Wednesday, March 26, 2008


Improving Medical Quality

It uses to be a medical axiom to do the right thing for the patient, no matter what. Well, times have changed. Now the message is to do the right thing for the patient as long as the practice, hospital or insurance company isn’t hurt.

Insurance companies monitor and send dunning letters to doctors rating their performance by how many medications they used, the number of referrals they make to specialists, and how long they keep the patient in the hospital. Officially, these letters are strictly informative, with no rewards or penalties. But they tell the doctor how to do the right thing for the patient.

Today, the insurance company got bolder, setting goals, holding back or delaying dollar payments, for failure to meet these goals. This can account to thousands of dollars. There is no scientific basis for these edicts. One must either go along with it or go out of business.

Point deductions occur if a non-generic drug is prescribed. Doctors are checked to see if the patient had too many tests, or missed immunizations or appointments. and is not using electronic prescribing programs. These electronic programs often fail after 5 pm.

Doctors are motivated with wall plaques, showing goal scores, and quality improvement scores. High grades make the doctor superior to his colleagues and he can earn performance bonuses. All these managing care plans also take precious time from seeing patients.

It is advantageous to take care of people who don’t need much care. It is also a good idea to avoid the unemployed middle class patient. By excluding high-risk patients with preexisting conditions, the insurance company can make a great profit.

The big ploy is to rate one doctor against another and make them all dependent on improving goals and payments, making reimbursement complex, and thus distract them from caring for their patients.

Overhead rises tremendously, with a need for a full time nurse and receptionist to strictly handle all the new quality improvement ideas created by pencil pushers.

There is an incentive to get rid of sick and poor patients. All the programs have everything to do about money and nothing to do about improving patient care.

Doctors have little to say these days about the care of their patients. Template cookbook care is now the order of the day. There is no creative analytic thinking necessary.

Despite a push to increase medical school enrollment by 15%, it’s hard to imagine bright and talented collegians will want to get into medicine. Fill out the checklist and call the insurance company’s phone book operator to see what you are allowed to do for the patients. There is little time to spend listening to patients and asking probing questions. Patients are deprived of true medical care.

I am unaware of any pilot study to see if these programs improve care. No programs can ever be violated and the problems keep mounting.

Do you really think government programs will simplify everything?
Source: NEJM 12.27.2007
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Monday, March 24, 2008




The FDA has reported that up to 21 deaths and 448 allergic reactions may be linked to the blood thinning product heparin..
One million doses are sold very month. The drug is most commonly used to prevent blood clots in patients undergoing kidney dialysis Heparin has been sold and used in the U.S. since the 1930’s to prevent blood clots from occurring in patients.

Patients were seen having severe reactions to the drug Heparin. Reactions included vomiting, dropping blood pressure to the point where they can go into shock,

The use of the Baxter produces half of the heparin sold in the United States. Baxter makes roughly half of the United States supply of heparin, used widely for surgical and dialysis patients

On 2/11/08 Baxter HealthCare Corp. announced that it would stop producing the blood thinner after numerous reports of serious allergic reactions and patient deaths.


The FDA has reportedly received more than 350 complaints regarding health problems that have been associated with the heparin medication in recent years. These problems seem to be most prevalent in patients who were undergoing kidney dialysis and heart surgery.
The FDA said that the problem was first reported to the U.S. Centers for Disease Control and Prevention (CDC) in January. Most of the allergic reactions occurred in dialysis centers, and in patients receiving a high dose of heparin in a short period of time. Currently, the cause of the allergic reactions is still unknown despite finding chondroitn recently as filler in the heparin..


China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration.

China has never given authority for the FDA to inspect their factories and the FDA never felt it was necessary because China was not a drug manufacturer but only a producer of chemical ingredients

However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency’s jurisdiction.


The raw material for heparin comes from the mucous membrane of pig intestines. It is collected, cooked, and dried to create heparin, which is filled in vials and sold to Baxter labs.

A factory in China gets the raw material from 2 wholesaler and they have 12 suppliers. Blue ear pig disease recently infected the pigs, and depleted the raw material stock. The suppliers were forced to get 70% of their raw material from small village factories that slaughtered sick pigs. Many family style barrels stored enzymes, and resins of the pig intestines in wastewater. The villages accepted low prices and the suppliers bought the material. Neither certification nor inspection was necessary.

