Health – Page 89 – artdiamondblog.com

FDA Hurts Consumers with New Burdens on Small Firms Making Proven Drugs

"Larry Blansett, chief executive of the Blansett Pharmacal Company, sells a wide range of what he calls legacy drugs." Source of caption and photo: online version of the NYT article cited below.

(p. C1) In the 1970s, Larry Blansett was producing a wide array of prescription cough syrups, antihistamine tablets and pain killers at the company he co-founded, UAD Laboratories. But the Food and Drug Administration was not keeping a close watch.

Mr. Blansett continues to sell the same range of products at his latest venture, the Blansett Pharmacal Company, which employs about 90 people in North Little Rock, Ark. “We grew gradually at first, but are now a national company,” he said.

Now, however, the F.D.A. has begun to crack down on the thousands of drugs that have never had to go through the agency’s stringent approval process, many of them made by small companies like Blansett Pharmacal. And those companies are crying foul.

. . .

Perry Cole, executive director of the Branded Pharmaceutical Association, . . . said these drugs — the makers call them legacy drugs and define them as (p. C5) drugs that have been prescribed for at least 25 years and have gained a history for safety and efficacy — were far safer than many prescription drugs of recent vintage, like Viagra, which he said had been associated with hundreds of premature deaths.

. . .

The agency began its campaign against the makers of unapproved drugs in June 2006, and immediately began ordering companies that made products that it deemed potentially hazardous to file new drug applications or take them off the market.

In December, for example, it told firms to stop making unapproved products containing quinine, which has been used since the 1600s to treat malaria. The one company that made an approved quinine product, Qualaquin, was the Mutual Pharmaceutical Company of Philadelphia, and the F.D.A’s action, in effect, granted Mutual a temporary monopoly.

For the full story, see:

BRENT BOWERS. "Small Business; A Headache for Small Drug Makers." The New York Times (Thurs., October 18, 2007): C1 & C5.

(Note: ellipses added.)

Doctors Seek New Business Models to Avoid Paperwork and Insurance Regulation

"Dr. Steven Meed works for Sickday Medical House Calls, a service in Manhattan." Source of caption and photo: online version of the NYT article quoted and cited below.

“We have that perfect storm. The current system doesn’t work well for patients or physicians,” said Dr. Rick Kellerman, a doctor who works in Wichita, Kan., and is president of the American Academy of Family Physicians. "More doctors are coming up with new home business practice models. They’re exasperated with paperwork and insurance regulation.”

The demand for primary care physicians outweighs the supply in many cities, so patients can wait weeks, and even months, for appointments, and hospital emergency rooms are becoming overloaded with nonemergency cases. Health insurance premiums, meanwhile, have continued to rise.

Some doctors are doing things like taking only house-call appointments or operating “micropractices” in which they work without front-office staff and nurses and see their patients in a smaller one-room office, Dr. Kellerman said.

When making house calls, “you get paid,” said Dr. Steven Meed, one of eight New York physicians working for Sickday Medical House Calls, which started last year and serves patients in Manhattan. “The paperwork overhead is kept at a minimum, the fee is fixed and it’s not going to be reduced.”

For the full story, see:

JENNIFER ALSEVER. "SPENDING; Retro Medicine: Doctors Making House Calls (for a Price)." The New York Times, SundayBusiness Section (Sun., September 23, 2007): 6.

"He took the subway, top, to travel to the apartment of a patient, Kayla McDermott, who had a sore throat." Source of caption and photos: online version of the NYT article cited above.

Incentives for Organ Donations Would Save Lives

Sally Satel is a medical doctor and a resident scholar at the Amerrican Enterprise Institute. Source of photo: http://www.aei.org/publications/filter.all,pubID.25785/pub_detail.asp

(p. A12) At the annual meeting of The American Society of Transplant Surgeons this winter a straw poll revealed that 80 to 85% were in favor of studying incentives for living donors, according to society president Arthur Matas. In 2003, the American Medical Association testified on behalf of legislation that would have permitted pilot studies of incentives for deceased organs.

The public seems receptive as well, according to a new Gallup poll on attitudes toward donation of organs after death. The most striking results were among 18 to 34 year olds wherein an impressive 34% said that incentives would make them "more likely" to donate while 6% said less likely. . . .

. . .

The idea of combining organ donation with material gain can make people queasy. Yet the mix of financial and humanitarian motives is commonplace. No one objects, for example, to a tax credit for charitable contributions–a financial incentive to complement the "pure" motive of giving to others. The great teachers who enlighten us and the doctors who heal us inspire no less gratitude because they are paid. An increase in the supply of kidneys will ameliorate suffering and prevent needless death. This is more important than whether an organ has been given freely or for material gain. . . .

