New worries tarnish arthritis drugs

[Guest guest]

From what I'm reading today, I suspect that all of the pain

relieving drugs known as -2 inhibitors will be pulled from the

market. Additionally, there appears to be a move for investigation

of the FDA practices for drug approvals. This pendulum swings two

ways. We want them to be careful in their approvals but I suspect

that an already very lengthy process of approvals for new drugs will

now be even longer and that includes the approval for the orphan

drugs. I have to wonder how this is going to affect the very ill

patients who are waiting for these appovals.

Alice

From Vioxx to Bextra, pain medications are linked to heart risksThe

Associated Press

Updated: 11:16 a.m. ET Nov. 11, 2004 WASHINGTON - One by one,

arthritis drugs that promised to ease pain without causing ulcers

are losing their luster.

In September, Merck & Co. yanked Vioxx from the market when a trial

showed that long-term use of the painkiller nearly doubled the risk

of heart attack and stroke.

This week, researchers said a preliminary study indicated that

Bextra — another painkiller in the same class — also more than

doubled the risk of heart attacks and strokes among patients with

heart disease.

Pfizer, which manufactures Bextra, said researchers

made " unsubstantiated conclusions " during their presentation at the

annual meeting of the American Heart Association in New Orleans. The

company also said the research was " based on information that has

not been published in a medical journal or subject to independent

scientific review. "

`Arthritis drugs are not saving people's lives. Ironically, they're

inducing heart attacks and may be losing people's lives.'

— Dr. J. Topol

Cardiologist, Cleveland Clinic

The news sent a ripple through the meeting and caused the company's

stock to tumble.

Pfizer already has told regulators it will add to its packaging a

black box warning, the most strident alert, to warn consumers of a

potentially fatal skin reaction linked to Bextra.

Scientists renewed a call for more studies of the painkillers in

patients with heart disease, the group likely to suffer the most

harm from this class of drugs known as cox-2 inhibitors. For

clinicians at Kaiser Permanente, which serves 8.3 million patients,

the Bextra study already has prompted discussion of safer

alternatives. And some pressured the Food and Drug Administration to

halt advertising directed at consumers.

" Arthritis drugs are not saving people's lives. Ironically, they're

inducing heart attacks and may be losing people's lives, " said Dr.

J. Topol, a Cleveland Clinic cardiologist who was among the

first to warn about heart woes associated with the new painkillers.

The FDA controls drug marketing directed at consumers, Topol

said. " The reality is they could shut that down at any time. "

Kathleen Quinn, an FDA spokeswoman, could not say which actions the

agency would take.

The FDA doesn't discuss negotiations or talks with companies, she

said. " We will be taking a look at the whole class of drugs. "

Quinn said the FDA has not accelerated the timing of an upcoming

meeting on cox-2 inhibitors, currently planned for mid-February.

Study: Bextra heart risks similar to Vioxx

http://www.msnbc.msn.com/id/6450969/

What's a bone-weary consumer to do?

Experts give contrasting advice.

The cox-2 drugs were praised for blocking the enzyme that causes the

pain and swelling of arthritis inflammation. The drugs, however,

were selective in their targets, bypassing the cox-1 enzyme that

helps the stomach maintain a protective lining.

Talley, the chemist who invented the Celebrex and Bextra

molecules, said the cox-2 drugs helped people who couldn't tolerate

the older generation of painkillers. " I do think these drugs have

been a tremendous benefit to folks. And they've been extensively

studied, " Talley said.

Consumers and doctors agreed, to the tune of 40 million cox-2

inhibitor prescriptions written in the first nine months of 2004,

according to IMS Health, a company that tracks drug industry trends.

Whether there is a classwide problem with cox-2 inhibitors, to many,

remains debatable.

" I would hate for people to go off these medications on what may

turn out to be unfounded rumors, " said Dr. A. Tindall,

incoming president of the American College of Rheumatology. " Each

drug has to be carefully scrutinized. I don't think they've quite

done that with Bextra to the extent they did with Vioxx. "

Clinicians who are the decision-makers at Kaiser Permanente,

however, are alarmed by the Bextra findings and agree that there are

safer alternatives.

" These drugs are no better for control of pain than Motrin, " said

Campen, Kaiser's medical director of pharmacy operations. And

most people don't enjoy the expensive drug's slight benefit because

they're not at risk for stomach ulcers, Campen said.

Topol, of the Cleveland Clinic, said naproxen should be the first

anti-inflammatory of choice for people with arthritis who have heart

problems.

" If there's even a potential risk for heart disease, that's where

you don't want to err in the wrong drug class, " Topol said.

To examine heart risk associated with Bextra, a Wake Forest

University School of Medicine researcher looked at studies involving

some of the most vulnerable patients, those with heart disease

undergoing coronary artery bypass graft surgery.

Taking Bextra more than doubled the risk of heart attacks and

stroke, compared with dummy pills.

Dr. Curt Furberg, a public health sciences professor at Wake Forest,

questioned the timing of Pfizer's release of the data. The company

mentioned the study in a statement in October.

" I think it's healthy to get the information out and have a debate.

I think it will probably pressure Pfizer to be more open, " said

Furberg, among the academicians invited to attend the FDA's February

session on cox-2 inhibitors.