Sunday, March 13, 2016

Hip replacement patients could face increased risk of cancer


Fresh fears have been raised over the safety of hip replacements received by tens of thousands of British people.

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FRESH FEARS have been raised over the safety of hip replacements received by tens of thousands of British people.
The British study is understood to have detected changes to cells in the bladders of more than one in five patients who were monitored after being given "metal-on-metal" hip replacements 
Early findings from a study on the effects of "metal-on-metal" devices suggest the implants could increase the risk of cancer and genetic damage.
One patient who took part in the research, and was found to have abnormal cell changes to the bladder, said he was now desperate to have his implant removed because he feared for his long-term health.
The British study is understood to have detected changes to cells in the bladders of more than one in five patients who were monitored after being given "metal-on-metal" hip replacements.
The disclosure of the study comes after last week's investigation byThe Sunday Telegraph, which revealed that regulators have such grave concerns about the safety of 30,000 of the devices that they are preparing to issue new guidance on them.
Problems occur with the implants when friction between the metal ball and cup causes minuscule metal filings to break off, which can seep into the blood and cause inflammation, destroying muscle and bone.
There are also concerns that metal traces in the blood could put major organs at risk of being slowly poisoned, and increase the chance of cancer - in particular in the kidneys and bladder.
The new in-depth research on 72 patients found genetic damage to the bladders of 17 people - including three patients who developed full-blown cancer.
The proportion of patients who had suffered DNA damage may be significant, because such changes can cause mutations which in turn lead to cancer.
Orthopaedic consultants in Bristol who undertook the study said they hope to present the results to other surgeons next month.
Their study was launched after the Medicines and Healthcare products Regulatory Agency (MHRA) warned that all 40,000 Britons with "metal-on-metal" devices should undergo annual checks, with scans and blood tests if doctors find symptoms that suggest metal leakage.
A type of device made by one company, DePuy - a subsidiary of global health giant Johnson & Johnson - which was received by almost 10,000 patients was taken off the market in 2010 because of concerns about its high failure rate.
One of the participants in the trial, David Jose, 51, from Clifton, near Bristol, had a hip "resurfacing" operation in 2007, a year before retiring as a police officer.
The father of two had been suffering hip pain from playing football and rugby.
In May last year he was told that the tests had found atypical cells which were not at this stage cancerous.
He saw Angus Maclean, an orthopaedic surgeon at Southmead Hospital involved in the study, who said that the trial had established three cases in which patients had developed bladder cancer, and 14 more including Mr Jose who had changes to their chromosomes.
The doctor told him researchers "could not believe" what had been found, describing the findings as "shocking".
He said he was expecting the research to "make front page news", when it was published in a couple of months' time. Nine months on, the findings have not been published.
Mr Jose, who now suffers from a host of unexplained health problems has now undergone further procedures which have established that so far he does not have bladder cancer.
However, he remains in fear about the consequences of the cell changes, and is desperate to have the device removed.
He said: "I do not know what this thing is doing to me; that is what is frightening, the fact that this is all unknown."
Mr Maclean said he could not talk about the study, except to say that he hoped the findings would be presented next month, at the annual British Hip Society conference.
A spokesman for the University of Bristol, which is running the study, said analysis of the results from the trial was still ongoing, and that the research would be peer reviewed and published.
The MHRA said there was no evidence of an increased incidence of cancer among people with metal-on-metal replacement hips.
A spokesman for DePuy said that since the recall decision, the company had worked to provide patients and surgeons with the information and support they needed.
Metal-on-metal implants were introduced in the UK in the 1990s when they were promoted as offering better mobility than replacements which use a metal ball and plastic socket.
They were seen as a better option for younger patients, who were likely to be more active and put more pressure on the joint.
The problems have been found to affect people of all ages but studies have found young and petite women are particularly at risk.

