Cancer Drug Shortages Affect Children
Source: NPR Health News
This isn’t the first time we’ve heard about the crisis of drug shortages in U.S. Hospitals. However, it isn’t just patented drugs anymore -it’s the generics. One particular generic drug, methotraxate, has been the deciding factor in the lives or deaths of children with acute lymphoblastic leukemia and osteogenic sarcoma. High doses of methotrexate are given to children with these cancers. “There’s really no known curative therapy without methotrexate,” according to Dr. Howard Weinstein of Massachusetts General Hospital. “Based on our current outlook, if we don’t get any supply, we’re going to be out of methotrexate in the next couple of weeks.” Weeks, not months, at a major hospital. And they aren’t alone, the situation is just as critical at the Children’s Hospital and Clinics of Minnesota.
Why is it so difficult to obtain methotrexate for children with these cancers? Medical Oncologists (cancer doctors) inject methotrexate directly into the spines of patients with ALL. The treatment requires high doses of the drug. Because it is going directly into the spine, it must be free of alcohol-based preservatives which could cause paralysis. A major manufacturer of injectable methotrexate, Ben Venue Laboratories of Bedford, Ohio, was shut down by the FDA in November of 2011. Why? A host of reasons including mold on the walls of the factory and rust from manufacturing equipment literally falling into open vials. For those of you picturing white sterile laboratories free of contamination, you’d be incorrect.
In corrective action, Ben Venue Laboratories claims to have invested over $250 million and three years of time upgrading facilities to restore safe production. Unfortunately Ben Venue Laboratories is also the sole world-wide manufacturer of Doxil, a drug previously used to treat women with ovarian and breast cancers, which is now unobtainable.
Again, manufacturers of off-patent generic drugs claim that the costs are high to produce the drugs and that the rewards (profits) are low. Various forms of subsidies have been suggested to encourage drug manufacturers to continue to produce much-needed medications, such as methotrexate. The costs of not producing these drugs is fairly high as well.
Posted by: David M. Schwadron, Esquire
Hepatitis C Vaccine in Development?
Source: BBC Health
Early clinical trials of a manufactured hepatitis C vaccine has shown what researchers at Oxford Univesity are calling ”promising” results. The study involved only 41 patients and was complicated by the fact that the virus alters its appearance.
Designing a vaccine has been difficult as the virus changes its appearance, making it hard to find something to target. Hepatitis, a disease affecting the liver, is caused by five main viruses – A, B and C, and, more rarely D and E. Hepatitis B is the most common, and can be passed from mother to baby at birth or in early childhood as well as through contaminated injections, injected drug use, unprotected sex and other means. Hepatitis C is also spread through using unsterile needles and less commonly through unsafe sex, and sharing razors or toothbrushes, for example. The E virus, caught from infected water or food, is a common cause of outbreaks of the disease in developing countries, said the World Health Organization. Many of those carrying hepatitis are not aware they have it and can unknowingly transmit it to others.
The first worldwide estimates in drug users show 10 million people have hepatitis C while another 1.3 million have hepatitis B. Only a small number of those who could benefit from antiviral drugs recive them. Only 1 in 5 infants around the world are vaccinated against hepatitis B at birth, they say. About 67% of injecting drug users in the world have been exposed to hepatitis C, while around 10% have come into contact with hepatitis B. According to statistics from the U.S. Centers for Disease Control and Prevention, there are more than 700,000 cases of viral hepatitis per year in the United States -more than half of which are asymptomatic. The virus is found worldwide with the highest levels in under-developed countries.
The researchers say a vaccine “would be a major step forward”. So just how does one make an antiviral vaccine? The researchers modified common cold viruses with genetic material from the hepatitis C virus. The idea is to develop an immune system response against the hepatitis C virus. Of the 41 healthy patients given the vaccine, a ”very strong” immune response was demonstrated. This response lasted for at least a year and had no major side-effects. The research was led by Prof Louisa Degenhardt of the Centre for Population Health, Burnet Institute, Melbourne, Australia, and Paul Nelson from the National Drug and Alcohol Research Centre at the University of New South Wales.
Posted by: David M. Schwadron, Esquire
Medicaid Cuts to Impact Nursing Home Care in NJ?
Source: The Record
This Summer, New Jersey officials voted to move to a reimbursement system that would allow homes that care for the patients with greater medical needs to be paid at a higher daily Medicaid reimbursement rate. However the negative impact upon revenues for homes which care for healthy patients prompted a slow adoption process. During the course of this wrangling, Governor Christie’s budget for the state called for some $75 million in Medicaid spending reductions. The Christie plan was for a 3% cut across homes but was applied disporportionally.
