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Arsenal of Antibiotics Not Being Restocked
One sunny April morning six years ago, an 18-month old curly-haired toddler woke up with flu-like symptoms. By afternoon he was struggling for breath and went into septic shock. Hospital physicians gave him intravenous antibiotics, but the drugs failed and he was dead by the afternoon of the next day. He was the victim of a highly drug-resistant bacterium, MRSA.
We have come to expect that we can cure just about any infection; however, as we all know, bacteria can evade the drugs in our arsenal, and that arsenal is not being replenished with new antibiotics.
Drug companies seem to be abandoning the research and development of antibacterials, citing high development costs, low return on investment and, increasingly, a nearly decade-long stalemate with the FDA over how to bring new antibiotics to market.
Soon we could be defenseless against bacteria that can resist all existing antibiotics, which would mean more victims like Simon-dead from a staph infection that drugs used to conquer easily.
There is a regulatory impasse over whether drug companies seeking FDA approval for antibiotics should be required to run much more stringent clinical trials. The FDA says there are advances in the science of clinical trial design and they don't want to approve products that don't work.
However, the pharmaceutical industry and some infectious-disease specialists say the proposed rules will make it so difficult and expensive to gain approval for new antibiotics that the few remaining companies will abandon the field altogether.
http://articles.chicagotribune.com/2010-08-06/health/ct-met-antibiotics-crisis-20100806_1_
antibiotics-clinical-trials-fda-approval
Medicare's Fraud Cases Get Cold
The private sleuths hired by Medicare to investigate fraud don't seem to be that interested in hot pursuit. Many cases go cold, making it difficult to catch the perpetrators, much less recover money for taxpayers. A recent IG report revealed that out of $835 million in questionable Medicare payments identified by private contractors in 2007, the government was only able to recover some $55 million, or about 7 percent. It takes an average of six months for these companies to refer cases of fraud to law enforcement.
http://www.pharmacistelink.com/index.php/healthcare-legislation-regulation/21671
Pharmacogenetics Guidelines Available
The National Academy of Clinical Biochemistry has new guidelines that address the use of pharmacogenetics, including therapeutic drug monitoring, in clinical settings. The document describes the pharmacogenomics of drug metabolism at the population level and gives rationales for genotyping to guide the use of warfarin, tamoxifen, atomoxetine, abacavir, and irinotecan.
http://www.aacc.org/members/nacb/LMPG/OnlineGuide/PublishedGuidelines/
LAACP/Documents/PGx_Guidelines.pdf
J&J Discloses More Subpoenas Over Consumer Recalls
J & J has disclosed that they have received multiple subpoenas from federal prosecutors related to repeated recalls of Tylenol and other consumer health products. The grand jury subpoenas request "documents broadly relating to" both the recent recalls of products made by McNeil Consumer Healthcare and inspections of two of the unit's factories.
The Fort Washington, Pennsylvania plant has been shut down since April due to multiple problems and is expected to remain shut until at least next summer.
The Lancaster, Pennsylvania plant is operated by a joint venture called Johnson & Johnson (J&J)/Merck Consumer Pharmaceuticals Co. The FDA inspectors noted many severe problems after spending 12 days there, from not following rules for manufacturing quality to poor record-keeping.
The New Brunswick, New Jersey-based J&J has been under scrutiny by Congress, FDA officials, and others for eight recalls since September covering tens of millions of bottles of pain reliever Tylenol and other popular nonprescription medicines. The recalls also include some liquid medications for children.
The manager of the Fort Washington plant has since been fired, 300 of the 400 workers there will lose their jobs shortly and the fiasco led J&J to sharply reduce its 2010 profit forecast.
A recent July 21 FDA report on inspections at the Lancaster factory in the past month indicates a pattern of ignoring rules for manufacturing and quality, failure to investigate problems that could affect the composition of products, carelessness in cleaning and maintaining equipment, and shoddy record-keeping. In some cases, medicine batches made during equipment failures were not checked for quality. That factory makes nonprescription heartburn medicines Mylanta and Pepcid, plus Imodium for diarrhea.
http://www.google.com/hostednews/ap/article
/ALeqM5gKNufIGxLdxRyZ8TPAzFIe83oA1gD9HHH0UG0
Another Unintended Results of a Congressional Bill
Family and friends have suddenly found themselves blocked from shipping cigarettes and other tobacco products to American troops in Afghanistan and Iraq because of a new law meant to hamper smuggling and underage sales through the mail.
The Prevent All Cigarette Trafficking Act of 2009 quietly took effect June 29. It cut off those care packages by effectively requiring that tobacco be sent with one particular kind of U.S. Postal Service shipping that requires a signature for delivery but does not deliver to most overseas military addresses.
Many soldiers do not have easy access to the stores on some Afghanistan bases that sell cigarettes and many do not keep a lot of cash while deployed; so, the only way they have to get cigarettes is through family members.
The law was created to prevent minors from ordering cigarettes through the mail and to prevent trafficking by requiring tracking and confirmation that the recipient is of legal age. It allows small shipments of tobacco products, but only via Express Mail because that's the only postal service product that meets the identification requirements under the law.
The issue is that Express Mail is not available to some overseas military destinations, primarily Iraq or Afghanistan. Families don't have any other options for shipping cigarettes. The law only affects the U.S. Postal Service because UPS and FedEx do not allow consumer-to-consumer shipping of tobacco.
The bill's sponsor said that the law did not intend to restrict mailing tobacco to soldiers, and they are looking for a resolution to the problem.
http://www.google.com/hostednews/ap/article
/ALeqM5ja-MWXjaW4gYKCXlY8rHboRpUUgD9HGK09O0
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