Colorado Law Blog

The Food and Drug Administration took a step many consider long-overdue and proposed new rules yesterday that would make it tougher for scientists with industry ties to offer advice about approving new drugs and medical devices. The FDA said that most scientists with $50,000 or more in stock, consulting fees or other financial links to companies should be barred from making recommendations to the agency about a related product. Scientists with smaller financial interests would be allowed to participate in agency advisory meetings but could not vote.

The Food and Drug Administration took a step many consider long-overdue and proposed new rules yesterday that would make it tougher for scientists with industry ties to offer advice about approving new drugs and medical devices. The FDA said that most scientists with $50,000 or more in stock, consulting fees or other financial links to companies should be barred from making recommendations to the agency about a related product. Scientists with smaller financial interests would be allowed to participate in agency advisory meetings but could not vote.

The proposed rules fall short of recommendations made by an Institute of Medicine blue-ribbon panel which advised that a majority of advisory committee members be free of conflicts. Critics of the FDA say these conflicts have led committees to endorse unsafe products.

One example often cited by critics was the 2005 advisory committee vote in favor of allowing Vioxx to return to the market after its manufacturer voluntarily withdrew it. The committee also voted to keep another painkiller, Bextra, on the market. Ten of 32 panel members were later found to have had conflicts of interest, and their votes affected the outcome. The FDA subsequently decided against allowing the sale of Vioxx and asked Bextra's maker to stop selling its drug.

A study published last year in The Journal of the American Medical Association reviewed advisory panel meetings over three years, and found that more than half of the panel members had a conflict of interest at 22 percent of the meetings surveyed. The study surveyed 221 meetings held by 16 advisory panels from 2001 to 2004. It found that at least one member had a conflict in 73 percent of the meetings.

It is questionable whether the new rules will keep many scientists from participating in the advisory panels as most have financial ties to industry of less than $50,000. But the rules may encourage the FDA to step up its recruitment of scientists who have no industry ties at all.

Since 2000, the FDA has been screening its advisers for conflicts before meetings. Yet that effort only led to further criticism of industry taint, because the agency granted waivers that allowed many scientists to continue participating on the panels, citing the need for their expertise.

FDA officials said the new rules should put an end to those concerns by establishing clear standards for when and how scientists may participate. The agency could also decide to impose additional limits on the participation of experts who meet the new guidelines, if there is a perception of a serious conflict.

The FDA is seeking public comment for the next 60 days.

Posted by Linda Chalat at 10:06 AM | Permalink | Comments (0) | TrackBacks (0)

Wyoming and Arkansas are the deadliest states for truck crashes, according to Citizens for Reliable and Safe Highways, a safety group that has called for tougher federal regulation to reduce fatalities resulting from big rig truck crashes. The number of nationwide fatalities each week has remained above 100 nationwide for years.

The safest states for truck crashes were Rhode Island and Massachusetts, based on the number of fatalities per 100,000 residents during 2005, the most recent year with complete figures.

In 2005 Wyoming had 6.09 deaths in big truck crashes per 100,000 residents, followed by Arkansas at 4.17, Oklahoma at 3.41, New Mexico at 3.27, Mississippi at 3.12, and West Virginia at 3.03. Colorado fell mid-range in the list of states, with 1.5 deaths per 100,000 residents.

The safest state, Rhode Island, had 0.09 fatalities per 100,000 residents, followed by Massachusetts at 0.38, Connecticut at 0.48, District of Columbia at 0.54, Hawaii at 0.71, Alaska at 0.75, New York at 0.76, New Hampshire at 0.84 and Delaware at 0.95.

The largest increases in truck fatality rates between 2004 and 2005 came in Oklahoma, South Carolina and Louisiana. The greatest drops were in Alabama, Indiana and South Dakota.

In 1999, when the federal Motor Carrier Safety Administration agency was created, 5,380 people died in crashes with big trucks, in 2005 the number of fatalities was 5,212. For the past four years, the number of fatalities has been rising. One explanation for the recent rise in fatalities points the finger at the motor carrier administration for increasing the number of hours a driver can operate a truck by 28 percent since 2003, up to as much as 88 hours over an eight-day tour of duty. See Big Rigs Pose Big Risk.

Colorado - 2005 Large Truck Crash Facts:

65 Large Trucks Involved in Fatal Crashes
68 Fatalities in Crashes Involving Large Trucks
2,429 Large Trucks Involved in Non-Fatal Crashes
654 Large Trucks Involved in Injury Crashes
856 Injuries in Crashes Involving Large Trucks

Statistics from:
Truck Safety Coalition
Federal Motor Carrier Safety Administration

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Earlier this week The Boston Globe reported on the very sad case of 77-year-old Jean Dwyer. Mrs. Dwyer seemed distressed as she lay in her bed at a Norwell, MA nursing home last fall, but she could not explain to her grown daughter what was wrong due to her dementia. Her daughter attended her bedside daily for a couple of weeks, and was ultimately told that her mother's organs were shutting down and that she was near death.