Later, suppliers were forced to use sheep intestines because of continued pig shortages. We stopped using sheep in the U.S. because of acrapies in the sheep that could be transferred to humans causing mad cow encephalitis.

After the FDA sent inspectors to evaluate the Chinese facilities it reported on March 19, 2008, that heparin sold by Baxter was contaminated with condroitin sulfate, a compound less expensive to manufacture than heparin. Heparin was diluted with 50% of this filler, which acted as a blood thinner but was much cheaper to manufacture. Whether this was the problem causing the deadly reactions is still not known.


In December, American and Chinese regulators signed an agreement under which China promised to begin registering at least some of the thousands of chemical companies that sell drug ingredients. Some of these companies are the source of counterfeit or diluted drugs, including those used to treat malaria.

Discussions that led to the accord began after an unlicensed chemical plant in China made a tainted drug ingredient that poisoned more than 170 people in Panama, killing at least 115.

Congress has criticized the oversight by the Food and Drug Administration of bulk pharmaceutical ingredients made by foreign manufacturers and sold in the United States. A growing number of those ingredients now come from China. Of the 700 approved Chinese drug plants, the United States agency has inspected only 10 to 20 each year. And heart surgery. Since the end of December, there have been about 350 reports of adverse reactions associated with Baxter's heparin product.


Authorities are urging doctors to use non-Baxter vials of heparin. Baxter sells roughly half the heparin sold in the U.S. and has agreed to halt making heparin products associated with the reported adverse effects

One wonders about other drug ingredients shipped by China in the manufacture of our drugs. Will other blood thinners as Warfarin also known under the brand names of Coumadin, Jantoven, Marevan, and Waran) be checked also?


The death toll is up to  81 in the U.S.  Eleven countries have now reported adverse reactions.  After an inspection, unclean tanks were noted and raw materials arrived from unacceptable vendors.  There appears to be no adequate way to remove the impurities.  Still the origin of the source of contamination is unknown.   Deaths occured only in the U.S.  It seems our american doctors use large amounts of heparin in infusions and give the heparin quickly.

The FDA has set up 3 inspection centers in China but have not got Chinese approval yet to be there.   It will  take 15 million dollars more to inspect the Chinese drug plants every two years as they are inspected in the US.   The FDA says it needs 56 million more dollars to inspect foreign plants. It would take 13 years to check every foreign drug plant and 1900 years to check every foreign food plant.

Where would the money come from?  The domestic and foreign markets would be charged fees to pay for these inspections.

There is much concern about the safety of our Chinese imports.  First there was poisonous toothpaste, then lead tainted toys, toxic pet food, tainted fish, and now contaminated medicine.

Where does it end?  The rest of the story is still untold.  Stay tuned.

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Many web based entrepreneurs are selling genetic nutritional information and claim they can look at your genetic information and figure out what you must eat to have stronger bones, shiny hair, and good health.

Scientists have not yet developed a good understanding of how genes contribute to your health and how they can affect diseases. Yet commercialization of these gene detections is far ahead of the science itself.

The sequencing of DNA code has given information that potentially might prevent, diagnose, and even cure diseases. It may soon match a drug to you the patient. It would predict which medicine would work best for you and what the best dosage would be.


Selling nutrigenetic information has attracted companies to sell genetic tests, promising to give you diet guidance based on their results. Sciona, Genelex, Genove, Suracell and others market such panel tests.

For up to $270 these web sites will send you a kit to collect DNA from by swabbing the inside of your cheek, and a filling out a questionnaire on your life style. You get a report on 19 unrelated genes and an analysis of what this information SUGGESTS and how you should exercise and what you should eat.

It is estimated that over 40,000 such tests have been done over the last 3 years. Demand seems to be growing with the ASSUMPTION that lifestyle DNA tests is the future of genetics.

The government showed in April 2006 how customers were misled about false gene assessments of heart, insulin resistance, and susceptibility to inflammation and antioxidant activity. None of this could have been determined from genetic results and customer questionnaires. The genetic community worries that people will lose faith in the legitimate tests that are now being discovered almost daily.

MANY genes are involved in diabetes, cancer and hear disease. They all interact, and it is hard to predict how they will interact on you, the patient. You might exercise and eat right and still be unlucky and come down with a disease. Many people get cancers and have no known genetic factors.

