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MCI for ban on gifts to docs by pharma cos
Medical Council of India has written to Union ministry of health and family welfare for an amendment in Indian Medical Council (professional conduct, etiquette and ethics) regulations, 2002, to prohibit doctors from accepting any gift from any pharmaceutical or allied health care industry.
The move is likely to face stiff resistance from the pharma lobby as well as a section of doctors who have been benefiting from largesses showed by the pharma industry. MCI chairman Dr Ketan Desai, an Ahmedabad-based urologist, said the council has forwarded to the Centre an MCI resolution adopted on November 18 titled “Building a healthy relationship based on self-regulation between doctors and pharmaceutical and allied health sector industries and preventing unscrupulous practices by doctors.”
The resolution was passed by the MCI’s executive committee based on the recommendations of a sub-committee.
There are new proposed guidelines for a medical practitioner to carry out, participate in, work in research projects funded by pharmaceutical and allied health care industries. The particular research proposal will need to have due permission from the competent authorities concerned.
Dr Desai said: “If these recommendations are made a part of the ethics regulations of the MCI by suitable amendment, it will go a long way in ushering in a credible, transparent, just and scientific relationship between doctors and pharmaceutical and allied health care industries.”
(Available from: http://timesofindia.indiatimes.com/city/ahmedabad/MCI-for-ban-on-gifts-to-docs-by-pharma-cos/articleshow/5273491.cms )
No more freebies for docs
Pharma industry has submitted a self-regulatory code of conduct to the government that curbs unethical sales promotion and marketing expenses, bans non-medical and personal gifts, payments in cash, freebies and all-expense paid junkets for doctors and their families.
Industry body Organization of Pharmaceutical Producers of India (OPPI) has drawn up a code on the insistence of government, which was concerned about increase in unethical marketing practices and prescription drug promotions by pharma companies.
A source said, "The code has been communicated to all industry associations, like Indian Pharmaceutical Alliance (IPA), to build a consensus and will be finalized over the next week. This will be the first comprehensive code for the entire industry, which will not only tighten rules regarding acceptance of gifts and bring in transparency in sales promotions, but also ban bribes to doctors for drug promotions."
Till now, associations like OPPI and Indian Drug Manufacturers Association (IDMA) have an operational code, which has given rise to certain grey areas and scope for misuse. Significantly, for companies that violate these regulations, there is a "public disclosure norm", which will disclose the errant companies name, the drug involved and nature of complaints, on all the associations' websites.
"This will be a great deterrent for violators as it will tarnish their reputation and brand, which, if they deal globally, will have a multiplier effect," the industry official stated.
The code says that pharma companies can sponsor doctors to international scientific conferences, but companies cannot organize exotic overseas trips for them. "No company may organize or sponsor an event for healthcare professionals (doctors) that take place outside the home country unless it is appropriate and justified to do so from logistical and security point of view, and only to impart scientific or educational information."
And, "any sponsorship provided to individual healthcare professionals must not be conditional upon an obligation to prescribe, recommend or promote any pharma product". But experts feel that the code lacks teeth since it is not legally binding on companies. However, the small-scale industry has not accepted the code since it is not legally-binding on companies.
( Available from: http://timesofindia.indiatimes.com/articleshow/msid-5324844,prtpage-1.cms )
Docs bunk med meet for freebies
About 4,000 doctors registered to attend the Cardiological Society of India’s (CSI) annual conference. However, less than half of them
participated in the academic programme of the conference. Hardly surprising, considering the diversions available for them and their families in the form of tours and freebie distribution at the meet venue. Extracurricular participation was higher than academic participation.
Loud music boomed from the hospitality tent, films were screened and pearl, diamond and gold jewellery was sold at one end. Luxury cars zipped in and out of grounds picking up families or dropping people off. Bags, calendars, books, diaries, perfumes and chocolates were distributed for free from stalls. There were lucky draws and on-thespot quizzes to win prizes.
This jamboree was part of the 61st CSI annual conference in Kochi. Just over 3,300 of the 4,000 who had registered turned up. A glance through the scientific program of the conference would give the impression of a highly enlightening academic meet of accomplished doctors from across the country.
However, just about 2,000 are claimed to have attended the first day. The numbers dwindled as the days progressed. Barring the main hall where about 250-400 were found attending, two others had just 50-150 participants depending on the time of the day. The remaining five halls remained virtually empty.
