Category: Regulations

Proletariat Loses Money Investing in Ponzi Scheme Supported by Chinese Communists

(p. B1) HONG KONG — At every turn in his improbably rapid rise, Ding Ning, 34, went to great efforts to convey the image of strong government backing for his Internet financing business.
There was his company’s lavish annual meeting and banquet last year in Beijing’s Great Hall of the People, where China’s legislature meets and where top government leaders host official functions. Adding a splash of celebrity to the event were Zhou Tao, a nationally famous actress and host on the government’s main television broadcaster, and several mid-ranking officials, bureaucrats and lawmakers.
There were the positive profiles in state-controlled media, as well as the company’s advertising on official TV. There was the section of his company’s website devoted to building Communist Party spirit.
But it all came crashing down in dramatic fashion for Mr. Ding this week, when the police alleged that his financing business, Ezubao, was a $7.6 billion Ponzi scheme and announced 21 arrests, including of Mr. Ding. The company was shut down.
, , ,
(p. B7) In interviews, former staff and investors described the signals of strong state support as one of the keys to Ezubao’s rapid rise.
“Many people joined Ezubao because they saw the support from the government and from some government officials,” said Feng Zhe, 36, a Beijing resident who worked as a salesman at the company from June of last year until December.
Mr. Feng said a number of his friends and family members invested in Ezubao’s products and suffered losses. “Many people bought their products because the government has lent the company credibility,” he added.

For the full story, see:
NEIL GOUGH. “Feeling Twice Victimized.” The New York Times (Sat., Feb. 6, 2016): B1 & B7.
(Note: ellipsis added.)
(Note: the online version of the article has the date Feb. 5, 2016, and has the title “Ponzi Scheme in China Gained Credibility From State Media.”)

Communist Chinese One Child Laws Violated Basic Human Rights

On Sat., Jan. 17, 2016 I caught the re-broadcast of an interview with Mei Fong that C-SPAN’s web site suggests was first broadcast on Jan. 11, 2016. The interview focused on Fong’s book on the history, causes and effects of China’s one child laws. Fong is understated in her style, but it is clear that the Chinese communist government violated the rights of many Chinese citizens by forcing them to have unwanted abortions, and to undergo unwanted sterilizations. In many cases, when their “one child” died in a disaster, or of natural causes, parents desperately rushed to try to have the forced sterilization reversed.

Fong’s book, that she discussed on C-SPAN, is:
Fong, Mei. One Child: The Story of China’s Most Radical Experiment. Boston, MA: Houghton Mifflin Harcourt, 2016.

Medical Establishment Relies on “Accepted Dogma”

(p. A3) The Food and Drug Administration and leading cardiologists are warning that aortic heart valves from animal tissue–implanted surgically in thousands of patients world-wide–can develop tiny blood clots, causing the valves to function improperly.
The findings hit the field of cardiology as something of a shock, as these valves from pig and cow tissue have been used for three decades in patients with malfunctioning valves. In addition, the tissue valves have been regarded as less likely to produce blood clots than mechanical valves made of synthetic materials.
. . .
Cardiologist Eric Topol, chief academic officer at Scripps Health in San Diego, called it “remarkable” that such a finding could emerge after three decades of use of the animal-tissue valves. The idea that they lead to less clotting, he said, was “accepted dogma that wasn’t looked at.”

For the full story, see:
THOMAS M. BURTON. “Clot Risk Is Seen in Some Heart Valves.” The Wall Street Journal (Tues., Oct. 6, 2015): A3.
(Note: ellipsis added.)
(Note: the online version of the article has the date Oct. 5, 2015, and has the title “Clot Risk Is Seen in Some Heart Valves.” Where there were minor differences between the print and online versions, the passages quoted above follow the online version.)

Eric Topol, quoted above, has written persuasively for more medical innovation, in his:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.

Gene Therapy Again Showing Promise

(p. B2) Biotechnology startup Spark Therapeutics Inc. said its experimental gene therapy improved vision among patients with hereditary vision impairment in a clinical trial, without the serious safety problems that have dogged the emerging field of gene therapy in the past.
. . .
Spark said it plans to seek U.S. Food and Drug Administration approval to market its treatment next year, which could make it the first gene therapy to reach the U.S. market if regulators approve it for sale. . . .
Gene therapy involves the injection of genetic material into a person’s cells to treat or prevent a disease. The research stalled after some study participants died or developed cancer after receiving gene therapies in the late 1990s and 2000s.
But gene therapy is gaining ground again. In 2012, the European Commission approved the Western world’s first gene therapy, UniQure NV’s Glybera, for the treatment of patients with a rare enzyme deficiency. The therapy hasn’t been approved for sale in the U.S.

