“This repeal effort was started by legislators concerned that the law is hurting the state’s economy,” explained PhRMA’s Senior Assistant General Counsel Marjorie Powell in a prepared statement. “And it is certainly true that it adds an extra level of administrative complexity for companies in the state. Pharmaceutical marketing is already effectively regulated by such federal government agencies as the Food and Drug Administration.”

The Massachusetts ban was part of the larger Health Care Cost and Quality Act. Although the bill is best known for extending health insurance almost universally in the state, it also created a new code of conduct for sales reps and established penalties for wayward reps of up to $5,000 per violation. It also created the Massachusetts Public Health Council, which has the power to create rules further limiting marketing practices.

Last year the Council passed new rules for both pharma and medical device companies, making Massachusetts the state with the most comprehensive marketing and disclosure code. The rules specifically mandate disclosure of fees, payments and other compensation to doctors; ban promotional items such as pens and mugs; and restrict meals to those provided at training or educational events. Payments for research and clinical trials, rebates and discounts, prescription drugs provided for patient use and demonstration units for charity care are exempt. All other payments of $50 or more must be disclosed.

Currently, Vermont and Maine have bans on all food service “gifts” to physicians. Minnesota limits gifts to under $50, while California, Louisiana, Maine, Massachusetts, West Virginia and the District of Columbia all require pharmaceutical and biotech companies to report marketing spending on physicians, but do not ban food service outright.

Personalized medicine has been one of healthcare’s most anticipated and least understood treatment paradigms. Physicians remain optimistic regarding its future, however the 52 doctors surveyed differed in their views in its implications for therapeutic research and development (R&D). Patients, by contrast, were viewed as increasingly interested in embracing the therapy.

Physicians were asked in which therapeutic areas do they feel the use of personalized medicine—for example, the use of genetic testing to tailor drug therapy to an individual—would be most prevalent. Of the doctors surveyed, nearly 58 percent said oncology/hematology, followed closely by cardiology (48 percent), allergy and immunology (38.5 percent), endocrinology (32 percent), and rheumatology (nearly 29 percent). In contrast, doctors felt the therapy would be least common in orthopedic surgery and obstetrics/gynecology.

Clinicians disagreed, however, on whether financial incentives are strong enough to encourage widespread collaboration between developers, payers, consumers, and pharma. When asked, “How will the adoption of personalized medicine affect the priorities and processes for pharma/biotech R&D?” physicians’ anonymous responses ranged from, “More opportunity for profit will drive new genetic testing,” to “No effect.” (It should be noted that a greater percentage of doctors did feel that opportunities for profit and for developing new drugs would increase.)

The Cost of Adoption
Much like a new consumer technology or ‘green’ product, the limits to widespread adoption are directly affected by the costs to the patient or payer. This is backed up by the Lehrman/Bloomberg survey, in which nearly 81 percent of respondents felt the adoption rate was directly affected by the willingness of the patient or payer to pay. And even when personalized medicine is adopted, 79 percent of physicians feel it would be only narrowly embraced.

These numbers are based on several factors, not least of which is the collaboration between diagnostics companies, drug makers (including pharma companies and biotech firms), patients, and physicians, the combination of which is where survey respondents think the big push will come from. Several clinicians believed that therapeutic companies would continue to target known genetic situations where biomarkers are linked to disease. Others believed that the entire R&D paradigm would change to link effective therapy to individual patient genetic profiles. The biggest detriment to adoption seemed to fall on whether the right incentives are in place to foster collaboration between the therapeutic and diagnostic companies toward developing personalized medicine therapies—are the financial incentives strong enough to encourage the collaboration needed?

Overall, what is garnered from the Lehrman/Bloomberg survey on The Future of Personalized Medicine is that diagnostic and therapeutic companies will have to partner to champion wider adoption rates. It is this participation that will help to alleviate payer and patient concerns over paying for additional screenings as well as higher targeted therapy costs.

Guest Blog by Tom Norton of NHD Smart Communications. You can reach him at tnorton@nhdcomm.com.

Amidst all the gurgling of oil last week(bad! bad! bad!), a competing thunderstorm of words erupted as Doug Elmendorf, Director of CBO, had the temerity to revisit the real costs of the new HCR law. Addressing something that, for whatever reason, this lifelong Hill bureaucrat  just couldn’t get done about eight weeks ago as the bill was coursing its way through Congress, the leader of the CBO came clean and spoke his mind. (Do remember that Mr. Elmendorf had been unceremoniously called to the White House in July 2009 during the heat of the HCR debate to “get his facts straight”, personally, with President Obama. So maybe this simple, short PP was a little bit of payback?)

