How did we get here? The 2010 report shows that compared with last year’s data, the country’s obesity epidemic is growing steadily. The report’s summary also points out that in 1991, no state had an obesity rate above 20%.

“Obesity is one of the biggest public health challenges the country has ever faced, and troubling disparities exist based on race, ethnicity, region, and income,” said Jeffrey Levi, executive director of TFAH. “This report shows that the country has taken bold steps to address the obesity crisis in recent years, but the nation’s response has yet to fully match the magnitude of the problem. Millions of Americans still face barriers—like the high cost of healthy foods and lack of access to safe places to be physically active—that make healthy choices challenging.”

Some examples of the racial, ethnic, regional, and income disparities Levi mentions are given in the report’s findings:

• Adult obesity rates for Blacks and Latinos were higher than for Whites in at least 40 states and the District of Columbia
• Ten out of the 11 states with the highest rates of obesity were in the South
• Thirty-five percent of adults earning less than $15,000 per year were obese compared with 24.5% of adults earning $50,000 or more per year
•  The number of states where adult obesity rates exceed 30% doubled in the past year, from four to eight.

Perhaps the most troublesome is the data on childhood obesity. The results show that:

•  Childhood obesity rates ranged from 9.6% (Oregon) to a high of 21.9% (Mississippi)
• Eight states, plus the District of Columbia, have childhood obesity rates greater than 20%
• Nine of the 10 states with the highest rates of obese children are in the South, as are nine out of the 10 states with the highest rates of poverty.

A poll on childhood obesity was included in this year’s report. Eighty-four percent of parents said their children are at a healthy weight, however, research shows that one-third of children are overweight or obese, according to the report. This finding suggests that parents do not think of their own children as having a weight problem. Additionally, the poll results showed that 80% percent of Americans identified childhood obesity as a growing problem, and 50% of Americans believe the issue is so important that we need to invest more to prevent it immediately.

In February of this year, Michelle Obama launched the “Let’s Move” program, an ambitious campaign seeking to end childhood obesity within a generation. The program’s goal is “that children born today will reach adulthood at a healthy weight.” Public and private organizations have already started working toward that goal by taking steps to help parents make healthy, informed choices; serve healthier food in schools; help people access healthy, affordable food; increase the number of farmer’s markets; and encourage more physical activity. At the same time as the Let’s Move launch, President Obama announced the formation of a task force on childhood obesity that would identify ways to maximize resources and set benchmarks to achieve the Let’s Move goal.

Following the announcement of the “Let’s Move” campaign, FDA Commissioner Margaret Hamburg wrote an open letter to industry in March calling for better nutrition labeling on food packaging to help consumers make healthier choices. Hamburg focused on the food industry’s use of what could be misleading information to consumers and urged companies to make sure their labeling did not contain unauthorized health or nutrition claims.

And, of course, there are pharmaceutical treatments on the market and in development to fight obesity. Just yesterday, Eisai announced it made a deal with Arena Pharmaceuticals to commercialize the drug candidate lorcaserin, which is designed to control appetite and satiety. Eisai will pay Arena $50 million upfront, up to $90 million in milestone payments, and roughly 30% of product sales. With FDA approval, Eisai will sell the drug in the US. The companies expect an answer from FDA by October of this year.

It is promising that with these measures we can begin to overcome the many complex causes and factors related to the obesity epidemic—physical, emotional, social, ethnic, economic—that we deal with as individuals and as a nation. I sincerely hope that in years to come we can celebrate our country’s 250th 4th of July as a slimmer, healthier America.

First, the Act will mean an increase in drugmakers’ sales, according to a PriceWaterhouseCoopers (PWC) report. About 32 million additional people will be insured by 2019, and about half of them will be covered by Medicaid. The insured are more likely to fill prescriptions, so this is to the industry’s benefit. But the Act will also raise the rebates required of branded-drug manufacturers from 15.1% to 23.1%. Will this hurt drugmakers? Probably not. “The impact of an increase in the Medicaid rebate rate may be less extensive than believed as rebates currently in place already exceed this rate,” says the PWC report.

Previously, pharmaceutical companies often lost sales when beneficiaries entered the doughnut hole in Medicare coverage. But the Act contains several provisions to help patients move through the hole quickly. As of the Act’s signing, the government will pay a $250 rebate to each patient in the hole. By 2011, manufacturers will have to provide 50% discounts on branded drugs to patients in the doughnut hole. Although this might sound bad, the PWC report notes that drugmakers already provide discounts on prescriptions filled in the coverage gap. So this part of the Act might not affect drugmakers much, except perhaps by boosting sales.

