This 3D Printed Smart Pill Can Live Inside Your Stomach for a Month

People are very willing to get creative in the name of our health. We wear FitBits that count every single step we take. We snooze next to SleepScore Max sensors that monitor breathing patterns with echolocation. But would you swallow an ingestible, Bluetooth-enabled sensor that can stay in your stomach for weeks at a time and collect data from the depths of your stomach?

Image courtesy of researchers

In a study published today in Advanced Materials Technologies, a research team at MIT tells Inverse they have developed a prototype that does just that after two years of development.

“It makes it easier for patients to be patients,” explains Giovanni Traverso, a senior author of the study.

Since 2016, Traverso and Yong Lin Kong, now an assistant professor of chemical engineering at the University of Utah, have led a team exploring the idea of long-term ingestibles that can monitor core temperature, detect infections and even dole out medication, all while communicating with an outside device, like a smart phone or tablet.

Image courtesy of researchers
This ingestible sensor is built to last for weeks inside your stomach. 

Kong says the idea for the ingestible grew out of trials for implantable medical devices. More infrequent dosing results in better compliance, so if you can just take one pill that metes out medication gradually, you could theoretically save lots of lives. But the implantation process, he says, can be a painful one and may require a surgical procedure. The risk for complications – infection, rejection – has always been high. Long-term implantations are often unsuccessful because of the body’s inflammatory immune responses. Kong and Traverso decided to try figuring out a way to start leveraging the unique properties of the stomach, a large organ that’s evolved to withstand the presence of foreign objects.

The sensor itself is housed in a swallowable capsule, around the size of fish oil supplement, says Traverso, a gastroenterologist at Brigham & Young Women’s Hospital and medical engineer MIT. The capsule is ingested and settles into the patient’s stomach; the outside coating wears away, leaving the 3-D printed sensor to monitor the body from its core.

Image courtesy of researchers
The sensor is Bluetooth-enabled for wireless communication with an outside device. 

The sensor is currently powered by several minuscule batteries, though the scientists have been considering a model that harvests energy from the G.I. tract.

Potential uses for the sensor are fairly diverse. Perhaps it could be used to keep tabs on soldiers at risk for hypothermia, says Traverso. Cancer patients with compromised immune systems could benefit from internal monitoring for infection; scientists have even built the sensor to house tiny compartments for potential medicine distribution, whose dose could be triggered by a physician’s iPad. Early detection for internal bleeding and high blood pressure are other possibilities.

The ultimate dream is to build smart capsules that can sense, react and serve as platforms for mobile health communication, says Traverso, though human testing for the sensor is still several years away. In the meantime, the team has begun considering ways to house and protect the massive amounts of health data that will be collected. The team is reportedly in talks with several bioinformatics teams.

Of course, even in light of all the promise, ingestibles may still be a tough sell. “We promise it’s not scary to swallow a sensor that will sit inside you and text your doctor” is a lot for a patient to, er. But as both Kong and Traverso point out, there’s already so much data monitoring in our every day lives. What’s a little bit more?

Ghost in the Machine: How Big Pharma Controls Our Perception of Drug Safety and Effectiveness

Drug Safety and Media Shaped by Big Pharma

In this article, we look at the “Ghost in the Machine” – the murderous forces in our health care system that harm patients instead of help them. This article will expose the deceptions that occur in almost all facets of health care today for no reason other than money. It will also expose the identities of the ghost’s “puppet masters” who perpetrate health misinformation and unethical drug marketing for profit, whether it’s Big Pharma or its helpers in academia, government and nongovernment agencies.

It should surprise no one that, in most cases, promotion of dangerous drugs and misleading health information is a direct result of conflicts of interest. For example, with the exception of CBS, every major U.S. media outlet keeps at least one person from the drug industry on its board, which clearly explains the dearth of reporting on Pharma dangers and corruption.1

The drug industry also spends billions a year on TV ads — revenue from just nine prescription drugs was worth $100 million in one year — which also stifles negative news stories about Pharma.2

Even so-called “public” media like PBS and NPR have accepted money from GlaxoSmithKline (GSK) and UnitedHealthcare.3 Similar conflicts of interest exist at medical journals, universities, medical associations, advocacy groups and government agencies, including those that are supposed to regulate the drug industry. The result is the Ghost in the Machine that we live with today — deceived patients taking expensive, often dangerous drugs and soaring health costs.

Revolving Doors Between Pharma and Government

One of the most damaging conflicts of interest is the revolving door between industry and government. It allows the worst forms of cronyism, quid pro quo arrangements and approval of dangerous drugs. Both Robert Califf, former Food and Drug Administration (FDA) Commissioner, and Scott Gottlieb, the current FDA Commissioner, are shining examples of conflicts of interest.

Before his appointment by President Obama in 2015, Califf received money from 23 drug companies including giants like Johnson & Johnson, Lilly, Merck, Schering-Plough and GSK, according to a disclosure statement on the website of Duke Clinical Research Institute.4 He even praised the involvement of Pharma in government affairs.

Gottlieb was named FDA commissioner this year by President Trump, despite his high-profile work as a Pharma consultant and stock trader. While serving as FDA deputy commissioner for medical and scientific affairs before becoming commissioner, Gottlieb had to recuse himself from work related to nine drug companies, including Roche, Sanofi-Aventis, Eli Lilly and Proctor & Gamble, because of his financial links.5,6

Another example of the “revolving door” between government and industry is former director of the Centers for Disease Control and Prevention (CDC) Julie Gerberding, who left the agency in 2009 where she had overseen vaccine decisions to head Merck’s vaccines division.7,8 In 2015, she sold 38,368 shares of her Merck stock valued at $2 million.9,10 Thomas Insel, former director of the National Institute of Mental Health (NIMH) also used the revolving door, leaving government for industry in 2015.11

And who can forget former Texas governor Rick Perry, who mandated that all girls in Texas be vaccinated with Gardasil, an HPV vaccine made by Merck, after his former chief of staff became a Merck lobbyist?12 Stipends from industry to government also skew drug messages. Gilead Sciences, an aggressive marketer of hepatitis C drugs, likely earned the right to add the CDC’s name to its ads because of its gifts to the CDC Foundation.13

Pharma/Academia Partnerships Are Lucrative Thanks to Taxpayers

Academia was once a source of unbiased drug and health information, untainted by Big Pharma and Big Pharma’s money. Not anymore. Universities now have a “renewed interest in partnering with pharmaceutical companies and are investing resources to ensure successful collaborations,” writes Pharma Voice.14 This is how Dr. Terrence Norchi, president and CEO of Arch Therapeutics, explains the profitable new partnerships.15

“For the past 15 years, the pipelines of the big [drug] companies have been drying up … At the same time, there is a tremendous amount of pressure on academic institutions in this country and abroad. To survive, many universities will have to find creative ways to make themselves more relevant. There are opportunities to mutually solve these challenges between academia and industry.”

Such Pharma/academia partnerships date back to the Bayh-Dole Act of 1980, which allowed universities to “patent discoveries that stem from government-funded research and then license them exclusively to companies in return for royalties,” wrote Marcia Angell, former editor-in-chief of the New England Journal of Medicine and Harvard lecturer, in the Boston Review.16,17

Similar laws also allow industry to co-opt and profit from NIH-funded research, which is also taxpayer supported, says Angell. Before the Bayh-Dole Act, government-funded discoveries were in the public domain — as they should be. Between 2000 and 2011 more than half of all new drugs approved in the United States were developed by collaborations with other entities such as universities.18

Increasingly, academia does not even attempt to hide its dual allegiances. Susan Desmond-Hellmann was invited to apply to be Chancellor of the University of California, San Francisco (UCSF), which includes a medical school, while serving as president of product development at Genentech.19 She remained at UCSF until 2014 after which she joined the Gates Foundation, which has its own serious conflicts of interest that you will read about in the Ghost in the Machine series.

Drug Trials Now Riddled With Conflicts of Interest

The faster Pharma can get a drug to market, the more money it makes — even if safety problems emerge later. Legal settlements from injury suits are simply built into the cost of the product launch and marketing. Gag orders with injured parties keep the dangerous side effects from reaching the public and dampening sales.

There are many examples of drugs rushed to market before they were proven safe, such as the painkiller Vioxx, estimated to have killed over 60,000 people, and the new, expensive hepatitis C drugs that were marketed before their ability to reactivate pre-existing hepatitis B was known.20,21

One way in which dangerous drugs are now rushed to market is the fast work of contract research organizations (CROs) to which Pharma increasingly outsources drug trials. CROs conduct drug trial design, recruitment, enrollment and consent of subjects, as well as preparation of the final drug submission package to the FDA in turnkey operations. If and when the new drug is approved, they will also take care of marketing and branding.

Another compromise in drug safety comes from the changing face of institutional review boards (IRBs), groups of medical professionals, laypeople and ethicists who monitor human safety during drug trials. Once linked to academic settings or hospital, IRBs have become for-profit ventures paid by the companies who do the research. When the financial livelihoods of members of IRBs depend on the company that hires them, that is a huge conflict of interest.

One example of the changing face of IRBs was revealed in a sting operation devised by Congress and the General Accountability Office. When they asked a Colorado review board to oversee a study of Adhesiabloc, a product designed to reduce scar tissue after surgery, it agreed to the work though neither the drug, developer nor lead researcher even existed.22

How can human subjects be protected in such eagerness to acquire new work? To cut costs, Pharma also increasingly runs trials in poor countries where informed consent is not easily explained and subjects sometimes think they are receiving real medical care.23

Conflicts of Interest Abound in Research

In the Ghost in the Machine series, we will review conflicts of interest in publishing that skews the perception of a drug’s safety in the public’s eyes as well as among medical professionals. Research and scientific papers boosting the benefits of new drugs and downplaying their risks often appears in medical journals, ghostwritten by the drug industry with a medical professional’s name attached for credibility.24

For example, the popularity of the withdrawn Vioxx, the birth defect-linked Paxil, Neurontin, and the cancer and heart disease-linked hormone replacement therapy drugs all stemmed from papers ghostwritten by industry. In 2016, the National Press Club in Washington held a half-day conference for reporters, scientists and business executives to discuss how well the news covered science called “Lost in Translation: Is Science Explained Fairly in the Media?”

But it was clear that the conference was biased as it grew from a partnership between Scientific American magazine, Johnson & Johnson and GMO Answers, a group funded by members of The Council for Biotechnology Information, which includes Bayer, Dow AgroSciences, DuPont, Syngenta and Monsanto.25 The event represented a popular new trend, wrote Paul Raeburn:26

“The conference was an example of what is now a widespread and growing practice in the publishing industry: the use of ‘branded partnerships’ to extended publishers’ reach and boost their income. While these arrangements might generate revenue, they also raise important questions about journalistic credibility.

After all, how can news outlets like Scientific American, a respected — even revered — source of science news, maintain the appearance of impartiality while accepting checks from companies they cover? And should respected journalists lend their names and reputations to such conferences by participating on the panels?”

Examples of branded and ghostwritten content invading publishing are not hard to find. Recently, ProPublica and Consumer Reports reported that hepatitis C drugmaker AbbVie funded a special issue of the American Journal of Managed Care on hepatitis C research, using a Stanford professor as guest editor-in-chief.27

Even books are funded by Pharma. A 1999 textbook written to help primary care doctors diagnose psychiatric conditions was funded entirely by GlaxoSmithKline (GSK), which makes pills for psychiatric conditions. Its authors were two prominent psychiatrists, one of whom was on GSK’s speaker’s bureau; the other was investigated by Congress for undeclared GSK income.28

Nonprofit Organizations Push the Pharma Agenda

Recently I wrote that philanthropist Bill Gates was leading the pack as one of the most destructive “do-gooders” on the planet, and that his views on addressing poverty and disease in poor countries were shortsighted and misinformed. Why? Because the Bill & Melinda Gates Foundation (B&MGF) is one of the world’s foremost promoters of mass-vaccination efforts, which are a major part of the Pharma agenda.

Two of the B&MGF’s research heads were hired right out of Pharma — one from GlaxoSmithKline, with whom the B&MGF had a long-standing collaboration, and the other from Novartis.29 In 2002, B&MGF began buying billions in drug stocks and subsequently added huge amounts of Monsanto stock as well. Not surprisingly, the foundation is also a leading international promoter of GMO crops and technology.

