Medicine and the market: the Vioxx and flu vaccine debacles

[Guest guest]

Medicine and the market: the Vioxx and flu vaccine debacles

 

By Patrick Martin

8 October 2004

 

http://www.wsws.org/articles/2004/oct2004/viox-o08.shtml

 

Two events of the past week have further exposed the official

lie—endlessly propounded by the corporate media and the politicians of

the Democratic and Republican parties—

that " the market " can provide a rational and effective solution

to the deepening crisis of health care in the United States.

 

Last Thursday, September 30, the huge drug company Merck,

long one of the most profitable U.S. corporations,

announced it was recalling its arthritis drug Vioxx, used by more than

two million people worldwide.

Merck took the action after a study confirmed what has long been

suspected by cardiologists: the drug is associated with a sharply

increased risk of heart attack and stroke.

 

Five days later, on October 5, Chiron Corp. announced that its entire

production run of flu vaccine had to be scrapped because of

contamination problems, cutting the U.S. supply of vaccine in half only

days before the start of the flu season.

Federal health officials immediately issued guidelines for cutting back

the scope of vaccination campaigns, suggesting a focus on selected

high-risk groups, including infants between 6 and 23 months, the

elderly, and those suffering from asthma and other respiratory

problems.

 

What connects these two events, which threaten the health of millions

of

people?

Both are byproducts of the subordination of the health care system to

the profit motive.

 

In the case of Vioxx, it is questionable whether the drug should ever

have been released to the public.

The class of drugs of which it is part, called COX-2 inhibitors, have

little demonstrated medical superiority over such proven

over-the-counter pain relievers as aspirin and acetaminophen, though

they cost 100 times more.

 

Once they received FDA approval in 1999, Vioxx and its counterparts

like

Pfizer's Celebrex were heavily promoted as anti-inflammatory wonder

drugs free of the gastrointestinal side effects experienced by some

aspirin users.

Overstated claims were backed by marketing muscle: by one report, a

staggering $3.2 billion was spent on advertising and other promotional

efforts for COX-2 inhibitors in 2003 alone.

 

Merck spent $100 million on direct-to-consumer Vioxx advertising in

2003, aimed at pushing arthritis sufferers to ask their doctors to

prescribe the drug. It expended $500 million more to promote the drug

to

doctors and pharmacists and in medical journals.

Far more was spent to sell the drug than to conduct research on its

safety and efficacy.

 

The reason is clear: a successful " best-selling " drug is a profit

bonanza. Vioxx generated $2.5 billion in worldwide sales for Merck in

2003, 11 percent of the firm's total revenues.

A measure of its importance to the company's bottom line is that the

news of its withdrawal sparked a sell off in shares that slashed the

company's stock market valuation by $27 billion in a single day.

 

Almost from the beginning, medical professionals have raised questions

about the safety of COX-2 inhibitors, particularly for heart patients.

Since the drug is believed to work by inhibiting cells that produce

anti-clotting factors in the blood, the implications in terms of

possible heart attack and stroke are fairly obvious.

But no studies on the effects of the drug on heart patients have been

done. Nor did the FDA mandate any study of the long-term effects,

limiting the required study period for this class of new drugs to 6 to

12 months.

 

The longer study that produced the latest evidence was commissioned by

Merck itself, in an effort to demonstrate that Vioxx had positive

effects in reducing the risk of polyps in the colon—a feature that

would

have have increased the drug's commercial value.

But the researchers found such an alarming increase in heart problems

after use of Vioxx for 18 months that they urged the company to call

off

the study and take immediate action.

 

The study found that the risk of heart attack, stroke or blood clots

doubled with the use of Vioxx, compared to patients taking a placebo.

News accounts have described the increased risk as " small, " but the

numbers do not bear this out.

 

Those taking Vioxx experienced 15 heart-related incidents per thousand

people over three years, compared to 7.5 events for those not taking

Vioxx. Given that 2 million people currently take the drug, that

suggests an additional 15,000 heart attacks, strokes or blood clots

over

a three-year period.

 

Even Merck's own chief scientist described the finding as " stunning "

and

urged immediate recall of the product.

 

According to a paper released October 6 by the New England Journal of

Medicine, the toll from Vioxx may be even higher. Co-author Eric Topol

wrote that " it is possible that there are tens of thousands of patients

who have had major adverse events attributable to " the drug.

In a subsequent comment to the press, Dr. Topol put the number at

30,000

to 100,000.

 

The other factor in the recall decision was the rising number of

lawsuits by patients alleging harm from the drug.

More than 200 lawsuits had been filed before Vioxx was recalled.

