Thalidomide production


Thalidomide production increases
Now is it free to manufacture thalidomide at a large scale. And make big money. Make trip with us inside a thalidomide plant.

The Chemie Grünenthal patent on thalidomide has expired. To day it is legal for anyone to start the manufacturing of thalidomide. Because the molecular structure is easily available in the textbooks of chemistry, and the production method is no longer patented, it is quite a cheap drug to manufacture. There are have no development costs and manufacturers do not have to do clinical trials, they can start to make money from day one.

Thalidomide is a cheap drug to manufacture, the formula is in the textbooks, and the production method is no longer patented.

And the drug companies expects vast profits, now when thalidomide in the process of being used against big endemic diseases like cancer, TB, diabetes, AIDS and MS.

Numerous production sites

As far as we Thalidomide's know, the drug is produced at facilities in Wales , Mexico , Argentina , USA and Brazil . There are also several facilities in Peoples Republic of China . The original producer, Chemie Grünenthal, does not produce or sell thalidomide any more.

State-run pharmaceutical factories in China began mass-producing the drug in the 1980s to help supply a national programme to fight leprosy. Doctors found that it rapidly relieved the swollen sores and raging fevers that sometimes accompanied the infection.

"A very effective drug"

"It is a very effective treatment," said Professor Li Wenzhong at the institute of dermatology in Nanjing to Sunday Times. "In certain circumstances such as pregnancy it is not suitable, but used properly it is safe."

China began mass-producing thalidomide in the 1980s as a part of a national programme to fight leprosy. There is a fear that there are a growing number of thalidomide cases in leprosy colonies, "hidden" in China 's remote provinces.

As the drug gained respectability, it was tested for other complaints.

"Chinese doctors like it because it has many applications," said Dr Zhang Guo Cheng, a surgeon at the national rehabilitation centre for sexually transmitted diseases and leprosy control to Sunday Times.

There are fears that the growing use of thalidomide is spawning a black market in the drug. Unscrupulous racketeers in China have allegedly sold the tablets as a pain reliever or a sleeping pill. In some remote areas of China , sufferers from incurable afflictions believe thalidomide has mystical healing powers - among them thousands of lepers who have been left permanently disfigured by the disease.

A growing number of "hidden" Chinese thalidomide victims.

There is a concern that in China 's far-flung provinces there may be a growing number of "hidden" thalidomide cases, whose malformations are blamed on other causes. One British epidemiologist said to Sunday Times: "I am certain China has thalidomide victims, but they are not recognised as such or are kept out of the public view." According to Sunday Times Chinese authorities denies any such problems and says its comprehensive programme of ultra-sound testing of pregnant mothers would quickly detect foetal abnormalities.

Tour a thalidomide plant

The use of thalidomide is spreading, no doubt. Production-facilities open's up in almost all continents. But what can be found inside the factory walls? Let's visit the British thalidomide plant. You will get an interesting view of the arguments of the thalidomide's fans.

Thalidomide has been used in Great Britain since 1977. The HIV unit of Chelsea and Westminster Hospital supplies thalidomide to about 120 patients a year — 500 to 800 capsules's a month — mostly for severe mouth ulcers. The HIV pharmacy used to get its supplies of dodgy, little white, powdery tablets from Brazil . But it wasn't sure how much thalidomide there actually was in each tablet.

Nowadays the British supply of thalidomide does not come from Brazil , but from Wales .

Photo: Chris Steele-Perkins, Magnum

The production of thalidomide continues, now in more countries then ever. This photo is taken inside the thalidomide production site in Merthyr Tydfil in south Wales . The volume is increasing each year. When production started 1986 the thalidomide capsules was made only two days per week. Now the machinery is working all the year round. Each tablet is sold for $1.30 USD and the profit is considerable.

A small company called Penn Pharmaceuticals manufactures the drug to a much higher standard than the Brazilians. The small capsules are off-white and unmarked. The clue lay on the white plastic pot: Sauramide 100mg (Thalidomide). Man.16/03/95. Exp.15/03/97.

Penn Pharmaceuticals Ltd lies in the valleys near British thalidomide are now manufactured near Merthyr Tydfil, south Wales . It looks like any ugly sheet-metal and concrete box on any industrial site, and it shares its estate with British Steel and a tubing company. The current construction work at Penn indicates that business is going well, and the photographs of visits from Prince Charles and Prince Andrew in reception suggest the expansion is not going unrecognised.

