This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

J&J Discs Face Backlash

European Experience

Ironically, fans of Charite kept pointing to the European experience as proof of the disc's success. They also suggested that data from Europe -- where Charites have been on the market for 17 years -- reduced the need for extended clinical trials in the U.S.

But many who participated in last year's hearing, including the FDA's own expert engineer, expressed concern about the length of the U.S. study. They indicated that many complications would not even surface until well after the study had ended.

"I think that we have already all pretty much agreed that two years is probably not a safe length of time to follow these patients," said Maureen Finnegan, a voting member of the advisory panel with financial ties to the industry. "So I do think that there needs to be a long-term follow-up."

In the end, however, the panel unanimously recommended approval of the devices with some conditions attached. Specifically, the group called for continued monitoring of trial participants and specialized training for surgeons who will be performing the procedures.

During the FDA hearing process, the so-called Spine Arthroplasty Society had already promised to help with the latter.

"Until I read this transcript, I had never heard of this society," Rosen says. "Given that I am a university spine surgeon, one would think I might even be invited to join or participate."

Rosen marvels that such a society -- dedicated to a brand-new procedure in the U.S. market -- already exists in the first place. However, industry critics have long claimed that some professional and consumer advocacy groups are, in fact, little more than fronts for the big health care companies themselves. The SAS Web site, which discloses nothing about the society's funding, almost exclusively promotes the new artificial discs.

5 of 6

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs