Since vacations are good for Congress and the President, we figured why not this Blog. See you after Labor Day.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.
Experts Redesign Common Microbe to Fight Drug-Resistant Bacteria
E. coli bacteria is seen in an image taken by an electron microscope. REUTERS/USDA/Handout
Researchers in Singapore have re-engineered a harmless strain of bacteria to fight another common, drug-resistant microbe that spreads in hospitals and is deadly to patients with weak 1) ___ systems. To fight the Pseudomonas aeruginosa bacterium, the scientists used a strain of the E.coli bacteria that is normally present in the human 2) ___. They inserted into E.coli foreign 3) ___ fragments that empowered it to sense the offending pathogen and quickly produce and release a deadly toxin. “Once it (re-engineered E.coli) detects the presence of the aeruginosa, it produces a 4) ___ and the killing molecule will be released to kill the pathogen,” said assistant professor Chueh Loo Poh, a member of the research team at the Nanyang Technological University’s School of Chemical and Biomedical Engineering.
“Our engineered 5) ___ inhibited the growth of the (pathogen) by 90%,” said lead author of the paper, assistant professor Matthew Wook Chang. The team published their findings in the journal Molecular Systems Biology on Tuesday. While many 6) ___ unleash a blanket attack on both good and bad bacteria, the re-engineered E.coli targets specific invaders, in this case, the P. aeruginosa. The same formula can be used to redesign other 7) ___ to fight other infective agents, such as the Vibrio cholerae which causes cholera, said Chang. “We can easily change the sensing 8) ___,” he said.
Apart from offering possible new therapies, the team believes re-engineered bacteria can be made into probiotics and consumed in food such as yoghurt. 9) ___ are live bacteria that are beneficial to their hosts. The team is now testing its re-engineered E.coli on animals and hope to carry out clinical 10) ___ in people infected with Pseudomonas aeruginosa later.
ANSWERS: 1) immune; 2) gut; 3) DNA; 4) toxin; 5) bacteria; 6) antibiotics; 7) microbes; 8) device; 9) Probiotics; 10) trials
Epidemics Helped Shape the Modern Metropolis
Photo: New York Historical Society
Horatio Bartley, an apothecary, put together a pamphlet of illustrations and descriptions of cholera cases at one of the city’s cholera hospitals. Of the 410 patients admitted to this hospital, 179 died. The attempted remedies included pouring boiling water on the victims. Marinus Willet Jr., the physician-in-chief, recounted, “We soon abandoned this remedy, because we derived no benefit from it, and its application produced great agitation in the mind of the patient.” From Bartley’s pamphlet: “J.G. aged thirty-one, admitted six o’clock, P.M. July 17th, 1832, in the stage of collapse. Was rubbed with camphorated mercurial ointment, until reaction was produced; he was then put under hospital treatment. 22d. Ptyalism [excessive salivation] being induced, was ordered small doses of sulphur, and a wash of the same for the mouth. At six o’clock P.M. diarrhea increasing, was ordered an anodyne enema. He was under medical treatment until 24th, when he died, at three o’clock, P.M.”
Cholera is an acute illness characterized by watery diarrhea. The toxin released by the bacteria causes increased secretion of water and chloride ions in the intestine, which can produce massive diarrhea. Death can result from the severe dehydration brought on by the diarrhea.
The New York City epidemic of cholera, cause unknown and prognosis dire, reached its peak in July 1832. The upper classes escaped to their country houses. The New York Evening Post reported, “The roads, in all directions, were lined with well-filled stagecoaches, livery coaches, private vehicles and equestrians, all panic-struck, fleeing the city, as we may suppose the inhabitants of Pompeii fled when the red lava showered down upon their houses.”
An assistant to the painter Asher B. Durand described the scene near the center of the outbreak. “There is no business doing here if I except that done by Cholera, Doctors, Undertakers, Coffinmakers, &c,” he wrote. “Our bustling city now wears a most gloomy & desolate aspect — one may take a walk up & down Broadway & scarce meet a soul.” The epidemic left 3,515 dead out of a population of 250,000. (The equivalent death toll in today’s city of eight million would exceed 100,000.)
The outbreak, highlighted the vulnerabilities of life in overcrowded cities in a time of deplorable sanitation and before medical science recognized the role of germs in disease. Cities were growing faster in population than in understanding what it took to make them fit places to live – an urban problem probably as old as the Sumerians of Mesopotamia. The initial response to the epidemic, Kenneth T. Jackson, a professor of history at Columbia University, said recently, exposed more than ever the city’s divisions of class, race and religion. The disease hit hardest in the poorest neighborhoods, particularly the slum known as Five Points, where African-Americans and immigrant Irish Catholics were crowded in squalor and stench. “Other New Yorkers looked down on the victims,” said Dr. Jackson, editor of The Encyclopedia of New York City. “If you got cholera, it was your own fault.”
