The Food and Drug Administration and pharmaceutical giant Merck have agreed on a "special protocol assessment" that will determine if the cancer drug oral deforolimus for patients with cancer of the body's connective tissue(s).

Merck and partner Ariad will begin patient enrollment for deforolimus later in September, with progression-free survival being the endpoint of the Phase III trial. The second endpoint? How about overall patient survival?

Since there are currently very few effective treatments for sarcoma cancers, my bet is that this new drug will be on the market the date the Phase III trial officially concludes.

It appears pharmaceutical giant Merck is wanting to get a larger piece of the cancer drug pie. The company iaspartnering with Ariad Pharmaceuticals to develop a new cancer treatment (in an experimental stage) with the potential to make the smaller Ariad over a billion greenbacks.

Genentech's Avastin has been selling like hotcakes lately, and the world is sure to see a slew of new-generation cancer drugs by 2010 if my crystal ball is correct. Right now, Ariad's experimental cancer drug -- known as 'AP23573' -- is helping define a new category of cancer drugs that block certain proteins and effectively "starve" cancer cells.

To the delight of both Ariad and Merck, AP23573 is on "fast track" mode for a quicker review (and most likely, approval) and it's also been set at a status by the FDA which promotes treatments for rare diseases.

Merck, maker of the cervical cancer vaccine Gardasil, is backing off its lobbying campaign following pressure from medical groups and parents who believe the vaccine should not be mandated as a school attendance requirement for adolescent girls.

The public outcry that caused Merck to announce its stop order on Tuesday stems from the fact that the vaccine protects against the sexually transmitted human papilloma virus (HPV), which causes cervical cancer. School-mandated vaccines are typically for diseases spread through casual contact, such as measles and mumps.

Merck's medical director for vaccines, Dr. Richard M. Haupt says, "We're concerned that our role in supporting school requirements is a distraction from that goal, and as such have suspended our lobbying efforts," adding that the company will continue providing information about the vaccine upon request.

Gardasil, launched in June and the first vaccine to prevent cervical cancer, has inspired controversy since day one. There's the cost -- $360 for three required shots -- and all sorts of insurance concerns and conservative groups who worry the vaccine encourages premarital sex and interferes with parental rights. Even those in support of the vaccine -- like the American Academy of Pediatrics and the American Academy of Family Practitioners -- question Merck's quick push to market this drug, especially in light of the company's withdrawn painkiller Vioxx.

"I believe that their timing was a little bit premature so soon after (Gardasil's) release, before we have a picture of whether there are going to be any untoward side effects," says Dr. Anne Francis, who chairs an American Academy of Pediatrics committee.

Legislatures in 20 states have taken steps to mandate the vaccine for young girls. And with the exception of Texas governor Rick Perry's February 2 executive order requiring Texas girls entering the sixth grade in 2008 get vaccinated, nothing has been made official so far.

Come September 2008, 11 and 12-year-old girls in Texas entering the sixth grade will receive three shots of the Gardasil vaccine used to prevent cervical cancer.

Texas is the first state to require that young schoolgirls receive the cervical cancer vaccine, approved for use by the FDA in June and proven to protect against the most common strains of the human papilloma virus (HPV) -- the cause of most cervical cases cervical cancers.

Texas governor Rick Perry (R), who just signed an executive order making this mandate official, believes the high cost of treating diseases and ensuring the health and well-being of our population justifies the vaccine requirement.

Perry, who has been met with opposition from those concerned that HPV vaccination of young girls promotes premarital sex and interferes with parental rights, will allow parents to opt out of the vaccination requirement with documentation citing religious or philosophical reasons. But he hopes most will comply with the cervical cancer vaccine he believes is no different than immunization against diseases such as polio.

Gardasil drugmaker Merck stands to make billions if the vaccine is made mandatory across the country. The series of three necessary shots cost $360.

Perry, who received $6,000 from Merck's political action committee during his re-election campaign, has other ties to the company. His former chief of staff is one of Merck's three lobbyists in Texas, and his current chief of staff's mother-in-law is state director for Women in Government -- a group active in introducing bills across the country that affect women.

The United Arab Emirates (UAE) is the first country in the Middle East to acquire the cervical cancer vaccine, Gardasil.