“The Bill & Melinda Gates ‘Foundation’ is essentially a huge tax-avoidance scheme for enormously-wealthy capitalists who have made billions from exploiting the world’s people,” writes Ruben Rosenberg Colorni. “The foundation invests, tax free, money from Gates and the ‘donations’ from others, in the very companies in which Gates owns millions in stocks, thus guaranteeing returns through both sales as well as intellectual-property rights.”

In a 2011 Forbes interview, Bill Gates admitted the new profitability of vaccines. “Ten or 15 years ago, nobody in the drug business would have held up vaccines as profit centers,” he said, conceding that “vaccines are so tough, particularly because of liability issues.” But now, “people are making money in the vaccine business,” he noted. His statements characterize the Ghost in the Machine well.

There Is a Final Irony to the Ghost in the Machine

While mainstream medicine, which is dominated and influenced by Pharma, assails natural, nonprescription treatments that are less expensive and usually safer as worthless and untrustworthy, many Pharma companies are trying to enter the vitamin and supplement industry themselves. It is easy to see why. Supplements and natural products often treat or prevent the conditions on which Pharma makes most of its money.

They are used by the most desirable customers to Pharma — patients who say they have “excellent” or “very good” health and have high discretionary income.30 Such patients often prefer natural treatments like probiotic-rich fermented food for heartburn instead of Pharma’s dangerous proton pump inhibitors. They are not deceived by the Ghost in the Machine.

Part 2: Success Breeds Greed, Which Gets in the Way of Ethics, Common Sense and Caution

Direct-to-consumer (DTC) drug advertising, which began in 1997, has done a lot more than make Pharma arguably the most profitable industry in the world and a Wall Street success story. It has greatly increased the number of prescription drugs that Americans take. In 1992, five years before DTC advertising began, Americans took an average of seven prescription drugs a year. A mere 15 years later that number had nearly doubled to 12 per year.31,32

To sell drugs, aggressive drug advertising whips up fears over rare diseases like exocrine pancreatic insufficiency (introduced at the 2017 Super Bowl) and make a disease out of common, nearly universal conditions to frighten and motivate people into taking prescription drugs.

Another DTC advertising tactic is convincing people to take drugs simply because they might be “at risk” of a condition. Sadly, drug advertising is not the only way Pharma gets dangerous drugs into the nation’s medicine chests. Thanks to outrageous conflicts of interest at the U.S. Food and Drug Administration (FDA) — the new FDA Commissioner, Dr. Scott Gottlieb, is a drug company consultant — drugs that would once have not been approved fly through their approvals.

DTC Advertising Does More Harm Than Good

Pharma-funded “patient groups” also create a false sense of demand for an expensive drug. And, last year, the FDA began clearing the way for Pharma “off-label” speech, once illegal.33 Now marketers and drug reps can claim benefits to their drugs not backed by the FDA, raising the question of “why have an FDA?”

Aggressive drug ads telling people to get medication from their doctors are especially unethical in the middle of an opioid epidemic and war on drugs. Moreover, the 21st Century Cures Act, passed in 2016, allocates $1 million to “opioid addiction” treatment drugs to address the opioid crisis Big Pharma created, allowing the industry to profit twice.34

Pharma’s marketing of dangerous drugs, often which is often completely unnecessary, does not just harm overmedicated people. Poor people who legitimately need medical care and medication are also neglected because no profits can be made from them.

DTC Advertising Creates Patients

As previously noted, DTC advertising has greatly increased the number of prescription drugs taken in the U.S. A decade and a half after DTC began, the use of prescription medication went up 71 percent, adding $180 billion to U.S. medical spending.35

By 2014, 70 percent of adults and 25 percent of children in the U.S. were on at least one prescription drug.36 Today, 20 percent of Americans are on five or more prescription drugs.37 DTC drug advertising “is now the most prominent type of health communication that the public encounters,” reported Pharmacy and Therapeutics, adding:38

“The average American television viewer watches as many as nine drug ads a day, totaling 16 hours per year, which far exceeds the amount of time the average individual spends with a primary care physician.”

Pharma is legally required to include risk information about drugs in its ads, but the info seldom scares patients away. Everything from actors who use an appealing voice tone, to beautiful images and music choices is designed to make you tune out the risks.

DTC Ads Are Highly Effective

DTC ads are so effective, the average number of prescriptions for advertised drugs is nine times greater than prescriptions for non-DTC advertised products.39

DTC ads have put tremendous pressure on doctors who are aware that denying a prescription request can decrease patient satisfaction and cause patients to switch doctors. “Refusal skills” have even been taught to doctors, says an article at the Center for Health Journalism:40

“Writing a prescription may seem quicker but ‘explaining to a patient why a highly-advertised drug might not be appropriate only takes three minutes,’ said [Dr.] Richard Pinckney, professor at the University of Vermont College of Medicine where such a program existed.

‘The insurance savings could pay for programs like these,’ he said. The Vermont project included ‘secret shoppers’ who asked doctors for an expensive brand name drug they had seen on TV after the refusal training.

‘Doctors have a hard time saying no if a drug is effective, even if it is expensive,’ said [Dr.] Audiey Kao, vice president of ethics at the American Medical Association at a 2010 conference. Doctors are ‘nervous’ that rebuffed patients will go elsewhere, agreed Dr. Pinckney.”

Highlighting Symptoms Sells Pills

Once upon a time, a medical professional sought to reassure patients and tell them they were not sick. Who remembers, “Take two aspirins and call me in the morning?” Today, thanks to DTC advertising, patients receive the exact opposite message: You probably are sick and should see your doctor.

Normal conditions like sad moods or indigestion are now said to signify potentially serious conditions, and when someone has no symptoms at all they could still be “at risk” of silent killer diseases, say DTC ads. Some DTC ads even tell you what to tell your doctor when you visit him or her and provide coupons to provide a discount for the drug being promoted.

This type of advertising is called “disease awareness” and Pharma says it is “educational” since it acquaints people with conditions and symptoms they may not know about. The truth is it increases hypochondria, self-diagnosis and the pool of patients who might use a new, advertised drug.

Sometimes disease awareness ads are “unbranded,” meaning they do not even mention the drug they are selling. This leads people to believe they are hearing public service messages from a government agency instead of calculated Pharma messages to make people think they are sick.

One example of a disease “grown” by DTC advertising is gastroesophageal reflux disease (GERD). If you have heartburn, acid reflux, GERD, peptic ulcer disease or any acid-related condition, chances are you’ve been offered a prescription for a proton pump inhibitor (PPI) like the best-selling Prilosec.

Contrary to Pharma marketing, PPIs actually cause the very symptoms they’re intended to prevent by creating “rebound acid hypersecretion” when you stop taking them; built-up acid can be unleashed with a vengeance. In one study, more than 40 percent of healthy volunteers experienced heartburn, acid regurgitation and dyspepsia (pain and fullness in your abdomen) in the weeks after stopping PPIs; these were symptoms they did not have before.

Other Diseases Grown by DTC Advertising

One of the clearest examples of how DTC advertising “grows” the amount of people identifying with a condition has been the statin drug class, prescribed to reduce the risk of cardiovascular disease and mortality.

Until it went off patent, Pfizer’s Lipitor was the best-selling drug in the world.41 The popularity of statins reflects Americans’ and medical practitioners’ impulse to treat a condition quickly with a pill rather than more slowly but more effectively with lifestyle changes. Needless to say, Pharma makes no money on better lifestyle choices. Here is how AlterNet described the success of statins.42

Patients loved statins because they could ignore diet and exercise advice and still, apparently, reduce heart attack risks; their body would ‘forgive’ the bacon cheeseburger. But not all medical voices agreed. Some wondered why the nation spent approximately $20 billion a year on cholesterol-lowering drugs instead of effective, less dangerous and less expensive lifestyle and diet changes.”

Another example of an overexposed condition is erectile dysfunction (ED). According to the National Institutes of Health (NIH), approximately 12 percent of men younger than 60 and 30 percent older than 70 suffer from ED. However, the market for the top three ED drugs is over $1 billion annually and expected to reach $3.2 billion by 2022. This means many men are treating a condition that may be well within the range of normal.

The same overdiagnosis and overtreatment can be seen with low testosterone or “low T.” Rather than making diet and exercise changes, men are erroneously told they need to treat their testosterone decline with drugs.

Pills for Rare Diseases Are Pharma’s Biggest Profit Center

If you have noticed aggressive DTC advertising for drugs that treat rare diseases, you are right. Approximately 1.2 percent of Americans (3.2 million) have schizophrenia, yet drugs that treat the condition have been among Pharma’s bestsellers.43 Specialized, highly expensive drugs that treat rare mental disorders, cancers, autoimmune diseases and other specialized ailments “have been growing in leaps and bounds in recent years,” says the financial site Motley Fool:44

“[That] means that volume may not necessarily be driving sales of these therapies higher so much as price hikes. A good example would be Amgen’s … anti-inflammatory drug Enbrel, which grew revenue by 14 [percent] in 2016, but actually had units sold of the drug fall by 6 [percent] year-over-year. This means price increases drove its 14 [percent] total growth.”

Rheumatoid arthritis (RA), which also afflicts a small number of people, is very aggressively advertised because of the high price tags of the drugs that treat it. As I have often warned, rheumatoid arthritis drugs are among the most dangerous drugs available. Humira, Remicade and similar drugs double your chances of getting a serious infection and triple your risk of some cancers. They also fail miserably in not addressing the underlying foundational reasons why the condition began in the first place.

The drugs are linked to lymphoma, tuberculosis, pneumonia and skin, gastrointestinal, breast and lung tumors. Older patients who take the drug for long periods are at highest risk.

These dangerous drugs are almost always unnecessary for most people taking them. It has been my experience that virtually all rheumatologists are clueless about the root cause of the disease they are treating. Because they don’t have a clue about the cause, they have to rely on toxic concoctions that can devastate your health.

Over the past 16 years, however, I’ve treated more than 3,000 patients safely by using my extensive RA protocol, which does address the underlying conditions, as does my new book “Fat for Fuel,” which helps you optimize your mitochondrial function.

Greed Sends Health Care Costs Soaring

In the past few years, the public, health care professionals and Congress itself have been appalled at Pharma’s profiteering. Many remember how Martin Shkreli, former Turing Pharmaceuticals CEO, raised the price of the life-saving drug Daraprim, crucial for AIDS patients, from $13.50 a tablet to $750 per tablet, and the similar EpiPen price hikes.

Valeant Pharmaceuticals International Inc. hiked the price of a once-daily form of Wellbutrin, a 30-year-old antidepressant, to $1,400 a month despite the existence of a $30 generic, and refused to lower prices on the millions hospitals pay for its life-saving heart medicines.45

The ruse of patient assistance for expensive drugs is just that: a ruse. Pharma, trying to look like it has a heart, simply shifts the high cost to privately insured patients and still gets its high prices. Taxpayers also pay. A Senate committee found that the hepatitis C drugs Sovaldi and Harvoni cost taxpayers $5 billion in 2014. Of course, there are cheaper drugs, but they are not the ones promoted, reported Pharmacy and Therapeutics:46

“Another common complaint is that manufacturers often use DTCPA [direct-to-consumer pharmaceutical advertising] to promote expensive ‘me-too’ or ‘copycat’ drugs that might not offer any significant benefits over older and cheaper medications. 

For example, two heavily promoted diabetes treatments, rosiglitazone (Avandia, GlaxoSmithKline) and pioglitazone (Actos, Takeda), were found to be no more effective — or safe — than older drugs, even though they were much more expensive.

In another study, older drugs for the treatment of schizophrenia were found to be equally effective and to cost as much as $600 per month less than olanzapine (Zyprexa, Eli Lilly), quetiapine (Seroquel, AstraZeneca), or risperidone (Risperdal, Janssen).”

Other Ways Pharma Ensures Its High Prices

As mentioned, outrageous conflicts of interest at the FDA allow drugs that once might not have been approved to fly through their approvals and onto Wall Street.47

It is no surprise, then, when rushed-to-market drugs are withdrawn, since an insufficient amount of time was allotted for safety problems to emerge. Patient front groups — a typical “astroturf” strategy, since they are not really grassroots — keep drug prices high. According to AlterNet:48

“More than 80 percent of patient groups are Pharma-funded … including the National Hemophilia Foundation, the American Diabetes Association and the National Psoriasis Foundation.

