HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, May 16, 2009

Dr. Thomas Frieden: New Head of Centers for Disease Control and Prevention

The Associated Press reports on President Obama's selection for head of the Centers for Disease Control and Prevention - Dr. Thomas Frieden, currently New York's Health Commissioner.  The AP's story provides,

For seven years, Dr. Thomas Frieden has been the nagging conscience of the nation's biggest city, the man who made sure New Yorkers couldn't smoke in bars or eat french fries cooked in artery-clogging trans fats. Now, the city's health commissioner will be taking his crusade against unhealthy living national as the head of the U.S. Centers for Disease Control and Prevention.

President Barack Obama announced Friday that he has picked the 48-year-old Frieden to lead the public health agency, where he will be faced with some immediate decisions on how to deal with the swine flu outbreak, including whether to produce a vaccine. Frieden also may play a role in health care reform. The selection reunites Frieden with an agency where he worked as an infectious-disease detective at the beginning of his career. . . .

In a 2004 editorial in the American Journal of Public Health, he chided most public health agencies for being "asleep at the switch" on chronic disease. "Local health departments generally do a good job of monitoring and controlling conditions that killed people in the United States 100 years ago," while doing little about modern-day threats like diabetes, he wrote.

It is unclear how Frieden's approach will play in the rest of America. His support of needle exchange programs and condom distribution to help prevent the spread of AIDS (he distributed tens of millions of free condoms, proudly stamped with the city's NYC logo and the slogan "Get Some!") may not sit well with conservatives.  Civil libertarians have chafed at his attempts to force changes in our diets, including, most recently, a push to get restaurants to use less salt. New York magazine's Web site greeted the news of Frieden's appointment with the headline, "Health Commissioner Thomas Frieden to Take Fun-Hating National." . . . .

He will begin at the CDC in June. His appointment does not require Senate confirmation.

May 16, 2009 | Permalink | Comments (0) | TrackBack (0)

Friday, May 15, 2009

Free Drugs - Is this for real?

I am sure that most of you have heard that Pfizer has decided to offer free drugs to individuals who lose their jobs.  Here is a great take with some further information on the Maintain program from Doc Gurley writing at SFGate.com:

Okay, just the threat of healthcare reform has industry promising to stop excluding the sick, to stop discriminating against women, and to hand over 2 trillion dollars to Obama. What else can they offer us, a kidney?  Um, try a little further south. Today Pfizer offered America Viagra. Free! For a year!

If, that is, you can prove a) that you've been on it for three months, and b) you have lost your job. Clearly there's no longer any reason to feel unmanned by a lay-off. You can still hold your head high.

The PR for this move is phenomenal - tales of weeping reps, company meetings spent wondering how to help all the diabetics who can't afford their medicines. The Pfizer answer, obviously, was free Viagra. Or Lyrica. Or Lipitor. Or Celebrex, which, BTW, very few people should be taking any more...

If you're noticing a theme with that list of drugs, you're not alone. Rumor is, these particular drugs may have been picked as freebies because there are way cheaper (and equally effective) generics out there. . . .   By offering these drugs free, in addition to lots of great PR, Pfizer can build brand loyalty and keep patients from switching to generics.

As a doctor, I wanted to find out what other free drugs are available. . . .    I called the 1-866-706-2400 Pfizer information number, sat on hold, punched the "doctor" number and then got transferred to the free-drug program line. I spoke to an informed, competent actual human being (named Jennifer). The way the program will work is that you must apply, showing both that you were employed (then laid off - keep that severance letter!), that you were on one of these drugs for three months, and that you were/are not eligible for pharmacy benefits. To get the pills, a doctor would then re-write a prescription, and a 90-day supply of the drugs will be mailed directly to you on an on-going basis, free-of-charge, for one year, or until you're re-insured. Basically Pfizer will function as a direct-to-you pharmacy benefits service. I went down a list of their products and asked about a Pfizer brand drug in several categories to see if it was covered. Jennifer kindly looked them up one by one to see if they would be free.

