"Odd Couple" Fights for Chance to Destroy Diabetes
Lee Iococca, the almost-mythic auto executive of the previous generation -- "fathered" the Ford Mustang and saved the Chrysler line from almost-certain extinction -- in retirement seems bent on helping to eliminate diabetes in our lifetime. It is questionable whether he will succeed, but you can count on a good try.
This time his contribution will be limited to helping raise the money that will permit an embattled scientist -- Dr. Denise Faustman -- to proceed with research that has been lauded by some, opposed by many. Mr. Iacocca is chairing a fund that hopes to raise $11 million for the project; he has personally contributed $1 million to that cause.
Dr. Faustman is an associate professor of medicine at Harvard and on the staff of the diabetes unit at Mass General. She has published a long list of scientific papers dealing with the disease and its treatment. Most importantly, she has succeeded in curing diabetes in laboratory mice, which is a breakthrough that has never been matched.
Though it is a lot more involved than this…basically, diabetes occurs when white blood cells misread signals and fight necessary islet cells as "foreign" invaders. She is certain this proves that Type 1 (juvenile) diabetes can be treated and all-but-eliminated with the easily-available and inexpensive ($11 a vial) drug BBG that is approved as an immune system stimulant.
Her request for research grants from the Juvenile Diabetes Research Association has been rejected, as have similar requests to the pharmaceutical companies. Problem is she is going against a recently-reported more-costly, more-involved but more-conventional treatment…all based on the assumption that a long-range cure lies within stem cell research and pancreatic cell transplants.
But the research grant "door" isn't totally closed to Dr. Faustman. In spite of their initial rejection, the Juvenile Diabetic Research Foundation is apparently underwriting a project at the University of Chicago to learn if other researchers can replicate her findings. Meanwhile Mr. Iacocca -- whose wife Mary's early death was caused by the complications of diabetes -- continues his fund-raising efforts.
……………Marginal note: researchers at the Harvard School of Public Health recently-presented a study of Type 2 (adult onset) diabetes and concluded that people who ate red meat, processed meats and other foods favored in "western" civilizations (excessive intake of sweets, french fries and highly-refined grains such as white bread) were much more prone to develop the disease. Their conclusions were based on an analysis of data gathered from close to 70,000 women over a 14-year period. All the women were diabetes-free at the start of the program.
Close to 50% more of the women that followed a "modest western diet" developed diabetes than did participants following a "regular" diet, which included large amounts of fish, fruits, vegetables and whole grains. And chances of developing the disease increased with the amounts of "red meat meals" eaten each day. For example, an additional serving of red meat apparently increases the risk of developing diabetes by 26%; increase that daily serving one more time and the incidence of developing diabetes goes up to over 39%.
"EZ Passing" Drugs
A version of the EZ Pass electronic identification system is now being tested -- with FDA approval -- in an effort to stop the flow of counterfeit drugs. It uses a minute-sized radio antenna right on the labels of medicine bottles to identify the real from the counterfeit. Initial trials will be limited to the large bottles that pharmacists use, because the feds report this is where most problems begin and incidents occur. The labels will remain voluntary until 2007. After that it is expected that the FDA will set mandatory standards, with the expectation that "signal friendly" labels will become part of many prescriptions filled in the United States. To become "signal friendly", the labels must emit the right bar-code-like numbers when submitted to a miniature radio signal, most likely in the form of a simple and transportable "wand". One technical expert refers to this labeling technique as "bar codes that bark".
It is all part of the hoped-for deployment of RFID (Radio Frequency Identification) that informed technologists say will be covering just about every industry in guarding against counterfeits and speeding check-out lines in a wide variety of retail locations.
Apparently we have a small window of opportunity to get into this policing because current counterfeit drug problems are still rare…but with an occasional uncomfortably-large "uptick". For example, in 2001, more than 200,000 bottles of counterfeit Lipitor made it to market. But the problem is definitely growing and it seems that organized crime is looking for ways to break in. They are currently concentrating on the wholesaler system that transships more than half the 14,000 approved prescription drugs in the United States.