Unlike most upper-class residents, John Pintard, the respected civic leader who was the historical society’s founder, remained in the stricken city. The epidemic, he wrote in an attitude typical of his peers, “is almost exclusively confined to the lower classes of intemperate dissolute & filthy people huddled together like swine in their polluted habitations.” In another letter, his judgment was even harsher. “Those sickened must be cured or die off, & being chiefly of the very scum of the city, the quicker [their] dispatch the sooner the malady will cease.”
Science and medicine advanced more slowly in the 19th century. It was 1883 before the bacterium Vibrio cholerae was discovered to be the agent causing the gastrointestinal disease. But a turning point in prevention came in 1854, when a London physician, Dr. John Snow, established the connection between contaminated water and cholera. Dr. Snow tested the idea by plotting cholera cases on a map of Soho. This showed that most of the victims drew their water from a public pump on Broad (now Broadwick) Street. An infected baby’s diapers had been dumped into a cesspool near the well. A recent book, “Ghost Map,” by Steven Johnson, recounts the discovery.
The cholera research was an early application of mapping in medical investigations, a technique that has become widespread now that computers facilitate the display and analysis of such data. Historians of medicine credit Dr. Snow with advancing the modern germ theory of disease and laying the foundations of scientific epidemiology.
The cholera menace thus prompted cities to begin cleaning up their fouled nests. This came too late for victims of the 1832 epidemic in New York, or one that followed in 1849. By then, the city’s population had doubled, to 500,000, and deaths by cholera rose to 5,071. The city in 1832 had expanded as far north as 14th Street. People were squeezed out of the lower wards by the influx of immigrants. Some, escaping earlier outbreaks of malaria and yellow fever, had sought a haven in the clean air and open land of the village called Greenwich. Walking in Greenwich Village today, one is struck by the number of small brick houses bearing markers with dates immediately after 1832. It may be no coincidence that John Blauvelt, a carter working the piers, built his on West 10th Street (then Amos Street) the year after the cholera epidemic.
New Yorkers should have suspected that the scourge was on its way. Cholera, originally confined to South Asia, had started spreading in 1817 from seaport to seaport, presumably carried by infected sailors. The disease struck London in 1831 and reached New York the next June.
No one was prepared, not even doctors. They generally believed that miasmas, the noxious vapors from rotting organic matter, carried infections, an idea inspiring literature of death in Rome and Venice. The cholera in Five Points seemed to bear out the hypothesis.
Five Points was a slum that had metastasized from an intersection of five streets north of City Hall through the area that is now Foley Square and Chinatown. “All that is loathsome, drooping and decayed is here,” Charles Dickens wrote after a visit. Martin Scorsese’s movie “Gangs of New York” captures the lowlife there later in the 19th century, when it was still an urban sinkhole.
The exhibition includes illustrations of the thugs and gamblers, the stray dogs and pigs that inhabited the streets of mud and manure. The pigs at least were useful as garbage collectors and sources of food. For victims, the onset of cholera was sudden: an attack of diarrhea and vomiting, followed by abdominal cramps and then acute shock, signaling
The collapse of the circulatory system. Some survived the illness, despite the lack of effective remedies. Posters from the time described recommended treatments, including laudanum (morphine), calomel (mercury) as a binding laxative, and camphor as an anesthetic. High doses sometimes did more harm than good. Poultices of mustard, cayenne pepper and hot vinegar were also applied, as well as opium suppositories and tobacco enemas.
Many victims, nearly half the cases at one hospital, died within a day of admission. After private hospitals began turning away patients, the city set up emergency public hospitals in schools and other buildings. One, on Rivington Street, bore the brunt, and sketches of its patients’ faces contorted in the throes of death look down from the exhibition walls.
In stark contrast, Asher Durand, who had escaped with his family to their country home in New Jersey, painted his children happily eating apples in a sunny orchard. The idyllic canvas hangs a few feet, and a world, away from the scenes of Five Points. While many Protestants sat out the epidemic at safe distances, the city’s Catholics, many of whom were poor immigrants, mostly Irish, had no choice but to stay. Their nuns and priests also remained to offer comfort and some help, and they emerged as the few heroes in the ordeal. “The Sisters of Charity performed heroic service, and many of them died,” said Stephen R. Edidin, co-curator of the exhibition, with Joseph Ditta. “As a result, there was some reduction of anti-Catholic sentiments and a new respect for the Catholic clergy, who risked their lives in the epidemic. The feeling didn’t last, of course.”
Despite the epidemics of ’32 and ’49, people still flocked to New York and other teeming cities. But the first outbreak bolstered support for the Croton Aqueduct system to bring clean upstate water to the city, a project, completed in 1842, that led to the phasing out of private and neighborhood wells that were often polluted with human and animal waste. In 1849, the municipal government banished more than 20,000 pigs to the outer reaches of the city. A similar effort in previous years had provoked riots, but this time a public chastened by epidemic complied.