Check it out:

  • A seizure drug, Dilantin - free
  • Injected once-a-month birth control, Depo-Provera - free
  • A diabetes pill, Glucotrol - free
  • An anti-psychotic, Geodon - free
  • A sleeping pill, Halcion - free
  • An antibiotic, Zithromax - free
  • Jennifer and I could only find one, rarely used inhaler, Spirivia - free
  • An antidepressant, Zoloft - free

Pfizer Score: A

I'm serious - and this from little ole cynical moi. The only reason Pfizer didn't get an A+ is because they don't have an actual list to share yet - with doctors or the public. I also asked a clinical question, which was: How can an antibiotic be on the list - almost no one should be taking one for three months continuously. Jennifer admitted that could be an issue, but didn't have an answer.

Bottom line:

The Pfizer free drug giveaway program, called Maintain, is better than I expected. If you've been (and stay) a loyal Pfizer customer, you could be unemployed and get many of your pills through the mail - at least that's the promise for now.. . .

May 15, 2009 | Permalink | Comments (0) | TrackBack (0)

Are Cheerios drugs?

The FDA has sent General Mills, the manufacturer of Cheerios, a warning letter.  It seems that General Mills went a little far in its advertising claims about the health benefits of eating the cereal.  The AP reports,

Federal regulators are scolding the maker of Cheerios, saying it made inappropriate claims about the popular cereal's ability to lower cholesterol and treat heart disease.

The Food and Drug Administration says in a warning letter to General Mills that language on the Cheerios box suggests the cereal is designed to prevent or treat heart disease. Regulators say that only FDA-approved drugs are allowed to make such claims.  Among other claims, the labeling states: "you can lower your cholesterol 4 percent in six weeks."

General Mills said the health claims on Cheerios have been approved for 12 years and the FDA's complaints deal with how the language appears on the box. The company said in a statement that the science was not in question.

May 15, 2009 | Permalink | Comments (0) | TrackBack (0)

Thursday, May 14, 2009

Video of Potential Supreme Court Picks

Slate.com has a brief video collection of some of the individuals who have been named as the potential Supreme Court Justice to replace Justice Souter.  It is a fun review with some interesting moments.

May 14, 2009 | Permalink | Comments (0) | TrackBack (0)

The Informed Consumer Choices in Health Care Act of 2009

Time Magazine has a brief story on the many varieties of health insurance that individuals have and how difficult it is to figure out what will and will not be covered.  Karen Tumulty writes,

The fact is, it's hard to be an informed consumer when you are buying a product as complicated as health insurance. As Georgetown University's Karen Pollitz and a team of researchers discovered recently, even policies that look alike can offer very different coverage. They studied two policies in California, for instance, and found that someone undergoing a typical course of breast cancer treatment would end up spending under $4000 with one plan and more $38,000 with the other –- even though the two policies had offered similar deductibles, co-payments, and out-of-pocket limits. They summed up the problem this way:

Knowing whether insurance provides adequate coverage can be a challenge. Health insurance policies are complex products, highly variable in their design, and key information about how coverage works is not always disclosed during marketing. Further, health insurance promises protection against future, unknown events. Consumers who are healthy today can find it difficult to anticipate future medical problems and costs and harder still to evaluate how insurance might cover those needs . . . .

It turns out there are three people on Capitol Hill who agree. Senator Jay Rockefeller (D-W.Va.) and Congresswomen Rosa DeLauro (D-Conn.) and Allyson Schwartz (D-Pa.) plan to introduce a bill today that they are calling The Informed Consumer Choices in Health Care Act of 2009. Among its provisions is a requirement that insurance policies provide an explanation of the coverage they offer, similar to the nutrition label you now see on a packaged food. Something that looks like this, explaining how the policy would work under a variety of scenarios for various diseases and conditions like heart attacks and cancer. . . . 

