Encouraging Health

Despite doubts surrounding HPV vaccine Gardasil’s medical and cost benefits, Merck wants to market the drug to women over the age of 26

A recent study reported that vaccinating older women against the human papillomavirus (HPV) can be effective in significantly reducing the rate of cervical cancer, prompting pharmaceutical company Merck & Co. to seek to expand marketing of its drug to an older demographic.

Using a mathematical model, researchers at the University of Alabama concluded that vaccinating women by ages 12 through 45 could cut cervical cancer rates up to 55 percent for 45-year-old women. The mathematical model assumed a 100 percent vaccination rate against HPV, which causes most cases of cervical cancer.

Gardasil, a vaccination developed by Merck, protects against HPV strains 16 and 18, which lead to approximately 70 percent of all cervical cancer cases. The virus also protects against HPV types 6 and 11, which cause genital warts.

The vaccination has been approved by the FDA for women ages 9 through 26 but doesn’t protect anyone who has already been infected with HPV. “The thinking has been that girls must be vaccinated before they are sexually active, because HPV is so common,” reported Reuters.

But Merck now wants to target an older market after the number of Gardasil vaccinations went down nearly 35 percent in July and August. Merck seeks to garner sales from women who have not typically used the vaccine. According to Bev Lybrand, Merck’s senior vice president of vaccines, “We see tremendous opportunity. We have a number of programs under way to get after these women.”

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A COMMON form of testicular cancer can be cured with a single jab of chemotherapy, researchers revealed yesterday.

Carboplatin – currently often used to treat ovarian and lung cancer – could replace the need for radiotherapy in men with early-stage seminoma.

Experts say the drug is a “safer cure” for the cancer, with fewer long-term health risks.

Up to 45 per cent of testicular cancers are classed as early-stage seminoma amounting to between 780 and 880 cases in the UK each year.

In the largest ever trial involving this form of the disease, a single carboplatin injection was used to treat 573 patients with early-stage seminoma.

The results were compared with 904 men given two or three weeks of daily radiotherapy – the current standard treatment.

Those patients given carboplatin experienced fewer side-effects and were able to get back to their normal lives quicker than the men on radiotherapy.

Of the 573 patients given carboplatin, only 5 per cent relapsed – but none of the men died from their cancer following further treatment.

Men with seminomas usually have the testicle removed where the cancer occurred. In one in 20 cases, the other testicle also develops cancer. Those treated with carboplatin were less likely to develop cancer in the other testicle.

Only two out of 573 developed cancer in the other testicle, compared with 15 out of 904 patients treated with radiotherapy.

Side-effects of radiotherapy can include sickness and tiredness in the short term, with more serious long-term problems such as swelling and fibrosis, when tissue becomes less stretchy due to the radiation.

Dr Ben Mead, an honorary senior lecturer in medical oncology at the University of Southampton’s School of Medicine, who presented the study, said: “Giving patients a carboplatin injection rather than radiotherapy is less unpleasant with fewer long-term risks.”

Professor Peter Johnson, Cancer Research UK’s chief clinician, said seminoma was a “great success story for the field of cancer research”.

“This trial now shows that chemotherapy can cure early stage seminoma, so that men diagnosed with the disease can be successfully treated with fewer side-effects.”

Sally Stenning, from the Medical Research Council’s clinical trials unit, which ran the trial, said: “Testicular cancer caught early is now one of the most curable forms of cancer.”

The results of the study are due to be presented today at the National Cancer Research Institute’s cancer conference in Birmingham.

For the millions of sufferers of a bladder condition called painful bladder syndrome/interstitial cystitis, hope is on the way, developed by urologic surgeon and researcher Lowell Parsons, M.D. of the University of California, San Diego Medical Center.

“What our team has identified is an experimental drug therapy that can provide pain relief to patients within 20 minutes,” said Parsons, professor of surgery at UC San Diego School of Medicine. “Depending on the individual, in my experience, one dose can last from 6 to 40 hours. The ability of the therapy to provide immediate relief is something entirely new for sufferers of interstitial cystitis.”

