Great article in today’s Washington Post: “Doctors, Legislators Resist Drugmakers’ Prying Eyes”. The article discusses the now-hot issue of whether the data of what drugs Doctors prescribe should be private, or whether drug companies should be able to purchase that data from pharmacies.

The article features the National Physicians Alliance, which has a new campaign on this issue (featured in our recent blog entry, “Doctors: Big Pharma is watching you!”)

In that entry, we raised the issue of whether doctors know that their prescribing data is being sold. All indications are that many if not most doctors are not aware of this. But how would most Doctors feel if they knew that the American Medical Association was selling their information to drug companies? As the article points out:

The American Medical Association, a larger and far more established group, makes millions of dollars each year by helping data-mining companies link prescribing data to individual physicians. It does so by licensing access to the AMA Physician Masterfile, a database containing names, birth dates, educational background, specialties and addresses for more than 800,000 doctors.

After complaints from some members, the AMA last year began allowing doctors to “opt out” and shield their individual prescribing information from salespeople, although drug companies can still get it. So far, 7,476 doctors have opted out, AMA officials said.

It’s not abundantly clear on the AMA website how physicians go about opting out, but this page appears to be a likely candidate.

The New England Journal of Medicine yesterday released a study showing that Avandia, a popular drug for treatment of Diabetes, increases the risk of heart attack by 43%.

This story was widely reported in the mainstream media (see, e.g., the Associated Press story) and pharmaceutical/health care blogs. We can expect much more on this story in the weeks to come.

Annual U.S. sales of Avandia were $2.2 billion in 2006, putting the drug well into the blockbuster category. This does not include sales of Avandamet, which combines Avandia with metformin, another diabetes drug. Either way, this is a very profitable drug for Glaxo Smith Kline, and their stock took a significant and predictable hit yesterday on the news.

This is only the latest in a string of revelations about GSK drugs. PAL members were among those that sued GSK for a variety of alleged illegal activity (see PAL’s pages on the Relafen, Augmentin, and Average Wholesale Price settlements, totalling $174 million).

Several years ago, former NY Attorney General (and now NY Governor) Elliot Spitzer sued GSK for concealing the fact that Paxil increases suicidal thoughts and behavior in depressed children and teens. As part of that settlement, GSK agreed to publish their clinical trials in a publicly available clinical trials registry. (GSK also agreed to pay $63.8 million to parents who purchased Paxil for their children, as part of a consumer class action. In fact, parents who did so can submit claims for reimbursement from that settlement from now until August 31, 2007 – details at www.paxilpediatricsettlement.com.)

In fact, much of the data in the NEJM study came from that registry. This underscores the importance of such registries, and of the necessity of mandating that drug companies register all their clinical trials in such registries. Various federal and state bills have been filed to enact such a mandate. (See the National Conference of State Legislatures for updated info on these bills.)

Given the importance of this information, why don’t more government prosecutions of drug company fraud include provisions requiring the defendant to submit all its trials to these registries? We previously discussed in this blog the question of whether recent US Attorney settlements with drug companies have real and lasting imapct. (See “Do government fraud settlements deter illegal pharma behavior?”)

Finally, this news further demonstrates the inadequacy of the FDA’s oversight of drug safety after a drug has been approved. In 2006, the Office of the Inspector General of HHS issued a report showing that numerous studies of prescription drugs that the FDA required drug makers to conduct after the drug had been approved had apparently not been conducted or even begun, and the FDA took little action to address the shortfall.

The studies that are used to approve a new drug usually involve, at most, a few thousand patients using the drug for short periods. But many side effects and safety issues only emerge after millions of people have taken the drug, and often only after a number of years. “Post-market” studies are essential to identify these problems. The FDA’s failure to ensure that these studies are done (or lack of authority to do anything meaningful when the studies are not done, depending on who you ask) is a huge and gaping hole in the U.S. drug safety system. Patients and doctors rightly want effective treatments to be available as quickly as possible. But that must be balanced with ongoing monitoring of the safety of drugs, to ensure that side effects and problems that only emerge later are detected and acted upon.

