Twenty-eleven and 2012 are going to be remembered in the near term as very profitable periods of the generic manufacture of many formerly branded mega-sellers. Of course, the agent getting the most media ink this week is atorvastatin (Lipitor), the ubiquitous cholesterol lowering pill whose miraculous ways even prompted a short-lived lobby to go OTC.

The pharma company Pfizer, it could be reasoned, would still have some skin in the game in spite of generic availability. Specifically, partnerships with pharma benefit managers and insurers would still give the company a stake in orgs that would inhibit generic availability by offering rebates and discounts of branded Lipitor. It is the potential for actions like this which gets the attention of legislators (specifically Democrats) who want fair competition — as opposed to stymied innovations in generic marketing from pocketed profits by PBMs and insurance companies.

Detailed in an NYT piece last month, the prospect for limited availability of generics — specifically for Medicare Part D beneficiaries is a sobering one. Pfizer claims cost equivalencies (with respect to lower co-pays on branded Lipitor) for beneficiaries if the pharma company is able to offer those discounts to third parties. It is an interesting development in what is usually an uneventful and mundane process.

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The DOJ decision has been handed down. Merck Co. will pay $321.6 million in criminal fines and $628.4 million as a civil settlement agreement. It also will plead guilty to a misdemeanor charge stemming from the premature marketing of the market-recalled drug targeted to treatment of rheumatoid arthritis, usurping FDA approval for that indication.

Merck agreed to pay an undisclosed sum to the states of Florida, New York and South Carolina to resolve suits alleging the drug maker failed to adequately warn patients of Vioxx’s risks before halting sales in 2004, Russ Herman, a lawyer for former users of the drug, said in the Nov. 10 filing.

For those who have already forgotten, Vioxx was yanked from the pharma marketplace in 2004 after evidence showed the drug doubled the risk of heart attack and stroke. In 2007, three years later, the company paid $4.85 billion to settle approx. 50,000 Vioxx-related lawsuits. | LINK

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The president will issue an executive order today requiring the FDA to act on potential drug shortages in the phrama marketplace. Previously, drug companies were only required to notify the agency if a preparation was to be discontinued. Any other notification would be completely voluntary on the part of the manufacturer. The executive branch action is only the latest maneuver^[1] by this administration to “get tough” in the way of roadblocks initiated by the GOP in the legislature to nix his jobs bill en toto.

Most preparations affected are used in the aucte setting: electrolyte mixtures, chemotherapeutics, and anesthetics. The FDA reported over 170 instances of shortages in 2010, with an increase projected for this year. President Obama also expressed his support for legislation that would require streamlining the notification process; pharma companies would have to notify the FDA of shortages six months in advance. All of this is good news for patients, who stand to benefit the most from timely intervention in acute medical treatments. | LINK

1. In the past week, Obama has issued orders creating relief for “underwater” homeowners and current college students with high tuition debt.

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The rise in prescription drug abuse in this country has been muted somewhat by the traditional messaging by anti-drug campaigns which advocate the overarching “just say no” philosophy … and have done so since the heady days of the Reagan administration some 25 years ago. A different kind of advocacy is needed, say the appropriate groups; that is, one of attention toward the ripple effect of the “other” illicit drug — the prescription narcotic (including, most notably, hydrocodone and oxycodone).

In scenarios in which the levels of violent crimes (pharmacy robberies and assaults) are belied by the common perceptions of acquisition of such drugs (petty theft, paper script forgeries, etc), it’s easy to see why some say the FDA has been lukewarm at efforts to control this burgeoning problem.

The 12-year delay in the federal regulators’ final decision about hydrocodone – the second most-abused pain drug – has been agonizing, to say the least — all the more so as the Drug Enforcement Administration and Food and Drug Administration are apparently still studying whether to move hydrocodone-containing medicines to Schedule II category of medicines from the less restrictive Schedule III. Advocates for tighter controls over hydrocodone opine that it is time the government took concrete action to save lives — since a study funded by the National Institutes of Health has shown that nearly 8 percent of the 12th-graders in the US have abused hydrocodone in the last year.

