HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, October 10, 2009

Web Tool Offers Side-by-Side Comparison of Major Health Care Reform Proposals

A new web tool that allows for a side-by-side comparison of the leading health care reform proposals is now available from the Kaiser Family Foundation:  

This interactive side-by-side compares the leading comprehensive reform proposals across a number of key characteristics and plan components. Included in this side-by-side are proposals for moving toward universal coverage that have been put forward by the President and Members of Congress. In an effort to capture the most important proposals, we have included those that have been formally introduced as legislation as well as those that have been offered as draft proposals or as policy options. It will be regularly updated to reflect changes in the proposals and to incorporate major new proposals as they are announced. This side-by-side offers a summary of the major components of these proposals; detailed descriptions of provisions relating to the Medicare and Medicaid programs can be found online.


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

Thursday, October 8, 2009

A Challenge to the FDA’s Entire Regulatory Scheme for Health Care Products: Botox Manufacturer Files Lawsuit Asserting First Amendment Protection for Off Label Drug Claims

In a move that could undermine the entire FDA premarket approval process for all health care products, the maker of Botox has filed a legal action against the government claiming first amendment protection for the distribution of “truthful, relevant information” to doctors regarding off-label uses of its drugs.


As Natasha Singer of the New York Times reports:


The Food and Drug Administration approves medicines for specific therapeutic indications. Once a drug is approved for a specific use, doctors are then free to use their medical judgment to prescribe the drugs for other unapproved, or off-label, uses. Manufacturers, however, are prohibited from promoting off-label uses to medical providers or advertising such uses directly to the public.


Botox, an injectable drug that can temporarily reduce muscle or gland activity, is approved in the United States to treat crossed eyes, eyelid spasms, excessive sweating, severe neck contortions and wrinkles. But many doctors use the drug for unapproved indications like facial spasms, vocal cord problems and migraine headaches.


‘If you could get a drug approved for one narrow use and then market it for everything else, there would be no incentive or motivation for a company to prepare data to ensure that it meets the standard for safety and efficacy,’ said Marc J. Scheineson, a lawyer specializing in food and drug regulation at Alston & Bird in Washington.


It appears that the Botox suit is claiming free speech protections that are similar to those provided for dietary supplements. See Pearson and Shaw v. Shalala, 1999 U.S. App. LEXIS 464 (Jan. 15, 1999).  However, dietary supplements are targeted to healthy portions of the population to help maintain or enhance health. Drugs are marketed to unhealthy, vulnerable portions of the population claim to aid in an individual’s struggle to return to normal health. This difference should be outcome determinative in the Botox case. 

In an attempt to place this issue in historical context, the following provides a very brief summary of the long history of the relationship between the Food Drug and Cosmetic Act, the FDA and predatory commercial interests which suggests that there are lessons from the past that can assist in the analysis of this current regulatory issue.  


Over the 100 year history of the FDA, Congress has been steadfast in balancing the protection of individual choice in matters involving self-regarding behavior, such as food choices, with the need to protect vulnerable consumers from harm from third parties who are marketing health care products.  It has done so by linking the level of product regulation with the health status of the product’s targeted population. Accordingly, the greatest amount of regulatory protection has been applied when products are targeted at vulnerable, unhealthy populations and claim to aid in an individual’s struggle to return to normal health.  Examples of products that fall into this category include drugs and devices.


For these products, the modern FDCA establishes a premarket enforcement process that places the majority of the cost and burden on the product manufacturer to establish safety and efficacy through the clinical trial process prior to distribution to the public.  Without premarket approval from the FDA, these products will be deemed both adulterated and misbranded as a matter of law.  Conversely, the FDCA requires less regulatory protection when products are targeted to healthy populations for use in maintaining or improving a normal state of health.  Examples of products that fall into this category are foods and narrow categories of functional foods and dietary supplements.  For these products, the FDA  carries the burden of removing an unsafe or ineffective product by proving that it is adulterated or misbranded.


A review of the history of quack medicines supports this public health strategy. The late nineteenth and early twentieth centuries saw a remarkable growth in the marketing of sham products to treat and cure disease. At that time, the rate at which quack medicines were being introduced into the market far outpaced the development of the science necessary to establish the efficacy and identify the risks associated with each new product. This scientific lag time created a period when there was an information void that predatory commercial interests were quick to use to their advantage.  As the FDA carried the burden of proof to show that a product did not work or was unsafe in order to remove the product from the market, during this lag time predatory commercial interests were able to profit from scientific uncertainty to the detriment of public health. 


During this long period in U.S. history, the curative claims of predatory sham medicine salesmen were limited only by the gullibility of their targets.  In many cases, the degree of gullibility was proportional to the level of desperation of the individual for a cure. The more dire the condition, the more vulnerable an individual was to the ‘flim flam’ of the greedy snake oil salesman.  And the more dire the condition, the greater the degree of harm when the sham medicine did not work, causing injury over and above the original illness and/or causing a delay in seeking effective medical treatment. Thus, this lag time between initial marketing of a sham product and the development of the science necessary to resolve uncertainties over the new product’s safety and effectiveness was very costly in terms of human suffering and loss of life.

