DA VINCI CODE

Da Vinci code

“ I have offended God and mankind ,because my work did not reach the quality it should have”-Leonardo of Vinci-Italy –  Painter and Man of science

A Hollywood mega movie based on top seller ‘Da Vinci code ‘was a record breaker. I never saw the movie due to unknown but yet unsuspicious reasons. It is based on cracking code in paintings by Leonardo Da Vinci. In this movie an Art Historian played by Tom hanks deciphers the hidden messages in Da Vinci works.

Vinci was a real life painter who excelled in the art and is considered as a foremost representative of his style which is inimitable. His style was termed as High Renaissance. The Italian painters works are spread in cathedrals and museums all over Europe .That he was a man of science was discovered later based on his writing and notings  in scrap and workbooks which contained engineering drawings and technical illustrations of inventions  which he wrote from Right to left requiring mirror to read it. His other jottings were studies in anatomy. He painted very limited paintings as his interests shifted from one subject to other. The famous being The Last supper and Mona Lisa

One of his famous paintings which has drawn awe all over world is ‘Mona Lisa’ an Oil on Panel painting of 77 by 55 centimeter dimension .It is a portrait of an lady, may be an unknown model but the painting became famous due to the demeanor of the woman who is in relaxed mood with an amused gaze .When I visited Louvre Museum there was a rush around this art piece and continuous clicking of cameras with flood of flashlights. It was difficult to get near it as many scrambled to get closer to it. May be art aficionados I thought .But the real reason is to look continuously at this painting which comes alive when you concentrate on it. Mona Lisa was painted in years 1503 to 1505.The facial anatomy is characterized by ample subcutaneous fats blending into various regions very smoothly a feat where facial muscles put optimum stress on the tissues above it to be expressive of amusement and relief in a dignified way. Only a man of science can achieve these expressive tones in eyes and the lips which are held in a small smile.

Leonardo strived to achieve perfection in drawings as for him they were work of science and design as much as works of Art. He used the technique of sfumato-Subtle blending of tones .It is said that Sfumato is beyond technique. It is a form of poem delimiting boundaries of human expression and form. In Mona Lisa the background too is mysterious as compared to plain background of portraits in that era.

Now Art historian Silvano Vincenti and his group are reading more into Mona Lisa painting and using high definition magnification of eyes in the painting have discerned Letters LV in her Right eye and C and E or B in left eye. Other group has discovered 72 or L and a 2 painted in the mysterious background bridge that forms the backdrop. This may be asking too much as if you look at any old building walls you tend to see faces and designs and letters init by chance occurrence as different patterns rise out of the paint wearing out. Mind sets change after people are exposed to media creativity just as they change after they witness a masterpiece such as Mona Lisa

Mona Lisa is a sensation as a painting but the persona in the portrait is not a celebrity albeit a high class woman who is exudes patience   and understanding. The woman is not beautiful by any standard like the Afghan Woman on the National Geographic who became a darling of literate elite in 1970s

Here I choose to digress a bit to drive in my point as I put on record the fact that I had the good fortune to own a copy of that issue which I held for a long while .Now I was never a subscriber of NatGeo  as I could never afford  it and surely felt  miserable for that state of affair envying those who had the access to the highly photogenic masterpieces which arrived with precise periodicity. Remember, there was no Television in those days but NatGeo Magazine was sufficient to arouse and satisfy that never ending desire and quest for unknown places and people across the globe .I was a proud owner of some issues which I had   purchased from roadside Kabadi shop. I would glance and flip through the issues again and again especially to admire the Afghan Woman on the cover for the perfection of her feature and the nativity of her expression. Eventually the National Geographic launched a ‘hunt’ for this remarkable woman and traced her to a small village in Afganistan.She did entertain the team from NatGeo but refused to remove the  Burkha to let everyone see her although a picture did appear on the magazine cover later. I was lucky once  again to watch the episodes on NatGeo  of her discovery or rather her rediscovery .How I had wished  I had that Magazine issue which got misplaced  as it  would have brought fortune and fame at my doorsteps.

