Nicholas Bachynsky

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Nicholas Bachynsky, a medical doctor and twice-convicted criminal whose licenses were revoked in the early 1990s, is largely responsible for the persistance of intracellular hyperthermia {ICHT} as a treatment. This article discusses his treatment theories and warns against reliance on ICHT or anyone who has ever prescribed it.

Bachynsky claims that ICHT is effective against cancer and Lyme disease. During 2003, he oversaw its administration at the Villa Preziosa Medical Facility in Laveno-Mombello, an Italian city near the Swiss/Italian border. The clinic's now-defunct Web site, which was registered to Life Extensions SA, of Phoenix, Arizona, stated:

Intracellular Hyperthermia Therapy (ICHT) is a patent pending, new method of heat delivery . . . . based on heating cells "from the inside-out." This is accomplished by uncoupling a basic biologic process known as oxidative phosphorylation. An uncoupling agent is delivered so as to create a short circuit ("futile cycle") within the inner mitochondrial membrane (mitochondria are intracellular energy producing organelles that make ATP and utilize 95% of all oxygen consumed). This short circuit is created by a biochemical process that shuttles protons back into the mitochondrial matrix and increases heat production at the expense of useful energy (ATP) synthesis. The net result of ICHT therapy is the conversion of mitochondria from efficient "powerhouses" of energy production to "chemical furnaces," heating cells from the "inside out."

The dominant effects of hyperthermia appear to be related to the increase in oxygen free radical formation at the level of the mitochondrion. Increased oxygen free radicals induce a series of lethal biochemical events inside the cell that induces death of the cancer cell through either apoptosis or necrosis. Since ICTH initially heats mitochondria, far less heating is required to get the desired effects. Do to their much higher metabolic rates tumor cells are selectively heated to temperatures far greater than that of normal cells.

. . . . Conventional hyperthermia ("outside-in") heats the exterior of the cell first, and only after going through multiple layers of other tissues. Moreover, ICHT heats tumor cells far in excess of their normal counterparts. This selective heating occurs because the amount of heat produced by uncoupling not only depends on the dose of uncoupler, but also on the metabolic rate of targeted tissues or cells.

Aggressive malignancies have much higher metabolic rates (levels of heat production) than their normal counterparts. In fact, the level of histologic grading (undifferentiation, mitotic index, etc.) correlates directly with metabolic activity. Metabolic rates in some tumors have been shown to be 10 to 30 times greater than their normal counterparts. Thus, if normal cells are uncoupled and heat production is increased four-fold (non-lethal), heat production in tumor cells is increased 4 times their existing metabolic rate, i.e., 40 to 120 fold greater (lethal for many tumors). Conventional hyperthermia heats all cells uniformly and thus has a far smaller therapeutic index and target selectivity [1].

Various Internet postings [2] indicate that Bachynsky's ICHT involves the intravenous administration of 2-4- dinitrophenol (DNP), which the U.S. Food and Drug Administration (FDA) banned more than 60 years ago. Although DNP can disrupt mitrochondrial function as described in the first paragraph of the above statement, the rest of the statement is misleading. Our consultants have noted:

  • The temperature of cells, whether benign or malignant, is not independently determined by the amount of heat the cell produces. Body temperature is closely regulated by the nervous system through such mechanisms as blood-flow changes, sweating, and shivering. These mechanisms influence cell temperature from the "outside in" and not from the "inside out" as ICHT proponents claim.
  • There is no scientific reason to believe that hyperthermia increases free radical production. Uncoupling does not necessarily lead to more free radical production. In some cases, it leads to less.
  • Cellular differentiation (how closely the cells resemble the corresponding normal cells) is not related to metabolic rate. Some cancers whose cells look relatively benign under the microscope can grow as aggressively as those whose microscopic characteritics look ominous.
  • Although tumor cells sometimes have higher metabolic rates than their corresponding normal cells, it also matters how these rates compare to those of other tissues in the body. For example, parts of the tumor that have relatively less blood supply will probably metabolize relatively slowly, although they are less able to dispose of heat. Thus, even if ICHT could weaken or destroy cells according to their metabolic rates, it could not harm cancer cells having low metabolic rates without harming normal cells that are more metabolically active. If the killing required metabolic rates high enough to skip all normal cells, then some cancer cells having lower metabolic rates would also be spared.
  • There is no scientific evidence that DNP is safe or effective as a cancer treatment.

