Senate Told to Strengthen Drug Safety Bill Posted by Earl Lui at 11/17/06 04:15 PM

The U.S. Senate’s Health, Education, Labor & Pensions Committee held a hearing yesterday on an important bill to reform the FDA. For the most part, everybody asked the panel to make the bill stronger, according to a story in the Washington Post. Everybody that is, except the drug industry.

“Now the FDA urgently needs treatment,” said Sen. Ted Kennedy, who will chair the committee in the new Congress. Witnesses testifying included the head of the Institute of Medicine panel that issued a scathing critique of the FDA’s safety efforts, a prominent physician and medical researcher, and Jim Guest, President and CEO of Consumers Union.

When the drug industry had its turn, a spokesperson defended direct-to-consumer ads for prescription drugs. According to the New Jersey Star-Ledger, Adrian Thomas of Johnson & Johnson claimed that “DTC advertising plays a valuable role in educating patients about diseases and treatments.”

Yes, drug ads to consumers are so valuable that only two countries on the planet permit them (the U.S. and New Zealand, and New Zealand is reconsidering)! Let’s be clear: real education about one’s health means unbiased information about a disease or condition and ALL alternatives for treatment, including diet or lifestyle changes. “Education” does not mean a constant barrage of 30-second ads selling one particular drug—that’s sales, not education.

comments (3)

1 Posted by Ellen at 11/28/06 07:48 PM

Typical of Pharma to be the only ones in the room to defend DTC advertising and to start bargaining already as to how long there should be no DTC as a safety move for new drugs.

I am glad that everyone spoke out in favor of a stronger bill. I for one hope that one safety move to be considered is to contract with a non-governmental entity to monitor worldwide label warnings and significant negative findings of a drug for its first five years. The FDA has a reputation as being the last westernized country to place a warning on a label. If it had acted right away with a warning once Japan and the UK had required Lilly to place a warning on Zyprexa, my son might be alive today.

2 Posted by Mathy Milling Downing at 11/28/06 09:08 PM

I attended this hearing and was fortunate enough to meet Mr. James Guest. I was impressed with the large number of people who attended the session, and the majority of comments made during testimony. Mr. Guest actually mentioned my little girl, Candace, who took her own life at 12 years of age, after having been prescribed Zoloft for test anxiety, and also Tim Wytzak, who was prescribed Zoloft as a sleeping agent and hanged himself five weeks later. It brought to light that these horrific incidents are happening to real people, and should not be viewed only as statistics. The FDA has become so politicized that safety has become secondary to the financial gain of PHARMA.

3 Posted by Leo at 01/19/07 06:17 PM

The government should organize easy access to Medline and Health topics, medical dictionaries, directories and publications. WBR LeoP