The point I want to make is that Women are beautiful but Womanhood is more beautiful .To me this is Da Vinci Code ,a code of ethics and  immense character of a woman , a code of  morality and of dignity ,a code of conduct and  stature  and the only the inimitable  Leonardo Da Vinci could get  this code on a canvass in the form of a Portrait. Mona Lisa is an example of this superlative expression of womanhood on canvas and as it hangs  on the Parisian museum is a tribute to this humble great artist.

Another woman of equal stature would be Lady Diana and her immense stateliness and superiority .Anyone who saw her was awestruck by her poise and serenity. She was Womanhood personified .It is an enigma like the Da Vinci Code that she met sudden violent death with Dodi Fayed her very good friend   in one of the by lanes of Paris not very far from the famed painting of Mona Lisa

C L O S E      E N C O U N T E R

(With The Fourth Estate)

 9-03-2011

On Sun, 06 Mar 2011 10:54:24 +0530 Supriya Sobti <supriya.sobti@aljazeera.net> wrote
>Dear Dr Dilip,
>
>I am journalist working on a story related to clinical trials in India.
>We are particularly looking for participants of clinical trials sponsored by US pharma companies who may have had an adverse reaction to
>a trial drug. or perhaps someone's family member passed away during or shortly after being on it.
>f you know of any such trial participants and could share their details with us I’d really appreciate it!
>
>I look forward to hearing from you.
>
>Many thanks in advance,
>
>Regards,
>
>
>SUPRIYA SOBTI | PRODUCER | NEWS & PROGRAMMING
>AL JAZEERA ENGLISH
>INDIA
>phone + 91-9619071456
>web www.aljazeera.net/english
>
>Notice: This email is intended only for the use of the individual or entity named above and may contain information that is confidential and privileged. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this email is strictly prohibited. Opinions, conclusions and other information in this message that do not relate to the official business of our firm shall be understood as neither given nor endorsed by it.
>

Subject: Re: Clinical trials....

From: "DilipVishnu maydeo"<dr_dilipmaydeo@rediffmail.com> Sun, 06 Mar 2011 11:29:37

To: "Supriya Sobti"<supriya.sobti@aljazeera.net> and others

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Hello ,
Was involved with an high end antibiotic in Nosocomial Pneumonia .We at our institution did 2nd largest series for that indication. But due to proper selection, monitoring ,quick response and documentation ,had no ADR or more sinister outcome.In fact we from the data generated concluded that existing antibiotics are as good as the new intended antibiotic. This molecule was eventually launched and we were called for the launching event. But we were surprised that no reference was made to our study in the dossier handout.
Incidentally the Largest series had 3 times our subjects. This is possible if the selection criteria are not strictly adhered to.It is in such circumstances that ADRs are maximum.

In another situation for an Anti TB drug we refused to conduct the trial as the basic premise of the trial was not clear and was scientifically irrational. Role of World Bank in such community driven trials is suspect. Our own know how on therapeutics of TB is cutting edge and clinically outsourced trials on anti TB drugs should not be entertained on poor patients.

Trials of Alternate day regimens and twice weekly regimens for TB were conducted 1n 1970s at leading TB research institutes in the country with favorable results.Inspite of the costs having come down drastically in last 30 years, It was surprising that Indian Government gave a go ahead to world bank funded DOTS after 25 years in form of RNTCP.The world bank needs to give royalty to the individuals and institutions who conducted these studies off setting their own interests. Moreover this DOTS treatment has spurned XDR TB due to inherent mathematically provable fallacies on compliance and operational issues.

We were also involved in yet another Anti Asthmatic drug which was proved to be safe and became as established drug all over .Although skeptic at the beginning we realized consistent ly good out comes. This drug has a great role in Step down treatment from Steroids.