Lastly, it is a sobering thought that, had the NY Attorney General not learned of GSK’s deception regarding Paxil, and sued, and required GSK to submit all its trials to a public registry, the information about Avandia might not have been discovered. How many more Avandia users would have had a heart attack as a result? And how many more Avandia and Vioxx disasters are lurking, unknown, in the hidden and unavailable data of drugmakers that are not subject to the kinds of settlement that GSK is?

Here’s the latest installment of Ask Pharmie, where our guide Pharmie answers your questions on all things pharmaceutical.

At my local drugstore, I see drugs that are available Over-the-Counter (without a prescription) that I used to need a prescription for. How do drugs go from being prescription-only to being available Over-the-Counter?

Drugs that you can buy without a prescription are called Over-the-Counter (OTC) drugs. There are hundreds of different drugs that are OTC – cough and cold medications, pain relievers (aspirin, ibuprofen, etc), heartburn drugs, and many others. Many of these drugs have been available for a very long time, and have long track records for safety. Others are newer, and often started out as prescription drugs.

Some drugs that have made the switch in the past few years are the heartburn drugs Zantac, Pepcid, and Prilosec OTC, and the allergy drug Claritin.

Why would a drug company want to switch its drug from prescription-only to Over-the-Counter?

There are a number of reasons. Since it’s easier for a patient to get an OTC drug (you don’t have to visit the doctor and get a prescription), it’s likely that more people will buy it. So switching a drug to OTC can increase a company’s sales. Many people also have the impression that Over-the-Counter drugs are “safer” than prescription drugs, even though this is not necessarily the case. So switching a drug from prescription to OTC can convince people who might worry about the drug’s safety to buy it.

But sometimes drug companies make this switch as part of a larger strategy to protect and increase their profits. This usually happens when a prescription drug’s patent is about to expire. A company that discovers a new drug gets a patent that prohibits anyone else from selling that drug for a certain number of years. When that patent expires, the company’s profits on that drug drop, as competitors start selling generic versions of it. Brand-name drug companies have used a variety of questionable schemes to protect their sales when this happens. Sometimes they introduce an “extended release” version of the drug (that lasts, say, 12 hours instead of 6); or they introduce a “new” brand-name drug that’s really a minor tweak of the old drug.

Sometimes, as part of this, the brand-name drug company will try to get the FDA to switch the drug from prescription-only to Over-the-Counter. When Prilosec’s patent expired, the manufacturer petitioned the FDA to make it over the counter, while at the same time introducing a “new” prescription drug, Nexium. Claritin’s manufacturer did the same thing when its patent expired, while introducing Clarinex, a “new” prescription allergy drug.

Making this switch has a couple of effects:

• It can hurt the sales of the generic versions of the prescription drug, since it’s easier for consumers to just buy the OTC drug than go to the doctor and get a prescription. There are already numerous obstacles to generic drug companies making cheaper prescription generics available to consumers. This tactic just adds to those obstacles, potentially hurting consumers in the long run as fewer generics come onto the market.
• Health plans usually will not cover the OTC version, but often will cover the “new” brand-name prescription drug. Health plan co-payments for drugs are often lower than even the cost of the OTC drug, meaning that it’s often actually cheaper for the consumer to pay the co-payment for an expensive brand-name prescription drug than the full-price of the OTC version. But the overall cost to the health care system, and thus to all of us, is higher because of the higher price of the brand-name prescription drug.
• The manufacturer usually starts a splashy advertising campaign to convince consumers that the “new” drug is a major breakthrough that makes it worth the high pricetag. They may also run ads for the OTC version. When Nexium came on to the market, AstraZeneca spent huge amounts on ads focusing on its treatment for “gastric reflux disease,” a serious sounding disease, while ads for Prilosec OTC (essentially the same drug) focused on heartburn, a reasonably-harmless sounding symptom.
• If the company does new studies (clinical trials) as part of its request to the FDA to allow the switch, it gets to be the only OTC version on the market for three years. It can then aggressively market the OTC version and preserve a good-size chunk of its profits on the drug.

Who decides if a drug should be made Over-the-Counter?

