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Friday, October 16, 2015

Big Pharma and the FDA: An Unholy Marriage

As the presidential debates heat up and the nation listens to the candidates voice their opinions on domestic and foreign policies, one grievous omission stands out. The failure to have a sustained political dialogue about the American health epidemic due to the abuse of opioids, a group of drugs that includes heroin and prescription painkillers, makes one wonder just how much the federal government supports immediate action to combat the disease of addiction. Does the government even believe drug abuse is one of the most important issues facing the country.

The abuse has had a devastating impact on public health and safety in the United States.

America has become a place where pain is unacceptable. The lack of tolerance for accepting any pain has created a society dependent upon powerful prescription pain relievers for the slightest ailment. The number of prescriptions for opioids (like hydrocodone and oxycodone products) have escalated from around 76 million in 1991 to nearly 207 million in 2013, with the United States their biggest consumer globally, accounting for almost 100 percent of the world total for hydrocodone (e.g., Vicodin) and 81 percent for oxycodone (e.g., Percocet).

It is estimated that 2.1 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers in 2012 and an estimated 467,000 were addicted to heroin. There is also growing evidence to suggest a relationship between increased non-medical use of opioid analgesics and heroin abuse in the United States.

(Substance Abuse and Mental Health Services Administration. Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings. 2013.)

The number of unintentional overdose deaths from prescription pain relievers has soared in the United States, more than quadrupling since 1999. According to the Centers for Disease Control and Prevention (CDC), approximately 110 Americans, on average, died from drug poisoning every day in 2011. Prescription drugs were involved in more than half of the 41,300 drug poisoning deaths that year, and opioid pain relievers were involved in nearly 17,000 of these deaths. There were about 4,400 drug poisoning deaths involving heroin. Drug poisoning deaths even outnumbered deaths from gunshot wounds or motor vehicle crashes.

("National Vital Statistics Report." National Center for Health Statistics/CDC. June, 2014.)

Several factors are likely to have contributed to the severity of the current prescription drug abuse problem. Besides the drastic increases in the number of prescriptions written and dispensed, there has been a greater social acceptability for using medications for different purposes, and the aggressive marketing by pharmaceutical companies.  These factors together have helped create the broad “environmental availability” of prescription medications in general and opioid analgesics in particular.

In his book Crony Capitalism in America 2008-2012, Hunter Lewis exposes the incestuous relationship between government and the drug industry. Lewis, who serves as president of ANH-USA’s board of directors, has written nine books on moral philosophy, psychology, and economics, including the widely acclaimed Are the Rich Necessary?

Lewis describes a system known as "crony capitalism" as political favors in exchange for money.Chapter 15 is titled "Big Pharma and FDA: A Marriage Not Made in Heaven." Here is an excerpt:

"The drug industry at one time was called the patent medicine industry. This is still the more revealing name. Drug companies devote themselves to inventing non-natural molecules for use in medicine. Why non-natural? Because molecules previously occurring in nature cannot, as a rule, be patented. It is essential to develop a patentable medicine; only a medicine protected by a government patent can hope to recoup the enormous cost of taking a new drug through the government’s approval process.

"Getting a new drug through the US Food and Drug Administration (FDA) is not just expensive ($1 billion on average). It also requires having the right people on your side. Drug companies know that they must hire former FDA employees to assist with the process. They also hire leading experts as consultants, some of the same experts who may be called on by the FDA to serve on its screening panels. Direct payments must also be made to support the FDA’s budget.

"All these financial ties encourage a “wink and a nod” relationship between researchers working for drug companies and regulators, who are often the same people, thanks to the revolving door. As the Economist magazine writes:

"'Pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a company’s drug.'

"The bad behavior extends far beyond the industry itself. Drug regulators, who do get access to some of the hidden results, often guard them jealously, even from academic researchers, seeming to serve the interests of the firms whose products they are supposed to police. The French journal Prescrire applied to Europe’s drug regulator for information on the diet drug rimonabant. The regulator sent back 68 pages in which virtually every sentence was blacked out. . . .

"Medical journals frequently fail to perform basic checks on the papers they print, so all sorts of sharp practice goes uncorrected. Many published studies are not written by the academics whose names they bear, but by commercial ghostwriters paid by drug firms. Doctors are bombarded with advertising encouraging them to prescribe certain drugs...

"What the Economist calls 'bad behavior' also spills over from the medical world to the financial world. Just since 2008, 75 people have been charged with trying to profit from inside information about drug approvals or company mergers related to patentable drugs. One of them, an FDA chemist named Cheng Yi Liang with access to the Agency’s approval database, pleaded guilty to insider trading on 25 companies for a total gain of $3.78 million over five years. Others with larger resources to invest have made much larger sums. Rod Rothstein, the US Attorney for Maryland who helped prosecute the FDA case, has noted that 'healthcare is particularly attractive to criminals because so much turns on government regulatory approval.'

Dr. Ben Goldacre, author of Bad Pharma, summarizes the entire drug approval process as follows: '[It] is broken. . . . The people you should have been able to trust to fix [the]problems have failed you.'

"Although the costs of drug approval keep growing, along with the related corruption, the financial payoff for those ultimately winning approval can be astronomical, because approval also brings with it a government-protected monopoly. Only FDA-approved drugs can be prescribed within government programs such as Medicare. Doctors may prescribe unapproved substances outside of Medicare, Medicaid, or the Veteran’s Administration, but by doing so risk losing their license to practice. Some approved drugs may be priced as high as $500,000 per year per patient.