Finally, after the work of Dr. Snow in London and a lesser cholera outbreak in New York in 1866, the Metropolitan Board of Health was established with doctors in commanding roles and broad powers to clean up the city. Inspectors went to houses and burned clothing of people who had just died. They cleared the filth, spread lime and instructed survivors in proper sanitation.
Cities had learned, or should have, that epidemics as a consequence of urbanization were their responsibility to prevent and control.
Cholera is still a threat wherever drinking water is polluted. But Dr. Ho says that people should no longer die of it, if they are treated promptly and properly with rehydration fluids to restore their ravaged bodies. (From John Noble Wilford, The New York Times)
Cigarette Smoking Implicated in Half of Bladder Cancers in Women
In 2011, approximately 69,250 people will be diagnosed with bladder cancer in the US, and 14,990 will die from the disease.
Previous studies indicate that the population attributable risk (PAR) of bladder cancer for tobacco smoking is 50% to 65% in men and 20% to 30% in women and that current cigarette smoking triples bladder cancer risk relative to never smoking. During the last 30 years, incidence rates have remained stable in the United States in men (123.8 per 100 000 person-years to 142.2 per 100 000 person-years) and women (32.5 per 100,000 person-years to 33.2 per 100,000 person-years).
Although there have been reductions in the concentrations of tar and nicotine in cigarette smoke, there have been apparent increases in the concentrations of certain carcinogens associated with bladder cancer. A 2009 NCI/DCEG study was the first to suggest a higher risk for smoking-induced bladder cancer than previously reported. That report, based on data from the New England Bladder Cancer Study, found that the association between cigarette smoking and risk of bladder cancer appeared to be stronger than it was in the mid-1990s.
According to an article published in the Journal of the American Medical Association (2011;306:737-745), it was shown that current cigarette smokers have a higher risk of bladder cancer than previously reported, and the risk in women is now comparable to that in men. The study used data from over 450,000 participants in the NIH-AARP Diet and Health Study, a questionnaire-based study that was initiated in 1995, with follow-up through the end of 2006.
While previous studies showed that only 20 to 30% of bladder cancer cases in women were caused by smoking, these new data indicate that smoking is responsible for about half of female bladder cancer cases – similar to the proportion found in men in current and previous studies. The increase in the proportion of smoking-attributable bladder cancer cases among women may be a result of the increased prevalence of smoking by women, so that men and women are about equally likely to smoke, as observed in the current study and in the U.S. population overall, according to surveillance by the CDC. The majority of the earlier studies were conducted at time periods or in geographic regions where smoking was much less common among women.
In the current study, former smokers were twice as likely to develop bladder cancer as never smokers, and current smokers were four times more likely than those who never smoked. As with many other smoking-related cancers, smoking cessation was associated with reduced bladder cancer risk. Participants who had been smoke-free for at least 10 years had a lower incidence of bladder cancer compared to those who quit for shorter periods of time or who still smoked.
According to the authors, even though smoking carries the same risk for men and women, men are still about four times more likely to be diagnosed with bladder cancer, and that the study results suggest that difference in smoking rates explain only part of the higher incidence rates in American men. The authors added that occupational exposures, as well as physiologic differences, may contribute to the gender disparity.
Nasal Spray Flu Vaccine Works in Kids
Influenza vaccinations for young children are provided in a two-dose, prime-boost combination. The first vaccine dose is designed to prime the immune system to produce a favorable antibody response, and the second vaccine dose is the “boost” designed to spur an immune response.
According to a study published online in The Journal of Infectious Diseases (DOI: 10.1093/infdis/JIR436; 15 August 2011), children younger than 3 years old receive the same protective antibody response from the recommended two doses of licensed seasonal influenza vaccines regardless of whether the two doses are injected by needle, inhaled through a nasal spray or provided through one dose of each in any order. In addition, the study found that young children who received at least one dose of the nasal spray vaccine – a live, attenuated influenza virus vaccine (LAIV) – made a wide array of immune T cells which may be important for protection against many diverse flu strains.
The study took place during the 2005-2006 and the 2006-2007 flu seasons and involved 53 children aged 6 to 35 months. Study participants were divided into four groups of roughly equal size. None of the children had received an influenza vaccine before. During the study, all children received an initial dose of licensed seasonal flu vaccine and a booster dose one month later. In two groups, the vaccines matched, with children receiving two injections of a trivalent, inactivated vaccine (TIV) injection or two LAIV nasal spray vaccines. Children in the other two groups received a combination of vaccines, with a dose of LAIV given either before or after TIV.
According to the authors, kids who have never been immunized against flu are generally advised to receive two doses of inactivated or live, attenuated vaccine to ensure adequate antibody responses, and vaccination schedules combining one dose of TIV with one dose of LAIV have not been recommended because clinical studies of these combinations have not been done previously.
