Tuesday, April 15, 2014

Drug Companies Lobbying the Government in the United States


It’s no surprise that American corporations spend billions of dollars each year on lobbying government, trying to gain favorable treatment from legislators. And succeeding wildly. What some may find a bit surprising is which industry spends the most in these efforts.

Wendell Potter of the Center for Public Integrity, says that it is the pharmaceutical industry! According to, it spent a total of over $2.6 billion on lobbying activities from 1998 through 2012. In comparison, energy companies spent a mere $1.4 billion.

So what are their lobbyists seeking in return? Well, one obvious thing is that pharmaceutical companies engage in outrageous pricing practices, particularly in the United States. Drugs cost far more in the States than they do in most other countries.  

The companies also keep exclusive rights to manufacture new drugs for 20 years or more. 

This despite the fact that drug price inflation is one of the main drivers of health care costs for individuals and families and threatens the fiscal health of our public health care programs.  

The industry's policy goals include: resisting government-run health care, ensuring a quicker approval process for drugs and products entering the market, and strengthening intellectual property protections. Top 2008 contributor Pfizer supports efforts to protect pharmaceutical manufacturers by restricting the use of generic copies of their drugs.

The gap between what Americans and citizens of other countries pay for drugs is actually increasing. So, in response, many people started to buy their medications from sellers in other countries. Canada was particularly attractive for this purpose. What were the drug companies to do? With a push from their lobbyists, the practice of individuals importing their medications from Canada was made illegal.

This is kind of funny, since it is also true that a lot of the drugs available in Canada are manufactured in the United States to begin with, and the exact same drug companies are selling them in both countries!

According to a paper published by the National Institute of Health, an amazingly stupid argument that was made to justify this consisted of scare tactics designed to frighten an ill-informed public. Here it is:

Many concerns restrict drug reimportation from being a legal practice in the US. These include safety, efficacy, and therapeutic equivalency of reimported drugs. While these drugs are manufactured in the US, the storage and packaging conditions in countries where drugs were exported cannot be monitored by the US Food and Drug Administration (FDA). In addition, inappropriate storage conditions while reimporting medications back to the US may degrade the quality of drugs. 

The most important issue is distinguishing between drugs that are manufactured in the US from those which were manufactured elsewhere. Although technically ‘reimportation’ involves importing back drugs manufactured in the US, there are no means to check the originality of drugs. Similarly, it is difficult to determine whether the drugs purchased from other countries have the same dosage form, potency, and amount of active ingredient as the prescribed medication... The pharmaceutical industry criticizes the reimportation practice due to the potential harm to the recovery of the research and development (R&D) costs required for new drugs. While these opponents prevent the
 legalization of drug reimportation, various consumer advocacy groups support the practice.

The bit about dosage form, potency, and the amount of active ingredients is especially insane because pharmaceutical companies in the US import many of their ingredients for their products from countries such as China or India, where safety and quality oversight by the government is considerably worse than it is in Canada.

Readers may also be familiar with another law that came courtesy of Pharma lobbying: While private insurers, hospitals and even the US Department of Veterans Affairs can bargain with drug makers to get better deals on prices, the Medicare Part D drug program cannot. The Congressional Budget Office estimates that the government could save $112 billion over the coming decade if Congress reconsidered this 2006 gift to drug makers and instead gave Medicare the ability to negotiate prices. 

Do you really believe that the only way to keep the program from going broke is to cut benefits and raise the eligibility age for Medicare from 65 to 67?

Not surprisingly, when the Medicare Part D program was first passed by the US Congress, one of the only major classes of drugs explicitly excluded from all support was benzodiazepines. This restriction was finally eliminated, but only this year.

Readers of this blog already know that I think that Big Pharma has purposely demonized this class of drugs by doing such things as grossly exaggerating its dangers of addiction. Benzo’s are just too cheap, safe, and effective for their tastes. They want you to buy their expensive and far more potentially toxic antipsychotics and other classes of medication if you need a sedative. 

Since the Health Industry practically wrote the Medicare Part D legislation, I think it’s reasonable to assume that this is why benzo’s were excluded, although I can’t prove it.

Efforts to restrict the use of benzo’s have also been made at the state level.  Just last year, my state of Tennessee made it illegal for pharmacies to dispense more than 30 days of a benzo at one time. Most insurance plans these days make it cheaper for their customers to get a 90 day supply of meds than three 30 day supplies - not to mention the fact that patients have to make extra trips to the pharmacy. So this new law makes benzo prescriptions a headache for many consumers.

The ostensible reason for the law? To prevent deaths by overdose. Now it is true that opiate addicts and those on methadone maintenance programs have combined those drugs with benzodiazepines in fatal overdoses, as the combination can depress breathing. But so can the opiates all by themselves.  

That drug combination is actually just about the only way that benzo’s can cause deaths, short of someone falling asleep in the bathtub like Whitney Houston or choking on the actual pills. Not to mention that most of the addicts who overdose get all their pills illegally anyway, so the law accomplishes absolutely nothing other than creating a problem for those who have a legitimate need for the medication, such as patients who have panic disorder.

