November 2004

Flu drug creates drug‑resistant virus

The drug industry often hypes new drugs in order to boost stock prices, and the medical profession is frequently just as overly optimistic ‑ but in reality, the benefits of most of the drugs studied and marketed are minimal.

According to a study published in the British medical journal The Lancet, that's again the case with a drug that was supposed to act as a front‑line defense for the next flu pandemic. It turns out that using the drug creates in a drug‑resistant influenza virus capable of infecting new human hosts.

The study of Japanese children with influenza and treated with the antiviral drug oseltamivir was conducted by an international team of researchers led by virologist Yoshihiro Kawaoka of the University of Wisconsin‑Madison and the University of Tokyo. Results of the study showed that nearly 20 percent of patients treated with the drug produced mutant drug‑resistant viruses as soon as four days after treatment. Moreover, patients continued to shed significant amounts of infectious viral particles even after five days of treatment with the potent antiviral agent.

"The problem with this compound is that a single (genetic) mutation makes the virus resistant," says Kawaoka, an authority on influenza who holds an appointment at the UW‑Madison School of Veterinary Medicine.

The finding is important because it provides evidence that influenza viruses can easily and quickly thwart one of the few lines of defense for a disease that claims many lives each year and that, in a pandemic, is among the world's most feared and deadly diseases.

"The importance of this work is that when a pandemic occurs with a new virus and this drug is extensively used, then we may be faced with the rapid appearance of resistant viruses," Kawaoka says.

At present, there are only two strategies for stemming the spread of influenza: vaccines and antiviral drugs. Vaccines use inactivated forms of a virus in hopes of boosting the immune system and thwarting the infection. Antiviral drugs such as oseltamivir work by inhibiting key proteins on the surface of the virus, locking them in their host cells and supposedly preventing the virus from escaping and infecting new cells and hosts.

The last flu pandemic was in 1968. The influenza pandemic of 1918 was a global tragedy, claiming 21 million lives ‑‑ more than died in battle in World War I. One billion people ‑‑ nearly half of the earth's population at the time ‑ were infected.

The new study of Japanese children portrays what might happen in a pandemic as the immune system of a child, never before exposed to a flu virus, mirrors the adult human immune system exposed to the new, more virulent forms of flu virus at the root of pandemics.

"Most of the children we looked at are younger than 3 years old," Kawaoka explains. "They're encountering the flu virus for the first time. In this respect, our population of patients might be considered comparable to one experiencing pandemic influenza in the absence of pre‑existing immunity."

The study of 50 Japanese children with influenza, says Kawaoka, suggests that oseltamivir‑resistant viruses arise frequently in children treated with the drug.

"We don't know how virulent these viruses are, but they can be a source of another infection, possibly by resistant viruses," he says.

Oseltamivir is a well‑known drug and is widely used in Japan. Its use in the United States is restricted, primarily because of cost.

SOURCE: "Resistant influenza A viruses in children treated with oseltamivir: descriptive study" The Lancet, August 31, 2004.

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Cash practices gaining in popularity among MDs

Although many doctors of chiropractic have advocated cash practices for years, the medical profession has been slower to turn its back on third‑party reimbursements. Now, however, factors like increasing criminalization, diminishing third‑party reimbursements and HIPAA privacy regulations are forcing more medical doctors to reconsider their reliance on insurance company payments.

In their testimony before the Congressional Joint Economic Committee, members of the Association of American Physicians and Surgeons (AAPS) told lawmakers that the current system wasn't working and that many of their colleagues where tossing insurance forms out the window in favor of cash practices.

Committee Chairman Sen. Robert F. Bennett of Utah noted that, "we're here to explore how some doctors are finding alternatives to the traditional third‑party payer health care system, and at the same time providing better care for their patients." He added, "Many doctors are frustrated by the state of our current health care system, and their patients are too. Doctors are continually faced with third‑party entities interfering in their practice, pushing them toward a system that focuses on arcane regulations, not on patient care ... Low reimbursement rates require physicians to increase the number of patients they see and shorten the length of office visits. They must also shoulder the burdens of increased practice costs, time‑consuming paperwork, and rising medical liability premiums."

