Attacking Cancer From the Inside
One of the dreams of cancer patients may be within reach; not now, but somewhere in the not-too-distant future. It is still very early-on, with many stages of research to go - but nanotechno-ogy is gearing up to help fight cancer. The most-recent patients have been small -- laboratory mice infected with human prostate cancer -- but the results have been uniformly excellent.
Nanotechnology is generally referred to as the science of manipulating matter -- such as antibodies -- to finite size, which enables them to travel within the human system. (“Nano” is derived from the Greek word for dwarf.) Best estimate is that one million nanos can fit on the head of a pin!
Working as a team, scientists at Harvard Medical School and MIT combined their talents and embedded nanoparticles into human cancer cells that had previously been implanted into the fleshy area on the side of mice. The mice were divided into five groups, each receiving different injections.
One group received nano injections filled with saltwater; the second group received nano injections that had no “filler”. Both groups died. Two groups received nano injections that included non-cancer-targeted drugs; this had some initial negative effects on the cancer cells, but the cancer quickly rebounded.
The fifth and final group received injections of nanoparticles containing the cancer drug Taxotere - and the tumors completely disappeared. All results were tracked over a hundred-day period.
The scientists say that -- down the road -- the targeted injection area method could most likely be supplemented, or more-likely replaced, by injecting nanoparticles into the bloodstream and have them seek out the tumors on their own. The scientists also say they hope to attempt human trials in about two years. Which means this “miracle”, if it happens, is still about ten years away from general use.
Two other early-stage treatments are promising, each specifi-cally targeted towards breast cancer. The first is being researched simultaneously in the United States, Spain and Italy; it surprisingly concerns the possible anti-cancer abilities of the over-the-counter sleep aid Melatonin..
Thinking goes as follows - natural Melatonin is produced by the body in an effort to regulate cycles of sleep and wakefulness, which are often themselves regulated by light and dark. Industrialized nations use artificial light to fend off the darkness; therefore its people most likely produce less Melatonin. Third world countries have less artificial light at their disposal; therefore their people most likely produce less Melatonin. There are ab-normally higher levels of breast cancer in industrialized nations!
The researchers are currently involved in a wide variety of studies to learn if there is an apparent discovery here - and, if so, whether science can perhaps also use Melatonin to even fight a wide variety of cancers.
Finally, hope of a more-immediate nature, as reported in the Journal of Clinical Oncology.
In a Phase III test and prior to surgery, researchers at the U. of Texas MD Anderson Cancer Center treated patients afflicted with a particularly aggressive type of breast cancer (HER-2) with the drug Herceptin in addition to the usual chemo.
The new treatment destroyed 42% more tumors than in the control group. This surprising level of success prompted the researchers to suspend the trial and offer this combination therapy on a broader basis.
HHS Awards IT Start-Up Contracts
Four E-Health consortiums were recently awarded one-year contracts totaling $18.6 million to develop the architecture of a prototype network for the “national health information highway”. Leaders of the winning consortiums are IBM, Accenture, Computer Sciences and Northrup Grumman. All involved companies will supplement these funds with considerable amounts of their own money, simply because their initial effort -- covering a dozen regions across the country -- will solidify their positions as leaders in E-Health projects that will eventually roll out and reach into the billions of dollars.
The four lead companies will each work with as many as ten sub-contractors on the project. More than 70 corporate groups originally made presentations for the contracts.
The winning groups will work in three separate regions of the country to develop local health networks over the coming year. Every group can and most likely will use slightly different technologies; only rule is that they must be compatible with other networks, so that information can be coordinated and used by all. The goal of course is a digital sharing of facts, diagnoses and treatments - and to move this information “seamlessly” along the network as needed. Involving hospitals, pharmacies, labs and physicians. Increasing the quality of care patients receive and the personal health information patients can receive about their conditions.
There is a marked difference between the direction being taken in the United States and that taken by several other countries such as Britain, for example, where their National Health Service is financing and effectively micro-managing every aspect of their EMR “highway”.
According to Dr. David Brailer, Coordinator of Health Information Technology, we start with no firm commitments to a single pathway. Objective of this initial step is the creation of perhaps-competing networks, each working within its region in an attempt to find the best way to get the job done effectively and economically. Hope is that the variety of thinking will result in slightly different -- perhaps faster, perhaps more cost-efficient, more-innovative -- methods of electronic operations. But never forgetting the key element: each system must retain the ability to interact with the other. Competing but compatible approaches.
Example given was the various and somewhat different ATM networks that, though they may vary slightly in actual operation, enable customers to complete all their transactions literally in seconds - wherever they may be.
Work on the prototypes began last month and is scheduled to be completed by the end of 2006. The contracts contain a provision for a one-year extension if it is found that additional basic start-up work is needed.