For the full story, see:
PETER LOFTUS. “Eye Gene Therapy Shows Promise.” The Wall Street Journal (Tues., Oct. 6, 2015): B2.
(Note: ellipses added.)
(Note: the online version of the article has the date Oct. 5, 2015, and has the title “Gene Therapy for Visually Impaired Shows Promise.” Where there were minor differences between the print and online versions, the passages quoted above follow the online version.)

Regulations Slow Eradication of Cancer

(p. D3) . . . the triumph of chemotherapy for Hodgkin’s and then for many other tumors opened an interlocking series of dilemmas. In the clinic and the hospital, the new protocols demanded that doctors muster the courage to make their patients very sick in order to make them well. But how sick was too sick? The risks and benefits of the powerful treatments now needed careful, deliberate assessment at every stage of the disease.
Similar questions dogged those who developed, evaluated and regulated the drugs. How poisonous could these agents safely be? How assiduously should desperate patients be saved by their government from pharmaceutical risk?
Dr. DeVita stands firmly among those affirming cancer patients’ right to aggressive treatment. One particular exchange summarizes his philosophy: “Do your patients speak to you after you do this to them?” one skeptic asked him early on. “The answer is yes,” he replied, “and for a lot longer.”
The regulatory caution of the Food and Drug Administration has been a thorn in his side for decades: “I’d like to be able to say that as cancer drugs have become increasingly more complex and sophisticated, the F.D.A. has as well. But it has not.” In fact, he writes, “the rate-limiting step in eradicating cancer today is not the science but the regulatory environment we work in.”

For the full review, see:
ABIGAIL ZUGER, M.D. “An Unbowed Warrior.” The New York Times (Tues., Dec.. 1, 2015): D3.
(Note: ellipsis added.)
(Note: the online version of the review has the date NOV. 30, 2015, and has the title “Review: Science and Politics Collide in ‘The Death of Cancer’.”)

The book under review, is:
DeVita, Vincent T., and Elizabeth DeVita-Raeburn. The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable–and How We Can Get There. New York: Sarah Crichton Books, 2015.

Anti-GMO Chipotle No Longer Wears Health Halo

(p. A13) . . . if you need an anecdote for how the year unfolded for the anti-GMO movement, look no further than Chipotle. Last spring the fast food company announced with great fanfare that it would take GMO ingredients off its menu. It was all downhill after that. As was quickly pointed out, Chipotle wasn’t being fully truthful, since its soft drinks and cheese contain genetically modified ingredients, and its meat comes from animals fed genetically modified grains. A lawsuit filed in California, which is pending, accused Chipotle of false advertising and deceptive marketing.
Then cases of food-borne illnesses hit Chipotle locations across the country. Supporters of traditional agriculture, who have felt maligned by the burrito company, started keeping a tally of the number of people sickened by Chipotle’s food (ongoing, but more than 300) versus the number sickened by GMOs (zero). As the year winds to a close, the company that once wore the restaurant industry’s health halo is apologizing, preparing for lawsuits, recentralizing its vegetable preparation and cutting locally sourced ingredients.

For the full commentary, see:
JULIE KELLY. “The March of Genetic Food Progress; ‘Farmaceuticals’ and other GM products are slowly being approved, despite political scare campaigns.” The Wall Street Journal (Weds., Dec. 30, 2015): A13.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date Dec. 29, 2015.)

Affirmative Action Reduces Number of Black Scientists

Malcolm Gladwell, in chapter three of David and Goliath, persuasively argues that science students who would thrive at a solid public university, may be at the bottom of their class at Harvard, and in discouragement switch to an easier non-science major. Gladwell’s argument has implications for affirmative action, as noted by Gail Heriot in the passages quoted below.

(p. A13) . . . , numerous studies–as I explain in a recent report for the Heritage Foundation–show that the supposed beneficiaries of affirmative action are less likely to go on to high-prestige careers than otherwise-identical students who attend schools where their entering academic credentials put them in the middle of the class or higher. In other words, encouraging black students to attend schools where their entering credentials place them near the bottom of the class has resulted in fewer black physicians, engineers, scientists, lawyers and professors than would otherwise be the case.

