Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do. They note that the prevailing diseases in other countries, such as malaria and tuberculosis, can skew the outcome of clinical trials. […]
One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.” […]
To have an effective regulatory system you need a clear chain of command—you need to know who is responsible to whom, all the way up and down the line. There is no effective chain of command in modern American drug testing. Around the time that drugmakers began shifting clinical trials abroad, in the 1990s, they also began to contract out all phases of development and testing, putting them in the hands of for-profit companies. It used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas. They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns. The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals. The work looks like agribusiness, not research. […]
The F.D.A., the federal agency charged with oversight of the food and drugs that Americans consume, is rife with conflicts of interest. Doctors who insist the drug you take is perfectly safe may be collecting hundreds of thousands of dollars from the company selling the drug. (ProPublica, an independent, nonprofit news organization that is compiling an ongoing catalogue of pharmaceutical-company payments to physicians, has identified 17,000 doctors who have collected speaking and consulting fees, including nearly 400 who have received $100,000 or more since 2009.) Quite often, the F.D.A. never bothers to check for interlocking financial interests. […]
If the globalization of clinical trials for adult medications has drawn little attention, foreign trials for children’s drugs have attracted even less. The Argentinean province of Santiago del Estero, with a population of nearly a million, is one of the country’s poorest. In 2008 seven babies participating in drug testing in the province suffered what the U.S. clinical-trials community refers to as “an adverse event”: they died. The deaths occurred as the children took part in a medical trial to test the safety of a new vaccine, Synflorix, to prevent pneumonia, ear infections, and other pneumococcal diseases. Developed by GlaxoSmithKline, the world’s fourth-largest pharmaceutical company in terms of global prescription-drug sales, the new vaccine was intended to compete against an existing vaccine. In all, at least 14 infants enrolled in clinical trials for the drug died during the testing. Their parents, some illiterate, had their children signed up without understanding that they were taking part in an experiment. Local doctors who persuaded parents to enroll their babies in the trial reportedly received $350 per child. The two lead investigators contracted by Glaxo were fined by the Argentinean government. So was Glaxo, though the company maintained that the mortality rate of the children “did not exceed the rate in the regions and countries participating in the study.” No independent group conducted an investigation or performed autopsies. As it happens, the brother of the lead investigator in Santiago del Estero was the Argentinean provincial health minister. […]
In the mid-90s, Glaxo conducted clinical trials on the antidepressant Paxil in the United States, Europe, and South America. Paxil is a member of a class of drugs called selective serotonin re-uptake inhibitors. The class includes Zoloft, Prozac, and Lexapro. In the United Kingdom, Paxil is sold as Seroxat. The clinical trials showed that the drug had no beneficial effect on adolescents; some of the trials indicated that the placebo was more effective than the drug itself. But Glaxo neglected to share this information with consumers; annual sales of the drug had reached $5 billion in 2003. In an internal document obtained by the Canadian Medical Association Journal, the company emphasized how important it was to “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.” The memo went on to warn that “it would be commercially unacceptable to include a statement that efficacy had not been demonstrated.” After the document was released a Glaxo spokesperson said that the “memo draws an inappropriate conclusion and is not consistent with the facts.” […]
In theory, pharmaceutical companies are barred from selling a drug for any purpose other than the one that the F.D.A. has approved on the basis of clinical testing. But the reality is different. The minute a drug receives the green light from the F.D.A. for a specific treatment, the sponsoring company and its allies begin campaigns to make it available for other purposes or for other types of patients. The antidepressant Paxil was tested on adults but sold off-label to treat children. Seroquel, an anti-psychotic, was marketed as a treatment for depression. Physicians, often on retainer from pharmaceutical companies, are free to prescribe a drug for any reason if they entertain a belief that it will work. This practice turns the population at large into unwitting guinea pigs whose adverse reactions may go unreported or even unrecognized. […]
In 2009 the Government Accountability Office conducted a sting operation, winning approval for a clinical trial involving human subjects; the institutional review board failed to discover (if it even tried) that it was dealing with “a bogus company with falsified credentials” and a fake medical device. This was in Los Angeles. If that is oversight in the U.S., imagine what it’s like in Kazakhstan or Uganda. […]
In 2009, according to the Institute for Safe Medication Practices, 19,551 people died in the United States as a direct result of the prescription drugs they took. That’s just the reported number. It’s decidedly low, because it is estimated that only about 10 percent of such deaths are reported. Conservatively, then, the annual American death toll from prescription drugs considered “safe” can be put at around 200,000. That is three times the number of people who die every year from diabetes, four times the number who die from kidney disease. Overall, deaths from F.D.A.-approved prescription drugs dwarf the number of people who die from street drugs such as cocaine and heroin. They dwarf the number who die every year in automobile accidents. So far, these deaths have triggered no medical crusades, no tough new regulations. After a dozen or so deaths linked to runaway Toyotas, Japanese executives were summoned to appear before lawmakers in Washington and were subjected to an onslaught of humiliating publicity. When the pharmaceutical industry meets with lawmakers, it is mainly to provide campaign contributions.
