America’s Other Drug Problem
America has a serious drug problem, but it’s not one most Americans have heard of. The problem is not illegal drugs, but rather a critical shortage of many life-saving legal drugs. And the federal government is about to make things worse.
During the past year, medical professionals have received alarming reports about critical shortages of important drugs. These drugs aren’t the common over-the-counter medications that consumers purchase in their local drugstores. Rather, the shortages are in various injectable drugs typically administered to seriously ill patients in hospitals.
Melly Alazraki of Daily Finance reports that the shortages include “vital medications such as chemotherapy, antibiotics, analgesics (painkillers), anesthetics and more.” ABC News details how Minnesota cancer patient Mark McKee was suddenly told at a scheduled chemotherapy session that the hospital did not have enough of the critical medication doxorubicin for his prescribed treatment. Despite the fact that his tumor had grown recently, his doctors told him he had to settle for a significantly reduced dose and hope that “something may be better than nothing.”
Of course, various factors can contribute to the shortage of any specific drug — for instance, a manufacturing problem at a key factory or difficulty obtaining a particular raw material from an unstable foreign country. But as ABC News notes, often the problem is simply that “the production cost outweighs the profits.” And a leading cause of this problem is the federal government, specifically in the form of the Food and Drug Administration (FDA).
FDA regulations impose an enormous financial burden on drug companies. In a detailed critique of the FDA, pharmaceutical industry writer Stella Daily Zawistowski observes that the FDA drug approval process currently costs companies approximately $800 million “from the time a molecule is discovered in the laboratory through animal trials and multiple stages of trials with human subjects.” Furthermore, the 20-year patent clock starts “ticking” once the drug is discovered, even though the drug approval process often takes more than 10 years. Hence, a company that spent enormous sums developing a new drug might enjoy less than half of that theoretical 20-year patent life to recover its initial investment before other companies start selling chemically identical cheaper “generic” versions.
In addition to stifling the development of new drugs, Zawistowski emphasizes that the FDA also distorts the market for the types of drugs being developed. It’s generally faster and cheaper for pharmaceutical companies to get FDA approval for “copycat” drugs that are minor variations of already-approved medications than to get approval for groundbreaking new drug categories. Hence, we see a plethora of cholesterol drugs, sleep aids, and antidepressants — and fewer advances in other vital categories, such as antibiotics effective against drug-resistant bacteria. In fact, UCLA medical school professor Dr. Brad Spellberg has warned that our pipeline of these vitally needed new medications is nearly empty because the FDA is “a huge impediment to getting a new antibiotic to market.”
The FDA drug approval process is so onerous that many experts believe that certain drugs currently in widespread use would never have been approved by today’s FDA — including penicillin, aspirin, and acetaminophen (Tylenol). In 2010, the FDA approved a mere 21 drugs — what the Wall Street Journal calls “a relatively modest figure” and a continuation of the “drought in recent years.”
The Obama administration has acknowledged that the slow pace of new drug development is a problem. However, their response is not to reduce government barriers to private drug development — but rather to create a new government agency to supposedly “fix” this problem. According to the New York Times, the Obama administration will create a “National Center for Advancing Translational Sciences” within the National Institutes of Health (NIH) to “help” promote new drug development. But many scientific and industry experts are deeply skeptical that this new program will succeed. As Wake Forest University biochemistry professor Mark Lively asks, “the NIH is not likely to be very good at drug discovery, so why are they doing this?”
There’s no reason to think that a government agency would be better at picking pharmaceutical winners and losers than a private company that has its own money on the line and is motivated to earn a profit. Rather than creating yet another bureaucracy to “encourage” the development of drugs the government deems worthy, the government should consider a radical alternative. It should reduce the regulatory burdens on the pharmaceutical industry by phasing out — and eventually abolishing — the FDA.
John Stossel and others have explained how abolishing the FDA and allowing private rating agencies to monitor the safety and effectiveness of drugs would better protect consumers against unsafe products.
Private ratings agencies already work superbly in other industries. The private Underwriters Laboratories (UL) tests and approves numerous products ranging from hair dryers to Christmas lights to bulletproof glass. Manufacturers gladly pay for their testing and certification because many retailers won’t stock products without the UL seal of approval.
Similarly, the Snell Memorial Foundation (SMF) performs similar testing and certification of safety helmets. As John Graham of the Pacific Research Institute writes [pdf]:
Many people engaged in activities for which helmets are an important safety feature, such as mountain biking, value the SMF certification, and this motivates manufacturers to submit their helmets for testing at their own cost although there is no legal requirement to do so.
The SMF limits itself to the business of researching and testing the effectiveness of helmets. It does not advocate for mandatory helmet laws and has never lobbied on any pertinent legislation.
The government does have a legitimate role in protecting Americans from force or fraud. Hence, if a drug company sells unsafe products under false pretenses, it can and should be punished. But otherwise, doctors and patients should be left free to exercise their own best rational judgment whether or not to use a drug based on the manufacturer’s truthfully reported test results (and the tests of independent rating agencies they trust).
In a free market, businesses prosper by selling products of value to their customers — not by killing those customers. The self-interest of patients and doctors seeking the best value for themselves in a highly competitive marketplace — and the self-interest of drug companies and independent rating agencies whose reputations are at stake — will be far more effective in protecting patient safety than a government bureaucrat punching a clock somewhere in Washington, D.C.
Abolishing the FDA would allow honest drug makers to produce (and doctors and patients to use) drugs according to their own best judgment free from government interference — as is their right. In such a free market, the result would be cheaper, more numerous, and more plentiful drugs.
Recall the words of Ayn Rand:
government “help” to business is just as disastrous as government persecution, and that the only way a government can be of service to national prosperity is by keeping its hands off. (“Leave Us Alone,” Chapter 13, Capitalism: The Unknown Ideal)
Nowhere is this more true than in the pharmaceutical industry. Rather than government “help” in the form of a new federal agency — or further government hindrance in the form of the FDA — the government should simply get out of the way. If we eliminate the government interference that prevents valuable new drugs from reaching patients, we could save countless lives. And a few years from now, if you get sick and you need a powerful new antibiotic that is currently just a promising idea scribbled in a bright young scientist’s laboratory notebook, one of those lives saved might be your own.
