[Ip-health] David Henry, an unlikely villain?

[James Love]

Dr. David Henry is a member of this list, a highly regarded expert on
pharmacuetical drug pricing, an advisor to the World Health Organization
and several NGOs and public health bodies, and apparently an unpopular
guy with Pfizer and other big drug companies.  Now he is an ex-member of
the Australian Pharmaceutical Benefits Advisory Committee.   Jamie

http://www.theage.com.au/news/2001/02/02/FFXDWW14OIC.html

Too many bitter pills 

By JULIE-ANNE DAVIES
Friday 2 February 2001

David Henry seems an unlikely villain. The Scottish-born doctor has been
accused, in his role on the federal body approving pharmaceutical
benefits, of crimes including the deaths of children and the prolonged
suffering of cancer victims when drugs haven't been approved for
listing. And now, it seems, it's time for him to pay up.

Professor Henry, along with the Melbourne paediatrician Dr Sian Hughes,
have been dumped from a little-known but highly influential federal
government regulatory body, the Pharmaceutical Benefits Advisory
Committee.

The committee chairman, Professor Don Birkett, who was retiring but had
been asked by the government to stay on while the newly appointed
members and chairman found their feet, quit in disgust two days ago.

He has refused to serve because of the government's decision to put a
former drug industry executive on the PBAC, which Birkett likened to
"putting a wolf in the hen house". At least another three members have
indicated they will not remain on any authority that includes a drug
industry representative.

This group of doctors and pharmacists determines, on behalf of us all,
which medicines Australians can buy at affordable prices. It's a key and
expensive component of Medicare, a government-subsidised drug scheme
that spends $3.8 billion of taxpayers' money annually.

Henry, along with his 11 colleagues, has for the past decade fought a
David-and-Goliath battle with one of the world's most powerful and rich
industries - the drug companies. A listing on the Pharmaceutical
Benefits Schedule guarantees a market and enormous profits. Witness the
bitter dispute in the courts over the committee's decision not to
include the male impotence pill Viagra on the schedule. Pfizer, the
US-based company, says the decision cost it about $50 million in
revenue. Looked at another way, Australian taxpayers won't be paying
dearly to help improve people's sex lives. The outcome of the company's
appeal is imminent.

Henry's dumping is, he says, a result of intense lobbying by the
pharmaceutical industry. His scalp has been offered up by the Howard
Government in an attempt to appease industry frustration at what it
claims is Australia's overly restrictive drug policy. 

As chairman of the economic subcommittee of the PBAC, Henry had built an
international reputation as an expert on determining the
cost-effectiveness of new drugs.

"I was seen as an impediment to the industry's interests, namely getting
their drugs on the shelves, so I had to be gotten rid of," Henry told
The Age. "I believe the chair of the PBAC, Professor Birkett, and myself
were seen by the pharmaceutical industry to have presided over a process
where the companies didn't get what they wanted and we as committee
chairs were held responsible."

These are serious accusations and Henry has thought deeply before
deciding to go public. He knows whistleblowers generally enjoy brief
glory and often years of payback.

"I'm telling my story," he explains, "because I want Australians to
realise what this industry is capable of. Their tactics are not confined
to other nations, their influence is also felt right here and affects us
all."

There have been three reviews of the PBAC in the past decade - all,
Henry asserts, because of lobbying by the industry. "Unfortunately for
the drug companies, these reviews didn't produce the results they
wanted: the dismantling of our evidentiary approach."

So, he says, the companies began lobbying Health Minister Michael
Wooldridge and his parliamentary secretary Grant Tambling. In August,
1999, Birkett and Henry requested a meeting with Wooldridge because they
feared "our view was not being heard in Canberra".

"We believed the industry was pushing the government to conduct a major
and, it must be said, hostile review of the scheme and the committee,"
Henry says. "At that meeting, Wooldridge made it abundantly clear that
he was being lobbied by the industry and my strong impression was that
he was not happy about it but he felt he had to listen."

What happened next alarmed PBAC members. One of Wooldridge's key
advisers, Rachel David, who had been present when Henry and Birkett
outlined their concerns to him, left the government and went to work for
Pfizer.

"If it was known she was moving to Pfizer," says Henry, "then clearly
she should not have been present at that meeting. This occurred within
weeks of our meeting."

David has since left Pfizer and could not be contacted.

In October, Henry and Birkett were summoned to another meeting, this
time with Wooldridge's new adviser, Bill Coote, and a staff member from
Tambling's office.

"We were told the industry was up in arms about the committee and the
minister felt there must be a problem because the drug companies were
complaining so bitterly. No examples were given, just the view that
there was a problem and the committee was not doing its job properly and
that a major review was necessary."

Henry and Birkett argued against the review - there had, they said,
already been two: one by the former Industry Commission and one by the
national audit office. Both had found no major problems with the
existing system and committee.

"We did start to get paranoid because we'd been reviewed twice at
industry's behest, we were being sued and the minister's adviser had
just gone to work for the company that was suing us - Pfizer."

