The FDA has admitted that it was under a great deal of political pressure to approve ReGen Biologics Inc.s Menaflex knee device designed to repair torn meniscus.
After the FDA had rejected Menaflex for its 510(K) approval process (no human clinical trials necessary) three times, two US Senators lobbied the FDA to approve the medical device. Both US Senators from New Jersey Frank Lautenberg and Robert Menendez as well as US Reps. Steve Rothman and Frank Pallone, Jr. called the FDA in 2007 and 2008 in order to encourage them to approve Menaflex. The medical device was approved in spite of 3 previous rejections.
Due in part to the media report, the FDA is now reviewing the process by which Menaflex was approved. That process may take months but will consider whether the medical device should remain on the market.
The revelation of Congressional influence at the FDA may be surprising to some since members of Congress, especially Iowa’s Charles Grassley, have been pushing for more transparency in influence peddling regarding the approval of medical devices and pharmaceutical drugs.

Earlier this month, Salix Pharmaceuticals, Ltd. received approval to begin marketing its new Metoclopramide drug to treat diabetic gastroparesis and gastroesophageal reflux disease (GERD). However, unlike the brand name version of the drug, Reglan and its earlier generic counterparts, this new metoclopramide drug will be required to carry the strongest FDA warning, a black box warning which advises physicians about the drug’s dangers and association with the permanent movement disorder tardive dyskinesia. The new drug will also advise physicians and healthcare professionals that the drug should not be taken for a period longer than 12 weeks to avoid any onset of the neurological disorder tardive dyskinesia.
Earlier versions of the drug did not carry such a warning and patients that have contracted the permanent disorder have filed Reglan lawsuits against the manufacturers of both Reglan and the various generic equivalents known as metoclopramide.

The defective Chinese drywall that has plagued many Florida homeowners as well as homeowners from 26 other states has caught the attention of Inez Tenenbaum, newly appointed head of the Consumer Product Safety Commission.
Earlier this week, the CPSC chief was in Florida on an inspection tour of homes affected by the Chinese drywall problem. She was able to see first-hand the devastation wrought by the defective drywall. During her tour, she accepted Senator Bill Nelson’s contention that the federal agency hasn’t acted fast enough to come to the aid of ailing homeowners.
Tenenbaum also stated that a Chinese drywall recall will not be issued because it’s not practical or effective since not all of the drywall has caused damage to residences. However, she did say that her agency would put together a remediation plan. Her agency has received 1,311 Chinese drywall complaints so far. Some of those complaints have chosen to file lawsuits which are now consolidated in a multidistrict litigation in the US District Court, Eastern District of Louisiana.

Zicam lawsuits may be consolidated into an MDL. The U.S. Judicial Panel on Multidistrict Litigation will consider whether to consolidate the lawsuits against the manufacturer of Zicam, Matrixx Initiatives on Thursday of this week.
On June 15, 2009, FDA officials warned consumers to stop using Zicam nasal gel and swabs because they had received reports that Zicam users had lost their sense of smell. According to the FDA, at least 130 reports of smell loss have been filed with the FDA.
According to the lawsuits, the loss of the sense of smell has been linked to Zicam’s active ingredient, zinc gluconate. Until the complaints were made public, Zicam had not drawn the scrutiny of the FDA since the nasal swabs and gels were considered homeopathic remedies.

Lawsuits against manufacturers of denture creams are being filed in an MDL (multi district litigation) in Miami, Florida. The lawsuits have been sparked by a chemical interaction between zinc and copper. Zinc, an ingredient in the denture cream, helps the adhesive qualities of the cream but also depletes the body’s copper supply. The lawsuits filed against Proctor & Gamble, the maker of Fixodent and GlaxoSmithKline which makes Poligrip, claim that the denture creams are defective in that their chemical composition leads to the copper depletion. Copper depletion can cause neurological problems and deficiencies. The lawsuits claim that the companies’ failed to warn consumers of the potential health issues related to their products.
According to the Associated Press, “A copper deficiency can cause nerve damage, resulting in symptoms such as weakness and numbness in arms and legs; difficulty walking and loss of balance; and even cognitive or memory impairment, according to the National Institutes of Health.”

