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June 1, 2019

Regulating the health sector


June 1, 2019

The recent conviction of a pharmaceutical company's chairman in the United States has created a ray of hope that unbridled medicine manufacturing companies will be held accountable for what many critics call fraudulent and deceptive sale practices aimed at forcing consumers to buy medicines unnecessarily. Such conviction, if upheld by high courts, could go a long way in deterring drug-manufacturing companies from using corrupt practices in a mad race to sell their wares. It could also create a situation where the overall health system could be reformed to purge it of unethical methods.

According to media reports, John Kapoor, the 76-year old former chairman of Insys Therapeutics, accused of paying doctors millions of dollars in bribes to prescribe opiods, was found guilty of racketeering conspiracy. Four other employees of the company were also convicted. Prosecutors told the jury that the chairman and the others were accused of bribing doctors across the US to boost sales of Subsys and misleading insurers to have payment approved for the drug, which is meant for cancer patients in severe pain and can cost as much as $19,000 a month. It was further revealed that the bribes were paid in the form of fees for sham speaking engagements that were billed as educational opportunities for other doctors.

According to health experts, opioid overdose claimed nearly 400,000 lives in the US between 1999 and 2017. It is estimated that around two million Americans are addicted to the drugs, which include both prescription painkillers and illegal drugs. Media reports claim this is not the first time that Insys has been accused of corrupt practices. A number of states in America sued the company, which also agreed last year to pay $150 million to settle a federal investigation into inappropriate sales. But many believe that only fines cannot help tide over the phenomenon of opioid overdose. The convictions are likely to embolden federal authorities to bring more cases against top executives of opioid manufacturers.

Overdose of medicines has become a serious problem in the world, especially the use of opioids. About 275 million people worldwide (5.6 percent of the global population aged 15–64 years) used drugs at least once during 2016. Among them, about 34 million people used opioids and about 19 million used opiates. There were an estimated 27 million people who suffered from opioid use disorders in 2016. The majority of people dependent on opioids used illicitly cultivated and manufactured heroin, but an increasing proportion used prescription opioids. Roughly 450,000 people died as a result of drug use in 2015. Of those deaths, about 160,000 were directly associated with drug use disorders and about 118,000 with opioid use disorders. Overdose deaths contribute to roughly a third and a half of all drug-related deaths, which are attributable in most cases to opioids.

Many critics believe that pharma companies are partly responsible for this overuse of medicines, especially that of opioids. They run rambunctious marketing campaigns and even their marketing budget exceeds that of the R&D budget. According to a report by Transparency International, "The marketing of medicines constitutes a large part of pharmaceutical company expenditure. Nine out of the ten largest pharmaceutical companies spent more on marketing than on R&D in 2013. In the United States alone the pharmaceutical industry spends an estimated $42 billion on promotional activities that target doctors annually, which is equal to US$61,000 per doctor on average."

The anti-corruption watchdog further notes, "Multiple marketing corruption scandals have made headlines in the last five years. For example, in 2011 Johnson & Johnson (J&J) paid $70 million to settle claims it bribed doctors in Greece, Poland and Romania to prescribe its medicines. The 2014 Access to Medicine Index Report found that 18 of the 20 largest pharmaceutical companies have been found guilty of unethical marketing practices, despite their commitment to adhere to codes of conduct and ethical marketing."

An analysis by Transparency International in February 2016 showed that of all companies subject to an ongoing and unresolved corruption related investigation by US authorities, just under ten percent were biotechs and pharmaceuticals, and of these at least six cases related to sales and marketing practices. "There are several methods for a corrupt pharmaceutical company to unethically market its medicines. At its most simple a pharmaceutical company can bribe a HCP (Health Care Professionals) directly with payments so its medicines are more likely to be prescribed. More abstrusely individuals may include a pharmaceutical company’s medicine on the national list that is reimbursed by public funds, in return for an indirect bribe by being sent to inappropriate holiday destinations for lavish conferences. Corrupt marketing practices also include pharmaceutical companies providing misleading information regarding the safety and efficacy of a medicine to influence doctors’ prescribing habits and encouraging off-label, unlicensed use to increase sales. In 2004 it was estimated that the US pharmaceutical industry spent US$20.4 billion on pharmaceutical industry."

In countries like the US, the regulators are still strong despite Trump's efforts to make them irrelevant but in developing countries like Pakistan the regulators themselves seem to be involved in encouraging the malpractices of the pharma industry. It is an open secret that pharma firms in Pakistan pay heavy bribes to doctors for prescribing medicines and the regulator or the department concerned tends to turn a blind eye. Even children are not spared from the unnecessary prescription of antibiotics.

It is very common for the medical representatives of such companies to offer doctors carpets, air conditioners and other such things. The companies also offer holiday trips. In the past, they would send doctors to Murree and some other hilly resorts in Pakistan, but now even extravagant trips to Dubai, Bangkok and even European destinations are offered. As a result, not only has the use of common medicines increased, the prescription of antibiotics and injectables has also skyrocketed in the last few decades. Hundreds or perhaps thousands of laboratories across the country are also now in contact with doctors offering commission on prescribing a myriad of laboratory tests. There are also complaints that many medical practitioners deliberately push patients towards a situation where surgery becomes inevitable, especially in pregnancy cases.

Both the federal and provincial governments have pumped billions of rupees into the purchase of expensive machinery for laboratory tests during the last three decades. Even then it is a common practice for doctors at state-run hospitals to refer patients to private laboratories for tests. The cost of such tests is unbearable for ordinary Pakistanis, especially the working class. Then every hospital wants patients to have tests done from their own laboratories, rejecting reports from tests conducted by other laboratories. This is bringing disrepute to doctors and medical practitioners.

To tide over this phenomenon, doctors bodies like the Pakistan Medical Association, should spring into action to thwart such unethical practices. Strict implementation on the laws related to the regulation of the pharma industry, free medical education, an end to corporate interference in hospitals' affairs, a reasonable raise in doctors and medical staff's salaries at state-run hospitals, strict monitoring of new machines at government hospitals and massive awareness campaigns about preventive care could be some of the ways to counter this situation.

The recent price hike in medicines makes it important to take urgent actions for the regulation of not only the pharma industry but the health sector as well. A few companies cannot be allowed to play havoc with the lives of millions. Therefore, the federal and provincial governments should come up with a joint mechanism to address the issue of malpractices in the health sector on a war footing.

The writer is a freelance journalist.

Email: [email protected]

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