When it comes to the profits of drug companies, however, this concern for drug addicts evaporates. The pharmaceutical industry wants pseudephedrine, its over-the-counter cold and allergy medicine, to remain easily and readily available for consumers who use the product.  

Unfortunately, that drug is also used by drug dealers to manufacture methamphetamine, and this has caused legislatures across the country to try to limit the ease by which the average consumer can buy it. (Of course Adderall, a drug which is almost a identical to meth, is not a big legislative concern).

In response, the drug companies have suddenly jumped to the defense of the consumer. Not only do the companies lobby governments to reduce these regulations, but they are now appealing directly to the public to lobby their legislatures against them. I actually agree with them on this particular point. There are other better, effective ways to limit the use of pseudephedrine in meth production. But the double standard for pseudephendrine and benzodiazepines is palpable.

A drug company trade group deceptively named the Consumer Health Care Product Association has a website designed to motivate consumers to act in their behalf and write their state legislators:  You know how I heard about it? The group has radio ads promoting it across Tennessee, because Tennessee is one state considering further limiting access to pseudephendrine.


  1. Take a look at this wiki page. I had to look in the comments section in order to find out who's really behind the Consumer Health Care Product Association. Clever devils. When you google, you come up with a the top dozen hits… as self-promotion. The are NOT a consumer group, but are using consumers to get get their way. Still not sure how it keeps them profitable, however. Limits over the counter sales, I guess… and fuels the explosion of meth labs across the Southeast....

  2. I am one of those people who uses (per script from my psychiatrist) the lowest dosage of Seroquel for sleep. My doc informed me that Seroquel acts as an antihistamine at these low dosages. That went in one ear and out the other. Until I stepped on a nail, got a tetanus shot and took a powerful antibiotic to prevent infection. All three of these "create" histamine reaction in the body. (There are histamine producing cells in the foot, for good reason!) One night I woke with a panic attack, something I have only heard about from friends who have them, so I knew what not to do. I did not take myself to the hospital to look for a medical answer. I got up, sat in the dark and breathed until my pulse rate went down and then took my "antihistamine" and waited until its effects kicked in. Fell asleep sitting up, and was ever so grateful for the medication in this emergency situation.

    The next day, I deciphered what had likely happened. And since then I have been quite curious about Seroquel. I am not sure it works this way for everyone--where it is only a low dosage that has the single effect of causing sleep, by taking away my cares. What I have read on several good websites is that it is a drug with several functional groups on it, each one able to act on different receptors at different concentrations. It acts on histamine (H) receptors at the lowest concentrations (25-50 mg?), and then as the H-receptors are "filled" at higher concentrations it "spills over" to occupy serotonin receptors and finally on dopamine receptors.

    I know now that when Seroquel is acting as an antihistamine, it is breaking the blood-brain barrier. Doctors of neurology warn against using such an "old-time" histamine on the brain. When I asked my usual doctor what the long-term effects of year-round antihistamines are… he said there were no untoward effects. As a person sensitive to medications (every time I try one, as an antibiotic, proton-pump inhibitor, what have you… I usually have a bad response and have to ask to be taken off the medication), how can I make my doctor fully aware that this medication may be a problem for me?

    And would it be hard for you to promote a weaning program for a patient who asked you to help them with Seroquel? How would you anticipate dealing with the issue of falling asleep and staying asleep in a patient who had sleep concerns?

    Thanks for your good work!

    1. I can't give specific medical advice in this forum, but in general: sedation is a side effect of Seroquel that may or may not be due to its effect on histamine.

      If someone is on the lowest dose (25 mg?), most people can just stop it without any withdrawal symptoms, although there may of course be "rebound" insomnia.

      Sleep issues treatment depends on what is creating the problem. If it's insomnia unrelated to another mental problem such as chronic generalized anxiety or panic, then "sleep hygiene" and other behavioral, non-medical approaches to sleep induction should be tried first.

      Also, for the majority of people, the old benzodiazepines like valium, at low doses, are still the safest and most effective sleep mediations. They can of course be abused, but so can dang near anything.

  3. Dr. Allen, it came to my attention through reading some work by neurologists, that it has indeed been documented that the H1 receptors in the brain are what make the old-style antihistamines effective for sleep. Perhaps it is not tried and proven yet, how exactly seroquel works.. but I can tell you that when you do a read on wiki about histamines.. they are indeed known to create vigilance and anxiety in the brain. It was not until 1991, that it was discovered that histamines are neurotransmitters… I encourage you to investigate this at your leisure. It would help your patients, too.

    I know that seroquel used to be used as a sedative in the elderly and that was a killer… for many. A good friend of mine with epilepsy that she now knows to treat with magnesium citrate, was told as a young woman never to take antihistamines.. And now we have… Seroquel!

    And now, for me to find my way off this medication, and trust sleeping naturally. I am weaning, 1/4 pill at a time…and it is not easy!

    Twenty five milligrams is small, but for me this medication is potent!

    Blessings and again, thank you~