Boston Scientific Ordered by the FDA to Halt Sales of Gynecological Mesh

Boston Scientific and another transvaginal mesh manufacturer were ordered by the U.S. Food and Drug Administration (FDA) on April 16 to stop selling and distributing the products. The move comes in response to safety concerns regarding the surgical implants, which have been used in more than 2 million women. [1]

Transvaginal surgical mesh is used to repair weak or damaged tissue and provides support for women suffering from pelvic organ prolapse (POP). The condition occurs when muscles and tissues supporting the uterus, bladder, and rectum become weak, allowing one or more of the pelvic organs to drop or press into or out of the vagina. [1] [2]

Neither Boston Scientific nor the other company, Coloplast, have demonstrated the safety or efficacy of the devices, according to the FDA.

In a statement, Jeffrey Shuren, a physician and director of the FDA’s Center for Devices and Radiological Health, said:

“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP.”

The agency reclassified the devices as high risk in 2016, requiring both companies to win the FDA’s approval under its most stringent review process to keep selling the implants. Tens of thousands of women have filed lawsuits alleging that transvaginal surgical mesh caused them life-altering pain or injury.

Read: Johnson & Johnson Sued Again over Transvaginal Mesh Marketing

The Mayo Clinic says that transvaginal mesh for POP repair can cause complications such as erosion and pain, infection, bleeding, pain during sex, organ perforation, and urinary problems. In many cases, these complications require further treatment, including surgery.

The percentage of transvaginal POP mesh procedures has declined in recent years amid warnings about their potential risks.

The medical device makers have 10 days to come up with plans for pulling the products from the market. [2]

Boston Scientific said it is “deeply disappointed by the FDA’s decision,” and that “the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”

Coloplast took a humbler approach to the FDA’s demand, saying in a statement:

“Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps.”

Sources:

[1] CBS News

[2] Fierce Biotech

E-mails Show Coca-Cola Tried to Influence CDC Health Officials

The 2 most important keys to a healthy lifestyle are diet and exercise. But Coca-Cola desperately wants people to believe that diet isn’t as important as exercise, which isn’t much of a surprise, considering the products the company makes. But what you may not know is that Coca-Cola is willing to sink to low levels in order to deceive the public in order to sell more products.

A report published January 29 in the health policy journal Milbank Quarterly reveals that e-mails between Coca-Cola and top officials from the U.S. Centers for Disease Control and Prevention (CDC) show that the company tried to use its influence with the agency to push the World Health Organization (WHO) to emphasize exercise over diet as the solution to the obesity epidemic.

The report is new, but the methods are not.

The Coca-Cola Deception

Back in 2013, the corporation came out with an advertising campaign centered on the nation’s status on health and obesity. In the ads, Coca-Cola claimed to be doing its part to fight obesity by creating products that help people lose weight. In other words, diet soda.

As we wrote in 2013, Coca-Cola explains in the campaign how it can play an important role in fighting obesity by offering low- and no-calorie beverages, and stresses that the obesity epidemic is not caused simply by consuming the calories in its products.

Coca-Cola has been accused in the past of paying scientists to shift the blame away from junk food and sugary drinks for causing the obesity epidemic. The company was even caught red-handed donating large sums of money to “charities” that published propaganda telling people that soda has nothing to do with obesity, diabetes, and the many other health problems associated with obesity. It was further revealed that Coca-Cola paid health writers, bloggers, and spokespeople to push soda on the public as a healthy beverage.

This time, consumer groups are accusing the company of trying to sway the CDC toward policies that would benefit its products by corresponding with top agency officials and donating to the CDC Foundation. These alleged actions were discovered through Freedom of Information Act (FOIA) requests.

For example, former Coca-Cola senior vice president Alex Malaspina wrote in one newly discovered e-mail that the WHO “should not only consider sugary foods as the only cause of obesity but to also consider the lifestyle changes that have been occurring throughout the universe.”

