Exposed: how drugs giant pushed Vioxx painkiller

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" Zeus " <info

Marketing tactics of Vioxx/Cash payments to Arthritis Charities

Thu, 25 Aug 2005 14:58:47 +0100

 

 

 

This story could be repeated by most drugs on the market if the true

information would come to light.

 

 

 

 

 

http://news.independent.co.uk/uk/health_medical/article307428.ece

 

Exposed: how drugs giant pushed Vioxx painkiller

 

The growing furore surrounding the painkiller Vioxx could prove to be

the most expensive legal action ever faced by a drugs company and

raises questions about the marketing tactics used by a

multibillion-pound pharmaceutical giant.

By Maxine Frith Social Affairs Correspondent

Published: 22 August 2005

 

At least 300 British patients who claim to have suffered heart attacks

and strokes as a result of Vioxx, as well as the relatives of others

who died, are to sue the makers, Merck, for millions of pounds in the

US courts. More than 4,000 sufferers from around the world have also

lodged negligence claims against Merck, with experts warning that the

company faces a " potentially unlimited " flood of cases that could

cost it more than $50bn (£28bn).

 

Merck is accused of deliberately withholding information about the

potentially fatal side-effects of Vioxx from regulators on both sides

of the Atlantic and misleading doctors about the risks of the drug in

its desire to rush its product on to the market. Evidence given to

congressional hearings in the US has also revealed how sales

representatives employed by Merck were told to dodge questions about

the side-effects.

 

The case highlights the way pharmaceutical companies can distort

scientific data on a product to exaggerate its benefits.

 

More than 20 million people, including 400,000 in the UK, took Vioxx

before Merck withdrew it last September following a study suggesting

that taking the drug for more than 18 months could double the risk of

heart attacks in some people. Merck claims that the drug was

thoroughly tested and has strenuously denied any wrongdoing.

 

The hopes of those suing have been buoyed by a ruling by a court in

Texas last week that the drugs giant was responsible for the death of

an American man who died in 2001 after taking Vioxx. Merck was ordered

to pay his widow $253m in damages after the jury heard testimony that

Vioxx had been rushed on to the market without proper testing and that

doctors had not been told of the potential risks of the drug.

 

British solicitors dealing with the class action said they were

deluged with calls from more alleged victims over the weekend after

details of the Texas case emerged. Russell Spargo, of MSB solicitors

in Liverpool, which is dealing with 150 claimants, said: " This is a

ticking bomb for Merck. The Texan case was seen as one of the weakest

claims and Merck were convinced that they would win it. This could run

into millions of pounds for the British victims alone. "

 

Mr Spargo said American research estimated that more than 60,000

people may have died as a result of taking Vioxx ­ a death toll

greater than American fatalities in the Vietnam war. " This is a drug

that should never have been marketed in the way it was. "

 

The scale of the Vioxx case outstrips the Thalidomide scandal that led

to the 1968 Medicines Act governing the way in which drugs are

regulated. The Medicines and Healthcare Products Regulatory Agency

(MHRA) which approves drugs in the UK, has launched an investigation

into whether Merck deliberately withheld information on Vioxx when it

applied for a British licence in 1999.

 

Documents in the Texas case alleged that officials at Merck knew as

early as 1998 that the drug was linked to an increased risk of

cardiovascular problems, but that the data was suppressed.

 

Vioxx was one of a new class of anti-inflammatory drugs called COX-2

inhibitors that were believed to be more effective than old-style

painkillers, and with a reduced risk of ulcers and gastric problems.

 

Merck was competing with other drugs giants, including Pfizer, to

bring the first COX-2 drug on to the market for treating arthritis and

other conditions. The profits would have potentially run into billions

of pounds, and the rival companies were spending millions on making

and marketing their drugs.

 

Among allegations being investigated is the possibility that in the

rush to beat Pfizer, Merck did not tell the US Food and Drugs

Administration or the MHRA about the known risks of Vioxx. Nancy

Santanello, a chief researcher for Merck, told the Texas trial the

company's research unit had raised concerns as early as 1998 over the

increased risk of heart attacks and strokes.

 

The punitive damages was equivalent to a 2001 estimate by Merck of the

extra profit it would make if it could delay an FDA warning on the

heart risks of its drug.

