Stem cell treatment warning

A company operating out of South Africa is charging tens of thousands of pounds for stem cell treatments, using cells that should not be injected into people, putting the lives of their vulnerable and chronically ill patients at risk, BBC TWO's Newsnight programme has uncovered.

The company, called Advanced Cell Therapeutics (ACT), has been buying cord blood stem cells from California, storing them in the UK as a staging post, then shipping them to clinics in Europe and Africa where doctors inject them into their patients.

ACT claims the cells have a beneficial effect for a host of diseases and conditions from spinal cord injury, lung cancer, deafness and HIV/AIDS. But the majority of their patients come from the UK, seeking help for multiple sclerosis.

Biomark

Newsnight has spoken to former ACT employees, and established that the two individuals behind the company, Stephen Van Rooyen and Laura Brown, are the same people being pursued by the FBI for an alleged fraudulent stem cell business in the United States, run via a company called Biomark. The pair are living in South Africa, operating under various aliases, and face an extradition hearing by US authorities on 5 September, 2006.

At a clinic in Rotterdam, run by a doctor called Robert Trossel, who administers stem cells on behalf of ACT, Newsnight filmed a vial of cord blood stem cells about to be injected into a two-year old boy. His mother had travelled from Australia under the impression that the treatment might ease the severe after-effects of a meningitis infection in her son, Ethan Regan. The vial was labelled AllCells - a company based in California.

Legal action

The general manager of AllCells, Jay Tong, told Newsnight he was shocked that his cells were being injected into people. He made clear, as does the company's website, that the cells are intended only for research purposes. They are not guaranteed free from bacterial and viral contamination to the standard that would allow them to be used even in animal models, let alone people. He asked "has anyone died?"

When we put our findings to Dr Trossel, he said: "When confronted with the evidence yesterday, ACT admitted incorrect product delivery on this occasion. We are taking legal action against them and have cancelled all ACT patients until further notice."

Potential health risks

In Cape Town, Newsnight interviewed two former ACT employees, and spoke to Dr Catherine Orridge, who was the medical director of ACT until she became suspicious of the source of the stem cells and found out for herself where they were coming from.

Like Newsnight, she saw the AllCells name on a vial, contacted the company and was devastated to discover that the cells should be used for research purposes only. She is anxious about potential health risks to patients posed by the cells because they contain animal protein. Patients are not told this, so are put at risk of an allergic reaction - including anaphylactic shock, which can be fatal, she says.

Stem cell scientists see enormous potential benefit for medicine from stem cells in the future. But they say it is simply a false hope to use cord blood stem cells in the vast majority of the range of conditions ACT claims.

Professor Colin Blakemore, chief executive of the Medical Research Council told Newsnight:

"I'm shocked. I am taking what you tell me as true, and my first concern is for the patients, very vulnerable, obviously desperate for treatments and that desperation is being exploited by charlatans it seems to me."

UK role

Newsnight has also uncovered that the UK has been performing a vital role in ACT's business. A company called CryoStore was holding the frozen stem cells in its Greenwich warehouse.

CryoStore's manager, Malcolm Wilkinson, said in a statement:

"We were advised by ACT that the material was for research purposes. We were not aware of what form this research took."

He said he was seeking advice from the UK's Human Tissue Authority (HTA). When we informed him of the FBI's interest in the individuals behind ACT (known to him as Biomark) he told us he had severed his links with them. He sent ACT's stem cells to another storage facility in the UK and informed the HTA. When we told him our findings he confirmed that that all the material he had held for ACT was from AllCells…

The stem cells are now being stored at Thermo Electron Biorepository Services in Hertfordshire, who say they will probably not continue to store them. They are waiting for written confirmation of what the company in South Africa they've been dealing with, BioCell, has told them verbally - namely that the material is for research purposes only.

"We wouldn't want to condone any unethical treatment," head of operations Robert Jones told us. "Injecting into people would be a clinical purpose, not research."

The HTA said it's done everything it can within the limits of current legislation to advise them about the wisdom of storing cells if they know they are intended for use in people when they are not fit for that purpose.

