Science Weekly podcast: The birds and the bees (X-rated version)

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Nature’s most intimate sexual secrets; Peter Atkins on the limits of science; plus, why chemistry often gets overlooked

Target Health in the Media

New Clinical Trial Transformation Initiative (CTTI) Publication

As part of the Clinical Trial Transformation Initiative’s (CTTI) commitment to optimizing clinical trial processes, Target Health is pleased to announce the acceptance for publication, in Clinical Trials: Journal of the Society for Clinical Trials, a manuscript entitled “A Survey of Current Practices to Monitor Clinical Trial Conduct Quality.” This CTTI-driven manuscript was coauthored by a team from Pfizer; FDA; Roche; Training Extension/Pastor Consulting, Inc.; University of Minnesota; Bristol-Myers Squibb Co. and Target Health Inc.

Webinar on eSource

Target Health is very pleased to announce that Elsevier Press has invited Dr. Jules T. Mitchel, President of Target Health,, to present a Webinar on eSource in the clinical trial space. The Webinar will take place on 12 April 2011 between 1pm-2:30pm EST. Details to follow as the time gets closer.

The Webinar attendees will gain the following;

  • A historical perspective presenting FDA views about “source record.” How FDA has opened the door to direct data entry and how to deal with compliance issues
  • What are the risks of not having a “paper backup”
  • How to address the impact of direct data entry as well as the electronic health/medical record (EHR/EMR) in clinical research operations and data management
  • See several approaches of the paradigm shift in product development as a result of direct data entry

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, at www.TargetHealth.com.

FDA Approves First 3-D Mammogram

A Doctor Looking at a Series of Mammograms.

The first three-dimensional mammogram device was approved this past Friday by the US FDA, in the hopes that the new technology would improve early breast cancer 1) ___. Currently the only technology on the market produces two-dimensional X-ray images of the 2) ___.

“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnostic and 3) ___ approaches,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

A pair of studies reviewed by the FDA showed a 7% improvement in the ability of 4) ___ to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone. The new device, called the Selenia Dimensions System, is made by the Massachusetts-based company Hologic and functions as an upgrade to its current 2-D FDA approved 5) ___ technology system.

The National Cancer Institute recommends that women over 6) ___ get mammograms to screen for breast cancer every one or 7) ___ years.

ANSWERS: 1) detection; 2) breast; 3) treatment; 4) radiologists; 5) diagnostic; 6) forty; 7) two

Origins of Rx Traced Back 5000 Years in Egypt

The Eye of Horus, the symbol for Jupiter, and the Rx symbol, share similar elements

In a special report, the Voice of America has traced the origin of the sign “Rx”, the history of which goes back 5000 years in Egypt. The sign is seen on drug stores and on bottles of pills and other medicines. The sign is formed by a line across the right foot of the letter “R.” It represents the word “prescription.” It has come to mean “take this medicine.”

The sign has its beginnings five thousand years ago in Egypt. At that time, people prayed to Horus the falcon god, the god of the Sun. It was said that when Horus was a child, he was attacked by Seth, the demon of evil. Folklore says that the evil Seth put out the eye of the young Horus. The mother of Horus called for help. Her cry was answered by Thoth, the god of learning and magic. Thoth, with his wisdom and special powers, healed the eye of Horus, and the child was able to see again.

The ancient Egyptians used a drawing of the eye of Horus as a magic sign to protect themselves from disease, suffering and evil. They cut this sign in the stones they used for buildings. It was painted on the papyrus rolls used for writing about medicine and doctors. For thousands of years, the eye of Horus remained as a sign of the god’s help to the suffering and sick.