Short version: If there is a shortage of drugs its got nothing to do with the FDA approval process.
Longer version
I couldn’t find any mention of the $800 million figure in the link you provided, but lets say it’s right. The $800 million figure isn’t the cost of having the FDA, it’s the cost of finding out that a drug is safe, that it acctualy has some efficacy and also meeting the beuracratic requirements of the FDA.
The R+D costs of the top six American drug companies are about $25 billion per year [1] (from Wikipedia so, you know). A study by the universty of York [2] estimates marketting costs to be higher than R+D costs, but lets be conservative and say they’re equal, so thats $50 billion per year to get and keep a drugs in the market (and we’re not bothering to count costs such as production).
Even if we blame ALL of the cost of getting a drug registered on the FDA and it all disapeared if the FDA went away the over 98% of the cost would remain.
So we can blame a MAXIMUM of 2% of drugs comapines costs on the FDA for which we, the patients, get assurance that drugs are safe and that they acctually work. If there is a shortage of drugs it is not being caused by a process which is adding at worst 2% to costs.
Lastly, you hit the nail on the head when you said that “In a free market, businesses prosper by selling products of value to their customers”. You know that a key part of a free market is eqaulity of information; that patients and doctors have to have as much information about a drug as the company. That’s wahat the aproval process does. Without it there is no free market in drugs just a ‘Lemons market’[3] or in this case a snake-oil market.
References
[1] http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies
[2] http://www.sciencedaily.com/releases/2008/01/080105140107.htm
[3] http://hydrogen.its.ucdavis.edu/eec/education/EEC-classes/eeclimate/class-readings/akerlof-the%20market%20for%20lemons.pdf
This last one is very good, I’d reccomend it to everyone.
It is $800 million per drug but the real barrier is time. The FDA was originally created by legislation written by a homeopathic physician who was a Senator. Homeopaths have a philosophy that does not include new drugs or the exotic drugs that are now curing diseases that were once incurable. I was a medical student when the first cancer and leukemia patients were cured. I was in the pediatric cancer clinic at Children’s Hospital in LA when the very first children had gone five years without recurrence of their leukemia. Some of the parents didn’t know what to do. They had always assumed their children would die of the disease.
Now there are drugs that completely stop the symptoms and joint destruction of rheumatoid arthritis. New cancer drugs are getting closer to the basic mechanism of cancer. We are in danger of slowing this process and that would cost a lot of lives. The present day vaccine shortages are largely due to the interference of the Clinton Administration. Now, another Democratic administration thinks it can plan the future. More shortages will be the result.
Given the provenance of your “sources”, here’s an even shorter version: You are a liar who loves big government.
My wife spent two decades making a living at doing nothing other than keeping the paperwork strait to show compliance to the FDA for a HUGE pharmaceutical company.
The cost of that alone was enormous.
True, marketing is expensive, but is dwarfed by the requirements (which are hugely and unnecessarily redundant)of the FDA.
Many of what is required by that government beast is to ensure it’s own survival and growth. As with most government agencies, it’s a bunch on non-producers who’s primary function is to justify their own jobs.
Many new medications and medical devices are taken up to 98% completion of the approval process only to be withdrawn, loosing the company every cent of development. Entire departments eliminated because of the constantly mutating burden heaped upon private industry by the government. Those departments, by the way, being staffed by people with families.
And sourcing Wikipedia? Heh, you funny.
There are two distinct forms of regulation. One form like the governor on an engine, keeps it within speed tolerance but is not particularly concerned with the reason to keep a steady rpm. The other is control which would be concerned with the rpms.
In our power plants there is a need to keep the rotational speed at a constant rpm. This does not affect the generating of the power but the cycles that are important to so many of its uses. A variable cycle will throw instruments off calibration.
As Jwill points out one form of control hampers growth and innovation hindering improvement and that happens to be our government’s favorite. I can’t say we have no need of regulation but we do need to keep an eye on what we are regulating.
…unless it’s $800 million per drug.
It is indeed, $800M PER DRUG. It costs an estimated $1B PER DRUG to bring a drug to market. Much of this expense is consumed meeting FDA regulatory requirements. Some of what the FDA demands would have to be performed even if the FDA didn’t exist, but without a doubt, the FDA imposes a significant economic barrier on the pharmaceutical industry.
You’re exactly right. My husband is a pharmaceutical chemist. The first drug he worked on was Lipitor, back in 1987. (It didn’t get approved until 1997.) I remember the day he told me the NDA (new drug application) had been sent to the FDA–in a U-Haul moving van. Literally. A couple hundred boxes full of paperwork. No, I’m not kidding.
That’s fairly typical. In the defense industry, a mid-size contract will fill a C-130, so it doesn’t surprise me that a drug application would be of similar size.
A question. Is this information overload? Who has the ability to wade through all that paperwork and come to a reasonable conclusion?
That also applies to our current and recent legislation.
~ Pr 10:19 ¶ In the multitude of words there wanteth not sin: but he that refraineth his lips is wise. ~
This is almost always the case when there is an excess of words.
And I’m sure this problem will only get “better” under Obamacare. Which would only make sense because, under Obamacare, we won’t have any doctors left to prescribe the right drugs. Yep, that socialized medicine will be to die for, literally.
Obama and his relatives and cronies are not concerned about any of us. He’s feathered his own nest well enough that he needn’t worry about drug shortages. If need be, he can always jet off to somewhere else in the world where those drugs are available. But we don’t get to do that. For us, it’s the death panels…
This is sad on so many levels. How many times must the people tell the politicians to LEAVE US ALONE before they get it? I dislike being pessimistic, but the number of people who can actually see through the wool covering their eyes is growing less and less as time marches on. In twenty years an even larger portion of the populace will be inculcated to the wonders of government. In forty years we may be the “proles” in George Orwell’s 1984.
To anyone who can still see past the veil of government “goodness”: prepare to retake our government by means of public office or by supporting those that are keenly aware of needing to limit the government.
