A major story of 2011 that has gone largely unnoticed is the prescription drug shortage currently playing out in the United States. While it’s not making mainstream headlines, there’s a crushing shortage of pharmaceuticals in the hospitals across the US that threatens the health of and well-being of many high-risk patients. The drug shortage is affecting hospitals as well, forcing them to raise fees, absorb higher costs, and even ration vital drugs to the most at-risk patients for certain conditions. Ovarian cancer patients, as well as those suffering from diabetes and high blood pressure, are increasingly being left without important treatments due to the shortage.

Vital Drugs In Short Supply

photo credit: Big C Harvey

While Aspirin and other generic drugs aren’t in any danger of a supply crunch in the near future, more obscure but nonetheless important medications are running out faster than many hospitals can restock them. One specific chemotherapy drug known as Doxil is experiencing an acute shortage, though it’s hardly the only one. A recent survey by the American Hospital Association showed that nearly half of all hospitals in the country are experiencing shortages of at least 20 obscure but important drugs. Furthermore, the FDA reports that the number of drugs that are officially experiencing a supply crunch have gone from 61 in 2005 to 168 in 2011.

Heart of the Problem

One of the biggest reasons for the shortage is a trend of consolidation within the pharmaceutical industry. While Doxil is sold under the brand name Caelyx by Johnson & Johnson Inc., it’s actually manufactured in just one facility located in Ohio. The fact that there’s often only one or two sources of a specific drug makes for a particularly vulnerable point of failure in the supply chain. Another reason for the shortages in many of the other drugs cited by the AHA survey is that some have lost their patent protection, meaning that generic drug makers can now cheaply manufacture them. That cuts down on the original patent holder’s profit margin, and many have opted to simply stop making them.

The Impacts Being Felt

photo credit: Nils Geylen

If a particular drug goes out of production, there’s almost always an alternative in the form of another medication. However, the alternative drugs often don’t work as well as the original treatments. Doctors are forced by necessity to prescribe less effective pharmaceuticals which usually have worse side effects. Many patients are now on waiting lists for such drugs, which is a reality they’ll have to get used to until the production of drugs that are in short supply is increased to meet the demand.

Solutions Going Forward

The drug shortage in the United States has been severe enough to prompt President Barack Obama to issue an executive order empowering the FDA to import drugs as needed from foreign suppliers. As for drugs that are in short supply but can now be manufactured generically due to lapses in patent protection, it should be a matter of time before they’re available in plentiful quantities again. This  drug shortage episode highlights the problems that still exist within the healthcare industry in the US. Hopefully, it will serve as a cautionary tale so it doesn’t happen needlessly in the future.

If you are expecting a new baby, it is critical that you ensure neonatal intensive care will be covered should the need arise, or else you may find yourself struggling to pay out-of-pocket costs.

As an expectant parent, you have no doubt taken the time to make sure that the hospital where you intend to have your little one and your obstetrician are in your network of health insurance. This is because you know that using a provider that is out of your healthcare network could lead to high out-of-pocket costs. Your health insurance plan may pay 60% of the charges, as opposed to the usual 80% or more.

On the contrary, like many other expectant parents, you may not realize that an ugly surprise may be coming your way should your baby be born prematurely or require special care for any other reason. The unfortunate fact is that the NICU personnel, even those at an in-network hospital, may not be in your health insurance network.

According to the Director of Media Relations for the American Hospital Association Marie Watteau, “Some hospitals do contract with other clinical provider groups to run their NICUs.” The companies that provide NICU services often do not accept the same insurers as the hospital. Ms. Watteau says, “When selecting a hospital, pregnant women should … verify that all hospital care, including NICU care and physician services are in network.”

photo credit: proisraeli

One couple a few years ago, Sonji and Nathan Wilkes of Englewood, Colorado, were sure they had taken care of all things insurance related before their son, Thomas, was born. The hospital where Thomas was born and the obstetrician that they chose were both in their health insurance network. After speaking with their coverage provider, they expected their out-of-pocket expenses to be around $400.