The result? One nursing home in Wyckoff, which three years ago opened a 68-bed, post-acute care unit to accommodate sicker patients, saw its daily per-Medicaid-patient reimbursement rate drop from $198 to $187, although the new rate system had previously promised to raise that figure to $225. The state notified nursing homes of the revised Medicaid rates in early October, more than three months into the current fiscal year, meaning some facilities would have to pay back a portion of reimbursements already received.
Since then, nursing home advocates have been lobbying the Christie administration and lawmakers for some relief from cuts they say could in time force them to cut staff or services. Advocates say county-operated nursing homes also could be among the most hurt by the rate changes as they tend to serve patients who are predominantly on Medicaid. State Sen. Loretta Weinberg, D-Teaneck, outgoing chairwoman of the Health, Human Services and Senior Citizens committee, said she is discussing potential solutions with other legislative leaders but doubts anything could be done in the current fiscal year to roll back cuts, as some nursing home operators are hoping.
“I think these cuts are harmful, and they are harmful to the most vulnerable of populations,” Weinberg said. “We need to hear from the people who are affected. We need their voices on this.”
”There is a lot of uncertainty,” said Larry Lane, vice president for government relations at Nursing Home Giant -Genesis Health Care, a national chain that operates 30 nursing homes and three assisted living centers in New Jersey alone, which together will lose between $6 and $7 million in Medicaid cuts. On the labor side, Service Employees International Union Local 1199, which represents 7,000 long-term care workers in New Jersey, is already concerned that some homes are not staffed adequately, nor trained well enough, to care for these sicker patients, said Milly Silva, executive vice president. “No one wants to see a tragedy where somebody ends up injured because of a lack of staff,” Silva said. No indeed.
Posted by: Gayle R. Lewis, Esquire
HPV Test is Better than Pap Test for Cervical Cancer?
Sources: The Lancet; US Preventivie Serivices Task Force; WebMD
It appears that way. It is largely accepted that 90% of all cervical cancers are caused by the Human Papillomavirus (HPV). Accordingly, a team of Dutch researchers set out to determine whether detecting the cause of the majority of cervical cancers could out-predict the traditional test. 45,000 women from ages 29 to 56 were screened using both the Pap (Papanicolaou) test and the HPV test.
- The USPSTF strongly recommends screening for cervical cancer in women who have been sexually active and have a cervix.
- The USPSTF recommends against routinely screening women older than age 65 for cervical cancer if they have had adequate recent screening with normal Pap smears and are not otherwise at high risk for cervical cancer.
- The USPSTF recommends against routine Pap smear screening in women who have had a total hysterectomy for benign disease.
- The USPSTF concludes that the evidence is insufficient to recommend for or against the routine use of new technologies to screen for cervical cancer.
- The USPSTF concludes that the evidence is insufficient to recommend for or against the routine use of human papillomavirus (HPV) testing as a primary screening test for cervical cancer.
Perhaps this study will be the first of many which leads the USPSTF to conclude otherwise.
Posted by: David M. Schwadron, Esquire
Reducing Your Risk for Breast Cancer.
Sources: NPR; the Institutes of Medicine of the National Academies; Susan G. Komen for the Cure.
A new report which aims to give women practical information on breast cancer and advice for reducing their individual risk for breast cancer has been published. Breast Cancer and the Environment: A Life Course Approach is a consensus review of the evidence. from the Institute of Medicine of the National Academies. The work was sponsored by Susan G. Komen for the Cure.
Don’t have the time to read all that’s contained in there? We understand. Thankfully there is a handle Table which we encourage you to review. Simple environmental and life-style changes can have a dramatic effect upon your individual risk for breast cancer.
Posted by: David M. Schwadron, Esquire
New Jersey Mammography Centers, Bankruptcy and You.
An Open Letter to Women who underwent Breast Mammography in Northern New Jersey in 2009 and 2010!
Did you have a mammogram scheduled and performed at any of the following New Jersey Mammography Centers:
Bergen Open MRI & Diagnostics, located at 1 W. Ridgewood Ave., Paramus, NJ;
Englewood Imaging Center, P.A., located at 177 N. Dean Street, Suite 102, Englewood, NJ;
or Imaging Center of Oradell, LLC, located at 680 Kindremack Road, Oradell, NJ.
You should be aware that these facilities have underwent or are now undergoing bankruptcy proceedings. What does that mean for you? It means that you may experience difficulty and delay in obtaining the results of your diagnostic studies. This can have serious consquences to your health. If you have breast cancer, then any delay in the diagnosis of breast cancer can mean a missed opportunity for treatment and the possibility of a cure. Facilities performing breast mammography have reporting requirements which are established by Federal Law. The failure to timely and properly interpret and report the results of a mammogram which reveals breast cancer is not only a violation of Federal Law, it is in our opinion, malpractice.