Bachynsky's cancer treatment took two weeks. Over a 4-day period, the DNP plus very low doses of chemotherapy were administered through an indwelling catheter that was placed in a vein that delivers blood to the area of the tumor. Before and afterward, DNP was administered without the catheter. The cost for a cancer patient was $15,000 for the catheterization and $35,000 for the ICHT. In addition to treating cancer, Bachynsky also used DNP to treat Lyme disease for a fee said to be $20,000 [2].

Bachynsky's Backgound

Bachynsky graduated from the University of Tennessee School of Medicine and practiced in Houston, Texas. During the mid-1980s, he operated "Physicians Clinics," a chain of weight-loss facilities in Texas and neighboring states which advertised that DNP "forces your metabolism to burn thousands more calories" and offered to produce weight loss of up to 15 pounds a week "without starving." [3] The clinics also offered a smoking-cessation program. The centerpiece of his weight-loss program was DNP, which he dispensed under the name Mitcal. When state and federal authorities realized what he was doing, they went to court to stop him. In 1986, Bachynsky was found guilty of violating the Texas Food, Drug, and Cosmetic Act and ordered to pay $86,000 in fines and attorney's costs. The presiding judge also enjoined further use of DNP without FDA approval. When Bachynsky persisted, he was charged with violating the injunction and fined $100,000 by the judge. Although DNP can cause weight loss by speeding up metabolism, the FDA banned it during the 1930s because it can also produce severe skin reactions, jaundice, cataracts, disturbances of smell and taste, and agranulocytosis, a potentially fatal disorder in which production of blood cells is impaired. According to an article in the February 1987 FDA Consumer, some 14,000 people were treated at Bachynsky's clinics at a cost of approximately $1,300 [3].

In 1987, the Texas State Board of Medical Examiners revoked Bachynsky's license for "overprescribing or misprescribing drugs, but an appeals court overturned the Board's ruling [4]. In 1988, a federal grand jury in Houston, Texas, returned an 87-count indictment against Bachynsky., his wife and son, and 18 other persons on charges arising out of a scheme to defraud insurance companies and the Department of Defense (DOD) through submission of false medical claims. In 1989, he pled guilty to one count of racketeering and one count of conspiring to defraud the Internal Revenue Service and was sentenced to 121 months in prison and three years of supervised release; fined $35,000; and ordered to forfeit many items of property. Court documents indicate that he had billed the insurance companies for unnecessary tests and billed DOD for tests that were never performed. Because most patients' insurance did not cover weight-loss or smoking-cessation programs, false diagnoses were submitted to qualify for insurance payments. The Government estimated that the total loss from Bachynsky's fraudulent scheme was between $15 and $37 million [5]. The criminal conviction enabled the Texas medical board to revoke his license in 1990 and the New York State followed suit in 1991.

In 1990, a Texas jury convicted Donald Ivan Esacove, a former Bachynsky employee, of two counts of mail fraud and six counts of money laundering. In 1991, a Circuit Court of Appeals upheld the conviction, in a ruling that contains this blistering attack on Bachynsky's character:

Esacove's troubles are intimately wrapped up with the criminal escapades of Nicholas Bachynsky, a Houston physician and his longtime employer. To say that Bachynsky had a penchant for fraud is a prize-winning understatement. He established a nationwide network of weight loss and smoking cessation clinics that, through hordes of unnecessary tests and false claims, bilked over fifteen million dollars from patients and their insurers. So that he might pocket further insurance proceeds, Bachynsky directed an employee, Ronald Day, to arrange for the "theft" of his (that is, Bachynsky's) Mercedes-Benz. In a similar scheme, he ordered his antique store, "Carlo Ashton Antiques," burglarized and then filed a vastly inflated claim for the purloined merchandise. And whenever one of Bachynsky's corporations—he controlled several—neared the end of its fiscal year, he would shunt money from that corporation to one of his others in order to shelter, illegally, earnings from taxation. . . .

