Medical Scam: With no laws, pharma firms have a field day

IN THE absence of any penal provisions that may be applied in cases where pharmaceutical majors use unethical practices to woo doctors to promote drugs, pharma companies brazenly offer incentives to doctors, flouting the Department of Pharmaceuticals’ ‘voluntary code’.

As a result, while a December 2009 code of medical ethics developed by the Medical Council of India (MCI) includes legal provisions to punish doctors who accept gifts from pharmaceutical companies in return for aggressively prescribing certain drugs, there is nothing to stop drug manufacturers’ unethical practices.

Santhosh M R of the Centre for Trade and Development (CENTAD), an organisation that conducted a study on pharmaceutical companies on behalf of the Competition Commission of India (CCI), says, “In the absence of any legal provision, no company can be prosecuted (for such activities). Thus, they are fearless.” On Thursday, DNA reported that the country’s top pharma firms routinely offer considerations ranging from gifts including electronics and gold coins to foreign trips to doctors who achieve pre-fixed targets for prescriptions of certain drugs.

The 58th report of the Parliamentary Standing Committee on Health and Family Welfare dated May 8, 2012 says there appears to be little logic in keeping the code for companies a voluntary one. “The Committee has been given to understand that the voluntary code has generally not been successful in curbing unethical practices and off-label promotion of drugs,” the report says, adding that the Secretary (Pharmaceuticals) was unable to offer any valid reason for not making the uniform code a statutory provision.

A statement to DNA from the World Health Organization also opined that implementation of the code must be reviewed. “If it is found that it has not been voluntarily and effectively implemented by pharmaceutical associations/ companies, the government should consider making it a statutory or binding regulation,” the WHO said.

Also worrying is that companies keep the working and service conditions of medical representatives, the foot soldiers who meet doctors and promote drugs, highly suspect.

While the Sales Promotion Employee (Conditions and Services) Act, 1976 empowers medical representatives and regulates their service conditions, the Federation of Medical & Sales Representatives’ Association of India (FMRAI) which represents more than 1.5 lakh medical representatives, says almost no pharma firm issues legally amended appointment letters as stipulated by the Act. “If they give appointments under Form A, they would be bound by the Act and all the labour laws would prevail. In such a scenario, the employees will have a stronger say and can refuse to participate in unethical practices,” said JS Majumdar, former general secretary of the association.

“This in turn would mean that they would be forced to undertake unethical practices.Even if they are caught, the blame would come on representatives and doctors,” Santhosh added.

Several appointment letters of sales promotion employees accessed by DNA show that they are recruited as territory business managers, product executive and product specialists, etc. In fact, when the issue was brought to the notice of the central government in August 2010, KM Gupta, economic advisor to the Centre’s labour department, sent a letter to labour secretaries of all states advising imprisonment as a penalty for employers who violate the provisions of the Act.

The FMRAI also gave a memorandum to the Labour Minister, Government of Mahrashtra, in February 2012 regarding the violation of the law by pharma companies.
Courtesy:
Sandeep Pai l Mumbai
Published Date:  Dec 28, 2012
http://epaper.dnaindia.com/story.aspx?id=35299&boxid=13525&ed_date=2012-12-28&ed_code=820009&ed_page=10

Medical Scam: ‘Pharma firms-doctors nexus puts patients at risk’

Responding to reports in DNA about unethical practices adopted by pharmaceutical companies to incentivise doctors to promote certain drugs, medical practitioners agreed that the long-term repercussions of such brazen wooing of doctors with gifts and foreign trips could be serious.

“Due to incentives, some doctors start over-prescribing to achieve the targets and the stockist goes out of his way to sell the products. This ultimately affects the customers in terms of high costs and overdosing,” said Dr Suchitra Ramkumar, a medical practitioner and trustee of Citizen Consumer and Civic Action Group (CAG).
Apart from the fact that doctors’ overzealousness in prescribing drugs could see rising healthcare costs, there is also the issue of medical side-effects. “Over-prescribing may lead to patients going through various physical problems due to side–effects,”said Dr Satyajit Kr Singh MS, Fellowship of the Royal College of Surgeons(FRCS) and Ex. Lecturer of the Diplomate Institute of Urology (London), who has worked in various countries across the world.

