So the combination of both Plavix and a PPI up to now has been relatively common.

    Recent studies, however, show that one-year risk of cardiovascular events is increased more than 50% in patients taking a proton-pump inhibitor (PPI) on top of clopidogrel, as compared with patients not taking a PPI.

    In addition, the risk seems to be a class effect for all the PPI medications, according to this latest retrospective cohort study of more than 16,700 patients who received clopidogrel post-stenting for coronary artery disease. Professional society guidelines recommend the use of PPIs to treat and prevent gastrointestinal ulcers and bleeding in patients on antiplatelet therapy. However, increasing use of PPIs in this setting has raised questions as to whether PPIs may attenuate clopidogrel's antiplatelet response by interfering with CYP2C19-mediated clopidogrel metabolism. This means that the same enzyme in the liver metabolizes both Plavix and PPIs. Therefore, the addition of a PPI can spur a less active form of Plavix to be produced, reducing its beneficial effects.

    This new data the results of the Clopidogrel Medco Outcomes study was presented May 6, 2009 as a late-breaking clinical trial during the first day of the Society for Cardiovascular Angiography and Interventions (SCAI) 2009 Scientific Sessions. The study compared major adverse cardiovascular events (MACE).

    Higher MACE [major adverse cardiovascular events] occur with PPIs

    One study showed that this combination is associated with a 70 percent increased risk of heart attack, a 48 percent increased risk of stroke and a 35 percent increased risk for the need for repeat coronary procedures. The overall incidence of major adverse cardiovascular events was 51 percent higher in those taking Plavix and a PPI than in those taking Plavix alone.

    In this latest study, one-year risk of MACE was significantly higher in PPI-treated subjects, at 25.1%, as compared with patients who did not take a PPI, at 17.9%. They also looked at the CV risk associated with individual PPIs, restricting their analysis to PPIs with sufficient patient numbers to detect a difference in risk similar to that seen in the overall population, with adequate statistical power. Don’t be fooled by those who claim rabeprazole is safer than all the other PPIs. Due to low numbers, rabeprazole, taken by just 298 patients, could not be addressed in this analysis, however, each of the PPIs, individually, was associated with a higher risk of major cardiovascular events vs no PPI use, ranging from a 24.3% increased risk with lansoprazole to a 29.2% risk with pantoprazole.

    While this particular study is the largest to date to address the question of a PPI-clopidogrel interaction, two other, smaller studies have found disparate results.
    Of note, hospitalization rates for upper-GI bleeding were low across all groups of PPI use, in the range of 1.1%. Also of interest, investigators looked at PPI use among patients who were not treated with clopidogrel and found no increased risk of CV events in this group, as compared with patients taking neither a PPI nor clopidogrel.

    These results provide further support for the hypothesis that PPIs attenuate the effects of clopidogrel. Considering all available evidence, PPI use should be limited to situations clearly indicated in patients on clopidogrel after coronary stenting.

    Considering all the available evidence, PPI use should be limited in patients taking clopidogrel, based on the physician's judgment.

    Physicians need to do a better job of discriminating between patients who are just at risk of GI symptoms or who may have had previous GI disease and patients who actually have current GI problems. It is the latter group in whom concomitant PIs are likely to be useful. Physicians are urged to take the time to discuss the risks and benefits with patients and to emphasize that patients should not because stop clopidogrel therapy if so prescribed by your doctor.

    Concomitant H2-receptor-antagonist therapy showed no effects of these other ant heartburn agents on CV events. In an analysis of 9862 patients taking clopidogrel, but not a PPI, 472 received an H2 blocker, while 9390 did not. The incidence of cardiovascular events was 20.3% for patients taking H2 blockers and 17.8% in patient not taking these agents, a statistically nonsignificant difference.

    Given the thousands of patients who receive stents each year, coupled with the significant risks demonstrated in this study, it might be better to use alternative medications for GI symptoms in patients with stents when appropriate. These alternative heartburn medications include histamine (H2) blockers (Zantac [ranitidine, Boehringer Ingelheim], Tagamet [cimetidine, GlaxoSmithKline]) or antacids. In those patients when the use of PPIs may still be warranted, based on the patient's medical problems, it should be taken at the direction of the patient's cardiologist, gastroenterologist, or primary physician and closely monitored.

    • Platelet-function test finds fault with omeprazole/clopidogrel combo, but not with other PPIs
    [Acute Coronary Syndromes > Acute coronary syndromes; Apr 10, 2009]
    • More data support adverse clopidogrel and proton-pump inhibitor interaction
    [Acute Coronary Syndromes > Acute coronary syndromes; Mar 03, 2009]
    • Increased risk of reinfarction with clopidogrel and proton-pump inhibitors
    [Acute Coronary Syndromes > Acute coronary syndromes; Jan 29, 2009]
    • FDA continuing to study effectiveness of clopidogrel
    [Acute Coronary Syndromes > Acute coronary syndromes; Jan 26, 2009]
    • Omeprazole reduces antiplatelet effect of clopidogrel?
    [Clinical cardiology > Clinical cardiology; Jan 14, 2008]

    Tuesday, May 19, 2009

    Part II of II: GERD- Heartburn of Pregnancy

    Part II of II.

