FDA and ACS Wrongly Endorsed Sunscreen with Retinyl Palmitate

Some consumers let their guard down on medical issues, assuming that the government Food and Drug Administration (FDA), and large incumbent bureaucratic non-profits, like the American Cancer Society (ACS), will protect them—it ain’t necessarily so. Caveat emptor should remain the rule for consumers.

(p. 39) Of note, one of the reasons for the lack of updating the rules and acknowledging UVA rays has been heavy pressure from sunscreen manufacturers, which include Johnson and Johnson (Neutrogena), Merck-Schering Plough (Coppertone), Proctor and Gamble (Olay), and L’Oreal. Interestingly, in Europe products that provide solid UVA protection have been available for years. The concerns run even deeper because many of the products (41 percent in the United States) contain a form of vitamin A known as retinyl palmitate, which has been associated with increased likelihood of skin cancer. There are, however, no randomized studies, but biological plausibility and the observational findings of a rising incidence of basal cell (p. 40) carcinoma and melanoma, despite the widespread use of sunscreens. In mid-2011, the FDA finally unveiled some new rules about sunscreen claims.

This issue really hit home when my wife brought out a tube of Neutrogena Ultra Sheer Dry-Tough SPF 30 Sunblock. It claims “Broad Spectrum UVNUVB Protection” despite repeatedly failing UVA tests. But the real eye-opener is to find the American Cancer Society logo on the front of the tube with the message “Help Block Out Skin Cancer.” Now what is the American Cancer Society logo doing on the tube of Neutrogena? The fine print on the bottom reads: “The American Cancer Society (ACS) and Neutrogena, working together to help prevent skin cancer, support the use of sunscreen. The ACS does not endorse any specific product. Neutrogena pays a royalty to the ACS for the use of its logo.”

Source:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.

The Kairos of Creative Destruction in Medicine

Wikipedia tells us that “Kairos” “is an ancient Greek word meaning the right or opportune moment (the supreme moment).”

(p. x) With a medical profession that is particularly incapable of making a transition to practicing individualized medicine, despite a new array of powerful tools, isn’t it time for consumers to drive this capability? The median of human beings is not the message. The revolution in technology that is based on the primacy of individuals mandates a revolution by consumers in order for new medicine to take hold.

Now you’ve probably thought “creative destruction” is a pretty harsh term to apply to medicine. But we desperately need medicine to he Schumpetered, to be radically transformed. We need the digital world to invade (p. xi) the medical cocoon and to exploit the newfound and exciting technological capabilities of digitizing human beings. Some will consider this to be a unique, opportune moment in medicine, a veritable once-in-a-lifetime Kairos.
This book is intended to arm consumers to move us forward.

Source:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.
(Note: italics in original.)

Instead of Fixing “Inadequate Schools,” Adderall Is Prescribed to “Struggling” Students

RocafortAmandaAndSonQuintn2012-10-12.jpg “Amanda Rocafort and her son Quintn in Woodstock, Ga. Quintn takes the medication Risperdal.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. A1) CANTON, Ga. — When Dr. Michael Anderson hears about his low-income patients struggling in elementary school, he usually gives them a taste of some powerful medicine: Adderall.

The pills boost focus and impulse control in children with attention deficit hyperactivity disorder. Although A.D.H.D is the diagnosis Dr. Anderson makes, he calls the disorder “made up” and “an excuse” to prescribe the pills to treat what he considers the children’s true ill — poor academic performance in inadequate schools.

For the full story, see:
ALAN SCHWARZ. “Attention Disorder or Not, Pills to Help in School.” The New York Times (Tues., October 9, 2012): A1 & A18.

Openness to Creative Destruction Will Speed Health Care Progress

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Source of book image: http://si.wsj.net/public/resources/images/OB-RQ412_bkrvme_DV_20120202132402.jpg

Eric Topol has bucked the medical establishment before. In entries on August 20, 2006 and on December 26, 2006 on this blog, he was quoted as arguing that stents were being overused. Now he argues that the medical establishment is slowing progress that could reduce disability and extend life. He advocates the sequencing of each of our genomes and a medical revolution that will fine-tune treatment to our genomic differences.
Many agree with Topol’s view of the future of medicine, but many medical schools are neglecting teaching future doctors about the therapeutic implications of individual genomics.
Topol calls for the creative destruction of medical education and other medical institutions.
The early part of the book is weak because it discusses subjects on which Topol is not an expert—such as the history and applications of information technology. In these sections, he too often tediously explains the obvious and widely known. Sometimes in this section of the book, he is just wrong, as when (p. 14) he claims that Werner Sombart originated “creative destruction.”
After the early chapters the book comes into its own when Topol discusses medical advances and challenges. While his early prose may be aimed too low, his later prose may be aimed too high—but it is better to be talked up to than down to, and the best of the later chapters contain some fascinating descriptions of what is happening on the frontiers of medicine, and what could be happening if we change policies and institutions to make medicine more open to creative destruction.
In the following few weeks, I will be quoting several of the more important or thought-provoking passages.