“Women who suffer from this condition may find themselves having to urinate ten or more times per day, usually have pain or symptom flares after sexual intercourse, and frequently have chronic pelvic pain,” said Parsons. “Fortunately, given the right diagnosis, it’s treatable.”

The drug therapy, with positive results in a recent Phase 2 study, is a combination of an anesthetic and heparin delivered directly into the bladder via a catheter. The anesthetic provides rapid pain relief while heparin restores the protective mucus layer of the bladder.

Normally the bladder is protected by mucus, a slippery substance made up of mucin, water, cells, and inorganic salts. The layer helps the bladder store urine safely and comfortably. In its absence, irritating urinary salts such as potassium leak into the bladder wall injuring nerves and causing pain.

Triggers for flare ups of interstitial cystitis are sexual intercourse, menstruation, exercise, flying in planes or travel that requires extensive sitting, and pelvic surgery. Parsons estimates that one out of every four women in the U.S. suffers from some form of this condition while 6-8% of men may exhibit symptoms. Children who are late bedwetters sometimes show early signs of the condition.

Currently, one of the most effective treatments for interstitial cystitis is a drug called Elmiron, an FDA-approved drug that has been on the market for more than a decade, which Parsons began developing 30 years ago. Elmiron helps restore or heal the bladder lining and works best by taking the medication over a 6-12 month period.

The new drug therapy combination has been licensed by UC San Diego Technology Transfer & Intellectual Property Services to Urigen Pharmaceuticals, Inc. for further clinical development and commercialization.

A team of researchers from the University of Rochester Medical Centre and Princeton University has discovered that existing anti-obesity drugs can be used to treat infections like flu, hepatitis or HIV.

Metabolism refers to a process by which living things break down nutrients to produce energy. For instance, the breakdown glucose and its conversation via chain reactions into adenosine triphosphate, the energy-storing currency of cellular life.

Glucose can also be converted into fatty acids - the lipid building blocks of human hormones and cell membranes - that are used by influenza, HIV and hepatitis viruses to build their viral cover and hijack human cells.

During the study, the researchers developed a new technique to analyse the mechanisms regarding how such viruses penetrate the metabolic building blocks from their cellular hosts.

They also studied the fluxes or concentration and turnover, of interchangeable molecules within the metabolic reactions that convert sugars into fatty acids.

“Using new fluxomic techniques, our study reveals that viral infection takes control of cellular metabolism and drives, among other things, marked increases in fatty acid synthesis,” Nature magazine quoted Dr. Joshua Munger, assistant professor of Biochemistry and Biophysics at the University of Rochester Medical Centre, and a study author, as saying.

“We also found that if you target these increases in fatty acid metabolism using existing anti-obesity and anti-metabolism drugs, you inhibit viral replication,” Munger added.

The new technique enabled the researchers to measure the changes in metabolic flux in human cells as they became infected by human cytomegalovirus (HCMV), an enveloped virus of the b-herpes family that infects most human adults and that causes severe disease in those with weakened immune systems.

The team used drugs known to inhibit enzymes that build fatty acids, acetyl-CoA carboxylase (ACC) and fatty acid synthase (FAS), used in the treatment of obesity and high cholesterol, to determine whether HCMV-induced fatty acid production was necessary for enveloped viruses to make copies of themselves.

They found that treatment with TOFA, an ACC inhibitor, led to a more than thousand-fold reduction in HCMV replication, while C75, an inhibitor of FAS, resulted in a more than 100-fold reduction.

aFDA updates label to say Gardasil guards against cancers of vagina, vulva

The Food and Drug Administration has updated the label of Merck’s cervical cancer vaccine Gardasil, adding new information about its protective effects against two other gynecological cancers.

The new labeling indicates the vaccine also protects against cancers of the vagina and vulva, which affect more than 5,000 women in the U.S. each year, according to Merck.

The vaccine works by defending against four strains of the human papillomavirus, which cause the majority of cervical cancers. A Merck scientists said the virus accounts for a smaller portion of vaginal and vulvar cancers, though he added it plays a role in more than half of them.

