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Hyping A Supplement for HIV

Hyping A Supplement for HIV

Picture of Peter Lipson

Dr. Lipson writes his own blog called White Coat Underground, contributes and helps edit at Science-Based Medicine, and contributes to The Science Business Blog at Forbes.com where this piece originally appeared.

When writing about the pharmaceutical industry it's easy to become jaded. This is despite the remarkable medical advances made possible by the drug companies. It seems like each report of sleazy practices is worse than the last. If it isn't unfavorable data being swept under the rug, then it's positive data being over-hyped in remarkably creative ways. So it doesn't surprise me when I get emails asking me to hype the latest new thing.

Not all of these emails are ham-handed; they don't all read like newspaper cut-out ransom notes or Nigerian scams (although many do). Some are quite sophisticated, like a note from a friendly reader, a "just thought you would be interested". The latest missive in my inbox was neither deceptive nor sophisticated. It was from a PR firm offering an "opportunity to interview an esteemed HIV/AIDS and nutrition specialist."

I'm fairly certain my readership isn't so big that I'm going to get a chance at Montagnier, Gallo, or Ho. But the letter says he is "well-known in the global AIDS/HIV community" and "a pioneer". I'm an internist, and I read a lot, but I certainly don't know all of the big players in HIV medicine, so I figured it couldn't hurt to hop onto the internet and learn a little bit more about Dr. Jon Kaiser. According to his publicist:

Dr. Kaiser is very passionate about advocating nutritional supplementation and views it integral to successful disease and general health management. He would more than like to share and engage in a discussion about the supplements and the impact of the proposed reforms to supplement laws. I've included more information on Dr. Kaiser and K-PAX and I have pasted links to a 2001 double-blind, placebo-controlled study funded by Bristol-Myers Squibb that demonstrated an increase in the number of CD4 lymphocytes in HIV-infected patients who were taking Dr. Kaiser's natural immune support formula compared to patients taking a placebo (in addition to standard HIV medications). This formula has been refined over 15 years and is now in clinical trials with the goal of receiving FDA approval. If successful, Dr. Kaiser will be one of the first nutritional suppliers to gain FDA approval for the use of a nutritional supplement as an adjunctive therapy for disease management.

Now that's interesting. The only K-PAX I'd ever heard of spawned an alien named Prot who looks just like Kevin Spacey. So what kind of results is this guy seeing in the clinic?

Though long term stability in my patients has always been the rule, I can now definitely say that the progression of HIV disease in my practice is an extremely rare event. This experience, which has encompassed the care of over 500 HIV(+) patients during the past five years, allows me to make the following statements: Not one patient who has come to me during the past six years with a CD4 count of greater than 300 cells/mm3 has progressed to below that level. Not one patient who has come to me during the past six years with a CD4 count of greater than 50 cells/mm3 has become seriously ill or died from an HIV-related illness.

Wow. That is impressive. The treatment of HIV is very complicated, and it can be difficult for even the best patient remain adherent all of the time. I treat a lot of comparatively less complex treatment problems such as hypertension, and I can't claim that level of success (nor can most of my peers). So who is this guy?

According to the State of California, he is a licensed physician specializing in internal medicine and HIV medicine. This is despite the additional fact that he is not board certified in any specialty. In fact, he's not even board eligible since he completed only one year of post-graduate training. To specialize in internal medicine requires three years post-graduate training, and to specialize in infectious diseases generally requires an additional 1-2 years of post-graduate training. It's not unheard of for older HIV specialists to not have formal infectious disease training---many of them were internists who invented the field of HIV medicine out of necessity when the epidemic first appeared. But to practice internal medicine or infectious disease with only one year of post-graduate training is very, very unusual.

That doesn't mean he's not a good doctor. According to his CV, he is good enough at what he does that his peers have allowed him to serve on a number of boards of an HIV specialist organization called the American Academy of HIV Medicine. When I tried to verify this at the AAHIVM website, I couldn't find him listed, so I wrote his publicist. Dr. Kaiser responded:

As a founding member of the American Academy of HIV Medicine, I was intimately involved in setting policy objectives for the organization in its early development phase beginning in 2000. I formed the Academy's Reimbursement Committee in 2000, and was quoted in the attached AAHIVM newsletter (see middle column, paragraph #2). I have also been certified as an HIV Specialist by the organization on two separate occasions (see attached). It appears my membership to the national organization and California chapter inadvertently lapsed when I moved offices. This has been corrected and my membership is now currently active.

I'll have to take him at his word on that; the attached certificate covers a one year period and AAHIVM's website has yet to be updated. Anyway, given his claims about his successes in the clinic, I was quite curious to check out the data behind his claims. Actually, he hasn't published data on his clinical outcomes, but he has published a brief report in theJournal of Acquired Immune Deficiency Syndromes (JAIDS). In the letter I received from the publicist, Kaiser claims that his supplement K-PAX increases CD4 counts in HIV patients. CD4 cells are the type of cell whose numbers fall so precipitously in patient with AIDS. CD4 cell deficiency is one of the most dramatic laboratory findings in HIV patients, but it is not the only abnormality. Other types of immune cells may be present in normal numbers but function poorly. And CD4 counts, while roughly correlating with the appearance of some opportunistic infections, are not the most useful measure of disease activity in HIV.

