I questioned the Minister and the Senior Health Department Bureaucrats about the behaviour of former TGA head, Professor Skerritt, who spent 11 years in charge of the TGA before resigning last year and soon after accepted a position on the board of Medicines Australia. This is the peak body representing and lobbying for pharmaceutical companies. The deputy chair for instance is the Head of Pfizer in Australia.
The answers I received in this session highlight that former senior bureaucrats like Professor Skerritt only have one rule to follow—they can’t lobby the Government for 12 months. That’s the only rule applying to former senior health officials. That’s not good enough.
Professor Skerritt and the TGA spent the COVID years dismantling and re-assembling Australia’s drug assessment process to provide drug companies with streamlined approvals, free from the need to provide testing of brand new drugs. Approval has gone from active inquiry to a desktop review of provided literature, before rubber-stamping. This appointment does not pass the pub test.
A Royal Commission must look into the TGA’s behaviour during COVID and the changes made to our drug approval process, without public debate.
Transcript
Senator ROBERTS: Thank you for being here again today. Professor Skerritt’s career includes a period as deputy head of the Department of Health and Aged Care and as head of the Therapeutic Goods Administration. Eight months after leaving the TGA, Professor Skerritt has been appointed to the board of a lobby group, Medicines Australia—in fact, the leading pharmaceutical industry lobby group. The deputy chair of that organisation is the Managing Director of Pfizer. There are other members on the board who are heads of other companies. As head of the TGA, Professor Skerritt introduced the mRNA into Australia and provided authorisation—without testing, as he admitted to me—creating a whole new industry that he is now working in. Does this sound like an appropriate arrangement to you? It sounds like a massive conflict of interest to me. It’s just brazen, like the rules don’t apply to him—or are there no rules?
Mr Comley: I don’t know whether Professor Lawler or Ms Balmanno want to comment. There are rules in terms of former public servants and what they can do, but those rules are largely limited to lobbying activities related to their previous departments. There’s not a broader prohibition on their activity in related areas that they’ve worked in the Public Service.
Senator ROBERTS: He has joined the most significant, powerful lobby group for the pharmaceutical sector, which he was previously regulating.
Mr Comley: As long as he’s not undertaking lobbying activity to us—I think it’s in a 12-month period—that is appropriate.
Ms Balmanno: His obligations in relation to confidentiality of any information gained while in the Public Service continue to apply.
Senator ROBERTS: Let’s unpack that a bit further. This is what Medicines Australia’s latest annual report said about Professor Skerritt: After 11 years leadership of the TGA, Prof John Skerrit retired in April Professor Skerritt has been a cornerstone of our health system for many years. … Medicines Australia and member companies worked closely with his Department during the Medicines and Medical Devices Review, and the rapid registration of COVID-19 vaccines and treatments. On behalf of our industry, members and Board, we thank him for his service and dedication to Australia. Medicines Australia hired him as a thankyou for tearing up years of prudent drug approval and testing while authorising a whole new mRNA drug industry with no testing. How could you read this any other way?
Mr Comley: I’ll allow Professor Lawler to comment first and then I may come back. I do note the point Ms Balmanno made that the obligations for confidentiality and use of information are still retained even when someone has left the service.
Prof. Lawler: Thanks for the question. I recognise that there are a number of underlying elements to your comments around testing and evaluation that I don’t think are necessarily the main thrust of your question. I would highlight that our interaction with Medicines Australia is predominantly through our very well publicised stakeholder engagement processes. We don’t interact directly with the board. We don’t receive lobbying approaches from board members of organisations. We haven’t received any lobbying approaches from Professor Skerritt. The decision—
Senator ROBERTS: With respect, I’m not talking about the board interacting. I’m talking about a former senior member of TGA—the senior member; the head of the TGA—now being on the Medicines Australia board.