The racket relevant here stems from Bachynsky's entry into bankruptcy on April 14, 1987. In the bankruptcy petition and accompanying schedules, Bachynsky made no mention of many of his assets, including several of his corporate interests. To maintain this ruse, and to hide other pre-petition assets from the bankruptcy court's watchful eye, Bachynsky and Esacove laundered checks that were payable to Bachynsky through a checking account that Esacove had opened for his son, Benjamin. Over the course of some two years, a host of checks from an array of sources were laundered through this so-called "Benjie account."

In September 1988, a federal grand jury began investigating Bachynsky's financial affairs. On October 1 of that same year, Day, by then an FBI informant, wore a recording device into a meeting with Bachynsky, during which the latter explained, in detail, his and Esacove's use of the Benjie account and fretted over a way to rationalize such use to the grand jury. Any incriminating particulars Bachynsky neglected to bring up in the October 1 meeting were brought up—and recorded—during an October 2 gathering of Bachynsky, Day, and Bachynsky's girlfriend, where again Bachynsky sought advice on how to explain away the laundered funds [6].

Bachynsky was imprisoned in 1989 and released in August 1997. After his release, he treated patients in Mexico and then Switzerland and in 2001 helped form a company (Helvetia Pharmaceuticals) that supposedly would sponsor research into his methods. In 2003, he lived in Florida and commuted to Italy about once a month to administer the treatment. The toll-free number on his Web site was answered by his patient coordinator, Charles Field, at a Florida location [7].

In 2004, Bachynsky and three associates were indicted for fraud in connection with their marketing of stock and notes for Helvetia Pharmaceuticals [8]. The others pled guilty, but he went to trial and in February 2008 was convicted of one count of conspiracy, three counts of wire fraud, and one count of securities fraud. The jury also returned a supplemental verdict forfeiting his interest in $450,000 in United States currency and two Swiss bank accounts. During the trial, the government proved that Helvetia's sales materials failed to disclose that ICHT is extremely dangerous and that Bachynsky's licenses had been revoked [9]. His sentencing has been delayed several times.

Treatment Unsubstantiated and Dangerous

Hyperthermia (heat therapy) is based on the observation that some cancer cells are more heat-sensitive than their normal counterparts. The heat may be applied by using high-frequency waves that heat the tumor (local therapy), heating blood that goes to an area (regional therapy), or heating the entire body with a thermal chamber, warm blankets, or another external heat source (whole-body hyperthermia). Unfortunately, research into hyperthermia has found little practical application. Studies have shown that local and regional hyperthermia may enhance the effect of radiation therapy in local and regional control and the effectiveness of chemotherapy for a few cancers. Whole-body therapy should be considered experimental [10,11].

The Life Extension SA Web site states that "Numerous scientific publications have shown that hyperthermia augments the effects of chemotherapy." [1]. However, the research does not appear relevant to DNP. On January 30, I did a series of Medline searches to see whether DNP had been studied as cancer treatment, a Lyme disease treatment, or a hypothermic agent. I found a few articles about DNP and hyperthermia in laboratory animals (not humans), but no evidence that DNP has been studied as a treatment for cancer or Lyme disease. Moreover, even if DNP could kill cancer cells or the organism that causes Lyme, it would still be too toxic to use for that purpose [12]. According to a report from the Swiss Department of the Interior, it is not approved for drug use in any country in the world [13].

The danger of DNP was highlighted by a recent case in which Sean Zhang an Indiana businessman, was convicted of mail fraud in connection with the death of a 22-year-old customer. Zhang sold DNP through the Internet by contacting potential customers through chatrooms and discussion boards that focused on weight loss, fitness and body-building [14].

