Friday, August 26, 2016

The Senator’s Daughter Who Raised Prices on the EpiPen

Members of Congress are in an unusual position as they demand an explanation for Mylan NV’s 400 percent price hike for the EpiPen and focus attention squarely on its CEO: Heather Bresch.


If lawmakers follow the usual script, Bresch could get called up to Capitol Hill next month to explain her company’s justification for raising the price on the life-saving allergy shot. But that could be awkward, since she’s the daughter of Democratic Senator Joe Manchin of West Virginia.


The scrutiny on EpiPen intensified Wednesday after Democratic nominee Hillary Clinton called the price increase “outrageous,” sending Mylan’s stock down as much as 6.2 percent. The intense political pressure could lead regulators to speed up their review of a rival product by Teva Pharmaceutical Industries Ltd., according to some analysts, or force Mylan to curb prices -- in both cases hurting revenue and profits.


While CEO Bresch’s family ties may mute the ire of some lawmakers, others are already asking the company about taxpayers having to foot the bill for these price increases -- particularly after Bresch and the company successfully pushed legislation to encourage use of the EpiPen in schools nationwide.


Mylan is the latest drugmaker to provoke congressional ire for steep price hikes. Martin Shkreli and executives from the company he used to lead, Turing Pharmaceuticals AG, and executives from Valeant Pharmaceuticals International Inc. were called before congressional committees earlier this year to explain why they bought the rights to older drugs that lacked competition and raised the prices.


The Mylan controversy fits a similar pattern. Mylan has increased the price of its EpiPen from about $57 a shot when it took over sales of the product in 2007 to more than $600 for two auto-injectors. But the company’s EpiPen is a more mainstream drug used to treat life-threatening allergic reactions from bee stings, food allergies or other triggers, which could give the issue a larger constituency.


Mylan declined to comment when asked to explain the price hike or Bresch’s role in promoting legislation. Manchin’s office also didn’t respond to requests for comment.
Members in both chambers expressed outrage this week.
“I am deeply concerned by this significant price increase for a product that has been on the market for more than three decades, and by Mylan’s failure to publicly explain the recent cost increase, which places a significant burden on parents, schools and other purchasers of the EpiPen,” Senator Mark Warner, a Virginia Democrat, said Tuesday in a statement, noting that he is a parent of a child with severe allergies.


On Wednesday, the Senate Special Committee on Aging asked Bresch to turn over information used by Mylan’s board of directors related to the price increases. The panel wrote a letter to Bresch asking her to “provide a briefing to Committee staff on the pricing of EpiPen at a mutually convenient time no later than two weeks from today.” The letter was signed by the committee’s chairman, Republican Senator Susan Collins of Maine, and its top Democrat, Claire McCaskill of Missouri.


The issue of the price increase became presidential campaign fodder after Clinton issued her statement.
“Since there is no apparent justification in this case, I am calling on Mylan to immediately reduce the price of EpiPens,” Clinton said in a statement from her campaign.
Mylan’s shares, which have dropped this week as the scrutiny increased, fell further after Clinton’s comments. The stock was down 6.1 percent to $42.86 at 3:25 p.m. in New York, bringing the three-day losses to more than 11 percent.


Congressional anger may be fueled by the company’s tactics in pushing legislation that helped boost the use of EpiPens.


Mylan spent about $4 million in 2012 and 2013 on lobbying for access to EpiPens generally and for legislation, including the 2013 School Access to Emergency Epinephrine Act, according to lobbying disclosure forms filed with the Office of the Clerk for the House of Representatives. Mylan also was the top corporate sponsor of a group called Food Allergy Research & Education that was the key lobbyist pushing for the bill encouraging schools to stock epinephrine auto-injectors, of which EpiPen is by far the leading product.


But Bresch’s connections to Capitol Hill already have some lawmakers tiptoeing around the usual Washington blame game.


For example, Blumenthal, a member of the Senate Judiciary Committee and a co-sponsor of the 2013 schools bill, asked Bresch in a letter Monday to explain the “shocking price increases.”