But university administrators don’t want to hear that their support for affirmative action has left many intended beneficiaries worse off, and they refuse to take the evidence seriously.
The mainstream media support them on this. The Washington Post, for instance, recently featured a story lamenting that black students are less likely to major in science and engineering than their Asian or white counterparts. Left unstated was why. As my report shows, while black students tend to be a little more interested in majoring in science and engineering than whites when they first enter college, they transfer into softer majors in much larger numbers and so end up with fewer science or engineering degrees.
This is not because they don’t have the right stuff. Many do–as demonstrated by the fact that students with identical entering academic credentials attending somewhat less competitive schools persevere in their quest for a science or engineering degree and ultimately succeed. Rather, for many, it is because they took on too much, too soon given their level of academic preparation.

For the full commentary, see:
GAIL HERIOT. “Why Aren’t There More Black Scientists? The evidence suggests that one reason is the perverse impact of university racial preferences.” The Wall Street Journal (Thurs., Oct. 22, 2015): A13.
(Note: ellipsis added.)
(Note: the online version of the commentary was updated on Oct. 21, 2015.)

Heriot’s report for the Heritage Foundation, is:
Heriot, Gail. “A “Dubious Expediency”: How Race-Preferential Admissions Policies on Campus Hurt Minority Students.” Heritage Foundation Special Report #167, Aug. 31, 2015.

Gladwell’s book, mentioned above, is:
Gladwell, Malcolm. David and Goliath: Underdogs, Misfits, and the Art of Battling Giants. New York, NY: Little, Brown and Company, 2013.

Hungry Suffer Due to G.M.O. Bans by Europe’s “Coalition of the Ignorant”

(p. 6) CALL it the “Coalition of the Ignorant.” By the first week of October [2015], 17 European countries — including Austria, Denmark, France, Germany, Greece, Hungary, Italy, the Netherlands and Poland — had used new European Union rules to announce bans on the cultivation of genetically modified crops.
. . .
I have spent time with malnourished children in Tanzania whose families were going hungry because cassava crops were wiped out by brown-streak disease. That was particularly painful because in neighboring Uganda I had recently visited trial plots of genetically modified cassava that demonstrated complete resistance to the virus. The faces of the hungry children come to mind every time I hear European politicians boast about their country’s G.M.O. ban and demand that the rest of the world follow suit — as Scotland’s minister did in August.
Thanks to Europe’s Coalition of the Ignorant, we are witnessing a historic injustice perpetrated by the well fed on the food insecure. Europe’s stance, if taken up internationally, risks marginalizing a critically important technology that we must surely employ if humanity is to feed itself sustainably in an increasingly difficult and challenging future. I can only hope that the Continent’s policy makers come to their senses before it is too late.

For the full commentary, see:
MARK LYNAS. “With G.M.O. Policies, Europe Turns Against Science.” The New York Times, SundayReview Section (Sun., OCT. 25, 2015): 6.
(Note: ellipsis, and bracketed year, added.)
(Note: the online version of the commentary was updated on OCT. 24, 2015, and has the title “With G.M.O. Policies, Europe Turns Against Science.”)

FDA Forces Child to Go to London to Get Drug to Fight His Cancer

(p. A15) How far would you go to get a drug that could save your child’s life? Across an ocean? That is exactly what the federal government is forcing some American families with dying children to do.
In 2012, when Diego Morris was 11 years old, he was diagnosed with a deadly cancer in his leg called osteosarcoma. Doctors at St. Jude Children’s Research Hospital in Memphis, Tenn., removed the tumor, but the prognosis was poor. There was a significant risk that even extensive chemotherapy after surgery would not prevent the cancer from returning.
Fortunately, a team of doctors at MD Anderson Cancer Center in Houston and Memorial Sloan Kettering Cancer Center in New York City had developed a revolutionary new drug, mifamurtide (MTP), that can prevent osteosarcoma from coming back. A study by Dr. Eugenie Kleinerman of MD Anderson and Dr. Paul Meyers of Sloan Kettering showed the drug resulted in a 30% reduction in the osteosarcoma mortality rate at eight years after diagnosis.
The drug was approved in 2009 by the European Medicines Agency and is currently the standard of care in Europe, Israel and many other countries. In 2012 it received the prestigious Prix Galien Award, the gold medal for pharmaceutical research and development in the United Kingdom.
MPT was exactly what Diego needed. But there was one problem: The drug was not available in America because the Food and Drug Administration had rejected it, demanding additional studies. That meant that Diego had to travel from Phoenix to London to get the drug he needed to save his life–a drug that was available in almost every industrialized nation and should have been available in the U.S.

For the full commentary, see:

DARCY OLSEN. “Winning the Right to Save Your Own Life; As the FDA dawdles, 24 states pass ‘right-to-try’ laws giving terminally ill patients access to drugs.” The Wall Street Journal (Fri., Nov. 27, 2015): A15.
(Note: the online version of the commentary has the date Nov. 26, 2015.)

