Sometimes the whole is not greater than the sum of the parts, just more expensive.

Last week, we reported on GlaxoSmithKline’s newly-approved combination drug for migraines, Treximet. (‘GlaxoSmithKline sets out to dupe migraine sufferers with Treximet smoke and mirrors“) Treximet simply combines Imitrex, a migraine medication that is going generic later this year, with naproxen sodium, better known as over-the-counter Aleve.

“Combination pills” have long been a tactic for brand-name drug companies to try to squeeze a little more profit out of drugs that are going generic — in fact, Schering-Plough and Merck are famous for another little joint venture combo drug, Vytorin (Zocor/simvastatin and Zetia/ezetimibe), which has been much in the news lately for its lackluster effectiveness.

Lately it seems like big pharma is just insulting our intelligence, repackaging drugs that have been around for a while into combo pills and trying to pass them off as “innovations” onto an unsuspecting public. That certainly seems to be the case with Schering-Plough’s (NYSE:SGP) and Merck’s (NYSE:MRK) latest proposed joint venture – a combination pill of Singulair and Claritin, two drugs approved for treatment of “allergic rhinitis,” aka allergies (Singulair is also approved to treat asthma). The two companies gleefully report that the FDA has accepted a New Drug Application for the combination.

Claritin has been available over-the-counter for several years, at an average monthly cost of $6-18, according to Consumer Reports Best Buy Drugs. Singulair is prescription-only, with its patent set to expire in 2012. Last year, Merck added new information to Singulair’s label to report new “adverse events” that were noted in people taking Singulair, including depression and suicidality (suicidal thinking and behavior).

Tellingly, the press release doesn’t claim that the combination works better than simply taking Singulair and Claritin together but in separate pills. It says “In clinical trials supporting the NDA, the combination product provided a consistent and clinically relevant effect on congestion that was not demonstrated with the individual components.” Which, as we pointed out in our entry on Treximet, is like saying that a chocolate cake tastes better than the ingredients (flour, eggs, sugar) eaten separately.

Combination drugs like these are intended to serve one purpose: to increase the manufacturers’ market share, particularly in the face of impending generic competition. Schering-Plough has been down a road like this already with Claritin — when Claritin was set to go generic, they introduced Clarinex. Clarinex (desloratidine) is simply a metabolite of Claritin (loratidine) — in a nutshell, Clarinex is what Claritin becomes in your liver. As one blogger put it, “if you’ve taken Claritin, you’ve taken Clarinex.” Thankfully, doctors and patients weren’t really fooled, and sales of Clarinex were never very impressive. I stand corrected! According to this item on Pharmalot, 2007 sales of Clarinex were $799 million! (See “Clarinex Patent Fight Nothing To Sneeze At“)

Today I’m seeking to introduce a term for combination drugs that the world doesn’t need into the pharamceutical vernacular.

“Goober Grape” Drugs

What’s a Goober Grape Drug?

Goober Grape, for the (fortunately) uninitiated, is a appalling combination of peanut butter and jelly in a single jar.

Until Goober Grape came along, millions of parents were forced to endure the mind-numbing routine of spreading peanut butter first, and then jelly. Until this breakthrough miraculously cut that spreading time in half, freeing generations of parents for loftier pursuits.

So henceforth, a “Goober Grape Drug” refers to any combination drug that offers no additional clinical advantage and only the most ridiculously minimal increase in patient convenience. There are certainly conditions in which combination pills are important, in that reducing the number of pills to be taken increases patient compliance, but allergies sure as heck ain’t one of ‘em.

If and when this Claritin/Singulair combination is approved by the FDA, we at Prescription Access Litigation will most likely give it one of our coveted Bitter Pill Awards. Till then, we’ll content ourselves with giving it our first ever designation as a Goober Grape Drug.

Will the FDA approve? Who knows! Probably, since to be approved by the FDA, a drug only has to show that it is better than a placebo (aka a sugar pill aka nothing at all). And since Singulair and Claritin have already each separately cleared that hurdle, a combination of them likely will as well. Hopefully, if it is approved, doctors, patients and insurers will give it the cold shoulder. But, to paraphrase an old saying, “No one ever went broke trying to overestimate the willingness of the American health care system to pay for drugs of questionable value.”

