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Saturday, October 4, 2014

Life of Medicines

​I came across this ARTICLE -A Pill for every ill? Given below
I would like to have opinions from doctors. As a common man I feel MBBS must have one or two full year[s] of pharmacological studies in depth and government must subsidize setting up a bio chemical analytic lab for every doctor who sets up a clinic to test the real contents/claimed components of the medicine and whether the indicated potency is there in the medicines. This will enhance knowledge and also provide more employment to a very vital paramedical segment.

After all doctors are also human beings and they trust the pharma companies worse still the literature vomited by the sales reps with nice ties around the neck and lots of lies from the mouth [probably the doctors must demand an insurance cover for medicines they prescribe to patients in case of any adverse indications or no effect at all and this compensation must be paid by the pharma company itself. Then we can expect some changes in the medicine mafia.]

Though, unfortunately, most governments are backed financially by pharma and liquor barons.

This does not mean all that all the pharma companies do are bad but the problem is that onus of chaffing the dubious aspects in the pharma trade lies with the highly specialized and knowledge based few like the scientists and doctors whom the society respects and trusts desperately because it knows that both the common man and the politicians lack the relevant domain knowledge or are totally ignorant.

Reading many books on any subject confuses, clarifies, coruscates and ultimately leads to some clarity or at least offers greater choice.

A very important part of life’s experience is the churning it undergoes from various views, perceptions, assumptions, knowledge gathering etc

Here is Great Scholar Dr. B.M.Hegde with great academic credentials and greater clarity in both his understanding and approach to problems with his vast knowledge base. I am a great fan of him for the past many years.

Here are some of his speeches, all extremely worth listening to ands each one is a gem and I have  posted his lectures in my Facebook several times in the past few years.


A Pill for every ill? - I
Prof Dr BM Hegde | 01/10/2014 04:33 PM | 
pharma companies, pills, illness, surgery
The business goals of pharma companies influence the mission of research institutions and the final results. Young doctors are learning that there is a pill for every ill and a surgical correction for every anatomic deviation from the normal

“Who lies for you will lie against you.”  -  Bosnian Proverb.  

The recent disclosures by the The New York Times that more than 47% of the Harvard Medical School faculty is on the regular pay roll of drug companies should give us a wakeup call. All thinkers need to believe what I had been writing for years that most of what doctors learn from textbooks and their teachers is the ‘wisdom’ distilled by the vested interests in pharmaceutical and medical devices industries!  

The Harvard revelation is only the tip of the iceberg. In India, where we do not have such audits, the numbers must be prohibitive. Many doctors make a comfortable living thanks to the largesse of the industry. The unholy marriage between the academia and the industry should cease forthwith for the good of humanity. 

Intelligence is derived from the roots inter (between) and ligere (to choose). An intelligent doctor, therefore, should be able to choose between the good and the evil for the sake of his/her patients as also to become a person of value and not just a person of success. Albert Einstein wrote that one should “try to be a man of value, rather than a man of success.” An editorial in the New England Journal of Medicine deplores the evil in medical science. 

My lamentations about medicine having gone to the market place, riding piggyback on technology, making it almost impossible to believe any of the short case-control studies published even in the “respectable” journals for years, had only fallen on deaf ears. I have become a laughing stock in the higher echelons of the Indian medical academia! 

I am told that a group of cardiologists in Mumbai, when asked to assess me for the Fellowship of the Academy of Medical Sciences some years ago, had opined, “He is only a quack and has no idea what cardiology is all about!”  I did become Fellow-thanks to a few thinkers still in the organisation.

“The ties between clinical research and industry include not only grant support, but also a host of other financial arrangements. Researchers serve as consultants to companies whose products they are studying, join the advisory boards, and the speakers’ bureaus, enter into patent and royalty arrangements, agree to be listed authors of articles ghost written by interested companies, promote drugs and devices at company sponsored symposia, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in companies. Academic medical institutions are themselves growing increasingly beholden to industry. Harvard used to be an exception; but they are also softening their stand,” wrote Marcia Angell.  

I could quote some of my bitter experiences, which I had shared with readers from time to time, here to complete the picture. Time was when a symposium on treatment of high blood pressure was held in a five-star hotel in Goa. I was pitted to speak against a star speaker from America. This gentleman is a regular company “employee”, having a very high academic status in addition. The drug in question was a receptor blocker of a particular new variety. 

While the American went on to describe the drug as the panacea for all hypertensives and should be the first drug of choice, I had to, per force, take the opposite stand as I was convinced that this drug was not the drug of first choice. This great master ridiculed me and the audience, of course, was with him! 