However, in an interview Tuesday, he was less eager to talk about Bresch herself or the prospect that she might soon be testifying to the committee.
He initially answered during one telephone call that he was unaware that she had any direct involvement in the pricing. Then, in a follow-up call, Blumenthal responded when asked again about the possibility of her coming before Congress by saying, “I am just not going to comment on that.”
Bresch, 47, has been CEO of Mylan since 2012 and previously held other senior posts at the company, including as head of government relations. Last year, she had to defend the company after it moved its corporate address overseas to lower its U.S. taxes in a transaction known as an inversion. Now incorporated in the Netherlands, its principal executive office is in Canonsburg, Pennsylvania.

Wednesday, July 6, 2016

GlaxoSmithKline fined $3bn after bribing doctors to increase drugs sales

The pharmaceutical group GlaxoSmithKline has been fined $3bn (£1.9bn) after admitting bribing doctors and encouraging the prescription of unsuitable antidepressants to children. Glaxo is also expected to admit failing to report safety problems with the diabetes drug Avandia in a district court in Boston on Thursday.


The company encouraged sales reps in the US to mis-sell three drugs to doctors and lavished hospitality and kickbacks on those who agreed to write extra prescriptions, including trips to resorts in Bermuda, Jamaica and California.


The company admitted corporate misconduct over the antidepressants Paxil and Wellbutrin and asthma drug Advair.


Psychiatrists and their partners were flown to five-star hotels, on all-expenses-paid trips where speakers, paid up to $2,500 to attend, gave presentations on the drugs. They could enjoy diving, golf, fishing and other extra activities arranged by the company.
GSK also paid for articles on its drugs to appear in medical journals and "independent" doctors were hired by the company to promote the treatments, according to court documents.
Paxil – which was only approved for adults – was promoted as suitable for children and teenagers by the company despite trials that showed it was ineffective, according to prosecutors.


Children and teenagers are only treated with antidepressants in exceptional circumstances due to an increased risk of suicide.
GSK held eight lavish three-day events in 2000 and 2001 at hotels in Puerto Rico, Hawaii and Palm Springs, California, to promote the drug to doctors for unapproved use.
Those who attended were given $750, free board and lodging and access to activities including snorkelling, golf, deep-sea fishing, rafting, glass-bottomed boat rides, hot-air balloon rides and, on one trip, a tour of the Bacardi rum distillery, all paid for by GSK.
Air fares were also covered for doctors and spouses, in most cases, and speakers at the event were paid $2,500 each.

Before one event, the compere said: "We have a wonderful and unforgettable night planned. Without giving it all away, I can tell you – you'll be experiencing a taste of luxury."
Not everyone was impressed, though. One psychiatrist complained: "The style of the conference would have been suitable for a convention of cosmetics sales reps; this is supposed to be a scientific meeting. To me, the music, lights, videos, emcees are offputting and a distraction, even demeaning."
GSK also published an article in a medical journal that mis-stated the drug's safety for children, despite the journal asking several times to change the wording.


Copies of the misleading article were given to sales representatives to pass on to doctors in the hope that it would secure more business. Tickets to sports matches were exchanged for discussions about Paxil, with one doctor writing: "Dinner and a Yankee game with family. Talked about Paxil studies in children."


Despite knowing that three trials had failed to prove its effectiveness on children, Glaxo published a report entitled "Positioning Paxil in the adolescent depression market – getting a headstart"
The second drug to be mis-sold was Wellbutrin – another antidepressant aimed only at adults.

The prosecution said the company paid $275,000 to Dr Drew Pinsky, who hosted a popular radio show, to promote the drug on his programme, in particular for unapproved uses – GSK claimed it could treat weight gain, sexual dysfunction, ADHD and bulimia.
Pinsky, who had not declared his GSK income to listeners, said Wellbutrin could give women 60 orgasms a night. A study of 25 people using the drug for eight weeks was pushed by a PR firm hired by GSK, generating headlines including "Bigger than Viagra? It sounds too good to be true: a drug to help you stop smoking, stay happy and lose weight" and "Now That is a Wonder Drug".
When a GSK-funded doctor refused to remove safety concerns about the drug from an article he was writing, GSK removed his funding.