 

Despite these legal actions, critical articles in medical journals and

studies that suggested, but did not conclusively prove, heightened

cardiac risks, the FDA merely required Merck to add a warning about

possible heart complications to its warning label.

The agency did not order any safety studies, despite the large number

of

prescriptions—more than 84 million—issued for the drug.

 

This is in keeping with the Bush administration's general approach to

regulation of business, which has been to sabotage federal oversight

when it cannot abolish it altogether.

Though spending on drug promotion has increased relentlessly, the FDA

has cut the number of warning letters issued for misleading drug

advertising from 82 in 2000 to 24 in 2003.

While 11 prescription drugs were recalled for safety reasons in

1997-2001, no drug had been recalled since then, until Merck

voluntarily

recalled Vioxx last week.

 

In the case of influenza vaccine, the immediate cause of the supply

disruption, according to Chiron Corp., the manufacturer, was accidental

contamination at its plant in Liverpool, England.

Chiron initially reported that it was discarding a lot containing 6 to

8

million doses, but after British regulators visited the plant the whole

production line was shut down pending further investigation.

The contaminant was a bacteria called Serrati, which can cause severe

and even fatal infections.

 

Chiron CEO Howard Pien blamed the contamination on human error in the

drug's processing.

But there is no question that profit considerations underlie the

debacle, which has wiped out half of the 100 million doses of

injectable

vaccine required for the US flu season.

 

There are only two companies licensed by the FDA to make flu vaccine

for

the US market, Chiron and Adventis-Pasteur of France.

 

Vaccine production is an inherently marginal business for a

profit-making company, because of the long lead times required in the

production process—it takes about six months to grow live viruses in

chicken eggs—and because demand varies erratically based on the

intensity and scope of the flu season worldwide.

 

The big US drug company Wyeth stopped making injectable flu vaccine

several years ago, focusing instead on a nasal spray vaccine developed

by its MedImmune subsidiary.

The nasal spray costs five times as much and is not approved as safe

for

small children or the elderly, the most critical target group for flu

vaccination.

 

Many vaccines for other diseases also have a similarly fragile

infrastructure, with a few suppliers, or only a single one, for similar

reasons:

market forces prevail over the enormous social need for an adequate

supply.

It is not commercially profitable to produce additional vaccine to

assure that there will always be enough on hand, even in case of an

epidemic.

 

The flu vaccine supply crisis underscores the hypocrisy of the Bush

administration's opposition to allowing the American public to purchase

prescription drugs from foreign suppliers, especially those based in

Canada.

 

Tommy Thompson, Bush's secretary of health and human services, claims

that the FDA cannot assure that drugs from Canadian pharmacies are

safe,

and the FDA has threatened prosecution of cities, states and

individuals

who have sought to purchase such drugs by mail-order or over the

Internet.

 

The reality is that pharmaceuticals are a global market and the big

drug

companies operate without regard to national boundaries.

 

Chiron, for instance, based in California, acquired the British company

PowderJect last year and invested heavily to ramp up production at the

Liverpool plant, 90 percent of it exported back to the U.S.

 

Chiron is itself 40 percent owned by Novartis, the huge Swiss-based

pharmaceutical maker.

 

The Bush administration policy has nothing to do with safety. It has a

crass commercial purpose: to protect the profits of the U.S.-based drug

manufacturers, who have a captive market in the American population,

compelled to pay prices two or three times the level elsewhere.

 

The common thread in both of these episodes is that medical

professionals have repeatedly issued warnings.

They were disasters not only foreseen, but foretold over and over

again,

but to no avail.

 

Dr. Topol, head of cardiology at the Cleveland Clinic, a leading heart

institute, wrote scathing critiques of Vioxx more than three years ago,

arguing that the COX-2 inhibitors were essentially worthless, offering

" marginal efficiency, heightened risk, and excessive cost " compared to

aspirin and other cheap alternatives.

Similar warnings were made about the insufficiency of the supply system

for flu vaccine.

 

Such alerts, even from the most prestigious medical authorities,

counted

for little compared to the profits of giant transnational corporations.

As Dr. Topol noted in a column last week in the New York Times, there

is

" a conflict between the interests of the public and the interests of a

company with a blockbuster drug that had sales of $2.5 billion in

2003. "

 

This conflict is inherent in the profit system.

It can be resolved only by putting an end to that system, and placing

the provision of medical care on a civilized and humane basis.

 

Medical care, including the supply of prescription drugs, must be a

basic human right, provided free to all who need it, at state expense.

 

This program of socialized medicine requires placing the pharmaceutical

companies and the other giant corporations that dominate health

care—insurance, medical supply, hospital management, etc.—under public

ownership and democratic control.