Peter Fodor, MD: Liposuction

Peter Fodor on Liposuction

Originally post By Scott Hensley on the WSJ health Blog

Avastin for Breast Cancer: The Pre-History

Update, December 16, 2010

The FDA revoked the indication for Avastin to treat breast cancer.

December 11, 2007

The Wall Street Journal

Avastin for Breast Cancer: The Pre-History

An FDA advisory panel’s no-vote last week on Avastin for breast cancer prompted the folks at a Web site called the Healthcare Channel to crow about a video they posted earlier this year questioning the drug’s use in breast cancer. Full story and video found here

Pfizer’s CEO replaced

December 6, 2010

Pfizer’s CEO, Jeffrey Kindler, was abruptly replaced over the weekend. Many analyst believe that it was related to the poor stock performance, unsuccessful drug development, and bad acquisitions. In January of 2009, Mr. Kindler acquired Wyeth. The HCC was very critical of the move. The Fox Business discussion can be viewed below.

FDA Seeks Data on Arena Obesity Drug

The Wall Street Journal

By ALICIA MUNDY And GEORGE STAHL

The Food and Drug Administration said it cannot approve the obesity drug lorcaserin from Arena Pharmaceuticals Inc. because of potential safety risks and data showing the drug has a “minimal” effect on weight loss.

Arena, backed by a vocal group of investors, said it believes the drug still can be brought to market once the company supplies more data to the FDA.

But the FDA move again shows how high the regulatory bar is for obesity drugs. Another weight-loss pill, Vivus Inc.’s Qnexa, was rejected by an FDA advisory panel in July over concerns about long-term safety and is due for a decision by the FDA this week.

In early October, Abbott Laboratories pulled the appetite suppressant Meridia from the market at the FDA’s request. The agency cited concerns that the drug, first approved in 1997, could lead to heart attacks or strokes.

An FDA letter to Arena discussed the need for more positive data on lorcaserin’s long-term efficacy and concerns about an early study on rats that showed breast-tumor growth among the females, the company said.

“This is an important step for us toward the FDA’s approval of lorcaserin,” said Jack Lief, Arena’s chief executive. He added, “We will work with the agency to address the issues.”

The FDA wants Arena to hire an independent pathologist to re-evaluate the company’s data on the rat tumors. No study showed tumor growth in humans. If the review isn’t conclusive, the FDA could request more studies.

The FDA letter said that the current weight-loss data didn’t include diabetes patients. Arena will have initial results of a one-year weight-loss trial involving patients with Type 2 diabetes in a few weeks and will give full information to the FDA by the end of the year, the company said.

Some investors said they will continue to push for FDA approval of lorcaserin.

Shareholders have been conducting an unusually aggressive lobbying campaign to get Congress to intervene and urge FDA officials to approve the drug. The investors’ activism surged after an FDA advisory committee voted down the drug 9-5 in September, citing modest efficacy. Arena stock lost 73% of its value that September week.

The investors have been conducting their own detailed research on lorcaserin and have flooded the FDA with messages saying that the rat study was misinterpreted and the weight loss is more significant than the advisory panel judged. Arena says it isn’t involved in the investor campaign.

One shareholder, Ardeis Scott, said the FDA’s letter was a “fair response.” Dr. Scott, an emergency-medicine doctor in the Tampa Bay, Fla., area, added: “I have to feel the public outcry by investor groups played a significant role.”

Other observers were less sanguine. “The drug is delayed many years, if I had to guess, because of the safety issues and lack of good efficacy results,” said pharmaceutical-industry analyst Steven Greer of The Healthcare Channel video site.

The FDA didn’t release its letter to Arena and declined to comment on the letter’s contents. The company was set to hold a conference call Monday.

Obesity has been a difficult field for drug companies because the side effects of any drug need to be minimal due to potential long-term use by otherwise healthy patients. Lorcaserin, like other obesity drugs before the FDA, works by affecting the patient’s central nervous system to quell appetite.

Although the spread of obesity means the need is high, the area has been plagued with multiple disappointments and lackluster sales. No new treatments have been approved since 1999 in the U.S.

Write to Alicia Mundy at alicia.mundy@wsj.com and George Stahl at george.stahl@dowjones.com

William Boden, MD: discusses DTC TV ads for Cypher stents

May 15, 2008 Wall Street Journal, Scott Hensley

Stent Skeptic Blasts JNJ

Jessie Cheung, MD: Overview of treating face wrinkles with injections and fillers

December 23, 2008, 9:02 AM ET, Wall Street Journal

http://blogs.wsj.com/health/2008/12/23/economy-be-damned-im-getting-my-botox/tab/print/

Economy Be Damned: I’m Getting My Botox

Patients may be cutting back on some treatments amid the recession, but they’re not letting slimmer pocketbooks take their Botox away from them.

“It’s like comfort food,” says Maralyn Burr of Omaha, Neb., who in June lost her job as a district sales manager for Borders bookstores. With $140,000 in debt from her 22-year-old daughter’s musical education, Burr told the WSJ she’s slashed spending and all but stopped eating out. But she hasn’t given up her Restylane and Botox injections.

She’s not alone. Nearly three-quarters of plastic surgeons responding to a survey this fall said demand has increased or held steady for minimally invasive procedures, including the Botox anti-wrinkle drug, dermal fillers used to plump up lips and smile lines, and skin-smoothing chemical peels, according to the American Society of Plastic Surgeons. At the same time, the survey found a steep drop in demand for plastic surgeries such as breast augmentation and nose reshaping. (See this post from early this year, which took note of a similar pattern.)

Patients may be scrimping on big-ticket procedures but appear to be ponying up a few hundred dollars now and then for injections.

Even so, the companies that make these products aren’t brimming with confidence. Allergan, which makes Botox, cut its 2008 guidance for the product, citing overall “subdued demand,” and Medicis recently has been offering a $100 consumer rebate on its Restylane antiwrinkle products.

Botox Bonus: For more info on the non-surgical alternatives for improving the appearance of your face, see this video with NYU dermatologist Jessie Cheung.

Robert Litchfield, MD: Knee arthroscopy for arthritis

September 10, 2008

The New England Journal of Medicine has an important landmark study comparing the use of knee arthroscopy and physical therapy for Osteoarthritis pain. This study was designed to answer controversies of previous negative trials.