In the battle to prop up the ‘Affordable Care Act’, some may want you to believe that our doctors of tomorrow will have the same research and development– and innovation–as we enjoy today.  This is unlikely, however, as the complex politics of insurance companies, drug stores, and Big PhRMA battle for the hearts, minds, and wallets of American patients.

SAN DIEGO – Sunday, February 19, 2012:  Evidence-based medicine is a concept whereby medical decisions are made based on objective studies and outcomes.  It makes sense. Treatments should work in the real work, improving and extending lives and the quality of life.  Obamacare, however, is anything but ‘evidence-based’. In fact, the Independent Payment Advisory Board (IPAB) and the local Accountable Care Organizations (ACOs) of the new healthcare law will make decisions based mostly (but not entirely) on politics, regional powerbrokers, and cost. If a drug or treatment ‘sort of’ works, and it costs a lot less, then peripheral issues of side effects, efficacy, and quality of care will take a back seat.

One of the most personal and important aspects of every patient’s life is his/her reliance on prescription drugs. Nowadays, the integrity of a medical doctor’s ability to maintain a faithful and private relationship with his patients is being compromised. With little more than a phone call to an office nurse, prescriptions are being switched by pharmacists, who are rewarded financially for such behavior. New electronic platforms mandated under the new health care reform law also serve to coerce physicians away from certain medications in favor of less expensive (and often less effective) alternative generic drugs.

The fallacy of ‘targeted intervention’ or TIP®

The CEO of a company that was mentioned in this column last week, in an article on the pharmacy industry’s ‘kick-back’ program (which rewards pharmacists with financial bonuses to switch patients from brand drugs to less expensive ‘therapeutically similar’ generics in the same class), took issue with my criticism of his industry.  I respect his right to make a living, but must further explain what his business model is hiding from the public.

The article of 2/14/12, entitled “The Scheme to Change Your Doctor’s Prescription – A Glimpse of Obamacare or Just Unethical Profiteering,” made the point that a patient deserves a ‘pharmacy bill of rights’. Patients need to be able to consult with their physician when ‘therapeutic’ drug switches are made, and they need to know if such a switch rewards the pharmacy chain and pharmacists financially. Patients deserve to know that some programs, such as United Healthcare’s Medco even threaten to take their business away from pharmacies that are not successful in effecting such patient drug switches.

A United Healthcare memo to pharmacies states, “effective February 1, 2010, United Healthcare, processed by Medco, implemented a process to encourage members to switch…to lower cost alternatives…if you are not successful in encouraging the patient to switch to a lower cost alternative, you will lose the prescription to mail order.” In other words, the pharmacy either plays along with the drug-switching scheme, or loses the patient business altogether to a mandated ‘mail-order’ program.

If the pharmacy industry CEO truly believed his industry was basing decisions to switch patient prescriptions on ‘evidence’ for improved quality, then he would also agree to support ‘transparency laws’ which would bring the behind-the-scenes pay-backs to pharmacists into the light of day. Transparency laws—none of which exist today for the pharmacy industry—would make it illegal to apply financial kickbacks to pharmacists, or at least mandate that patients are informed of the financial reward given to the pharmacist for switching out the patient’s prescription.

Dangers of Pharmacy TIP® Schemes

It is hard to believe that TIP practices actually (if ever) switch patients from efficaciously inferior generic medications to more expensive and better brand drugs. Here’s an example of where the TIP scheme profits pharmacies and pharmacists at the potential expense of patient well-being:

Let’s consider the TIP practice of paying a pharmacist $20 dollars to move a patient from a much lower dose branded cholesterol-lowering statin (Atorvastatin) to a therapeutically and chemically different, maximum dose generic statin (i.e., Simvastatin). The only similarity between these two drugs is that Atorvastatin, at 40 mg. (at half the dose needed by Simvastatin), reduces the LDL cholesterol by 50%; with Simvastatin, the LDL cholesterol is reduced by 50% as well but only at twice the dose amount. What is not communicated to patients is that Simvastatin has a greater potential for severe drug interactions (especially at higher doses) and the drug levels or plasma levels can increase much more significantly than atorvastatin.

