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WELCOME TO DRUG WORLD: DRUGMAKERS GET AWAY WITH ANYTHING

By January 29, 2022June 10th, 2024No Comments

This is a chapter excerpted from Butchered by “Healthcare,” available on Amazon.

It was a situation for despair, but there was no alternative but to keep one’s nerve.

Colonel Heinz-Gunther Guderian, a Panzer commander facing the Allied invaders on D-day

Wendy Dolin learned the hard way about antidepressants. Her husband Stewart threw himself in front of a train a week after he started taking generic Paxil. Mr. Dolin’s doctors gave him the drug for job-related anxiety, but it creates intolerable restlessness in three to five percent of people using it. He was last seen pacing back and forth on the train platform.

He killed himself despite what his family thought was a perfect life. His two grown children adored him, and he loved his career, travel, skiing, and his work. He was happily married to his high school sweetheart. When Ms. Dolin sued the drug company, testimony established that it had hidden Paxil-related suicides.

For two decades, while making billions of dollars, the manufacturer had been quietly settling thousands of similar cases. In 2017, Ms. Dolin won a three million dollar judgment. Her attorneys had spent a million dollars, but the company filed an appeal. It claimed that the original manufacturer was not responsible for subsequent generic versions of the medication.

The following story may be worse. David Carmichael took Paxil for two periods of several months each and felt suicidal each time. His doctor advised him that increasing his dose would decrease his stress. When he did, he went from suicidal to homicidal and killed his 11-year-old son. The circumstances indicted Paxil, and Mr. Carmichael believes it was the cause. Since blaming the drug was impractical for his legal defense, this was not brought forward at his trial. The court acquitted him of murder because he was believed to be temporarily psychotic, which means out of touch with reality.

SSRIstories.org has about 5000 first-hand news stories about situations like these. The drug companies claim that the drugs are bystanders and that the perpetrators are prone to violence. A half-hour spent on this website makes a compelling circumstantial case that the drugs are the cause.

Corporate criminals calculate they will make money even if they are caught, convicted, and fined.

The Ford Pinto’s gas tank sometimes exploded when the car was rear-ended. Ford knew about it but risked more deaths and lawsuits. They calculated that this was cheaper than a recall. After about 500 people died in fires and hundreds of lawsuits were filed, the press discovered the coverup.

British Petroleum (BP) had criminally lax safety practices, so the Deepwater Horizon oil spill in the Gulf of Mexico was not a surprise to industry observers. Eleven people died, and the spill devastated the southern coast of Louisiana. By 2016, BP’s settlements and restitution for manslaughter and other crimes were projected to exceed $62 billion. But since their annual gross revenues that year were $183 billion, this was just a cost of doing business.

Volkswagen AG faked their emissions testing. When this came out, it damaged their reputation, and their stock price dropped by a third. By 2016, the fines and settlements in the US alone were over $25 billion. Their gross revenue that year was $259 billion, so it was, again, just another cost of doing business.

Pharmaceutical corporations violate more criminal laws than any industry in history, as measured by their criminal settlements. The top 22 drugmaker payoffs since 2004 have their own Wikipedia page of shame. Nine of the ten largest companies are there, and five payments are for more than a billion dollars. Ralph Nader’s group Public Citizen has catalogued their crimes for decades. The medical device companies’ behavior is similar. Prosecutors allow these businesses to admit little and keep their executives out of jail if they pay up.

Besides psychiatric drugs, many other medications are killers. About 50,000 people die each year in the US from opioids, and until the recent street fentanyl crisis, two-thirds of these involved prescriptions. Hospital medication fatalities have been well known since a 1998 meta-analysis in JAMA. Out of 39 studies of millions of US patients, there were about 100,000 deaths in 1994 alone.

The renowned Danish physician and researcher Peter Gøtzsche estimated that the total annual drug-related fatalities in the US and Europe was 200,000. This included hospitals and outpatients. It is the third-highest cause of death after heart disease and cancer.

The primary way US federal prosecutors attempt to hold pharmaceutical corporations to account is for “off-label marketing.” Physicians have flexibility for prescribing patient-by-patient, but corporations are only supposed to promote products for the reasons stated on the product information label. Nevertheless, drug representatives hound doctors to prescribe medicines in unsanctioned ways. They also pay experts to speak about these “off-label” treatments. Strangely, while promoting drugs for off-label use is illegal, hiring experts to promote the drugs off-label in the guise of continued medical education is lawful.

Examples of this brand of criminality follow.
✪ In 2012, GlaxoSmithKline (GSK) paid a record $3 billion settlement and agreed to plead guilty to federal criminal charges. It was then the single largest healthcare fraud settlement. The company was alleged to have marketed unapproved uses of medications, lied to physicians about safety, lied in medical journals, and illegally promoted drugs for children. This involved ten medications: Avandia, Wellbutrin, Paxil, Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, and Valtrex. As usual, there were no admissions of wrongdoing. Their stock rose nearly two percent after the agreement made the news. GSK’s gross receipts were $27 billion (2016), so the massive fine was a bit more than a single month’s total revenue, another cost of doing business.
✪ In 2009, Pfizer accepted a $2.3 billion fine settling civil and criminal allegations for illegal marketing of their anti-inflammatory Bextra. John Kopchinski, a former Pfizer sales representative and whistleblower, said, “The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player.” It was the fourth Pfizer settlement within a decade and only sixteen days of their total revenue.