Then came what Henry describes as an act of extreme political influence,
prompted he believes by a series of articles in The Sydney Morning
Herald, which foreshadowed the review. Ken Smith, another of
Wooldridge's staff members, attended a PBAC meeting early in 2000 and
raised with its members the possibility of a federal police inquiry,
apparently over allegations of leaks to the media. 

"There was stunned silence when he finished speaking," Henry recalls.
"He then said the review was off."

Smith now works for Pfizer in Hong Kong.

The PBAC has been held up internationally as a stunning example of smart
health economics in an age when governments the world over are trying to
contain costs. Its emphasis is on making drug companies prove not only
the safety, efficacy and quality of their product, but the
cost-effectiveness over existing treatments. It was seen as a radical
approach when adopted in the early 1990s.

Australia is a minnow in the world pharmaceutical market but, the
industry's fear, partially realised, is that other bigger, more
lucrative markets might copy the scheme. Melbourne GP Dr John McDonald,
a PBAC member for 18 years until he retired last year, is convinced this
fear is driving the industry's lobbying.

"It's the international implications of what we do here that's got them
worried," McDonald says. "Australia is the standard by which other
nations judge their own processes and if markets like the US - and Al
Gore was talking about it in the lead-up to the US election - and Third
World nations like India and Malaysia adopt our approach, then the drug
companies will really start to feel it."

Because of this "tough love" approach, Australians pay less for
prescription medicine than do almost anyone else in the world. But it is
a method that has elicited strong criticism from not only the industry
but also doctors and patients who have mounted emotional campaigns in
the past decade to pressure the government to subsidise a drug the
committee has rejected. Famous brawls, aside from the most recent Viagra
dispute, include: Taxol, the breast cancer drug; Immigran, the migraine
cure; and arthritis wonder drug Celebrex, a recent addition to the
schedule and to date the most expensive. 

Alan Evans of the Australian Pharmaceutical Manufacturers Association
describes the PBAC as an "interesting animal" but denies his
organisation has lobbied government to have certain committee members
removed.

"I'm not prone to telling lies," Evans says. "Yes, I've met with
government to discuss the implementation of the Tambling review, but I
have not had a meeting with the minister over the PBAC membership.

"Look, the fact is consumers in the US are tired of paying higher prices
for their drugs while Australians enjoy unheard-of low prices. The
cost-effectiveness approach adopted by the Australian committee is an
inexact science and we have a situation at present where drugs are
approved by one authority, the Therapeutic Goods Administration for
safety and efficacy, and then the PBAC gets involved and starts knocking
drugs back. It's ridiculous."

Evans says it is not uncommon for companies simply to withdraw medicines
from the Australian market if they fail to get a PBS listing, although
they have already won TGA approval. "Here the government is the monopoly
purchaser and if it's not buying, then you have to question whether it
is worth the effort of putting your drugs on the shelves."

Drug companies' tactics in the lead-up to a PBAC decision on whether to
list a drug on the Pharmaceutical Benefits Schedule vary from the subtle
to the blindingly obvious. Committee members are bombarded with letters
from patient support groups and doctors pleading the case for a drug to
be listed.

"Often these letters have clearly been generated by the drug companies,"
Henry says.

"Patient support groups - that I believe are genuine - are misled by
drug companies about new products. The drugs are talked up and people
who are desperate want to believe there is a miracle cure around the
corner.

"Being accused of killing children is always unpleasant, but that's the
level to which their tactics sometimes degenerate."

The accusations would follow if the committee rejected a drug for
listing.

The media is a powerful pawn in the drug industry's campaign to have a
drug listed. Stories will begin to appear in the lead-up to a drug being
considered by the PBAC because patient support groups and the industry
plant them, Henry says.

One of the most controversial PBS listings in recent years involved the
anti-inflammatory drug Celebrex, used to treat arthritis. In the lead-up
to the committee's consideration of Pfizer's submission, an
advertisement featuring two people running towards each other on a beach
ran on prime-time television. The ad showed the devastating impact of
arthritis and told viewers to contact their doctor to ask about a new
drug for the disease. The advertisement was made under the auspices of
the Arthritis Foundation of Australia, but Pfizer paid for it.

"It was a very hostile campaign," Henry says. "We were being petitioned
by the rheumatologists, the Health Minister was under extreme pressure,
and then there was the TV ad."

The committee did approve the listing of Celebrex but attached
recommendations concerning the price that the government should pay
Pfizer for the drug. In an unprecedented move, the five-member Pricing
Authority, whose job it is to negotiate on behalf of government with
industry, rejected the recommendations, instead agreeing to pay Pfizer
almost twice what the PBAC recommended. The government backed the
pricing authority.

The result is that five months after being listed, Celebrex has the
fastest-growing market share of any drug in Australia. In its first five
months it has cost taxpayers nearly $100 million - nearly half the total
Wooldridge had budgeted on spending on Celebrex over four years.