May 14, 2009 | Permalink | Comments (0) | TrackBack (0)

Wednesday, May 13, 2009

Professor Bard: Op-ed on the Swine Flu Preparation

Now that we have had some time to react to the swine flu, Professor Bard has some thoughts on the way in which health officials have responded and are responding to this public health threat.  She writes,

There is a Yiddish saying which translates as “man plans and God laughs” and another that describes “any problem that can be solved with money” as “not a problem.” In the case of the past few days’ media frenzy over the discovery of a new strain of influenza, H1N1, it is easy to misunderstand these messages. Clearly, the dire predictions about the deadly “swine flu” did not come true and although highly infectious, this new strain of flu doesn’t seem particularly lethal. But no one’s laughing with relief. Instead, many members of the public, media and government are reacting to this wonderful news with outrage. How dare the media and the public health establishment frighten them with unsubstantiated hype? Have we all been victims of some sort of hoax or joke? How can we spend money, especially now, to plan for something that probably won’t happen. I suggest that this is entirely the wrong message.

Until the mailing of anthrax spores to politicians and media figures in the weeks following 9/11, the threat of either bioterrorism or pandemic flu were ignored and those who tried to raise the issue dismissed as alarmists. Was the world in any greater danger of either natural pandemic or bioterrorism after 9/11 than before? Absolutely not. Did that scare make us more ready? Indeed it did. For the first time in more than 40 years, since the end of the terrifying polio epidemics, federal, state and local governments started assessing and rebuilding their almost nonexistent public health infrastructures. Today, almost every business, school and government agency has a pandemic flu plan, yet the infrastructure to address a true pandemic doesn’t exist. . . .

So what should be our take-home message? Well, the idea that we can really plan against doomsday is laughable. But the notion that we won’t spend the money to plan for a lot of very bad things that are actually relatively likely to happen but might not because of disaster fatigue isn’t funny. There are plenty of threats that we do have the ability to address with adequate resources and H1N1 is a perfect example. Within days scientists were working on a vaccine and the CDC was distributing stocks of antiviral drugs all over the country. It’s a problem we can solve with money. The threat of pandemic flu and other disease is as real today as it was in 1918 when ten times as many Americans died of influenza at home as on the battlefield in World War I. Consistent funding for planning and maintaining the public health infrastructure is what can prevent disaster. Lets not let what looks like a narrow escape turn out to be an excuse to stop spending money on public-health infrastructure. Planning isn’t anything to laugh about.

May 13, 2009 | Permalink | Comments (0) | TrackBack (0)

Same Sex Couples in the Hospital

The New York Times provides some insight into the issues facing same sex couples in the hospital.  Tara Parker-Pope writes,

During a medical emergency, a patient’s husband, wife, parents or other family members often are close by, overseeing treatment, making medical decisions and keeping vigil at the bedside.  But what happens if the hospital won’t allow you to stay with your partner or child?

That’s the challenge many same-sex couples face during health care emergencies when hospital security personnel, administrators and even doctors and nurses exclude them from a patient’s room because they aren’t “real” family members. The issue is addressed in a new report from The Human Rights Campaign Foundation, a gay, lesbian, bisexual and transgender civil rights group, and the Gay and Lesbian Medical Association. The groups have created a Healthcare Equality Index for hospitals that focuses on five key areas: patient rights, visitation, decision-making, cultural competency training and employment policies and benefits.

This year, 166 facilities across the country agreed to participate in the report, about twice as many as last year. The group says nearly 75 percent of the hospitals have policies to protect their patients from discrimination on the basis of sexual orientation. However, sometimes the policies aren’t correctly implemented by hospital workers. Some examples of unfair treatment of gay couples cited by the group include:

  • A Bakersfield, Calif., couple rushed their child to the emergency room with a 104 degree fever. The women were registered domestic partners, but the hospital only allowed the biological mother to stay with the child. Although hospitals typically allow both parents to stay with a child during treatment, in this case, the second parent was forced to stay in the waiting room.

  • An Oregon man whose registered domestic partner was unconscious was told to leave the hospital room because it was time for family members to make decisions about his care. He was forced to plead his case before hospital administrators before being allowed to stay with his partner, who was dying. . . .

While heterosexual couples typically don’t have to provide marriage licenses to hospitals in order to prove they are husband and wife, same sex couples often must document their relationship to hospital officials before being allowed to take part in a partner’s care.