A doctor, a veteran of many such annual conferences said: "In every large conference of this kind there are more doctors outside the conference than inside it. In fact the joke is that doctors attending conferences are divided into three kinds — the hallmarkers, who stay inside the halls, attend lectures dutifully, take notes and ask a lot of questions, the stalwarts who scour the pharma company stalls sweeping up all the freebies and the 'outstanding' ones who are always outside the conference venue making merry." The hallmarkers, quite obviously, were outnumbered at Kochi.
A good number of doctors never attended any session, and instead, were holidaying with family in Kumarakom, Munnar and other nearby hotspots, all at the cost of the drug company hosting them. Companies had also blocked hotel rooms in advance.
(Available from : http://economictimes.indiatimes.com/articleshow/5361055.cms?prtpage=1)
COVER STORY
We want raw data, now
This week’s BMJ is dominated by a cluster of articles on oseltamivir (Tamiflu). Between them the articles conclude that the evidence that oseltamivir reduces complications in otherwise healthy people with pandemic influenza is now uncertain and that we need a radical change in the rules on access to trial data.
Briefly, in updating their Cochrane review, published this week, Tom Jefferson and colleagues failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the risk of complications in healthy adults with influenza. These claims have formed a key part of decisions to stockpile the drug and make it widely available.
Only after questions were put by the BMJ and Channel 4 News has the manufacturer Roche committed to making "full study reports" available on a password protected site. Some questions remain about who did what in the Roche trials, how patients were recruited, and why some neuropsychiatric adverse events were not reported. A response from Roche is published in our letters pages and their full point by point response is also published online (doi:10.1136/bmj.b5374).
Should the BMJ be publishing the Cochrane review given that a more complete analysis of the evidence may be possible in the next few months? Yes, because Cochrane reviews are by their nature interim rather than definitive. They exist in the present tense, always to be superseded by the next update. They are based on the best information available to the reviewers at the time they complete their review. The Cochrane reviewers have told the BMJ that they will update their review to incorporate eight unpublished Roche trials when they are provided with individual patient data.
Where does this leave oseltamivir, on which governments around the world have spent billions of pounds? The papers in this week’s journal relate only to its use in healthy adults with influenza. But they say nothing about its use in patients judged to be at high risk of complications—pregnant women, children under 5, and those with underlying medical conditions; and uncertainty over its role in reducing complications in healthy adults still leaves it as a useful drug for reducing the duration of symptoms. However, as Peter Doshi points out (doi:10.1136/bmj.b5164), on this outcome it has yet to be compared in head to head trials with non-steroidal inflammatory drugs or paracetamol. And given the drug’s known side effects, the risk-benefit profile shifts considerably if we are talking only in terms of symptom relief.
We don’t know yet whether this episode will turn out to be a decisive battle or merely a skirmish in the fight for greater transparency in drug evaluation. But it is a legitimate scientific concern that data used to support important health policy strategies are held only by a commercial organization and have not been subject to full external scrutiny and review. It can’t be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug. Individual patient data from all trials of drugs should be readily available for scientific scrutiny.
(Fiona Godlee, editor, BMJ In BMJ 2009;339:b5405; Published 10 December 2009)
"A lie gets halfway around the world before the truth has a chance to get its pants on."
Dear Fiona Godlee,
BMJ has come of age, thank you for this editorial. Writing a rapid response in your journal in September, I showed how hollow the claim about the safety and efficacy of the H1N1 vaccine was. (1) Thank you for publishing that and some others on connected topics. (2, 3, and 4).
Now readers can see how accurate those were. “We are being told that this new fast tracked, poorly tested vaccine is very safe and effective. The results of the testing on this vaccine were reported in the New England Journal of Medicine. It is instructive to learn that the tests for safety and to assess complications lasted only 7 days after the vaccine, an incredibly short period of follow-up.