    Gastro-esophageal reflux is the phrase used to describe the backward flow or regurgitation of stomach contents passing up into the esophagus. The typical symptom of GERD is a burning discomfort behind the breast bone. Some describe heartburn as indigestion, a "sour" stomach, pain in the upper abdomen or chest, regurgitation of food or bitter liquid into the mouth or excessive production of saliva. GERD is a common condition and symptoms of heartburn are experienced at least once a month by more than 60 million Americans.

    For women, the first experience with heartburn is often during pregnancy. Studies suggest that over 50% of pregnant women will experience heartburn during pregnancy. This is due to hormones of pregnancy and pressure from the growing fetus. Symptoms of heartburn resolve in most of these women after delivery of the baby.

    What causes GERD?
    Acid is produced in the stomach every day. Normally, a small amount of acid passes into the esophagus through a valve between the esophagus and stomach called the lower esophageal sphincter. When the frequency or amount of acid in contact with your esophagus increases, symptoms and damage to your esophagus can occur.

    What are the stimuli of heartburn?
    Eating a large, especially fatty meal
    Tomato sauces (spaghetti & pizza)
    Lying down after a meal
    Chocolate, peppermint
    Coffee and tea
    Alcohol and carbonated beverages
    Some muscle relaxers and blood pressure medicines
    Excess weight
    Eat more frequent, but smaller meals

    What to avoid?
    fatty food, coffee & tea, chocolate, peppermint, alcohol, smoking, carbonated beverages.

    What to do?
    Maintain a normal weight
    Avoid eating 2-3 hrs before bedtime
    Elevate the head of the bed 4-6 inches
    Don’t lie down after eating

    What medications are effective in relieving symptoms?
    (liquid or tablets):
    Tums®, Rolaids®, Mylanta®, Maalox®, Gaviscon®, and many others.

    OTC Acid Blockers:
    Pepcid AC® , Tagamet HB® , Zantac AC® ., Prilosec OTC®
    *Important Note: If you are pregnant or nursing a baby, seek the advice of a doctor before using OTC acid blockers.

    Proton Pump Inhibitors:
    esomeprazole, Nexium®; or
    lansoprazole, Prevacid®; or
    pentaprazole, Protonix®; or
    rabeprazole, Aciphex®;

    Pro-motility Drugs:
    cisapride, Propulsid®

    Prescription Strength Antacids:
    sucralfate, Carafate®

    Prescription Strength H2 Blockers:
    cimetidine, Tagamet® , ranitidine, Zantac® , famotidine, Pepcid® , nizatadine, Axid®

    When should you see a doctor about symptoms of heartburn?

    If you have any of the following:
    Symptoms of heartburn two or more times a week
    Don’t get lasting relief on medication you are taking
    Difficulty swallowing, especially solids
    Choking, wheezing, hoarseness caused by regurgitation of acid into the throat
    Signs of bleeding (vomiting dark coffee ground-like material or passage of tarry black bowel movements)
    Unexplained weight loss
    Reflux symptoms over more than one year

    What treatments for heartburn are safe during pregnancy?
    During pregnancy, the medical treatment of reflux should be balanced to alleviate the mother’s symptoms of heartburn, while protecting the developing fetus.

    Step 1: Modification of diet & lifestyle

    Step 2: Antacids are probably safe.

    Sodium bicarbonate can cause a condition known as metabolic acidosis and should be avoided during pregnancy. Magnesium containing antacids may interfere with uterine contractions during labor and should be avoided during the last trimester of pregnancy.

    Step 3: sucralfate (Carafate®) has a good record for safety and results with pregnant patients. Acid blockers can probably be administered safely, but require a doctor’s supervision.

    Step 4: Other medical therapy should only be used when the benefit of the medicine for the mother outweighs the risk of the medicine to the developing fetus.

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Monday, May 18, 2009

    Is it Heartburn or a Heart Attack?

    Part I of II :GERD

    The experts say “It doesn’t often begins as a sharp, burning sensation in the chest. Many times it seems either like a pressure or burning or indigestion in the chest.”

    Is the pain heartburn, or might it be a heart attack?

    It's often difficult for people to tell the difference. Complicating the issue is that some people with diagnosed heart disease will also have heartburn, Those are the patients who want to say, 'Oh, this is just heartburn' and not worry about it. If, however, you have any heart history, a cardiologist should be consulted.

    But even people without known heart disease who have heartburn shouldn't always just pop an over-the-counter antacid either. Overreacting in seeking medical help is always better than under-reacting.

