Pharma and Its Golden Hoard

© Chrisjeanes | Dreamstime.com - Smaug - The Hobbit Photo

© Chrisjeanes | Dreamstime.com – Smaug – The Hobbit Photo

The debate over the cost of drug development goes all the way back to the late 1950s. The then Chairman of the U.S. Senate’s Anti-Trust and Monopoly Subcommittee said that the pharmaceutical industry had: 1) predatory pricing and excessive margins related to their patents; 2) that extravagant increases in costs and prices were due to large expenditures in marketing; and 3) most of the industry’s new products were no more effective than the ones already on the market. It seems that little has changed over the past fifty-five years.

An often-quoted 2003 study on the cost of drug development by DiMasi et al., “The Price of Innovation,” concluded that it cost an estimated $802 million in 2000 dollars to bring a new drug to market. The 2014 profile released by PhRMA, the advocacy group for the U.S. pharmaceutical industry, estimated that it cost $1.2 billion to develop a new drug. PhRMA noted that: “some more recent studies estimate the cost to be even higher.” In contradiction of the higher R&D estimates of DiMasi and PhRMA, Light and Warburton suggested that: “R&D costs companies a median of $43.4 million per new drug.” This is less than 1/18th of the $802 million estimate by DiMasi et al.

Deciding whose figures to trust can be tricky. For example, Light and Warburton pointed out that the Tufts Center for the Study of Drug Development, where the DiMasi study was conducted, has received “substantial industry funding for years.” Among the concerns they had with the DiMasi study were: inflated costs for drug trials; exaggerated time for R&D; corporate financial risk for R&D was much lower than reported; average costs based on “means” and not “medians,” leading to inflated figures. Using the median trial costs reported by DiMasi (74% of the mean trail costs), they said: “the $802 million figure would have been reduced to $593 million had median costs been used.”

Scott Gavura in “What Does a New Drug Cost” part 1 looked at both the DiMasi study and its critique by Light and Warburton. Gavura said he found the Light and Warburton figure “implausibly small.” In “What Does a New Drug Cost” part 2, he elaborated, saying that he thought their estimates “were based on a sequence of highly implausible assumptions;” the average drug development cost would be higher in the real world. He asked if the low-hanging fruit in drug development is gone. “A growing concern with the pharmaceutical industry is its overall productivity in delivering new drugs.” Gavura concluded his article by stating that he thought criticism of the pharmaceutical industry was justified, if it was done for the right reasons.

Being skeptical of R&D estimates is wise. Data on individual drugs is not transparent, and estimates must incorporate a number of assumptions which have the potential to bias the conclusions.  This lack of transparency fuels suspicion of the process. But we should also be equally skeptical of arguments that dismiss or diminish the growing problems with R&D. There is good evidence to suggest that drug development is a risky, expensive endeavor, and that this work is getting harder.

In a 2008 article published in PLOS Medicine, “The Cost of Pushing Pills,” Gagnon and Lexichin explored the reported expenditures of the pharmaceutical industry and concluded that: “pharmaceutical companies spend almost twice as much on promotion as they do on R&D.”  Their estimate was made from highly reliable sources, one of them being IMS Health, a company relied upon by both the federal government and the pharmaceutical industry for information on the healthcare industry.

Their revised estimates for promotional spending in the US for 2004 was $57.5 billion, twice that of IMS Health. This compares to the $31.5 billion reported by the National Science Foundation for domestic industrial pharmaceutical R&D in 2004. “These numbers clearly show how promotion predominates over R&D in the pharmaceutical industry, contrary to the industry’s claim.”

Allen Frances, the chair of the DSM-IV, has become an outspoken critic of modern psychiatry, the DSM-5, and “Big Pharma.” He reported in Saving Normal that worldwide pharmaceutical sales exceed $700 billion each year. Half of that figure is spent in North America and another one fourth in Europe. Rick Newman reported that Pharma’s profit margin was 16.4 percent, the seventh highest among the industries tracked by Morningside, an independent investment research firm.

The justification of high prices and huge profits by pharmaceutical companies was “mostly fluff,” according to Frances. “Drug pricing has no relation to real cost or value and instead reflects Pharma’s monopoly position in the market and its dominance over politicians.”  At its worst, he said that pharmaceutical research is a “deceptive shell game” meant to seduce and mislead doctors and the public. “The claim that drugs are so expensive because they require so much research is pure smoke screen.”

In The Desolation of Smaug, the final scene shows the dragon Smaug rising up out of molten gold. Goaded by the unsuccessful attempt of the dwarves to destroy him, he flies off to take his revenge on the unsuspecting Lake-town of Esgaroth. Over the past sixty years we have allowed Pharma to gather a golden hoard through its profits from drug development. Like Smaug, Pharma jealously guards its hoard. If we take on a quest to right this injustice, we must be careful not to loose an angry, vengeful dragon upon an unsuspecting humanity by mistake.


E-Cigarettes and E-Joints

E-cigarettes were marketed as safer alternatives to regular cigarettes and even smoking cessation aides. Now they are being modified and marketed as THC delivery systems—an e-joint, if you will. Sound strange? I found several YouTube videos on using or converting e-cigarettes for use with marijuana products like hash oil. Here is a short “how to” video. If you prefer more professional vaporizers, you can try the Wacky Puffer and other commercial products.