It took a series of highly publicized public health crises [including the thalidomide crisis described below] to create the political will needed to pass legislation to close this ‘space between’ created by scientific uncertainty.  This was accomplished by switching the burden of proof of safety and effectiveness from the FDA and onto drug manufacturers.  As more fully discussed in the following sections, it was not until 1962 that legislation was passed that required manufacturers to obtain premarket approval for new drugs from the FDA by producing “substantial evidence” that the product is both safe and effective for its intended use.  The Drug Amendments of 1962 allowed the FDA to make the transition from its former inefficient and costly police role of enforcing specific statutory prohibitions by removing adulterated and misbranded products from the market, to its current gatekeeper role of preventing those products from entering the market in the first place.  Thus, from 1962 until 1994 [with the passage of DSHEA dealing with dietary supplements], manufacturers were no longer able to ‘play in the grey’ and take commercial advantage of the scientific uncertainty over the safety and effectiveness of a product to the detriment of public health.


See Van Tassel, K.,Slaying the Hydra: The History of Quack Medicine, The Obesity Epidemic and the FDA's Battle to Regulate Dietary Supplements, 6 Indiana Health L. J. 203-251 (2009).

What the manufacturer of Botox wants to achieve is the ability for drug manufacturers to once again promote drugs while there is scientific uncertainty over their safety and effectiveness. They are taking the first step toward this goal by claiming this free speech in the context of communication to physicians. While the debate starts over this question, it will be prudent to recall the lessons taught by the Thalidomide case which occurred prior to the 1962 Drug Amendments and involved the distribution of drug to thousands of patients by doctors while there was still scientific uncertainty over its safety:


Thalidomide was widely distributed in Germany, Japan and the United Kingdom for sedative purposes and for the treatment of nausea in pregnancy for several years. In 1960, William S. Merrell Company, the manufacturer of the American version of Thalidomide, Kevadon, applied for FDA approval. However, it was clear to Dr. Frances Kelsey, one of the FDA officers examining the application, that the drug had not been adequately tested for safety before distribution.  In spite of pressure to approve the drug placed by the manufacturer on both the FDA and Dr. Kelsey individually, Dr. Kelsey insisted that the drug needed additional testing to prove safety before FDA approval could be granted.  In 1961, Dr. Kelsey learned of a possible connection between nerve damage in adults and Thalidomide. [These babies were born with phocomelia, which is a Greek word that combines the words ‘seal’ and ‘limb’ … where the long bones of the infants’ arms had almost completely failed to grow; their arms were so short that their hands extended almost directly from their shoulders. Their legs were less affected but showed signs of a similar distortion of growth . . . .”]. She requested that Merrell provide studies on the use of its Thalidomide product on pregnant women.  In 1962, it was discovered that Thalidomide was causing serious birth defects in children. While the application for Thalidomide was pending for FDA approval, hundreds of severely deformed babies were being born in Germany. [Worldwide, it is estimated that 8,000 severely deformed babies were born because of thalidomide].Without the FDA’s knowledge, Thalidomide had already been provided to 20,000 patients in the United States as part of an “investigational study.”


October 8, 2009 | Permalink | Comments (0) | TrackBack (0)

Is Now the Right Time: Should the United States Consider Adding Adjuvants to the H1N1 Vaccine?

Is now the time to use an emergency exception to the FDA approval process for the addition of adjuvants to the H1N1 vaccine? Some argue that this measure should be taken in the U.S. order to protect people in other countries from the flu pandemic.

What exactly are adjuvants and why are they added to vaccines? The New York Times reports that

[t]he term adjuvant, from a Latin word meaning “to help,” was coined in the 1920s by Gaston Ramon, a veterinarian at the Pasteur Institute in France, who observed that horses given diphtheria toxin had a stronger immune response if they had some inflammation at the injection site. Among his first adjuvants were bread crumbs and tapioca.... Within a few years, scientists discovered that aluminum salts could prompt an immune response. Alum, as this adjuvant is often called, is now used in various vaccines, including those for tetanus and hepatitis B. It is a relatively weak adjuvant. But about 80 years after its discovery, it is still the only one used in vaccines the United States.

What are the benefits of adjuvants?

That is the crux of a debate over adjuvants — a class of substances that somewhat mysteriously increase the potency of vaccines. Early studies suggest that adjuvants (pronounced AD-joo-vants) could allow four times as many people to be immunized against the H1N1 pandemic influenza with a given amount of vaccine. So with the world facing possibly severe shortages of vaccine, the World Health Organization and some health experts have been calling for the use of adjuvants to stretch the vaccine supply.