For the full commentary, see:

Satel, Sally. "Doing Well By Doing Good." The Wall Street Journal (Fri, March 16 2007): A12.

(Note: ellipses added.)

Unintended Consequences of Health Privacy Law

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

(p. A1) An emergency room nurse in Palos Heights, Ill., told Gerard Nussbaum he could not stay with his father-in-law while the elderly man was being treated after a stroke. Another nurse threatened Mr. Nussbaum with arrest for scanning his relative’s medical chart to prove to her that she was about to administer a dangerous second round of sedatives.

The nurses who threatened him with eviction and arrest both made the same claim, Mr. Nussbaum said: that access to his father-in-law and his medical information were prohibited under the Health Insurance Portability and Accountability Act, or Hipaa, as the federal law is known.

Mr. Nussbaum, a health care and Hipaa consultant, knew better and stood his ground. Nothing in the law prevented his involvement. But the confrontation drove home the way Hipaa is misunderstood by medical professionals, as well as the frustration — and even peril — that comes in its wake.

Government studies released in the last few months show the frustration is widespread, an unintended consequence of the 1996 law.

. . .

(p. A12)

Most common are seat-of-the-pants decisions made by employees who feel safer saying “no” than “yes” in the face of ambiguity.

. . .

Ms. McAndrew said there was no way to know how often information was withheld. Of the 27,778 privacy complaints filed since 2003, the only cases investigated, she said, were complaints filed by patients who were denied access to their own information, the one unambiguous violation of the law.

Complaints not investigated include the plights of adult children looking after their parents from afar. Experts say family members frequently hear, “I can’t tell you that because of Hipaa,” when they call to check on the patient’s condition.

That is what happened to Nancy Banks, who drove from Bartlesville, Okla., to her mother’s bedside at Town and Country Hospital in Tampa, Fla., last week because Ms. Banks could not find out what she needed to know over the telephone.

Her 82-year-old mother had had a stroke. When Ms. Banks called her room she heard her mother “screaming and yelling and crying,” but conversation was impossible. So Ms. Banks tried the nursing station.

Whoever answered the phone was not helpful, so Ms. Banks hit the road. Twenty-two hours later, she arrived at the hospital.

But more of the same awaited her. She said her mother’s nurse told her that “because of the Hipaa laws I can get in trouble if I tell you anything.”

In the morning, she could speak to the doctor, she was told.

The next day, Ms. Banks was finally informed that her mother had had heart failure and that her kidneys were shutting down.

“I understand privacy laws, but this has gone too far,” Ms. Banks said. “I’m her daughter. This isn’t right.”

A hospital spokeswoman, Elena Mesa, was asked if nurses were following Hipaa protocol when they denied adult children information about their parents.

She could not answer the question, Ms. Mesa said, because Hipaa prevented her from such discussions with the press.

For the full story, see:

JANE GROSS. "Keeping Patients’ Details Private, Even From Kin." The New York Times (Tues., July 3, 2007): A1 & A12.

(Note: ellipses added.)

After nurses refused to tell her what was wrong over the phone, Nancy Banks (left) drove 22 hours to find out that her mother Lourene Trusler (right) had had a stroke. Source of photo: online version of the NYT article cited above.

Texas Shows Tort Reform Works

"Dr. Donald W. Patrick, executive director of the Texas Medical Board, with applications for medical licenses sent to it." Source of caption and photo: online version of the NYT article quoted, and cited, below.

HOUSTON, Oct. 4 — In Texas, it can be a long wait for a doctor: up to six months.

That is not for an appointment. That is the time it can take the Texas Medical Board to process applications to practice.

Four years after Texas voters approved a constitutional amendment limiting awards in medical malpractice lawsuits, doctors are responding as supporters predicted, arriving from all parts of the country to swell the ranks of specialists at Texas hospitals and bring professional health care to some long-underserved rural areas.

The influx, raising the state’s abysmally low ranking in physicians per capita, has flooded the medical board’s offices in Austin with applications for licenses, close to 2,500 at last count.

“It was hard to believe at first; we thought it was a spike,” said Dr. Donald W. Patrick, executive director of the medical board and a neurosurgeon and lawyer. But Dr. Patrick said the trend — licenses up 18 percent since 2003, when the damage caps were enacted — has held, with an even sharper jump of 30 percent in the last fiscal year, compared with the year before.

“Doctors are coming to Texas because they sense a friendlier malpractice climate,” he said.

For the full story, see:

RALPH BLUMENTHAL. "After Texas Caps Malpractice Awards, Doctors Rush to Practice There." The New York Times (Fri., October 5, 2007): A21.

