News

---

Commercial sensitivity or patient protection? Secrecy and medicine safety

---

The researchers – who included academics from the University of Sydney, Macquarie University and York University in Canada – published a paper looking into the transparency of information given by manufacturers and regulators about post-market evidence of medicines’ harmful effects.
 
They were very concerned by what they found.
 
‘Our [findings] demonstrate an unacceptable secrecy around potentially serious harmful effects of medicines, which has no place in modern medicine and should not be tolerated by regulatory agencies,’ Associate Professor Barbara Mintzes, study co-author from the University of Sydney’s Charles Perkins Centre and School of Pharmacy, said.
 
Dr Evan Ackermann, a GP with an interest in the regulation of the pharmaceutical industry, believes the study highlights a serious problem.  
 
‘The Sydney University team should be congratulated for exposing a national flaw in our drug safety regulations and practices,’ he told newsGP. 
 
‘This is a very important finding in the development of comprehensive drug safety practices in Australia.’
 
Medicines must undergo a series of trials before their release into market, but the research team was concerned about what happens after they have been cleared for use in the field.
 
‘[Pre-market] trials are conducted on relatively small numbers of patients for relatively short periods of time and in highly selected groups, so it’s understandable that new and potentially serious safety problems can be identified once drugs have been marketed and used by larger numbers of people,’ Associate Professor Mintzes explained.
 
Once post-market evidence about medicines starts to gather, clinicians are dependent on pharmacological companies to disseminate it. Information providing practical harm-reduction advice is often delivered in letters to clinicians from manufacturers and regulators.
 
Researchers tested the availability of this post-market drug advice by identifying 207 drugs from 39 companies. These drugs had been the subject of warnings in the UK, US and Canada – but had no publicly available warnings in Australia, despite some potentially severe consequences, including increased risk of heart failure, seizures or death.
 
Researchers sought out the same information for the Australian market from the Therapeutic Goods Association (TGA). However, the TGA instead suggested the researchers make direct requests to the manufacturers.
 
Of the 39 companies contacted by the researchers:

• 24 provided no letters or information
• 15 provided information, either letters or confirmation of no warnings sent out
• nine refused to provide information, claiming it was ‘commercial in confidence’ or ‘not provided to the general public’
• seven did not respond
• five said they would respond, but did not
• three suggested contacting the TGA. 

The TGA also refused two Freedom of Information requests, as this would ‘divert resources’ from other operations.
 
Chair of the RACGP Expert Committee – Quality Care, Professor Mark Morgan, believes there is a strong need to improve the communication of new safety warnings to doctors, perhaps even by automation.
 
‘Given that the vast majority of prescriptions are written by computer and dispensed on the PBS [Pharmaceutical Benefits Scheme], the information exists to identify which doctors have prescribed and which patients are taking a particular medication,’ he told newsGP.
 
‘It should be possible to alert the doctor who prescribed a medication about a new safety warning in a secure and direct way. It should also be possible to rapidly update drug databases in prescribing software so new safety warnings are included.’ 

The researchers believe there needs to be more regulatory oversight of the distribution of information about medication safety.
 
Professor Morgan also questioned why such information is seldom released to the public.
 
‘My guess is that it is bad for the business of selling medications and there is a fear patients will immediately stop taking them,’ he said. ‘But I believe the public – our patients – are able to understand risk if this is communicated clearly.’
 
The study authors expressed concern that confidentiality of commercial information may be prioritised over potential threats to patient safety, and would like to see increased regulatory oversight in this area.
 
‘We’re currently operating in a policy vacuum,’ Associate Professor Mintzes said. ‘The TGA regards these safety warnings as the property of the manufacturer and has no legislated authority over the communications, leaving companies free to choose whether to release them or not.
 
‘To ensure ongoing access to critical safety information, we urgently need to develop explicit transparency policies on all post-market safety communication, and ideally a publicly available searchable online database of all post-market safety warnings on medicines.’
 
Dr Ackermann agrees and believes that, for the safety of patients, the situation must be remedied as soon as possible.
 
‘Drug safety is a very important national initiative,’ he said. ‘We have to admit that our current state of medication management has not delivered drug safety to the Australian people.
 
‘The PBS, the MedsChecks, the medication reviews have all failed and we need to think of innovative new ways to address this problem. But it starts with a clear pharmacovigilance process, which documents and disseminates all drug adverse reactions.’

---

---

Medicine safety Pharmaceutical industry Post-market drug surveillance Regulation TGA Therapeutic Goods Administration University of Sydney

---