How Big Pharma Buys Doctors and Regulators

How Big Pharma Buys Doctors and Regulators

by

Dr. Robert Gorter, MD, PhD. and Ty Bollinger

October 28th, 2022

BIG PHARMA

Western medicine as we now know it lives in orbit around the pharmaceutical industry. Medical schools teach doctors how to match symptoms with prescriptions, hospitals negotiate with insurance companies based on the cost of drugs, and the race is ongoing to create the latest and greatest drug that will cure what ails ya.

The healers of today are no longer the heroes of the old. The healers of today are trained, funded, and accountable to the pharmaceutical industry. Today’s modern medical mafia has deceived us, is deceiving us and will continue to deceive us if left unchecked. All in the name of profits.

Bribing Doctors on all levels

First, it’s important to understand that most doctors receive gifts from Big Pharma in one form or another. A 2018 survey published in the Journal of General Internal Medicine found that nearly three out of four doctors have financial ties to Big Pharma. The vast majority of these relationships were with representatives of a prescription drug or medical device manufacturers. Gifts included drug samples, meals, travels for continuous medical education in 5-star resorts, and payment for consulting or advisory roles.

Since 2013, federal law has required that payments to doctors by medical device and pharmaceutical companies be publicly reported. The database (which you can access here) has published over 11.5 million records between August 2013 and December 2017, reflecting $8.4 billion in gifts and payments. Question: who pays for these billions of direct or indirect bribes? Exactly: the tax payer.

Dr. Aaron S. Kesselheim, an associate professor of medicine at Harvard Medical School and lead author of the survey, says this may be influencing doctors’ behavior. According to the study, “Free samples are used as a marketing tool and have been linked to prescribing of high-cost, brand-name drugs over lower-cost generic alternatives.” He suggests that money paid for public speaking and consulting engagements may have an even more acute impact on doctor behavior. “Social scientists will tell you that any amount of money will influence people, but I think larger sums can influence behavior even more,” Dr. Kesselheim said in a statement to The New York Times,

This information is terrifying.

We trust our physicians to make the best recommendations for our health, but the majority of these doctors are receiving gifts from Big Pharma that may influence the treatments they recommend. For example, an orthopedic surgeon in Manhattan received almost $2,000,000 from companies that manufacture hip and knee replacement products between 2015 and 2017. Not coincidentally, the surgeon, Dr. Geoffrey Westrich, performs hundreds of hip and knee replacements each year. In 2017, this doctor received $870,573 in general payments from pharmaceutical and medical device companies, including $448,000 for “consulting fees”, $28,580 for non-educational speaking engagements, and over $23,000 in travel and lodging.

Is it possible that these payments have no effect on the equipment, materials, and drugs the good doctor uses?

Dr. Kesselheim: “Financial connections between physicians and industry remain a prevalent force affecting prescribing practices and health care costs.”

And while health insurance often shields patients from the bulk of these inflated prices, they end up being passed down in the form of higher rates and higher deductibles. And who profits? Big Pharma and the medical device industry.

Remember Purdue Pharma, the maker of OxyContin? In 2015 they paid nearly $12 million to doctors not associated with research studies. This included 4 payments totaling over $460,000 to Dr. Glen Apseloff, the president and lead researcher at Ohio Clinical Trials, Inc. These were reported as “consulting fees” and were paid directly to Dr. Apseloff, not Ohio Clinical Trials.

We have talked about how doctors can profit from chemotherapy, and the lengths pharmaceutical companies will go to promote their products. Medical schools focus almost exclusively on pharmaceutical and surgical intervention strategies used to reactively address health issues rather than homeopathic strategies to proactively prevent these diseases in the first place.

And why not? There’s far more money in prescription drugs and medical equipment than there is in holistic and homeopathic treatments.  In a 2009 article by Dr. Art Van Zee, it was reported that Purdue Pharma conducted more than 40 national pain management and speaker-training conferences at resorts in Florida, Arizona, and California. More than 5000 physicians, pharmacists, and nurses attended these all-expenses-paid symposia, where they were recruited and trained for Purdue’s national speaker bureau. This coincided with the launch of OxyContin.

It is well documented that this type of pharmaceutical company symposium influences physicians’ prescribing, even though the physicians who attend such symposia believe that such enticements do not alter their prescribing patterns,” says Dr. Van Zee. Dr. Kesselheim agrees, saying that company-sponsored presentations “provide a very narrow educational experience.”