The report states:

“The e-mails we obtained using FOIA requests reveal efforts by Coca-Cola to lobby the CDC to advance corporate objectives rather than health, including to influence the World Health Organization.”

There is little doubt that the Western diet, as a whole, is contributing greatly to obesity worldwide, particularly in America. Americans’ lust for over-consuming fast food, junk food, and processed food is insatiable and the eating pattern carries much of the blame for the nation’s expanding waistline. But the Western diet is also sugar-laden, and that’s the information Coca-Cola wants kept out of the public eye.

And it’s not just Coca-Cola. PepsiCo and other beverage makers have sought to shift the blame away from sugar and toward a lack of physical activity by influencing policymakers and lawmakers, and through misleading marketing campaigns and so-called philanthropy for years.

Peter Lurie, president of the Center for Science in the Public Interest, said:

“One of the things the sugar industry has so far been quite successful in is denying the strong and emerging science related to the adverse effects of sugary drinks.”

Even before there were thousands of soda options to choose from, the sugar industry was trying to convince Americans that sugar was near-harmless. In the 1960’s, the industry paid Harvard scientists to author studies showing that the worst health effects of sugar were cavities and hyperactivity. It laid the blame for obesity and heart disease on fat, and the American public blindly bought into the propaganda. It wasn’t long before no-fat and low-fat products became commonplace.

In reality, low-fat foods contain about 20% more sugar than full-fat products. So while Americans were gobbling up more sugar and less fat thinking they were being healthy in doing so, the sugar industry lined its pockets on the money it made off of people’s naiveté and trusting natures. After all, if Harvard scientists say something is good for you, surely it is. Right?

Coca-Cola is still betting that buyers don’t understand the relationship between health and diet.

Nason Maani Hessari, a research fellow in the Department of Health Services Research and Policy at the London School of Hygiene & Tropical Medicine in the United Kingdom, who was first author of the new paper, said that:

“…these e-mail exchanges show what appear to be attempts to leverage personal relationships at the CDC to further these goals at the expense of population health – and lead to questions about whether organizations like the CDC should refrain from engaging in partnerships where there is such a potential for conflict of interest.” [2]

CDC: A Willing Partner

Dr. Michael Siegel, professor of community health sciences in the Boston University School of Public Health called the depth of collaboration between Coca-Cola and the CDC “a little bit scary.” He also co-authored of a paper published in 2016 in the American Journal of Preventative Medicine detailing how Coca-Cola and PepsiCo sponsored at least 96 national health organizations at the same time the companies were lobbying against public health bills intended to reduce how many sugary sodas people drink.

“To me, the most disturbing aspect was the extent to which CDC officials were actually helping the company achieve its lobbying objective, and there were examples of giving them advice, providing contact information, helping them try to fight against soda taxes.

The larger implications of this, in my view, are that it really highlights the need to put up barrier walls – talking about building walls – but we need to have some barrier walls built between our government agencies and these corporations to prevent undue influence from occurring.”

Here is the truth: The occasional sugary drink is fine, but it should be a treat, and not part of your daily lifestyle – no matter what anyone says.

Sources:

[1] The Washington Post

[2] CNN

The Trouble with Studying Government-Provided Marijuana

Researchers are finally studying the medicinal effects of marijuana after many years of marijuana advocates begging and pleading for science to investigate what they already knew – that the plant has the power to ease seizures, help people sleep, and much more. But scientists aren’t studying the stuff you can buy on the street or in dispensaries, so can we trust their conclusions?

All it takes is a quick glance at the photo above to realize that scientists are using…well, crap…in their studies. And it’s not their fault; this is the schwag the government provides. It’s full of leaves and stems, it’s lighter in color, and it’s stringy. It’s almost like the government is afraid to give ’em the real stuff. [1]

Scientists are starting to get a little angry about the quality of cannabis they’re being forced to use. You can’t study medical-quality marijuana if you’re being provided with what looks like a bag of oregano.