We are already aware of at least one patient who has been harmed because these mammography centers did not send her mammogram results to the patient or to her doctors!
Do not delay. If you believe that your mammogram was misread or if you have not received any results from the mammograms performed at the above-mentioned Mammography Centers in 2009 and 2010, contact the Lewis Law Firm. It’s your health, you deserve answers.
The Lewis Law Firm is authorized to conduct business in NJ and PA. The opinions expressed herein are the opinions of the Lewis Law Firm only and are not meant as medical advice or opinion.
Posted by: the Lewis Law Firm
Women with Breast Cancer Quit Meds, According to Recent Study.
Source: Chicago’s Northwestern University News Center; www.northwestern.edu
In what has been termed the “first study in which women are actually asked questions,” a staggering 36% of postmenopausal women who are treated for estrogen-sensitive breast cancer quit using drugs that help prevent the disease from recurring. Universally the reason is because of side effects of the medication, which are more severe and widespread than previously known. Researchers noted that women do not tell their doctors about all of the side effects they experience or their degree.
“Clinicians consistently underestimate the side effects associated with treatment,” said lead investigator Lynne Wagner, Associate Professor at Northwestern University Feinberg School of Medicine and a clinical psychologist at Robert H. Lurie Comprehensive Cancer Center of Northwestern University. “They give patients a drug they hope will help them, so they have a motivation to underrate the negative effects. Patients don’t want to be complainers and don’t want their doctor to discontinue treatment. So no one knew how bad it really was for patients.”
Among reported side effects, the most common one causing cessation of treatment was joint pain. Other side effects women reported as compromising their quality of life were hot flashes, decreased libido, weight gain, feeling bloated, breast sensitivity, mood swings, irritability and nausea. 2/3 of all breast cancers are stimulated by estrogen and the drugs given to women halt the production of estrogen in the body. This causes symptoms commonly associated with menopause.
The women at highest risk for quitting the medications before the recommended five years are those who still are experiencing residual side effects from recent chemotherapy or radiation therapy when they start the aromatase therapy. “The more miserable they were before they started, the more likely they were to quit,” according to Wagner.
The Northwestern study surveyed 686 women with a detailed questionnaire about their symptoms before treatment and at 3, 6, 12 and 24 months after starting treatment. The researchers found after three months of treatment that 33-35% of women had severe joint pain, 28-29% percent had hot flashes, 24% had decreased libido, 15-24% experienced fatigue, 16-17% reported night sweats and 14-17 % felt anxiety. 36% of women ended treatment before an average of 4.1 years. After two years, 10% had quit; the remainder quit between 25 months and the 4.1 years. When one considers that the risk of recurrence of breast cancer in this group of women is high, it is concerning that they would voluntarily stop their medical therapy because of side effects. Perhaps more research into better drugs with less side effects is needed. The research was funded by the National Cancer Institute.
Posted by: Gayle R. Lewis, Esquire
Nursing Homes Over Medicating Patients?
Source: NY Daily News; Eli Lilly & Co.
According to Audits conducted on Nursing Home Facilities in the United States, elderly patients with dementia are too often prescribed anti-psychotic drugs to calm disruptive behavior. The Senate Committe on Aging is apparently having hearings on this issue. Health and Human Services Inspector General, Daniel Levinson has stated that recent government audits raise concerns about the use of antipsychotics by elderly people with dementia in nursing homes, raising their risk of death and wasting money for the US healthcare system.
More than half of such prescriptions were wrongly paid for in 2007 by government Medicare because the patients did not exhibit symptoms of schizophrenia or bipolar disorder, amounting to about 230 million dollars in waste. One audit showed 14 percent of nursing home residents had Medicare claims for antipsychotic drugs, Levinson said.
Toby Edelman, Senior policy attorney in the office of the Center for Medicare Advocacy, Tobt Edelman, said that the estimate was low because it only included some kinds of anti-psychotics. “Nursing facilities’ self-reported data indicate that in the third quarter of 2010, 26.2 percent of residents had received antipsychotic drugs in the previous seven days. That is approximately 350,000 individuals,” she said. “Facilities reported they gave antipsychotic drugs to many residents who did not have a psychosis, including 40 percent of patients at high risk because of behavior issues.”
Sadly, this issue is not new -the same Senate committee issued a report on the misuse of drugs in nursing homes back in 1975. Although it is against federal law the practice of medication control continues, because of serious understaffing in nursing facilities, high turnover of staff, and “aggressive off-label marketing of anti-psychotic drugs.” In particular, in 2009, Eli Lilly Company accepted a Misdemeanor Charge related to Zyprexa(R) (olanzapine).Promotion Between 1999 and 2001. Lilly promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia, although Zyprexa is not approved for such uses. As part of this agreement regarding the criminal investigation, Lilly agreed to pay $615 million. Under terms for the resolution of the civil investigations, Lilly agreed to make payments totaling nearly $800 million.
