This report from USA today notes a Federal Judge ruling that disparaging remarks regarding creationism is an infringement on a student’s 1st amendment rights.
He ruled that depicting:
“creationism as “religious, superstitious nonsense,” did violate Farnan’s constitutional rights.”
Medicynical note: I wasn’t aware the Constitution protected nonsensical beliefs.
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There seem to be innumerable products on the market that tout the benefit of “detoxification” and the idea that wastes build up in the colon and need cleansing. This is the basis of the widely used naturopathic remedy of colonic irrigation and various detox forumulas.
Consumer’s reports notes:
“We found insufficient reliable evidence that colon-cleansing products are safe or effective for improving general health. But we did find some cause for concern. When they are administered too often, laxatives and enemas might prevent normal bowel movements or lead to a potentially deadly depletion of vital electrolytes.”
And regarding waste accumulation:
“Waste does not accumulate in firm masses on intestinal walls, spreading toxins into the bloodstream, says Mark DeLegge, M.D., a spokesman for the American Gastroenterological Association in Bethesda, Md. He suggests staying regular by eating foods that are rich in fiber, including vegetables (broccoli, carrots, spinach, and squash), fruits (apples, bananas, and pears), whole grains (barley, whole or rolled oats, and whole wheat), and legumes (beans, lentils, peanuts, and peas).”
Medicynical note: Quackery has endless variations.
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Posted in Alternative Medicine, General Cynicism
The notion that the market will provide efficient, quality health insurance is a figment of the same imagination that brought us gimmicky mortgages, derivatives and credit default swaps.
Some horror stories in the Seattle PI (website paper):
“We read everything, and it looked like it was really good,”
“But a year later, his wife underwent surgery and Stewart was saddled with $20,000 in medical bills. He has been quarreling since with the insurance company, which said his wife had a pre-existing condition.”
“a Bainbridge Island woman sued her insurance company, alleging that it misled her into thinking she had comprehensive coverage only to later burden her with $135,000 in bills.”
Average consumers cannot fully understand the strengths and limitations of proffered policies. Asking them to do so opens the door to all types of abuses a noted above. Policies have contingencies that people don’t fully understand. Deductibles expressed as per cent of fees sound reasonable until one is confronted with $100,000 or more in bills.
Medicynical note: We need standardized policies with equal benefit structures. Companies would compete on the quality of services, amount of deductibles and copays, and the efficiency of their administrative services.
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Posted in General Cynicism, Health Economics
Gifts from drug companies to doctors continue despite reports to the contrary. Companies claim that such gifts are ethical and necessary. The NY Times notes:
“Drug companies spend billions (medicynical emphasis) of dollars wooing doctors – more than they spend on research or consumer advertising. Much of this money is spent on giving doctors free drug samples, free food, free medical refresher courses and payments for marketing lectures. The institute’s report recommends that nearly all of these efforts end.”
Imagine the cost savings to consumers if drug companies spent less on marketing. These companies claim it takes $800,000,000 to bring a new drug to market. How much of this inflated figure is gifts to doctors aimed an influencing their treatment decisions? If we presume the NY Times is correct and more is spent on gifts and advertising then research then the real cost of new drugs is significantly less than companies claim. Guess who ultimately pays for all this?
With drug prices increasing faster than any other part of health care expenditures is it too much to ask, as the IOM (Institute of Medicine) does, that companies and docs forgo this unethical practice?
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Posted in Ethics, General Cynicism, Health Economics
Mexico: almost 2000 suspected infections, 152 suspected deaths from swine flu – 20 confirmed deaths,
US: 50 confirmed cases (Ohio 1 case, Kansas 2 cases, Texas 2 cases, New York 28 cases and California 7 cases)
Canada: 6 confirmed cases
New Zealand – 3 confirmed cases
UK – 2 confirmed cases
Spain- 2 confirmed cases
Israel – 1 confirmed case
Countries with suspected cases: Brazil, Guatemala, Peru, Australia, and South Korea, and seven EU states
This outbreak, more here and here, has potential for a pandemic, an event anticipated and feared by infectious disease epidemiologists for the last 80 years. A H1N1 virus (similar to the causative agent of the1918 epidemic) has jumped from swine to man and has shown the ability to pass through several generations of infected individuals.
WHO deputy chief Keiji Fukuda said this was a “significant step towards pandemic influenza” but a pandemic should not be considered inevitable.