Egypt became a province of the Roman Empire in 30 BCE, following the defeat of Marc Antony and Ptolemaic Queen Cleopatra VII by Octavian. Long after the fall of the ancient Egyptian civilization, doctors and alchemists in Europe continued the custom of showing a sign of the gods’ help and protection. For a while, the prescription sign changed from the eye of Horus to the sign for Jupiter, the chief god of the Romans. Jupiter’s sign looked much like the printed number “four.” Over the centuries, features of the Eye of Horus and the Symbol of Jupiter, merged to become today’s easily recognized capital “R” with a line across its foot. If you look closely at the major lines of the eye of Horus, you can see the elements of the symbol Rx.

Association of Myocardial Enzyme Elevation and Survival Following Coronary Artery Bypass Graft Surgery

Several small studies have suggested that cardiac enzyme elevation in the 24 hours following coronary artery bypass graft (CABG) surgery is associated with worse prognosis, but a definitive study is not available. Also, the long-term prognostic impact of small increases of perioperative enzyme has not been reported. As a result, a study published in the Journal of the American Medical Association (2011;305:585-5910) was performed to quantify the relationship between peak post-CABG elevation of biomarkers of myocardial damage and early, intermediate-, and long-term mortality, including determining whether there is a threshold below which elevations lack prognostic significance.

The data sources included randomized clinical trials or registries of patients undergoing CABG surgery in which post-procedural biomarker and mortality data were collected and included. A search of the PubMed database was performed in July 2008 using the search terms coronary artery bypass, troponin, creatinine kinase (CK-MB), and mortality. Studies included those evaluating mortality and CK-MB, troponin, or both. Two independent reviewers determined study eligibility.

A total of 18,908 patients from 7 studies were included in the analysis. Follow-up varied from 3 months to 5 years.

Results showed that when CK-MB was calculated as a ratio between peak day-1 CK-MB level and the upper limit of normal (ULN), patients with higher CK-MB ratios had greater 30-day mortality risks than those with lower ratios. For example, patients with a CK-MB ratio of 0 to less than 1 had a 30-day mortality risk of 0.86%, and those with CK-MB ratios of 1 to less than 2, and 2 to less than 5, had respective 30-day mortality risks of 0.95% and 2.09%. A similar trend was noted for mortality risk at 30 days to 1 year after CABG.

In addition, each 5-point increase in day-1 CK-MB level above the ULN produced a significant 17% increase in mortality risk between 30 days and 1 year post-surgery (p<0.001). However, at 1 to 5 years after CABG, each 5-point increment above normal resulted in a non-significant 5% increase in mortality risk. Similar analyses using troponin as the marker of necrosis led to the same conclusions.

According to the authors, among patients who had undergone CABG surgery, elevation of CK-MB or troponin levels within the first 24 hours was independently associated with increased intermediate- and long-term risk of mortality.

ONCOLOGY

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Sunitinib Malate for the Treatment of Pancreatic Neuroendocrine Tumors

The multitargeted tyrosine kinase inhibitor sunitinib has shown activity against pancreatic neuroendocrine tumors in preclinical models and phase 1 and 2 trials. As a result, a multinational, randomized, double-blind, placebo-controlled phase 3 trial of sunitinib was performed in patients with advanced, well-differentiated pancreatic neuroendocrine tumors (New England Journal of Medicine, 2011;364:501-513). As part of study’s inclusion criteria, all patients had Response Evaluation Criteria in Solid Tumors (RECIST) defined disease progression documented within 12 months before baseline. A total of 171 patients were randomly assigned (in a 1:1 ratio) to receive best supportive care with either sunitinib at a dose of 37.5 mg per day or placebo. The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, and safety.

The study was discontinued early after the independent data and safety monitoring committee observed more serious adverse events and deaths in the placebo group as well as a difference in progression-free survival favoring sunitinib. Median progression-free survival was 11.4 months in the sunitinib group as compared with 5.5 months in the placebo group (hazard ratio for progression or death, 0.42; P<0.001). A Cox proportional-hazards analysis of progression-free survival according to baseline characteristics favored sunitinib in all subgroups studied. The objective response rate was 9.3% in the sunitinib group versus 0% in the placebo group. At the data cutoff point, 9 deaths were reported in the sunitinib group (10%) versus 21 deaths in the placebo group (25%) (hazard ratio for death, 0.41; P=0.02). The most frequent adverse events in the sunitinib group were diarrhea, nausea, vomiting, asthenia, and fatigue.

