Healthy Policy

Better pharmaceutical safety

Commenter Martin has started his own blog, and I want to be sure to link to it before I end my tenure here.  He's got an interesting post up about a recent NEJM series debating the various conduits to improved drug safety.  What's clear from his post, and the expert's writings he excerpts, is that there's no easy answer for reforming the FDA.

In my mind, a few things need to happen.  Last year the NIH introduced a strict set of new ethics requirements.  These rules were not extended to the FDA, to its detriment, as former commissioner Lester Crawford proves quite well.

But we do have to think seriously about the question of improving drug safety in practical ways.  Many have called for more extensive/longer clinical trials.  That will delay necessary treatments for years.  A better method of ensuring safety is to simply forbid the pharmaceutical companies from operating their own clinical trials.  Study after study has shown that when corporations run their own trials the drug is much more likely to come out positively. 

These results should be public as well; it's ridiculous that we let these corporations put potentially dangerous products on the market but keep questionable safety information to themselves. 

Stop lookin over my shoulder!

There are 90,000 drug reps in this country. 

That, and other interesting tidbits in today's New York Times article. 

Aspirin, Pharma, and You

The Wall Street Journal took a gander at the number of "aspirin resistance" papers in the last few years and found some peculiar trends.  Namely, that there's been a lot of talk all the sudden about aspirin resistance.

For my fellow non-health care practitioners, aspirin resistance basically means aspirin doesn't lower your blood pressure or prevent clotting like it should, and therefore you must need some other expensive prescription medication.

A dozen papers were published in 2002 alone examining this condition, and many more have followed.  Besides confusion over the correct way to identify patients with aspirin resistance, researchers don't know if these people can actually be helped by other medications either.  And most experts agree that the number of people with such resistance is quite small.

The pharmaceutical industry doesn't see it that way, and has seized the opportunity to promote sales of prescription products like Plavix along with the tests that measure aspirin resistance.  Their efforts, propelled by publicization in medical and trade journals, are working.  Producers of laboratory tests that measure aspirin resistance have seen their sales grow in double digits.  And Medicare ordered 43,000 such tests, twice as many as it did only two years ago. 

Aspirin resistance could be potentially devastating for those it affects, and heart surgery and hospitalization is certainly much more expensive than these tests.  But a doubling of tests for this rare condition in two years is troubling, and points to physician pressuring (and caving), non-disclosure of conflicts of interest, and plain old improper focus of research dollars (see my previous post for a better location). 

190 subpoenas for pharma

Bad news for pharma:

The Federal Trade Commission on Wednesday announced that it plans to subpoena 190 drug companies in an investigation of possible anti-competitive practices in the pharmaceutical industry, the AP/Los Angeles Times reports. The subpoenas, which require approval from the Office of Management and Budget, would be part of a probe into whether pharmaceutical companies are suppressing competition by releasing authorized generic versions of their own brand-name drugs to coincide with the introduction of products from generic drug makers. Under federal law, after a generic pharmaceutical company successfully challenges a patent held by a brand-name manufacturer, it has six months of exclusivity to sell the drug in the generic market by itself. However, a loophole allows brand-name manufacturers to authorize their own generic versions, which increasingly are entering the market at the beginning of the six-month exclusivity period. Generic drug manufacturers depend on that exclusivity period to recover their costs and make a profit, but with authorized generics entering the generic market sooner, profit margins are falling for generic manufacturers.

If definitely appears that this is an industry-wide practice, given that such a large number of firms are receiving subpoenas.

What I meant was...

Go read this.

Hungry?

So that sleeping medicine Ambien?  Apparently it does funny things to you:

The sleeping pill Ambien seems to unlock a primitive desire to eat in some patients, according to emerging medical case studies that describe how the drug's users sometimes sleepwalk into their kitchens, claw through their refrigerators like animals and consume calories ranging into the thousands.

The next morning, the night eaters remember nothing about their foraging. But they wake up to find telltale clues: mouthfuls of peanut butter, Tostitos in their beds, kitchen counters overflowing with flour, missing food, and even lighted ovens and stoves. Some are so embarrassed, they delay telling anyone, even as they gain weight.