Sue Sisley is a researcher who has just embarked on a first-of-its-kind clinical trial of government medical marijuana for military veterans suffering with PTSD. The study has its difficulties. Sisley says she once got a batch of federal marijuana that resembled green talcum powder.

“It didn’t resemble cannabis. It didn’t smell like cannabis.” [2]

Read: 21 Lawmakers Push Veterans Affairs to Allow Medical Marijuana

She’s not the only one who thinks government weed is a joke. Jake Browne, a cannabis critic for the Denver Post’s Cannabist marijuana news site, says:

“That is, flat out, not a usable form of cannabis.” [1]

Browne, who has reviewed dozens of strains professionally, adds:

“In two decades of smoking weed, I’ve never seen anything that looks like that. People typically smoke the flower of the plant, but here you can clearly see stems and leaves in there as well, parts that should be discarded. Inhaling that would be like eating an apple, including the seeds inside it and the branch it grew on.” [1]

Source: PBS News Hour

It’s unlikely also that Sisley just got a bad batch.

The University of Mississippi is the only facility permitted to grow federal marijuana. The program is overseen by the National Institute on Drug Abuse (NIDA), so it all comes from one place. Last summer, the DEA formally took steps to allow other entities to supply marijuana for research purposes, but so far none have been approved.

The potency of marijuana grown at the university tops out at 13% THC, but Sisley’s testing revealed that one of NIDA’s strains that was allegedly 13% THC was actually only 8%. The typical commercial weed available in Colorado is about 19% THC. Some higher-end strains can reach 30% or more.

How do you study whiskey when all you have is Mike’s Hard Lemonade? Crappy weed is OK if you’re using it to study how marijuana affects the body in a lab setting, but you can’t use NIDA weed to find out how the plant affects people in the real world. It doesn’t work in highly controlled medical experiments either. So says Rick Doblin, founding director of the Multidisciplinary Association for Psychedelic Studies (MAPS), a group that’s been working with Sisley on the PTSD trial.

Potency is only one of the problems being encountered by researchers. Remember the batch of government weed Sisley got that resembled green talcum powder? Well, some of the samples tested positive for mold. [2]

The government allows only one source of marijuana for clinical research in the United States; and “they weren’t able to produce what we were asking for,” Sisley says.

Sisley and her colleagues were finally able to enroll their first trial subjects, but it took 4 months and 3 rounds of testing after the initial delivery of bad weed. Mold can be dangerous, after all, particularly in people with mold allergies and in people with compromised immune systems. In fact, immunocompromised people were excluded from Sisley’s study.

Doblin says that this recent episode:

“…shows that NIDA is completely inadequate as a source of marijuana for drug development research.” [2]

He adds:

“They’re in no way capable of assuming the rights and responsibilities for handling a drug that we’re hoping to be approved by the FDA as prescription medicine.”

Sisley agrees, and says:

“…if you’re trying to do a study where you imitate what patients do in the real world, you can’t.”

Sources:

[1] The Washington Post

[2] PBS News Hour


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Jury Slams Johnson & Johnson with $417M Verdict over Talc-Cancer Link

A jury awarded a California woman $417 million on August 21, 2017 after she developed ovarian cancer as a result of using Johnson & Johnson Baby Powder for decades as part of her regular feminine hygiene routine. The award includes $70 million in compensatory damages and $347 million in punitive damages.

Los Angeles resident Eva Echeverria, 63, said she had used Johnson & Johnson Baby Powder since she was 11. She stopped using the product in 2016, after reading about another woman who had also developed ovarian cancer as a result of using the powder.

Hundreds of other cases are currently awaiting trial in California. Thousands of similar cases are progressing through state and federal courts, even as we speak. Juries elsewhere have returned 4 other verdicts against Johnson & Johnson.

Read: Johnson & Johnson Loses Another Talcum Powder-Cancer Lawsuit

The plaintiffs allege Johnson & Johnson ignored studies linking it’s Johnson’s Baby Powder and Shower to Shower products to cancer. [2]

Echeverria was diagnosed with ovarian cancer in 2007. She had a softball-sized tumor removed from one of her ovaries, but she is now at the end of her life and was too sick to attend the trial.

