Wednesday 10 July 2013

‘Reading between the lines’ and ‘Taking with a pinch / grain of salt’



‘Reading between the lines’ and ‘Taking with a pinch / grain of salt’

This is not an advice to you – to read between the lines, or for that matter – to find the hidden meaning in the fine prints that you read from time to time. But coining of these two phrases and using them as a caption, in here, did occur to me while I was actually engaged in the act – of reading. More often than not we take many things at their face value, especially what we read in the articles in the print media or ‘infos’ sms / emails sent to us.  We take it as the gospel truth, without verifying either the credentials of the writer or the authenticity of the written material. And this belief is so well established in our minds that we ‘share’ this gospel truth with our Face Book friends.  Sometimes this info received as sms, email or F.B. share may do more harm than good.
As I was saying, the whole idea occurred to me while I was reading an article on the recently banned diabetes drug, Pioglitazone. There were arguments both in  favour of the imposed Government Ban as well as against it.  In Europe, especially in France and Germany, it is already banned and in US, it is sold with this warning:

In US :IMPORTANT WARNING:

Pioglitazone and other similar medications for diabetes may cause or worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start to take pioglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease; high cholesterol or fats in the blood; high blood pressure; coronary artery disease (narrowing of the blood vessels that supply blood to the heart); a heart attack; an irregular heartbeat; or sleep apnea. Your doctor may tell you not to take pioglitazone or may monitor you carefully during your treatment.
If you develop congestive heart failure, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking pioglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; needing to sleep with extra pillows under your head in order to breathe easier while lying down; frequent dry cough or wheezing; difficulty thinking clearly or confusion; fast or racing heart beat; not able to walk or exercise as well; or increased tiredness.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pioglitazone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http:www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking pioglitazone.

What side effects can this medication cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Pioglitazone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

·         headache
·         muscle pain
·         pain in the arms or legs
·         sore throat
·         gas

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

·         changes in vision
·         vision loss
·         frequent, painful, or difficult urination
·         cloudy, discolored, or bloody urine
·         back or abdominal pain
You should know that pioglitazone may cause liver problems. Stop taking pioglitazone and call your doctor right away if you have nausea, vomiting, loss of appetite, pain in the upper right part of the stomach, flu-like symptoms, dark urine, yellowing of the skin or eyes, unusual bleeding or bruising, or lack of energy.
In clinical studies, more people who took pioglitazone for more than one year developed bladder cancer than people who did not take pioglitazone Talk to your doctor about the risk of taking this medication.
In clinical studies, more women who took pioglitazone have developed fractures (broken bones), especially of the hands, upper arms, or feet, than women who did not take pioglitazone. Men who took pioglitazone did not have a greater risk of developing fractures than men who did not take the medication. If you are a woman, talk to your doctor about the risk of taking this medication.

One argument against the ban is this: India is a country of young diabetics.  The drug is well tolerated by the young and hence the blanket ban is unjustified. There is clearly no consensus about the drug being harmful, which is why the rest of Europe continues to use it. Then there are others, like this doctor and to put it in his own words, “There is no denying that the drug has adverse effects (ironically, yet they say not harmful) but its judicious use can curb the risk factors.” However, medical associations and experts have little data to vouch for its safety.

So I conclude, from the above argument that the drug could still be safely prescribed to a young under proper and strict medical supervision. But I was shocked  when a doctor prescribed it to my sister-in –law, who is 60+. (May be the doctor thinks she is young).  Now, is this what you call judicious use? So do talk to your doctor about the risks of taking pioglitazone, in case you are on it.