Gullian Barre paralysis can occur even months after a vaccine as can seizures, behavioral problems and neuro-developmental disorders in children. It is interesting to note that the authors of the safety study for our swine flu vaccine were all employees of the maker of the vaccine CSL Biotherapeutics and eight held equity interest in the company. This admission is part of the disclosure policy of the New England Journal of Medicine. It is always important to keep in mind when you hear about this vaccine being safe and produced just like the seasonal flu vaccine -- What else do they not know about this vaccine that they will discover months, years or even decades later. Once injected with the vaccine and you develop a complication there will be little that can be done to treat the life-long degenerative disorder it produces. ” (5)
To cap it now comes the bombshell from Denmark which bares it all. Katrina Megget, a journalist, writing in the Pharma Times of the 3rd Decemebr 2009 has this to say under the title Swine ‘Flu labeled a conspiracy. “The swine flu pandemic has been named as the “most ambitious scam and corruption of our time” after pharma has been found to be in bed with the World Health Organization. Journalists from Denmark have reported links between the World Health Organization and pharmaceutical companies where firms have been covertly paying top WHO scientists. In the meantime, pharma profits from flu drugs have soared.
The journalists from the newspaper Information claim the public and political hysteria to swine flu is a result of an efficient public relations campaign, spearheaded by the WHO experts that have been prejudiced by pharma’s ready cash.” (http://www.pharmatimes.com/WorldNews/article.aspx?id=17017)
She goes on: “The lead target in the allegations is Dutch doctor Albert Ostenhaus, who has promoted the need for vaccinations through the WHO and the media and headed a panel that advised the WHO to announce that swine flu had reached pandemic level. Reports claim Ostenhaus is paid by several vaccine manufacturers and the Netherlands government is believed to be investigating his activities. Other WHO advisors are understood to also advise big pharma and have been allegedly concealing their pharma- funded salaries. Meanwhile, further questions have been raised about the WHO’s independence over the H1N1 flu virus after various documents found medicines and vaccinations were mentioned more than 40 times while traditional hand washing and the use of masks to combat the disease were only mentioned twice. The pharma industry is expected to make between seven and 10 billion Euros in 2009 from the sales of swine flu related drugs, according to JP Morgan.
“One of the extraordinary features of this influenza — and the whole influenza saga — is that there are some people who make predictions year after year, and they get worse and worse. None of them so far have come about, and these people are still there making these predictions. For example, what happened with the bird flu, which was supposed to kill us all? Nothing. But that doesn’t stop these people from always making their predictions. Sometimes you get the feeling that there is a whole industry almost waiting for a pandemic to occur,” said Jefferson. Jefferson states that pharmaceutical companies have built a machine around the impending pandemic and are already cashing in. “And there’s a lot of money involved, and influence, and careers, and entire institutions! And all it took was one of these influenza viruses to mutate to start the machine grinding,” writes Tom Jefferson. (6) in the German news Spiegel Online.
Now I understand why my articles and blogs get rejected. I think ahead of times! Telling the truth could be sacrilege.
Yours ever,
B. M. Hegde
References:
1) Hegde BM. In the information society nobody thinks. BMJ 2009; 339: b3471 eletter
2) Hegde BM. It is amazing how complete is the delusion that medical care is health care? BMJ 2009; 339: b4444. eletter.
3) Hegde BM. The science and the art of medicine BMJ 2009; 339: b4125 eletter.
4) Hegde BM. Be careful about reading health books, you may die of a misprint. BMJ 2009; 339: b4010. eletter.
5) Blalock R. Swine ‘flu-one of the most massive cover ups in American history. articles.mercola.com/.../What-We-Have-Learned-About-the-Great- Swine-Flu-Pandemic.aspx - Cached -
6) Jefferson T. Swine ‘Flu Fear mongering. German News. Spiegel Online.
COVER STORY
Past Publications in Pediascene on the issue of Industry & Medical Profession:


COVER STORY
PIL against Vaccines
IN THE HIGH COURT OF DELHI AT NEW DELHI
(CIVIL ORIGINAL JURISDICTION)
Writ Petition (Civil) No. .................... Of 2009
Public Interest Litigation
A Writ Petition in public interest under Article 226 of the Constitution of India highlighting how irrational vaccines are being arbitrarily introduced and promoted by the Government at the behest of vaccine manufacturers and other vested interests.