In Kaiser's study, published as a "rapid communication", he measured many parameters in addition to CD4 count. This was a very small study (40 patients) with a very brief follow up period (12 weeks). In the results section, the author notes that there were differences in the characteristics between the test and control groups, and that these differences were not statistically significant:

(1) the micronutrient group had a lower CD4 count at baseline when compared with the placebo group (CD4: 357 ± 154 cells/?L vs. 467 ± 262 cells/?L, P = 0.13), (2) the participants in the micronutrient treatment group reported a greater number of months of neuropathy symptoms preceding enrollment than those in the control group (means: 21.4 months vs. 12.2 months, P = 0.14; medians: 14.2 months vs. 2.5 months), and (3) the micronutrient treatment group contained 3 patients with diabetes mellitus compared with zero in the placebo group (P = 0.09).

It is technically correct that most of these differences were not statistically significant. But look at the results:

The mean absolute CD4 count increased significantly by an average of 65 cells in the micronutrient group versus a 6-cell decline in the placebo group at 12 weeks (P = 0.029)

CD4 counts vary quite a bit, and are an imperfect measure of disease activity and immune function. As we can see from his groups, there was a very large range of CD4 counts in each group at the start. An average change in CD4 count of 65 seems anemic at best. Kaiser is more optimistic:

This study demonstrates that a micronutrient supplement administered to HIV-infected patients taking stable HAART significantly enhances CD4 lymphocyte reconstitution. Our findings support the potential for a broad-spectrum micronutrient supplement to be used as adjuvant therapy in combination with HAART to provide patients with a more robust CD4 cell rebound after initiating antiretroviral treatment.

I find the data from this pilot study entirely unconvincing. His conclusions are hyperbolic and premature. That's not unusual, though. Researchers sometimes get a bit excited about their work, and as an inexperienced author, perhaps he can be forgiven for a little unrestrained enthusiasm.

But it gets a bit more interesting that that. In a letter to the editor, a careful reader noted something unusual. A patient showed him a brochure claiming that K-PAX could raise CD4 counts by 26%. K-PAX, it seems, is the same product used in Kaiser's study. The writer was concerned:

Most disturbingly, the first author on the paper, Jon D. Kaiser, MD, seems to be the same person mentioned in the brochure as the developer of K-Pax Vitamins.

Given the recent controversies at other medical journals about the failure of authors to disclose potential conflicts of interest, I am sure that this article would not have been published without disclosure (or at all) if the Editors had been aware of the conflicts of interest in this case.

There is a long, sordid history of conflicts of interest in published research. Some drug companies have gone so far as to print their own faux-journals containing only favorable studies. That is why most journals have strict disclosure rules for conflicts of interest. A study being sponsored by a drug manufacturer does not invalidate it, but failure to disclose this connection is unethical and problematic on many levels.

Kaiser was (correctly) allowed to respond:

After reporting the improved immune reconstitution of patients taking the micronutrients plus highly active antiretroviral therapy (HAART) to the Bristol-Myers Squibb team, I anticipated that they would show interest in pursuing the development of a therapy that had the potential to act as a safe and beneficial immune modulator.

On learning that they had no interest in pursuing the development of this compound, I chose to form a company, K-PAX, Inc., to keep the micronutrient supplement in production and make it available for sale while I worked to get the study results published.

I neglected to inform the Editors of this journal of this conflict of interest and any potential bias that existed during the paper's submission and publication process. Nor did I inform the other authors on the paper of my financial interest in the company. They received no personal compensation for their efforts.

In other words, he is the guy who makes and sells K-PAX, and he owned up to failing to disclose this profound conflict of interest. I asked Kaiser through his publicist about this. His response was less conciliatory:

This research study was performed before there ever was a company or financial interest in a product (2001-2003). The data were analyzed by an independent Data Analysis Firm selected by Bristol-Myers Squibb in 2001. The JAIDS editorial board performed a thorough evaluation after Dr. Smith raised his concerns and found no evidence that either the data analysis or study conclusions were inaccurate.

I'm unimpressed by this response. The use of one small study with an undisclosed conflict of interest and to promote a product makes me uncomfortable. I am not comforted by the claims of "independent data analysis". Conflicts of interest can affect more than just data analysis: they can poison every step of a study. But even had this study been done without any conflicts of interest, it's a small, problematic study. What's worse is in the letter sent to me, he says

Building upon his success in HIV patients, Dr. Kaiser is applying the lessons learnt in HIV to patients with cancer, Chronic Fatigue Syndrome and other chronic diseases, general health and the elderly.

HIV is a serious disease, the study of which underlies many modern advances in biology and medicine. To try to piggyback one's own interests on this foundation is unseemly at best. To then claim to apply these ideas even more broadly is deeply unsettling.

