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.

We’ve written about in the past on the PAL blog about, Provigil, a prescription drug used to treat narcolepsy and other sleep conditions, which is made by Cephalon (NasdaqGS:CEPH). [See previous posts such as "FTC member speaks out on Provigil generics payoff case," and "Jessica’s story: No help from Cephalon for cost of Provigil"]

Cephalon is alleged to have paid off four generic drug companies to keep more affordable generic versions of Provigil off the market. PAL member AFSCME District Council 37 Health & Security Plan joined a nationwide class action lawsuit in Eastern Pennsylvania against Cephalon and the four generic companies (Teva, Ranbaxy, Barr and Mylan) on behalf of a nationwide class of consumers, health plans and other “third party payors.”

The Federal Trade Commission also sued Cephalon back in February, in the U.S. District Court for the District of Columbia. Yesterday, the Judge hearing that case ordered that the FTC’s case be transferred to the Eastern District of Pennsylvania, where the class action lawsuit is pending.

In ordering the transfer, the Judge in the FTC case primarily relied on the conclusion that having the FTC case and the class action before the same Judge would avoid “inconsistent judgments.” As Judge John D. Bates wrote in his opinion:

The most compelling point in Cephalon’s favor is the risk of inconsistent judgments that would arise if this case is not transferred. Although there are some differences between the private parties’ claims against Cephalon and the government’s case — namely that the private litigants must demonstrate antitrust injury and prove damages — at the core the two matters involve identical issues of fact and law. Hence, absent transfer to the Eastern District of Pennsylvania, Cephalon would be forced simultaneously to litigate two cases in two different courts arising out of precisely the same conduct. That obviously presents a serious risk of inconsistent judgments. If this Court, for instance, were to find that reverse-payment settlements are lawful while the district court in Pennsylvania reached the opposite result, or vice versa, Cephalon would face a classic case of conflicting judgments. That is exactly the sort of inconsistent result that transfer can ameliorate.

The Judge then went on to accuse the FTC of “forum shopping,” and of in fact looking to create inconsistent judgments so as to increase the likelihood that the Supreme Court would accept a case and determine once and for all whether reverse payment settlements violate the antitrust laws. As the Judge wrote:

Indeed, the FTC would likely be content if this case did result in inconsistent judgments. That is because, as Cephalon points out, the Commission is rather openly shopping for a circuit split on the issue of reverse-payment Hatch-Waxman settlements, and all the better if the FTC could potentially arrange for two courts of appeals — the Third and D.C. Circuits — to decide that question in the context of what is essentially the same case. To be sure, the Commission is free to exercise its prosecutorial judgment to pursue a strategy that it believes will ultimately result in Supreme Court review. But it strikes this Court as both odd and unreasonable to do so at the expense of exposing a single defendant (engaged in a single course of conduct) to conflicting judgments in order to advance the agency’s enforcement goals. The danger, and burden, of inconsistent judgments against one defendant based on the same events, in short, outweighs whatever legitimate interest the FTC may have in achieving that result for strategic reasons.

In 2006, the Supreme Court refused to hear an appeal in a case the FTC brought against Schering-Plough, challenging a payoff of a generic drug maker that had sought to bring a generic version of Schering’s K-Dur to market. Similarly, the Supreme Court had also refused to hear an appeal of a class action originally brought in federal court in New York, challenging a generics payoff concerning the prescription drug for breast cancer, Tamoxifen.

These two refusals by the Supreme Court to address the issue of whether a brand-name drug company paying off a generic drug company not to bring a generic to market violates the federal antitrust laws left the question open. Since that time, there has been a resurgence of such payoffs, resulting in consumers being deprived of less expensive generic drugs.

We at Prescription Access Litigation remain committed to challenging such deals and exposing them for the crude, anti-consumer payoffs that they are. It’s unclear what effect the transfer of the FTC’s case to Pennsylvania will have. Stay tuned.

Pharmacy Benefit Managers (PBMs) are companies that contract with health plans and insurance companies to administer their prescription drug benefits, negotiate with drug companies, manage their lists of covered drugs (formularies), and the like. Unfortunately, PBMs have been accused of failing to protect the interests of their clients, and of instead protecting their own bottom lines. For instance, PBMs negotiate with drug companies for rebates based on the volume of drugs that the PBM’s client health plans purchase, but often fail to pass on these rebates to the health plans. PBMs have also been accused of switching patients’ prescriptions when the PBM has a financial incentive to do so (such as higher rebates from a drug company) but without the patient’s or physician’s permission.