There are over 1000 genetic tests on the market. The FDA does NOT regulate any of them for their safety nor their effectiveness. The FDA only regulates tests that are sold as medical devices, but not tests done by clinical labs for diagnosis, prevention and treatment of diseases. The FDA regulations do not cover these labs because they do not diagnose disease. They come awful close to diagnosing by giving predictions about disease predispositions.

We all expect great things from the Human Genome Product. One cannot get personalized medicine without a review of tests by an independent expert and some oversight over the labs doing the testing. BUYER BEWARE.
Sources; Am Journal Human Genetics, Vol 8, Sept 2007 items/d06577t.pdf.

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Friday, March 7, 2008


Source: NEJM 12.01.07

Inability to keep an erection strong enough to permit satisfactory sex is called Erectile Dysfunction. Five percent of men in their 40’s and 15% of men in there 70’s complain of this problem.

Years ago it was thought that is was in the mind. Now we recognize its causes and can treat this problem and maintain intimate relationships.
See for more information on intimate marital problems.

Erections occur because of increased artery and vein flow through the smooth muscle and sinusoids of the penis. Nitric oxide is made triggering the smooth muscle cells to relax. The veins are then blocked by compression resulting in an erection.

EDS may be the only symptom of serious medical problems. Biologic and psychological often cause this problem. Coronary disease accounts for two thirds of the cases and medications for 25% of the cases.

The other 9% are caused by: metabolic syndrome, enlarged prostate, heart disease, and neuralgic diseases as Parkinsonism, smoking, diabetes, and endocrine problems. Symptoms may disappear by losing weight, exercising, stop smoking and relieving stress.

Use of Viagra and other medications that relax the smooth muscles work in 51% of patients. Failure occurs because of vasodilatation reactions in other parts of the body resulting in myocardial infarctions and coronary ischemia. Vision and headaches and nausea also can occur in use of these medications.

Marked physical activity during sex increases the sympathetic activity that raises the heart rate and the blood pressure. If coronary ischemia is present or nitroglycerine is used, the blood pressure may dangerously drop.

Prostaglandin E can be injected into the penile smooth muscle. This decreases the calcium in the cells and increases AMP. Full rigidity occurs in 50% of the patients. By adding papaverine, TRIMIX, the success rate is much higher.

These suppositories are put in the urethra. Success rate is about 43% in men who do not respond to Viagra. There is a small risk of erections longer than 4 hours. This is called priaprism.

This can be given transdermally and is 80% successful. Giving it in the muscle results in a 50% success rate. There are some drawbacks to this treatment. Breasts may enlarge, sleep apnea may occur, prostate may enlarge, cholesterol may rise, and liver enzymes may be affected. A trial of 3 months is recommended. If complications occur, treatment is stopped.

If nothing works one can consider a penile device.
Vacuum erections trap blood in the penis by use of an elastic band at the base of the penis. One third of men are satisfied.

Surgical implants into the penis with inflatable implant or a malleable implant. Most men are very satisfied.

Non-genital massage, behavioral interventions and sex instructions may help.

Known drugs causing EDS are diuretics, beta-blockers, cardiac drugs
cholesterol lowering drugs as statins, antidepressants and tranquilizers, anticonvulsant, cocaine, and alcohol.

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Thursday, March 6, 2008



A study from Boston reviewing nursing home use of antibiotics claim the patients received no benefit from the antibiotics used and the patients would be better served by use of oxygen and pain medications.

The study was of 214 patients of whom 150 had Alzheimer’s disease, and the rest had some degree of dementia. Half of the patients had antibiotics for respiratory infections and one third had urinary infections.
Two thirds of patients get antibiotics in nursing home and 40% of them become drug resistant. In the last two weeks of life 40% of the patients currently get antibiotics. Lead author Dr. D’Agota stated antibiotics could cause an unnecessary burden and they are not sure it will improve the quality of life or prolong their lives.

The suggestion is that we should not treat people with dementia when they get infections. There is an increase risk of contributing to antibiotic resistance.

COMMENT: The patients can’t make these judgments but it is hoped their families and society would have difficulty embracing the opinions of the authors of this study. Are we at that point that costs overshadow the treatment of elderly patients in nursing homes?

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Now that the drug companies can’t directly influence the doctors with visits and gifts, they are directly reaching the patients with magazine and TV drug advertising. And it really works.

