Millions of people suffer from severe, debilitating acne that does not respond to over-the-counter treatments such as acne washes and benzoyl peroxide, and even resists prescription antibiotics. Ongoing severe acne can cause physical effects such as pain, infection, and scarring, and social and emotional effects such as shame and low self-esteem. According to the Acne Resource Center:

Of the 85% of teenagers (between the ages of 12 and 24) that suffer from acne, 25% will have permanent scars ranging from severe to light. The American Dermatologist Association finds that:

• 20% of all adults have active acne
• 60 million Americans have active acne
• 20 million Americans have acne badly enough to cause scars.

Acne affects people regardless of age, gender or race. While thoroughly treatable, of those who suffer from acne:

• 11% will see a physician
• 20% will go to a skin care center
• 30% will use an over-the-counter medication from a drug store or pharmacy
• 40+% will do nothing

The concept of 40% of sufferers doing nothing is tragic. Since 1982, we have had access to a prescription drug that treats serious cases of cystic or nodular acne. That was the year isotretinoin, under the trade name Accutane, was approved by the FDA for the treatment of severe acne. Its exact mechanism is not known, but it is thought to limit the production of sebum. Most patients see significant improvement, or remission, after a 15-to-20-week course of treatment with isotretinoin.

The drug was controversial from the start, as it is known to cause teratogenic birth defects. All physicians and patients involved with this treatment must abide by a strict pregnancy risk-management program. Isotretinoin has some other serious side effects, too. Mild side effects involve skin dryness and eye dryness, rashes, headaches, hair thinning, and backaches. More serious side effects include inflammatory bowel disease, alopecia, catacracts, blood glucose problems, and more. Because of these side effects, it is only recommended to treat the most severe cases of disfiguring acne, and patients must pay close attention to side effects.

Availability of the drug has changed this year, resulting in some confusion in consumers. Earlier this year, in July 2009, Swiss drugmaker Roche announced that it was discontinuing its sales of Accutane and moving to delist with the FDA. This was not done for safety and efficacy reasons (although Roche has had to defend itself in many lawsuits), but rather because generics of Accutane (isotretinoin) have been available since 2002 and now dominate the market. Accutane itself had only held on to a 4-5% share of market, and it did not make business sense Roche to keep selling it.

Accutane is still available in many countries outside of the United States. Within the United States, its generic form, isotretinoin, is available, and this drug is also marketed as under several different names within the United States: Claravis, Amnesteem, Sotret are a few of the best-known.

Accutane being retired in the U.S. has caused a great deal of confusion among consumers. Posts on many popular acne-related message boards reveal people trying to compare side effects and benefits of several different brand names that are all essentially isotretinoin. To clarify: there is no difference between Accutane, Sotret, Claravis, or generic isotretinoin except for their makers and packaging.

If your doctor has prescribed a cream instead of a pill, topical isotretinoin is marketed under the trade name Isotrex.

If you are one of the millions suffering from acne, know that you do have options, and your condition can improve.

Earlier this month, a closely-watched trial over the osteoporosis drug Fosamax ended in mistrial, to the frustration of nearly everyone involved. The trial was marked by great tension, with a deadlocked jury, reports of threats of physical violence, and a judge-ordered cooling-down period.

What could cause such intense drama? Well, this was just one of approximately 900 state and federal cases pending against Fosamax, alleging that that medication causes osteonecrosis of the jaw (the death of jawbone tissue). In large part, the tension in the Manhattan courtroom was that this trial — the first — was supposed to be an indicator of how these hundreds of similar cases might proceed. The other major factor is that it is notoriously difficult to “prove” drug-related injuries, and this difficulty was definitely shown in the frustration and tension among jury members.

Millions of women have taken Fosamax (alendronate), a Merck drug that was approved in 1995 to treat osteoporosis associated with menopause, and in 1997 to prevent osteoporosis itself. Until the recent introduction of some competing medications, it was one of the most popular drugs in the U.S. It is still prescribed millions of times per year to women suffering from bone loss.

In short, Merck’s defense on this topic is that there is no definitive evidence that Fosamax causes the death of jaw tissue, while plaintiffs and their lawyers insist that Merck overpromoted Fosamax without warning doctors about the potential for jaw injury. Obviously, no conclusions were reached.

Of course, this is of great interest to women who may have taken, or are considering taking, Fosamax. Only your doctor can decide what is the right choice for you, but we thought we would enumerate the other medications available for treating osteoporosis for those doing research on Fosamax alternatives. One very important thing to be aware of it is that Fosamax is not the only osteoporosis drug in this class (the bisphosphonates), which all have a similar mode of action. Fosamax is being talked about most in the media, but all are associated with some amount of risk of damaging the jaw.

If you do choose to take a bisphophonate, know these facts:

• A high proportion of jaw injuries occur following high-dose intravenous administration, so that is a particularly risky way to take the medication.
• As many as 60% of the cases are preceded by a dental surgical procedure involving the jaw. In short, women who are expecting major dental work should consider delaying treatment with Fosamax, Boniva, Actonel or similar drugs until after their dental surgery.

Here are the main alternatives on the market for Fosamax:

1. Actonel (risedronate) is a bisphosphonate manufactured and marketed by Procter & Gamble and Sanofi-Aventis. It belongs to the same family of drugs as Fosamax, and may be associated with the same jaw side effects.
2. Boniva (ibandronate) is also a bisphosphonate, manufactured and marketed by GlaxoSmithKline and Roche Laboratories. It is a competitor to Fosamax, and may also affect the jaw tissue.
3. Evista (raloxifene) is NOT a bisphosphonate , but rather an oral selective estrogen receptor modulator from Eli Lilly and Company that affects bones through estrogen. Evista may be an interesting alternative for women concerned about their jaw health or planning oral surgery.

Also this month, The Wall Street Journal published an article called “From the Osteoporosis Front, Updates on Potential New Drugs.” These are the up-and-comers in clinical trials and going before the FDA. The story covers the latest news about Wyeth’s Viviant, Pfizer’s Fablyn, Amgen’s denosumab, and other upcoming treatments for osteoporosis.

If you are interested in following the Fosamax case that ended in a mistrial, it is expected to be re-tried in the spring. The name of the case is “In re Fosamax Products Liability Litigation, U.S. District Court, Southern District of New York (Manhattan), No. 06-1789.”

This documentary trailer specifically references the Vioxx scandal — but it serves as a general reminder of the toxic relationship between the FDA and Big Pharma. Check it out:

According to Reuters via Pharmalot, Roche Pharmaceuticals is

expected to post a 33 percent increase in full-year net profit for 2006 to 9.11 billion Swiss francs ($7.33 billion), according to the average of a Reuters poll of 15 analysts. Sales are seen up 17 percent at 41.65 billion francs, with drugs sales 21 percent higher at 32.94 billion francs.

A strong demand this winter for Roche’s flu vaccine Tamiflu is one reason for the higher-than-expected earnings.