Wednesday, March 9, 2016

Thalidomide scandal: 60-year timeline


Thalidomide was used in the late 1950s and early 1960s to combat morning sickness, but led to children being born without limbs. Now its German inventor has issued an apology
Thalidomide
 Capsules of Celgene-brand thalidomide. Celgene was granted approval in the US in 1998 to market the drug with severe restrictions for use against leprosy. Photograph: Mike Derer/AP
1953 The anti-morning sickness drug thalidomide is created in Germany by the Grünenthal Group.
1958 Thalidomide is first licensed for use in the UK.
1961 An Australian doctor, William McBride, writes to the Lancet medical journal after noticing an increase in the number of deformed babies born at his hospital, all to mothers who had taken thalidomide. The drug is withdrawn later the same year.
1968 The UK manufacturer Distillers Biochemicals Ltd (now Diageo) reaches a compensation settlement after a legal battle with the families of those affected.
1972 The Sunday Times publishes a front-page lead under the banner "Our thalidomide children, a cause for national shame", part of a long-running campaign for further compensation. Eventually, a total of £28m is paid out by Diageo during the 1970s.
2004 Thalidomide is made available on a named patient basis, meaning doctors can give it to patients only on a case-by-case basis and at their own discretion, under strict controls.
2005 A Kenyan boy with no arms or legs is granted a visa to travel to the UK to receive medical treatment after a campaign by the charity Thalidomide UK. It is not known what caused 14-month-old Freddie Musean Mtile's disabilities, but the charity says the drug is still used in the treatment of leprosy and Aids in developing countries. Mtile dies from a fungal infection the following year. Separately, Diageo agrees to more than double its compensation payouts to thalidomide victims from £2.8m a year to about £6.5m.
2007 A study shows that thalidomide can significantly improve the survival chances of bone-marrow cancer patients. Researchers say adding thalidomide to standard treatment extended the lives of elderly patients with multiple myeloma by an average of 18 months.
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2008 The drug is approved for the treatment of multiple myeloma by the European Medicines Agency.
2009 Scientists at the University of Aberdeen claim they have solved a "50-year puzzle" after discovering how thalidomide causes limb defects. They found that a component of the drug prevented the growth of new blood vessels in developing embryos, stunting limb growth. The government agrees to pay a £20m grant to the Thalidomide Trust over three years, after another campaign by the Sunday Times.
2010 The health minister Mike O'Brien makes a formal apology to thalidomide victims, expressing "sincere regret and deep sympathy" on behalf of the government. The apology gets a mixed response from victims, with some describing it as too little, too late. Eighteen Northern Irish thalidomide survivors receive a formal apology and £1m compensation from the devolved assembly.
2012 The inventor of thalidomide, the Grünenthal Group, releases a statement saying it regrets the consequences of the drug.

Tuesday, March 8, 2016

Unit 731-4

UNIT 731Bobby Stringer's
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Unlocking a Deadly Secret

text By Nicholas D. Kristof
New York Times
(Excerpts)