Book discussed:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.

Garfield’s Doctors “Basically Tortured Him to Death”

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Source of book image: http://rsirving.files.wordpress.com/2012/04/destinyrepublic.jpeg

(p. 15) Had Garfield been left where he lay, he might well have survived; the bullet failed to hit his spine or penetrate any vital organs. Instead, he was given over to the care of doctors, who basically tortured him to death over the next 11 weeks. Two of them repeatedly probed his wound with their unsterilized fingers and instruments before having him carted back to the White House on a hay-and-horsehair mattress.

There, control of the president was seized by a quack with the incredible name of Dr. Doctor Willard Bliss. Dr. Doctor Bliss insisted on stuffing Garfield with heavy meals and alcohol, which brought on protracted waves of vomiting. He and his assistants went on probing the wound several times a day, causing infections that burrowed enormous tunnels of pus throughout the president’s body.
Garfield’s medical “care” is one of the most fascinating, if appalling, parts of Millard’s narrative. Joseph Lister had been demonstrating for years how his theories on the prevention of infection could save lives and limbs, but American doctors largely ignored his advice, not wanting to “go to all the trouble” of washing hands and instruments, Millard writes, enamored of the macho trappings of their profession, the pus and blood and what they referred to fondly as the “good old surgical stink” of the operating room.
Further undermining the president’s recovery was his sickroom in the White House — then a rotting, vermin-ridden structure with broken sewage pipes. Outside, Washington was a pestilential stink hole; besides the first lady, four White House servants and Guiteau himself had contracted malaria. Hoping to save Garfield from the same, Bliss fed him large doses of quinine, causing more intestinal cramping.
The people rallied around their president even as his doctors failed him. The great Western explorer and geologist John Wesley Powell helped design Ameri­ca’s first air-conditioning system to relieve Garfield’s agony. Alexander Graham Bell worked tirelessly to invent a device that could locate the bullet. (It failed when Dr. Bliss insisted he search only the wrong side of Garfield’s torso.) Two thousand people worked overnight to lay 3,200 feet of railroad track, so the president might be taken to a cottage on the Jersey Shore. When the engine couldn’t make the grade, hundreds of men stepped forward to push his train up the final hill.
The president endured everything with amazing fortitude and patience, even remarking near the end, when he learned a fund was being taken up for his family: “How kind and thoughtful! What a generous people!”
“General Garfield died from malpractice,” Guiteau claimed, defending himself at his spectacle of a trial. This was true, but not enough to save Guiteau from the gallows.

For the full review, see:
KEVIN BAKER. “Death of a President.” The New York Times Book Review (Sun., October 2, 2011): 14-15.
(Note: the online version of the review has the date September 30, 2011, and has the title “The Doctors Who Killed a President.”)

The full reference for the book under review, is:
Millard, Candice. Destiny of the Republic: A Tale of Madness, Medicine and the Murder of a President. New York: Doubleday, 2011.

People “Reward the Providers of Dangerously Misleading Information”

(p. 262) As Nassim Taleb has argued, inadequate appreciation of the uncertainty of the environment inevitably leads economic agents to take risks they should avoid. However, optimism is highly valued, socially and in the market; people and firms reward the providers of dangerously misleading information more than they reward truth tellers. One of the lessons of the financial crisis that led to the Great Recession is that there are periods in which competition, among experts and among organizations, creates powerful forces that favor a collective blindness to risk and uncertainty.
The social and economic pressures that favor overconfidence are not (p. 263) restricted to financial forecasting. Other professionals must deal with the fact that an expert worthy of the name is expected to display high confidence. Philip Tetlock observed that the most overconfident experts were the most likely to be invited to strut their stuff in news shows. Overconfidence also appears to be endemic in medicine. A study of patients who died in the ICU compared autopsy results with the diagnosis that physicians had provided while the patients were still alive. Physicians also reported their confidence. The result: “clinicians who were ‘completely certain’ of the diagnosis antemortem were wrong 40% of the time.” Here again, expert overconfidence is encouraged by their clients: “Generally, it is considered a weakness and a sign of vulnerability for clinicians to appear unsure. Confidence is valued over uncertainty and there is a prevailing censure against disclosing uncertainty to patients.” Experts who acknowledge the full extent of their ignorance may expect to be replaced by more confident competitors, who are better able to gain the trust of clients. An unbiased appreciation of uncertainty is a cornerstone of rationality–but it is not what people and organizations want. Extreme uncertainty is paralyzing under dangerous circumstances, and the admission that one is merely guessing is especially unacceptable when the stakes are high. Acting on pretended knowledge is often the preferred solution.

