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Studies, Hearings on Drug Safety Worry Norfolk, Va.-Area Patients

Posted on: Wednesday, 24 November 2004, 12:00 CST

Nov. 23--Willard Ashburn started taking the drug Crestor more than six months ago to lower his cholesterol.

Then, last week, the 53-year-old Virginia Beach resident heard news reports that a federal scientist raised concerns about the safety of five drugs, Crestor among them.

"A bell goes off in your head that says, 'I need to investigate this,'" Ashburn said. He decided to stop taking the drug. Today he'll visit his family-practice doctor to ask about trying something else.

He's one of three patients that Virginia Beach family-practice physician Mitchell Miller heard from Friday and Monday, and one of many patients across the country who have similar concerns about the safety of the drugs they are taking.

The ball of worries started rolling in late September when the arthritis drug Vioxx was removed from the market by Merck and Co. because a study showed that the drug increases the risk of heart attacks, strokes and other serious ailments.

When the Senate Finance Committee heard testimony last week about whether Vioxx was removed from the market in a timely fashion, FDA drug-safety reviewer David Graham also questioned the safety of Meridia, Crestor, Accutan, Bextra and Serevent. However, drug makers and an FDA official have said the comments were inappropriate and exaggerated.

On Monday, patients received more fuel for worry when news reports indicated that drug company Bayer AG had been slow in removing Baycol from the market in 2001. A new study found that the risks of using the cholesterol-lowering medication were far greater than had been believed.

Now some patients don't know whom to believe, and whether to trust the FDA to adequately screen drugs for safety. "It's a scary situation, especially when you see what went on with Vioxx," Ashburn said.

The remarks from the FDA researcher also have put doctors in a difficult situation. Miller said doctors rely on the FDA to screen drugs for safety. Until the agency comes out with an official report, or a drug company withdraws a medication, or a patient complains about particular side effects, then doctors generally keep prescribing them.

When patients hear reports through the media, however, they sometimes take matters into their own hands.

"If someone says, 'Based on this report, I'm afraid to take it,' I don't want to say, 'Take it anyway,-" Miller said. "If someone is uncomfortable taking a drug, we'll have them come in and tell them what the other options are."

Dr. Shearin Murphy-Higgs, a physician with Consultants in Internal Medicine, said he's noticed a four- to five-fold increase in the queries from patients about drug safety since the Vioxx withdrawal from the market.

Some arthritis patients had switched from Vioxx to Bextra, one of the latest drugs now being questioned. Many of his patients also are questioning the safety of Crestor, and asking about alternatives.

He said some of the studies implicating the drugs mentioned by the FDA reviewer last week were not as well-conducted as the Merck study, so he's hesitant to discontinue use of them if they're helping patients. However, if patients are leery of a drug, he'll suggest an alternative after reviewing their medical history.

Murphy-Higgs, whose Sentara Medical Group practice is based in Norfolk, said he believes there needs to be more research conducted by government agencies -- not drug companies -- to ensure drug safety.

"So much medical research is driven by pharmaceutical companies that doctors get to a point where they don't know who to trust either," Murphy-Higgs said.

Dr. Themis Pangalos, a Norfolk allergist, said he has received a phone call from one patient asking about a drug mentioned at Thursday's hearing. The drug, Serevent, is an asthma drug usually used in combination with a steroid.

Pangalos said he has had no complaints about the drug from patients he's prescribed it to, and the person who called was not having problems either. "No problems, just fear," he said.

Dr. Sahira Humadi, a doctor with Ghent Family Practice, said that after Vioxx was removed from the market, she received a few calls from patients who were using similar types of pain-reliever drugs such as Bextra and Celebrex. The patients asked whether they should drop the drug.

Her advice to them was to continue using the drug, since studies had not shown them to be unsafe.

DRUGS IN QUESTION:

--Accutane: An acne medication made by Roche Pharmaceuticals that can cause birth defects when pregnant women use it.

--Bextra: A painkiller made by Pfizer to treat osteoarthritis, rheumatoid arthritis and menstrual pain, Bextra can increase the risk of heart attacks.

--Crestor: A cholesterol-lowering drug made by AstraZeneca that can trigger kidney failure and a rare muscle-weakening disease.

--Meridia: A weight-loss pill manufactured by Abbott Laboratories that can cause increased blood pressure in some patients.

--Serevent: A GlaxoSmithKline asthma drug, shown during an abandoned trial to increase the risk of asthma-related deaths and life-threatening episodes.

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(c) 2004, The Virginian-Pilot, Norfolk, Va. Distributed by Knight Ridder/Tribune Business News. For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.

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Source: The Virginian-Pilot

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