However, the United States appears to be hesitant to add adjuvants to its H1N1 vaccine. Some officials fear that the addition of adjuvants, with unknown risks, will add to the controversy over vaccinations generally and discourage people from getting vaccinated.

What are the potential risks officials are referring to? Reporter Andrew Pollack of the NYT explains that 

[w]hile adjuvants tend to increase the temporary pain, swelling or fatigue caused by a vaccine, the main concern is whether they might cause an autoimmune disease, like rheumatoid arthritis, in which the immune system attacks the body’s own tissues. Some animal studies have suggested that possibility.

Because very little is known about our body’s immune system response to foreign substances such as adjuvants, and because the adjuvanted H1N1 vaccine has not gone through the FDA approval process, the safety of an adjuvanted vaccine is unknown. Moreover, even after the FDA approval process, there will still be a level of uncertainty over the safety of an adjuvanted vaccine for some time. This is because studies have shown that fifty percent of the side effects produced by any drug are not apparent until after FDA approval and the drug has been distributed to the population.

Because the adjuvanted H1N1 vaccine has not gone through the standard FDA approval process, its use would fall under a so-called emergency use authorization. The question becomes whether this is the time for the FDA to use its emergency approval powers?

Coupled with the unknown risks that adjuvants may harbor is the public fear that this uncertainty brings. An unintended consequence may be that the lack of empirical studies will be used by the anti-vaccine movement to bolster their cause.

The benefits and risks of adding adjuvants to the H1N1 vaccine will have to be assessed more closely in the coming weeks. The unanswered question is whether this is the time to use an emergency exception to FDA approval for adjuvants in order to protect people in other countries from the flu pandemic.

Marissa Anne Del Mauro

October 8, 2009 | Permalink | Comments (0) | TrackBack (0)

Health Care Bill Gets 'Cost Analysis Green Light' by Congressional Budget Office

The non-partisan Congressional Budget Office released its much-anticipated report on the Senate Finance Committee legislation to revise the Health Care System reports the New York Times, The Washington Post, Los Angeles Times, BBC and The Wall Street Journal. The cost analysis demonstrated that the bill will reduce deficits by a total of $81 billion over the next 10 years while providing health insurance to 29 million uninsured Americans.

According to the NYT:

The report clears the way for the Finance Committee chairman, Senator Max Baucus, Democrat of Montana, to push for a panel vote within the next few days, and sets the stage for Democrats to take legislation to the floor for debate by the full Senate this month.

As reported by Robert Pear and David Herszenhorn of the NYT, the Budget Office Report points to the following as the main costs and coverage additions:  

▪ 29 million uninsured will be covered.

▪ 25 million, one-third illegal immigrants, remain uncovered.

▪ Portion of non-elderly with insurance will increase over 10 years to 94% from 83% today.

 ▪ A proposed expansion of Medicaid to include an additional 14 million people will add $345 billion to federal Medicaid spending and $33 billion in State Medicaid spending over the next 10 years.

▪ Subsidies to help low and middle income people buy insurance will add $201 billion in federal costs over 10 years.

And here are the main savings and revenue provisions: 

▪ A proposed tax on high-cost insurance policies would raise $201 billion over 10 years.

▪ Penalties of $750 per year would be paid by people who go without insurance would total $4 billion over 10 years (less than the $20 billion expected under the original proposal).

▪ Employers who did not provide health benefits would pay $23 billion in penalties (down from $27 billion).

▪ A Medicare commission would be created, with power to make cutbacks in the program, unless blocked by subsequent legislative action which would save $22 billion over 10 years.

▪ The bill would establish insurance cooperatives, to compete with private insurers. But the budget office said the co-ops would not establish “a significant market presence in many areas.”

▪ The budget office found that the Finance Committee would reduce payments to private Medicare Advantage plans by $117 billion over 10 years while cutting the growth of Medicare payments to other health providers by $162 billion.


October 8, 2009 | Permalink | Comments (0) | TrackBack (0)

Sunday, October 4, 2009

Job Growth Continues in Health-Care

The Wall Street Journal Health Blog reports here and here that job growth is continuing in health care:  

As usual, the month-to-month gain wasn’t huge — about 19,000 new health-care jobs were added during September, bringing the total to 13.67 million, according to the seasonally adjusted estimate out Friday from the Bureau of Labor Statistics.

But over the past year, with consistent gains, the sector has added about 300,000 jobs. During the same period, the total number of nonfarm jobs nationwide fell by about 6 million, to 131 million.

Every subcategory within health care showed job growth in September. The biggies: Doctors’ offices added 5,300 jobs, hospitals added 4,600 slots, home health-care services added 3,400 jobs and nursing-care facilities added 2,100 jobs.


October 4, 2009 | Permalink | Comments (0) | TrackBack (0)