In 2004, the District of Columbia City Council passed “AccessRx,” a law to provide low-income seniors and uninsured people in DC access to affordable prescription drugs through a discount program. The law also contained a provision that required Pharmacy Benefit Managers (PBMs) to be more transparent. PBMs are companies that contract with health plans and insurance companies to administer their prescription drug benefits, negotiate with drug companies, manage their lists of covered drugs (formularies), and the like.

The law said that PBMs owe a “fiduciary duty” to their health plan customers, and required them to disclose their contracts with pharmacies, and to pass on rebates they receive from drug companies to their health plan customers.

The PBM industry trade group, the Pharmaceutical Care Management Association (PCMA), sued DC in Federal Court to block the law. The PCMA initially succeeded in getting the Court to issue preliminary injunction preventing the law from going into effect. The Court of Appeals for the DC Circuit ordered the District Court to reconsider its ruling after the First Circuit Court of Appeals upheld a similar law passed by the state of Maine that the PCMA had also sued to block.

The District Court held that, since PCMA had lost its challenge to a very similar law in Maine, it was precluded from challenging the DC law, under the legal doctrine of “collateral estoppel.” Collateral estoppel basically blocks a party from re-litigating an issue that it has already argued – and lost – in another case. Since the PCMA had argued the same issues on a nearly identical law in the Maine case, the DC District Court held that it could not relitigate those issues on the DC law.

The PCMA, predictably, appealed, and on April 18, 2008 the Court of Appeals for the DC Circuit held that collateral estoppel does not apply. (We here at Prescription Access Litigation had joined an amicus curiae (friend of the Court) brief written by AARP, supporting DC’s law). This means that the PCMA gets a second bite at the apple to challenge laws that states pass to regulate the activities of PBMs.

To learn more about PBMs and what states can do to regulate their activities, visit the National Legislative Association on Prescription Drug Prices’s (NLARx) page on PBMs

To read the DC Circuit Court of Appeals Decision, go here.

** Breaking News: To see updated information about the cost of Treximet, see our more recent post on this topic, from October 14, 2008: Was PAL right about GSK’s Goober Grape Drug, Treximet? Yes and No. **

GlaxoSmithKline (NYSE:GSK) sells a popular brand-name prescription drug for migraines, Imitrex. 2007 U.S. sales of Imitrex were $1.12 billion, making it a “blockbuster” in drug industry parlance. A single pill of Imitrex costs about $25.

Glaxo has certainly done its part over the years to preserve its market share on drugs with expiring patents and to prevent consumers from having access to more affordable generic versions, as alleged in several lawsuits that we here at PAL have been involved in (see Relafen and Augmentin, for example).

Well, $1.12 billion in annual sales is too good to just give up, right? Even if Imitrex’s patent is expiring next February? Not surprisingly, then, Glaxo has done a number of things to keep a generic version of Imitrex (sumatriptan) off the pharmacy shelves:

• Later this year, Glaxo will begin selling an “authorized generic” version of Imitrex. Authorized generics really should be called “fake” generics, because they’re most often not generics at all, but the company’s own pill technically sold by a different company, under a license. In this case, the shill licensee is Dr. Reddy’s, a generic drug company that originally challenged Glaxo’s Imitrex patent and then settled when Glaxo sued them for patent infringement.
• Also later this year (December 2008), Ranbaxy, another generic drug maker, will also begin selling a generic version of Imitrex. Again, this stems from a settlement between Glaxo and the generic maker.

Great, right? Two generic versions of Imitrex will be available by the end of the year! Huzzah! A victory for patients, right?

Not so fast! You don’t think Glaxo is going to let its billion dollar baby leave home so easily, do you?

Introducing GSK’s Treximet! Treximet was just approved by the FDA for acute treatment of migraines in adults.

Is Treximet a fabulous new breakthrough treatment for migraines?

Umm… No.

It is a combination of Imitrex (soon to be available as a generic) and naproxen sodium (commonly known as Aleve, available Over the Counter).

So Treximet is a combination of (a) a soon to be generic drug and (b) an Over the Counter drug. Yet you can be sure that Treximet’s price will be similar to what Imitrex costs right now ($25 a pill) and there’s a good chance it will be more expensive, as new drugs typically are ($30 a pill? More? Who knows?).

How much would it cost a patient to take these 2 drugs separately?