The reactions range from fairly benign sleepwalking episodes to hallucinations, violent outbursts and, most troubling of all, driving while asleep

Pharma and medication compliance

This article from the New York Times is a good read.  Drug companies have realized that non-compliance with medication regimens represents billions in lost profits every year as prescriptions aren't refilled on a regular schedule (if they're refilled at all).

Two things come to mind:

It really is better for patients to take their medication as prescribed.  The article cites a blood pressure med commercial that urges patients to take their med as directed.  And they should -- it's tough on your heart and downright dangerous to let your blood pressure skip around.

But the recent reduction in health spending came, in large part, from less utilization of prescription drugs.  If drug company informational campaigns are successful, we can expect to see those savings reversed. 

Two sides to every coin, indeed. 

Unsales reps

One of the proposals from Jerry Avorn's book Powerful Medicines is coming into existence:

The Wall Street Journal on Monday examined a state-funded program in Pennsylvania that sends "unsales representatives" to physician offices to encourage the use of generic and other medications that cost less than brand-name treatments. The program is based on the research of Jerry Avorn, a professor of medicine at Harvard University, who has established a system called "academic detailing," which seeks to encourage physicians to make prescription decisions based on scientific evidence rather than promotions from pharmaceutical company sales representatives. In Pennsylvania, the state Department of Aging through a contractor will pay $3 million to a foundation led by Avorn over three years to implement an "unsales" force to counter promotions by pharmaceutical companies and reduce medication costs for the state. Members of the unsales force visit physician offices and discuss alternatives to brand-name medications, such as generic and over-the-counter treatments or behavioral modifications (Hensley, Wall Street Journal, 3/13).

The key thing here will be if this program can help enact systematic changes.  It doesn't work very well for the state to keep sending "unsales reps" year after year at a hefty price tag.  But if the practice can help change prescribing culture after a few years, it will pay for itself. 

Not keeping promises

65% of Promised Drug Studies Pending

At first glance, that headline gives the impression that 65% of studies are in existence.  That seems pretty pitiful.  But if you read it closely, you see the word "pending", and realize that only 35% of said studies are given life.

Drug companies have launched barely a third of the follow-up studies they agreed to undertake once their new medications were on the market, the government said yesterday.

Often the drugs received expedited approval from federal regulators on the condition that the studies be carried out.

The FDA said it relies on the so-called Phase 4 studies to gather additional information about a drug's safety, efficacy or use. The outcome of those studies can lead to changes in how a drug is made, prescribed and used. The FDA also can require the studies after it has approved a drug.

The pharmaceutical industry does this because we let them.  The extent to which they've been able to game the FDA is almost laughable.  Laughable that the FDA is still able to claim independence and authority at all.

These behaviors won't change without tough rule shifts at the FDA.  The most effective way to do that may be to start a new organization from scratch, with a new crop of officials, ethics rules, and procedures. 

WSJ vs. NEJM

Via Health Care Renewal, the Wall Street Journal goes after the New England Journal of Medicine:

The New England Journal is joining the ranks of academic publications risking their reputations as non-partisan arbiters of good science in order to rumble in the political tarpits.

The facts and timing of the Merck ambush certainly suggest as much. Late last year the New England Journal published an 'Expression of Concern' about a Vioxx study it carried in 2000, baldly accusing researchers of omitting key data to make the painkiller appear more safe.

What has Dr. Curfman [Executive Editor of the New England Journal] in a dither is the fact that three more participants [in the group treated with Vioxx] also suffered heart attacks - although only after the cutoff date that had been determined by an outside safety panel for the study.

In fact, as prominent scientists have since attested, the authors were simply following the rules of science. 'If the outcomes truly occurred after the close of the study, then they don't belong in the study,' Brian Strom, an epidemiologist at the University of Pennsylvania, told Nature magazine. . .

Unfortunately, the attack on Merck isn't isolated, but is part of a growing trend among scientific journals that have joined business-bashing and other liberal campaigns.

To the untrained eye, 3 more heart attacks doesn't sound like a big deal.  But in the context of the study, 3 additional heart attacks increased the rate of heart attacks from 17 to 20.  We call that statistically significant, my friends.  If an organization is supposed to stand up for science, doesn't that mean reporting it?  Not hiding it?  Pharmaceutical companies are the ones keeping science for the sake of science off the table.  That's through multiple efforts, most recently the realization that companies are excluding both the name of the drug studied and final results in several trials on the new clinical trial registry. 