Academic Entrepreneurs in a Toxic Wasteland

The Berkeley Pit was once a copper mine, and now holds a lake of toxic waste. Source of photo: online version of the NYT article quoted and cited below.

Here are a few paragraphs from a fascinating story about a couple of people who seem to be practicing what Taleb is preaching in The Black Swan:

BUTTE, Mont. — Death sits on the east side of this city, a 40-billion-gallon pit filled with corrosive water the color of a scab. On the opposite side sits the small laboratory of Don and Andrea Stierle, whose stacks of plastic Petri dishes are smeared with organisms pulled from the pit. Early tests indicate that some of those organisms may help produce the next generation of cancer drugs.

From death’s soup, the Stierles hope to coax life.

“I love the idea of looking at toxic waste and finding something of value,” said Ms. Stierle, 52, a chemistry researcher at Montana Tech of the University of Montana.

For decades, scientists assumed that nothing could live in the Berkeley Pit, a hole 1,780 feet deep and a mile and a half wide that was one of the world’s largest copper mines until 1982, when the Atlantic Richfield Company suspended work there. The pit filled with water that turned as acidic as vinegar, laced with high concentrations of arsenic, aluminum, cadmium and zinc.

. . .

Mr. Stierle is a tenured professor at Montana Tech, but his wife gets paid only for teaching an occasional class or if there is a grant to finance her research. From 1996 to 2001 they applied for dozens of grants, but received only rejection letters. So they financed their own research, using personal savings and $12,000 in annual patent royalty payments. In 2001, they won a six-year, $800,000 grant from the United States Geological Survey.

“Their work is considered a very high-risk approach,” said Matthew D. Kane, a program director at the National Science Foundation. “It takes a long time to get funding, and some luck to find active compounds.”

Unlike scientists at large research universities, who commonly teach only one class a year and employ graduate students to run their laboratories, Mr. Stierle teaches four classes each semester at a college with 2,000 undergraduates and no major research presence.

. . .

The couple said they were negotiating privately with a pharmaceutical company to test some of the compounds they have discovered and possibly turn them into drugs. As they wait, they open another Mason jar filled with murky pit water, draw a sample and return to work.

“The pit very easily could have been a complete waste of time,” Mr. Stierle said. “We just had luck and worked our butts off. We take that first walk into the dark.”

For the full story, see:

CHRISTOPHER MAAG. "In the Battle Against Cancer, Researchers Find Hope in a Toxic Wasteland." The New York Times (Tues., October 9, 2007): A21.

(Note: ellipses added.)

In the photo immediately above, Don and Andrea Steirle work in their lab. The map to the left shows the location of the Berkeley Pit. Source of the photo and map: online version of the NYT article quoted and cited above.

Incentives, and Unintended Consequences, in Medicine

A clever image, but is it apt, since the article claims doctors are extracting money, rather than injecting it? Source of image: online version of the NYT article quoted and cited below.

If patients paid for their own care, doctors would have a greater incentive to improve overall care that is valued by patients. The perverse incentives of the current government Medicare reimbursement rules would be gone.

One main lesson from the article below is to show how fundamentally hard it is for the government to get the incentives right: they tried to re-jigger the reimbursement rules, but the law of unintended consequences once again bit them in their collective ass (or more accurately, alas, it bit us).

(p. C1) When Medicare cracked down two years ago on profits that doctors made on drugs they administered to patients in their offices, it ended a windfall worth hundreds of thousands of dollars a year for each physician.

The change, which mainly affected drugs to treat cancer and its side effects, had an immediate effect. In all, cancer doctors billed about $4.4 billion for chemotherapy and anemia medications in 2005, down from $5.6 billion in 2004, with Medicare covering 80 percent of the bills in each year. The difference mostly represented profit that doctors had made on the drugs.

But the change did not reduce overall federal spending on cancer care, which increased slightly. And cancer doctors say the change did nothing to reduce a larger problem in cancer treatment.

Some physicians say that cancer doctors responded to Medicare’s change by performing additional treatments that got them the best reimbursements, whether or not the treatments benefited patients. Those doctors also say that Medicare’s reimbursement policies are responsible.

“The system doesn’t value the time we spend with patients,” said Dr. Peter Eisenberg, a cancer doctor in Greenbrae, Calif., and a former director of the American Society of Clinical Oncology. “The system values procedures.”

The ballooning cost of cancer treatment, one of Medicare’s most expensive categories, offers a vivid example of how difficult it may be to rein in the nation’s runaway health care spending without fundamentally changing the way doctors are paid.

