Confessions of a Quackbuster

This blog deals with healthcare consumer protection, and is therefore about quackery, healthfraud, chiropractic, and other forms of so-Called "Alternative" Medicine (sCAM).

Monday, July 04, 2005

Shaky science: Experts question anthrax lotion (Bio-Germ)

Shaky science: Experts question anthrax lotion

Experts question Dallas man's anthrax product; supporters back off

05:04 PM CDT on Saturday, July 2, 2005

By MICHAEL GRABELL / The Dallas Morning News

A Dallas businessman claims to have the answer for an anthrax attack – a 16-ounce, $179 bottle of skin lotion, made from grapefruit seeds and the oil of an Australian tree.

He's won scientific backing from a microbiologist at a University of Texas branch known for bioterrorism research. A respected police chief and a veteran North Texas congressman have supported him. Some public safety agencies have talked about using federal homeland-security grants to buy the lotion and related products, which are sold as the Bio-Germ Protection kit.

"This certainly appears to be a breakthrough and the answer to the anthrax problem," U.S. Rep. Ralph Hall says on a Bio-Germ promotional video.

But the company is built on little more than shaky science and the long-standing friendships of the businessman's father, The Dallas Morning News has found. The U.S. Food and Drug Administration says Bio-Germ lacks federal approval and could face scrutiny for claims made on its Web site.

The businessman, scientist, congressman and police chief said they had no intentions of misleading the public. They said they only wanted to help the country be prepared for a terrorist attack.

After The News began making inquiries, UT officials investigated the microbiologist, John Heggers, and ruled last week that he had overstated his research to support a commercial product.

"Dr. Heggers has committed significant scientific misconduct by making excessive and false claims based on his research," the officials wrote. "His misconduct is all the more egregious because his false claims involve nationally important public policy."

A burn specialist at the UT Medical Branch in Galveston, Dr. Heggers, published the only scientific article on Bio-Germ in an obscure online journal run by two of his former medical residents. The journal retracted the study after two scientists listed as co-authors disputed the article's findings and said they had never read or approved it.

About a dozen anthrax experts who reviewed the article for The News said Dr. Heggers' work had little value because he failed to test spores – the highly infectious form of anthrax that terrorists made into a powder and mailed in the 2001 attacks. Instead, the experts said, Dr. Heggers tested a weak form of the bacteria that is sometimes found in livestock carcasses and easily killed with rubbing alcohol.

Yet Dr. Heggers wrote that Bio-Germ would protect the public from an anthrax attack, and he later said it probably would counter other bioterrorist threats, such as smallpox and the plague. It met government safety standards, he said, and he urged police and fire departments to buy it.

He now says he exaggerated.

"Scientists must stay close to the facts they discover and not let hopes and expectations get ahead of them," Dr. Heggers wrote The News in an e-mail. "I failed in that regard, and for that I apologize; but I assure you my intentions were honorable and not mercenary."

He also acknowledged that he has overstated findings about an alternative therapy for cancer and AIDS. Based on a study of a single patient – himself – he concluded in a 2002 presentation that aloe vera "can be used effectively as an anti-cancer alternative."

Bio-Germ founder Allan Lord would not comment on The News' findings. He referred questions to the products' developer, Robert Heiman, who said he was unaware that Bio-Germ was being sold. Mr. Heiman said that the products are still in testing and that he believes they will prove effective.

Mr. Hall said he was merely doing a favor for a longtime friend and did not feel that he was endorsing the product by appearing on the video in his Rockwall congressional office.

"I'm pretty innocent in this thing," said Mr. Hall, the No. 2 Republican on the House Science Committee. "I was trying to help a friend and the American people. I didn't mean to mislead anyone."

He said he helped Bio-Germ get a meeting with top U.S. Health and Human Services officials by calling another friend – Tommy Thompson, who was secretary of the department, which oversees the FDA and the Centers for Disease Control and Prevention. Mr. Hall said he would have done that for any constituent.

Congressional ethics rules caution members from appearing as if they are endorsing a product in an official capacity.

"That is definitely unusual to see a member of Congress endorsing a product and clearly raises some serious questions about the appropriateness of it," said Larry Noble, executive director of the nonpartisan Center for Responsive Politics.