Update: Apparently, the FDA issued a “non-approvable” letter for this combination yesterday. (See Schering-Plough’s press release on the letter). A “non-approvable,” despite what it sounds like, does not mean that the FDA has conclusively rejected a new drug. Rather, it means the application is not approvable in its current form. Drug companies frequently amend or add to their applications upon receiving such a letter, and at times later get approval.

Readers, we invite your nominations/suggestions of other Goober Grape Drugs — please post in the comments.

The brand-name pharmaceutical industry constantly pushes the myth that its expensive blockbusters are breakthrough treatments that greatly increase people’s health and well-being, and thus are worth the high price-tag. That myth has more holes than a slice of swiss cheese, yet they keep pushing it on the American public like it’s one of their drugs.

As Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of “The Truth About the Drug Companies” (see an interview with Dr. Angell in PAL’s newsletter here) famously said, “Important new drugs do not need much promotion. Me-too drugs do.” So drugs which offer little breakthrough in treatment need to be (over)hyped.

For years, the drug industry has touted antidepressants (particularly SSRIs - Selective Serontin Reuptake Inhibitors — Prozac, Paxil, Wellbutrin, Zoloft, Celexa, Lexapro, etc. as one of its major successes. Yet, this week, a major meta-analysis (a study that reviews the full range of studies and articles on a particular drug) was published in the open-access medical journal PLoS (Public Library of Science) Medicine. That article concluded that, for the majority of patients, SSRI antidepressants are barely better than a placebo.

It’s likely that patients in the U.S. (and their health plans, and government health care programs like Medicare, Medicaid, the Veterans Administration, the military health care plan Tri-Care, etc) have spent tens of billions of dollars on antidepressants in the past decade, despite the fact that for many of them, it was likely a waste of money, exposed them to the risk of side effects, and may have resulted in their not availing themselves of other non-pharmaceutical options for treating their depression.

The billions that the industry spent on marketing these drugs, both to consumers and to doctors, led millions to believe that relief was just a pill away (We gave the makers of Paxil, one of these antidepressants, one of our Bitter Pill Awards in 2005, the Cure for the Human Condition Award: For Hawking Pills to Treat the Trials of Everyday Life).

Drugs for depression are just one of numerous groups of drugs for which the benefits are overhyped and people for whom an expensive drug is unnecessary or overkill are convinced to take it in lieu of something cheaper, that’s been around longer and whose risks and benefits are more well known.

“Statin” drugs for reducing high cholesterol are another group of drugs that have been massively overhyped, and that also have been in the news a great deal lately. Last month, the results of a study of Schering-Plough and Merck’s combination-cholesterol drug Vytorin, the ENHANCE study, were released, showing that it offered no benefit over simvastatin (Zocor), a statin that last year went generic. Vytorin is a combination of Zocor and Zetia, which is also sold by itself. Vytorin and Zetia together have more than $5 billion in sales.

Statin drugs have also been in the news because of the revelation that Dr. Robert Jarvik, Pfizer’s boat-rowing pitchman for Lipitor, is not a licensed physician, cannot write a prescription for Lipitor or any drug for that matter, and is not even a rower (a stunt double was used in the Lipitor ads). We’ve blogged about Jarvik-gate here on several occasions, including proposing some other famous “doctors” who aren’t licensed physicians that Pharma ought consider using as paid flaks — including Dr. Teeth from the Muppets, Basketball legend Dr. J, Dr. Nick Riviera from the Simpsons, and New Orleans musical legend Dr. John).

Of course, the real Lipitor story is not Dr. Robert Jarvik and his rowing and prescribing credentials. At best, he’s a bit player in this drama. The real story is how incredibly overhyped Lipitor is. Pfizer boasts it’s the “most powerful” statin as though that means that everyone with high cholesterol should be on it. But for many (perhaps most) people with high cholesterol, using Lipitor is like using a chainsaw to cut paper instead of scissors: that is, unnecessary overkill. Members of the PAL coalition filed a lawsuit against Pfizer in 2005, alleging that Lipitor had been overhyped and promoted to patients for whom it offered no benefit, and we gave them and AstraZeneca, the makers of Crestor, a Bitter Pill Award in 2006: The “Got Cholesterol?” Award: For Overpromoting Expensive Brand-Name Statins.

But even that’s not the real story — there are larger questions about statins. For instance, does lowering your cholesterol translate into a lower risk of heart attack or heart deaths on January 17 was Do Cholesterol Drugs Do Any Good? Research suggests that, except among high-risk heart patients, the benefits of statins such as Lipitor are overstated.