. . .

(p. C6) Now, oncologists are lobbying Medicare officials and members of Congress to reverse some of the changes and again raise the prices the government pays for drugs.

But Dr. Robert Geller, who worked as an oncologist in private practice from 1996 to 2005 before leaving to become senior medical director at Alexion, a biotechnology company, said that increasing drug reimbursement might raise oncologists’ profits but would not relieve the system’s deeper flaws.

As long as oncologists continue to be paid by the procedure instead of for spending time with patients, they will find ways to game the system, however much money they make or lose on prescribing drugs, he said.

“People go where the money is, and you’d like to believe it’s different in medicine, but it’s really no different in medicine,” Dr. Geller said. “When you start thinking of oncology as a business, then all these decisions make sense.”

For the full story, see:

ALEX BERENSON. "A Stubborn Case Of Spending On Cancer Care." The New York Times (Tues., June 12, 2007): C1 & C6.

(Note: ellipsis added.)

Source of graph: online version of the NYT article quoted and cited above.

Mugabe Driven by Quest for Power, More than from Paranoia, or Marxism: More on Why Africa is Poor

No one outside of Mr. Mugabe’s inner circle, of course, can say with certainty why he has pursued policies since 2000 that have produced economic and social bedlam. For his part, Mr. Mugabe says Zimbabwe’s chaos is the product of a Western plot to reassert colonial rule, while he is simply taking steps to fight that off.

Among many outside that circle, however, the growing conviction is that Zimbabwe’s descent is neither the result of paranoia nor the product of Mr. Mugabe’s longstanding belief in Marxist economic theory. Instead, they say, Zimbabwe is fast becoming a kleptocracy, and the government’s seemingly inexplicable policies are in fact preserving and expanding it.

. . .

Mr. Mugabe’s government declares currency trading illegal, but regularly dumps vast stacks of new bills on the black market, still wrapped in plastic, to raise foreign exchange for its own needs, business leaders and economists say.

The nation’s extraordinary hyperinflation, last pegged by analysts at 10,000 percent a year, is an economic disaster that, by all accounts, the government needs to address. Yet after it ordered merchants in July to slash their prices, cadres of policemen and soldiers moved into shops to enforce the new controls, scoop up bargains and give friends and political heavyweights preferential access to cheap goods.

. . .

Mr. Mugabe’s 25-bedroom mansion in Borrowdale, the gated high-end suburb of Harare, the capital, is the locus of a boomlet that has spawned luxury homes for government and party officials. (Mr. Mugabe said his mansion was built with goods and labor donated by foreign governments.)

Mr. Mugabe arrived to open Zimbabwe’s Parliament this month in a Rolls-Royce. Equally telling, the legislature’s parking lot was crammed with luxury cars.

Such riches have been accompanied by a steep decline in living standards for just about everyone else. The death rate for Zimbabweans under the age of 5 grew by 65 percent from 1990 to 2005, even as the rate for the world’s poorest nations dropped. Average life expectancy here is among the world’s lowest, according to the United Nations.

For the full commentary, see:

MICHAEL WINES. "News Analysis; Zimbabwe’s Chaos: The Powerful Thrive." The New York Times (Fri., August 3, 2007): A8.

(Note: ellipses added.)

“A Payment System that Rewards Everybody for Staying Busy”

Source of map: online version of the NYT article cited below.

(p. H6) WHY does health care for the average Medicare patient cost nearly twice as much a year in New Jersey, at $8,076, as it does in Hawaii, at $4,529?

The differences are one example of perplexing geographic variations in medical expenses and quality. And in a study that has important implications for the nation’s $2 trillion health care tab, researchers have found that more intensive and expensive care does not necessarily mean better outcomes. In fact, the opposite may be true.

The Dartmouth Atlas of Health Care, a research group that studies variations and costs in medical care, sums it up like this: Geography is destiny. It means that your chances of undergoing certain surgical procedures, visiting the doctor often or even dying in a hospital or at home are related to where you live.

For example, Medicare patients living in Rhode Island undergo knee replacements at a rate of 5 in 1,000 people. In Nebraska, the number rises to 10 in 1,000. Female Medicare enrollees who receive a diagnosis of breast cancer have nearly seven times the chance of having a mastectomy in South Dakota, where the rate is 2 in 1,000, as they do in Vermont, where the rate is .3 in 1,000.

. . .

In communities with surplus hospital beds, research shows, patients do not necessarily get more elective surgery, but they have more hospital stays, more frequent doctor’s visits and are more likely to be referred to specialists.

Dr. Elliott S. Fisher, who studies health care economics and is a member of the Dartmouth research group, said that part of the problem was the way doctors and hospitals were paid.

