pharmaceutical company

Home » pharmaceutical company

Pharmaceutical Industry Terrified Weed Legalization Will Put Them Out of Business

in Drugs, Economic Liberty, Liberator Online, News You Can Use, Personal Liberty by Alice Salles Comments are off

Pharmaceutical Industry Terrified Weed Legalization Will Put Them Out of Business

This article was featured in our weekly newsletter, the Liberator Online. To receive it in your inbox, sign up here.

The opioid epidemic is a real issue in America. So much so that the U.S. Attorney General Loretta Lynch started telling young folks that marijuana isn’t really the problem. Instead, Lynch explained, legally prescribed medications are to blame for the increase in opioid abuse.

But while learning that the head of the United States Department of Justice has just argued that weed does not represent a real threat may sound promising, it’s important to remember that marijuana is still a Schedule I drug. Meaning that the federal government still sees marijuana as a substance “with no currently accepted medical use and a high potential for abuse.”

ManufacturingRecently, a group of marijuana legalization activists got an initiative known as Proposition 205 in the ballot in Arizona.

The initiative would allow Arizona residents who are older than 21 to possess up to an ounce of marijuana in public. Prop 205 would also allow consumers to grow up to six plants at home, giving them the option to give other adults up to an ounce at a time of its produce “without remuneration.”

But with the good news came another discovery.

The group that, alone, donated $500,000 to the effort to oppose the Arizona marijuana legalization campaign, is a local pharmaceutical company known as Insys, and it produces oral sprays used in the delivery of an opioid painkiller known as fentanyl.

According to Reason, the same company is planning on marketing yet another device that would deliver dronabinol, a synthetic version of tetrahydrocannabinol, or THC: The main mind-altering ingredient in cannabis.

When donating to kill the initiative, the company contended that its opposition to marijuana legalization is due to Prop 205’s “[failure] to to protect the safety of Arizona’s citizens, and particularly its children.” According to Reason’s Jacob Sullum, what Insys is truly worried about is “the impact that legalization might have on its bottom line, since marijuana could compete with its products.”

And why is Insys so concerned? Perhaps because a recent study published in the American Journal of Public Health contends that, in states where marijuana use is legal to a certain extent, fatally injured drivers are “less likely to test positive for opioids.” Sullum adds that this finding, along with the results of other studies show that “making marijuana legally available to patients saves lives by reducing their consumption of more dangerous medications.”

The data analyzed by researchers comes from the Fatality Analysis Reporting System (FARS). By looking at the data gathered from 18 states where 80 percent of drivers who died in auto crashes were drug-tested, researchers found that, between 1999 and 2013, drivers between the ages of 21 and 40 were half as likely to test positive for opioids where medical marijuana laws had been implemented.

In these same states, researchers found that painkiller prescriptions fell by 3,645 daily doses per physician. Researchers concluded that “the passage of the medical marijuana laws” are directly associated with “the observed shifts in prescribing patterns.”

As the industry begins to fear the consequences of ending the drug war, we begin to understand that their dominance over the market is mainly due to their rent-seeking practices, which keep their leaders close to lawmakers, helping the industry to exert enough influence to sway public policy in a way that benefits them.

Without the presence of a government body giving companies special protections while outlawing particular drug transactions, drug providers are able to compete freely and in the open, giving consumers better and safer options.

It’s time to finally put an end to the drug war and admit that, rent-seeking will never help the nation heal from all of the negative consequences of our country’s ongoing romance with crony capitalism.

Is it Corporate Greed That Led to Turing Pharmaceuticals’ “Price Gouging” on Daraprim?

in Ask Dr. Ruwart, Liberator Online by Mary Ruwart Comments are off

Is it Corporate Greed That Led to Turing Pharmaceuticals’ “Price Gouging” on Daraprim?

This article was featured in our weekly newsletter, the Liberator Online. To receive it in your inbox, sign up here.

Question: Is it corporate greed that led to Turing Pharmaceuticals’ “price gouging” on Daraprim?

Turing PharmaceuticalsOver the last couple of days, the media has been aghast as Turing Pharmaceuticals CEO, Martin Shkreli announced his plan to increase the price of Daraprim from $13.50 to $750 a pill. Daraprim was patented in the 1950s, and is used for treating parasitic infections in fewer than 13,000 people a year in the U.S.  Turing bought exclusive rights to distribute the drug in the U.S. from Impax for $55 million; drug sales are less than $10 million/year.  Impax itself bought daraprim several years earlier. It upped the price from $1 to $13.50/pill, causing the number of prescriptions to drop about 30%.

