As a follow-up to a DP post on the unusual strategy pharma company Pfizer is implementing in trying to protect market share for the formerly solely branded drug Lipitor, here’s another take on the issue. According to one analyst profiled, Pfizer faces an uphill battle in trying to convince the pharma marketplace that its branded agent is more clinically efficacious than generic atorvastatin.

Pfizer is doing a so-so job of convincing health plans and [pharma benefit managers] that Lipitor is somehow better than a generic. On a scale of 1 to 10, Pfizer received a 4. Nonetheless, 54.8 percent say they will offer the authorized generic, which is being sold by Watson Pharmaceuticals. Meanwhile, only 30.4 percent report they will receive added rebates or discounts from Pfizer.

Of course, the pharma company stands to lose a ton during its loss of exclusivity over the next 6 months, but it will remain tenacious — as many analysts do not believe future antitrust issues will occur. Perhaps even more interesting is the new ground being broken here: can healthcare consumers be weaned off of generics and stay loyal to branded medications — if insurers and key third parties allow them to gain incentives by continuing to utilize them? | LINK

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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 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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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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A healthcare informatics company issues a report today that I really do not find surprising. The trends of Pharma of late are much fewer fast-tracked medications in the pipeline, decreased NDAs for many novel and like-classed (so-called “me-too” drugs) medications, and — are you ready for this? — much greater healthcare consumer spending on generics, which, according to the report, now make up almost 80 percent of the pharma marketplace.

It would be too easy to blame this on the economy. At the root of this and other findings detailed in the report are forces more complex in the healthcare economy than just the principles of supply and demand. After all, while there are fewer patient visits and greater demand by providers and health systems for payments by third parties, you can bet that Pharma still manages to turn a profit. Just take a look at the volume of sales by therapeutic areas: anti-cancer drugs continue to lead the way.

The top five therapy classes were: oncologics, with $22.3 billion in 2010 spending; respiratory agents, at $19.3 billion; lipid regulators, at $18.7 billion; antidiabetes drugs, at $16.9 billion; and antipsychotics, at $16.1 billion. Growth in spending among these classes ranged from 0.9 percent for lipid regulators to 12.5 percent for antidiabetes medications.

Although consumers, third party payers, hospitals, and providers all appear to be embracing quality provisions as a way to control costs, it is somewhat less clear what this pharmacologic austerity will ultimately mean for the management of chronic disease and how that will impact the cost of healthcare over the next 10 years. | LINK [PDF] to IMS report

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The one year anniversary of the ACA is giving many time to reflect on its passage and what it really means for the future of healthcare delivery in the foreseeable future. One thing’s for certain — the controversy surrounding it on all sides will not be going away any time soon. Whereas the public is portrayed in the media as being, at worst, “evenly divided”^[1] on the issue (just like every other manufactured boilerplate lately — take your pick), many supporters are saying that the reform law’s original form and intent will eventually get the full support of the American public.

Detractors, not to be outdone, are more emboldened than ever to make this issue a Campaign ’12 one — and a very potent issue, at that. Although the road to the ACA’s passage was characterized by cogent and passionate debate on most levels, the labels applied by opponents — both Republican and Democratic — seemed to take center stage, almost screaming out to any fence-sitters to give up on lobbying for it. In the end, however, the bill survived threats of “death panels”, Tea Party protests, and GOP-stoked fears that ironically warned of the insolvency of Medicare should the measure become law.

The controversy surrounding the reform law is not over by a long shot. Even as healthcare consumers, states, insurance companies, pharma companies, and the federal government hunker down to to accept their roles in the wake of the law, its current incarnation will only be preserved if sound implementation by 2014 overcomes the political rhetoric on the left and right. If the most salient effects of the law — increasing access via exchanges, eradication of pre-existing condition denials, closure of the Medicare Part D doughnut hole, and eliminating coverage and payment inequities in Medicare Advantage plans — remain intact by mid-decade, perhaps the most beneficial result will be that healthcare consumer will receive high-quality, cost effective healthcare delivery without giving the means to this end even a fleeting second thought.

1. Actually, in comparison to those who want the law expanded or remain as is, only 1 in 5 want some sort of repeal — be it piecemeal, or full. Source here.

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The potential for adverse effects among the proton pump inhibitor (PPI) class of drugs will probably get a lot of play in 2011. It’s a class which is well known to consumers, especially those who have been bombarded with the popular “little purple pill” ads for, essentially, what seems like an interminable campaign (it doesn’t hurt that Nexium is one of the country’s top ten branded drugs in terms of sales in 2009).