WSJ's "anonymous" (read: pharma lobbyist) op-ed contributor doesn't like the negative press for pharmaceutical companies and decided to nit-pick on one unspoken rule of trial reporting.  But shame on the person arguing that severe events like heart attacks shouldn't be considered because they occurred after the study.  This isn't a game about when adverse events should "count" -- it's health.  Merck seriously paid for hiding their results -- billions of dollars in lost revenue and even more tarnished image. 

Even so, this is a curious op-ed from the WSJ, mostly because the NEJM basically pushed through this new clinical trial reporting system which is now aiding pharmaceutical companies.  NEJM is also chock full of multi-page bright colored pharmaceutical ads.  And historically, if the journal has had any bent at all, it's been to the right.  If anything, NEJM's "expression of concern" was an assertion of power, a declaration from that it won't be used as a pawn in pharma's games and be dragged down in the dirt of public opinion as well.

Pharma's faltering - what does it mean for the FDA?

The number of drugs approved by the FDA in 2005 fell to 20 from 36 in 2004:

The lower approval numbers have led some industry executives "to complain that the FDA is denying approval to good new treatments because of the criticism the agency has faced from lawmakers" over Merck's Vioxx, which was pulled from the market over safety concerns, the Times reports. Most of the drugs that did receive FDA approval in 2005 were treatments for relatively rare diseases, while the agency delayed approval for more prominent treatments, such as Bristol-Myers Squibb's diabetes drug Pargluva. FDA and drug companies both "seem to agree that the process for testing and developing new drugs needs improvement," the Times reports.

The FDA doesn't need to approve a certain amount of drugs every year in order to be a viable, competent organization. Clearly we're seeing fallout from Vioxx and other pharmaceutials pulled from the market -- drug companies have ample reason to be more careful with safety questions. That's not a bad thing.

It can quickly turn nasty, however, if the FDA is dragging its feet unnecessarily. In the case of the diabetes drug Pargluva, the AMA gave a warning not to approve without further investigation because a brand new study indicated a higher risk of adverse cardiovascular events. That's a legitimate reason for delaying.

On the other hand, Plan B is languishing eternally because of pure politics. That is unacceptable.

Drug companies are struggling with slumping sales and they won't put up with a spooked FDA for long. If you remember from this post on ethics, certain interest groups are calling for changes in the way the FDA approves drugs, namely by including variables like ethical concerns and cost. Major changes are a definite possibility, and you can't underestimate the impact of a redefined FDA. Thankfully public opinion is with safety and efficacy concerns -- Pharma can't pull a Medicare Part D on this one.

Killing two birds with one stone

A new AARP study estimates that the new Part D Drug Benefit will be cheaper than reimporting drugs from Canada.

The new analysis, titled “The New Math: Cheaper than Canada? The drug benefit may be the better deal,” used the government’s Medicare plan finder to compare “stand alone” plans that cover all of a senior’s prescription needs to the cost of acquiring drugs across the border. It concluded that seniors who enroll in a low-cost Medicare prescription-drug plan would save more in drug costs this year than if they were to buy the same drugs in Canada.

While Canadian drug prices are still cheaper than prices in the United States, AARP found that when a senior includes all out-of-pocket costs — premiums, deductibles and payments for medications — the price is lower.

This is a substantial shift on the part of AARP, which has been a major proponent of efforts to make the importation of Canadian drugs legal.

The drug benefit should be cheaper than reimporting drugs from Canada -- otherwise it'd be fairly useless legislation. (That's not to say the legislation isn't useless on other fronts). When you purchase your drugs from Canada you pay for them out of pocket. With the drug benefit, although you pay premiums and co-pays, your drugs are paid for by insurance. And while drugs are cheaper in Canada -- they're not that cheap.

The thing to realize here is how genius PhRMA's lobbyists are. They were simultaneously able to interdict price negotiation while ensuring the benefit would silence political enemies on a key battle. Couple that with Nevada's attorney general announcing their drug reimportation program has insurmountable legal problems, and well, the chances of lower drug prices through government efforts are just not looking good.

