ST. LOUIS – Philip Needleman, the St. Louis scientist who invented a class of painkillers known as Cox-2 inhibitors, said concern over increased cardiovascular risk should not derail cancer trials using the drugs.
Cox-2 enzymes, which cause inflammation and pain, have been found in every stage of cancers that invade epithelia tissue, including cancers of the esophagus, breast, stomach and colon, he said.
“My biggest frustration would be if the cancer potential did not get fully investigated,” Needleman said.
Needleman discovered the Cox-2 enzyme while he was chairman of the pharmacology department at Washington University Medical School. He developed Celebrex and Bextra Cox-2 inhibitors as chief scientist for Monsanto Co.
Needleman is retired from the industry and works with Washington University as well as Prospect Ventures Partners.
An advisory committee to the Food and Drug Administration on Friday echoed Needleman’s contention that not all Cox-2 drugs are equal when it comes to risk.
However, the committee said all of the approved Cox-2 drugs pose some risk and should carry strong black-box warnings on the inserts.
FDA scientist David Graham has contended there’s no need for the drugs.
Needleman said Merck & Co.’s Vioxx, a drug pulled from the market last year in the largest-ever drug recall, had a clear signal that it increased risk for heart attack and stroke.
Pfizer’s Bextra and paracoxib sodium, an injectible version yet to be approved by the FDA, have not undergone long-term safety studies, but they appear to pose greater risk of side effects than Celebrex.
The limited-time drug safety trials required for FDA approval of a new drug are of limited benefit in assessing risks when a drug is released to the population at large for long-term use.
“I don’t think there was ever a drug that looked safer than Celebrex at the right dose,” Needleman said.
Last week, Health and Human Services Secretary Michael Leavitt said the FDA would establish a Drug Safety Oversight Board to conduct ongoing reviews of the safety of drugs on the market.
“No one says you should ignore the cardiovascular risk issue,” Needleman said. He thinks the FDA should tap into large HMO databases to track adverse effects in large populations.
Send questions/comments to the editors.
Success. Please wait for the page to reload. If the page does not reload within 5 seconds, please refresh the page.
Enter your email and password to access comments.
Hi, to comment on stories you must . This profile is in addition to your subscription and website login.
Already have a commenting profile? .
Invalid username/password.
Please check your email to confirm and complete your registration.
Only subscribers are eligible to post comments. Please subscribe or login first for digital access. Here’s why.
Use the form below to reset your password. When you've submitted your account email, we will send an email with a reset code.