The study found that all four dosing patterns were safe and induced similar levels of protective antibodies. However, when the study looked at responses from the T-cell arm of the immune system, a striking difference emerged. They could not detect influenza-specific T cells in children who received only TIV. But the kids who received at least one dose of LAIV nasal spray vaccine produced significant amounts of three important T-cell subtypes that are likely to confer additional protection beyond that afforded by antibodies alone.
Previous studies have demonstrated that children are better protected against influenza infection and disease by LAIV than by TIV. However, few studies have examined the T-cell responses elicited by LAIV when given to very young children who have little prior natural exposure to seasonal influenza viruses. Distinguishing T-cell responses due to vaccination from those arising after natural exposure to influenza virus becomes more difficult as a child ages. Because the children in the trial were all younger than 3 years old, the investigators were be confident that spikes in levels of the three T-cell subtypes that were detected were likely due to the vaccinations.
Children who received only one dose of LAIV had T-cell responses similar to those who received two, and the order of vaccine types did not make a significant difference in the size of the T-cell response. However, because LAIV has sometimes been associated with increased incidence of wheezing in the youngest recipients, the results of this trial suggest that the best regimen for kids younger than 24 months may be TIV followed by LAIV. However, larger clinical trials are required to confirm the safety and efficacy of such an approach.
In a separate series of experiments using influenza virus-infected cells grown in the laboratory, the authors showed that LAIV, but not TIV, induces T cells that recognize genetic sequences shared by a diverse set of influenza viruses. In contrast to currently used flu vaccines – which must be given annually because circulating influenza viruses change from season to season – a vaccine capable of eliciting broad T-cell responses aimed at a portion of virus shared by multiple strains could provide decades-long protection against many or all flu strains.
Red Meat Consumption and Risk of Diabetes
Since the relationship between consumption of different types of red meats and risk of type 2 diabetes (T2D) remains uncertain, a study published online (10 August 2011) in the American Journal of Clinical Nutrition (doi: 10.3945/ajcn.111.018978), was performed to evaluate the association between unprocessed and processed red meat consumption and incident T2D in US adults.
The study followed 37,083 men in the Health Professionals Follow-Up Study (1986–2006), 79,570 women in the Nurses’ Health Study I (1980-2008), and 87,504 women in the Nurses’ Health Study II (1991–2005). Diet was assessed by validated food-frequency questionnaires, and data were updated every 4 years. Incident T2D was confirmed by a validated supplementary questionnaire.
Results showed that during 4,033,322 person-years of follow-up, 13,759 incident T2D cases were documented. After adjustment for age, BMI, and other lifestyle and dietary risk factors, both unprocessed and processed red meat intakes were positively associated with T2D risk in each cohort (all P-trend <0.001). The pooled hazards ratios (HRs) for a one serving/day increase of unprocessed, processed, and total red meat consumption were 1.12, 1.32, and 1.14, respectively. The results were confirmed by a meta-analysis (442,101 participants and 28,228 diabetes cases): the RRs were 1.19 and 1.51 for 100 g of unprocessed red meat and for 50 g of unprocessed red meat, respectively. The authors estimated that substitutions of one serving of nuts, low-fat dairy, and whole grains per day for one serving of red meat per day were associated with a 16–35% lower risk of T2D.
The authors concluded that the results suggest that red meat consumption, particularly processed red meat, is associated with an increased risk of T2D.
TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
Finally a Deal in Place for Inspecting Foreign Drugs
The following is based on an article published in the New York Times.
At its present pace, the FDA would need more than 13 years to inspect every foreign drug plant exporting to the US. Some plants have never been inspected, which saves them huge sums in cleanup and other compliance costs – an important reason that drug manufacturing is disappearing from the US and that tainted-drug scandals occur.
In one infamous case, Chinese manufacturers deliberately substituted a cheap fake for the dried pig intestines used to make the blood-thinning drug heparin. The tainted drug was linked to 81 deaths and exposed tens of thousands of people to danger. The FDA had never inspected the plants making the crucial ingredients, a larger problem that only now, more than three years later, may be fixed.
After decades of failed attempts, the federal government and the generic drug industry have reached an agreement that is almost certain to pass Congress and that will lead to routine inspections of these overseas plants, potentially transforming the enormous global medicine trade. Under the landmark agreement, expected to be completed within weeks, generic drug companies – which make 75% of the prescription medicines sold in the United States – would pay $299 million in annual fees to underwrite inspections of foreign manufacturing plants every two years, the same frequency required of domestic plants. Self-interest helped drive the agreement because the industry will not only get speedier approvals of new products as part of the deal but also may avoid scandals involving tainted medicines, which tend to hurt confidence in the entire industry.
Dr. Margaret Hamburg, commissioner of the F.D.A., said she was pleased with the generic drug fee proposals. “If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough,” Dr. Hamburg said. “FDA’s entire generic drug program would be placed on a much more stable footing.”