A business plan

Bio-Germ's roots trace to late 2001, when anthrax-laden letters killed five people, sickened 17, terrified postal workers and closed government offices for months. Mr. Hall pushed for congressional hearings as officials scrambled to decontaminate the buildings.

Mr. Lord, in the skin-care business, followed the headlines and saw an opportunity. At the time, he was selling a tree resin that bees use to make hives, citing research Dr. Heggers had done on the resin's antibiotic properties.

"The consensus seemed to be that the government needed private industry to come up with some sort of kit to protect us," said Mr. Lord, who shuttles between Texas and a Southern California home. He made the statement during The News' initial research on his products, before declining to answer most questions.

After he and Mr. Heiman developed their Bio-Germ formula, Mr. Lord's father, retired Dallas insurance agent Doug Lord, asked Dr. Heggers to test it.

The two had met in the 1990s when Doug Lord served on the board of governors for the Galveston Shriners Hospital, where Dr. Heggers worked in addition to his UTMB duties. The elder Lord oversaw finances for the clinical microbiology department, which Dr. Heggers managed.

Dr. Heggers said he was already planning to experiment with alternative therapies for anthrax, although he normally doesn't work with the bacteria or on bioterrorism research. In petri dishes, he tested 17 burn creams and disinfectants, including Bio-Germ, to see if any would inhibit growth of the bacteria's weak form. Bio-Germ, he reported, was one of 15 that did.

Dr. Heggers informed several product makers of his findings, and he appeared on Bio-Germ's promotional video. Doug Lord then enlisted two more friends in high places.

First was Mr. Hall, whom he had known for about 50 years. They met when Mr. Hall was a professional boxing promoter and Mr. Lord managed a local fighter named Curtis Cokes, who became welterweight champion of the world.

Mr. Hall promoted many of his fights and became a good friend of Mr. Lord – even being listed as his first reference when Mr. Lord filed for custody of his son's children in 1989.

"Ralph Hall believes in me," Mr. Lord said. "We've been together for years and years and years. Because of me, he was willing."

Next was McKinney Police Chief Doug Kowalski, who teaches homeland-security seminars around the country and led the Dallas police SWAT team for a decade. He had worked with Mr. Lord for years on police charity rodeos that raised money for the Shriners hospital.

Chief Kowalski went on the video, in uniform.

"This is the type of product that will be very beneficial to first responders," Chief Kowalski says while holding the Bio-Germ kit. It includes the skin lotion plus a nasal spray – purportedly to treat inhalation anthrax – and an aerosol for decontaminating buildings.

Then Allan Lord began making the rounds at conventions of police chiefs, emergency medical technicians and jail employees. Dr. Heggers sometimes accompanied him as he showed the video to North Texas officials, some of whom told The News they wanted to buy Bio-Germ.

Dr. Heggers also attended a meeting on behalf of Bio-Germ in October 2004 with Stewart Simonson, assistant secretary for Health and Human Services, UTMB confirmed. Bio-Germ paid for both trips, but Dr. Heggers did not receive other money, according to the university.

Mr. Lord also showed off a letter from Dr. Heggers on the stationery of UTMB, one of three places in the U.S. permitted to handle the most dangerous germs.

The journal article "details the success in eradicating the anthrax bug," Dr. Heggers wrote in the letter, addressing Mr. Lord and Mr. Heiman as "fellow colleagues." "We believe it will be successful against smallpox, the plague and other pathogens possibly used by terrorists."

He added that Bio-Germ "should be rolled out to our nation's first responders, military and as soon as possibly to the citizenry of our country." And he promised to provide Bio-Germ with scientific support in the future.

The science

Dr. Heggers is widely known for his research into alternative therapies, especially aloe, to prevent infections in burns. In the early 1980s, he gained fame as one of the first medical researchers to find evidence that silicone breast implants could rupture inside the body.

When first contacted by The News, Dr. Heggers defended his anthrax research and his decision to go on camera.

"You tell me why I wouldn't appear on the video if I had the ability to provide information to the world that there is a product out there that is going to prevent infection," he said. "Why did Senator Dole get out there and talk about Viagra and sexual dysfunction?"

