HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Tuesday, May 1, 2007

Free Drug Samples: Not so Healthy

Well, those who say the best things in life are free . . .they could be wrong when it comes to free drug samples.  The New York Times reports today,

Patients like going home with free samples because it saves them a trip to the drugstore and a co-pay, and doctors are happy to oblige, because samples help patients get started on treatment right away.

But now some leading academic medical centers are restricting the use of samples, and a smattering of physician practices are shutting down the sample cabinet. These critics say doctors should be choosing the most appropriate medication for a patient based on the best scientific evidence available — not just grabbing something from the office stash that happens to fit the bill.

“The doctor will say, ‘Here, start on this, and let’s see how it works,’ ” said David J. Rothman, president of the Institute on Medicine as a Profession, a research group at Columbia. “The question to the doctor is: If you didn’t have it in your drawer, would that have been your drug of choice?”

The crackdown on free samples comes amid growing concern about the close ties between physicians and drug companies. Critics like Dr. Rothman say physicians don’t realize the extent to which their medical judgment is influenced by their acceptance of the samples. They point to studies like a 2002 paper in the journal Annals of Family Medicine finding that the number of doctors who treated high blood pressure with the “first line” drugs recommended by national guidelines was low, but increased sharply when free samples were removed. . . . .

But there’s an upside to the samples. Using samples, a doctor can see if a patient can tolerate a new medication before the patient goes out and buys a 30-day supply. Physicians who treat poor people like to have samples on hand for them, and for uninsured patients.

Samples also provide patients with the convenience of one-stop shopping, said Dr. Hema A. Sundaram, a dermatologist in suburban Washington. “Usually a patient has waited some time to see a doctor and rearranged their whole working schedule, and then it may be another four or five days before they can fill a prescription,” she said. “They’re often busy, working people, with family responsibilities. I feel there shouldn’t be any further delay.” (Dr. Sundaram acknowledges that she is paid for speaking on behalf of drug companies.)

And many physicians say they like using samples because the sales representatives are an important source of medical education, helping to keep the doctors up to date on the latest therapies.

As for the bottom line, it’s not at all clear that samples save patients money. Critics say they may actually drive up the cost of health care in the long run, because the drugs being promoted are the most expensive brand-name medications. Since many conditions require lifelong treatment, the patient would have to buy the medicine sooner or later.

“You’re going to be paying more, because you’re taking the new, advanced drug,” Dr. Rothman said. “And you may have done just fine on the old-fashioned generic.”

May 1, 2007 | Permalink | Comments (0) | TrackBack (0)

More From the FDA

The blog, Lilbrit, has some more news about the FDA's recent handling of the melaimine that somehow got into lots of food in the United States.  She refers us to a new FDA Alert found on the FDA website, and explains how broad it truly is:

IA #99-29, 4/27/07,  IMPORT ALERT #99-29, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ALL VEGETABLE PROTEIN PRODUCTS FROM CHINA FOR ANIMAL OR HUMAN FOOD USE DUE TO THE PRESENCE OF MELAMINE AND/OR MELAMINE ANALOGS"

TYPE OF ALERT: Detention Without Physical Examination (Countrywide)

[...]

PRODUCTS: Wheat Gluten
   Rice Gluten
   Rice Protein
   Rice Protein Concentrate
   Corn Gluten
   Corn Gluten Meal
   Corn By-Products
   Soy Protein
   Soy Gluten
   Proteins (includes amino acids and protein hydrosylates)
   Mung Bean Protein

PROBLEM: Poisonous or Deleterious Substance Unfit For Food
   Unsafe Food Additive

PAF:          PES

COUNTRY:      China (CN)

MANUFACTURER/SHIPPER:     All

CHARGES:   "The article is subject to refusal of admission pursuant to
     section 801(a)(3) in that it appears to bear or contain a
     poisonous or deleterious substance, which may render it
     injurious to health [Adulteration, section 402(a)(1)]"

Lilbrit:  Look at that list now--it includes just about every form of grain protein there is. Soy, rice and mung bean proteins that go into cookies and pizza dough and baby food, as well as countless "healthy" smoothies served at juice bars across the country. Would you like a sprinkle of melamine  splash of cyanuric acid shot of protein powder in your mango shake for just a dollar more?

This summer I had decided to grow some herbs in pots in backyard - perhaps it is time to consider an expansion of that idea.

May 1, 2007 | Permalink | Comments (0) | TrackBack (0)

Monday, April 30, 2007

Sick Reviewed

Kevin Drum highlights a review by Phil Longman of Sick, Jon Cohn's new book about America's rather inefficient and expensive healthcare system.  Longman disagrees with Cohn's conclusion that the main problem with our health care system is money.  Longman believes that "Money can't really be our core problem, he says, since the evidence indicates that the more you spend, the worse your treatment is likely to be:"

According to a recent RAND study published in the New England Journal of Medicine, uninsured patients receive only 53.7 percent of the care experts believe they should get — that is, appropriate, evidence-based treatment. But according to the same study, patients with private, fee-for-service insurance are even less likely to receive the proper care. Indeed, among Americans receiving acute care, those who lack insurance stand a slightly better chance of receiving proper treatment than patients covered by Medicaid, Medicare, or any form of private insurance.

....[Dr. Elliot Fisher] found that in America's highest-spending hospitals, only 74.8 percent of heart attack victims receive aspirin upon discharge from the hospital, as opposed to 83.5 percent in lower-budget competitors. This may be one reason why survival rates for heart attack victims are actually higher in low-spending hospitals than in high-spending hospitals.