But the most insidious are the mental health front groups like the National Alliance for Mental Health (NAMI) and Mental Health America. Not only do psychiatric drugs represent four-digit outlays per month per patient, and sometimes much more, patients are kept on them for decades or for life, with few medical attempts to determine if patients still need them or ever needed them.

Side effects of the drug cocktails are viewed, thanks to Pharma spin, as confirmation of the ‘mental illness,’ not the side effects they almost always are. The use of such drugs in the elderly, despite their links to death in those with dementia, has become epidemic and is an underreported cause of falls.”

To defend its high prices, Pharma has also rolled out PR campaigns targeting lawmakers who want to stop the profiteering. They are designed to show the “value” that drugs that cost five and six figures represent. The prices are always presented as fixed and non-negotiable, but the Senate Finance Committee said last year they do not reflect research and development but are simply an opportunistic and arbitrary “revenue” push.49

The message of the campaigns, showing patients whose lives were saved or lengthened by expensive Pharma medicines, is that questioning Pharma’s outrageous drug prices means you’re heartless and don’t care about these patients’ lives. Even as Pharma companies seek to incorporate overseas to duck U.S. taxes, and manufacture almost all their drugs overseas, these campaigns also claim its high-priced medicines help the U.S. economy by creating jobs, like for “sheet metal workers.”50

Part 3: Pride and the Politics of Vaccines

There needs to be an open, rational discussion about vaccination, infectious diseases and health. After all, don’t all of us want our children to be healthy and safe from unnecessary harm?

If we want to protect the health of all children, we cannot continue to ignore the signs that public health policies making mandatory use of multiple vaccines in early childhood as our nation’s No. 1 disease prevention strategy have gotten to the point where we have no idea how children’s lives are being sacrificed in the name of “the greater good.”

From my point of view, there can be little doubt that we need to review the safety and effectiveness of the current vaccination program in the U.S., and that this review needs to include methodologically sound investigative studies that are not compromised by conflicts of interest within industry and government. If we don’t do that now, we may not be able to stop further damage to the health of future generations.

Vaccine History is Shameful

Many are aware of the unethical and manipulative marketing of today’s vaccines. But the roots of the greed-based marketing — battling over markets, patents, intellectual property, profits, “turf” and prestige — could be seen 20 years ago with the Children’s Vaccine Initiative (CVI).51

The CVI was founded in 1990 after the World Children’s Summit in New York City by the Rockefeller Foundation, United Nations Development Program (UNDP), United Nations International Children’s Emergency Fund (UNICEF), the World Bank and the World Health Organization (WHO) with an overarching goal of vaccinating all the children in the world with vaccines endorsed by the WHO and governments.52

Reportedly, CVI has been marked by a rivalry for leadership between the World Health Organization (WHO), UNICEF and the U.S. The CVI was created as a means for UNICEF to fund research and development of vaccines for distribution globally without directly giving money to WHO.

There were difficulties inherent in coordinating the efforts of different governments and public-private partnerships. Also, there were questions about vaccine production itself, such as would the ability of drug companies and governments to quickly produce large quantities of vaccines end up compromising the quality of vaccines?

According to the book, “The Politics of International Health: The Children’s Vaccine Initiative and the Struggle to Develop Vaccines for the Third World,” the U.S. Department of Defense was a cooperative partner with CVI:53 “The Army, unlike the public sector generally, worked closely with private pharmaceutical companies to make sure that the vaccines it needs were actually produced. It could not afford to leave decisions to the marketplace.”

Overseas Vaccine Disasters

Increasingly, Big Pharma produces, tests and sells its vaccines in poorer, undeveloped countries — sometimes with disastrous results. This is what happened with Gardasil, a Merck vaccine against the human papilloma virus (HPV), which is linked to venereal warts and cervical cancer. As reported by Counterpunch:54

“Merck attempted to cast the vaccine as lifesaving — even in poor countries with much more pressing disease risks — but Pap smear tests are equally effective in preventing [through detection] cervical cancer and cost much less. Nor are the vaccines clearly safe. [In 2015], judges in India’s Supreme Court demanded answers after children died during a trial of Gardasil and Cervarix, GlaxoSmithKline’s counterpart vaccine.” 55

Young tribal girls as young as 9 were given Gardasil and Cervarix HPV vaccines with no informed consent or even awareness that they were participating in an experimental vaccine trial. The study was funded by the Bill & Melinda Gates Foundation.56

The pharmaceutical industry likes overseas clinical trials because regulations are less strict and sometimes nonexistent, and product liability lawsuits involving personal injury are unlikely. In fact, trial participants often welcome the test drugs thinking they are being given important or needed medical care.

Clinical trial participants in foreign countries, especially those who live in poverty with little education or access to medical care, are also “drug-naïve” — they have not used the antibiotics, statins, psychiatric and GERD medications so common in industrialized countries.57 Clinical trials require that participants have a “washout” period to ensure any drug residues in their bodies do not confound the trial results, and subjects in poor countries have no drugs to “wash out.”

Many medical ethicists also question whether trials of pharmaceutical products should be conducted on people who don’t need them or won’t receive them after the trial. If the drug (or vaccine) will not be available free or for a reasonable cost for a significant time afterward, the trial itself is unethical in that it is “exporting the risk of research to those who will, in the end, not be able to afford the resulting medical products,”58 say ethicists.

And informed consent? Some ethicists have argued that videotapes of informed consent statements by trial participants would protect them much better than the current written consent forms being used because of language barriers and the fact that some trial participants in impoverished countries cannot read.

Big Pharma Conflicts of Interest Abound

Mainstream media are financially linked to Big Pharma through drug ads (estimated to account for as much as 72 percent of commercials)59 and through allowing drug company representatives to serve as board members. Here is how Organic Consumers Association (OCA) describes the conflicts:60

“There are brazen and unhidden conflicts of interest between mainstream media and vaccine makers which color reporting and discourage safety questions.

‘According to a 2009 study by Fairness and Accuracy in Reporting, with the exception of CBS, every major media outlet in the United States shares at least one board member with at least one drug company,’ reports Mike Papantonio, of the ‘America’s Lawyer’ TV show. ‘These board members wake up, they go to a meeting at Merck or Pfizer, and then they have their driver take them over to a meeting at a TV station,’ says Papantonio.”

The government is also in the vaccine “biz.” Vaccine safety activist Robert F. Kennedy Jr. reported that the CDC owns more than 20 different vaccine patents and sells $4.1 billion in vaccines each year, noting that those patents create a significant undisclosed conflict of interest when it comes to the agency’s involvement in vaccine safety. It is a case of the fox guarding the henhouse.

The New York Times reported that most experts who served on Centers for Disease Control and Prevention advisory panels to evaluate flu and cervical cancer vaccines had potential conflicts that were never resolved.61 The vaccine industry also “gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters,” according to a CBS investigative report.62

Unscientific ‘Conclusions’ Reached by News Outlets

Almost all news sites parrot the Big Vax party line in shocking abdication of journalistic ethics. For example, no news outlet would declare “all drugs safe” because they clearly are not, yet they obligingly declare “all vaccines safe,” which insults the public’s intelligence. In addition to published reports of vaccine injuries,63 there are many reports of vaccines recalled for safety issues.

No, all vaccines are not “safe” and every pharmaceutical product carries a risk of injury or death that can be greater for some people than others.

To get a clearer understanding of the many safety concerns raised by vaccine researchers, get a copy of Neil Z. Miller’s book, “Miller’s Review of Critical Vaccine Studies: 400 Important Scientific Papers Summarized for Parents and Researchers.” In it, he reviews the vaccine safety and efficacy concerns raised by 400 peer-reviewed published studies.

Imagine a news outlet blaming motor vehicle accidents in which the motorist fell asleep and harmed others on the motorist’s refusal to take stimulants for sleepiness. As outrageous as that would be, headlines from respected news sites do exactly that when they blame disease outbreaks on “anti-vaxxers.”

As scientists and reporters with integrity know, causation can almost never be claimed; the preferred terms are “linked, “associated” and “correlated.” “Anti-vaccine activists spark a state’s worst measles outbreak in decades,” trumpeted The Washington Post in May.64“Anti-vaxxers brought their war to Minnesota — then came measles,” screamed Wired.65

“Attempts by anti-vaccine activists to influence the Somali parents of Minnesota have ended with a measles outbreak that has made dozens of kids sick,” declared The Daily Beast.66 “Anti-vaccine groups blamed in Minnesota measles outbreak,” charged CNN.67 Conveniently ignored is the fact that the CDC maintains a Vaccine Adverse Event Reporting System (VAERS) that in February revealed 416 deaths from measles vaccines MEA, MER, MM, MMR or MMRV.68

The Science is Ignored

Earlier this year, Kennedy, chairman of the World Mercury Project, actor Robert De Niro and others held a press conference at the National Press Club in Washington D.C., calling for an open and honest discussion about vaccine safety. Appearing in a video was the late Dr. Bernadine Healy, who was the first female director of the National Institutes of Health, serving from 1991 until 1993.

She was also professor of medicine at Johns Hopkins University, professor and dean of the College of Medicine and Public Health at Ohio State University and president of the American Red Cross and the American Heart Association.69 In the video, Healy expresses concern that no government attempts have been made to see if a population of susceptible people exists for whom vaccines are risky.

She said she did not believe “the public would lose faith in vaccines” if such a population were found, a fear she said was expressed at the Institute of Medicine. She also lamented how animal studies which suggest vaccine links to neurological damage have been ignored. One such study was savaged by pro-vaccine scientists. As reported by OCA:70

A 2010 paper published in Acta Neurobiologiae Experimentalis, a quarterly peer-reviewed scientific journal covering neuroscience, found that ‘rhesus macaque infants receiving the complete U.S. childhood vaccine schedule’ did not ‘undergo the maturational changes over time in amygdala volume that was observed in unexposed animals.’

Pro-vaccine scientists pounced. Not enough monkeys were used to establish a scientific finding, said one scientist. Opposite findings about the amygdala have been reached, which invalidate the study, said another scientist.

One angry scientist was even willing to discredit the monkey study by claiming that monkeys are not a valid model for human disease — thus annulling millions of experiments including the ones on which human drugs are approved! Of course, many in the animal welfare community have questioned the validity of animal ‘models.’”

‘Vaccine Court’ Protects Vaccine Makers’ Interests, Not the Public

The U.S. Court of Federal Claims in Washington D.C. handles contested vaccine injury and death cases in what has become known as “vaccine court.” The vaccine injury compensation program (VICP) is a “no-fault” alternative to the traditional civil court lawsuit and was established in 1986 after a string of high-profile lawsuits by parents of vaccine injured children had hauled vaccine manufacturers into court to have their cases heard in front of juries.

At the time, parents were suing vaccine manufacturers after their children were brain injured or died following federally recommended and state mandated DPT (diphtheria, pertussis, tetanus) vaccines, or children were left paralyzed by live oral polio vaccinations (OPV).

Several DPT injury lawsuits against the vaccine makers in the 1970s and early 1980s resulted in multimillion-dollar jury verdicts. At that point, vaccine manufacturers threatened to stop producing DPT, MMR and oral polio (the only childhood vaccines at the time) if civil litigation were allowed to continue.

Common sense would have dictated that such lawsuits were a sign that vaccine manufacturers needed to raise safety standards and produce less toxic vaccines. Instead, Congress buckled to industry pressure and gave vaccine manufacturers the legal protection they demanded through the National Childhood Vaccine Injury Act.

As a result, vaccine makers have no incentive to produce the safest vaccines possible, especially when many childhood vaccines are state mandated for school attendance and 2 out of 3 vaccine injured children are turned away from the VICP with no compensation.

Vaccine Court Cases Are Usually Dismissed and Seldom Publicized

Many Americans do not even realize the vaccine court exists because the Department of Health & Human Services does not publicize the existence of a federal vaccine injury compensation program and few VICP claims are ever disclosed, let alone publicized. In fact, two-thirds of claims received are dismissed.