    In the common variety heartburn, or GERD [ gastro-esophageal reflux disorder] stomach acid moves up into the esophagus and causes irritation. It might require a doctor's intervention, to rule out that what a person is feeling stems from heartburn and not heart problems, which can have similar symptoms.

    So what's a person to do?

    Pay attention to the pattern of heartburn. If people have heartburn on a regular basis after eating specific foods -- every time they eat a greasy pepperoni pizza or drink a large glass of orange juice, for instance -- the food is generally the origin of the symptoms. If, however, if they start having “heartburn” and have not eaten any of the food or drinks that previously triggered a heartburn episode. That would merit a call for medical help.

    Pay attention to when the heartburn occurs. If the heartburn follows consumption of a specific food, it's probably run-of-the-mill heartburn, which when it becomes severe will need prompt medical attention.

    See a doctor if heartburn is severe and begins to affect quality of life. A medical visit in such an instance, though, would not be as urgently needed as it would be for those with pain and swallowing problems along with heartburn.

    If heartburn is a new experience, have it checked out asap. That needs to be evaluated pretty quickly because people with first-time heartburn and risk factors for heart disease -- including high blood pressure, high cholesterol, diabetes, a family history of heart problems and active cigarette smoking -- should seek prompt medical help.

    Other “red flag” reasons to quickly talk to a doctor or go to the emergency room.

    • If heartburn accompanies exercise or other exertion.

    • If a severe episode of heartburn does not get better with antacids. Garden-variety heartburn should subside fairly quickly. An episode might last up to a few hours, and then disappear in varying lengths of time, depending on the type of remedy used to combat it. "If you take an antacid, their effect is usually immediate," "If you take an H-2 blocker [such as Zantac or Tagamet], it may be 30 minutes.

    • If heartburn comes with other symptoms, such as shortness of breath or arm pain.

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Sunday, May 17, 2009


    Am I dreaming? Is this surreal?

    Because "Cheerios is a food not a drug," the claims that it "lowers cholesterol and reduces the risk of heart disease and cancer violates federal law," says the FDA in a letter to General Mills.

    The FDA appears to have just wakened to the fact that Cheerios’ cholesterol-lowering claim has been featured on the Cheerios box for more than two years and the heart health claim was approved by the FDA 12 years ago. "The science is not in question, admits the FDA. "The scientific body of evidence supporting the heart health claim was the basis for FDA's approval of the heart health claim, and the clinical study supporting Cheerios' cholesterol-lowering benefits is very strong,"

    “But,” says the FDA “Cheerios marketing of health benefits fails to include language the FDA requires about other foods that help reduce risks. According to the agency the information on the box leaves out any reference to fruits, vegetables, and fiber,” the FDA letter said. The FDA states that while the agency allows a health claim linking soluble fiber from whole grain oats to a reduced risk of heart disease by means of lowering cholesterol, Cheerios boxes have cholesterol as a prominent, stand-alone claim, the FDA pointed out in its 5/5/09 letter.

    “Your claim does not convey that all these factors together help to reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of the total daily diet.” "[Therefore] based on claims made on your product's label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug," the FDA said in a letter to General Mills which was posted on the federal agency's website.

    This is the first attack against a “mainstream food product” in more than nine years and showed the agency is exerting its new authority under a new President Barack Obama.

    Thus the advertising by Cheerios on its box [that gives me such happy reassurance at breakfast about lowering cholesterol] don't "convey that it’s not just soluble fiber but all these factors together [ i.e. fruits and vegetables] help to reduce the risk of heart disease."
    It does not "enable the public to understand the significance of the claim in the context of the total daily diet,” says the FDA. For instance, recommends the FDA “a company should say on its box that “a diet low in saturated fat and high in fiber-rich foods such as fruit, vegetables and whole grains may reduce the risk of heart disease.”

    What’s more says the FDA, the claim about lowering cholesterol "qualifies Cheerios under US regulations as an unapproved new drug."

    In its warning letter, the FDA said that unless the cereal maker takes action to "correct the violations" on its labels, "boxes of Cheerios could disappear from supermarket and wholesaler shelves around the United States and the company could face legal action." Thus, claims that the 68-year-old whole-grain oat cereal lowers cholesterol and reduces the risk of heart disease and cancer violates federal law, the agency said. As a result General Mills faces seizure of products or an injunction against making and distributing Cheerios.

    HELLO! Do you think that maybe the FDA is going too far? Does the FDA think we’re all idiots?

    The FDA is threatening to consider Cheerios as a new drug because it has not been "recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease." That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.

    I hope this is not a sign of worse things to come. I don’t know what I’d do if I had to obtain a prescription on my next doctor’s visit to get my favorite cereal. This would more than double the price of a box of cereal.

    And what about the reassuring reading on the box? Does that mean I’ll have to mix some spinach and broccoli over the cereal before I pour the milk?

