|From: LindyBill||4/9/2007 6:01:01 AM|
|The bigger picture [Mark Steyn]|
But it's not all homecoming heroes in Britain. First, in business news:
From the corridors of power to high-street banks, Sharia finance is on the lips of UK policymakers, businesses and private customers... Changes to the tax system, unveiled in [the Chancellor's] most recent Budget, will potentially make the UK a key global centre in the development of Islamic finance - a market currently estimated to be worth over US$500bn worldwide.
And on a not unrelated note:
Britain has been a victim of terrorism, but at the same time it is the largest exporter of terrorism in the non-Muslim world... One cannot help but place Britain, alongside Saudi Arabia, Pakistan, Egypt, Algeria, etc. at the top of the list of countries that regularly export terrorists to the rest of the world. The basic difference is that the Islamists in Britain enjoy the protection of the law and the sympathy of many political figures in Britain.
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|From: LindyBill||4/9/2007 6:05:49 AM|
|I am glad to see that these type of movies are losing big time.|
"Hyped 'Grindhouse' Is Ground Up At B.O."
By Ed Driscoll · April 08, 2007 07:51 PM · Hollywood, Interrupted
I thought the trailer for Quentin Tarantino and Robert Rodriguez's Grindhouse looked absolutely vile, youtube.com so I can't say I'm disappointed to read this post by Nikke Finke:
"But today, major players in the movie capital were talking about the utter collapse at the box office of Grindhouse, that double-feature from celebrated directors Quentin Tarantino and Robert Rodriguez. (I had wondered here if the movie could live up to the Weinsteins' hype.) Despite decent reviews, the hard "R"-rated pic filled with blood and violence took in just $12 million this weekend -- nowhere near even the lowest $20 mil opening predicted (or the $25 mil debut anticipated after midnight sneaks were arranged in major cities). The weekend take was far, far below the openings for, say, Rodriguez's Sin City ($29.1 mil) or Tarantino's Kill Bill 1 ($22 mil) and 2 ($25.1 mil). The Weinstein Co. has been plagued by bomb after bomb since its 2005 inception after Miramax founders Harvey and Bob couldn't come to terms with Disney. The new company had a lot riding on this pic in terms of reputation. (Not to mention money: I hear the real budget for Grindhouse is $67.5 mil though Harvey and Bob were spinning it as low $50s.) But the take of only $5 mil Friday, $4 mil Saturday, and an estimated $2.9 mil Sunday from the 2,624 theaters where the Planet Terror and Death Proof combo (complete with its block of fake movie trailers) is playing, was only good enough for 4th place among the Top 10 movies. Worse, the the box office dropped an unusually large 19% from Friday to Saturday. And its per screen average was anemic, meaning that the pic was playing in near empty venues.
As Nikke Finke concludes, "Instead, this weekend followed 2007's trend of making family films and PG-13 comedies the favorites at the box office". That's not going to be news to Michael Medved and Brent Bozell.
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|From: LindyBill||4/9/2007 7:26:13 AM|
|GOP VIXEN BLOG ..............These guys are totally shameless. From Faye Turney's story in today's Sun:|
"...Earlier it was revealed staff from the Iranian embassy in London phoned Faye's mother-in-law to try to coax her to Tehran.
They traced Sue Turney, 60, by calling every Turney in her local phone book.
Faye said: 'They told her if she went to Tehran it may help to secure my release.' The calls stopped after Foreign Office protests."
Well, if you don't like your mother-in-law seems like a creative way to get her out of your hair. ("Sorry, hubby, but the mullahs took your mum prisoner...")
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|From: LindyBill||4/9/2007 7:42:57 AM|
|Do you believe this story?|
BETSY'S PAGE BLOG
One factor that Hillary Clinton will have to overcome in her path to the presidency is the questions people still have about veracity, both from her and her husband. Perhaps people have forgotten the details of the Rose Law Firm's billing records or the firing of the White House Travel Office, but there is still that aura of dishonest hanging over the couple. Polls continually show that people think that Hillary Clinton is not a sincere person and that she would say whatever it takes to sell herself to the American people.
With that in mind, how likely is it that people will believe her story that, in 1975, after the Vietnam War and right before she got married to Bill Clinton, that she popped into an Arkansas Marines Recruiting Office with an honest desire to find out about enlisting in the Marines? Jim Geraghty reports that the New Republic repeats this tale in their (subscription only) story on Mrs. Clinton and the Iraq War. The story smelled when she first trotted it out in 1994 and the reporter for the New York Times who covered Mrs. Clinton's tale was none other than a somewhat skeptical Maureen Dowd.
"But, even given the fact that the nation has become accustomed to Mrs. Clinton's intriguing shape-shifting -- from liberal do-gooder to high-risk commodities trader, from power lawyer to cookie baker, from health care czar to housewife supervising the menu for the state dinner for the Emperor and Empress of Japan -- the latest one is still jarring. Macho Contrast to Clinton
First, it presented a macho contrast to a President who had just visited England, where news reports recalled the letter he wrote from there to a representative of the Reserve Officers Training Corps at the University of Arkansas, explaining why many members of his generation loved their country but still found themselves "loathing" the military.
And it did not seem to fit in with the First Lady's own persona. After all, Hillary Rodham was an up-and-coming legal star involved with an up-and-coming political star. She had made a celebrated appearance in Life magazine as an anti-establishment commencement speaker at Wellesley College, where, as president of the student government, she had organized teach-ins on her opposition to the Vietnam War.
She was a Yale law school graduate who had worked on the anti-war Presidential campaigns of Eugene J. McCarthy and George McGovern.
Mrs. Clinton told friends that she had moved to Arkansas for only one reason: to be with Bill Clinton. Years later, she would tell Vanity Fair that she had stayed because "I didn't see anything out there that I thought was more exciting or challenging than what I had in front of me."
She and Mr. Clinton married on Oct. 11, 1975 in Fayetteville.