• Naproxen sodium can be had for about 8 cents a pill. A single Aleve pill has 220 mg of naproxen sodium. There’s 500 mg of naproxen sodium in Treximet, so a patient would have to take about 2 1/4 Aleve pills to get to 500 mg. Since you can’t really take 1/4 of a pill, let’s assume most patients would take 2. 2 pills would give you 440 mg, so that’s pretty close to the 500 mg. Cost: 16 cents.
• We don’t yet know how much generic Imitrex will cost. But the price of a generic typically drops to about 30% of the brand-name’s price within 6 months of the drug’s patent expiring and more generic companies introducing their own versions. So it’s safe to assume that generix Imitrex will cost about $7.50 by middle of 2009. (Even before then, the price of generic Imitrex will begin dropping from the current price of $25 a pill.) Cost: $7.50

So, by spending $7.50 on generic Imitrex and 16 cents on over-the-counter Aleve, you can get the same thing you’d get in a Treximet — which is very likely to cost $25 or more. Why would you bother with the Treximet? I guess it’s fewer pills to take, but is that worth at least $18 in additional cost?

Interesting, Glaxo apparent didn’t even try to compare Treximet to a standalone-combination of Imitrex and naproxen sodium. Their press release on the FDA approval says:

“Treximet provided more patients migraine pain relief at two and four hours compared to sumatriptan 85 mg, naproxen sodium 500 mg or placebo alone.”

In other words, Treximet worked better than just Imitrex, or just naproxen sodium, or nothing at all. This is kind of like saying that a chocolate cake tastes better than eating the ingredients separately (a bowl of flour, a few eggs, some chocolate) or eating nothing at all.

Here’s some other things I think you can safely gaze into the crystal ball to see:

• Glaxo’s pharmaceutical salespeople will descend on doctors’ offices like ants at a picnic and aggressively pitch Treximet to doctors of all kinds (neurologists, headache specialists, internists and family physicians).
• TV ads will appear in prime time singing the praises of this “new” treatment for migraines. People frolicking through fields of flowers may or may not appear.

Is this the kind of “breakthrough treatment” than PhRMA is always arguing justifies the high cost of prescription drugs?

This type of putting “old wine in new flasks” is straight from Big Pharma’s tired playbook. Instead of engaging in the harder, more long-term process of discovering genuinely new medications, drug companies instead “tweak” existing blockbuster drugs in the most minor of ways, including:

• Combining two existing drugs, such as was done with Vytorin (made up of Zocor, which had gone generic, and Zetia)
• Making a “extended release” version (once a day, once a month, etc)
• Making a “new” version that’s just a chemical tweak of the original but not any better (as Nexium is of the now-generic and over-the-counter Prilosec)

Conclusion: Migraine sufferers, don’t be suckered by Glaxo’s poorly-concealed bait and switch. And go read Consumer Reports Best Buy Drugs report on migraine medications.

We write frequently on this blog about “off label” marketing — that’s the practice of prescription drug & medical device companies illegally promoting their products for uses or conditions that are not approved by the FDA.

Here’s the “elevator” version of what off-label marketing is and why it’s illegal:

Before any prescription drug can be sold in the U.S., the Food and Drug Administration must find that the drug is “safe and effective” for the conditions that the company wants to sell it for and at the dosages that it seeks to sell. However, once it’s on the market, a doctor can prescribe it for any condition or purpose or type of patient, regardless of whether the FDA approved it for that or not.

In some specialties (particularly oncology), off-label is very common and is the so-called “standard of care.” Important new uses for drugs have at times been found through off-label prescribing. Since many drugs are not tested on children as part of FDA approval, much (possibly most?) pediatric prescribing is off-label.

So off-label prescribing is perfectly legal (as long as it doesn’t go so far afield that it constitutes malpractice) and is not regulated by the FDA. However, off-label marketing is very much illegal – it’s considered “misbranding” under section 502(a) of the Food Drug and Cosmetics Act (FDCA). In other words, a drug company cannot promote a drug for off-label purposes — because the off-label use has not been shown to be safe and effective, is an end-run around the FDA’s approval process, and eliminates the drug company’s incentive to submit an application to have the off-label use approved.

Back in February, the FDA published its Draft Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices and requested public comment on its proposed rules.

