How to get drugs that are not FDA approved? PLEASE HELP?

Question

My future mother in law has a brian tumor or brain cancer that is terminal. She says the doctor told her about a drug that is used in Europe, but it is not fda approved, it could stop the tumor or cancer from growing and possibly save her life. She does not want to order drugs over the internet (who knows what they could be?). She is married to a retired military man so she has excellent ins. but I don't think it would help get a drug that is not fda aprroved. Please help!!!

Answer 1

If the medication is in trials in the US, she might be able to participate in the trials. She could also get the drugs by traveling to a country where the drugs are currently legal and speaking with a doctor there. Insurance does not normally cover unapproved drugs; as I recall from my time in the service unapproved drugs were specifically excluded from insurance coverage. Many drug trials provide the drugs for free.

Answer 2

Her doctor should know of some medical trials available using this drug. It was certainly unprofessional to give her hope by telling her of drugs that she couldn't get in the US. Drugs that aren't approved by the FDA aren't necessarily "bad". They just haven't gone through the rigorous testing standards that the FDA requires.

Answer 3

Most mail order from Great Britain and Canada are legitimate. Check the company on the net.this is not a direct answer to your question but read the following article from New Scientist a Science weekly magasine from England. Copy the article A.S.A.P. as Yhoo may pull it because of copyright problems.

Dr Coley's famous fever
02 November 2002
From New Scientist Print Edition. Subscribe and get 4 free issues.
Stephanie Pain






Dr William Coley was astonished. The man's medical records were quite clear. His case was hopeless. In the space of three years, the man had had five operations to remove a tumour from his neck. The last was a failure: it was impossible to remove the whole tumour. He would die soon. As if that wasn't bad enough, the poor man then suffered two attacks of erysipelas, a skin infection that produced a lurid red rash and high fever. But when the fever broke and the man had recovered, his tumour had vanished. Seven years later, he was still alive and well. There could be only one explanation for the disappearance of the man's tumour: whatever had caused the fever had also destroyed the cancer.

Coley, a young surgeon at the Memorial Sloan-Kettering Cancer Center in New York, reasoned that if a chance infection could make tumours vanish, then it should be possible to achieve the same effect by deliberately infecting cancer patients. In 1891, Coley began to test his theory. He brewed up cultures of the bacterium responsible for erysipelas - and injected the stuff into the worst, inoperable tumours. Some began to shrink within hours. Some disappeared temporarily. And some never came back at all.

FOR centuries, the only real treatment for cancer was surgery. By the 1870s, when William Coley began his medical career in New York, patients at least had the benefit of antiseptics and effective, if rather dodgy, anaesthetics. Yet despite these improvements, surgeons were having less success than their predecessors a century earlier. Coley had become only too aware of this.

Coley's first cancer patient was a 19-year-old girl with a malignant tumour in her right arm. Despite early diagnosis and swift amputation of the arm, the cancer returned and spread quickly. She died soon after. Coley began delving into old medical books to find out more about the disease. In the past, he discovered, cancers that were cut out rarely returned. One surgeon working in the 1770s cured six out of every seven patients. Yet by the second half of the 19th century, surgery cured only one in four.

Coley discovered something else. For hundreds of years, doctors had reported cases of tumours that disappeared, apparently spontaneously. Searching his own hospital's records he came across a patient whose neck tumour had vanished seven years before. Coley tracked him down and found he was still alive. All these people had something in common apart from their miraculous recovery. They had all been struck down by an acute infectious disease. It might have been flu or measles, or something much worse - malaria, smallpox or syphilis, or like the man in New York, erysipelas. In most cases, when their fever subsided, their tumours had broken down and been absorbed or sloughed off.

Infection seemed to be the key to the "miracle cures" and also to the success of early surgeons. Without antiseptics or antibiotics, patients who had their cancers carved out almost inevitably picked up infections from dirty instruments, dirty hands and unhygienic dressings. But by the 18th century, some surgeons knew enough about infection to try primitive forms of "immunotherapy" on their cancer patients. Some slapped on a septic dressing from an infected patient. A few went so far as to inject material from patients with malaria or syphilis into tumours. Sometimes it worked. The infection seemed to reach those last vestiges of a tumour that the surgeon couldn't.

But by Coley's time, cleanliness and hygiene were the order of the day and surgeons had no truck with the idea of deliberately infecting patients. Occasionally, though, a patient caught an infection by accident. In the case of the man with the neck tumour, Coley had seen the result. "There was no possibility of attributing the cure to any other cause than the erysipelas," he told the New York Academy of Medicine in 1892. And if accidental infection with erysipelas could get rid of a tumour, he argued, "it seemed fair to presume that the same benign action would be exerted in a similar case if erysipelas could be artificially produced".