So, if she was talking to a Marine recruiter in 1975 before the marriage, was she briefly considering joining the few, the proud and the brave of the corps as an alternative to life with Mr. Clinton, who was already being widely touted as a sure thing for Arkansas Attorney General?"
Geraghty reprints a letter from a military recruiter in 1975 who casts some more doubt on Hillary's story that she was immediately given the brush-off from the Marines recruiter due to her age and eyesight. Perhaps the story is true that Hillary had a whim to sign up for the Marines right before she married Bill Clinton. I don't believe it, but there are many who would give her the benefit of the doubt. But I somehow suspect that the question will remain in the air - why would she tell such a story and what does the waiting 20 years later to trot out the anecdote say about her? Doesn't it just add to that whole air about her that she and her husband would say anything if they thought it would win them a few votes or some favorable press coverage? betsyspage.blogspot.com
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|To: LindyBill who wrote (201905)||4/9/2007 7:45:15 AM|
|Anyone who believes anything Hillary says, SURELY must believe in the TOOTH FAIRY. Hillary believes in one thing, and one thing only, POWER. Were she to have her way, she would attempt Governmental control over every significant aspect of our lives. jdn|
|RecommendKeepReplyMark as Last ReadRead Replies (1)|
|From: LindyBill||4/9/2007 7:51:03 AM|
|The Golden Age of Medical Innovation|
By John Calfee
THE AMERICAN MAGAZINE
From the March/April 2007 Issue
Critics grouse about a sluggish drug pipeline, but they are looking in the wrong place. John Calfee shows that innovation in drugs and medical devices in the U.S. is rampant. New treatments are fighting breast cancer, macular degeneration, rheumatoid arthritis, and many more diseases. Why the success?
Last December, the editors of Science magazine—the widely respected journal of the American Association for the Advancement of Science—selected ten "breakthroughs" of the year.
Number one was the solution to the "Poincaré Conjecture," a topological puzzle that had confounded mathematicians for a century. Number four was the discovery of a 375-million-year-old fossil that filled an evolutionary gap between fish and birds. But it was breakthrough number six that got my attention—"a ray of hope for macular degeneration patients." It related the stunning clinical-trial results for ranibizumab, a drug sold under the brand name Lucentis by Genentech, its developer and manufacturer.
Lucentis is a monoclonal antibody—made, using biotech methods, from genetically engineered bacteria—that attacks a protein responsible for the leading cause of blindness in seniors. Age-related macular degeneration, or AMD, affects a part of the retina and causes blind spots, which expand over time, in the center of the field of vision. It is a disease that had previously defied all attempts even at delaying the inevitable decline toward blindness. But with Lucentis, the eyesight of about 95 percent of AMD patients either improved or stopped getting worse—a stunning achievement.
Biotechnology has lately provided many other breakthroughs. In January, an article in The Lancet, a British medical journal, described the latest striking results for another Genentech drug, Herceptin, which treats an aggressive form of breast cancer that affects about 50,000 women a year. The cancer is characterized by an overabundance of a protein called human epithelial growth factor receptor-2 (HER2), which stimulates the growth of tumors. In 2005, research published in The New England Journal of Medicine found that, when administered after surgery, Herceptin reduced the odds of a recurrence by half. An accompanying editorial concluded that the key result "suggests a dramatic and perhaps permanent perturbation of the natural history of the disease, maybe even a cure," and that "our care of patients with HER2-positive breast cancer must change today." The new Lancet study went even further, documenting mortality declines after only two years of use, an unheard-of result in treating breast cancer. Other biotech treatments approved recently include Enbrel, for psoriasis, a painful skin condition; Remicade, for Crohn's disease, an inflammatory digestive-tract disorder; Rituxan, for rheumatoid arthritis; and Avastin, for several different cancers.
Golden Age - EyeEnbrel was developed by Immunex, a Seattle company that was purchased in 2001 by Amgen, the world's largest biotech firm. Remicade is a product of Centocor, the biomedical firm that pioneered monoclonal antibody technology. And Rituxan and Avastin are from Genentech, one of the early biotech firms that is now seeing a boom in revenues, up 40 percent in 2006 to $9 billion.
The remarkable treatments these firms have developed seem at odds with the widespread notion that medical innovation has all but come to a halt. A recent report by the Government Accountability Office, for example, has warned, in the words of a popular website that covers drug research news, "that the pharmaceutical industry is not producing enough new drugs despite spending more on research and development." In a similar vein, Democratic Representative Henry Waxman, the new chairman of the House Committee on Government Reform, stated, "Many aspects of the drug development system need to be examined to determine how to encourage research that focuses on breakthrough treatments rather than drug industry profits."
Yet breakthroughs are precisely what are being achieved. Why aren't they more widely recognized? One reason is that none of the treatments I have just described would appear on a list of innovative new drug approvals over the past few years. The results all came from clinical trials involving drugs that had already been approved for something else—often a different stage of cancer, sometimes a different type of cancer, and occasionally a different illness altogether.
Rituxan, for example, which was found to treat rheumatoid arthritis, was originally approved for cancer, and Enbrel (psoriasis) and Remicade (Crohn's disease) had originally been approved for rheumatoid arthritis. Lucentis, the AMD fighter that made Science magazine's list of breakthroughs, was what pharmaceutical industry critics derisively call a "me-too" drug. It was created by tweaking the molecular structure of another, older drug, Avastin, which itself was originally approved for colorectal cancer but now has also been approved for certain kinds of lung cancer, and has been submitted to the Food and Drug Administration to be used against breast cancer and possibly kidney cancer as well.
These developments illustrate why, at the very time we keep hearing that progress has stalled, medicine today is actually in a new golden age of innovation. In this new era, the most important advances in treatment often come from products which have been on the market for a while but whose properties were not completely understood until intensive research after the drug was introduced. In cancer treatment, Avastin is a mini-pipeline all by itself, with some 20 clinical trials underway for different cancers or stages of cancer.