The desire for secrecy on the part of public health officials is understandable. If Americans were routinely informed of the vaccine injury and death claims processed through the VICP, public doubts about vaccine safety would escalate. Still, disturbing vaccine-related injuries have surfaced, often though legal firms, according to Opednews:71

“In 2011, in a report in the Pace Environmental Law Review, the researchers identified 83 NVICP cases in which victims demonstrated evidence of autism (though the cases often emphasized other injuries) resulting in more than $96.7 million in settlements.

In addition to 32 cases which included the presence of autism-like symptoms, there were 51 cases interviewed by the researchers in which parents said their child’s vaccine injury led to “an autism diagnosis, autistic features or autistic-like behaviors.”

“In another case, petitioners claim that within 48 hours after their baby received a DPT vaccine, he began to seizure and an MRI subsequently revealed suspicious black lesions. Like many children with seizure disorders he needed around the clock care and supervision. Eight years after a claim was filed, the boy received $7 million for a lifetime of medical care from the NVICP.”

In yet another case, described by Opednews, a 2-month-old baby girl “started to have seizures, abnormal breathing [and] irregular heartbeats” hours after receiving a the same, routine DPT vaccine. In the following six years, the girl suffered from cognitive delays, cerebral palsy, encephalopathy and seizures.

Mercury Is Not the Only Vaccine Risk

While Kennedy focuses on the potential role of thimerosal in vaccine damage, researchers have presented a number of other potential mechanisms of vaccine harm, including the long-acknowledged ability of vaccines to cause brain inflammation (encephalitis/encephalopathy), the toxic effects of aluminum adjuvants and other toxic vaccine ingredients, and the hazards of immune overstimulation by virtually any means.

For example, pertussis toxin and live measles virus can cause brain inflammation and permanent brain damage — regardless of thimerosal. Moreover, vaccine safety is not simply a matter of proving or disproving the link between vaccines in general and autism specifically.

There are many other, potentially severe side effects, including immune system dysfunction, that can lead to or exacerbate any number of health problems. Veterinary scientists have even noted increasing rates of autoimmune problems in dogs following vaccination.

Research has shown an increase in death following receipt of inactivated vaccines suggesting vaccine adjuvants can also be culprits. Aluminum adjuvants might be a factor, but it appears inactivated vaccines may also program your immune system in a way that decreases your body’s ability to fight off disease later.

Moreover, the gut-brain axis and the compelling synergy between compromised gut flora and autism can be triggered by vaccines. The potential for DNA fragments and retroviral contaminants in vaccines to produce an exaggerated and potentially lethal immune response is also possible and underreported. Clearly the presentation of vaccines as “always safe” and the vilification of vaccine activists comes out the greed-based vaccine business model.

Part 4: The War on Supplements, Essential Oils and Homeopathy

If you suspect that supplements are more popular than ever, you are right. More than half of American adults have used one or more supplements and more than half of women and 43 percent of men used a supplement of some kind within the last 30 days.72,73

While that means not taking vitamins or supplements is now a minority position, it also means Big Pharma is trying to get “in on” the supplement business. The U.S. retail sales of vitamins and supplements is expected to exceed $36 billion in 2017.74 While that’s less than a tenth of what Pharma rakes in annually, it has nevertheless caught the drug industry’s attention.

Also, the highest users of supplements and alternative therapies are the most desirable demographic to marketers — those reporting “excellent” or “very good” health, usually with a higher discretionary income.75 No wonder Pharma and Pharma-supported voices have launched an all-out smear campaign against supplements and alternative therapies. Both categories lack the huge price tags of drugs and encourage patient education and self-care.

Supplements and natural products also often treat or prevent the very conditions that enrich drug companies, which further explains Big Pharma’s wrath. For example, omega-3 fats such as krill oil and other nonprescription products lower heart disease risks without using dangerous statins.

Prescription drugs can also increase the need for supplements. If you take a diuretic, an acid-blocking PPI or the diabetes drug metformin, you are more likely to develop vitamin or mineral deficiencies.76

Traditional Media Outlets Question Value of Supplements

In 2016, the Journal of the American Medical Association published a large study of U.S. supplement usage that found, according to The New York Times:77

“Americans spend more than $30 billion a year on dietary supplements — vitamins, minerals and herbal products, among others — many of which are unnecessary or of doubtful benefit to those taking them. That comes to about $100 a year for every man, woman and child for substances that are often of questionable value.”

Elsewhere in recent years, negative news articles about vitamin C, vitamin A and beta-carotene, vitamin E, vitamin B6, vitamin D, calcium and multivitamins have run. Supplements like ginkgo biloba, echinacea, fish oil and ephedrine are also under attack, as are homeopathy and aromatherapy.78,79,80,81

Some articles, many written by medical professionals, say supplements are ineffective and a waste of your money; others actually accuse supplements of causing or risking physical harm and even shortening lives. Some medical specialists also accuse supplements of impeding or interfering with drugs taken for other medical conditions.82

In addition to print media and the web, TV news media have joined in the discrediting of the supplement industry, exposing alleged disreputable manufacturers and lobbyists.

While I would never defend unethical makers of supplements who put the public at risk, these same news shows largely give Big Pharma a pass even though prescription drugs put the public at a much greater risk. Prescription drug overdoses are the ninth leading cause of death in the U.S., and the death toll continues to rise thanks to the growing opioid addiction crisis.83

Pharma Is a Pot Calling the Kettle Black

Leading Pharma’s campaign to discredit supplements is the charge that unproven health benefits, not backed by the U.S. Food and Drug Administration (FDA), are claimed by supplement makers. Yet almost every major drug company has entered into a settlement for the same thing, known as “off-label marketing” in the prescription drug world. At least 31 drug companies have been charged with such false promotion including Pfizer, Eli Lilly, Johnson & Johnson, Novartis, Forest, Amgen and Allergan.84

Pfizer paid a $430 million fine for off-label marketing of Neurontin for the non-FDA approved indication of bipolar disorder.85 Eli Lilly engaged in another off-label marketing scheme, trying to market the selective estrogen receptor modulator Evista for the unapproved FDA indication of prevention of breast cancer, and unleashed hundreds of drug reps to sell the unapproved use.

Reps were told to hide a disclosure page that said, “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established,” from the doctors they were trying to sell on the drug, according to the Department of Justice.86 Scott Gottlieb, the new FDA Commissioner, drug stock trader and Pharma consultant, defended Evista’s off-label marketing in a Wall Street Journal oped.87

Questions About Product Purity Cut Both Ways

Another way that Pharma-friendly voices try to discredit supplements they have yet to sell themselves is through raising questions about their purity, label accuracy and manufacturing process. Here is a quote from Dr. Paul A. Offit, one of the nation’s leading drug and vaccine defenders, in an interview about his 2014 book “Do You Believe in Magic?” on Medscape:88

“Look at what happened with this vitamin-maker called Purity First. Purity First, a few weeks ago, had all of its products recalled by the FDA. They made three products. They made vitamin C. They made a multimineral preparation, and they made a B-complex vitamin preparation.

What happened was there were 25 women in Connecticut who started to develop symptoms of increased hair where they didn’t want hair to be, deepening of the voice, and loss of menstrual cycles because they were inadvertently taking anabolic steroids.

Anabolic steroids had contaminated those preparations. How does that happen?… Just imagine if vaccines were inadvertently contaminated with anabolic steroids. You would never hear the end of it, but here somehow it all gets a free pass.”

Offit is dead wrong. Drugs, vaccines and medical products are frequently recalled for quality and contamination though recalls are seldom reported in the mainstream press. In April 2017, GlaxoSmithKline recalled nearly 600,000 defective Ventolin inhalers.89 In March 2017, generic giant Mylan (of EpiPen fame) said it was recalling 4,005,177 bottles of the cholesterol fighter atorvastatin because of the “potential of an elevated bioburden with identification of objectionable organisms.”90

Recalls of biologics (drugs that contain an ingredient extracted from a “biological” source such as cells from humans, animals or microorganisms) have increased significantly, especially for vaccines. From 2007 to 2010, 14 vaccine recalls and 13 recalls for immunoglobulins were made. Additionally, vaccines are not adequately tested for safety and effectiveness using methodologically sound scientific studies before they are licensed, so all of their side effects and long-term negative health outcomes are often unknown.

Examples of Supplements, Essential Oils and Homeopathy Therapy at Work

The medical literature includes notable examples of supplements and natural remedies that function as valuable medicines. Why do we so rarely, if ever, hear of them on health news sites or TV? Supplements and natural substances cannot be patented and hence present no profit potential for Pharma no matter how dramatic their actions. Here are some supplements for which there is promising evidence of effectiveness:

Folic acid, when added to enalapril (an ACE inhibitor used to treat high blood pressure, diabetic kidney disease and heart failure) produced a significant reduction in stroke occurrence in 2015 JAMA research.91
Oregano might be effective against the norovirus, say investigators at the University of Arizona.92
High doses of vitamin C may be useful in the treatment of ovarian cancer, boost the power of chemotherapy and ward off stroke, research indicates.93,94,95
Multivitamins and olive oil are under investigation for their roles in managing breast cancer.96,97
A compound found in a Japanese mushroom could be a cure for the currently untreatable human papilloma virus.98
Vitamin E likely plays an important role in deterring miscarriage.99
Preliminary evidence even suggests that micronutrients could be beneficial in treating adult attention deficit hyperactivity disorder (ADHD), according to 2014 research published in The British Journal of Psychiatry.100
When children with ADHD inhaled vetiver essential oil three times a day for 30 days they had improved brain wave patterns and behavior and did better in school.
In patients with allergies, those using homeopathy reported improvements in nasal airflow compared with a placebo group and researchers described a “clear, significant and clinically relevant improvement in nasal inspiratory peak flow, similar to that found with topical steroids.”

Don’t Rule Out Vitamin D

In the past few years, vitamin D has gone from a vitamin “hero” whose deficiency potentially explained many maladies, to VNG (Vitamin Non Grata).101,102 The same flip-flop has been seen with calcium, once a good guy, now potentially another supplemental bad guy.103 In fact, vitamin D has been so demonized, the pro-Pharma Forbes site actually writes:104

“Vitamin D supplements, to put it plainly, are a waste of money. (For those concerned about osteoporosis, the widely used drug alendronate (Fosamax®), has been shown to increase bone density by about 5 percent, as explained in a 2011 article by Dr. Sundeep Khosia. But Fosamax has side effects.)”

The “side effects” mentioned by Forbes are an understatement. Bisphosphonate bone drugs such as Fosamax and Boniva have been linked to esophageal cancer, jawbone death, heart problems, intractable pain and the very fractures they are supposed to prevent.105 They are one of the most dangerous drug classes ever marketed.

Far from a waste of money, vitamin D made such a difference in a 2014 breast cancer survival study, an investigator said “There is no compelling reason to wait for further studies to incorporate vitamin D supplements into standard care regimens.”106 Research suggests it may have a valuable role in multiple sclerosis management, diabetes and depression, chronic liver disease and diseases of older age.107,108,109,110

Further Ironies

Even as the drug industry attacks the safety, reliability and effectiveness of vitamins and supplements, it creates them itself. In 2013, PGT Healthcare LLP (a venture of Procter & Gamble, Teva and Swisse Wellness) said it would expand its range of more than 100 vitamins, minerals and supplements.111

Other drug giants are also in the supplement business. Sometimes making vitamins results in drug companies making positive instead of negative statements. Here is what research funded by Roche (now DSM Nutritional Products) BASF and Pfizer found about multivitamins112

“A daily multivitamin can help a man reduce his risk of cancer, according to new research from Brigham and Women’s Hospital (BWH). The first-of-its kind study will be presented October 17 at the 11th Annual AACR International Conference on Frontiers in Cancer Prevention Research and published online the same day in the Journal of the American Medical Association.”

