Monday 5 October 2009

26 ...for the Pharmacists

June 15: The medicinal claims made for Scientology’s Purification Rundown – and the high doses of vitamins used – amount to the illegal practice of pharmacy, said the lawyer representing France's Order of Pharmacists.

After several days in which attendance had dropped off during the Paris trial of six Scientologists and two of the movement’s organisations, the chamber was packed at the opening of the fourth and final week.

This was when each of the lawyers would make their final speeches. They had had five days since the last sitting to marshal the evidence of the preceding weeks and hone their arguments, the better to convince the three judges.

The two lawyers for the plaintiffs were due to go first, followed by the prosecution. And in the days that followed, the court was due to hear from the lawyers for the defence who, as always, had the right to the last word.

Maître Olivier Saumon, the lawyer for the National Council for the Order of Pharmacists (CNOP), was the first to set out his case.

France’s professional organisation for pharmacists had an interest in the affair because of Scientology’s Purification Rundown, the programme of exercise, sauna sessions and – most controversially in this case – high doses of vitamins and minerals.

Four of the defendants faced charges related to this aspect of the Rundown: Aline Fabre, who supervised the Rundown at the Paris Celebrity Centre, was charged with the illegal exercise of pharmacy.

So was Marie-Anne Pasturel, who had acted as an intermediary for the sale of the vitamins to Scientologists in France by a British based company run by Scientologists.

Both Alain Rosenberg, executive director of the Celebrity Centre at the time, and Sabine Jacquart, the centre’s president, were charged with complicity in the illegal practice of pharmacy.

Neither of the two Scientology organisations on trial – the Celebrity Centre and SEL, the Scientology bookshop – was charged in connection with the illegal practice of pharmacy.

Saumon started by recalling the account that the plaintiff Aude-Claire Malton had given to investigators.

She had described how eight people had been packed into a sauna, where the temperature had been 65 degrees. The exercise element of the programme had consisted of running in a square near the centre.

But they had also had to take vitamins – and large amounts of them – which she had bought by mail order from G&G.

Aline Fabre had supplied her with a contact name and a number for G&G in France: that was Marie-Anne Pasturel. She had sent off a cheque for 990 francs (150 euros) and received two boxes of vitamins in return.

According to what Malton had told investigators, said Saumon, it had been Fabre who decided how many vitamins participants took during the Rundown people – though Fabre, in her court testimony, had denied this.

Each person had to write down how they felt in a file, said Malton. And after they had finished running, they would take the vitamins and spend four to five hours in the sauna. And the doses were increased every day.

The programme normally lasted between 15 and 30 days, Malton had told investigators: but in her case, it had finished after 13 days.

In all, she was taking vitamins from seven or eight different sachets, as well as a diluted vinegar-calcium-magnesium solution known as Cal-Mag (see note five to Section 17); and spoonfuls of oil, all of which was meant to help eliminate the toxins.

So for the first few days, she was taking at least 10 different pills, Malton told investigators: “The last days, I must have taken 20 to 25 pills.”

But when, towards the end of the programme, she started getting stomach cramps, she was allowed take some of them at home to space out the doses.

The former plaintiff Eric Aubry had also told investigators he had he sent off for the vitamins by mail after having received the details from Fabre.

Fabre had served the pills to participants along with a serving of yoghurt, Aubry had said: and like Malton, he recalled having taken a considerable number of pills on a daily basis.

His experience of the Rundown had included hallucinations and aggressive mood swings, Saumon reminded the court.

Doses well above normal levels

But what exactly had they been taking? Malton had handed over what remained of her products to investigators: they included Vitamins A, B, C, D and E and the Cal-Mag solution. She had also been taking Vitamin B3 (niacin), but had thrown that away.

Professor Gilbert Pepin, a biologist with a doctorate in pharmacy and an appointed expert to the Paris courts, was commissioned to examine the products and their packaging.