Whatever, to his everlasting glory, Mr. Elmendorf screwed up his courage on May 26th and pronounced the following official OMB view on costs associated with the newly passed Obamacare: “Rising health costs will put tremendous pressure on the federal budget during the next few decades and beyond. In CBO’s judgment, the health legislation enacted earlier this year does not substantially diminish that pressure.”  Check it out. The deck’s simplicity and clarity are killer. Put another way,  Mr. Elmendorf felt constrained to suggest that the U.S. cannot spend money it does not have.  Indeed, in a none too subtle fashion, he comes very close to suggesting that Obamacare is an exercise in ‘Mad Hatter’ math (See, in particular, Slide #13).

Peter Orzag, former CBO director, and now Director of the Obama Office of Management and Budget was apparently stunned, as, it seems, was the entire Administration.  The slide deck circulated all over Capitol Hill for one week before Orzag, on June 2nd, issued this tardy retort to Elmendorf’s OMB bombshell: “The Act (Obamacare) has the potential to fundamentally transform our health system into one that delivers better care at lower cost. This potential isn’t fully captured in CBO’s numbers…” Whoa.  Case closed, huh?

Even more surprising is that once this first strafing run by Elmendorf was over, and on the same day that Orzag released his lame response to CBO, none other than the New York Times unloaded with both barrels presenting a front page story suggesting that the much praised and oft referred to Dartmouth Atlas of Health Care, widely quoted during HCR battle as the defining  study that declared that all health care everywhere should cost about the same, and that in particular, ‘cheaper care was better care,’ was, well, skewed…Or so said the NYT.

And once again a shocked Peter Orzag responded lamely, this time to the NYT article, stating, “I do not rely on the Dartmouth Atlas alone to prove that huge savings are possible in HCR.”  Enough said.

So let us review.  In the course of one week, we learned that:

A. The new law that is supposed to cost less and give us more, very likely won’t, courtesy of Mr. Elmendorf.

B. The primary study that led to the widely held view that cheaper care is better care during the HCR debate, is wrong, courtesy of the New York Times.

Leading us where?

Well let’s take the last point, first. In considering what the NYT was up to with their expose of the Dartmouth Atlas, I honestly have no answer. Do you get it? I was personally amazed that the publication went all out in its attack on the Administration and still am befuddled as to exactly what was going on there. If you tell me it was journalistic ‘fairness’ at work, fine. But LOL.

In the case of Elmendorf, however, seems to me that sometimes people just need to make a clean breast of things.*  For the last year, it’s been pretty obvious that his nominally Democratic political future is over. Really, has been since his CBO “scoring” single handedly derailed the entire HCR show for several weeks last summer when he found the Senate’s version of the bill was a trillion dollar, plus, budget buster… So, this spring he knew exactly what he was doing and seems to me, he had just decided he wouldn’t go quietly into the night given what he knew was the fiscal enormity of this new law.  And, as a result, I frankly doubt we’ll be hearing a lot more from Doug Elmendorf at CBO. Too bad.

That’s my Point of View. What do you think?

* ‘Make a clean breast of it’ is a suggestion that the ‘breast’ is the seat of the one’s emotions and secrets; one’s ‘heart’. To disclose this openly was to clean one’s heart of impurity.

This column was originally published on The Norton Point of View on the NHD Smart Communications website, www.nhdcomm.com and is available for download there.  The opinions expressed in the Norton Point of View are solely those of Tom Norton and do not represent the position of NHD Smart Communications and Advanstar Communications.

Last week’s annual meeting of BIO in Chicago once again proved illustrative in showcasing the high profile that governments now plays as the biotech sector’s chief advocate. While private venture capitalists confined themselves to the margins of the meeting, the Convention hall was bursting at the seams with host country “pavilions,” each designed to highlight its status as destination partner of choice for the industry.

Missing from the slick videos, graphics and takeaway tchotskes was any real sense of the importance of pricing and reimbursement levels that can accommodate the high cost of capital, increased regulation and long development lead times that together have sharply lowered effective periods of market exclusivity for biotech. Instead, the talk was all about building more Potemkin villages around infrastructure – tax breaks, R&D allowances, funding for basic research and facilitation of academic partnerships – that do little to compensate those who risk private capital for a profitable return on the investment.

