www.guardian.co.uk/frontpag...6,00.html

Drug firms' lobby tactics revealed

Documents show how companies try to get new medicines fast-tracked

Rob Evans and Sarah Boseley
Thursday September 28, 2006
The Guardian

Multinational drug companies have been lobbying ministers in an attempt to subvert the independent appraisal process and get their expensive new medicines approved for large-scale use in the NHS, the Guardian can reveal.

Over the eight months from October to May this year, senior executives from 10 drug companies met ministers to press for favourable decisions on their products. The executives were highly critical of the National Institute for Clinical Excellence (Nice), an independent expert body set up to decide which drugs are cost-effective for use in the NHS.

Documents obtained by the Guardian under Freedom of Information legislation reveal that:

· The world's biggest drug company, Pfizer, warned ministers that it could take its business elsewhere. "Pfizer ... noted that there is complacency in some quarters of Whitehall regarding their continued investment in the UK," the minutes of the meeting record.

Ministers later agreed to a special meeting where six companies could lobby for their drugs for Alzheimer's disease.

· Two companies lobbied ministers for wider access by patients to their drugs, both of which were later turned down by Nice on the grounds that they were not effective enough and too expensive.

The pharmaceutical industry is a major contributor to the UK economy. Its total investment in research and development was more than £3.4bn in 2004, which, a Whitehall briefing note points out, "represents around a quarter of the UK's total manufacturing industry expenditure".

Decisions by Nice, set up seven years ago, are crucial for the companies. It decides whether a drug should be universally available to patients in the NHS. Chaired by Prof Sir Michael Rawlings, Nice draws on scientific experts and consults doctors, patients, drug companies and the Department of Health. The government invariably accepts its final recommendations. Although ministers say they cannot influence Nice, the documents reveal a constant stream of high-level visitors from drug companies.

Manufacturers, led by Pfizer, have been complaining to ministers about Nice's position on their controversial Alzheimer's drugs. Originally Nice decided to allow them, then it reversed its position, saying they should be used only for a minority of patients with moderate disease.

At a meeting in October with the minister, Pfizer executives made it clear they "were unhappy with the Nice decision ... and thought their processes were flawed". They requested a special meeting with ministers where all the companies making Alzheimer's drugs could put their case.

The documents prepared by civil servants for the Pfizer meeting outline the wealth and scale of the US company, which in 2004 had revenue of $52.5bn (£28bn) and a net income of over $11bn.

But, Pfizer executives warn the minister, it could always take its business elsewhere. "Pfizer ... noted that there is complacency in some quarters of Whitehall regarding their continued investment in the UK," the minutes record. "Pfizer asked for more public support from the government for a robust pharmaceutical industry in the UK and more consultation/dialogue with the government."

The subsequent meeting with all the companies took place in December. The minister, Jane Kennedy, was confronted by eight managing directors, vice-presidents and senior executives from six drug companies. The executives lobbied hard for the Nice ruling to be overturned by the government.

A memo reports the summing-up of Johnson & Johnson's vice-president David Brickwood: "Nice should take into account what the companies see as the overwhelming views of patients, carers and clinicians on the efficacy of the drugs."

In a statement, Pfizer said it "regularly meets with key stakeholders, including government ministers, to keep them up to date with issues relating to our business". A variety of topics were discussed, it said.

"Nice and health technology assessment remains a topical issue coupled with the proposed ban on medicines for mild Alzheimer's disease. We believe this is the wrong decision and have appealed along with other manufacturers of anti-dementia medicines."

In February, Eli Lilly lobbied hard for its drug Alimta, designed to treat the asbestos-linked cancer mesothelioma. Its executives gave a presentation to Ms Kennedy, incorporating newspaper cuttings claiming that cancer victims were dying for want of the drug. The minister agreed that there should be a high-level meeting between her ministry and the Department for Work and Pensions.

But in June, Nice said there was insufficient evidence to show that Alimta was better than other cheaper treatments, recommending that the NHS should not use it. A Lilly spokesman said it was legitimate for the company to make representations to the DoH but it was not seeking to undermine Nice. "We are fully engaged and committed to the Nice process," he said

Pressure was brought to bear on ministers by another company, Johnson & Johnson, over its bone cancer drug Velcade. A briefing for Ms Kennedy before a meeting with the company's executives in November says: "Johnson & Johnson have written to the Department of Health numerous times over the past 12 months about Velcade." The company wanted its drug fast-tracked for approval by Nice.

Velcade was one of the five drugs Nice was asked by ministers to handle through its new fast-track procedure. But Nice's appraisal committee has given a preliminary opinion that it is not suitable for use in the NHS.

A Johnson and Johnson spokesman said the company was not trying to "unduly influence" Nice but it was legitimate to seek to persuade ministers to speed up the appraisal of Velcade. The company did not want to comment on its lobbying over Alzheimer's drugs.

In May, the health minister Andy Burnham met Peter Dolan, then chief executive of Bristol-Myers Squibb and chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA), the powerful industry body in the US, which has been highly critical of Nice.

Richard Marsh, director of external affairs at Bristol-Myers Squibb, who also attended the meeting, told the Guardian that his company had wanted to raise a number of issues, including Nice, with the minister.