The agency says many factors — chief among them the logistics involved in augmenting widespread training and retraining of healthcare providers as to the merits of prescribing in this new climate of addiction — have complicated movement forward on the matter. It’s a problem that’s not going away anytime soon. Those hoping for a sweeping decision by the FDA to correct things are better off considering scenarios in which the government agency can partner with other entities to begin to address oversight in prescribing lapses, formulary monitoring, and drug utilization reviews in healthcare organizations. | LINK

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Prescription drug premiums under Medicare Part D will not be increasing next year — not exactly surprising, considering the profound availability of generics in the pharma marketplace currently. Still, welcome news to beneficiaries. As a matter of fact, within the next couple of years, many longstanding branded bestsellers are due to flip generic…a bonanza for competition within this space.^[1] Elderly patients are also due rebates and discounts on branded preparations this year as a result of reform. Obama’s provision to shut off of the MMA 2003 stipulation regarding donut hole gaps in coverage under Medicare will continue include more beneficiaries, as a result. | LINK

1. Pfizer plans to pursue OTC status once bestselling Lipitor goes generic.

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Clarence Thomas wrote for the 5-4 decision in which companies were shielded from lawsuits by consumers suffering from adverse effects of certain drugs. Anthony Kennedy, the SCOTUS justice often seen as the court’s swing vote, wrote for the majority opinion in another pharma case which strikes down a Vermont law that banned companies from using data mining techniques to obtain information about the prescription drugs individual doctors have a preference in prescribing.

Federal law requires the makers of brand-name drugs to label their products with FDA-approved warning information and to update the warnings when reports of new problems arise. But in a 5-4 decision, the high court said this same legal duty to warn patients of newly revealed dangers did not extend to the makers of copy-cat generic drugs.

I actually agree with Thomas on this decision. Fed law should trump state law in this case. Generic formulations are essentially chemical equivalents of their branded predecessors and, as such, really cannot be held accountable to novel warnings not appearing on the branded parent drug. A ruling in the reverse could open the door to flurries of suits for a range of untoward events for a multitude of generics — only adding to the cost of already fiscally overburdened healthcare delivery at the outset of reform (emphasis below, mine).

In the second decision, the court by a 6-3 vote struck down a Vermont law that barred pharmacies, drug makers and others from buying or selling prescription records from patients for marketing purposes. [...] Writing for the court, Justice Anthony M. Kennedy said that “information is speech,” and that under the 1st Amendment, the government usually cannot restrict speech because it does not approve of the message. “If pharmaceutical marketing affects treatment decisions,” he said, it does so because doctors find it persuasive”.

Exactly. This case highlights the effect Pharma representatives have always had on the prescribing patterns of physicians and protects the ultimate decision maker at the point of healthcare delivery — the provider. Is it any wonder why reps have been essentially banned from many healthcare systems in many markets nationwide? | LINK

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First, and almost immediately out of the box, it was the concern for serious mental health effects.^[1] Now, somewhat controversial smoking cessation drug varenicline (Chantix) is the target of the FDA with respect to the increased risk of heart disease for those taking it. Of course, the FDA rates this as only a “small” risk as it “continues to evaluate its safety”.

The new warning comes from a 700-person trial in which patients who took Chantix (varenicline) over 12 weeks were more likely to experience an adverse heart event after one year than those who received a placebo. All of the patients had already been diagnosed with heart disease. For both groups, the heart attack risk was still small: 7 out of 353 patients taking Chantix had a nonfatal heart attack, versus 3 out of 350 who took a placebo.

1. Pfizer, the drug’s manufacturer was also the target of claims of an increased risk of suicidal ideation for those taking the drug — to a lesser extent, night terrors and delirium.

