Monday, December 22, 2003
British Medical Association's call for review of medical ethics training.
Sunday, December 21, 2003
There’s a Blurry Line Between Rx and O.T.C.
At the heart of its decisions, the FDA says, are straightforward scientific and medical questions. Is there a low potential for abuse or misuse? Can consumers use it for self-diagnosed conditions? Can the drug be adequately labeled? Are doctors needed for its safe and effective use?It also says:
The decision to sell a drug by prescription, experts say, may involve factors that have nothing to do with science or patient safety. Marketing and financial considerations, politics, doctors' concerns and consumer psychology all may play a role.How can both statements be true? Consider the morning-after pill, which an expert panel has recommended to FDA Commissioner Mark McClellan be made available as an OTC drug, and the competing social agendas at work:
If the morning-after pill were sold over the counter, doctors who opposed the change said at the F.D.A. hearing, teenagers would avoid counseling on responsible sexual behavior. Some also said that making the drug over the counter would interfere with their relationship with their patients. Those favoring the change said that teenagers are going to have unprotected sex in any case and needed a safe way to avoid pregnancy.And then there's the impact of insurance:
In other cases, straightforward commercial considerations can determine how a company wants a drug classified. For example, drug manufacturers know that patients with drug coverage often prefer prescriptions to paying the full cost of over-the-counter drugs.You can stay abreast of developments in the drug field by monitoring the home page of the FDA's Center for Drug Evaluation and Research, which also features a handy daily or weekly e-mail update service. There's also an OTC information page there.
Doctors say they see this insurance effect all the time. Dr. James Osborne, an internist in Greensboro, N.C., says when patients with occasional heartburn ask for a prescription for Nexium, he often suggests they buy Pepsid, which costs 24 cents a day for the four pills needed to equal prescription strength, or about 17 times less than Nexium. "They say, 'It doesn't matter, doc. I have a drug card,' " Dr. Osborne said.
Wednesday, December 17, 2003
More on medical marijuana.
Medical marijuana use survives US Controlled Substances Act.
B. Factual BackgroundThe court concluded that this entirely local, entirely intrastate activity of growing and using the pot fell outside the federal government's authority to regulate or criminalize pursuant to its power to regulate interstate commerce. This case will be the talk of Constitutional Law classes all across the country in January. The Commerce Clause has been so expansively interpreted in such a long line of cases over so many decades that any opinion that perceives a limit on Congress' power to regulate commerce will be seen as an outlier, no matter how compelling the facts. Indeed, you can count on the fingers of one hand the number of cases (since 1937) in which the Supreme Court has ruled that Congress exceeded its powers under the Commerce Clause, and all of them have been decided in the last 10 years. The thinking was that a more conservative Supreme Court thought the activist Congress needed to have its wings clipped so that it wouldn't have a blank check to regulate any activity it wanted to touch, no matter how local and no matter how much it was a subject of traditional state concern.
Appellants Angel McClary Raich and Diane Monson (the “patient appellants”) are California citizens who currently use marijuana as a medical treatment. Appellant Raich has been diagnosed with more than ten serious medical conditions, including an inoperable brain tumor, life-threatening weight loss, a seizure disorder, nausea, and several chronic pain disorders. Appellant Monson suffers from severe chronic back pain and constant, painful muscle spasms. Her doctor states that these symptoms are caused by a degenerative disease of the spine. Raich has been using marijuana as a medication for over five years, every two waking hours of every day. Her doctor contends that Raich has tried essentially all other legal alternatives and all are either ineffective or result in intolerable side effects; her doctor has provided a list of thirty-five medications that fall into the latter category alone. Raich’s doctor states that foregoing marijuana treatment may be fatal. Monson has been using marijuana as a medication since 1999. Monson’s doctor also contends that alternative medications have been tried and are either ineffective or produce intolerable side effects. As the district court put it: “Traditional medicine has utterly failed these women . . . .”
Appellant Monson cultivates her own marijuana. Raich is unable to cultivate her own. Instead, her two caregivers, appellants John Doe Number One and John Doe Number Two, grow it for her. These caregivers provide Raich with her
marijuana free of charge. They have sued anonymously in order to protect Raich’s supply of medical marijuana. In growing marijuana for Raich, they allegedly use only soil, water, nutrients, growing equipment, supplies and lumber originating from or manufactured within California. Although these caregivers cultivate marijuana for Raich, she processes some of the marijuana into cannabis oils, balm, and foods.