Marketing vitamins also subjects Big Pharma to the same false claims charges it cites about the supplement industry. Pfizer, which makes Centrum products, was sued to remove its claims that the products support “energy and immunity,” “heart health,” “eye health,” “breast health,” “bone health” and “colon health.”113

And although Merck announced December 14 that it plans to sell its subsidiary, Seven Seas, a quick look at its Seven Seas Multivitamin Complete reveals claims that it contains ingredients that “provide adults with energy … as well as a healthy heart … good eye sight, healthy bones and digestion system.”114

Part 5: Lies, Denial, Deceit and Manipulative ‘Research’

In the last decade, vaccines have become Big Pharma’s biggest profit center. A report published by MarketsandMarkets estimates the global vaccine market, currently valued at $34.30 billion a year, will grow to an astounding $49.27 billion by 2022.115

Why the boom? As blockbuster drugs like Lipitor, Viagra, Seroquel, Zyprexa, Singular and Concerta have gone off patent, vaccines prove a lucrative replacement. Not only are they priced much higher than pills, governments and NGOs shamelessly help market vaccines to huge swaths of the world’s population.

These unethical partnerships, using taxpayer or NGO money, advance misleading research intended to frighten the public. Worse, they discredit vaccine critics who raise legitimate safety and efficacy questions and even discredit the families and victims of vaccine injuries themselves. To cash in on vaccine profits Big Pharma, governments and NGOs have characterized all vaccines as “life-saving.” One of the clearest examples is the attempt to present vaccines against the HPV virus as vaccines “against cancer.”

“Science” articles warn that as many as 90 percent of adults, especially baby boomers, silently harbor the HPV virus much like articles that warn many baby boomers are infected with the Hepatitis C virus.

In both cases, the drug industry is trying to “grow” the market for its products by inflating the amount of estimated sufferers. Reporters either wittingly or unwittingly help in the effort by repeating the drug industry supplied “facts.” The truth is more than 90 percent of HPV infections are cleared by the body116 without symptoms and only 20 percent of HPV infections are the high-risk type that could develop into cancer if not identified and treated.117

Big Pharma’s misleading advertising is not working, though. Many families of adolescent boys and girls targeted by HPV vaccine marketing by drug companies and government health officials are refusing the vaccine.118

Reacting to the HPV vaccine dropouts, Big Pharma launched an offensive “shame” campaign last year in which young adults with cancer blame their parents for not vaccinating them when they were adolescents. The ads were so over-the-top even supporters of the vaccine complained. Twitter remarks accused the company of trying to guilt-trip parents to bolster corporate profits.119

The Bill & Melinda Gates Foundation Promotes Vaccines and Their Profits

One of the world’s leading funders of vaccine development and promotion is the Bill & Melinda Gates Foundation (B&MGF).120 In 2002, it began buying billions in drug stocks121 and subsequently added huge amounts of Monsanto stock.122 Two of the B&MGF’s research heads were hired right out of Pharma — one from GlaxoSmithKline, with whom the B&MGF had a long-standing collaboration, and the other from Novartis.123

Even more shocking, it hired the former president of product development at Genentech to serve as its current CEO, Dr. Susan Desmond-Hellmann.124 This is how health writer Ruben Rosenberg Colorni describes the true nature of the foundation:125

“The Bill & Melinda Gates ‘Foundation’ is essentially a huge tax-avoidance scheme for enormously-wealthy capitalists who have made billions from exploiting the world’s people. The foundation invests, tax free, money from Gates and the ‘donations’ from others, in the very companies in which Gates owns millions in stocks, thus guaranteeing returns through both sales as well as intellectual-property rights.

To add insult to injury, the system perpetuates the spread of disease rather than aids in their eradication, thus perpetually justifying his endeavors to ‘eradicate’ them (solving a problem they are creating).”

In a 2011 Forbes interview, Bill Gates admitted the new profitability of vaccines.126 “Ten or 15 years ago, nobody in the drug business would have held up vaccines as profit centers,” he said, conceding that “vaccines are so tough, particularly because of liability issues.” But now, “people are making money in the vaccine business,” he noted.

Questions About Overseas Vaccination Programs

Questions about the ethics of the Bill & Melinda Gates Foundation’s overseas vaccination programs have swirled for years, specifically a study aimed at validating a low-cost way to screen for cervical cancer in India.127 This summer, STAT News reported that “new evidence of ethical lapses” has been published.128

Dr. Eric Suba, a pathologist at Kaiser Permanente Medical Center in San Francisco and co-author of the paper, provided STAT with a copy and links to supporting documents. In an interview, he described the Mumbai study, which ended in 2015, in stark terms: ‘catastrophic, ‘monumentally unethical, and a radical departure from normal scientific procedures’ …

Critics of the 18-year trial said that U.S.-funded Indian researchers used ineffective screening that endangered thousands of poor women in Mumbai. They were told the test could help prevent cancer, but far fewer pre-cancerous lesions were found than expected, suggesting that some lesions were missed — possibly leading to an unknown number of deaths.”

In 2015, judges in India’s Supreme Court heard a challenge claiming the Bill & Melinda Gates Foundation failed to obtain the informed consent of the children or their parents and demanded answers about juvenile deaths from the vaccine trial.129

The Bill & Melinda Gates Foundation Is a Big Investor in Monsanto and Promoter of GMOs

In 2012, Bill Gates announced he would try to end world hunger by growing more genetically modified (GM) crops. He had already invested $27 million into Monsanto. At the time, I said Gates was leading the pack as one of the most destructive “do-gooders” on the planet and that his views on addressing poverty and disease in poor countries were short-sighted and misinformed.

Shortly thereafter, a team of 900 scientists funded by the World Bank and United Nations determined the use of GM crops is not a meaningful solution to the complex situation of world hunger. The Seattle Times also called Bill Gates’ support of GM crops as a solution for world hunger unsound science. It’s an undisputed fact that the introduction of genetically engineered crops lead to diminished biodiversity — the direct opposite of what the world needs.

To save the planet and ourselves, small-scale organic and sustainable farming not only must prevail but flourish, and GM crops do not help; rather, they threaten their existence. Seeds have always been sold and swapped freely between farmers, preserving biodiversity, and without that basis, you cannot have food sovereignty. With fewer farmers, “feeding the hungry with GM crops” is nothing but a pipe dream.

A clear example of the false promise of GM crops is seen with the GM Golden Rice designed to bring beta-carotene to the diets of people in poor countries and supported by the Bill & Melinda Gates Foundation’s donation of $20 million. The GM crop was ill conceived for two reasons. People eating the low-fat, poor diets seen in poor countries generally cannot convert beta-carotene to vitamin A. and it was estimated that someone would have to eat 16 pounds of Golden Rice a day to receive the benefits.

Unethical Vaccine Marketing Only Tells Half the Story

As I said earlier, marketing of the HPV vaccine relies on half-truths, scare tactics and alarmist advertising. By manipulatively presenting it as a “vaccine against cancer,” which all but neglectful parents would give to their children, vaccine makers hope to occlude the real questions about safety and documented injuries.130,131 A few years after the vaccines were launched, questions about research and transparency had already arisen, according to the Huffington Post.132

“Critics ask why the primary endpoint in trials was not cervical cancer, but lesions that could become malignant and why placebo data was spun to make the vaccine look more effective … There are also transparency questions. Why did former First Lady Laura Bush work with Merck-funded citizen front groups to promote the original vaccine and why are governors like Texas’ Rick Perry trying to mandate vaccination of all girls?

University of Queensland lecturer Dr. Andrew Gunn was silenced by his university when he dared to question the vaccine and ordered to apologize to the vaccine maker, CSL, according to the Courier Mail. Dr. Gunn expressed doubts about the vaccine’s ‘marketing as a solution to cancer of the cervix when at best it’s expected to prevent about two-thirds of cases and ‘the incorrect and dangerous perception that it might make Pap smears unnecessary’…

And one of Gardasil’s and Cervarix’s [two HPV vaccines] original developers, Dr. Diane Harper, a consultant to the World Health Organization, also questioned the vaccine’s lack of safety and effectiveness … only to appear to retract her remarks later.”

‘Herd Immunity’ Incorrectly Used to Sell Vaccines

Vaccine makers and the governments and NGOs that help their marketing use the concept of “herd immunity” to sell mass vaccination — the idea that the vaccination rate in a given community must be kept high so that those who have not been immunized do not endanger others.

But of course, HPV, which is a sexually transmitted disease (STD), is not spread through mere close proximity to another person like non-STD diseases. You can’t transmit or get HPV infection in a public setting, like in a classroom or crowded elevator. Maybe that is why the “cancer prevention” angle is pushed.

Purveyors of the herd immunity theory never seem to be able to explain why the majority of outbreaks of diseases targeted by vaccines occur in communities thought to have already achieved herd immunity status, i.e., where the majority of people are fully vaccinated and transmission of infection “should” not occur.

In fact, health officials appear to deliberately confuse the public. Natural herd immunity certainly exists but artificial vaccine-acquired herd immunity, which is temporary at best, is a misnomer. Vaccination and natural exposure to a given disease produce two qualitatively different types of immune responses.

Also see: Herd Immunity vs. Viral Shedding: Who’s Infecting Whom?

Vaccine Injuries Dismissed and Downplayed

Vaccine injuries are well-documented and the HPV vaccine is a case in point. Here is what the Indian Medical Journal of Medical Ethics reported in 2017.133

“The human papillomavirus (HPV) vaccine has been linked to a number of serious adverse reactions. The range of symptoms is diverse and they develop in a multi-layered manner over an extended period of time. The argument for the safety and effectiveness of the HPV vaccine overlooks the following flaws:

(i) [No] consideration is given to the genetic basis of autoimmune diseases, and arguments that do not take this into account cannot assure the safety of the vaccine; (ii) the immune evasion mechanisms of HPV, which require the HPV vaccine to maintain an extraordinarily high antibody level for a long period of time for it to be effective, are disregarded;

and (iii) the limitations of effectiveness of the vaccine. We also discuss various issues that came up in the course of developing, promoting and distributing the vaccine, as well as the pitfalls encountered in monitoring adverse events and epidemiological verification.”

Yet vaccine makers, government regulatory agencies and doctors administering vaccines continue to insist the many injuries seen after vaccination are mere coincidences and not caused by the vaccines. Controlled clinical trials have found no causal association between HPV vaccination and different adverse effects, say the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.134

In addition to inflating the number of people suffering from diseases such as HPV, vaccine promoters inflate the effectiveness of their vaccines. The HPV vaccine has cut infections by up to 90 percent in the past 10 years, brags one science website, as if cutting infections and cutting the incidence of cancer were the same thing. It is especially irresponsible because the cancer rates cannot be determined until years or decades after the vaccine is given.135

Protect Your Right to Informed Consent and Defend Vaccine Exemptions

With all the uncertainty surrounding the safety and efficacy of vaccines, it’s critical to protect your right to make independent health choices and exercise voluntary informed consent to vaccination. It is urgent that everyone in America stand up and fight to protect and expand vaccine informed consent protections in state public health and employment laws. The best way to do this is to get personally involved with your state legislators and educating the leaders in your community.

National vaccine policy recommendations are made at the federal level but vaccine laws are made at the state level. It is at the state level where your action to protect your vaccine choice rights can have the greatest impact.

It is critical for EVERYONE to get involved now in standing up for the legal right to make voluntary vaccine choices in America because those choices are being threatened by lobbyists representing drug companies, medical trade associations, and public health officials, who are trying to persuade legislators to strip all vaccine exemptions from public health laws.

Signing up for NVIC’s free Advocacy Portal at gives you immediate, easy access to your own state legislators on your smart phone or computer so you can make your voice heard. You will be kept up-to-date on the latest state bills threatening your vaccine choice rights and get practical, useful information to help you become an effective vaccine choice advocate in your own community.

Also, when national vaccine issues come up, you will have the up-to-date information and call to action items you need at your fingertips. So please, as your first step, sign up for the NVIC Advocacy Portal.

Share Your Story With the Media and People You Know

If you or a family member has suffered a serious vaccine reaction, injury, or death, please talk about it. If we don’t share information and experiences with one another, everybody feels alone and afraid to speak up. Write a letter to the editor if you have a different perspective on a vaccine story that appears in your local newspaper. Make a call in to a radio talk show that is only presenting one side of the vaccine story.

I must be frank with you; you have to be brave because you might be strongly criticized for daring to talk about the “other side” of the vaccine story. Be prepared for it and have the courage to not back down. Only by sharing our perspective and what we know to be true about vaccination, will the public conversation about vaccination open up so people are not afraid to talk about it.

