When she was diagnosed with multiple sclerosis, a Minnesota woman thought that her carefully chosen neurologist had her best interests in mind when prescribing initial treatments to modify the disease. That was before a little detective work uncovered the real motivation for her physician’s patterns of prescribing that left her even more debilitated than when she was initially showing symptoms.

It worried me that none of them ever suggested that I discontinue treatment—or switch to another treatment—even after I reported that my injection site reactions were affecting my quality of life. Despite the fact that my neurologist insisted that I begin disease-modifying therapy, I was never contacted by him, his nurse, or anyone else in the neurology clinic with questions about how my Copaxone injections were going.

The patient, a U of M philosophy graduate student, puts into her own words the ethical issue she gradually uncovered while under the specialist’s care. Just how influential are pharma companies’ financial compensations for physicians who choose to prescribe their products? Just how willing are they to prescribe knowingly untested medications without concern as to their problematic and potentially lethal adverse effects? Her answer came at her next appointment, after enduring months of increasingly debilitating pain and enfeebling function from the trial with the first drug.

[M]y neurologist informed me that I’d begun to develop lesions inside my brain stem. He explained that this was a very bad place to have lesions, occupied as it is with regulating some of the body’s basic functions, such as breathing. He strongly recommended that I go back on MS treatment, suggesting this time a drug called Tysabri (natalizumab), which had worked wonders for some of his patients but also carried some amount of risk. Worried about the new lesions, but knowing little about the drug he was advising, I told him I’d think about it. I needed to be convinced through my own investigations that this drug would be worth taking.

Her investigations were not only telling, but they are also indicative of an all-to-familiar refrain for patients of (mostly specialist) physicians who pocket major coin from pharma companies to get these ridiculously expensive agents to the marketplace, at the risk of patient harm. In Minnesota, the patient was assisted by a database which lists pharmaceutical third parties with which a prescribing physician has a financial interest. She makes little doubt of her eagerness for this requirement to spread nationally as the result of the reform law. | PDF LINK

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This item comes as no surprise to those of us who primarily treat the elderly.

According to researchers, nearly 100,000 hospitalizations every year are linked to adverse drug events such as allergic reactions and unintentional overdoses. Nearly half, or 48.1 percent, of those hospitalized were adults 80 years old or older.

Those agents? Insulin, older generation anti-diabetic drugs (oral), aspirin, and warfarin. It is quite true — and as equally disturbing — that these medications are not only responsible for discrete adverse drug reactions in their own right, but their pharmacological behaviors are responsible for a substantial number of interactions whose iterative clinical manifestations are truly logarithmic in scope. | LINK | Abstract LINK

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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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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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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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Drug shortages in hospitals were somewhat of a rarity at one time. For many reasons (not all of them economic) a trend in the late 2000s continuing up to today notes a disturbing pattern of many pharmaceuticals whose usage permeates multiple departments in an acute care setting. From the emergency department to the ICU, this problem is just beginning to percolate.^[1] In fact, in the month of May 2011 alone, major shortages in a range of agents contributed to the over 90 such cases in the first quarter of ’11. Antibiotics such as ciprofloxacin (already on an endangered species list in many hospitals due to increasing resistance patterns) lead the pack.

The major reasons cited? Product recalls (less of an issue with fewer NDAs), contaminated vials, demand fluctuations, and improvements on the manufacturing end (production plants). From an economic standpoint, lower profit margins for generics allows for less of an incentive for manufacturers to produce the low cost agents — creating a problem for their availability. Higher cost branded drugs may also create more of a problem during an availability crisis because substitutions may not render the same quality of care — representing a case for comparative research as a marker for quality. Although the overall numbers of deaths due to pharmaceutical shortages pales in comparison to the incidence of other more numerous causes of avoidable and preventable hospital deaths,^[2] the issue of med availability is a compelling one that deserves increased scrutiny. | LINK

1. As many as 211 drugs were listed as in short supply in 2010, three times more than in 2006.
2. According to the Institute for Safe Medication Practices, two patients died last year because their substitute painkiller dosage was wrong – at the time there was a shortage of morphine.

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It’s got bipartisan support, and it would call for transparency the amount that Medicare pays providers for treating patients.^[1] Sens. Wyden (D-MA) and Grassley (R-IA) are introducing the Medicare Data Access for Transparency and Accountability Act . Its passage into law would override an existing 1979 proviso that keeps such numbers confidential. The original intention of such a law is out of step with the tenets of reform and the new bill’s introduction is a welcome sight in the race to combat Medicare fraud. It is interesting to note that the current injunction has languished for over thirty years — its origins resulting from the obligations of a Florida district court on behalf of the AMA and that state’s medical association to keep such data secret.

The AMA still has that position, arguing that release of providers’ Medicare billing info violates privacy in this area and amounts to a form of identity theft. A pretty weak argument when one considers the reason for transparency in this situation: last year the WSJ ran a series of articles highlighting physicians receiving payments in the millions for running unnecessary testing, surgeries, and procedures on Medicare beneficiaries based upon access to limited Medicare claims data. | Sen. Grassley’s statement here | LINK 2

1. The law would provide information on how much individual physicians receive from Medicare for treating seniors on a FFS basis — expensive level-4 office visits, procedures, etc. — would be posted online.

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Policy wonks, regulatory agencies, legislators, and just about any interested person can usually obtain access to a physician’s relationship with pharma companies and the drugs they pitch. It wasn’t too long ago that this information was more challenging to find, let alone synthesize. Over the past twenty years, Minnesota has pioneered efforts through legislative action designed to strengthen consumer protections with regard to freedom of disclosure laws. Large state mandated databases now report routinely on physicians, pharmacists, and other providers in the state, as a result.

Increasingly, however, disclosure information reported to inquiring third parties has been lacking in accuracy — more specifically, the reports lack effective auditing mechanisms for the purpose of ensuring the most accurate disclosure data regarding provider payouts from pharma relationships. The net effect is that there are usually major discrepancies in what pharma companies are required to post versus what the state posts. Physicians, as a result, may be incorrectly characterized as to their degree of involvement. This, of course, has implications for both healthcare systems, consumers of healthcare, and state and local governments if reform — as it applies to spending on healthcare — is to make any sense of just how much waste is occurring at the hands of Pharma and its industry sponsored payouts. | LINK | LINK to ProPublica’s Dollars for Docs database (Minnesota)

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