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Tag: Pharma

PHARMA/TECH: Should big Pharma be blogging? by Shahid Shah

In the light of the recent tattle in the pharma blogosphere of the hijacking of Cialis’ brand identity and Lilly’s apparent inability to do squat about it, Shahid Shah, who besides being a healthcare IT expert is also becoming a corporate blogging evangelist, sent me this guest submission suggesting a little more specificity about blogging on pharmaceutical and regulated products. As many THCB readers know Shahid runs theHITSphere  blog aggregator as well as his own Healthcare IT Guy blog. I also think many of his thoughts are applicable to other health care corporations concerned about blogging, such as providers and insurers. And of course I like his pitch to pharma companies to hire me to help them figure this out!

Corporate blogging is certainly not new but it hasn’t really taken off because executives are always nervous about public statements they make, especially if they run a public company. Until now only small firms, who have much to gain with direct 2-way contact with their customers, have really engaged their clients through blogs. Now, however, even the big companies as different as McDonalds and Microsoft have become corporate bloggers with different degrees of success.

The pharmaceutical industry is certainly one group of companies that could use increased goodwill that comes from direct contact with their customers. If anyone should be blogging from a corporate perspective it should be big pharma because what it does directly touches the lives of its customers in a way very few other industries do. The level of importance people give to their health and the way that they bond with their healthcare providers (and by extension the drugs they take) is very important. Most pharma companies are worried about the FDA and cite that as a big concern about why they don’t blog. But, I think that’s a mistake.

Pharma shouldn’t worry too much about what the FDA has to say specifically for blogs. Blogging does not impact anything that wouldn’t already be public anyway. For example, if a pharmaceutical firm has a call center where they answer questions about their drugs’ on-label use, a blog would be no different. In fact, drug firms can improve customer service by providing tips, tools, and guidance on how best to use their drugs. I would recommend that firms start to create blogs that start to tell stories of why scientists (in their own words) are focusing on certain diseases, how far technology has come along, how exactly drugs go from an idea to discovery to production. All these would bring customers closer to them, not alienate them. And, the FDA won’t complain about anything that doesn’t cause off-label use. I spoke with an FDA counsel this week and she basically said the same thing: anything that’s covered by existing guidance would apply to blogs, too (she didn’t provide official legal guidance, it was just a comment stating the obvious).

If a drug vendor starts a blog or discussion forum about its products and doesn’t mis-communicate about efficacy of its products or fitness for a particular purpose it shouldn’t get into trouble. Companies won’t have problems with regulators if they stick to the truth about their products and improve the way customers interact with them. That doesn’t mean they shouldn’t be careful about what they say — but that goes for anything a company says. It’s not something special to blogging but blogging does make it easy for people to say whatever they want (like folks do in an email).

So, if you’re not blogging today don’t blame the feds. If you’re not creating corporate blogs, it’s due to a lack of vision and innovation and perhaps a lack of respect of your customers, not the FDA. Guys like me and Matthew can help you devise an appropriate strategy to allow direct communication, improved customer service, and who knows in a few years people may stop thinking of big pharma in a poor light like they do now.

Oh, and by the way, don’t think that just because you’re not blogging about your own products that nobody else is. Nature abhors a vacuum and so does the blogging community. Third parties are already talking about your drugs and company in their own blogs and forums. Given the growing influence of blogs on consumers, pharmaceutical companies can not afford to dismiss comments made about their products by bloggers and must create their own presence within the blogosphere. Why not take the initiative and help navigate people to the “official” word about your drugs?

PHARMA/POLICY: Suggestions for advancing beyond indignation & conventional wisdom, by The Industry Veteran

Today I’m off to a meeting on Pay for Performance, so I hope I’ll have something riveting for you all later. Meanwhile, as I’ve overblogged (and been over-exposed) in the past week or so, I thought that this morning I’d leave you all with the dulcet tones of The Industry Veteran. As the scandal of pharma and med device companies bribing doctors has got serious enough that even the New York Times has noticed, today the Veteran’s thoughts turn to the issue of how big Pharma might be made to keep to the letter and spirit of whatever new guidelines eventually get suggested to them regarding physician “incentives”—and not simply ignored as the previous many go-rounds have been. As you may have guessed, the Veteran’s suggestions are a little, shall we say, unusual:

I guess the symbiotic corruption of Big Pharma and physicians has become part of the conventional wisdom if the staid editorial column of the NYTimes issues an admonitory tsk-tsk. Well a dog does have four legs and the sun rises in the east, so in good Times-Democratic Party fashion, it’s worth deploring this state of affairs and mentioning that, together, we can do better. Meanwhile Billy Joe Tauzin and the AMA’s Babbitts will again confirm Lincoln Steffan’s opinion concerning muckraking’s futility by showing the crooks how to avoid getting caught next time.

