As we reported last month, PAL coalition member Change to Win launched a campaign to challenge CVS Caremark’s [NYSE:CVS] sending of a letter to doctors of specific patients, apparently promoting Merck’s [NYSE:MRK] diabetes drug Januvia. Change to Win launched a website for the campaign, Alarmed about CVS Caremark.

This week, Change to Win announced a broader campaign targetting CVS, Cure CVS Now. On Thursday, December 4, Change to Win held press conferences around the country to announce & launch the campaign, and to issue a report on CVS’s practices, Cure CVS: From Low Quality to High Prices, CVS Is Failing Our Communities.

The press conference in Boston featured speakers from a number of community & labor organizations in the Greater Boston area, including the very young:

At the Cure CVS website describes:

CVS’s growth has come at a high price for many of the communities in which CVS operates. The company’s mission is "to improve the lives of those we serve by making innovative and high-quality health and pharmacy services safe, affordable and easy to access." But, according to the results of a 14-month investigation, CVS actually fails to provide equal and fair access to its services, based on analyses of several key measures. And regulators have raised concerns about quality, overcharges, privacy protection and safety related to CVS.

Explore the issues around some of those concerns:

• CVS Fails to Provide Equal Access
• CVS’s Questionable Products and Services
• CVS May Not Offer a Fair Price
• CVS’s Failure to Protect Private Information
• CVS’s Press for Profits May Put Patient Care at Risk

Change to Win’s investigation and report focus primarily on the “retail,” non-pharmacy side of CVS’s business. We hope that they will also investigate practices and quality at the pharmacy counter. We here at PAL and our coalition members work on numerous aspects of how the pharmaceutical supply affects consumers, but we know that the pharmacy counter is “where the rubber meets the road.”

Since CVS is the nation’s largest pharmacy chain, the public should know how CVS is measuring up on things like pricing of drugs to the uninsured, encouraging use of generics, working conditions for pharmacists and pharmacy technicians (which of course affects consumers as well — in terms of quality of service and prevention of errors), protecting the privacy of patient prescription records, ensuring that patients understand how to take their drugs, etc.

We’ll continue to post updates on Change to Win’s campaigns concerning CVS as they become available.

We noted this Newsday story with pleasure: “2 drug chains to provide Rx translation services,” about an agreement between NY Attorney General Andrew Cuomo and the pharmacy chains CVS (NYSE:CVS) & Rite-Aid (NYSE:RAD). Says the article:

CVS and Rite-Aid, will advise pharmacy customers about prescriptions with spoken and written translations in Spanish, Chinese, Italian, Russian, French and Polish, Cuomo said in a news release.

Cuomo’s office launched an undercover investigation after a Brooklyn-based nonprofit, Make the Road by Walking New York, complained that pharmacies “routinely fail to advise non-English-speaking customers in a language that allows them to understand the purpose, dosage and side effects of their medications,” according to the release.

State law requires pharmacists to “personally provide information about prescription drugs to all patients, orally and in writing,” the release said.

This is great news, given that patients whose first language is not English face major obstacles to getting adequate health care. Recognizing this problem, there are state and federal laws requiring that health care providers (and pharmacies, at least in NY) ensure language access for all their patients/customers.

A patient who can’t read or understand the instructions for a prescription drug can’t take it correctly. They may not understand how often to take it, what time of day to take it, whether to take it with food or not, and whether it has any dangerous drug interactions.

Failing to ensure that the millions of such patients can understand how to take their drugs isn’t just important for them individually and their families — it’s important for the health care system as a whole. Patients who can’t comply with their prescription drug regimen because of language barriers are more likely to have their chronic conditions not controlled. This can lead to a worsening of those conditions (e.g. heart disease, high blood pressure, diabetes), putting them at an increased risk of complications and even death. It also puts them at an increased risk of injury caused by their drugs — because of accidental overdosing and drug interactions.

There’s one thing in particular that jumped out while reading the Newsday story:

CVS and Rite-Aid, will advise pharmacy customers about prescriptions with spoken and written translations

[emphasis added]

If this means that CVS and Rite-Aid will be translating a drug’s official FDA-approved label, who is responsible for the content and accuracy of the translated label? Is it the drug store, which translated it? Or the manufacturer, which wrote the original? Manufacturers would argue, understandably, that they’re not responsible for something they didn’t write/translate.