Source:
Kahneman, Daniel. Thinking, Fast and Slow. New York: Farrar, Straus and Giroux, 2011.

Environmental “Witch-Hunt” Kills “Golden Rice”

(p. C4) Vitamin A deficiency affects the immune system, leading to illness and frequently to blindness. It probably causes more deaths than malaria, HIV or tuberculosis, killing as many people every single day as the Fukushima tsunami. It can be solved by eating green vegetables and meat, but for many poor Asians, who can afford only rice, that remains an impossible dream. To deal with the problem, “biofortification” with genetically modified food plants is 1/10th as costly as dietary supplements.
“Golden rice”–with two extra genes to make beta-carotene, the raw material for vitamin A–was a technical triumph, identical to ordinary rice except in color. Painstaking negotiations led to companies waiving their patent rights so the plant could be grown and regrown free by anybody.
Yet today, 14 years later, it still has not been licensed to growers anywhere in the world. The reason is regulatory red tape deliberately imposed to appease the opponents of genetic modification, which Adrian Dubock, head of the golden rice project, describes as “a witch-hunt for suspected theoretical environmental problems…[because] many activist NGOs thought that genetically engineered crops should be opposed as part of their anti-globalization agenda.”
It is surprising to find that an effective solution to the problem consistently rated by experts as the poor world’s highest priority has been stubbornly opposed by so many pressure groups supposedly acting on behalf of the poor.

For the full commentary, see:
MATT RIDLEY. “MIND & MATTER; Red Tape Hobbles a Harvest of Life-Saving Rice.” The Wall Street Journal (Sat., May 18, 2012): C4.
(Note: ellipsis in original.)
(Note: the online version of the article has the date May 18, 2012.)

In Cancer Treatment “a Breakthrough Moment”?

(p. A1) CHICAGO–Medical science efforts to harness the power of the immune system against cancer are beginning to bear fruit after decades of frustration, opening up a hopeful new front in the long battle against the disease.
In studies being presented Saturday, researchers said two experimental drugs by Bristol-Myers Squibb Co. . . . significantly shrank tumors in some patients with advanced skin, lung and kidney cancers.
Especially promising was that the drugs worked against several types of cancer, researchers said of the early findings. Most of the patients whose tumors responded significantly to the treatment saw long-term results.
. . .
(p. A2) Taken together, the findings are provoking excitement among researchers and the drug industry that immunotherapy has finally arrived as a viable cancer-fighting strategy.
“Those of us in the field really see this as a breakthrough moment,” said Suzanne Topalian, a researcher at Johns Hopkins School of Medicine and lead author of one of the studies. Both are being presented by Hopkins researchers at the annual meeting of the American Society of Clinical Oncology and published online by the New England Journal of Medicine.

For the full story, see:
RON WINSLOW. “New Cancer Drugs Use Body’s Own Defenses.” The Wall Street Journal (Sat., June 2, 2012): A1-A2.
(Note: ellipses added.)
(Note: the online version of the story has the date June 1, 2012.)

In Health Care, He Who Pays the Piper, Calls the Tune

(p. A15) Under the Bloomberg plan, any cup or bottle of sugary drink larger than 16 ounces at a public venue would be verboten, beginning early next year.
. . .
Here is the ultimate justification for the Bloomberg soft-drink ban, not to mention his smoking ban, his transfat ban, and his unsuccessful efforts to enact a soda tax and prohibit buying high-calorie drinks with food stamps: The taxpayer is picking up the bill.
Call it the growing chattelization of the beneficiary class under government health-care programs. Bloombergism is a secular trend. Los Angeles has sought to ban new fast-food shops in neighborhoods disproportionately populated by Medicaid recipients, Utah to increase Medicaid copays for smokers, Arizona to impose a special tax on Medicaid recipients who smoke or are overweight.

For the full commentary, see:
HOLMAN W. JENKINS, JR. “BUSINESS WORLD; The 5th Avenue to Serfdom; Nobody thought about taking away your Big Gulp until the government began to pay for everyone’s health care.” The Wall Street Journal (Sat., June 2, 2012): A15.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date June 1, 2012.)

Veterinarians Can Suggest Innovative Hypotheses to Doctors

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Source of book image: online version of the WSJ review quoted and cited below.

