MEDICARE TO PAY FOR PET FOR ALZHEIMER DISEASE
Medicare has decided to cover the use of PET for Alzheimer disease, a controversial move that reverses the decision not to cover it made just over a year ago. The Centers for Medicare and Medicaid Services (CMS) is currently reviewing public comments on the coverage decision, and is expected to issue a final draft next month. The coverage will apply to patients suspected of having Alzheimer disease, but for whom a clinical evaluation is inconclusive, as a tool for confirming or discounting a diagnosis of Alzheimer disease. It will also apply, in the context of clinical trials, to patients with unexplained memory loss and early dementia.
The decision could influence private insurers, who often base coverage decisions on the Medicare system, to cover PET for diagnosing Alzheimer disease, as well.
A year ago, CMS concluded that PET would not improve the practice of routinely treating patients with the diagnosis of mild cognitive impairment or dementia. The decision was made pending further evidence, and CMS officials engaged independent experts from the Alzheimer's Association and medical professional organizations, as well as the National Institute on Aging, to examine the latest studies and offer recommendations. The conclusion: PET is a useful tool for diagnosing Alzheimer disease in difficult clinical cases, but there is limited evidence on its usefulness in evaluating cognitive impairment, and more research is needed.
“This decision will allow the possibility of a more precise diagnosis of Alzheimer disease or other dementia in difficult cases where a routine diagnosis is inconclusive,” said Sheldon Goldberg, President and CEO of the Alzheimer's Association, in a news release. “This is important in order to inform patients with greater certainty the reason for their symptoms, get them on appropriate treatments, and enable them to plan for their care.”
The draft decision is available online here: www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=104. The CMS officials also plan to further study the use of PET in guiding treatment and predicting the course of Alzheimer disease, according to a news release.
NEW NIH CONFLICT OF INTEREST RULES
NIH Director Elias A. Zerhouni, MD, outlined the NIH plans for new conflict-of-interest policies for its employees in testimony before a Congressional Committee in late June. The new guidelines, which will manage relations between high-level NIH employees and industry and academic institutions, are based in part on the recommendations of the NIH Blue Ribbon Panel on Conflict of Interest Policies.
Commenting by phone, Roger J. Porter, MD, praised Dr. Zerhouni's plan to manage conflicts of interest. “He has done a good job and is as close as you can get to being fair to government employees and still having a firewall between those dispensing money and those receiving it,” he said. Dr. Porter spent 20 years with the NINDS, culminating in the position of NINDS Deputy Director, before leaving to become Vice President of Clinical Pharmacology at Wyeth. He has since retired.
The rules aim to stringently limit the financial or other compensation that NIH employees can receive from outside institutions, particularly pharmaceutical and biotechnology companies, but purposefully fall short of a total ban. Stock holdings and award receipts will be very limited, with only approved bona fide awards allowed. Consultation with institutions that receive NIH grants and participation on industry corporate boards will not be allowed.
Finally, outside activities with industry players will be limited for most NIH employees and will require approval of the Deputy Ethics Counselor – but such consultation arrangements will be forbidden to senior NIH employees and those who make extramural funding decisions.
Dr. Porter called this last provision the “single most important factor” in preventing conflicts of interest, and noted the rule existed when he worked at the NIH. “If you are in charge of dispensing money at the NIH, you shouldn't have any dealings with recipient organizations in any way that could create a conflict of interest,” Dr. Porter said. Grants “should be awarded purely on the basis of scientific merit, and any suggestion that there is another reason embarrasses the NIH.”
Other provisions of Dr. Zerhouni's plan include increasing the responsibility of managers in handling conflicts of interest, honing education for employees, and improving oversight mechanisms and tracking systems for conflict of interest documentation. His testimony to Congress is available online here: www.nih.gov/about/director/062204zerhouni_COI.pdf.
GAO ASSESSES RISKS OF ONLINE PHARMACIES
A General Accounting Office (GAO) report on buying prescription medications online offers mixed news for physicians concerned with patient safety. On the plus side, all of the Canadian pharmacies tested required a prescription before dispensing drugs and most of the drugs ordered had the correct chemical composition. On the down side, investigators were able to buy drugs without a doctor-provided prescription from many Web sites – including 24 for US pharmacies – and almost all of the drugs bought from pharmacies in foreign countries – such as Argentina, India, Mexico, Pakistan, and Spain – were not approved for US sale.
GAO officials ordered one of 13 different drugs from 90 online pharmacies. The 13 drugs are frequently prescribed, often counterfeited, or have safety or prescribing restrictions. The list included three pain medications – hydrocodone, oxycodone, and narcotic analgesics and acetaminophen – and two drugs for mental illnesses – sertraline and clozapine. They received 68 orders – 45 of those without sending in a prescription. However, many of these sites – 24 in the US and 3 in other countries – provided the patient with a prescription based on an online questionnaire. The officials were unable to obtain two out of the list of 13 online, however.
Drugs with safety restrictions and narcotics were harder to obtain than commonly prescribed drugs. These drugs were offered on fewer sites, and many sites that advertised them replaced them with a less potent drug during the purchasing process, or simply did not sent the order.
Common safety complaints included the fact that some drugs were missing instructions and warning labels; there was no temperature control for temperature-sensitive drugs; and some of the packaging was punctured or unconventional. Most of the prescriptions purchased from pharmacies outside of the US were not approved for US sale – because, for example, they were missing label information or came from unapproved manufacturing facilities. However, only four samples were deemed counterfeits by their respective manufacturers, with the remainder considered chemically equivalent. Commenting on the report, the Food and Drug Administration noted that chemical equivalency does not necessarily mean therapeutic equivalency.
This study “shows how the Internet has changed our lives, in many ways that are not all good,” said Gloria Galloway, MD, Associate Professor in the Departments of Neurology and Pediatrics at Ohio State University in Columbus and member of the AAN Patient Safety Workgroup, in an e-mail message. She noted that this study raises two major red flags. First, “many of the medications purchased in this report have potential for misuse and abuse, and are addictive in nature. The fact that many of these were purchased without a physician-directed prescription is alarming.”
Secondly, she continued, “four of the drugs purchased online were not chemically the drug intended…. There can be major morbidity and mortality associated with using the wrong medication.” She concluded, “More study is needed to determine the safety of online ordering of prescription medications from anywhere – including Canada.”
WOMAN IN US DIES OF VCJD, SAFEGUARDS PROPOSED
The only US case of variant Creutzfeldt-Jakob disease (vCJD) has proved fatal. Charlene Singh, age 25, died of the disease in late June. She began showing symptoms of vCJD in late 2001, and her situation had been monitored by the Centers for Disease Control and Prevention since her probable diagnosis in 2002.
Experts believe she contracted the disease from eating infected meat while in Britain, where she was born and lived before moving to the US in 1992. Although she received experimental quinacrine for three months, her condition deteriorated rapidly in 2002.
In other news, HHS is expanding the safeguards in place to keep bovine spongiform encephalopathy (BSE) – the suspected cause of vCJD – out of the US food supply. The new rules, put in place in July, ban high-risk materials from cattle in human food, including dietary supplements, and cosmetics. The banned materials include the brain and spinal cord of cows 30 months old or older, the tonsils of cows of all ages, and other portions known to have high concentrations of the prions that cause BSE