Fresh off recent news that more than 1,000 people have filed lawsuits for damages due to cholesterol-lowering drugs since April this year, comes the remarkable story reported in the Wall Street Journal that Regeneron Pharmaceuticals, Inc. and Sanofi SA are spending $67.5 million to purchase a voucher that will allow them to get the FDA to fast-track approval of a new class of cholesterol drugs. By purchasing this voucher, they hope to beat rival drug company Amgen, Inc. in being first to market with these new cholesterol-lowering drugs. Bloomberg Businessweek is reporting that this is a first-of-its-kind deal offered by the FDA to fast track a drug through the purchase of a voucher. However, the original voucher issued by the FDA was not even for a cholesterol lowering drug. It was originally issued to BioMarin Pharmaceutical under a 2012 law designed to reward companies for investing in drugs for rare childhood diseases. This law, which the FDA says was "intended to encourage the development of treatments for rare pediatric diseases," also allowed those awarded such vouchers to sell them to other drug companies for the development of other drugs. This has effectively created a type of legal "black market" where drug companies can sell these vouchers to the highest bidder, even though they were intended by the FDA to approve new drugs specifically for the "development of treatments for rare pediatric diseases." Since this apparently does not raise any ethical questions in the mainstream media, I will raise them here.
If you are one of the 40 million Americans who take an aspirin every day, you may want to heed the latest warning from the US Food and Drug Administration (FDA). After many decades of promoting aspirin, the FDA now says that if you have not experienced a heart problem, you should not be taking a daily aspirin—even if you have a family history of heart disease. This represents a significant departure from FDA's prior position on aspirin for the prevention of heart attacks.
Phthalates are synthetic chemicals used in plastics, lubricants, insect repellants, nail polish, perfumes, and, yes, even in prescription drugs. Phthalates have a number of well known health risks and it’s been well established that patients who take drugs containing phthalates absorb that chemical into their body. In 2012, the FDA politely asked drug companies not to use phthalates in their drugs. This is despite the fact that the FDA has full power to ban phthalates. Why would the FDA issue a voluntary guidance, when they have the power to ban harmful substances outright? The answer, as always, can be reduced to three little words: “Follow the money.” Drug companies today pay a large proportion of the FDA’s budget, and FDA career personnel may hope to work for drug companies later in their career.
No medical drug in the US can be released for public use unless and until the FDA says it is safe and effective. That’s the rule. The FDA is spitting out drug approvals month after month and year after year, and the drugs are routinely killing 100,000 people a year and maiming two million more, which adds up to a million deaths per decade and 20 million maimings per decade. The FDA and the federal government are doing nothing about it, even though they know what’s going on. This is mass murder. Not accidental death.
What does the FDA know about farming? “Jack Manure,” apparently. In January 2011, after one of the most underhanded legislative maneuvers we’ve ever seen, the disastrous Food Safety Modernization Act (FSMA) was signed into law. The FSMA gave the FDA unprecedented power over American farms. And as we pointed out at the time, the FDA knows absolutely nothing about farming. In January 2013, the FDA issued draft rules for produce, decreeing that farmers would have to wait nine months between applying manure and harvesting. This will take many organic fields out of production for an entire growing season, economically crippling small farmers.
Antibiotic-resistant bacteria infect two million Americans every year, causing at least 23,000 deaths. Nearly 25 million pounds of antibiotics are administered to US livestock every year for purposes other than treating disease, such as making the animals grow bigger faster. The European Center for Disease Prevention and Control (ECDC) ruled that antibiotic resistance is a major threat to public health worldwide, and the primary cause for this man-made epidemic is the widespread misuse of antibiotics. Denmark stopped the widespread use of antibiotics in their pork industry 14 years ago. The European Union has also banned the routine use of antibiotics in animal feed over concerns of antibiotic-resistant bacteria. What’s standing in the way of curbing antibiotic use in the U.S.? In a word, industry. For instance, the American Pork Industry doesn’t want to curb antibiotic use, as this would mean raising the cost of producing pork by an estimated $5 for every 100 pounds of pork brought to market. The pharmaceutical industry is obviously against it as well.
Last week we told you about FDA’s sneak attack to ban folate, the B9 vitamin essential to human life. This week, we tell you why the drug industry may want to ban folate and keep it all to itself: it could be a ploy to make billions on a new, patented SSRI/folate combo drug.
The FDA is condemning children to death by refusing to allow them access to experimental cancer treatments, even though it has the authority to grant such access to terminal patients who have not responded to conventional treatment. Six years ago, 10-year-old Braiden was enrolled in a clinical trial for his incurable brain tumor. The “experimental” drug Antineoplaston (ANP) was the sole treating agent. He went into full remission, and suffered no toxic side effects. An MRI recently revealed Braiden’s tumor has reoccurred. The FDA is now refusing to allow Braiden to go back on ANP even though the treatment has already proven its efficacy through his previous remission. Many other terminal patients are also being prevented from accessing ANP.
You can’t live without this vitamin. But the FDA wants to reserve the natural form for monopoly drug companies, leaving only the synthetic form for supplements. The FDA has just released a new 109-page guidance on the revision of nutrition and supplement labels. On page 69, the agency slipped in two little paragraphs that could risk the health of millions of people who desperately need folate. It’s a sneak attack so quiet and unobtrusive that few people will even realize it’s there.
Jim Crawford started New Morning Farm in Maryland many decades ago. He was young and idealistic. He had little or no money and had to start small. He believed in sustainable agriculture and wanted to produce fresh and healthy produce to sell in farmers’ markets to the urban public. He succeeded and became increasingly well known both for his ideals and his produce. This may be why the FDA picked him out for a site visit. An inspector appeared without warning and told him that his operation would have to change. It didn't matter that no health problem had ever been associated with Crawford’s impeccably run operation. The Food Safety Modernization Act for the first time gave the FDA direct authority over our farms. It should have been obvious to everyone that putting the FDA in direct charge of farms was a terrible idea. Much of the FDA’s budget is paid for by Big Pharma instead of the taxpayers, which creates a serious conflict of interest.