Free Drugs Go to Wealthy & Insured

Free drug samples go to wealthy and insured
Neediest least likely to get medicines marketed by pharmaceutical firms

WASHINGTON - Insured and wealthy Americans were more likely than the poor to get billions of dollars in free drug samples distributed by pharmaceutical companies to win patient and doctor loyalty, a study released on Wednesday showed.

The pharmaceutical industry contends that the samples help the uninsured and people with low incomes, but the study of prescription use by nearly 33,000 U.S. residents during 2003 found that the neediest were least likely to get samples.

“Our findings suggest the free samples serve as a marketing tool, not a safety net,” said Dr. Sarah Cutrona, co-author of the report to be published in the February issue of the American Journal of Public Health.

The Pharmaceutical Research and Manufacturers of America, a trade group representing most major drugmakers, called the study out of date and said a major facet of the problem is that many uninsured do not get health care from doctors’ offices.

Samples are popular among doctors who want to try new drugs.

“As important as free pharmaceutical samples are in improving healthcare, they represent one �?? not the only �?? option for patients in need,” Ken Johnson, a spokesman for the group, said in a statement.

Lack of access to regular medical care by the uninsured and underinsured is a major factor contributing to who gets free drug samples, the report said. The uninsured are more likely to get care from emergency rooms and clinics.

Nearly 47 million people living in the United States do not have health insurance.

New, expensive drugs promoted
About $16.4 billion in drug samples were given out in the United States in 2004, up from $4.9 billion in 1996, the study said. Distributed by sales representatives, samples are nearly always the newest, most expensive drugs, the report said.

Critics have said that in addition to steering doctors and patients to pricey drugs, samples can lead to medications being used for conditions they were not intended to treat.

Drugmakers are forbidden from recommending drugs for uses for which they have not been approved by the U.S. Food and Drug Administration, but doctors can prescribe drugs for any use.

The now-recalled painkiller Vioxx, made by Merck & Co, was the most frequently distributed free drug sample in 2002, the study found.

Vioxx was often prescribed beyond its approved uses before it was withdrawn from the marketplace because of a link to an increased rate of heart attacks and death.

The study analyzed U.S. government data in a 2003 nationally representative survey, and found that about 12 percent of Americans had received at least one free sample.

About 13 percent of those with insurance were given a sample, while about 10 percent of those who were uninsured for all or part of the year got one.

Seventy-two percent of those who received a sample had income in excess of 200 percent above poverty level, while 28 percent had income below poverty level.

William Shrank, a physician at Boston’s Brigham and Women’s Hospital who studies pharmaceutical use in large populations, said the study “helps debunk the assertion” that drug samples help the needy.

Brigham and Women’s Hospital bans sales representatives, but Shrank described how early in his career he worked at academic centers where representatives freely roamed the halls. For doctors short of time and unable to keep up with medical literature, “You are getting biased data. It’s not objective,” Shrank said.

Why would samples of new drugs go to patients who then couldn’t get on the drug due to medicare restrictions? That would seem cruel.

Wooohooo! Free drugs!

Just when you think big pharma cant get any lower.

[quote]Gambles wrote:
Just when you think big pharma cant get any lower. [/quote]

I assume this is facetious, given the samples were given to doctors, who then decided the patients to whom they would distribute the samples.

Does anyone know why the pharmaceutical companies would make an argument about their samples - I wonder what regulations they are trying to avoid. If I had to guess, it would be regulations regarding the distribution of prescription drugs.

Well it just makes business sense to do that. Why distribute samples to people that can’t afford your product? You didn’t think that the Big Pharma companies were in this for some other reason than making money did you?

The real news is that this is actually news to some people… big pharmaceutical companies are the most degenerate corporations on the face of the earth. I wouldn’t sweep the floors at Merk or Eli Lilly for a million dollars a year. And I have a feeling that their fucking shit is almost up… they have pissed off a lot people, their shit is coming out into the open, and it is going to come back to bite them in the ass sooner or later. Just watch.

[quote]BostonBarrister wrote:
Gambles wrote:
Just when you think big pharma cant get any lower.

I assume this is facetious, given the samples were given to doctors, who then decided the patients to whom they would distribute the samples.[/quote]

you got a point, the docs do decide.

[quote]belligerent wrote:
The real news is that this is actually news to some people… big pharmaceutical companies are the most degenerate corporations on the face of the earth. I wouldn’t sweep the floors at Merk or Eli Lilly for a million dollars a year. And I have a feeling that their fucking shit is almost up… they have pissed off a lot people, their shit is coming out into the open, and it is going to come back to bite them in the ass sooner or later. Just watch. [/quote]

Hopefully! But even if a massive uproar from the consumers did happen The government (Big pahrma’s business partner)would have their back. I mean jus look at how the FDA attacks perfectly safe supplements but protects and even endorses some drugs.

[quote]Gambles wrote:
belligerent wrote:
The real news is that this is actually news to some people… big pharmaceutical companies are the most degenerate corporations on the face of the earth. I wouldn’t sweep the floors at Merk or Eli Lilly for a million dollars a year. And I have a feeling that their fucking shit is almost up… they have pissed off a lot people, their shit is coming out into the open, and it is going to come back to bite them in the ass sooner or later. Just watch. Hopefully! But even if a massive uproar from the consumers did happen The government (Big pahrma’s business partner)would have their back. I mean jus look at how the FDA attacks perfectly safe supplements but protects and even endorses some drugs.

