Upjohn and FDA criticised over Halcion

Upjohn and FDA criticised over Halcion

Gun-toting Australians take aim than 70 000 people in the streets of to Parliament House on June 1, to protest about the recent agreement by state an...

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Gun-toting Australians take aim than

70 000 people in the streets of to Parliament House on June 1, to protest about the recent agreement by state and federal governments to ban the possession and sale of military-style weapons. 30 000 gathered the following day to support the new laws. the Obtaining agreement of all the state and territory governments, which was prompted by the mass shooting in Tasmania on March 28, is only the first step in the implementation of the new scheme. Each of the eight state and territory governments

ore marched Melbourne

must now

put the ments

In

legislate

new

into the

farmers, subject to

have

loading

face

.22s and

guns to control feral

animals. Now, the chairman of the government’s ad hoc committee on the

of the new gun laws has indicated that his committee might soften the scheme by

implementation

allowing

owners

their semi-

automatics to single or double shot action

(Thus theyeasily fall into capable of converting them back.) opposed to gun control could hands

Firing squad of

FDA criticised

force appointed by the US and Drug Administration has concluded that Upjohn may have obscured information material to the safety of Halcion (triazolam), and has recommended that the Department of Justice investigate. But because the task force did not "refer" the matter, Upjohn may not face prosecution. The task force, however, continues to report findings to the department and the Attorney for the Western District of Michigan, which has also been

A task Food

The task force also criticised FDA’s actions, saying that the agency should have notified the department of Upjohn irregularities in 1992. The company, now known as Pharmacia & Upjohn, says it stands by Halcion, and according to a statement by Ley Smith, executive vice president, the firm has "cooperated with all investigations, inspections, and evaluations of Halcion and of our company, and we will continue to cooperate, willingly and promptly". Halcion is sold in 90 countries, but was banned in the UK in late 1991 after allegations that Upjohn had

investigating Upjohn.

gun

to convert

weapons.

pressure is on new Prime Minister John Howard to deliver. Conservative governments in Australia are made up of a coalition of Liberal and National

Upjohn and

police approval, low-powered selfpump-action shot-

to

access to

arrange-

mounting opposition, much

1616

National parties are founded in the rural community-a stronghold of the anti-gun-regulation lobby. The first concession in the new scheme was an agreement for

parties.

to

place.

new weapons-control law

at

Those have warned of "blood in the streets" before they let their guns be taken away. The Prime Minister has been referred to in the national media as

over

Halcion

submitted 1992

an

incomplete safety data. In FDA advisory committee

concluded that Halcion was safe and effective at recommended doses, but the controversy continued. In late 1992, the FDA’s division of scientific investigations concluded that no further action was warranted. But in April, 1994, an FDA investigator in Detroit filed a report alleging that Upjohn "had engaged in misconduct" regarding Halcion. This led to the formation of the task force. Now the task force says that while the 1994 FDA report did not find any punishable violations, if the inspector had been allowed to investigate further, "additional evidence might have been obtained". Despite evidence that Upjohn may have concealed data, the task force concluded that Halcion is safe and effective when prescribed according to

US labelling. FDA Don McLearn says there

current

spokesman

are "still some lingering questions" that will be addressed at an advisory committee meeting later this year.

Alicia Ault Barnett

"Jackboot Johnny" and

as

the "leader

of a Stalinist totalitarian regime". In New South Wales, the last remaining Labor State in Australia, a May by-election in a rural electorate saw a 14% swing sweep the sitting National Party member from office, despite the tendency of such by-elections to go against the government. The gun lobby claims this result as evidence of its clout. Coinciding with the Melbourne rally, the Sporting Shooters Association president, Ted Drane, and independent West Australian MP, Graeme Campbell (who was expelled from the Labor Party last year) have formed a new political party. The pair said that the new gun laws were an attack on basic freedoms and that opponents must elect their own MPs to protect their rights. In the face of mounting political pressure, Howard remains resolute that the the US situation, whereby politicians have allowed themselves to be intimidated by a too-powerful gun lobby, will not be seen in Australia.

Stephen Cordner, Kathy Ettershank

New Hampshire bans "exclusive" contracts

Health tions

maintenance

operating

organisain

New

Hampshire are now banned from offering exclusive contracts to physicians. Governor Steve Merrill signed a law last month instituting the ban after state legislators and some outside HMOs agreed that exclusive

arrangements

were

quashing competition and inflating health-premium rates. Advocates of the ban point to the example set by Healthsource-one of the dominant HMOs in New Hampshire that uses exclusive contracts. In 1995, the HMO bought the only paediatric practices in two towns. One hospital then had to hire a new paediatrician because most of the physicians had exclusive contracts with Healthsource. Chris Henchey, vice president for operations at Healthsource, says that complaints about exclusive contracts mask the real issue. The barrier to entry for competitors "was really the companies’ unwillingness to invest the hardware or resources in developing their network". 11