Re: Medicine in 2004: Proceed with caution

[Guest guest]

There is no reason to believe that federal health agencies

are any more vigilent or any less conflicted with the pharmaceutical

industry when monitoring the safety of vaccines than they are monitoring the

safety of drugs. And the solution to insuring the safety of flu vaccine does

not depend on everyone using it.

http://www.usatoday.com/news/health/2004-12-28-medicine-year_x.htm

USA Today

Posted 12/28/2004 9:01 PM

Medicine in 2004: Proceed with caution

By USA TODAY staff

The year in medicine can be summed up best as the year Americans

increasingly were forced to peer into their medicine cabinets with a wary

eye. Alarming headlines about one blockbuster drug were soon supplanted by

fresh headlines warning about some other popular medication. A look at the

major medical stories of 2004:

Merck, Vioxx's maker, pulled the drug off the market in September.

By Amy Sancetta, AP

Classes of certain drugs under attack

Even before Vioxx and Celebrex came on the market in 1999, they were being

touted as " super-aspirins. " Vioxx and Celebrex, so-called COX-2 inhibitors

that were approved to treat arthritis and acute pain conditions, quickly

became blockbuster drugs.

So it was stunning news when Merck, Vioxx's maker, pulled the drug off the

market Sept. 30 after a company-sponsored study found that patients who took

Vioxx were more likely to have a heart attack or stroke than those on a

placebo.

Patients wondered why they hadn't known about this sooner. Sen. Chuck

Grassley, R-Iowa, suggested during a Senate hearing that the Food and Drug

Administration was " too cozy " with drug companies and downplayed earlier

signs of trouble with Vioxx. FDA scientist Graham testified that he

had concerns about five other drugs as well: Accutane for acne; Bextra, a

COX-2 inhibitor; Crestor, a cholesterol-lowering statin; Meridia for weight

loss; and Serevent for asthma. Their makers defended the drugs' safety.

On Dec. 9, the FDA made Pfizer add a warning on Bextra's label. Two studies

had shown that short-term use by patients who already had heart disease

might trigger heart attacks or strokes. On Dec. 17, the National Institutes

of Health announced it was stopping a colon cancer prevention trial because

participants receiving Celebrex were at least 2½ times more likely to have a

heart attack or stroke than those receiving a placebo.

And if arthritis patients weren't confused enough, NIH announced Dec. 20

that it had halted an Alzheimer's prevention study involving Celebrex and

naproxen, sold over-the-counter as Aleve. This time, Aleve was found to

raise the risk of heart attack or stroke 50% over that seen with a placebo.

Celebrex, Bextra and Aleve remain on the market, although at the FDA's

request, Pfizer has pulled Celebrex advertisements. In February, an FDA

advisory committee will discuss the safety of COX-2 inhibitors, and Congress

is expected to continue the debate about whether the FDA is capable of

protecting Americans from potentially risky medicine.

Flu vaccine comes up short

The sudden shortage of flu vaccine, occurring as it did on the eve of the

2004-05 flu season, sent health officials and consumers into a tailspin.

Federal health officials quickly instituted a priority list that recommended

restricting vaccine to people at high risk for serious illness from flu,

such as babies, pregnant women, the elderly and anyone with chronic health

problems.

Doctors, hospitals and health departments that ordered their vaccine from

Chiron were out of luck after the vaccine maker's license was suspended Oct.

5 because of contaminated vaccine, cutting the USA's flu shot supply nearly

in half. Customers of Aventis Pasteur, the only other maker of flu shots,

shared their bounty in many cases, but that didn't prevent long lines at flu

clinics and a lot of scrambling by local and state health officials.

The shortage created a frantic demand that prompted thefts of flu shots from

doctor's offices, price gouging and a new travel innovation: flu vaccine

tourist weekends in Canada.

It also brought to light the weaknesses in the vaccine supply system,

generating calls for better federal oversight of vaccine manufacturers,

efforts to encourage more vaccine makers to enter the U.S. market and more

research into new technologies for making flu vaccine. Vaccine makers say

they make only as much as they can sell. The challenge, public health

experts say, is to persuade more Americans to get a flu shot every year.

Antidepressants and possible suicide link

The Food and Drug Administration in October said antidepressants must carry

" black box " labels, the strongest warning available, cautioning that the

pills could increase suicidal behaviors in children. The FDA also said

everyone picking up antidepressant prescriptions should get medication

guides describing the drug's proven risks and benefits.

The action capped eight months of mounting pressure on the FDA from Congress

and dozens of parents who testified at two public hearings that

antidepressants had caused their children to commit suicide. About 2 in 100

children taking the pills will think about or attempt suicide because

they're on antidepressants, according to studies of more than 4,000

children.

More than 1 million U.S. children were taking antidepressants in March when

the FDA advised doctors and parents to monitor children on the pills for

worsening depression or anxiety. Afterward, pediatric prescriptions for the

drugs began to drop, preliminary reports suggested.

Some experts worry that parents and doctors will be so afraid of giving

antidepressants to children who need them that there could be more suicides.

Also unknown: whether more depressed children will get therapy instead of

drugs. " We hope the black boxes will force a dialogue between doctors and

families about all kinds of treatments, including the non-medical ones, and

the risks and benefits of each, " says University of Florida psychiatrist

Wayne Goodman, chairman of the FDA scientific advisory panel that

recommended the warnings.

Acceptable LDL levels lowered

The headlines easily might have trumpeted " Cholesterol guidelines hit new

low. " That's because the federal government has endorsed pushing levels of

LDL, bad cholesterol, lower than the accepted standard for people with a

very high risk of having new heart attacks or strokes.

The revised guidelines by the government's National Cholesterol Education

Program established a new " very-high-risk " category for patients and set a

record-low target of 70 milligrams per deciliter of LDL in blood for

eligible patients. The current target is " less than 100 " mg/dl. Doctors have

long known that less LDL adds up to healthier arteries, but " how low do you

go " has been a popular subject for debate among heart specialists.

A hint of an answer emerged in two recent studies involving high-dose

cholesterol-lowering drugs. One showed that a high-dose statin drug could

halt coronary artery disease, while the second showed that patients were

more likely to survive if they took a dose high enough to push their LDL to

target lows.

Bonow, chief of cardiology at Northwestern University Health Science

Center, added that more studies promise to give doctors more guidance on

which patients should be treated the most aggressively to lower their risk

of heart attack. Also forthcoming will be results from studies looking at

drugs designed to boost levels of good cholesterol, or HDL.

Contributing: Rita Rubin, Anita Manning, Marilyn Elias, Steve Sternberg