The investigation also found that sales representatives set up "Operation Hustle" to promote the drug to doctors, including trips to Jamaica, Bermuda and one talk coinciding with the annual Boston Tall Ships flotilla. Speakers were paid up to $2,500 for a one-hour presentation – up to three times a day – earning far more than they did working in their surgeries.
One speaker, Dr James Pradko, was paid nearly $1.5m by GSK over three years to speak about the drug. He also produced a DVD funded by the company, which was claimed to be independent. It was shown more than 900 times to doctors.


The hope was that doctors would be persuaded to prescribe the drug to patients over its rivals.
The last drug under scrutiny was Advair, GSK's bestselling asthma treatment.
The drug was launched to sales representatives in Las Vegas using images of slot machines, emphasising the bonuses they could make through sales. At the event, the then chief executive, Jean-Pierre Garnier, said: "What is the number one reason why you should love to be a GSK sales rep? Advair's bonus plan. Yeah!"


The company pushed the drug as the ultimate answer for tackling asthma, saying it should be the drug of choice for treating all cases. However, it had been approved only for treating severe cases, as other drugs were more suitable for mild asthma. GSK published material calling mild asthma a "myth" in an attempt to boost sales, according to the prosecution.
About $600,000 a year was given to district sales representatives for entertainment, including regular golf lessons, Nascar racing days, fishing trips, and baseball and basketball tickets.
US attorney Carmin Ortiz said: "The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts."

Wednesday, June 1, 2016

Tom Hanks blames himself for Type 2 diabetes diagnosis - knows he can reverse it naturally

(NaturalNews) Most people diagnosed with Type-2 diabetes believe it's a condition they will have for the rest of their lives. Convinced that there is little they can do to stop it, they accept their diagnoses and allow the pharmaceutical system to manage their condition for the rest of their lives. It's a helpless mindset, a thought process that gets imprinted into their minds by a clueless medical culture that has a hard time seeing and admitting the root causes of the metabolic problems associated with Type-2 diabetes.


Type-2 diabetes can actually be reversed solely through natural lifestyle changes. Famous actor Tom Hanks knows this, and has spoke out about his problems publicly. "I'm part of the lazy American generation that has blindly kept dancing through the party and now finds ourselves with a malady," he said, as reported by Womanista. "I was heavy. You've seen me in movies. You know what I looked like. I was a total idiot."

"I thought I could avoid it by removing the buns from my cheeseburgers," he explained. "Well, it takes a little bit more than that."

Hanks has publicly remarked that he grew up learning very little about nutrition as a child, and this lack of knowledge has affected him as an adult. On The Late Show with David Letterman in 2013, he opened up about getting a diagnosis and feeling trapped with it. "My doctor said, 'Look, if you can weigh as much as you weighed in high school, you will essentially be completely healthy. You will not have Type 2 diabetes,' And then I said to her, 'Well, then, I'm gonna have Type 2 diabetes, because there is no way I can weigh as much as I did in high school.'"

Tom Hanks knows that the diagnosis can be entirely eliminated from his life, making way for an entirely new, healthy lifestyle. He has recently decided to stop compromising his health for movie roles.

"I've talked to a number of actors who have gained weight for roles, and just the sheer physical toll it puts on one's knees and shoulders—no one wants to do it again," Hanks said at the 2013 BFI London Film Festival. "I'm 57 and I don't think I'm going to take on any job or go on vacation again and see to it that I can gain 30 pounds."

The good news is that Tom Hanks knows that Type-2 diabetes is something he can overcome. He just has to change key areas of his lifestyle so he can naturally reverse it.


Learn more: http://www.naturalnews.com/054214_Tom_Hanks_type_2_diabetes_natural_cures.html#ixzz4ALIunPFt

Wednesday, March 30, 2016

Pediatrics Journal says to stop calling breastfeeding "natural" !!

A new article in the journal Pediatrics is calling on health professionals to stop saying that breastfeeding is natural, arguing that doing so gives the impression that natural parenting practices are healthier.