Shkreli’s assertion that the profits would be used to develop a better drug for treating toxoplasmosis was met with skepticism.  Shkreli is a former hedge fund manager, not a pharma veteran, and might not be aware that the new drug will have to be tested against daraprim itself. Testing against placebo would be unethical, given that daraprim is part of the treatment standard.  Showing superiority, in terms of effectiveness or side effects, is much more difficult against another drug than placebo. Indeed, given the small number of patients who need the drug, it might be impossible to show the “statistical significance” required by the FDA, since large numbers of patients can’t be tested.

Why, you might ask, can Shkreli price his drug so high and not fear that a generic competitor will undercut him? After all, the daraprim no longer has patent protection.

The answer: Turing Pharmaceuticals has a de facto monopoly, courtesy of the ever-increasing costs of gaining FDA approval, both for new drugs (over $1 billion and 11 years) and generics. Any generic company could make daraprim; its patent expired decades ago.

However, the FDA would require that the company demonstrate that its pill released the drug into the blood stream at the same rate as the original daraprim.  Coupled with the cost of setting up FDA-approved manufacturing facilities for the new drug, a turn-around time of a couple years or so due to regulatory red-tape, and the expensive clinical trials, a generic company would need to commit to spending many millions, perhaps tens of millions, even with the special exemptions that the FDA gives drugs that have small or “orphan” patient populations.  After jumping through all of these costly hoops, the competitor might be unable to take a substantial part of the market from Turing should it choose to lower its prices for the sole reason of preventing the competitor from getting a foothold.

The $750 pill might be considered an example of “corporate greed.”  However, Turing probably wouldn’t have even attempted such a price hike without high cost of FDA-mandated drug development, both new and generic, which virtually eliminated his competition.


Who’s to Blame for Dangerous Prescription Drugs: The FDA or Big Pharma?

in Ask Dr. Ruwart, Healthcare, Liberator Online, Libertarian Answers on Issues, Libertarian Stances on Issues by Mary Ruwart Comments are off

(From the Ask Dr. Ruwart section in Volume 19, No. 10 of the Liberator Online. Subscribe here!)

QUESTION: The pharmaceutical company is sometimes caught pressuring the FDA to approve drugs with dangerous prescription drugsside effects and the FDA does so. Who is the prime mover of aggression here, the FDA or the pharmaceutical cartel?

MY SHORT ANSWER: It’s the karmic circle. The American public allowed the FDA to regulate the pharmaceutical companies under the largely erroneous assumption that they were nefarious. In the beginning, the primary loss to the American public was fewer life-saving drugs, since more money had to be spent on development instead of discovering new drugs.

The regulations reshaped the industry in a way that encouraged graft, as the regulations got more onerous. The industry “fought back” with the Prescription Drug User Fee Act which lets companies pay about $1 million for a faster review. This co-opted the regulators, since about half of their budget now comes from such fees.

In addition to losing many life-saving drugs, the drugs that we get now are less safe. The biggest safety problem with drugs on the market today is that they are meant for long-term use, which amplifies side effects. That’s because only drugs for long-term use can recover the high cost of development that regulations have produced. Even with the high prices of drugs, only 3/10 recover their costs.

This is a lose-lose situation for the American public, the industry itself (which has become close to unsustainable), and even the regulators, who will one day die or watch their loved ones die from diseases that might have been cured without regulations.

LEARN MORE: Suggested additional reading on this topic from Liberator Online editor James W. Harris:

* “Abolishing the FDA: FDA Policies Keep People Sick and Create a False Sense of Security“ by Larry Van Heerden The Freeman, March 1, 2007.

Excerpt: “The Food and Drug Administration (FDA) started out as a bulwark against snake-oil peddling. It has since swung back and forth between hostility and subservience to the drug industry. The FDA seems indifferent to the many deaths its own intransigence has caused and imperious when forced to defend its actions in court, resulting in a system that withholds life-saving drugs from the market, approves dangerous drugs, and denies everyone freedom of choice. The time has come to seriously consider abolishing the FDA.”