Consent form

Newsnight has spoken to Stephen Van Rooyen, who has so far declined our offer of an interview on camera and has not confirmed or denied that ACT's stem cells come from AllCells.

He has pointed out that ACT's patients sign a consent form in which they are told about the risk of an allergic reaction. But that form does not mention animal protein.

When we asked him if his cells come from AllCells, Mr Van Rooyen said:

"I'm sure you understand where I'm coming from here. This is a highly sensitive business, the number of companies around the world that have the technology to produce this kind of cell is very limited and by us going out on the BBC and explaining where our source is is equivalent to commercial suicide. Every single company, individual, doctor, would then be able to go directly to the source."

"In terms of patients having an issue with the safety of the cells and their origin. The most important thing there is that the cells are supported with a certificate of analysis provided to the doctors. The doctors review that. We have a five year track record with not a single negative side effect and the vast majority of people having benefited. That surely matters more than anything. We're not talking about people with minor conditions. We're talking about people who have been sent home to die."

Newsnight contacted Ethan Regan's mother, Sybil, and told her about the origin of the stem cells used in her son's £13,000 injection. She said she was:

"Really disappointed, deceived, duped. What can I say? There are a lot of colourful words I can use but I am not going to. I am really disappointed if the allegations I have heard are true, then it's not fair… the financial perspective doesn't concern me but from a health point of view for Ethan it really does."

Susan Watts' report was shown on Newsnight on Tuesday, 29 August, 2006.

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Cephalosporin chemical reactivity

Conclusion

The inherent chemical reactivity of cephalosporins implies that the opening of the β-lactam ring by nucleophilic reagents generates an intermediate cephalosporoyl which is chemically unstable and that suffers multiple fragmentation reactions. Despite the structural similarities with penicillins, those cephalosporins that have a good R2 leaving group undergo the process of expulsion when they conjugate to carrier proteins by opening of the β-lactam ring. For these cephalosporins the unstable dihydrothiazine moiety is enough to undergo further degradation processes. As a result, conjugation of cephalosporins by the β-lactam ring leads to loss of the R2 side chain and to fractionation of the dihydrothiazine ring and this does not form part of the epitope presented in the hapten-carrier conjugate. Only the R1 side chain and a fragment of the β-lactam ring remain bound to the carrier protein, constituting the epitope resulting from these conjugates. The presence of an R2 side chain that may act as a good leaving group is closely related to enhanced reactivity of the β-lactam ring for nucleophilic attack. The effect of the R2 side chain on the conjugation of the carrier protein can be interpreted only from a kinetic perspective, such that an increase in the capacity of the R2 as a leaving group results in increased reactivity for the attack of nucleophiles to the β-lactam ring, increasing the facility and kinetics of the conjugation process.  Printer- Friendly Email ThisAcknowledgements

We thank Ian Johnston for the English version of the manuscript.Funding Information

Supported by grants from Ministerio de Sanidad (FIS PI02/0666, PI03/1165), Ministerio de Educacion y Ciencia (BQU 2001/3624) and Plan Andaluz de Investigacion Junda de AndaluciaAbbreviation Notes

RAST = radioallergosorbent test.Reprint Address

Correspondence to Ezequiel Perez-Inestrosa, Organic Chemistry, University of Malaga, 29071 Malaga, Spain E-mail: inestrosa@uma.es

Curr Opin Allergy Clin Immunol.  2005;5(4):323-330.  ©2005 Lippincott Williams & Wilkins
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Probiotics in Controlling Gastric Colonization by H pylori?