Buying the FDA

From 2014 to 2019, the FDA approved nearly 150 new anticancer drugs. And although this may seem like good news, cancer patients may want to hold their applause. As it turns out, a significant portion of these approvals – nearly 1 in 3 – were based on clinical trials that do not prove the effectiveness of the drugs.

A study published last month in JAMA Oncology evaluated 143 cancer drugs approved by the FDA between 2013 and 2018.

Analysts found that 17% used “suboptimal control arms” and showed no benefit over standard therapies. In other words, many anticancer drugs approved by the FDA haven’t shown any real benefit to patients. And the safety of these drugs is often not considered in the comparison.

To better understand the implications of the new analysis, it is important that we first understand the process for drug approval.

Most drugs seeking FDA approval undergo something called randomized clinical trials to prove their efficacy. This means that participants are separated randomly into different groups to compare the effects of different drugs.

In a randomized clinical trial, the group that does not receive the experimental treatment is called the control arm. The control arm may receive no treatment, a placebo, or the accepted standard of care.

But what happens when new drugs are tested against inferior therapies? Or therapies that are rarely used? This is called a “suboptimal” control arm, and it essentially nullifies any findings of the study. When the control arm is suboptimal, there is no scientific evidence that the new drug offers any benefit over the standard of care.

What this means is that the FDA is regularly approving new anticancer drugs that may not be any better than the standard drugs already in use. But whenever a new drug is approved, company stock goes up and people get paid. And as long as the new drug outperforms the control arm, it’s off to market.

Here’s a list of anticancer drugs approved by the FDA based on suboptimal control arms since 2013:

  • afatinib
  • apalutamide
  • bosutinib
  • brentuximab vedotin
  • brigatinib
  • cabozantinib
  • ceritinib
  • everolimus
  • ixazomib (+ lenalidomide + dexamethasone)
  • obinutuzumab (+ bendamustine)
  • obinutuzumab (+ chlorambucil)
  • olaparib
  • olaratumab
  • pembrolizumab
  • ramucirumab
  • venetoclax

Cancer patients deserve better, and companies should not be allowed to set their own parameters for success. According to the study’s lead author, Talal Hilal:

The take-home message from our analyses is that FDA approval doesn’t automatically make a new drug better than treatments doctors are currently using… People being treated for cancer must often withstand physical and financial toxicity. It is only right that any new treatments offered to them must have been proven to be better than what is already available.”

Hilal suggests that the FDA set clear standards for acceptable control arms to ensure better outcomes for patients, but we’ve seen how hard it can be to get the FDA to regulate an industry that pays them so handsomely. In fact, we discussed the way that pharmaceutical companies influence FDA approval decisions not long ago.

Johnson & Johnson, the latest company on trial for fueling the opioid crisis, recently won a timely approval for their cancer drug Balversa. Here’s how big pharma makes sure their drugs get approved:

When a new therapy is up for FDA approval, advisory committees are formed to review the new drug and vote on whether or not it should be approved. The FDA always follows these recommendations.

But a look into the finances of these committee members paints a more sinister picture. Physicians who sit on these advisory boards nearly always end up taking money from the companies relying on their votes. These bribes are not well-masked, showing up as consulting fees, travel compensation, or research grants.

According to sciencemag.org

“An analysis of pharma payments to 107 physicians who advised the FDA on 28 drugs approved from 2008 to 2014 found that a majority later got money for travel or consulting, or received research subsidies from the makers of the drugs on which they voted or from competing firms.”

The reason that the FDA is so corrupt may have to do with its employees. In July of 2019, former FDA commissioner Scott Gottlieb took on a new position – on the board of pharmaceutical giant Pfizer.

Mr. Gottlieb will now profit from a company that he was responsible for regulating less than 3 months prior. The move has been widely criticized, and for good reason. The revolving door between government regulators and the pharmaceutical industry has completely eroded the public’s faith in the FDA.

Pfizer is a massive company worth billions. Since Gottlieb was nominated as FDA commissioner, Pfizer’s market value has exploded from $200 billion to $240 billion. For the first year as commissioner, Gottlieb was forced to recuse himself from making decisions involving nearly 20 pharmaceutical companies with whom he had relationships. These companies included Vertex Pharmaceuticals, GlaxoSmithKline, and Bristol-Myers Squibb, among many others.

Before becoming commissioner, he also did work for Pfizer.