How much longer are we going to let “regulations”, that are not duly imposed by our founding documents, kill us off? If food doesn’t meet the FDA’s standard, we are not allowed to eat. If the drugs we need to live are not lobbied correctly, we are not allowed to have medicine. If a coal factory puts soot into the air, we are not allowed to have electricity. If we build a “clean” energy option, we will not have ENOUGH electricity. If our children do not measure up to a “federal standard” they are told it is okay to not be excellent and are sent off to college still. If the schools harboring said students do not report absolute success they stand to lose all federal aid.
FDA, EPA, DOE are but a few of the government “goodness” institutes that are weakening the willpower and ability of the people to fight back. We are in the middle of a transition from democracy into a faceless dictatorship.
President Obama may be terrible. We can fire him by voting. The same goes for the House of Representatives and the Senate. However, can we fire the head of the EPA? Can we vote him out? Can we vote on the policies that the EPA hangs around our necks like albatrosses? No, we cannot. That is why the most important thing that must be on every voter’s mind is to find politicians who WILL get rid of these toxic organizations.
Time is running out my fellow Americans. You may not see the result tomorrow, or in four years time. That is the point of this takeover. Incrementally push the envelope so that no one is startled or aware of a coup d’etat. An animal that lowers its guard will be eaten by its predator.
Guess what? We’re that animal, and the government is the predator.
Zamir,you have some good thoughts and observations. I want to address one of them.
“If the schools harboring said students do not report absolute success they stand to lose all federal aid.”
Whether you gamble of not I do not know and that is not the issue but if you play the lottery or visit the casinos they are both living off the customer without contributing to the gross national production. Like our government subsidies, entitlements and welfare, it all comes out of our own pocket. The lottery has no source of funds but your ticket so the pay out must be less than the income, otherwise they would be out of business very shortly. The attraction is the chance return of big money from a small input but you, the customer, are paying the winner. The lottery has made no profit to cover that expense. It is not “free” money nor has there been any increase in value.
If we shut down the Department of Education(?), a questionable entity, it would cut off this federal spending that also comes out of your own pocket and education would cost no more in the long run.
Besides that, we would not be paying expensive bureaucrats.
This applies to all government “help”. We are supporting a beast with our income to do what we should be doing for ourselves. There is a need for government but that is another story, one we should study.
Most of government consists of getting in the way. Take the Bitterroot Valley in Montana where I used to live. The federally-owned forests are dying from a beetle infestation that has claimed millions of trees. There is a commercial use for these trees, but the Green lobby files lawsuit after lawsuit to prevent their harvest. So everybody is waiting for the inevitable mighty firestorm to sweep them away. Smoke from one Montana blaze in the early part of the 20th century darkened the sky over Moscow. It’s the natural way, evidently. The forests on adjoining lands owned by Indian tribes not subject to frivolous lawsuits by environmentalists are managed according to good forestry principles and don’t face this danger.
The “green” lobby? Indeed. It’s all about money. Money for THEM.
It’s also about their hatred for people. People other than themselves, that is.
Dr. Hsieh points one of the crucial fallacies behind the regulatory state: the assumption that the creation of new products: pharmaceutical drugs, automobiles, investment portfolios, etc. happen automatically and the only important part is to avoid what the government decides is “unacceptable risk.” But regulations actually stifle the very creation of the wondrous products of an industrialized civilization, and the more onerous the regulations, the less creation of new products we’ll see. If we want prosperity, our regulatory overlords need to leave us alone!
Nice job, Paul.
If abolishing the FDA is too much for one’s preferences, some alternatives:
The FDA would be much less harmful if it approved drugs based on only safety testing, rather than also requiring tests for efficacy. As David R. Henderson & Charles Hooper write in Forbes:
Read the whole article: Markets Can Determine Drug Efficacy
Another reform, short of abolishing the whole agency, as to allow any drug that has been approved by drug approval agencies in other countries. The FDA probably wouldn’t like giving up its power.
http://www.patientpowernow.org/2008/11/fda-drug-approval-denationalization/
Or how about limiting the FDA to giving its seal of approval for safety, and (gasp!) letting doctors and patients decide if a medication is appropriate.
Also, a good reference is: http://fdareview.org.
That can’t be right.
If 65% of development costs is for efficacy teting and 35% of costs is for safety testing thane that leaves 0% for all the other drug development activities.
What other development costs would there be? You test to see if the drug is effective and test its safety and side effects. If you are thinking of the costs of creating the chemical that is being tested as a drug, those costs are insignificant compared to the costs of the FDA-regulated Phase 1, Phase 2, and Phase 3 trials.
The objective of the statists is to reduce the population to a level that they believe Gaia can support. Removing life-saving drugs facilitates achieving that objective. A side benefit is that it also reduces the load on Social Security and Medicare. By dragging out the drug approval process and reducing the window of sole ownership, they also reduce the profits of Big Pharma, destroying another industry. But they really care for the little guy more than those cold-hearted conservatives.
Yes, there is nothing like the prosperity we enjoy through scarcity and nothing like unavailability to make things scarce nor like rules and regulations to guarantee such scarcity.
Exactly.
FDA caused 1,000,000 deaths from heart attacks and stroke
by 10 year delay of adrenalin blockers in USA after proven in Europe, I calculate.
FDA saved hundreds of deformities by similar caution with thalidomide.
Which have you heard about?
I agree with Stossel – better without FDA!
Go big pharma!
Signed,
Pill Pusher M.D.
You’ll want those pills when all other treatments are denied to you by the government.
But by then, you’ll be denied pills, too. It’s already happening.
Incidentally, wake up. There has been a concerted effort the past couple of decades to
get Americans off surgery and onto drugs. Or are you just supercilious by nature?
No, Peg C., I’m just very cautious and skeptical of pharmaceuticals and I believe an ounce of prevention is worth a pound of vaunted and often unreliable or questionable ‘cure’.
You have to remember, these pharma-tards are the same idiots who kept pushing “anti-depressants” which turned out to be pretty much a ‘placebo’ and even ‘harmful’ for most folks except for the most disturbed of individuals.