“There is a real disconnect between what might be a good written policy or state law and actual implementation of that policy or law,” said Ellen Kahn, family project director for the HRC. “If you’re presenting as two men in a couple and you say, ‘This is my partner. I’ll make medical decisions,’ you’re asked a lot of questions. Who is this person to you? Do you have legal documentation that verifies that? A parent, sister or nephew could have more rights under the law than a same-sex partner who has been together 20 years.” . . .

May 13, 2009 | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 12, 2009

Patenting Genes

The New York Times reports on a recent law suit filed against Myriad Genetics for patenting a genes closely linked to breast and ovarian cancer.  John Schwartz writes,

When Genae Girard received a diagnosis of breast cancer in 2006, she knew she would be facing medical challenges and high expenses. But she did not expect to run into patent problems.  Ms. Girard took a genetic test to see if her genes also put her at increased risk for ovarian cancer, which might require the removal of her ovaries. The test came back positive, so she wanted a second opinion from another test. But there can be no second opinion. A decision by the government more than 10 years ago allowed a single company, Myriad Genetics, to own the patent on two genes that are closely associated with increased risk for breast cancer and ovarian cancer, and on the testing that measures that risk.

On Tuesday, Ms. Girard, 39, who lives in the Austin, Tex., area, filed a lawsuit against Myriad and the Patent Office, challenging the decision to grant a patent on a gene to Myriad and companies like it. She was joined by four other cancer patients, by professional organizations of pathologists with more than 100,000 members and by several individual pathologists and genetic researchers. The lawsuit, believed to be the first of its kind, was organized by the American Civil Liberties Union and filed in federal court in New York. It blends patent law, medical science, breast cancer activism and an unusual civil liberties argument in ways that could make it a landmark case. . . .

Dr. Chung and others involved with the suit do not accuse Myriad of being a poor steward of the information concerning the two genes at issue in the suit, known as BRCA1 and BRCA2, but they argue that BRCA testing would improve if market forces were allowed to work.  Harry Ostrer, director of the human genetics program at the New York University School of Medicine and a plaintiff in the case, said that many laboratories could perform the BRCA tests faster than Myriad, and for less money than the more than $3,000 the company charged. Laboratories like his, he said, could focus on the mysteries still unsolved in gene variants. But if he tried to offer such services today, he said, he would be risking a patent infringement lawsuit from Myriad. . . .

The decision to allow gene patents was controversial from the start; patents are normally not granted for products of nature or laws of nature. The companies successfully argued that they had done something that made the genes more than nature’s work: they had isolated and purified the DNA, and thus had patented something they had created — even though it corresponded to the sequence of an actual gene. . . .

In the future, genetic tests are likely to involve the analysis of many genes at once, or even of a person’s full set of genes. Some 20 percent of the human genome is already included in patent claims, amounting to thousands of individual genes, says a draft report from the National Institutes of Health. The report warns that “it may be difficult for any one developer to obtain all the needed licenses” to develop the next generations of tests. . . .

May 12, 2009 | Permalink | Comments (0) | TrackBack (0)

Medicare Future Financial Problems

Ezra Klein provides a brief overview of the annual trustees report released today and what it means for the future of the Medicare program.  He writes,

The Annual Trustees Report is out today, telling us something akin to what we already knew: Medicare and Social Security are in bad shape, and getting worse. The headlines will emphasize the dates of insolvency. Medicare runs out of money in 2017, two years earlier than anticipated by last year's report. Social Security falls in 2037, four years earlier than predicted in last year's report. But as the WaPo graph to your right shows, these estimates change year-to-year. The exact year might make the headlines, but it's the least reliable piece of the report. . . .

Conversely, the crude fix for Medicare -- and this is only the hospital insurance side of Medicare -- is more brutal. "The Medicare Report shows that the HI Trust Fund could be brought into actuarial balance over the next 75 years by changes equivalent to an immediate 134 percent increase in the payroll tax (from a rate of 2.9 percent to 6.78 percent), or an immediate 53 percent reduction in program outlays, or some combination of the two." To put it simply, imagine how much health care your grandparents can access. Now cut it by a bit more than half. They're not allowed to be in the hospitals on every odd day, or on holidays. There you go.