On the other hand, the Act requires each pharmaceutical manufacturer to pay a fee based on its share of total branded-drug sales to government programs. Executives told of this detail might have responded, “I knew there was a down side.” Not so fast. The Act divides sales amounts into five ranges and taxes each range at a different percentage. A company with $300 million in sales would pay nothing on its first $5 million, 10% on sales between $5 and $125 million, 40% on sales between $125 million and $225 million, and 75% on sales between $225 million and $300 million. “Given the fixed dollar amount, over time, the impact diminishes relative to pharmaceutical sales,” said the PWC report.

Finally, large biopharmaceutical companies knew right away that healthcare reform would be good for them because the Act gives innovators 12 years of data exclusivity. Many small biopharmaceutical companies and manufacturers of generic biologics likely felt left out when they heard the news, but there’s a silver lining. The Act allocates $1 billion for a two-year temporary tax credit to encourage the development of new therapies. The 50% tax credit will go to companies with 250 employees or fewer, and is intended to help small, undercapitalized biotech companies, according to the PWC report.

At worst, healthcare reform will likely have little effect on drugmakers’ pocketbooks. At best, it will increase their sales without greatly increasing the amount of tax or rebates they pay. Pharmaceutical executives may soon be moved to paraphrase Patrick Henry and say, “If this be socialism, make the most of it.”

At first blush, it looks like drugmakers took a beating. The New York Times said that the drug industry receives “harsh treatment” in the bill. In June 2009, President Obama and the Pharmaceutical Research and Manufacturers of America (PhRMA) agreed that the industry would provide $80 billion in rebates and discounts on branded pharmaceuticals over 10 years. The House bill would require drugmakers to provide another $60 billion in rebates over the same period, making a total of $140 billion in concessions.

These rebates might have been what Ken Johnson, PhRMA’s senior vice-president, had in mind when he said in a press release that the House bill would kill tens of thousands of jobs in the pharmaceutical industry. Yet the additional rebates might not be included in the healthcare-reform bill that the Senate eventually passes.

The House bill also would enable the government to negotiate the prices that Medicare pays for drugs, a policy that the industry has so far opposed. On the other hand, the bill would not allow Medicare to create a formulary. This omission essentially vitiates Medicare’s price-negotiating power, said Steven D. Findlay, senior health-policy analyst of Consumers Union, in the New York Times article.

Ultimately, I think it’s too soon to draw conclusions about what healthcare-reform legislation will mean for the pharmaceutical industry. The Senate has yet to pass its own version of the bill. The Senate bill might not, for example, require the additional rebates from the industry that the House bill does. It might, as the House bill does, give biologics protection from generic competition for 12 years. And after the Senate passes its bill, it will have to be reconciled with the House bill.

Despite its initial alarm, PhRMA seems determined to withhold its judgment. “This is a three-act play, and a good critic doesn’t write a review after the opening scenes,” said Johnson in the press release. Time will tell what shape the final legislation takes. It is at least conceivable that the industry could gain from healthcare reform. The law that Obama finally signs could expand the industry’s market, increase drug sales, and provide incentives for innovation.

In a statement released after the vote, BIO’s President Jim Greenwood said the exclusivity period would ensure innovation, presumably because it would provide incentives for investing in biopharmaceutical innovators. Greenwood also remarked that the legislation would help avoid patient and provider “confusion” over biosimilar products. I can’t understand what Greenwood means by that, unless he takes “confusion” to mean “choice.”

The Generic Pharmaceutical Association (GPhA) also weighed in last week, expressing its disappointment in the House Committee. The Eshoo bill would delay the introduction of affordable medicines, said GPhA President and CEO Kathleen Jaeger in a statement released last week. H.R. 3200 does not include a “reasonable and proven successful period of market exclusivity,” Jaeger said, alluding to the Waxman amendment.

President Obama had reiterated his support for a seven-year exclusivity period for biopharmaceuticals two days before the Committee vote. Party loyalty apparently did not influence the Committee members’ deliberations. The shape of the bill that will end up on Obama’s desk remains to be seen, but BIO can claim an important victory for the moment.

Strong opposition can block legislation quite effectively, as Sen. John McCain (R-AZ) recently discovered. A Senate Committee defeated his amendment to allow the reimportation of prescription drugs when McCain tried to append it to the “Affordable Health Choices Act.” And the amendment was withdrawn from the “Family Smoking Prevention and Tobacco Control Act” before that.

Likewise, an approval pathway for follow-on biologics that does not contain 12 years of data exclusivity will face stiff opposition from BIO. Rep. Henry Waxman’s (D-CA) “Promoting Innovation and Access to Life-Saving Medicine Act” has faced criticism from Congress and industry alike. At first blush, you might predict its fate to be similar to that of McCain’s drug-reimportation amendment.

But, as Senior Editor Patricia Van Arnum noted, the White House has signaled its preference for an approach similar to Waxman’s. BIO called the approach a “risky short cut to biosimilars” and will undoubtedly be bending lawmakers’ ears about its preference. Nevertheless, the Presidential imprimatur could make a great difference. President Obama remains widely popular and might have enough political strength to draw the Congressional support he needs to codify his vision for follow-on biologics.