The FDA regulates OTC drugs, just as it regulates prescription drugs. The FDA decides whether to allow a drug to make the switch from prescription to OTC. To approve a drug as an Over-the-Counter drug, the FDA must find that:

• Its benefits outweigh its risks: In other words, the improvements to your health from taking the drug are more important then any negative side effects.
• Its potential for misuse and abuse is low: That is, the drug should not be habit forming and shouldn’t cause a cheap “high” that would encourage people to overuse it.
• The consumer can use it for self-diagnosed conditions: The drug isn’t for something that needs testing or a doctor’s diagnosis, like high cholesterol. Instead, the drug treats a symptom that’s obvious to the average consumer, like a headache or allergy.
• The drug can be adequately labeled: The warnings and instructions for use are clear and easy to understand without any training.
• The drug does not need a doctor’s supervision: The drug is easy to use. For example, the drug doesn’t need a doctor to monitor and change the dosage.

Is there anything wrong with switching drugs from prescription-only to Over-the-Counter?

For many, if not most, of the OTC drugs that are at your local pharmacy, there is no problem with them being available without a prescription: their risks or side effects are low, how to use them is clear, they treat things that patients can easily recognize, they give the consumer greater choices, etc.

But not every drug should be “self-prescribed” nor should every condition be “self-medicated.” Many diseases and conditions require a physician to diagnose them in the first place, and then to monitor them and select the right medication. For many complicated diseases, a doctor needs to occasionally change the dosage of a drug or even what drug is given, and to monitor for side effects or complications. Conditions like high cholesterol, diabetes, high blood pressure and asthma are not good candidates for making the drugs to treat them available Over-the-Counter. There are also lifestyle changes (such as diet and exercise) that are an important part of treating conditions like these, and doctors play a vital role in encouraging patients to make those changes.

Isn’t there a middle-ground between prescription-only and OTC? Can’t we have consumers get some medications from behind the pharmacy counter, so at least the pharmacist can make sure the patient understands what it’s for and how to use it?

In the US, prescription-only and OTC are really the only two ways drugs are dispensed. There are a handful of exceptions. Recently, the federal government required that cold and sinus medications with pseudoephedrine (such as Sudafed) be kept behind the counter (BTC), to prevent people from stealing or buying large quantities to make illegal drugs. Plan B, an Emergency Contraceptive, is kept behind the counter, because the FDA only allowed it to be sold OTC to patients aged 18 years and older. This allows the pharmacist to check a customer’s age before the drug is sold to them.

But many other countries give greater leeway to keep OTC drugs “behind-the-counter.” In some countries (like Australia, England, France, and Germany), some drugs that can be bought without a prescription must be requested directly from a pharmacist. This allows pharmacists to act as an intermediary and to advise consumers on whether they need an OTC drug and which one to choose.

As dozens of blockbuster drugs begin to lose their patents in the next few years, we can expect to see more switches from prescription-only to OTC. It’s not clear that these switches are always in the best interests of patients, but sometimes are designed primarily for the drug company’s bottom line.

Ask Pharmie answers readers’ questions about the pharmaceutical industry, drug marketing, drug pricing, and the like. He does not answer medical or treatment questions, or render medical advice. We encourage readers to send their questions to Pharmie.

How many pharmaceutical executives does it take to screw in a light bulb?
(By Prescription Access Litigation)

Seven:

1. One to screw in the light bulb;
2. One to file a patent for “A method for insertion of a light-emitting glass fixture into a power source by rotational motion”;
3. One to create an ad encouraging consumers to “Ask your electrician if SuperBright XR is right for you”;
4. One to sue the manufacturers of cheaper, longer-lasting, but equally bright, compact fluorescent light bulbs;
5. One to launch an awareness campaign for Chronic Darkness Syndrome;
6. One to testify before Congress against government negotiation on the price of light bulbs; and
7. One to lobby against the importation of cheaper Canadian light bulbs.

It’s amazing how few doctors are aware — and how shocked they are to learn – that pharmaceutical companies routinely purchase their prescribing data from pharmacies. So that attractive detailer walking into the Doctor’s office knows exactly how many prescriptions you’ve written for their company’s product versus the competitors’. And they know how the Doctor’s prescribing changed since they last visited.

This allows pharmaceutical salespeople, and the pharmaceutical companies for whom they work, to target their sales pitches — that is, a doctor who’s reluctant to prescribe new drugs right after they’ve come on the market requires perhaps a softer sell than one who prescribes new drugs aggressively at the start. It also allows detailers to tailor their pitches over time — they can see what worked from their last visit right there in the data they purchase from pharmacies.