Keep drinkin’ the kool-aid if it makes you feel ‘better’.
I thank God for the people at pharmaceutical companies who created the medicines that make it possible for me and my children to live happy, healthy lives. I also thank God that you have been blessed with no need to take such medicines. I sincerely hope that you may never have need of them, because it is psychologically very hard to have your life saved by someone you once vilified and called a [something]-tard.
Your belief in drugs to ‘save you’ is tragic.
Yes, certain drugs can get you through a horrible case of this or that ‘condition’ but drugs won’t ‘cure’ you of cancer or herpes or Aids or being an asshat.
Learn the difference. Rinse. Repeat.
“Your belief in drugs to ‘save you’ is tragic.
Yes, certain drugs can get you through a horrible case of this or that ‘condition’ but drugs won’t ‘cure’ you of cancer or herpes or Aids or being an asshat.”
O rly?
Leukemia + chemotherapy = cure. Leukemia + nothing = death.
Which would you choose?
Educate yourself beyond the big pharma propaganda:
http://www.naturalnews.com/Index.html
And “Natural News” is an objective source. Sure. Whatever.
All of this “natural” hype is just so much snake oil. Chemicals are chemicals, whether they come from “natural” sources or from a factory. It’s just another way of scamming hypochondriacs and rich people, of which I am neither.
Obviously a Democrat. Democrats always whine about ‘Big Pharma’, ‘Big Oil’, ‘Big Money’ and “Big (insert industry here) in order to hide the fact that these businesses are populated by people.
LOL! I’ve been posting as an outspoken conservative Repub on PJM for over two years. Where the hell have you been??????????
BTW, I also think it’s horrible to foribly give little boys ADHD drugs for…well, being “little boys”.
Sorry, if I don’t fit the perfect zombieland you’re currently living in.
Roy said:
If 65% of development costs is for efficacy teting and 35% of costs is for safety testing thane that leaves 0% for all the other drug development activities.
Actually Roy, that is about right. The costs of keeping medicinal chemists on staff and synthesizing new drug compounds are a rounding error in comparison to the testing required to meet the FDA regulatory burdens. To put in perspective: a generic, to get on the market, has to make the formulation and do a bioequivalency study, which costs on average around 1-5 million in R&D costs, depending on your overhead, how easy the drug is to make, etc. Once FDA approves a product, with the exception of biologics, most small molecules COGS is between 2-10% of the brand pharma price. It is about 90-95% of the generic price (assuming multiple generic entries). Almost all API (active ingredient) is coming from India and China unless it is from Teva on the generic (and increasingly brand) side; it is too expensive to make in the US anymore.
The big problem with drug research is that the best ideas for truly innovative new leads are not usually coming from big brand pharma and its bureaucracy, or even NIH sponsored research. (Abbott is a perfect example – crap innovation, great licensing-in and marketing strategy produces its profits). Paxil came from a Danish gum manufacturer; pregabalin from Northwestern U; alendronate from Gentili; anastrozole grew out of fungicide research. The Japanese went far doing “me too” drugs, but have since faltered. But the startups can’t deal with FDA today; to even submit an NDA will translate into at least 2 years of pre-IND filings, etc., and over 50 volumes of submissions where every i and t must be crossed in the right bureucratic way, using the FDA-approved electronic submission format. If you are a start-up with a good idea, you will NEVER be able to comply with the FDA regulatory burden to even get into Phase I (first human)/II (dose-ranging) trials, let alone the Phase III efficacy studies, and that is assuming you don’t run into stupid FDA tricks (google UFT and Bristol Myers and the Cancer letter to see how FDA kept a cancer drug used safely in Japan for decades off the market because FDA wanted the brand company to test the product without one of the key components (uracil) that helped efficacy). By the time a startup has the data needed to attract interest from big brand pharma in a basic molecule, assuming the patent protection is good, you still won’t get it backed if it doesn’t have a potential billion dollar market because brand pharma doesn’t want to devote its regulatory infrastructure to developing the right reports FDA demands given the cost-benefit/lost opportunity analysis. Get rid of the FDA and yeah, you’ll get a lot of quacks, but you’ll also get stuff that really works.
FWIW, it won’t work to restrict FDA to “safety” only – that was the standards circa 1960s, and FDA was still using “safety” to regulate efficacy through the back door.
(Also: Alexander Fleming only discovered penicillin by way of a drop of mucus from his nose that fell on his petri dish. He decidedly was not adhering to GMP practices, but how many discoveries do we miss by being perfect that way?)
Oh, and don’t ignore the effect on present USA drug supply resulting from FDA’s import bans on Apotex (biggest Canadian generic supplier) and putting the screws to Teva on some regulatory snit fit. They supply a tremendous amount of the US market …
Really good comment, but I want to respond to this: “Get rid of the FDA and yeah, you’ll get a lot of quacks, but you’ll also get stuff that really works.”
It’s not as if we don’t have plenty of quacks already (think homeopaths and anti-vaccine zealots for starters). If people are determined to believe in magic, not even the FDA can stop them — and I don’t think abolishing the FDA will affect the number of believers in magic.
The FDA imposed costs of new drug development are a serious impediment to getting new drugs, but have nothing to do with the shortages of already approved drugs mentioned by the author. Why aren’t drug companies supplying ample quantities of their approved drugs?
Just-in-time manufacturing. Why should a pharma company eat the cost of having stockpiles of drugs hanging around?
Govt. interference has effectively killed off market rewards for drug development. Pharma has no idea whether they’ll be able to sell new drugs at market value because Obamacare will likely be dictating prices. Not exactly an innovation-friendly environment.
So now, pharma companies are doing what’s necessary to eke out a respectable bottom line so their investors don’t abandon them. JIT manufacturing saves money, so pharma’s doing it.
If Big Govt. backs off, you’ll see a flurry of new drugs on the market, and our drug supplies will be more than adequate.
As I noted above, both Apotex and Teva have been fighting with FDA and FDA has issued an import ban against Apotex at least on the solid oral dosing forms. See http://www.nytimes.com/2010/04/16/business/16generic.html; and http://online.wsj.com/article/SB10001424052748704471204575210322401203714.html. These two are the key suppliers in the injectables market. Hospira is a branch of Abbott, so its injectables market is more quirky.