Posted by: Gayle R. Lewis, Esquire
Hospitals Are More Dangerous on Weekends
Sources: BBC Health News; Dr. Foster Intelligence Hospital Guide 2001-2011; Journal of the American Medical Association
A British research company, Dr. Foster Intelligence, has studied hospitals in the UK from 2001 to 2011 and noticed that there was a ”worrying” 10% spike in deaths compared with weekdays across 147 British Hospitals. The researchers concluded that some of those deaths could have been avoided with better staffing and access to services such as diagnostics. From the report, “Being admitted to hospital at weekends is risky. Patients are less likely to get treated promptly and more likely to die. The chances of survival are better in hospitals that have more senior doctors on site. But some hospitals with A&E departments have very few senior doctors in hospital at weekends or overnight.”
Dr Foster, which works closely with the Department of Health, said its findings needed to be investigated urgently. It looked at death rates using four measures – deaths in hospital, deaths in hospital and within 30 days of discharge, deaths linked to low-risk conditions and deaths after surgery. In total, 42 hospitals had higher than expected mortality rates on at least one measure, of which at least 22 were flagged up in two categories and two in three.
On the weekend performance, Roger Taylor, director of research at the group, said a shortage of senior doctors was at the heart of the problem. “It’s about having the more experienced staff in the hospital, looking after patients out of normal working hours.” Overall, 8.1% of those admitted at weekends died compared with 7.4% from Monday to Friday, once those having elective operations such as hip and knee replacements were discounted. Another notable finding of the report was, “Better care saves money. Hospitals that implement best practice in helping patients recover quickly from surgery achieve better outcomes for less money.” (Take that Tort Reformers).
Wondering what that has to do with care here in the US? Similar trends have been noticed in the same time period. In 2008, the Journal of the American Medical Association published findings that hospital care may be significantly worse on the weekends and at night than on weekdays. After reviewing the survival rates among patients across the country who experienced cardiac arrest during their hospital stays, researchers at Virginia Commonwealth University found that patient mortality rates were higher at certain times of day and on weekends, even when they factored in clinical variables like the patient’s condition and what the different heart rhythms were.
Dr. Mary Ann Peberdy and her colleagues looked at data on 86,748 adult in-hospital cardiac arrests occurring at 507 hospitals between 2000 and 2007, and found that the survival rate during weekdays and weekday evenings was 20.6 percent, while the survival rate on the weekend was only 17.4 percent and an even more disturbing 14.7 percent at night. That means patients were about 41% more likely to survive if they were treated during the day from Monday to Friday. And that wasn’t the first study to find a marked difference in hospital patients’ outcomes depending on when they are treated. A smaller report on heart attack survival rates at New Jersey hospitals was reported in the New England Journal of Medicine (2007) indicating similar trends for higher rates of death for patients admitted with acute MI (heart attacks) on weekends.
Posted by: Gayle R. Lewis, Eswquire
Avastin No Longer Approved for Breast Cancer
Source: US Food and Drug Administration (FDA)
The US FDA has revoked it’s prior approval of Avastin for the treatment of metastatic breast cancer. Avastin came onto the market as being a meidication with great promise for the treatment of metastatic breast cancer. FDA Commissioner Margaret Hamburg stated plainly in her Decision of the Commissioner, that, “[T]there is no benefit to breast cancer patients that would justify its risks.” Among Avastin’s more significant side effects are: heart attack; heart failure; and, severe bleeding.
Avastin was orginally granted “Accelerated Approval” by the FDA in 2008. Accelerated approval is an FDA process which “fast-tracks” drugs which might treat life-threatening conditions where evidence suggests that following more testing the drug’s effectiveness will be proven. However, in this case, a different approval measure was used, Progression Free Survival (PFS) or demonstrating that patients survive longer while taking the drug. Avastin’s sponsor, Genetech, Inc. had produced one study which suggested that the PFS was a median of 5.5 months. However when the date for this single study was later produced, the 5.5 month survival was not supported and the dangers of the drug were found to outweigh the benefits. Genetech was unable to provide any additional studies which suggested that Avastin had a clear clinical benefit for women with breast cancer.
Obviously disappointed with the decision, Genentech put out the following statement, ”We are disappointed with this outcome.” Yes there was more. But don’t feel too badly for Big Pharma, Avastin will remain on the market despite the known risks of the drug. The FDA has approved Avastin for the treatment of certain types of brain, colon, kidney and lung cancers and doctors are still free to prescribe Avastin for any use they see fit, including breast cancer (so-called “off label” usage).
Posted by: David M. Schwadron, Esquire