 

At least 300 British patients who claim to have suffered heart attacks

and strokes as a result of Vioxx, as well as the relatives of others

who died, are to sue the makers, Merck, for millions of pounds in the

US courts. More than 4,000 sufferers from around the world have also

lodged negligence claims against Merck, with experts warning that the

company faces a " potentially unlimited " flood of cases that could

cost it more than $50bn (£28bn).

 

The hopes of those suing have been buoyed by a ruling by a court in

Texas last week that the drugs giant was responsible for the death of

an American man who died in 2001 after taking Vioxx. Merck was ordered

to pay his widow $253m in damages after the jury heard testimony that

Vioxx had been rushed on to the market without proper testing and that

doctors had not been told of the potential risks of the drug.

 

British solicitors dealing with the class action said they were

deluged with calls from more alleged victims over the weekend after

details of the Texas case emerged. Russell Spargo, of MSB solicitors

in Liverpool, which is dealing with 150 claimants, said: " This is a

ticking bomb for Merck. The Texan case was seen as one of the weakest

claims and Merck were convinced that they would win it. This could run

into millions of pounds for the British victims alone. "

 

Mr Spargo said American research estimated that more than 60,000

people may have died as a result of taking Vioxx ­ a death toll

greater than American fatalities in the Vietnam war. " This is a drug

that should never have been marketed in the way it was. "

 

The scale of the Vioxx case outstrips the Thalidomide scandal that led

to the 1968 Medicines Act governing the way in which drugs are

regulated. The Medicines and Healthcare Products Regulatory Agency

(MHRA) which approves drugs in the UK, has launched an investigation

into whether Merck deliberately withheld information on Vioxx when it

applied for a British licence in 1999.

 

Documents in the Texas case alleged that officials at Merck knew as

early as 1998 that the drug was linked to an increased risk of

cardiovascular problems, but that the data was suppressed.

 

Vioxx was one of a new class of anti-inflammatory drugs called COX-2

inhibitors that were believed to be more effective than old-style

painkillers, and with a reduced risk of ulcers and gastric problems.

 

Merck was competing with other drugs giants, including Pfizer, to

bring the first COX-2 drug on to the market for treating arthritis and

other conditions. The profits would have potentially run into billions

of pounds, and the rival companies were spending millions on making

and marketing their drugs.

 

Among allegations being investigated is the possibility that in the

rush to beat Pfizer, Merck did not tell the US Food and Drugs

Administration or the MHRA about the known risks of Vioxx. Nancy

Santanello, a chief researcher for Merck, told the Texas trial the

company's research unit had raised concerns as early as 1998 over the

increased risk of heart attacks and strokes.

 

The punitive damages was equivalent to a 2001 estimate by Merck of the

extra profit it would make if it could delay an FDA warning on the

heart risks of its drug.

 

_

Exposed: Vioxx firm's cash payments made to arthritis charities

 

By Maxine Frith, Social Affairs Correspondent

 

 

Published: 24 August 2005

 

Leading arthritis charities have accepted thousands of pounds in

sponsorship and donations from Merck, the drugs company that stands

accused of deliberately suppressing information about the health risks

of its painkiller Vioxx.

 

The financial links with the pharmaceutical giant have led some

critics to accuse charities of a potential conflict of interest,

particularly where they run helplines offering supposedly impartial

advice on treatments and pain relief to patients.

 

Vioxx was heavily marketed as the safest and most effective drug for

arthritis and related conditions when it was launched in the UK six

years ago. Arthritis Care, one of the biggest charities in the field,

received £26,000 from Merck in 2004 alone.

 

Other recipients included the National Rheumatoid Arthritis Society,

the National Osteoporosis Society and the British Society for

Rheumatology.

 

Experts said that the relationship between Merck and arthritis groups

was merely a small part of a bigger problem, with millions of pounds

being spent by drugs companies in return for their corporate logo and

name being featured on websites and literature created by respected

and influential charities.

 

Sapna Malik, a solicitor representing more than 50 patients who are

suing Merck over Vioxx, said: " I am sure the charities would say that

they act independently of the companies that give them money, but it

is an unhealthy relationship.