In March 2000, while I was on a lecture tour of some Universities in the US, early morning wake up alarm in my hotel room was blaring out the news item that this very drug, in the first-ever human study, had caused many more heart failures, while it was being touted as the drug to prevent heart failure. 

The study has since been stopped and the newscaster was asking nearly a million Americans who are already on the drug to contact their doctors to get the drug changed immediately. I tried in vain to contact the “great” man but to no avail. This happens again and again. 

The drug in question was one of the alpha blockers. Any blocker, alpha, beta, ACE or H1—or, for that matter, any other drug that blocks any normal body function, is not conducive to normal body physiology. Recent revelations about metaprolol in the POISE study are a good example. There are others ills, which follow all the above blockers but space does not permit me to go into them in greater details.  

No one has so far described science in a way that satisfies everyone. “Science, for example, can not give absolute proofs of the laws of nature because, although we can test an idea repeatedly, we can never be sure that an exception does not exist,” says Michael Cross in the New Scientist 2000 February 19th.  Every time something goes wrong and is detected, anyone could take refuge under this clause. This statement of Cross should not be misread to say that science is not good. It only goes to emphasize the fact that scientific methods are but one of the many ways to human wisdom. 

One other subtle way of taking the practicing doctor for a ride by the companies is the use of confusing statistical jargon, which, unfortunately, most medical students do not get to study in the medical school. This specially applies to the risk factor correcting efforts using drugs, a real money-spinner. 

While there are 17 studies (RCTs) in the area of blood pressure lowering drugs where the collective relative risk reduction (RRR) was only -20% and this is the one sold in the journal articles and company literature. If one were to analyse the absolute risk reduction (ARR) it comes down to -0.8% only! This will translate into a very insignificant survival benefit (SB) of just 0.8%. 

To put it differently, if a healthy man with moderately raised blood pressure were to take the drugs religiously for five years to reduce his box blood pressure, despite lots of other inconveniences due to the drug in question, his chance of survival becomes 96.8%, whereas it would still be 96% without any drug at all for five years but with simple change of mode of living!

Almost identical figures arise from all the cholesterol-lowering drugs. That is not all. The number needed to treat (NNT) unnecessarily is another serious matter. To save one young man with mild to moderate hypertension from a possible stroke in the next five years the doctor will have to treat 850 normal people with the same level of BP for a period of five years. The adverse drug reactions of those drugs in five years would be enormous, to say the least, both in morbidity and mortality, leave alone the cost! Practising doctors get to see only the RRR figures that look very impressive. The table below shows it all! 

In the next part we will examine why there is such a large nexus between the academia and the “for-profit” industry.
Moneylife » A Pill for every ill? - II
A Pill for every ill? - II
Prof Dr BM Hegde | 02/10/2014 12:28 PM | 
pharma companies, pills, illness, surgery
There is no free lunch in this world. Pharmaceutical companies try and catch doctors very young when they are still house officers. These young doctors then learn from pharma companies that every ill can be cured with a pill. This is concluding part of a two part series

For one thing, even hospitals have come under the latter umbrella! It is argued that ties between industry and academia are necessary for “technology-transfer”, a word invented after 1980s, when the American Government passed the Bayh-Dole Act which allowed academic institutions supported by Federal grants to patent and license new products discovered by their faculty in return for royalties. This law is cited when large-scale tie-ups go on between these two institutions. It is needless to say that we follow that rule blindly in our country. The second reason given is that academic institutions needed the money very badly. These are the main reasons why we are where we are today. The business goals of the companies influence the mission of the research institutions and also influence their final results.

One of the reasons why the cost of modern medical treatment, both medical and surgical, has skyrocketed is because the expenses incurred by the industry for its sponsored trips of medical scientists, meals in top of the range hotels, gifts, honorariums, conference and symposia expenses, consulting fees, and research grants eventually are paid by the consumer! There is no free lunch in this world. Companies try and catch doctors very young when they are still house officers. Rothman records in a report that the companies’ gifts are intended to buy the goodwill of young physicians with long prescribing lives ahead of them. Similar is the situation in many areas where the industry uses the talent of the academia for their research. Ultimately, it is a Faustian bargain.

Clinical research organizations (CROs) are mushrooming in India at alarming pace.  The brokers for the western drug companies want to test their new molecules in the third world countries, as many of the western countries have banned such studies. Especially after the Northwick Park Hospital tragedy in London where, a single drug put all the volunteers into serious near fatal unknown adverse effect costing the hospital millions of pounds! These CROs are a menace to us, as we do not have the genuine informed consent in our set up with most of our patients still very poor and illiterate to understand the intricacies that are built into every new drug trial! I wonder if it is ethical to do such studies at all. Who cares for ethics these days, anyway?  

