American College of Physicians: Internal Medicine — Doctors for Adults ®

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In the News for the Week of 5-9-06

Flu update

Medicare Part D

  • Report: Helpline not much help to many callers

Clinical news in the headlines

The business of medicine

CMS update

ACP news


Flu update

White House releases pandemic response plan

As concerns mount about the spread of the H5N1 avian influenza virus, the federal government last week outlined its implementation plan for responding to a pandemic.

The draft plan, issued by administration, calls for federal departments and agencies to implement more than 300 actions, including stockpiling 75 million doses of antiviral drugs and 20 million doses of vaccine, said the May 3 New York Times. A May 3 White House news release said the plan also sets clear expectations for state and local governments and other non-federal entities.

The report warned that a pandemic would severely disrupt the economy and that businesses should prepare for as many as 40% of their employees to be absent for up to two weeks.

According to the draft paln, companies should take measures to prevent the spread of the virus, including allowing employees to telecommute, cutting back on meetings, staggering shifts and adopting liberal leave policies. The federal government will create policies for screening travelers for symptoms and make recommendations on quarantines.

The government also plans to create stockpiles of masks, suits, disinfectants and antiviral medication for poultry workers, said the New York Times. At its worst, the report warned, a pandemic could cause up to 2 million deaths in the United States.

The White House news release is online.

The New York Times is online.

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Government inks $1 billion in flu vaccine contracts

In related news, the federal government last week awarded $1 billion in contracts to five drug companies working to develop more efficient flu-vaccine production methods.

The five companies, which include U.S. firms MedImmune Inc. ($169 million), based in Gaithersburg, Md., and DynPort Vaccine Co. ($41 million) in Frederick, Md., will build or expand their U.S.-based vaccine production facilities, said the May 5 Washington Post. The companies’ goal is to grow flu vaccine virus in cell cultures, instead of the more time-consuming, less predictable method of using fertilized chicken eggs, and apply for FDA approval of the new vaccines.

If production proceeds as anticipated, the five companies should be able to produce a total of about 300 million doses of vaccine, enough to vaccinate the entire U.S. population, said the Washington Post.

The contracts do not guarantee the federal government a specified supply or price but act as an inducement for drug companies to dedicate resources to vaccine development here in the U. S., said the Washington Post. The three other contracts went to GlaxoSmithKline PLC ($275 million), based near London; Belgium-based Solvay Pharmaceuticals ($299 million); and Switzerland’s Novartis AG ($221 million).

The Washington Post is online.

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Medicare Part D

Report: Helpline not much help to many callers

A government study released last week found that seniors often received false or incomplete information when they called to get details on Medicare’s new prescription drug program.

The report by the Government Accountability Office (GAO) also said that beneficiaries had to wait from between a few minutes to almost an hour on hold and that Medicare’s Web site and written materials were confusing for many seniors, according to the May 4 Washington Post. The article added that the criticism had revived calls by Congressional Democrats to extend the May 15 deadline for signing up for the Part D benefit.

For the study, GAO representatives posing as seniors placed 500 calls to the 800-MEDICARE helpline during January and February of this year. According to the report, customer service representatives responded to questions accurately about two-thirds of the time, while the remaining responses were either inaccurate, incomplete or didn’t apply to the question. About 5% of the calls were either not answered or were disconnected.

Response accuracy varied widely, the report said. For example, Medicare representatives responded accurately 90% of the time when asked about beneficiaries’ eligibility but only 41% of the time when asked which drug plan would be the least expensive. Telephone operators often told callers that they could not identify the least expensive plans without the caller’s personal information, which is incorrect.

The government has made recent improvements to the helpline to take care of some of those glitches, said the Washington Post. For example, the call-wait time has significantly improved in the past several months. Officials also emphasized that the helpline is only one source of information seniors can use to find out about drug-plan options.

Highlights of the GAO report are online.

The Washington Post is online.

More information is on ACP's Medicare Part D Web site.

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Clinical news in the headlines

Study dims hope for effective HRT alternatives

A review of nonhormonal therapies for menopausal hot flashes found that some alternatives may help women who cannot take estrogen but that none work as well as hormones.

The findings leave little choice for most women seeking a safe alternative to estrogen, said the May 3 New York Times. Physicians had once recommended hormones to most women. That recommendation changed after the Women’s Health Initiative in 2002 reported that hormones did not prevent heart disease and can increase the risk of blood clots, strokes, heart attacks and breast cancer.

The review, published in the May 3 Journal of the American Medical Association (JAMA), included 43 trials involving antidepressants, clonidine, soy and red clover isoflavone extracts, and other prescribed medications used to treat hot flashes.

Women taking the hypertension drug clonidine or antidepressants experienced approximately one less hot flash per day, while the natural isoflavone treatments had no effect. Researchers noted that other studies have found that estrogen resulted in as many as three fewer hot flashes per day and made them less severe.

The results indicate that alternative treatments are not optimal choices for most women, said the authors. They noted that even though antidepressants, as well as clonidine and the seizure drug gabapentin, had some effect, little is known about using them long-term for hot flashes, and all have side effects.

In addition, the authors noted that it was difficult to find reliable data on nonhormonal therapies and that most of the trials reviewed had methodological deficiencies. The review also did not describe the relative effectiveness of different therapies, as few of the trials involved direct treatment comparisons.