However, when Thomas was born, he was diagnosed with hemophilia and he received treatment in the NICU. Within just a few weeks, Sonji and Nathan received a bill for the special care for $50,000. Nathan Wilkes said, “We just thought it was part of the hospital. We had no idea that it was even an option that the NICU could be in a different network.”

Recently, a key democrat testified against a major provision of the health care reform law, which is supposed to help with the control of Medicare expenses by encouraging the rationing of care.

The #2 Democrat on the House Budget Committee, Representative Allyson Schwartz of Pennsylvania, is an esteemed voice on issues related to health care policy. The Energy and Commerce Committee Republicans invited Ms. Schwartz to speak at a recent hearing on the reform law’s cost-control panel. She said that the president’s indicated desire to enhance the Independent Payment Advisory Board to pare down Medicare expenses “was one of the reasons” that she spoke out.

Schwartz said, “There are Democrats who also have concerns about the IPAB,” she continued, “and that’s been true from the beginning. I would say on behalf of myself and Democrats who care about this as well, it would be better to repeal this part of the law.”

In April of 2011, President Obama proposed an increase in the authority of the Independent Payment Advisory Board as an alternative to the Medicare overhaul proposed by House Republicans. He laid out his proposal, saying that in as little as twelve years, the deficit would be reduced by as much as four trillion dollars. This would be done primarily by reducing the threshold as the Independent Payment Advisory Board goes into effect under the law and issues recommendations on which Congress must act if the cost of Medicare goes up beyond a specific target.

A former health care executive and current vice president of the New Democrat Coalition, Representative Schwartz is one of eight democrats that have signed on in repeal of the provisions. She said that she has talked with her fellow democrats in Congress as well as the White House regarding her intention, making it clear that she is staying strong as an advocate of the health care reform law.

When the Senate Minority Leader Mitch McConnell filed the brief supporting the court case claiming that healthcare reform is unconstitutional, it was hailed as united opposition by the GOP to Obama’s new healthcare law. However, there were a few names missing from the brief.

McConnell recently filed the brief in Florida federal court. The brief argues that the individual mandate section of the Patient Protection and Affordable Care Act, or PPACA, is not constitutional. Those who oppose the individual mandate believe that it gives too much power to Congress, allowing them to regulate the activities of the American people.

Happy To Sign

Thirty-one of McConnell’s GOP colleagues agree with filing the brief and were happy to sign their names. However, the remaining GOP members did not feel the same way.

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“Where, as in this case with respect to the PPACA’s Individual Mandate, Congress legislates without authority, it damages its institutional legitimacy and precipitates divisive federalism conflicts like the instant litigation,” claims those who signed the brief. “The long term harms that the PPACA may do to our governmental institutions and constitutional architecture are at least as important as are the specific consequences of the PPACA.”

The explanations range from obvious to speculative for the GOP members who decided not to sign the brief. Among the abstainers are three members who will not be around next year.

Senator George Voinovich of Ohio is up for retirement and is no willing to become excessively political in his last days. The same may be true for Senator Judd Gregg of New Hampshire, although his office remained mute when asked why he did not sign the brief.

The Senator’s spokesperson, Otto Heck said, “We are not going to be able to talk about that.” When he was asked why not, he simply said, “We just aren’t going to talk about that.“

In the second quarter of 2011, lobbying expenses decreased for many health insurance companies, such as Aetna, Inc. and Humana Inc. This is especially the case for Humana, which spent just $180,000 for lobbying. This is only sixty-five percent of the amount that was spent on lobbying in the first quarter of the year, and only two-thirds that of the previous year.

The majority of the costs were concentrated on last year’s health care reform bill, the Small Business Health Relief Act of 2011, the FIT Kids Act as well as the Medicare Data Access for Transparency and Accountability Act.

Also, Human lobbied in opposition to the annual fees enforced by the health care reform bill on health insurance companies in addition to a number of other restrictions and charges.

The bill for health care overhaul was passed in order to protect individuals in this country that do not have insurance. The goal of the bill is to provide coverage for more than a million uninsured Americans. Although the bill is predicted to produce new business for the health care insurance companies, it places a large number of fees and limitations on them as well. Therefore, many insurance companies are in disapproval of the recently passed health care reform bill.

