Duh, like we didn't see this one coming...

[Guest guest]

http://www.foxnews.com/story/0,2933,140180,00.html

 

In a sharp pivot, many medical authorities are questioning the fundamental

safety guarantees for American drugs, threatening to dull the national

appetite that has demanded and devoured pharmaceuticals at a faster clip for

nearly a generation.

 

In a challenge unthinkable even two months ago, Dr. Catherine DeAngelis,

editor of the Journal of the American Medical Association, now compares the

drug safety system to a dangerous building:

 

" This building is on very shaky ground. Would I condemn it? No, but I would

tell people, 'You go in at your own risk.' "

 

In recent months, troubling news about several high-profile drugs has sapped

confidence in the system for flushing out dangerous medicines and assuring

the supply of safe ones. Worries abound over the safety of antidepressants

(search), the recall of blockbuster pain reliever Vioxx (search), and a

winter with rationed flu vaccine (search).

 

Such intense outcries over safety have rarely been heard since the 1960s,

when the European thalidomide (search) scandal of deformed babies motivated

this country to fashion a more protective federal Food and Drug

Administration.

 

Since the late 1980s, Americans have mostly been begging for faster approval

of presumed lifesaving drugs for such diseases as AIDS and cancer. Lately,

they are wondering if medicines - now pumped out by a $200 billion annual

industrial powerhouse - are arriving too fast and doing too much harm. Are

medicines safe? they ask.

 

 

Interviewed in recent days by The Associated Press, experts within and

outside government respond with some jarring answers: No drug is ever fully

safe, any more than a drive down the highway. The safety net isn't designed

to catch rare side effects until drugs reach the market. By then, regulators

are often powerless to spot mistakes quickly and reluctant to jump on them,

according to many drug authorities.

 

Dr. Jerry Avorn, a Harvard Medical School expert who wrote a book on the

drug industry, says recent revelations about the FDA suggest " a culture of

denial " about dangerous side effects, especially once a drug is on the

market. Some authorities contend that FDA's post-marketing safety monitors

need more independence from the unit that evaluates drugs for approval.

 

Dr. Steven Galson, acting director of FDA's drug operation, says the agency

forces companies to overcome " a high hurdle " to demonstrate drug safety.

However, he also says that " the group that approves new drugs does invest a

lot of time and energy, and it is a very legitimate question to ask if they

can (properly) look at new information that comes up. "

 

Some policy specialists think the safety system ruptured in recent years,

allowing far too many of the 100,000 annual drug deaths estimated in one

study. Others say many flaws are old. Some weaknesses may reflect much

heavier drug use than in the past and the slow evolution of the safety

apparatus. Nearly everyone believes repair is possible, but few predict

quick sweeping action.

 

" The system itself is completely broken, " says Dr. David Graham, a senior

safety scientist at FDA who has begun speaking outside the agency's chain of

command. " The system is incapable of preventing another Vioxx. " He says the

agency approves drugs if it can't prove them unsafe, instead of forcing

makers to demonstrate safety - a point challenged by his superior, Galson.

 

Graham has put forth his own list of five marketed drugs to re-evaluate. Dr.

Sidney Wolfe, director of the nonprofit Public Citizen Health Research

Group, says there are better, safer alternatives to more than 180 drugs.

 

Yet only 16 drugs have been pulled from the market since 1997, mostly

voluntarily - if under FDA pressure. Some FDA defenders say a new

antidepressant warning and Merck's withdrawal of Vioxx prove the system is

working.

 

Many analysts trace purported safety failings to 1992, when Congress adopted

industry-paid user fees to pay for faster FDA reviews. Waits for standard

drug approval have typically been cut by more than half, to under one year,

government data show.

 

However, critics say the funding makes the industry, not the public, the

agency's master. Also, many members of influential FDA advisory panels have

ties to drug companies.

 

" The industry has now captured the agency that is supposed to be regulating

it, " claims Dr. Marcia Angell, a former editor of the New England Journal of

Medicine who wrote a recent book on the drug industry.

 

The corporate influence has seeped into doctor's offices too, where drug

salesmen make routine house calls. Doctors often prescribe drugs for

conditions beyond their demonstrated usefulness, often to satisfy patients

who may have seen an ad depicting a treated illness as a prance through a

flower bed.

 

Yet relatively few new drugs are dramatic or one-of-a-kind additions to the

national medicine cabinet. Last year, less than a third of 72 new drugs had

novel active ingredients, and the FDA viewed only a quarter as " significant

improvements. " Makers must show only that their drug works better than a

dummy treatment, not better than a competing drug.

 

Drug testing usually involves just a few thousand patients, with few elderly

or having special conditions. " When a new drug is marketed, there will

usually be safety problems as yet unknown, " says Dr. Brian Strom, a drug

risk specialist at the University of Pennsylvania.

 

The FDA's Galson says it is legitimate to ask if more or better testing is

needed. " Everybody knows that the system we have now is not adequate to pick

up all adverse events that will occur once a drug gets out into the

population. The question is, are we willing to pay for more trials? " he

says. He adds that, above all, the FDA must do more to expose its data and

decision-making to doctors and patients.

 

Tony Plohoros, a spokesman for Vioxx maker Merck, cautioned against

requiring more safety data for drug approval, potentially delaying patient

access to important new medicines.

 

Many experts think safety especially suffers later, when rare harmful

effects pop up only with mass consumption. Doctors are merely encouraged to

report them, and the FDA forces the industry to carry out relatively few

studies of drugs on the market, critics say.

 

Many critics argue that an independent body should take over this monitoring

role with heftier public funding, stronger authority to stop bad drugs and a

firewall against industry pressure.

 

" If a plane crashes off the coast of New York, we don't leave the

investigation to the controllers that were controlling the plane and the

airline that was flying it, " says Dr. Alastair Wood, a Vanderbilt University

pharmacologist and FDA drug safety adviser.

 

Despite such complaints, most critics readily acknowledge that thousands of

Americans survive or lead better lives thanks to effective drugs. " Medicines

that receive FDA approval are among the safest in the world, " Acting

Commissioner Lester Crawford declared recently. The agency has commissioned

the independent nonprofit Institute of Medicine (news - web sites) to study

drug safety and recommend improvements.

 

Drug makers say their profits drive innovation. Jeff Trewhitt, a spokesman

for the Pharmaceutical Research and Manufacturers of America, says the

latest problems cropped up in just a handful of more than 10,000 treatments.

 

" In the vast majority of cases, these medications are doing what they are

supposed to do, " he says.

[Guest guest]

thank you for sharing this shelby.

 

Hugs

Deana

 

 

Shelby Blakely wrote:

 

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