Prof. Lawler: Working on the board. As Ms Balmanno and the secretary have highlighted, there are code of conduct provisions that relate to the lobbying activities of former senior employees. We’re not lobbied by Professor Skerritt. We interact with Medicines Australia as we do—
Senator ROBERTS: I’m not talking about that. I’m talking about—
CHAIR: Senator Roberts, you do need to allow Professor Lawler to finish his sentences. Professor Lawler, please continue.
Senator ROBERTS: Sorry.
Prof. Lawler: I may be incorrect in this, but I’m taking that there is undue influence being applied to the decisions of the TGA by a former senior leader of that organisation?
Senator ROBERTS: No, that’s not what I’m—
Prof. Lawler: Sorry. I would ask for clarification then.
Senator ROBERTS: My question is: is his appointment a reward for work he has done in the past?
Prof. Lawler: Thank you for the question. The decisions that are taken by Medicines Australia on who does or does not sit on their board are questions for them.
Senator ROBERTS: It certainly doesn’t look good. It looks like he’s being rewarded for things he’s done for them in the past when he was head of the TGA. The Chief Executive Officer of Medicines Australia is Ms Elizabeth de Somer. Is this the same person who was a member of your Health Technology Assessment Policy and Methods Review reference committee, which is a paid position responsible for: … ensuring that our assessment processes keep pace with rapid advances in health technology and barriers to access are minimised. That’s from your website. Barriers to the entry of her products. Are we paying the pharmaceutical industry to promote pharmaceutical industry agendas to neuter our approval process? This is not looking good.
Mr Comley: I will ask Ms Shakespeare to comment.
CHAIR: Senator Roberts, I do ask that you direct things to the officials as questions. It’s reasonable to ask questions of them.
Senator ROBERTS: I did. I said, ‘Barriers to entry of her products’—
CHAIR: My hearing of it was that it was a statement, given how you finished.
Senator ROBERTS: My last words were a statement, but my question was: are we paying the pharmaceutical industry to promote pharmaceutical industry agendas to neuter our approval process?
CHAIR: Followed by a statement. Please continue; I just remind you to please direct things as questions.
Mr Comley: I will throw to Ms Shakespeare, but I’ll make a general comment that, where we, or other departments within government, are supporting reviews of policy matters that affect a range of stakeholders, it’s not uncommon for those stakeholders to be part of that review process. It’s also not uncommon for those stakeholders to be very clear when people declare what conflicts of interest they have and that people be aware of that. But there is a real balance here in having appropriate expertise in the room, including of what will happen on the ground, with making that policy process. Most of those reviews—almost all that I can think of—are never the final decision-maker. They make an input to government decision-making which is informed by their experience on the ground. Ms Shakespeare may have some further information.
Ms Shakespeare: Ms de Somer, who’s the Chief Executive Officer of Medicines Australia, is a member of the health technology assessment review panel. The membership of the review panel was established under an agreement between the government and Medicines Australia, called a strategic agreement. She’s not paid for the work on that; it’s not a paid position. It’s a review led by an independent chair and it has other experts on it, including the Chair of the Pharmaceutical Benefits Advisory Committee. It has two consumer representatives, a government representative and also experts in health technology assessment.
Senator ROBERTS: So the government has a—I’m sorry, continue.
Ms Shakespeare: As Mr Comley said, the review is currently underway. It’s going to prepare recommendations to the government, but the government will decide whether or not it implements those recommendations.
Senator ROBERTS: So the government has an agreement with Medicines Australia?
Ms Shakespeare: We have a strategic agreement with Medicines Australia. We’ve got strategic agreements with a range of different groups.
Senator ROBERTS: Where is the talk about ensuring safety across long-term use, which used to keep Australia safe for generations? Now it’s all about, it seems, not costing pharmaceutical companies money and approving killer drugs, like remdesivir and molnupiravir, that would never have been approved on a cost-benefit safety analysis before Professor Skerritt rewrote the rulebook. Are you aware of this?
