Category: Regulations

After Wife’s Cancer, F.D.A. Regulator Cuts Decision Time from Six to Five Months (Beyond Years Spent Testing)

(p. 1) BETHESDA, Md. — Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators.
So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr. Richard Pazdur, has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.
He was also Mary’s husband.
In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and passion to fight the disease that patient advocates thought he lacked.
. . .
(p. 13) Certainly there has been a change at the powerful agency. Since Ms. Pazdur learned she had ovarian cancer in 2012, approvals for drugs have been faster than at any time in the F.D.A.’s modern history. Although companies go through a yearslong discovery and testing process with new drugs before filing a formal application with the F.D.A., the average decision time on drugs by Dr. Pazdur’s oncology group has come down to five months from six months. That is a major acceleration in a pharmaceutical industry where every month’s delay can mean thousands of lives lost and sometimes hundreds of millions of dollars in sales that, given limited patent times, can never be recovered.
When asked specifically how his wife’s illness had changed his work at the F.D.A., Dr. Pazdur said he was intent on making decisions more quickly.
“I have a much greater sense of urgency these days,” Dr. Pazdur, 63, said in an interview. “I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate.”

For the full story, see:
GARDINER HARRIS. “A Wife’s Cancer Prods the F.D.A.” The New York Times, First Section (Sun., JAN. 3, 2016): 1 & 13.
(Note: ellipsis added.)
(Note: the online version of the story has the date JAN. 2, 2016, and has the title “F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval.”)

Federal Regulations Restrict Concrete Innovation

(p. B1) Chris Tuan, a professor of civil engineering for the University of Nebraska at the Peter Kiewit Institute, has been perfecting an electrically semiconductive concrete over the past 20 years.
The mixture includes a 20 percent mix of steel fibers, shavings and carbon added to a traditional concrete mix. Steel reinforcing bars serve as the conductor, and once electricity is added, the concrete heats to 35 to 40 degrees — just enough to melt the ice and snow.
. . .
For now, the concrete can’t be used in public spaces. Anything exposed and electrified above 48 volts — much less than the 208 volts used in Tuan’s concrete — is considered high voltage and is not allowed. Federal law will have to be rewritten to change that.
. . .
Tuan said traditional concrete needs to be replaced every five years or so. Without chemical use, the electric concrete lasts much longer, with fewer potholes. His concrete is also maintenance-free, because the power cords and conductive rods are encased in the concrete and not exposed to the elements.
. . .
In 2013 Tuan also implemented his concrete on ramps in China. He recently installed a private driveway in Regency using the legally allowed 48-volt limit, which is less energy efficient.
“If the government or if insurance agencies approve this technology, then everybody can use it,” Tuan said. “But right now, it’s almost cost prohibitive.”

For the full story, see:
Reece Ristau. “In Concrete World, This Is Hot Stuff.” Omaha World-Herald (Tues., JAN. 15, 2016): B1 & B2.
(Note: ellipses added.)
(Note: the online version of the story has the title “Special Concrete Mix Can Melt Snow and Ice All by Itself — Just Add Electricity.”)

Ugly, Invasive, Depressing Federal LEDs Disrupt Sleep and Increase Risk of Breast Cancer

(p. B1) In my repellently contented middle age, I don’t seek blue light. Like most sane people, I spurn restaurants whose lighting glares. I recoil from mirrors under fluorescent tubes. I switch on an overhead only to track down a water bug while wielding a flip-flop. Yet each evening from March onward, in the Brooklyn neighborhood where I live part of the year, it seems as if the overhead is always on.
Along with other parts of South Brooklyn, Windsor Terrace is an early recipient of the Department of Transportation’s new light-emitting diode streetlights. New Yorkers who have not yet been introduced to these lights: We are living in your future.
Our new street “lamps” — too cozy a word for the icy arrays now screaming through our windows — are meant to be installed across all five boroughs by 2017. Indeed, any resident of an American municipality that has money problems (and what city doesn’t?) should take heed.
In interviews with the media, my fellow experimental subjects have compared the nighttime environment under the new streetlights to a film set, a prison yard, “a strip mall in outer space” and “the mother ship coming in for a landing” in “Close Encounters of the Third Kind.” Although going half-blind at 58, I can read by the beam that the new lamp blasts into our front room without tapping our own Con Ed service. Once the LEDs went in, our next-door neighbor began walking her dog at night in sunglasses.
Medical research has firmly established that blue-spectrum LED light can disrupt sleep patterns. This is the same illumination that radiates in far smaller doses from smartphone and computer screens, to which we’re advised to avoid exposure for at least an hour before bed, because it can suppress the production of melatonin. . . .
While the same light has also been associated with increased risk of breast cancer and mood disorders, in all honesty my biggest beef with LEDs has nothing to do with health issues. These lights are ugly. They’re invasive. They’re depressing. New York deserves better.
. . .
Even fiscally and environmentally conscientious California has compromised on this point. Berkeley, Oakland and San Francisco have all opted for yellow-rich LEDs. These cities have willingly made the modest 10-15 percent sacrifice in efficiency for an ambience that more closely embodies what Germans call Gemütlichkeit and Danes call hygge: an atmosphere of hospitality, homeyness, intimacy and well-being.
. . .
As currently conceived, the D.O.T.’s streetlight plan amounts to mass civic vandalism. If my focus on aesthetics makes this issue sound trivial, the sensory experience of daily life is not a frivolous matter. Even in junior high school, I understood that lighting isn’t only about what you see, but how you feel.