Most of these shipments are carefully monitored, since three majors -- McKesson, AmerisourceBergen and Cardinal -- control about 90% of this trade. But the numbers of smaller wholesaler companies are literally "exploding" across the United States. Some with little more than a couple of rooms and several large refrigerators; apparently few are satisfactorily regulated by state pharmacy boards.
A secondary advantage of this system is tracking stolen prescription drugs. A missing RFID-identified shipment can be put on a law enforcement "watch list" and picked up almost immediately if an attempt is made to put them into normal distribution channels.
One of the first products that is expected to carry this RFID identification on their bottles is Pfizer's Viagra, often referred to as probably the most-counterfeited drug in the world. GlaxoSmith Kline says it will be using RFID tags in the next 12-18 months to follow at least one lead drug especially susceptible to counterfeiting. From plant to consumer!
Heart Hopes Abound
Heart disease seems to once again be on the "front burner" with a dramatic new scanner in place and a new type of stent working a seemingly-smooth path though various test stages. Together they could add years of life to many cardiologists' toughest cases. And perhaps even reduce some imaging bills.
First the scanner, which has been installed in several locations around the country. Currently four giant manufacturers - Siemens, General Electric, Philips and Toshiba -- are actively marketing their most-advanced version in a race to get the lion's share of this new technology. Many medical economists say these systems could make it possible for America to eventually use this one piece of equipment to replace the variety of diagnostic tests now required in treating patients with initially-undetermined chest pains.
First thing to possibly and eventually go seem to be angiograms, which are beaten on price alone….about $700 per for the new technology as against $4,000 for the more-invasive angiogram. Additionally, the new non-invasive scans reportedly take seconds to run and leave the patient ready to walk away right after. These new scans can actually "see" every detail inside and around the blood vessels.
Downsiders seem more cautious, saying that it could easily fall to questionable use or simple overuse…and that it is also four times as expensive as the often-quite-satisfactory CT scans which are currently in use in over 30,000 locations across the world.
Big cost of the equipment ($1.5 to $2 million each) is, to a great degree, due to the fact that the new scans have as many as 64 detectors…making them able to produce far more "visuals" than any existing equipment. They can also show dangerous areas of fatty deposits in arteries that are not blocked, but could rupture. Find them, treat them with drugs instead of emergency methods and we save lives and even money overall. GE claims the scans pay for themselves by also saving so many other tests. Response to that is… But we still have to write off the "old" equipment!
Siemens has already installed twenty machines, one of which is in NYU Medical Center. Mount Sinai says it has several machines from several companies, apparently using and testing them against each other at the same time.
………….Short postscript about stents mentioned above. Plastic stents that will disintegrate and be absorbed by the body are being developed by leading suppliers of the permanent type - plastic on metal -- that have sometimes caused problems. Many researchers are now convinced that stents do not provide any additional benefit to angioplasty patients after a couple of months…and they can cause inflammation, which in turn can lead to new circulatory problems.
At least one company now has them in human trials.
Battle Over "Interchangeable" Drugs
The new Medicare drug law is still a year away, but the controversy has already begun about which products can make the formularies and which can't. Also…if anyone has the right to dictate the makeup of these lists, since the plan mandates that private health plans will deliver the benefits.
On the one side is thinking best exemplified by the Veteran's Administration, whose cost-cutting has been highly praised for getting best-possible rates on prescription drugs for its patients and for the Defense Department. They do it by keeping their formularies to a minimum, claiming what they see as minute differences between competing products don't affect patient care. And in an area where a larger-dose pill often costs little more than its smaller-dose version, they are not above pill-splitting. (In fact, they supply the pill-splitter, as needed, free to patients.)
