This Day On The Street
Continue to site
ADVERTISEMENT
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

J&J Discs Face Backlash

"Any time you do a study, there are certain data that are considered outliers," Gupta acknowledges. "However -- and this is a big 'however' -- in almost all good studies, that is a very small percentage of the total sample size. ... Whenever a significant percentage is excluded, for any reason, it leaves a reviewer skeptical of the data analysis."

Colamarino says those patients spent more time in the operating room, lost slightly more blood and suffered a higher rate of adverse events than other participants in the study. However, she says, they actually had better clinical outcomes than the other patients based on two measures. She also stresses that Johnson & Johnson supplied the FDA with safety data on the training patients during the approval process.

Still, Brent Blumenstein -- a voting member of the FDA advisory panel -- specifically complained about omitted patients during the Charite hearing.

"The sponsor's definition of the ITT (intent-to-treat) population ... is incorrect because it deletes randomized patients," Blumenstein said. "To modify the definition of ITT or analysis by arm by deleting patients is tantamount to saying someone is only partly dead."

Like the rest of the panel members, Blumenstein nevertheless went on to vote for approval of the device anyway.

Warning Bells

The panel's decision came despite grave warnings from orthopedic surgeons in the field.

Granted, the first -- John Peloza -- was working as a consultant for Johnson & Johnson competitor Medtronic. But his concerns would later be amplified by testimony from a European surgeon who, while flown in for the FDA hearing by Medtronic as well, has studied the Charite discs extensively and implanted many of them himself.

Most importantly, Peloza stressed, the discs should last a lifetime in the fairly young patients who would be seeking them.

3 of 6

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
JNJ $99.98 0.00%
MDT $76.88 0.00%
SYK $96.11 0.00%
AAPL $129.96 0.00%
FB $80.44 0.00%

Markets

DOW 18,011.94 -28.43 -0.16%
S&P 500 2,109.60 -2.13 -0.10%
NASDAQ 5,076.5240 -6.4050 -0.13%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs