Locking Up Life-Saving Drugs
Prescription laws make us sicker and poorer.
Kerry Howley


At a time when blockbuster drugs are revolutionizing the treatment of high cholesterol, Janice Alston can feel the first effects of heart disease creeping up on her. The 51-year-old resident of North Carolina says a common drug called Zetia would help her fight the cholesterol clogging her arteries. But as an uninsured, low-income home care professional, Alston isn’t willing to pay for the doctor’s visit and associated tests it would take to get the prescription.

With a history of hospitalization for heart disease, she knows she is taking a risk by avoiding the clinic, and as a licensed nurse’s assistant, she feels confident she can assess and treat her own symptoms. If the drug were available over the counter, she says, she would buy it.

“It’s just not worth it to me right now,” she says, listing the barriers—from taking time off from work to paying full price for a doctor’s visit— between her and the drug she’d like to take.

Alston is one of 90 million Americans suffering from high cholesterol. Six months ago, a cholesterol-lowering drug called Mevacor was set to be reclassified as an over-the-counter medicine, a move that would have made the drug physically and financially available to people like Alston. Mevacor, made by Merck, is a statin—a class of drugs so safe, with benefits so clear, that doctors joke about putting them in the water supply. Only about 13 million Americans are currently taking statins, but federal guidelines suggest 23 million more should be on a similar regime.

Hoping to encourage more widespread use, the United Kingdom dropped the prescription requirement for Zocor, another Merck statin, in 2004. But Merck has had no such luck on this side of the Atlantic.

Last January a Food and Drug Administration (FDA) advisory panel considered a proposal to put Mevacor within easier reach. As they had during previous hearings in 2000, members of the committee fretted that patients would muck up dosages, lose track of cholesterol levels, and make poor decisions about diet and exercise if popping a pill appeared to produce the same results as a healthy lifestyle. One of only three doctors who voted to put the drug over the counter—David Schade, a professor at the University of New Mexico Department of Internal Medicine—based his vote on lack of access for the uninsured. “I vote yes for the overriding reason that there are millions of Americans in this country with no health insurance and absolutely no access to a statin except, of course, to fly to Britain,” he said. “I think that these people deserve the right to lower their risk and prevent cardiovascular disease.”

Despite Schade’s opposition, the panel voted 20-3 to keep the drug’s prescription-only status. By keeping statins locked within the burdensome and, for some, inaccessible health care system, the decision dampened hopes that statins could find wider use among the millions of Americans who ought to be taking them. For the time being, access to these lifesaving drugs depends on the tiny percentage of the population legally empowered to dole them out.

Statins are not the only class of safe drugs still under lock and key. Medical information is available to more people than ever before, and Americans are buying more drugs and making more-sophisticated choices about their health. Yet access to everything from insulin to Viagra still requires a day off from work and a trip to the doctor’s office. For Americans growing more knowledgeable about the specifics of self-care, the prescription regime presents a significant and sometimes insurmountable barrier.

Faced with a growing conflict between the FDA’s excessive caution and patients’ eagerness to self-medicate, doctors have started to call for a different system—most notably, for “behind the counter” status, an approach that puts pharmacists between patients and drugs. But this downgrading of gatekeepers fails to address other issues keeping drugs out of reach. Only a system geared toward making drugs available over the counter automatically, whether directly after FDA approval or after a predetermined trial period, will ensure that patients’ treatment is determined by their interests, not those of government or industry.


http://www.reason.com/0508/fe.kh.locking.shtml

You have to wonder: is the FDA saving us from harmful drugs, or are they preventing us from getting healthy drugs?

Is the FDA killing more people than it's saving?

The FDA is there to do what the drug companies tell them to do. They then tell us they are doing it for public safety. That is all.

This could also be another strong argument for National Health Care.

Now, I'm not saying that everybody should be on a completely level playing field. Those with enough money to do so should be able to purchase superior health care plans with greater benefits to them and their families. But a base line, minimum-standard-of-living health care plan could easily be afforded by the world's richest nation, and would drastically improve health and harmony among the populace.

The FDA's reasons aside, their ruling is making it harder for Americans to survive. And in the long run--hell, even in the not-so-long-run, the burden is shared equally among all Americans.

