No mug? Drug makers cut out goodies for doctors

Starting Jan. 1, the pharmaceutical industry has agreed to a voluntary moratorium on the kind of branded goodies — Viagra pens, Zoloft soap dispensers, Lipitor mugs — that were meant to foster good will and, some would say, encourage doctors to prescribe more of the drugs.

No longer will Merck furnish doctors with purplish adhesive bandages advertising Gardasil, a vaccine against the human papillomavirus. Banished, too, are black T-shirts from Allergan adorned with rhinestones that spell out B-O-T-O-X. So are pens advertising the Sepracor sleep drug Lunesta, in whose barrel floats the brand’s mascot, a somnolent moth.

Some skeptics deride the voluntary ban as a superficial measure that does nothing to curb the far larger amounts drug companies spend each year on various other efforts to influence physicians. But proponents welcome it as a step toward ending the barrage of drug brands and logos that surround, and may subliminally influence, doctors and patients.

The new voluntary industry guidelines try to counter the impression that gifts to doctors are intended to unduly influence medicine. The code, drawn up by Pharmaceutical Research and Manufacturers of America, an industry group in Washington, bars drug companies from giving doctors branded pens, staplers, flash drives, paperweights, calculators and the like.

The guidelines also reiterate the group’s 2002 code, which prohibited more expensive goods and services like tickets to professional sports games and junkets to resorts. And it asks companies that finance medical courses, conferences or scholarships to leave the selection of study material and scholarship recipients to outside program coordinators.

Diane Bieri, the executive vice president of Pharmaceutical Research and Manufacturers of America, said the updated guidelines were not an admission that gifts could influence doctors’ prescribing habits. Instead, she said, they were meant to emphasize the educational nature of the relationship between industry and doctors.

But some critics said the code did not go far enough to address the influence of drug marketing on the practice of medicine. The guidelines, for example, still permit drug makers to underwrite free lunches for doctors and their staffs or to sponsor dinners for doctors at restaurants, as long as the meals are accompanied by educational presentations.

Last year, besides giving away nearly $16 billion in free drug samples to doctors, pharmaceutical companies spent more than $6 billion on “detailing” — an industry term for the sales activities of drug representatives including office visits to doctors, meal-time presentations and branded pens and other handouts, according to IMS Health, a healthcare information company.

The industry code also permits drug makers to pay doctors as consultants “based on fair market value” — which critics say means that companies can continue to pay individual doctors tens of thousands of dollars or more a year.

The restrictions come as a blow to the makers and distributors of promotional products, an industry with an annual turnover of about $19 billion, according to Promotional Products Association International, a trade group. Such companies, accustomed to orders of up to a million pens a drug, stand to lose around $1 billion a year in sales as a result of the drug industry’s voluntary ban, the group said. (NY Times)  Visit here for the complete story

Study links osteoporosis drugs to jaw trouble

The proportion of people taking widely prescribed oral osteoporosis drugs who develop a nasty jaw condition may be much higher than previously thought, a new study suggests. Previous reports had indicated that the risk of developing osteonecrosis of the jaw (ONJ) from bisphosphonates in pill form were "negligible," although there was a noted risk in people taking the higher-dose intravenous form of the drug.

But Dr. Parish Sedghizadeh, an assistant professor of clinical dentistry at the University of Southern California School of Dentistry in Los Angeles, said his clinic is seeing one to four new cases a week, compared to one a year in the past. This led him to investigate the phenomenon and publish the findings in the Jan. 1 issue of the Journal of the American Dental Association. ONJ is characterized by pain, soft-tissue swelling, infection, loose teeth and exposed bone.

Bisphosphonates are medications used to reduce the risk of bone fracture and to increase bone mass in people with osteoporosis. They're also used to slow bone "turnover" in people who have cancer that has spread to their bones, and in people who have the blood cancer multiple myeloma. Use of bisphosphonates has been associated with other problems in the past, including an increased risk of atrial fibrillation (a type of abnormal heart rhythm), unusual fractures of the thigh bone, and inflammatory eye disease.

After searching the USC School of Dentistry's electronic medical records database, the study authors found that nine of 208 patients taking Fosamax had active ONJ, a prevalence of about 4 percent. All were patients who had undergone some kind of dental procedure, such as having a tooth removed.

Fosamax (alendronate) is the most widely prescribed oral bisphosphonate and has been the 21st most prescribed drug in the United States since 2006, according to background information in the study. The jaw complication has been seen in patients taking Fosamax for as little as one year. It seems to occur most frequently after routine tooth extraction, the study authors said.

Although no one is sure why bisphosphonates seem to have this effect only on jaw bones, Sedghizadeh speculated that the drugs may make it easier for bacteria to adhere to bone that is exposed after a tooth extraction.