Comparisons of cervical cancer statistics for the years 1998 through 2005 show incidences of the disease tripling during this span of time. So acquisition of the vaccine is a true blessing for the women of this country.

"We are proud to have placed the UAE on the map with leading countries such as the US, Australia and EU by approving Gardasil, the first breakthrough vaccine that prevents the cancer," said Dr Wisam Haddadin, Franchise Manager, Gulf Region, Merck Sharp & Dohme.

Gardasil, distributed by Merck, Sharp, & Dohme, is now available in more than 33 countries for the prevention of cervical cancer, most commonly caused by HPV (human papilloma virus). About 2.3 million women are currently diagnosed with cervical cancer worldwide. About 800 women die of the disease every day.

United States drug company Merck hopes to offer the cervical cancer vaccine Gardasil to developing countries at much lower prices -- within months, if possible.

Currently, the three-dose vaccine is not affordable in the developing world -- where 80 percent of cervical cancer deaths occur and 95 percent of females have never had a Pap test . And while the exact discounted price has not yet been determined, Merck professionals report they are committed to slashing the price of Gardasil for these women.

Merck also aims to help developing countries receive drugs sooner. Right now, there is a time lag of 15 to 20 years between the approval of drugs in the West and the time they reach these countries.

Tampa's H. Lee Moffitt Cancer Center & Research Institute, the only comprehensive cancer center in Florida, has just partnered with Merck & Co., one of the world's largest drug companies, to develop personalized cancer treatments using a patient's genetic profile.

The two powerhouse entities will form a for-profit company called M2Gen on donated land near the University of South Florida. And in the span of just a few years, researchers plan to compile a database of tumor tissue and other medical information to determine why some patients respond to treatment while others do not. The database could house information on more than 30,000 patients within five years and will enable researchers to identify biological markers that could help doctors choose the most effective treatment based on the genetic make-up of each patient's tumor.

Blind treatment -- where everyone receives the same thing -- will be a thing of the past as tailor-made therapies replace the one-size-fits-all approach.

Florida Governor Jeb Bush says of the partnership that will create more than 170 high-paying jobs, "Man, I don't know if you can think of a better Christmas present than that."

A popular baldness drug manufactured by Merck & Co Inc called Finasteride, better know as Propecia, can mask an important marker used to detect prostate cancer. High levels of the PSA in the blood can signal prostate cancer or other problems such as an enlarged prostate.

Propecia has been shown in a study to artificially lower the prostate specific antigen (PSA). Dr. Anthony D'Amico, the lead author of the study from Brigham and Women's Hospital in Boston, recommends middle-aged men taking Propecia to have their PSA levels multiplied by two to account for the difference. He says, "The main finding is that this drug called Propecia, which men use for hair loss typically between the ages of 30-60, affects the PSA levels".

Merck said in a statement that information has been included for customers on the label since the product was first introduced in 1997. It advises patients who undergo serum PSA tests to tell their doctor if they are taking Propecia.

It may be on the label but I hope our doctors are aware of this. Are they asking the patients if they are using Propecia? I'm sure there are plenty of men who have not read the fine print and don't mention this information to their physicians.

Deep within the pages of ancient texts detailing the remedies used by Chinese medicine practitioners, is there a cure for cancer waiting to be rediscovered? The global pharmaceutical company Merck thinks there might be a reference or two to natural cancer-fighting products used by healers then that is obscurely hidden and not known now in modern western medicine.

Merck has entered into a deal with Hong Kong's Chi-Med to look for evidence of promising products that the pharmaceutical company can research and test in clinical trials. According to the article Merck looks for ancient Chinese cancer cure written by Susie Mesure, "Western pharmaceutical companies are increasingly outsourcing their drug discovery work, with many looking east for the solution to medical mysteries that Western doctors cannot solve."

Traditional Chinese Medicine, TCM, is a practice of medicine that combines medicinal herbs, nutrition, meditation, massage, exercise and acupuncture with an applied philosophy in the harmonious balance of yin and yang for treating illness. In all fairness, because this system of medicine has developed over thousands of years, and my understanding limited by Western educational influence, the definition I have given is a very brief, and possibly incomplete, overview of TCM. If you are interested in learning more about TCM, begin by visiting Traditional Chinese Medicine at Wikipedia.