Complete Disclosure
In an apparent effort to head off complaints of unfair secretiveness and lack-of-information regarding clinical trials, the International Federation of Pharmaceutical Manufacturers & Associations has worked for many months establishing the web portal www.ifpma.org/clinicaltrials, which is now up and running. It’s stated aim is to provide doctors and patients with detailed facts and basic information that covers from how and why clinical trials are set up, to how and why individuals may attempt to get personally involved in a specific trial, to final results or to results-so-far of a specific ongoing trial.
The sponsors say the objective is to provide better, easier-to-access in-depth information for both patients and doctors - making them aware of both the potential benefits and possible failings of these new drugs.
In yet another effort to neutralize the image of secrecy that has apparently dogged them for years, the site goes to great lengths to help viewers quickly reach the exact area of facts they are seeking. The site also explains in detail to the uninitiated the various stages of trials from I to IV, talks about pre-trial efforts, even spells out the meanings of basic terms such as “placebo” and “control group”. It discusses in detail the possible risks to participants.
One of the apparent key reasons for this ongoing effort, of course has been the high level of controversy which has led to accusations that the pharmaceutical companies often mask at least some of the facts involved in most trials and “paper over” negative results. The drug companies have consistently defended themselves by stating that this is only an effort to maintain proprietary information that would give competitors an unfair edge.
But the Vioxx trials and many like it have apparently proved to the pharmaceuticals they have got to get the facts out or face even more litigation.
Several pharmaceutical companies have already launched somewhat-more-basic individual sites, but this is the first collaborative effort. The site members include Novartis, Merck, AstraZeneca, GlaxoSmithKline, Sanofi-Aventis and Pfizer, with perhaps more to come.
Drug Import Battles Continue
The efforts of local and state governments for the right to bring drugs over the border from Canada keeps causing trouble on all sides. Latest potential casualty is David Duncan, the embattled executive of DC-bordering Montgomery County, Maryland, instructed by his county board to take actions that he agrees with but feels will effectively break the law.
The FDA -- whose offices are within the county -- previously refused to grant the county a federal waiver to set up a pilot “feasibility program” which would include county schools, employees and retirees. The FDA’s blanket rejection included a statement that the agency simply cannot assure Americans that drugs delivered from foreign countries are safe. The county council then passed a strong vote to ignore the FDA ruling and immediately implement the program for county employees and retirees. (The school board had held back, refusing to participate without FDA approval.)
Mr. Duncan said that, though he wholly agreed with the premise, he would not countersign or implement the bill without FDA approval - simply because that would be illegal. An angry council president threatened that if Mr. Duncan won’t implement it, he will.
Meanwhile, the county has filed suit in federal court to get the FDA ruling set aside, claiming the agency simply dismissed the request out of hand. A positive response from the court would solve the problems, but though many such actions have been brought by states and municipalities, none have succeeded.
Frustrated and cash-strapped county council members say they have been seeking a logical solution for a year and have a conditional agreement with a health benefits company in Windsor, Ontario to obtain and ship the drugs.
State of the Art IT
A whole new generation of software security companies is quietly emerging; their work starts where the mass-market computer protection services top off. Their service is to anticipate and protect against software problems before anyone else thinks of causing that particular form of trouble.
Companies like Tipping Point and iDefense now actively seek out and pay substantial fees to the best of the hackers to find flaws in clients’ systems - which are then locked down before a possible illegal break-in can occur. Theory is, illegal hackers will never stop seeking and eventually finding flaws even in the most sophisticated system. Complaint is the company is effectively “paying ransom” up front.
"Talk Medicine"
A Dallas-based company by the name of TeleDoc is now offering over-the-phone primary medical care 24/7. Often including pre-scriptions for all but controlled substances. TeleDoc claims it has treated 40,000 patients so far and is operating in all fifty states.
This is not the first such service; there are several in start-up now and each is obviously quite controversial. Many seem to be struggling, this one seems to be doing rather well. The company has an 800 number. The call is forwarded to a doctor who is licensed to practice in the patient’s state. Patients under 12 are not accepted. Consultation is said to be limited to non-emergency problems such as respiratory infections, allergies and sprains.
Subscribers are required to pay a registration fee of $18.00 plus a monthly “membership fee” of $4.25 for an individual or $7.00 for a family - plus $35 for each telephone medical consult. A call-back is guaranteed within three hours or there is no charge for the “visit”.
TeleDoc says their physicians spend an average of 15 minutes on the phone with the patient - first checking the individual’s overall medical history, then moving on to pertinent questions regarding the reason for the call and patient’s current symptoms.