“Hugh Pennington, a leading bacteriologist in the UK, said on Tuesday that it was difficult to make any predictions about the outbreak because of its nature. It’s a new virus – we’ve never before seen this combination of swine virus and human virus genes,”
What can be presumed at present:
1. If the disease spreads worldwide, there will be excess mortality. As bad as the 1918 episode, not so far. We don’t have enough information to estimate mortality rates. Of interest was the severity of the disease in 1918 among younger groups. That implied residual immunity from earlier viral disease exposure that protected the elderly. It’s too early to tell whether there will be a similar pattern with the current problem.
Watch out for the disease in overpopulated areas. In 1918 the world’s population was 1.8 billion and the virus killed over 50 million people. Our population now is approaching 7 billion.
2. The severity of the disease is unclear. In Mexico mortality appears significantly higher than elsewhere, so far. This may be deceptive if the cases we know of represent a small part of those infected–the rest with minor upper respiratory disease. (as implied in this Guardian article) Alternatively, the Mexican experience may represent a virus with more severe ramifications that altered pathogenicity with passage through succeeding generations of infected people. A question of great concern is whether a more pathogenic strain will emerge. In 1918, there were periods when the virus appeared to be less severe and then abruptly changed. We’re still not sure what happened then but it’s possible, perhaps likely, that a similar course can occur now.
3. Those with impaired immune systems will be particularly vulnerable.
5. The CDC notes regarding antiviral drugs: ”
“There are four influenza antiviral drugs approved for use in the United States (oseltamivir, zanamivir, amantadine and rimantadine). The swine influenza A (H1N1) viruses that have been detected in humans in the United States and Mexico are resistant to amantadine and rimantadine so these drugs will not work against these swine influenza viruses. Laboratory testing on these swine influenza A (H1N1) viruses so far indicate that they are susceptible (sensitive) to oseltamivir and zanamivir.”
While oseltamivir (Tamiflu) and zanamivir (Relenza) may have activity in lab settings, there is no information yet whether they will prevent complications or mortality in actual patients.
CDC does recommend:
“Treatment: If you get sick, antiviral drugs can make your illness milder and make you feel better faster. They may also prevent serious influenza complications. For treatment, antiviral drugs work best if started as soon after getting sick as possible, and might not work if started more than 48 hours after illness starts.”
“Prevention: Influenza antiviral drugs also can be used to prevent influenza when they are given to a person who is not ill, but who has been or may be near a person with swine influenza. When used to prevent the flu, antiviral drugs are about 70% to 90% effective. When used for prevention, the number of days that they should be used will vary depending on a person’s particular situation.”
6. Vaccine development and testing will take some time, at least 4 months, probably more.
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Posted in General Cynicism, Swine Flu
Some are wondering why the new flu has emerged. I’ve seen questions about whether it was “manufactured.” But when something occurs that has been expected for many years why should we jump first to paranoid ideation?
Look at CDC info here and here or try the book “The Great Influenza: The Epic Story of the Greatest Plague” by John Barry for info.
The epidemic of 1918 occurred in the context of WW I during which large groups of susceptible people were thrown together in training and on ships going to war. The virus’s pathogenicity varied as it passed through generations of patients.
What will happen with the current epidemic will depend on how effectively we mobilize to isolate cases (some problems with this) ; the underlying nature of the virus; and how quickly we are able to explore the virus and find a vaccine. For what it’s worthTamiflu (oseltamivir) and Relenza (zanamivir) have been shown to be active against samples of the disease virus.
We have the advantage today of better understanding of viral diseases and a research establishment that may have been primed by the false alarms of the 70’s and the recent SAR’s outbreak. On the other hand our transportation system can spread disease worldwide within a few hours.
From the CDC:
| State | # of laboratory confirmed cases |
|
|---|---|---|
| California | 7 cases | |
| Kansas | 2 cases | |
| New York City | 8 cases | |
| Ohio | 1 case | |
| Texas | 2 cases | |
| TOTAL COUNT | 20 cases | |
| International Human Cases of Swine Flu Infection See: World Health Organization |
||
| As of April 26, 2009 9:00 AM ET | ||
Stay tuned.
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Posted in General Cynicism, Swine Flu
Gina Kolata’s article in the NY Times (4/24/2009) omits noting the high cost of new approaches to cancer treatment but does highlight the limited progress that has been made.
Over the past 50 years she notes the death rate from cancer has declined only 5% and success in treatment of advanced diseases has been limited.