Today, we at Prescription Access Litigation, along with our colleagues at The Prescription Project, National Physicians Alliance, and US PIRG submitted our comments, calling on the FDA not to issue the Draft Guidance as a final Guidance. The FDA’s Draft Guidance would make it much easier for pharmaceutical companies and their salespeople to distribute reprints of medical journal articles discussing off-label uses to physicians.

It is ironic that the FDA is working to make it easier for drug companies to market drugs for off-label purposes when there have been so many revelations and allegations of egregious illegal off-label marketing in the past few years, including off-label marketing of Pfizer’s Neurontin (which resulted in a $430 Million settlement with the U.S. Attorney and state Attorneys General), and of Eli Lilly’s Zyprexa.

Among the reasons we cite for why the FDA’s draft guidance is a bad idea:

“Distribution of single studies by pharmaceutical representatives is not an effective way to facilitate evidence based decision making and thus does not prioritize patient safety or public health. Specifically:

• Early evidence is often contradicted.
• Single trials can be misleading and may not adequately assess drug effectiveness or
  safety.
• Statistically, any individual study has a good chance of coming to the wrong
  conclusion.
• Trials stopped early for benefit are found to be less striking on further review.

The Draft Guidance would allow drug companies to distribute journal articles from any peer-reviewed medical journal. However, as we point out in our comments:

“The FDA drug approval process requires review of all data regarding a drug, both published and unpublished. In contrast, the editorial review processes employed by peer reviewed journals do not. Journal review processes vary widely and publication in a peer reviewed journal is not in and of itself a guarantee of quality.

• FDA approval requires access to full data.
• Journal reviewers only have access to what has previously been published.
• Published studies may lack appropriate controls, design or statistical analysis.
• Industry has the potential to fund and publish individual studies with substantial bias.
• Industry-funded trials and reviews are more likely than independent evaluations to be
  favorable toward the sponsor’s drug.
• Publication bias means negative studies are less likely to be known by reviewers.
• Industry, motivated to sell more product, could selectively choose to distribute studies
  that show its products in a favorable light.
• Industry has frequently been shown to play an invisible role in funding and even
  “ghost writing” published studies that are published under the names of academic
  physicians.
• FDA lacks resources to review all distributed studies and ensure they meet a high
  standard.

To see our comments in their entirety, go here.

To see the other comments that have been submitted and the full text of the draft guidance, go here.

The New England Journal of Medicine ran a terrific “Sounding Board” piece just last week on this topic by Drs. Jerry Avorn & Aaron Kesselheim of Brigham & Women’s Hospital: Pharmaceutical Promotion to Physicians and First Amendment Rights (subscription required)

We here at Prescription Access Litigation focus on pharmaceutical issues in the United States – how much drugs cost, how they’re marketed, etc. And as many problems as there are here in the U.S. with people getting access to medicines for life-threatening conditions, those problems increase exponentially in developing countries. In fact, the pharmaceutical industry’s misplaced priorities mean that we have at least five different hardly-distinguishable prescription drugs for heartburn but almost no new treatments for the diseases that affect billions but that aren’t “profitable” – malaria, tuberculosis, and countless other diseases of which we in the U.S. have the luxury of ignorance.

Sonia Shah, the author of the excellent expose, The Body Hunters: Testing New Drugs on the World’s Poorest Patients, has started a new website, ResurgentMalaria.com.

As she describes it, ResurgentMalaria.com is ” the first-ever website devoted to independent commentary and news about malaria, a wily scourge that has stalked humankind since we evolved from apes. Created in conjunction with my new book on malaria (forthcoming from Farrar, Straus & Giroux in 2009), ResurgentMalaria.com features the latest news without the spin, provocative commentary, in-depth histories, and a lively discussion on what it all means.”

A recent entry here on this blog quoted Bill Gates (whose Bill and Melinda Gates Foundation has made malaria eradication one of its top priorities), who said “Malaria kills 1 million people a year; baldness hasn’t killed anyone yet. Less than 10 percent of the money spent on curing baldness is spent on fighting malaria.”

(from Chicago Tribune, Microsoft’s Gates says computers not cure-all, February 25, 2008)

We bring you the third installment of our new feature, PAL Coalition Member Spotlights. In these Spotlights, we introduce you to our coalition members and give you the opportunity to hear from them about the work they do and the pressing concerns of their members.

Health Care For All (HCFA) is the sister organization to Community Catalyst (PAL’s parent organization) and a core member of the Prescription Access Litigation coalition.