So not only is the pharmacy drug-switching scheme pushing patients to a different drug, but it saddles the patient with a drug that is being utilized at the HIGHEST approved dose. This alone can increase the chance of upset stomach, myopathy, increased CK elevations, Liver enzyme elevations, increase chance for rhabdomyolysis (which can lead to death) and ultimately result in poor patient compliance due to side effects. If you add on the increased potential for an adverse drug interaction by taking the MAXIMUM dose of Simvastatin (to other potential medicines the patient is taking), the drug’s plasma levels can go dangerously high and lead to even greater negative events and outcomes.

This is not a demonstration of evidence-based medicine, but rather profit-based scheming on the part of unethical business practices hiding behind the premise of healthcare reform and cost-savings.

Note again, in the example above, that the brand drug, Atorvastatin, carries the same potential risks but is safer because it usually achieves clinical results at low to moderate dosing levels—not the ‘high’ levels needed to effect such change with the use of the generic Simvastatin. Bottom line: drugs in the same ‘therapeutic class’ are not always clinically equivalent. {reference:  JAMA, May 16, 2001—Vol 285, No. 19; ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, Dec. 2001, p. 3445–3450, Vol  45, No. 12}

The Obamacare law works to impair research and development by drug manufacturers, thus decreasing the likelihood that new and improved medications will be created to cure new and existing diseases in the future.  It also encourages (and even rewards) pharmacies, health insurers and health systems to disrupt the doctor-patient relationship in pursuit of cost-cutting, rationing, and corporate schemes  that place ‘system’ priorities above ‘patient’ priorities.

Broader Healthcare Reform Economics

The President’s 2013 budget includes provisions to give Medicaid prescription drug rebates to the Medicare Part D program and reduce data exclusivity for innovator biologics from 12 years to seven.  The budget also prohibits certain patent settlements between brand and generic drug manufacturers, and contains cost-saving schemes to increase the impact of Independent Payment Advisory Board (IPAB).  Like the insurance industry kickback to pharmacies to push potentially less effective drugs, the IPAB will apply similar mechanisms to restrict effective medical and surgical treatment options.

Gaming the politics of healthcare reform is not exclusive to the ‘pharmacy’ industry, which deals in drug delivery/retail sales.  The ‘pharmaceutical’ industry (drug manufactures/research and development, called Big PhRMA for the Pharmaceutical Research and Manufacturers of America) also made a potentially catastrophic mistake in lending the President its support for Obamacare back in 2010. By doing so, they not only short-changed their own long-term profit potential, but also weakened a crucial American resource for new patient care innovations. Big PhRMA is a crucial link in the development of new cures and treatments in healthcare.

The full text of the President’s 2013 budget reveals that the pharmaceutical industry will have to pay $156 billion over the next decade in patient/drug rebates and discounts, in addition to the $80 billion in concessions made in the Oval Office in the run-up to the ‘Affordable Care Act’s’ passage in 2010. For FY2013, the White House projects a $1.3 trillion shortfall, based on projected outlays of $3.8 trillion and revenues of $2.5 trillion. The FY2013 budget proposes $941 billion in program spending by Department of Health and Human Services (HHS) agencies, including the Centers for Medicare and Medicaid Services (CMS), National Institutes of Health (NIH), Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ), and the Office of the Inspector General (OIG).

However the politics of Obamacare may play out, there are mandates, rules, and unnecessary government rules to squeeze quality—as well as expense—out of the patient care experience.  Nowhere is this better demonstrated that in the context of the drug and pharmacy industries.  Instead of incentivizing these corporate giants to innovate and provide access to the underserved, the government creates perverse motives to circumvent the traditional physician-patient relationship. Ultimately, patients become secondary to economics, and are often unaware of clinically significant decisions that are forced upon them. Systemic cost savings is valuable, but not at the expense of patient safety.

http://communities.washingtontimes.com/neighborhood/medicine-and-politics-america/2012/feb/19/drug-stores-lack-transparency-and-evidence-based-m/

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