The essential steps required to promote rapid commercialization of research, where government has to pull back and basically let the market work for itself, just didn’t seem to be part of the conversation. It’s another sign that the “public utility” model may well be the most realistic scenario driving the industry’s future; ironically, its the most innovative research segment – biotech – that seems to be leading the way.

One example of this disconnect between advocacy of “front end” support for innovation and neglect of the “back end,” where products face an increasingly skeptical phalanx of payers, was the appearance of Sir Michael Rawlins in a series of impromptu exchanges at BIO hosted by the UK Department of Business, Innovation and Skills. Rawlins heads the National Institute for Health and Clinical Excellence [NICE], which reviews medicines for evidence of cost-effectiveness prior to listing on the NHS,. NICE is criticized in some quarters of industry for holding back access to medicines on grounds that their clinical value is insufficient when weighted against strict metrics of affordability.

Rawlins made a number of useful points in suggesting where governments are heading in this puzzling, increasingly disconnected game to “promote” biotech:

• What’s wrong with good evidence to help politicians decide where to commit scarce public funds for health? Rawlins noted flatly that results of the UK election will not compromise the mandate of NICE in critically appraising medicines for listing in line with the priorities and resources of the NHS – all three major parties support the organization’s role “without hesitation.”
• NICE has broadened its roots as a leader in the politics of public health. Rawlins himself is chairing a bipartisan government commission to review the entire UK regulatory climate for medicines, with recommendations due by the end of the year. By default, NICE is thus likely to survive this critical review unscathed.
• Austerity will help promote the NICE reputation by deflecting criticism away from politicians in making unpopular resource choices. Rawlins believes that drastic cuts in public spending to restore the fiscal balance in the UK will actually enhance the value of metrics-driven tools to ensure decisions are made fairly and on the basis of independent evidence. Hence NICE is actually likely to grow in political stature as a consequence of the urgent need to curb public spending.
• Can you “define” innovation? NICE believes it can. A new priority for NICE in 2010 is identifying areas to “disinvest,” including recommending the removal of some medicines from NHS reimbursement. However, Rawlins is no fan of the big pharma “headroom for innovation” argument – new molecules will still have to prove their merit as “value drivers,” regardless of whether such disinvestment frees up funds for alternative use.
• NICE work carries significant implications beyond the UK. As the financial crisis spreads to more countries, reliance on appropriate evidence to ration health care will increase, and NICE is determined to sell its model to anyone who is interested. Rawlins said NICE has created an international consulting unit with a five person staff. It is working closely with a number of multilateral agencies – including the World Bank and the Inter American Development Bank [IADB] – as well as the UK Department for International Development [DFID] to promote health technology assessment tools in emerging middle-income markets. The focus is on helping countries decide what to spend on medicines through therapeutic targets and clinical guidelines, rather than individual product appraisals. Nevertheless, it’s a trend that will affect biotech fortunes for good or bad in markets that are slated to account for much of the growth in global pharmaceutical spending over the next 10 years.

Data analytics firm SAS, last week, played host to a bevy of pharma executives at the company’s Health Care & Life Sciences Executive Conference. The highlight, however, was a duel keynote speech from former Arkansas Governor Mike Huckabee and his sparring partner, former Massachusetts director of health and human services Philip Johnston.

The topic of conversation: Healthcare reform. What else?

Huckabee was in pure TV personality mode, revving up the packed room with his take on the state of healthcare.

“Today, if we were going to redo Wizard of Oz, Dorothy would be going to Washington with people with no heart, no guts, and no courage,” he said to the crowd.

Diagnosed in 2002 with Type 2 Diabetes, Huckabee (who by his own account once weighed as much as 300 pounds) was told by doctors that he would only have a decade left to live if he didn’t change his lifestyle—and that the decade would not be fun. He said that he decided to start being concerned about his health and exercise more.

“While weight is important, it’s not the only thing we must be concerned with,” he said. “The goal of a person shouldn’t be weight control, but health control. There isn’t a healthcare crisis in America, there’s a health crisis. As far as pharma innovation, physicians, and tools, there are a whole lot of ways where our healthcare system is doing well.”

His main point was that until Congress addresses the fundamental problem of health reform—not healthcare reform—nothing will change.