In the meantime, Humana’s rival insurance company Aetna spent more than $900,000 in lobbying costs in the second quarter of this year, which highlights a decline of more than forty percent from the previous year and a 17% decline from the year’s first quarter.

Aetna lobbied in opposition of the health care reform bill, which is causing a great deal of concern for all of the insurance companies. Instead, Aetna lobbied for a legislation to withdraw the directive from the bill that requires all Americans to obtain insurance coverage.

Audax Health™ and ValueOptions® recently announced a joint venture for an interactive health management program for the beneficiaries of Medicaid aimed at improving health outcomes through game mechanics and social networking that engages and assesses the needs of members.

Part of the program will involve ValueOptions using the Audax Careverge® platform as a way to engage the Medicaid members in the management of their own wellbeing by identifying and addressing possible health issues. The platform makes it possible for ValueOptions to employ members to evaluate their health and develop plans for personal health management. In addition, it also allows the organization to send messages to their members reminding them of appointments or to take medication.

Online Communities

In online communities, members of the Medicaid program are able to interact with industry experts and share their experiences with other members who may be faced with the same challenges.

photo credit: joe.ross

Audax Careverge® is a groundbreaking platform for health management. Using the power of game mechanics and social networking, it tracks health information, identifies potential health concerns and produces personalized information in real time, which makes it possible for consumers to make the most informed decisions.

The founder and CEO of Audax Health Grant Verstandig says that getting people healthy and encouraging healthy lifestyles is incredibly important to health care reform in the United States.

Why Are Consumers Engaging In Social Interaction?

Verstandig said, “The challenge is in engaging consumers to be part of a process that is largely impersonal and unrewarding. Social media and gaming sites have exploded because people are rewarded when they engage in often very personal ways online. When you make personal health management tangible, quantifiable, interactive and rewarding, like ValueOptions will be doing, you engage consumers to improve their own health and wellness.”

ValueOptions’ Chief Information and Technology Officer, Bob Esposito said, “ValueOptions will use the Careverge Web solution to provide a sense of community for our Medicaid members, giving them a platform where they may reach out to other members, share their experiences and even research health-related information privately.”

Four-and-a-half decades ago, Congress passed revolutionary legislation to create the Medicaid and Medicare programs, which ensured millions of Americans would be able to get the health care that they need.

While the politics surrounding the development of such programs was unequivocally liberal, the aid of a Republican, John Byrnes, was crucial in the drafting of this health care safety net for people in need. Through all of the recessions and wars, surpluses and deficits, in addition to administrations that were both democratic as well as republican the Medicare and Medicaid programs have been there as a stronghold for individuals of the middle class.

Families Suffer the Consequences

These days, families in this country are still suffering the consequences of a merciless economic crisis. This dire economic situation has the Medicaid and Medicare programs under fierce attack. Millions of Americans are without jobs, facing foreclosures on their homes and struggling just to satisfy the basic needs of their families. For the past thirty years, wages have continued to decline or grow stagnant, which is eroding away the promise of quality life for children in America.

photo credit: sethdickens

However, instead of addressing the suffering of the people, elected officials in this country have made the decision to cut the ropes of the Medicaid and Medicare health safety net. These state and federal leaders feel that it is best to cut these programs rather than spend the time and money that it would take to protect or enhance them.

House Republicans have developed a federal budget that would eliminate the guarantee of coverage through Medicaid and reduce federal contribution to the program by close to $800 billion over the next ten years. In addition, House Republicans have also proposed changes that would make it possible for states to refuse coverage to seniors, people living with disabilities, pregnant women and children.

Medicare as we know it would be a thing of the past. The traditional benefits offered by Medicaid would be replaced by vouchers to buy health insurance via the private market. The new budget would do away with Medicare and replace it with Rationcare.

The quantity and quality of education, especially for females, could significantly affect future trends in the growth of global population. According to research that was published in the July 29 issue of the journal Science, predictions of population trends in the future that do not indisputably include education in their exploration may be flawed.