According to the authors, continuous daily administration of sunitinib at a dose of 37.5 mg improved progression-free survival, overall survival, and the objective response rate as compared with placebo among patients with advanced pancreatic neuroendocrine tumors.

Wireless Pulmonary Artery Hemodynamic Monitoring in CHF

Results of previous studies support the hypothesis that implantable hemodynamic monitoring systems might reduce rates of hospitalization in patients with congestive heart failure (CHF). As a result, a study published online in The Lancet (10 February 2011), was performed to assess this approach.

Patients with New York Heart Association (NYHA) class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure were enrolled in 64 centers in the US. Patients were randomly assigned by use of a centralized electronic system to management with a wireless implantable hemodynamic monitoring (W-IHM) system (treatment group) or to a control group, for a period of at least 6 months. Only patients were masked to their assignment group. In the treatment group, clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group. The primary efficacy endpoint was the rate of heart-failure-related hospitalizations at 6 months. The safety endpoints assessed at 6 months were freedom from device-related or system-related complications (DSRC) and freedom from pressure-sensor failures. All analyses were by intention to treat.

In 6 months, 83 heart-failure-related hospitalizations were reported in the treatment group (n=270) compared with 120 in the control group (n=280; rate 0.31 vs. 0.44, hazard ratio [HR] 0.70, p<0.0001). During the entire follow-up (mean 15 months), the treatment group had a 39% reduction in heart-failure-related hospitalization compared with the control group (153 vs. 253, HR 0.64, p<0.0001). Eight patients had DSRC and overall freedom from DSRC was 98.6% compared with a prespecified performance criterion of 80% (p<0.0001). Overall freedom from pressure-sensor failures was 100%.

According to the authors, the results are consistent with, and extend, previous findings by definitively showing a significant and large reduction in hospitalization for patients with NYHA class III heart failure who were managed with a wireless implantable hemodynamic monitoring system. The authors added that the addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart failure management.

TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.

Risky Business of Drug Research – New Paradigm Needed

Scarcely a week (sometimes it seems scarcely a day) goes by without the announcement of a significant setback in the pharmaceutical industry. Unsurprisingly then, there seems to be a similar frequency of announcements of cutbacks in the R&D enterprise at numerous companies.

While the specifics differ, a theme is emerging, and it is a theme with implications that impact all with a stake in healthcare, especially patients with unmet medical needs. These industry adjustments, therefore, warrant our attention.

It seems not so long ago that the pharmaceutical industry was immune from the challenges that faced more pedestrian businesses. The industry enjoyed patent protected products with high margins and a relatively unencumbered ability to interact with customers. This included (in the late 1990’s) the liberalization of regulations governing the disclosure of adverse effects in direct to consumer (DTC) advertising, a change in approach that encouraged the widespread incorporation of DTC communications into marketing strategies thereby creating an entirely new set of “customers” for the industry.

With unexpected speed, virtually all of these “positives” have eroded. Hugely successful products have lost (or are about to lose) patent protection, succumbing to generic competition and eroding margins. Concurrently, an array of societal entities, public and private, have criticized, regulated, legally challenged, and ultimately diminished the effectiveness of historically successful marketing and sales practices.

At the same time, and critically important, the productivity of the established research model with its large, centralized, company owned and controlled, (and very expensive) research centers, has repeatedly been disappointing.

Quite simply, the cost, time – and risk – of continuing to conduct R&D using the current model have become prohibitive. Successes have simply been too few and far between to replenish eroding pipelines. The times call for a new model, and we are, with consolidations, cuts, and creative partnerships, witnessing its birth.