Perhaps, you must have read in papers about one Mr. Manilal Gala (67), who had been advised a heart surgery (bypass) way back in December, 2012. He did what many patients normally do – look for ways to bypass the bypass surgery. However, six months later and poorer by about a lakh of rupees, having spent it on an alternative therapy (chelation), he landed at Lilavati Hospital with a heart that was barely beating, working at a tenth of the normal pumping rate,  and with calcified arteries like those of much older patients and his kidneys functioning par below normal.
Dr Kumar believes the chelation therapy that Gala opted for didn't work well for him."Gala went to a centre in Borivli that started the treatment without seeking an angiography report," said Dr Kumar. Gala felt good for the four months that the therapy lasted, but thereafter, his health deteriorated. An angiography done last month showed a complex heart disease spread across three blood vessels.
Doctors say skipping the bypass is not often the best idea. "Patients should thoroughly investigate whether alternative therapies are good for them," said Dr Kumar.
Dr Pratiksha Gandhi, a preventive heart specialist who offers enhanced external counterpulsation to heart patients, said, "Alternative therapies have their limitations. Any doctor who offers such procedures should select patients with care." However, she said alternatives such as EECP offered patients a palliative care. "They take away the discomfort and prepare patients for surgery," she added.
Dr Rohit Sane of MadhavBaug, which offers ayurvedic cure for heart blockages, concurs. "Patients have to do a six-minute exercise. Those who fail have to do a bridge therapy before the main treatment."
Then the other day my daughter received the following information and the sender wanted it to be shared with her other friends on Face Book:

USEFUL INFO !!! 
Recently, a person (who is this person) was admitted to a nursing home at Kandivli, Mumbai, due to severe chest pain. He had an earlier attack in 1997 and was under treatment. The doctors now suggested Angiography. 
  Upon undergoing Angiography at Hinduja Hospital, doctors diagnosed multiple blockages for which Angioplasty was fuled out (must have meant 'ruled out')  and instead, (was) suggested 'Bypass Surgery'. That evening, he was brought home as doctor (had) suggested his heart being very weak, bypass can be (could be) performed only after 15 - 20 days. 
  Meanwhile, whilst discussing the matter with relatives and close friends, fresh  information came from a family friend. 
  A new treatment known as - Chelation Therapy has been introduced into the Indian medical theatre. 
  With this therapy, a patient who has to undergo by-pass need not do so. Instead, the patient is given about 18 bottles of blood in which certain medicaments are injected. The blood cleans the system and removes all blockages from the heart and arteries.  The number of bottles given may increase depending upon the age-factor and health of patient. 
Cost per bottle may be around Rs.2,500/- Treatment takes about a month. 
Currently, only a few doctors in India specialise in this field, and one of them is Dr.-------------- at Malad (Mumbai). 
He has a list of patients who had to undergo by-pass from Lilavati, Hinduja and other major hospitals but instead, after undergoing the new treatment, they are absolutely fine and are leading a normal life. 
Doctor's details for your info are: 
  Dr.----------------
Hospital Tel: -                   . Mob:  -------Email: -------
Dr_________________
Integrative Cardiac -________.
. Vastrapur, Ahmedabad,, 380015, Gujarat,

From Sources ... pls also take advice from your family doctor  forward to all ur friends & relatives. ]

I advised my daughter against sharing this info on Face Book, on two counts:
I] Mr. Gala’s experience on undergoing this therapy as reported in the papers and lack of data on this therapy.
What is this Chelation Therapy? Here is what I found:

Chelation Therapy:
Unproven Claims and Unsound Theories

Saul Green, Ph.D.

Chelation therapy, as discussed in this article, is a series of intravenous infusions containing disodium EDTA[ organic chemical ethylenediaminetetraacetic acid (EDTA)] and various other substances. It is sometimes done by swallowing EDTA or other agents in pill form. Proponents claim that EDTA chelation therapy is effective against atherosclerosis and many other serious health problems. Its use is widespread because patients have been led to believe that it is a valid alternative to established medical interventions such as coronary bypass surgery. However, there is no scientific evidence that this is so. It is also used to treat nonexistent "lead poisoning," "mercury poisoning," and other alleged toxic states that practitioners diagnose with tests on blood, urine, and/or hair.
The proponents' viewpoints have been summarized in four books: The Chelation Answer: How to Prevent Hardening of the Arteries and Rejuvenate Your Cardiovascular System (1982), by Morton Walker, D.P.M., and Garry Gordon, M.D.; Chelation Therapy: The Key to Unclogging Y our Arteries (1985), by John Parks Trowbridge, M.D., and Morton Walker D.P.M.; A Textbook on EDTA Chelation Therapy (1989), by Elmer M. Cranton, M.D.; and Bypassing Bypass: The New Technique of Chelation Therapy (2nd edition, 1990), by Elmer Cranton, M.D., and Arline Brecher. The scientific jargon in these books may create the false impression that chelation therapy for atherosclerosis, and a host of other conditions, is scientifically sound. The authors allege that between 300,000 and 500,000 patients have safely benefited. However, their evidence consists of anecdotes, testimonials, and poorly designed experiments.
This article identifies the major claims made for EDTA chelation and examines each in light of established scientific fact. The sources used for this review included position papers of professional societies, technical textbooks, research and review articles, newspaper articles, patient testimonials, medical records, legal depositions, transcripts of court testimony, privately published books, clinic brochures, and personal correspondence. [Note: Chelation with other substances has legitimate use in a few situations. For example, deferoxamine (Desferol) is used to treat iron-overload from multiple transfusions. But this is not related to the topic of this article, and chelation with disodium EDTA is not a substitute for Desferol chelation.]