We interviewed HCFA’s Consumer Health Policy Coordinator, Lisa Kaplan Howe about HCFA’s work on prescription drugs and their involvement with PAL lawsuits. Enjoy!

PAL: What is the mission of HCFA?

Lisa Kaplan Howe (LKH): HCFA seeks to create a consumer-centered health care system that provides comprehensive, affordable, accessible, culturally competent, high quality care and consumer education for everyone, especially the most vulnerable. We work to achieve this as leaders in public policy, advocacy, education and service to consumers in Massachusetts.

PAL: What is your role at HCFA?

LKH:I am the Consumer Health Policy Coordinator. I am a member of the policy team, and I manage our private market health care policy work and advocacy, including our private insurance and prescription drug work. I coordinate our newest coalition, the Massachusetts Prescription Reform Coalition, and I work with our health reform coalition, the Affordable Care Today (ACT!!) coalition.

Prescription Reform Coalition Launch at the Massachusetts State House

PAL: How does the high cost of prescription drugs affect your constituency?

LKH:The high cost of prescription drugs impacts all Massachusetts residents. Growing numbers of people rely on medications to maintain their health and, even people who consider themselves generally healthy, may find themselves needing to take medications from time-to-time. The high cost of drugs threatens access to necessary medications and threatens peoples’ financial stability. Even the insured suffer from growing cost-sharing and premiums as a result of the cost of drugs. Massachusetts health reform and the stability of our state budget are also threatened by growing health care costs.

PAL: What is one thing you think should be done to change the way drugs are priced or marketed?

LKH: HCFA and the Massachusetts Prescription Reform Coalition have focused on ways that the state can take action against inappropriate drug marketing. One of our top priorities is a statewide ban on gifts to physicians.

Studies show that industry gifts inappropriately impact prescribing decisions, lead to unnecessary prescribing of the most expensive drugs instead of lower-cost and equally safe and effective alternatives and drive up the cost of drugs. Each year the pharmaceutical industry spends over $7 billion marketing to physicians. We all pay for the gifts, meals and other inducements they provide at the pharmacy counter. We are excited that our Senate President has introduced comprehensive cost control legislation in MA that includes the nation’s strongest gift ban.

PAL: What does your organization do to educate your members about prescription drug issues?

LKH: We launched the Massachusetts Prescription Reform Coalition in January. We have been working since then to make sure that our legislators and the general public understands the threat of excessive pharmaceutical marketing.

PAL: Has your organization been a plaintiff in one of PAL’s lawsuits?

LKH: We have been a plaintiff in several PAL lawsuits. (Celebrex, Neurontin anti-trust, OxyContin, Relafen, Tamoxifin, Wellbutrin, Lipitor, and AWP)

PAL: What was that experience like for you/your organization?

LKH: We value the opportunity to take a stand against inappropriate pharmaceutical marketing on behalf of our members and all MA residents. We do most of our work through legislation, and the PAL lawsuits are a great compliment to that work and our mission.

PAL: What are some of the most pressing needs of your members?

LKH: All Massachusetts residents suffer from the rising cost of health care. We are thrilled that since our comprehensive health reform law passed in April 2006, nearly 340,000 MA residents have become newly insured. It is an amazing accomplishment that immeasurably impacts people’s lives. However, we know that there are others who still cannot afford coverage. It will only be possible to ensure the long term success of health reform and to expand coverage to all MA residents if we take steps to fight the rise in all health care costs, including the cost of prescription drugs.

To learn more about Health Care for All, visit their website, and take a look at their blog, A Healthy Blog.

The Prescription Access Litigation coalition has more than 130 organizational members that represent over 13 million individuals. The coalition includes consumer advocacy organizations, senior citizen groups, health care advocacy groups, labor unions, union benefit funds, nonprofit health plans, and others. PAL coalition members join class action lawsuits, help get the word out about new lawsuits and settlements, and participate in advocacy campaigns to curtail runaway drug marketing and unethical drug pricing. If your organization is interested in joining the PAL coalition, learn more here.

PAL extends an enthusiastic welcome to the National Education Association (NEA) to our Coalition. Founded in 1857, NEA has over 3.2 million members, making it the nation’s largest professional employee association! NEA’s work at every level of public education—from pre-school to university graduate programs. NEA has affiliate organizations in every state and in more than 14,000 communities across the United States.

NEA is doing their part to advocate for consumers. They currently lobby on issues of Prescription costs, quality and transparency and train state and local affiliate staff who spread the word to members in the states.