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Saturday, May 16, 2009


    Thus if the new Obama money on the health care scene will do more comparative studies to make sure current guidelines are appropriate, that’s great.

    What we need most are evidence based outcome studies showing the benefits of quality metrics on mortality/morbidity in concert with the application of such studies rather than experts getting together to hammer out compromised clinical practice guidelines as exists today.

    Groups representing African-American, Hispanic or elderly patients argue that they will be underrepresented in future clinical trials. Whether this is true or not, the whole point of comparative effectiveness is to move medical practice beyond the limits of ordinary randomized trials, by looking at a broader range of evidence that includes the actual experience of patients undergoing treatment. Comparative effectiveness is to see what works in practice, rather than over generalizing from a few unrepresentative studies.

    However as I see it there is another bugaboo. Policymakers and research funders, such as the National Institutes of Health, often assume that the final steps in the translation of clinical research — the decision to act on new medical evidence and its implementation in routine care — are seamless and automatic. We clinicians know that changing the behavior of physicians and patients is difficult. Many of the assumptions regarding the most important aspect of such research — the ultimate implementation of its findings into health care — have had little empirical support.

    The dominant White House voice on health policy is Peter Orszag, the budget chief who champions "comparative effectiveness research" -- studying the patterns of clinical practice to determine which drugs and treatments work best and therefore necessary and which treatments are un-necessary and therefore non re-imburseable.

    The Obama Administration thinks it can use "comparative effectiveness research" analysis to weed out wasteful or unnecessary care. They say that by paying more "if the treatment has been shown to be effective and necessary and a little less if not," as Mr. Orszag recently was quoted, that un-necessary treatment will stop. He cites Dartmouth data that shows health-care spending varies wildly between regions, often with little or no correlation to “health outcomes.” Does anyone really believe that un-necessary treatment will eventually be reimbursed at all?

    And haven’t we’ve seen “comparative effectiveness” before?

    Under managed care in the 1980’s and 90’s, doctors and hospitals had to undergo prior "utilization review" by HMOs to reduce “unnecessary” hospitalizations, surgeries, tests, prescriptions etc. This cost-effectiveness gatekeeping was supposed to have disciplined health spending. “What happened next to this version of the dream is known to all,” says the WSJ. Administrative hassles led to a consumer backlash, with patients feeling they were getting inferior care in return for insurer profits. The political class eventually forced the HMOs to dilute or end most of their cost-control strategies.

    Will the same course of events happen again?

    It is for this reason that a shift is needed from the "science of recommendation to a science of implementation."

    The creation of a CER initiative focused on developing and disseminating effectiveness reviews is an essential, but not yet a sufficient, step toward the routine provision of safe, high-quality health care to all Americans.

    We also need evidence-based methods for discovering and describing how the findings of clinical trials and CER can be efficiently implemented and incorporated into routine practice.

    An implementation research and development program designed for this purpose could fulfill three important objectives.

    • It could accelerate the translation of evidence into everyday care.
    • It could enhance the opportunities for doctors and patients to define value (balancing expected benefits with costs) on the basis of their understanding of local contexts and constraints.
    • It could allow providers and patients to communicate with researchers and policymakers about clinically important issues earlier in the research process.

    Local factors such as infrastructure, existing processes, the degree of buy-in by clinicians and administrators, and the costs associated with change may vary widely among hospitals and regions.

    The Federal Coordinating Council must therefore remain mindful that the primary goal of CER is to enhance the translation of new medical discoveries into safe and high-quality health care for all Americans.

    This goal can be achieved only if our investment in CER includes a commitment to implementation research.

    This has not yet been done.

    But a step in the right direction was taken by Sen. Arlen Specter, D-PA, who recently introduced legislation that would authorize the establishment of the Cures Acceleration Network (CAN). Under the bill, a new $2 billion agency would provide funds to translate research discoveries from the bench to the bedside, and would operate as an independent agency; it would not be part of HHS. The CAN would make awards outside of the traditional funding stream to accelerate the development of cures and treatments including but not limited to drugs, devices and behavioral therapies. The CAN would have a flexible expedited review process to get monies into the hands of the grantees as quickly as possible. These development funds would complement the research dollars provided to the NIH and would not compete or take monies away from the NIH.

    Let’s hope bills like these don’t get stalled.

    Friday, May 15, 2009



    The CER (Comparative Effectiveness Program) Debate; Snippets from the May 7, 2009 NEJM & THE May 12 WSJ.

    • One congressman, a physician, sent out an "alert" through the Republican Study Committee, warning that the CER legislation would create "a permanent government rationing board prescribing care instead of doctors and patients." The true intent of the CER provision, he was alleged was "to enable the government to ration care.”

    • George Will states "that with such a system, "Congress could restrict the tax exclusion for private health insurance to `insurance that complies with the Board's recommendation.' The CER, which would dramatically advance government control — and rationing — of health care, should be thoroughly debated, not stealthily created in the name of `stimulus.'"