Index

Photos of the experiments, etc

Morioka, Japan
He is a cheerful old farmer who jokes as he serves rice cakes made by his wife and then he switches easily to explaining what it is like to cut open a 30-year-old man who is tied naked to abed and dissect him alive, without anesthetic. "The fellow knew that it was over for him and so he didn't struggle when 'they led him into the room and tied ,him down," recalled the 72-year-old farmer, then a medical assistant in a Japanese army unit in China in World War II. "But when I picked up the scalpel, that's when he began screaming "I cut him open from the chest to the stomach and he screamed terribly and his face was all twisted in agony. He made this unimaginable sound, he was screaming so horribly. But then finally he stopped. This was all in a day's work for the surgeons, but it really left an impression on me because it was my first time." Japanese doctor vivisecting a Chinese Finally, the old man, who insisted on anonymity, explained the reason for the vivisection: The prisoner, who was Chinese, had been deliberately ~ infected with the plague, as part of a research project, the full horror of which is only now emerging, to develop plague bombs for use in World War II. After infecting him, the researchers decided to cut him open to see what the disease does to a man's inside. "That research program was one of the great secrets of Japan during and after World War II: a vast project to develop weapons of biological warfare, including plague, anthrax, cholera and a dozen other pathogens. unit 731 of the Japanese Imperial Army conducted research by experimenting on humans and by "field testing" plague bombs by dropping them on Chinese cities to see whether they could start plague outbreaks. They could. A trickle ofinformation about the germ warfare program has turned into a stream and now a torrent. Half a century after the end of the war, a rush of books, documentaries and exhibitions are unlocking the past and helping arouse interest in Japan in the atrocities committed by some of Japan's most distinguished doctors. Scholars and former members of the unit say that at least 3000 people and by some accounts several times that number were killed in the medical experiments; none survived. No one knows how many died in the "field testing" It is becoming evident that the Japanese officers in charge of the program hoped to use their weapons against the United States. They proposed using balloon bombs to carry disease to America and they had a plan in the summer of 1945 to use kamikaze pilots to dump plague infected fleas on San Diego. The research was kept secret after the end of World War II in part because the U.S. Army granted immunity from war crimes prosecution to the doctors in exchange for their research data. Japanese and U.S. documents show that the United States helped cover up the human experimentation and instead of putting the ringleaders on trial, it gave them stipends. The accounts now emerging are wrenching to read even after so much time has passed: a Russian mother and daughter reportedly left in a gas chamber, for example, as doctors peer through the thick glass and time their convulsions, watching as the woman sprawls over her child in a futile effort to save her from the gas.  

The origin of Germ warfare

Japan's biological weapons program was born in the 1930s, in part because Japanese officials were impressed that germ warfare had been banned by the Geneva Protocol of 1925. If it was so awful that it had to be banned under international law, the officers reasoned, it must make a great weapon. The Japanese army, which was then occupying a large chunk of China, evicted the residents of eight villages near the city of Harbin in Manchuria to make way for the headquarters of Unit 731. One advantage of China, from the Japanese point of view, was the availability of research subjects on whom germs could be tested. The subjects were called marutas. or logs, and most were Communist sympathizers or ordinary criminals. The majority were Chinese, but there were also many Russian expatriates living in China. Takeo Wane, 71, a former medical worker in Unit 731 who now lives in the northern Japanese city of Morioka, said he once saw a 6-foot high glass jar in which 3 Western man was pickled in formaldehyde. The man had been cut into two pieces, vertically, and Wane guesses that he was a Russian because there were many Russians then living in the area The Unit 731 headquarters contained many other such jars with specimens. They contained feet, heads, internal organs, all neatly labeled. "I saw samples with labels saying 'American,' 'English' and 'Frenchman,' but most were Chinese, Koreans and Mongolians" said a Unit 731 veteran who insisted on anonymity. Medical researchers also locked up diseased prisoners with healthy ones, to see how readily various ailments would spread. The doctors locked others inside a pressure chamber to see how much the body can withstand before the eyes pop from their sockets. Victims were often taken to a proving ground called Anda, where they were tied to stakes in a pattern and then bombarded with test weapons to see how effective the new technologies were. Planes sprayed the zone with a plague culture or dropped bombs with plague-infested fleas to see how many people and at what distance from the center would die. The Japanese army regularly conducted field tests to see whether biological warfare would work outside the laboratory. Planes dropped plague-infected fleas over Ningbo in eastern China and over Changde in north-central China and plague outbreaks were later reported. Japanese troops also dropped cholera and typhoid cultures in wells and ponds, but the results were often counterproductive. In 1942, germ warfare specialists distributed dysentery, cholera and typhoid in Zhejiang Province in China. but Japanese soldiers themselves became ill and 1,700 died of the diseases, scholars say.
Sheldon Harris, a historian at California State University, in Northridge, estimates that more than 200,000 Chinese were killed in germ warfare field experiments. Hams -author ofa book on Unit 731, "Factories of Death" also says that plague-infected animals were released as the war was ending and caused outbreaks of the plague that killed at least 30,000 people in the Harbin area from 1946 through 1948. The leading scholar of Unit 731 in Japan, Keiichi Tsuneishi, is skeptical of such numbers. Tsuneishi, who has led the efforts in Japan to uncover atrocities by Unit 731, says that the attack on Ningbo killed about 100 people and that there is no evidence for huge outbreaks of disease set off by field trials.  