The announcement has received much criticism, with one U.S. Senator calling for his resignation, saying that the move “smacks of corruption.” Leigh Turner, a bioethicist at the University of Minnesota, tweeted the following:

„The next chapter of Scott Gottlieb’s career will be played out in the inner sanctums of Big Pharma — forever reinforcing the FDA’s critics of the revolving door between the agency and the industry.”

Though Gottlieb has said that he is “proud” of his relationship with Pfizer and that he’s “very confident” about his record at the FDA, his dealings with the massive pharmaceutical corporation were sketchy, to say the least. When it came to concerns about Pfizer’s rheumatoid arthritis medication, Gottlieb was notably very soft.

In February 2022, a safety trial run by Pfizer found that higher doses of the drug Xeljanz resulted in a “statistically and clinically important difference” in the instances of blood clots and death. While Gottlieb’s counterparts in the European Union quickly put restrictions on the drug, the FDA simply warned doctors of the study’s results.

In addition, to rheumatoid arthritis, the drug was marketed for the treatment of ulcerative colitis and psoriatic arthritis. But the safety study required by the FDA did not focus on these other conditions, even though the dangerous higher doses were already recommended for patients with ulcerative colitis. Patients with inflammatory bowel disease like colitis have a higher risk of clots – as much as 3 times higher. Nevertheless, these patients continue to receive the dangerous higher dose.

“It sounds like a reward for a job well done,” said Carl Elliot, another bioethicist from the University of Minnesota. While Gottlieb denies any involvement in the decisions about Xeljanz, his prior involvement with Pfizer and quick appointment to the board following his resignation certainly raise doubts. “It sure does look suspicious,” Elliot said in an interview.

Unfortunately, the unseemly relationship between Big Pharma and the FDA is nothing new. For nearly 40 years, every FDA commissioner but one has joined the board of a pharmaceutical company after leaving the agency.

Robert Califf

Scott Gottlieb’s predecessor, Robert Califf, was a consultant who was paid tens of thousands of dollars by the pharmaceutical industry. His clients included Merck, AstraZeneca, Eli Lilly, and Johnson & Johnson, the last of which paid him over $78,000 in 2012. Following his tenure as commissioner, he took a job with the publicly traded pharma company Biokinetics.

Margaret Hamburg

Before Califf, Margaret Hamburg was in charge of the FDA. She was charged in a racketeering lawsuit shortly after leaving the office. The suit accused Hamburg of collusion, conspiracy, and racketeering involving Johnson & Johnson’s drug Levaquin. Hamburg and J&J allegedly withheld the risks of the drug, which ended up killing over 5,000 patients and leaving tens of thousands injured by life-threatening diseases.

During her tenure, Hamburg’s husband made hundreds of millions thanks to her work with Johnson & Johnson. She also approved the opioid painkiller Zohydro ER, manufactured by Zogenix Pharmaceuticals. An advisory panel voted 11-2 against approving the drug, citing its risk for abuse and overdose. They were joined by law enforcement agencies, anti-addiction groups, and addiction experts who voiced the same concerns.

Hamburg’s husband’s hedge fund held stock in the drug and made tens of millions on its approval. After stepping down as FDA commissioner, she took a lucrative job with Alnylam Pharmaceuticals.

Andrew von Eschenbach

Before Hamburg was appointed, Andrew Von Eschenbach was the FDA head. After leaving his post, von Eschenbach took a position on the board of BioTime, a publicly traded biotechnology company that develops stem cell therapies and cancer drugs. Von Eschenbach took over the FDA suddenly, after a 2-month stint by his predecessor, Lester Crawford.

Lester Crawford

Lester Crawford served only a few months before resigning in the wake of allegations that he had failed to disclose conflicts of interest. A year later, he pled guilty to conflict of interest and false reporting of information about stocks he owned in agricultural and pharmaceutical companies – the very industries he was meant to regulate.

He was given 3 years of probation and a fine. He soon joined Policy Directions, a lobbying firm that represents companies regulated by the FDA, including Merck, Nestle, and Alpharma Inc., a pharmaceutical company specializing in morphine-based painkillers.

Mark McClellan and Jane Henney

Before Crawford, the FDA was run by Mark McClellan, who went on to work for Johnson & Johnson. McClellan was preceded by Jane Henney, who followed her FDA appointment by becoming a director at Amerisourcebergen Corp, a wholesale drug company. The cycle is virtually endless.