    • Talk-show host Rush Limbaugh warned that once the stimulus bill "computerizes everybody's health record," a new federal bureaucracy "will monitor treatments to make sure your doctor is doing what the federal government deems appropriate."

    • A single-payer system is fiscally unsustainable without rationing says one pundit-“Why do you think the stimulus package pours $1.1 billion into medical

    "comparative effectiveness research"? It is the perfect setup for medical rationing. Because once you establish what is "best practice" for expensive operations, medical tests and aggressive therapies, you've laid the premise for funding some and denying others,” say opponents.

    So What? What’s all the excitement about?

    Right now, “there is no place that helps you sort through a specific option and how that compares to another,” says the director of the Agency for Healthcare Research and Quality. Under the comparative effectiveness program, the Department of Health and Human Services and two agencies under it —the National Institutes of Health and the Agency for Healthcare Research and Quality — will finance studies that will look at various treatments and will pay for the development of information-gathering tools, like databases of patients being treated for a certain condition.

    The American Reinvestment and Recovery Act gives comparative-effectiveness research (CER) a large boost in funding over the next two years. Despite a consensus that better information about the relative effectiveness of different medical interventions is needed to improve the quality and value of care, some including those quoted above, oppose CER. They have taken the familiar tack that this program will not take adequate account of individual patient differences and may impede the development and adoption of improvements in medical care and "stymie progress in personalized medicine." This is code for medical rationing on a grand scale and withholding of treatments thought best for you by your personal physician.

    But what's wrong with that? asks one debater.

    Even if you want to call it rationing so what? Rationing is not quite as alien to America as we think. We already ration kidneys and hearts for transplant according to survivability criteria as well as by queuing. A nationalized health insurance system would ration everything from MRIs to intensive care by myriad similar criteria.

    It is estimated that a third to a half of one's lifetime health costs are consumed in the last six months of life. Accordingly, Britain's National Health Service can deny treatments it deems not cost-effective -- and if you're old and infirm, the cost-effectiveness of treating you plummets. In Canada, they ration by queuing. You can wait forever for so-called elective procedures like hip replacements.

    The controversy stems in part from a perceived contradiction between the concepts of CER and personalized medicine. In CER, groups of patients are analyzed to compare the effectiveness of alternative medical strategies, with the intent of informing clinical decisions and policies affecting health care. The very name "personalized medicine" suggests an approach to care that is based on individuals rather than groups. The term has been used to describe the consideration of characteristics such as age, coexisting conditions, preferences, and beliefs in crafting an individual management strategy. As the stimulus bill was being debated the opposition to CER found its voice in commentators who claimed that these studies will inevitably lead to government domination of the doctor–patient relationship, "cookbook medicine," and medical rationing. Certainly, important issues do arise in trying to translate CER findings into specific decisions regarding patient care and reimbursement.

    But the most critical question facing CER: Will its results significantly improve the quality and safety of the health care received by the average patient?

    The problem with many current clinical practice guidelines being used to improve quality care is the lack of outcome studies showing proof that the use of process quality measurements or metrics will improve morbidity or mortality in the real world. I have long maintained that P4P "pay-for-performance" is really "pay-for-process."
    Rather than measuring and rewarding improved outcomes, the program which is also being adopted by state and private insurers rewards adherence to practice guidelines. I agree with Groopman that using the current quality guidelines seems like good thinking superficially, but these rigid rules cannot fit the complexity of the human condition. There is little or no evidence the quality measures that comprise the guidelines correlate with improved outcomes. When measuring outcomes be prepared for surprises. As I recalled in III of III fof last week’s articles, the UCLA study of over 5,000 patients at 91 hospitals published in 2007 in the Journal of the American Medical Association found that the application of most federal quality process measures did not change mortality from heart failure.

    Thursday, May 14, 2009

    Does Cancer Screening Really Help All?

    No evidence so far that it helps with certain cancers reports Robert W. Rebar, MD [Journal Watch General Medicine, 2009].

    As much one would like to believe that early detection for all automatically leads to better care, that is not always the case. Although it is true that finding and treating cancer at an early stage will help in some cases — such as colon cancer and Pap smears that reduce deaths from cervical cancer — the data are less conclusive for at least three other cancers.

    Ovarian carcinoma
    Ovarian carcinoma is the leading cause of death from gynecologic malignancies in the U.S., reports Robert W. Rebar, MD largely because diagnosis usually is not made until disease is advanced.

    In a study funded by the National Cancer Institute, of more than 30,000 women in the study’s screening arm who underwent at least one annual screen, 11.1% had at least one positive test result. The positive predictive value of the tests ranged from 1.0% to 1.3% during different screening rounds, and 4.7 to 6.2 cancers per 10,000 women were identified with screening. The ratio of surgeries to detected invasive ovarian cancer cases was 19.5 to 1.