Different companies are trying different strategies, appropriate in a vibrant economy, but certain trends are emerging. We will see a higher number of more creative partnerships among traditional “big” PhRMA companies, academic institutions, entrepreneurial “start-ups” and CROs like Target Health. Creative financing and risk sharing arrangements will need to emerge to enable these partnerships. For example, one problem needing solution is management of the increased risk from commercial hurdles presented by requirements for market driven comparative data sets, requirements that are inherently less predictable than the data required for regulatory approval. This risk likely makes it more difficult for fledgling innovator companies to attract venture funding.

While these challenges are daunting, they are not insurmountable, especially since it is in the interests of all parties: government, industry, providers, (and especially) patients–and the organizations that represent them–that we be successful. It promises to be an “interesting” decade.  By Mark L. Horn MD, MPH, CMO of Target Health Inc.

For more information about our expertise in Medical Affairs, contact Dr. Mark L. Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

These reputed aphrodisiacs may liven up your love life

Reviewed by Laura J. Martin, MD

WebMD.com, by Elizabeth M. Ward MS, RD  —  If your love life needs a tune-up, and you’re tempted to try certain foods to reignite the spark, edible aphrodisiacs can turn up the heat in more ways than one.

“For centuries, the smell, taste, and appearance of food has been touted as passion-producing,” says Sari Greaves, RD, spokeswoman for the American Dietetic Association and co-author of the Cardiac Recovery Cookbook.

Some foods are reputed to strip away inhibitions. Others claim to put you in the mood for lovemaking, and still others boast of improving blood flow to your genitals, enhancing performance and pleasure.

There’s more folklore than scientific proof to substantiate the link between food and passionate sex. But that’s no reason why you and your partner should shy away from these so-called natural love potions.

It’s a win-win situation. The most notorious food aphrodisiacs are a treasure trove of nutrients necessary for sexual prowess and good health.

Sexually Suggestive Fruits and Vegetables

Some people find produce erotic. Bananas, asparagus, cucumbers and carrots speak for themselves on that score.

Avocados, Greaves says, were prized by the Aztecs, who called them “testicle trees” because they grow in pairs. Ancient Greeks and Romans feasted on figs to promote potency.  And let’s not forget pomegranates, also known as “love apples.”

Those ancient civilizations were on to something. Fruits and vegetables are loaded with vitamins and minerals required to produce sex hormones necessary for sexual arousal and pleasure.

Honey

Ever wonder where the term “honeymoon” came from?

Centuries ago, newlyweds in Europe drank honey wine during the first month of marriage to improve their sexual stamina. As a bonus, the long-ago lovebirds also got small amounts of beneficial vitamins, minerals, and antioxidants from honey.

Chocolate

The Aztec emperor Montezuma’s chocolate consumption is legendary. Rumor has it that he drank 50 glasses of honey-sweetened chocolate a day in the name of virility.

Perhaps Montezuma valued chocolate for its feel-good qualities, too.  Cocoa beans contain phenylethamine, a compound that triggers the release of endorphins, compounds associated with pleasure.

Nowadays, cocoa powder processed without alkaline provides the biggest bang for the buck. It contains the highest levels of the antioxidants associated with lower blood cholesterol levels, reduced inflammation in blood vessels, and maximum blood flow. Darker chocolate contains more cocoa powder.

Oysters

Oysters are dripping with dopamine, a compound that stirs feelings of sexual desire, and pleasure. These mollusks are also bursting with zinc, a mineral that fosters the production of testosterone, necessary for arousal and pleasure in men and women.

You may need to resist the temptation to ply your paramour with raw oysters – your romantic interlude could end with a severe case of food poisoning. Most raw oysters in the U.S. carry a bacterium called Vibrio vulnificus.  Healthy people are unlikely to have adverse affects from eating raw oysters, but those with diabetes, liver disease, immune systems disorders, AIDS, and other chronic diseases can end up with a severe infection that may be fatal.

Salmon

You can’t get down when you’re uptight. Eating salmon can help brighten your disposition.

