Health – Page 52 – artdiamondblog.com

Private Companies Beat Government in Accessible and Affordable Health Care

A CVS pharmacy MinuteClinic. Source of photo: online version of the WSJ article cited below.

It’s Friday evening and you suspect that your child might have strep throat or a worsening ear infection. Do you bundle him up and wait half the night in an emergency room? Or do you suffer through the weekend and hope that you can get an appointment with your pediatrician on Monday — taking time off your job to drive across town for another wait in the doctor’s office?

Every parent has faced this dilemma. But now there are new options, courtesy of the competitive marketplace. You might instead be able to take a quick trip on Friday night to a RediClinic in the nearby Wal-Mart or a MinuteClinic at CVS, where you will be seen by a nurse practitioner within 15 minutes, most likely getting a prescription that you can have filled right there. Cost of the visit? Generally between $40 and $60.

These new retail health clinics are opening in big box stores and local pharmacies around the country to treat common maladies at prices lower than a typical doctor’s visit and much lower than the emergency room. No appointment necessary. Open daytime, evenings and weekends. Most take insurance.

Much like the response to Hurricane Katrina, private companies are far ahead of the government in answering Americans’ needs, this time for more accessible and more affordable health care. Political leaders across the country seeking to expand government’s role in health care should take note.

For the full commentary, see:

GRACE-MARIE TURNER. "Customer Health Care." The Wall Street Journal (Mon., May 14, 2007): A17.

FDA Rejects Long-Lasting Disappearance of Disease as a “Theoretical Construct”

Consider the FDA’s handling of Genasense, a new drug for melanoma and chronic lymphocytic leukemia (CLL), two often terminal forms of cancer. The drug is being developed by Genta, a small, innovative company with only one approved drug and limited financial resources. Despite compelling evidence that Genasense is making progress in fighting both diseases, the FDA appears determined to kill the drug.

In the case of the melanoma application, instead of reviewing the clinical-trial data in accordance with usual methods (which showed positive results), the FDA chose a nonstandard statistical approach aimed at discrediting the results. The agency used this analysis in its briefing to its advisory committee, claiming that the drug might not be effective. The committee then relied on that information to vote against approval.

. . .

The FDA’s inane answer to the CLL experts was that the long-lasting disappearance of disease in patients taking Genasense was a "theoretical construct" and not grounds for approval.

The experts explained to the FDA that complete responses in advanced CLL patients are the medical equivalent of the Holy Grail. The FDA finally agreed, but was unimpressed with emerging data showing responders to Genasense living longer than responders in the control group.

The experts were unanimous in advising that Genasense should be approved, but the FDA was unmoved. The agency’s Dr. Pazdur suggested that Genta could make the drug available as an unapproved treatment through an expanded access program — this from a regulator fond of stating that the best way to get a drug to patients in need is through approval! In this case the agency was saying to Genta: We are not going to approve your drug, but any patient who needs it can have it so long as you give it away.

. . .

The FDA’s handling of Genasense lays bare the all too common, aggressive incompetence of the FDA’s cancer-drug division and should lead to an immediate examination of its policies and leadership, followed by swift corrective action.

As for the FDA’s belief that their power to control us and even deny us the pursuit of life itself is unlimited under the Constitution, we can only hope the appeals court disagrees. An agency that blocks progress against deadly diseases — while arguing that its power to do so is above challenge — is in dire need of a court supervised review.

For the full commentary, see:

STEVEN WALKER. "Drug Czars." The Wall Street Journal (Fri., May 4, 2007): A15.

(Note: ellipses added.)

Incentives Matter in Medicine, But Profit is Not the Problem

Source of graphic: online version of the NYT article quoted and cited below.

In the article excerpted below, the profit motive in medicine is painted as the villain of the piece. But the problem is not the profit motive. The problem is that government occupational licensing and regulation in medicine raises barriers to entry for low-cost competitors to enter, innovate, and compete.

(p. A1) Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes.

Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers.