A number of state legislatures and medical societies -- including the American Academy of Family Physicians -- strongly oppose the idea. Several states have imposed rules of procedure that seriously restrict the concept. Others are investigating the legality of the practice. TeleDoc’s answer to all this is that it has not received any reports of complaints of “improper treatment”.
Canada Steps Up
Tanzania, in deepest Africa, is one of the poorest countries in the world with little or no healthcare services; in fact one in six children die before the age of five; and they die of easily-defeatable diseases. A decade ago, the deeply-in-debt country initiated a pilot program called TEHIP (Tanzanian Essential Health Interventions Project) in two of its districts.
TEHIP is based on a simple and often-overlooked premise: when child healthcare cash is short - concentrate your effort. Monitor the youngsters to learn what is causing the majority of these deaths, then use the few funds you have to concentrate on attacking those causes! In Tanzania’s case, the causes were malaria and diarrhea.
Using this thinking, the program reduced death rates for youngsters by 50% and did it at a cost of $2 a patient a year. The country’s per capita income is $342; the amount spent on healthcare averages $9.50 a year per person. Program expansion to the entire country was a next-logical step, but the funds and the expertise just wasn’t there.
Until Canada, suffering its own well-reported healthcare-delivery financial problems, volunteered to help. Offering $7 million and medical-related knowledge with the locals supplying $12 million and willing hands. A lot of money in a poor country.
The program is now going nationwide. Canada’s contribution will pay for and equip a number of soon-to-be-constructed regional training centers and to train the staff, hands-on.
HIPAA Not Good Enough!
Seems strange after all the effort and trouble so many have had establishing and enforcing all the rules of compliance - but fears and complaints of “not enough” are still manifesting themselves on at least two fronts.
The Electronic Privacy and Information Center in Washington cites both the large number of security breaches in the financial services area and the increasing incidence of identify theft as wake up calls that HIPAA needs even more personal information firewalls. Another group, the Citizens for Health has filed a lawsuit stating that HIPAA regs still too-easily permit personal health information to be disclosed without patient warning - and that, just during the initial switchover period, the feds effectively permitted healthcare and insurance reps -- often with the assistance of hackers access to personal healthcare records of 1.5 million patients.
Among other things, complaint is the HIPAA law sounds good, means well but lacks tough standards of enforcement and liability.
Ginseng Anyone?
A double-blind catch-a-cold study of 323 volunteers at the University of Alberta, Canada, was recently reported in the Canadian Journal of Medicine. One group took 200-milligram tablets of a product rich in North American ginseng extract; the control group took an identical-looking placebo.
Subjects were asked to regularly submit a record of symptoms in various categories that included cases of fever, headache, sore throat, runny nose, headache - which participants ranked from zero for “no symptoms” during a given period to three for “severe symptoms”.
Ten percent of the “ginseng group” reported two or more colds during the study’s four-month period. But more than twice as many -- 23% -- of the control group reported two or more colds during the same period. Also the placebo groups reported colds that were more severe and lasted on average two days longer than the “ginsing group”.
The authors said they consider the results “promising” but in need of large-scale additional testing. Which we hope they are conducting as you read this.
Acupuncture Goes A Bit Mainstream
It is starting to gain professional recognition of a sort. According to a recent survey by the CDC, hundreds of thousands of Americans are getting relief from pain through acupuncture - and that often their first treatment is the result of a doctor’s suggestion. The hows and whys it works in many cases are still not fully understood in the medical profession, but there is apparently a growing belief that these carefully-placed needles sometimes do work better for some patients than many of the pain-killing prescription medicines.
Aside from the talk of yin and yang and of “life forces” flowing through the body, it seems that acupuncture affects activity in several parts of the brain - and just may work its “magic” by reducing the emotional elements of pain. Hormone release could play a part in this. But basically it seems as of now, that the pain may still be there, but the patients doesn’t mind it quite so much.
Nothing definitive just yet, but there is lots of research going on at some of the nation’s top medical centers...such as NIH, University of Pennsylvania, Mass General, UCLA. Everything points to the fact that there just may be more to acupuncture than we westerners have imagined.
Medical Minutia
The National Museum of Health and Medicine, within the Walter Reed Army Hospital complex in Washington, D. C., is dedicated to tracing medical practice and illustrating the tools-of-treatment used through the ages - with particular emphasis on tracing and illustrating Medicine in America, of course.
One segment includes more than 12,000 surgical-type instruments - another features more than 5,000 skeletal specimens that have played a vital part in analyzing and treating disease and medicating serious injuries. There are also over 350 photos and illustrations of medical treatments - many rather surprising - that date back to the Civil War.
Coding Tips
New codes were added to CPT for 2006 to report harvesting and later grafting of a patient’s own skin. This procedure is performed on patients who have experienced a large percentage of severe burns.