But also, the major wholesalers (eg McKesson, Caremark) and retail chains (CVS, Wal-Mart, Walgreens) never want to pay more than just above cost on anything to the generic manufacturers. So if you are a generic, and have the opportunity to devote your plant to making a drug just coming off patent where your price is 50-70% of the brand price, or making a drug where you will have commodity pricing, you’ll rationally pick the former. The generic industry as a whole will make similar choices, leaving open supply holes until the wholesalers wake up and realize they need to meet that supply (at higher prices). But it takes time to redirect the supply chain, order the right raw materials to make literally tons of product (because it is not cost-effective to make kilo-batch scale product), and then get that out the door.
Also, unlike a lot of other inventory, all drugs come with an expiration date. Most pharmacies will sometimes make a “stockpile” purchase (eg two bottles of 1000′s) then draw that down over the course of a year, instead of buying smaller amounts more regularly (eg 30′s every month). Shelf-life of a lot of injectables are even shorter. So it can actually be pretty easy to get caught short. Most pharma manufacturers, brand and generic, do not keep drug stockpiles on hand. It is more cost-effective to send close-to-expiring drug out into the less stringent markets (eg India/China/Africa/South America) for sale than to keep it in a warehouse somewhere.
On the other side of that same coin lies a similar problem. Drugs to cure are in shortage, sure, but drugs used to separate barbarians from society are, too, in short supply.
http://www.nytimes.com/2011/01/22/us/22lethal.html
And, while murderers seem to have countless tools and techniques in their arsenal, the freaks we pay (by force) to put these dogs down can’t seem to figure out what to do in the absence of these lethal drugs. Remind me, what is the point in government? Oh ya, to loot and dispense welfare.
drugs can certainly save you from : burns, trauma, infections, some forms of cancer, as well as many other ailments . As a country we certainly try desperately to stay alive on other peoples money . Everyone will inevitably die from something and if we were spending our own money we wouldn’t use so many medicines late in our lives . But to reject western medicine entirely is foolish. You of course have that right but then who is the asshat ?
Delia, if you don’t want to take the drugs, don’t. Prevent me and my family from having them to take is a whole other issue.
Sorry if I don’t want my tax dollars to go to a largely over-hyped skull-phuck. Is there an opt-in and an opt-out? I’ll gladly opt-out and you can opt-in for all of those precious and life ‘saving’ DRUGS.
My husband is a big bad pharma chemist who is currently working on cancer drugs. He and every single person he works with are chasing two goals: the Holy Grail of Cancer Cure, and the Help-As-Many-People-As-Possible Treatments Until We Find the Cure. Sorry to burst your bubble, but they do NOT sit around and dream up ways to keep people sick.
My dad lived 3 good years with treatment for his esophageal cancer. He made the CHOICE to be treated, knowing damn well there was no cure. He DECIDED to stick around as long as he could for his family. Your insistence that the industry pursue only cures TAKES AWAY THE CHOICE for patients like my father.
If you want to sit around and wait for a cancer cure while the disease eats you alive, so be it. Or go have one of those coffee enemas that are supposed to cure cancer. Leave the rest of us out of it.
Well, could you ask your big pharma hubby why many “life-extending” cancer medications are so expensive? Sorry but the “cancer industry” is indeed an ‘industry’ (like it or not).
People who smoke, drink heavily, eat unhealthily, sit around too much and/or are obese end up with all kinds of health problems (cancer being just one of many). Again, prevention is worth a pound of very expensive temporary ‘life extension’. I’m not inferring that your father lived an unhealthy lifestyle, but, unfortunately a lot of people do and then demand to have their lives extended with expensive treatments they can’t afford.
No, I don’t need a “coffee enema” cure. I prefer to stay fit, eat healthy, drink in moderation and not smoke and to strengthen my immune system. Crazy talk, I know!
Why don’t you ask your natural foods friends why organic healthy foods are so expensive? They are ridiculously priced compared to processed food. If they really cared about people, they would provide their food for free or charge less than McDonald’s so people could afford to buy it for their kids. Of why is it that they don’t they give that kind of food away?
Face it they are just an industry and they only care about gouging the public.
Do you really think big pharma can be compared to small, organic operations? Really? And, believe me, I’ll give up some other unnecessary artery-clogging, body-damaging “luxuries” in order to eat and live healthier. But, do go on and have your cigs and grease-burgers just so long as I don’t have to foot the bill for you.
The medications are expensive because it costs a fortune to develop and manufacture them. My husband’s company is a small biotech, funded primarily by venture capital, and in 10 years has not yet turned a profit. There are hundreds of small biotechs just like it all around the country, all in the same financial boat. And there are so many kinds of cancers, most of which require different drugs, so there is little opportunity to profit by mass production. Profit instead has to come through pricing. But I’m sure you won’t believe that. You obviously prefer your meme of corporate greed.
If cancer is a lifestyle issue, that doesn’t explain why my 9-year-old uncle, my 12-year-old cousin, my 4-year-old cousin, and my 9-MONTH-old nephew all contracted cancer. So, do they deserve life-extending treatments, while my father–who lived the stressful life of a soldier, husband, father, divorcee, worker, and widower–does not?
My father’s private insurer paid for his treatment. I’ll be happy when Obamacare is gone, hopefully to be replaced by a completely free-market solution. Then I won’t have to listen to people like you complaining about something that’s really none of your damn business.
Oh wonderful, Delia, a know it all. Guess what, I have work with patients who ate the right things, exercise daily and work in strenuous jobs that does not involve exposure to carcinogens and yet their bodies develop cancerous tumors. Explain to me that?? I have seen patients who freaking drank and smoke their way as well as stuffed themselves into old age and their only diagnosis was Hypertension.
Since you are health nut, I will make a prediction, by the time you reach 70, you will a) be suffering from GERD B) Hypertension c)Diabetes and CHF. You will be the patient who is in denial, wants everything done and a whiner. It is people like you that makes life difficult to us health professionals. People like you are brave over the internet when you are healthy, just wait until life, genetics and old age gets into you.