For the full story, see:

ALEX BERENSON and ANDREW POLLACK. "Doctors Reap Millions for Anemia Drugs." The New York Times (Weds., May 9, 2007): A1 & C4.

Bernice Wilson’s kidney dialysis treatment includes the anti-anemia drug Epogen. Source of photo: online version of the NYT article quoted and cited above.

FDA Should Not Restrict Drugs the Terminally Ill Choose to Use

On March 1, a federal appeals court will hear oral arguments in the case of the Abigail Alliance organization’s lawsuit to change systems at the Food and Drug Administration to allow terminally ill patients access to promising drugs that have successfully completed initial stages of human safety testing. Because of my former role in the oncology division at the FDA, and in my eight-year experience as a cancer patient advocate on behalf of my son, I may be able to shed some light on the regulatory policy, medical drug development and patient rights issues surrounding this landmark case.

. . .

Patients have valid arguments in demanding greater access to promising agents under development. Public servants should respect citizens who advocate that they be allowed to have a say in methods of their treatment when terminally ill, and government officials should have very compelling reasons for denying such access. New drug development will not suffer if a small minority of patients fighting for their lives, with no other options and in concert with their physician, gain access to a potentially beneficial agent with an established basic safety profile.

For the full commentary, see:

MARK THORNTON. "The Clinical Trial." The Wall Street Journal (Mon., February 12, 2007): A14.

(Note: ellipsis added.)

According to the online version of USA Today, the court did hear oral arguments on March 1st, and ". . . isn’t likely to rule for several months, . . . "

Source: http://www.usatoday.com/news/nation/2007-04-02-unapproved-drugs_N.htm

More Evidence that Statins Match Stents for Long Life and Fewer Heart Attacks

A stent from Boston Scientific. Source of photo: online version of the NYT article cited below.

Dr. Boden would not have been so "incredulous" if he had read August 2006 and December 2006 entries on artdiamondblog.com. My title for this entry could have read "Statins Beat Stents" if I had taken account of statin’s being less invasive than stents, with lower risk of complications.

NEW ORLEANS, March 26 — Many heart patients routinely implanted with stents to open arteries gain no lasting benefit compared with those treated just with drugs, researchers reported Monday.

The researchers said patients with stents to prop open coronary blood vessels in addition to being treated with statins and other heart drugs in a five-year trial had better blood flow to the heart than patients treated only with drugs.

But they did not live longer or suffer fewer heart attacks, a finding that confirmed the results of smaller studies.

The researchers also found that the stents were highly successful at improving blood flow and relieving symptoms, including chest pain and shortness of breath, but that the advantage disappeared over time.

“When I saw the results, I was incredulous,” said Dr. William E. Boden, a cardiologist at the University at Buffalo School of Medicine and Biomedical Sciences, lead author of a report on the study published online on Monday by The New England Journal of Medicine.

For the full story, see:

BARNABY J. FEDER. "In Trial, Drugs Equal Benefits of Artery Stents." The New York Times (Tues., March 27, 2007): A1 & A13.

Medicare Part D Privatization “Has Succeeded”

The author of the commentary excerpted below, won the Nobel Prize in economics in 2000.

Last year, Medicare underwent a major expansion with the addition of Part D prescription drug coverage. A controversial feature of this new program was its organization as a market in which consumers could choose among various plans offered competitively by different insurers and HMOs, rather than the single-payer, single-product model used elsewhere in the Medicare system. Proponents of this design touted the choices it would offer consumers, and the benefits of competition for product quality and cost; opponents objected that consumers would be overwhelmed by the complexity of the market, and that it was unnecessarily generous to pharmaceutical and insurance companies.

Part D is a massive social experiment on the ability of a privatized market to deliver social services effectively. With the support of the National Institute on Aging, my research group has monitored consumer choices and outcomes from the new Part D market. . . .

. . .

My overall conclusion is that, so far, the Part D program has succeeded in getting affordable prescription drugs to the senior population. Its privatized structure has not been a significant impediment to delivery of these services. Competition among insurers seems to have been effective in keeping a lid on costs, and assuring reasonable quality control. We do not have an experiment in which we can determine whether a single-product system could have done as well, or better, along these dimensions, but I think it is reasonable to say that the Part D market has performed as well as its partisans hoped, and far better than its detractors expected.