And while you're here, head over to MedGadget's 2005 Medical Weblog Awards and vote for me for best Health Policies/Ethics blog. Thanks!

Pharma can't get it right

Great wrap-up of problems at the clinical trial research company SFBC International by Health Care Renewal:

Let's see what today's news holds: Sen. Grassley opens probe of abuses at this CRO and the top officers quit before "showtime"; safety issues; death and injury; complaints by over 100 doctors about the improprieties in the industry documented by Bloomberg's; conflicts of interest; unlicenced doctors as president & chair; non-lawyers running the legal department; non-CPA CEO's listing themselves as CPA's in SEC filings; $15 million mansions; "inappropriate" behavior with trial subjects followed by threats to deport them.

Do we have all the bases of medical corruption covered here in this one story? It seems so. Absolutely amazing. The pharmaceutical industry still wonders why they've lost credibility with the public regarding integrity.

Indeed.

Disclosing Pharmaceutical Trials

Via Kaiser, pharmaceutical companies are making a half-hearted effort:

Pharmaceutical companies are providing more required information about clinical trials on a federal Web site but are withholding the names of drugs being tested and the main outcomes being measured in some cases, according to a study published Thursday in the New England Journal of Medicine, the AP/Boston Globe reports (Marchione, AP/Boston Globe, 12/28/05). The Web site -- Clinicaltrials.gov -- was created in 2002. It is a public registry of clinical trials of drugs and devices for treating serious illnesses and includes trials on both experimental treatments and treatments already approved for other uses. Editors of the world's leading medical journals in 2004 said they would no longer publish the results of studies not listed on the Web site or on a similar public space. Researchers had until Sept. 13, 2005, to register trials in order to have their work published in major journals, and from May to October 2005 the number of registered trials increased 73% to 22,714 (Sataline, Wall Street Journal, 12/29/05). The study in NEJM -- headed by Deborah Zarin of NIH's National Library of Medicine, which runs the registry -- primarily examined whether listings revealed the name of the drug and the main outcomes being measured (AP/Boston Globe, 12/28/05). The study found that the "vast majority" of companies provided the information, but four -- Merck, Pfizer, GlaxoSmithKline and Eli Lilly -- have withheld the names of some drugs.

Come on, people. The rules surrounding this registry should mandate drug name disclosure. It's extremely unhelpful to disclose negative/poor trial results, but not be able to glean further information on the efficacy of the drug.

It's just one more example of the choke hold pharma retains on our representatives. But this isn't oil or bridges to remote Alaskan islands -- we're talking pills. That go in millions of patient's bodies. We really require this research. With more confusion on antidepressants to the repititon of clinical trials, the current research system is a labyrinth.

This kind of behavior is inexcusable. What's the point of a drug registry if we let companies hide their results?

Bad News for Pharma Marches On

Health Care Renewal has an eloquent summary of Guidant's recent troubles, and what it means for patients:

Attorney General Elliot Spitzer has sued Guidant for fraud, charging it concealed defects in its implantable cardiac defibrillators (ICDs, devices that use electric shocks to the heart to attempt to restore normal rhythm). In summary:

• Guidant has admitted that it did not disclose information about defects in ICDs to doctors and patients.

• These ICDs are very expensive, costing about $25,000.

• Had the physicians and patients known prospectively that the ICDs were not as reliable as previously thought, they might have chosen not to implant them, and implanting such flawed defibrillators provided less benefit to the population of patients receiving them than they thought they would receive.

• Thus, by concealing the information, Guidant likely made more money and increased costs to the health care system, but decreased the benefits to patients.

It's as simple as that, folks. Go read the entire post for more of the story.

Cheerleading and Drugs, a Beautiful Combination

Remember the New York Times article on cheerleaders-cum-pharmaceutical reps a couple weeks back? My editors at Campus Progress decided it was worthy of my discerning pen. And thus my sixth column was born:

Considering the lax regulations surrounding doctor-pharmaceutical rep interactions, it should be no surprise that the tiny girl on top of the pyramid is now among the pharmaceutical industry’s ranks. It’s no secret that attractive people can be more persuasive than their less lovely counterparts. But do the ranks of reps really resemble the cast of Bring It On or did the article make a trend piece mountain out of a molehill?

