Faulty prescriptions

Print edition : May 13, 2016

A pharmacist separating banned drugs at a shop in Chennai on March 23. Photo: M. Vedhan

The Centre’s decision to ban 350 fixed-dose combination drugs brings to the fore the urgent need to curb the unethical practices in the pharmaceutical industry in marketing irrational formulations through inducements to doctors and in other ways.

ON March 12, the Union Ministry of Health and Family Welfare banned nearly 350 fixed-dose combination (FDC) drugs, including common cough syrups, painkillers and other analgesics that were available across the counter without prescriptions. The ostensible reason was that these drugs lacked therapeutic justification but were aggressively marketed by leading pharmaceutical companies over the years. Although some of the common analgesics in the list had long been banned in other countries, they had manufacturing approval from state drug control authorities in India. The Jan Swasthya Abhiyaan (JSA), a broad front of health activists and professionals, has pointed out that since they did not have marketing approval, the drugs were marketed illegally. The health sector and health experts have welcomed the government’s move.

Leading pharmaceutical companies have been accused of resorting to unfair marketing practices such as giving gifts to doctors, sponsoring doctors’ foreign trips, organising medical conferences and giving financial incentives. Pharmaceutical companies are known to target doctors, especially specialists in chronic maladies such as diabetes, asthma and cardiovascular diseases. As treatment for these diseases is long term, pharmaceutical companies approach specialists to prescribe and push their products. Frontline has access to 91 airline tickets (involving more than one destination) that a major pharmaceutical company offered to doctors in July 2015. The pleasure trips were sponsored under the garb of “Continuous Medical Education” (CME). Interestingly, the company-sponsored trips took place in violation of the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP).

The pharmaceutical major conducts in-practice usage and performance (IPUP) studies of various drugs. Frontline has in its possession the format of a study for one drug, Covance, recommended for the treatment of hypertension. The pro forma, drafted by a medical professional on the rolls of the pharmaceutical company, specifies that doctors enlisting themselves for the study will be required to report their experience with the drug and provide other details such as adverse events relating to the drug use; they will be paid a professional fee of Rs.1,000 for every patient. Frontline has a copy of a cheque for an amount of Rs.25,000 given to a doctor through the IPUP for prescribing a drug called Teleact. It is being marketed after the regulatory approval was obtained, but the study, according to the objectives specified in the pro forma, was done because “it is important to know how it performs in day-to-day practice of individual medical practitioners”. An email correspondence dated October 16, 2015, from a regional manager of the pharmaceutical major, expresses happiness over the success of the IPUP campaign thus: “Let me share the joy of success of the IPUP campaign at Kottayam Hq. They were selling CEPODEM 100 DS at an average of 150 bottles per month. With the help of IPUP, they will be crossing 1,500 bottles in this single month October if not 2,000. The contributors are only 4 drs [doctors], which gives you the amplitude regarding right customer, right approach [sic] and determination.” Another correspondence on the same day addressed to “Team” said: “If we are investing IPUP with proper profiling of the customer, ROI [return of investment] is ensured. Let us utilise investments judiciously after doing homework. Eagerly waiting for more success stories.” Frontline has copies of all these documents that indicate the success of the inducement tactics if nothing else. In an email correspondence dated May 30, 2015, a manager of the company asks medical representatives to give details of “big ticket doctors for CRM [customer relationship management], who can contribute monthly above 50 k [thousand]”. The contribution naturally refers to business. Frontline has the supporting documents for this as well.

Camp approach

The sale and promotion of drugs is governed by two laws, the Drug and Magic Remedies (Objectionable Advertisements) Act, 1954, and the Sales Promotion Employees (Conditions of Service) Act, 1976. Neither of them encompasses a policy on promotion of drugs, many of which admittedly have no therapeutic justification. The drugs are promoted in subtle and obvious ways. The subtle ways include organisation of medical camps to mobilise patients.

A source associated with the industry said that the stated purpose of such camps would be to create awareness among the public. but what they achieved in reality was to secure patients for doctors. These camps would conduct tests to detect asthma, arthritis, haemoglobin levels and thyroid malfunction. “The machines and the tests would be presented in a manner that would compel the camp attendees to take those medicines. Another common way to attract patients is by way of mass vaccination camps in educational institutions by approaching the parent-teacher associations. The hepatitis vaccination is one such ‘camp approach’, which incidentally is not a part of the WHO [World Health Organisation] vaccination regime,” the source said. Industry sources said that earlier the pharmaceutical companies used to provide as gifts pens, paperweights, writing pads, thermometers, etc., carrying the brand names of some products. Now the gifts ranged from payment of the equated monthly instalments of car loans, sponsorship of foreign tours of doctors and their families, and giving money to conduct surveys or prepare study reports, and gifts such as air conditioners and refrigerators.