 

Beyond exposing corruption and pointing out contradictions within the American system of political economy, Steffans, Ida Tarbell and their colleagues provided negligible help in showing a way out. Your note on HSAs in South Africa reminded me that it was Steffans who visited collective farms in the Soviet Union and returned to say, “I have seen the future and it works.” Upton Sinclair turned to health foods and crackpot schemes in California before running a feckless campaign for governor.

 

To avoid a perpetuation of same-old, same-old in health care, allow me to offer some guidelines for regulation and punishment meant to guide the life-diminishing hands of lawyers and legislators.

 

First, let’s deal with the manufacturers. Capitalism works by essentially outsourcing the regulatory oversight function to the same private concerns whose activity requires such monitoring. This is true even in a so-called “regulated” industry such as health care. That’s not necessarily bad because the latitude it permits businessmen and their hirelings in science, law and elsewhere facilitates innovation and attention to consumer demands. Unfortunately, since the pursuit of unconscionable profits also beats ethical constraint every time (and “twice on Sunday,” as my barber on Sixth Avenue used to say), this outsourcing usually becomes a license to steal, maim and kill.

 

Now despite the many shortcomings of the Sarbannes-Oxley law (it was, after all, intended to make up the revenue shortfalls of big accounting firms in the wake of the Enron/Arthur Andersen auditing scandal), I do admire the fact that it recognizes corporations are not shapeless forces of nature. To the contrary these institutions represent the lengthened shadows of a few greedy bastards at the top and, accordingly, the law requires that these officers sign to the veracity of Sarbannes-Oxley statements under liability for criminal penalties. It is thus in pharmaceuticals as well. The CEOs in that industry generally made their abbreviated, Bush-like journeys from birth on third base to home plate by functioning as the most effectively devious, unscrupulous, alpha-males within their various launching milieus. For that reason legislation prohibiting manufacturers from bribing, improperly inducing or influencing physicians should be directed principally toward the fiduciary officers rather than shareholders’ earnings. Any agreements between the companies and their officers related to indemnifying or otherwise reimbursing executives for these financial penalties should be construed as efforts to defeat the statutes and held for naught.

 

Legislation on this matter should also recognize that in cases of the culturally middle class, a little shame administered in front of the country club peers, the trophy wives and the compliant secretaries goes a long way. In other words degradation rituals should be made integral parts of regulatory penalties. We’re talking more than just mandatory perp walks here. The executives who derive enormous satisfaction from preening around as the dominant males within their respective companies should literally have their pants pulled down. This means mandatory Internet publication of their three-sided, nude photos: front view, side view (to show the paunch beneath the $2,000 suits) and rear bent-over view (to be advertised as previews for other inmates).

 

Legislation drafters must also deal with the greed and narcissistic egotism of physicians on this matter. I believe remediation here is a far more pedestrian matter. Physicians generally regard the advance of damnation as consisting of more work, less pay, less discretion in their professional decision making, more clerical duties and less deference from their support staffs. For this reason penalties should make even casual transgressors realize their Dantean fantasies. They must receive sentences that oblige them to practice medicine in circumstances that turn to ashes every reason that led them to medical school and their residencies.

 

Instead of providing scientific interest, the work of bribe-taking physicians must become mind-numbing drudgery. Their well-being must be placed into the hands of bulldog secretaries, each lacking the ability to add a column of four numbers. Far from receiving the fawning deference of women or the respect of men, they must be made to work in post office surroundings that all but brand large L’s on their foreheads.

 

Legislation can achieve a general deterrent effect from these punishments by requiring that once offenders are released, they must discuss their experiences with colleagues in detail after resuming private practice.