It wasn't until the nursing home sent Dwyer to a wound clinic at a local hospital on Oct. 19 that her daughter discovered the true source of her mother's agony. The poor woman had a gaping wound on her ankle that left her bone and ligaments exposed. Dwyer's organs were not shutting down, but a raging infection from the sore had spread into her bloodstream and her right leg had to be amputated to save her life. She is now living comfortably in a new nursing home and has progressed to the use of a wheelchair.

As a result of poor care and weak enforcement of public laws regulating long-term care facilities, Mrs. Dwyer and others like her — residents and their families — turn to the civil justice system as a last resort. Most lawsuits against long-term care facilities are brought for multiple, serious omissions of care that cause life-threatening pressure sores, permanently contracted muscles, infections, broken bones, malnutrition, or dehydration.

The reasons are complex, but the overwhelming reason for negligent care is a chronic lack of well-trained and well-supervised nursing staff to provide necessary care. A 2001 federal study, based on research by leading experts in long-term care, documented that more than half of all nursing homes do not employ enough nursing staff to avoid harm to residents, and more than nine out of ten do not employ enough nurses and nursing assistants to provide good care. Ninety percent of care in nursing homes is given by nurse aides who struggle to do their jobs with little training, low pay, few benefits, minimal professional supervision, and limited resources. In 2002, annual turnover rates among nursing assistants exceeded 80 percent in 19 states, and exceeded 100 percent in 10 states. A 2005 analysis of nursing home staffing data shows that the proportion of care provided by registered nurses is declining in spite of increases in Medicare funding earmarked for nursing. Furthermore, the U.S. Department of Health and Human Services’ Office of Inspector General found that only 38 percent of medical directors visit their nursing homes more than once a week.

In 2004, long-term care ombudsmen investigated nearly 20,000 complaints against nursing homes related to abuse, gross neglect, and exploitation, and over 87,000 complaints about resident care. Also in 2004, regulatory agencies cited 26.2 percent of nursing homes nationwide for violations related to quality of care. Many of the facilities where neglect and abuse occur are repeat poor performers with long histories of serious, identified problems that state regulators have allowed to continue year after year. In fact, the U.S. Government Accountability Office’s chief healthcare investigator told the Senate Finance Committee in 2003 that more than 300,000 elderly and disabled residents lived in chronically deficient nursing homes where they were “at risk of harm due to woefully deficient care.” He said residents suffered serious harm or died “when physicians’ orders were ignored, when residents were allowed to deteriorate due to malnutrition or dehydration without any intervention, or because bedsores went undiagnosed or . . . were not treated properly.”

Despite the widespread evidence of neglect and abuse in nursing homes, residents and their loved ones often have little recourse when serious harm, injury, or even death results. Government studies show that state regulatory agencies also suffer from understaffing and have high turnover rates among their surveyors, creating a shortage of experienced investigators. According to the Government Accountability Office (GAO) and the Office of Inspector General, state survey agencies frequently fail to cite facilities for harming residents, even when they find serious injuries; and when facilities are cited for deficiencies, fines often fail to reflect the seriousness of the violations.

More than 2.5 million American elders and disabled adults live in nursing homes, assisted living facilities, and other board and care settings because they require around-the-clock nursing care and/or assistance. Some of these vulnerable adults suffer from neglect and abuse that can only be described as horrific. For them, and for their families, courts are the last resort and civil lawsuits are pleas for those responsible and our society to recognize their plight and keep others from suffering needlessly.

In civil suits, the only way the court can compensate victims for injuries is by providing financial compensation for damages. Most civil cases involving persons who are in the workforce seek economic damages—reimbursement for out-of-pocket expenses like medical bills and lost wages or future earning potential. Non-economic damages are sometimes referred to as awards for “pain and suffering.” Unlike reimbursement for economic damages, non-economic damages are the only compensation a jury can award for the injury or wrongful death itself. Since economic damages are rarely an option for long-term care residents because they do not have an earned income or earnings potential, non-economic damages are the only remedy available to compensate for painful injuries, permanent loss of limbs, loss of ability to function, and death.