The agreement will not affect the making of over-the-counter medicines or vitamins, whose global supply chains are even more vulnerable to tampering since government inspectors almost never visit their makers. Aspirin and vitamin C supplements, among others, are now made almost entirely in uninspected plants in China. Nor will the agreement change the FDA’s oversight of name-brand prescription medicines. Although branded drugs usually have more secure supply chains than those of generics, major pharmaceutical companies have moved aggressively into China in recent years and often rely on rarely inspected suppliers.
Federal officials for years have expressed concerns about the nation’s growing reliance on sometimes mysterious foreign drug suppliers, but they had largely despaired of fixing the problem. Congress has never given the FDA the money needed to inspect these plants, and for nearly two decades the generic drug industry resisted proposals to pay inspection fees. The industry changed its stance for several reasons. First, the heparin scandal scared everyone. The fake ingredient was good enough to pass a sophisticated test, so the conspirators probably knew that deaths would result, reflecting a callous level of greed. And the Chinese government refused to allow the FDA to investigate, suggesting that the perpetrators were not only smart but politically well connected. Second, the generic drug industry is no longer a motley collection of struggling mom-and-pop companies. Years of consolidation have created giants like Israel-based Teva Pharmaceuticals that understand that their businesses depend on winning the confidence of patients and regulators alike, and they can afford to pay the fees needed to achieve that confidence.
Medscape.com, August 18, 2011, by Arthur L. Caplan PhD, – Hi. I am Art Caplan at the University of Pennsylvania Center for Bioethics. Today I am going to talk to you a little bit about the growing practice of “concierge” or “boutique” medicine. What is concierge medicine? Basically, in concierge medicine you ask your patients to pay an additional fee (usually $1500-$2000 a year), and in return they receive better service. You promise that if they join the plan, you will answer their phone calls. You might give them your cell phone number. You might be in a situation in which concierge patients have more time available when they come in for an office visit, and you are going to help them wend their way through the hospital and gain access to specialists. In other words, patients are going to get more of you for the money.
What is fueling this shift toward concierge practice, particularly in primary care? It is the red tape, hassles, bureaucracy, micromanagement, and too much overhead cost that primary care providers in particular are facing in the current healthcare environment. There is just not enough time to see patients, and people feel as though they are on an assembly line. It’s understandable that the idea of having patients pay more as a way of getting out of a broken system might come to the fore. A lot of people are doing this. There are probably 6000 primary care physicians alone who have shifted over to a concierge practice. To be honest, concierge medicine for the superrich has always been around. The person who has an addiction who goes off to the Betty Ford Clinic and the executive who takes a jet for an executive physical at the Mayo Clinic: These are versions of concierge or boutique medical practice. Now it’s expanding into the middle class.
What is the downside, and what are the ethical worries about this growing type of practice? First, there aren’t enough primary care providers around to begin with. We all know that we have too many specialists, not enough generalists, and not enough primary care providers in the United States. If you take a significant number of them out of the pool available to every patient and make them available only to people who can pay additional fees, it results in a bigger workload for the rest of the providers who are doing primary care. No matter how you look at it, if you allow providers to buy out, you are going to leave other patients with lower-quality care, and you are going to burden the remaining primary care practitioners (who don’t take the concierge route) with more work.
There is also the issue that if patients aren’t in a boutique or concierge practice, they are going to wind up getting lower-quality care because they might see more physician extenders. There are certainly great physician extenders — both nurses and physician assistants — but patients don’t understand that they may be seeing someone with a bit less training and may be paying the same money or fees for someone with less qualification.
At the end of the day, we have a justice issue. Concierge practice is a business solution to what is essentially a broken system. We must find different ways of solving the problems with healthcare, other than having people pay a fee to escape the broken system. Concierge medicine is fundamentally unjust. We have to come up with a better answer. It will probably be something along the lines of what is being proposed for healthcare reform. Concierge medicine is more a symptom of a broken system than it is a solution.
Thanks for listening. I’m Art Caplan at the University of Pennsylvania.
Rebuttal: Concierge Practice Is a Doctor’s Right
Leslie Kane, MA; Bernard Kaminetsky, MD
Medscape’s recent video commentary by ethicist Arthur Caplan, PhD, “Concierge Practice: Unjust for Patients and Doctors Alike,” provoked a flood of heated responses. To present the contrasting point of view, Medscape interviewed Bernard Kaminetsky, MD, board certified in internal medicine and nephrology.
Dr. Kaminetsky is the Medical Director of MDVIP, a company with a national network of primary care physicians who provide personalized care, focusing on wellness and prevention, and use a concierge-type model. Dr. Kaminetsky was a founding partner in a primary care practice based in Boca Raton, Florida. In 2001, he transitioned his practice to the MDVIP model. He recently left his primary care practice to serve as the national representative for MDVIP. Dr. Kaminetsky has testified before the Joint Economic Committee of the US Congress on the importance of wellness and prevention. He is a graduate of Albert Einstein College of Medicine and a former assistant professor at New York University School of Medicine.