The dominant role of post-approval research extends to many other drugs used as what are called "targeted therapies," which, as the National Cancer Institute defines the term, "block the growth and spread of cancer by interfering with specific molecules involved in carcinogenesis (the process by which normal cells become cancer cells) and tumor growth." Some of these targeted therapies find value in treating a completely different illness. More successes are, no doubt, on the way. For example, unexpected results in treating patients with Gleevec, developed by Novartis and one of the first and most spectacular of the targeted cancer drugs, sparked curiosity about its ability to prevent diabetes, while researchers are looking at tantalizing evidence that the HIV drug Viread, made by Gilead, may act against hepatitis B.
A second characteristic of this new era is that competition from follow-on or me-too drugs has been raised to extraordinary levels of scientific sophistication. After Avastin finally demonstrated the therapeutic benefits of inhibiting the angiogenesis (growth of new blood vessels) that feeds rapidly growing cancer cells, competition emerged with amazing speed. Several Avastin-like drugs, which, like Lucentis, may treat new diseases, are in late-stage clinical trials. The same thing has happened to other breakthrough biotech drugs for cancer. Herceptin, for example, faces competition from Iressa and Tarceva, currently on the market, while lapatinib and pertuzumab are in late-stage clinical trials. Tykerb, which is also effective against tumors that have evolved to resist Herceptin, is close to FDA approval. Competition has also emerged for targeted drugs to treat rheumatoid arthritis, osteoporosis, and other conditions. Lucentis may soon face competition from another biotech cancer drug in clinical trials for macular degeneration.
The story of spectacular new uses for old drugs is not a new one. It happened to blood pressure drugs, ulcer preventatives, and the statin class of cholesterol-reducing drugs like Lipitor, which we now know also prevents strokes. But the development of new uses and the creation of new competitors happen faster with today's drugs that are more precisely targeted at very specific biological mechanisms in the human body. This may seem paradoxical, but the targeted mechanisms tend to play many roles in the body and are typically part of a cascade of events that can be interrupted in many different ways—and, thus, by many different cleverly designed drugs.
It is research on entirely new drug mechanisms—that is, drugs that operate in the body in ways that are quite different from the way drugs have operated in the past—which usually marks the origins of therapeutic revolutions. Progress is punctuated with both successes and failures. And often the crucial result tells researchers what will not work. Today, several pharmaceutical firms are trying to figure out the cause of Pfizer's spectacular failure last year with torcetrapib, a biotech drug designed to increase HDL, or high-density lipoprotein, the "good cholesterol" that prevents heart attacks. HDL research continues, with huge benefits for patients if someone eventually achieves success.
Initial successes, such as Mevacor, the first statin cholesterol-reducing drug, typically provide only a glimmer of what a new mechanism can achieve after it is refined to far greater efficiency through competitive research to find those notorious me-too drugs.
In the search for entirely new mechanisms, however, uncertainty abounds. For decades, research on the mechanism that would power Avastin was the lonely obsession of biologist and pediatric surgeon Judah Folkman at Children's Hospital in Boston. He never quite achieved complete failure, and when success finally came, it opened the door to a new approach to cancer research: controlling tumors by targeting the blood vessels that help them grow.
The past two decades have also seen concerted efforts to devise entirely new ways to treat HIV infection and depression—conditions where therapy has long been dominated by a multitude of drugs employing closely related mechanisms. After years of failure, Merck is finally close to FDA approval of the first integrase inhibitor, employing a completely new method of fighting HIV. Recent years have also seen pharmaceutical-based revolutions in rheumatoid arthritis, osteoporosis, and of course, heart disease, where the death rate has dropped by 29 percent in a decade.
Also, far from the public eye, progress is finally being made on autologous vaccines for cancer and Alzheimer's disease. (Such vaccines are created from a sick patient's own cells.) These new treatments are part of a larger search for therapeutic vaccines—that is, drugs that do not merely boost the immune system but harness it to attack specific causes of illness. In the meantime, traditional vaccine R&D is in a renaissance, with brand-new preventatives for cervical cancer and rotavirus (a form of diarrhea that can and often does kill young children).
The usual methods for measuring progress in drug research simply do not work any longer. Industry critics—such as Marcia Angell, former editor of The New England Journal of Medicine and author of The Truth About the Drug Companies, a 2004 book that was praised in The New York Times—focus relentlessly on tallies of new drug approvals while excoriating me-too drugs. In its November 2006 report, entitled "New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts," the GAO also drew its conclusions based on new drug applications, or NDAs, to the FDA, while giving scant attention to follow-on research. The GAO report pointed out that NDAs had risen annually from 74 to 129 between 1993 and 1999, then started sliding, ending at 102 in 2004, the final year of the study.
There are better ways to mark progress. Post-approval randomized clinical trials, to which the marketplace (physicians, third-party payers, and, above all, patients) responds with gusto, provide extremely valuable information on where drug therapy is taking us. Virtually all the results I have described came from such trials, some of them designed for FDA supplemental approval and some just for the medical community at large.
We don't hear much about these trials in the rancorous debate over what the pharmaceutical industry has done for us lately. Instead, we get a scorecard of NDAs. This is unsurprising, because NDA counts are easy numbers to grab, but the true nature of healthcare innovation is the slow, but immensely productive, adaptation by doctors, hospitals, clinics, patients, and society at large to new therapeutic possibilities.
The treatment of heart attacks and strokes, for example, requires broad changes in behavior by emergency personnel and hospitals as well as better knowledge in the general population; otherwise, the best antidotes will be used too late. This arduous adaption process, which only begins with new drugs (or new breakthrough uses for old ones, like aspirin), has been documented by Harvard's David Cutler, Mary Beth Landrum, and Kate Stewart in a recent National Bureau of Economic Research paper with an abstract that begins, "There is little empirical evidence to explain why disability declined among the elderly over the past 20 years."