 

" How can a charity that has taken money from Merck and features its

logo, then offer impartial advice if something goes wrong? Drugs

companies want to get something for their money, and the emerging

situation surrounding Merck has brought the way in which this can

prove to be a conflict of interest to the fore. "

 

Vioxx was launched in the UK in 1999 and it was aggressively marketed

to GPs, hospital consultants and patient groups as a new type of

painkiller that was more effective and safer than old-style

anti-inflammatory drugs. It promised to be particularly useful for

arthritis sufferers.

 

But it was withdrawn in September last year after it emerged that it

was linked to a doubling of heart attacks and strokes in patients.

Merck is now facing legal action from more than 4,000 patients around

the world, including 300 in Britain, who claim that they or their

relatives suffered or died as a result of Vioxx.

 

It is estimated to have contributed to the deaths of around 60,000 people.

 

Merck has also been hit by allegations that it knew as early as 1998

that the drug carried increased risks of cardiovascular problems, but

withheld the information from both the US Food and Drugs

Administration and the UK's Medicines and Healthcare Products

Regulatory Agency (MHRA) when applying for licences.

 

The Independent has now learnt that many of the biggest arthritis

charities have been long-standing recipients of sponsorship and

donations from Merck's UK subsidiary, Merck Sharp and Dohme (MSD). The

website for Arthritis Care says its creation was " made possible with

support from Merck Sharp and Dohme " .

 

Arthritis Care was one of several organisations that submitted

evidence to the NHS drugs assessment body, the National Institute for

Clinical Excellence (Nice), in 2000 when it was investigating how

widely Vioxx should be prescribed in Britain. Since the scandal

surrounding Vioxx emerged, Arthritis Care has said it cannot comment

until the MHRA has concluded its investigations. The charity accepted

£10,000 from MSD in 2003 and £26,000 last year, a spokesman said.

 

He added: " Arthritis Care does not advise or recommend specific

medications to people with arthritis. As a patient representative body

we provide factual information on living with arthritis. Arthritis

Care does not moderate its messages according to the wishes of

external agencies. "

 

A report by the National Rheumatoid Arthritis Society in 2003,The

Painful Truth, called for faster access to new medication and was

sponsored by MSD, which it names on the title page. A spokeswoman said

the charity had " clear rules " about how it accepted money from the

industry and that it would refuse to work with any company that acted

deceitfully.

 

The British Rheumatology Society, which represents clinicians and

scientists, also has MSD as a commercial sponsor. David Isenberg, the

BRS's president, said it did not accept money for endorsing drugs or

companies.

 

Other organisations were unwilling to publicly criticise the arthritis

charities. One insider said: " It can be difficult as you desperately

need the money and these drugs companies come offering it on a plate,

but I think it's more trouble than it's worth getting into bed with

the pharma industry ... And it's not just arthritis charities - it's

going on everywhere in the voluntary sector, although it's not shouted

about. That tells you how murky it can be. "

 

MSD was asked to comment on its donations and links to charities, but

the company did not respond.

 

 

 

 

'Company should be in dock'

 

Donald Clark, 69, husband of Vioxx taker

 

Irene Clark was a fit and healthy grandmother who spent every

lunchtime supervising children in the playground of a nearby primary

school.

 

Yet within two months of being prescribed Vioxx, the 62-year-old

suffered a massive heart attack and died.

 

It was only when the drug was withdrawn in September last year that

her husband, Donald, made the link with his wife's death. Mr Clark,

69, from Gillingham, Kent, has now joined the legal action against

Merck, with hundreds of other British people.

 

He said: " I blame myself because I suggested she went to the doctor

and asked for different medication because the old drugs weren't doing

her any good. It's a nightmare. The drugs company should be up in the

dock for murder. "

 

Mrs Clark had suffered from rheumatoid arthritis in her knees and

shoulders for some years. Her GP prescribed her Vioxx, in a liquid

rather than tablet form. It worked well, and Mrs Clark obtained a

repeat prescription.

 

On 1 August 2003, Mr Clarkfound her slumped at the top of the stairs

in their home. " The doctor said she had had a massive heart attack.

Irene had never had any heart trouble, " he said.

 

A year after Mrs Clark's death, Merck voluntarily withdrew Vioxx from

the market. It was only then that Mr Clark made the link.