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HealthBiz: What holds back HIV/AIDS drugs?

Posted - Jul. 8, 2004 at 3:20 p.m.



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WASHINGTON, Jul 08, 2004 (United Press International via COMTEX) -- Experts on HIV/AIDS from science, medicine and policy will meet in Bangkok next week for the XV International AIDS Conference and will face the very difficult task of figuring out how to move critical drugs to developing countries, such as those in sub-Saharan Africa, that lack the infrastructure to support coordinated programs.

The Institute of Medicine released a report Wednesday concluding that the biggest problem in getting anti-retroviral medications to HIV/AIDS victims is a shortage of healthcare and support workers in poor countries.

The IOM said drug prices have come down and donations of money are up, but still needed is a "Peace Corps-like" group to ensure the drugs are distributed effectively.

"Solving the AIDS crisis will take more than just inexpensive drugs," Haile Debas, a member of the IOM panel and a professor at the University of California, San Francisco, said in a statement. "Success now hinges more on having adequate infrastructures to distribute therapies and sufficient numbers of trained healthcare workers in developing countries."

The IOM said nearly 40 million people are infected with HIV, but only 400,000 in developing countries have access to treatment. The institute estimates total annual HIV/AIDS funding needs will be $10.7 billion for 2005 and almost $15 billion by 2007 -- compared to the $4.2 billion provided in 2003.

UPI's HealthBiz asked Roger Bate, a health policy analyst at the moderately conservative American Enterprise Institute, what was preventing AIDS drugs from reaching victims in developing countries.

"It's probably poverty," Bate answered, "but most important after that is lack of political will."

Governments must take their HIV/AIDS problems seriously -- some do not -- and create the social and political infrastructure needed to ensure access to treatment, he said.

They also need to consider wider consequences. For example, when a country treats HIV-infected children, it needs to prepare for a substantial numbers of orphans if the infected mothers die.

Bate said he generally agrees with the IOM on the problem, but he has a different -- and admittedly minority -- view of the solution. He said encouraging developing countries to adopt democracy is a better long-term strategy. Democracy tends to create a more stable social-economic infrastructure, through which HIV/AIDS programs can function more effectively.

"It doesn't matter how much money you throw at a country if they don't set up a (structure) that can use it," he said. "You can't divorce a health issue from the political issues."

Developing nations also often hurt their own cause by imposing taxes or tariffs on incoming prescription drugs. Bate said some nations have made exceptions to remove tariffs on HIV/AIDS medicines, but they do not represent the norm.

What is not the problem, Bate wrote in a policy analysis released by AEI this week, is pharmaceutical patents. He noted, however, that South Africa is an exception because it has imposed patents that limit drug distribution.

"The argument that drug patents and drug company profits are blocking access to drugs is an appealing and simple one, but the reality is somewhat different," he wrote in the analysis. "Research into the actual extent of drug patenting of ARV therapy in Africa and of essential drugs in most poor countries shows that (drug patent-related restrictions) rarely exist."

Bate said out of 795 possible patents for AIDS drugs, only 172 are in force and there is no relationship between the number of patents a country has for these drugs and drug access.

RADIOLOGY TURF BATTLES

Radiologists consider it a growing problem: physicians who are not trained radiologists doing imaging scans, from X-rays to MRIs, in their offices, interpreting them on their own and billing for them.

This type of self-referral takes advantage of a loophole in the Stark laws, which prevent doctors who own a financial interest in a healthcare facility from referring their Medicare patients there. Stark does allow physicians to purchase imaging equipment, however, and set it up in their own offices to do scans.

Dr. David Levin, former chairman of the Department of Radiology at Thomas Jefferson University Hospital in Philadelphia, told HealthBiz the medical literature shows "when non-radiologists try to interpret images they make a lot of mistakes."

That's not surprising, he said. "They're not trained for the most part."

Levin has written commentaries and authored a report, published in the July issue of the Journal of the American College of Radiology, that analyzes medical studies showing higher error rates involved in this practice. His bottom line is the error rate is higher when non-radiologists interpret X-rays or CT scans or MRIs on their own.

"I'm sympathetic to these people -- they're trying to make a buck, trying to meet their expenses," he said. "It's getting almost impossible to run a practice these days, but I don't think the answer to it is self-referral."

Potential solutions, Levin suggested, might include some type of privileging program that would limit which physicians are allowed to read images. For example, an orthopedic surgeon with some training might be authorized to read plain X-rays of bones but not an MRI.

Another possibility is prohibiting non-radiologists from installing imaging equipment in their offices. Maryland has such a law, but Levin said it is the only jurisdiction of which he's aware that has passed such legislation.

WHAT DO THE DEMOCRATS WANT?

It's difficult these days to keep track of what the Democrats want to do about Medicare discount drug cards. They have been highly critical of the program -- which has met with only lukewarm acceptance by seniors. To date, only 3.7 million have enrolled and most of them were forced to do so by their Medicare HMO.

Minority members of the House Government Reform Committee repeatedly have pointed out mistakes and problems. Just this week, they wrote to Health and Human Services Secretary Tommy Thompson, identifying numerous pharmacies listed on the Medicare Web site as participants, but who do not accept the drug cards.

"Many drug card sponsors use 'passive acceptance agreements' to identify participating pharmacies," the letter said. "Under these agreements, unless a pharmacy specifically told the sponsor that they would not be participating, the sponsor listed them as a participant."

Out of 20 drug card sponsors reviewed, at least five used such passive acceptance agreements, the letter said: AdvancePCS, Anthem Prescription Management, Argus Health Systems, Pharmacare and Medco Health Solutions. Committee staff found 45 cases in which card sponsors listed pharmacies that did not accept the discount cards.

The letter also mentioned the Rexall drug store in Langdon, N.D., which is listed on the Web site as participating in the discount program, but has been closed for at least three years.

Despite these complaints, Democrats have been pushing for HHS to enroll low-income elderly automatically into the discount program. Last month, Senate Democrats even introduced a bill to accomplish that end. The goal, of course, is giving $600 to low-income recipients along with the discounts, even though the extra money remains tied to participation in a program they view as highly flawed.

FEDERAL COURT BACKS PBMS IN DRUG LAW CASE

A federal court in Maine has taken the side of pharmacy benefit managers in upholding a lower court's injunction that blocks part of Maine's new drug discount program.

The Pharmaceutical Care Management Association has brought suit in Maine and the District of Columbia against one specific business aspect of these low-income, drug-subsidy programs. The lobby group objects to language in the legislation that requires transparency and full disclosure by PBMs of their discounts and contracts with pharmaceutical companies and other vendors.

Maine officials had asked the court to scale back the injunction and the court refused. The lower court had ruled the law's language violated the U.S. Constitution and would make public PBM proprietary information without compensation.

CALIFORNIA MALPRACTICE CAPS CUTS PAYOUTS

A RAND Corp. study released Thursday finds California's law that caps non-economic awards in medical malpractice lawsuits has done its job -- sort of -- by reducing payments to plaintiffs by 30 percent. The law's limits on attorney fees, however, slightly skewed the numbers, so plaintiffs actually got only 15 percent less than they would have without the limits on awards.

Plaintiff attorneys seemed to get the worst of it -- the law reduced their collections by 60 percent.

The study also finds cases involving patients who died were much more likely to have awards reduced than non-fatal injury cases.

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E-mail ebeck@upi.com

Copyright 2004 by United Press International.

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