A few scholars are measuring the health impact of the broad sweep of drug development. Economist Cutler and his two colleagues found that new medical technology, mainly drugs, accounted for most of the spectacular 55 percent drop in heart disease deaths between 1975 and 1995. A group of public-health scholars determined that HIV drugs have extended the lives of patients by an amazing 18 years. In a series of econometric studies using a wide variety of data sets, economist Frank Lichtenberg has found a strong and consistent connection between the adoption of newer drugs and various health and economic benefits, including longevity. For example, new drugs extended the lives of cancer patients at a cost of less than $3,000 per life-year—even before the arrival of the latest targeted therapies like Herceptin and Avastin.
Like pharmaceuticals, most medical devices must receive FDA approval before they are sold to the public. The variety of devices is astonishing, ranging from bedpans, bandages, and syringes to cochlear implants (which help the profoundly deaf to hear), implantable heart defibrillators (which provide a jolt if the heartbeat becomes irregular), and drug-eluting stents (which keep formerly clogged arteries open). While the FDA approves a few hundred new drugs and variants (like special forms of dosing) annually, the agency has recently been approving new medical devices at the rate of 3,000 per year, and permitting the introduction of another 5,000 without formal approval. The technically sophisticated part of the device market is so new that it was not even subject to direct regulation by the FDA until 1976.
Golden Age - SpineOne reason we don't hear much about FDA statistics on new device approvals is that Congress constructed a bizarre regulatory regime that classifies some of the most innovative new products as variants of old ones—the so-called 510(k) class. But even for devices that, like drugs, go through the pre-marketing approval process, what really counts, again, is what we learn after approval. Most cardiac stents, for example, are used in ways not strictly in accordance with the FDA label, while new applications of MRI (magnetic resonance imaging) machines are a staple of the medical literature.
We don't see many headlines about the inadequacy of medical-device research and development—not because R&D works better in the device market than in the pharmaceutical market, but because it's harder to focus on a few misleading numbers as sole indicators of innovation. What we do see, if we look closely enough, is steady and accelerating progress.
In contrast to pharmaceuticals, where progress often arrives in the form of new information about old drugs, progress in the device industry typically consists of improvements in the devices themselves and, often, in the training and skills necessary for physicians to get greater benefits from them. With cardiac stents and minimally invasive surgery, for example, the skill of the practitioner can determine whether a new model is better than the old one. Progress also comes from sharper displays, smaller manufacturing tolerances, more precisely controlled robotics, new packaging for better sterilization, and on and on.
This environment of incremental improvements, speedy and pervasive competition, and better physician training results in changes that cannot be summarized by simple benchmarks. Even clinical trial data are scarce because it is hard to conduct random testing for devices whose utility depends on the skill of users. Also, incremental advances make it hard to finish a trial and analyze its results before the device being tested (a miniature TV transmitter for gastrointestinal endoscopy, for example) becomes obsolete. So even profoundly useful innovations in medical devices often fail to generate the sorts of data that make it to the newspaper pages.
Important progress has been made on diagnostics for HIV, other sexually transmitted diseases such as chlamydia and gonorrhea, congestive heart failure, hepatitis B and C, and hundreds of other targets.
In the meantime, innovation is moving ahead on another critical healthcare front: diagnostics—that is, techniques for judging whether someone has a disease and how virulent it is, how the disease might react to a drug, and the likelihood of severe side effects. Important progress has been made on diagnostics for HIV, other sexually transmitted diseases such as chlamydia and gonorrhea, congestive heart failure, hepatitis B and C, and hundreds of other targets. The DNA decoding revolution has strongly affected diagnostics, generating tests for genetic mutations (including those involved in breast and lung cancer) and the remarkable creation of genomic arrays, which are sheets typically made of glass with snippets of DNA that can quickly reveal links between, say, a drug and cancer cells.
There's a symbiotic relationship between diagnostics and treatment. For example, a series of trials has demonstrated the striking benefits of adjusting blood glucose levels in diabetics daily or even several times a day. Manufacturers have introduced more accurate, more convenient, and less painful glucose measurement devices that are now critical for better treatment. For some drugs, a precise diagnostic tool can reduce costs and improve safety. In fact, some of the targeted cancer drugs, including Herceptin and Iressa, would be nearly useless without gene-based diagnostics that indicate whether the medicines will work at all.
It's no surprise that advances in applied science—biology, materials (ceramics, glass, metals, plastics), chemistry, computing, and the like—would profoundly affect R&D in medical technology. But what's not appreciated is the extent to which different parts of the medical technology industry have themselves converged to form a nearly seamless entity.
Consider breast cancer treatment, which today involves targeted drugs (along with older ones, still very useful), several molecular diagnostics that determine what drugs to use, improved imaging tools (with digital spot view mammography rapidly replacing analog), and a variety of devices such as less-invasive stereotactic core needle biopsies, minimally invasive lymph node surgery, better brachytherapy (radiation therapy using tiny "seeds"), and intensity-modulated radiation therapy. A recent academic review of two decades of drug treatment concluded, "Though much remains to be discovered, and some hard battles no doubt remain to be fought, the end of breast cancer as a serious cause of human mortality is now in sight." This convergence process is also happening with the rapidly advancing treatments for colorectal and lung cancer and for diabetes, which threatens to become the single most expensive illness in the United States.
Rapid technological change usually threatens entrenched interests, including competitors facing eclipse and trade unions wanting to protect their membership. In medical technology markets, threats to continuing innovation seem to arise from different sources. Here are the kinds of threats that can end a golden age:
Intellectual Property: The surest way to hobble medical technology is to damage intellectual property (IP) protections, mainly patents. Drug companies simply won't spend the nearly $1 billion needed to develop the average new medicine if they have uncertain ownership when they're through. While the lack of a rigorous IP regime in developing nations has deterred the development of new drugs and vaccines for tuberculosis and malaria, the good news is that the World Trade Organization's TRIPS agreement is slowly buttressing R&D incentives to attack diseases in these poor countries.