Most doctors aren’t aware that this goes on, and most patients certainly aren’t aware of it. Many, rightly so, regard it as a crass invasion of their privacy. The New Hampshire Legislature passed the “Prescription Confidentiality Act” last year banning the sale of doctors’ prescribing data for commercial purposes. That law was recently struck down by a Federal District Court, in a case brought by IMS Health and others. Prescription Access Litigation, AARP and others had filed an amicus curiae (“friend of the court”) brief supporting the law and calling for the lawsuit to be dismissed. Hopefully, the state of New Hampshire will appeal the ruling.

Enter the National Physicians Alliance, “founded to restore physicians’ primary emphasis on the core values of our profession: service, integrity, and advocacy.” They have a new campaign supporting other states’ legislative efforts to “ban the sale of physician prescribing data for commercial and marketing purposes.” See their creative 1-minute video on the issue below.

The Prescription Drug User Fee Act (PDUFA) reauthorization, passed last week by the Senate (but not yet by the House of Representatives) contained a wide variety of sections unrelated to FDA User Fees. One of these, section 519 would permit the FDA to impose monetary fines for pharmaceutical companies issuing “false or misleading” drug ads. The maximum fine for a first violation in a 3-year period would be $150,000, and a maximum of $300,000 for any additional violations in a 3-year period.

Back in 2005, PAL called for the FDA to seek from Congress the authority to issue civil monetary penalties, in our testimony at the FDA’s hearing on Direct-to-Consumer Advertising. Without such authority, the FDA’s power to regulate DTCA is essentially limited to issuing unenforceable “untitled” and “warning” letters. Given the number of recidivists in this area (see US PIRG’s report, “Turning Medicine Into Snake Oil“), this power is akin to an old joke (from Robin Williams, I believe) about unarmed British police shouting at a fleeing felon, “Stop, or I’ll Shout ‘Stop’ Again!”

It’s clear that for any standards regarding drug ads to be taken seriously, the FDA needs the ability to enforce them. Whether the fines included in the Senate’s PDUFA bill do the trick, however, is unclear. The fines listed are maximums, and even those are likely to be hotly contested by any companies upon whom they are sought to be imposed. It is uncertain whether fines in this amount would have any deterrent effect, or whether they might be, like much much larger US Attorney settlements recently reported upon here in this blog, slaps on the wrist. $150,000 is probably not far from the cost of a modest advertising buy on a major network, and certainly a small amount compared to even short-term sales of any blockbuster drug.

At the least, however, the notion that the FDA needs greater authority and powers to regulate drug advertising is now part of the public debate. And that is certainly a good thing.

Thanks to the various blogs (BrandWeekNrx, PharmaGossip, PharmaLot, PharmaBlogosphere, and others) that reported on this blog’s inaugural posts. To clarify, the name of the blog is not “Ask Pharmie.”

Ask Pharmie is a feature that will appear from time to time on the blog, answering readers’ questions about the pharmaceutical industry and its pricing and marketing tactics. The name of the blog is, compared to the luminaries of the Pharma Blogosphere, quite plain: simply, The Prescription Access Litigation Blog.

FTC Commissioner Supports Bill Banning Reverse Payments
PAL and 20 other organizations recently sent letters to the members of the House Energy and Commerce Committee, supporting HR 1092, the “Protecting Consumer Access to Generic Drugs Act of 2007.” FDANews.com Drug Daily Bulletin reports today:

Lawmakers at a House subcommittee hearing debated whether a bill that would ban reverse payment agreements would discourage generic companies from introducing new drugs or allow more generic products at lower prices for consumers.

H.R. 1902, the “Protecting Consumer Access to Generic Drugs Act of 2007,” would prohibit reverse payment deals where brand pharmaceutical companies compensate generic companies to delay introducing a generic drug to the market. However, it would authorize the FTC to make exemptions allowing the payments if they would be good for consumer interests.

Under reverse payment agreements, brand name and generic companies can stop competing and share the savings consumers should get, Rep. Bobby Rush (D-Ill.) said during a House Subcommittee on Commerce, Trade and Consumer Protection hearing. Reverse payments are costing consumers and government programs “billions and billions of dollars,” he added.

