A Troubling Trend: Genital Herpes Infections are on the Rise

While studying the pathogenesis of Neisseria gonorrhoeae in Portland, OR in the early 1980s, genital herpes had replace gonorrhea as the scourge of the sexually transmitted disease community. To help to combat the spread of genital herpes, my labmates and I joined the Portland Venereal Disease Action Committee, a grass roots organization that provided public outreach and education about sexually transmitted diseases (STDs). A few years later, the Regan Administration finally admitted to the American public that HIV/AIDS was real and that HIV infections were likely to reach epidemic proportions. While genital herpes can be painful, uncomfortable and often emotionally debilitating, the unprecedented morbidity and mortality of HIV/AIDS almost pushed genital herpes into infectious diseases obscurity. Now that HIV/AIDS is more treatable than ever before, epidemiologists and sexually transmitted diseases experts have begun to reexamine the infection rates and incidence of other STDs (including herpes, gonorrhea, Chlamydia and syphilis) among Americans. To that end, I read today a very troubling article about the infection rates and incidence of genital herpes among sexually active Americans. Here are some of the facts gleaned from a recent CDC report on genital herpes:

  1. One in six Americans aged 14 to 49 are infected with genital herpes, making the virus — herpes simplex 2 — one of the most common sexually transmitted diseases in the United States
  2. Research shows that people with genital herpes are two to three times as likely to acquire H.I.V. as those without herpes
  3. H.I.V.-infected individuals also infected with genital herpes are more likely to transmit H.I.V. to others
  4. Infection rates for women are almost twice the rate of men
  5. Blacks are three times as likely to be infected as whites
  6. Black women have the highest rates of infection, with almost half infected

Looking back, it is understandable why HIV/AIDS took precedent over genital herpes infections. After all, most people usually don’t die from genital herpes. However, the rising infection rates of the disease suggest that the American public needs to be better educated the spread and prevention of genital herpes infections. There is no question that discussions about STDs are embarrassing and often difficult. However, these days, they can be the difference between live and death!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

 

The Curious Case of Wrinkles, Botox and FDA

One day after the US Food and Drug Administration (FDA) approved Dysport, a new product that will compete with Botox, the agency ordered that labels for all botulinal toxin-based drugs must carry a black box safety warning. For those of you who may not know, that is the most stringent kind of safety warning label—viewed by many in the industry as “the kiss of death”— that the agency can order to appear on the products that it regulates. 

Black boxes (literally a black box with bold-face risk information) are typically reserved for medications that are know to have serious or life-threatening side effects or risks. For example, many antidepressants—most recently serotonin re uptake inhibitors (SRIs)—carry black box warnings of increased danger of suicidal thoughts and actions. 

Over the last 20 years FDA approved Botox to treat crossed eyes, eyelid spasm, severe underarm sweating and cervical dystonia (a painful and severe neck condition that can cause an abnormal head position) Cosmetic Botox was approved to treat skin folds and wrinkles in 2002. Allergan, the company that manufactures Botox, reported $1.3 billion in worldwide sales of the drug in 2008. 

Botox and Dysport are injectible products made from the highly paralytic toxins produced by the bacterium Clostridium botulinum. Botulinal toxins interfere with muscle contractions and patients with botulism food poisoning exhibit what is known as “flaccid paralysis.” Afflicted individuals cannot breather and will die without early intervention. FDA order the black box safety warning labels because there were numerous reports of serious health problems, complications and deaths caused by the drug spreading from the site of injection to other parts of the body. 

Most of the problems with Botox resulted from the overuse of Botox for unapproved treatments like limb spasticity in children with cerebral palsy (although misuse of the product for cosmetic purposes may have also contributed to the problems). The agency will now require that all botulism-based products carry a black box warning explaining that the medication has the potential to spread from the site of injection to other body sites—with the potential to cause serious problems like difficulties swallowing or breathing. Also, it will require manufacturers of botulinal products [Allergan (Botox) and Ipsen/Medicis Pharmaceuticals (Dysport)] to send physicians letters warning of the risks and to craft medical guides given to patients at the time of injection. 

The new warning labels will likely do little to discourage the rampant use of Botox and Dysport for cosmetic indications. After all, beauty will always come before safety! 

Until next time... 

Good Luck and Good Job Hunting (looking younger may help)

 

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FDA Adds Black Box Safety Warning to EPO Drugs

Amgen announced today that US regulators added black box warnings to its erythropoietin drugs, Epogen and Aranesp. Similar warnings were also added to Johnson and Johnson’s Procrit which is licensed from Amgen. For those of you who don’t know, getting a black box warning on a drug label is like getting the “kiss of death” from a marketing and sales perspective. It certainly will not help sales of these products!

The new warnings approved by the Food and Drug Administration warn that the company's drugs increased death and accelerated tumor growth in patients with several types of cancer, including breast and cervical. Prior labeling warned of similar risks in other types of cancers.

The actions taken by the agency were not unexpected but suffice it to say there are a lot of unhappy Amgen and Johnson & Johnson employees in a Thousand Oaks, CA and New Brunswick, NJ

Until next time….

Good Luck and Good Job Hunting!!!!!!!

Hot Off the Press: "May Cause Heart Attack" Added to GSK's Avandia Label

The FDA ruled today that GlaxoSmithKline’s blockbuster diabetes drug Avandia will now carry as part of its label a warning advising that its use might raise the risk of suffering a heart attack.

A black box warning is the sternest warning a drug can carry and still remain on the market in the U.S. Avandia already carries a black box warning advising it could cause or exacerbate congestive heart failure in some patients.

With 2006 sales of almost $3 billion, Avandia has been a major revenue driver for Glaxo.

Look for continued corporate right sizing at GSK through 2008.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!