Medical translation is a delicate art, and minor changes in translation can have major consequences for the meaning of the text once it’s translated. Who does the translating is key. There are translators, and then there are translators. Nuances of meaning and idiom are notoriously tricky, yet are key to adequate understanding. PAL’s parent organization, Community Catalyst, learned this while translating its Generics are Powerful Medicine materials into Spanish (those Spanish-language consumer materials about generic drugs are here.

Some other questions came to mind:

• How will these written translations be done? They can’t be done on an as-needed basis – you can’t exactly translate a drug’s label, or even the instructions for taking it, on the spot in the pharmacy. If they’re done prospectively, what drugs will they be done for? There are tens of thousands of prescription medications on the market in the U.S. Yet a huge percentage of dispensed prescriptions are concentrated in a very small number of best-selling drugs. CVS and Rite-Aid aren’t going to translate the label of every drug on the market, so how do they decide which to do?
• What if there are changes to the drug’s label? Is there an ongoing obligation for CVS and Rite-Aid to update the translations? What if, for instance, new risk information is added to a drug’s label and the pharmacy doesn’t add that to the translation? This could present a liability risk to the pharmacy.
• What if there’s a discrepancy between the original label and the translation? Another possible liability risk for the pharmacy
• How do small independent and community pharmacies fulfill this obligation? They don’t have the resources and the staff to do such translations that chains like CVS and Rite Aid do. Does this place them at an even greater competitive disadvantage than they already are?
• If drug manufacturers know that their drugs’ labels have been translated, do they have an obligation to ensure that those translations are accurate? On the one hand, you can’t make a drug maker responsible for every mis-translation of things they write. But on the other hand, if they know a major chain has translated their materials, do they have a responsibility to check the accuracy?
• How do you guard against differing translations? No two translators will translate the same item the same way. Will there be uniformity throughout, say, all of CVS’s stores? What if CVS’s translation differs from Rite-Aid’s? Consumers change pharmacies at times — this can create patient confusion.

The growth of the number of patients in the U.S. who are not fluent or literate in English suggests that translation of prescription drug instructions and labels is going to be an increasing need. The problems above suggest that there’s a need for uniformity. Perhaps drug manfacturers should proactively translate their materials and labels to ensure accuracy and uniformity. The question arises whether a translated label would require the same FDA approval as the original label, and whether FDA has (a) the capacity to review translations and (b) the regulatory or statutory power to do so.

This is an issue that pharmacists, manufacturers, regulators and advocates for improved language access in health care need to address.

We’d be very interested in pharmacists’ take on this issue. How have you dealt with this in your pharmacy? What do you think needs to be done to ensure that non-English speakers understand their medications? How do we take these steps without overburdening pharmacists, particularly those in small independent and community pharmacies?

The Prescription Access Litigation Blog has been on summer vacation recently, sunning itself at the beach, drinking iced tea, and playing volleyball with other blogs at Blog Camp. It’s now back, tanned, rested, and ready to deliver an ice-cold cup of refreshing pharmaceutical news and outrage to you, our thirsty readers.

And its first post-summer-break item is a dispatch straight from the Department of Unbelievably Evil & Greedy Schemes:

Business Week ran a special report yesterday (July 23, 2008), with the frightening title:

“They Know What’s in Your Medicine Cabinet: How insurance companies dig up applicants’ prescriptions—and use them to deny coverage”.

Here’s the rub:

That prescription you just picked up at the drugstore could hurt your chances of getting health insurance.

An untold number of people have been rejected for medical coverage for a reason they never could have guessed: Insurance companies are using huge, commercially available prescription databases to screen out applicants based on their drug purchases.

This is one of the latest revelations concerning the practice of pharmaceutical datamining. There’s a fact that few people know, but that should be printed on huge signs at every pharmacy:

Pharmacies sell information about the prescriptions they fill to companies that then sell that information to health plans, pharmaceutical companies and others that use it for marketing purposes.

The use of this information that’s most widely known is for drug company marketing. Companies like IMS Health and Verispan buy data from pharmacies detailing the prescribing records of doctors. That data is supposed to have any details about individual patients removed, or “scrubbed.” These companies then turn around and sell this information to drug companies. The drug companies give this information to the sales people, who then descend on doctors’ offices, armed with the details of exactly what drugs the doctor has prescribed, and how that’s changed over time. They can then tailor their pitch accordingly.

That practice is bad enough, and a number of states have passed or are trying to pass laws outlawing this “datamining.” (And datamining companies have sued to block these laws in every state in which they’ve been passed — we at PAL joined a “friend of the Court” brief defending Maine’s law. Read more about that here.) It’s an issue that the Prescription Project and the National Legislative Association on Prescription Drug Prices are working very hard on.