Echeverria’s attorney, Mark Robinson, said:

“Mrs. Echeverria is dying from this ovarian cancer and she said to me all she wanted to do was to help the other women throughout the whole country who have ovarian cancer for using Johnson & Johnson for 20 and 30 years.

She really didn’t want sympathy. She just wanted to get a message out to help these other women.” [3]

Robinson added:

“Johnson & Johnson had many warning bells over a 30 year period but failed to warn the women who were buying its product.”

In her testimony, Echeverria said that if Johnson & Johnson Baby Powder had come with a warning label about the potential for cancer, she would have stopped using it much sooner. [1]

Due to the fact that talcum powder is legally considered a cosmetic, Johnson & Johnson has no legal obligation to include a warning label. As a cosmetic product, talcum powder does not have to undergo a review by the FDA.

Some other talc-based products on the market do carry labels that mention the potential risk of ovarian cancer after frequent application for feminine hygiene. Many women apply talcum powder to their genital area, or on sanitary napkins, to prevent odor and chaffing.

Research into the link between talcum powder and ovarian cancer has been a mixed bag of results. According to the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC), the genital use of talc-based body powder is “possibly carcinogenic to humans.”

Jury: Johnson & Johnson Failed To Warn Of Talc Powder-Cancer Risk

The American Cancer Society (ACS) says the U.S. National Toxicology Program  has not fully reviewed talc as a possible carcinogen.

In a statement, Johnson & Johnson said it plans to appeal the verdict.

Carol Goodrich, a representative for Johnson & Johnson Consumer Inc., said in a statement:

“Ovarian cancer is a devastating diagnosis and we deeply sympathize with the women and families impacted by this disease.

We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s Baby Powder. In April, the National Cancer Institute’s Physician Data Query Editorial Board wrote, ‘The weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.’ We are preparing for additional trials in the US and we will continue to defend the safety of Johnson’s Baby Powder.”

Sources:

[1] CNN

[2] Los Angeles Times

[3] The Washington Post


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National Park Bottled Water “Ban” Reversed By Trump Administration

The news is awash with fire and brimstone warnings about plastic pollution, both on land and at sea. To help battle back against the trillions of pieces of plastic littering the planet, the National Park Service put a policy in place in 2011 encouraging national parks to end the sale of bottled water. It wasn’t an outright ban, but 23 out of 417 national parks went on to restrict bottled water sales. In mid-August 2017, the Trump Administration reversed the Obama-era policy.

The policy was rolled back “in close consultation with Department of Interior leadership,” the International Bottled Water Association (IBWA) said in a statement. [2]

Acting National Park Service Director Michael T. Reynolds said in a statement:

“While we will continue to encourage the use of free water bottle filling stations as appropriate, ultimately it should be up to our visitors to decide how best to keep themselves and their families hydrated during a visit to a national park.” [1]

The ban surely reduced some of the plastic litter plaguing national parks, but aspects of the policy made little sense. The 23 national parks that stopped selling bottled water continued to sell bottles of sweetened drinks, so the policy basically zeroed in on 1 source of pollution while essentially ignoring other sources, and made it impossible for visitors to those particular parks to purchase a healthy beverage option.

Jill Culora, vice president of IBWA, said:

“The rescinded policy was seriously flawed.”

The parks that banned the sale of bottled water tried to make up for it by spending millions installing water stations.

The policy was established to reduce waste, Culora said, but “people coming to the parks that banned the sale of bottled water were still allowed to buy other less healthy beverages – including carbonated soft drinks, sports drinks, teas, milk, beer, and wine – that are packaged in much heavier plastic, glass, cans, and cardboard containers.”