If a group of low-income uninsured workers fall ill and are incapable of doing anything but staying home until they either get better or die, the work they miss out on causes a greater burden to be placed on the workers who do show up in good health. These workers then work themselves harder and are at greater risk for infection or disease. Alternatively, the productivity of a company suffers from decreased worker population, and profits decrease proportionally.

With a minimum National health care plan, everybody from the laborers to the executives would have greater access to a higher standard of living.

I encourage you to read the entire article. I'd post the whole thing if it weren't against the posting guidelines. It's a really good read, loaded with very pertinent information that I was not aware of until now.

So I guess nobody cares about this, eh? It's possible that ten thousand people died in New Orleans. The number of dead American soldiers in Iraq is approaching 2000. But how many people are dying because they can't get life-saving medication, because the FDA is more interested in maintaining the drug companies' profit margins than they are in saving American lives?

Heart disease is the number one killer of Americans. Maybe we should care?

the FDA is more interested in maintaining the drug companies' profit margins than they are in saving American lives

How does this relate to the example (Mevacor) given in the article? In that case, the drug company (Merck) was pushing for the drug to be made available over the counter, and the FDA denied them. I fail to see how denying the company's request can be seen as 'maintaining their profit margin'.

How does this relate to the example (Mevacor) given in the article? In that case, the drug company (Merck) was pushing for the drug to be made available over the counter, and the FDA denied them. I fail to see how denying the company's request can be seen as 'maintaining their profit margin'.

Well, that's true. This case is an exception. Perhaps I was wrong.

In this case, I would call the FDA a bunch of elitist pigs who think they know what's best for everyone else in the country, and are allowing Americans to die for their unfounded sense of superiority.

Is that better? :D

Well, that's true. This case is an exception. Perhaps I was wrong.
Not really much of an exception - there have been a number of cases where the FDA has pulled drugs from the market or otherwise found itself at loggerheads with individual drug companies or PhRMA.


In this case, I would call the FDA a bunch of elitist pigs who think they know what's best for everyone else in the country, and are allowing Americans to die for their unfounded sense of superiority.
Hah, yes. That said, there are complications - letting the consumer decide for him/herself what medication is appropriate is all well and good, but only insofar as the manufacturers (and the FDA!) are insulated from any potential stupidity on the part of the consumer. The consumption of anything that futzes with biological systems is always going to have some element of risk, and it should be made clear that self-medication entails accepting that risk and any arising consequences. Provided that consumers are willing to do this and accept that it's their own lookout if they do something dumb (e.g. take medication that's known to conflict with other medications they are on or overdose themselves or whatever), I'd agree that there's little harm in making more drugs available OTC.

Even if the motive was profits for the drug companies (which believe me, I am against) I think drugs like this need to be supervised by a doctor. You need the dose monitored and blood tests regularly, for a number of reasons. Cholesterol-fighting drugs are not the kind that should be OTC.

The FDA is there to do what the drug companies tell them to do. They then tell us they are doing it for public safety. That is all.

You are totally incorrect. The FDA imposes enormous costs on the development of new drugs, making it horrendously expensive to bring life saving treatments to the market. A drug company has to spend of millions of dollars on research, development, and testing, then has to wait years for FDA approval, assuming animal rights nuts don't destroy the labs where the testing is taking place and they have to start all over again. That is what is driving the cost of prescription drugs ever higher. The FDA is no friend of the drug companies.

So I guess nobody cares about this, eh? It's possible that ten thousand people died in New Orleans. The number of dead American soldiers in Iraq is approaching 2000. But how many people are dying because they can't get life-saving medication, because the FDA is more interested in maintaining the drug companies' profit margins than they are in saving American lives?

Heart disease is the number one killer of Americans. Maybe we should care?

The FDA is a federal agency. It no more cares about drug companies' profit margins than it cares about the cost of tea in China. It makes the process for bringing new drugs to market much more expensive and lengthy than it really has to be.

This could also be another strong argument for National Health Care.

Now, I'm not saying that everybody should be on a completely level playing field. Those with enough money to do so should be able to purchase superior health care plans with greater benefits to them and their families. But a base line, minimum-standard-of-living health care plan could easily be afforded by the world's richest nation, and would drastically improve health and harmony among the populace.

The FDA's reasons aside, their ruling is making it harder for Americans to survive. And in the long run--hell, even in the not-so-long-run, the burden is shared equally among all Americans.