Eliot Spitzer sued GlaxoSmithKline when he was New York’s attorney general. He said, “What we’re learning is that money [fines] doesn’t deter corporate malfeasance. The only thing that will work in my view is CEOs and officials being forced to resign and individual culpability being enforced (2004).” People need to go to jail.

Litigation records are the visible tip of an enormous iceberg of concealed graft. Even bribery of foreign government officials, as reflected in US criminal settlements, has become commonplace, as described in a 2017 Public Citizen article. The BMJ (formerly the British Medical Journal) describes scandals almost weekly.

Peter Rost, former Pfizer marketing vice president, compared the drugmakers to mobsters:

It’s scary how many similarities there are between this industry and the mob… obscene amounts of money… killings and deaths… [bribing] politicians and others… The difference is, all these people in the drug industry look upon themselves… as law-abiding citizens… However, when they get together as a group… It’s almost like when you have war atrocities; people do things they don’t think they’re capable of… because the group can validate what you’re doing as okay.

The Whistleblower: Confessions of a Healthcare Hitman

By 2002, the top 10 drugmakers’ profits equaled those of all the other 490 Fortune 500 companies together. Drug manufacturers, showered with federal and insurance money, have 20-25 percent net profit margins. Pfizer’s have been phenomenal: 51 percent in 2013, 43 percent in 2014, 40 percent in 2017, and 44 percent in 2018. Thriving industries which freely compete and are not state-supported average less than 10 percent net profit margins.

Courageous Cassandras introduced me to drug industry practices. Ben Goldacre wrote the following about drug studies:

Drugs are tested by people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analyzed using techniques which were flawed by design, in such a way that they exaggerate the benefits of treatments…  You can compare your drug with something you know to be rubbish–a drug at an inadequate dose perhaps, or a sugar pill…  you could peek at your results halfway through, and stop your trial early if they look good. 

Bad Pharma, 2012

David Healy is an academic psychiatrist who wrote Pharmageddon (2012). He says that for twenty-five years the corporations have been fabricating diseases and syndromes and then marketing the drugs to treat them. He also says that over half of our pharmaceutical spending is for proprietary medications with dubious benefits such as antidepressants or statins. He calls the current drug approval system “research misconduct on a grand, international scale.”

Ghostwriters paid by industry draft more than half of all drug studies and even some textbooks. Academics whose careers depend on publication claim authorship and lend their credibility. Editors at prestigious journals give these authors a pass. At the same time that this misconduct is sanctioned, students are crucified for plagiarism and medical licenses are revoked for physicians who change patient records. These are misdemeanors compared to the industry’s murderous practices.

A Guardian article (2009) described how a pharmaceutical company offered writing services to Dr. Healy to emphasize “the main commercially important points” of an antidepressant. Their rewrite of his paper made a mediocre medicine sound fantastic, so he took his name off the article. Healy wrote that many drugs are about the same and that their sales depend mainly on marketing.

When academic physicians want to author a paper, they often approach a pharmaceutical company that has the research, evaluation, and writing teams in place. Only ten percent of trials are still run inside the US because data scams are easier to pull off where there is less scrutiny. In The Citizen Patient (2013), Nortin Hadler adds:

[Contract Research Organizations, CROs, are] contracted to test for efficacy rather than to try to disprove efficacy. The latter is sound science. The former is profitable. The CROs, the recruited physicians, and usually the patients all receive remuneration for their participation. Long gone are the days when drug trials were free of vested interests, conflicts of interest, marketing undercurrents, and fraud. Some scandals [involve] “paper patients” and data massaging.

Dr. Robert Fiddes, a Southern California family practitioner, developed a business doing medical studies with fabricated data. He said, “…most researchers are forced to cheat because drug companies issue requirements for test subjects that sound good in marketing material but are impossible to meet in the real world…  anyone successful in the business was skirting the rules.”  He went to jail for 15 months after being convicted of research fraud.

Studies confirm that company money destroys study integrity. In a 2007 analysis of 192 studies of statin drugs, favorable outcomes occurred twenty times more often with drugmaker funding than with other sources of support. In a review of psychiatric medications, trials paid for by the companies were positive 78 percent of the time, while with outside funding, only 48 percent were favorable. In a survey of 161 studies about harmful chemical exposures, only 14 percent found adverse health effects when industry-funded, but 60 percent revealed harm when independently funded. Other reviews of hundreds of trials also confirm funding bias. Expert witness bias is a well-known analogous situation. Lawyers, like corporations, pick witnesses who favor the viewpoint of whoever writes their check.