The USC School of Dentistry now screens every patient for bisphosphonate use. "As a school now, we don't have complications any more, we only have referrals," Sedghizadeh said. "We put patients on anti-microbial, anti-fungal rinse one week pre-operatively or post-operatively. If they have been on bisphosphonates six months or a year or longer, then we have a prevention protocol which has been very, very effective." (Washington Post) Visit here for the complete story Visit here for the complete story

FDA Advisory: Innohep (tinzaparin sodium injection)

Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.

In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. Visit here for more information
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep

Chains' ties run deep on pharmacy boards

When the Illinois Board of Pharmacy meets, Philip Burgess, national director of pharmacy affairs at Walgreens (WAG), the Illinois-based firm that's the nation's largest drugstore chain in sales and profits, chairs the sessions. Michael Podgurski, vice president of pharmacy services for Rite Aid, (RAD) leads pharmacy board meetings in Pennsylvania.  Bob Dufour, the former director of pharmacy services for Arkansas-based Wal-Mart (WMT), chairs that state's board. Kay Hanson, the pharmacy regulatory affairs manager for Target (TGT), serves on the board in Minnesota, the firm's corporate base. And James DeVita, CVS' (CVS) quality assurance director, is on the Massachusetts board.

The five executives aren't the only retail chain pharmacists who serve on the state panels assigned to oversee prescription drug safety for the American public. A USA TODAY examination shows employees of major drugstore chains or supermarket pharmacies accounted for nearly one in four of the 295 pharmacists on the panels this year.

The appointments give consumers the benefit of the pharmacists' expertise. But they also give the chains a network with potential say about decisions that affect the pharmacy industry.

Most chain pharmacists abstain from votes that have a direct impact on their firms. DeVita, for instance, didn't vote on a 2005-06 investigation of CVS prescription errors, records show. But USA TODAY's examination, which included a survey of pharmacy boards in the 50 states and the District of Columbia, plus court and government records and information from the firms, found potential or alleged conflicts.

Pharmacy chains and an industry group representing them dispute any such conclusion. "Members of pharmacy boards serve as advocates for public safety, not as representatives of their employers," says CVS spokesman Michael DeAngelis, echoing Walgreens, Rite Aid and Wal-Mart.

The chains say pharmacists use their own judgment on board issues. But Walgreens spokesman Michael Polzin says the firm's pharmacists on the panels may ask for background "on an industry issue the board is debating … and we may supply it."

Pharmacy board members, typically appointed by state governors, are assigned to protect public health and safety in the dispensing of prescription drugs. Pharmacists comprise the majority of each board, but the panels also include non-pharmacists appointed to represent the public.

Although duties vary from state to state, the boards typically license pharmacies and pharmacists, set training standards, oversee pharmacy inspections and hold disciplinary proceedings for alleged safety violations.

As drugstore chains grew, their pharmacists have won dozens of board seats. USA TODAY documented that network, finding that Walgreens and CVS, the two largest chains, are tied for the most with at least 21 seats each.

States require board members to obey conflict of interest regulations. But USA TODAY's review of board records, meeting minutes and interviews — which followed February stories that showed pharmacies' policies can contribute to prescription errors — found potential conflicts. (USA Today) Visit here for the complete article http://www.usatoday.com/money/industries/health/2008-12-30-pharmacies-boards-mistakes-prescriptions_N.htm

Errors involving medications common in outpatient cancer treatment

Seven percent of adults and 19 percent of children taking chemotherapy drugs in outpatient clinics or at home were given the wrong dose or experienced other mistakes involving their medications, according to a new study led by Kathleen E. Walsh, MD, assistant professor of pediatrics at the University of Massachusetts Medical School, and published in the January 1, 2009 issue of the Journal of Clinical Oncology.

"As cancer care continues to shift from the hospital to the outpatient setting, the complexity of care is increasing, as is the potential for medication errors, particularly in the outpatient and home settings," said Dr. Walsh, who is also a Robert Wood Johnson Physician Faculty Scholar.

An analysis of data on nearly 1,300 patient visits at three adult oncology outpatient clinics and 117 visits at one pediatric facility between September 1, 2005 and May 31, 2006 showed that errors in medication were more common than previously reported by oncology patients. Of the 90 medication errors involving adults, 55 had the potential to harm the patient and 11 did cause harm.

The errors included administration of incorrect medication doses due to confusion over conflicting orders – one written at the time of diagnosis and the other on the day of administration. Patients were also harmed by over-hydration prior to administration of medication, resulting in pulmonary edema and recurrent complaints of abdominal pain and constipation. More than 50 percent of errors involving adults were in clinic administration, 28 percent in ordering of medications, and 7 percent in use of the drugs in patients' homes.

About 40 percent of the 22 medication errors in children had the potential to cause harm and four children were harmed. More than 70 percent of the errors in children occurred at home. Examples of pediatric errors included parents giving the wrong dose or the wrong number of doses per day of medicines because of a caregiver's confusion about instructions.