He had concluded that the vitamins were being marketed as medicines rather than just food supplements, which suggested there was a prima facie case of illegal practice of pharmacy.

A second report, by Dr Véronique Brion, a specialist in clinical pharmacology, had told investigators that the quantities of vitamins Malton had been taking were far in excess of the normally recommended doses.

This discrepancy was particularly striking in the case of Vitamin A, Brion had reported. At doses higher than 150,000 IU (international units), vitamin A was classified as a toxic substance: Malton’s dose had been 750,000 IU.

This was perhaps the first time in a case of illegal exercise of pharmacy that one of the products in question was on the list of toxic substances, said Saumon.

The third element Saumon quoted from the investigators’ files was a letter from France’s health products watchdog, the AFSSAPS.[1]

Their view was that several of the vitamins sold to Malton, namely the 250-milligramme tablets of Vitamin B1; the 500-milligramme tablets of Vitamin C – and particularly the 5,000-IU tablets of Vitamin A – contained doses of vitamins and minerals well above the recommended daily doses.

Doses at this level were equivalent to those for special pharmaceutical use, which had to be authorised before being put on the market.

Here again then, the suggestion was that given the high doses of vitamins involved, the Purification Rundown strayed into territory reserved for registered pharmacists.

The CNOP was a plaintiff in this case because it took the same view: it believed that the Scientologists had encroached on their professional domain, said Saumon. And as he developed his argument, he quoted a string of French court decisions and European legislation to support his points.

There were those who argued that pharmacists were unfairly trying to protect their monopoly in this domain, he said: but it was worth remembering just what their role was.

Pharmacists sold anything that could be classified as a medicine designed for use by humans: and it was their role and responsibility to ensure that the products they sold met the strict standards required in this field.

“These products are produced in pharmaceutical labs to certain standards – and it is these standards that are covered by the offence of the illegal exercise of pharmacy,” said Saumon.

There was no question that the vitamins sold for the Rundown were being taken in such quantity that they could no longer be classified as food supplements but as medicines – and thus fell into the pharmacists’ domain, he argued.

“It is not that they should be sold in a pharmacy, but when they become a medicine then they should be produced in a pharmaceutical laboratory to be sold as such,” he said.

“They must respect good practices – in particular, ensuring that each ingredient has been properly monitored so that it can be traced [back to its producer].” And products of this kind also had to be cleared before their release on to the market, a process that took two years, he added.

“Many businesses have wanted to get around this by calling it a food supplement,” he continued: but the laws were in place to ensure that this did not happen.

Products were used as medicines

Saumon recalled the comments of one of the experts called to testify on the package of vitamins required for the Rundown.

After a series of cautious answers to the questions put to him by Judge Sophie-Hélène Château, Stéphane Lange, a senior inspector at the AFSSAPS (the health products watchdog) and a court-appointed expert had finally cut to the chase.

“Do you want a direct answer? This seems to me to be quackery,” he told the judge.

Those were strong words from Lange, said Saumon. But he added: “We are talking total quackery here – but only if these products are incontestably pharmaceutical products.”

And it was worth noting that the doses involved in the Purification Rundown were even higher than those proposed by the manufacturers of the vitamins themselves, he added. So these were pharmaceutical products and not food supplements.

The legal definition of a medicine was based on its presentation and its function, said Saumon. A product was a medicine by presentation if it was packaged and presented as a medicine; it was a medicine by function if it was used to restore, correct or change a person’s physiological condition.

Moreover, said Saumon, the jurisprudence in this field said that if there was any doubt in the matter, then the court should rule that the product in question was a medicine.

So far as presentation was concerned, G&G’s packaging of the vitamins left no room for doubt, he argued.

(Earlier in the trial, Judge Château, referring to the case files, had noted that some of the advertising for G&G said that their products could cure illness, that they constituted an “effective treatment”.)

Regarding function, he said, the definition had changed over time, and he went into some detail on the changes in the legal definitions and the relevant jurisprudence.