Experts interviewed by the New York Times said that a short course of estrogen may be the best option for women with severe symptoms, except those with breast cancer. Antidepressants appear to present fewer risks than hormones, they said, but little is known about using them long-term.

The JAMA abstract is online.

The New York Times is online.

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Review: beta-blockers and stroke risk

A review of drug trials for hypertension found that while beta-blockers benefit some patients with existing heart conditions, they increase the risk of stroke in others, relative to other antihypertensive treatments.

The review of 13 randomized controlled trials compared beta-blockers with placebo, no treatment and other antihypertensive drugs in patients with primary hypertension, and evaluated all-cause mortality, cardiovascular morbidity or both.

Patients who received beta-blockers had a lower incidence of stroke than patients on placebo or no treatment. However, patients on atenolol had a higher incidence of stroke than those on other drugs, the results being inconclusive for other beta-blockers. The review is abstracted in the May-June ACP Journal Club.

Beta-blockers have received mixed reviews on their net survival benefit, said reviewer Peter Rudd, FACP, of Stanford University School of Medicine. Comparisons of atenolol and metroprolol suggest that agents in the same drug class can have different long-term effects. Possible reasons for these effects include a deranged lipid profile, exacerbated insulin resistance and increased platelet aggregation.

The review should prompt physicians to reconsider patients’ important comorbid conditions, said Dr. Rudd. Patients with documented coronary insufficiency or congestive heart failure may benefit from using beta-blockers but these drugs may be less beneficial for other patients with hypertension and increase their risk for stroke.

Dr. Rudd suggested that physicians consider alternatives to beta-blockers for patients with comorbid conditions that put them at higher risk for stroke. Alternatives include thiazide diuretics, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers and calcium-channel blockers.

Peer ratings for this review: general internal medicine, family practice, general practice, cardiology: 6/7 stars.

ACP Journal Club is online.

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The business of medicine

Physician groups protest drug company data-gathering

Opposition is mounting among medical groups to the pharmaceutical industry’s practice of gathering data on physicians’ prescribing patterns, according to news reports last week.

In response to complaints about the practice by state medical associations in California and elsewhere, the AMA announced plans to give physicians the option of making their prescribing information unavailable to sales representatives, said the May 4 New York Times. The AMA, which has contracts with data vendors, said that an opt-out program would be preferable to banning data-gathering because it would allow the pharmaceutical industry to keep a valuable source of data while giving physicians an opportunity to limit access to their information.

In 2003, the College raised the issue in the AMA's House of Delegates by submitting a resolution that called for prohibiting the sale or release of physicians’ prescribing data. The House of Delegates then agreed to explore the scope of physician and/or patient data-gathering and assess how those data were being used.

Some states, including New Hampshire, Arizona and West Virginia, may enact legislation to limit or ban data-gathering, said the New York Times. A New Hampshire state representative interviewed in the article contended that the AMA’s opt-out plan would not go far enough.

Even though the plan would allow doctors to stop information from going to sales reps, the representative said, the plan would not prevent drug companies from buying the same information from data vendors. Vendors, such as IMS Health, which is based in Fairfield, Conn., gather data from retail pharmacy chains and drug plan managers to sell to drug companies.

Physicians who oppose data-gathering say it allows drug reps to target physicians for perks or to encourage them to prescribe higher-priced brand-name drugs over generics, said the New York Times. Reps use data to find out if a physician prescribes a drug often or if he is among the first to prescribe a new drug, which helps companies target their promotional efforts.

In California, the state medical association is starting its own program to allow physicians to get comparisons of their prescribing patterns on 17 classes of drugs from data vendors, regardless of whether they opt out through the AMA, said the article.

The AMA’s opt-out program is slated to take effect July 1 through an online sign-up registry, the New York Times said. The registry will allow doctors listed in the “AMA Physician Masterfile” to ban drug company sales reps from accessing their prescribing data for three years.

More information is on the AMA's prescribing data information center online.

The New York Times is online.

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CMS update

New Medicare enrollment forms now available online

Physicians who need to initially enroll in the Medicare provider program or make changes to the business information filed with their Medicare contractor should begin to use updated forms that were introduced last week.

The enrollment forms need to be submitted whenever physicians open a new practice, hire a new physician, change their billing company or make other business changes. While the form is available online, you still need to mail it into your Medicare carrier.

The new Medicare enrollment application form in PDF format is now available on the CMS' Web site.

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ACP news

College supports tax credits for organ donation

ACP has come out in favor of providing some tax credits to living organ donors.

In a recent letter to Rep. Joe Wilson (R-S.C.), ACP President Lynne M. Kirk, FACP, expressed support for Rep. Wilson’s introduction of the “Living Organ Donor Tax Credit Act of 2005” (H.R. 2474). The bill would provide a tax credit of up to $5,000 to organ donors to make up for any unreimbursed costs or lost wages associated with organ transplantation.

Dr. Kirk pointed out that such a credit is in line with the College’s "Ethics Manual, Fifth Edition," which discourages any direct financial incentives for organ donation. The manual states that direct incentives linked to organ transplants have the potential to exploit families of limited means. Rep. Wilson's bill, Dr. Kirk wrote, is less likely to raise the same ethical concerns.

Dr. Kirk’s letter to Rep. Wilson is online.

Information about ACP’s "Ethics Manual" is also online.

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Copyright 2006 by the American College of Physicians.

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