Anti-inflammatory Properties of Probiotic Strains

As described previously, L. acidophilus LB and L. johnsonii La1 decrease gastric inflammation in colonized animals.[30,32] This was also observed with other probiotic strains: L. salivarius WB1004 (108 CFU/mL) was able to displace H. pylori adhering to the MKN45 cell line and to exert an anti-inflammatory effect by decreasing dose dependently the release by these cells of IL-8.[33] Therefore, this same probiotic strain was used to evaluate its preventive effect in gnotobiotic BALB/c mice mono-colonized by H. pylori. Administration of L. salivarius prevented H. pylori colonization and the development of gastritis; this effect was specific of this probiotic as it was not observed with other micro-organisms such as E. faecalis and S. aureus. Administration of L. salivarius after infection eradicated H. pylori and reversed gastric inflammation. Similar observations were reported with L. rhamnosus R0011 and L. acidophilus R0052[34] and with L. gasseri OLL2716.[35] Furthermore, the intake of yogurt containing this latter strain protected rats in a dose-dependent manner against acute gastric lesions induced by oral administration of HCl, compared with the administration of non-fermented milk.[36] The size of the gastric lesions was decreased by yogurt and this was associated with significantly increased levels of PGE2 in the gastric mucosa. Such protective activity was inhibited when indomethacin was injected, confirming the importance of prostaglandins in this effect.

Increased levels of 6-ketoprostaglandin F1-α, EGF and bFGF have also been implicated in the protective effect displayed by strains of B. breve and B. bifidum against gastric ulceration induced by acetic acid or ethanol in rats.[37] Interestingly, the oral administration of the polysaccharide fractions of these micro-organisms exerted a similar anti-ulcer effect. The intensity of this activity correlated with the rhamnose content of the polysaccharides, those with more than 60% of rhamnose being the most effective in inducing healing of the gastric mucosa.  Printer- Friendly Email This

Aliment Pharmacol Ther.  2006;23(8):1077-1086.  ©2006 Blackwell Publishing
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Doctor Visits Up Among Persons Aged 45 and Older

Patients aged 45 years and older are visiting the doctor's office more often than persons in that age group did 10 years ago. In 2001, persons aged 45 years and older accounted for 53.1% of all physician visits.

These findings are from the National Ambulatory Medical Care Survey (NAMCS), which was conducted by the CDC. The survey looks at medical care provided in physicians' offices.

The CDC reports that "seniors and older baby boomers are visiting the doctor more often to manage multiple chronic conditions, obtain newly available drugs, and seek preventive care."

The number of persons aged 45 years and older increased by 11% during the last decade, but the percentage of physician visits by this age group over this same period increased by 26%. The total number of physician visits per person per year for persons aged 45 years and older increased 17%, from 4 in 1992 to 4.7 in 2001.

During 2001, an estimated 880.5 million visits were made to physicians' offices in the United States, an average of 3.1 visits per person. Although the US population has increased 12% since 1992, the number of visits to physicians' offices increased 16%, from 762 million annual visits. Females had a higher visit rate than males, and whites had a higher rate of visits (3.4 visits per person) than blacks (1.9 visits).

More medications are being prescribed as well, according to the report. In 2001, 1.3 billion drugs were prescribed or ordered by physicians for their patients, compared with 922.6 million in 1992.

Between 1992 and 2001, physician visits on average became more complex, with patient age increasing, more diagnoses rendered per visit, and more patients having multiple medications to manage (Cover Figure). One reason for the increase in complexity is that the mean patient age increased from 40 years to 44.6 years.

About half of all visits were to the patient's primary care physician. More than one third of office visits were for chronic conditions, 35.3% were for acute conditions, 16.8% for preventive care, 11.2% for injuries, and 5.6% for pre- and postsurgical consultations. The percentage of visits by new patients decreased by 20% from 1992 to 2001.

Diagnostic and screening services were ordered or provided at 82.8% of visits, and therapeutic and preventive services were ordered or prescribed at 41.4% of visits.

A total of 1.3 billion drugs were prescribed or provided at 61.9% of office visits. Although the percentage of office visits with any drug mention remained fairly constant (63.8% in 1992 and 61.9% in 2001), the average number of drug mentions increased from 1.21 mentions per visit in 1992 to 1.43 in 2001, up 22%. On average, 2.4 medications were ordered or provided at each office visit with any mention of a medication. As the number of past visits to the physician increased, so did the average drug-mention rate. The percentage of visits with at least 1 drug mention ranged from 80.6% for psychiatrists to 21.6% for general surgeons.

In 2001, 89.2% of physician office visits had a duration of 6 to 30 minutes. Overall, the mean time spent with a physician was 18.6 minutes. Time spent in face-to-face contact between the physician and the patient was estimated and recorded by the physician.