“With breast cancer, for example, only 20 percent with metastatic disease – cancer that has spread outside the breast, like to bones, brain, lungs or liver – live five years or more, barely changed since the war on cancer began.”
“colorectal cancer , only 10 percent with metastatic disease survive five years. That number, too, has hardly changed over the past four decades. The number has long been about 30 percent for metastatic prostate cancer , and in the single digits for lung cancer.”
But the for drug companies financial results have been spectacular. Drugs, even relatively ineffective ones, may be priced at $100,000/year for the drug alone as noted here.
In the rare instance when a drug is effective the cost is even higher. Gleevec (imitinib), developed largely with tax funds for treatment of chronic myelogenous leukemia, is priced by Novartis in the range of $50,000-$100,000/year (depending on stage of disease and indication). These patients may live 10 years or more at a cost of $500,000 to a million dollars for the drug alone. Is this reasonable? It it the best we can do? Can we afford successful treatments?
The problem with cancer is that it is a genetic disease. As one ages and cells divide mistakes in DNA replication occur. These are random, occurring simply because nature isn’t perfect or because of influence of carcinogens. We can try to control the latter but cancer prevention is not simply a matter of smoking cessation (thought that helps) or diet modification and vitamins (they don’t appear to work). We can try to treat but this ordinarily won’t eradicate the genetic cause.
Medicynical note: The letters to the editor in response to the Kolata article are remarkable. Some quite informed. Some with THE answer: a diet cure , pot, homeopathy, diet to lower the body’s pH, etc.
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Genentech has released preliminary results on the use of Avastin in adjuvant therapy of colon cancer. The treatment failed. (Adjuvant treatment is given to selected patients, generally Dukes 3 colon cancer, after complete resection in hopes of preventing recurrence) Details will be presented at the ASCO meetings in May.
The article in the NY Times notes:
“The existing chemotherapy already keeps about 70 percent of colon cancer patients free of the disease three years after their surgery.”
However, it’s not correct to state that current treatment keeps 70% of people free of cancer. If people who receive treatment were compared to those who did not, the benefit would be about 10%. That is, the recurrence rate would be around 40% for those not treated and 30% for those receiving treatment. That means 30% will recur no matter what we do and 60% wouldn’t recur (in the time period) without therapy.
This article notes the limited efficacy of treatment vs placebo.
“1526 patients with resected B (56%) and C (44%) carcinoma of the colon were enrolled and 1493 were confirmed as eligible. 736 were assigned to the treatment group and 757 to the control group. Fluorouracil/folinic acid significantly reduced mortality by 22% (95% CI 3-38; p = 0.029) and events by 35% (22-46; p < 0.0001), increasing 3-year event-free survival from 62% to 71% and overall survival from 78% to 83%. Compliance with treatment was good; more than 80% of patients completed the planned treatment.”
More recent regimens don’t appear to do much better:
“Oxaliplatin has significant activity when combined with 5-FU-leucovorin in patients with metastatic colorectal cancer. In the 2,246 patients with resected stage II or stage III colon cancer in the MOSAIC study, the toxic effects and efficacy of FOLFOX4 were compared with the same 5-FU-leucovorin regimen without oxaliplatin administered for 6 months.[27] The preliminary results of the study with 37 months of follow-up demonstrated a significant improvement in DFS at 3 years (77.8% vs. 72.9%, P = .01) in favor of FOLFOX4. When reported, there was no difference in overall survival.”
I don’t want to imply that treatment is completely ineffective as some people do not recur after therapy. It is however inefficient in that the great majority of patients receive no benefit.
Using a very expensive drug such as Avastin ($50-100,000 for a course of therapy) for this indication should lead to concerns about cost efficiency and the cost of a QALY (Quality Adjusted life Year). In this case the drug failed but drug companies view adjuvant use as one of the most profitable, and I don’t necessarily mean beneficial, areas and will continue trials.
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This family represents the failings of our health care establishment. Some issues:
1. A system that facilitates insurers dropping coverage.
2.. When you lose work you lose insurance.
3. Individual ratings discriminate against those who need the coverage most.
4. Care is compromised by delays–(shame on MD Anderson)
“But during Jake’s check-up in December, Ms. Walker told the hospital that her son would be uninsured at the end of January. She said a hospital official then told her that if she was not able to pay up front, she should take her son elsewhere.”
5. Texas’ high risk pool is almost useless for those with financial limitations because of high rates which range from $400-1200/month.