“In a payment system that rewards everybody for staying busy, every bit of capacity you have, whether it’s the number of specialists or the number of intensive care beds or the M.R.I. scanner, has to stay fully occupied because they bought them already and they have to keep paying for them,” Dr. Fisher said in a telephone interview.

. . .

Paradoxically, the Dartmouth research, which confirms some similar studies, shows that patients in high-cost areas are not necessarily getting better care. Dr. Fisher said that he and his colleagues found higher mortality rates in higher-spending regions.

. . .

Extra care without better outcomes translates into waste in the health care system. Some experts say that waste accounts for as much as if not more than 30 percent of the national spending on health care. Such spending now totals 16 percent of the gross domestic product.

For full story, see:

STEPHANIE SAUL. "TREATMENTS; Need a Knee Replaced? Check Your ZIP Code." The New York Times (Mon., June 11, 2007): H6.

(Note: ellipses added.)

Source of map: online version of the NYT article cited above.

“We’re Not Looking to Achieve Incremental Advances”

Genentech CEO Dr. Arthur D. Levinson. Source of image: online version of the WSJ article cited below.

(p. B1) WSJ: You have multiple blockbuster biotech drugs on the market and more on the way. In such an uncertain business, how do you manage scientists to achieve that kind of success?

Dr. Levinson: We are first and foremost committed to doing great science. If a drug can’t be the first in class or the best in class, we’re just not interested. We’re not looking to achieve incremental advances or extend patents or do X, Y, Z unless it is going to really matter for patients. That allows us to bring in phenomenal scientists and encourage them to do the basic and translational research.

We decided 15 years ago that we would be committing (p. B2) to oncology, which at the time for us was new. We are now the leading producer of anticancer drugs in the United States. We took a lot of risks. In many cases, those risks paid off. We are now also in immunology. Again, the role of management here is to set the broad direction and then hire absolutely the best scientists and bring them in and say, ‘Do your stuff.’

For the full interview, see:

MARILYN CHASE. The Wall Street Journal "How Genentech Wins At Blockbuster Drugs CEO to Critics of Prices: ‘Give Me a Break’." The Wall Street Journal (Tues., June 5, 2007): B1 & B2.

Source of graph: online version of the WSJ article cited above.

Perverse Incentives in Medicine

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

(p. A1) Stark evidence that high medical payments do not necessarily buy high-quality patient care is presented in a hospital study set for release today.

In a Pennsylvania government survey of the state’s 60 hospitals that perform heart bypass surgery, the best-paid hospital received nearly $100,000, on average, for the operation while the least-paid got less than $20,000. At both, patients had comparable lengths of stay and death rates.

And among the 20 hospitals serving metropolitan Philadelphia, two of the highest paid actually had higher-than-expected death rates, the survey found.

Hospitals say there are numerous reasons for some of the high payments, including the fact that a single very expensive case can push up the averages.

Still, the Pennsylvania findings support a growing national consensus that as consumers, insurers and employers pay more for care, they are not necessarily getting better care. Expensive medicine may, in fact, be poor medicine.

“For most consumers, the fact that there is no connection between quality and cost is one of the dirty secrets of medicine,” said Peter V. Lee, the chief executive of the Pacific Business Group on Health, a California group of employers that provide health care coverage for workers.

. . .

(p. C4) And the survey found that good care can go unrewarded. One Philadelphia area hospital, Main Line Health’s Lankenau center, which performs a large number of bypass surgeries and has a high success rate, according to the survey, was paid an average of $33,549 by private insurers. That was less than half the nearly $80,000 in average payments received by the other hospitals, with poorer track records.

. . .

“The current reimbursement paradigm is fundamentally broken,” said Dr. Ronald Paulus, an executive with Geisinger, who says there is no current financial incentive for a hospital to provide the kind of care that leads to better outcomes and lower payments.

. . .

The problem, according to some health policy experts, is that the hospitals may, in fact, be rewarded for poor care: keeping patients too long because they caught an infrection or had a complication. That, they say, could be the main lesson of the Pennsylvania survey.

"What this highlights is the assumption that more money means better care is flat-out wrong," said Mr. Lee, the chief executive of the California employer group. "It’s easy to pay for bad quality, and we pay for it every day."

For the full story, see:

REED ABELSON. "In Health Care, Cost Isn’t Proof of High Quality." The New York Times (Thurs., June 14, 2007): A1 & C4.

(Note: The last three paragraphs, and the last sentence of the fourth from the last paragraph, of the print version of the article, are missing from the online version.)

(Note: ellipses added.)