IN THE HIGH COURT OF DELHI AT NEW DELHI
(CIVIL ORIGINAL JURISDICTION)
To,
THE HON’BLE CHIEF JUSTICE OF DELHI AND HIS COMPANION JUDGES OF THE HON’BLE HIGH COURT OF DELHI, AT NEW DELHI
MOST RESPECTFULLY SHOWETH: -
That the Petitioners are filing the instant writ petition in public interest highlighting how irrational vaccines are being introduced in the public health system by the Government, under the influence of vaccine manufacturers and international agencies like World Health Organization (WHO), without proper epidemiological and medical studies. Petitioners (who are generally pro-vaccine and pro-modern medicine) are appalled at how in the absence of a rational vaccine policy, newer and newer vaccines are being pushed by the Government into the national immunization programme. Vaccines which are either of little utility or which are not required at all are being introduced and promoted by the Government at the behest of these vested interests and, at the same time, basic vaccines that are the right of every child are not being made available under the Universal Immunization Programme (UIP) to 53% of the population – mostly poor living in rural areas who should be the priority for any immunization program as the poor cannot afford the consequences of disease.
2) Under the Expanded Programme of Immunization (EPI), 6 primary vaccines are covered: BCG, DPT, DT, TT, Measles and Polio. At a time when the Government has utterly failed to ensure that every child receives these vaccines and the country is facing a shortage of these vaccines, new vaccines of questionable utility and efficacy are sought to being introduced in an arbitrary and irrational manner, and at huge cost. These expensive vaccines, after being introduced, are very likely to be cornered by the urban elite at the expense of the exchequer. The only beneficiaries of this are the vaccine manufacturers. Government has shown little interest to make the EPI vaccines available to the large number of children who are either poor or are in remote rural areas and thereby violating their Fundamental Rights guaranteed under Article 14 and 21 of the Constitution.
3) The Petitioners is highlighting the Government’s arbitrary policy on vaccines by using, as case studies, the proposed introduction of Hepatitis B, Haemophilus influenzae Type B (Hib), Pneumococcal and the Pentavalent vaccines which are of doubtful utility, unproven efficacy, expensive and are not required. World over, before a vaccine is introduced in the public health system, a number of studies are carried out with proper methodology and expertise, taking into account a number of factors, and also conflict of interest is strictly guarded against. In India, not only these tests are not being done, adverse studies against these new vaccines are deliberately being ignored. It is of note that the very studies that were done by the WHO to demonstrate the need for the vaccines in India showed that there was very low incidence of the disease and as such there was little sense in introducing the vaccine and these very studies were ignored in the recommendation made to GOI to introduce the vaccine. This practice of selectively ignoring studies (even those done by the ICMR with funding from the WHO) which are inconvenient, goes against the basic tenets of Evidence Based Medicine and results in promoting irrational medicine. This Petition seeks a direction to the Government to formulate a rule-based rational vaccine policy by which vaccines are scientifically evaluated in a transparent manner before they become part of country’s UIP. This Petition also seeks an immediate stay against the introduction of Hepatitis B, Haemophilus influenzae Type B (Hib), Pneumococcal and the Pentavalent vaccines till the requisite studies are carried out.
Memo of Parties
In the matter of:
Dr. K. B. Saxena (Ph.D)
Petitioner No. 1 |
Dr. N. J. Kurian (Ph.D)
Petitioner No. 5 |
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Prof. S. K. Mittal (MD)
Petitioner No. 2 |
Dr. Ritu Priya (MD)
Petitioner No. 6 |
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Prof. Debabar Banerji (MD)
Petitioner No. 3 |
Dr. Mira Shiva (MD)
Petitioner No. 7 |
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Prof. Imrana Qadeer (MD)
Petitioner No. 4 |
Dr. Jacob M Puliyel (MD MRCP MPhil)
Petitioner No. 8 |
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Dr. Gopal Dabade (MBBS, DLO)
Petitioner No. 9 |
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Versus
The Union of India Respondent No. 1 | National Technical Advisory Group of Immunization
Respondent No. 2 | Indian Council Of Medical Research
Respondent No. 3 |
High court issues notice
The Delhi High Court Wednesday issued a notice to the union health ministry on introduction of vaccines without proper medical research.
A division bench of Chief Justice Ajit Prakash Shah and Justice S. Muralidhar said, “This is a serious issue. It shows that medical facilities provided by the government are just mockery.”
The court asked the health ministry to respond to the notice by Jan 13. The court was hearing a petition that alleged that vaccines are being introduced in the public health system by the government under the influence of vaccine manufacturers and international agencies like the World Health Organization (WHO), without proper epidemiological and medical studies.