The authors have started a public campaign to end the positive use of the word natural, claiming that it is associated with such "problematic" practices as home birth, homeschooling and the rejection of GMO foods, and that natural parenting movements are interfering with vaccination efforts. 


In the article, Unintended Consequences of Invoking the “Natural” in Breastfeeding Promotion, Jessica Martucci and Anne Barnhill, Medical Ethics and Health Policy researchers at Penn Medicine, wrote: Building on this critical work, we are concerned about breastfeeding promotion that praises breastfeeding as the “natural” way to feed infants. This messaging plays into a powerful perspective that “natural” approaches to health are better... Promoting breastfeeding as “natural” may be ethically problematic, and, even more troublingly, it may bolster this belief that “natural” approaches are presumptively healthier.


The authors are especially concerned that promoting natural practices such as breastfeeding will harm vaccination rates, since many parents who follow natural parenting practices also delay or decline vaccines for their children.


They also cite other examples of the "fallacy" that natural choices are intrinsically better, including the rejection of GMO foods, the preference for organic over conventionally grown foods and concerns over water fluoridation. Apparently the risk of giving the impression that natural choices can ever be positive choices is so great, that the authors conclude that the word natural should not be used in a positive context even if it means undermining breastfeeding.

Monday, March 14, 2016

Statin drugs increase risk for diabetes and weight gain

(NaturalNews) Pfizer's Lipitor (atorvastatin) is a record-breaking drug, a prescription with the highest peak sales of any drug on the market. Statin drugs like this one, along with other brand equivalents and generics, are a medical doctor's go-to "solution" for managing patient's cholesterol levels. These drugs are formulated to alter liver function, reducing the efficiency of a specific liver enzyme that produces cholesterol.


Under the spell of statins, liver cells are then more capable of capturing low-density lipoprotein cholesterol from the blood of patients, potentially reducing risk of heart attack and stroke. Statin drugs are often prescribed after one has suffered a major vascular event to prevent future incidents. However, suppressing the natural function of enzymes in the liver may very well invite new problems in the human body.

Taking statins increases type 2 diabetes risk by 12 percent


New research from the University College London (UCL) and the University of Glasgow finds that these statin drugs are more risky than rewarding, increasing risk for diabetes and weight gain. A large-scale analysis investigated the mechanism by which statins increase a patient's risk of type 2 diabetes.

In clinical trials that studied the effect of stain drugs on heart disease and stroke, 130,000 participants also underwent tests to determine diabetes risk in relation to the statin drugs. Over a four-year period, patients on statins gained an excess of 240 grams and were 12 percent more likely to develop type 2 diabetes versus those on placebo. The researchers were able to see that statins and variants of an enzyme-encoding gene in liver cells had a similar effect for increasing risk for type 2 diabetes and weight gain.

Coauthor Dr. Daniel Swerdlow of the UCL Institute of Cardiovascular Science confirmed that the findings were related to the statin drugs that participants were taking. "Commonly occurring variants in the gene encoding the same liver enzyme are associated with a lower LDL-cholesterol," he explained, but "Incorporating information from up to 220 000 individuals, we found that these genetic variants were also associated with a higher weight and marginally higher type 2 diabetes risk."

Swerdlow explained the effects of these genetic variants: "The effects were very much smaller than from statin treatment, but the genetic findings indicate that the weight gain and diabetes risk observed in the analysis from trials are related to the known mechanism of action of statins rather than some other unintended effect."


Statins are a risky way to try and prevent cardiovascular disease

In the study, co-senior author Professor Aroon Hingorani explained that suppressing these specific liver enzymes causes future metabolic distress in patients: "The genetic findings of our study help to explain the mechanism by which statins increase weight and diabetes risk. However, the effects of the genetic variants are orders of magnitude lower than the effects of statins."

The UK National Institute for Health and Care Excellence recommends that doctors prescribe statins for those who are deemed at a 10 percent higher risk for developing cardiovascular disease within the next decade. Broad suggestions like these can catapult entire populations of healthy people on a course with unintended side effects like type 2 diabetes.

Is controlling cholesterol levels in this way an effective solution or are statins a misleading racket? What are better ways for doctors to encourage patients to maintain a healthy vascular system without the need for these risky statin drugs?