Early History

The term chelate, from the Greek chele for claw, refers to the "claw-like" structure of the organic chemical ethylenediaminetetraacetic acid (EDTA), first synthesized in Germany in the 1930s. With this claw, EDTA binds di- and trivalent metallic ions to form a stable ring structure. EDTA is water-soluble and chelates only metallic ions that are dissolved in water. At pH 7.4 (the normal pH of blood) the strength with which EDTA binds dissolved metals, in decreasing order, is: iron+++ (ferric ion), mercury++, copper++, aluminum+++, nickel++, lead++, cobalt++, zinc++, iron++ (ferrous ion), cadmium++, manganese++, magnesium++, and calcium++.
Mercury, lead, and cadmium cannot be metabolized by the body and, if accumulated, can cause toxic effects by interfering with various physiological functions. These substances are called "heavy metals," a term applied to metallic elements whose specific gravity is about 5.0 or greater, especially those that are poisonous. Aluminum is not a nutrient, but iron, copper, nickel, cobalt, zinc, manganese, magnesium, and calcium are essential nutrients that are needed for normal metabolic activity.
After EDTA was found effective in chelating and removing toxic metals from the blood, some scientists postulated that hardened arteries could be softened if the calcium in their walls was removed. The first indication that EDTA treatment might benefit patients with atherosclerosis came from Clarke, Clarke, and Mosher, who, in 1956, reported that patients with occlusive peripheral vascular disease said they felt better after treatment with EDTA [1].
In 1960, Meltzer et al., who had studied ten patients with angina pectoris, reported that there was no objective evidence of improvement in any of them that could be ascribed to the course of EDTA chelation treatment. However, during the next two months, most of the patients began reporting unusual improvement in their symptoms. Prompted by these results, Kitchell et al. studied the effects of chelation on 28 additional patients and reappraised the course of the ten patients used in the original trial [2]. They found that although 25 of the 38 patients had exhibited improved anginal patterns and half had shown improvement in electrocardiographic patterns several months after the treatment had begun, these effects were not lasting. At the time of the report, 12 of the 38 had died and only 15 reported feeling better. (This "improvement" was not significant, however, because it was no better than would be expected with proven methods and because there was no control group for comparison.) Kitchell et al. concluded that EDTA chelation, as used in this study, was "not a useful clinical tool in the treatment of coronary disease."
The "Approved" Protocol
The primary organization promoting chelation therapy is the American College for Advancement in Medicine (ACAM), which was founded in 1973 as the American Academy for Medical Preventics. Since its inception, ACAM's focus has been the promotion of chelation therapy. The group conducts courses, sponsors the American Journal of Advancement in Medicine, and administers a "board certification" program that is not recognized by the scientific community. ACAM's online directory lists about 850 members, about 550 of whom indicate that they practice chelation therapy.
In 1989, an ACAM protocol for "the safe and effective administration of EDTA chelation therapy" was included in Cranton's "textbook," a 420-page special issue of the journal that contains 28 articles and a foreword by Linus Pauling. The protocol calls for intravenous infusion of 500 to 1,000 ml of a solution containing 50 mg of disodium EDTA per kilogram of body weight, plus heparin, magnesium chloride, a local anesthetic (to prevent pain at the infusion site), several B-vitamins, and 4 to 20 grams of vitamin C. This solution is infused slowly over 3.5 to 4 hours, one to three times a week. The initial recommendation is about 30 such treatments, with the possibility of additional ones later. Additional vitamins, minerals, and other substances—prescribed orally—"vary according to preferences of both patients and physicians." Lifestyle modification, which includes stress reduction, caffeine avoidance, alcohol limitation, smoking cessation, exercise, and nutritional counseling, is encouraged as part of the complete therapeutic program. The number of treatments to achieve "optimal therapeutic benefit" for patients with symptomatic disease is said to range from 20 ("minimum"), 30 (usually needed), or 40 ("not uncommon" before benefit is reported") to as many as 100 or more over a period of several years. "Full benefit does not normally occur for up to 3 months after a series is completed," the protocol states—and "follow-up treatments may be given once or twice monthly for long-term maintenance, to sustain improvement and to prevent recurrence of symptoms." The cost, typically $75 to $125 per treatment, is not covered by most insurance companies. Some chelationists, in an attempt to secure coverage for their patients, misstate on their insurance claims that they are treating heavy-metal poisoning.
In 1997, ACAM issued a revised protocol describing the same procedures but adding circumstances (contraindications) under which chelation should not be performed. As in 1989, the document gives no criteria for determining: (1) who should be treated, (2) how much treatment should be given, or (3) how to tell whether the treatment is working.
