Doctors, governments, and drug regulators must watch the way drug companies operate because the dearth of new medicines is taking profit chasing to new heights, an expert has warned.
Joe Collier, emeritus professor of drug policy at St George’s, University of London, issued his advice in the wake of an investigation by the BBC’s Newsnight programme, which suggested that Reckitt Benckiser, the makers of Gaviscon (sodium alginate and potassium bicarbonate), maintained an effective monopoly on the market for years after the drug came off patent.
The investigation, which was broadcast last Friday, claimed that the company had created obstacles to block rival manufacturers from selling cheaper generic copies, resulting in there still being no generic version of Gaviscon almost 10 years after the product’s patent expired in 1999.
A former employee turned whistleblower claimed on Newsnight that the company had “cheated the NHS” and that a generic formulation of Gaviscon could have saved the health service “millions of pounds.” Reckitt Benckiser, however, maintain that it is a responsible company that has behaved honestly and responsibly at all times.
Professor Collier warned that whatever efforts were made to tighten the law or industry codes of conduct, drug companies would find a way to push their boundaries to the limit.
“Doctors, governments, and regulators of medicines have got to recognise that the industry may not have the best interests of patients or the NHS at heart. They should . . . try to force the industry to behave in a way that is socially responsible,” Professor Collier told the BMJ. “But of course social responsibility does not bring profitability.”
The situation with Gaviscon was highly unusual, according to Ike Iheanacho, editor of the Drug and Therapeutics Bulletin. He said that generic versions of most drugs become swiftly available once the patent expires, usually within a matter of months.
But Reckitt Benckiser had successfully exploited some unique features of Gaviscon to retain its share of the indigestion drugs market, he claimed.
BBC investigators claimed that the lack of a generic version of Gaviscon had cost the NHS £40m (€52m; $81m). Meanwhile the company still had 88% of the market for alginic acid compounds in the NHS with no generic in sight.
Gaviscon is unusual in that it was launched without a generic name, and its chemical composition was not known, unlike for most drugs.
But when a generic name was to be announced in 2000 Reckitt Benckiser objected, claiming reasons of patient health and safety. More objections followed in 2005 and 2006, with similar reasons cited.
In 2003 the company insisted that a monograph be developed for Gaviscon by the British Pharmacopoeia Commission, which is part of the Medicines and Healthcare Products Regulatory Agency. Again this delayed the possibility of developing generic versions of Gaviscon.
A monograph was finally issued for Gaviscon in August 2006, but a generic name for Gaviscon is still to be decided.
Leaked memos from the company show the thought process of some of its senior people. One executive wrote, “Should we not drag it out as long as possible . . . nine million pounds of business is at stake.”
While legal advice was sought on the company’s objections to generic names it introduced a more expensive and newly patented version of its product, Gaviscon Advance.
Dr Iheanacho claims that no evidence shows that Gaviscon Advance is more effective or safer than Gaviscon. But the company used various means to switch patients to the new formulation, often doing this automatically as they gained access to patient databases when they entered general practices, claimed the BBC investigation.
In a statement, Reckitt Benckiser said that it was shocked by the allegations. “We also refute much of what has been reported which implies a power and influence we simply do not possess,” it added.
“Nevertheless, we are deeply concerned by the inappropriate sentiment expressed in some of the historic internal correspondence . . . We take this very seriously and have instigated an immediate internal investigation, and will take action.”
The practice of switching patients is widely used in the drug industry. GlaxoSmithKline and Wyeth were forced to abandon schemes for paying a third party or practice staff to switch patients to new formulations of salmeterol (Serevent) and lansoprazole (Zoton) (BMJ 2004;329:875; doi: 10.1136/bmj.329.7471.875-a).
A spokesperson for the Office of Fair Trading said that it is aware of the case and is considering whether Reckitt Benckiser has breached competition laws. The health select committee is also expected to investigate the case.
In June 2005 the European Commission fined AstraZeneca €60m for supplying regulatory agencies throughout Europe with misleading information about when the patent of its drug omeprazole (Losec) was issued, in a bid to delay development of a generic version. The company is appealing.