But, as the Business Week report describes, an even more nefarious use of this prescribing data is emerging. A few choice excerpts and factoids from that article:

• “Traditionally, applicants have been asked to provide insurers with a description of past illnesses. About 30% are deemed uninsurable because of their histories, according to industry veterans. Prescription profiles could add another hurdle, making it especially difficult for the 47 million Americans who lack insurance to acquire coverage.”
• “Most consumers and even many insurance agents are unaware that Humana, UnitedHealth Group , Aetna (AET), Blue Cross plans, and other insurance giants have ready access to applicants’ prescription histories. These online reports, available in seconds from a pair of little-known intermediary companies at a cost of only about $15 per search, typically include voluminous information going back five years on dosage, refills, and possible medical conditions. The reports also provide a numerical score predicting what a person may cost an insurer in the future.”
• “drugs for depression and other mental health conditions are often red flags to insurers.”

It’s likely that other classes of drugs are red flags as well — anything that suggests a “preexisting condition,” particularly a serious or chronic one, might make an insurer lean towards denying a consumer coverage. So drugs for diabetes, arthritis, HIV/AIDS and any number of conditions might raise similar flags.

What’s particularly troubling about this is that, because of the nature of prescription drugs, there’s no way for consumers to be “anonymous” in the way that they can be in virtually every other product they buy. For instance, let’s say you go to the drug store to buy something that you’d rather not call attention to – be it diarrhea medication, contraceptives, or the latest issue of Us Weekly. You just pay cash and don’t use your store “frequent buyers card” (like the CVS ExtraCare card). Voila – anonymity.

But you can’t do that with a prescription drug. You need a prescription from your doctor, which identifies you, and your information gets entered into the pharmacy’s computer system. What’s ironic about this is that one can argue that there’s a greater interest in having your prescriptions kept private than in having your other purchases kept private.

How can pharmacies disclose my prescription information? Isn’t it private?
This data is private, and is protected from disclosure by HIPAA, the Health Insurance Portability & Accountability Act. UNLESS you give someone PERMISSION to access that information. And that’s exactly what millions of consumers are doing, without realizing it, when they apply for health insurance. As Business Week says:

When applying for insurance, individuals routinely sign paperwork allowing providers to review their medical history. To comply with the privacy provisions of the federal Health Insurance Portability & Accountability Act, most insurers have now added a reference to prescription history in the lengthy fine print consumers are instructed to read.

The FTC forced the industry to begin disclosing the use of prescription information under a different federal statute, the Fair Credit Reporting Act. Insurers now are required to tell applicants the address of the company that assembled the data. Copies of prescription reports are supposed to be available to consumers at no charge under federal law.

But these disclosures are typically buried and never read by the overwhelmingly majority of consumers that are “agreeing” to them by signing that health insurance application. And there’s likely nothing you can do about it either — if you refuse to allow the health insurer access to your medical records, in all likelihood, they can and probably will just turn down your application. I believe that’s what they call a Catch-22, or perhaps being caught between a rock and a hard place.

Now that the practice is coming to light, hopefully privacy advocates and those working to make insurance easier to access will begin raising a hue and cry about this, and get the attention of legislators and regulators. In the meantime, it cant hurt to read the fine print when you apply for health insurance and ask your pharmacy what they do with your prescription records and whether it’s possible for you to “opt out” of whatever programs they have that sell that information.

On August 27, 2007, Judge Patti B. Saris of the U.S. District Court for the District of Massachusetts issued an order allowed the case of New England Carpenters Health Benefits Funds et. al. v. First Databank, Inc., and McKesson (NYSE:MCK) to proceed as a class action. The lawsuit was brought by PAL members New England Carpenters Health Benefits Funds and AFSCME District Council 37 Health and Security Plan in June 2005 and February 2006.

The case alleged that First Databank, the preeminent publisher of whole prescription drug pricing information, and McKesson, one of the three largest prescription drug wholesalers, conspired to increase the “Average Wholesale Prices” published by First Databank for hundreds of brand-name prescription drugs. The “Average Wholesale Price,” or AWP, is a benchmark figure used by health plans and Pharmacy Benefit Managers to determine how much to pay pharmacies for prescription drugs that are dispensed to patients with insurance. For instance, a health plan may have a contract to pay a pharmacy AWP minus 15% for drugs given to its members.