"Requiring that medication orders be written on the day of administration, following review of lab results, may be a simple strategy for preventing errors among adults, while most of the errors involving children may have been avoided by better communication and support for parents of children who use chemotherapy medications at home," said Dr. Walsh.

Blood sugar control linked to memory decline, study says

Spikes in blood sugar can take a toll on memory by affecting the dentate gyrus, an area of the brain within the hippocampus that helps form memories, a new study reports. Researchers said the effects can be seen even when levels of blood sugar, or glucose, are only moderately elevated, a finding that may help explain normal age-related cognitive decline, since glucose regulation worsens with age.

The study, by researchers at Columbia University Medical Center and funded in part by the National Institute on Aging, was published in the December issue of Annals of Neurology.

“If we conclude this is underlying normal age-related cognitive decline, then it affects all of us,” said lead investigator Dr. Scott Small, associate professor of neurology at Columbia University Medical Center. The ability to regulate glucose starts deteriorating by the third or fourth decade of life, he added. Since glucose regulation is improved with physical activity, Dr. Small said, “We have a behavioral recommendation — physical exercise.”

In the study, researchers used high-resolution functional magnetic resonance imaging to map brain regions in 240 elderly subjects. They found a correlation between elevated blood glucose levels and reduced cerebral blood volume, or blood flow, in the dentate gyrus, an indication of reduced metabolic activity and function in that region of the brain.

Bruce S. McEwen, who heads the neuroendocrinology lab at Rockefeller University in New York and was not involved in the research, said the study’s findings were “compelling,” with important implications not just for the elderly but for the growing number of overweight children and teens at risk of Type 2 diabetes.

Previous observational studies have shown that physical activity reduces the risk of cognitive decline, and studies have also found that diabetes increases the risk of dementia. Earlier studies had also found a link between Type 2 diabetes and dysfunction in the dentate gyrus. (NY Times) Visit here for the complete story http://www.nytimes.com/2009/01/01/health/31memory.html?ref=health

Hospitals' caution on capex a concern for Cardinal Health

A rocky economy is prompting hospitals to exercise caution in capital spending, which is raising some concern on Wall Street about risks for Cardinal Health Inc. (CAH), a supplier of medical equipment and technology. Cardinal, perhaps better known for its core drug-distribution business, has said it is closely monitoring hospital customers' capital spending, which the company calls a "key variable" in 2009.

Cardinal's clinical and medical products, or CMP, business, which the company aims to spin off in 2009, saw a pause in some hospital customers' capital expenditures (capex) late in the company's fiscal first quarter and into the second quarter, which correspond to the calendar third and fourth quarters. The company has said the pause will affect its fiscal second-quarter results.

Cardinal hasn't provided a public update on hospital customer spending since commenting on the matter last month, and no one was available to provide an update, company spokesman Troy Kirkpatrick said Tuesday. Cardinal plans to spin off by mid-2009 its CMP business, which is growing faster and generating higher margins than its sluggish drug-distribution operation.

Analysts also have raised concerns about economics and risks for drug distributor McKesson Corp. (MCK), which sells automation technology to hospitals. Baird's Coldwell was less concerned about near-term risks to McKesson, however, saying it is exposed to hospitals through its healthcare software and services, an area where observers are seeing slightly less of a spending slowdown than in capex.

Also, he said, Cardinal's hospital-exposed CMP business is a much larger contributor to the company than McKesson's information-technology business is to McKesson profits.

Cardinal has the lowest price-to-earnings valuation among the big-three drug wholesalers, which also include AmerisourceBergen Corp. (ABC). All three companies are down significantly this year, although AmerisourceBergen is off less sharply than the others. (CNN Money) Visit here for the complete article http://money.cnn.com/news/newsfeeds/articles/djf500/200812301711DOWJONESDJONLINE000366_FORTUNE5.htm

Woman accused of trying to steal newborn at hospital

A newborn and its mother were reunited Wednesday after hospital staff and a state-of-the-art security system helped to thwart a kidnapping attempt, police say. The woman was arrested at Nashville General Hospital at Meharry after posing as a nurse in scrubs and attempting to walk away with a newborn baby, according to Metro police.

The woman had told nurses that she was a visiting friend and then entered the 23-year-old mother's room. She then told the young mother that she needed to take the baby's temperature and took the newborn from the room, police say. When she tried to leave the maternity floor an automatic electronic security system was triggered.

The system is automatic and immediately locks down the women's services area, hospital spokeswoman Cathy Everett said. Elevators are shut down and staff go to alert stations, Everett said. "The floor shuts down," Everett said. "But it's not just an electronic security system. The people know exactly what to do. We have mock drills."

The security system has been in place for four years. Everett said the hospital has had no other kidnapping attempts. (The Tennessean) Visit here for the story http://www.tennessean.com/article/20090101/NEWS01/901010348/1006