Merck Baldness Drugs cause Sexual Side Effects and Destroy Sperm

Labels changed for drugs for baldness, enlarged prostate. Proscar, Propecia effects continued after use was ended-FDA

REUTERS | APRIL 16, 2012

(Reuters) – Prescribing labels for Merck & Co’s drugs for baldness and enlarged prostate will add reports of sexual side effects that continued after use of the medicines was stopped, U.S. health regulators said.

Labels will be revised for Proscar, which treats symptoms of enlarged prostate, and hair-loss treatment Propecia, the Food and Drug Administration said. The active ingredient in both drugs is finasteride.

The Propecia label will now include notification of problems with libido, ejaculation and orgasms that continued after use of the drug was ended. Proscar’s label will include notification of decreased libido.

The labels of both drugs will also include a description of reports of male infertility and poor semen quality that normalized or improved after use of the drugs was stopped.

In announcing the label changes, FDA cited events reported to the agency.

“The cases suggest a broader range of adverse effects than previously reported in patients taking these drugs,” FDA said in a notification posted on its website. But it also said no clear causal links between finasteride and sexual adverse events had been established.

FDA said sexual side effects were included in the labels of both drugs when they were approved in the 1990s. But in subsequent clinical trials, the side effects were resolved in patients who stopped using the drugs as well as in most patients who continued therapy, the agency said.

Last year, the labels of both drugs were revised to include erectile dysfunction that continued after patients stopped using the drugs, the FDA said.

Only a small percentage of men who use the drugs have experienced sexual side effects, the agency added. For example, it said, an analysis of clinical trials showed 3.8 percent of men taking Propecia reported one or more of the sexual side effects, compared with 2.1 percent of those who received a placebo.

FDA said it believes that finasteride remains safe and effective for its approved uses and that patients on Proscar and Propecia should contact their doctors if they have concerns.

In a statement, Merck said it believes both drugs are generally well tolerated and effective for their intended uses and that it supports efforts to ensure patient safety through monitoring of reported side effects.

The drugs are relatively modest-sized products for the U.S. drugmaker. Merck reported $447 million in Propecia sales last year, and $223 million for Proscar.

Merck shares were down 0.5 percent to $38.27 in afternoon trading on the New York Stock Exchange.

TSA Puts Off Safety Study of X-ray Body Scanners

Previous independent observations  and studies have signaled how the body scanners do cause cancer due to the radiation. Furthermore, airport scanner operators have been diagnosed with cancer a few years after working next to the machines.

by Michael Grabell
ProPublica
November 16, 2011

The head of the Transportation Security Administration has backed off a public commitment to conduct a new independent study of X-ray body scanners used at airport security lanes around the country.

Earlier this month, a ProPublica/PBS NewsHour investigation found that the TSA had glossed over research [1] that the X-ray scanners could lead to a small number of cancer cases. The scanners emit low levels of ionizing radiation, which has been shown to damage DNA. In addition, several safety reviewers who initially advised the government on the scanners said they had concerns about the machines being used, as they are today, on millions of airline passengers.

At a Senate hearing after the story ran, TSA Administrator John Pistole agreed to a request by Sen. Susan Collins, R-Maine, to conduct a new independent study [2] of the health effects of the X-ray scanners, also known as backscatters.

But at a Senate hearing [3] of a different committee last week, Pistole said he had since received a draft report on the machines by the Department of Homeland Security’s inspector general, or IG, that might render the independent study unnecessary.

“My strong belief is those types of machines are still completely safe,” Pistole said. “If the determination is that this IG study is not sufficient, then I will look at still yet another additional study.”

According to a summary obtained by ProPublica, the inspector general concluded the machines are within industry standards for radiation exposure limits. But the summary also suggests the report focuses mostly on how the TSA monitors and maintains the machines. The full report won’t be released for several weeks.

“I hope the Obama administration is not backing away from an independent study of the health effects of these radiation-emitting machines,” Collins said in a statement to ProPublica. “What I asked for — and what the administrator committed to — was an independent study on the health effects of [the] machines, not just a study on whether TSA is doing an adequate job of inspecting, maintaining and operating” them.

The inspector general’s report calls on the TSA to ensure that radiation surveys are conducted for unintended emissions, that calibrations are consistently documented and that airport screeners complete annual radiation safety training. The inspector general also advised the agency to determine how much on-the-job training is needed for screeners who operate the backscatters and to ensure that accidental radiation overdoses are properly reported.

It’s unclear whether the recommendations resulted from any problems found during the investigation, or are general reminders about best practices. It’s also unclear whether investigators measured the radiation doses from the machines themselves or relied on inspections conducted by the manufacturer.