For the full commentary, see:

DANIEL L. MCFADDEN. "A Dog’s Breakfast." The Wall Street Journal (Fri., February 16, 2007): A15.

(Note: ellipses added.)

DNA Scientist-Entrepreneur Venter at Sea

The projected path of Venter’s Sorcerer II ship in collecting sea organisms. Source of map: http://scrippsnews.ucsd.edu/Releases/?releaseID=706

Craig Venter’s private gene-sequencing effort beat the government’s effort. His new research is being funded by a $24.5 million private grant from the Gordon and Betty Moore Foundation. (For more information beyond the WSJ article excerpted below, see the Scripps Institution of Oceanography press release.)

(p. B1) Marine microbes are among the most abundant life form on the planet and among the most mysterious. Now, results from the first phase of a global expedition are expected to provide a glimpse into this long-hidden world while potentially leading to new drugs and even fighting climate change.

Craig Venter, the brash biologist who helped crack the human genome seven years ago, says he and other scientists have used DNA-analysis techniques to discover millions of new genes and thousands of new proteins in ocean microbes. These microscopic life forms are mainly bacteria and organisms known as archaea.

"Everything we’ve seen is a surprise," Mr. Venter said in a phone interview from his marine research vessel, Sorcerer II, in the Sea of Cortez. The unexpected variety of microbial DNA he’s found overturns earlier notions that the oceans are a homogenous soup of bacteria and other microscopic life. The details are being published today in the Public Library of Science Biology, an Internet-based scientific journal.

A diverse supply of microbial DNA from the oceans could be a rich lode for scientists. Drug companies are hunting for new compounds in sea creatures, especially to attack cancer and neurodegenerative diseases. The new data will also allow researchers to compare the DNA of oceanic bacteria to the genetic code of microorganisms that cause human disease.

"This is the largest DNA sequence ever obtained, and the magnitude of what’s being done is entirely unparalleled," said Douglas Bartlett, professor of marine microbiology at the University of California, San Diego, who isn’t involved in Dr. Venter’s project. Marine microbes "have all kind of metabolic activity. It is expected that [Dr. Venter’s team] will discover new pathways for making drugs and treating infectious disease."

For the full story, see:

GAUTAM NAIK. "Seafaring Scientist Sees Rich Promise In Tiny Organisms." The Wall Street Journal (Tues., March 13, 2007): B1 & B5.

Photo on left shows Venter (on left) on his Socerer II research ship. Photo on right shows a slide of sea bacteria collected by Venter. Source of photos: http://scrippsnews.ucsd.edu/Releases/?releaseID=706

Why More Cancer Screening May Not Lead to Longer Lives

(p. D8) Most of us interpret “increased survival” to mean fewer deaths. But it does not, because survival is subject to two powerful distortions.

The first is called lead-time bias. Simply advancing the time of diagnosis (as with CT screening) will always increase survival.

Imagine two patients with lung cancer. Even if both die at age 70, a patient with cancer diagnosed by spiral CT screening at age 59 has a longer survival than one with cancer diagnosed because of symptoms (cough, weight loss and so on) at age 67. The first patient survives 11 years; the second 3 years. But both died at the same age. Survival is increased, but mortality is the same.

A second source of distortion results from overdiagnosis, when screening finds cancers that were never destined to progress and cause death. Overdiagnosis bias can also drastically inflate survival statistics, even if mortality is unchanged.

To understand why, you need to understand the definition of the two statistics. Both are fractions. Survival is calculated over a fixed period, for example 5 or 10 years.

Overdiagnosis inflates both the numerator of the survival statistic (number alive at a specified time) and the denominator (number of diagnoses). For the mortality statistic, overdiagnosis has no effect on the numerator (number of deaths) or the denominator (number studied). Perhaps the easiest way to understand this is to imagine if we told all the people in the country that they had lung cancer today: lung cancer mortality would be unchanged, but lung cancer survival would skyrocket.