Price Controls: Innovation is senseless if successful products can't be priced well above the marginal costs of manufacturing and distribution. But consumers, encouraged by politicians, resent paying those prices—especially when the same products are sold for less in other wealthy nations. As a result, the power of price controls in many European countries and in Canada raises the specter of similar controls in the United States. Other than the dismantling of intellectual property, no policy would be more destructive to innovation than price controls.
Unfortunately, public discussion of drug pricing is informed by fundamental misunderstandings of the economics of medical-technology R&D on the part of journalists and even prominent academic writers. Especially dangerous is the view that, since recent years have not brought much innovation, little of value would be sacrificed even if price controls impose disincentives for research in the private sector. The illusion that publicly funded R&D can replace private markets contributes to this thinking. In fact, financial risk-taking in pursuit of exceptional profits has been the only reliable source of pharmaceutical innovation that proceeds all the way from laboratory to bedside.
Golden Age - Blood CellsThe most immediate threat to pricing freedom is entirely novel. The National Institutes of Health, encouraged by a New England Journal of Medicine editorial, has embarked on a clinical trial to compare Lucentis to off-label Avastin in treating macular degeneration. The explicit purpose is to demonstrate that AMD can be treated at a fraction of the cost of Lucentis by using tiny amounts of Avastin, whose primary use in cancer therapy involves far larger doses. The goal is not to control prices directly but to undermine a pricing structure that is essential to R&D. If firms cannot charge a higher price per milligram for a new use at a much smaller dose, there is no incentive to research it. The NIH seeks to prevent Genentech from reaping a payoff from developing the very therapy that was on Science magazine's list of the ten breakthroughs of the year. It is hard to think of a worse signal to send to the developers of targeted drugs.
FDA Regulation: The Food and Drug Administration has come under vigorous attack from Congress, the news media, and, most important, medical academics. Although the FDA acquitted itself well in the most important episode, the withdrawal of the pain reliever Vioxx, overzealous attacks on its handling of drug safety are bound to cause the agency to tighten its standards for new drug approvals. Look, for example, at the agency's refusal to describe its new standards for the testing of antibiotics, including such basic matters as when trials must include a placebo control.
A recent Institute of Medicine report strongly criticized FDA handling of drug safety and proposed many changes, including marketing restrictions and stronger agency powers, even to the point of making controls on physician-prescribing a precondition for some new drug approvals. The vehicle for legislating changes will no doubt be the Prescription Drug User Fee Act (PDUFA), which is up for renewal this year. User fees collected under PDUFA cover the costs of faster new-drug reviews.
Marketing Restrictions: On the surface, marketing may appear to be wasteful. You often hear, even from intelligent critics, the argument that advertising and other marketing costs detract from R&D expenditures. (The truth is that marketing, by boosting sales, increases returns to R&D and provides the cash needed for research.) Certainly, marketing can encourage people to use drugs inefficiently—but at the root of that problem is the fact that third parties, mainly insurance companies, are footing most of the bill, so patients have little incentive to monitor costs.
'Though much remains to be discovered, and some hard battles no doubt remain to be fought, the end of breast cancer as a serious cause of human mortality is now in sight.'
In fact, for a wide variety of drugs, devices, and diagnostics, the real problem is underuse; people are suffering and dying because they do not know about the technologies that can help them. Certainly, promotion can also deceive patients and physicians, but a rich literature demonstrates Americans' innate skepticism toward advertising. People are smarter than many politicians think. Still, we can probably expect continued attacks on pharmaceutical marketing at both the state and federal level.
Litigation: Abusive lawsuits can destroy medical innovation. They nearly did so with childhood vaccines before those preventatives were moved out of the tort liability system in 1986. Most litigation against drug companies runs in cycles. The 1990s were relatively quiet, other than the exceptional case of the Fen-Phen (fenfluramine-phentermine) diet drug combination, which never involved active marketing by the manufacturer before it was removed for safety reasons. Now, we are in a powerful upturn in the cycle, fueled by demonization of the industry by the media, resentment at prices seen as too high, and the drug-safety furor triggered mainly by Merck's Vioxx, a popular painkiller that was removed from the market because of cardiovascular risk. Much of Vioxx's appeal to doctors and patients was that it could substitute for medicines that have serious side effects—including death—in treating such diseases as osteoarthritis.
The current wave of litigation against Merck has yet to reveal its full contours, with final costs likely to range from a billion dollars to tens of billions. But at the core of the matter lies the unsettling fact that juries are being required to answer a scientific question—whether Vioxx actually caused the heart attack or stroke being litigated—that can't accurately be decided. So far, no diagnostic tool exists to make the judgment.
Other drugs in litigation, such as hormone replacement therapy and certain forms of birth control, present similar issues. Will a litigation explosion pose serious threats to further innovation in medical technology? There's no clear answer, but the danger is real.
For now, however, far from being in a slowdown, innovation in pharmaceuticals, medical devices, and diagnostics is accelerating. The forces that led to the creation of the breakthroughs—advances in computer software and hardware, imaging, genomics, exotic materials, and much more—are far from mature stages of development.
We are in a golden age of medical innovation—but not in the sense that this is a shining era upon which historians will look with fondness (like the great age of classical music) distant decades from now. In free markets, every glittering age of technology is succeeded by another that is even more glittering. Only unwise public policy can make the fire go out.
John Calfee is a resident scholar at the American Enterprise Institute.
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|From: LindyBill||4/9/2007 7:58:04 AM|
|Lefty Blogs Ignore MIT Prof on Global Warming|
If a leading expert writes an op-ed in a national news magazine contradicting the conventional wisdom of the "lapdog media", will a liberal read it?
I'd say there's a 70 percent chance that won't happen, at least as long as the subject is global warming. Richard S. Lindzen, a well-respected and widely published professor of meteorology at MIT just published a very clear-headed and sober editorial in this week's Newsweek. It got picked up by Drudge and a number of right-leaning blogs but as of this posting, has not been written about by any popular left-wing blogs.