Admitting that the practice of accepting gifts does exist among doctors across the country, Dr BS Garg, president of the Maharashtra Voluntary Heath Association of India (VHAI) working in Wardha, said, “In districts, the doctors and chemists are even more closely interlinked and so by offering incentives to them, the companies are trying to capture the market. All the money which a pharma company invests in buying gifts or offering incentives is ultimately recovered from the customer.”

The World Health Organistaion in a statement to DNA said the uniqueness of the Indian healthcare system is its relatively well-established private healthcare system. “This means that all decisions with regard to patient care are made by individual or a group of doctors, making doctors very important as a client to pharmaceutical companies. Understanding the MCI Code is only part of the compliance programme for pharmaceutical companies. From a more practical perspective, companies need be aware that anti-corruption compliance is not an additional value to risk management, but an indispensable part of the whole corporate business,” the statement said.

Dean of the Lokmanya Tilak Municipal General Hospital, Sion, one of Mumbai’s largest civic government-run hospitals, Dr SuleimanMerchant, said there would be no takers if there were no givers. “So if there are strict laws in the country for the gift takers, there should be equally strict laws for Pharma companies too,” he said, mirrorring the opinion of several experts. “Not all are involved in this unethical practice,” he added.

According to the President of the Indian Medical Association (Maharashtra) DrAnil Pachnekar also agreed that doctors often face the repercussions while companies offering these gifts get away. “Pharma companies target doctors with more prescriptive power, be it in cities or smaller towns. The ones who are caught are dealt out punishment, but the pharma companies are left out. The crackdown is only on doctors and companies get away because they have a strong lobby.”
Courtesy:
Sandeep Pai l Mumbai
Published Date:  Dec 29, 2012
http://epaper.dnaindia.com/story.aspx?id=35391&boxid=15333&ed_date=2012-12-29&ed_code=820009&ed_page=9

Scam In Medical Field : Pharma firms ply doctors with gifts

So that docs prescribe their costly medicines... it is a win-win for both parties at the expense of patients
Even as the prime minister Manmohan Singh-led National Development Council meets on Thursday to discuss a law to curb unethical practices adopted by pharmaceutical companies to persuade doctors to promote their products, a four-month investigation by DNA has shown that the ‘pay-for-prescription’ practice flourishes. While doctors admit that there is a grave danger of drugs being overused when pharmaceutical companies woo doctors and stockists with various sops for promoting their drugs, even the  parliamentary standing committee on health and family welfare in a report dated May 8, 2012 says there is no let-up in this “evil practice”. It says, “... pharma companies continue to sponsor foreign trips of many doctors and shower them with high value gifts like air conditioners, cars, music systems, gold chains etc... to obliging prescribers who then prescribe costlier drugs as quid pro quo. Ultimately all these expenses get added up to the cost of drugs.”

What’s more, the pharma firm-doctor nexus is not limited to innocuous over-the-counter drugs, a DNA investigation has found.

Take the example of US Vitamin (USV) Ltd, a major player in the oral antibiotics market. In August 2011, its product manager wrote to company representatives appreciating their efforts in making

its product, Drego-D, the Number 1 prescribed brand in the preceding two months. The letter went on to say they should also push another drug, Drego, similarly, given the huge opportunity it presents. All doctors except paediatricians have the potential to prescribe Drego, the letter urged. Drego and Drego-D are both Schedule H drugs, to be sold only on the prescription of a registered medical practitioner.

The letter goes on to detail the promotional activities for the Drego group of drugs, including “on demand campaign” every month specifically for general practitioners, ENT specialists, orthopaedics, gynaecologists and more.