For the full commentary, see:
LIONEL SHRIVER. “Ruining That Moody Urban Glow.” The New York Times, SundayReview Section (Sun., OCT. 18, 2015): 5.
(Note: ellipses added.)
(Note: the online version of the commentary has the date OCT. 17, 2015.)

Regulatory Costs Slow Development of Lifesaving Antibiotics

(p. A13) In the 1980s, 29 new antibiotics were approved; another 23 were approved during the 1990s. But only nine new drugs made it to market from 2000-10, and a study by the Pew Charitable Trusts shows few drugs in development for the most serious microbial threats such as multidrug resistant Acinetobacter and Pseudomonas aeruginosa.
. . .
To revitalize the search for lifesaving antibiotics, the Food and Drug Administration needs a new way to approve them. Legislation proposed in both the House and the Senate would create a new regulatory pathway that would enable the FDA to approve drugs specifically for patients whose serious infections can’t be treated with existing drugs, and for whom there are few or no other treatment options.
For these patients, the FDA would be empowered to approve new drugs based on fewer or smaller clinical studies than for antibiotics intended for broader use. The goal is to reduce the cost of development and accelerate the availability of new drugs for a targeted public health need.

For the full commentary, see:
JONATHAN LEFF And ALLAN COUKELL. “How to End the Regulatory Slowdown for New Antibiotics; With the threat from lethal drug-resistant bacteria growing, the FDA needs to speed up its approval process.” The Wall Street Journal (Fri., July 3, 2015): A13.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date July 2, 2015.)

More Evidence for Stigler’s Capture Theory

(p. A15) WASHINGTON — Marilyn B. Tavenner, the former Obama administration official in charge of the rollout of HealthCare.gov, was chosen on Wednesday to be the top lobbyist for the nation’s health insurance industry.
Ms. Tavenner, who stepped down from her federal job in February, will become president and chief executive of America’s Health Insurance Plans, the trade group whose members include Aetna, Anthem, Humana, Kaiser Permanente and many Blue Cross and Blue Shield companies.
As the new voice for insurers, Ms. Tavenner will lead the industry in a time of tumultuous changes and challenges, including delicate negotiations with Congress over the future of the Affordable Care Act.
. . .
The board of America’s Health Insurance Plans unanimously elected Ms. Tavenner at a meeting here on Wednesday, according to Mark B. Ganz, the board chairman, who is also the chief executive of Cambia Health Solutions, based in Portland, Ore.
. . .
Mr. Ganz said that Ms. Tavenner had “the trust and respect of members of Congress from both sides of the aisle.”
Senator John Barrasso, Republican of Wyoming, described the selection in more negative terms. “While millions of Americans are still being hurt by Obamacare’s soaring costs and fewer choices,” he said, “Ms. Tavenner’s appointment shows how the law has created a cozy and profitable relationship for some.”

For the full story, see:
ROBERT PEAR. “Head of Obama’s Health Care Rollout to Lobby for Insurers.” The New York Times (Thurs., JULY 16, 2015): A15.
(Note: ellipses added.)
(Note: the online version of the story has the date JULY 15, 2015.)

Feds’ Dietary Policy Is “an Obstacle to Sensible Change”

(p. A25) BOSTON — SINCE the publication of the federal government’s 1980 Dietary Guidelines, dietary policy has focused on reducing total fat in the American diet — specifically, to no more than 30 percent of a person’s daily calories. This fear of fat has had far-reaching impacts, from consumer preferences to the billions of dollars spent by the military, government-run hospitals and school districts on food. As we argue in a recently published article in The Journal of the American Medical Association, 35 years after that policy shift, it’s long past time for us to exonerate dietary fat.
. . .
Recent research has established the futility of focusing on low-fat foods. Confirming many other observations, large randomized trials in 2006 and 2013 showed that a low-fat diet had no significant benefits for heart disease, stroke, diabetes or cancer risks, while a high-fat, Mediterranean-style diet rich in nuts or extra-virgin olive oil — exceeding 40 percent of calories in total fat — significantly reduced cardiovascular disease, diabetes and long-term weight gain. Other studies have shown that high-fat diets are similar to, or better than, low-fat diets for short-term weight loss, and that types of foods, rather than fat content, relate to long-term weight gain.
. . .
The limit on total fat is an outdated concept, an obstacle to sensible change that promotes harmful low-fat foods, undermines efforts to limit refined grains and added sugars, and discourages the food industry from developing products higher in healthy fats.

For the full commentary, see:
DARIUSH MOZAFFARIAN and DAVID S. LUDWIG. “Stop Fearing Fat.” The New York Times (Thurs., JULY 9, 2015): A25.
(Note: ellipses added.)
(Note: the online version of the commentary has the title “Why Is the Federal Government Afraid of Fat?”)

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.