UK Pharma Association Displaying Acute Anxiety / FDA approves Focalin XR for ADHD

Tue, 14 Jun 2005

The good news is that British physicians are taking a more cautious approach and cutting down on their prescribing of drugs whose adverse side effects often do more harm than good.

But the pharmaceutical industry is upset because for the first time in 20 years prescription drug sales are down in the UK See IMS Health sales data, 1999-2005

No doubt, among the contributing factors to physicians’ increased caution were a series of revelations about industry’s inordinate influence on the drug approval process: The Health Committee of the British House of Commons report, “The Influence of the Pharmaceutical Industry,” issued April, 2005, is a landmark document not just of value to UK health care officials.

It provides American officials and analysts with an intelligent road map for examining the much larger scope of the factors that undermine the health and safety of the American people who consume far more prescription drugs than do the British. See: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf and
https://ahrp.org/infomail/05/04/06.php

The Association of British Pharmaceuticals Industry–whose only concern is profitability–is calling for “immediate action” to protect its market. In contrast to the US, the UK government pays for health care services under the National Health Service, including prescription drugs. This gives the UK government greater leveredge over physicians’ prescribing practice guidelines through the National Institute for Clinical Excellence (NICE), which evaluates newly approved drugs to ensure the NHS gets value for money from new treatments.

The UK pharmaceutical industry association is lobbying Parliament to adopt rules “to force doctors to prescribe new treatments at the earliest opportunity.”

Indeed, the ABPI would make it “obligatory” for general practitioners (GPs) “to take up new drugs as soon as they are approved…”

This demonstrates an inherent conflict of interest–a collision between industry’s detrmination to bolster profits, while physicians responsibility to protect the health of their patients.

New drugs have not proven to be in the best interest of patients–they have proven to be high income producing products.

According to IMS Health the US leads the world in speed of prescribing new drugs (Spain is a close second); Japan and the UK are more cautious. A study is needed to compare health and mortality rates in countries that are fast on the trigger prescribing the latest drugs with those that are more cautious.

The bad news is, the FDA has just approved yet another Schedule II controlled substance–DEXMETHYLPHENIDATE HYDROCHLORIDE– (i.e. addictive stimulant drug) for the treatment of a manufactured epidemic– ADHD. The FDA has approved long-acting Focalin for use in children and adults in apparent disregard of the risks of adverse effects the drug poses.

The FDA-approved label indicates that in clinical trials 76% of children testing Focalin had adverse events:

Children in clinical trials suffered the following adverse events–not listed are events occurring at less than 5%.

Gastrointestinal disorders………….. 38% (Focalin)………………..19% (placebo)

Dyspepsia……………………………………. 8%………………………………….4%

Metabolism and nutrition disorders 34%……………………………..11%

Decreased appetite ……………………….30%…………………………….. 9%

Nervous system disorders……………. 30%……………………………..13%

Headache ……………………………………….25%……………………………..11%

Psychiatric disorders ………………………26%……………………………..15%

Anxiety………………………………………………..6%………………………………. 0%

And 7.3% of children on Focalin suffered adverse drug reactions so severe, they discontinued the trial.

In adult trials, adverse events in patients taking Focalin were dose related: between 84% and 94% suffered an adverse effect.

Gastrointestinal disorders—-between 28%–44% on Focalin– compared to 19% on placebo

Nervous system disorders—between 37%–50% on Focalin– compared to 28% on placebo

Psychiatric disorders———–between 40%–46%–on Focalin– compared to 30% on placebo

Anxiety——————————-between 5%–11%–on Focalin—-compared to 2% on placebo

See Focalin label details: http://www.fda.gov/cder/foi/label/2005/021802lbl.pdf

Focalin joins the list of ADHD drugs whose labels indicate they stunt children’s growth: Ritalin– Adderall– Strattera– Concerta– Metadate– Dexedrine– Attenade — Cylert

Contact: Vera Hassner Sharav
212-595-8974

Times online
June 06, 2005
GPs accused of ‘Luddism’ over drugs
By Richard Irving

THE UK drugs industry has called for urgent changes to speed up the way doctors adopt new medicines, after an unprecedented decline in sales over the past four months – the first slump since records began.

Vincent Lawton, president of the Association for the British Pharmaceuticals Industry, hit out at the reluctance of GPs to switch to new life-saving medicines when they are approved for use in the NHS.

“At times, the conservatism of British doctors borders on Luddism,” Mr Lawton said.

He added that rules were needed to force doctors to prescribe new treatments at the earliest opportunity. “There should be an obligation for GPs to take up new drugs as soon as they are approved. Doctors’ rewards should be linked to their prescription record.”

Mr Lawton said that immediate action was needed to support the UK pharmaceuticals market. “This is not just a blip. I am quite certain that without intervention the market faces a significant decline.”

According to IMS Health, an independent consultant, sales of branded and generic drugs fell 1.1 per cent during the first four months of the year, the first decline in more than 20 years. The take-up of new drugs in Britain ranks among the lowest in the developed world and the UK accounts for just 3 per cent of total pharmaceutical sales.

Mr Lawton also called on the National Institute for Clinical Excellence (NICE), the government body that ensures the NHS gets value for money from new treatments, to overhaul its appraisals process. At present NICE reviews new drugs at the time of their launch. GPs usually refrain from prescribing treatments until the review is complete, which can take up to three years. Mr Lawton said that NICE should delay its cost-efficiency appraisal until five years after the drug’s launch.

“You only find out the true economies of a new drug when it is in the wider population,” he said.

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