Our corpus of experience is heterogenic and we tend to conclude that basic rationale needs to be examined and clinical trials seen as very sophisticated research rather that a business model to multiply incomes in a scenario of opportunistic me too molecules being introduced in and encashed  in a charged   brand management  Marketing environment   .There is  therefore  a distinct need to endorse social marketing as a modality over traditional competitive marketing as a 'spit and polish' charismatic activity.

2^nd Email to Supriya

India and mainly Maharashtra especially cities like Mumbai and Pune are hubs for Clinical trials. From 2009 a Register is maintained at Centre for studies in Ethics and Rights for listing these trials although it is not mandatory for Pharmacokinetic or Bioavailability studies to be registered. From 2006 to 2011 there was a 36% increase in number of Clinical Trials.

Interestingly there is no correlation between the epidemiology of diseases and trial scenarios which means that Indians are being used as Guinea pigs. This scene is due to trials being  outsourced to the country partly due to the fact that they can be done at a very economical price and partly due to the fact that skilled and dedicated personnel are available for conduct of such trials.

The discrepancy is illustrated aptly by the fact that TB is most prevalent disease however TB drug trials conducted are < 1% whereas Cancer trials are maximum at 13 % even when Cancer does not rank as a major killer in the country unlike the western hemisphere. Trials on prenatal conditions stand at 2.9%.

Source : TIMES of India

ADRs/death results for the following reasons 1) Poor quality of Induction and motivation 2) Not assigning responsibility to junior staff 3) Inadequate remuneration to junior staff 4) Communication gaps between patients and Junior staff or between juniors and seniors 5) Not following the inclusion criteria or lack of understanding of the criteria 6) Inadequate monitoring and or reporting 7) Drug interactions and  undeclared co morbidities 8) Lack of appreciation of seriousness of certain clinical signs and inadequate clinical training to staff including nursing staff 9) Monetary gains and suppression of information for being deported from trial and loss of monies 10) laziness to document ADRs immediately and improper filling of forms due to other clinical responsibilities.

Dr Dilip Maydeo MD ,DIM,MCAAI

Subject: Re: Clinical trials Scenario

From: "DilipVishnu maydeo"<dr_dilipmaydeo@rediffmail.com> Mon, 07 Mar 2011 22:41:29

To: "Supriya Sobti"<supriya.sobti@aljazeera.net> and others

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Actually I am not a clinical pharmacologist who specialize in conduct of trials. I am a clinician with interest in clinical research and drug evaluations. Because you wrote , I wrote back.i surely can spend some time with you with documents if I can lay my hands on them.

Having worked for Pharma industry in past, I am able to appreciate the business aspects of the activity. Being a perfectionist, I do not undertake any study unless I am satisfied about the ethical aspects of any study.Incidently Clinical research is not only about drugs ,it can be about technology ,bioengineering, Biodesign and bedside monitoring as well. Your team is welcome to interact with me if it is mutually convenient. Please keep me informed.
My cell number is : 9821041983


On Mon, 07 Mar 2011 22:10:32 +0530 Supriya Sobti <supriya.sobti@aljazeera.net> wrote
>Doc many thanks for your email. That was very informative.
>
>I just wanted to double check if there are any US sponsored trials that you conducting at the moment? Either in the recruitment phase or on-going.
>
>We will be in Mumbai later this week and if you are available and willing to talk to us about how you conduct trials (perhaps even show us some patient interaction - how people are told about a clinical trial at the time of signing the consent form etc..) then we'd definitely like to spend some time with you.
>
>I look fwd to hearing from you.
>
>Best,
>Supriya

Sent on my BlackBerry® from Vodafone

---

From: DilipVishnu maydeo <dr_dilipmaydeo@rediffmail.com>

Date: Mon, 7 Mar 2011 07:17:45 +0300

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At 12 noon they walked into my office point blank. I was ready for them but not the questions as I was not given any questions in advance which is an etiquette  .This was their Modus Operandi to get onto their subject aggressively so that caution is flung to the wind. Any defense is ruled out.