We cannot allow the drug companies and medical trade associations funded by drug companies or public health officials promoting forced use of a growing list of vaccines to dominate the conversation about vaccination.

The vaccine injured cannot be swept under the carpet and treated like nothing more than “statistically acceptable collateral damage” of national one-size-fits-all mandatory vaccination policies that put way too many people at risk for injury and death. We shouldn’t be treating people like guinea pigs instead of human beings.

Internet Resources Where You Can Learn More

I encourage you to visit the website of the non-profit charity, the National Vaccine Information Center (NVIC), at

  • NVIC Memorial for Vaccine Victims: View descriptions and photos of children and adults, who have suffered vaccine reactions, injuries, and deaths. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
  • If You Vaccinate, Ask 8 Questions: Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
  • Vaccine Freedom Wall: View or post descriptions of harassment and sanctions by doctors, employers, and school and health officials for making independent vaccine choices.
  • Vaccine Failure Wall: View or post descriptions about vaccines that have failed to work and protect the vaccinated from disease.

Connect With Your Doctor or Find a New One That Will Listen and Care

If your pediatrician or doctor refuses to provide medical care to you or your child unless you agree to get vaccines you don’t want, I strongly encourage you to have the courage to find another doctor. Harassment, intimidation, and refusal of medical care is becoming the modus operandi of the medical establishment in an effort to stop the change in attitude of many parents about vaccinations after they become truly educated about health and vaccination. However, there is hope.

At least 15 percent of young doctors recently polled admit that they’re starting to adopt a more individualized approach to vaccinations in direct response to the vaccine safety concerns of parents.

It is good news that there is a growing number of smart young doctors, who prefer to work as partners with parents in making personalized vaccine decisions for children, including delaying vaccinations or giving children fewer vaccines on the same day or continuing to provide medical care for those families, who decline use of one or more vaccines.

So take the time to locate a doctor, who treats you with compassion and respect, and is willing to work with you to do what is right for your child.

Sources and References:

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There is not lack of controversy in the pharmaceutical industry, particularly when it comes to drug prices. Unethical, profit-generating tactics used by Big Pharma have never been clearer than the recent actions taken by South African Aspen Pharmacare. This company tried to drive up the price of five different cancer drugs as much as 4,000 percent. Moreover, it threatened to stop supplying the much-needed medication if health authorities didn’t agree to the higher prices.

Foul Tactics Used to Increase Cancer Drug Prices

Aspen Pharmacare purchased the rights to five different cancer drugs from British firm GlaxoSmithKline (GSK) in 2009. As part of the deal, GSK became one of Aspen’s main investors. It received 16 percent stake in the company, which it sold off in 2013 and 2016.

In 2012, Aspen started to raise cancer drug prices in major European markets such as Britain, Spain and Italy. The Times reports:

The price rises meant that the cost of busulfan, used by leukaemia patients, rose from £5.20 to £65.22 a pack in England and Wales during 2013, an increase of more than 1,100 per cent. The price of chlorambucil, also used to treat blood cancer, rose from £8.36 to £40.51 a pack in the same year.

When Aspen purchased the rights from GSK, it dropped the brand names. In Britain, the drug maker was able to exploit a loophole that allows companies to raise drug prices for unbranded generics.


In mainland Europe, Aspen targeted health authorities with its price hikes. The Timesclaims that it has documents and internal emails that show how Aspen “took an ‘aggressive’ approach to negotiations, sometimes creating shortages of the medicines or threatening to stop supplying the drugs altogether to force health authorities to accept its demands.”

For example, Aspen pressured Italian authorities to pay price increases of up to 2,100 percent. The increase took effect over only three months. Moreover, Spanish authorities faced price hikes of up to 4,000 percent. The Spanish Ministry did not agree to pay the higher prices. As a result, Aspen stopped supplying the Spanish market with its five cancer drugs.

In addition to busulfan, Aspen purchased rights to mercaptopurine, a treatment for acute lymphoblastic leukaemia, which occurs in children. Some of Aspen’s medicines treat several types of cancer particularly prevalent among the elderly.

Big Pharma’s Price Gouging in the U.S.

Price gouging by drug makers is not exclusive to Aspen Pharmacare or the European region. Currently, the United States is one of the most lucrative markets for Big Pharma. This isn’t just because of the sheer amount of people in the U.S. population who take prescription medications. More importantly, in the U.S. drug companies are charging up to 10 times as much for pharmaceuticals when compared to other developed countries.

FDA Panel Splits on Softening Chantix Warning

Two FDA advisory committees delivered a split decision on whether or not to remove a black box warning label from two key smoking cessation drugs, with the final tally in favor of removal.
But the vote Wednesday was close with the Psychopharmacologic Drugs Advisory Committee, and Drug Safety and Risk management Advisory Committee members pretty evenly split: 10 voted to remove the warning, four voted to modify warning language to reflect results from a recently completed postmarketing trial and five wanted the warned to stay unchanged.

FDA does not have to honor the committees’ vote, and a vote this close is often considered a null recommendation.
Pfizer, which makes varenicline (Chantix), is declaring a win: “We look forward to the FDA’s decision on the CHANTIX labeling,” Freda Lewis-Hall, MD, DFAPA, Chief Medical Officer and executive vice president at Pfizer, said in a statement e-mailed just after the vote. “We are pleased with the Committees’ (sic) recommendation to remove the boxed warning and believe this is an important step toward updating the CHANTIX labeling to more accurately reflect its neuropsychiatric safety profile.”
GlaxoSmithKline, which manufactures bupropion (Zyban), is being more cautious: “This was a committee recommendation which FDA can accept, reject or modify,” a spokeswoman wrote in an email Thurdsday. “For that reason, we’ll wait to hear from FDA about the Zyban label and then work closely with FDA to take necessary actions, if any.”
Varenicline, approved by FDA in 2006, and bupropion (Zyban) (1997) have been shown to help smokers quit better than nicotine patches and placebos. But because these drugs have also been linked to psychiatric reactions, FDA ordered the black box warning for varenicline and bupropion in 2009 based on reports of increased risk of suicidal ideation among users. At the same time the agency ordered manufacturers Pfizer and GlaxoSmithKline (Zyban) to complete a placebo-controlled postmarket safety trial.
“Because patients with a history of psychiatric illness did not participate in the initial clinical efficacy trials that supported approval of the NDA (new drug application), it was also important to ascertain whether the medications were effective in these patients, in order to understand the balance of risks and benefits,” according to an FDA briefing document released publicly Monday.

Pfizer and GlaxoSmithKline funded the randomized, double blind, active- and placebo-controlled, multinational study (called EAGLES); they also employed several study authors.
The 3-year trial ended in January 2015 and results were published in Lancet in April this year, showing that patients with or without a history of psychiatric activity were not more likely to suffer psychiatric episodes when taking varenicline or bupropion than those taking a placebo. “Regarding efficacy, this trial provides clear confirmation that all three medications (including nicotine replacement therapies) are more effective than placebo in patients with and without histories of psychiatric diagnoses,” the FDA reported in the new review.
“This is the largest randomized, controlled trial to date comparing these smoking-cessation medications directly and comparing them with placebo,” researcher Robert Anthenelli, MD, told MedPage Today in April. “We are hoping that the recognition that these medications are safe for smokers with and without psychiatric disorders will encourage people to try and quit and feel comfortable that they can use any of the available medications.”
Lingering Questions
But FDA reviewers had questioned the study’s sample and how data were collected and analyzed: Patients with substance abuse issues were not included and investigators struggled to code reactions consistently. One researcher coded a patient who was hospitalized for depression after taking varenicline as having suffered a “mild” reaction, for example.
“Despite efforts to actively solicit information about the range of complex and ill-defined experiences that patients have reported in postmarketing cases, this trial did not seem to have identified many of the types of cases that had been previously identified to be of concern,” FDA reported.
On Wednesday, many committee members raised other concerns with the trial’s conduct, and with setting a precedent by removing the black box warning. Several committee members worried that removing the warning would signal to patients and providers that the drug has been proven safe, and would preclude them from mulling the potential drastic side effects.
“I don’t really feel fully reassured that this trial captured the essence of what was being reported,” said Rajesh Narendran, MD, a Pittsburgh psychiatrist. “I think removing the black box does send the wrong message. Keeping it in there in my opinion has very little harm.”
Others questioned Pfizer and GlaxoSmithKline. “I felt more time was needed to complete a more robust sensitivity analysis,” said Elaine H. Morrato, DrPH, a public health dean with the University of Colorado, who voted to leave the warning untouched. “I had the sense that the sponsors were turning in new analyses one week ago. The FDA I’d imagine would want more time to complete analyses.”
The FDA itself may have had the harshest words for the companies, citing the yes-no data they turned in instead of the informative narratives about reactions to the drug that they had been asked to complete. “This is not the first time asking the company for informative narratives,” said Sharon Hertz, MD, director of anaesthesia, analgesia, and addiction. Speaking about FDA’s role reviewing such studies in general, she added: “We expect companies to identify problems and bring them forward.”
Words of Praise
But the majority of committee members praised the study’s rigor; a few of those who voted to remove the warning said the study supplied the evidence needed to make them comfortable using Varenicline to address a major public health problem.
“The risk-benefit ratio is as clear as anything I have ever seen,” said David Pickar, MD, a Johns Hopkins Medical School psychiatry professor who said he works with psychiatric patients. Looking at his fellow committee members, Pickar added: “For you, these are adverse events, but the benefit to these patients could be substantial in the most fundamental thing, which is being alive.”
Many of the committee members who voted to modify the warning cited uncertainty about the drugs’ effects, despite praising the trial overall. “My read of what we heard today is that I don’t know,” said acting chairperson Ruth M. Parker, MD, a professor at Emory University School of medicine. “I do think the label should be changed to reflect trial findings.”
This is the second time the FDA is reviewing the black box warning on varenicline. In 2014 the agency declined to remove the box warning from Chantix when Pfizer submitted new data from other studies, because an advisory committee recommended waiting for the postmarketing study data.

Google Sister Company, Drug Maker to Develop Nerve Implants

One of Google’s sister companies will team up with pharmaceuticals firm GlaxoSmithKline to develop tiny implants that can tap nerves and change their electronic signals as a way of treating chronic illnesses.

GSK and Verily Life Sciences, a subsidiary of Google parent company Alphabet, have agreed to create a new company known as Galvani Bioelectronics, which will be based in Britain, with a second research hub in South San Francisco, California.

They said Monday that they will invest 540 million pounds ($714 million), with GSK owning 55 percent of the venture and Verily the rest.

In the growing field of bioelectronic medicine, the implants that are used to cuff a nerve are currently the size of a jelly bean. The aim is to make them as small as a grain of rice.

GSK brings medical knowledge to the table. Verily brings expertise in miniaturization.

“Many of the processes of the human body are controlled by electrical signals firing between the nervous system and the body’s organs, which may become distorted in many chronic diseases,” said Moncef Slaoui, GSK’s chairman of global vaccines. “Bioelectronic medicine’s vision is to employ the latest advances in biology and technology to interpret this electrical conversation and to correct the irregular patterns found in disease states, using miniaturized devices attached to individual nerves.”

The announcement comes less than a week after GSK pledged to invest 275 million pounds in three plants in Britain, sweeping aside concerns about growth following the country’s decision to leave the European Union.

Galvani Bioelectronics will employ around 30 scientists, engineers and clinicians.

Antiseptic gel to prevent infections in newborn babies gets EU approval

Gel reformulated from GlaxoSmithKline mouthwash will be used to fight umbilical cord infections in developing countries.

A mother holds her newborn baby, who suffered from an umbilical cord infection, in Makoror, Kenya.
A mother holds her newborn baby, who suffered from an umbilical cord infection, in Makoror, Kenya.
A mother holds her newborn baby, who suffered from an umbilical cord infection, in Makoror,
An antiseptic gel to help prevent umbilical cord infections in newborn babies, which was developed from a mouthwash, has been given the green light by European regulators.