On the other side is most of the pharmaceutical companies and PhARMA, which insist proper patient care requires the broadest possible formulary, the widest-possible choices. This obviously would limit many "bulk buys" and thereby increase costs. At the same time, the drug companies say success of this program depends on how many people sign up and patients have to see their drugs -- by brand name -- on the list or they won't enroll.
The American Medical Association has strongly recommended that the government should negotiate with the drug companies to assure best-possible prices, whichever way the formulary battle goes. But the current law specifically states that the feds must stay out of price-and-product negotiations with the drug companies, all of which could lead to "price-fixing".
Legislation eliminating that condition is sure to be introduced early in the year. Leaders of that battle will certainly point out that, from its inception, Medicare has negotiated or mandated costs and fees with hospitals and all manner of medical practitioners.
Latest "Healthiness" Scorecard
Ranking began in 1990 by an insurance company interested in learning why their healthcare costs varied so much state-to-state. Today the job is done by two public health organizations and a healthcare advocacy group: United Health Foundation and the American Public Health Association, plus the Partnership for Prevention.
Going right to your bottom line…New Jersey's healthiness standing came in at number seventeen in 2004, as against 18th in 2003. Pennsylvania was ranked 25th in 2004, down from 24th in last year. New York 31st in 2004, it was 31st in 2003. All lower than we may have imagined simply because each state has so many facilities…plus the ability to attract first-rate professionals. But read on, and blame the relatively low ratings on our frenetic drivers if you wish.
The three healthiest states are Minnesota, New Hampshire and Vermont. Reason given for these high ratings are: low rates of poverty, equally low rates of premature death, safer-than-average drivers and excellent rates of spending on public health. Minnesota has ranked either first or second in every year of the survey.
At the bottom of the list are Tennessee, Mississippi and Louisiana.
States were scored according to data supplied by the CDC, the Census Bureau, the National Safety Council and a number of smaller, specialty organizations. Major changes since the first analysis in 1990 are: motor vehicle deaths dropped to 1.6 from 2.5 per 100 million miles driven…infant mortality dropped 31% in that period…smoking dropped to 22% from 30%.
On the flip side…since 1990 obesity almost doubled from 12% to 23% and those without health insurance rose from 13% to 16%. Also, first-year-of-life infant mortality rose -- from 6.9 deaths to 7 for every live birth last year -- for the first time in 40 years. Avery small but troubling trend line, since our system prides itself with constantly making life better and safer for the kids.
Another Perspective
Way out west in the "badlands", where the patients and doctors are often few and far apart, healthcare service can be affected by things we never imagine. For example, Blue Cross and Blue Shield of Montana has initiated an anti-trust suit in federal court against the only radiology group in Missoula, Montana. Complaint is they dropped out of the plan in 2003 and refuse to rejoin until the rate structure is improved. The radiologists state that the Blue's action is designed to break up their 12-physician group and thereby make them more amenable to the Blue's too-low rates. Reportedly 93% of state's physicians and 65% of the state's patients are in the Blue's net.
The action has had an unexpected immediate reaction from a local surgical group and a neurology group: both have now announced they will also opt out of their Blue Cross Blue Shield contracts.
The Blue's action argues that their members have now paid $1.3 million out of their own pockets because Missoula Radiology is not in-plan…and that they have a fiduciary responsibility to protect their 250,000 plan-members. Also named in the suit is Advanced Imaging, a scanning center jointly owned by the doctors' group and a Missoula hospital, which gives them a "lock" on imagining services in the area. The radiology group claims the hospital initiated this exclusive non-compete contract in order to assure consistent and always-available service for their patients.
UK Doctors: Make IT User-Friendly
The British Medical Association has much the same problems with IT which seem to run rampant on our side of the ocean: design engineers and software specialists too-often don't stop to ask what the medical professionals need and use. Apparently the BMA now thinks enough is enough and is starting to speak out as the country initiates the first steps in what has been described as "a massive effort to upgrade the IT infrastructure".
