Sunday, February 16, 2003

Scientists linked to Heimlich investigated


Experiment infects AIDS patients in China with malaria

By Robert Anglen
The Cincinnati Enquirer

[photo]
Dr. Heimlich


Two prominent Los Angeles AIDS researchers are being investigated for taking part in a controversial medical experiment with Cincinnati physician Henry Heimlich to infect AIDS patients in China with malaria.

A medical oversight board at the University of California Los Angeles wants to know whether doctors John Fahey and Najib Aziz violated university policies that regulate tests on humans.

The investigation once again raises questions about Dr. Heimlich's work at Cincinnati's nonprofit Heimlich Institute, which is partnered with Deaconess Hospital. (This is the same Dr. Heimlich who developed the Heimlich maneuver, used to expel food from the throats of choking victims.)

His experiments - which seek to destroy HIV, the AIDS-causing virus, by inducing high malarial fevers- have been criticized by the Centers for Disease Control and the Food and Drug Administration and condemned by other health professionals and human rights advocates as a medical "atrocity.''

Both Dr. Fahey and Dr. Aziz deny involvement in Dr. Heimlich's malaria studies, and UCLA officials say they have asked Dr. Heimlich "to omit UCLA from all references relating to malaria studies or other Heimlich Institute research. Any claims of an affiliation with UCLA are inaccurate."

But documents obtained by the Enquirer show the doctors have been active in the malaria experiments since 1996.

Letters written by Dr. Fahey on UCLA stationary detail how doctors helped Dr. Heimlich set up the experiments, analyzed data, provided chemical reagents, made multiple trips to the test locations in China, reviewed test protocols and offered to obtain funding through grants at UCLA.

"I greatly appreciated all of the data you shared with us on this visit," Dr. Fahey wrote to Chen Xiao Ping, the doctor overseeing the experiments for Dr. Heimlich in China. "I want to assure you that we regard this as confidential information. My colleagues and I will gladly help with the analysis but not share it with others. You should report your result directly to Dr. Heimlich."

Dr. Fahey forwarded this e-mail, dated Nov. 10, 1998, to Dr. Aziz and UCLA School of Medicine researcher Barbara Hered.

MALARIOTHERAPY
Cincinnati's Dr. Henry Heimlich says malaria can be used to cure AIDS, cancer and Lyme disease through a process called malariotherapy. Dr. Heimlich has been sharply criticized by state, federal and international health organizations for these experiments.

This is how he explained the process at a conference in October:

His theory is based on tests performed in 1918 by Nobel Prize winner (medicine) Julius Wagner-Jauregg, who reported that malariotherapy cured neurosyphilis.

The idea is to inject AIDS patients with malaria to induce high fevers that will kill the HIV virus.

After 10-12 fevers and after approximately three weeks, the malaria is cured with drugs.

The fevers allegedly spark an immune reaction, which reverses AIDS' attack on patients' immune system.

In one study, malariotherapy was performed on eight HIV-positive men, ages 23-40, in China. After the malaria was cured, the patients were monitored for two years.

Heimlich contends that malariotherapy is affordable and available to patients who would not normally have access to expensive drugs.

In another letter to Dr. Heimlich, dated Aug. 8, 1996, Dr. Fahey described the malaria experiments - called malariotherapy - as "striking" and offered to help continue research through UCLA.

"I wondered if we could help you ... we could, perhaps, develop a means of helping your Chinese colleagues in carrying out their studies," Dr. Fahey wrote. "Assistance with reagents and quality control samples for (test) measurements as well as for other parameters of HIV infection."

Contacted at his California home, Dr. Fahey would not comment. He also did not respond to an e-mail detailing the contents of his letters to Dr. Heimlich and Dr. Chen. Dr. Aziz also would not comment.

Dr. Heimlich, who has credited Dr. Fahey for his support, says he has no idea why the doctors would say they are not involved. He says they provided technical assistance for years and used their labs to analyze data and suggest ways to proceed.

"Dr. Fahey is an outstanding professional. He was involved in the original work in China," Dr. Heimlich says. "He is a renowned scientist involved in AIDS research. He asked to contribute. He did an excellent job."

For years, Dr. Heimlich has been criticized by state, federal and international health organizations over malariotherapy. Despite this, Heimlich proudly continues his work in China and says he wants to expand malariotherapy to Africa.

From his Cincinnati institute on Straight Street, the 83-year-old Dr. Heimlich solicits private donations for malariotherapy research and distributes a quarterly newsletter about his work to "promote peaceful solutions to international problems." He is the father of Hamilton County Commissioner Phil Heimlich.

He often is at odds with medical professionals. One of his most public fights has been with the American Red Cross over the agency's refusal to adopt the Heimlich maneuver as the first response in drowning rescues instead of traditional CPR.

Dr. Heimlich says his critics are motivated by politics rather than legitimate medical concern.

Malariotherapy research was the topic of Heimlich's presentation to the respected Pan Africa AIDS Conference in Nashville, Tenn., last October.

"They don't question my work," he says, adding that his tests offer a chance to end the scourge of AIDS.

Officials with the Pan Africa Conference could not be reached. However, Peter Lurie, a former AIDS researcher and now a physician with Public Citizen's Health Research Group in Washington, D.C., calls the malariotherapy studies dangerous and unnecessary.