*sigh* This will be my last reply on this subject since I’ve obviously ruffled quite a few feathers.
Firstly, Taxpayer I’m truly sorry for so many of your family members contracting different cancers, I have a fairly long history of cancer of different varieties in my own as well and it’s an awful thing to witness. Don’t you wish to find out why cancer happens rather than just treating cancer with temporary ‘solutions’? If drugs can only save people for so long before remission or death occurs, shouldn’t we be adamantly finding the reasons behind the cause of cancer? If for some people it is more than just “lifestyle” then what? Is it something toxic in pesticides or in the environment and if so what can we do about that?
As far as shortages, perhaps if more people adapted healthier lifestyles that would free up more studies on cancer to help prevent or cure it and to also help those who have contracted it through no fault of their own.
I’ve had some very poor experiences with doctors in general so I’m more skeptical of the medical profession and the drug companies.
I truly hope health and happiness for everyone, that is my sincerest prayer.
Folks;
http://www.cancer.org/Cancer/CancerCauses/index?ssSourceSiteId=null
Quote “What Causes Cancer? – Cancer is a complex group of diseases with many possible causes. In this section you can learn more about the known causes of cancer, including genetic factors; lifestyle factors such as tobacco use, diet, and physical activity; certain types of infections; and environmetal exposures to different types of chemicals and radiation.”
FACT:
We DO have control over lifestyle factors like smoking, diet and exercise. If more people paid attention to the controllable factors – obesity is a major problem in this country – cancer could be reduced significantly.
No one’s saying lifestyle doesn’t impact cancer incidence. However, it’s unfair to assume that everyone with “lifestyle issues” contracts cancer due to that lifestyle. There is no way to know for a fact whether someone’s cancer came from eating too much cheesecake, smoking cigarettes, or spending too much time on the couch. Correlation is not causation. This kind of misunderstanding could lead to denials of medical insurance payment/coverage based on lifestyle, when there is no proof.
Taxpayer;
With your logic, there’s no point in creating a healthy lifestyle for oneself since “there’s no way to know” and “correlation doesn’t equal causation”. That is contrary to numerous studies showing the effect of bad diet and lazy habits on your health. Now, that doesn’t mean that everyone who eats tofu and exercises regularly is immune from illness, but it does prove that the chances of serious illness can be considerably reduced.
And to that argument, I point out the Japanese, who have one of the longest and healthiest lifespans in world because they take very good care of themselves.
As far as junk foods are concerned, it’s really about portion control and stringent calorie counting and you can even lose weight and lower your cholesterol on crap food just like this nutrition professor did:
http://www.cnn.com/2010/HEALTH/11/08/twinkie.diet.professor/index.html
So, there you go. Even people who can’t afford or don’t want to eat the best and healthiest foods can still lose weight and/or maintain a healthy weight if they don’t stuff their faces like pigs every day and get off of rotund their behinds and actually move. I personally wouldn’t suggest living on junk food as main diet to anyone and of course you can eat a lot bigger portion of vegetables, fruits and lean meat for the same calories and probably feel much more satisfied and less constipated than you will with a smaller meal of junk food but the choice is yours and excuses don’t fly any longer. Gluttony, drugs, smoking and sloth do increase disease, poor circulation and overall lowered health for the majority of human beings whether some people want to admit to it or not whatever their personal excuses or agenda might be.
The trick, of course, is to take drugs off the market for people who are near end-of-life, since they will not have much time to protest and their families will drop the matter after their deaths as an inefficient use of time and resources.
Dear Moderator: Can you moderate-away the obvious trolls such as Delia? Her comments do nothing for either side of the keep FDA/eliminate FDA debate.
You might as well throw in all of the folks who keep responding to my posts.
Dr T;
Delia makes some rather good points.
Moderator: Second Dr T’s request.
Moderator: Ditto Dr. T and mike H.
Concerning Delia, don’t feed the trolls. She would be much more effective if she made reasoned arguments for her position on the virtues of organic/natural food and healthy lifestyles as a way to minimize ill health–we might even find some grounds for agreement and enlightenment, but she prefers insults and bomb throwing. Thus, she is a troll and to be ignored.
if people want to bypass all fda regulations then why can’t those people sign up to be human guinea pigs and sign a guarantee of sorts that they won’t sue the drug company or doctors who administer them should their organs shut down or they die sooner than later etc.?
as far as drug-shortages go, why are there so many people needing these drugs? i’m apt to believe dalia has it right and that is that americans are partially to blame for the overload on the medical and drug establishments. when do people start taking more personal responsibility for their resultant ailments? when do folks forgo the cable tv and junk food in place of higher quality food? when do people grow up and stop expecting big government to save them from themselves?
samsonite
I really wish it was that simple. Most Americans will not go see the doctor until it’s too late and that goes for both the healthy and the not so healthy. Another thing, because there is no federal tort reform, doctors and hospitals tend to be overly aggressive in treating the patient or as we say, over diagnose and over treat the patient.
Drug shortages are not for current medications, it’s for new medications especially for Antibiotic resistant diseases , cancers, heart diseases, strokes and others as well. It’s easy to say that most people don’t need them and that’s true, but there are many patients who does not improve on what we currently have now and they might need those new meds to treat, alleviate their symptoms or if they are lucky, cure their diseases.
Bob W
Again, what you said is true, but the problem is this, most patients and clients demand that their doctor treat them with Antibiotics even for the common cold. Guess who are the ones who never finished their drug regimen, poor and indigent patients and surprisingly, well educated people who should know better. The former is about lack of money and more or less, lack of education. The latter is about arrogance, a know it all attitude and denial of what ails them.
Real cure is far away because of the FDA’s bureaucracy and politics as well as technology for whatever permanent cure you are aiming for. Don’t you know that it takes numerous trials and studies before even one medical machine or medically invasive procedures be cleared for use by the FDA. Years, not months.
Those of us who worked in healthcare can’t wait for the CURE, but realistically, it takes time, resources and yet to discover technology to develop a cure for everything.