As the Diocese of Bridgeport prepares for the Supreme Court’s verdict on whether the sexual abuse documents remain sealed, the Bishop of the diocese is preparing his priests to deal with the worst case scenario. It appears to be an odd strategy since most of the documents have been discussed in media reports of the sexual abuse lawsuits against priests in the Diocese of Bridgeport. In fighting the release of the documents, Bishop Lori’s actions have had the exact opposite of his desired effect. In fighting the release of the documents all the way to the Supreme Court, he’s actually drawn more attention to them. Lori insists he’s fighting to protect those who’ve been falsely accused but one has to wonder about his tactics. Those who’ve been erroneously accused will show up as such in the documents. No further argument needs to be made about it. His obsession and tireless efforts at preventing the public disclosure of the abuse papers only serves to increase the public’s interest in them. It’s a curious strategy for an obviously capable bishop to take. Even if the Supreme Court agrees and orders the documents to remain sealed, the public will have questions about what is contained in those documents.
If the Catholic Church is serious about reform and true renewal, why not release the documents and let the public view them? Why continue the cover-up?

Promethazine, a sedative used to treat such conditions as nausea and vomiting, has received a black box warning (the strongest available) from the FDA. The warning comes after the sedation drug has been linked to a higher risk of amputation. The drug’s brand name Phenergan was involved in a highly publicized Supreme Court case earlier this year. Wyeth Pharmaceuticals, the maker of promethazine, will have one month to created the wording for the black box warning.
According to an Associated Press report, “The FDA said Wednesday that makers of generic promethazine will have to put a “black box” warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene.
The FDA said promethazine should be injected deep into muscle, never into an artery or under the skin and, when given intravenously, it should be done slowly and at a low concentration. That’s because the drug can leach out of a vein and seriously damage surrounding tissue.”

As a result of its March 2009 inspection of Bayer’s German plant located in Bergkamen, the FDA has sent the pharmaceutical company a warning letter concerning its quality control procedures at the manufacturing plant.
The FDA letter warned, “”We remain concerned with your released and distributed API batches used in the manufacture of finished products intended for the U.S. market.” While Bayer downplayed the issue, company spokeswoman did say they were taking steps to address the concerns delineated in the warning letter. Bayer was also quick to state that the substance of the warning letter revealed no consumer safety threat. “Based on our assessment at this point in time, we have identified no safety and efficacy impact on our products in relation to the (good manufacturing practice) issues as cited by the FDA,” Bayer spokeswoman Rose Talarico said in an emailed statement.

Tysabri was pulled from the US market in 2005 after the MS drug had been linked to a rare but dangerous drug infection, progressive multifocal leukoencephalopathy (PML). Biogen, Tysabri’s manufacturer has revealed that 11 brain infection cases have been linked to Tysabri since the drug came back on the market in 2006. Both cases come from Europe.
While Tysabri has been known to successfully treat the symptoms of multiple sclerosis, prolonged use of the drug has been associated with PML. The New England Journal of Medicine reported the latest 2 brain infections and noted a study by Dr. Igor Koralnik of Harvard Medical Center that showed an increase in the virus that causes PML in patients that took Tysabri for a year or longer.
Tysabri, marketed jointly by Biogen and the Irish company Elan Corp Plc, is popular with MS patients as well as doctors. It’s estimated that some 43,000 patients are currently using the drug. Tysabri is an important drug in the Biogen family of pharmaceuticals and has been responsible for a large part of the company’s profits so it comes as no surprise the company is downplaying this latest New England Journal of Medical report.

Dietary supplements was the focus of a lengthy article in the Wall St. Journal a few weeks ago. The report was highly informative and offered the consumer ways in which dietary supplements could be checked. After reading the article, I came to the conclusion that it would take hours of research to determine that a dietary supplement was safe. Actually, the article said that after doing the proper research, one could be reasonably certain a substance was safe.
This is disturbing since most of us conclude that products sold in health food stores such as GNC are safe and healthy for consumption. Even if we read the product’s label we can’t be certain that the product is safe since we don’t always know how natural ingredients react in combination with other natural ingredients. The labeling may not even be accurate.
If you think I’m exaggerating ask Philadelphia Phillies pitcher JC Romero who was suspended late last year for using banned substances. Romero swears he was suspended after consuming dietary supplements purchased at a New Jersey GNC store.
The problem with dietary supplements and so-called natural products such as kava kava concerns the fact that these so-called natural products aren’t regulated in the same fashion as prescription drugs.
In the last nine months, the FDA has issued more than 70 warnings concerning the potentially dangerous side effects of natural products including dietary supplements and weight loss products. It’s a growing problem with no solution being offered at the present time.