Any suggestion however that these changes worked in the defendants’ favour was difficult to sustain, he argued. “From the moment you have an active agent you have a medicine by function.”

And if this was the case, it trumped any defence that these vitamins were simply food supplements, said Saumon. “If something is found to be a medicine by presentation or function – or both – then there is no need to look at whether the product fits the definition of a food supplement.”

The court had heard a number of witnesses – and at least one expert for the defence – describe the Purification Rundown as something altogether more harmless. “For some, the Purification Rundown is nothing more than a stage in the religious process of Scientology,” said Saumon.

Yet Scientology’s own witness, Dr David Root had defended the Rundown on medical grounds. “For him, there was no doubt as to whether the cure could restore people physically,” he said.

Saumon had asked Dr. Root how many of the 4,000 people he had treated on the programme.

“I don’t claim to cure any one of them,” Dr. Root had replied. “What I did was to improve their conditions. But I would say that 98 to 99 percent had significantly improvement in their conditions when they came to see me.”

And Dr. Root ran the Purification Rundown as a medical programme for the treatment of work-related illnesses, Saumon reminded the court. “Quite clearly then, we are not talking about food supplements here: we are in the medical domain.”

Saumon noted in passing campaigners such as Dr Robert Verkerk, founder of the UK-based pressure group the Alliance for Natural Health, and a prominent opponent of greater regulation in this area.

The ANH is campaigning against moves the European Union to regulate the natural health industry, setting dosage limits for vitamins and minerals to limit.[2]

It was clear too, that some European countries, such as the Netherlands, took a more laissez-faire approach to the therapeutic use of vitamins, he added.

(He was aware of course that Judge Château had earlier reproached the defendant Pasturel when she argued that the sale of such vitamins was legal in the Netherlands. “But we are in France,” the judge had replied. “In the Netherlands, you can buy hashish in the coffee shops. You should bear that in mind.”)

But Hubbard had created the Rundown himself, said Saumon: so what had he intended it for?

“He explains that this procedure is for people who have taken drug overdoses, and for people who are suffering from sunburn and that this would get rid of it,” he said.[3]

Clearly then, Hubbard was offering this as a therapeutic treatment, which brought it into the medical category.

“There was a culpable blindness”

If one considered the vitamins and minerals that Malton had used, the way the products had been packaged and the doses involved, one could only draw one conclusion, said Saumon: “There is not a single product that can escape [the charge of] the illegal practice of pharmacy.”

The doses set out by Hubbard were routinely higher than those recommended by medically qualified professionals.

For example, the maximum recommended daily dose of niacin, or Vitamin B3, was 54 mg, Saumon noted: yet Hubbard had recommended taking between 100 and 5,000 mg of niacin per day during the Rundown.

And as for the dangerous side-effects described by the court-appointed experts, Scientologists simply interpreted them as evidence that the process was working, said Saumon.

“Sometimes the symptoms created – in particular by niacin – are seen as being beneficial rather than considered as being one of the dangerous effects of niacin,” he added.[4]

So for example, Fabre had described seeing signs of toxins coming out of the body, when the marks of somebody’s swimming costume had appeared on their body during the sweating process in the sauna. (She had also claimed that the process could eliminate radiation from the body.)

Yet Dr Véronique Brion, during her court testimony, had said that the symptoms that Malton had reported during her time on the programme– stomach cramps, a skin rash and sleeping difficulties leading to constant fatigue – could be explained by the high doses of vitamins she had taken.

The defendant Fabre had told the court that all she did was make sure participants followed the doses set out by Scientology founder L. Ron Hubbard in his book, Clear Body, Clear Mind.

But the testimony of Malton and Aubry suggested she had taken a more active part, said Saumon. Malton in particular recalled that Fabre had brought her the pre-prepared doses each day she did the programme.

The defendant Marie-Anne Pasturel, had said in her defence that she had just acted as an intermediary, said Saumon.