A Harvard University researcher estimated in testimony before the Senate Special Committee on Aging in 2004 that 80 percent of all compensation in nursing home lawsuits is for non-economic damages. He testified that caps on non-economic damages would block the ability of injured residents and their families to hold nursing homes
accountable for their negligence. Unfortunately, medical malpractice bills that have been introduced by federal lawmakers and enacted into law by some state legislatures include such caps. The caps would limit non-economic damages to $250,000 in health care lawsuits, including those against nursing homes and assisted living facilities, while allowing unlimited economic damages for the able-bodied. The effective result of this is that it would become financially impossible for attorneys to bring cases for victims who do not have economic damages. The costs of bringing a case to trial — the costs incurred in discovery, obtaining the testimony of expert witnesses, depositions, and research — can easily reach into the tens or even hundreds of thousands of dollars. When the cost of bringing a case approaches the maximum compensation a jury can provide under an artificial and arbitrary cap, legitimate cases will be locked out of the courtroom. In contrast, a jury would have no limit on the amount it could award a corporate executive who brought a tort case for loss of income. Limiting non-economic damages devalues the lives of older Americans and increases vulnerability to abuse and neglect of every citizen in his or her final years.

In addition to making it almost impossible for residents to bring lawsuits against nursing homes or assisted living facilities, the limit on damages would remove the deterrent effect that monetary penalties have had on facility behavior, especially on facilities that are owned by multi-million dollar corporations. Indeed, the president of a health care insurer in Colorado says lawsuits are having a positive effect. He told an insurance trade journal that the nursing home industry is “correcting itself,” conducting more background checks on workers and improving nurse staffing because more insurance carriers “will not take on the risk unless staffing ratios meet certain targets.”

Posted by Linda Chalat at 11:32 AM | Permalink | Comments (0) | TrackBacks (0)

Last Halloween it was New York City funeral homes partaking in clandestine selling of cadaver parts, see Modern Day Body Snatchers – now the former director of the cadaver donor program at the University of California, Los Angeles, along with his modern-day Igor, have been charged with conspiracy and grand theft. Both have been accused of illegally trading body parts that had been donated to the University for Medical Research.

The criminal charges came three years after the authorities first arrested the men and then freed them as the campus police investigated what they called complicated dealings involving hundreds of body parts. Henry Reid, who directed the University’s program from 1997 to 2004, and Ernest Nelson, who operated a business transporting body parts, were arrested Wednesday.

The criminal complaint by the Los Angeles County district attorney’s office alleges that from May 1999 to February 2004, the two conspired to defraud U.C.L.A. of donor bodies for personal financial gain. Mr. Reid, the complaint asserts, sold human body parts to Mr. Nelson, for $43,000. Mr. Nelson, who operated the Empire Anatomical Company, then made over $1 million by selling the remains to more than 20 private medical, pharmaceutical and hospital research companies.

The investigation led U.C.L.A. to temporarily suspend its willed body program. As more stories of black market dealings come to light, the real danger is the loss of willing donors of organs and bodies. Approximately 50 to 75 people can benefit from one person's organs. However, thousands of people die each year due to the critical shortage of transplantable organs and tissues. In the U.S. alone, an estimated 14 people die each day because donor organs are unavailable.

Organ transplantation is no longer considered experimental. It is now a viable treatment option for many patients experiencing end-stage organ failure. In 1984, the United States Congress passed the National Organ Transplant Act classifying human organs as a national resource and not subject to compensation or sale. However, a world-wide trade in body parts and organs has developed, along with “medical tourism,” and a lucrative domestic black market.

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Four years ago the Florida Legislature capped certain types of pain and suffering damages in medical malpractice suits, yet Florida doctors still pay the highest malpractice insurance rates in the country. Now, the high premiums for doctors mean ultimatums given to patients - sign away rights to sue over possible medical mistakes or maybe give up your doctor.

Gov. Charlie Crist has asked the Office of Insurance Regulation Commissioner Kevin McCarty to recommend the next course of action. "If in fact the rates are shown not to go down, even though we have a (lawsuit damages) cap, it has to make you wonder what's going on," Crist said recently. "That was the whole point and purpose, as I understood it.”

In 2003, insurance rates for doctors and claim numbers had skyrocketed and driven all but four malpractice insurers out of the state. Doctors were dropping their policies or eliminating high-risk procedures. Thousands of doctors marched on Tallahassee, demanding relief and some in Tampa Bay protested by delaying surgeries.

The Legislature met in three contentious special sessions before agreeing on a $500,000 cap, reasoning that cap would reduce malpractice claims and thus insurance rates.

As predicted, malpractice claims have gone down. Payouts on claims and legal expenses dropped in Florida about 43 percent between 2003 and 2005, the most recent data available. In 2003, Florida companies paid over $989-million and by 2005 that figure was $557-million, according to National Association of Insurance Commissioners records.

Yet, malpractice premiums haven't reflected the reduced risk. The 2003 legislative reforms required malpractice premiums be cut by 8 percent, but with rate hikes already in the pipeline the legislation did little more than slow the pace of rising rates.

In the meantime, some of the state's largest malpractice insurers are profiting on the difference between current premium rates and the lower claims. FPIC Insurance Group Inc., the publicly traded parent of Florida's largest malpractice insurer, reported a 47 percent increase in profits in 2006 compared to 2005, according to federal filings. Its subsidiary, First Professionals Insurance Co., insures more than a third of Florida doctors, hospitals and clinics, according to the state.