Medscape: In a concierge medical practice, doctors generally charge an annual access fee, have a smaller number of patients, and spend more time with each patient. Some have said that this is unjust or unfair, particularly given the shortage of primary care doctors. How would you respond to that?
Dr. Kaminetsky: Let’s look at it from the patient’s perspective: Is it fair for patients to have an experience — as is common in conventional practice — where visits are very short and doctors are essentially reactive to acute problems because they have very little time for prevention and wellness? And the doctor knowingly is neglecting his or her ability to spend the time necessary with the patient to actually prevent the heart disease or diabetes from forming because there simply isn’t time. Is that fair to patients?
When you add the caveat of “given the limited number of primary care physicians,” that is predicated on the notion that if a doctor does not transition his or her practice to concierge or boutique practice, that doctor would still be seeing their regular panel of 2500 or 3000 patients. That’s a very flawed assumption.
There’s ample literature documenting that among physicians over age 55, as many as 50% indicated a desire to stop practicing primary care within 5 years. Yet we have quite a few doctors in our network over age 70. They very clearly and unequivocally would have hung up the shingle if they did not have a model where they could practice at a slower pace, with greater interaction with the patient. They find it more fulfilling. Doctors are staying in practice because this model exists.
With only a small percentage of medical students going into primary care, if we have a method for attracting more to primary care while fulfilling our obligation to patients to give them the best care possible, who could argue with that?
Medscape: We’ve heard concierge care criticized because many patients can’t afford it.
Dr. Kaminetsky: Let’s qualify “afford”: $1500 [an annual amount commonly charged for concierge access] is clearly a middle class expense. That’s about $125 a month. It’s what people spend in Starbucks. Smokers spend more than that on cigarettes. We have patients who very clearly have said, “We make choices. My health is of primary concern to me. I will order my priorities in a way that $1500 is more important for my health and wellness and potential longevity than some other luxury.”
Medscape: What about those for whom $1500 is a lot of money?
Dr. Kaminetsky: How is that different from the fact that when I was in practice, I didn’t know a single physician who accepted Medicaid because the reimbursement is so abysmally low? Every patient who has Medicaid is also denied the opportunity to see any physician they want. The system is not predicated on the notion that anyone can see any doctor of their choice. We have tiers of insurance: If you’re enrolled in an HMO, you generally can’t see any doctor you want to. So everybody is limited or circumscribed by the situation in which they find themselves or by their insurance.
Medscape: Some have said that a concierge practice is merely a bad response to a bad healthcare system– that two wrongs don’t make a right — and that the solution should be to fix the system. Is there validity to that statement?
Dr. Kaminetsky: Actually, no. Concierge care is an excellent solution because it addresses those patients who desire to have an emphasis on wellness and prevention and those doctors who feel a professional obligation to provide it.
No one suggests that this model is a solution to the healthcare crisis in this country. No one would make so bold a statement. But it is a solution for a niche population, which by its nature will always be a niche population. We have a many-tiered pluralistic system of healthcare delivery in this country, and this is one more offering.
In its small manner, it’s actually a very good solution.
Medscape: When doctors transition to a concierge practice, many of their patients will choose to — or will be forced to — find new physicians. Do doctors who make the switch to concierge medicine express that they feel guilty about doing so or feel badly about patients who decide to leave?
Dr. Kaminetsky: Every doctor does. When you take care of people for years, you have a relationship with them. But with my own patients, when I did this in 2001, the overwhelming sentiment expressed by my patients was “I understand why you’re doing this, even though I choose not to participate.” And of course doctors feel ambivalent; I felt ambivalent. When I’m in the hospital and see a former patient there, I invariably greet them and talk to them.
A physician who doesn’t feel some ambivalence does not have appropriate feelings for a physician.
Medscape: Primary care doctors may go into concierge practices because they want to earn more money. Yet they get criticized because some people feel that doctors have an obligation to society and should stay in a traditional practice and see more patients, even if they earn less doing so. How would you respond to that?
Dr. Kaminetsky: A number of years ago, I saw a poll showing that doctors’ incomes were way overestimated by the population at large. The public more than doubled the average primary care salary. Based on those assumptions, people say that doctors can certainly afford to make less.
But the public and patients are sometimes surprised to find out that there are very hard-working primary care doctors who are struggling with their kids’ tuition, do not take any vacations, and haven’t saved a nickel for retirement. One can’t honestly expect people to live their lives in that fashion, as their incomes keep dropping, without thinking, “Oh my God, what am I going to do?”
In many ways, I don’t consider doctors that different from clergymen in our relationship to our patients and the emotional support that we offer them. That being said, many physicians in a concierge practice say that it’s never been about money. The benefit is that it does allow them to practice in a different way.
With this practice model, because people are members of a smaller practice, the doctor is able to spend more time with the patient and this translates into better care.