According to AAPS member, Dr. Robert Berry, director of the PATMOS EmergiClinic in Greeneville, Tenn., thousands of MDs have turned to cash‑based practices, reducing their administrative and compliance costs and passing those savings to patients.

"The only way I can keep my price so low is by avoiding the crushing overhead and hassles that other physicians allow third‑party payers to impose on their practices," testified Dr. Berry.

When patients are reluctant to forego insurance, Berry uses a simple analogy. "If you don't have insurance for routine car maintenance, then why have it for routine medical care since fees at our clinic run anywhere between an oil change and a brake job?"

Kathryn Serkes, policy and public affairs counsel for AAPS, which has provided support for cash‑based practices since 1997, stated: "The move to cash‑based practices is concrete evidence of the atmosphere of fear and frustration in which doctors practice today. Money is not the issue ‑‑ control is. More doctors would rather treat uninsured patients, possibly for free, than jump through insurance and government regulatory hoops."

Physician income is controlled by the government and health plans, but there is no control on their expenses, AAPS representatives explained. David MacDonald and Vern Cherewatanko, founders of SimpleCare, started their cash‑based clinics after the managed care market squeezed them so severely by increasing overhead and hassles while cutting reimbursement to the point that they were losing money.

With five clinics and $10 million in billings, their average reimbursement was $43 per patient, while the average costs ran $50, of which $20 alone was attributed to billing.

The switch to cash only also allows MDs to avoid the complicated process of complying with Medicare regulations, a process that often requires significant time and work on the part of the doctor and staff.

A 1997 survey conducted by AAPS shows that the average cost to a physician's office process a Medicare claim is more than $24, amounting to about $60,000 in annual costs to the average office. A 2003 survey revealed that physicians and their staff spend almost one‑fourth (22%) of all of their time devoted to Medicare paperwork and compliance.

Of particular note is that physicians prefer uninsured to Medicare patients, turning them away 50% less frequently than Medicare patients (17% and 33% respectively).

Much of the testimony emphasized that dependence on third‑party payment is a relatively recent phenomenon, and many older doctors look back fondly at the "good old days" when doctors focused more on caring for patients than on justifying insurance claims.

"I love being a physician," said Dr. Alieta Eck. "But unless we give our physicians the respect and freedom they need to practice the compassionate medicine for which they were trained, we will watch the deterioration of the greatest health care delivered anywhere in the world."

Many chiropractors reached that same conclusion years ago, advocating a cash practice system that cut all ties to the insurance industry. Since the 1980s, for example, Dr. Dennis Nikitow has been preaching the wisdom of cash practices. David Singer, DC, president of David Singer Enterprises, and Eric Plasker, DC, founder of The Family Practice are also long‑time advocates of the cash practice.

"Patients who drop out of care after their insurance coverage runs dry is a common ailment for doctors," said Dr. Singer said in an article for The Chiropractic Journal. "Building a cash practice gives people the chance they need to get the care they deserve. Ultimately, it is about helping more people get under chiropractic care than you ever imagined was possible."

In another TCJ article, Dr. Plasker pointed to an additional benefit of avoiding the insurance trap. "Cash practice is a great way to go because you don't have to wait to get paid," he explained. My first month in practice, I collected over $19,000. This was because the patients were paying me directly and then getting reimbursed by the insurance company."

SOURCES: "The Doctor is In, Even If Insurance Is Out," Joint Economic Committee Hearing, April 28, 2004, Association of American Physicians and Surgeons, Inc. (www.aapsonline.org/)

"Fundamentals to building a cash practice," by Dr. David Singer, The Chiropractic Journal, August 2001.

"Handling finances in a family practice," by Dr. Eric Plasker, The Chiropractic Journal, Nov. 1998.