Forty percent of the studies of antidepressants remain unpublished, undoubtedly because they revealed that the drugs did not work. In the published trials, industry may remove data, ghostwriters may misrepresent the information, or they may switch patients into categories that change outcomes. Suicide, violence, and other issues may be under-reported or hidden. As the rules exist now, drug companies are entitled to conceal whatever study information they want because they own it. The administrators and patient-volunteers sign gag contracts.

Another often-used hoax is to publish positive studies over and over. For example, a 2005 review from Cochrane, arguably the most respected source in medicine, found a Zyprexa research data set that showed up 142 times in various publications. Zyprexa’s cost is many times that of older drugs, although it is not more beneficial.

John Braithwaite is a pharmaceutical company whistle blower and author of Pharmaceuticals, Corporate Crime, and Public Health (2014). He said that marketing departments dominate the drug companies. He described the concealed studies and the decline of innovation in favor of promoting established classes of medications that make quick profits.

He suggested applying whistleblower laws from the False Claims Act to corporate crime. Whistleblowers get a portion of settlements, which “privatizes law enforcement.” These incentives work, but they are currently only used for fraud against the government. Braithwaite said corporate penalties should be criminal rather than civil. He believes “corporate capital punishment” is the only way to get their attention. This means government takeover and sale of all assets. He calls this “corporate execution.”

Federal prosecutors are powerful, but unfortunately, we have given these companies such enormous resources that they can afford vast lobbying operations and rich political payments. This effectively squelches most laws that could hold them criminally accountable. The standards for criminal conviction are high, so these cases are tough to prosecute against wealthy white-collar defendants. The prosecutors have discretion, and their culture is to leave the troublesome cases alone.

Civil suits have lower requirements for proof than criminal cases. Some plaintiffs’ attorneys have made inroads against the corporations. As of the publication date of this book, Purdue Pharma and Insys, both guilty of premeditated mass murder using opioids, are finally being bankrupted by plaintiffs’ lawyers. Prosecutors, who were incapable of taking down Perdue themselves, decided in 2020 to feed on the kill. The company pled guilty to felony charges including a criminal fine of $3.5 billion and $2 billion in criminal forfeiture.

Remarkably, another company purchased the Insys fentanyl spray out of bankruptcy, and they continue to sell it.

The pharmaceutical industry finances 50 to 70 percent of all physicians’ continuing medical education (2015/2018). This was $1500 per doctor each year, or $700 million total. For research, in 1977, the industry was paying for 29 percent, but by 2009, it was 60 percent and by 2014, 86 percent. Very little of this was an issue 40 years ago, but now they even fund medical schools.

How did the drugmakers get so out of control? The pharmaceutical companies’ 2019 gross revenue, the total amount spent on drugs worldwide, was over $1.3 trillion (1300 billion). This had increased from one trillion in 2014. It is more than the gross domestic product (GDP) of any country except the top fourteen.

This industry is more than twice the size of Big Tobacco, which has only $500 billion in yearly global revenue. The National Football League’s gross receipts in 2018 were $14.5 billion. This would not have put it in the top ten pharmaceutical corporations, which had from $24 billion to $52 billion in revenues in 2019.

The drug industry claims its research budget justifies the outrageous pricing. Figures vary by company and source, but crudely, research is 14 percent, and marketing might be 20-25 percent of revenue. Marcia Angell, former editor of the NEJM, said marketing and administration together is 35 percent. But they likely spend double this on marketing. Another source claimed the cost of clinical trials was only one percent of the expense of bringing drugs to market (Sept. 24, 2018, JAMA Internal Medicine).

In 2003, a law slid through Congress stipulating that Medicare, the world’s largest drug buyer, could no longer negotiate prices with corporations. The statute directed them to pay 106 percent of the companies’ average wholesale price. Although this seemed reasonable, it allowed corporations to price-fix. The Veteran’s Administration, which was not part of the deal, now pays only about fifty percent of the Medicare rate for each medication. Even the notoriously wasteful US military bargains with competing defense contractors.

The US pharmaceutical lobby paid to make this happen. They spent $4 billion from 1998 through 2018, more than aerospace, defense, and oil/gas combined. The finance sector had the only lobby that was close—$5.1 billion between 1998 and 2008, but this figure included campaign contributions.

The US is only 4.3 percent of the world population, but soon after this legislation passed, 75 percent of the drugmakers’ worldwide profits and nearly half of all medication spending came from the US. The committee chairman who pushed the law through, Wilbert Joseph Tauzin II, retired to a $2 million a year pharmaceutical company job. A final, almost surreal detail is that half of these pharmaceutical companies are not based in the US and do not pay our taxes. This law allowed these outsiders to gouge us right along with the domestic corporations.

POSTSCRIPT: Several other government-fueled industrial sectors also have high profit margins. Sarah Chayes in Thieves of State (2015) says that, besides healthcare, these include energy and banking, with 20-25 percent profits. We support the wasteful defense industry, but it does not post numbers like these. Tobacco had direct subsidies until 2014 and still had about 14 percent net margins in 2019.  These companies all receive “free” money from the government rather than having to complete for it in the marketplace. Chayes says this transforms them into criminal or near-criminal enterprises as measured by their prosecutions.

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