Uconn Medical School Blog, Spring/Summer 2011 – Why should one even entertain the idea of going into medicine? Many have a notion that becoming a doctor will guarantee a fantastically lavish lifestyle but that is not necessarily the case. Indeed certain specialties “pay” more than others however the path to “high pay” is an arduous one. Medicine is a discipline which requires lifelong learning as well as serious commitment. Needless to say there is quite an arduous path to become a cardiologist who earns six to seven figures.
So why then should one go into a career with so much at stake? The best way I can convince you is by telling you why I chose to go into medicine. I have always been interested in the sciences. My desire to go into medicine was truly solidified in fifth grade, when my grandmother passed away due to cancer came. In that instant I wished I could have done something to help so I told myself I would go into a field which would directly better the lives of others.
Apart from the familial motivations, I was also very motivated to pursue a career in medicine because of the eventual fruits that it would bear. My decision to become a doctor was not completely blind. Over the past few years I have volunteered for patient transport at the hospital near my home, I have seen many liver transplant surgeries, and I have been a part of research endeavors at
UCONN as well as Children’s Hospital in Boston. Going through these experiences not only helped me realize that becoming a doctor was the right choice, but helped me better appreciate the humanitarian aspect of science and medicine. Seeing how appreciative patients were of the doctors’ help made it all the more enjoyable.
My ultimate goal in becoming a doctor is to lift the burden a person is experiencing as much as I can. As a physician, you are the main person a patient trusts with his/her well-being. Having that much of a positive influence in a person’s life is more than one could ask for. I have always felt that there is no greater satisfaction than knowing you have done a positive deed/ brought a smile to someone. That is what defines a doctor- the ability to bring a smile to someone who may be feeling less-than-happy at a particular moment. This humanitarian aspect of medicine has truly attracted me to becoming a physician.
You may ask, “well, yes it is nice to help those in need, but you do not have a life in your 20s.” My answer to that is, no matter what degree one wants to attain, a certain degree of hard work is required. Yes, the path to becoming a physician is a long one, but it is also an extremely rewarding one. If science classes seem difficult to you in high school or in college, one thing to keep in mind is that medical education is vastly different than the education in the preceding years.
I have viewed high school and undergraduateeducation as preparatory for the rigors of medical school. They have taught me how to study, how to allocate my time, and how to deal with success and failure – all of which are important aspects of medicine.
I believe I have become a mature academic scholar from my high school and undergraduate education. Getting back to the rigors of medicine, it is a fact that medical education is expensive, but once you begin practicing, paying off debt will become easier. In addition to that, just as in many other professions, physicians do get paid prior to practice. Residents and Fellows do get some monetary compensation for their efforts ($40-60,000.
In addition to that, the medical profession has many avenues open if one wants to be involved with medicine but not be a physician. One can be a medical assistant or one can even go into teaching. Medicine is a divergent field which has a degree with worldly possibilities. If one is interested in research he/she can do an MD/PhD program which would compound medical sciences with research. Or if one is interested in the business aspect of medicine, he/she can be an MD/MBA. As you can see, there are plenty of choices one has other than just becoming a doctor!!!
More than anything, the one thing I want to stress is passion. Whether you are interested in Chemical Engineering, or Nursing or any other discipline, passion is the key ingredient to success. One can attain a degree without passion but enjoying the mundane days of work requires passion. Medicine especially requires passion because there will be times of great disappointment as well as times of great excitement, and passion will help to deal with both situations. My passion surfaced through my grandmother’s passing and I knew at that point that whether I would be an MD or DO, I would be in a profession that would improve the health of those who are ailing.
There are new discoveries and new knowledge bases being formed, so it never gets “boring”. I have known physicians who went to Las Vegas or Los Angeles for conferences, and it is essentially a “study abroad” opportunity that doctors are able to have. Personally, there is no better feeling that helping another person improve their life, and I feel that becoming a physician is one of the most direct ways one can do that!!! So when choosing what you want to do with your life, always remember, think about how it will make you a better person. Will it be a job or an avocation for you? And most importantly, is it something you are passionate about? If you are interested in helping others, if you enjoy sciences, if you want variety in your life, and if you are ready for life-long learning and excitement, then becoming a doctor is definitely something you should consider!!!!
Ultimately it is not what you do that defines you, it is how you do it!!!
Good Luck with all your future endeavors!!
Pacing the Heart with Light
Pace maker: Heart cells, shown in red, surround a cluster of donor cells carrying a light-sensitive protein, in green, that stimulates the cells when exposed to blue light. Credit: Emilia Entcheva.
A new study uses optogenetics to control beating heart cells, pointing the way toward a better pacemaker
MIT Technology Review, August 17, 2011, by Courtney Humphries – In the past few years optogenetics, using a combination of genetic manipulation and simple pulses of light, has made it possible to control cells in the brain with astonishing precision—altering brain activity and even behavior in animals.