Chi-Med will be scanning information in a library of 10,000 natural substances for those that might hold potential in a cure for cancer. It will be interesting what they find.

Lymphomas are cancers of the lymphatic system. There are two general types of lymphomas. Hodgkin's Disease, named after Dr. Thomas Hodgkin who first recognized the disease in 1832, and Non-Hodgkin's Disease (NHL). The difference between these two cancers is that Hodgkin's disease contains specific cells that are not seen in any other lymphomas. Non-Hodgkin's lymphoma is actually a group of about ten different types. One rare type of NHL is called cutaneous T-cell lymphoma (CTCL).

CTCL accounts for about one in twenty cases of NHL. It mainly affects the skin and can often mimic several skin disorders. It is caused by the uncontrolled growth of a type of white blood cell in the skin called a T-cell.

The Food and Drug Administration approved the drug Zolinza on Friday to treat cutaneous T-cell lymphoma. The FDA says drug should be used if there is a recurrence of CTCL or if the disease persists or gets worse with other medications.

Zolinza is thought to silence some genes that when left unchecked allow cancerous cells to grow. It is a new class of cancer drugs called histone deacetylase inhibitors. At the current time the cancer.gov website lists 36 clinical trials involving Zolinza alone or in combination with other drugs.

Merck & Co. Inc, the maker of Zolinza, plan on studying the drug as a tumor-fighting treatment for other cancers, including the breast and lung cancer.

Don't say I didn't warn you ahead of time we were going to hit this pothole on the cervical cancer vaccine road.  To briefly recap, last month I noticed Merck was running a television PSA, Tell Someone, in an attempt raise awareness about the virus that can lead to cervical cancer. Not once did it mention anything about the cervical cancer vaccine Merck was hoping to win FDA approval for -- and the same cervical cancer vaccine that will be available as early as next month. Let's remember this vaccine works best if administered to girls before they become sexually active. I mused that this was an intentional preemptive move on the part of Merck to the inevitable resistance from the Christian-right and other religious groups over a vaccine associated with sexual activity.

I predicted it was going to be a controversial issue and debate where sexual activity of teenage girls became the focal point and not the potentially life-saving cancer prevention vaccine. I was betting that the awareness-raising ad campaign from the drug company in the virus link to cervical cancer was an attempt to minimize the debate with an educational approach.

Sure enough, today I ran across a Reuters news article reporting just such an admission on the part of the drug company and discussion we will call the big bump in the road. Merck admits that its educational PSA was an effort to win over the Christian Right to the benefits of a vaccine to prevent cancer. Hang on to your seat -- we are coming up to the pothole.  Merck has revealed its plans to push for the vaccine as mandatory to school admission.

This is where the opposition from the Christian-right becomes more of an abyss than a pothole. The Christian Right feels the cervical cancer vaccine will lead to promiscuity and a false sense of security. Evangelical Christian groups, such as the Family Research Council and Focus on the Family, believe that it should be left up to parents to decide if their daughters are protected against cervical cancer by way of a vaccine. It's all about sex. It's all about the religious philosophies concerning sexual activity and eventually -- and sadly -- little to do with saving lives or preventing cancer.

Out of New Zealand comes reporting that four New Zealanders have suffered rotting jawbones after taking a bisphosphates medication prescribed to help prevent bone loss for patients suffering from osteoporosis and bone cancers. At least 15 Americans are suing Merck after developing breakdown of bone in the jaw due to taking Fosamax prescribed to strengthen bone and prevent bone loss.

According to the report, while the New Zealand patients were not taking the brand name drug, Fosamax, they were taking a similar version of the same drug. In total, about 2500 cases of rotting jaws have been reported. Merck is the same company who was forced to take Vioxx, an arthritis drug, off the market after a study showed it doubled the risk of heart attacks or strokes if patients took it for longer than 18 months. Perhaps we need to take a closer look into the medicine cabinet -- and start asking more questions -- before we rush to get a glass of water and down the newest approved pill. A new cancer drug is about to hit the market. Let's take a look.