The relative urgency of Medicare's problem is pretty simple to explain. As the Trustees Report says, "While both programs face demographic challenges, rapidly growing health care costs also affect Medicare." In other words, Social Security is only affected by demographics. Medicare is also being buffeted by rising health care prices. If we can't get those under control, we can't fix Medicare. And if we can't fix Medicare, then it's not just the Medicare program that will be insolvent. It's the federal government.

May 12, 2009 | Permalink | Comments (0) | TrackBack (0)

Monday, May 11, 2009

Diane Rehm on Health Reform

Today's Diane Rehm -

10:00Update on Health Care Reform

Guest host: Steve Roberts

Guest host Steve Roberts leads a discussion of the latest efforts to meet time lines set by Congress and the White House to overhaul the nation's health care system, including proposals to offer a public insurance option.

Guests

Russell Mokhiber, Founder of "Single Payer Action" and owner/editor of the weekly newsletter "Corporate Crime Reporter."

Len Nichols, director of the health policy program at the New America Foundation

Julie Rovner, health policy correspondent for National Public Radio, author of "Health Care Policy and Politics A-Z," and contributing editor for National Journal's CongressDaily.

Stuart Butler, Vice President, Domestic and Economic Policy Studies, The Heritage Foundation

May 11, 2009 | Permalink | Comments (0) | TrackBack (0)

Dueling Opinion Pieces Health Reform

Paul Krugman of the New York Times has an opinion piece on health care reform today and states,

Is this the end for Harry and Louise? 

Harry and Louise were the fictional couple who appeared in advertisements run by the insurance industry in 1993, fretting about what would happen if “government bureaucrats” started making health care decisions. The ads helped kill the Clinton health care plan, and have stood, ever since, as a symbol of the ability of powerful special interests to block health care reform.  But on Saturday, excited administration officials called me to say that this time the medical-industrial complex (their term, not mine) is offering to be helpful.

Six major industry players — including America’s Health Insurance Plans (AHIP), a descendant of the lobbying group that spawned Harry and Louise — have sent a letter to President Obama sketching out a plan to control health care costs. What’s more, the letter implicitly endorses much of what administration officials have been saying about health economics.

Are there reasons to be suspicious about this gift? You bet — and I’ll get to that in a bit. But first things first: on the face of it, this is tremendously good news. . . . .  

Before we start celebrating, however, we have to ask the obvious question. Is this gift a Trojan horse? After all, several of the organizations that sent that letter have in the past been major villains when it comes to health care policy.   I’ve already mentioned AHIP. There’s also the Pharmaceutical Research and Manufacturers of America (PhRMA), the lobbying group that helped push through the Medicare Modernization Act of 2003 — a bill that both prevented Medicare from bargaining over drug prices and locked in huge overpayments to private insurers. Indeed, one of the new letter’s signatories is former Representative Billy Tauzin, who shepherded that bill through Congress then immediately left public office to become PhRMA’s lavishly paid president.

The point is that there’s every reason to be cynical about these players’ motives. Remember that what the rest of us call health care costs, they call income. . . .

I would strongly urge the Obama administration to hang tough in the bargaining ahead. In particular, AHIP will surely try to use the good will created by its stance on cost control to kill an important part of health reform: giving Americans the choice of buying into a public insurance plan as an alternative to private insurers. The administration should not give in on this point.

But let me not be too negative. The fact that the medical-industrial complex is trying to shape health care reform rather than block it is a tremendously good omen. It looks as if America may finally get what every other advanced country already has: a system that guarantees essential health care to all its citizens. . . .

The Wall Street Journal's Kimberle A. Strassel takes a very different approach and writes,

Listen. That sound of silence? That's what's known as the united Republican response to President Barack Obama's drive to socialize health care.