Unproven Claims
Proponents claim that chelation therapy is effective against atherosclerosis, coronary heart disease, and peripheral vascular disease. Its supposed benefits include increased collateral blood circulation; decreased blood viscosity; improved cell membrane function; improved intracellular organelle function; decreased arterial vasospasm; decreased free radical formation; inhibition of the aging process; reversal of atherosclerosis; decrease in angina; reversal of gangrene; improvement of skin color, healing of diabetic ulcers. Proponents also claim that chelation is effective against arthritis; multiple sclerosis; Parkinson's disease; psoriasis; Alzheimer's disease; and problems with vision, hearing, smell, muscle coordination, and sexual potency. None of these claimed benefits has been demonstrated by well-designed clinical trials.
In a retrospective study of 2,870 patients treated with NaMgEDTA, Olszewer and Carter (1989) concluded that EDTA chelation therapy benefited patients with cardiac disease, peripheral vascular disease and cerebrovascular disease. These conclusions were not justified because the people who received the treatment were not compared to people who did not.
In 1990, these authors carried out a "double-blind study" in which EDTA chelation was used to treat ten patients with peripheral vascular disease. The authors claimed that this was the first such study. The patients' progress was evaluated by measuring changes in their blood pressure and their performance in exercise stress tests before, during, and after the course of treatment. The authors claimed that EDTA had a significant impact on the patients' clinical status because the removal of calcium, copper and zinc from the vascular compartment corrected cholesterol and lipoprotein metabolism; triggered a parathyroid response that pulled calcium from the bones; decreased platelet aggregation; lessened iron-generated free radical formation; reduced membrane lipid peroxidation; decreased plaque formation; and prevented intracellular calcium accumulation.
Between 1963 and 1985, independent physicians published at least fifteen separate reports documenting the case histories of more than seventy patients who had received chelation treatments. They found no evidence of change in the atherosclerotic disease process, no decrease in the size of atherosclerotic plaques, and no evidence that narrowed arteries opened wider.
More recently, the results of two randomized, controlled, double-blind clinical trials of chelation therapy were published in peer-reviewed German medical journals. The first was conducted by Curt Diehm, M.D., at the University of Heidelberg Medical Clinic [3]. Diehm studied 45 patients who had intermittent claudication, a condition in which impaired circulation causes the individual to develop pain in the legs upon walking. About half of the patients were treated with EDTA and the rest received Bencyclan, a bloodthinning agent. In addition to determining the effect of each agent on the ability to perform pain-free walking exercises, Diehm measured the progress of the disease process in each patient during the four-week treatment period and three months after treatment was stopped. Statistical evaluation of the results after the blinding code was broken showed that patients in both groups had equally increased ability to perform pain-free walking exercises and that treatment with EDTA did not result in any change in the patients' blood flow, red cell viscosity, red-cell aggregation, or triglyceride and cholesterol levels. Diehm also concluded that the improvements in walking measurements in both groups were directly related to his success in convincing them of his strong interest in their well being and his ability to motivate them to make an effort to perform greater activity.
In the second trial, R. Hopf, a cardiologist at the University of Frankfurt, tested chelation in patients with coronary heart disease [4]. In this trial, 16 patients with angiographic evidence of coronary heart disease were randomized and divided into an EDTA-treated and an untreated group. Before treatment, the treated group averaged 2.1 significantly narrowed coronary arteries, while the untreated group averaged 2.6. Patients were infused with 500 ml of either the EDTA solution or dilute salt water (a placebo) at three-day intervals for a total of 20 infusions. On completion of the trial, patients in both groups said they felt better and performed weightlifting tests equally well. However, comparison of both groups before and after treatment, using angiography and other tests, indicated no improvement in blood flow through the patients' coronary arteries and a slight progression of their atherosclerosis. Hopf concluded that chelation had no effect on diseased coronary arteries.
This is an excerpt from a 1996 flyer from an osteopathic physician whose radio advertisements invite people who have been advised to have coronary bypass surgery to consult him first. There is no published scientific evidence that chelation therapy can render bypass surgery unnecessary or can help people with any of the conditions listed in the ad. The experience to which the ad refers is not a trustworthy substitute for scientific testing. People with coronary artery disease who need bypass surgery and choose chelation instead place themselves at great risk.