“Why do southerners eat fried food?” Huckabee asked. “Many of us are from generations of abject poverty and if you take food and fry it, you can take the cheapest meat and bread it and fry it and serve it, you can feed the same amount of food and feed more people. Anything that came out of Southern kitchen was fried.

“For me it was also religion. I’m Baptist, and one day when I was in school we had to bring in a religious symbol for show and tell, and I brought in a casserole.”

He said that he felt that it was wrong that healthcare companies are made out to be criminals. “If companies don’t bring in more money than they pay out, they will not be able to stay in business,” Huckabee explained. “The health insurance companies did a poor job supporting themselves. People in the medicare program are twice as likely to be denied benefits than a private insurance company.”

Finally, Huckabee predicted that the US will eventually have two levels of service in this country: a concierge service for patients with wealth, while others will be in plan that will be paid through reimbursement by government. This will create a system of polarization.

Philip Johnston took the stage with a presentation showing how Massachusetts’ universal healthcare plan works, and why it is a good model for the federal healthcare plan.

“It took us 70 years to get to this point. FDR was going to introduce a health coverage plan, but dropped it because he didn’t think it could get passed. Truman was the first to introduce comprehensive health insurance,” Johnston said. “This period now is the most exciting and hopefully the most innovative since Medicare.”

Johnston led his speech with a simple graphic: Transformation = Reform + Technology. He explained how Ted Kennedy worked with then-Massachusetts Governor Mitt Romney and the members of his administration to bring about health reform in Massachusetts. The reform law, which provides nearly universal coverage to state residents, was enacted as Chapter 58 of the Acts of 2006 of the Mass General Court.

“Everyone has to get in the game, and it isn’t free, and what you pay is higher than the penalty,” Johnston said. “What happened was that the vast majority of people took the insurance to have peace of mind.”

Comparisons of key provisions:

• Similar Exchanges: state-based marketplaces for insurance plans to compete (subsidized and unsubsidized)
• No public option in either Massachusetts or national plan
• Coverage expansion – US law provides subsidies up to 400 percent of poverty ($43,320/individual, $88,200 family)

“There’s no way federal legislation would be repealed,” Johnston said. “They need a two-thirds majority vote to repeal. Let’s try to make it work, not only in Mass, but in all 50 states. Let’s show the world that while we are well behind them, we are ready to step up to the plate and hit the ball out of the park.”

The Center for Business Intelligence, on Monday, revealed winners of its annual Strategic Patient Adherence Awards as part of its two-day conference about patient compliance with their drug regiments.

This year’s award winners are:

• Best Integrated Program—Shire Pharmaceuticals: FOSRENOL ON TRACK Direct To Patient Support Program
• Best Disease State Program—BMS/Sanofi-Aventis Canada & Rx Canada: My Plavix Partner Program
• Scientific Excellence Award—Merck: Medication Non-Fulfillment Rates and Reasons:  Systematic Review
• Innovation Award #1—Kaiser Permanente: B-Smart Program
• Innovation Award #2—Pfizer/Walgreens Patient Adherence Collaboration Project

Pharm Exec chatted with Robert Nauman, one of the judges and principal at Biopharma Advisors to find out more about the state of adherence programs in the drug industry.

Where is industry at right now with regard to adherence programs?

The pharma industry is at a point where they are falling behind other channels within the healthcare space in being able to provide adherence programs. The industry has never been very customer-centric over the past 15 years. They tried it, but struggled with customer-based programs.

That’s partly because their model is built around generating medical content. But that content is highly regulated. Today’s patients have very specific information needs, and we are seeing a trend towards behavioral-specific content that would move the needle for a particular patient.

Isn’t that positive for industry and patients?

Yes, but pharma is having a tough time getting behavioral-specific content through the FDA regulatory review process through a drug company. A lot of the adherence initiatives that are going on are marginally effective for two reasons. One, the content isn’t really valued by the end user; and secondly, none of them have been able to build programs of significant scale at this point in time. No one has ever reached a million patients through an adherence program. Some of these therapies have millions of patients on these drugs, but only register 15,000 people in the programs.

Are there any leaders in the area?

Healthcare providers like Kaiser, Partners Health, and MEDCO are really picking the ball up and running with it. Industries role is being relegated to a second string player. Also, I think collaboration/integration was a clear theme with all the award winners.