Now scientists are starting to look beyond the brain as they explore the technology’s potential applications. A recent study in Circulation: Arrhythmia & Electrophysiology showed how modified cells that respond to low-energy blue light can be used to stimulate heart tissue to beat. The researchers say this represents a first step toward a new, more efficient and precise kind of pacemaker. Light-sensitive cells could serve as a conductor of the heart’s rhythm, creating a biological pacemaker generated from the patient’s own cells.
Optogenetics involves genetically engineering cells with light-sensitive proteins, so that scientists can activate them with light. One of the obstacles in using optogenetics as a clinical tool is the need to introduce genes into cells. To get around the problem, the researchers in the current study, led by Emilia Entcheva, a bioengineer at SUNY Stony Brook, decided to take advantages of the tight communication between heart-muscle cells. These cells beat synchronously because they are coupled to one another through cell junctions.
Rather than having to modify every cell in the heart to respond to light, Entcheva says, it’s possible to inject a small population of light-sensitive donor cells, and allow those cells to couple with, and orchestrate, the beating of the normal tissue.
To test the approach, the researchers created a line of light-sensitive cells and paired them with heart cells. When stimulated by light, this hybrid cell population contracted in waves that matched the electrical pulses.
Entcheva says she envisions harvesting cells from a patient and genetically altering them to respond to light. By injecting enough modified cells—she estimates that half a million, or a couple of millimeters of tissue, should be enough—it could possible to pace the entire heart. She says that light would use less power than electricity, while offering “unprecedented spatial and temporal resolution”—an advantage in targeting specific parts of the heart. The most likely way to deliver light, she says, would be through thin fiber-optic cables.
The technique has more immediate applications as a research tool, for probing the workings of heart cells or helping test for possible cardiac side effects in drugs. Light, Enthcheva says, would enable more high-throughput screening than current methods, which rely on stimulating cells with electrodes.
Miguel Valderrábano, a cardiologist at the Methodist Hospital in Houston, says that for the past decade scientists have been working on new kinds of biological pacemakers, which usually incorporate cells that are genetically engineered to beat spontaneously in a specific way. The idea of creating cells that instead respond to light is an intriguing new strategy, he says: “It is definitely a conceptual breakthrough in the field of biological pacemaking.”
Like other approaches, the technique faces significant hurdles—for instance, making sure the pacemaker cells integrate properly with normal cells. Although biological pacemakers are attractive in theory, they must demonstrate significant advantages over the tried-and-tested electrical devices. “Biological pacemakers have a hard road ahead to outperform regular pacemakers,” says Valderrábano.
New research provides the first direct biological evidence for a genetic contribution to people’s intelligence (Photo Credit: Nat. Geographic)
ScienceDaily.com, August 16, 2011 — University of Manchester scientists, working with colleagues in Edinburgh and Australia, have provided the first direct biological evidence for a genetic contribution to people’s intelligence.
Previous studies on twins and adopted people suggested that there is a substantial genetic contribution to thinking skills, but this new study — published in the journal Molecular Psychiatry — is the first to find a genetic contribution by testing people’s DNA for genetic variations.
The team studied two types of intelligence in more than 3,500 people from Edinburgh, Aberdeen, Newcastle and Manchester. The paper, by Dr Neil Pendleton and colleagues, found that 40% to 50% of people’s differences in these abilities could be traced to genetic differences.
The study examined more than half a million genetic markers on every person in the study. The new findings were made possible using a new type of analysis invented by Professor Peter Visscher and colleagues in Brisbane. As well as the findings in people from Scotland and England, the team checked their results in a separate group of people from Norway.
Dr Pendleton, who led the Manchester team in the Centre for Integrated Genomic Research, said: “This is the first reported research to examine the intelligence of healthy older adults and, using a comprehensive genetic survey, we were able to show a substantial genetic contribution in our ability to think.
“The study confirms the earlier findings of the research in twins. However, that research could not show which genes were or were not contributing to cognitive ability. Our work demonstrates that the number of individual genes involved in intelligence is large, which is similar to other human traits, such as height.
“We can now use the findings to better understand how these genes interact with each other and the environment, which has an equally significant contribution. With our collaborators, we will take this work forward to find the biological mechanisms that could maintain our intellectual abilities and wellbeing in late life. ”
The study, in collaboration with Professor Ian Deary at the University of Edinburgh, was funded in Manchester by the Biotechnology and Biological Sciences Research Council.
G Davies, A Tenesa, A Payton, J Yang, S E Harris, D Liewald, X Ke, S Le Hellard, A Christoforou, M Luciano, K McGhee, L Lopez, A J Gow, J Corley, P Redmond, H C Fox, P Haggarty, L J Whalley, G McNeill, M E Goddard, T Espeseth, A J Lundervold, I Reinvang, A Pickles, V M Steen, W Ollier, D J Porteous, M Horan, J M Starr, N Pendleton, P M Visscher, I J Deary. Genome-wide association studies establish that human intelligence is highly heritable and polygenic. Molecular Psychiatry, 2011; DOI: 10.1038/mp.2011.85