Drugs: not a good vs evil story

[Guest guest]

The response to the editorial is a good one. There is complexity to

the issue of medication use; though our culture loves a simplistic

good vs. evil story, this is not one.

Sierra

> This Editorial appears in USA Today, December 27th, 2004 Page

14A. It

> is in response to the newspaper's editorial staff opinion that

follows.

>

>

>

> Take drugs off the market

>

> By Sidney Wolfe

>

> Amid the furor involving pain drugs, it may be of interest to

ponder the

> theoretical problem of the Food and Drug Administration prematurely

> deciding to ban a drug whose benefits outweigh its risks. But we

must

> confront the reality that during the past 10 years, there is

> overwhelming evidence that the FDA repeatedly delayed withdrawing

many

> drugs long after clear, unequivocal evidence of risks that

outweighed

> any demonstrable benefits.

>

> The often-failed FDA strategy of " risk management, " a dangerous

interim

> alternative to taking drugs off the market, has ensured that

thousands

> of people were injured or killed after certain drugs should have

been

> pulled.

>

> A recent example is the diabetes drug Rezulin, first marketed in

1997.

> By that December, it was taken off the market in the United Kingdom

> because of liver damage, many cases having occurred in the United

> States.

>

> In July 1998, Public Citizen petitioned the FDA to ban the drug,

which,

> although lowering blood sugar by a different mechanism than earlier

> diabetes drugs, had no evidence of improved mortality or morbidity.

By

> July 1998, there were 560 reported cases of liver damage, including

26

> deaths.

>

> After failed efforts at " risk management, " Rezulin was withdrawn

from

> the market in January 2000, by which time there were hundreds of

> additional cases of liver damage and 63 deaths. Other belatedly

banned

> drugs include the painkiller Duract, the blood-pressure drug

Posicor and

> the cholesterol-lowering drug Baycol.

>

> Decisions to approve or remove drugs must be based on adequate

evidence

> of both benefits and risks. For Vioxx, Celebrex and Bextra - the

three

> COX-2 inhibitor pain/arthritis drugs - at approval there was no

evidence

> that they were more effective than older drugs.

>

> Only Vioxx, now withdrawn because of a significant increase in heart

> attacks, proved to be less dangerous to the gastrointestinal tract

than

> older drugs. Celebrex and Bextra did not. Although at approval

there was

> no evidence of increased cardiac risk from Vioxx or Celebrex, less

than

> a year later a 2001 study on Vioxx found it was five times more

likely

> than naproxen (Aleve) to cause heart attacks, and a Celebrex study

> prompted FDA concerns about cardiac risks for that drug.

>

> Removing Celebrex from the market will be a major step forward for

> public health. For naproxen, the evidence of its harm is

preliminary at

> best, and it is unlikely to pose cardiac risks as high as those

> documented for Vioxx or Celebrex. There is no basis for removing it

from

> the market.

>

> Unique risks without unique benefits should always be the algorithm

for

> removing drugs.

>

>

>

> Sidney Wolfe is the director of Public Citizen's Health Research

Group

> and co-author of the new edition of Worst Pills, Best Pills. Public

> Citizen's Web site, www.worstpills.org, lists what it says are safer

> alternatives to 181 drugs.

>

> _____________________________________________

>

>

> The Previous Editorial by Dr. Wolfe was in response to the USA Today

> Editorial Staff's opinion that follows:

>

>

> The Vioxx/Celebrex dilemma: Who should take the risk?

>

> " This is a very confusing situation, " a top Food and Drug

Administration

> scientist, Kweder, said of the controversy over Celebrex and

> other popular pain relievers. If the FDA is confused, imagine the

> feelings of doctors and patients caught in the backlash.

>

> The story so far: Celebrex, along with Vioxx and Bextra, were a new

> class of drugs that held great promise to relieve suffering from

> arthritis without causing the digestive discomfort and bleeding

> associated with older medications. They were heavily marketed, and

sales

> reached billions of dollars.