In testimony before the US House of Representatives’s Subcommittee on Courts and Competition Policy last week, Richard A. Feinstein, director of the Federal Trade Commission’s (FTC) Bureau of Competition, identified pay-for-delay patent settlements as an obstacle to generic competition and to efforts to contain rising healthcare costs. Under pay-for-delay settlements, makers of generic drugs agree to delay the introduction of their products in return for a cash payment. The European Commission called these settlements anticompetitive in a report issued in November 2008.

In his testimony, Feinstein supported H.R. 1706, the Protecting Consumer Access to Generic Drugs Act of 2009, which would prohibit such settlements. A similar bill was introduced in the Senate in February. FTC has attempted to use its antitrust enforcement powers to stop pay-for-delay agreements, but courts have tended to be lenient on them, Feinstein said. Pay-for-delay settlements have thus become a viable strategy for innovators, and antitrust enforcement has gotten difficult as a consequence.

The Pharmaceutical Care Management Association argues that generic drugs could save consumers billions of dollars, but patients cannot buy drugs that are not yet marketed. The courts’ tendency to accept pay-for-delay settlements seems to indicate that legislative action is necessary. Explicitly prohibiting these settlements would likely foster competition, a goal that free-marketeers should certainly get behind. And if the House and Senate bills reduced patients’ expenses (as well as those of government and private healthcare payors), they would represent a step toward achieving Obama’s goal of healthcare reform.

So far, the first quarter of 2009 has been full of initiatives that call for, if not push for, change in the pharmaceutical industry and in medical science overall. Some may say it started when Obama took office. Within six weeks of leading the country, he announced $1.1 billion for comparative effectiveness research. Then, his proposed FY 2010 budget included support for a regulatory pathway for follow-on biologics. And this week, he reversed the ban on the use of federal funding for stem-cell research.

Others may say industry change began a couple of years ago with the start of the global recession and the end of the blockbuster moment. Companies have been forced to restructure and downsize while maintaining a global presence and market share. They’ve been encouraged to specialize in niche products and then to diversify their portfolio (biologics, anyone?). And now, says PricewaterhouseCoopers, they need to restrategize once again.

The accounting firm has released a new report as part of its Pharma 2020 series, Marketing the Future—Which path will you take?,  that highlights how the industry needs to re-examine its marketing and pricing plans. The full report is available for download, but some highlights include:

 o      Pay-for-performance is on the rise. In other words, drug manufacturers need to do more than ensure their products are safe and effective. They need to ensure their products provide “value for money” and are “better than” alternative therapies already on the market. “By 2020, we think that all new medicines will be paid for on the basis of the outcomes they deliver,” says the report. (A bill introduced in the Senate March 4 would allow wholesalers and pharmacies to import qualifying drugs from countries abroad—also impacting competition and pricing decisions.)

o      Pharma will be able to play a larger role in health management (e.g., prevention of disease) but will have to improve its public image first.

o      Detailing and gifts to doctors as well as DTC advertising are not all they’re chalked up to be and should remain on the decline.

o      Marketing/Sales departments as well as healthcare payers, patients, and doctors will need to be more heavily involved in R&D to determine which drug candidates are best to focus on in terms of the overall value chain.

o      ePrescribing and electronic health records are inevitable (Congress recently passed a law to increase ePrescribing in the Medicare program and Obama’s stimulus package calls for the use of electronic medical records; other countries are already ahead in this game).

o      Even though mergers and acquisitions are helping to diversify company pipelines, demand for generic drugs and specialty drugs are not going to go away. To stay at the top, therefore, drug companies may want to look into healthcare packages and bundled products, and take on more of a “brand” focus (respected brands will also go a long way toward improving pharma’s public image).

o      In the regulatory arena, harmonization will be more prominent and “live licenses” are likely to be the method of “drug approval” by a regulatory agency. These licenses will allow a manufacturer to release a new drug to multiple countries simultaneously, on the condition that further in-life testing in various populations will lead to “rapidly evolving labels” on the new products.

 If PWC’s predictions are accurate, much change is on the way. Although a large portion of the life sciences community has been waiting for some of the pending changes (e.g., a follow-on biologics pathway, additional stem-cell research) for quite a while, the industry overall is not so ecstatic about other changes (i.e., comparative effectiveness research, overseas drug imports). For decades, pharma has had control over its market and what its products are worth. But it looks as though a combination of the global economic downturn, the end of the blockbuster-drug era, and a more liberal US administration are coalescing to change industry practice as we know it. 

Sebelius served two tenures as her state’s insurance commissioner and proposed various initiatives to improve and protect Kansans’ health. A Democrat, she was twice elected in a largely Republican state, and has established a reputation for bipartisanship. These points should all work in the governor’s favor.