And with more and more of its activities moving overseas, the industry’s behavior will become more impenetrable, and more dangerous, than ever.
Donald L. Barlett (b. 1936) is an American investigative journalist and author who often collaborates with James B. Steele (b. 1943). According to The Washington Journalism Review (Magazine) they were a better investigative reporting team than even Bob Woodward and Carl Bernstein. Together they have won two Pulitzer Prizes, two National Magazine Awards and six George Polk Awards. In addition, they have been recognized by their peers with awards from Investigative Reporters and Editors on five separate occasions. They are known for their reporting technique of delving deep into documents and then, after what could be a long investigative period, interviewing the necessary sources. The duo has been working together for over 40 years and is frequently referred to as Barlett and Steele.
•(1:00) The latest studies in the leading causes of death in the US.
•(1:05) #1: HEART DISEASE
•(8:05) Endotoxinemia: “The bloodstream becomes awash with bacterial toxins that are present in animal products.” These toxins aren’t destroyed by stomach acid, pancreatic enzymes or cooking (the meat). “Saturated fat boosts the absorption of these toxins into our bloodstream.”
•(10:18) #2: CANCER
•(12:43) “The blood of those on a vegan diet was dramatically less hospitable to cancer.”
•(16:55) “5,000 hours in the gym was no match for a plant-based diet.”
•(18:41) IGF-1 (Insulin-like Growth Factor 1): a cancer-promoting growth hormone. Levels decrease when on a plant-based diet.
•(21:05) How plant-based do our diets have to get? “Only vegans had significantly lower levels (of IGF-1).”
•(23:25) #3: Chronic lower respiratory diseases (EMPHYSEMA)
•(25:40) #4: STROKES. “Preventing strokes is all about eating potassium-rich foods.” Top five sources of potassium: Tomatoes, concentrated orange juice, beet greens, white beans and dates.
•(27:24) #6: ALZHEIMER’S disease. It’s been known for twenty years that those who eat meat (including poultry and fish) are 2-3 times more likely to become demented than vegetarians.
•(28:06) #7: DIABETES. It can be prevented and treated with a plant-based diet.
•(28:40) Obesity. Good bacteria in our gut break down fibre and produce propionate, which is absorbed into the bloodstream. Propionate inhibits cholesterol synthesis; helps to make us feel fuller longer; has an anti-obesity effect. Can boost population of good bacteria by feeding them more fibre (ie. eating more plants).
•(30:57) Meat and weight gain. Out of two people eating the same amount of calories, the one consuming meat gained more weight. Chicken found to be the greatest contributor to weight gain.
•(33:55) #8: KIDNEY FAILURE. It can be prevented and treated with a plant-based diet because the kidneys are highly vascular organs that filter our entire bloodstream. Three significant risk factors for declining kidney function: animal protein, animal fat and cholesterol.
•(35:12) #9: Respiratory infections (INFLUENZA and PNEUMONIA). Kale has immunostimulatory effects.
•(36:37) There’s serotonin, dopamine and other neurotransmitters in plants. High plant sources of serotonin: kiwis, plums, tomatoes, pineapple, plantains and bananas.
•(37:54) #11: SEPTICEMIA (blood infection). “Women eating meat are getting urinary tract infections (UTIs) from eating meat contaminated with fecal bacteria (E. coli) that crawl up into their bladder. And chickens are the most likely reservoir.”
•(42:12) #12: LIVER DISEASE and cirrhosis. “It’s been known for 35 years that a vegetable protein diet can be used to treat liver failure, significantly reducing the toxins that otherwise would build up eating meat with a less than functional liver.”