>

> Three months ago, a study confirmed fears that Vioxx increased the

risk

> of heart attack and stroke. Now Vioxx is off the market, pulled by

its

> manufacturer, and last Thursday the FDA urged doctors to limit

> prescriptions for Celebrex and Bextra.

>

> The Vioxx debacle exposed a much larger danger: The FDA's

monitoring of

> new drugs is inept. Even after Vioxx was implicated in up to 40,000

> deaths, the agency seemed to react only after one of its scientists,

> Graham, turned whistleblower and told Congress that the FDA's

> procedures guarantee that unsafe drugs remain on the market.

>

> As we've noted previously, that problem needs to be addressed

urgently.

> Drugs that show Vioxx-like dangers should be removed, or their use

> should be sharply restricted. But another danger is emerging: the

risk

> that overreaction will make helpful drugs unavailable to seriously

ill

> patients for whom significant risk is acceptable.

>

> The consumer group Public Citizen, for instance, is urging that 181

> drugs be taken off the market. Doing so, no doubt, would save some

> lives. It also would relegate many others to pain, disability and

> premature death.

>

> Nearly half of Americans take at least one prescription drug, and

rarely

> are the safety issues clear-cut.

>

> Consider Celebrex. A study released earlier this month found that

> patients who received several times the typical dose had an

increased

> risk of heart attack and stroke. Previous studies showed the

opposite.

> Another new study found that Celebrex caused fewer heart problems

than

> naproxen (sold over the counter as Aleve).

>

> If Celebrex were pulled from the market, millions who've found

relief

> from painful, disabling arthritis would have to switch to other

> medicines such as ibuprofen or naproxen. But those drugs cause

severe

> gastrointestinal problems in some people, resulting in more than

16,000

> deaths a year. Patients and doctors have to decide whether the

potential

> cardiac risk outweighs the drug's benefit.

>

> Certainty about drugs is impossible because clinical trials before

FDA

> approval involve only a few thousand patients. New risks, or

benefits,

> can emerge once the drug is prescribed to millions. Vioxx, for

example,

> was showing promise for preventing precancerous colon polyps.

>

> Overreaction can cause harm by:

>

> *Delaying new drug approvals. Some patient-advocacy groups worry

that

> the FDA is slowing approval of new drugs for cancer and other deadly

> diseases. Marqibo, a pill to treat an aggressive cancer that kills

at

> least half of all patients with it, was turned down for accelerated

> approval earlier this month. That caution may be appropriate, but

there

> is another side: " The number of people who die because of delayed

> approval far exceeds the number hurt by unsafe drugs, " says

> of Abigail Alliance, a group that wants quicker access to new

> drugs.

>

> *Distorting the level of risk. Clinical studies often contradict

each

> other, and wide-ranging conclusions are drawn from small samples.

In the

> recently reported link between naproxen and cardiac risk, fewer

than 3%

> of the 2,500 elderly patients suffered heart attacks or strokes over

> three years, a relatively small number for that age group. " We're

being

> given flash results based on single trials that haven't been

properly

> analyzed, " says Weber, associate dean of New York's

Downstate

> College of Medicine. " There may or may not be a safety problem. At

this

> point, we don't know. "

>

> *Jeopardizing health. In October, the FDA ordered antidepressants to

> carry tough labels warning of increased suicidal behavior in

children.

> Banning the drugs would have threatened the health of a million kids

> getting relief from the agony of depression. The suicide rate in 15

> nations has dropped by one-third during the past 15 years since

these

> drugs were introduced. The FDA was right to urge greater monitoring

> instead.

>

> Make no mistake: The FDA is badly off-track. It's not watching

closely

> enough to see that the drugs it approves are safe as well as

effective.

> But most often, the right solution will be to restrict a drug's

use, not

> to ban it.

>

> Risk can be controlled.

>

> It can't be eliminated.

>

>

>

>

>

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org