It didn’t take too long to get from the first e-cigarette to the e-joint. In was only in 2003 that a Chinese pharmacist developed the first e-cigarette. They were introduced to Europe in 2006 and to the U.S. soon after. In 2008, the WHO said it did not consider the e-cigarette to be a legitimate smoking cessation aid. The first Vapefest was held in March of 2010 in Richmond Virginia. In April of 2011, the FDA announced that e-cigarettes would be regulated like traditional tobacco products under the Food Drug and Cosmetic Act. Any e-cigarette product claiming to help stop smoking or that it provides any other health benefit will be strictly regulated as a drug or medical device.

A July 2014 report by the World Health Organization (WHO) suggested a variety of restrictions for e-cigarettes, including a ban on indoor use of e-cigarettes until “exhaled vapor is proven to be not harmful to bystanders and reasonable evidence exists that smoke-free policy enforcement is not undermined.”  The Fix pointed out how the tobacco industry is entering the e-cigarette industry. Phillip Morris International has purchased the UK company Nicocigs, an e-cigarette maker. The Fix has several articles on e-cigarettes available, including pro and con sounding titles.

In October of 2014, six U.S. senators signed a letter to the FDA urging companies to label e-cigarettes, “listing all of the health threats the products pose.” Then there is Dr. Nathan Cobb, an assistant professor of medicine at Georgetown School of Medicine who thinks e-cigarettes could bring down traditional smoking and save thousands of lives in the process. However, Dr. Stanton Glantz, doesn’t believe that e-cigarettes are as effective in helping people quit smoking as marketing claims they are.

This commentary assumes that e-cigarettes, as currently in the marketplace, will help people quit smoking and ignores the consistent evidence from population-based studies that smokers who use e-cigarettes are about one-third less likely to quit smoking.

There is growing concern that e-cigarettes aren’t really that safe. Ryan Aliapoulios on the AfterPartyChat website noted the obvious problem, “they still deliver the same addictive chemical at the root of so many other health problems: nicotine.”  He mentioned a study, “A Molecular Basis for Nicotine as a Gateway Drug,” that said while e-cigarettes eliminate some of the morbidity from combustible tobacco, they are “pure nicotine-delivery devices.” They have the same effects on the brain as smoking tobacco and they pose the same risk of addiction.

The authors said the use of e-cigarettes is rapidly increasing among adolescents and young adults. “Our society needs to be concerned about the effect of e-cigarettes on the brain, especially in young people, and the potential for creating a new generation of persons addicted to nicotine.”

In “E-Cigarettes Are Not As Harmless As We’ve Been Told,” The Fix reported that Dr. Glantz and his research team found that e-cigarettes produced greater risk than initially thought, “delivering high levels of nano particles which can trigger inflammation and have been linked to asthma, stroke, heart disease, and diabetes.” Glantz was furthered quoted as saying that e-cigarettes are rapidly increasing in popularity with kids. While they are promoted by tobaccos companies that have purchased e-cigarette companies as a way to quit smoking, a safer less polluting alternative to regular cigarettes, “What the evidence to date shows is that while a puff on an e-cigarette isn’t as dangerous as a puff on a regular cigarette, the main effect they seem to be having is to keep people smoking cigarettes.”

So what about e-joints? They actually exist, according to Scientific American. There is a Dutch company, E-Njoint, BV that has released what it says is the first electronic joint—the E-njoint Disposable. It is battery-powered and vaporizes a liquid vegetable-glycerin and polypropylene-glycol with added flavoring. Polypropylene-glycol is the “e-liquid” used in e-cigarettes. Glycerin is colorless and odorless liquid that is widely used in pharmaceutical formulations.

The next version of the E-Njoint will be both rechargeable and capable of being filled with cannabis or a derivative. “Once the cartridges are empty, users are able to fill these cartridges with a liquid. Those liquids may be standard liquids bought at any store around the world or it could be an extract of a cannabis plant.” The company also plans to release an e-joint that can be used with “dry herbs,” like marijuana.

Pamela Ling of the Tobacco Control Policy Fellowship at the University of California, San Francisco’s Center for Tobacco Research and Education said that while the Dutch company is the first to call its product an ‘electronic joint,’ “the idea of using electronic vaporizers for THC or marijuana is not new, and this company is far from the first. ”

An NPR report on “vape pens,” handheld vaporizers for marijuana, noted how they are reshaping the marijuana business and culture. Two years ago, one man was selling vape pens out of the trunk of his car. Now his company, Grenco Science, has a 6,000 square foot headquarters in central Los Angeles.

The concentrates used in vape pens can be very strong. As I noted in a previous, article, “A Little Dab Will Do Ya,” hash oil concentrations can reach 90 percent THC, while the most potent marijuana is usually no more than 20 percent. These high THC levels are even a concern for Allen St. Pierre, the executive director of NORML, the National Organization to Reform Marijuana Laws:

Between the fact that you can potentially pass out with a single inhalation, or you can have such property damage and potential bodily harm just producing it … these [issues of the vape pen] definitely need to be addressed. . . . This is a screaming call for regulation if there ever was one.