The 20 most frequently reported primary diagnoses for 2001 accounted for 41.7% of all physician office visits. Essential hypertension, ar throp athies and related disorders, acute upper respiratory tract infections (excluding pharyngitis), and diabetes mellitus were the leading illness-related primary diagnoses.

The top 5 therapeutic classes for drugs mentioned during visits were cardiovascular-renal drugs (14.7% of mentions), pain relievers (12.1%), respiratory tract drugs, hormones, and CNS drugs. Increases were seen in the use of CNS agents, metabolic and/or nutrient agents, and hormones. The increase in metabolic drugs is directly related to the increase in the use of lipid-lowering drugs.

In 1992, the 5 drugs prescribed most often were amoxicillin, Amoxil, Lasix, Ceclor, and Zantac. In 2001, the top 5 drugs were Lipitor, Celebrex, Vioxx, Claritin, and Lasix (Table). Changes also occurred in the types of services provided by physicians. There were more diagnostic services, counseling services, and surgical procedures ordered or provided in 2001 than in 1992.

Half of office-based physicians were in primary care, 22.1% were in surgical specialties, and 2.6% were in medical specialties. Approximately one third of office-based physicians were in solo practice, 40.8% were in a single-specialty group practice, and 25.9% were in a multispeciality group practice. During a typical week, physicians in office-based practices averaged 80 office visits, 16 telephone consults, 13 hospital visits, 0.9 house calls, and 0.5 e-mail consultations. Approximately 10% of physicians reported not having any managed care contracts, while 35.1% reported having more than 10 contracts.

Private insurance was the primary expected payment source (58% of visits). Government agencies (Medicare and Medicaid and/or state Children's Health Insurance Program) were the payment source for 29% of office visits, with Medicare accounting for 21.8%.

From 1997 through 2001, the percentage of visits by patients with private insurance increased from 53.1% to 58.8%. This was offset by a decline in percentage of visits by patients who self-paid, which dropped to 4% in 2001 from 7.7% in 1992. The percentage of visits paid by Medicare and Medicaid remained fairly constant between 1997 and 2001.

The 2001 NAMCS survey also found that 18.2% of office-based physicians had electronic patient medical records.

Data for the Cover Figure and in "Trend of the Month" are from the National Ambulatory Medical Care Survey: 2001 Summary. Additional information about physician office visits is available from the NCHS Ambulatory Health Care Web site: www.cdc.gov/nchs.

Drug Benefit Trends 15(9):6-7, 2003. © 2003 Cliggott Publishing, Division of SCP Communications
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Results of post-treatment external body part swabs were available from 159 patients.

Amoxicillin was prescribed to 42 patients, amoxicillin/clavulanic acid to 56, cefaclor to 35, and clarithromycin to 44.
The clinical cure rates were 79.5% (35 of 44) in the clarithromycin unit, 92% (39 of 42) in the amoxicillin mathematical building block (p = 0.14 for compare with clarithromycin), 100% (56 of 56) in the amoxicillin/clavulanic acid mathematical radical (p = 0.0003 for investigation with clarithromycin), and 97.1% (34 of 35) in the cefaclor assemblage computer memory unit (p = 0.03 for comparability with clarithromycin).
Bacterial eradication assertion rates were 77.2% (34 of 44) with clarithromycin, 88.8% (32 of 36) with amoxicillin conception entity (p = 0.28 for duplication with clarithromycin), 95.8% (46 of 48) with amoxicillin/clavulanic acid (p = 0.03 for likeness with clarithromycin), and 90.3% (28 of 31) with cefaclor (p = 0.24 for similarity with clarithromycin).
All 180 strains were susceptible to penicillin (MIC90 <0.06
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150 patients were treated with ceftibuten.