The study uses an innovative multi-state population modeling approach to integrate education fulfillment level, in conjunction with sex and age. The addition of education in the investigation adds a human quality element to forecasts of migration, mortality and fertility. Education also has an impact on health, democracy and economic growth, so such projections offer a more inclusive view of conditions affecting human well-being.

The recent research supports earlier discoveries that formal education attained by women, in most cases, is the single important contributing factor to growth of the population. Women who achieve a higher level of education tend to have fewer children, be healthier and be less at risk of infant fatalities.

Education also seems to be a major influence on child survival, more than household wealth. In addition, the research found that if concentrated determination was not focused on fast tracking education, the population of the world could stay under nine billion by the year 2050. Therefore, the outlook of global population relies greatly on the progress in education.

Co-author Samir K.C. says, “The most pessimistic scenario of ‘constant enrollment numbers’ (CEN), assumes no new schools are built and the number of people attending schools remains constant, which, under conditions of population growth, means declining enrolment rates.” He also said, “Under these two extreme scenarios, population size in 2050 could vary by as much as 1 billion-with 8.8 billion people expected under the fast track scenario and as many as 9.9 billion under the constant enrolment numbers scenario… The effect is greatest in countries with current high fertility rates and high education differentials.”
photo credit: Vectorportal

According to the United States Institute of Medicine, it is time for the Food and Drug Administration to make a few changes after 35 years of the same methods. In a recently released report, the group has hopes of changing the way the agency regulates medical devices.

Most medical devices make it to the market through the fast-track 510(k) process of approval, which is the vanguard of pending discussions.

The document requested by the US Food and Drug Administration is anticipated to recommend that medical devices, including pacemakers and artificial joints be put through a more arduous approval process before they are permitted release on the market.

According to Section 510(k) of the Food, Drug and Cosmetic Act, medical device manufacturers are required to register and notify the Food and Drug Administrat

ion that they intend to market that medical device a minimum of ninety days prior to action. This is referred to officially as Premarket Notification, or PMN.

This way, it is possible for the Food and Drug Administration to determine if the medical device is comparable to a medical device that is already in place in one of the classification categories. New medical devices that are unclassified will still be identifiable.

To be more specific, medical device manufacturers have to submit a premarket notification to the FDA, which states their intentions to introduce a new medical device into commercial distribution or to reestablish a medical device that has been altered significantly in a way that effectiveness and safely may have been affected. These modifications and changes may relate to material, design, chemical composition, manufacturing process, energy source or the intended use of the device.

According to the deputy director of Public Citizen’s Health Research Group Dr. Michael Carome, “FDA’s oversight and review process is too weak and needs to be strengthened. We believe that the process for approving devices under the 510(k) program frequently is deficient because of the application and the loose interpretation of what it means to be ’substantially equivalent to a predicate device.”

photo credit: mullica

U.K. drug manufacturer GlaxcoSmithKline[1] has announced it will sell the nonprescription diet drug Alli as well as a number of other over-the-counter brands.

Alli was touted as a potential blockbuster; however, sales never met expectations. Reports in 2010 of a small number of people suffering liver damage after taking the drug damaged its reputation.

Selling Over The Counter

The company recently announced plans to sell other over-the-counter brands that had over $800 million in sales annually. Other popular brands to be sold include Goody’s, Solpadeine and Abtei.

GlaxcoSmithKline launched Alli in 2007 with an exaggerated marketing campaign, including internet ads, print ads, extravagant in-store displays and televisions spots. In addition, a website was set up for Alli users who wanted to exchange diet tips and obtain advice from experienced dieticians. GlaxcoSmithKline even put out a book featuring recipes and dieting advice that was sold in many major drug retailers across the country.

Sales Drop

However, sales soon began to sputter. In 2007, the company collected nearly $245 million in Alli sales; in 2008, sales dropped to just over $122 million. A launch throughout Europe the next year rallied in sales of more than $331 million, but the company recently acknowledged that consumer demand for the drug in the U.S. and abroad was falling.

Though GlaxcoSmithKline claims Alli is “safe and effective when used as directed,” they are selling because Alli as well as the other over-the-counter brands “lacked sufficient critical mass in some product categories and certain brands have lacked focus due to other global priorities.”

photo credit: spikevicious