What did I conclude? Are cheerleaders really storming the likes of Pharma, or is it just good old fashioned sensationalism?

Click over to find out.

Oh No You Didn't...

The New England Journal of Medicine is pissed:

Dr. Gregory D. Curfman, the journal's executive editor, sharply criticized Merck for the way it presented data from the clinical trial. The study, called Vigor, covered more than 8,000 patients and was published in the journal in November 2000, almost four years before Merck stopped selling the drug.

"They did not disclose all they knew," Dr. Curfman said. "There were serious negative consequences for the public health as a result of that." . . . In the editorial, "Expression of Concern," the journal said that the authors of the study had deleted some data about strokes and other vascular problems suffered by patients in the Vigor trial two days before it submitted the results to the publication.

The authors, some of whom worked for Merck, also underreported the number of heart attacks suffered by patients taking Vioxx, claiming that there were 17 heart attacks when there were actually 20, the journal said. The authors have been asked to correct the study, the journal said.

The article claims this will be bad news for Merck in the courtroom, which I'm inclined to believe given that the principal investigator (PI), one of the key witnesses for the defense, was implicated by NEJM.

Ideally, companies would take a hard look at this and decide to keep a few more clinical trials pure. Somehow I doubt it, but I'm keeping my fingers crossed.

Pharma's (not so) Surprising Dirty Tricks

Via Health Care Renewal, Pharma's establishing a nasty pattern of intimidation and retaliation against doctors who challenge with their findings:

So the theme is intimidation, coercion, and/or threatened punishment of health care professionals who dare to speak out about dangers of drugs or potential reseach misconduct of pharmaceutical companies. Particularly distressing was that in two cases (but presumably not that of Dr. Topol, to the credit of the Cleveland Clinic), pressure by a commercial entity apparently resulted in adverse action by the the professional's employer, even though the employers in these cases, a UK university, and a US federal agency, ought by their very natures and stated missions to protect the rights of their professional employees to honestly communicate about scientific and medical matters.

Head over to the post to learn more -- the case details are very much worth reading.

In terms of the FDA investigating the veterinarian, it's pretty fishy to go after doctors based on the pharmaceutical company's wishes. It just reinforces all the B.S. happening at the agency lately, between Lester Crawford and Plan B, removing the black box labels on anti-depressents, silicone implant approval... on and on and on. We're way past due for a major overhaul.

And the Sketch Goes On...

Good to see Pharma's unwavering committment to altering clinical trial data continues:

In short, Blumsohn was the lead scientist (principle investigator) for a clinical study of a Procter & Gamble (P&G) drug, Actonel (risedronate). After Blumsohn lead data collection efforts for this randomized controlled trial, P&G refused to give him the raw data from the trial, or to allow an independent analysis of this data. P&G arranged for three abstracts to be written about study results, which designated Blumsohn first author, even though he did not draft the abstracts, nor, again, have access to the data to which they alluded. Blumsohn eventually made his concerns known about his inability to access the data to several officials at his university. Because, however, the University charged that he did not go through proper channels, and eventually talked to the news media, it has suspended him.

Clearly the chain of conspirators extends beyond Pharma. I can't believe the University suspended him.

In any case, go read the post for the whole story. It's infuriating.

The Truth About Viagra

Disclaimer: This post contains commentary on things of a sexual nature. If reading the words "penis" and "vagina" makes you squirm (no, not in that way) you best cover your eyes and scroll down.

Apparently sales of Viagra and similar drugs (known as Erectile Dysfunction, or ED drugs) are dropping:

Seven years after Pfizer made Viagra a cultural touchstone and commercial blockbuster, the market for impotence medicines appears to have fallen well short of what was once predicted.

Heavy advertising to consumers, totaling more than $400 million in 2004, has made Viagra and its newer competitors, Cialis and Levitra, among the best-known drug brands in the United States, and their combined global sales reached about $2.5 billion last year. But the number of new prescriptions for the drugs has fallen steadily this year. Doctors wrote about 10 percent fewer new prescriptions in October than they did in October of 2004.

I've always had concerns about the number of people taking Viagra and similar drugs because I believe there are consequences that extend far beyond the ability to have an erection.