Prof. Lawler: Sorry, I’m struggling. There were two questions there, and I’m not quite clear on what it is that you’re asking. Are we aware of—
Senator ROBERTS: Are you aware of Professor Skerritt’s involvement in approving antivirals molnupiravir and remdesivir, which are killer drugs, it seems—they’ve got very bad records overseas. What I’m saying is: rather than putting safety paramount, are the TGA and the department of health removing barriers to pharmaceutical company approvals?
Prof. Lawler: I see. Thank you for the question, Senator. No.
Senator ROBERTS: The patent cliff is a real problem—I’ll explain what that is in a minute—facing the pharmaceutical industry. Billions of dollars of sales are at risk as patents expire around the same time, producing a loss of revenue totalling $200 billion this decade for the pharmaceutical companies. MRNA technology, which has not been tested, will be the saviour of the drug industry, allowing drugs that are now off patent to be replaced with new mRNA drugs. I understand that in America they’re favouring two companies, one of which is Pfizer. That means the new drugs will be subject to patent, meaning profits all around—wonderful!—except for taxpayers.
Minister, has your government—and the previous government—made a deliberate decision to allow patents on these novel mRNA products to save the profitability of the pharmaceutical industry over considerations of safety and financial cost to taxpayers?
Senator McCarthy: I might start with acknowledging that Professor Skerritt did a commendable job in his previous role, and we certainly wish him all the best in what he’s doing going forward I think your questions place a slur on people’s character, and you might want to have a good look at that. People who move on, whether it’s in political life or in other forms of organisations, deserve the opportunity to move on.
Senator ROBERTS: And I want to protect the taxpayer by making sure there are no conflicts of interest. You didn’t answer my question, Minister.
Senator McCarthy: I’ll take your question on notice.
Senator ROBERTS: I will repeat it. Has your government—
CHAIR: Senator Roberts, you don’t need to repeat it. The minister’s taken it on notice.
I watched the Senate inquiry when you asked why the antiviral molnupiravir should be removed from the PBS.
My GP is unaware of the inefficacy of the drug but says it has less side effects than paxlovid. Only 2 drugs in their “toolbox”.
My parents were prescribed molnupiravir. Full price $1102.24.
The Govt subsidised this down to $7.25.
Is the real reason it is not removed?
Large doses of this “antiviral” are given when people are already sick fighting Covid. If they are ineffective and burdening people’s natural fighting ability, what real harm are they doing?
My GP has had 4 vaccinations and has also been infected by Covid 4 times in the past 12 months. He has also taken antivirals 4 times.
This is corruption and collusion.
Thank you for highlighting this drug. I will not buy it and rely on my own immune system. I do however think that ivermectin with zinc should be at least offered to Gp’s “toolbox” as an alternate to molnupiravir.
The TGA is corrupt!
Doctors are still prescribing statins to deal with high cholesterol levels. But do not warn patients that there is a dangerous side-effect. This is muscle weakness. Go into any nursing home and check how many patients who can hardly walk and you will find they are on statins !!!
My wife has warned many patients and nonresidents that she sees shuffling around as to the reason they can hardly walk. If they take her advice they see an improvement within weeks.
Work out the savings to taxpayers if this drug is banned.
Must amount to millions of dollars!
There are suitable alternatives to statins.
My wife talks from personal experience! Ask around in your office if they know relatives and friends who are experiencing difficulties walking. A local politician was grateful for this information as her husband was finding it difficult to walk. Coming good now.
The head of the TGA, Prof. Skerrett told my wife that he leaves it up to the doctors to warn their patients. But they do not. A few doctors have taken their patients off statins because of this information given to them. The TGA should emphasise the need to be warned of this side effect.
Politicians do not want to address this delicate problem. Perhaps they are too busy!
Think again of the saving to be made!
One politician told me that all drugs have side effects so this is too big a subject to deal with! Does the health of Australians not matter? And the budget problems would be resolved!
Best wishes,
David