If a group of low-income uninsured workers fall ill and are incapable of doing anything but staying home until they either get better or die, the work they miss out on causes a greater burden to be placed on the workers who do show up in good health. These workers then work themselves harder and are at greater risk for infection or disease. Alternatively, the productivity of a company suffers from decreased worker population, and profits decrease proportionally.

With a minimum National health care plan, everybody from the laborers to the executives would have greater access to a higher standard of living.

That sounds very attractive on paper. Unfortunately, it only works until people start abusing it. If it costs nothing out of pocket to visit a doctor, people WILL see the doctor for every little ache and pain. This has happened everywhere socialized medicine has been tried. the inevitable result is shortages and reduced quality of care.

Edit - I could see a low-cost version working, but not a completely "free" version. I put free in quotes because someone is paying the cost. It's basic economics. Cost <> price.

Hah, yes. That said, there are complications - letting the consumer decide for him/herself what medication is appropriate is all well and good, but only insofar as the manufacturers (and the FDA!) are insulated from any potential stupidity on the part of the consumer. The consumption of anything that futzes with biological systems is always going to have some element of risk, and it should be made clear that self-medication entails accepting that risk and any arising consequences. Provided that consumers are willing to do this and accept that it's their own lookout if they do something dumb (e.g. take medication that's known to conflict with other medications they are on or overdose themselves or whatever), I'd agree that there's little harm in making more drugs available OTC.

Well, either way there's risk. That's just the name of the game when you're fighting health problems. But what we really need to start thinking about is this: Would the risk of choosing our own medications be more than the risk of waiting for the FDA to choose them for us? For every patient who would accidentally kill themselves because of drug interactions, how many patients are dying today because they can't get the drugs they need to live?

The FDA is a federal agency. It no more cares about drug companies' profit margins than it cares about the cost of tea in China. It makes the process for bringing new drugs to market much more expensive and lengthy than it really has to be.

You're right. I take it back.

Well, either way there's risk. That's just the name of the game when you're fighting health problems. But what we really need to start thinking about is this: Would the risk of choosing our own medications be more than the risk of waiting for the FDA to choose them for us? For every patient who would accidentally kill themselves because of drug interactions, how many patients are dying today because they can't get the drugs they need to live?

I would rather assume that people are intelligent and can read labels than to assume they must be protected from every possible harm they could accidently do to themselves.

It seems to me that on the one hand, people are complaining that the FDA releases drugs too easily, allowing drugs to the market before adequate testing. On the other hand, you have people complaining that life saving drugs are being held back from the public.
Can people at least choose one thing to complain about and stick with it?

It seems to me that on the one hand, people are complaining that the FDA releases drugs too easily, allowing drugs to the market before adequate testing.

I didn't see anybody saying that.

Good article Feenix. Thanks for posting it.

I didn't see anybody saying that.


Look here. (http://www.discussanything.com/forums/showthread.php?t=79973&page=5&pp=20)

Look here. (http://www.discussanything.com/forums/showthread.php?t=79973&page=5&pp=20)

Well, that was Corporate Avenger, who thinks that every single problem anyone in the universe has ever had was caused by corporations. I don't think there's any one person complaining about both sides of the issue.

Well, that was Corporate Avenger, who thinks that every single problem anyone in the universe has ever had was caused by corporations. I don't think there's any one person complaining about both sides of the issue.


Corporate Avenger never said anything of the sort.

The real problem is when corporations and government collude together, which is out of control in this country.

When government officials leave government they go into the private sector working for companies they used to oversee, and vice versa. The mob still exists, they just moved up into government and control corporations.

Corporate Avenger never said anything of the sort.

The real problem is when corporations and government collude together, which is out of control in this country.

When government officials leave government they go into the private sector working for companies they used to oversee, and vice versa. The mob still exists, they just moved up into government and control corporations.

okay, that's great.


sooo... let's get rid of the FDA then.

Corporate Avenger never said anything of the sort.

The real problem is when corporations and government collude together, which is out of control in this country.

When government officials leave government they go into the private sector working for companies they used to oversee, and vice versa. The mob still exists, they just moved up into government and control corporations.

In this case, the FDA works AGAINST the best wishes of drug companies, as it adds years and millions of dollars to the cost of getting new drugs to market.