Health Business Blog

Mainstream gynecologists are warning against “vaginal rejuvenation,” which they call unproven and risky. Of particular concern is a Dr. David Matlock, who trademarks his procedures and trains physicians for rates approaching or exceeding $50,000.

From the Wall St. Journal:

Although there are legitimate reasons for genital plastic surgery, the physicians group’s warning said the specific procedures cited “are not medically indicated.”

Many gynecologists say the majority of such procedures aren’t backed by solid scientific studies. They say potential risks, including infection, scarring, nerve damage and loss of sensation, outweigh possible — if any — benefits.

“To do this for cosmetic reasons, and to say it will improve sexual fulfillment is totally absurd,” says Thomas Stovall, past president of the Society of Gynecologic Surgeons and a clinical professor at the University of Tennessee at Memphis.

Still, in my book this is nothing compared with re-virginization.

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MedTripInfo, a site dedicated to information on medical tourism, has launched a new survey question: What is the single biggest barrier to the growth of medical tourism?

Cast your vote today. You can also view and discuss earlier questions in the Surveys and Polls forum. Examples include:

• If you needed to have a heart valve repaired, where would you have it done?
• By the year 2010, what percent of US health care insurers will routinely pay for patients to travel abroad for surgery?

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I’m accepting submissions for the next Cavalcade of Risk blog carnival, which will be hosted here on the Health Business Blog on September 12. Your best bet is to use the Blog Carnival submission form.

Any risk-related post is welcome. I will be including a section on medical tourism, so would love to get a few posts on that topic.

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Questcor Pharmaceuticals has announced “a new strategy and business model for H.P. Acthar Gel(R).”

Translation: the company has obtained orphan drug status for a product that has been used for decades –including for the orphan indication of Infantile Spasms– and is raising the price 20-fold, from about $1000 per vial to $20,000 per vial (according to my source).

The Orphan drug law has benefits. It encourages companies to pursue treatments for diseases afflicting small numbers of patients. In my opinion it shouldn’t be used in situations like this for an existing drug with a widespread existing use.

The press release is very defensive, as it should be. It cites the fact that the company has been losing money and is incurring costs for the new indication and for manufacturing upgrades. It mentions a program to make the drug available for those who can’t afford it, and talks about Questcor’s participation with patient advocacy groups.

If insurance companies are smart they’ll read this paragraph and react accordingly:

Questcor’s implementation of this new pricing model creates risks and uncertainties for Questcor, including risks associated with the possibility of lower unit sales, the refusal of third-party payors to provide reimbursement for purchases of Acthar, and the financial impact of the return to Questcor or sale to third parties of previously sold product. Questcor could receive negative publicity as a result of its adoption of this new strategy, and responding to inquiries from the press or patient advocacy groups, or dealing with litigation against Questcor, could divert the attention of key employees from operating Questcor’s business.

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In today’s NEJM, Richard G. Frank, PhD lays out some of the issues regarding generic biologics. He suggests using the Hatch-Waxman Act –which enabled the generic drug industry to flourish– as a starting point. The article, Regulation of Follow-on Biologics, is available free. His conclusion:

The prospect of the loss of patent protection for tens of billions of dollars’ worth of biopharmaceuticals increases the urgency of the need for a regulatory policy that promotes price competition and preserves the safety and efficacy standards that Americans expect from prescription drugs. In my opinion, the Hatch–Waxman framework is not sufficient to cover both relatively simple biopharmaceuticals and very large and complex molecules — a new regulatory framework is needed. Because of the need for complex, situation-specific judgments, the FDA should be granted a great deal of discretion. The conflicting goals of bolstering price competition in biopharmaceutical markets and preserving the incentives for innovation call for a nuanced policy that must be based on the best current science and key features of the economics of biopharmaceutical markets — not on the impassioned claims of the interested parties.

The problem with Hatch-Waxman is that its success has put blinders on policymakers and analysts. There’s a simpler and better solution as I’ve advocated several times over the past year (see Paradox or Idiocy? for example):

Regulate the prices of biotech drugs once they go off patent. That eliminates safety concerns, lowers the regulatory burden, and guarantees lower prices, all without reducing the incentive for innovation. The only losers are the companies that would develop and manufacture generic biologics.

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Check out the latest Cavalcade of Risk at the Health Affairs Blog. I’ll be hosting the next edition here in a couple of weeks.

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Laurence J. Kotlikoff is professor of economics at Boston University and author of a forthcoming book, The Healthcare Fix. I’m underwhelmed by his op-ed piece in the Boston Globe, We are all uninsured now.

Kolitkoff proposes a strange amalgam of radically ambitious and timid reforms.

On the one hand he would abolish Medicare, Medicaid and employer based health care, and have the government give everyone a voucher based on their health status. Unhealthy people would get bigger vouchers and insurers would be forced to accept the vouchers.

I can’t imagine those things happening and I don’t think they’re a good idea.

On the other hand he would keep the current insurance and health care delivery systems in place.

Nothing would be nationalized. Virtually all of the cost would be covered by redirecting existing government healthcare expenditures as well as tax breaks. Doctors, hospitals, and insurers would continue to market their services on a competitive basis.

I’m willing to give Kolikoff the benefit of the doubt. Maybe the book explains how the government is going to rate everyone’s health status every year, or how leaving the existing health care delivery and insurance system intact is going to solve anything. But I doubt it.

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It’s not news to readers of this blog that hospitals are dangerous. I’ve even advised bringing your own physician to the hospital as an advocate if you can. So I agree with the advice in today’s Boston Globe, Patient, protect thyself, which advises patients to ask doctors and nurses questions, such as:

• Did you wash your hands?
• Are all these tubes needed?
• Did you start antibiotics too soon before surgery?
• Could you check the central line for signs of infection?
• Is the bed at a proper angle, since the patient is on a ventilator?

It all makes good sense, and as Betsy McCaughey, chairwoman of the Committee to Reduce Infection Deaths says: “If you’re worried about being too aggressive, just remember: Your life is at stake.”

But let’s face it. It’s unacceptable that patients and their advocates need to do this, especially at “top” hospitals.

It got me thinking. What would be the analogous instructions to clients and customers of other service providers?

For pilots and flight attendants:

• Did you put fuel in the plane?
• Could you make sure to close the door?
• Is the runway long enough?

For fire dispatchers:

• Can you remind the firefighters to bring a ladder since I’m on the 3rd floor?
• Can you make sure the air tanks aren’t empty?
• Did you write down my address?

For police officers

• Could you make sure not to leave your gun lying around?

For lawyers

• Is your opinion based on the laws of this state?
• Did you spell check?

For financial planners

• Are those recommendations based on my portfolio?
• Is that mutual fund manager you recommended in prison?

Am I off base here?

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If you’ve just given birth and started breastfeeding chances are high you’ve been pressured directly or indirectly to give the baby formula while you’re in the hospital. After all the baby’s weight tends to fall for a week or so and you may feel like you’re not giving him or her enough nutrition.

Turns out newborns on formula tend to be overfed, which may lead to obesity later in life. Just something to think about.

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Check out Change of Shift, the nursing blog carnival. It’s hosted this time at Nurse Ratched’s Place.

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