Visitors were also allowed to carry food wrapped in plastic into the parks. [2]

Read: This is Why We Need to Stop Using Plastic (Infographic)

The bottled water policy encouraged visitors to use water fountains and bring refillable bottles to quench their thirst. The park service says it is discontinuing the policy to give visitors more hydration options.

In a statement, the National Park Service said:

“The change in policy comes after a review of the policy’s aims and impact in close consultation with Department of the Interior leadership.” [1]

Still, every little bit of conservation helps. In a statement, the Sierra Club’s public lands policy director, Athan Manuel, said:

“actions that roll back protections on our National Parks and public lands only move our country backward — putting the importance of local economies, wildlife and communities on the back burner.”

The Sierra Club noted that the bottled water ban in national parks was intended to increase sustainability and cut carbon emissions.

Read: Plastic Bottles Could Lead to Environmental Crisis, Scientists Warn

And the nonprofit group Corporate Accountability International (CAI) pointed out that the Trump Administration recently appointed a deputy secretary at the Department of the Interior who previously was employed by a law firm that has represented one of the nation’s largest bottled water companies.

David Bernhardt was confirmed by the Senate as deputy interior secretary only weeks ago. He is a former lobbyist with the law firm Brownstein Hyatt Farber Schreck, which has represented Nestlé Waters, the distributor of the Deer Park brand. [2]

Nestlé is notorious for its former chairman and CEO, Peter Brabeck-Letmathe, who in 2013 said that drinking water is a not a human right and should be privatized.

Jesse Bragg, spokesperson for CAI, said in a statement:

“The [bottled-water] industry has lobbied Congress to block this policy for years.” [1]

Bragg added that this is an “example of the industry pulling the strings behind the scenes to protect is profits.”

Sources:

[1] NPR

[2] The Washington Post


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Fracking Giant Sues Citizen for Speaking out Against Fracking

Fracking giant Cabot Oil & Gas Corp. is suing Dimock, Pennsylvania resident Ray Kemble and his attorneys for $5 million after Kemble accused the gas driller of polluting residential wells in Pennsylvania. Cabot alleges that Kemble and his lawyers extorted the company through a “frivolous” lawsuit. [1]

In 2013, an EPA official wrote in an internal report that fracking conducted by Cabot Oil & Gas Corp. caused methane to leak into domestic water wells in Dimock, completely contradicting Cabot’s assessment, which said the methane gas was naturally occurring. [2]

State regulators initially got involved in 2010 and said Cabot’s drilling contaminated local wells, though a subsequent EPA investigation in 2012 found the water posed no health risks to Dimock residents.

Though the 2013 report didn’t exactly contract the EPA’s finding that the water was safe to use, it did show that at least one official determined that Cabot’s work damaged water wells.

Read: Study: People Living Near Fracking Sites Suffer Severe Health Problems

Now, Cabot is suing Kemble, claiming that his efforts to garner media attention to his polluted well “harmed” the company. The energy company alleges in the suit that Kemble’s actions breached a 2012 settlement that was part of an ongoing federal class action lawsuit over Dimock’s water quality.

Kemble says that even now his water “burns the back of your throat, makes you gag, makes you want to puke.” According to the outspoken Pennsylvanian, who, along with other community members, was featured in the 2010 documentary “Gasland,” said that things only got worse after Cabot fracked 3 wells near his house. [3]

In August 2017, scientists from the Agency for Toxic Substances and Disease Registry (ATSDR), a public health agency, again tested the water at Kemble’s home and about 2 dozen other houses.

A report released by the ATSDR in 2016 found contamination in some of Dimock’s well-water, but the tests did not look at what was casing the contamination. [4]

Read: Fracking Contaminates Groundwater, Study Proves

George Stark, Cabot’s director of external affairs, said of the lawsuit:

“Cabot will protect its rights and pursue justice against those who irresponsibly and maliciously abuse the legal system.” [1]

Source: Sierra Club BC

In April 2017, Kemble and his lawyers filed a federal lawsuit accusing Cabot of continuing to pollute Kemble’s water supply. However, the suit was withdrawn 2 months later. [3]

According to Cabot, the claims Kemble made in the lawsuit were the subject of a 2012 settlement between the driller and dozens of Dimock residents – including Kemble – and were barred by the statute of limitations. Cabot claims in the lawsuit that Kemble had breached the 2012 settlement by publicly discussing the company and the alleged damage it did to his water supply.