Vets face less government regulation and so are freer to rapidly innovate. They may thus be a promising source of innovative hypotheses for medical doctors.

(p. D2) Cardiologist Barbara Natterson-Horowitz made her first foray into the world of animal medicine when she was asked to treat Spitzbuben, an exceedingly cute emperor tamarin suffering from heart failure.

But first, the veterinarian at the Los Angeles Zoo warned Dr. Natterson-Horowitz: Mere eye contact with the tiny primate could trigger a potentially fatal surge of stress hormones. What she learns from that experience spurs a journey to examine the links between the human and animal condition–and the discovery that the species are closer than she ever imagined.
. . .
The authors recommend that doctors, who often look with disdain on veterinarians, go the next step and collaborate with them in a cross-disciplinary “zoobiquitous” approach–using knowledge about how animals live, die and heal to spark innovative hypothesis for advancing medicine.

For the full review, see:
LAURA LANDRO. “Healthy Reader.” The Wall Street Journal (Tues., June 12, 2012): D2.
(Note: ellipsis added.)
(Note: the online version of the review has the date June 11, 2012.)

The book being reviewed, is:
Natterson-Horowitz, Barbara, and Kathryn Bowers. Zoobiquity: What Animals Can Teach Us About Health and the Science of Healing. New York: Alfred A. Knopf, 2012.

Take U.S.D.A. and C.D.C. Advice with a Grain of Salt

(p. 8) When I spent the better part of a year researching the state of the salt science back in 1998 — already a quarter century into the eat-less-salt recommendations — journal editors and public health administrators were still remarkably candid in their assessment of how flimsy the evidence was implicating salt as the cause of hypertension.
“You can say without any shadow of a doubt,” as I was told then by Drummond Rennie, an editor for The Journal of the American Medical Association, that the authorities pushing the eat-less-salt message had “made a commitment to salt education that goes way beyond the scientific facts.”
While, back then, the evidence merely failed to demonstrate that salt was harmful, the evidence from studies published over the past two years actually suggests that restricting how much salt we eat can increase our likelihood of dying prematurely. Put simply, the possibility has been raised that if we were to eat as little salt as the U.S.D.A. and the C.D.C. recommend, we’d be harming rather than helping ourselves.
. . .
When researchers have looked at all the relevant trials and tried to make sense of them, they’ve continued to support Dr. Stamler’s “inconsistent and contradictory” assessment. Last year, two such “meta-analyses” were published by the Cochrane Collaboration, an international nonprofit organization founded to conduct unbiased reviews of medical evidence. The first of the two reviews concluded that cutting back “the amount of salt eaten reduces blood pressure, but there is insufficient evidence to confirm the predicted reductions in people dying prematurely or suffering cardiovascular disease.” The second concluded that “we do not know if low salt diets improve or worsen health outcomes.”
. . .
(p. 9) A 1972 paper in The New England Journal of Medicine reported that the less salt people ate, the higher their levels of a substance secreted by the kidneys, called renin, which set off a physiological cascade of events that seemed to end with an increased risk of heart disease. In this scenario: eat less salt, secrete more renin, get heart disease, die prematurely.
With nearly everyone focused on the supposed benefits of salt restriction, little research was done to look at the potential dangers. But four years ago, Italian researchers began publishing the results from a series of clinical trials, all of which reported that, among patients with heart failure, reducing salt consumption increased the risk of death.
Those trials have been followed by a slew of studies suggesting that reducing sodium to anything like what government policy refers to as a “safe upper limit” is likely to do more harm than good. These covered some 100,000 people in more than 30 countries and showed that salt consumption is remarkably stable among populations over time.
. . .
One could still argue that all these people should reduce their salt intake to prevent hypertension, except for the fact that four of these studies — involving Type 1 diabetics, Type 2 diabetics, healthy Europeans and patients with chronic heart failure — reported that the people eating salt at the lower limit of normal were more likely to have heart disease than those eating smack in the middle of the normal range. Effectively what the 1972 paper would have predicted.
. . .
Maybe now the prevailing beliefs should be changed. The British scientist and educator Thomas Huxley, known as Darwin’s bulldog for his advocacy of evolution, may have put it best back in 1860. “My business,” he wrote, “is to teach my aspirations to conform themselves to fact, not to try and make facts harmonize with my aspirations.”

For the full commentary, see:
GARY TAUBES. “OPINION; Salt, We Misjudged You.” The New York Times, SundayReview Section (Sun., June 3, 2012): 8-9.
(Note: ellipses added.)
(Note: the online version of the commentary has the date June 2, 2012.)