[/quote]

The FDA ignores most supplements. Their record is certainly mixed in this area. I think they need to do more to make sure the supplements are what they claim to be but they also need to let people decide what to put in their body.

[quote]Zap Branigan wrote:
Gambles wrote:
belligerent wrote:
The real news is that this is actually news to some people… big pharmaceutical companies are the most degenerate corporations on the face of the earth. I wouldn’t sweep the floors at Merk or Eli Lilly for a million dollars a year. And I have a feeling that their fucking shit is almost up… they have pissed off a lot people, their shit is coming out into the open, and it is going to come back to bite them in the ass sooner or later. Just watch. Hopefully! But even if a massive uproar from the consumers did happen The government (Big pahrma’s business partner)would have their back. I mean jus look at how the FDA attacks perfectly safe supplements but protects and even endorses some drugs.

The FDA ignores most supplements. Their record is certainly mixed in this area. I think they need to do more to make sure the supplements are what they claim to be but they also need to let people decide what to put in their body.[/quote]

Some concepts need correcting.

The FDA is charged with ensuring the “efficacy” and “safety” of drugs–and the definitions change fluidly from time to time. But they do not regulate “supplements” or “natural products” thanks to Orin Hatch. Nor perhaps should they.

First, it is estimated that proving efficacy and safety costs $860 millions, on the average, to bring a single new drug to market through the FDA process. So “belligerent” would have to forego his handsome salary for 860+ years for Lilly to break even.
No supplement could afford to undergo that scrutiny, and therefore no supplement is allowed to claim health or medicinal benefit.

Second, If the FDA were to actually apply the same standards to supplements, they would disappear from the shelves; they could not withstand the standards of efficacy, nor consistency of content.

I will not need to read the article which is the subject of this thread; the study is a tautology.
Most of what occurs in doctor’s offices in the aggregate is care for the insured or the underinsured, not the uninsured. And in the average internist office one third or more of the patients have MediCare, sometimes with a supplement. I have no problems with samples for these folks; they often serve the patient when he or she is in the ridiculous “donut hole.” For example, I will dispense without charge, to some women in this situation, medication worth $300 per month, often for one to three months. (And, no, I was not brainwashed to prescribe these jewels in the first place.)

I could strain to find an ethical problem in this, but I do not feel that my prescribing habits or my ethics are compromised to the degree suggested in the article.

Do I like Big Pharma? No, but the reasons are more insidious than the posters and even Arnold Relman would suggest.

The uninsured don’t go in for check ups… therefore the docs have no way to give them samples.

Fuckin pharmaceuticals… fuckin with the poor people…

[quote]DrSkeptix wrote:

Some concepts need correcting.

The FDA is charged with ensuring the “efficacy” and “safety” of drugs–and the definitions change fluidly from time to time. But they do not regulate “supplements” or “natural products” thanks to Orin Hatch. Nor perhaps should they.

First, it is estimated that proving efficacy and safety costs $860 millions, on the average, to bring a single new drug to market through the FDA process. So “belligerent” would have to forego his handsome salary for 860+ years for Lilly to break even.
No supplement could afford to undergo that scrutiny, and therefore no supplement is allowed to claim health or medicinal benefit.

Second, If the FDA were to actually apply the same standards to supplements, they would disappear from the shelves; they could not withstand the standards of efficacy, nor consistency of content.

I will not need to read the article which is the subject of this thread; the study is a tautology.
Most of what occurs in doctor’s offices in the aggregate is care for the insured or the underinsured, not the uninsured. And in the average internist office one third or more of the patients have MediCare, sometimes with a supplement. I have no problems with samples for these folks; they often serve the patient when he or she is in the ridiculous “donut hole.” For example, I will dispense without charge, to some women in this situation, medication worth $300 per month, often for one to three months. (And, no, I was not brainwashed to prescribe these jewels in the first place.)

I could strain to find an ethical problem in this, but I do not feel that my prescribing habits or my ethics are compromised to the degree suggested in the article.

Do I like Big Pharma? No, but the reasons are more insidious than the posters and even Arnold Relman would suggest.
[/quote]

First, to everyone: I’m an attorney, but I’m not your attorney and you cannot take this as legal advice. This post is just my opinion, and if you have a particular legal question you should consult your own attorney.


Excellent post Dr. Skeptix. I would add two simple points: 1) that the FDA is a bureaucracy, and thus the motivation of the average employee is to say “no” to whatever pops up on his/her radar screen, or at least to demand proof to the level that he/she would not be held responsible for letting something into the market; and 2) that right now, the FDA is massively underfunded to meet its mandates, so it focuses its efforts on the most highly visible areas and ignores a lot of other areas - kind of scary how little policing goes on regarding internet sales and advertising.

W/r/t supplements, one needs to consider that they were specifically exempted from the drug regime provided that they, among other things, adhere to certain standards regarding their claims. See this link for a general overview: http://www.cfsan.fda.gov/~dms/supplmnt.html

The main problem with a lot of supplements is that they want to claim they work like drugs, i.e., they want to claim that you should take a supplement to treat a condition or normalize a body functionality. They can’t do that under current law - but again, enforcement is currently underfunded and lax.

ADDENDUM: This FAQ about supplements by the FDA is quite informative regarding supplements’ regulation: http://www.cfsan.fda.gov/~dms/ds-oview.html#safe