FDA regulations are for lessening risk by death because of those very same drugs. We should invest more money into finding the reasons why disease happens and not just treating the problem with temporary fixes. Is there something in the water? Is it pesticides? Is it phalates leeching into our bodies? Where are the thorough studies to find the answers to this and many more questions? Drugs are only a band-aid on a much more frightening problem. The reason we now have “super-bugs” is because of the very drugs (namely antibiotics) that were issued out far too often coupled with people not being responsible and finishing their prescriptions once they “felt better”. Drugs might help you hang on for a couple more years but if that is the only intent for such drugs, I’m sorry, but it seems like a huge waste of time and resources better spent on helping find a real cure and not simply a death-stay.
Let’s consider just what some of those “band-aid” drugs actually do:
Statin drugs lower cholesterol, which in turn lowers the risk of heart disease and stroke. No statins = more heart attacks and strokes, both of which are expensive, debilitating, and deadly.
Antihypertension drugs keep otherwise uncontrollable blood pressure at manageable levels, thus reducing heart damage and risk of heart attack. No antihypertension drugs = more heart attacks, which are expensive, debilitating, and deadly.
Corticosteroids reduce a variety of inflammatory conditions, the most dangerous of which are asthma and transplant rejection. No corticosteroids = kids dying of asthma and few (if any) successful transplants.
Yes, it would be awesome if we could find exactly what causes things like high cholesterol, asthma, or hypertension. Scientists look for causes, but they’ll be the first to say that science is incredibly ignorant of nature’s complexity. And humans have this funny preference for living as long as possible, so they ask scientists to develop a treatment if a cure is not available.
Especially in America, we don’t know how good we have it. If we didn’t have the drugs I mentioned above, thousands of people would be enduring painful surgeries, lengthy hospital stays, loss of income, and possibly permanent disability or death. And our medical costs would be MANY times what they are now.
Instead of recognition for how far we’ve come, all I hear is a bunch of spoiled brats whining that they can’t get instantaneously cured–preferably with just one pill.
Excellent article. I agree wholeheartedly that we need to abolish the FDA (along with all the other meddling government programs). I just don’t understand why people can’t see that testing new drugs could be much better handled in the private sector where there is incentive to investigate, test and evaluate new drugs more quickly and accurately.
Delia said,
“Don’t you wish to find out why cancer happens rather than just treating cancer with temporary ‘solutions’? If drugs can only save people for so long before remission or death occurs, shouldn’t we be adamantly finding the reasons behind the cause of cancer? If for some people it is more than just “lifestyle” then what? Is it something toxic in pesticides or in the environment and if so what can we do about that?”
——————————–
Of course I want to know. But here’s the reality: In the most recent developments in cancer research, scientists THINK they’ve found what MIGHT be the trigger of the abnormal angiogenesis of cancer. Meaning, we are still far away from identifying the root cause–which further means, we are light-years away from a cure.
I’m cheering on the continued work towards a cure, but I’m not foolish enough to think we should abandon development of better treatments. After all, it may be a man treated for testicular cancer, a woman treated for breast cancer, or a child treated for leukemia, who eventually finds the cause or the cure.
My grandparents prayed for a treatment for cancer in 1957, but there was none, and my 9-year-old uncle died. In 1964, my aunt and uncle, an Army nurse and doctor with access to some of the best physicians on the planet, prayed for a treatment for my 12-year-old cousin. But there was none, and she also died. Advances in treatment allowed my 4-year-old cousin to survive and grow up to be a happy mother of 3; and my nephew to be cancer-free and ready to graduate from high school this spring.
Developing treatments is not the ideal. But if it helps someone you love, you’ll take what you can get. And I’m grateful for the treatments which have helped the ones I love.
Your article mention how regulation affects the production side of the equation. There are also regulations that affect usage and payment for these crucial medicines. I am an emergency physician and this week I had to ration my use of nitroglycerine drips in the treatment of chest pain/acute coronary syndrome/heart attack patients.
Most of a hospitals inpatient admissions come through the emergency department (80% in most hospitals). The ER is under a federal law called EMTALA that effectively provides an unfunded mandate to see and treat everyone who presents regardless of ability (or intention) of paying. This results in 50-75% of visits being from patients who do not pay anything for care. This creates the cost shifting that accounts for the $100 Tylenol you see on a hospital bill. However, even this cost-shifting cannot make up the difference, AND government payors and insurance companies are no longer willing to bear the burden of this unfunded mandate, and will not pay cost-shifted rates. With many of these drugs not being paid for, hospitals negotiate for prices that are lower. The demanded price drops so low that the incentive to manufacture falls off or the hospital cannot pay a price that makes production financially feasible.
When Obamacare provides wider mandates and prohibits such cost-shifting you can expect to see even more dramatic shortages. It is not just regulation on the production side that causes shortages….regulation on the usage side does as well.
@ Doug McGuff, MD:
You make some excellent points. How many of these people who show up in the ER can even speak English? How many of these patients are drug-addicts or drunks? How do you even prescribe medication for someone who can’t understand enough English or is too inebriated to be trusted to properly take the meds? 50-75% of patients not paying is absolutely egregious. This is why the poor especially need to be better educated about their own health and drug/alcohol problems. It’s little wonder we have super-viruses running rampant in hospital settings.
@ Nevetsch and the others, why do you call someone a troll who said one snarky comment and then a bunch of commenters jumped on it for an argument and he/she replied in kind? Are you all self-appointed hall-monitors on Pajamas Media now? There are some lefty trolls who definitely make themselves known here and Delia isn’t one of them from what I’ve read here throughout this website. I thought Delia’s suggestions were spot-on if perhaps a little acerbic at first. Some people just don’t trust the medical establishment and that’s certainly not something that is uncommon and questioning people who might have a personal and vested interest in not curing a disease which would put them out of business is something everyone should do in matters of health.
Under Obamacare, this whole situation is going to mushroom out of control.
