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Sarah Houlton, PhD, is Pharmaceutical Executive’s international correspondent.
A recently released report claims pharma hides bad clinical trial results and over-promotes drugs. Tougher regs are being called for.
An influential UK government committee has called for tougher regulation of the pharmaceutical industry. In a report, "The Influence of the Pharmaceutical Industry," issued last month, the House of Commons' Health Select Committee, made up of members of Parliament, claims that the industry has been over-promoting its products and hiding bad results of clinical trials. While acknowledging that the pharma industry has produced many life-saving medicines and made a great contribution to healthcare, the Committee believes drug companies have become increasingly focused on marketing.
It also has harsh words for the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), claiming that it lacks the "discipline and leadership needed to protect patients' health needs." Another attack was reserved for the lack of transparency in the industry's funding of patient groups, which frequently call for a more widespread use of new medicines. Finally, the report claims that doctors are "sometimes too willing to accept hospitality from the industry and act uncritically" on the information the industry provides.
The report flies in the face of the government's current thinking, which is to use a lighter touch with the industry. On the contrary, the Committee's chairman, David Hinchliffe, says public health would be best served if regulators used a stronger hand.
"Drug companies need effective discipline and regulation, and these have been lacking," said Hinchliffe at the time the report was launched. "The pharmaceutical industry is extremely powerful and influences healthcare at every level. We have developed an over-reliance on medicines. They have been over-prescribed, and patients have suffered as a result."
The industry's response to the report is somewhat mixed. The Association of the British Pharmaceutical Industry has welcomed some parts—particularly, the report's call for improved side-effects monitoring and reporting, and for publishing information about patient group funding and the financial benefits the industry gives to doctors; the association also agrees with a move for improved new drug information for patients.
But it strongly disagrees with much of the rest of the report. First, the report asserts that the United Kingdom has a vast and increasing consumption of drugs. "Not so," says the Association's current president, Vincent Lawton, managing director of Merck Sharp & Dohme. "We have one of the lowest spends on medicines in Europe," he claims. "We have the slowest uptake of medicines in Europe in the first five years after launch, and not the prescribing 'explosion' following launch, as was stated by the Committee."
Lawton also refutes the notion that intensive marketing encourages inappropriate prescribing. "The reality [is] that four out of five doctors choose to see between just one and four reps per month," he says. "More importantly, they value the clinical and product information that the reps provide for them."
Thirdly, Lawton claims that a number of the Committee's recommendations would restrict information to prescribers, and restrict prescribing freedom. "Other recommendations would introduce yet more hurdles for new medicines' acceptance at the local level," he says. "We believe the only loser would be the patient."
A full response from the government will be published in the next few months. Health Minister Lord Warner says he believes government has an effective and proper working relationship with an industry that contributes a great deal to the health and wealth of the UK.
"Government and industry should view this as an opportunity to address the public concern that this inquiry reflects, about the lack of transparency in some of the current systems and processes," Warner says. "Rightly or wrongly, that perception makes the public think that things are being hidden from them."
He cites actions that have already been taken: instating memberships of safety of medicines bodies, and directly notifying patients about adverse drug reactions. "But some parts of the industry have to do better on public clinical trials data on a voluntary basis, or government will be forced to act," Warner says.
"We have to consider criticism, where it is fair, and explain our case where it is mistaken," Lawton adds. "However, where it is deliberately distorted by narrow mindedness and ignorance, we must assertively counter those criticisms without descending to the level from which they come. We need to be aware that if we behave like a beleaguered industry, we run the risk of becoming one."
Sarah Houlton, PhD, is Pharmaceutical Executive's global correspondent. She can be reached at email@example.com