 

I offer the above suggestions in the interest of enlightened penology, which as it turns out, is equivalent in policy terms to better health care.

PHARMA/POLICY: Anyone know about best price?

This is pretty interesting, and it relates to real wonkery AND to more stretching of the truth by my favorite health plan lobbyist, Karen Ignagni. In the article Drug firms to get profits windfall, a Univ of Minnesota Professor estimates that because the dual eligibles are no longer in Medicaid — they’re the ones that have been automatically moved to Medicare — and therefore they don’t have to offer "best price", they can charge higher prices to the taxpayer for their drugs.

The boost in profits comes from a shift in the drug coverage of 6.4 million poor and elderly people from Medicaid to the new Medicare drug benefit. Unlike Medicaid, which requires drug companies to charge their lowest or "best price" for medications, the Medicare program relies on competition among private drug plans to keep prices low.By eliminating the need to discount drugs for the government, the industry can now pocket the savings. "The net effect over 10 years is probably closer to $40 billion in extra profit," said Stephen Schondelmeyer, a pharmaceutical economics professor at the University of Minnesota. A little-known study by the Prudential Equity Group from June 2005 estimated that the makers of three anti-psychotic medications stand to benefit most from the change, taking in roughly $1.1 billion in new profits on products used by the 6.4 million who are Medicare’s most poor and frail patients.Experts say drug prices in the Medicare program will be higher this year than prices under Medicaid because the private Medicare drug plans won’t likely match the price discounts achieved by Medicaid, the joint state and federal health program for the poor.

Now hang on a second. This raises two key points. Not one week ago, Karen Ignagni said that the exact opposite was true. State medicaid directors were apparently telling her that they were getting worse deals than the private plans she represents. So which is true?  Well guess who I’m more likely to believe. After all, did PhRMA pay all those political contributions to end up losing money

And then one thing that I just don’t know. Suspend your disbelief and pretend that at least in some cases for some drugs, Ignagni is telling the truth. Presumably best price still applies to the rest of the Medicaid program. Are deals between Pharma and Medicare Part D PDPs exempt from Medicaid best price? Anyone know?

PHARMA/POLICY: Richard Paey’s case hits 60 Minutes

Richard Paey was put in jail for 25 years basically taking pain pills, so that instead the state in Florida can fund his medical care. Oh the prosecutor said that he forged prescriptions, even though at first he wanted to go after his doctor.  Well this shameful attack on a wheelchair-bound patient is finally getting some attention. Last Sunday is made it onto 60 Minutes.

Much of the thanks for this must go to John Tierney from the New York Times, who continually writes about the craziness of our war on patients and doctors. He pointed out in his column that the prosecutor is an earnest man who genuinely believes that he is doing the right thing, and claims that he made no medical judgments even though his entire case is based on his made-up "fact" that "no one could take 25 pills a day". He reminds me of the concentration camp guard, who was sure he was just following orders.

You’d think that, as Jeb Bush has a daughter who herself was in trouble for forging prescriptions, and apparently was just a regular addict, the wise Christian governor of Florida could find a little mercy in his heart.

 

PHARMA/HEALTH PLANS/PBMs/POLICY: Meanwhile Ignangi on drug pricing, best price and fraud

I’m listening to the webcast of the KFF Forum on Medicare, and in the middle Karen Ignagni comes out with this gem.

But Karen Ignagni, president and CEO of America’s Health Insurance Plans, countered that so far, health insurers are beating Uncle Sam at the negotiating table. "I’m hearing shock from (state) Medicaid directors that we’re getting better prices than they are," she told UPI. "I don’t know of any other government program where the real costs are less than the estimates," she said, arguing that the plans are offering "affordable products" with low premiums and low deductibles.

Ignagni is either lying here (or massively overstating the truth from a few anecdotes), or going to find a few men in sharp suits from the rich part of K street funded by big Pharma coming down to see her carrying baseball bats.

You see, Medicaid plans get from pharma manufacturers what’s known as “best price”. In other words if they give a better price to another customer, they also have to give that price to Medicaid. Medicaid is still of course buying its drugs for its non-Medicare dual eligible population. The drug companies know this, so I doubt that what she’s saying is true. But if it is true that Ignagni’s health plan members are getting a better price than the states are, then the states can go back to the pharma manufacturers to get a better rebate — oh, and also prosecute Pharma companies for fraud over not giving them best price, as has happened many times.