Yet Sebelius could face problems during her confirmation hearings because of her support for abortion rights. Last year, Sebelius vetoed a state law regulating abortion because she believed it would endanger women’s lives by permitting unconstitutional interference with a woman’s decision to terminate her pregnancy. Her veto raised the ire of prolife organizations.

If Sebelius is confirmed, her qualifications might not ensure that her term as secretary is productive. As The New York Times noted, Sebelius has struggled to find common ground with Republicans on healthcare issues, despite her bipartisanship. Republican lawmakers stymied her attempts to institute universal healthcare and to raise cigarette taxes to subsidize medical treatment for the poor.

Sebelius seems a capable candidate for secretary of HHS. Yet the success of her confirmation hearings and her possible tenure as secretary will depend nearly as much on others’ attitudes as they do on her abilities.

No doubt millions were moved by President Barack Obama’s inauguration speech yesterday. Having listened to and read it several times, it occurred to me that many of his messages apply directly to our industry.

Take this statement, for example: “Our journey has never been one of shortcuts or settling for less…. it has been the risk-takers, the doers, the makers of things…who have carried us up the long, rugged path towards prosperity and freedom.”

Granted, the President was speaking of Americans who took chances throughout this country’s history to improve the equality and lives of those around them. But scientists, chemists, and engineers are also “makers of things” and also working to improve lives. It’s this very population that takes chances every day to try to develop new medicines and delivery methods to treat people in need. And we all know that the individuals in quality control and managerial departments spend their days making sure no shortcuts are taken along the way.

And how about this statement from Obama’s speech: “Our workers are no less productive than when this crisis began. Our minds are no less inventive, our goods and services no less needed than they were last week or last month or last year. Our capacity remains undiminished.” Can not the “crisis” he refers to apply to the multiple breaches this industry has seen in supply-chain security and quality over the past two years, or to the thousands of job cuts drug companies and manufacturers are being forced to make in this economy, or even to the lack of resources so desperately needed by FDA to carry out its ever-growing agenda? And yet, amid these crises, pharma’s work is still vital to global health.

One more statement caught my attention: “Our challenges may be new. The instruments with which we meet them may be new. But those values upon which our success depends…. are true…. What is demanded then is a return to these truths. What is required of us now is a new era of responsibility…”

Many conferences of late have focused on the growing challenges in the pharmaceutical and biopharmaceutical industry. With new demands for quality systems and process monitoring tools, such as PAT, everything seems in flux. But the basic components of this industry—to make safe and effective drugs to help individuals who are sick and need treatment—have not changed, and they never will.

Now it’s probably not very likely that President Obama was thinking of the pharma industry as he stood on the Capitol steps yesterday afternoon. But in my mind, there’s no reason why his messages, goals, advice, and enthusiasm should not apply directly to us. We’re all thinkers, we’re all part of the working population, and we’re all ultimately responsible for what we do and how we do it.

In the last three months, more than 13.5 million Americans (roughly 20% of adults who use long-term prescribed medication) have stretched out their medications by reducing dosages or taking drugs less often than prescribed, according to a survey conducted by International Communications Research (ICR), an independent market-research firm.

ICR’s figure includes more than 12 million adult patients taking oral medications and more than 1 million adult patients taking injectable therapies. An ICR press release states that even about 10% of patients who take critical drugs that must be injected by a health professional are stretching out these expensive prescriptions. Respondents to the ICR survey most often cited cost, insurance coverage, and medication copay as the reasons that they have begun stretching out their prescriptions.

A consumer study conducted by Manhattan Research, a pharmaceutical and healthcare market-research company, produced similar results. The study found that nearly 40 million US adults decided not to fill a prescription in the past year because of the cost, according to a company press release. “Healthcare costs and accessibility are major barriers for Americans,” said Meredith Abreu Ressi, the company’s vice-president of research, in the press release.

Patients will likely petition the new Obama administration for help, but they can also look to pharmaceutical companies for assistance. For example, Sanofi-Aventis US (Bridgewater, NJ) has increased access to its nononcology Patient Assistance Programs (PAPs), which help consumers obtain needed medications. Beginning on New Year’s Day, these PAPs will include eligible uninsured patients with incomes that are 250% of the Federal Poverty Level. Uninsured individuals with incomes as high as $26,000 and uninsured families of four with combined income of $53,000 may be eligible to receive the company’s prescription drugs for free. Sanofi-Aventis US’s PAPs include medicines for disease states such as diabetes, rheumatoid arthritis, deep-vein thrombosis, and pulmonary embolism.

In the days before the Obama administration is sworn in and gains its footing, it is encouraging to see that some companies recognize the importance of helping patients in financial need.

See Angie Drakulich’s recent blog post on a similar topic.