Shire’s On Track program was an integration of a lot of different marketing efforts that were designed as a multi-channel approach to improving adherence. It included targeted mailings, pharmacy letters, and a financial assistance program—all integrated in under an umbrella of a patient-support program that offered soup-to-nuts patient support.

There were a number of Canadian nominations this year; the Canadian branches of Bristol-Myers Squibb and Sanofi-Aventis won best disease state program. Is this trend telling?

This says something to the larger companies that tend to silo different patient initiatives and don’t tie them together. Because Canadian healthcare is national in scope, the programs they have must work together.

Can you talk a bit about the innovation awards?

The innovation awards were given to companies that we felt were fairly unique in some particular aspect of what they were doing. Maybe they didn’t fit into the criteria we were looking at in terms of best disease state program or best branded, but it helped evolve how we will look at entries in the future.

For example, Kaiser Permanente has a program that trains physicians and developed a process by which they could identify and target non-adherent patients for specific adherence interventions within the Kaiser Permanente system. They rolled this program out into their group in Southern California and had a significant impact in adherence rates in the patients that they ran through the program.

Why did you choose the collaboration between Pfizer and Walgreens?

Our second innovation award went to the Pfizer/Walgreens, which was interesting because Pfizer invested in the program but was completely hands-off and didn’t control it. It was Walgreens that made the investment to retrain its people to do motivational interviewing at the pharmacy counter. Rather than ask if a customer has any questions about a treatment, the pharmacist helps coach the customer about their disease and why it’s important to take his or her medication.

The program has shown an increase in adherence by 47 percent over the test group and proves that personalized interactions work.

Do you see things moving in the right direction?

I do, I just don’t think they are moving fast enough. There is also a rationale that industry shouldn’t be the only one paying for these programs, because adherence isn’t just a brand problem. One of the things we brought up at the conference was the concern over who will pay for these programs. Almost 75 percent of the medications dispensed today are generics and that is only going to grow. It shouldn’t just be pharma’s responsibility.

Call it an amuse bouche in anticipation of the banquet to come for consultants, lawyers and economists.

1. Healthcare is now not only a business, but a social good. With passage of the act, the US finally joins all the other OECD industrialized democracies—save for Mexico and Turkey—in declaring comprehensive, universal coverage an objective of government policy. Evidence from abroad shows that this commitment results inevitably in a rise in regulatory oversight as governments assume the difficult task of making equity concerns an element of market practice. In Europe and Japan, decisions are usually made by small elites, but in the US context this means a proliferation of new commissions, panels, and advisory groups, each with conflicting mandates and subject to influence by a range of interest affiliations. In both cases, “equity” eventually emerges as an empty rhetorical construct because where the public interest—let alone the patient—factors in is very unclear.

2. The consolidation “wave” becomes a tsunami. A simple rule of economics is that when demand—bringing more people into the healthcare system—is not balanced by increased supply—through more physicians and providers—prices and costs will rise. This in turn puts more pressure on margins for all players, and the predictable coping response is to try to control these market forces by becoming the dominant player. Hence what were once defining features of US healthcare—diversity, flexibility, and choice, especially among providers—will yield to the imperatives of size and scale. The trend is already evident in the networking of physician practices, multisite and geographically dominant hospital consortia, and the transformation of Big Pharma from product-niche innovators to service-oriented distribution platforms. And in a near majority of the 50 states today, the market for individual health insurance is effectively controlled by a single provider. While attention has been focused on increased payer clout, provider consolidation is growing too and will set the stage for major conflicts in the next few years over who gets paid, how much, and for what service. Renegotiation of reimbursement codes under CMS will serve as the politicized backdrop for the debate.

3. Reform is framed only as legislative intent—responsibility for execution lies elsewhere. Thousands of pages of implementing regulations must be drafted in a process that is likely to run through 2014, when key elements of the bill are slated to take effect; many of the most significant initiatives in the bill are being tested in the form of HHS waivers or pilot projects. These latter can take as long as a decade to furnish the evidence that can drive real policy changes, by which time technology or market realities will have made their findings obsolete. In addition, the 50 state governments are expected to assume responsibility for many provisions, from enrolling new Medicaid eligibles (to meet the law’s goal of adding 32 million new insured by 2019) to organizing the local insurance market exchanges that will allow consumers to obtain coverage at affordable prices.