•(43:10) #13: Essential HYPERTENSION (high blood pressure). Risk decreases as you eliminate animal products from your diet. It only takes 12 days of eating a vegan diet to reduce blood pressure.
•(44:50) #14: PARKINSON’S disease. There’s a correlation between dairy products and increased risk of getting the disease. “Dairy products in the US are contaminated with neurotoxic chemicals…The concern is that these toxins may accumulate in the brain over long periods of consumption.”
•(46:05) #15: Aspiration PNEUMONIA. It is due to swallowing problems caused by Parkinson’s, having a stroke etc.
•(47:10) “Precription drugs kill more than 100,000 Americans every year.” These are just the deaths from adverse side effects, which means that the 6th leading cause of death is doctors.
•(50:17) Finland’s success in reducing saturated fat intake and heart disease rates. “A berry project was launched to help dairy farmers switch to berry farming.” There was an 80% drop in heart disease mortality rates among males aged 35-64 years, from 1969 to 2006.
Physicians Committee for Responsible Medicine, the Washington-based non-profit dedicated to preventive medicine and a vegan diet, sued the U.S. departments of Agriculture and Health and Human Services today, claiming the agencies have too many conflicts of interest to issue clear and science-based dietary guidelines.
Illicit Drug Activity by Country (selective list):
Justin Freeman (former patrol officer): Pot arrests are a monumental waste. Of everything. First you find it. Then you secure it as evidence. Then you handcuff. Then you search. Load. Radio. Transport. Drive time. Disembark. Secure duty weapon. Buzz into the jail. Paperwork. Property log. Ticket. Metal detect.
Then, while the jail is re-searching, fingerprinting, processing, photographing and securing, I’m leaving, going to HQ, into the property room, dime bag into heat seal bag, property form, evidence tape, submission. Then comes the report, with its person tab, property tab, narrative. Then a sergeant reads, sends back, rereads, edits, approves.
The ticket goes to records to be stamped, separated, forwarded. The marijuana goes to the chronically (pun acknowledged) backlogged forensics lab, which must verify the “green, leafy substance whose smell, based on my training and observation, matched that of marijuana” is, indeed, marijuana. They generate a report which is forwarded to me in the event of a trial. The prosecutor has long since gotten my ticket, and set a court date for the accused. A subpoena is mailed; they bounce back as often as they’re delivered.
Suspect shows, pleads not guilty. Trial date is set. I get subpoenaed. There’s a high probability suspect doesn’t show. Prosecutor asks for and gets issuance of an arrest warrant. I leave after ninety seconds, but get paid the minimum for a court appearance: two and one-half hours’ pay. Six months later I pull a car over; our toker is a passenger, whom I must now arrest because of the arrest warrant.
And the cycle repeats.
Bottom line: Though marijuana most likely pales in cancer risk when compared to cigarette smoking, it’s better to play it safe. There are reasons in addition to lung cancer risk (and the fact that it is illegal) to avoid marijuana. Marijuana likely increases the risk of testicular cancer, prostate cancer, cervical cancer, a type of brain tumor, and the risk of leukemia in the offspring of women who use it during pregnancy.
A major downside of the medical use of marijuana is the drug’s ill effects on working memory, the ability to transiently hold and process information for reasoning, comprehension and learning…Marijuana’s major psychoactive ingredient (THC) impairs memory independently of its direct effects on neurons.
The Things that Hate Us, Atmosphere
[Pic via GQ.com]
Lance Armstrong Stripped of Tour de France Titles by USADA | COMMENT: Don’t forget that Marion Jones passed all her blood tests too. The head of Balco (company in steroid scandal) recently said that only fools fail drug tests. The former head of the World Anti Doping Agency recently said that if you fail a drug test, you also fail an IQ test. Drug testing is still far behind drug concealment methods, and many dirty athletes ‘pass’ drug tests.
Besides, Lance Armstrong was found with a banned corticosteroid in his system in the 1999 Tour de France, and synthetic EPO in his urine samples from the 2000(?) Tour de France when those frozen samples were tested with improved methods in 2004. According to a former teammate, he also tested positive for EPO during the 2001 Tour de Suisse. A big part of this investigation was about bribing authorities and the organized cover-up involving the head of the international cycling union.
The guy was a great bike racer, but he is also a cheat.