According to the article, 5 million men in U.S. take ED drugs, which is by no means a small number. I want to preface my concerns by saying that I absolutely believe there are men with persistent ED for whom these drugs are a life-saver, and I recognize the gravity of sexual dysfunction problems. My concern is that taking these pills when one only has occasional problems changes the nature of sex itself.

I've never dated anyone who takes Viagra (then again, I'm 22 so I wouldn't expect to for quite some time). But I would imagine taking it would have some problematic effects. Like having to plan sexual encounters around the medication. Or having sex when both parties aren't entirely willing because they don't want to "waste" the pill.

It's also another thing in our increasingly sexed-up culture that serves to give people something else to feel insecure about. Before Viagra, aging also meant changes in your sex life. It meant less sex -- but that was the consequence of both men and women's bodies being less able to do so (after menopause vaginas undergo a lot changes in terms of lubrication, atrophy, etc). Viagra does more than assist men, it puts expectations on both parties -- women don't have a magic cure to make sex like it was when they were younger (especially since the risks of Hormone Replacement Therapy were revealed). Which, frankly, gives me concerns about infidelity and other strains on the relationship associated with new unbalanced discontent. It puts more pressure on men to perform, and solidifies the idea that without a perfectly working penis, you are not a man.

It's also over-medicalization of problems. Many men have occasional ED. Something that, in my mind, doesn't necessitate an expensive prescription to fix, but is just a part of life and aging. I'm glad that prescriptions are dropping, because taking these drugs changes interactions with our partners in ways that we don't always realize until it’s too late.

Amazing Pharmaceutical Rep Wonders!

I'm in the midst of my next column, which will dwell on pharmaceutical companies. As part of my research I picked up Jerry Avorn's Powerful Medicines. It's a fantastic book so far and I definitely recommend it to anyone who's interested in the FDA and the pharmaceutical industry. He spends a chapter discussing the various ways pharmaceutical reps try and ingratiate themselves with doctors, from mugs that display messages when heated to offering to author papers on their behalf:

The come-on usually begins plausibly enough: "Dr. Avorn, because of your expertise in this area, we'd like to invite you to write an overview of this clinical issue. To compensate you for your effort, we can provide and honorarium of $2,000. We realize how busy you are, so we'll prepare a draft to save your valuable time. You can then review and approve it, and we'll take care of the rest."

Imagine that in your job. Someone comes and says, “Hey, sign this paper and we’ll give you $2,000.” Say your practice is struggling – you could really use the extra money. Or maybe they’re offering to fly you to the Caribbean for a conference (that’d be my bigger weakness). Only the strictest professionals can continue to resist that kind of cash on a consistent basis. It’s something worth thinking about at length, because doctors are offered much more than those ubiquitous pens.

Safe or Unsafe?

Ezra's got a great post up about RU-486 naysayers:

You can't argue with his loss, but let's put this in perspective. Including his daughter, there are four deaths that can potentially be linked to RU-486. But: "Each year, use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) accounts for an estimated 7,600 deaths and 76,000 hospitalizations in the United States." (NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, ketoprofen, and tiaprofenic acid.)

Medicine kills people. Medical treatment kills people. Being in hospitals kills people. Medical errors kill people. Improper treatment protocols kill people. Now, doctors, hospitals, and pharmaceuticals cure more than they kill, and we as a society have decided easing our headaches and muscle pains is worth 7,600 deaths a year, but pretending that medicine is safe and RU-486 is dangerous is just crap.

I second his opinion, and raise him an article about liver poisoning due to tylenol:

Dr. Davern and a team of colleagues from other centers led by Dr. Anne Larson at the University of Washington Medical Center in Seattle, tracked the 662 consecutive patients who showed up with acute liver failure at 23 transplant centers across the United States from 1998 to 2003.

Acetaminophen poisoning was to blame in nearly half the patients, the scientists found. The proportion of cases linked to the drug rose to 51 percent in 2003 from 28 percent in 1998. Not all the poisonings were accidental. An estimated 44 percent were suicide attempts by people who swallowed fistfuls of pills.

Even tylenol, considered a very safe drug, can cause accidental liver poisoning. Like Plan B before it, it's important to recognize that politics, not safety, is the name of this game.