The TSA uses two types of body scanners [4]. With the backscatter machines that have been the focus of health concerns, a passenger stands between two large blue boxes and is scanned with a pencil X-ray beam that moves rapidly left to right and up and down the body. With the other kind of scanner, called a millimeter-wave machine, a passenger enters a chamber that looks like a round phone booth and is scanned with a form of low-energy radio waves, which do not strip electrons from atoms and have not been shown to cause cancer.

In recent years, the TSA has commissioned tests of the X-ray scanners by the Food and Drug Administration and the Johns Hopkins University Applied Physics Laboratory. In addition, survey teams from the Army Public Health Command visit airports to check the machines.

Those tests have all shown that the X-ray scanners emit extremely low levels of radiation, equivalent to the radiation received in a few minutes of flying. But the tests haven’t doused questions from some outside radiation experts about why the TSA doesn’t use only the millimeter-wave machines, which the agency also deems highly effective.

The European Union on Monday prohibited the use of X-ray body scanners [5] in European airports “in order not to risk jeopardizing citizens’ health and safety.”

But others have pointed to problems with millimeter-wave machines. Germany announced earlier this year that it would forgo the machines after concluding that they produced too many false positives.

There are currently 500 body scanners, split about evenly between the two technologies, deployed in airports. The TSA plans to deploy 1,275 backscatter and millimeter-wave scanners covering more than half its security lanes by the end of 2012 and 1,800 covering nearly all lanes by 2014.

U.S. Universities and Big Pharma Conduct Illegal Human Experiments in Africa

People’s Constitution
November 9, 2011

A new policy brief faults prominent institutions and drug companies like Pfizer, Columbia University, Johns Hopkins University, and Population Council, for their involvement in unethical and illegal human experimentation in Africa.

The report is titled “Non-Consensual Research in Africa: The Outsourcing of Tuskegee” in reference to the illegal human experiment conducted in Tuskegee, Alabama, between 1932 and 1972 by the US Public Health Service. In that experiment, some 600 impoverished African-American men were observed in a study on the progression of untreated syphilis. Some of the men were intentionally infected with the disease and all of them were denied the cure. Regrettably, the report notes, no one was held accountable for this crime against humanity.

The new report details human experiments led by US researchers and drug companies on Africans who are typically undereducated, poor, and lack full understanding of their rights. The human subjects often are led to believe that they are receiving medical treatment from governmental health services or health ministries.

These practices hearken back to the appalling experiments carried out by US researchers in Guatemala in the 1940s where hundreds of Guatemalans were deliberately infected with sexually transmitted diseases without information or consent. President Obama formally apologized to Guatemala for these experiments last year.

Human experimentation in the United States is regulated by the Office of Research Integrity and various Ethical Research Institutional Boards. Many African countries lack these institutions. Even when they exist, they lack independence and are controlled by corrupt government officials.

In one experiment on HIV sponsored by Gilead Sciences, the Centers for Disease Control, and the Bill and Melinda Gates Foundation and operated by Family Health International, Cameroonian subjects were given details about the experiment in English even though many spoke only French and were illiterate. Five women were allegedly infected with HIV in the experiment but were not given antiretroviral drugs.

In another experiment in Nigeria led by Pfizer physicians, researchers injected children with an antibiotic called Trovan during a meningitis outbreak without providing their families with informed consent forms that fully disclose the side effects and purpose of the experiment. Eleven children died and many were left paralyzed.

In South Africa and Namibia, mothers with HIV/AIDS are routinely sterilized without their informed consent. Countries that perform these procedures are known to receive funding in the form of grants and incentives from USAID and other aid organizations.

The report explains that US researchers and drug companies violate the laws and protocols of the Declaration at Helsinki (1964) and the Belmont Report which provide ethical guidelines on human experimentation.

Moreover, the results of unethical and fraudulent experiments are laundered in the United States and Europe through the peer-review system. Many of the “peers” who review these experiments are themselves involved in the same unethical conduct. Others are concerned about the possibility of professional alienation if they speak out.

The authors make several demands so that these practices are ended. They include holding congressional hearings so that the matter is brought to the public’s attention and enacting new legislation to ensure that drugs are not approved by the FDA unless the research on which they are based comply with ethical research principles.

U.S. to Ban Epinephrine Inhalers to Sell more Prescription Drugs

by Mark Hemingway
Weekly Standard
September 23, 2011

Remember how Obama recently waived new ozone regulations at the EPA because they were too costly? Well, it seems that the Obama administration is would rather make people with Asthma cough up money than let them make a surely inconsequential contribution to depleting the ozone layer:

Asthma patients who rely on over-the-counter inhalers will need to switch to prescription-only alternatives as part of the federal government’s latest attempt to protect the Earth’s atmosphere.

The Food and Drug Administration said Thursday patients who use the epinephrine inhalers to treat mild asthma will need to switch by Dec. 31 to other types that do not contain chlorofluorocarbons, an aerosol substance once found in a variety of spray products.