GlaxoSmithKline developed the product, called Umbipro, with the charity Save the Children for use in developing countries. The gel will be sold at a not-for-profit price and could save 422,000 lives over five years, according to UN estimates.
Scientists reformulated the chlorhexidine solution found in its Corsodyl mouthwash into a gel that can be applied to newly cut umbilical cords. There is a greater risk of infection – a major cause of newborn deaths – in developing countries across Asia and sub-Saharan Africa, where more births happen at home and unsterile materials such as dung and ash are traditionally used on the umbilical cord stump.
The antiseptic gel was endorsed by the European Medicines Agency on Friday, an important step in getting it to developing countries. It will need to be approved by local regulators. GSK said it would submit applications in countries with moderate to high neonatal mortality rates.

Once approved, the company plans to initially produce about 6m units, packaged in single-use foil sachets that can be opened without scissors. The UK drugmaker said it would also share its manufacturing knowledge with other companies interested in making the gel.

Patrick Vallance, who runs GSK’s pharmaceuticals research and development department, said the gel proved the value of collaboration between makers of pharmaceuticals and over-the-counter healthcare products such as toothpaste and mouthwash.

The idea for the gel was triggered by a UN commission report in 2012 that identified chlorhexidine as an overlooked treatment which could potentially save 422,000 neonatal lives over five years.

COPD Treatment Now Approved for Asthma

The FDA today expanded the indication of GlaxoSmithKline and Theravance’s fluticasone furoate/vilanterol (Breo Ellipta), approving it for the once-daily treatment of asthma in patients aged 18 years and older.   A fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate and the long-acting beta2-agonist (LABA) vilanterol, Breo Ellipta was previously approved for the treatment of chronic obstructive pulmonary disease.   The FDA based its nod on the results of a clinical trial program that evaluated the drug’s safety and efficacy for the treatment of asthma in 12,000 patients aged 12 years and older. In March 2015, the agency’s advisory committee recommended the expanded indication for adult patients in a 16-4 vote.   “We believe the approval of Breo Ellipta as a once-daily ICS/LABA treatment for adults with asthma is a significant catalyst for Theravance, as asthma affects nearly 19 million adults in the US,” said Theravance president and CEO Michael W. Aguiar in a press release. “We are pleased by today’s approval of Breo Ellipta and look forward to making this important medicine available to the appropriate adult patients among those living with the disease.”   In a response letter regarding the proposed use of Breo Ellipta for the treatment of asthma in patients aged 12 to 17 years, the FDA stated the submitted data did not show adequate risk-benefit to support the approval in these patients. Additionally, the drug is not indicated for the relief of acute bronchospasm.

FDA Approves Arnuity Ellipta

FDA Approves Arnuity Ellipta (fluticasone furoate) for the Treatment of Asthma

GlaxoSmithKline plc today announced that the Food and Drug Administration has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm.
The approved doses are Arnuity Ellipta 100mcg and 200mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio.

Darrell Baker, Senior Vice President & Head, GSK Global Respiratory Franchise, said, “The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the US and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients.”

The efficacy and safety of Arnuity Ellipta have been evaluated in more than 3,600 patients with asthma.

Arnuity and Ellipta are trademarks of the GlaxoSmithKline group of companies.

About asthma

Asthma is a chronic lung disease that inflames and narrows the airways.1 Approximately 26 million people in the USA currently have asthma.2 Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.3

The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

Important Safety Information

The following Important Safety Information is based on the Highlights section of the Prescribing Information for Arnuity Ellipta. Please consult the full Prescribing Information for all the labeled safety information for Arnuity Ellipta.

Arnuity Ellipta is contraindicated for primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins or any ingredients of Arnuity Ellipta.

Candida albicans infection of the mouth and throat may occur in patients treated with Arnuity Ellipta.

Do not use Arnuity Ellipta for relief of acute symptoms.

Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.

Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to Arnuity Ellipta.

Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals.

Discontinue Arnuity Ellipta and institute alternative therapy if paradoxical bronchospasm occurs.

Monitor patients with major risk factors for decreased bone mineral content.

Monitor growth of adolescent patients.

Close monitoring for glaucoma and cataracts is warranted.

The most common adverse reactions (reported in greater than or equal to 5% of subjects) with Arnuity Ellipta were upper respiratory tract infection, nasopharyngitis, headache, and bronchitis.

Use Arnuity Ellipta with caution in patients taking strong cytochrome P450 3A4 inhibitors (eg ketoconazole) because this may cause systemic corticosteroid effects.

Fluticasone furoate exposure may increase in patients with moderate or severe hepatic impairment. Monitor for systemic corticosteroid effects.,/p>

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under Item 3.D ‘Risk factors’ in the company’s Annual Report on Form 20-F for 2013.

Global Initiative for Asthma. Pocket Guide for asthma management and prevention. Updated 2014.
American Lung Association, Epidemiology and Statitics Unit, Research and Program Services Division,Trends in Asthma Morbidity and Mortality, September 2012,
Demoly et al. Eur Respir Rev. 2012 Mar 1;21(123):66-74. doi: 10.1183/09059180.00008111.
Posted: August 2014

The 10 Biggest Events of 2013.

  • Big money, big data, and some big layoffs made the biggest headlines in biopharma during 2013. So did big layoffs by big pharma, and a big political squabble that resulted in NIH and FDA closing most of their doors for 16 days. Below are details of these and more of the biggest biopharma developments of the past 12 months.

    The 10 Biggest Events of 2013


    The FDA laid the proverbial hammer on direct-to-consumer gene testing pioneer 23andMe in November, ordering the company to stop selling its Saliva Collection Kit and Personal Genome Service (PGS), while obtaining agency approval to market the $99 “spit kit.” The company promised to comply, while adding it will continue to provide consumers both ancestry-related information and raw genetic data without interpretation, continue conducting research using its database of genetic and phenotypic data, and maintain its educational efforts.

    In a warning letter to 23andMe, FDA’s Center for Devices and Radiological Health (CDRH) said it considered PGS as being “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.” The enforcement action drew sharp criticism from free-market advocates who echoed 23andMe and its CEO Ann Wojcicki in arguing the tests were not diagnostic in nature, but intended only to furnish data upon which health decisions could be based. In responses posted on the company’s blog, critics also accused FDA of attempting to stifle innovation for the benefit of big pharma and doctors—an argument denied by Commissioner Margaret A. Hamburg, M.D., who contended the agency’s sole focus was ensuring patient safety.

    Both sides have reduced their rhetoric in recent days, with Wojcicki acknowledging her company had not communicated proactively enough with FDA, and the agency insisting it’s not trying to kill DTC genetic testing. That’s usually the first sign of a meeting of minds, but whether that happens won’t be apparent until next year at the earliest.

  • DRUG DEVELOPMENT: Hepatitis C, Diabetes, Respiratory, and Cancer Approvals

    Hepatitis C saw a few new drugs approved by FDA—including Olysio (simeprevir) from Johnson & Johnson’s Janssen Pharmaceuticals unit, while Gilead Sciences’ treatment Sovaldi (sofosbuvir) could boast that it was the first drug to ever show sufficient safety and efficacy to treat certain types of HCV infection without the need for injection of interferon at the same time.

    Olysio was approved in combination with interferon and ribavirin, and Solvadi, with ribavirin or with ribavirin and peginterferon-alfa. AbbVie reported positive Phase III results for its genotype 1 Hep C drug candidate, three direct-acting-antiviral (3D) regimen plus ribavirin, namely 96% sustained virologic response after 12 weeks, or SVR12.

    Earlier this year Janssen won FDA marketing authorization for Invokana (canaglifozin) tablets, the first sodium-glucose co-transporter 2 (SGLT2) inhibitor approved as a diabetes treatment; the drug is indicated for adults with type 2 diabetes. FDA approved three Takeda drugs for type 2 diabetes in a single day in January—Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets.

    GlaxoSmithKline (GSK) and Theravance won the agency’s nod for the chronic obstructive pulmonary disease (COPD) drug Breo Ellipta, a once-daily inhalable drug that is expected to rack up blockbuster-level sales of more than a billion dollars—sales GSK will need in order to recoup losses expected in a few years once generic versions of its best-selling product, Advair, reach the market.

    Among cancer drugs approved this year were Celgene’s Pomalyst (pomalidomide) for multiple myeloma, while Roche’s Genentech subsidiary won authorization to market Gazyva (obinutuzumab or GA101), in combination with chlorambucil chemotherapy for people with previously untreated chronic lymphocytic leukemia (CLL)—the first drug on which FDA bestowed its “Breakthrough” designation. Genentech also won FDA’s approval for the Herceptin-DM1 combination drug Kadcyla (T-DM1 or ado-trastuzumab emtansine), for patients with HER2-positive, metastatic breast cancer. GSK hit the proverbial trifecta in May, as FDA approved two of its melanoma drugs—Tafinlar (dabrafenib) and Mekinist (trametinib)—and a companion diagnostic designed to detect the gene mutations expressed by the tumors each treatment is designed to fight. Bayer and Algeta won FDA approval for their prostate cancer drug Xofigo in May, six months before Bayer offered to buy its partner for about $2.4 billion.

    Cancer drugs account for 22% of Phase III pipelines among top-25 drug companies, and 30% of Phase II, according to a Decision Resources report released in November.

  • GENE PATENTING: Myriad of Lawsuits

    Companies looking to patent human genes won a mixed verdict from the U.S. Supreme Court in June, when the justices unanimously ruling that Myriad Genetics’ claims for seven patents related to breast cancer susceptibility genes BRCA 1 and 2—but also holding that companies can patent composite DNA (cDNA) and other synthetic genetic material that does not meet the “Product of nature” exemption from patentability.

    While some experts predicted a rush of competition leading to plunging prices for genetic tests, Myriad refused to roll over, instead vigorously defending its remaining 17 BRCA patents by suing, one-by-one, several of its rivals on infringement grounds: Ambry, Gene by Gene, Gene Dx, Quest Diagnostics, Invitae, and most recently, Laboratory Corporation of America (LabCorp). “It seems that the Supreme Court’s decision has really spurred Myriad to defend its perceived IP as much as possible against these companies,” much as Amgensuccessfully held off rivals for its erythropoetin products a decade ago, noted George Yu, an attorney with the law firm Schiff Hardin, told GEN.

    “There isn’t a case that comes to mind for diagnostics, and maybe that’s somewhat due to the ability to diagnose conditions and diseases in certain ways. It would seem you would need some portion of the BRCA gene to diagnose susceptibility to breast cancer due to your BRCA genotype,” Yu added.

    Myriad also rolled out new tests. In September, the company launched its myRisk Hereditary Cancer™ test, a 25-gene panel covering eight major cancers (breast, colorectal, endometrial, gastric, melanoma, ovarian, pancreatic, and prostate) at an average selling price of $3,700. In October the company introduced myPlan™ Lung Cancer, which carries a $3,400 list price; followed in November by myPath™ Melanoma, which has an average selling price of $1,500. By 2015, Myriad has said, it expects to discontinue several current tests, including the BRACAnalysis test at the center of the Supreme Court case.

  • IPO MARKET: Revival at Last

    The initial public offering (IPO) market finally delivered on years of revival hype by roaring back in 2013, with no less than 55 therapeutic, diagnostic, and industrial/agricultural biopharma companies going public this year as of December 10. According to data by Burrill & Co., they raised a combined $6.236 billion, one third of which came from the year’s single largest IPO, Zoetis, Pfizer’s animal-care spinout, with more than $2.2 billion raised. Zoetis was followed by CRO Quintiles ($525 million raised); and eye disease drug developer Ophthotech ($167 million).

    “A lot more money is coming into the sector,” Edward Ahn, Ph.D, managing director and CSO of MedCap Advisors, told GEN. The revival of the overall market was definitely one factor, since it brought more generalist investors back to make investments, he said. Yet investors also responded to FDA’s quickening pace of review and decisions on new drugs, aided by last year’s enactment of the 2012 Food and Drug Administration Safety and Innovation Act; and what Dr. Ahn said was a scarcity of quality companies in which to invest.

    He said another factor in the IPO revival was the Jumpstart Our Businesses (JOBS) Act, whose provisions include a five-year exemption from the Sarbanes-Oxley Act and confidential IPO pricing for smaller companies issuing their first public shares: “The regulations have really helped some small companies take their company public.”