“Anytime we have evidence of additional cancer protection, that’s a really important piece of information,” said Merck’s Rick Haupt, executive director for HPV vaccines.

It was not immediately clear what the additional indication would mean for sales of the vaccine, which have fallen short of the company expectations.

Merck has already scaled back full-year sales estimates for Gardasil from between $1.9 billion and $2.1 billion to between $1.4 billion and $1.6 billion, following regulatory setbacks and challenges making inroads with young adult patients.

First approved in 2006, Gardasil is the only cervical cancer vaccine approved for the lucrative U.S. market, though Merck has had limited success expanding use.

The FDA rejected Merck’s proposal in June to begin marketing the vaccine to women ages 27 to 45. It is currently approved for ages 9 to 26. The company’s expansion effort seems even less likely after a government-funded study released last month concluded the roughly $375 vaccine is not cost-effective for women in their 20s and older.

Gardasil is outselling rival GlaxoSmithKline’s Cervarix vaccine abroad. The Glaxo injection is still pending review at the FDA.

The positive announcement Friday breaks a string of FDA rejections for the Whitehouse Station, N.J.-based company. Earlier this year the agency denied applications to sell two new experimental cholesterol drugs and what would have been the first nonprescription cholesterol drug.

Don’t answer that e-mail. Doctor’s orders! See, your body doesn’t respond as well as you think it might to the “get ahead now, sleep when you’re retired” philosophy. A group of 32- to 59-year-olds who got fewer than five hours of sleep a night for several years were twice as likely to develop high blood pressure as those who got a healthy seven or eight hours each night.

If you’ve shorted your sleep in favor of peeking at your inbox one more time or searching for the ultimate Spider-Man costume for your kids, you’re like most people over 30 who are getting historically low levels of sleep. Blood pressure is on the rise in this young age group too, and is related to lack of sleep. Here’s how it works:

When you snooze, your body goes into a lower blood pressure mode. Too little time in this low-key state can lead to consistently high blood pressure.

Less sleep means you spend more time dealing with stress instead of resting.

Cutting back on a full night’s sleep again and again also adds to your desire to eat. That’s because lack of sleep leads to a lack of the feel-good brain chemical dopamine. Your brain receptors crave dopamine, so they trigger sugar cravings in your body because sugar also releases dopamine — but constantly overdoing sugary foods increases your weight and your high blood pressure risk.

If getting enough shut-eye is a challenge, consider this: Whatever’s tempting you to stay up late will still be there tomorrow. But with rest, you’ll do those tasks better — and probably faster.

Browse Watching Studio 60.

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Half-million quit pills for serious conditions in 2007 when faced with cost

Many people in Medicare with diabetes, high blood pressure and other chronic conditions stop taking their medicine when faced with picking up the entire cost of their prescriptions, researchers say.

About 3.4 million older and disabled people hit a gap, known as the doughnut hole, in their Medicare drug coverage in 2007. When that happened, they had to pay the entire costs of their medicine until they spent $3,850 out of pocket. Then, insurance coverage would kick in again.

About 15 percent of those hitting the coverage gap stopped their treatment regimen. That rate varied depending upon illness. For example, about 10 percent of diabetes patients stopped buying the medicine, as did 16 percent of patients with high blood pressure and 18 percent of patients with osteoporosis.

The drug benefit, which began in 2006, has come in under budget. Most participants report they are satisfied with the program. But many lawmakers and health analysts say improvements could be made.

“If a new president and Congress consider changes to the drug benefit, it will be important to keep in mind that the coverage gap has consequences for some patients with serious health conditions,” said Drew Altman, the chief executive officer and president of the Kaiser Family Foundation. The foundation conducted the study with researchers at Georgetown University and the University of Chicago.

2003 Congress crafted the hole
The Republican-led Congress in 2003 crafted the doughnut hole as a way to make the drug benefit more affordable for the federal government.

The researchers based their findings on pharmacy claims data provided by IMS Health, a company specializing in collecting health care data. They excluded people who get extra help in paying for their drug coverage because of their income; they do not pay the full cost of medicine even when in the doughnut hole.

Browse Healthy bpm and the “vacation state of mind”