Medical spokespeople at a recent e-Health conference in London berated the designers and literally pleaded to increase the "level of engagement" between the two groups...especially since they are dealing with a single system that will operate from the north of Scotland to Lands' End on England's southwest coast.
Immediate reason for all this concern is quite apparent. An early step -- an e-mail system called "connect" -- went live to 95,000 existing users after a long wait and with what the doctors' see as too-little input from the professionals it was deigned to support. It crashed almost immediately …and the entire project is apparently going "back to the drawing board".
The 10-year estimate for the project will include a database of electronic health records for 50 million patients that would be available to 30,000 doctors and include the ability to transmit prescriptions electronically. Promise is that the system would be geared to handle five billion transactions in three years. But cost estimates have already exploded from $11.4 billion to as much as $55 billion.
First HIPAA Prosecution
In a way proving that healthcare workers across the country have worked hard to protect patient's rights, the first HIPAA-related legal action was basically identity theft.
A United States District Judge in Seattle recently sentenced a healthcare technician to sixteen months in federal prison for applying for credit cards in the name of a seriously-ill cancer-care patient and then running up close to $9,000 in charges. All apparently based on the fact that the technician had sufficient information -- including the patient's social security number -- to get the various cards approved.
The charges began to accumulate in the fall of 2003, about six months after HIPAA went into effect. The patient reportedly complained to the card companies and the local police but didn't get any action until a TV station picked up the story. Apparently one of the viewers of that expose was a member of the U. S. Attorney's Office in Seattle, who then chose to both prosecute the technician and make a necessary high-profile HIPAA statement regarding patients' privacy rights.
Welcome to our 16th Year
Since January, 1990 and every month since, "On the Record" has been offering what we hope is an interesting and newsy overview of the healthcare field as it applies to our workaday professional lives.
Staff members are our reporters. Our editor is a medically-knowledgeable writer. Every article is originally-written.
Purpose, of course, is to inform, enlighten and occasionally entertain our readers. And to reinforce the image of professionalism, quality and dependability that has been NJPR's hallmark of service for over 30 years.
Thank you for reading.
Coding Tips
Second of two parts: "The future at last is near...
The American Medical Association (AMA) has just released an overview of changes for 2005. There will be 171 additions, 40 deleted codes and 61 revised codes in the 2005 CPT codebook. Major changes are occurring in breast surgery, debridement, radiology, procedures performed through a scope, pathology and laboratory, and transplantation. There will be codes for radio frequency destruction of varicose veins. Category II codes which are for data collection are expanding and will have its own appendix. Category III codes used for tracking will have codes move into the main section of the codebook. These are just some of the major changes coming in coding.
The meanings of assure, ensure and insure are close in definition and they ALL mean to be sure or certain, but their use is not always interchangeable. Assure also means to put one's mind at rest. Ensure means to make sure or certain to occur. Insure has the primary meaning of issuing or obtaining insurance in order to guarantee persons or property against risk.
Transcription Tips
Medical terms can be easily understood by breaking them down to their component elements: root, prefix, suffix, combining forms and compound words. The root word refers to the main body of the word. Prefix refers to one or two syllables placed before a word to modify or alter its meaning. Suffix refers to one or two syllables placed at the end of a word to modify or alter its meaning. Combining-form element results when a vowel (a, i, e or o) is added to a word root. Compound words result when two or more root words are used to form a word.
EXAMPLE: root: arth (joint) prefix: hemi- (half) suffix: -plasty (fixation, repair of) hemiarthroplasty: Partial fixation, repair of a joint.
Root: proct (rectum, anus) Combining-form: -o (relationship to the rectum, anus) suffix: itis (inflammation)
proctitis: inflammation of the rectum, anus (NOTE: the combining form -o is deleted from the combined form when the next letter is also a vowel, therefore NOT proctoitis).