Knowledge gained at the cost of human lives

Many of the human experiments were intended to develop new vaccines or treatments for medical problems the Japanese army faced. Many experiments remain secret, but an 18-page report prepared in 1945--and kept by a senior Japanese military officer until now--includes a summary of the unit's research. The report was prepared in English for U.S. intelligence officials and it shows the extraordinary range of the unit's work. There are scores of categories that describe research about which nothing is known. It is unclear what the prisoners had to endure for entries like "studies of burn scar" and "study of bullets lodged in the brains." Scholars say that the research was not contrived by mad scientists and that it was intelligently designed and' carried out. The medical findings saved many Japanese lives. For example, Unit 731 proved that the best treatment for frostbite was not rubbing the Limb, which had been the traditional method but immersion in water a bit warmer than 100 degrees, but never mom than 122 degrees. The cost of this scientific breakthrough was borne by those seized for medical experiments. They were taken outside and left with exposed arms, periodically drenched with water, until a guard decided that frostbite had set in. Testimony From a Japanese officer said this was determined after the "frozen arms, when struck with a short stick, emitted a sound resembling that which a board gives when it is struck." A booklet just published in Japan after a major exhibition about Unit 731 shows how doctors even experimented on a three-day-old baby, measuring the temperature with a needle stuck inside the infant's middle finger. "Usually a hand of a three-day-old infant is clenched into a fist", the booklet says, "but by sticking the needle in, the middle finger could be kept straight to make the experiment easier".

The Scope of Human experimentation

The human experimentation did not take place just in Unit 731, nor was it a rogue unit acting on its own. While it is unclear whether Emperor Hirohito knew of the atrocities, his younger brother, Prince Mikasa, toured Unit 731's headquarters in China and wrote in his memoirs that he was shown films showing how Chinese prisoners were "made to march on the plains of Manchuria for poison gas experiments on humans." In addition, the recollections of Dr. Ken Yuasa, 78, who still practices in a clinic in Tokyo, suggest that human experimentation may have been routine even outside Unit 731. Dr. Yuasa was an army medic in China, but he says he was never in Unit 731 and never had contact with it. Nevertheless. Dr. Yuasa says that when he was still in medical school In Japan, the students heard that ordinary doctors who went to China were allowed to vivisect patients. And sure enough, when Dr. Yuasa arrived in Shanxi Province in northcentral China in 1942, he was soon asked to attend a "practice surgery." Two Chinese men were brought in, stripped naked and given general anesthetic. Then Dr. Yuasa and the others began practicing various kinds of surgery: first an appendectomy, then an amputation of an arm and finally a tracheotomy. After 90 minutes, they were finished, so they killed the patient with an injection. When Dr. Yuasa was put in charge of a clinic, he said, he periodically asked the police for a Communist to dissect, and they sent one over. The vivisection was all for practice rather than for research, and Dr. Yuasa says they were routine among Japanese doctors working in China in the war. In addition, Dr. Yuasa - who is now deeply apologetic about what he did - said he cultivated typhoid germs in test tubes and passed them on, as he had been instructed to do, to another army unit. Someone from that unit, which also had no connection with Unit 731, later told him that the troops would use the test tubes to infect the wells of villages in Communist-held territory.  