  • JOBWATCH: Layoff-Go-Round Continues

    Round and round big pharma cost-cutting goes, and where (and when) the layoffs stop, nobody knows. Merck & Co. wielded the sharpest axe in 2013, when it said October 1 it will eliminate 8,500 jobs worldwide by the end of 2015, as part of a restructuring that will include shrinking its real estate footprint in New Jersey and moving its headquarters within the Garden State.

    Not far behind, AstraZeneca announced it was shedding an additional 3,900 additional jobs—2,300 selling, general, and administrative (SG&A) employees plus 1,600 R&D staffers. Those layoffs brought to 5,050—roughly 10% of the current workforce—the number of positions to be jettisoned through 2016. Also eliminating large numbers of jobs were Eli Lilly (1,245 U.S. sales reps due to expected patent-cliff revenue losses); Novartis (nearly 1,000 jobs at Ciba Vision, a consumer drugs plant in Lincoln, NE, and most recently 325 R&D staffers); and Endo Health Solutions (about 700 jobs, after failing to stop a generic version of its Opana ER [oxymorphone HCl] moderate-to-severe pain drug from reaching the market).

    The biggest layoff wave not to occur was the 5,000-job elimination announced by Teva in October. Israeli officials reacted with thunderous criticism, and the company withdrew its plans some three weeks later—a factor speculated as leading to the CEO’s resignation .

    • LAWSUITS: Maryland Wins on DNA Testing; Sequenom Loses on Diagnostic Patent

      A divided U.S. Supreme Court in June sided with the state of Maryland, and much of the nation’s law enforcement community, by ruling yesterday that authorities can take the DNA of criminal suspects upon arrest but before they are convicted of a crime. A 5–4 high-court majority sided with Maryland officials, who maintained that the state acted properly when it collected DNA by swabbing the cheek of Alonzo Jay King, Jr., when he was arrested in 2009, a year after the state expanded DNA sample collection to include suspects of felony first-degree assault. King was arrested on that charge, later dropped, as well as a misdemeanor or second-degree assault charge of which he was initially convicted. In dissent, Justice Antonin Scalia said the taking of DNA samples from persons not convicted of crimes violated the Fourth Amendment by searching for evidence of a crime without a basis for belief of guilt or incrimi¬nating evidence.

      In October, Judge Susan Illston of the U.S. District Court for the Northern District of California invalidated via summary judgment a Sequenom-licensed patent covering the detection of fetal cell-free DNA in the bloodstream of pregnant women. Judge Illston upheld a challenge from Ariosa Diagnostics, declaring that U.S. Patent No. 6,258,540 covered patent-ineligible subject matter—namely the presence of fetal DNA in the mother’s blood, which the judge said fell into the natural-phenomenon exemption from patentability under Section 101 of the U.S. Patent Code. Sequenom—which has said it will appeal the decision—used the patent to protect its MaterniT21 Plus noninvasive prenatal diagnostic test, which unlike older techniques such as amniocentesis or chorionic villus sampling doesn’t carry the same risk of miscarriage.

    • M&A DEALS: Thermo Fisher, Amgen Bag the Biggest Buys

      Thermo Fisher bagged the year’s biggest deal in April when it agreed to acquire Life Technologies for $13.6 billion, plus assumption of Life Tech’s $2.2 billion in debt. The transaction created a powerhouse in biopharma lab instrumentation and supplies with combined revenues of $16.3 billion and about 50,000 employees. But that workforce is expected to shrink over three years, as Thermo plans to cut $250 million by combining infrastructure with Life Tech, plus another $25 million by combining the companies’ commercial capabilities. In November, Thermo won European Commission clearance after agreeing to shed its cell culture (sera and media), gene modulation, and magnetic beads businesses. The deal is expected to win all remainingregulatory approvals and close in 2014.

      Next-biggest deal was Amgen’s $9.7 billion buy of Onyx Pharmaceuticals, in a deal that added Onyx’s multiple myeloma drug Kyprolis (carfilzomib) and two other drugs to Amgen’s cancer holdings. Valeant Pharmaceuticals snapped up Bausch & Lomb for $8.7 billion, creating a more-than-$3.5 billion-a-year eye-care giant—while Perrigo snapped up Elan for $8.6 billion, ending months of uncertainty about Elan’s future that included a hostile takeover bid by Royalty Pharma. On the smaller end of deals, Cubist Pharmaceuticals spent $1.2 billion on a pair of acquisitions, Trius Therapeutics (for $707 million) and Optimer Pharmaceuticals (an additional $535 million). And China’s BGI-Shenzhen cleared U.S. and Chinese regulatory hurdles to acquire Complete Genomics for $117.6 million.

      Not all deals succeeded: PharmAthene called off a planned merger with Theraclone Sciences for an undisclosed price, about a week after Theraclone was turned down for federal funds to advance development of its recombinant fully-human monoclonal antibody TCN-032 into Phase II trials for serious influenza, including pandemic flu.

    • NOTABLES: Resignation, Innovation, Incarceration, Recognition, and Acclamation

      • Jeremy Levin, D.Phil., stepped down in October as CEO of Teva Pharmaceutical Industries after just 17 months on the job, after the company disclosed later-withdrawn layoff plans (see JOBWATCH on page 1), reportedly following disagreements with the company’s board of directors led by Phillip Frost, M.D.
      • J. Craig Venter unveiled a digital biological converter capable of creating a copy of an organism from a distant location—“a biological fax machine,” as The New York Times put it.”
      • In an exclusive GEN interview, onetime Fortune 400 member and “king of biotech” David Blech blamed a desire to recreate his past and his bipolar disorder for actions resulting in his going to prison on federal charges of “manipulative and fraudulent trading activity.”
      • Novo Nordisk ended its association with marketing spokeswoman Paula Deen after the celebrity chef admitted to using a racial slur during a deposition in a since-dismissed workplace discrimination case.
      • James E. Rothman, Ph.D., of Yale University; Randy W. Schekman, Ph.D., of the University of California, Berkeley; and Thomas C. Südhof, M.D., of Stanford University co-won this year’s Nobel Prize in Physiology or Medicine for their discoveries on how key molecules are transported within and outside the cell through vesicles.
      • Martin Karplus, Ph.D., of Harvard University and France’s Université de Strasbourg; Michael Levitt, Ph.D., of Stanford University School of Medicine; and Arieh Warshel, Ph.D., of the University of Southern California won the chemistry Nobel Prize for laying the groundwork behind today’s computer models for understanding and predicting chemical processes.
      • And a past double-Nobel laureate, Frederick Sanger, acclaimed as “father of the genomic era” for research that laid essential groundwork for the sequencing of amino acids and later DNA, passed away November 19 at age 95.
    • RESEARCH: CRISPR, Junk DNA, and Big Data

      Nearly a year after its designation by Science as a runner-up for Breakthrough Technology of the Year 2012, GEN made its own pronouncement on CRISPR (clustered, regularly interspaced short palindromic repeats) and CRISPR-associated (Cas) proteins, saying the technologies have come of age.

      As GEN’s Patricia Fitzpatrick Diamond, Ph.D., reported in July, researchers believe that recent breakthroughs in understanding the mechanisms of CRISPR/Cas offer great potential for biotechnological applications and understanding evolutionary dynamics. Unlike other tools, CRISPRs are constructed from RNA—a cheaper and easier starting material. CRISPRs can be designed and customized to induce cuts at precise location in the genome, and can make nicks simultaneously at more than one genomic location, allowing researchers to look at the effects of combinations of mutations. Indeed, CRISPR’s gene editing methods, along with those of developing the gene editing methods of TALENs (transcription activator-like effector nucleases), are the basis of a new startup company founded in November by five pioneers in genome editing technology, Editas Medicine.

      This year could be remembered as the year researchers finally figured out the value of “junk” DNA. Scientists at Sydney’s Centenary Institute reported in August that the 97% of human DNA long referred to as junk is actually a previously unknown mechanism for regulating the activity of genes, thus increasing human understanding of the way cells develop and pointing to new possibilities for therapy. In a study published in Cell, John Rasko, Ph.D., and a team including Centenary’s head of bioinformatics, William Ritchie, Ph.D., showed how particular white blood cells used noncoding DNA to regulate the activity of a group of genes that determines their shape and function.

      Big data’s promise for lowering healthcare costs and advancing personalized medicine—McKinsey Global Institute estimates institutions could generate up to $100 billion in value annually by applying big data strategies—led Berg to join Mount Sinai’s Icahn School of Medicine in launching a pharmaceutical and diagnostic R&D partnership designed to leverage the power of multi-omic biology and data analytics.

    • SEQUESTRATION: Agencies Cope with Across-the-Board Budget Cuts

      NIH, FDA, and all other federal agencies were forced to cut spending across the board—by about 5% for nondefense agencies—in March to comply with the “sequestration” agreed to by both houses of Congress and President Obama in their Budget Control Act of 2011. The agencies fared worse in October, when the absence of a budget forced the federal government into a partial shutdown that lasted more than two weeks and made Congress the butt of jokes nationwide, from late-night TV comics to researchers and professional groups frustrated by their inability to get grants.

      “As America keeps hitting the brakes on scientific research, we are, in effect, accelerating the damage done to our continued leadership in global bioscience, in health outcomes, and in the economic power that we have always derived from basic research,” Stefano Bertuzzi, Ph.D., executive director of the American Society for Cell Biology (ASCB), said during the partial shutdown.

      Washington got back to work October 17, following a deal in which Obama joined the Republican-led House of Representatives and Democratic-led Senate in funding the federal government through January 15 and raising the nation’s borrowing limit or “debt ceiling” through February 7. The relative calm between the parties stretched into December with a bipartisan budget agreement for FY 2014 that will likely reverse much of the sequestration cut, though detailed agency budgets had yet to be decided at deadline. Also anybody’s guess is how long the era of good feeling will last into 2014, since a re-election year for the entire House and one-third of the Senate can be expected to re-ignite the partisan squabbling seen through so much of 2013.

FDA Approves Anoro Ellipta to Treat COPD

A new inhaled drug to treat a serious lung condition called chronic obstructive pulmonary disease (COPD) has been approved by the U.S. Food and Drug Administration.

GlaxoSmithKline‘s Anoro Ellipta is meant to be used once a day for long-term maintenance of airflow in patients with COPD. The lung disease makes breathing difficult and worsens over time.

“Anoro Ellipta works by helping the muscles around the airways of the lungs stay relaxed to increase airflow in patients with COPD,” Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in an agency news release.

“The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD,” he added.

Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, said the new medication is a “unique combination” of two drugs presently used for COPD. “It combines a drug similar to Spiriva and a [long-acting beta agonist] as found in Advair, he said. “There is no steroid in Anoro Ellipta.”

According to the FDA, Anoro Ellipta combines umeclidinium, a drug that prevents muscles around the large airways from tightening, and vilanterol, which improves breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs.

Another lung specialist, Dr. Charles Powell, called the approval a “promising development for patients with COPD,” noting other countries already allow this type of medication.

“Combined long-acting bronchodilators are available in Europe. Now we have the first approved combined long-acting bronchodilator medication available in the U.S.,” said Powell, who is chief of pulmonary, critical care and sleep medicine at the Mount Sinai – National Jewish Health Respiratory Institute in New York City.

“Combining two effective bronchodilators can result in improved lung function and medication compliance compared to traditional COPD inhaled medications,” Powell said.

The FDA approval is based on findings from more than 2,400 people with COPD. The results showed that those who took the drug had greater improvements in lung function than those who took a placebo. The most common side effects reported by patients who took Anoro Ellipta included sore throat, sinus infection, lower respiratory tract infection, constipation, diarrhea, pain in extremities, muscle spasms, neck pain and chest pain.

Serious side effects that can be caused by the drug include narrowing and obstruction of the airway, cardiovascular effects, increased pressure in the eyes, and worsening of urinary retention.

Anoro Ellipta is not approved for asthma treatment and should not be used as a rescue treatment for sudden breathing problems, the FDA said. The drug carries a boxed warning that the class of drugs that vilanterol belongs to increases the risk of asthma-related death.

“Patients with COPD need to be seen and examined before determining the appropriate use of this drug, as with any medication,” added Horovitz.

Cigarette smoking is the main contributor to COPD, which is the third leading cause of death in the United States. Symptoms can include chest tightness, chronic cough and excessive phlegm.