The goal of lung cancer screening is to reduce mortality — to save lives. Because the New England Journal study examines only survival, it cannot tell us whether any lives are saved. Because the JAMA study examines mortality, it is the more valid study. It also corroborates the Mayo trial finding that a significantly increased survival rate can coexist with no difference in mortality.

For the full essay, see:

H. Gilbert Welch, Steven Woloshin and Lisa M. Schwartz. "ESSAY; How Two Studies on Cancer Screening Led to Two Results." The New York Times (Tues., March 13, 2007): D5 & D8.

The New England Journal of Medicine article was published on Oct. 26, 2006, and the lead author was Claudia Henschke.

The JAMA article was published in March 2007.

Hospital Heart Care Better on Weekdays, than on Weekends

The open spaces in the weekend hospital parking lot on the left, compared to the crowded weekday lot on the right, is consistent with the findings of lower weekend staffing levels. (These photos are from Toronto’s Sunnybrook Hospital.) Source of photos: online version of the NYT article cited below.

An extensive study of heart attack patients in New Jersey finds that those who arrived at hospitals on weekends were less likely to receive aggressive treatment and were slightly more likely to die than those who arrived on weekdays, researchers are reporting today.

The study, based on an analysis of 231,164 heart attack patients admitted to New Jersey hospitals from 1987 to 2002, found a gap of almost 1 percentage point in heart attack death rates over one three-year span, 12.9 percent for weekend patients and 12 percent for weekday patients.

The deaths occurred within a month of admission.

In that period, 1999 to 2002, 10 percent of weekday patients had angioplasty to open blocked arteries on the day they were admitted, compared with 6.7 percent of weekend patients. Angioplasty within a few hours of the start of heart attacks can interrupt the attacks and save lives.

The study, led by William J. Kostis, a fourth-year medical student at the Robert Wood Johnson Medical School in New Brunswick, N.J., who also has a Ph.D. in electrical engineering, is being published today in The New England Journal of Medicine.

Dr. Donald A. Redelmeier, a professor of medicine at the University of Toronto who wrote an accompanying editorial, said the higher death rate on weekends “has everything to do with staffing in hospitals.” It can mean, Dr. Redelmeier said, that not enough expert medical staff members are available on weekends for prompt and aggressive treatment.

“It’s not just that there are fewer people around, but those who are around are often spread thinner,” he added. “And there is a shift in seniority, as well. The most skilled and savvy people don’t work weekends.”

For the full story, see:

GINA KOLATA. "Death Rate Higher in Heart Attack Patients Hospitalized on Weekends, Study Finds." The New York Times (Thurs., March 15, 2007): A19.

To the Ultimate Luddites: “Build Coffins, That’s All You’ll Need”

Charlton Heston as Robert Neville, the last scientist on earth. Source of photo: http://datacore.sciflicks.com/the_omega_man/images/the_omega_man_large_09.jpg

In the 1970s, one of my favorite films was "The Omega Man" (1971) starring Charlton Heston as the doctor/scientist who was the last healthy man on earth. A plague had killed most of humanity, leaving a few in a demented "tertiary" condition. Heston as "Robert Neville" had developed a vaccine, but only had been able to test it on himself, as the world collapsed.

Those in the "tertiary" state had been organized by a former broadcast commentator named "Matthias" into the "family" whose goal it was to burn books, and destroy all remnants of science and technology.

At one point near the end, the family captures Neville, and as the family destroys Neville’s paintings, and laboratory, Matthias rants that Neville is the last scientist, the last remnant of the old world, and that all will be well when they have destroyed him. Then comes one of my favorite exchanges.

Matthias: Now we must build.

Robert Neville: Build coffins, that’s all you’ll need.

When I saw the movie again today (3/16/07) for the first time in decades, I was worried that I had built it up in my memory, and that the reality would be way disappointing.

I was relieved to see that the movie, though not perfect, was still plenty good enough.