Indicant was the most frequently reported adverse outcome in both the ceftibuten (3%) and cefaclor (3%) groups.
For the act of adults with AECB, Bensch and associates compared the efficacy of ceftibuten with that of ciprofloxacin.
A total of 150 patients were treated with ceftibuten, 400 mg/d, and 153 patients received ciprofloxacin, 500 mg bid.
Microbiologic eradication was reported in 90% and 91% of patients in the ceftibuten and ciprofloxacin groups, respectively.
Work-clothing clinical succeeder occurred in 79% of the ceftibuten-treated unit and 84% of the ciprofloxacin-treated edifice cube.
The most common adverse events reported in the ceftibuten and ciprofloxacin groups were faultiness (4% in both groups), diarrhea (4% in both groups), and head ache (5% and 3%, respectively).
A randomized, single-blind alikeness of ceftibuten (400 mg/d) with clarithromycin (500 mg bid) in the proceeding of AECB in adults demonstrated clinical achiever rates of 84% and 87%, respectively.
The two agents had similar microbial eradication rates for H influenzae, M catarrhalis, S pneumoniae, and Haemophilus parainfluenzae.
The most common adverse conclusion reported by patients in both position groups was vexation.
Practitioners must evaluate these comparisons while realizing that there are wide geographic differences in condition to antimicrobial agents among gram-negative organisms as well as in the magnitude relation of PR-SP.
However, way group regarding LRTI in adults indicates that clinicians can have at least as much certainty in once-daily ceftibuten as in thrice-daily cefaclor, twice-daily ciprofloxacin, clarithromycin, or cefuroxime.
UTIs
TMP-SMX is usually one of the first-line agents prescribed for uncomplicated UTIs.
However, drive to this compounding has led to increased search in alternative therapy choices.
Ceftibuten is a reasonable soul because of its inhibitory body cognition against many organisms that lawsuit UTIs, including E coli (Table II).
In an open, noncomparative organic process, Mug and associates treated 68 women with uncomplicated UTIs with ceftibuten, 400 mg/d for 7 days.
Reevaluation of these children 5 to 9 days after cessation of therapy revealed successful clinical conclusion in 98% of ceftibuten-treated patients and in 96% of TMP-SMX-treated patients.
Only 2 ceftibuten recipients reported adverse effects, 1 with mild gastroenteritis and 1 with mild erythematous rash.
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A Real-World Retrospective Analysis Of Antibiotic Switch Rates in 630,000 Patients

Although several prospective studies have reported varying clinical outcomes among the cephalosporins, no retrospective studies have focused on physician prescribing patterns or nonaccomplishment rates in large populations.
This retrospective literary unfavorable judgment used a national penalisation claims database from a third-party payer accruement who received initial antibiotic therapy with a second- or third-generation cephalosporin to determine whether cephalosporins differ with bodily property to coverall outcomes, as measured by antibiotic railway line rails and medicine rates.
Ethical drug drug and electric control rates were calculated for all patients over a 21-day stop move initial achromatic color and Edward Douglas White Jr..
Among the cephalosporins, the second-generation player role cefaclor (including Ceclor and Ceclor CD) was associated with the lowest rate of conglomeration line trail events to other antibiotics (13.8%) (Pcefaclor have come under increasing look.
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H pylori Eradication With Sequential Therapy in Elderly Patients. Part 2

It is well-known that the life-expectation is battle worldwide, and
that the assets of family line aged more than 65 year is noticeably
increased in the last five decades, particularly in developed
countries. Aging is claimed to amount the risk for several
gastroduodenal disorders, such as gastric symptom with intestinal
metaplasia, peptic ulcer disease, ulcer bleeding and gastric Cancer.
Interestingly, the number of Helicobacter pylori unhealthiness
in developed countries has been definitely reported to be higher in the
elderly than in cohort patients, a ‘cohort effect’ beingness invoked as
a likely thought process. Helicobacter pylori incident
habitually causes chronic active voice gastritis, which significantly
enhances the risk for intestinal metaplasia in the appetite, and it is
undoubtedly involved in gastric carcinogenesis. Moreover, this
unhealthiness is the main pathogenetic gene of gastric and duodenal
ulcer, including peptic ulcer complications, such as bleeding or amoxicillin. Furthermore, an intricate - and only partially unravelled -
kinship between H. pylori and non-steroidal anti-inflammatory
drugs (NSAIDs) use in gastroduodenal pathology onrush has been reported
in elderly. Therefore, this contagion should be considered as a
clinically relevant progeny in geriatric patients. Scorn all these
considerations, only scanty data are currently available on H. pylori aid in aged citizenry.
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