    Unfortunately 72% of cancers were late stage. Because the prevalence of ovarian cancer is low, false positives are numerous and screening leads to surgery for many women who do not have cancer. The benefits of screening will outweigh the harms seems unlikely.

    Prostate cancer
    In an op-ed in USA Today (4/23/09), Kevin Pho, MD, a primary-care physician in New Hampshire, questions whether "early screening" is "always in the patient's best interest." Dr. Pho cited two studies appearing in the New England Journal of Medicine that examine "the effects of prostate cancer screening."

    In one study, "sponsored by the National Institutes of Health," researchers "found that such screening did not decrease deaths." Meanwhile, "the second study showed that for every death prevented, 50 men would suffer from over-diagnosis." To put the problem in context: Only 3% of men die from prostate cancer; 97% will die from something else.

    Almost one-third of those treated for prostate cancer suffer from significant side effects, including impotence and urinary incontinence. Taken together, the study found that the benefit was minimal, and far from definitive.

    Breast Cancer[see Part II in my series of article on Mammagraphy]

    Dr. K.Pho notes that "similar issues influence breast cancer screening decisions" and that physicians "cannot be sure of which cancers are dangerous." As a result, "for every life saved from breast cancer, 10 more lives will be affected by" biopsy or breast surgery. He concludes, There cannot be a one-size-fits-all approach" to preventive care.Because doctors cannot be sure of which cancers are dangerous, every woman with a suspicious finding is subjected to a biopsy or breast surgery. For every life saved from breast cancer, 10 more lives will be affected by the ensuing procedures.

    Other cancers
    The uncertainty surrounding tests is true of other cancers, including lung, skin (malignant melanoma), testicular and pancreatic (pancreatic adenocarcinoma), where little compelling evidence has shown that early screening is beneficial.

    My opinion
    The problem associated with these studies showing questionable or no benefit to a longer life for cancer victims is the statistics themselves. Statistics are still statistics and you are you. Some lives have been saved from early screening. But for every inspiring story of a person cured from cancer made possible by early detection, there are untold stories of many more who suffer from the side effects of unnecessary invasive procedures stemming from false positive test results.

    But when only 1% of a certain population of 100 benefits that 1% may be you-and as far as you’re concerned you are 100% of the study.

    Another example is that mammograms detect a number of slow-growing tumors that will never be harmful. But because doctors cannot be sure of which cancers are dangerous, every woman with a suspicious finding is subjected to a biopsy or breast surgery. Although it’s true that for every life saved from breast cancer, 10 more lives will be affected by the ensuing procedures, yours may be the life that’s saved.

    Unless you believe with Gilbert Welch, professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice, who says, "I place considerable value on not suffering the side effects of treatment" and "death is not the only outcome that matters," you may choose not to undergo these uncertain screening procedures.

    But at least you will be making an informed decision. As Dr. Pho states “patients must be better informed of the potential consequences either choice can bring.”

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Wednesday, May 13, 2009

    Farrah Fawcett Documentary

    This Friday May 15 former "Charlie's Angels" actress Farrah Fawcett will appear on most NBC TV stations in her documentary about her terminal disease. Please be sure to see it. Fawcett has been working on this documentary, "A Wing and a Prayer," for NBC about her cancer battle. Ms Fawcett age, 62, received a diagnosis of anal cancer in 2006.

    he American Cancer Society estimates that 5,000 new cases of anal cancer are diagnosed each year and about 680 people die from it annually. Meanwhile, colorectal cancer has 148,000 new cases and about 50,000 deaths each year. Anal cancer it treatable, but becomes more difficult to treat if tumor spreads Anal cancer affects more women and the illness is usually found in people who are in their early 60's.

    What are the symptoms?

    • More than half of anal cancer patients experience bleeding as a symptom. Others have no symptoms or report common conditions, such as “hemorrhoids, fissures, or warts.”

    • Symptoms also include itching or pain in that area. The most common thing people think it's a hemorrhoid and unfortunately do nothing significant about it.

    • changes in the diameter of stool,

    • abnormal discharge,

    The following stages are used to describe anal cancer:

    In stage 0, abnormal cells are found in the innermost lining of the anus. These abnormal cells may become cancer and spread into nearby normal tissue. Stage 0 is also called “carcinoma in situ.” In stage I, cancer has formed and the tumor is 2 centimeters or smaller. In stage II, the tumor is larger than 2 centimeters. In stage IIIA, the tumor may be any size and has spread to either: lymph nodes near the rectum; or nearby organs, such as the vagina, urethra, and bladder. In stage IIIB, the tumor may be any size and has spread: to nearby organs and to lymph nodes.

    In stage IV, the tumor may be any size and cancer may have spread to more distant lymph nodes or organs and has spread to distant parts of the body.
    What are the risk factors for anal cancer?