One third of patients ask their doctor about the advertised medicine.
Forty percent ask for the drug and 81% leave the office with some prescription. Seventy five percent of the doctors cave in and give the patient what the drug company advised.

Drug advertising went up from 2.6 billion dollars five years ago to 4.8 billion today.

Is this good for patients? It certainly costs the country more.

On another note, 25% of patients don’t fill the prescription from their doctors and another 20% under treat themselves by cutting their pills in half.
Sources: Kaiser Family Foundation
USA survey Jan 2008

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source: NEJM 1.23.2008

We find ourselves in a health care crisis with not enough doctors. Ten years ago there were too many doctors, especially specialists. Congress capped the number of funded Medicare residencies in 1997. The shift is not toward more general practitioners.

Because of increased economic growth, the residencies were increased to 10.000 graduates annually. Medical school enrollment was raised 15%. A shortage of doctors has occurred. Because of our aging population and increased physician visits, decreased productivity by part time female doctors working fewer hours, and doctor needs for more balanced lifestyles, It was felt that there would be a 10% deficit by 2020 with 90,000 more doctors needed. With universal health care, the shortage would become more acute.

The Association of American Medical Colleges has expanded recommendations for 30% more medical school graduates and more federal funding to support residency positions. Medical schools plan a 17% increase by 2012. Most of this increase will go to fill additional residency positions.

How will it help by adding more doctors to a system that frustrates patients who are disappointed with their current health care? Patients are angry at today’s goals for performance, workforce policies and initiatives, access to care, and absent personal and compassionate care.

Some regions have very few doctors in badly needed communities. Regional supply of cardiologists is badly needed in areas with Medicare patients. Some areas have a surplus of doctors and other areas with severe problems fail to meet the medical needs of communities. No one compares patient preference and needs in deciding the number of physicians needed in an area.

Doctors don’t go to areas of patient needs. Areas with low-income minority residents have great health needs. Yet few doctors open offices in these areas. Call it’ the inverse distribution of care law’.

Once enough doctors flock to an area, patients rarely get any benefit. This is confirmed in university academic centers treating elderly patients with chronic diseases It takes 16 doctors per 1000 patients to take care of end of life patients @ UCLA and only 8 in the average health center. Yet patients have the same outcome with a variable number of doctors giving service. Patient satisfaction is the same at both kinds of medical care. Better access to care provides better outcomes. The number of doctors does not equate to better quality of care.

Despite a 50% increase in supply of doctors over the last 20 years, only one out of 5 went to an area with a low supply of doctors. Eighty percent went to areas of oversupply.

How can you change physician settlement patterns?
More doctors result in the elderly having a higher hospitalization rate, higher ICU rate, and more doctors caring for each patient in an uncoordinated manner. Specialty services result in a lot of hospitalizations and a large number of expensive tests.

If we don’t increase the number of doctors our health care will suffer. But there are better ways to stop obsolete resources by having more primary care doctors. They can provide the best outcomes @ the lowest costs. Fewer Medicare specialists would be involved and there would be fewer ICU and hospital days resulting in lower health care costs.

Certainly, the doctor work force is now effective. Expanding the work force dramatically would be however being disruptive. Covering more uninsured children and reforming the payments to doctors would be money well spent. Lowering the litigation climate would also be a big saver in over utilized testing.

The goal should be to provide more access, better quality, and more efficiency with better outcomes.
Adding more doctors per capita will by itself not improve the system.

What do you think?
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Wednesday, March 5, 2008


JAMA MAR.03,2008

Most women will experience menopause between 47 and 51 years of age. They will have menopausal symptoms for about 5 years

A study called the Woman’s Health Initiative study was revisited reviewing findings of women in their 50’s. This current review found that women in there 50’s who took hormones actually had a 30% lower risk of dying than those who did not. Those taking estrogen also had a lower risk of severe coronary artery calcium deposits.

The only negative factor was a statistically insignificant finding that those who took hormone had a 0.31% increase in cancer. The role of individual cancers also was not statistically significant.

The WHI study was stopped abruptly in 20002 because it showed at that time, higher rates of cancer and heart disease in those taking hormones. The study was of 16,000 women with an average age of 63.

All this shows how much conflicting data is present on this subject. It seems almost too complex for the medical profession to interpret.

The effect on hormones on prevention of bone fractures will be evaluated from this study in the near future.

Stay tuned
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