"Sometimes the FDA or other branches of the federal government deliver opportunities to drug companies, not just protect them from potential competition. For example, federal researchers may develop a chemical which is then licensed to a friendly drug company. Or federal agencies will pay for drug research, or hire drug companies to conduct research. For example, laboratories at the National Cancer Institute are operated by SAIC Inc., a Defense Department contractor which is not a drug producer, but which is a major player in the drug industry, with funding from the U.S Department of Health and Human Services. The same company operates the government’s vaccine production facilities...

"In effect, then, drug companies are not really private companies competing in an open market. They are government-sponsored enterprises (GSEs) not unlike Fannie Mae or Freddie Mac and the big Wall Street banks and firms. It should not be surprising, therefore, that drug companies spend millions on political lobbying and campaign contributions. Many politicians rely on these campaign contributions and thus have a vested interest in maintaining the drug cartel, even though needlessly high drug costs contribute to soaring medical costs...

"The federal government is very careful to avoid charging any leading pharmaceutical company with criminal misconduct, because conviction under current federal law would terminate purchases from that source, and the government is too closely integrated with the drug/vaccine industry to allow that to happen. Thus, when Merck was found to have misled about its painkiller Vioxx, alleged to have caused at least 55,000 deaths (some estimates are much higher), the settlement with plaintiffs reached $4.9 billion. But Merck continued partnering with and selling to government without any interruption or even question."

(ANH-USA. "Big Pharma and FDA: A Marriage Not Made in Heaven."
Alliance for Natural Health. October 15, 2013.)

Sidney Wolfe, Director of Public Citizen's Health Research Group, speaks of the too FDA too-cozy relationship the FDA has with the industry it regulates:

"The pharmaceutical industry's influence gets exerted in a number of ways. One, starting 10 years ago [with the Prescription Drug User Fee Act (PDUFA)], the influence was exerted by their directly funding, paying cash right up front, for FDA review. So in many ways, the FDA started looking upon the industry as their client, instead of the public and the public health, which should be the client.

"A second way in which the industry influence occurs is by having leaders in the drug division who are spineless and gutless, and who don't like controversy. I have heard over and over again, directly from these people, 'Why can't this be settled on a scientific and medical basis?' They don't like to take on the very awesome forces of the drug industry and a lot of its indentured servants, so to speak, in academic medicine. So the attitude by the leaders there [is], 'avoid conflict' -- and avoiding conflict means doing what the industry wants.

"A third way in which the industry's influence has been allowed to grow considerably is the absence of congressional oversight. Up until 12 years ago, whenever the FDA would make a mistake -- such as the series of mistakes they've made in the late 1990s -- there would be a congressional hearing. They would have to explain to the legislative branch of the government what went wrong. They would be -- properly, and in the best public health sense -- on the defensive to try and explain what went wrong."

("How Dependent Is the FDA?" Frontline. PBS. Posted first 2003.)

Raymond Woosley, M.D., who was considered as a candidate for the Food and Drug Administration's commissioner position, says "the drug industry didn't want someone like myself, who was going to focus on toxicity and side effects." He didn't get the job, and Woosley explains his understanding of why: "It became clear that anyone who had focused on drug safety couldn't make it, just like people who had come right out of industry couldn't make it. Too far on the extremes to be acceptable."

Woosley believes the budgets of the FDA are determined by lobbyists who call for money to be spent in certain ways. He claims no one is lobbying for safety. Woosley says, "The pharmaceutical industry doesn't lobby for safety. They lobby for rapid review, rapid access to the marketplace. They haven't lobbied for drug safety; no one has. There are groups, consumer groups, that have spoken out, but not with a uniform voice. Large constituencies haven't joined together to say, 'Stop the harm.'" 

Wendell Potter, former CIGNA executive-turned-whistleblower, reports that the pharmaceutical industry spends the most each year to influence lawmakers, forking over a total of $2.6 billion on lobbying activities from 1998 through 2012, according to To get some perspective on just how big that number is, consider that oil and gas companies and their trade associations spent $1.4 billion lobbying Congress over the same time frame while the defense and aerospace industry spent $662 million, a fourth of the total spent by Big Pharma.

(Wendell Potter. "Big Pharma's stranglehold on Washington."
The Center for Public Integrity. February 11, 2013.)

The opioid epidemic (which includes the skyrocketing heroin addiction numbers) can be directly attributed to Big Pharma with players like Purdue and to the criminal policies and collaboration of the FDA. Unless we, as voters, demand our politicians devote considerable time and effort to changing the political face of America as it pertains to drugs, we will be at the mercy of legalized greed and addiction that rips the threads of our culture.

Understanding the nature of lobbying, testing, marketing, and distribution is vital to combatting drug addiction -- not just some, but all opiate drug addiction. The supply and demand -- be it for prescription drugs or illegal drugs like heroin -- is interrelated by both the composition and strength of the substances. And, yes, I believe the FDA and Big Pharma care little about safety when astronomical profits drive the system. The public stigma associated addiction actually contributes to the lack of concern for change as does America's insistence on a life free of pain.

I'm asking ... no, I'm begging ... people to demand much more attention to drug addiction. To change the stranglehold of opioid addiction requires that we elect people who will force change in government. From the concept of pain relief to the collaboration of big businesses and the federal government, we must evoke new and better strategies to deal with real-world chemical dependency. Maybe one place to begin a serious dialogue is in the presidential candidates debates.

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