A skin graft is taken from a patient to be cultured and grown in a laboratory, which can increase the size of the skin excised by up to 50 times the size of the graft harvested. Code 15040 is assigned for harvesting of skin for tissue cultured skin autograft, 100 sq cm or less.
These autografts arrive from the labs in sterile containers, and often come in 25 sq. cm. sections. The tissue-cultured skin is then grafted to the healing burn sites.
Codes 15150, 15151, & 15152 are assigned for tissue cultured epidermal autografts of the trunk, arms, legs, and codes
15155, 15156, and 15157 are assigned for tissue cultured epidermal autograft of the face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits.
Transcription Tips
"Don't use 'em!" Edit out contractions, jargon, abbreviations with contractions and slang, except in direct quotation: change can't to cannot, I'd to I would or I had, he's to he is or he has and it's to it is or it has (unless "it's" is used as a possessive, in which case, not expanded). Extend out any abbreviation that has been dictated as a contraction: Change OD'd to overdose and guaiac'd to guiaic test. If you use a contraction, be sure to place the apostrophe correctly: Mom reported, "He's been sick." Slang such as "dex" should be expanded to dexamethasone, "appy" to appendectomy and edit "Bovied" to (treated with or removed with) Bovie cautery.
Auditing the News
For most of us, talk has always been about the hard-driving “A” personality people that never seemed to stop striving and were therefore particularly susceptible to heart disease. Now there is a growing body of evidence developing that is switching this mantle to the newly-categorized “D” type, made up of people who are almost the exact opposite: often anxious and nervous, sometimes hostile.
For example, trials in the Netherlands of 875 people who had received stents to repair a portion of their coronary arteries concluded, after comprehensive followups, that type D patients were as much as four times as heart-attack-prone as all other personality types in the study. Surprising results; more study needed, of course.
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One of the leading pharmacy benefits management companies -- Express Scripts, Inc. -- has put a dollar value on the generalized claims that have been made for so long. Based on a recent three million prescription sampling of members’ records, they project that more than $20 billion a year could be saved in the U. S. if patients insisted on filling their prescriptions, whenever possible, with generics rather than the brand names.
ES says that the $20 billion saving is available here and now and will increase sharply in coming years. Conclusions are based on the benefit manager’s estimate that brand name prescriptions, on average, cost $60 more per prescription than generics.
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The somewhat good news is, according to latest figures from the U. S. Census Bureau, the percentage of Americans without health insurance remained stable at 15.7% in 2004. The really bad news is, due to America’s population increases, the actual number rose by 800,000 to 45.8 million. A bit better news is the number of uninsured children at least remained stable during that period; it’s 11.2% or 8.3 million.
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Another small but important step for EMR. Two counties in Oregon joined in an area-wide switchover to a regional electronic system that is anticipated to take three to five years to fully implement. A local physicians’ association, is spearheading the move with financial and tech support, as needed, for the close to 500 doctors involved.
The project’s estimated cost is $8 million during the initial three-year changeover period.
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Expanding with the times. The Health Information and Management Systems Society recently announced that it is expanding its reach by forming the HIMSS RHIO Federation. Their initial goal is to interest five to eight Regional Health Information Organizations into joining up in the near future.
HIMSS says there are already more than 200 RHIOs in the United States and Puerto Rico . Basic goals are to develop close interrelations, codify business rules and share data in this just-developing but most important area of IT.
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New York University’s Institute of Plastic Surgery recently celebrated its fiftieth year with a gathering of some of the once severely facially-disfigured patients it has helped. This is not a “beautiful makeover” center; each year it treats thousands of adults and children who just want to look close-to-normal.
Most can’t afford the huge expenses; some patients have had as many as ten operations, one young woman has had an unbelievable 78 facial operations since she was five years old. Luckily the Institute is financially supported by the National Institute for Facial Reconstruction.
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The pharmaceutical companies are suffering a severe backlash of confidence according to an end of the year survey that showed only 9% of Americans thought they were basically honest. This compared to 34% who trust banks!
The problem according to many industry experts may be the almost-constant direct-to-consumer TV advertising that keeps glorifying products which occasionally go bad.
According to the industry, the public takes for granted the breakthrough drugs but long remembers the errors and the lawsuits. And what is seen as “unfairly-high” prescription prices which the industry claims pays for the discoveries that lead to better and longer lives.
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According to a recently-reported study by Medco Health Solutions of adults aged 20 to 44, the use of sleep medications doubled between 2000 and 2004. And went up even more dramatically in the 10 to 19 age groups. The elderly are still the largest group of sleep-aid users.
Estimate is that 70 million Americans may be “sleep challenged” in some way. Children, it seems, have a problem falling asleep, while adults have a problem staying asleep!>>>>>>>>>>>>>>
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