II] On second count I felt that spreading (sharing) this particular info would be an ethical issue asI had read this article:
[Two city doctors pulled up for self-advertising
By Jyoti Shelar, Mumbai Mirror | Jul 9, 2013, 10.12 AM IST

A
For the first time in the last 20 years, the Maharashtra Medical Council (MMC) has slapped notices on five doctors in the state — including two from Mumbai — for advertising their services. The doctors have been asked to stop their advertisements with immediate effect.

According to MMC, the doctors are laparoscopic and bariatric surgeon Dr Amarnath Upadhye and physician Dr Anil Patil from Mumbai, acupuncturist Dr Lohiya Bhagwandas and physician Dr Umesh Mundada from Aurangabad, and physician Dr Shaukat Kazi from Pune. "All these doctors advertised their skills and their clinics in the print media to attract more patients. This is in violation of the code of medical ethics," said Dr Kishore Taori, MMC chairman.

When doctors swear by the much respected Hippocratic oath to practice medicine with all honesty, they also promise not to advertise or sell themselves as a commodity. However, the promise is soon forgotten and a considerable number of doctors promote their expertise in the print and electronic media and even by putting up hoardings and banners.

The MMC had last taken such action around two decades ago, hence the sudden crackdown has shaken the medical fraternity. "We were keen to resume this drive for a long time," Dr Taori said. "Our vigilance team will now look out for advertisements and issue notices to doctors as well as medical establishments that indulge in advertising."

He said that the council had received several complaints from NGOs about the same. "We will come down heavily on those who indulge in such blatant acts," he added.

The MMC has warned the doctors against advertising and demanded explanations from them. In the notices, MMC said, "It is for all doctors to follow the code of conduct seriously. MMC has decided to take serious action against advertisements in any form by individual doctors/hospitals.

Advertisement by corporate hospitals will involve action on the doctors of concerned specialty and recommendation to appropriated authority to cancel the registration of the hospitals/establishments."

Andheri based Dr Amarnath Upadhye, who was pulled up for tabloid advertisements offering weight loss surgeries in January, said, "I committed a mistake and have apologised. Many doctors issue such advertisements. I was pulled up probably because my colleagues complained about me."

Dr Anil Patil, who heads Vedicure Wellness Clinic in Dadar, was pulled up for repeatedly placing full page advertisements in the print media. "We also found that Dr Patil was an MBBS and was running an ayurveda clinic which he cannot do legally. He, however, explained that he just owns the clinic but does not prescribe ayurvedic medicine," said Dr Shivkumar Utture, member of MMC.

MMC are of the view that advertising is not only wrong but also increases the cost of healthcare, as doctors obviously raise their fees to recover the money spent on advertising.]

How do we know that this info that my daughter received, has not been sent (MAY AMOUNT TO SELF ADVERTISING ) at the behest of the doctors (mentioned in the said info)?

HENCE I HAVE DELETED NAMES OF ALL THE DOCTORS MENTIONED IN THE SAID INFO.

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