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Somewhat interesting that the TZD class of antidiabetic drugs in this country has been known mostly for a good (pioglitazone) and bad (rosiglitazone) actor — as the drugs work very similarly in treating the disorder. The latter drug has essentially had its reputation dragged through the mud over the past 10 years here, resulting in a an all-but revoked status^[1] because of its certain link to mortality stemming from a causative relation to the development of cardiac problems. Pioglitazone, marketed as Actos, has not had such a troublesome association; however, it has been relatively contraindicated for use in patients with syndromes that may predispose to fluid retention states.

In France, it is pioglitazone’s association with bladder cancer that may get it yanked from the market there.

The European Medicines Agency, which started a review of Actos’s potential cancer risk in March, said today that it will examine the results of the French study. The agency’s Committee for Medicinal Products for Human Use will discuss Actos at its next meeting the week of June 20. The agency didn’t recommend any changes in the use of Actos while the review is pending.

The FDA may be picking up on this, though, the agency is starting to sound like a broken record on the issue of potential adverse events from this class of antidiabetic drug: “information is still in its early stages — as it is too early to make a definitive conclusion as to the safety profile of pioglitazone”. The FDA took a similar stance on rosiglitazone at the beginning of its road to ruin. | LINK

1. Avandia (rosiglitazone) and such related drugs as Avandaryl (rosiglitazone and glimepiride) and Avandamet (rosiglitazone and metformin) will be available only by mail order from specially certified pharmacies and for certain patients, such as those already successfully treated with the drug and those who can’t control their blood sugar with other antidiabetic drugs.

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Comparative effectiveness research — the direct comparison of care interventions to determine which work best for which patients and which pose the greatest benefits and harms — has long been a pet issue for President Obama.^[1] Although the theory has really never been at the forefront of his very much publicized drive for the passage of the PPACA on his terms, it is a crucial foundation for his ultimate vision of quality healthcare delivery as the ultimate method of controlling costs.

Based upon the results of a new trial in JAMA, this vision has been sorely underutilized, even with stimulus funds to expand its availability. Of the almost 200 pharma products approved by the FDA between 2000 and 2010, only 100 had comparative-effectiveness data, researchers found. Whether or not such information was available depended on several factors, including the existence of an alternative treatment and research ethics. Additionally, the availability of comparative-effectiveness data varied based on treatment area, with proportions reaching up to nearly 90 percent for diabetes medications but only 33 percent for hormones and contraceptives.

It’s the overall lack of CER data and underrepresentation of much of that data into many facets of healthcare that will keep providers ignorant of the overall effectiveness with tried and true therapies versus expensive new agents constantly hitting the pharma marketplace. Although comparative FDA data need to be expanded and enriched, it is just the beginning of the long road in giving physicians all of the information — completely free of biases — to make the most medically informed, cost-effective decisions. This study should serve as a point from which CER can be better defined, as well. | LINK

1. The American Recovery and Reinvestment Act of 2009 allocated $1.1 billion to boost comparative-effectiveness research efforts.

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Many physicians, including myself, who see a majority of elderly patients are always interested in ways we can educate patients and concerned family members of the wide spectrum of clinical presentations of cognitive decline. For many Boomers who are now just turning 65 (as the first and oldest cohort does this very year) the specter of that “senior moment” possibly belying something more ominous and progressive is a little more than just an afterthought that can be dismissed. When the moment came for a discussion with the patient and the family over the concern of cognitive impairment, it was always a delicate balance with respect to validating patient concerns with the real world possibility of subclinical disease.

New diagnostic indicators and guidelines for primary care providers and their patients as recommended and formulated by the National Institute on Aging are out to demystify the process, while making research more goal focused, tangible, and accessible with respect to discovering therapies that can actually reverse progressive dementia.

While laudable in these efforts, the three-stage set of guidelines for diagnosis and treatment insertion offered by the NIA and Alzheimer Association is just the beginning. It certainly complements what we geriatricians have been doing quite adeptly for a couple of decades now — informing and educating patients and their families while squelching myths that could delay or, worse, prevent treatment from ever occurring. Of course, the ability for researchers to recruit the most appropriate patients for targeted clinical trials doesn’t hurt, either.

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