Co-senior author of the study Professor Naveed Sattar recommends, "Many patients eligible for statin treatment would also benefit from lifestyle changes including increased physical activity, eating more healthily and stopping smoking. The modest increases in weight and diabetes risk seen in this study could easily be mitigated by adopting healthier diets and lifestyles. Reinforcing the importance of lifestyle changes when discussing these issues with patients would further enhance the benefit of statin treatment in preventing heart attacks and strokes."


Learn more: http://www.naturalnews.com/053291_statin_drugs_diabetes_weight_gain.html#ixzz42u0sy52f


Wednesday, February 24, 2016

GARDASIL-Don't Do it to your Daughters!

New Concerns about the Human Papillomavirus Vaccine

American College of Pediatricians – January 2016
The American College of Pediatricians (The College) is committed to the health and well-being of children, including prevention of disease by vaccines. It has recently come to the attention of the College that one of the recommended vaccines could possibly be associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause.


There have been two case report series (3 cases each) published since 2013 in which post-menarcheal adolescent girls developed laboratory documented POF within weeks to several years of receiving Gardasil, a four-strain human papillomavirus vaccine (HPV4).1,2 Adverse events that occur after vaccines are frequently not caused by the vaccine and there has not been a noticeable rise in POF cases in the last 9 years since HPV4 vaccine has been widely used.


Nevertheless there are legitimate concerns that should be addressed: (1) long-term ovarian function was not assessed in either the original rat safety studies3,4 or in the human vaccine trials, (2) most primary care physicians are probably unaware of a possible association between HPV4 and POF and may not consider reporting POF cases or prolonged amenorrhea (missing menstrual periods) to the Vaccine Adverse Event Reporting System (VAERS), (3) potential mechanisms of action have been postulated based on autoimmune associations with the aluminum adjuvant used1 and previously documented ovarian toxicity in rats from another component, polysorbate 80,and (4) since licensure of Gardasil® in 2006, there have been about 213 VAERS reports (per the publicly available CDC WONDER VAERS database) involving amenorrhea, POF or premature menopause, 88% of which have been associated with Gardasil®.5 The two-strain HPV2, CervarixTM, was licensed late in 2009 and accounts for 4.7 % of VAERS amenorrhea reports since 2006, and 8.5% of those reports from February 2010 through May 2015. This compares to the pre-HPV vaccine period from 1990 to 2006 during which no cases of POF or premature menopause and 32 cases of amenorrhea were reported to VAERS.


Many adolescent females are vaccinated with influenza, meningococcal, and tetanus vaccines without getting Gardasil®, and yet only 5.6% of reports related to ovarian dysfunction since 2006 are associated with such vaccines in the absence of simultaneous Gardasil® administration. The overwhelming majority (76%) of VAERS reports since 2006 with ovarian failure, premature menopause, and/or amenorrhea are associated solely with Gardasil®. When VAERS reports since 2006 are restricted to cases in which amenorrhea occurred for at least 4 months and is not associated with other known causes like polycystic ovary syndrome or pregnancy, 86/89 cases are associated with Gardasil®, 3/89 with CervarixTM, and 0/89 with other vaccines administered independently of an HPV vaccine.5 Using the same criteria, there are only 7 reports of amenorrhea from 1990 through 2005 and no more than 2 of those associated with any one vaccine type.
Few other vaccines besides Gardasil® that are administered in adolescence contain polysorbate 80.6 Pre-licensure safety trials for Gardasil® used placebo that contained polysorbate 80 as well as aluminum adjuvant.2,7 Therefore, if such ingredients could cause ovarian dysfunction, an increase in amenorrhea probably would not have been detected in the placebo controlled trials. Furthermore, a large number of girls in the original trials were taking hormonal contraceptives which can mask ovarian dysfunction including amenorrhea and ovarian failure.2 Thus a causal relationship between human papillomavirus vaccines (if not Gardasil® specifically) and ovarian dysfunction cannot be ruled out at this time.