But it’s not just the FDA. Here’s a quick highlight reel of how the CDC has worked hard to protect patients:

  • In 2016, a group of CDC scientists filed an ethics complaint claiming that its agency officials were being manipulated by corporate interests. The CDC claims that it “does not accept commercial support” and has “no financial interests or other relationships with the manufacturers of commercial products.” As it turns out, several high-ranking CDC officials were discovered to be colluding with Coca-Cola to publish studies and influence public health policies in Coca-Cola’s favor. According to studies, Coca-Cola is linked to 180,000 deaths per year.
  • That same year, it was discovered that CDC officials lied to Congress about its WiseWoman heart disease prevention data and then covered up their lie. Millions of dollars were allocated to the project based on falsified data.
  • In 2018, the CDC decided to cut efforts to prevent disease outbreaks by 80%. The cuts included oversight and prevention efforts in China, where the Coronavirus outbreak first occurred.
  • In March of 2018, Robert R. Redfield became the director of the CDC, where he took a $375,000 annual salary – nearly 60% higher than his predecessor. Here’s his track record:
    • 1992: Redfield is accused of lying about the effects of an experimental HIV vaccine by the Defense Department.
    • 1993: A subsequent investigation by the U.S. Army found that Redfield had an inappropriate relationship with a private organization of the failed vaccine.
    • 2020: Redfield supported doomsday models of the coronavirus spread that were proven to be completely wrong. This model was the basis for the draconian lockdown measures (despite being WAY off), and Redfield continued to make excuses defending it.

But CDC failure during the coronavirus outbreak extends beyond Redfield…

  • At the beginning of the coronavirus outbreak, avoidable lab contaminations at the CDC ruined initial testing performed in the United States. Many of the tests were tainted with COVID-19.
  • Officials have also accused the CDC of lying to the president about their ability to produce test kits.
  • Emails reveal that chaos and a lack of organization at the CDC dramatically slowed early response to the virus.
  • The CDC also failed to use other diagnostic tools, refused help from qualified volunteers, and promoted cloth face masks that actually increase the risk of infection.
  • Perhaps worst, the CDC has continued to lie about the death count by artificially inflating it. CDC guidelines for determining COVID-19 deaths include:
    • Anyone who tests positive, even if they died from other causes.
    • Anyone who had COVID-19 symptoms, even if they aren’t tested.

BIG PHARMA

Julie Gerberding (personally well-known by Dr. Robert Gorter when they both worked in San Francisco in the beginning of the HIV/AIDS Epidemic: Dr. Gorter worked at the AIDS Clinic at San Francisco General Hospital / University of California San Francisco Medical School (UCSF) and Dr. Gerberding at the Department of Public Health in San Francisco) fulfilled first many years of chairmanship of the CDC. Then she switched to Merck’s Vaccine Division.

SEC filings show that Merck’s Vaccine Division President Julie Gerberding sold more than half of its Merck stock in January 2020 for $9.1 million. That transaction followed a wave of bad news for Merck’s flagship Gardasil® vaccine against HPV.

It is still uncertain whether vaccination against human papillomavirus (HPV) prevents cervical cancer, as studies were not designed to detect this outcome.

Big Pharma Stacks Safety Committees

In January 2016, Robert F. Kennedy, Jr., chairman of the board and chief legal counsel for Children’s Health Defense, was asked by then-president Donald Trump to run a vaccine safety commission.

Kennedy agreed to head the commission to “make sure the right studies were being done to make sure that each vaccine was actually working” by conducting control studies — “the same studies that are required for every other medication.”

But when it was announced that Kennedy would lead the vaccine safety commission, “there was panic throughout the industry and the public health regulatory agencies,” he said.

Next, came a financial power play.

Pfizer made a $1 million contribution to Trump, and Kennedy after which Trump appointed two people “hand-picked by Pfizer” as top officials for the government’s health regulatory agencies.

Those two people were Alex Azar, to run the U.S. Department of Health and Human Services (HHS), and Scott Gottlieb to run the FDA.

Both Azar and Gottlieb had executive ties to Big Pharma. That signaled the premature death of the control studies on vaccines.

“They killed the vaccine safety commission,” Kennedy said. “I don’t know exactly how it happened, but as soon as those guys got in there they stopped answering our calls or communicating with us.”

They say that the proof is in the pudding, and this pudding is SOUR. We’ve been led to believe that doctors are to be trusted and revered. That their vast knowledge extends beyond the marketing materials of Big Pharma. Regulatory bodies exist to protect us from unsafe drugs and practices. Insurance companies help keep medical costs down.

These are all LIES.

 

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