Why So Gloomy?
By Richard S. Lindzen
April 16, 2007 issue - Judging from the media in recent months, the debate over global warming is now over. There has been a net warming of the earth over the last century and a half, and our greenhouse gas emissions are contributing at some level. Both of these statements are almost certainly true. What of it? Recently many people have said that the earth is facing a crisis requiring urgent action. This statement has nothing to do with science. There is no compelling evidence that the warming trend we've seen will amount to anything close to catastrophe. What most commentators—and many scientists—seem to miss is that the only thing we can say with certainly about climate is that it changes. The earth is always warming or cooling by as much as a few tenths of a degree a year; periods of constant average temperatures are rare. Looking back on the earth's climate history, it's apparent that there's no such thing as an optimal temperature—a climate at which everything is just right. The current alarm rests on the false assumption not only that we live in a perfect world, temperaturewise, but also that our warming forecasts for the year 2040 are somehow more reliable than the weatherman's forecast for next week.
A warmer climate could prove to be more beneficial than the one we have now. Much of the alarm over climate change is based on ignorance of what is normal for weather and climate. There is no evidence, for instance, that extreme weather events are increasing in any systematic way, according to scientists at the U.S. National Hurricane Center, the World Meteorological Organization and the Intergovernmental Panel on Climate Change (which released the second part of this year's report earlier this month). Indeed, meteorological theory holds that, outside the tropics, weather in a warming world should be less variable, which might be a good thing.
In many other respects, the ill effects of warming are overblown. Sea levels, for example, have been increasing since the end of the last ice age. When you look at recent centuries in perspective, ignoring short-term fluctuations, the rate of sea-level rise has been relatively uniform (less than a couple of millimeters a year). There's even some evidence that the rate was higher in the first half of the twentieth century than in the second half. Overall, the risk of sea-level rise from global warming is less at almost any given location than that from other causes, such as tectonic motions of the earth's surface.
Many of the most alarming studies rely on long-range predictions using inherently untrustworthy climate models, similar to those that cannot accurately forecast the weather a week from now. Interpretations of these studies rarely consider that the impact of carbon on temperature goes down—not up—the more carbon accumulates in the atmosphere. Even if emissions were the sole cause of the recent temperature rise—a dubious proposition—future increases wouldn't be as steep as the climb in emissions.
Indeed, one overlooked mystery is why temperatures are not already higher. Various models predict that a doubling of CO2 in the atmosphere will raise the world's average temperature by as little as 1.5 degrees Celsius or as much as 4.5 degrees. The important thing about doubled CO2 (or any other greenhouse gas) is its "forcing"—its contribution to warming. At present, the greenhouse forcing is already about three-quarters of what one would get from a doubling of CO2. But average temperatures rose only about 0.6 degrees since the beginning of the industrial era, and the change hasn't been uniform—warming has largely occurred during the periods from 1919 to 1940 and from 1976 to 1998, with cooling in between. Researchers have been unable to explain this discrepancy.
Modelers claim to have simulated the warming and cooling that occurred before 1976 by choosing among various guesses as to what effect poorly observed volcanoes and unmeasured output from the sun have had. These factors, they claim, don't explain the warming of about 0.4 degrees C between 1976 and 1998. Climate modelers assume the cause must be greenhouse-gas emissions because they have no other explanation. This is a poor substitute for evidence, and simulation hardly constitutes explanation. Ten years ago climate modelers also couldn't account for the warming that occurred from about 1050 to 1300. They tried to expunge the medieval warm period from the observational record—an effort that is now generally discredited. The models have also severely underestimated short-term variability El Niño and the Intraseasonal Oscillation. Such phenomena illustrate the ability of the complex and turbulent climate system to vary significantly with no external cause whatever, and to do so over many years, even centuries.
Is there any point in pretending that CO2 increases will be catastrophic? Or could they be modest and on balance beneficial? India has warmed during the second half of the 20th century, and agricultural output has increased greatly. Infectious diseases like malaria are a matter not so much of temperature as poverty and public-health policies (like eliminating DDT). Exposure to cold is generally found to be both more dangerous and less comfortable.
Moreover, actions taken thus far to reduce emissions have already had negative consequences without improving our ability to adapt to climate change. An emphasis on ethanol, for instance, has led to angry protests against corn-price increases in Mexico, and forest clearing and habitat destruction in Southeast Asia. Carbon caps are likely to lead to increased prices, as well as corruption associated with permit trading. (Enron was a leading lobbyist for Kyoto because it had hoped to capitalize on emissions trading.) The alleged solutions have more potential for catastrophe than the putative problem. The conclusion of the late climate scientist Roger Revelle—Al Gore's supposed mentor—is worth pondering: the evidence for global warming thus far doesn't warrant any action unless it is justifiable on grounds that have nothing to do with climate.
Lindzen is the Alfred P. Sloan Professor of Meteorology at the Massachusetts Institute of Technology. His research has always been funded exclusively by the U.S. government. He receives no funding from any energy companies.
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|From: LindyBill||4/9/2007 8:05:26 AM|
|The NYT had to swallow hard to publish this story. Makes me think that some discourse is now allowed on this subject. But they need to cease this kind of nonsense.|
Last month, Brookside started a music class in which, with teacher approval, black boys are allowed to miss one period a week to learn to play conga drums and sing West African welcome songs.
The New York Times
April 9, 2007
To Close Gaps, Schools Focus on Black Boys
By WINNIE HU
OSSINING, N.Y. — In an effort to ensure racial diversity, the school system here in northern Westchester County is set up in an unusual way, its six school buildings divided not by neighborhood but by grade level. So all of the second and third graders in the Ossining Union Free School District attend the Brookside School.
