#India -Pharma firms ply doctors with gifts #medicalethics


Published: Thursday, Dec 27, 2012, 5:30 IST
By Sandeep Pai | Place: Mumbai | Agency: DNA

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. l Turn to p9

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.”

 

Supreme Court Canada invalidates Pfizer’s Viagra Patent


Supreme Court Voids Viagra Patent as Insufficient Disclosure Means It Fails the “Patent Bargain”

Canada’s top court has ruled that Pfizer’s patent on their groundbreaking erectile dysfunction drug Viagra won’t be valid for much longer. The unanimous decision opens the door to the production of a generic version of Viagra in the near future.

Thursday November 08, 2012 http://www.michaelgeist.ca/

The Supreme Court of Canada this morning shocked the pharmaceutical industry by voiding Pfizer’s patent in Canada for Viagra. The unanimous decision provides a strong reaffirmation of the policy behind patent law, namely that patents represent a quid pro quo bargain of public disclosure of inventions in return for a time limited monopoly in the invention. The Supreme Court describes it in this way:

The patent system is based on a “bargain”, or quid pro quo: the inventor is granted exclusive rights in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge. This is the basic policy rationale underlying the Act. The patent bargain encourages innovation and advances science and technology.

Disclosure is therefore a crucial part of the patent bargain.

The court clarifies that this involves not only a description of the invention and how it works, but rather a much more practical level of disclosure “to enable a person skilled in the art or the field of the invention to produce it using only the instructions contained in the disclosure.” In this case, the court finds that Pfizer failed to provide sufficient disclosure, concluding:

the public’s right to proper disclosure was denied in this case, since the claims ended with two individually claimed compounds, thereby obscuring the true invention. The disclosure failed to state in clear terms what the invention was. Pfizer gained a benefit from the Act – exclusive monopoly rights – while withholding disclosure in spite of its disclosure obligations under the Act. As a matter of policy and sound statutory interpretation, patentees cannot be allowed to “game” the system in this way.

Pfizer argued strenuously that this should not result in invalidating the patent, but Justice Lebel, writing for the court, found no other alternative. The Viagra patent is therefore voided in Canada (which will allow for generic substitutes) and the importance of the basic foundation of patent policy for the broader benefit of society reaffirmed.

#India- #Abbott suspends giving gifts to doctors #goodnews #medicalethics


 

 

 

 

By Frederik Joelving

 

NEW YORK | Tue Oct 16, 2012 6:03pm EDT

 

(Reuters Health) – Abbott Laboratories Inc has instructed its sales representatives in India not to give gifts to doctors, who are prohibited by local law from accepting them, a practice that has been used as a bargaining chip by companies wanting a piece of the country’s burgeoning healthcare market.

 

According to an internal email dated October 11 from Sudarshan Jain, managing director of Abbott Healthcare Pvt. Ltd, the gift-giving has been temporarily suspended.

 

“Only Abbott-approved clinical/scientific literature may be distributed to current and potential customers,” said the email, which was reviewed by Reuters on Tuesday. “No brand reminders or therapy reminders in your possession should be given to any current and potential customer and no further brand reminders or therapy reminders should be ordered.”

 

Accepting gifts or travel arrangements from drugmakers is against the law in India, but enforcement is inconsistent.

 

Public health experts say gift-giving leads to dangerous overprescribing and unnecessary use of expensive medications when cheaper versions are available. That can be a significant burden for the 400 million people in India who live on less than $1.25 a day.

 

A sales representative with Abbott Healthcare told Reuters that therapy reminders are low-value items such as pens, whereas brand reminders refer to electrical appliances and other pricier merchandise.

 

The representative, who spoke on condition of anonymity, said he was not worried about his job getting harder without the gifts, but, he quipped, it would certainly make his bag lighter.

 

As multinational drug companies ramp up investments in emerging markets to realize billions of dollars in annual sales, they have faced increased scrutiny from the United States and European governments. U.S. authorities are currently probing a number of leading global drugmakers for kickbacks and bribery overseas.

 

A Reuters investigation in September showed Abbott’s Indian subsidiaries plied doctors with scanners, vacuum cleaners, coffee makers and similar items in return for prescribing the company’s drugs to patients. Sales representatives were shown lists of gifts in strategy guides issued by the company.

 

In August, Pfizer Inc paid $60.2 million to settle a U.S. probe involving illegal payments to win business overseas, including kickbacks such as cellphones and tea sets given to doctors in China. Last year, Johnson & Johnson agreed to pay $70 million to settle U.S. charges under the Foreign Corrupt Practices Act (FCPA) that it had bribed healthcare providers in Greece, Poland and Romania.

 

Scott Davies, a spokesman for Chicago-based Abbott Labs, confirmed the decision but declined to say what had prompted the move. He said he was not aware of any inquiries from regulators about the company’s dealings in India.

 

“This is an internal action,” he told Reuters. “We are suspending that brand reminder program while we review it.”

 

Davies said the suspension encompasses Abbott Healthcare and Abbott True Care, but did not have information on whether other Indian subsidiaries would continue the practice. He declined to address travel payments.

 

(Editing by Ivan Oransky, Michele Gershberg, Maureen Bavdek and Claudia Parsons)

 

 

#Nestle NAN H.A. 1 Gold baby formula ‘making children sick’


HA 1 Gold_00103

Nestle‘s NAN H.A. 1 Gold. Picture: Nestle

Harry Paganin

Robert Paganin fed the new formula to his six-month-old son Harry for four weeks before discovering it was making his son sick. Picture: Supplied

Constant crying, rashes, dark green watery poo, dehydration and vomiting are among the symptoms babies have been experiencing since Nestle’s NAN H.A. 1 Gold switched to a “new improved” recipe.