More important, the confident predictions of the Democratic leadership in Congress that industry will toe the line based on how politicians interpret the law are misplaced—“gaming the system” to wrest competitive advantage will be firmly established as a tradable currency in reform. It is hard to conclude that the new law creates an environment where change is predictable.

4. Like all reforms, the new law has a domestic focus that fails to address healthcare as a driver of future US competitiveness in a global economy. There was little pushback on this score from the R&D industry, which chose to play the myopic “Washington insider card” to limit exposure to Medicare Part D price negotiation. This may have been a good short-term defense, but it ceded a larger opportunity to recast its image around a more positive agenda, focused on sustaining medical innovation as a driver of global competitiveness. The emphasis was on how drugs alone cannot bend the cost curve given their modest 10 percent share of overall health expenditures. Little mention was made of the more than 150,000 high-paying jobs lost in the R&D segment since 2007—a signal that US status as the global engine of new medicines may not endure.

5. No one—other than Big Pharma—thinks reform should preserve the industry’s high margins and profits. Failure to achieve a broader political realignment around support for the industry as part of an enlightened industrial policy agenda sets the stage for a new round of discussions about industry commitments beyond the $85 billion already pledged, as costs from additions to the insured population begin to mount over the next several years. More important, few observers have explored the policy precedent implied by the very notion of a drug industry “contribution” to defray the cost of expanded access. In a practical sense, how different is this from the punitive approaches taken by state systems like France, with its accord cadres that force the industry to bear the burden of compensating the government for annual overruns in budgeted drug spending, or the “one time” rebates in Germany that are now institutionalized through a consolidated network of sick funds?

6. Projected increases in volume sales of medicines do not guarantee higher profitability—the key metric that counts on Wall Street. A “race to the bottom” trend toward the commoditization of medicines through DIN-tagged generics will gather pace, while the service obligations and costs attached to gaining a good price for real innovations will continue to soar. To win access to reimbursement, high-priced biologics and specialty medicines will need to prove value through extensive testing in diverse, hard-to-recruit populations; against direct comparators rather than placebo; and after registration as well as before it. Investment in supplementary diagnostics will also be required, with the likely result of reducing the size of the treated population. All told, the impact could erode the innovator’s potential period of exclusivity and hence the advantages of a higher price point.

7. Reliance on comparative-effectiveness tools to determine access to medicines may be seen as “un-American,” but pressures to rely on an independent third party to render tough judgments on what health services to forgo suggest that barriers to doing so will eventually fall. Ironically, the driver of this change is likely to be the drug industry itself, as some companies seek to gain competitive advantage through more proactive engagement with the “value police.” This has been the experience in the UK, where many initial guarantees agreed to by industry in the operation of the National Institute for Health and Clinical Excellence [NICE] have been effectively removed as a consequence of efforts by individual companies to mitigate the impact of a negative technology appraisal on access to the NHS.

After months of increasingly rancorous debate, the House finally approved legislation March 21 that makes significant changes in the nation’s health care system. The Senate is slated to approve the House-passed changes to its original reform bill shortly.

Of most importance to pharmaceutical companies, the legislation promises to significantly expand the number of Americans with some kind of health care coverage. This will enlarge the market for prescription drugs and moderate pressures for price controls. The legislation sets up a scheme to eliminate the confusing and contentious “doughnut hole” in the Medicare program, while avoiding proposals for government negotiation of Medicare drug prices. Drug reimportation is off the table, at least for the moment.

A major plus for pharma is that the bill establishes a clear pathway for authorizing follow-on biologics. Brand-name firms won a 12-year data exclusivity period, despite loud protests from generics makers. But all manufacturers are likely to benefit from clearer policies on how to proceed in developing and regulating “biosimilars” and “biobetters.”

Pharmaceutical companies will finance the high cost of reform by paying additional fees and higher Medicaid rebates. Fees based on a company’s share of market are slated to total $28 billion over ten years, starting at $2.5 billion in 2011. The Medicaid rebate also increases from 15 percent to 23 percent.

The legislation reshapes the health insurance market as well as government health care programs, all promising to impact the coverage and delivery of prescription drugs. Implementation will be a huge challenge, especially for state governments. Republicans, as well as various interest groups, are already looking for revisions and challenges. We will examine these issues more fully in the next issue of Pharm Exec.