“Salmon harbors an abundance of omega-3 fats, which qualifies it as a natural mood booster,” says Susan Kleiner, PhD, RD, author of The Good Mood Diet: Feel Great While You Lose Weight.

Salmon also supplies large amounts of vitamin D.  Researchers at the University of Toronto have found that vitamin D appears to work in the brain like many antidepressantmedications do: by raising levels of serotonin, a neurotransmitter that induces feelings of calm and banishes bad moods.

Garlic

Rich in antioxidants that protect against cell damage, garlic is said to stir sexual desire and increase blood flow, says Greaves.

Just be sure to eat as much as your bed partner, as the effects of garlic can linger on your breath for hours.

Alcohol

Nothing says seduction like popping the cork on the best bottle of bubbly money can buy, if that’s what you enjoy.

A drink a day may help reduce the risk of heart disease in healthy people, but more than that may turn your tryst into a snooze fest.

Alcohol is a central nervous system downer.  Chronic drinking is linked to erectile dysfunction, which will put a damper on lovemaking.

The Couple that Eats Together, Sleeps Together?

If you enjoy foods with a reputation for making you hot to trot, you may be thinking about whipping up meals that will knock your socks off, and your partner’s.

“A delicious meal can be a prelude to sex,” Kleiner says.

The act of cooking together can be a form of foreplay, and the smell of food can ignite intimacy, too.

According to Greaves, research has shown that the aroma of pumpkin pie, cheese pizza, and buttered popcorn induced blood flow to the penis, and the combination of pumpkin pie and lavender did the best job.  Women, on the other hand, responded to a combination of Good & Plenty and cucumber.

The smell of vanilla is particularly alluring.  “Add vanilla extract to whole grain French toast or drop a vanilla bean into your champagne,” she recommends.

If you’re not interested in any of the foods with a reputation for enhancing your love life, are you doomed to a lust-free existence? Not at all.

What matters most is that you and your partner dine on meals that include foods that you both enjoy, as long as you don’t overeat or drink yourself into a stupor, Kleiner says. She puts it this way: “What you eat on a daily basis is far more important to overall sexual satisfaction that a single meal.”

Good Health, the Ultimate Aphrodisiac

In the long run, peak physical and emotional well-being is key to a satisfying sex life.

“If you want better sex, take care of your health,” advises Judith Reichman, MD, author of I’m Not In the Mood: What Every Woman Should Know About Improving Her Libido.

You don’t need to be model-thin to have a wonderful sex life, but if you’re uncomfortable with your weight, you may not be at your best in the bedroom for a few reasons.

“Being overweight may deflate your libido, especially if you don’t feel attractive,” says Kleiner.

Extra body fat raises the specter of elevated blood glucose levels that can damage the blood vessels and nerves that allow for arousal and sexual pleasure.  It also increases the risk for high blood pressure and clogged arteries.

Clear, flexible arteries allow maximum blood flow to all the right places during sex, enhancing your pleasure.

A balanced diet rich in whole grains, fruits, vegetables, legumes, and other lean protein foods helps to control your blood pressure, blood cholesterol levels, and your weight.

But don’t cut too many calories.

According to Reichman, upon menopause, women lose 90% of their circulating estrogen, which may result in less blood flowing to the genitals and diminished capacity for arousal.  Body fat offers some protection, because, like your ovaries, it produces estrogen.

Whatever your weight, exercise may help to ignite your love life by improving circulation, managing blood pressure, increasing energy levels, and helping you to look better, which can have a positive effect on your sex life.

Eat protein at every meal.

Protein is the ultimate fill-me-up food — it’s more satisfying than carbs or fats and keeps you feeling full for longer. It also helps preserve muscle mass and encourages fat burning.

Incorporate healthy proteins like

  • lean meat,
  • yogurt,
  • cheese,
  • nuts, or
  • beans
  • fish,  into your meals and snacks.

Happy Valentine’s Day !