(Dr Kaiser has responded to this piece, and I have responded to him at White Coat Underground. )

Comments

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Dr. Lipson. Thanks for your research on Dr. Kaiser. I've run into a few stumbling blocks myself.

It seems non-profit ASO's over here on the East Coast (NYC) readily open their doors to his pandering with their vulnerable client populations.

In addition he has come out with a "new" professional strength formulation of K-Pax who's raises my concern on safety at the supplementation levels he recommends. The cost is about 92% higher at my pharmacy $125 vs. $65 (for the regular formulation).

His formulation is covered by the NYState ADAP program - so it's free if you are on ADAP (have HIV and make under $44,000/year and are not Medicaid eligible.

I'm beginning to get the feeling that this guy is a classic snake charmer and that HIV infected people who can afford his product from out of their own pockets are waisting their money. In addition our State and Federal funded ADAP programs are being overly charged for this expensive supplement. Somehow he has convinced them to pay the full cost of his product.

Since his company is private - I cannot find any financial details. But in a recent lecture I attended personally he stated that his company has not made a profit since it started. So maybe he is a snake charmer with a genuine heart. But I do like the idea of pharmaceutical companies not making a profit - novel idea huh?

I am a HIV + individual with a background in research - so again I like to be informed. Your posting led me to do more research on my own. So thank you!

Michael K

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I worked in Jon kaiser's office in the 90's. I can tell you 100% that the reason Jon Kaiser claim to have never lost a patient is because he instructed his office manager to remove the dead patient's file after the patient passed away. Furthermore in his book, Healing HIV he completed cooked up the studies that he claim are based on research. It makes me sick to see a doctor sell hope in the form of expensive vitamins to a group of patients suffering from HIV/AIDS. I wish the activist HIV community would uncover this opportunist for the money making scams that he cooks up for sick people trying to manage their disease.

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A couple of years ago I attened one of Dr. Kaiser's health seminars. The data he presented was impressive so I began using K-Pax, paying a hefty sum in the process. I recently attended another seminar by Dr. Kaiser and was stunned to discover that he was using the same study he used years prior as "proof" that his vitamins were instrumental in increasing CD4 counts. When an individual asked about the cost of his product there were many in attendance that said they could not afford his supplements to which he replied that they could take half of the dosage and cut their costs. Hmmm...doesn't half the dosage equal half of the benefits? I almost left the seminar at this point but then Dr. Kaiser started talking about a new energy product that he recently developed. As it turns out, his energy product contains nearly the same formuation as the K-PAX vitimins. You may want to think twice about using anything this man sells.

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I have been IV+ for 28 years...my T-Cells were about 225, and dropped to a low of ~160. I moved to Santa Rosa and continued my care under Kaiser Permanente with Dr. Green, the Infectious Disease specialist.

He mentioned that he had seen some positive results and that I might consider taking it. I did so. After 3 months, my blood tests came back with ~350; I assumed it was a fluke. At 6 months, the results came back at ~700 and I was surprised.

I've been on K-Pax for about 10 years and have remained at 700+. I am not a medical professional, but simply have the impression that a higher level of T-Cells is a "good thing".

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I wonder when this article will fade into oblivion. We saw this bullshit article years ago before we invested in helping Dr. Kaiser further his work. Dr. Jon Kaiser knows more about the immune system and treating people with HIV and other immune disorders like CFS than Dr. Lipson will ever know. Seems to me that Dr. Lipson's article was based more on the fact that he thought Dr. Kaiser was a little braggadocios and set out to use his great USC medical school training to show everyone how smart he is. Dr. Kaiser did enter the medical profession at a point in time when the AIDS epidemic was exploding. He focused on researching and developing ways to strengthen his patient's immune systems, a passion that he still pursues today. As Dr. Kaiser pointed out to Dr. Lipson, there was no K-PAX at the time the study discussed was done. In fact, there were no plans for a K-PAX when the study was done. After Bristol Meyers Squibb decided to pass on getting the formula to market, Dr. Kaiser took on the challenge of forming K-PAX and marketing the product. I know Dr. Kaiser's HIV patients who are alive today largely based on his good care and professionalism appreciate all that he has done as do all of the CFS patients he has helped over the years.

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Thanks for your very professional article.

However, I think you should know what patient of his knows from first hand experience. My name is Robert Argento. I have a BS in Physics and an MA in Theology and I worked in Silicon Valley for about 15 years for companies like Oracle, Microsoft and Xerox -- as a technical writer and manager. I can testify that when I first began seeing Dr. Kaiser for chronic fatigue in about 1987, I could barely keep a job. His treatments, though very controversial, were effective enough to keep my in very good and strong health until I relocated in 2004. Under his care I was keeping pace with hot shot Asian engineers who were 22 or 23 years old. Me? I was 50 and dating women half my age who could not believe was over 35. And I continued to keep up with them all until I had turned 54 (when I relocated). Side effects? Nothing more troubling than any other treatments available.

Does that take away anything from your research? Of course not. I'm merely telling you my personal testimony, for what it's worth.

Best to you,
Robert Argento

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