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Doctors Urged Not To Induce Labor Unless Medically Necessary

Greg Webb — Thu, 06 Aug 2009 14:21:17 GMT

Under revised guidelines released recently by the nation’s association of obstetricians and gynecologists, physicians are being advised not to induce labor for non-medical reasons prior to thirty-nine weeks into a pregnancy. These guidelines, which are the first to be released since 1999, arrive after concern about the increase in the numbers of these procedures in the last twenty years; in 1990 the rate of induced labor was 90 per 1,000 births, however, this number increased to 225 per 1,000 births in 2006. The guidelines also describe when and how to induce labor in clear-cut medical situations, such as an irregular fetal heartbeat.

The guidelines are non-binding, but could be interpreted to hold the doctor liable if something goes wrong. Over the years, physicians who induce labor early for their patients’ convenience, as opposed to health concerns, have become commonplace. Patients often request early induction because they are tired of their pregnancy, want to make sure their doctor will be on duty to deliver their baby, or want to time their delivery to most efficiently manage their time off of work. While the guidelines take no position on these “soft” reasons for inducing labor, they do stress for the first time that mature fetal lung testing before thirty-nine weeks gestation by themselves are not enough to justify inducing. The guidelines also call for a physician who is capable of performing Caesarean sections (C-sections) to be on hand if inducing does not produce a successful vaginal delivery.

While many hope the consequences of these guidelines will lead to a reduction in the rate, a Houston ob-gyn called the new guidelines “lax” and was skeptical of whether they would have a significant effect. Many physicians feel a stronger statement needs to be issued to get hospitals on board. Although induction is relatively safe, it is being tied to the increased risk of C-sections; studies also found induced labor leads to higher medical costs due to longer stays in hospitals.

There is no specific number for the rate of inductions performed for non-medical reasons; studies have put it from 15 percent to 55 percent of the total number.

Originally posted at InjuryBoard by Greg Webb

Vermont Law Makes Payments to Doctors Public

Greg Webb — Sat, 30 May 2009 22:06:08 GMT

In an attempt to crack down on the medical industry’s payment to physicians, Vermont legislators have passed a law that requires drug and device manufacturers to publicly release the amount of all money given to doctors and other healthcare providers, naming names and listing the actual dollar amounts. This law is scheduled to go into effect July 1, and would also ban almost all industry gifts, even meals, to nurses, doctors, medical staff, pharmacists, health care facilities and healthcare administrators. It is believed to be the strictest state effort to regulate the marketing of medical products to physicians, though Minnesota and Massachusetts have less stringent laws in place. Ideally, the measure would allow residents of Vermont to annually learn how much each doctor was paid by makers of the brand-name drugs for which they wrote patients’ prescriptions, or how much money surgeons received from the manufacturers of certain devices, like stents, that they implant.

National legislators and medical groups are monitoring the different state laws, like the one in Vermont, in their quest to discover a link between health care costs and industry marketing. In Congress, Republican Senator Grassley and Democratic Senator Kohl have sponsored a bill that would require disclosure of the pharmaceutical industry’s payment to doctors. Vermont’s law, however, goes even further by showing the issue is inappropriate gift giving. It requires all payments to any health care provider be disclosed, as well as requiring device manufacturers to disclose information as well; the law is also the first to ban all free meals, which was a favored gift used in marketing to doctors, and closed a loophole that allowed companies to not disclose information by calling them “trade secrets”. The required disclosures, however, do not include payments for clinical research on products that are still under examination by the Food and Drug Administration (FDA).

Vermont legislators passed the measure after information was released by the attorney general stating manufacturers of medical products spent about $2.9 million in fiscal year 2008 on marketing to healthcare personnel in their state. About half of Vermont’s physicians were also given compensation from pharmaceutical companies; the manufacturers focused mainly on those doctors they considered “elite”, with only four percent of these doctors receiving more than sixty percent of the payments. The reports also raised the point that if drug manufacturers were willing to spend that much money in the small state of Vermont, what would the results be in the big states of New York and California?

This law is, at least at first glance, a positive step in curbing the corporate greed of the medical device and pharmaceutical industries. It will be interesting to see how this law plays out over the coming years as far as its success in actually accomplishing its goal and, perhaps, curbing health care costs. Hopefully, there are no bad, unintended consequences.

Originally posted at InjuryBoard by Greg Webb

Report Suggests FDA Should Improve Oversight of Doctor Conflicts

Greg Webb — Tue, 27 Jan 2009 08:00:00 GMT

The Food and Drug Administration needs to improve its oversight of the financial conflicts of doctors who participate in clinical testing before a drug is approved for sale, according to a government watchdog report.

The FDA lacks a complete list of doctors conducting research on new medicines, and it cannot determine which companies have submitted financial information for doctors working on studies, according to a report by the Department of Health and Human Services inspector general.

Of the 118 marketing applications of medicines or medical devices approved in 2007 which were examined by investigators, 42 percent of the applications lacked financial information, and 31 percent of the applications had no documented review of any financial data.

The report urged the FDA to take steps to ensure companies submit complete financial information, and that the submissions are reviewed by the agency. It also said that the FDA should require companies to submit doctors’ financial information before clinical trials on humans begin.

While the FDA agreed with most of the report’s ideas, it rejected the last, saying it “could have the unintended effect of adding to the complexity and cost of the clinical trial enterprise with no commensurate gain in the protection of human subjects or the quality of data.”