The Central government woke up to the unethical practices followed by pharmaceutical companies only in 2009. At a meeting attended by pharmaceutical industry associations on January 13, 2009, the Secretary of the Ministry of Chemicals and Fertilizers observed: “Keeping in view the seriousness of the allegations made in the medic reports, this department felt the need to take up the matter in the interests of consumers/patients as such promotional expenses being extended to doctors had direct implications on the pricing of drugs and its affordability.” A code of ethics and a mechanism for strict enforcement dealing with violations was formulated by the Organisation of Pharmaceutical Producers in India and the Indian Drug Manufacturers Association, which was rejected by the other associations. Interestingly, the government consulted only the pharmaceutical companies and not the other stakeholders such as public health experts and consumer associations. The process dragged on. A draft code was prepared, but not much was revealed in the public domain until December 2014 when the government, through a circular, announced the formation of the UCPMP and directed the pharmaceutical industry to adopt the code voluntarily and comply with it for a period of six months with effect from January 1, 2015. It also said the code would be reviewed on the basis of the inputs it received.

Designed to fail

The UCPMP, by its very nature, was voluntary with no statutory or legal backing for enforcement or affixing culpability. It was viewed as a mechanism in which the offenders themselves drafted a code to regulate their irregular and unethical practices. The very first paragraph of the code provided for a review after six months and “if it was found that it had not been implemented effectively by pharmaceutical associations/companies, the government may consider making it statutory”. The Federation of Medical Representative Associations of India (FMRAI) pointed out that a code that was voluntary did not exist anywhere else in the world. On June 3, 2015, the government called a meeting to review the UCPMP, but it was called off without citing any reasons. The code has been deemed faulty on many counts. For one, it protects rather than proscribes unethical behaviour. Under the section “General Points”, subsection 1.5 lays down that information about a drug, which must be accurate, balanced, fair, objective and not misleading directly or by implication, must be “capable of substantiation”. Critics point out that the phrase “must be ‘capable of substantiation’” should be substituted with “must be substantiated”.

Similarly, under the section “Claims and Comparisons”, subsection 2.7 lays down, curiously, that the “clinical and or scientific opinions of members of health care professionals must not be disparaged either directly or by implication”. This effectively forbids any criticism of industry-influenced studies, ghostwriting, misleading statements, articles or studies. The code is in direct contravention of the Drugs and Cosmetics Acts. For instance, in the section on “Textual and Audio Visual Promotional Material”, it does not make it compulsory to mention the name and address of the manufacturer.

Under another clause, the naming of “inactive ingredients” of the drug is not required, which is again in contravention of the Food and Safety Act, which makes mentioning of all ingredients compulsory. Sodium, for instance, can harm some patients but may be an inactive ingredient in a drug. The FMRAI has demanded that the legal term “sales promotion employees” should replace the term “medical representatives” who are mainly responsible for compliance with the code. It also said that the earnings of the sales promotion employees should not be linked to the sale of medicines. These stipulations, it said, would go a long way in correcting the unethical practice of inducing medical professionals to buy drugs.

The code lays down in Section 7.1 that “companies or their associations/representatives of any person acting on their behalf shall not extend any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations etc to health care professionals and their family members for vacation or for attending conferences, seminars workshops, CME programme as a delegate etc. It is clarified that in any seminar, conference or meeting organised by a pharmaceutical company for promoting a drug or disseminating information, if a medical practitioner participates as a delegate it will be on his or her cost.” It is not clear whether non-delegates can be sponsored in such a fashion. The code allows a lot of room for manoeuvre. However, the fact that the UCPMP details all the various categories of travel facilities provided by companies to medical practitioners is an indication of the extent of the rot.

Conflict of interest

Critics point out that the code has relied on the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002, which gives a lot of scope for paying professionals through other means. The real issue is that the code leaves it to the industry to take action against its own members—a major conflict of interest.

The Ethics Committee for Pharma Marketing Practices under the UCPMP will be composed of pharmaceutical industry representatives and associations. Even the review committee will consist of professionals from within the industry, leaving no room for any third-party intervention. Strangely, the committee set up by the government will have none of its representatives from the Ministries concerned. The ruling of the committee reviewing the complaints shall be final. Punishment for offenders ranges from suspension of the company from the association, reprimand of the company, publication of the details of the reprimand, issue of a corrective statement by the company to the media, recovery of items from the violators of the code and written submission of the action taken in writing to the committee. Simply put, the code has been designed for failure with its non-statutory status and weak provisions for penalty.

The code allows medical practitioners to work for pharmaceutical and allied health care industries in advisory capacities, as consultants, researchers, treating doctors or in any other professional capacity. It is known that pharmaceutical companies hire top doctors as advisers offering monetary benefits as compensation.

Illegal drug formulations

Pharmaceutical companies’ profits have risen tremendously over the years. While taking irrational formulations off the shelves may hurt the industry, it is significant that despite several court orders, these formulations have been allowed to prevail. The JSA pointed out that of the list of 370 essential medicines prescribed by the WHO, only 25 are fixed-dose combinations. The JSA is of the view that the major brands that have been banned and on which injunctions have been granted, are manufactured by prominent multinational companies (MNCs).

“None of these banned formulations would be allowed in the home countries of the MNCs concerned. All the companies concerned had access to information showing that their formulations were unscientific. Marketing of these drugs is unethical in all cases and illegal in many cases. The distorted business model of large companies has also been laid bare by the pleas of some of these companies. Pfizer and Abbott, two U.S.-based MNCs, who take pride in claiming that they are ‘innovator’ companies, now lament that a ban on their unethical cough syrups—Corex and Phensedyl—will jeopardise their entire operations in the country. Surely, giant MNCs should not depend on simple remedies like cough syrups to sustain their operations in a developing country,” the JSA’s statement noted.