In an emotional farewell address to PhRMA, President Billy Tauzin recapped his five years at the helm of the organization and his efforts to “recapture the value of the PhRMA brand” and to “re-earn the trust of people who had lost faith in us.” “We had to take the target off our backs—to wear a goodwill badge instead of a bull’s eye—and to prove our commitment to patients by our deeds, not just our words.”

He explained his support for health care reform, noting that instead of remaining “a one-party trade association, …we correctly reasoned that our only real enemy was disease and that only a fair and less partisan PhRMA would allow us to continue our work in the face of mounting and increasingly ugly partisan conflicts here in DC and around the country. That transition to a more balanced politics, while difficult then and now, continues to serve our critical mission. It was the right thing to do, and we would be wrong to let either national party determine our policies or our principles into the future.”

Tauzin warned industry leaders that the life-saving work of pharma companies “will never be fully appreciated. Face it and accept it. But know this for yourselves:  yours is not just about a life in business; yours is the real business of life.”

While the public may not understand the important work of pharma, Tauzin pointed to regulators who “should know better. It’s no excuse for health care bureaucrats who don’t even begin to understand the pain that real patients and their families experience waiting helplessly for an on-time decision on a new promising medicine or therapy, only to read about missed deadlines, unnecessary delays and bureaucratic barriers, all based on an increasingly excessive risk-averse premise. We need—we desperately need better balance here.

“And it’s no excuse for policymakers who can’t seem to recognize that life science research is the cornerstone of medical innovation and a huge part of our knowledge-based economy. Do we have to lose every last job in America before somebody connects the dots and calculates the losses?”

“It’s certainly no excuse for those who say nothing about the ads calling for more lawsuits against the products of medical innovation and then rail against an ad that informs patients about the warning signs of disease and the new options for treatment. Something is wrong in America when we make heroes of trial attorneys and villains of our medical scientists.”

It’s been less than three days since new broke of a massive earthquake in Haiti that all but leveled the struggling country. With thousands dead, a devastated infrastructure, and no emergency plan, countries and businesses around the world have joined in the effort to help the Haitian people with food, supplies, and money. Here’s what some pharma companies are doing to send relief to our neighbors.

“The recent earthquake has had a devastating impact on Haiti’s limited health care system, which was already facing significant challenges,” stated Catherine V. Babington, president, the Abbott Fund. “Building on our existing partnerships with humanitarian organizations in Haiti, we are providing funding and product donations to help address the immense and immediate health needs.”

• Teva Pharmaceuticals will be donating more than $7 million in medicine. Teva is working with several of its Non-Governmental Organization partners to ensure these drugs are delivered to Haiti without delay.
• King Pharmaceuticals donated $200,000 to the American Red Cross to help with its Haiti earthquake relief efforts.
• The Genentech Foundation committed $500,000 to support disaster relief. Here’s the break down: A grant of $200,000 to CARE will help provide  food, water and hygiene items to people in need. A grant of $200,000 to Mercy Corps will provide medical supplies  and support medical teams on the ground. A $100,000 grant to the American Red Cross International Fund will  go toward tarps, tents and other emergency housing items to provide shelter for  the millions left homeless.
• Sanofi-aventis has committed 1 million Euros in financial aid to long-term reconstruction initiatives and the rehabilitation of the population of Haiti.
• Pfizer pledged $1 million in product donations and $250,000 cash (to UNICEF and CARE). Additionally, Pfizer Canada is matching all employee donations up to $250.
• GSK donated $1.4 million in medicines to many different relief organizations, as well as $408,000 to the British Red Cross to treat water contamination.
• Bayer is providing medicines to the Red Cross to be distributed to earthquake victims. Additionally, the company is doubling employee donations up to EUR $100,000.
• Abbott announced on Wednesday that it would send $1 million $2.5 million in aid and medical products to Haiti. The first wave of support comes in the form of $100,000 in grants to the American Red Cross, Partners in Health, and Catholic Medical Mission Board.
• Lilly stated that it has pledged $250,000 in cash, half of which is being sent ASAP, and the other half will be staggered over the next year to help rebuild the country. The company will also match employee donations, up to $250,000.
• Amgen said that it would donate $2 million to the Haitian government to help bolster relief efforts. Additionally, the company will use its Disaster Relief Program Web site to help employees donate additional funds. All donations through the site will be matched by Amgen.

This list will be updated as we hear from other pharma companies. Please contact us at gkoroneos@advanstar.com if you know of a pharma company involved in the relief effort.