Securities Fraud

In October 2003, an Italian newspaper reported that Bachynsky had been charged with aggravated volountary manslaughter based on an investigation by Italian authorities in connection with the death of four patients. The report noted that the authorities and the U.S. Federal Bureau of Investigation had been unable to locate Bachynsky [13]. However, he was eventually apprehended and charged by the U.S. Government with 40 counts of conspiracy, mail fraud, wire fraud, and securities fraud. As of April 30, 2004, he has been in the federal prison in Miami, Florida. The indictment states that in 2001 and 2002, he and three others (Richard Anders, Arthur Scheinert, and Laurence Dean) persuaded at least 50 investors to invest more than $3.5 million in Helvetica Pharmaceuticals, which supposedly would operate a cancer clinic in Switzerland. Investors who bought the stock fo $1 a share were promised that the stock would rise to $5 and $6 once the company's stock offering "went public." However, the conspirators simply spent the money on themselves [15]. The company's business plan focused on ICHT as a treatment for cancer and AIDS [16]. Anders pled guilty and received a 10-year prison sentence. Scheinert, and Dean pled guilty and received 5-year prison sentences. Bachynsky went to trial in 2008 and was convicted of one count of conspiracy, three counts of wire fraud, and one count of securities fraud. His sentencing is scheduled for September 2008.

In June 2004, the Securities and Exchange Commission filed a civil suit seeking to recover the investors' money [17]. However, the suit was stayed until the criminal proceedings were completed and will probably see no further action.

Other ICHT Marketers Convicted

In December 2004, another former former Bachynsky associate—James Naples, D.P.M., of Texarkana, Texas—pleaded guilty to conspiring to obstruct justice during an investigation of his billing practices [16]. Court documents indicate that Naples, New Boston General Hospital, which Naples co-owned and controlled, and several associates improperly billed and were paid by Medicare and private insurers for treating cancer patients with DNP. Under the plea agreement: (a) Naples agreed to pay $2 million in restitution and voluntarily exclude himself from the Medicare program for 10 years and (b) the government dropped an indictment that had charged him with racketeering, conspiracy to obstruct justice, conspiracy to commit health care fraud, health care fraud, money laundering, and false claims [18]. In April 2005, Naples was sentenced to 2 years' probation and ordered to pay the $2 million.

ICHT using another chemical has been offered in the United States by T.R. Shantha, M.D., another former Bachynsky associate who operated Integrated Chemotherapy Specialists in Stockbridge, Georgia. (The Georgia medical board Web site lists him as Totada R. Shanthaveerappa, M.D.) One of Shantha's Web sites offered a long list of dubious methods "for the treatment of cancers and other curable and incurable diseases" and has stated: "We treat all kinds of chronic, incurable diseases with success!" Another of his sites claimed that, "We are the most advanced clinic in North America using multiple modalities to restore the immune system, provide quality of life, eradication of cancer, or at the very least provide disease control." [20]. I saw nothing in his description of treatment methods that supported any of these claims. In 2004, Shantha phoned me twice to ask that I remove his name from Quackwatch, saying that he was a respectable practitioner and "not a quack." He made a variety of claims about hyperthermia that I asked him to substantiate. I replied with a series of questions that he promised to answer but never did.

In December 2005, Shantha and his medical assistant Dan U. Bartoli were charged with 87 counts of health care fraud and distributing unapproved and misbranded drugs. Shantha has also been accused of laundering money. The indictment [21] alleged:

  • Shantha and Bartoli treated cancer patients with DNP, Ukrain, and hyperbaric oxygen, none of which have any value against the conditions for which he used them.
  • The pair also defrauded health insurance companies by submitting claims that disguised what treatments they were providing at the clinic. (Some claims used a procedure code for a standard chemotherapy drug that was not administered; others used an inappropriate code for an oxygen pump.)
  • Shantha laundered more than $4 million of the proceeds through transactions designed to conceal the nature, location, source, ownership, and control of the money.

The indictment also called for forfeiture of all money and property derived from the fraud scheme, including numerous bank accounts, a car, three homes owned by Shantha, and the Stockbridge medical clinic where he and Bartoli work. Shortly after the indictment was announced, the Georgia Composite State Medical Board suspended Shantha's license [22].