But some minority students, the black boys at Brookside, are set apart, in a way, by a special mentoring program that pairs them with black teachers for one-on-one guidance outside class, extra homework help, and cultural activities during the school day. “All the black boys used to end up in the office, so we had to do something,” said Lorraine Richardson, a second-grade teacher and mentor. “We wanted to teach them to help each other” instead of fight each other.
While many school districts have long worked to close the achievement gap between minority and white students, Ossining’s programs aimed to get black male students to college are a new frontier.
Ossining school officials said they were not singling out black boys, but after a district analysis of high school students’ grade-point averages revealed that black boys were performing far worse than any other group, they decided to act. In contrast, these officials said, the performance of black girls compared favorably with other students and did not warrant the same concern.
The district calls it a “moral imperative,” and administrators and teachers say their top priority is improving the academic performance of black male students, who account for less than 10 percent of the district’s 4,200 students but disproportionately and consistently rank at the bottom in grades and test scores. The programs are voluntary, school officials said, and some students choose not to take part.
The special efforts for Ossining’s black male students began in 2005 with a college-preparatory program for high schoolers and, starting last month, now stretch all the way to kindergarten, with 5-year-olds going on field trips to the American Museum of Natural History and Knicks and Mets games to practice counting.
Ossining’s unusual programs for black boys have drawn the attention of educators across the country as school districts in diversifying suburbs are coming under new pressure to address what many see as a seemingly intractable racial divide with no obvious solution.
The federal No Child Left Behind law’s requirement that test scores be analyzed for each racial group has over the past decade spotlighted the achievement gap even in predominantly white suburban districts.
Some of the nation’s leading minority scholars have praised Ossining’s approach, but other educators, parents and civil rights groups contend that such separate programs do more harm than good. Last year, the New York Civil Rights Coalition filed a complaint with the United States Department of Education over such a program at the City University of New York, and the group plans to file a complaint with the state against Ossining’s program.
“I think this is a form of racial profiling in the public school system,” said the coalition’s executive director, Michael Meyers. “What they’re doing here, under the guise of helping more boys, is they’re singling them out and making them feel inferior or different simply because of their race and gender.”
At a time of wider debate over the socioeconomic barriers facing black boys, the focus on boosting educational support has gained traction with policymakers. In Maryland, a state education task force asserted in December that “school, itself, is an at-risk environment for African-American male youth” and issued a 58-page report “to justify fixing it — whatever the cost.”
In New York and other large cities, such concerns have spurred the creation of all-male schools aimed at drawing black students. Now, with debate over the achievement gap spreading beyond city borders, efforts like Ossining’s — though few as comprehensive — are sprouting up in suburbs nationwide.
In Teaneck, N.J., school officials formed an after-school club for black boys in 2005, with local black businessmen serving as role models. In the Cleveland suburbs, the South Euclid-Lyndhurst district has spent more than $20,000 a year on clubs that reward black male students for good grades with sleepovers and guest speakers.
And in the neighboring community of Shaker Heights, one of the nation’s best-known honors programs for black male students, the Minority Achievement Committee Scholars, has since 2004 received calls from more than 40 school districts that want to copy its efforts.
Here in Ossining, where Sing Sing state prison looms as a reminder that more black men are behind bars than enrolled in college, Latoya Morris, who is black, said that most of her black male classmates dropped out of school before she graduated in 1999. Now the mother of a 5-year-old boy in kindergarten, Ms. Morris, a nurse, said the extra support for black boys makes sense because the statistics are stacked against them.
“I don’t want my son to be in jail when he becomes a teenager,” she said. “I want him to have the same chances as a white child.”
The school officials here noted that it is too soon to measure the impact of their programs with test scores, but that the percentage of black students enrolled in college-level courses in 11th and 12th grades has more than doubled to 55 percent this year from 26 percent in 2004.
In the lower grades, teachers have also reported that disciplinary referrals for black boys have dropped — as much as 80 percent at Brookside — and that the boys are missing fewer homework assignments and paying more attention in class. (Efforts are under way now to begin similar programs for Hispanic boys, who have also not performed well.)
Since Lenox Robinson, a 12-year-old sixth grader, joined the district’s mentoring program in October, he has begun saving pennies and quarters in a glass jar under his bed — he has $10 so far — to pay for college. Lenox failed science last marking period mainly because, he said, he stopped trying after his friends made fun of him, adding, “I realize I shouldn’t have done that.”
Programs aimed specifically at black students, and the boys in particular, are a departure from past efforts that sought to erase the achievement gap by raising the performance of every student, but are gaining acceptance in some circles.
This summer, the law firm Sullivan and Cromwell and the investment bank Goldman Sachs are scheduled to convene their third conference of educators and professionals in the past year to brainstorm on “winning strategies for young black men.”
While most schools are reluctant to focus on any particular group of students, opposition has lessened.
Some black scholars said that achievement-gap programs must be tailored to the needs of black male students if the programs are to succeed. Freeman A. Hrabowski III, president of the University of Maryland, Baltimore County, said that many black boys grow up with few male role models and in high-crime neighborhoods, where being smart in school is not considered cool. “You can’t just ignore the needs of a group and say all children are the same,” he said.
But Kati Haycock, president of the Education Trust, a Washington-based group that advocates for disadvantaged children, worried that such efforts may unintentionally lump together high-achieving black students with low-achieving ones and, in effect, “declare a whole set of kids at risk.”
“You do have to worry whether you’re creating a stereotype that is as damaging as the one you’re trying to replace,” she said.
The Ossining district is one of the most racially and economically mixed in the affluent Westchester suburbs: about 16 percent of the students are black and 38 percent Hispanic, and nearly one-third qualify for free and reduced lunches.
A New York Times analysis of state education data showed that, among about 150 districts that tested students in the 2004-5 school year, the most recent available, Ossining’s achievement gap between black and white students was in the top fifth. For fourth graders, the gap widened on the English tests from four years earlier, while for eighth graders, the gap narrowed during the same period but was still twice as big as in all the other districts.