On August 15, 2002, deputies from the Butte County Sheriff’s Department and agents from the Drug Enforcement Agency (“DEA”) came to Monson’s home. The sheriff’s deputies concluded that Monson’s use of marijuana was legal under the Compassionate Use Act. However, after a three-hour standoff involving the Butte County District Attorney and the United States Attorney for the Eastern District of California, the DEA agents seized and destroyed Monson’s six cannabis plants.
Now the worm has turned, and the liberal 9th Circuit (the most-reversed court of appeals in the federal system) has used this new view of the Commerce Clause to rule against John Ashcroft's Justice Department and uphold individual marijuana use in these cases. Stay tuned . . . I rather suspect the Department of Justice might want to run this one by SCOTUS. Meanwhile, news reports and commentary can be found on Google News.
Tuesday, December 16, 2003
Not-So-Public Relations - How the drug industry is branding itself with bioethics. By Carl Elliott
Somehow corporate-funded bioethicists have not been touched by the bad publicity. Many bioethicists continue to insist that they are learning from their industry relationships and shaping company policy for the better. A task force commissioned by the two major American professional bioethics bodies—the American Society for Bioethics and Humanities and the American Society of Law, Medicine and Ethics—concluded last year that private corporations should be encouraged to seek out paid bioethics consultants, because "bioethics will have an impact on that (corporate) activity only if bioethicists can be part of the dialogue." The task force went on to endorse the practice of bioethicists advertising their own services as private consultants.
So the next time you meet a bioethicist, pay close attention; he may look like a bioethicist, but when you peel back his mask, you just might see the adman smiling back.
Monday, December 08, 2003
Pattern of Mistakes Found in Zoo Deaths (washingtonpost.com).
Saturday, December 06, 2003
Links to N.Y. Times articles.
Fortunately, at least with respect to some of their reporting on Medicare, the Times has announced that it will keep their articles in a section of their web site that is free to the public. So -- again, in theory -- the link to the Times' web page for Reed Abelson's piece should be good for a long time, as well. I don't actually believe it and will continue to provide Userland or Google News links until the whole question of stability settles out.
Hospitals Say They’re Penalized by Medicare for Improving Care.
says it saves at least 70 lives a year. By giving the right drugs at discharge time to more people with congestive heart failure, Intermountain saves another 300 lives annually and prevents almost 600 additional hospital stays.And it's not just the providers who think the system is perverse:
But under Medicare, none of these good deeds go unpunished.
Intermountain says its initiatives have cost it millions of dollars in lost hospital admissions and lower Medicare reimbursements. In the mid-90's, for example, it made an average profit of 9 percent treating pneumonia patients; now, delivering better care, it loses an average of several hundred dollars on each case.
"The health care system is perverse," said a frustrated Dr. Brent C. James, who leads Intermountain's efforts to improve quality. "The payments are perverse. It pays us to harm patients, and it punishes us when we don't."
"Right now, Medicare's payment system is at best neutral and, in some cases, negative, in terms of quality — we think that is an untenable situation," said Glenn M. Hackbarth, the chairman of the Medicare Payment Advisory Commission, an independent panel of economists, health care executives and doctors that advises Congress on such issues as access to care, quality and what to pay health care providers.Even the departing head of the Medicare program agrees with this assessment: "'It's one of the fundamental problems Medicare faces,' said Thomas A. Scully, who as the administrator of the Centers for Medicare and Medicaid Services has encouraged better care by such steps as publicizing data about the quality of nursing home and home-health care and by experimenting with programs to reward hospitals for their efforts."
In a letter published in the current edition of Health Affairs, a scholarly journal, more than a dozen health care experts, including several former top Medicare officials, urged the program to take the lead in overhauling payment systems so that they reward good care.
Friday, December 05, 2003
Children's Hospital Bans Smoking by Staff.
Thursday, December 04, 2003
Even the conservative Cato Institute hates this Medicare reform law.
Clinton-era policy makers analyze Medicare reform law.
Wednesday, December 03, 2003
Medicare chief to resign.
Monday, December 01, 2003
Church May Penalize Politicians
I have no quarrel with the Catholic Church advocating public policy, nor should the Church -- or any church or religious organization -- feel constrained about identifying politicians with whom it agrees and disagrees. And any faith community has the right to define the content of its core beliefs, as well as to identify those whom it regards as "in" and "out" of the faith's traditions and beliefs. But at least since JFK tried to put this issue to rest, I thought American politicians, and the polity to which they appeal, had a pretty clear idea that politicians don't (and shouldn't) take their lead from church leaders. More to the point: Can't a Catholic politician believe privately that abortion or the death penalty is wrong and yet profess publicly that the country's policies should be open to alternative moral views? That a pro-choice law represents an appropriate balance of competing private moralities, even if -- as a practicing Catholic -- that politician might fervently desire that the law was otherwise?