Big Changes in Pharma Land

As many of you probably know, Merck announced yesterday that it will be cutting 7,000 jobs. It's a reaction to a slew of bad news for the pharmaceutical companies, including losing patent protection, Vioxx and other drug problems, and declining sales. Unfortunately for Pharma, the public is less than sympathetic:

The backlash among consumers upset about problematic drugs such as Vioxx was evident in a recent Harris poll measuring public attitudes toward industries. The October survey found that just 9 percent of Americans believed the pharmaceutical industry to be honest and trustworthy. Some 51 percent of the 1,833 adults polled said drug makers should be subject to more government regulation, second to only the oil industry, which was at 55 percent.

Ouch. A 9% approval rating is pretty awful, but the obvious result of lawsuits and other bad press. Most companies aren't reacting by trying to design better drugs for their key markets (heart disease), but their business model in general:

The company characterized the actions as the first phase of a worldwide restructuring aimed at lowering costs, improving efficiency and boosting competitiveness.

They are, however, going after the lucrative heroic image markets:

The big drug companies are likely to focus more on developing vaccines and treatments for cancer, AIDS and other life-threatening illnesses, said analyst David Moskowitz of Arlington investment bank Friedman, Billings, Ramsey Group Inc.

"These products have smaller markets than for other major drugs like those for cardiovascular disease," Moskowitz said. "But we are finding out that these products carry significant pricing power, and that is piquing the interest of the major pharmaceutical companies."

I find the evolution of Pharma's business model fascinating. One thing that always concerned me about the huge drug companies is that they have little incentive to develop drugs for rare diseases because so few people can take them. Instead they focused on huge lucrative markets -- heart disease, ED drugs, depression, etc. But the backlash brought by these drugs has pushed Pharma to offer more hope to the terrifying diagnosis of cancer or AIDS. Whether they can actually do so, and whether that pricing power is sufficient remains to be seen.

This is good news; we need more and better cancer and AIDS therapies. But we have to keep an important factor in mind, one that Matthew Holt has been drilling in lately. Therapies like those for cancer and AIDS are prohibitively expensive. Rounds can easily total $200,000. We, at some point, have to take a realistic look at health care costs and how much we're willing to pay. If my loved one would die without a $200,000 treatment I know I wouldn't blink in requesting it. If most of us believe that, we need to accept the reality of the cost. If that means employer-sponsored health care, it means major increases in premiums and cost sharing. If it means universal insurance, it means tax increases. Obviously waste can be cut out, and some spending can be brought under control. But new expensive therapies will continue down the pipe line.

Unfortuantely our politicians have skillfully insulated us against spending without feeling the pinch (can we say multi-billion dollar deficit?). Someday we will have to take an honest accounting of what good health care is worth, and that day is getting closer.

Further Effects of Medicare Part D

From Blue Cross Blue Shield News:

The Philadelphia Inquirer on Thursday examined pharmaceutical companies that plan to eliminate charitable prescription drug programs for seniors enrolled in the new Medicare prescription drug benefit. Last year, the pharmaceutical industry donated $4.1 billion wholesale value in prescription drugs through tax-deductible charities. However, under a decision released last week by the HHS Office of Inspector General, Medicare beneficiaries who enroll in the new prescription drug benefit will lose eligibility for the medications donated through the charities. According to the Inquirer, an estimated three million to four million Medicare beneficiaries nationwide will lose access to prescription drugs under the charitable programs on Jan. 1, 2006, as a result of the decision.

Rx Company Response
Some pharmaceutical companies -- such as Pfizer, Bristol-Myers Squibb and Merck -- have said that they will allow Medicare beneficiaries to decide whether to enroll in the prescription drug benefit or continue to receive medications through their charitable programs. Amy Rose, a spokesperson for Merck, said, "Our broad interest is making sure that the people who need them have access to their medicines. That's the overall goal of everyone in the industry." However, other pharmaceutical companies -- such as AstraZeneca, Wyeth and GlaxoSmithKline -- have said that they will eliminate their charitable programs for Medicare beneficiaries, regardless of whether they decide to enroll in the prescription drug benefit. Carla Burigatto, a spokesperson for AstraZeneca, said, "Our program always has been to provide access for people with no other coverage." Title II Community Aids National Network, a coalition of HIV/AIDS groups, has called on federal officials to revise the HHS OIG decision. In addition, the Pharmaceutical Research and Manufacturers of America has asked CMS to clarify the decision to allow Medicare beneficiaries who enroll in the prescription drug benefit to retain access to medications under their charitable programs "when their expenses hit a gap in coverage -- the so-called doughnut hole," in which annual prescription drug costs reach between $2,250 and $5,100, the Inquirer reports (Ginsberg, Philadelphia Inquirer, 11/17).