Detected a gap in the market

Roger Jones , the managing director, is 52 and used to work on the clinical programme at the Welcome Foundation, but says to the Independent he left to set up Penn in 1986 because he was frustrated with the slow rate of progress of many trials. He detected a gap in the market for a company that specialised in providing, with greater efficiency, drugs and placebos for patients, as well as bringing all the analytical methods up to speed. "That's Penn's business, our mission."

Jones says he has been interested in thalidomide since he first heard about it in the early Sixties. "I was never convinced that it was a classic teratogen (a drug causing physical defects in a foetus). Many more women had actually taken the drug during the fist, critical period than actually gave birth to damaged babies. The fact that they did give birth was a tragedy in every single case, but I would have expected a teratogen to have affected a far larger number of people," Jones said according to the Independent.

"I was also curious that the issue had never been resolved legally. The compensation was settled out of court, and I was very curious about that. I believe that there must have been evidence that did not come out, for otherwise why settle?"

British Thalidomide's has a completely another view: Their parents had no choice but to settle out of court - they were virtually blackmailed!

Roger Jones surmised that thalidomide interfered with a woman's natural body mechanism for identifying damaged foetuses. He believed that the number of people born with deformities was about the same as you would have naturally miscarrying in the first trimester. He discussed this with his colleagues at Welcome, but received little support. "Clinicians are non-iconoclastic," he concludes in the Independent. "They don't like outrageous suggestions of that kind."

Started at a small scale

Penn Pharmaceuticals began the production of thalidomide at a small scale, making the drug for ulcers, skin grafts and graft-versus-host disease long before the secrets of TNF-alpha and blood vessels were uncovered. Initially, Mr Jones says, the money the company was making from thalidomide was very modest. But then HIV pharmacists began calling for it, and researchers began looking at new ways of treating rheumatoid arthritis, and also the American manufacturer, Celgene, turned to Penn and wanted some help with their formulation.

The skill behind the operating procedure is mind-blowing
Roger Jones says that the operating procedure that goes into making his capsules "is mind-blowing". The basic ingredients are common knowledge, but the skill lies in the correct formulation of the five-stage synthesis to ensure good bio-availability (absorption into the bloodstream). He believes that the reason Grünenthal couldn't find a correct level of toxicity was because "the bloody thing wasn't being absorbed."

Clinical trials in UK

Penn Pharmaceuticals will not reveal who they supplies (beyond saying all the clinical trials are UK-based), nor will they say how many capsules the company makes. "Some competitor might quickly work out what the market would be worth and come to piling into it. If they want to come into this market, they have to take a risk," MD Roger Jones says to the Independent.

But Penn Pharmaceuticals admits that the thalidomide production is expanding each year. Earlier the drug was just made at weekends, and all the women who would normally work on the manufacture of other drugs were asked to leave the production site. "We had very good air-handling results," Jones says to the Independent, "but I was very concerned that, if there had been any fatal abnormality, then straightaway people would say it's your fault', and I really couldn't live with that."

Made all week round

Recently, a suite was designed solely for the men producing thalidomide, which means it can be made all-week round. To enter, one must change twice, into two separate sets of clothing and sterile hats and footwear. One passes through two airlocks. The suite is no larger than a typical double bedroom, and is dominated by two gleaming silver machines, one a vast mixer, the other a smaller, more complex contraption which Roger Jones do not want to be describe as the company's competitors can copy the production methods. In one corner, there are plastic bags of capsule shells. Along one wall there is an automated capsule counter. It's a familiar process to the staff now: each batch takes a few days.

Photo Chris Steele-Perkins, Magnum

British thalidomide is now manufactured in a new site near Merthyr Tydfil . The suite is no larger than a double bedroom.

A quick walk through the rest of the factory gives: a labelling department, the stringent quality control section, the site of the new canteen.

Roger Jones is confident in his believes that the power of thalidomide can do well and improve people's lives. He stresses that it was clearly not immoral to earn money from drugs that make people well. "Remember," he says to the Independent, "we are the guys wearing the white hats, not the black hats."

The authorities in the various countries claim that they have a 100% control of the production facilities and of the batches manufactured. But the Welsh example shows how small the production site is and how minimal the investment is before production can start.

Today when thalidomide is claimed to be potent against big endemic diseases like cancer, TB or AIDS there is always scrupulous individuals that take advantage of the situation. Sick people do not wait until researchers come up with the final solution. Greed is a major motivator. Racketeers get thalidomide and sells with a big profit to desperate people who suffer from a lethal disease. Right now there is an illegal export from Brazil and Mexico to the black market in USA . It is an understatement that the authorities have lost the control over the distribution of thalidomide, which is produces both legal illegal, now when there is big money at stake.

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