There are several explanations as to why premiums haven't come down, but one offered by consumer advocates is the lack of competition. In fact, 78 percent of all Florida's doctors, hospitals and clinics were insured by five companies in 2005, according to state market share report. The Florida Medical Association, the lobbying group that represents doctors, has been strikingly silent on the lack of reduction. It has a business relationship with First Professionals, offering minor discounts in coverage to its members.

In spite of the result obtained in Florida, the same ill-proved logic is being argued in Hawaii. The 1,300-member Hawaii Medical Association is lobbying for a bill that would cap the noneconomic damages in a malpractice suit at $500,000. Currently there is no cap on noneconomic damages. A House bill has passed the health and consumer protection committees and is scheduled for a final hearing today in the House Judiciary Committee. It is the last committee the bill must pass before it can cross over to the Senate.

The threat of malpractice suits and rising insurance premiums is just part of the reason doctors say they are closing their Hawaii practices, particularly in rural areas. For years, they have complained about decreasing reimbursements from government and private insurance carriers as well as increased pressures of the job.

While not all doctors pay high malpractice insurance premiums, rates for specialists such as general surgeons, neurosurgeons, orthopedics and obstetrician-gynecologists have increased by 58 percent in Hawaii since 2001 to an average $52,604 last year, according to the Medical Insurance Exchange of California, Hawaii's largest malpractice carrier covering 1,100 local doctors.

While the amount paid out for malpractice suits has risen in recent years, the number of malpractice claims has steadily dropped since 2001, when 173 claims were filed, compared to 115 claims filed last year, according to a report by the Medical Claims Conciliation Panel, a third-party panel created by the state in 1976 to screen out frivolous lawsuits.

Colorado was one of the first states in which tort reform arguments gained support in the state legislature. Caps on medical malpractice damages were put in place as early as 1986, and amended as recently as 2005. Currently, the Health Care Availability Act places a $300,000 cap on non-economic damages, which includes damages for physical impairment or disfigurement. The Colorado statute also provides that “the total amount recoverable for all damages for a course of care for all defendants in any civil action for damages in tort brought against a health care professional, as defined in §13-64-202, or a health care institution, as defined in §13-64-202, or as a result of binding arbitration, whether past damages, future damages, or a combination of both, shall not exceed one million dollars…” The limitations placed on Colorado victims of medical mistakes make the Florida and Hawaii caps look a little less onerous.

Posted by Linda Chalat at 02:46 PM | Permalink | Comments (0) | TrackBacks (0)

We hear daily reports on results from clinical trials for new drugs, and they have a tendency to show positive results - particularly in trials with drug-company funding. A new study appearing on the website of the American Cancer Society, analyzes 140 trials of breast-cancer drugs. In 2003, trials with pharmaceutical-company backing showed positive results in 84% of the studies, compared to just 54 % for trials without industry backing.

The study was led by Dr. Jeffrey Peppercorn, assistant professor of medicine at the University of North Carolina Lineberger Comprehensive Cancer Center., along with three researchers at the Dana-Farber Cancer Institute in Boston

The amount of funding from pharmaceutical companies now exceeds that from the National Institutes of Health. In fact, pharmaceutical-industry investment in research exceeds the entire operating budget of the NIH. That gives the pharmaceutical industry tremendous influence on the nature and direction of breast-cancer research. The greatest danger is that important clinical issues aren't being addressed.

The study revealed two trends. First, greater dug company involvement. In 2003, 58 percent of studies reported pharmaceutical involvement, versus 44 percent in 1993. But that may be because of more stringent disclosure requirements in recent years. Second, studies backed by pharmaceutical companies were significantly more likely to report positive results. In 2003, the likelihood of positive results was 84% for studies with pharmaceutical involvement, versus 54% in studies free of industry connections.

Though the reviewed breast cancer trials only numbered 140, similar trends have been documented in stroke trials, psychiatry trials, cardiovascular trials and several other areas of clinical research. The one previous study in oncology, looking at multiple myeloma, found that pharmaceutical studies reported positive results in 74 percent of trials compared to 47 percent of non-industry-sponsored trials.

Another issue complicating interpreting research results is the practice of burying studies with negative results, as has been alleged in the case of Vioxx studies in Europe. These “negative” studies are not published in journals. However, there is now a move to establish clinical-trial registries online. Trials would be registered prior to being performed, allowing for tracking regardless of the outcome.

Interestingly, Dr. Peppercorn offers two explanations for the discrepancy in positive results. It could represent bias in the reporting or in the interpretation of results. Or it could be that the industry-sponsored studies are superior, reflecting the pressure for-profit companies are under to make smarter or safer choices about what drugs to bring to trial.

For the complete Newsweek interview, click here.

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