The researchers systematically reviewed all relevant studies on the association suppressive medications and pneumonia that could be found up to August 2009. They found that out of every 200 inpatients being treated with acid suppressive drugs, one will develop pneumonia. [...] Since 40-70% of hospitalized patients receive these drugs it may mean that deaths from hospital-acquired pneumonia could be caused by acid suppressive medications. The impact of acid suppressive medication on community-acquired pneumonia could be much greater.

One can also add to the list, the following: osteoporotic fractures and recurrent small bowel infections. | LINK

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The role of the physician as spokesperson in the name of “expert analysis” is finally being called for what it is — a sham. Over the middle to latter years of my training, I cannot count the number of  times I either received solicitations (in the form of “special invitations”) by pharma representatives to listen to anointed “experts” deliver the latest “research findings” on drugs that I just had to prescribe to my patients — or else.

For years — well before the PR nightmare Pharma found itself in with reports of improper payments to physician cheerleaders for their products and industry-funded problematic trials which resulted in adverse patient events and lawsuits — the physicians who were hired by Pharma to support a new drug hitting the market had free reign essentially to say whatever they wanted about that drug, just as long as it was positive.

These physicians were really never questioned about financial disclosures, research methods, or anything else about the drugs Pharma wanted them to shill. In the heyday of carefree spending which presaged the current healthcare financial crisis the country is now experiencing, no one cared. As long as the drug did what it was purported to do, the physician spokesperson got paid, the Pharma company made profits, and physicians willing to take the bait — used hastily approved drugs when time-tested medications with known safety profiles would have done the trick.

The only bright spot in this scenario was that Pharma usually did some vetting in pandering to the right physician to deliver the goods. At the very least, the doctor was usually one who possessed board certification in his/her specialty, had no licensure infractions, or run-ins with professional societies or organizational peer committees.

That is, until recently.

Now, it appears that Pharma really doesn’t care who promotes their merch — just as long as someone with a pulse can deliver the goods. Unfortunately, this includes many troubled docs with suspended licenses — arising out of major boundary violations with patients, the performing of improper and even dangerous medical procedures, and claiming bogus academic credentials. In the spirit of public disclosure, a watchdog organization has investigated Pharma’s current practice of employing physicians with very troubled professional histories to deliver informercials on their products and has uncovered a wealth of disturbing information which should truly be on the forefont of patients’ minds in this era of prudent healthcare spending.

“Without question the public should care,” said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

The watchdog organization, ProPublica, is doing a service. It’s one that should immediately open up fruitful discourse on a practice — while not illegal — should be re-examined for the sake of patient safety, prudent healthcare spending, and bioethical thought. I suspect that, until there is more physician concern on this issue, lip service will prevail. Physicians must begin to police themselves and develop reasonable and responsible relations with Pharma that seek to provide beneficial information which the universe of physicians in this country can trust to deliver cost effective and safe healthcare. Otherwise, the art of medicine will continue its inevitable progression to the business of medicine, as fiduciary incentives take priority over ethical healthcare delivery.

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In an otherwise dull year for novel drug development, GSK is making positive news; it plans to expand into the realm of pharmaceutical development for the treatments of rare disorders. While this seems very noble for what it is, one mustn’t forget the harsh realities facing pharma companies in the dawn of healthcare reform: an overall cessation of FDA fasttracking of new drugs, increasing cynicism of patent-extending agents, the increasing threat of lawsuits and other legal issues surrounding many high-profile agents in the past decade, and the growth of unforeseen competition in the pharma marketplace at the hands of reform (plan rebates, more restricted Medicare Advantage contracts, etc.).

So, any method by which a pharma company can grow as current output faces increasing competition even among generic agents, is bound to be a plus for the company securing funding for these initiatives. Glaxo said it plans to have a list of about 200 illnesses that its rare disease unit will target.

Reflecting a growing push into rare diseases by big drug makers, GlaxoSmithKline PLC (GSK) Monday said it has identified around 200 such disorders that offer the best opportunity for clinical, regulatory and commercial success. Marc Dunoyer, who heads Glaxo’s rare disease unit, which was established in February, said that “with less than 10% of patients with rare diseases currently being treated worldwide, we recognize the size of the challenge, but also the opportunity to deliver new medicines to patients.” There are between 6,000 and 8,000 rare diseases currently identified, affecting around 6%-8% of the world’s population. Patient populations suffering from such illnesses are clearly defined and relatively easy to identify, with 70% of rare disorders being genetic in origin. Many rare diseases also involve clear molecular targets.

Glaxo plans worldwide distribution plans to combat the enormous costs of producing, marketing, and distributing such drugs. | LINK

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