In 2007, both settled their criminal case with plea bargains. Shantha pled guilty to one count of health care fraud, agreed to pay a total of $650,000 in asset forfeiture plus restitution, and was ordered to serve five years' probation followed by three years of supervised release. Bartoli pled guilty to one count of health care fraud, was held jointly liable for about $66,000 in restitution, and was sentenced to two years of supervised release. Shantha's medical license was revoked in May 2008 [23].

Acknowledgements

The analysis of the ICHT rationale was prepared with help from Thomas J. Wheeler, PhD, Associate Professor of Biochemistry and Molecular Biology, University of Louisville School of Medicine, and David Prager, MD, Professor of Clinical Medicine at M.S. Hershey Medical Center. Dr. Prager, a cancer specialist and clinical researcher, is board certified in medicine, hematology, medical oncology, and pathology (special competence in hematology).

References

  1. Cancer and heat therapy (hyperthermia). Life Extensions SA Web site, accessed Jan 29, 2003.
  2. Lymenet.org message board, Search for "Bachynsky," done Jan 29, 2003.
  3. Hecht A. Janssen W. [../../02ConsumerProtection/FDAActions/bachynsky.html Diet drug danger déja vu]. FDA Consumer 21(1):22-27, 1987.
  4. Simmons N and others. 6892 Questionable Doctors Disciplined By States or the Federal Government. Washington, DC: Public Citizen Health Research Group, June 1990.
  5. United States of America vs. Nicholas Bachynsky, 924 F.2d 561 (5th.Cir. 1991).
  6. United States of America vs. Donald Ivan , 924 F.2d 561 (5th.Cir. 1991).
  7. Bachynsky N. Lyme disease and intracellular heat. Lyme Matters, Dec 2002.
  8. [/01QuackeryRelatedTopics/Cancer/bachynsky.html Indictment of Richard A. Anders, Nicholas Bachynsky, Lawrence M. Dean, and Arthus Scheinert]. U.S. District Court, Southern Disrict of Florida. Filed May 2004.
  9. Defendant convicted of wire and securities fraud. USDOJ press release, May 6, 2008.
  10. Heat therapy. In American Cancer Society's Guide to Complementary and Alternative Cancer Methods. Atlanta: American Center Society, 2000, pp 131-132.
  11. Hyperthermia in cancer treatment. National Cancer Institute fact sheet, revised May 7, 2002.
  12. Caprette DR. Use of metabolic poisons to study mitochondria function. June 2000.
  13. Verbot der Anwendung von Dinitrophenol bleibt bis auf weiteres bestehen. Zurich: Swiss Department of the Interior, June 17, 2002.
  14. Defendant arrested in Indiana, charged with selling "DNP" toxic weight loss drug over the Internet—Baldwin, Long Island resident dies after ingesting the drug. U.S. Department of Justice press release, Sept 24, 2001.
  15. Cura anticancro, accusato di omicidio il medico texano, Oct 30, 2003.
  16. [bachynsky.html Indictment]. United States of America v. Richard A. Anders, Nicholas Bachynsky, Lawrence M. Dean, and Arthur Scheinert. U.S. District Court, Southern District of Florida, Case No. 04-020250, filed April 22, 2004.
  17. Securities and Exchange Commission v. Helvetia Pharmaceuticals, Inc., Richard A. Anders, Nicholas Bachynsky, Arthur Scheinert, and Laurence Dean. Case No. 04-60804-CIV-JORDAN (S.D. Fla., filed June 21, 2004.
  18. Podiatrist admits to conspiracy. USDOJ news release, Dec 22, 2004.
  19. McDermott LB. Naples back in hot seat. Texarkana Gazette, Sept 10, 2004.
  20. Canceralt.com home page, accessed Nov 19, 2004.
  21. Indictment. United States v. Todata R. Shanthaveerappa, M.D. (a/k/a T.R. Shantha, M.D.) and Dan U. Bartoli. Filed Dec 20, 2005.
  22. Order of summary suspension. In the matter of Totada Shanthaveerappa, M.D., Docket No. 20060063, Dec 23, 2005.
  23. Final decision. In the matter of Totada Shanthaveerappa, M.D. Docket No. 20060063, May 8, 2008.