No joke on ending charity coverage, which, although quite uncharitable, makes sense from a financial standpoint. Why should they give drugs away for free when people can access them for full cost (thanks to lobbying for no price negotiations)? But PhRMA's decision to push for donated pharmaceuticals in the donut hole (for explanation look here) seems totally out of left field. Considering the monumental lobbying effort to get the disaster-of-a-benefit passed, I must admit I'm shocked to see PhRMA doing something, well, nice. Kudos.

The Giant Stumbles

The New York Times reports on the faltering image of drug manufacturers:

A year after Merck's withdrawal of its arthritis medicine Vioxx led to an industrywide credibility crisis, the Food and Drug Administration is blocking new medicines that might previously have passed muster. Doctors are writing fewer prescriptions for antidepressants and other drugs whose safety has been challenged, like hormone replacement therapies for women in menopause.

Meanwhile, insurers and some states are taking advantage of the backlash against the industry to try shifting patients to older, generic drugs, arguing that they work as well as newer and more expensive branded medicines. Overall, prescriptions continue to rise slightly, but an increasing share of prescriptions are going to generic drugs. Also, consumers seem to be less responsive to aggressive drug marketing.

First, I can't believe it's been a year since Vioxx was pulled. Second, this is great news for patients. Generic drugs are no different than their much more expensive counterparts, and those that have been on the market longer are often essentially the same as the new drugs (the whole "me-too" phenomenon). Unnecessary therapies, HRT in particular, should be reduced. They have serious risks associated with their use, and it's something patients should weigh carefully.

Then there's the recent announcement about Ortho-Evra, the birth control patch. Apparently it delivers 60% more hormones than the Pill because estrogen is absorbed directly into the bloodstream rather than through the digestive system. The result? An increased risk of blood clot and stroke due to higher hormone levels.

Thursday's warning comes four months after reports that patch users die and suffer blood clots at a rate three times higher than women taking the pill.

Citing federal death and injury reports, The Associated Press found that about a dozen women, most in their late teens and early 20s, died in 2004 from blood clots believed to be related to the birth-control patch, and dozens more survived strokes and other clot-related problems.

This is a major oversight on the part of the manufacturer. When oral contraceptives were first introduced in the 1960's the hormone levels were astronomical compared those on the market today. Drug designers learned that a low dose of hormones is just as effective and reduces the risk of complications. Knowing all these things, and considering the simple difference between orally taking medication and putting it into the bloodstream, it seems careless. Surely this could have been avoided.

What's worse is how young these women were - late teens and early twenties. I was actually considering switching to the patch because it seemed easier -- I'm glad I didn't follow through.

Due in large part to all the bad press (now there's no way I'll get a patch subscription), sales are dropping:

But at some, including Pfizer and Merck, the largest and third-largest American companies in terms of revenue, sales are stagnant and profits are falling, leading to layoffs and - for the first time in years - cuts in research budgets.

In the third quarter, United States sales of prescription drugs fell 3 percent at Bristol-Myers Squibb, 4.5 percent at Johnson & Johnson, and 15 percent at Pfizer. Merck said its overall revenues fell 2 percent despite favorable foreign exchange trends.

After making more than all the other 490 Fortune 500 companies combined(at least until 2003, when oil took frist place), it's about time the pharmaceutical industry be held accountable for its oft-disregard for patients and their pocketbooks. But the cuts shouldn't be in their research budgets -- the problem is in the products themselves, and in the case of Ortho Evra, it seems more research was needed. Their profit margins need to fall back in line with other major corporations. Pfizer alone will make $8 billion in profits this year. Surely they can figure out how to recoup the negative press and make drugs safer with that much money.