In fact, there are a few “researchers” who would not have seen a single patient all their lives, but profess to the world about the drug treatment of major illnesses. The companies mainly target those diseases that are likely to be life long business for them like diabetes, high blood pressure, coronary artery disease etc. There are many guidelines all over the world for the treatment of these diseases. If one takes care to carefully scrutinize them, one quickly realizes how fallacious they are. To give an example of hypertension, there are six guidelines in all: we in India are trying to have our own guidelines, in addition. If all of them are computed together they cover just about 39% of the patients. For the rest, there are no guidelines. Young, but enthusiastic, doctors are getting frustrated looking at these. If any of the guidelines are not convenient to the drug makers, the companies get their “great brains” to refute them and have new guidelines. This happened with the American National Guidelines for high blood pressure management some time ago. (JNCV).

One could take any area for scrutiny. Anti-cholesterol drugs, anti-arrhythmic drugs, heart failure drugs, anti-hypertensive drugs, anti-diabetic drugs, pain killers, anti-cancer drugs or, for that matter, many of the procedures for surgical corrections and even some of the untested technologies like coronary care units, terminal care units, flow catheters and many other areas have their loads of skeletons in their cupboards. An unbiased audit would get these skeletons out of the cupboards. In fact, in a recent article in PLOSmedicine, Richard Smith, the former editor of the British Medical Journal and the present editor of the Cases Journal in London, showed elegantly how doctors today have become just puppets in the hands of the drug company barons.

“How much longer will medicine’s flagship educational events fly the colours of the drug industry”, asks Ray Moynihan, the editor of PLOS medicine and goes on to add, “In the heart of Manhattan Island one misty morning a few years back, I watched as hundreds of psychiatrists streamed into their flagship educational event, the annual congress. Even before arriving, they were welcomed by giant advertising billboards on the streets outside, plastered with the name of a major sponsor, Pfizer, the biggest drug company in the world and the maker of Zoloft, the world’s top selling antidepressant. Once inside, their first port of call was the huge exhibition hall, where well dressed salespeople moved among high-tech booths and hypnotic neon, exchanging pleasantries with doctors lining up to play video games and win prizes. And then, of course, there were the sponsored educational sessions. That year—2004—psychiatrists learnt about bipolar disorder over breakfast at the Marriott Marquis Hotel, courtesy of Eli Lilly. Over lunch at the Grand Hyatt they studied maternal depression, thanks to GlaxoSmithKline, and for dinner it was generalised anxiety disorder in the grand ballroom of the Roosevelt Hotel, funded by Pfizer,” in a recent article in the BMJ.  

When the gulf between the industry and the academia narrows, medical students and house officers, under the constant tutelage of industry representatives, learn to rely on drugs and devices. This is more often than they should do. Young doctors learn that there is a pill for every ill and a surgical correction for every anatomic deviation from the normal. Faculty members could get distracted from their teaching commitments. Doctors get used to these company courtesies of receiving gifts and favours to further their continuing medical education. In this generation, there is always an overemphasis on drugs and devices that could ultimately work against patient interests. The Hippocratic Oath really becomes hypocrates’ oath.

It is time to do a bit of introspection before it is too late in the day for us do even that. We should see that we are not open to the charge that we are for sale. Academic medical schools should educate their students on the ills of the prevailing scenario and have to inculcate in their students the love for ethics and give them a good idea of pharmaco-economics and the ways of the business world that may be alien to them at that stage in life.

Let us not forget that 80% of the world population even today does not have any touch with modern medicine, 62% of upper middle class Americans can not afford health insurance as the premia are sky high for them, 57% of Britons do wish to have alternative systems of medicine when they are ill, despite the fact that they have the free National Health Service. Let us also remember that patients could very well live without doctors, but doctors could never survive without patients!  For this write up, I have drawn heavily from my articles published earlier on similar subjects in 2001 and 2006.

“People are never satisfied. If they have a little, they want more. If they have a lot, they want still more. Once they have more, they wish they could be happy with little, but are incapable of making the slightest effort in that direction.”       Anon.

MOKSH: (Monitoring Knowledge & Social Health)
An International Network of Eminent Scientists Questioning 
                                  the Science Behind "Science"
Odisha, India
Disclaimer: Views expressed in my mails are my own and may not represent that of the organisation.

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