Public Citizen is a 32-year-old, nonprofit group founded by consumer advocate Ralph Nader. The Health Research Group provides oversight concerning drugs, medical devices, doctors and hospitals and occupational health. It works to identify and ban unsafe or ineffective drugs, medical devices and procedures.

"It is charlatanism of the highest order," Dr. Lurie says of malariotherapy. "It is exploiting the lack of decent medical care in China."

Dr. Heimlich began soliciting funds for malaria treatment of cancer, AIDS and Lyme disease in the late 1980s.

"Ever since then he's been coming up with new maneuvers," Dr. Lurie says. "Many or most of them have not worked. Some are incredibly grandiose."

Dr. Lurie included Dr. Heimlich's malariotherapy studies in a September 1997 New England Journal of Medicine article about "exploitive" medical procedures in developing countries.

Dr. Heimlich insists that he has approval to conduct his studies through a review board of doctors that is supposed to ensure federal regulations for ethical research are met. But that review board was disbanded several years ago after the Food and Drug Administration sharply criticized the China malaria experiment.

The review board overseeing Dr. Heimlich's China experiment was formed by an "alternative medicine" group called the Great Lakes College of Clinical Medicine.

In 2000, an FDA compliance director described Dr. Heimlich's procedures as inadequate. He said the experiments would not be permitted in the United States, that researchers failed to consider community attitudes in China and that there was no description of lifelong risks facing patients injected with malaria.

Dr. Heimlich called the report biased.

"We ask you," Dr. Heimlich wrote to FDA Commissioner Jane Henney, "to take immediate action vis--vis your employee and the unwarranted harm to our research that his bias and false accusations are causing."

In 1993, the U.S. Centers for Disease Control and Prevention questioned Dr. Heimlich's research. Carlos Campbell, CDC's chief of malaria studies at the time, said there was no evidence to support Heimlich's conclusions.

"No evidence currently exists to indicate that malaria infection would beneficially affect the course of HIV infection," Campbell wrote. "In fact, substantive concerns have been raised regarding the possibility that malaria therapy could (worsen) the course of HIV infection."

Los Angeles physician Paul Bronston, who serves as the national chair of the Ethics and Professional Policy Committee for the American College of Medical Quality, says there is still no evidence that the experiments have any merit.

"Indeed, there is evidence that it is very dangerous," he says.

Dr. Bronston organized a petition against Dr. Heimlich in 1994 over malaria experiments to treat Lyme disease, which were being conducted in Mexico. The experiments resulted in a groundswell of protest from the medical community.

Dr. Heimlich contends the China experiments have proved that malaria works to combat AIDS. He says that malaria strengthens the immune system and increases T-cells in AIDS patients.

T-cells are a common way to measure the severity of HIV. In a healthy person, T-cell counts are usually above 1,000. When counts fall below 200, patients are considered to have full-blown AIDS.

Dr. Heimlich says before being treated with malaria, eight male AIDS patients in China had T-cell counts that ranged from 269 to 1,868. Two years after malariotherapy, the T-cell counts in those patients were 570 to 2,063.

"These results ... confirm malariotherapy is safe and can be effective for HIV infected patients," Heimlich said in his Pan Africa presentation.

Both Dr. Lurie and Dr. Bronston say they are surprised that AIDS researchers would continue to be involved in malaria experiments after all of the continued negative publicity and criticism that Dr. Heimlich receives.

UCLA officials acknowledge that Dr. Fahey and Dr. Aziz helped train Dr. Chen along with other international scholars. But officials say the doctors were limited to teaching methods for conducting and evaluating AIDS research studies. Officials say the doctors never were involved in Dr. Heimlich's studies.

"Dr. Chen acknowledged the immunology training by Dr. Fahey in his research paper. However, Dr. Fahey was not a coauthor and did not collaborate on the malaria studies," UCLA officials said in a Nov. 27 statement.

But in his 1998 e-mail to Dr. Chen, Dr. Fahey attempted to discourage the Chinese doctor from naming UCLA doctors as authors on a research paper.

"It is more appropriate if you simply acknowledge assistance of Dr. Najib Aziz and myself in some aspects of the study in an acknowledgement paragraph or at the end of your manuscript," Dr. Fahey wrote. "You must understand that we want very much to see this study succeed but we think that we should not be among manuscript authors at this time."

In 1999, Dr. Chen and Dr. Heimlich coauthored a report on the malaria experiments for the Chinese Medical Sciences Journal. The paper notes that UCLA helped measure serums.

And in letters to Dr. Chen, Dr. Fahey arranged ways to ship reagents for studies to and from Los Angeles and Guangzhou, China.

The Office for the Protection of Research Subjects at UCLA, which is responsible for reviewing research protocols and ensuring that medical studies are ethical and do not involve abuse, began investigating Dr. Fahey and Dr. Aziz in October and initially cleared them of wrongdoing.

But this month, the office reopened its investigation. Associate Director Steven Peckman says his office received additional information, but will not comment about it.

After being advised of the memos between Dr. Heimlich and Dr. Fahey, UCLA spokesman Max Benavidez issued a new statement Friday. It acknowledges the ongoing investigation and says: "UCLA reiterates that the university has never approved any research studies pertaining to malariotherapy for HIV."

E-mail at ranglen@cincinnati.com.




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