The president has a plan, and he's laid it on the table. The industry groups that once helped Republicans beat HillaryCare are today sitting at that table. Unions are mobilized. A liberal umbrella group, Health Care for American Now, is spending $40 million to get a "public option," a new federal entitlement that would kill off private insurance. Democrats passed a budget blueprint that will allow them to cram through that "public option" with just 51 votes.  . . . .

            Republicans? They're trying to figure out what they think.    

Well, not all of them. Earlier this week I ended up in the office of Oklahoma Sen. Tom Coburn, where the doctor was hosting North Carolina Sen. Richard Burr. The duo is, for the second time, crafting a comprehensive reform that would lower costs, cover the uninsured, and put Americans in control of their health care. And while the senators decline to talk GOP politics, their bill raises the multitrillion-dollar question: Will the party have the nerve or sense to coalesce behind some such conservative alternative to the Democratic product? . . . .

Their (Republicans) own bill overhauls the tax code, currently stacked in favor of corporate employees, to provide a tax credit to every American to purchase insurance. It expands health-savings accounts. It creates state health-insurance exchanges, where private insurers compete to cover Americans, including the uninsured. (This is partly modeled on the Medicare drug program, which has provided seniors with choice and held down costs.)

More broadly, it seeks to reorient financial incentives so that the system is no longer focused, as Mr. Coburn puts it, on "sick care," but on preventing the chronic diseases that eat 75% of health expenditures. These incentives would be used to lower costs and discourage insurers from cherry-picking patients. The bill also dives into Medicare and Medicaid reform.

Yet no small number of Senate Republicans are biding their time in Max Baucus land, waiting to see what the Democratic finance chairman produces as a "bipartisan" product. (Read: A bill the president wants.) This crowd has taken to heart Mr. Obama's accusation that they are the party of "no," and think it might be easier to be the party of Baucus, or the party of Baucus-lite, or the party of nothing whatsoever. . . . .

As for Messrs. Coburn and Burr, they spent a good half hour with me enthusiastically explaining why a competitive market would improve health, provide control and choice, lower costs, and tackle entitlements. It's a good pitch. If only the rest of America could hear the party make it.

May 11, 2009 | Permalink | Comments (0) | TrackBack (0)

Sunday, May 10, 2009

Cutting Health Care Growth

The New York Times reports on the health industry and its willingness to slow health care spending.  Robert Pear reports,

Doctors, hospitals, drug makers and insurance companies will join President Obama on Monday in announcing their commitment to a sharp reduction in the growth of national health spending, White House officials said Sunday.  The officials said the plan could save $2,500 a year for a family of four in the fifth year and a total of $2 trillion for the nation over 10 years. That could make it less expensive for Congress to enact comprehensive health insurance coverage, a daunting challenge facing the Obama administration.

At this point, administration officials said, they do not have a way to enforce the commitment, other than by publicizing the performance of health care providers to hold them accountable. By offering to hold down costs voluntarily, providers said, they hope to stave off new government price constraints that might be imposed by Congress or a National Health Board of the kind favored by many Democrats.

In remarks prepared for delivery to health care providers on Monday, Mr. Obama says: “These groups are voluntarily coming together to make an unprecedented commitment. Over the next 10 years, from 2010 to 2019, they are pledging to cut the growth rate of national health care spending by 1.5 percentage points each year — an amount that’s equal to over $2 trillion.” “Reform is not a luxury that can be postponed, but a necessity that cannot wait,” Mr. Obama says.

In a letter addressed to Mr. Obama, six leaders of the health care industry say: “We will do our part to achieve your administration’s goal of decreasing by 1.5 percentage points the annual health care spending growth rate, saving $2 trillion or more. This represents more than a 20 percent reduction in the projected rate of growth.” The letter was signed by executives of the Advanced Medical Technology Association, a lobby for medical device manufacturers; the American Hospital Association; the American Medical Association; America’s Health Insurance Plans, a trade group for insurers; the Pharmaceutical Research and Manufacturers of America; and the Service Employees International Union. . . . .

May 10, 2009 | Permalink | Comments (0) | TrackBack (0)