Sarah Wells from Launceston in Tasmania put her 10-week-old son Oliver on the new formula and said she immediately noticed the bad side effects.

“A week after being on the formula, and the second can, Oliver’s face broke out in nasty eczema,” Ms Wells told news.com.au.

Ms Wells contacted Nestle, and was told by a customer service representative that babies often have reactions when switching to a new formula, then offered a $50 gift voucher.

Robert Paganin from Blackburn North in Victoria fed the new formula to his six-month-old son Harry for four weeks before he discovered it was making his son sick.

“Within 48 hours of changing he was fine, he was drinking the bigger bottle and finishing it, whereas on the other one he was refusing to drink,” Mr Paganin said.

“I am extremely disappointed and disgusted in Nestle playing with our babies’ wellbeing.”

Nestle external relations manager Margaret Stuart said the company ran tests when it switched calcium chloride for potassium chloride in the formula recipe.

“This testing did not show anything that could cause the reactions that parents are describing,” Ms Stuart said.

Ms Stuart said that the company takes concerns from parents very seriously, and in response to comments Nestle is running further testing using an independent laboratory in Australia.

“While we do not yet have final results, preliminary results of the microbiological profile indicate no food safety issue,” she said.

In the past six weeks, more than 100 reviews and comments have been posted by angry parents on consumer website Product Review.

“Old recipe was fantastic, new and improved a total disgrace , after 3-4 feeds of Nan H.A. Gold1 my baby was producing dark green liquid poo, excessive wind and restlessness,” posted Brett4646.

Meanwhile Joy16 posted: “We haven’t had such terrible days and nights like this before. Our twins cried constantly for 6 hours.”

“It is terrible!! It’s even worse when u ring the company and tell them and they still don’t take you seriously! My son smells revolting! He cries non stop!,” posted 4babies.

Read more: http://www.news.com.au/business/companies/nestle-nan-ha-1-gold-baby-formula-making-children-sick/story-fnda1bsz-1226445965641#ixzz237byNISG

WHO- contradictions- Gag order on Reproductive Health and Guidance for hormonal contraceptive


Invitees who attended back-to-back World Health Organization (WHO) consultations at the start of February were required to sign confidentiality agreements prohibiting them from talking about the meetings. They had to promise not to divulge anything that was said during the three days — not to colleagues, not to their networks, and especially not to journalists, who might misreport the facts. The world health body explained that journalists often exaggerate, and the UN doesn’t want to induce panic. The media will be informed when WHO holds an additional meeting of UN insiders on February 15, behind closed doors, and prepares a carefully worded public statement for release the next day.

The highly classified topic of discussion wasn’t a nuclear threat or a new virus that can kill within days. It was birth control.

WHO’s gag order is just the latest in a years-long effort by the United Nations’ AIDS apparatus to limit how much women know about possible links between HIV and injectable hormonal contraceptives. The UN appears to have forgotten that its job is not to control women’s sexual and reproductive decisions, but to inform them.

Here’s what the UN knows: In July 2011, researchers led by Renee Heffron at the University of Washington in Seattle presented findings from studies involving 3,790 sero-discordant couples (one HIV-negative and one HIV-positive partner) in east and southern Africa.1 The data compared women who had and women who had not used hormonal contraceptives during the research periods: twice as many HIV-negative hormonal contraceptive users acquired the virus. The rates of transmission from HIV-positive women to their male partners was also two times higher for users of hormonal contraceptives. (The findings focused on injectables because very few study participants took hormonal contraceptives in pill form, making the higher rates of HIV infection and transmission in that group “statistically insignificant.”)

In laypersons’ terms, hormonal contraceptives are products that adjust a woman’s hormone levels to prevent ovulation and pregnancy. In the east and southern African countries where the research was carried out, injectable hormonal contraceptives (“depot medroxyprogesterone acetate,” or DMPA) are the top choice of women who use contraceptives, and the Depo-Provera brand owned by pharmaceutical giant Pfizer, Inc. is the most widely used. Despite common side effects, popular features of the method are that one injection lasts three months, and a woman’s sex partner need not know that she is using a contraceptive.

The findings by Heffron and colleagues weren’t definitive; it would take years of additional research to determine beyond a doubt whether or not hormonal contraceptives actually double women’s risks of acquiring or transmitting HIV during unprotected sex. But the research team was concerned enough last July to say: “Our findings argue for policies to counsel women about the potential for increased HIV-1 risk with hormonal contraceptive use, especially injectable DMPA use, and the importance of dual protection with condoms to decrease HIV-1 risk.”

Read Original Artical here

and GUESS WHAT ?, WHO has just declared that “hormonal contraceptives are safe to use for women with or at risk of HIV” based on the meetings discussed below.

WHO upholds guidance on hormonal contraceptive use and HIV

Geneva, 16 February 2012. WHO has concluded, on the advice of its Guidelines Review Committee, that women living with HIV or at high risk of HIV can safely continue to use hormonal contraceptives to prevent pregnancy. The recommendation follows a thorough review of evidence about links between hormonal contraceptive use and HIV acquisition.

Current WHO recommendations in the Medical eligibility criteria for contraceptive use (2009 edition) therefore remain: there are no restrictions on the use of any hormonal contraceptive method for women living with HIV or at high risk of HIV. Couples seeking to prevent both unintended pregnancy and HIV should be strongly advised to use dual protection – condoms and another effective contraceptive method, such as hormonal contraceptives.

Read more here