The Prescription Access Litigation coalition has more than 130 organizational members that represent over 13 million individuals. The coalition includes consumer advocacy organizations, senior citizen groups, health care advocacy groups, labor unions, union benefit funds, nonprofit health plans, and others. PAL coalition members join class action lawsuits, help get the word out about new lawsuits and settlements, and participate in advocacy campaigns to curtail runaway drug marketing and unethical drug pricing. If your organization is interested in joining the PAL coalition, learn more here.

Over at A Healthy Blog, our friends at Health Care For All (a member of the Prescription Access Litigation coalition) report today on the fight that is brewing in the Massachusetts legislature over a proposed ban on pharma gifts to physicians. They quote an article from yesterday’s State House News Service:

Pharmaceutical companies are attacking Senate President Therese Murray’s effort to block their firms from providing gifts, meals or trips to doctors, calling it an anti-business policy that would hobble efforts to deliver cutting-edge drugs to patients. In a letter to the chairs of the Legislature’s Economic Development and Emerging Technologies Committee, executives from Pfizer, Amgen, Abbot Bioresearch Center, Genentech, all of which have facilities in Massachusetts, ripped the gift ban as counter to Beacon Hill’s painstaking efforts to lure the life sciences industry, highlighted by Gov. Deval Patrick’s nearly year-old $1 billion incentives plan headed for legislative approval.

It’s somewhat odd to cast a gifts and lunches to doctors as being on par with a $1 billion state incentive plan — unless perhaps the gifts and trips and meals are worth more than $1 billion to the industry — after all, Massachusetts has dozens of teaching hospitals and a new health care law that means more and more people with health insurance. The prescriptions written as a result of a modest investment in gifts and trips and meals could easily garner more than a billion in new sales.

To learn more about the proposed gift ban, go visit the Massachusetts Prescription Reform Coalition.

The National Institutes of Health has a new online database, the Dietary Supplements Labels Database. This website allows you to look up the ingredients of over 2,000 brands of dietary supplements. You can look up your vitamins or supplements by brand, active ingredient, or manufacturer.

Keep in mind that this database will only tell you the ingredients — it will NOT tell you anything about the purity of those ingredients, their safety, their potency, or how or where they were grown. And most importantly, it will not tell you whether any vitamin or supplement works.

Drug companies have to show that prescription and over-the-counter drugs are safe and effective before they can be sold. But “dietary supplement” companies do NOT have to show that their products are safe and effective. In fact, the FDA cannot take action against a dietary supplement from the market until it has shown to cause actual harm! So drugs can’t be sold until they’ve been shown safe and effective, but “dietary supplements” can be sold until they’re shown to be actually harmful. This is despite the fact that “supplements” are not inherently safer than drugs.

Consumers tend to be (rightly) skeptical of drug companies. Yet ironically they don’t extend that skepticism to dietary supplement companies. Millions of people spend billions of dollars on “supplements” that have not been shown to be effective. Take Airborne, for instance – it’s one of the most popular and bestselling supplements on the market. Millions of people believe it can treat the common cold. Yet there’s no evidence that that’s the case — the Center for Science in the Public Interest recently settled a class action lawsuit against the makers of Airborne. (If you bought Airborne, you may be able to get a refund from the settlement — go here for info: www.AirborneHealthSettlement.com

The reason that the FDA can’t do more to regulate the dietary supplement industry is because that industry — which hides behind its carefully crafted but frequently inaccurate image of being folksy, homespun, and dedicated to “natural health” — convinced Congress to pass the Dietary Supplement Health and Education Act (DSHEA) of 1994. Many consumers believe that the FDA carefully regulates supplements, but that’s not the case.

Bottom line: Be as skeptical about so-called “dietary supplements” (vitamins, herbs, minerals, homeopathic remedies, etc.) as you are about prescription drugs. In fact, you probably should be MORE skeptical. Drugs are at least required to show that they are safe and effective. Supplements are not. Even with all the flaws and gaps in the FDA’s review of drugs, it’s a whole lot better than nothing.

Here’s resources to learn more about supplements and how they are (barely) regulated: –

• Consumer Reports Health: Nutritional Supplements: Your Questions Answered
• Natural Causes: Death, Lies and Politics in America’s Vitamin and Herbal Supplement Industry by Dan Hurley
• Snake Oil Science: The Truth about Complementary and Alternative Medicine by R. Barker Bausell.