Manufacturers report either the AWPs for their drugs to First Databank, or another figure, Wholesale Acquisition Cost (WAC), which is the price that manufacturers typically sell their drugs to wholesalers. First Databank would then apply a “markup” of 20% or 25% to the WAC to calculate the AWP. The lawsuit alleged that:

“Beginning in late 2001, First DataBank and McKesson reached a secret agreement on how the WAC to AWP markup would be established for hundreds of brand-name drugs. McKesson and First DataBank, raised the WAC to AWP spread from 20% to 25% for over four hundred brand-name drugs that previously had received only the 20% markup.” (Memorandum & Order, p.6)

By raising the “spread” from 20% to 25%, this alleged scheme had the effect of raising the prices of the drugs in question by 4% across the board. Tens of millions of purchases of hundreds of drugs were thus made at the new, inflated prices, cause billions in unnecessary and allegedly illegal overpayments.

In October 2006, First Databank agreed to settle the case against it. First Databank agreed to rollback the “spread” on hundreds of drugs (representing 95% of the retail branded drug market) from 25% to 20%. This rollback will save an estimated $4 billion on drug spending in the first year alone. First Databank also agreed to go out of the business of publishing Average Wholesale Price data, which will result in health plans, Pharmacy Benefit Managers, and government programs shifting away from using the flawed AWP system to using a more transparent and accurate benchmark for paying for prescription drugs. In November 2006, the Court granted preliminary approval to that settlement. Just recently, in August 2007, the Court ordered that notices be published notifying consumers of the settlement and mailed to Third Party Payors (health plans, insurers, etc.)

McKesson, however, did not settle, and the plaintiffs continued to pursue the case against it aggressively. When a case is brought as a class action, it combines the claims of many individuals and entities into one lawsuit. This is particularly important when it would be infeasible for individuals to bring lawsuits on their own, such as when the damages that could be won in such a suit would be far outweighed by the costs of bringing it. The Judge must determine whether or not a case brought as a class action should in fact proceed as a class action. This is called “class certification.” Whether or not a class action is certified usually determines whether or not the case ultimately can go forward at all.

In her August 27 order, Judge Saris certified two classes:

• Class 1, Consumer Purchasers: All individual persons who paid, or incurred a debt enforceable at the time of judgment in this case to pay, a percentage co-payment for the Marked Up Drugs during the Class Period based on AWP, pursuant to a plan, which in turn reimbursed the cost of brand-name pharmaceutical drugs based on AWP. The Marked Up Drugs include all of the drugs identified in Exhibit A to the Second Amended Complaint and consist of certain brand-name drugs only; and
• Class 2, Third-Party Payors: All third-party payors (1) the pharmaceutical payments of which were based on AWP during the Class Period; (2) that made reimbursements for drugs based on an AWP that was marked up from 20 to 25% during the term of its contract with its PBM or with another entity involved in drug reimbursement; and (3) that used First DataBank or Medispan for determining the AWP of the marked up drugs. The Marked Up Drugs are all drugs identified in Exhibit A and consist of brand-name drugs only.

Excluded from the Class are (a) each defendant and any entity in which any defendant has a controlling interest, and their legal representatives, officers, directors, assignees and successors; (b) any co-conspirators; and (c) any governmental entities that purchased such drugs during the class period.

At this juncture, Class 1 is certified for liability and for damages, but Class 2 is only certified for liability and for
equitable relief. I defer deciding whether to certify the TPP class for purposes of damages until plaintiffs propose a feasible aggregate damage methodology for TPPs.

The importance of this case cannot be overstated — a massive fraud was allegedly perpetrated by two pharmaceutical industry middlemen that virtually no consumers were aware even existed. McKesson Corporation, not exactly a household name, had $88 billion in annual revenues last year, and was 18th on the Fortune 500 list. This puts them ahead of AT&T (#27), Procter & Gamble (#25), Costco (#32), and Target (#33), among many other more well-known companies. This alleged conspiracy caused consumers, health plans, employers and taxpayers to unnecessarily pay billions more for prescription drugs. This case illustrates how the arcane world of prescription drug pricing, which is so important to the well-being and pocketbooks of millions of Americans, resembles a lawless wild west sorely in need of a new Sheriff. The Judge’s certification of these two classes allows the case against McKesson to go forward.

The Judge’s order can be found here and it provides an interesting and readable overview not just of this alleged scheme but also of the bizarre world of how drug prices are determined. More about this case can be found here. The press release issued by the plaintiffs’ co-lead counsel can be found here.

The Southern supermarket chain Publix announced today that it will be offering seven common prescription antibiotics for free in its stores, located in Flora, George, South Carolina, Alabama and Tennessee. The move was reported in an AP story and in the Palm Beach Post.