Point of Information
Many consider Dr. Thomas Syndenham "the English Hippocrates". He published the treatise "Medical Observations" in 1669; it was perhaps the first compendium of patient illnesses and their reaction to various treatments.
The book quickly became a medical text and was used extensively as a reference well into the 19th century. Dr. Syndenham also wrote at length about fevers and gout...and is credited with being among the first to differentiate between measles and scarlet fever.
Auditing the News
Healthcare IT is "coming of age" and starting to set up its own certifications. CPEHR (Certified Professional Electronic Health Records) and CPEHT (Certified Professional Health Information Technology). The first credential is designed for health infor- mation people who work hands-on in the field. The second credential is for IT people who work more-generally in the healthcare field. Exams are being given by The Health Care Conference Administration at a price of $495. For more facts, call them at 1(800) 684-4549 or e-mail: registration@HealthITCertification.com
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Newest destination point for cut rate plastic surgery is Poland, now more accessible since it joined the EU and therefore made it eligible for at least some reimbursement from western European insurance companies for at least a portion of the cost.
Hesitation is still rampant among potential patients though. Polish doctors admit that most patients check thoroughly and demand proof of accreditation and pictures of their work before making that final commitment.
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Surgeons at the Henry Ford Hospital have extended telemedicine halfway around the world by permitting 1,500 doctors at a conference in Bombay, India to "sit in" on a two hour prostate surgery that uses a robotic arm to remove cancerous tissue. The halfway-around-the-world audience used 3-D glasses to view the procedure in dimension.
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Couple of months ago, the FDA approved a system that would implant a patient's medical records -- compacted to the size of a grain of rice -- into the fatty tissue of their arms. The "radio frequency identification chips" could then be scanned with equipment similar to the kind used at supermarket checkout counters…and their medical history would then pop out.
The product is called "VeriChip". Now one of the country's leading medical supply distributors to private MD practices is taking the product on. A bit scary.
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Common thinking is that much of medical research at universities is government-funded; just the opposite seems to be happening. Twenty years ago the feds funded up to 70% of this research; today the percentage has been halved and private industry (mostly the pharmaceuticals, of course) are funding the larger portion of current research.
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Viagra may have found another place on the medical chart. Its basic ingredient -- sildenafil citrate -- has proven effective in early clinical trials as a treatment for pulmonary arterial hypertension, which is caused by extremely high pressure in the artery carrying blood to the lungs. The disease affects an estimated 100,000 people (mainly women) in the United States and western Europe. It can leave people "breathless" after simple household chores or simple exercise.
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Background report. With all the poor oversight complaints now swirling around the FDA, it is interesting to note that the first "shot" was fired by the supposedly non-combative Swiss… members of a research team at the University of Berne. Their article, which appeared in the British Medical journal The Lancet, claimed that proof Vioxx could double the incidence of heart attacks was available early-on. They made their point by using FDA's own data records covering eighteen randomized and controlled Vioxx trials and eleven observational studies… which first ran in the year 2000.
The Lancet, which initially had applauded Merck's willingness to quickly withdraw Vioxx from the market, then took it all back in an accompanying and scathing editorial which laid a good deal of the blame squarely on the FDA .
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The devastating eye disease trachoma -- which eventually causes blindness in children and their caregivers -- infects 84 million people in 55 third-world nations of Africa, Southern Asia and in pockets of Brazil, interior Australia and Mexico. Now hopefully the disease can begin to be brought under control.
British researcher report, in an article in The New England Journal of Medicine, that they treated all members of a single East African village with the antibiotic erythromycin and, in just two months, the village's infection rate dropped from close to 10% to 2%. They then monitored patients over a two year period without finding a single reinfection.
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Glaxo -- Europe's largest pharmaceutical company -- has reported good early-stage test results for a vaccine that seems to protect women against two strains of virus which are responsible for 70% of cervical cancer This possible huge breakthrough was recently highlighted in a report in The Lancet.
Merck is said to be working on a similar product.
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