The “engagement” and “development activity” for these doctors included investment of Rs65,000/ year or Rs80,000 per year on one or two selected doctors for a single drug, the letter revealed. “...with such a line of promotion we are sure that you all will very easily achieve a minimum per member per month (PMPM) of 250 strips of Drego & 350 strips of Drego-D,” the letter said, going on

to insist that representatives should, during their field work, ensure that doctors give Drego prescriptions “on priority”.

The letter posted a target a business worth Rs14 crore for a single drug in a single year.

The company’s brochure also says doctors stood to win a smartphone or LCD television once they enter the “MPower Club” for a certain number of prescriptions of Zylera, a drug for nasal problems or asthma-like symptoms, also a Schedule H drug.

Franco India, expected to have a turnover of Rs2.1 billion this year, offers a variety of gifts to doctors, including a hamper of basmati rice, handmade orange soap, an all-in-one mobile phone charger and other stationery items.

Svizera Healthcare, a division of Maneesh Pharmaceuticals Limited, issued a brochure called Club Inspira 2010-2011, which invites doctors to become members by prescribing products worth

Rs50,000 between May and August 2010. The prescriptions would have to be for Si-Fixim, Si-Fixim XL, Si-Fixim CV, FlanZen, FlanZen D/DP and others.

These are all highly sensitive drugs. Si-Fixim is generally used for the treatment of infections caused by susceptible bacteria. Doctors prescribe the medicine to patients suffering from upper

respiratory tract infections, such as pharyngitis, sinusitis, tonsillitis and lower respiratory tract infections like acute bronchitis and acute exacerbation of chronic bronchitis etc. FlanZen is

prescribed for reducing inflammation and edema occurring due to rheumatic disorders, surgeries, breast engorgements, pregnancy-related thrombophlebitis as well as fibrocystic breast diseases.

It causes hypersensitivity reactions including rashes, abdominal discomfort and nausea if not taken properly.
Those entering the ‘club’ would be eligible for a gift, with their options ranging from a microwave oven, digital camera, a gold coin, etc.

While doctors get incentives for prescriptive drugs, incentives are offered to stockists for non-prescriptive drugs too. Though some may debate that there is nothing wrong in offering incentives to

the stockists, but others believe it does make the stockist unethically push for product in order to win the gifts.

While doctors get incentives for prescriptive drugs, incentives are offered to stockists for non-prescriptive drugs too.

A Gelusil festival extravaganza was announced by Pfizer to strengthen the product’s position as the Number 1 antacid in its category. Distributors were offered slab-wise gifts for achieving targets

and also a chance to participate in a lucky draw. A similar offer had been launched last year for Becosules, the vitamin supplement. On offer was a chance to win diamond pendants, gold chains, travel bags, LCD televisions, home theatres, and wrist-watches.

While most pharma companies DNA approached refused to respond to queries on ethical practices while promoting drugs, Pfizer spokesperson Shyam Kumar said the company takes

compliance with norms very seriously. “In fact, over the past several years, Pfizer has taken very significant steps to strengthen our internal controls and pioneer new procedures in the area of

compliance. Corporate integrity is an absolute priority for Pfizer, and we will continue to take appropriate actions to strengthen public trust in our company.”

Dr Kailash Sharma, member, board of governors, Medical Council of India, and director, academics, Tata Memorial hospital, said, ”MCI has already given strict guidelines but the practice of

accepting gifts is so prevalent, it becomes difficult to monitor. Doctors must restrain themselves from accepting gifts or foreign trips from pharma companies. There is a need to bring in penal

provisions for pharma companies, which offer gifts to doctors. There is also a need to audit the accounts of pharma companies to know how much they are spending on publicity.”
Courtesy:
Sandeep Pai l Mumbai
Published Date:  Dec 27, 2012
http://epaper.dnaindia.com/story.aspx?id=35279&boxid=23577&ed_date=2012-12-27&ed_code=820009&ed_page=1