Numerous Gardasil safety studies, including one released recently,8 have looked at demyelinating and autoimmune diseases and have not found any significant problems. Unfortunately, none of them except clinical safety pre-licensure studies totaling 11,778 vaccinees9 specifically addressed post-vaccination ovarian dysfunction. While data from those studies do not indicate an increased rate of amenorrhea after vaccination, the essential lack of saline placebos and the majority of participants taking hormonal contraceptives in those studies preclude meaningful data to rule out an effect on ovarian function.


A Vaccine Safety Datalink POF study is planned to address an association between these vaccines and POF, but it may be years before results will be determined. Plus, POF within a few years of vaccination could be the tip of the iceberg since ovarian dysfunction manifested by months of amenorrhea may later progress to POF. Meanwhile, the author of this statement has contacted the maker of Gardasil, the Advisory Committee on Immunization Practices (ACIP), and the Food and Drug Administration (FDA) to make known the above concerns and request that (1) more rat studies be done to look at long-term ovarian function after HPV4 injections, (2) the 89 VAERS reports identified with at least 4 months amenorrhea be reviewed by the CDC for further clarification since the publicly available WONDER VAERS database only contains initial reports, and (3) primary care providers be notified of a possible association between HPV and amenorrhea. A U.S. Government Representative responded that they “will continue to conduct studies and monitor the safety of HPV vaccines. Should the weight of the evidence from VAERS or VSD and other sources indicate a likely causal association between POF and HPV vaccines, appropriate action will be taken in terms of communication and public health response.”


The College is posting this statement so that individuals considering the use of human papillomavirus vaccines could be made aware of these concerns pending further action by the regulatory agencies and manufacturers. While there is no strong evidence of a causal relationship between HPV4 and ovarian dysfunction, this information should be public knowledge for physicians and patients considering these vaccines.
Primary author: Scott S. Field, MD
January 2016
The American College of Pediatricians is a national medical association of licensed physicians and healthcare professionals who specialize in the care of infants, children, and adolescents. The mission of the College is to enable all children to reach their optimal, physical and emotional health and well-being.

Friday, December 4, 2015

CDC issues flu vaccine apology: this year's vaccine doesn't work!

The following video from Gary Franchi of NextNewsNetwork reveals the shocking admission by the CDC that this year's flu vaccine doesn't work.

As this story has gone extremely viral, I've also added these additional links to other news stories that report on the CDC's admission that this year's flu shot contains the wrong strain:

Huffington Post: "Flu Vaccine Doesn't Protect Against This Season's Most Dominant Strain"

The Seattle Times: "Vaccine problems may signal rocky flu season" - "New evidence shows that FluMist and seasonal shots likely won't protect very well against this year's flu viruses..."

ABC News: "Flu vaccine may not be effective for this year's strains, CDC says"

Freedom Outpost: "CDC Health Advisory: Get Your Flu Shot. It "Might" Work This Year. Sort Of"



For the first time we can remember, the Centers for Disease Control and Prevention are going on the record, saying the flu vaccine won't work this year. The warning comes just before the busiest part of flu season, in January and February. Unfortunately, there won't be any refund for any of the patients or insurance companies who spent money on flu shots earlier this fall.

But don't worry. Just when you thought perhaps the CDC could boost their credibility, they found a way to put a sales pitch on the end of their warning. The CDC says if you do come down with the flu, there's a cure. It's just going to cost more money. Money that will end up profiting pharmaceutical giants, GlaxoSmithKline and Roche. CDC officials are urging doctors to prescribe two specific antiviral medications for any patients who come in with flu symptoms.

Just last week, the CDC issued a warning, prompting Americans to take the flu vaccine if they haven't already. Health officials said they had 160 million flu shots on the shelves and ready to go. But just earlier this week, Italy launched an official investigation after about a dozen people died within 48 hours of getting the flu shot. Their national health agency issued an immediate warning, saying DON'T take the vaccine. Here in America, the CDC isn't going that far. In fact, they found a way of turning this failed
vaccine into a promotion for yet another big pharma drug.
Learn more: http://www.naturalnews.com/047890_flu_vaccines_CDC_apology_medical_fraud.html#ixzz3tOYevp7B