“We just want to highlight how in the absence of a rational vaccine policy, newer and newer vaccines are being pushed by the government into the national immunization programme. Vaccines which are either of little utility or not required at all are being introduced and promoted by the government at the behest of these vested interests,” advocate Prashant Bhushan said in his petition.
COVER STORY
Every Child is important!!
Every child is important for nation. Being Health as basic concern, two immunization schedules are running simultaneously for same child.
“Ek phool do maali”-
National immunization schedule (NIS) is run and implemented by GOI to protect every child, free of cost from metros to remotest places. NIS is not updated frequently in light of current context. IAP recommends essential (NIS), additional, optional and special vaccines on payment. IAP schedule is updated regularly in view of disease epidemiology and vaccines availability.
Own interest?
Pharmaceutical companies are spending enormous money and time in vaccines R&D. They sponsor scientific events for getting favorable recommendation and promotion of their products to recover expenses and to earn even huge profits.
Pediatricians over emphasize (sometimes even instilling fear amongst parents) newer vaccines for hidden benefits like high profit (purchasing vaccines well below the MRP) or through different schemes launched by the vaccine companies. Some anxious parents go on demanding more and more.
Hidden issues?
- Are these newer vaccines listed at under category of essential medicines of ‘WHO’ and India?
- What are the criteria laid down by Drug controller General of India regarding their introduction and use?
- Are newer combinations (tetra or penta) indeed ethical or solely being promoted in name of “less pricks, less visits” or indirect selling strategy?
Pitfalls:
- Two immunization schedules (NIS, IAP): create confusion.
- Newer vaccines (costly): beyond reach of poor.
- Current immunization coverage: well short of desired level, not up to 100%!
- Unawareness: about more important Routine Immunization!
Recommendations (moral) of competent body-
Being a huge association of 17000 plus members, Academy must accept moral responsibility for all sections of the society! Should ignore affordability issues (diseases don’t see status!)
First, we should make plans and drive how to improve RI coverage: Cent-per-cent coverage of all vaccines under NIP.
For uniform benefit of additional or optional vaccines (costly) we can suggest the government to raise financial resources by making a corpus fund with aids from corporate sector, politicians, international health sector etc and pressurize the manufacturers regarding prices of vaccines before licensing or issuing recommendations.
Conclusion-
Like nature, a disease can affect anyone without enquiring status and affordability issue, so benefit of recommendation should be equal to all segments because “Every Child is Important”!
- Rakesh Chandra Chaurasia, Asstt. Prof- MLNMC, Allahabad
COVER STORY
Ethical guidelines for industry sponsorship:
The American College of Physicians and The World Medical Association suggest that it may not be possible to completely do away with industry support. So, rather than forbidding any connection between doctors and industry, the associations argue, it is better to establish ethical guidelines for industry sponsorship of conferences, research, and gifts to doctors. The guidelines suggest that:
• No individual doctors should receive direct payment from commercial companies to cover traveling expenses, room and board at a conference, or compensation for their time.
• Drug companies should have no influence on the content, presentation, choice of speakers, or
publication of results.
• The names of any companies providing financial support should be publicly disclosed. Funding for a conference can be accepted as a contribution to the general costs of the meeting but not as payment for any specific lecturer or participant.
• Physicians should not accept gifts, hospitality, services, and subsidies from industry if acceptance might diminish, or appear to others to diminish, the objectivity of professional judgment.
• All conference organizers and lecturers should disclose to conference participants any financial affiliations they have with manufacturers of products mentioned at the meeting or with manufacturers of competing products.
• If an organization allows industry sponsored hospitality, the hospitality should be modest and
arranged so that social activities do not compete with educational events.
• Conference organizers should ban the distribution of promotional materials in educational sessions unless the materials are clearly related to instruction.
• Conference organizers are responsible for discussing industry sponsorship with invited speakers, including support for such presentation aids as slides or literature reviews. This disclosure will give speakers the opportunity to screen the aids and accept or refuse them, or make modifications to ensure objectivity.
• Conference organizers and faculty should disclose any support they receive individually as consultants, investigators, or shareholders, and they should be sure that their relationships are explicitly listed in the CME program.
( Kalantri SP. In Indian J. Anaesth. 2004; 48 (1) : 28-30) |
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