    • A suppressed immune system,[e.g.HIV, certain medications]
    • HPV, [human papilloma virus], Thus getting vaccinated is a step in prevention.
    • STDs [sexually transmitted disease]
    • Being over 50 years old

    People tend to view anal cancer negatively, because they associate the cancer with a few of its publicized risk factors -- such as sexually transmitted diseases or anal sex—but it is only one of the risk factors, not the only risk factors.

    When anal cancer is caught early, chemotherapy and radiation are highly effective. But if the cancer doesn't respond to treatment and spreads to other areas of the body, the five-year survival rate plummets to less than 20 percent.

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

    Tuesday, May 12, 2009

    Something Worse Than Swine Flu Is Gaining On Us

    Maryland health officials said at least four people had been diagnosed with measles in including an 8-month-old infant who contracted the disease in a hospital waiting room. Virginia officials were also warning that an infected man may have exposed hundreds of people to the disease as he visited grocery stores and restaurants.

    Last year, 131 cases of measles were reported nationally, the most since 1996, according to the U.S. Centers for Disease Control and Prevention in contrast to the first seven years of the decade, when only 63 cases were reported.

    Experts say measles may be reestablishing itself in US. according the Washington Times (5/6/09, Goff) which reports, "While the uproar continues over a potential swine flu pandemic, there is a quiet controversy brewing about the return of an old disease that had once been nearly eradicated in the United States.”

    Many people have the impression it is not a serious disease, but Measles kills three out of 1,000 people who develop it.

    We should remember that 50 years ago - more than 100,000 children were hospitalized and 500 died annually. While in the decade before the U.S. measles vaccine program began in 1963, an estimated 3 million to 4 million people in this country were infected annually. Between 400 and 500 people died, 48,000 were hospitalized and another 1,000 developed a chronic disability from measles-related encephalitis, according to the CDC.

    This is a brief review of Measles to remind us of what we may be facing if, as stated by a noted pediatrician, "this uptick in measles could be the sign of something bigger."

    Many physicians have forgotten or have never experienced how dangerous measles could be.

    Measles virus infection can cause a variety of clinical syndromes including:
    • Severe measles,
    • giant cell pneumonia, and
    • measles inclusion body encephalitis in immunocompromised patients.

    The incubation period of measles is generally asymptomatic and lasts from 10 to 14 days. The appearance of symptoms typically include fever, malaise, and anorexia, followed by conjunctivitis, coryza, and cough. Patients may develop an exanthem known as Koplik's spots. These hich are 1 to 3 mm whitish, grayish, or bluish elevations with an erythematous base, seen on the buccal mucosa typically opposite the molar teeth. The characteristic skin rash is maculopapular and blanches, beginning on the face and spreading centrifugally to involve the neck, upper trunk, lower trunk and extremities. The lesions may become confluent, especially in areas such as the face where the rash develops first.

    This cranial-to-caudal progression of the rash is considered characteristic of measles.

    Complications of Measles include

    • Pneumonia — Patients with measles can develop secondary bacterial or viral pneumonia. In addition

    • Coinfection with other viruses can occur especially with para influenza, and adenovirus, but also with cytomegalovirus, enterovirus, influenza, and respiratory syncytial virus.Measles has also been associated with the subsequent development of bronchiectasis, which can predispose to recurrent respiratory infections

    • Acute disseminated encephalomyelitis — (ADEM, also known as post infectious or postvaccination encephalomyelitis); Post infectious encephalomyelitis presents soon after the initial clinical manifestations of measles have resolved. Past experience with measles epidemics identified a 10 to 20 percent mortality associated with ADEM. Furthermore, many survivors have residual neurologic abnormalities including behavior disorders, mental retardation, and epilepsy.

    • Tracheobronchitis — Measles virus can involve the upper respiratory tract and cause laryngotracheobronchitis (ie, croup), with its attendant complications.

    • Otitis media — When patients with measles develop otitis media, it is usually due to bacterial superinfection caused by the same bacterial pathogens that normally cause this infection.

    • Since measles is a disseminated infection, involvement of other organ systems can occur, including corneal ulceration, myocarditis, pericarditis, hepatitis, mesenteric lymphadenitis, diarrhea, and appendicitis.

    • Subacute sclerosing panencephalitis whereas subacute sclerosing panencephalitis (SSPE) presents seven to ten years after initial infection. It is a progressively fatal degenerative disease of the central nervous system. Its pathogenesis is not well understood, but persistent infection of the central nervous system with a genetic variant of measles virus may be involved. The typical patient with SSPE is under 20 years of age and develops SSPE seven to ten years after measles infection.

    Why Is This Increased Frequency Of Measles Happening Now?

    • A study in the United States in 1982 found a progressive fall in the number of cases of SSPE from 0.61 cases per million population in 1970 to 0.06 in 1980. The decline in SSPE cases paralleled the decline of measles cases, but with a lag time of several years.