The move follows on the heels of similar moves by other retailers, to offer selected generic drugs at low cost. Last year, for instance, Wal-Mart annoucned that it would offer a list of certain generic drugs at $4 per prescription.

What’s wrong with offering consumers free drugs? After all, many people, particularly people without insurance, have a hard time paying for prescription drugs. So free drugs will help them, won’t they?

It is true that free or discounted prescriptions can help patients, particularly the uninsured and low-income. But there is something peculiar and potentially disturbing about Publix’s move: The selection of antibiotics as the drugs to be offered for free.

Antibiotics are typically used for short periods of time to treat acute infections. Unfortunately, antibiotics are also massively overprescribed, which leads to the increase in infections which are resistant to common antibiotics. (See this June 2007 Denver Post article for more on the dangers of that resistance) The Palm Beach Post raised this concern in its article on the announcement:

Some public health officials have raised concerns about increasing use of some antibiotics because their overuse causes them to become less effective as the bacteria they target develop immunity.

The Publix initiative might contribute to that if doctors were to respond by increasing the number of prescriptions they write for the particular antibiotics the company is offering for free, said Lisa McGiffert, a health policy analyst for the Consumers Union, publisher of Consumer Reports, which has raised some concerns about antibiotic resistance

Will the fact that antibiotics are available for free at Publix cause doctors to prescribe more of them? Perhaps not. But there is still widespread inappropriate prescribing of antibiotics by physicians and nurse practitioners, often prodded by patient demands.

Another factor contributing to antibiotic resistance is patients not finishing the antibiotics they’ve been prescribed. It is still all too common for patients to stop taking their antibiotics when they begin to feel better. This allows bacteria to develop resistance to that particular antibiotic. It is a well-established principle of both economics and psychology that people’s perception of the value of a good relates to how much they paid for it — Thus, a patient who had to pay for their antibiotics is perhaps more likely to actually finish taking them, on the notion that “I paid for these pills, I don’t want to have wasted that money.”

The antibiotics being offered for free by Publix are all generics, and are not expensive compared to other prescription drugs. On drugstore.com, for instance, the cost of an illustrative prescrpition of 6 of the 7 antibiotics (oddly, Penicillin could not be found) covered by the program was:

amoxicillin: 30 capsules, 250mg $7.99
cephalexin: 30 capsules, 250mg: $8.99
erythromycin: 40 tablets, 250 mg: $9.91
ampicillin: 30 capsules, 250mg: $7.99
sulfamethoxazole-trimethoprim: 30 tablets, 400-80mg: $11.99
ciprofloxacin HCl: 30 tablets, 250mg: $113.65

The only one that was more than $12 was Cipro, which became famous several years ago during the Anthrax scare. $113.65 certainly isn’t cheap, but other forms of Cipro that patients frequently use are cheaper – for example, drugstore.com lists Cipro eye drops (0.3% Solution 2.5ml Bottle) at $15.99.

Since antibiotics are typically taken for a short period, this amounts to a very modest one-time savings. This underscores that this is mainly a marketing move, something which Publix more or less admitted in the Palm Beach Post story:

“No one else is doing this,” Publix spokeswoman Anne Hendricks said. “A couple of competitors offer low-cost. We have never been about that. We are always looking for ways to differentiate ourselves from the competition.”

The Lakeland-based company has 907 stores. In addition to Florida, Publix operates groceries in Georgia, South Carolina, Alabama and Tennessee.

With health care costs one of the biggest challenges facing many Americans, Crist said that the private sector’s involvement in the solution was “a great trend.”

Jenkins acknowledged that increasing pharmacy sales was a part of the company’s motivation but said the company also wanted to contribute to that trend.

“Frankly, we’re interested in building our pharmacy business,” Jenkins said. “But moreover, we want to help the citizens of our state have affordable health care, and we thought this was just a good start in doing that.”

The one-time savings this program represents does nothing to address the more serious problem of patients not having insurance or not being able to afford medications that they must (or should) take on an ongoing basis, such as medications for high blood pressure, diabetes, and other chronic conditions. The real cost obstacles in prescription drugs are not in generic antibiotics.

Just as the discount programs at WalMart and other chains did, it is likely that these free antibiotics will function as a “loss leader,” drawing people into Publix, where they will inevitably purchase other non-pharmacy items. Whether it will do anything of significance for people without drug coverage is much less certain.

One option for people without insurance is a Patient Assistance Program that offers steeply discounted generic drugs — www.Rxoutreach.org