PHARMA: McKinell’s over-Exubera-nce

Diabetes sufferers will have to wait a longer for Exubera, an inhaled insulin drug that supporters say transform the lives of people with the condition. Pfizer shares soared this morning after CEO Hank McKinnell said the drug has received FDA approval.

Turns out Mckinnell was just excited…..or perhaps over – Exubera-nt?

Anyway the stock market seems to think that he knows something.

PFE

 

POLICY: Over at TPMCafe, Medicare Part D

I have joined in a coversation about Part D with some other old farts and a couple of young punks (but very smart young punks — I was strugling to learn how to pick my nose at their age, and they’re health policy whizzes!) at TPMCafe. The section is called Drug Bill Debacle

Also don’t miss this cracker from a surgeon, Me and my HSA in which she shows why it’s great for her, but terrible for America!

PHARMA/POLICY: Drug coverage in Medicare Catastrophic (1988) and in the Clinton plan (1994), by MedPac

This is taken straight from a hard to navigate PDF document created in 2000 by MedPac (and advisory body on Medicare for the Congress). It’s a good primer on what happened, especially to  drug coverage under the by now forgotten Medicare Catastrophic Act. I reprint it here because there’s some confusion over that issue and I don’t want to have to do more writing myself when they’ve explained it so well!

Policymakers previously approached the issue of adding Medicare prescription drug coverage: in 1988, with the Medicare Catastrophic Coverage Act (MCCA) of 1988, and in 1994, with the Health Security Act. Both efforts failed, but for different reasons and under different circumstances.

Medicare Catastrophic Coverage Act of 1988

In 1988, Congress added a catastrophic benefit to Medicare that would have provided comprehensive coverage for outpatient drug expenses greater than $600 in 1991 with a 50 percent coinsurance, and those greater than $652 in 1992 with a 40 percent coinsurance. The coinsurance was to be lowered to 20 percent in 1993. The intent was to revise the deductible  annually, providing 16.8 percent of beneficiaries with benefits each year. The new coverage was to be entirely financed by  Medicare beneficiaries through an increase in the Part B premium and a supplementary surcharge. The surcharge was to cost higher-income beneficiaries those with incomes greater than about $40,000as much as $800 in 1989 and $1,050 in 1993 (Congressional Quarterly 1988, Coster 1990). Opposition to the new benefit was fueled by confusion about the specifics of the financing (many lower-income beneficiaries thought they had to pay the full surcharge), as well as other concerns.

First, enrollment in the program was mandatory, but many beneficiaries would never receive any benefits because their drug costs would never exceed the cap. Second, beneficiaries who already had drug coverage, from either Medigap or an employer-sponsored retiree plan, would be required to pay twice for the same benefit; these people also were the ones most likely to pay the maximum premium surcharge (although it is likely that retiree insurance premiums would either decline due to Medicare coverage or be a wrap-around benefit). Third, beneficiaries were required to start paying the supplemental premium in 1989, two years before the full benefit began. The law was ultimately repealed in 1989; few benefits had taken effect by this time.

Continue reading…

QUALITY/PHARMA: Statins in the water in the UK, but generic ones

And in more from the UK, statins are now going to be put in the water. Well not quite, but allowed to be given to anyone ever suspected of maybe in the future developing heart disease given to anyone ever suspected of maybe in the future developing heart disease, which in the UK is basically anyone.

Almost six million people in England and Wales — nearly 15 per cent of all adults — are from today eligible for treatment with statins under ground-breaking NHS guidelines. A report by the National Institute for Health and Clinical Excellence (NICE), which advises on best treatments, will recommend that anyone at risk of cardiovascular disease should be prescribed the drug.About 1.8 million adults in England and Wales currently take statins, which are thought to save 7,000 lives a year. Doctors believe that the new ruling will double uptake to 3.4 million people, saving another 10,000 lives a year.

While this might sound like fantastic news for the drug companies, I think that the decision might somehow be connected to the fact that most of the big statins (with the exception of I believe Lipitor and Crestor) have gone off patent in the UK, and one suspects that Pravachol and Zocor will be most popular!

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