The tenure of Dr. Lester M. Crawford as FDA Commissioner was a short one, with his resignation in September coming less than three months after his confirmation.

Dr. Crawford’s stay at the FDA as deputy commissioner, acting commissioner, and then as commissioner was never without controversy and his critics inside the agency, in Congress, and among consumer advocates often accused him of making decisions based on political considerations and not on medical or scientific grounds.

The inordinate (three-year) delay in acting on Barr Laboratories’ application to approve the over-the-counter (OTC) sale of the emergency contraceptive Plan B was seen by many as being driven by politics, although Dr. Crawford maintained his actions were motivated solely by scientific and legal considerations.
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The FDA has announced the approval of “a biologics license application (BLA) for Myozyme (alglucosidase alfa, rhGAA), the first treatment for patients with Pompe disease, a rare but severely debilitating disease. Pompe disease, which affects one in 40,000-300,000 individuals, drastically reduces a person’s muscle and respiratory function.”

Myozyme had been granted FDA “Orphan Drug” designation and was approved under a priority review. Myozyme is manufactured by Genzyme Corp. in Cambridge, Massachusetts.

So-called “orphan” products are developed to treat rare diseases or conditions that affect fewer than 200,000 people in the U.S.
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A review of records for the past 10 years indicates that the Consumer Product Safety Commission (CPSC) has announced eight recalls for various types of TV tables or TV stands that had the potential of allowing an unstable television to fall onto children thereby causing serious injuries or death.

Eight recalls between 1995 and 2006 for over 3 million such products contained reports of everything from relatively minor injuries to fractured skulls and deaths to young children as the result of being crushed under falling television sets.
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By Steven DiJoseph

The saga of the class of drugs known as COX-2 inhibitors has provided an ongoing glimpse into a number of aspects of the multi-billion dollar pharmaceutical industry. These so-called “super aspirins,” were seen by critics as over-priced painkillers that worked no better than older, safer, and far less expensive drugs. Supporters viewed them as safe and effective drugs that were easier on the stomach than other pain medications.

The three main COX-2s (Celebrex, Vioxx, and Bextra) quickly reached “blockbuster” status and produced billions of dollars in annual sales for Pfizer (Celebrex and Bextra) and Merck (Vioxx). Massive direct-to-consumer (DTC) marketing campaigns, featuring everything from celebrity spokespersons to classic rock and roll music, kept the drugs in the public eye on a 24/7 basis.

Between January 2003 and June 2004 alone, Merck & Co. spent almost $123.9 million dollars in DTC advertising to persuade the public that Vioxx offered safe and effective treatment for acute and chronic pain associated with osteoarthritis, primary dysmenorrhea (moderate to severe menstrual pain), and other problems.
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By Steven DiJoseph

No sooner had the ink dried on a Wall Street Journal report that Bausch & Lomb had learned of eye infections linked to its ReNu With Moisture-Loc from Hong Kong health officials in November 2005, than the timeline was moved backward yet again.

While Bausch & Lomb claims that the November time frame was the very earliest it knew of a potential problem, it now seems that, once again, the company may have been guilty of the cardinal sin of product recalls, delay and misinformation by the manufacturer.

The number of suspected or confirmed cases of Fusarium keratitis fungal eye infections in the U.S. has risen to 186 in 29 states according to the Centers for Disease Control and Prevention (CDC).
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The now infamous black skyscraper was once an integral part of the Wall Street financial district standing in the shadow of the twin towers of the World Trade Center (WTC). Then came September 11, 2001 and, from that day on, all references to the Deutsche Bank building at 130 Liberty Street have had disturbing implications.As the south tower of the WTC collapsed, the debris from that massive structure crashed into everything in the surrounding area including other smaller buildings. One of the most striking images from that catastrophe was the 40-story Deutsche Bank building being ripped open and laid bare by a huge section of the south tower as it plummeted to the street below.
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The Consumer Product Safety Commission and Selected Trading Corp. of Miami, Florida, have announced the voluntary recall of about 55,000 Children’s Necklaces manufactured in China that pose a danger of lead poisoning to children. Consumers should stop using recalled products immediately.

The recalled necklaces contain high levels of lead, posing a serious risk of lead poisoning and adverse health effects to young children. No injuries have been reported, however.
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At about the same time pharmaceutical giant Merck will be entering its second year of trials in the massive Vioxx litigation consisting of some 12,000 cases, Wyeth, another major drugmaker, will be starting the first trial involving its menopausal treatment, Prempro.

It is estimated that there are over 4,000 Prempro lawsuits pending and only the overwhelming number of Vioxx actions makes that figure look small. After all, everything is relative.

Nonetheless, the Prempro litigation promises to be quite expensive for Wyeth, which was known as American Home Products when it agreed to settle litigation arising from its diet “cocktail” fen-phen for $3.75 billion in 1999.
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A report by the Commonwealth Fund, a private, health care policy foundation has found that there has been a significant rise in the percentage of moderate- to middle-income working age Americans who did not have health insurance for some part of the year.

In 2001, the figure was 28%. In 2005, however, that figure soared to 41%. In addition, over 50% of the uninsured adults claimed to be having difficulties paying for their medical care directly or in repaying credit debt incurred to make those payments.
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The Consumer Product Safety Commission and Hoist Fitness Systems, Inc. have announced the voluntary recall of about 48,000 Hoist Exercise Benches manufactured in China. Consumers should stop using recalled products immediately. Hoist Fitness Systems Inc., also does business as Body Gear, of San Diego, California.

The bench’s front frame assembly (with the foot rest) can fail to lock into place allowing users who grab the bench to position themselves to get their fingers entrapped between the front and back frame assemblies. This poses laceration and amputation hazards.
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