Dr. Heggers insisted that Bio-Germ is not subject to FDA oversight. But he said it still met the agency's standards for safety and had no major side effects – although he hasn't tested it on animals or humans.

The FDA has a history of penalizing companies that sell products made from the same ingredients as Bio-Germ and that claim to treat illnesses.

"Any product that makes a drug claim, which is to help prevent, cure, treat or mitigate a condition, in order to promote that kind of product, it has to be shown to be safe and effective and approved by the FDA – and that's regardless of whether it's made with herbal ingredients, and that's regardless of whether the material is made for bioterrorism," said FDA spokesman Brad Stone.

Dr. Heggers also criticized the FDA when first interviewed, saying that its requirements are too stringent.

"The FDA is made up of a bunch of lawyers rather than scientists," he said.

As UTMB learned of The News' findings and began investigating, Dr. Heggers' tone changed. He said he had never seen Bio-Germ's video and wanted his name off the company Web site.

Meanwhile, two UTMB anthrax researchers he listed as co-authors of the journal article wrote a letter to Bio-Germ disputing Dr. Heggers' original claims.

The researchers, Johnny Peterson and Ashok Chopra, said they had not read the article before publication. They condemned Dr. Heggers' letter for saying that Bio-Germ might combat smallpox and the plague.

"This claim is simply outrageous," they wrote. "No one in the world would be allowed to test [it] against the smallpox virus except for two highly restricted (by international treaty) governmental facilities."

After coming under UTMB investigation, Dr. Heggers declined to speak over the phone but agreed to answer questions via e-mail. He said he referred to Mr. Lord and Mr. Heiman as colleagues by mistake, using a scientific term in a setting that could convey a business relationship.

The online Journal of Burns and Wounds, which published Dr. Heggers' study, withdrew it to prevent the journal from becoming "a vehicle for commercial exploitation," said editor Stephen Milner, a surgery professor at Johns Hopkins University and director of the Baltimore Regional Burn Center.

In an earlier interview, Dr. Milner called Dr. Heggers a "first-class" scientist and said the study was "quite a good article."

Dr. Milner completed his residency at UTMB and was a fellow at the Shriners hospital in the mid-1990s under Dr. Heggers, who sits on the journal's editorial board. Dr. Milner said the relationship had no bearing on the article's publication.

Johns Hopkins officials called Dr. Heggers' work questionable but said they could not discipline Dr. Milner because the university considers faculty members' publishing activities private.

Sales continue

None of this has stopped Mr. Lord from selling Bio-Germ online, although his Web site has removed references to Dr. Heggers and UTMB.

Doug Lord said he stands by his son.

"Somebody has to do something, and they're one of the first companies that's ever tried to do anything," he said. "I know they had it in their hearts to do something."

If the FDA determines that Bio-Germ is violating the law, it could warn the company to stop selling the products or refer the matter to federal prosecutors. The Federal Trade Commission also could seek penalties if it determines that Bio-Germ has made false or unsubstantiated claims.

Chief Kowalski said McKinney is still evaluating the products, which he once hoped to put in every squad car. He said he had been influenced by the scientific credentials and the apparent backing of Mr. Hall.

McKinney officials said that they see no problem with the chief going on the Bio-Germ video and that it's consistent with the chief's duty to look for new homeland security products.

"I don't have a major heartburn with it," Mayor Bill Whitfield said.

Chief Kowalski said he holds himself to a strict code of ethics and doesn't feel he did anything wrong by appearing on the Bio-Germ video.

"I can't endorse a product, but 'a product of this type' is what I can talk about," he said. "My whole interest in this is, 'What can we do to protect policemen, firemen and paramedics?' "

Mr. Hall said he qualified his statements about Bio-Germ by saying on the video that he is "no authority" on the science behind the products.

"I had no way of knowing if it was good, bad or indifferent," he said. "I wanted them to have a chance for somebody to look at it and tell them whether or not it really worked."

According to the House of Representatives Ethics Manual, "Members and employees of the House need to distinguish carefully between official and unofficial activities when they interact with private organizations."