Here are a few choice excerpts:

[Statins] are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006. Half of that went to Pfizer for its leading statin…
The second crucial point is hiding in plain sight in Pfizer’s own Lipitor newspaper ad. The dramatic 36% figure has an asterisk. Read the smaller type. It says: “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.”

Now do some simple math. The numbers in that sentence mean that for every 100 people in the trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit. Or to put it in terms of a little-known but useful statistic, the number needed to treat (or NNT) for one person to benefit is 100.

Compare that with, say, today’s standard antibiotic therapy to eradicate ulcer-causing H. pylori stomach bacteria. The NNT is 1.1. Give the drugs to 11 people, and 10 will be cured.

A low NNT is the sort of effective response many patients expect from the drugs they take. When Wright and others explain to patients without prior heart disease that only 1 in 100 is likely to benefit from taking statins for years, most are astonished. Many, like Winn, choose to opt out…

NNTs are the “dirty little secret” of the world of prescription drugs. And a perfect illustration of how hyping drugs through advertising to consumers and marketing to doctors (through the 100,000 salespeople employed by drug companies, self-serving biased clinical trials and corporate-influenced “continuing medical education”) doesn’t benefit patients. As the article says,

The truth about drugs’ effectiveness wouldn’t be as worrisome if consumers and doctors had an accurate picture of the state of knowledge and could make rational decisions about treatments. Studies by Darlington Hospital’s Trewby, UBC’s Wright, and others, however, show that patients expect far more than what the drugs actually deliver…

The whole statin story is a classic case of good drugs pushed too far, argues Dr. Howard Brody, professor of family medicine at the University of Texas Medical Branch at Galveston. The drug business is, after all, a business. Companies are supposed to boost sales and returns to shareholders. The problem they face, though, is that many drugs are most effective in relatively small subgroups of sufferers. With statins, these are the patients who already have heart disease. But that’s not a blockbuster market. So companies have every incentive to market their drugs as being essential for wider groups of people, for whom the benefits are, by definition, smaller.

Finally, an excellent piece posted today on Alternet examines the statin and cholesterol controversy in detail: The Cholesterol Con — Where Were the Doctors?

A major victory occurred today in the massive Average Wholesale Price lawsuit in the U.S. District Court for the District of Massachusetts. PAL’s press release on this is below. To learn more about this case, go here.

FOR IMMEDIATE RELEASE

June 21, 2007

Contact: Mark Snyder
617-275-2931, msnyder@communitycatalyst.org

Federal Court Rules Against Three Drug Companies in Average Wholesale Price Case
Judge finds Astra Zeneca, Bristol-Myers Squibb and Warrick acted “Unfairly and Deceptively”

BOSTON, MA – Today, Prescription Access Litigation (PAL) and Hagens Berman Sobol Shapiro LLP announced a landmark victory in a prescription drug lawsuit brought by members of PAL and others. Judge Patti Saris, of the U.S. District Court for the District of Massachusetts, found that AstraZeneca (NYSE: AZN), Warrick (a subsidiary of Schering-Plough (NYSE: SGP)) and Bristol-Myers Squibb (NYSE: BMY) violated the Massachusetts consumer protection act, Chapter 93A, by reporting false “Average Wholesale Prices” for a number of prescription drugs, including physician-administered drugs for cancer.

The “Average Wholesale Price,” or AWP, is a benchmark figure reported by drug manufacturers to commercial publications that publish compendia and electronic databases of prescription drug prices. Health plans, government health programs such as Medicaid and other “third party payors” use these AWP figures to determine how much to pay doctors and pharmacies for drugs which are given to their members and insureds.

The lawsuit is part of a much larger case, In re Pharmaceutical Industry Average Wholesale Price Litigation. Dozens of defendants, including the largest drug companies in the U.S., are alleged to have reported inflated and inaccurate AWPs for drugs covered by Medicare Part B, in order to increase sales of their drugs. Until 2003, Medicare reimbursed doctors for these drugs using a formula based on the AWP. However, the amount it cost doctors to purchase these drugs was much lower than the amount Medicare reimbursed them. Doctors profited from the difference, known as the “spread.” The defendants in this suit are alleged to have “marketed the spread” by artificially inflating the AWP so as to increase the amount the doctor would keep as profits by purchasing that company’s drug as opposed to a competitor’s.