What's more, these spendthrift hospitals often skip other routine preventative care such as flu vaccines, Pap smears, and mammograms. This general lack of attention to prevention and follow-up care in high-spending hospitals helps to explain why not only heart attack victims but also patients suffering from colon cancer and hip fractures stand a better chance of living longer if they stay away from "elite" hospitals and choose a lower-cost provider instead. Given this reality, it is perhaps not surprising that patient satisfaction also declines as a hospital's spending per patient rises.

Longman has his own book to sell, entitled, "Best Care Anywhere:  Why VA Care is Better than Yours?"
Perhaps the answer to all of our health care problems is contained in one of these books.  For the New York Times Book Review of "Sick"  click here.

April 30, 2007 | Permalink | Comments (0) | TrackBack (0)

Sunday, April 29, 2007

FDA: Not Exactly Keeping the US Food Supply Safe

Well, the FDA has apparently taken action against those pet food distributors - but not before some pigs and chickens were fed the tainted food.  oops!  I find it rather discouraging and frightening that the FDA has become either overly trusting of companies to clean themselves or so overworked that they cannot keep upwith all the issues facing food and drugs in the US.  As someone with neither the talent or the time to grow all my own food, I tend to agree with Christy Hardin Smith from Firedoglake who writes:

As the mother of a healthy, growing preschooler — who also happens to be a bit of a picky eater, but loves peanut butter toast — this is not only infuriating, it is downright terrifying:

The Food and Drug Administration has known for years about contamination problems at a Georgia peanut butter plant and on California spinach farms that led to disease outbreaks that killed three people, sickened hundreds, and forced one of the biggest product recalls in U.S. history, documents and interviews show.

Overwhelmed by huge growth in the number of food processors and imports, however, the agency took only limited steps to address the problems and relied on producers to police themselves, according to agency documents….  (emphasis mine)

They knew — KNEW!for years that there was a problem but relied on the companies to "police themselves"??!!?? Are they completely daft? (Don't answer that.)

As a mother, the thought that the FDA knew that my child, and every other peanut butter eating child in America, could potentially contract salmonella poisoning from a plant with a history of contamination issues but just kept right on allowing that company to manufacture the peanut butter without ensuring the safety of the product?  Even after the contamination was discovered? That is beyond incompetent and negligent.  Especially when you consider just how deadly salmonella can be to a small child.  And if you consider how many kids with compromised immune systems could be added into the mix with a food substance that kids eat by the jar on a weekly basis?  Or how many poor kids whose families can afford peanut butter as a staple for these kids, and who depend on this as a means of feeding the family several days a week for lunch and/or dinner?  Uh.  Mah.  Gawd.

As a former prosecutor, the words that I'm looking for are alleged criminal negligence and/or manslaughter. This is beyond infuriating and, as a parent, I am now asking myself "what else?" Beyond tainted peanut butter and spinach, what else is getting into our food supply that the FDA knows is a problem but isn't bothering to tell the public about it?  And, here's a question, if the FDA knew that there was a problem — then did these manufacturing and processing facilities also know and just keep right on churning this tainted food into the grocery stores anyway?

Here's a clue: you know of a problem in the food supply that could kill my child, the answer is not to keep your mouth shut and hope that the problem magically disappears on its own because the corporation might just be run by some good citizen who will shut down production, not worry about immediate bottom line profits and do the right thing. Nuh uh. You shut down production immediately, you fix the problem and you do not endanger my child. Is that clear enough for you?

As for some good news, the FDA's idea to permit chocolate manufactures to sell chocolate that doesn't contain cocoa butter has caused such an uproar that the FDA has extended the comment period.

April 29, 2007 | Permalink | Comments (0) | TrackBack (0)

Ezra Klein claims to have discovered worst OP-ED ever!

I have to agree that Douglas Shoen's op-ed, "A Health Care Agenda for America," is not very good but I will let you be the judge,  Here is Ezra Klein's take:

There's this wonderful moment in the Simpsons, where Burns goes into the doctor for a check-up, and the doctor explains that the only reason he's alive is that there are so many diseases trying to kill him that none can get through. They're all crowded at the door, struggling to enter. That's sort of describes my reaction to Doug Schoen's health care op-ed. I feel virtually incapable of engaging with it, paralyzed by the infinite expanse of logical holes, self-serving omissions, and political hackery riddling the article. But I shall soldier on.

"According to a Kaiser Family Foundation poll in March," Schoen writes, "after Iraq, healthcare is the single most important issue among American voters today." I've read that poll.  And I've read Doug Schoen's op-ed.  And the two have nothing to do with each other. 

Schoen's op-ed mentions the word "partisan" four times. It tells us that "[Americans] want to see healthcare needs and issues addressed in a spirit of partnership, not partisanship," that [w]hat is clear is that America wants everyone to work together in a constructive manner," that "[h]ealthcare should not become a partisan issue," that Medicare Part D "marked a huge bipartisan step forward" and that "working together, the members of the two parties were able to bring together the best ideas from both sides of the aisle to create a broad-based program that succeeds in achieving many critical goals."

Want to know the final vote tally on Medicare Part D was in the House of Representatives? 216-215. Want to know how long Tom DeLay extended the vote to dragoon and intimidate more members? Three hours. Want to know the Senate margin? 55-44. There was nothing bipartisan about it. It's widely acknowledged to possess huge failings owing entirely to drug company giveaways. George W. Bush is currently threatening to veto an overwhelmingly popular bill that would empower Medicare to bargain down drug prices -- a bill that Democrats made into a core part of their 2006 platform. Schoen mentions none of this.  He paints one of the most grotesquely partisan votes in history, a vote that literally led to ethics investigations against DeLay, as a bipartisan triumph. He ignores the overwhelmingly popular reform that Democrats have long been touting. He spins, he misrepresents, and he lies in order to strengthen the Republican bargaining position. . . .

April 29, 2007 | Permalink | Comments (0) | TrackBack (0)