Mr. Noble of the Center for Responsive Politics said he doubts that Mr. Hall will face any ethics inquiries. "It's that area where I don't think there's anything that specifically outlaws this," he said.

UTMB President John Stobo will now review the findings of a scientific integrity committee and decide whether to discipline or fire Dr. Heggers, a tenured professor.

The investigation comes at a critical time for UTMB as it tries to establish itself as one of the country's premier institutions for bioterrorism research.

"It's really an embarrassment for him to be associating the name of our university inappropriately with that material," said David H. Walker, a UTMB anthrax expert, who was not involved in the study but reviewed it for The News.

"I would hate to think of tax dollars being spent on that."


What is anthrax?
Anthrax is a disease caused by the bacterium Bacillus anthracis and is most commonly found in livestock. Infections usually occur when bacteria enter through a cut and cause sores. Antibiotics generally cure this form easily.

Terrorists, however, have manufactured the spore form of the bacterium into a powder that can be deadly if inhaled. Long- term treatment with antibiotics helps some victims.

What is Bio-Germ?
The company's $250 kit consists of a skin lotion, a nasal spray, an aerosol and a mask. According to the company:

The lotion can shield public safety workers responding to a potential terrorist attack.

The aerosol can be sprayed to decontaminate a room.

The spray can be used to treat inhaled spores.

Listed ingredients: Tea tree oil, grapefruit seed extract and urea, a common organic compound.

What the research did ...
Dr. John Heggers, a University of Texas Medical Branch scientist, tested Bio-Germ and several other over-the-counter products on anthrax bacteria in a petri dish. He found that most of the products inhibited the bacteria's growth.

... and didn't do:
Dr. Heggers did not test anthrax spores. Yet he wrote that Bio-Germ would protect the public from bioterrorism, which experts say is a baseless claim. There have been no animal tests to determine Bio-Germ's effectiveness or potential side effects.

SOURCES: Centers for Disease Control and Prevention; Bio-Germ Protection; Dallas Morning News research


A congressman, a University of Texas microbiologist and a police chief have supported Bio-Germ Protection's claim to have an answer for anthrax attacks. All have long-standing ties to Doug Lord, whose son Allan runs Bio-Germ. Another scientist, who formerly studied under the UT microbiologist, published the only research paper on Bio-Germ.

Allan Lord
He is marketing lotions and sprays that purport to protect people from bioterrorist weapons. Raised in Dallas, he lives in the Los Angeles area, although Bio-Germ's business address is his father's home near White Rock Lake. He has previously owned companies involved with television production, wine importing and skin care.

Doug Lord
Allan Lord's father helped finance Bio-Germ and persuaded three longtime associates to promote it. He is a retired insurance agent and boxing manager and former leader of Hella Shrine in Garland, a Masonic fraternity.

U.S. Rep. Ralph Hall
The Rockwall Republican praises Bio-Germ on a promotional video that has been shown to public safety officials across the country. As a high-ranking member of the House Science Committee, Mr. Hall pushed for hearings on decontaminating buildings targeted in the 2001 anthrax attacks. He has been a close friend of the Lords since the 1960s, when he was a boxing promoter and Doug Lord managed boxer Curtis Cokes, who became world welterweight champion.

Dr. John Heggers
The microbiologist conducted now-discredited research on Bio-Germ and other products at the University of Texas Medical Branch in Galveston. Then he endorsed Bio-Germ on a promotional video and in a letter that addressed Allan Lord as a "fellow colleague." Dr. Heggers also works at Galveston Shriners Hospital, on whose board of governors Doug Lord served from 1993 to 2002, overseeing spending by the microbiology department.

McKinney Police Chief Doug Kowalski
He appears on the video in uniform and has encouraged other Collin County public safety officials to consider buying Bio-Germ. The chief, who was Dallas SWAT commander for a decade, has known Doug Lord for years through Shriners hospital fundraising.

Dr. Stephen Milner
He is the founder and editor of the online Journal of Burns and Wounds, which published Dr. Heggers' anthrax research in December and recently withdrew it. Now a physician and burn expert at Johns Hopkins University in Baltimore, he was a resident at UTMB in the mid-1990s under Dr. Heggers.