Olsen’s commentary is related to her book:
Olsen, Darcy. The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need. New York: HarperCollins Publishers, 2015.

Cuomo Bans the Fracking that Could Revive New York’s Southern Tier

(p. A25) CONKLIN, N.Y. — The main grocery store here was replaced by a Family Dollar store, already faded. The historic front of the town hall, a castle no less, is crumbling, and donations are being solicited. The funds earmarked to strip off the lead paint from the castle’s exterior went instead to clear mold from the basement.
This town of roughly 5,500 residents looks alarmingly like dozens of other towns and cities in New York’s Southern Tier, a vast part of the state that runs parallel to Pennsylvania. Years ago, the region was a manufacturing powerhouse, a place where firms like General Electric and Westinghouse thrived. But over time companies have downsized, or left altogether, lured abroad or to states with lower taxes and fewer regulations.
. . .
In western New York, . . . , Gov. Andrew M. Cuomo, a Democrat, pledged $1 billion in 2012 to support economic development. Since then, he has poured hundreds of millions of dollars into numerous Buffalo-area projects.
The Southern Tier has proved to be a harder fix. It is predominantly rural and lacks a significant population core that typically attracts the private sector.
The region is resource rich, but landowners are angry the government will not let them capitalize on it. Some had pinned their hopes of an economic revival on the prospect of the state’s authorizing hydraulic fracturing, known as fracking; many of them can recite the payment formula gas companies were proposing: $500 a month per acre.
But the Cuomo administration, citing health risks, decided last year to ban the practice, leaving some farmers contemplating logging the timber on their land, a move that could destroy swaths of pristine forest.

For the full story, see:
SUSANNE CRAIG. “Former Hub of Manufacturing Ponders Next Act.” The New York Times (Weds., SEPT. 30, 2015): A20-A21.
(Note: ellipses added.)
(Note: the online version of the story has the date SEPT. 29, 2015, and has the title “New York’s Southern Tier, Once a Home for Big Business, Is Struggling.”)

FDA Has No Right to Stop the Terminally Ill from Seeking Cures

(p. C4) Ms. Olsen notes that “today, about 40 percent of cancer patients attempt to enroll in clinical trials, but only about 3 percent end up participating. That means that the vast majority don’t make the cut, whether because they fail to meet the strict criteria, or a trial is thousands of miles from their home.” Many of those who don’t get these experimental drugs are the sickest patients because they are deemed “too sick to be useful for the study.”
Ms. Olsen argues that terminally ill patients should be able to access such drugs–at their own risk and outside the context of FDA-required studies–if the companies are willing to provide them, and the book’s title alludes to her proposed remedy: the state-by-state campaign the Goldwater Institute is leading to pass “Right to Try” legislation. The bills would allow terminally ill patients who have “exhausted all conventional treatment options” to access an experimental treatment if their doctors believe it is “the best medical option to extend or save the patients’ life” and “the treatment has successfully completed basic safety testing and is part of the FDA’s ongoing evaluation and approval process.” Insurers, critically, would not be required to cover the treatment–a significant hurdle, largely unexplored here, since such costs could be significant.
The think tank’s campaign has been incredibly successful, with 24 states passing Right to Try laws to date. Still, Ms. Olsen doesn’t present such laws as a panacea. She doesn’t expect experimental treatments to always–or even often–work for terminally ill patients. But she believes that some chance is better than the alternative. “If you have the Right to Die, you have the Right to Try,” Ms. Olsen writes. “And you don’t have to wait on Washington to secure it.”
Yet therein lies the book’s main shortcoming. Washington, it turns out, has a fair bit of say here. Courts have found that the FDA’s powers to regulate drug development are extraordinarily broad. Many changes Ms. Olsen champions won’t be possible without congressional action to revamp the FDA’s drug development process and find new ways of paying for experimental drugs that would make widespread access sustainable for patients, companies and insurers. These issues, though touched on, are not grappled with in detail.

For the full review, see:
PAUL HOWARD. “BOOKSHELF; Hail Mary Medicine; Patients spend their last days pleading with reluctant drug companies and the FDA to get access to treatments that could save their lives.” The Wall Street Journal (Fri., Nov. 13, 2015): C4.
(Note: ellipses added.)
(Note: the online version of the review has the date Nov. 12, 2015.)

The book under review, is:
Olsen, Darcy. The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need. New York: HarperCollins Publishers, 2015.