    • The estimated incidence of SSPE was 8.5 cases per one million cases of measles that occurred during 1960-1974.

    • However, a follow-up study of cases of biopsy-proven SSPE identified from 1992 to 2003, suggests that the risk of this disease may now be 10-fold higher.

    There was a resurgence of measles infection in the United States in 1989 to 1991 due to low overall vaccination rates.

    • In 2008, CDC data indicate that "131 cases of measles were reported nationally, the most since 1996," with 63 of those incidences occurring in the "first seven years of the decade."

    • The "CDC said that as of 2006, the most recent year numbers are available, 93 percent of American children had received the measles vaccine."

    Yet, infectious disease experts say a vaccination rate of 95 percent is necessary to keep highly contagious diseases, such as measles, from becoming re-established in the US.

    Moreover, because vaccine rates are much lower in many countries, even developed European countries," people's globe-trotting habits mean that Americans are far from protected.

    This led the chief of infectious disease at the Children's Hospital of Philadelphia to opine that the U.S. may be seeing the crest of the vocal anti-vaccine movement, which has gained momentum over the past decade. The movement has been spurred by a feared link between vaccines and autism—which affects one in 150 children in the United States.

    In 1998, a study by British researcher Andrew Wakefield looked at 12 children with autism and suggested that the onset of their symptoms was linked to receiving the MMR vaccine. Though it was later discovered that Dr. Wakefield misrepresented some of the data, his findings had a major impact.

    As an example of what mis-information can do-Measles vaccination rates in the United Kingdom dropped almost immediately. In 1998, the year Dr. Wakefield's research was published in the Lancet medical journal, there were only 56 measles cases. The current rate of full MMR vaccine coverage for British children is only 77 percent. This resulted in 1,348 cases of measles in the U.K. last year, up 36 percent from 2007.

    In the past decade, at least 20 studies have shown no link between the MMR vaccine and autism. And February 2009, a special federal court after a thorough review ruled in three test cases that there was no link between the vaccine and autism.

    Despite the above factual evidence that measles vaccine does not cause autism and court rulings corroborating these facts, this growing anti-vaccine movement has not been dissuaded. In California, as in other states there are clusters of unvaccinated children, most of who are from upper-middle-class neighborhoods with supposedly educated parents. They have opted not to protect their children from measles.

    “Vaccine refusal,” says the May 7, 2009 NEJM, “ not only increases the individual risk of disease but also increases the risk for the whole community. As a result of substantial gains in reducing vaccine-preventable diseases, the memory of several infectious diseases has faded from the public consciousness and the risk–benefit calculus seems to have shifted in favor of the perceived risks of vaccination in some parents' minds. If the enormous benefits to society from vaccination are to be maintained, increased efforts will be needed to educate the public.


    In summary, vaccines are one of the greatest advances in medical history and in just the past 50 years, polio, measles, rubella, mumps, and Haemophilus influenzae type B disease have nearly disappeared in the U.S. Parents, however, are increasingly choosing to refuse vaccination of their children because of the fear of autism caused by vaccination, despite no credible evidence of an association.

    • In the early 1980s, all 50 states required immunization.

    • Rates of exemptions, however, for required school immunizations began to increase from about 1% in 1991 to 1.5% to 2.5% in 2004 despite the fact that unvaccinated children are significantly more likely to contract measles and pertussis than vaccinated children.

    • Unvaccinated children are more likely to be white, live in higher-income households, and have a married mother with a college education.

    • The Pediatric Committee on Bioethics advises against discontinuing care for families that refuse vaccines, 40% of pediatricians report that they will no longer provide care to families who refuse all vaccines.

    In view of the shift in perception about the safety of vaccines, we must remind our patients — and ourselves — that immunizations are responsible for saving more lives than virtually any other medical advance.

    • Parental doubts about the safety of childhood vaccinations therefore are leading to outbreaks of largely eradicated diseases like measles and whooping cough.

    A U.S. measles outbreak last year -- almost exclusively among unvaccinated people -- has sparked concern about places where many parents opt out of having their children vaccinated.
    Too many abstainers can put a town at risk. Parents must realize that if children live in a community that has a cluster of refusers, their risk of getting a vaccine-preventable disease goes up, just by virtue of who they play with.
    Eradicating a disease requires vaccinating a large percentage of the nearby population to stop infections from spreading -- what's called "herd immunity." Parents must understand that schools with many abstainers have been linked to outbreaks.
    As an example in Colorado, schools with an outbreak of whooping cough in the 1990s had an average of 4.3% of students who had opted out of vaccination, compared with 1.5% at schools without an outbreak.
    So stay alert for the post-Swine flu pandemics-the used to be common and very dangerous—Measles, Whooping Cough and all the rest of the killer diseases of the pre-vaccination era.

    Recommended Immunization Schedules

    JW Pediatr Adolesc Med Jan 28 2009

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.