Plans to take the germ war to the US homeland

In 1944, when Japan was nearing defeat, Tokyo's military planners seized on a remarkable way to hit back at the American heartland: they launched huge balloons that rode the prevailing winds to the continental United States. Although the American Government censored re. ports at the time, some 200 balloons landed in Western states, and bombs carried by the balloons killed a woman in Montana and six people in Oregon. Half a century later, there is evidence that it could have been far worse; some Japanese generals proposed loading the balloons with weapons of biological warfare, to create epidemics of plague or anthrax In the United States. Other army units wanted to send cattleplague virus to wipe out the American livestock industry or grain smut to wipe out the crops. Monument for Unit 731 in TokyoThere was a fierce debate in Tokyo, and a document discovered recently suggests that at a crucial meeting in late July 1944 it was Hideki Tojo - whom the United States later hanged for war crimes - who rejected the proposal to use germ warfare against the United States. At the time of the meeting, Tojo had just been ousted as Prime Minister and chief of the General Staff, but he retained enough authority to veto the proposal. He knew by then that Japan was likely to lose the war, and he feared that biological assaults on the United States would invite retaliation with germ or chemical weapons being developed by America. Yet the Japanese Army was apparently willing to use biological weapons against the Allies in some circumstances. When the United States prepared to attack the Pacific island of Saipan in the late spring of 1944, a submarine was sent from Japan to carry biological weapons it is unclear what kind - to the defenders. The submarine was sunk, Professor Tsuneishi says, and the Japanese troops had to rely on conventional weapons alone. As the end of the war approached In 1945, Unit 731 embarked on its wildest scheme of all. Codenamed Cherry Blossoms at Night, the plan was to use kamikaze pilots to infest California with the plague. Toshimi Mizobuchi, who was an instructor for new recruits in Unit 731, said the idea was to use 20 of the 500 new troops who arrived in Harbin in July 1945. A submarine was to take a few of them to the seas off Southern California, and then they were to fly -in a plane carried on board the submarine and contaminate San Diego with plague-infected fleas. The target date was to be Sept. 22, 1945. Ishio Obata, 73, who now lives in Ehime prefecture, acknowledged that he had been a chief of the Cherry Blossoms at Night attack force against San Diego, but he declined to discuss details. "It is such a terrible memory that I don't want to recall it," he said. Tadao Ishimaru, also 73, said he had learned only after returning to Japan that he had been a candidate for the strike force against San Diego. "I don't want to think about Unit 731," he said in a brief telephone interview. "Fifty years have passed since the war. Please let me remain silent." It Is unclear whether Cherry Blossoms at Night ever had a chance of being carried out. Japan did indeed have at least five submarines that carried two or three planes each, their wings folded against the fuselage like a bird. But a Japanese Navy specialist said the navy would have never allowed Its finest equipment to be used for an army plan like Cherry Blossoms at Night, partly because the highest priority in the summer of 1945 was to defend the main Japanese islands, not to launch attacks on the United States mainland. If the Cherry Blossoms at Night plan was ever serious, it became irrelevant as Japan prepared to sur-render in early August 1945. In the last days of the war, beginning on Aug. 9, Unit 731 used dynamite to try to destroy all evidence of its germ warfare program, scholars say.  

No Punishment, Little Remorse

Head of the Unit 731 Partly because the Americans helped cover up the biological warfare program in exchange for its data, Gen. Shiro Ishii, the head of Unit 731, was allowed to live peacefully until his death from throat cancer in 1959. Those around him in Unit 731 saw their careers flourish in the postwar period, rising to positions that included Governor of Tokyo, president of the Japan Medical Association and head of the Japan Olympic Committee. By conventional standards, few people were more cruel than the farmer who as a Unit 731 member carved up a Chinese prisoner without anesthetic, and who also acknowledged that he had helped poison rivers and wells. Yet his main intention in agreeing to an interview seemed to be to explain that Unit 731 was not really so brutal after all. Asked why he had not anesthetized the prisoner before dissecting him, the farmer explained: "Vivisection should be done under normal circumstances. If we'd used anesthesia, that might have affected the body organs and blood vessels that we were examining. So we couldn't have used anesthetic." When the topic of children came up, the farmer offered another justification: "Of course there were experiments on children. But probably their fathers were spies." "There's a possibility this could happen again," the old man said, smiling genially. "Because in a war, you have to win."

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