But she was a former employee of G&G, a Scientologist who knew Hubbard’s works perfectly well, said Saumon. “She knew exactly what she was doing.”

Fabre could not be said to have taken any personal profit from running the Purification Rundown at the Paris Celebrity, said Saumon – but Pasturel was earning a commission on the vitamins she sold. “It was her phone number on the order forms for G&G,” he said.

(During her testimony, Saumon had asked her if she had checked about the legal situation in France. She had put a few questions, said Pasturel: “For me, it was just a favour I was doing for friends.”)

As for the defendants Sabine Jacquart and Alain Rosenberg, as the senior officers at the Celebrity Centre at that time, they had to assume responsibility for what had happened on their watch, Saumon added.

Hubbard himself, by insisting that potential participants on the Rundown should undergo a proper examination by a doctor, was effectively acknowledging that this was a far from insignificant procedure, said Saumon.

He called for damages of 40,000 euros to be awarded to his client, the CNOP, and for costs of 15,000 euros, to be paid by the four defendants between them.

None of the defendants had any qualifications in pharmacy, he said. And they were involved in the importation of products that had not been authorised for the French market.

“Even the Scientologists said they did not think to consult the law on this question,” said Saumon. “There was a culpable blindness.”

[1]AFSSAPS: l'Agence française de sécurité sanitaire des produits de santé (the French Agency for the Safety of Health Products).
[2] See the ANH campaign briefing here. Whatever the merits of the ANH position, it is not hard to see why Scientology would back their resistance to further regulation of the use of vitamins, minerals and food supplements: the current trial is a case in point.
In April 2008, Dr. Verkerk was honoured for his campaigning work by the British wing of the Citizens Commission on Human Rights (CCHR), jointly founded by Scientology and the radical psychiatrist Dr. Thomas Szasz , to campaign against psychiatric abuses and expose their links to the pharmaceutical industry (CCHR release here).
[3] In fact, Hubbard was claiming rather more than that: as former Scientologist Roger Gonnet had pointed out in his testimony earlier, in several policy letters Hubbard said that the Niacin used in the Rundown could relieve the effects of radiation poisoning.
See for example, HCO Policy letter, February 6, 1978. “The Purification Rundown replaces the Sweat Program”:
“Niacin’s biochemical reaction is my own private, personal discovery. In the middle of the 1950s, I was doing work on radiation and I worked out that it must be niacin that operated on radiation… Niacin runs out radiation.”
Scientology still makes this claim today. “On the Purification program, because quantities of niacin are taken and because of the heat of the sauna, it is possible that it can have the effect of discharging a certain amount, possibly not all, of the accumulated radiation in people.”
Fabre had made the same claim during her testimony.
[4] Again, this is down to Hubbard’s writings on the Rundown, for while he warned about the effects of niacin, he said participants should continue the treatment anyway.
CAUTION: The manifestations niacin produces can be quite horrifying. Some of the somatics and manifestations the person may turn on are not just somatics in lots of cases, in my experience. I have seen a full blown case of skin cancer turn on and run out. So, a person can turn on skin cancer with this and if that should happen if niacin is continued the skin cancer has run out completely.
“Other things that may turn on are hives, flu symptoms, gastroenteritis (inflammation of the mucous membrane of the stomach and intestine), aching bones, upset stomach or a fearful or terrified condition. There seems to be no limit to the variety of phenomena that may occur with niacin.”
But Hubbard insisted that continuing the niacin treatment to the end would resolve the problem. “(Sometimes people chicken out on it and don’t finish the course and it leaves them hung up. This should not be allowed to happen.)”
From “The Purification Rundown replaces the Sweat Program” op. cit.
For more on these claims, see Chris Owen’s Narconon Exposed.

1 comment:

  1. Today I learned that a sponsor of "Drug-Free Marathon UK" is G&G . . I'm going to need a new irony meter :(