Medicare Part B pays 80% of the cost of drugs that are administered in a doctor’s office as well as a small number of self-administered drugs, such as asthma drugs used with a nebulizer. The remaining 20% is paid by individual Medicare recipients or by supplemental insurance, known as “Medigap” plans. Today’s ruling benefits health plans and consumers in Massachusetts who paid part or all of that 20%, as well as health plans that paid for these drugs for patients not enrolled in Medicare.

“Today’s decision rights a great wrong that was done by these three companies against some of our society’s sickest and most vulnerable patients,” said Alex Sugerman-Brozan, director of Prescription Access Litigation. “What could be more outrageous than taking advantage of cancer patients in the name of profits?” One of PAL’s coalition members, Pipefitters Local 537 Trust Fund, is a plaintiff in the case.

The Court found that the three defendants caused the publication of false and inflated Average Wholesale Prices for seven drugs:
• Astra Zeneca: Zoladex
• Bristol Myers Squibb: Taxol, Vepesid, Cytoxan, Blenoxane and Rubex
• Warrick: albuterol sulfate

“Prescription drugs are one of the fastest growing cost drivers in health care,” said John McDonough, Executive Director of Health Care For All, a Massachusetts advocacy group which is a member of the PAL coalition and a plaintiff in another part of the AWP case, “This decision puts drug companies on notice that they can’t get away with burdening the health care system by illegally and artificially increasing those costs.”

Although government programs (including Medicare Part B and Medicaid) are abandoning AWP, virtually all private health plans and insurers still use it. Today’s Court decision and a settlement in another lawsuit will help push these third party payors towards other benchmarks. In October 2006, a separate case brought by two PAL coalition members against First Databank, the main publisher of AWPs, was settled. In that settlement, First Databank agreed to roll back the AWP spreads on hundreds of drugs, and to stop publishing AWP data within two years of the settlement becoming final.

“This Court decision is yet another nail in the coffin of Average Wholesale Price,” said Sugerman-Brozan. “The day is long overdue for our health care system to pay for drugs based on real and accurate data, rather than on fictitious figures made up by drug companies that are more concerned about profits than patients.”

This summer, trials begin in another phase of this massive AWP litigation, with a trial set to begin in July against Bristol Myers Squibb on behalf of a nationwide class of individual Medicare beneficiaries. Steve Berman, lead attorney in the case and managing partner of Hagens Berman Sobol Shapiro LLP, said “We are looking forward to continuing the prosecution of this case against the remaining defendants who perpetrated similar if not identical wrongs against patients and insurers nationwide. We view this ruling as a big win that should serve notice to all defendants that they will be called to account for their wrongdoing.”

To view a copy of today’s decision, go to
www.prescriptionaccess.org/docs/AWP-6-21-07-Order.pdf

About PAL
Prescription Access Litigation (PAL) (www.prescriptionaccess.org) is a nationwide coalition of over 130 state, local, and national senior, labor and consumer health advocacy groups in 35 states and the District of Columbia fighting to make prescription drugs affordable. The organizations in the PAL coalition have a combined membership of over 13 million people. PAL works to end illegal drug industry practices that increase the price of prescription drugs beyond the reach of the American consumer, using class action litigation and public education. Since 2001, PAL members have filed 28 sets of lawsuits targeting such practices. News about PAL’s cases and public education efforts is published regularly on the PAL Blog at www.prescriptionaccess.org/blog

About Hagens Berman Sobol Shapiro LLP
The law firm of Hagens Berman Sobol Shapiro LLP is based in Seattle with offices in Chicago, Cambridge, Los Angeles, Phoenix and San Francisco. Since the firm’s founding in 1993, it has developed a nationally recognized practice in class-action and complex litigation. Among recent successes, HBSS has negotiated a pending $300 million settlement as lead counsel in the DRAM memory antitrust litigation; a $340 million recovery on behalf of Enron employees which is awaiting distribution; a $150 million settlement involving charges of illegally inflated charges for the drug Lupron, and served as co-counsel on the Visa/Mastercard litigation which resulted in a $3 billion settlement, the largest anti-trust settlement to date. HBSS also served as counsel in a $850 million settlement in the Washington Public Power Supply litigation and represented Washington and 12 other states in lawsuits against the tobacco industry that resulted in the largest settlement in the history of litigation. For a complete listing of HBSS cases, visit www.hbsslaw.com.