In 2016, some of Kemble’s neighbors, who had refused to sign a settlement agreement with Cabot, were awarded $4.2 million by a jury. However, in March 2017, that ruling was overturned. [4]

The judge overseeing the case ordered a new trial.

Two weeks later, Kemble filed his lawsuit against Cabot.

Sources:

[1] MintPress News

[2] The Washington Post

[3] Press Connects

[4] Hot Air

Sierra Club BC


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Study: Teen Pot Dependency DOWN Despite Looser Marijuana Laws

The legalization of marijuana around the country has many parents concerned that it will only get easier for their kids to get their hands on the vilified plant. But a study from Washington University School of Medicine in St. Louis should calm parents’ fears.

Researchers there studied a national database on drug use by over 216,000 preteens and teens ages 12-17, and found that fewer kids are dependent on marijuana, or struggling with school or relationships. All of these problems declined by 24% from 2002 to 2013.

During that time period, the number of kids who said they used marijuana in the previous 12 months dropped by 10%. Minor declines were also observed in the number of behavioral problems, such as fighting, shoplifting, and selling drugs.

Debunking the Myth: Legal Weed Does Not Increase Teen Marijuana Consumption

Behavioral issues and drug problems tend to go hand-in-hand. The “why” can go either way – when kids are no longer dependent on drugs, they have fewer serious problems. But kids who have fewer serious problems, or resolve them, are also less likely to be dependent on drugs.

The team wrote in the study, published in the Journal of the American Academy of Child & Adolescent Psychiatry:

“The reduction in the past-year prevalence of marijuana use disorders among adolescents took place during a period when 10 US states relaxed criminal sanctions against adult marijuana use and 13 states enacted medical marijuana policies. During this period, teenagers also became less likely to perceive marijuana use as risky, and marijuana use became more socially acceptable among young adults.”

Read: Physician Group Supports Federal Decriminalization, Regulation of Marijuana

Lead study author Richard Grucza, PhD, an associate professor of psychiatry atWashington University School of Medicine, said:

“We were surprised to see substantial declines in marijuana use and abuse. We don’t know how legalization is affecting young marijuana users, but it could be that many kids with behavioral problems are more likely to get treatment earlier in childhood, making them less likely to turn to pot during adolescence. But whatever is happening with these behavioral issues, it seems to be outweighing any effects of marijuana decriminalization.”

In 2002, about 16% of young people reported using marijuana during the previous year. By 2013, that number had dropped to below 14%. And the percentage of young people with “marijuana-use disorders” declined from about 4% to about 3%.

Grucza said:

“Other research shows that psychiatric disorders earlier in childhood are strong predictors of marijuana use later on. So it’s likely that if these disruptive behaviors are recognized earlier in life, we may be able to deliver therapies that will help prevent marijuana problems — and possibly problems with alcohol and other drugs, too.” [1]

The findings don’t mean that the loosening of marijuana laws are the reason behind the drop in marijuana dependence and behavioral/personal issues. But they do suggest that other factors – including broader behavioral and mental health trends – have a much broader effect on teen marijuana use than laws and attitudes towards pot.

Last year, a study published in Lancet Psychiatry found that legalizing medical marijuana had no effect on teen marijuana use at the state level. Other large surveys of adolescents have found that marijuana use among kids has been flat. And state-level federal survey data shows teen marijuana use has remained about the same, even in states where it has been legalized for adults.

Marijuana offers many health benefits, and there has never been a fatal overdose of cannabis in recorded history, though some studies have suggested that marijuana use may harm the developing teen brain.

Sources:

[1] Pain News Network

[2] The Sydney Morning Herald


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