Erysipelas is caused by Streptococcus pyogenes, a bacterium that produces painful and unpleasant symptoms but unlike gangrene, syphilis or tuberculosis, was rarely dangerous. Coley decided to "inoculate the first case of inoperable sarcoma that should present itself". In May 1891, he found a willing volunteer. The man had tumours in both his neck and his tonsils, and despite recent surgery they had reappeared and were growing fast. Coley injected a streptococcal soup directly into the tumours, every day or two for the next two months. The tumours shrank. The man began to feel better. In August Coley stopped the injections and the tumours began to grow again.

Coley acquired a more potent culture of streptococci and tried again. This time the patient developed full-blown fever. "The disease ran its course and I made little effort to check it," reported Coley. "At the end of two weeks, the tumour of the neck had disappeared." Almost two years later, when Coley reported his results, the tumour in the neck had not returned. And although the second tumour hadn't shrunk, it hadn't grown either. "Its malignant character must have been greatly modified," reported Coley, "as sarcoma of the tonsil is known to be rapidly fatal."

Coley tried his treatment on more patients. His sixth case was memorable. The patient was a middle-aged cigar maker with a lumpy skin tumour on his back and a second tumour in his groin, this one the size of a goose egg. Surgery failed and both tumours soon grew back. Coley injected them with his streptococcal brew. They shrank but showed no sign of breaking down.

He tried again with a fresh culture acquired from the great German bacteriologist Robert Koch. Almost immediately, the cigar maker grew feverish. His temperature hit 40 °C. The lump on his back responded immediately. "From the beginning of the attack the change that took place in the tumour was nothing short of marvellous," wrote Coley. "It lost its lustre and colour and had shrunk visibly in size within 24 hours." A few days later, the second tumour began to break down too. "Three weeks from the date of the attack both tumours had entirely disappeared."

To start with, Coley believed he needed live bacteria. But even daily injections sometimes failed to produce fever, while in other patients the infection ran out of control. Coley decided that the key factors in his streptococcal soup were bacterial toxins - and that dead bacteria might work just as well. He finally settled on a mix of dead streptococci and another bacterium called Serratia marcescens, which became known as Coley's toxins. These had the advantage of triggering the symptoms of sickness - chills and fever - without actual infection. Coley insisted that it wasn't so much the identity of the bacteria that was important but the technique he used to treat patients. It was essential to inject the toxins deep into the tumour, as often as necessary to cause fever, and keep this up for weeks or even months.

Coley's toxins produced good results from the start. Patients thought to be beyond all help saw their cancer disappear. Many of those who weren't cured lived much longer than they might otherwise. "He had successes you simply couldn't hope for today, curing even extensive metastatic disease," says Stephen Hoption Cann, an epidemiologist at the University of British Columbia who argues that it's worth taking another look at Coley's ideas.

Although patients flocked to the hospital for treatment, Coley found it increasingly difficult to treat them. His boss thought another new treatment, radiotherapy, more promising. "The response to radiotherapy was highly predictable," says Hoption Cann. "Irradiate the tumour and it shrinks. Unfortunately, it always came back." Its supporters believed that with a few modifications, radiotherapy would eventually be able to cure cancer. "Yet, here we are a hundred years later and if the cancer has spread, radiotherapy is not curative," says Hoption Cann.

Coley successfully treated hundreds of patients but his treatment was trickier and took longer. The dose had to be tailored to each patient and gradually increased to keep the immune response going. After his death in 1936, interest in Coley's toxins waned. Radiotherapy and, later, chemotherapy became standard treatments. Both knock out the immune system and so infection became something to be avoided at all cost.

The search for ways to stimulate the immune system to fight cancer continues. Researchers have narrowed their search, focusing on ways to trigger production of specific types of anti-cancer cells or particular tumour-suppressing molecules.

But Coley's vaccine worked precisely because it was so crude and stimulated a general immune response, says Hoption Cann. More important, he says, the immune system works at its best during a fever. "The body produces more immune cells. They are more mobile and more destructive."

What's more, there is growing evidence that the more infections people have - especially if they develop fever - the less likely they are to suffer certain cancers. Or, as the great 17th-century physician Thomas Sydenham once said: "Fever is a mighty engine which Nature brings into the world for the conquest of her enemies."

From issue 2367 of New Scientist magazine, 02 November 2002, page 54

Answer 4

she basically ******