Since 2005, Ossining’s programs for black boys have cost more than $50,000, most of it from donations, grants and a student telethon. School officials said they had not received any complaints about the district’s use of resources for this purpose.
None of more than two dozen parents who were interviewed directly criticized the focus on black boys, or said that the boys were receiving preferential treatment. But several said the programs should be made available to struggling students regardless of race.
Under the programs, the extra attention begins in elementary school; every black boy in fourth and fifth grades, for example, is assigned a team of teachers to track his academic progress.
The boys also meet black role models, while their parents attend workshops on planning for college. Motivation is emphasized throughout. As part of a recent dress for success contest, high school boys wore suits to school for a month. The two winners received hand-tailored suits.
Last month, Brookside started a music class in which, with teacher approval, black boys are allowed to miss one period a week to learn to play conga drums and sing West African welcome songs. After one recent drum fest, 9-year-old Arthur Stokeley, a third grader, sat down with his mentor, Ms. Richardson, to review his class work.
“So how was school today?” Ms. Richardson said.
“It was great,” Arthur said.
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|From: LindyBill||4/9/2007 8:17:02 AM|
|Bolton calls out Brits as wimps|
In this Financial Times piece yesterday, which Fox News is currently buzzing about. But for the non-subscribers among us, Bolton also was quoted for this lengthy piece printed in The Australian:
"...John Bolton, former US ambassador to the United Nations, was appalled. 'The Iranians learnt that if you poke people in the eye, they're happy when you stop,' he said.
There is circumstantial evidence that a deal was struck, despite denials. 'I hope we didn't negotiate with them because if we did, it is a mistake,' said Bolton.
...Michael Ledeen, a former US official who dealt with the Iranians during the Iran-contra affair, said: 'It's obvious there was a deal. It will only encourage the Iranians to believe that the West is weak.'
...For Bolton, the Iranians received dangerous encouragement: 'It was a low-cost experiment for them designed to see how tough a response they would get from Britain, Europe and, ultimately, the United States. The answer is "not much". It will embolden them to press ahead on the nuclear weapons front.'"
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|From: LindyBill||4/9/2007 8:25:18 AM|
|Restoration on the Half Shell|
By ROWAN JACOBSEN
NEW YORK TIMES OP-ED
Published: April 9, 2007
THIS year marks 400 years since the founding of the Jamestown colony, a span in which everything about the area has changed, not least the water. When John Smith first encountered the Chesapeake, he was struck by its beauty and bounty. "Heaven and earth never agreed better to frame a place for man's habitation," he wrote. The water was clear, fish teemed in its depths, and oysters lay "as thick as stones" on the bottom.
Don't try to look for those oysters today. They aren't there. Even if they were, you wouldn't be able to see them through the brown murk. Those oysters were the linchpin of a now-comatose ecosystem. Not only did they pave the bottom, providing footholds for aquatic plants, but they also formed prodigious "oyster reefs" 20 feet high and miles long that sheltered juvenile fish and crustaceans.
And they performed another vital function. Oysters eat algae. A single adult oyster can filter 50 gallons of water a day, and the uncountable billions that once inhabited the Chesapeake filtered the entire bay every few days. This allowed sunlight to penetrate to the bay bottom so eelgrass and other foundations of the food chain could thrive. By providing these three services — filtration, stabilization and habitation — oysters engineered the ecosystem.
Then they disappeared. Overharvesting was the main culprit, but pollution and disease played roles, too. Annual harvests on the Chesapeake plunged, from over 100 million pounds in 1880 to 20 million in 1960 and less than 250,000 pounds today.
Many East Coasters think that mid-Atlantic waters are supposed to look like brown soup. They're not. Too many nutrients wash downstream from cities and farms, feeding algae blooms, and there aren't enough oysters around to eat the algae. When the algae die and decay, they take the oxygen with them, causing the "dead zones" becoming all too common along America's coasts.
Today, everyone agrees that to restore the estuaries we need to restore the oysters. But how to do it? Government agencies spend about $300 million a year in oyster-restoration programs, with marginal results. Millions of baby oysters are grown in hatcheries and thrown into the Chesapeake every year, but without the structure provided by oyster reefs, they are crunched up by starfish, stingrays and other predators, buried under sediment, or killed by disease. Fewer wild oysters populate the Chesapeake today than when the restoration programs began in the 1990s.
Meanwhile, there is a movement to introduce a Chinese oyster into the bay that may grow faster and be more disease-resistant and pollution-tolerant. But the folly of introducing an alien species to a struggling ecosystem has been shown again and again. Zebra mussels, anyone?
Meanwhile, a real solution exists. Oyster farms are thriving in Virginia, New York and New England. On these aquaculture operations, billions of oysters spend one to three years in metal cages that function as artificial reefs. They filter water. Their shells provide habitat for numerous species. Sport fishermen have learned that striped bass, shad and other species congregate around them.
Aquaculture has a bad name. We picture fish farms with tons of feed being dumped into the water, creating the same algae-promoting conditions as pollution from cities and terrestrial farms. But the situation is reversed with oyster farms, because oysters are little filters. The farms provide far more water-cleaning benefits than all the government programs put together, don't cost taxpayers a cent, and support coastal economies. They also make better oysters: a farmed oyster is plumper, sweeter and prettier than its wild cousin.
So, have the Chesapeake watermen, who harvest what remains of the wild oyster fishery, embraced aquaculture? Hardly. They have resisted every attempt to privatize bottomland, even as they go out of business. And Maryland has obliged them with a series of regulations effectively hamstringing aquaculture.
This is wrongheaded. The rest of us should consider it our patriotic duty to eat more cultivated oysters. I know; it's tough. But opting for oysters over wild seafood takes the pressure off marine populations and supports the sustainable production of food along our coasts. It can even help the Chesapeake return to the state of beauty and bounty that stunned John Smith four centuries ago.
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