6. Cobra, as indicated, uses individual ratings which in this case resulted in a charge of over $1300/month.
7. Health care costs cause bankruptcy
Medicynical Note: The system is designed to facilitate profits for insurers and providers while disregarding the needs of patients.
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Drug companies claim the U.S. patent system encourages development of new drugs and that the high prices are a necessary corollary. (see this) Others have questions regarding the monopolistic practices legalized by the system. This FDA Backgrounder, and this chapter from Against Intellectual Monopoly by Michele Boldrin and David K. Levine offer more background information.
Wikipedia defines a patent as a “set of exclusive rights granted by a state to a person for a fixed period of time in exchange for the regulated, public disclosure of certain details of a device, method, process or composition of matter (substance) (known as an invention) which is new, inventive, and useful or industrially applicable.” The right to produce the product protected by the patent is subject to further regulation by various regulators.
The regulator of drug patents in the United States is the FDA. Over the years the rules governing drug patents have evolved. Some milestones include:
1938 Federal Food, Drug, and Cosmetic Act : For the first time it was required that a drug be shown safe.
1962 Kefauver-Harris Drug amendment: Required that the drug be proved effective before marketing.
1980 Dole-Bayh– Prior to this products developed under federal grants were in the public sphere. To encourage commercial development of these advances individuals and institutions were allowed to patent these developments and even license or sell the patent to private companies.
Products developed to a major extent with public funds, such as imatinib (Gleevac) and bevacizumab (Avastin), are taken private and the public then gets to pay whatever the drug company or developer wishes for the technology. The result of Dole-Bayh has been medical progress at a tremendous cost. Basic research has suffered as workers are continually looking for something to take private-akin to hitting the lottery. We’re talking tens to hundreds of millions of dollars in fees to the individuals and the sponsoring university of such research. This has literally changed the landscape of medical research and not all for the better. See this article for the rationale and the unintended consequences.
In part because of Dole-Bayh, prescription prices in the past 25 years have increased astronomically. The price of newly patented oncology medications has increased to 50-100 times the level of the seventies, 15-20 times that of the 80’s. Between 1990 and 2001 the average price of all types of prescriptions tripled. Not surprisingly drug profits, after paying all costs of development including research and drug promotion, are at the unprecedented level of 18-20 % of revenue. Some think Dole-Bayh as currently applied is a giveaway to the industry. They further maintain that the law has provisions calling for reasonable pricing of government financed inventions. It’s never been enforced.
1984 Hatch-Waxman act–extended the length of patents up to 5 years (normal patent length is 20 years) to make up for the time the drug took to be approved by the FDA. It also provides for accelerated approval of generic drugs by not requiring generic companies to repeat the original research that proved them safe and effective.
Drugs that are clearly effective and safe are FDA approved and marketed promptly and do not qualify for additional patent time sanctioned by Hatch-Waxman. On the other hand many of the drugs needing additional time for approval and wanting patent extensions have marginal efficacy and/or questions regarding toxicity. That’s what delayed their approval. Ironically, the terms of Hatch-Waxman will extend patents most for drugs that may deserve it least.
The law is gamed by patent holders through legal loop holes and payments to generic manufacturers that actually delay the marketing of competing generics. It’s been a boon to lawyers. A company with a patented drug for example has been able to delay a generic by 30 months simply by raising an objection to marketing it-this was done multiple times in some instances. In addition it allowed hundreds of millions of dollars in payments between the patent holder and generic companies to delay the release of generics. There has been some attempt to control this. The Greater Access to Affordable Pharmaceuticals law passed the Senate in 2002 and was reconsidered in 2003. The FDA revised the rules of Hatch Waxman to address this issue, but the affect of these changes remains unclear. This article from the July 1 2006 Times and this from the July 3, Washington Post indicate that the pharmaceutical industry continues to game the system.
Among the criticisms of patents is the notion that patents create monopolies which almost always result in inefficiencies, stifle competition (by definition), cause higher prices, lower quality and shortages.
It’s clear that our system of care has problems with inefficiency and pricing from the patent monopoly. We have the most costly health care system in the world but have mediocre results. Prices of pharmaceuticals have reached unprecedented levels. Medicynic has previously noted pricing of new cancer drugs/year exceeds the median and average incomes in the U.S. and more. The issues of lower quality and shortages apply because of aggressive marketing of mediocre patented drugs and because people lack access because of price–a pernicious form of health care rationing.
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Posted in General Cynicism, Health Economics, Patents
Medicynic 