“people who might have a personal and vested interest in not curing a disease which would put them out of business”
You insult my scientist husband and thousands of conscientious science and medical workers with your fallacious assumption. If my husband were put out of work because a cure for cancer was found, he’d be among the first to celebrate, big time. Then he’d go find something else to do. That’s the beauty of America–people aren’t forced into a career path by age 10 nor locked into a job for a lifetime, like communist systems in China and the former USSR.
The amount of money saved due to such a cure, and generated by those cured, would be astronomical. That’s also the beauty of America–the money would be invested in other endeavors. Take, for example, the polio vaccine. The economic benefits over the past 50+ years since the vaccine was introduced are huge.
Getting laid off is scary. My husband has been laid off twice in the past 7 years. But he wouldn’t for one moment choose job security over the chance to help the suffering. However, there’s no reason he should do it for free. That, too, is the beauty of America–we can make a decent living while doing really wonderful things for each other.
@ Taxpayer,
You seem to internalize people’s criticisms of the medical and pharmaceutical establishment as though they are direct attacks on your husband. Ma’am, you need to get a grip. People have every right to question such things because not all people are great, wonderful, humanitarian, self-sacrificial people such as your sainted husband. Some people really are evil and only in it for the monetary means to an end. Are you so naive to think everyone thinks exactly as your husband in the pharmaceutical industry? If that were the case, there would be no need for lawsuits in this great land of saints and angels.
Perhaps it would be wise to remove your emotionalism from the equation, stop hammering that you have “cancer in your family” for extra points (even though, it’s apparently nobody else’s business according to you and yet you feel the need to mention this anyhow) and allow others to voice their opinions without your shrill, spasmodic harping as though yours is the only opinion that counts because you’re married to someone in the ‘biz’. I know people in the medical profession and they aren’t all blindly trusting of pharmaceuticals either.
Of course, drugs are sadly necessary when all else fails. The points that were being made is that a good majority of people can avoid the all else fails scenario by education and lifestyle changes. There are plenty of medical studies and proof that lifestyle does indeed create more risk for disease and the burden on the drug manufacturers and hospitals and doctors is becoming unbearable because of this very reason. Just because some people are healthy and still get some diseases doesn’t excuse every other lard @ss in the USA from changing their ways. If we could reduce cancer and other diseases by taking personal responsibility and make those diseases much less common by controlling our own actions, there would be no drug-shortage or doctor or hospital shortage for people who do contract it a disease they had the misfortune to get despite a healthy lifestyle.
If America was healthy to begin with, Obamacare would be a joke to have ever been brought up in the first place.
Yes, I do take it personally because I hear this tripe said about the pharma industry on a freakin’ daily basis–for people just like you. I’m sick of people like you mischaracterizing and outright lying about the people who work hard to save your sorry as*es from one or another illness, or to help you live long enough to continue your baseless carping.
However, if this is not supposed to be personal, then you won’t take offense when I call you a pimp and your wife a who*re.
@Gary Harold,
The inability of patients to speak English is no problem whatsoever. The reason is another unfunded mandate. We are required to hire professional translators (either on-site or AT&T language line). I speak fluent spanish but am still required to use the “professional” translator. When I listen in on the translator (who is unaware that I am fluent in spanish), I find that they often translate inaccurately or editorialize in a way that could negatively affect patient care.
There are so many layers to the problem of government interference in health care that it would take a lifetime to discuss. The funny thing is that when the costs are shifted to the private sector, the statists blame the private sector for the high cost of health care when in fact these costs are just the shifted costs of government intervention.
If it did not violate HIPPA I would love to post photos of the i-phones, gold jewelry, gucci purses, dolce and gabana sunglasses and SUV’s with 22″ rims that are owned by the folks that are too poor to pay for their medical care.
@ Doug McGuff, MD:
The “supposed poor people” you describe sound more like thieves gaming the system than poor, downtrodden patients who can’t afford medical services. When people shop-lift the customers end up paying by prices going up too. With health-care this is obviously a far worse scenario. This is why big government will keep getting worse as more and more people want a free-ride and a bail-out which just keeps rising the costs for every other person. It’s a maddening cycle.
@ Taxpayer:
You are clearly unhinged and if I had a wife I’d be thankful she was nothing at all like you because you do your husband no service by your obvious lack of ability to see more than one side of an argument or opinion. If I have very little respect for some pharmaceutical establishments (try and notice the word “some” and improve your reading comprehension skills) who discover and create better ways to spontaneously abort fetuses via the morning after pill and other types of medications, well, pardon me for finding that absolutely reprehensible and yes, evil.
I didn’t buy your argument; I have a dog in the fight, which I made very clear; and I have a strong opinion. So you conclude that I’m “unhinged.” That’s a flying leap of illogic.
BTW, your deliberately vague “some” argument is a variation of the sophist straw man. Still NO SALE.
taxpayer have your husband up your meds. just reading your rants it is glaringly obvious you are a shrieking shill for the pharmaceutical industry and a weak one at that. i bet you are one of those obese american cows who cries that her fat butt has nothing to do with her overeating and everything to do with a glandular problem. give your poor husband a bj and stop making him look bad with your antics. lulz
Steve;
Was that really necessary?
Drug problem is a serious issue not only for America but for the entire world, it really needs to be taken care of….
Thanks for another informative blog. The place else could I get that kind of info written in such an ideal means? I have a mission that I am just now running on, and I’ve been on the glance out for such info.
Why do some of the commenters here think that if only people were healthier, that somehow magically there wouldn’t be any shortages? If people were healthier, the medical industries would be correspondingly smaller, and if the same POLICIES are in place, it doesn’t matter what the absolute size of the market is, the shortages WILL HAPPEN. This is basic economics, people. Sure, if everyone were mind-controlled to adopt whatever the current “healthy lifestyle” fad is, and miraculously the demand for health care dropped by 50% next year, you would only have an excess of health care providers for a VERY SHORT TIME before 50% of them went out of business and learned a different trade, and then we’d be right back to where we started, with sick people unable to get the medicines they NEED. RIGHT. NOW. because some pencil-pushing bureaucrat has decided to artificially cap the amount of medicine a company is ALLOWED to produce, come heck, high water, or pandemic. How is blaming the sick people for being sick going to solve this problem, again?