They were; one Canadian, One American and one French Man. They took charge and dictated the terms, they set the agenda .It was expected that I will succumb to their salvos and say something unconstitutional and ridiculous. That is not possible as a man of science equipped with a vocabulary of terms which have been a standard armamentarium to draw in certain points emphatically especially when the subject is close to your heart.

I was talking incessantly fielding one question after another, trying to illustrate my points as much. I was ruthless with and capitalization of Healthcare.

Healthcare Vs Fine Chemical Industry: Relevant points which I made was the confusion of layperson to consider Chemical and fine chemical drug industry as a part of health care industry. One is a manufacturing industry whereas another is a service industry. Doctors role was to deliver health care holistically not be looked upon as a prescribing extension of Medical Sales team.

Conferences: Conflict of Interests is highly prevalent although it is blatantly denied. Foreign jaunts used for promotion of products. Research has to be relevant to the country. Manpower utilization is justified due to availability but there is strong likely that it will be misused for  lesser effective molecules which may exhibited  as very useful additions to therapeutics. Most conferences are studded with papers which are sponsored for a consideration and cost of sponsorship is high. The timings of such presentation is strategically decided to allow maximum audience. Papers which talk highly favorable of a molecule are selected for award.

Responsibility: Onus of fair and quality trials are with Medical Professionals. The registry of ethical trials should be available to any interested party including competitor’s .Transparency is uppermost. Trial data cannot be withheld under the garb of privacy or secrecy of contract as results which can get extended to hundreds and thousands eventually has to be in public domain and it will be criminal to withhold any data be it positive or negative. Doctors should accept trials based on their expertise and get data from world literature and not rely on data given by the company which may be highly biased E.g. Omalizumab. ADRs are the ones when co morbidities are ruled out as the cause of the ADRs.Omalizumab is a failure in US and hence being tried on Indians to get back the monies spent on research of a useless drug is being sold in a garb of a post marketing study.

.ADRs & Deaths :Deaths associated with usage of molecules may be due to high intrinsic mortality of a condition but inefficacious molecules may be indirectly implicated .This is justified and only genuine molecules which are distinctly superior to existing molecules need be studied and accepted for clinical trials.Eg Doripenem vs. Cilanem.Doripenem was later indicated for abdominal sepsis and not nosocomial pneumonia. It was a drug which was being resurrected in 2007 for which I was a part of multicentre trial. From my own data of 17 odd cases I could conclude that this drug was not superior to many other existing high end antibiotics. I showed the master chart of those cases .2 deaths had occurred in Doripenem group co-incidentally these patients had high level of comorbidities.They clicked pictures of the chart.Doripenem belongs to Johnson & Johnson.It was a drug possibly discovered in 1967.Drug Lag still exists again for commercial reasons.

American Multinationals Companies should adopt the subjects throughout lifetime and not abandon subjects after the trial is done with. It is wrong to pose that the subjects are getting drugs which are unaffordable by them this is not true due to generic drugs being available in interiors at one fifth the cost for most life threatening conditions. Cancer is not number one killer in the country but infectious diseases most cases are thronging to cancer centers in towns and cities and becoming easy targets of clinical drug research. The biggest fallout of clinical trials is skill generation by Indian doctors. Ethical committee is a farce. The trials should document ethical committee minutes and relevant questioning by peers from all departments than by a high powered committee who gives the signal for monetary considerations. Failed drugs are being resurrected and possibly commercially exploited for unsuspecting patients by buying off his doctor. Commercial objectives are placed above ethical issues as money has become sparse in capitalalistic society and governments have ceased to be welfare states.Corporates have become bigger than nations. Another relevant issue is : Will Americans accept drugs based on trials done in India ,because of racial issue which translates biologically as Pharmacogenetics or ecological due to differing nutritional status of Indian subjects. What about Ethics committee meetings in US how are they administered? Are they not farcical too?

Many other points were raised and debated. A certain magazine bought by my wife came handy .I had read an article in the morning before the interview. They had read it too. At the end I was visibly tired. Very Passionate!!Was their response in unison .For me, it was a close brush with aliens belonging to another professional planet: The press