"Companies have a legitimate interest in getting the best for their products and getting a positive appraisal by Nice. Where they have an opportunity to raise issues with ministers, they can do that ... It may be that Nice has genuinely got a blind spot about something and a legitimate point can be made to ministers. I don't think the Nice process is necessarily undermined. It is up to the minister what they do with that information." He added that companies wanted to invest in countries with a "favourable environment". "


www.ameinfo.com/98006.html



Pfizer's anti-smoking pill Champix (In US it is Chantix )approved in Europe

Decision brings remarkable new treatment step closer to approval in the UAE.

Pfizer Inc said that the European Commission has approved Champix (varenicline), a novel pill for smoking cessation in adults. In addition, because smokers often need considerable support to quit successfully, Champix will be available with a patient support plan which smokers can customize to address their individual behavioral triggers as they try to quit smoking.

The decision brings the remarkable treatment a step closer to approval across the Middle East.

Smoking is a chronic relapsing medical condition that typically involves a physical and psychological addiction to nicotine. In Europe alone, more than 1.2 million people die each year from smoking-related diseases [OR SHOULD THAT BE OBESITY RELATED DISEASES?]. In addition to the human toll, there is a significant social and economic cost associated with smoking. By 2010, the World Health Organization (WHO) predicts the annual global cost of tobacco-related illness will be approximately $500 billion, with Europe accounting for up to $165 billion of this sum. While most smokers recognize the significant health risks associated with smoking, research shows that without adequate behavioral therapy and environmental support, most smokers relapse within a few days of trying to quit and few are able to remain quit.

In the Middle East, according to WHO statistics, half of adult males are smokers. With a consumption rate of 2,280 cigarettes per person per year, Kuwait ranks 19th globally in tobacco consumption while Saudi Arabia is 23rd, at 2,130 per person. In total, the countries of the Gulf Cooperation Council (GCC) as a whole spend US$ 800 million per year on tobacco. [NOTE THEY DON'T MENTION JAPAN!]

'Champix provides a unique and new treatment that was specifically designed to help people stop smoking,' said Dr. Michael Berelowitz, Pfizer Worldwide Medical. 'Most smokers do not continue to smoke out of choice, but because they are addicted to nicotine in tobacco.'

'Prior research has shown that the combination of behavior counseling and drug therapy is often more effective and cost-effective as health interventions than attempting to quit unaided. To meet these needs Pfizer will go beyond offering a new treatment by also providing customized behavioral support through a program designed to help smokers in the quit process,' he added.

Discovered and developed by Pfizer, Champix is specifically designed as an aid to smoking cessation. It is believed to work by reducing the severity of the smoker's urge to smoke and alleviating many withdrawal symptoms from nicotine. Moreover, if a person smokes a cigarette while receiving treatment, the medicine has the potential to diminish the sense of satisfaction associated with smoking.

Many European governments have instituted tobacco control policy changes that help create a more supportive environment for smokers who want to quit. These policies include bans on tobacco advertising and sponsorship, stronger public health warning labels, and smoking bans in all workplaces, including restaurants. Comprehensive workplace smoking bans have already been approved in Ireland, Italy, Malta, Norway, England, Scotland, Belgium and Lithuania. Similar policies are being considered in France, Germany and other countries.

In the Middle East, many countries are considering a range of anti-smoking measures. The UAE, for example, is set to enforce tougher public smoking laws before the end of the year, potentially giving officials the power to fine law breakers on the spot.

Current provisions in the law include a ban on smoking in some public places, including restaurants.

'Public health campaigns have increased people's understanding of the harmful health effects of smoking so that smokers are educated and more motivated to quit. In addition, more smokers are trying to quit today as a result of smoke-free policies and they need our support,' said Professor Bertrand Dautzenberg, Service of Pneumology and Intensive Care, Hospital Pitié-Salpétrière. 'With Champix's approval, healthcare professionals and smokers have a new treatment advance to help address this challenging addiction.'

The approval of Champix (varenicline) was based on a comprehensive clinical trial program including four pivotal trials involving approximately 4,000 cigarette smokers. Subjects on average had smoked about 21 cigarettes per day for an average of approximately 25 years. In two identically designed studies, patients receiving a 12-week course of varenicline therapy (1 mg twice daily) had nearly four times the odds of quitting versus those taking placebo and had nearly twice the odds of quitting versus those patients taking bupropion SR (150 mg twice daily), at the end of the 12-week course of therapy.
Patients in these studies were also provided with educational materials and received brief smoking-cessation counseling at each clinic visit. Patients were followed for an additional 40 weeks without treatment. After one year, approximately one-in-five patients who received the 12-week course of varenicline remained smoke-free. For those patients who quit at the end of 12 weeks with varenicline, a separate study showed that an additional course of 12 weeks treatment with varenicline resulted in a greater likelihood of long-term success in quitting smoking.

In trials, varenicline was generally well tolerated, with overall discontinuation rates similar to placebo (11.4% for varenicline vs. 9.7% for placebo). The most common side effects included nausea, abnormal dreams, headache, insomnia, constipation, gas and vomiting. [NOTE THEY DON'T MENTION THE LIFE THREATENING ADVERSE DRUG EFFECTS, such as HEART ATTACK, SUICIDALITY, DIABETES, KIDNEY FAILURE, etc]


This medication, varenicline, received U.S. Food and Drug Administration approval as an aid to smoking cessation treatment in May 2006 (with tradename Chantix™ (varenicline) in the United States)."