Drug giants from GSK, Abbott and Pfizer to Bayer have been fined for serious malpractices. They should be under close watch in India
Last week, Business Standard of Delhi front-paged a story that pharmaceutical multinationals Novartis, Pfizer, Bayer, Bristol Myers Squibb were involved in clinical trials in India that killed 438 people in 2011. Quoting data from the Drugs Controller General of India (DCGI), the newspaper listed the companies and the fatalities that resulted in the trials of each of these companies which also included a handful of domestic drugs manufacturers.
The companies, of course, denied that the deaths were due to the drugs administered during the trials and the US-based clinical organisation carrying out most of the trials, Quintiles, had a perfectly plausible explanation for this. Since most patients taking part in such trials had a pre-existing medical condition, deaths could, therefore, occur for a variety of reasons. But what made one’s skin prickle is the revelation that companies bank on doctors who can complete the trials quickly and pay them hefty sums for it. The ability of Big Pharma to rope in doctors for their malpractices is well known and well documented in the US and Europe. Just three weeks earlier, British drug company GlaxoSmithKline (GSK), one of the biggest pharma companies in the world, reached a record $3 billion settlement with the US for a number of sleazy practices. The ‘settlement’, which means no one is arrested, taken to court or jailed as they should be in view of the seriousness of the charges, has been described as historic because it is the largest healthcare fraud payout in the US.
Here’s some of what GSK did to make sure its business grew and grew—and be warned that it makes for unpleasant reading. It illegally promoted Paxil for treating depression in children from 1998 to 2003 although it was not approved for anyone under 18. It wrong sold Wellbutrin and also failed to report for seven years safety issues with diabetes drug Avandia, which was restricted in the US and banned in Europe because it increases sharply the risk of heart attack. There was more of the same. But what is pertinent here is the charge of paying kickbacks to doctors to prescribe several drugs. It showered doctors with gifts, consulting contracts, speaking fees and managed to rope in an unbelievable 49,000 of them as the company’s “speakers”—doctors who were paid around $2,000 for an hour’s promotional work.
While US newspapers are goggle-eyed at the amount of the settlement, a simple analysis reveals how insignificant the penalty is. During the period of malpractices, it raked in $27 billion on just three of its anti-depressants that it promoted illegally. Such fines, or settlements, are water off a duck’s back for a company with a market capital of over $115 billion. Its shares are riding high and the investment advisory still is ‘buy’.
That’s GSK. But all other MNCs exhibit a similar marketing flair. A couple of months ago, US multinational Abbott Laboratories was fined $1.5 billion for unlawful promotion of its drug Depakote, and what is particularly repugnant is that the company trained its sales force to target the elderly by misbranding the drug to control agitation and aggression in elderly dementia patients. Abbott created programmes and materials to train consultant pharmacists about the off-label use of the drug and reportedly paid millions of dollars in rebates to the pharmacy providers. More significantly, it was forced to discontinue clinical trial of Depakote in the treatment of dementia due to an increased incidence of “adverse events”.
The GSK case was taken up by the Justice Department 10 years after two whistleblowers brought the malpractices to the firm’s notice. It is telling that these pharma giants have rarely called their top executives to account for risking the lives of patients, specially children. Till the GSK deal was announced in early July it was Pfizer that held pride of place with a record fine of $2.3 billion for “improperly” marketing 13 drugs, including Viagra and cholesterol fighter Lipitor, which has been the world’s top-selling drug for years. Pfizer is said to have encouraged doctors to prescribe its drugs with free golf, massages and junkets to posh resorts.
Included in the roll of honour are Merck (settlement of $950 million in relation to its drug Vioxx); Johnson & Johnson ($600 million for charges that it gave kickbacks to nursing homes to market its drug falsely), Eli Lilly (settlement of $1.4 billion in relation to its drug Zyprexa), Novartis ($422.5 million for unapproved marketing of an epilepsy medicine and paying kickbacks to doctors to prescribe six drugs); Bristol-Myers Squibb ($499 million for overcharging government and questionable marketing practices).
Shouldn’t we worry? This is not to say Indian companies are paragons of virtue. Included in the DCGI data are five domestic firms. Since we have a tendency to absorb with alacrity all that the developed world has to teach us, it is time that government and patients started to keep strict tabs on this sector.
Read also: Ethics on trial