The action is part of an agreement signed by the U.S. and other nations to stop using substances that deplete the ozone layer, a region in the atmosphere that helps block harmful ultraviolet rays from the Sun.

But the switch to a greener inhaler will cost consumers more. Epinephrine inhalers are available via online retailers for around $20, whereas the alternatives, which contain the drug albuterol, range from $30 to $60.

The Atlantic’s Megan McArdle, an asthma sufferer, noted a while back that when consumers are forced to use environmentally friendly products they’re are almost always worse:

Er, industry also knew how to make low-flow toilets, which is why every toilet in my recently renovated rental house clogs at least once a week.  They knew how to make more energy efficient dryers, which is why even on high, I have to run every load through the dryer in said house twice.  And they knew how to make inexpensive compact flourescent bulbs, which is why my head hurts from the glare emitting from my bedroom lamp.    They also knew how to make asthma inhalers without CFCs, which is why I am hoarding old albuterol inhalers that, unlike the new ones, a) significantly improve my breathing and b) do not make me gag.  Etc.

Well, tough cookies asthma sufferers! You should have written bigger checks to the Democratic party while you had the chance.

20 U.S. States Consider Raw Milk Illegal

by Karen De Coster
Activist Post
August 1, 2011

On the raw milk front, Dairyherd.com has some interesting survey results on comparative raw milk regulations on a state-by-state basis. To summarize, thirty states allow consumers to transact with raw milk producers while twenty states prohibit that act of freedom. And don’t forget that federal laws prevent the sale of any raw milk, from anywhere, over state lines. The fed’s response to the good white stuff moving over state lines is sending in armed soldiers in full battle gear to destroy the enemy.

Thirteen mini-regimes in the US of A allow the sale of raw milk on the farm where where it was produced, while four of those thirteen only allow “incidental occurrences,” which, of course, cannot be defined. But arbitrary laws with a host of potential interpretations is how the feds are able to use arbitrary rule interpretations to seize product and regulate small producers out of business. The article defines incidental occurrences as “occasional sales, not as a regular course of business; no advertising.” Surely, the feds can interpret “occasional” and “regular” and “advertising” in a whole host of capricious ways.

Four of those thirteen states only allow raw goat milk while Kentucky and Rhode Island – now get this – require a prescription from a physician! Of course, you can interpret that to mean raw milk must be medicinal (ask Moms who cure their child’s allergies with raw milk), but then again, there’s no such thing as a Big Milk Pharma that exists as a corporate arm of the state to keep its products available for good health. Lastly, eleven states allow raw milk to be sold in retail stores outside of the farm.

Several of the states that allow the sale of raw milk for human consumption have various twists and turns in their laws that make it very difficult to get the milk from the farm to the consumer, which essentially limits, or in some cases prevents, the sale of the product. However, milk entrepreneurs whose businesses are stifled by fascist decrees have been creative enough to come up with the idea of herd shares that allow folks, in some far-flung way, to buy a “piece” of a herd and get their milk. Any time that people can conjure up visionary ways to skirt the laws of the totalitarian regime, freedom has taken a small step forward.

Meanwhile, the FDA is going after Tucker Adkins Dairy of South Carolina like gangbusters. All of three (maybe eight?) people allegedly got sick from the dairy’s raw milk. So three people are confirmed sick – diarrhea – and the FDA has thrown a ton of resources at the issue to propagandize against raw milk and tout the “safety” of the industrial milk product. The FDA even put out this newswire that was nothing more than an expensive, pure propaganda piece. Author and defender of food choice, Dave Gumpert, explains on his blog why the FDA felt compelled to launch its agitprop offensive.

Why would the FDA feel compelled to get the word out far and wide about a relatively small, locally confined outbreak of food-borne illness that for all practical purposes ended a month earlier? There are two reasons, which have received much attention here.

The FDA has a case pending against Amish farmer Dan Allgyer in federal district court, filed in April, in which it is seeking a permanent injunction against him serving a private food club that brings raw milk from Pennsylvania to Maryland. That case has been very controversial, and inspired a boisterious demonstration in Washington two months ago, featuring a cow outside the Capitol.

The FDA is also the target of the lawsuit filed by the Farm-to-Consumer Legal Defense Fund, which challenges the legality of the FDA’s ban on interstate sales of raw milk. The FDA has been unsuccessful thus far in its efforts to have the case thrown out, and perhaps frustrated in the process.

The FDA is, in desperation, trying to influence consumers against raw milk. Even so, sales of raw milk keep increasing and new consumers come into the market every day. At my grocery store – Detroit Eastern Market – where forty thousand people gather each week to buy, sell, and inform, I have noted that the raw milk protestors (people who want food freedom with their own body) are in high visibility this year, and sales of herd shares are being advertised all over the market. With large, colorful signs! It seems that the more the government carries on its safety parade through its futile campaign of disinformation, the more people seem to brush off the spin as nothing more than second-rate hype and ignorable noise.