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No Free Lunch
The Institute of Medicine issued a report in April calling for changes to limit conflicts of interest between medical professionals and the pharmaceutical industry. The IOM recommendations include physicians’ forgoing gifts of any value from drug or device makers as well as fees for industry-sponsored lectures. The report further suggests prohibiting impromptu visits by pharmaceutical representatives and limiting free drug samples for distribution only to patients who cannot afford the medications. A more controversial proposal includes eliminating industry-funded continuing medical education. The portion of CME supported by the pharma industry has risen from 34% to 48% over the past decade, according to IOM. While recognizing the importance of these programs, the report recommends phasing out industry funds over two years to allow time for the creation of a new system. IOM also suggests Congress pass a bill requiring pharmaceutical companies to disclose all payments to medical professionals and institutions on a public searchable database. Any researchers revealed to have financial conflicts will be prohibited from participating in testing therapies on humans.

None of these recommendations are binding, but universities and research groups may follow them to avoid scrutiny from the government. The Pharmaceutical Research and Manufacturers of America trade group cautions against adopting all the report recommendations. "Reports such as this can have far-reaching effects," says PhRMA Executive Vice President Diane Bieri. "When they admit in the report itself they don't have a lot of data to support these recommendations, we have to be aware of the negative effect they could have."
—Andrew Matthius

Diabetes Breakthrough

The newly burgeoning field of stem cell research has produced eggs in infertile mice, repaired Achilles tendons in racehorses, and treated rats that suffered ischemic strokes, but scientists have now demonstrated how it can directly benefit humans. In a study published recently in the Journal of the American Medical Association, type 1 diabetes was treated using newly diagnosed patients’ own stem cells in Brazil by researchers from the University of São Paulo and Northwestern University in Chicago. The patients afterward required no insulin injections for an average of 31 months. "I wouldn’t use the word cure," commented study co-author Dr. Richard Burt in Time. "But it appears we changed the natural history of the disease."

In type 1 diabetes, the immune system attacks insulin-producing beta cells in the pancreas. In this experimental treatment, the patients’ immune systems were wiped out with chemotherapy and rebuilt with stem cells collected from the patient’s own blood. The small Brazilian study found that following the stem cell transplant, 20 of the 23 patients’ beta cells were able to repopulate and produce insulin. A total of 12 patients did not require insulin shots for three years, which surpassed previous studies showing new beta cells surviving only six months. Some side effects did occur, with 2 patients developing pneumonia; 3, late endocrine dysfunction; and 9, a low sperm count. Some doctors question the treatment’s efficacy, attributing any improvement to the patients’ healthier diet and lifestyle. Others note the new treatment won’t help many long-term diabetics with few beta cells left. The FDA is currently considering approval of a larger, randomized trial at Northwestern to confirm the success of the treatment.
—A.M.

Hard Line on ED Ads

A bill introduced in Congress at the end of April aims to keep the "Viva Viagra" couple from dancing and the Levitra man from tossing a football until after 10p.m. Representative James Moran (D-VA) introduced the Families for ED Advertising Decency Act, HR 2175, to prohibit erectile dysfunction and male enhancement ads from airing between 6 a.m. and 10 p.m. on television and radio. Among those affected would be drugmakers Pfizer (Viagra), Bayer (Levitra), and Eli Lilly (Cialis). The bill claims these ads should be deemed indecent material and treated as such by the Federal Communications Commission with fines as high as $325,000. This would restrict the ads to the specified hours but would not affect any product placement or mention of the trademarked name. At press time, there were no hearings scheduled for the bill and Representative Robert Brady (D-PA) was the only co-sponsor.

"[These ads are] an intrusion into our daily lives that I believe has become inappropriate," Moran noted in a CNN interview. "There is a saturation of the television airwaves with these ED ads, and they have gotten more pervasive, more blunt, and less subtle." Pfizer responded with the statement: “Consumers need and want readily available, easy-to-understand health information. Advertisements for prescription medicines provide clear information about medical conditions and treatments and motivate consumers to have productive conversations with their physicians. Pfizer is committed to responsible advertising. We are continually looking for ways to improve our advertising. Our goal in advertising our products is to reach the people who would be most likely to benefit from them. In line with our policies and the policies of the industry, Viagra advertising is aired in shows most likely to reach men suffering from erectile dysfunction. ED can be a signal for other serious medical issues, including high blood pressure, diabetes, and cardiovascular disease."
—A.M.

Did You Know...What Lies Ahead
The Secrets of CEOs by Steve Tappin and Andrew Cave (Nicholas Brealey, 2008) reveals what 150 global chief executives believe are the five most important business realities today.

1) survival. Their advice is to keep the balance sheet strong but be conscious of what shouldn’t be cut, such as development of talent and technological innovation. Also be bold enough to take advantage of the situation by completing a merger or buyout at a lower cost.

2) hard globalization requires companies to rid themselves of a “home" base, adapt to each culture, and understand that the best materials, capital, and people could be found anywhere on the planet.

3) sustainabilitY involves preserving the environment as well as making ethical decisions that customers and employees can respect.

4) Web 3.0. Companies should watch technological trends to predict when virtual worlds, such as Second Life, will surpass social networks.

5) the war on talent and the multi-generational workforce. Human resource departments need to find the best talent globally and develop it.
—A.M.

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