Once more, it sounds as if the medical device manufacturers and pharmaceutical companies are, through big money, controlling or deeply influencing governmental decisions and oversight. This has also occurred with the Consumer Product Safety Commission (CPSC) and the toy industry, and NHTSA and the auto industry, for other examples. When the fox watches over the henhouse, something is wrong. I cannot imagine how the costs of such oversight would so dramatically impact the “complexity and cost of the clinical trial enterprise” so as to outweigh associated benefits of helping to prevent defective medications or medical devices from being too readily and quickly approved for public consumption. Perhaps I am too cynical.

Originally posted at InjuryBoard by Greg Webb

FDA Allowing Melamine to Remain in Infant Formula

Greg Webb — Mon, 26 Jan 2009 08:00:00 GMT

Scientists at Consumer’s Union, a nonprofit group, believe that a decision by the Food and Drug Administration to allow infant formula contaminated with melamine or its byproducts to remain on store shelves is “seriously flawed.”

The FDA tested 89 containers of U.S.-manufactured infant formula and reportedly detected traces of melamine in a can of milk-based liquid Nestle Good Start Supreme Infant Formula with Iron, and traces of cyanuric acid in three different cans of Mead Johnson’s Enfamil LIPIL with Iron.

The FDA says studies show that the dangers of health effects are only a concern when both chemicals are present. Because dual contamination is key, there have been no recalls of the formulas.

Consumer’s Union is concerned that the FDA was assuming parents would never feed their babies more than one type of formula. They point to a case where one mother fed her baby two different formulas because “one caused constipation, and one caused loose bowels, but together the baby’s digestion seemed just right.”

The International Formula Council, an organization representing major infant formula makers, said doctors generally recommend feeding infants only one type of formula.

An FDA spokeswoman said the agency’s testing “found that the U.S. supply of infant formula is safe,” but that they were reviewing Consumer’s Union concerns.

In China, melamine has caused sickness in 300,000 babies, killing at least six infants. There, melamine was intentionally added to watered-down milk in order to show higher protein levels in food quality tests. Byproducts of the milk ended up in various products, including infant formula and coffee creamers.

The concentration levels detected in U.S. infant formula samples were 10,000 times smaller than the levels detected in China’s infant formula. However, there has been little research on what levels are considered safe. Rep. Rosa DeLauro, who heads a panel which oversees the FDA budget, called for a zero-tolerance policy for melamine in domestic infant formula.

Originally posted at InjuryBoard by Greg Webb

Disruptive Doctors Causing Medical Errors and Workplace Problems

Greg Webb — Wed, 24 Dec 2008 08:00:00 GMT

Hospital staff members are blaming badly behaving doctors for low morale, stress, and high turnover, which contribute to medical mistakes, preventable complications, and even death, a recent study showed.

A survey of health care workers at 102 nonprofit hospitals from 2004 to 2007 found that 67 percent of respondents thought there was a link between disruptive behavior and medical mistakes, and 18 percent said they knew of a mistake that occurred because of a disruptive doctor. Dr. Alan Rosenstein, medical director for the West Coast region of VHA Inc., authored the study.

L. Silverthorn, a nurse in Washington, recounted a patient she knew was in danger; he had a shunt in his brain to drain fluid, but he was vomiting and had an extreme headache, two signs that the shunt was blocked and fluid was building up. She paged the on-call resident twice, receiving a response that she didn’t “know what to look for” because she’s “not a doctor.” After an ignored third page, she called the attending physician at home, who rushed the patient into surgery.

A survey by the Institute for Safe Medication Practices found that 40 percent of hospital staff members had been so intimidated by a doctor that they did not share their concerns about orders for medication that appeared to be incorrect. Consequently, 7 percent say they contributed to a medication error.

Abusive behavior by doctors has been decreasing in the past five to ten years, physicians and nurses report, though it is still a major problem. Some nurses say they have ducked scalpels thrown across the operating room, and more say they are insulted and yelled at, often in front of patients or other staff members. One-third of the nurses in Dr. Rosentein’s study knew of a nurse who had left a hospital because of a disruptive physician.

“Most people are trying to do the best job they can under a high-pressure situation,” said Dr. Joseph M. Heyman, chairman of the trustees of the American Medical Association. “About three to four percent of doctors are disruptive,” said Dr. William A. Norcross, director of a program at the University of California, San Diego, that offers anger management for physicians, “but that’s a big number, and they really gum up the works.”

The leading offenders of disruptive behavior are specialists in high-pressure fields such as neurosurgery, orthopedics, and cardiology. Dr. Peter B. Angood, chief patient safety officer at the Joint Commission, the nation’s leading independent hospital accreditation agency, witnessed an incident where a nurse called a surgeon to come verify his next patient and mark the operation spot. The surgeon yelled at the nurse to get the patient ready herself. The surgeon showed up late to the operating room, and wound up operating on the wrong part. The surgeon then “berated the entire team for their error . . . when the error was the surgeon’s because he failed to cooperate in the process,” Dr. Angood said. A hostile environment increases the risk of medical errors, said Dr. Angood. Dr. Norcross blames the training surgeons get. “That whole structure teaches a disruptive behavior.”

Things may be changing for the better. Two of the six core skills taught in medical schools and residency programs are good communication and leadership. Hospitals are also either “getting rid of [disruptive] doctors, or sending them to anger management,” noted D. Thomas R. Russell, executive director of the American College of Surgeons.

collaboration and communication between fields. Ms. Silverthorn says the changes are overdue, a view most other staff members agree with. “We go to school, we have a very important job, but there’s no respect.”

Originally posted at InjuryBoard by Greg Webb