The bill is a “fundamentally sound approach” to the problem of anticompetitive agreements between generic and brand drug firms, FTC Commissioner Jon Leibowitz said. The FTC currently reviews every settlement between companies under the Hatch-Waxman Act, so it is well prepared to make exemption judgments, he added.

Eleven former FTC commissioners have all supported enforcement efforts against reverse payments, according to Rush. However, critics of the bill said it would discourage generic companies by limiting the types of settlements companies can enter.

Also today, “Bristol Myers Squibb announced that it would plead guilty to two criminal charges for making false statements to a U.S. government agency about the company’s patent settlement for the blood thinner Plavix,” again according to FDANews.com Drug Daily Bulletin It is worth noting that the guilty plea apparently has nothing to do with the reverse payment agreement itself, or with the legality of such agreements. But rather, the plea only addresses the criminal charges of making false statements to a government agency concerning that settlement.

“Ask Pharmie” started as a feature in PAL’s newsletter, which was printed approximately quarterly until the end of 2006. (Archive issues are here.) We’ve now shifted from a printed newsletter to this exclusively online publications (including this blog), but Ask Pharmie will continue.

Pharmie, our guide to all things pharmaceutical, answers readers’ questions about the pharmaceutical industry, drug marketing, drug pricing, and the like. He does not answer medical or treatment questions, or render medical advice. We encourage readers to send their questions to Pharmie.

Here are some of Ask Pharmie’s archived Q&As:

• Why are there drug ads on TV that don’t tell you what the drug is for?
• What is a generic drug? (And other questions about generic drug)
• How can I make sure I am getting a drug that is effective, safe and affordable? How can I help my doctor get unbiased information? (and other related questions)

The New York Times ran a story on Wednesday about the pros and cons of doctors distributing prescription drug samples. The article cites the critique (with which we here at PAL are in agreement) that samples are a form of marketing, intended to get physicians to prescribe, and patients to use, the most-expensive and newest drugs (but not necessarily the most effective or the safest).

It is axiomatic that samples are a marketing tool, given the billions that brand-name drug companies spend on them every year — as is true with so much pharma marketing (DTCA, detailing, etc), if drug companies didn’t think there was a financial return, they wouldn’t spend such lavish sums on it.

And in the ubiquity of the sample cabinet in the modern physician’s office lies an opportunity for counter-marketing — the drug sample equivalent of counterdetailing, if you will (or “academic detailing,” as Dr Jerry Avorn, the creator of the concept, calls it). Why not have samples of the most useful, safest, most cost-effective generic drugs in the doctor’s office?

Short answer: There’s no profit in it for generic manufacturers.
There’s no way for any given generic manufacturer to ensure that when the patient goes to the pharmacy counter that they will get that manufacturer’s product, as opposed to, say, Teva’s or Mylan’s or any of the dozens of other generic companies’. So a generic manufacturer will not place samples in a doctor’s office when there are numerous competitors producing the same product. (One might justly ask, then, why the generics industry as a whole isn’t collaborating on such an effort — just as one might ask why there’s no generic industry TV ads to counter the “brand-name is better” mythology promoted by every DTCA ad out there — GPHA, what say you?)

Last year, PAL gave one our coveted “Good Guy Awards” to MedVantx, a company that places a “generic sample cabinet” in physicians’ offices. We awarded them the “Real Deal Award: For Promoting Safe, Effective Generics and Countering Drug Industry Marketing.”

MedVantx places an ATM-like machine in doctors’ offices that dispenses 20 of the most common generic medications in a 30-day supply, the typical amount in which a prescription is dispensed. Health insurers contract with MedVantx to place the machines in the offices of doctors in their physicians’ networks. The doctors can use the generic samples for any patient, regardless of what insurance they have, or even if they have no insurance. The savings to a health plan is significant – and to the individual as well, as the 30-day samples are free to the patient. Plus, by increasing the number of generic prescriptions written, the program saves patients money in the long-run as well, given generics’ much lower price tag.

We can only hope that such strategies catch on more and more. With insurers increasingly waiving copayments for generics, and otherwise incentivizing consumers to choose generics, strategies that also encourages doctors to increase their generic prescribing rate are long overdue.