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Picking government contractors, high-flying Dubai, and a dubious drug on the market

By Steven Brill
November 26, 2013

1. Who picks the contractors?

In the wake of the failed launch of Healthcare.gov there has been some spectacular insider coverage, particularly by the Washington Post and New York Times, of the failure of the private contractors to deliver what they promised when they won the assignments to build the federal insurance exchange. But while there has been some mention of problems with the contract procurement process itself (focusing on the notion that in Washington the IT providers who win the contracts are better at winning IT contracts than at doing cutting-edge IT), one piece of the story has so far been missing: Who actually decided to award the Healthcare.gov contract to CGI and the others who shared the work? And on exactly what basis?

We know the winners had invested heavily over the years to get on a list of pre-qualified companies who could bid on contracts like this one, a tortuous process that the best and brightest technology companies outside the Beltway typically don’t bother with because they have too much more rewarding work to do in the private sector, where the bidding process is more straightforward. But we still haven’t gotten a good picture of who in the government runs these processes.

I know from some reporting I’ve done recently that in Kentucky, to take one example, the contractor that won the job to build that state’s Obamacare website was chosen by a committee that did not include the person who was actually in charge of building the Kentucky exchange. In other words, the person who would supervise the outside vendor, and whose career depended on whether the contractor did a good job, had nothing to do with picking the contractor. In fact, I’m told that the official in charge of the website didn’t meet the leader of the contracting team until after the choice was made.

It turns out that the lead Kentucky contractor — Deloitte Consulting — did a great job, and its team worked perfectly in synch with the state officials supervising them. But that seems to be more a matter of good luck than a procurement process designed to produce teamwork and accountability. Imagine a private corporation picking a supplier to work on a key project without the executive supervising the project being allowed to meet the supplier’s team leader first.

I’m assuming that’s what happened in Washington at the Department of Health and Human Services. As with most states, federal procurement regulations require a walled-off selection process intended to prevent corruption by having mid-level civil servants rather than higher-ranking officials, who are often political appointees, make these big-money choices.

Is that what happened? Who chose these contractors and how?

2. Dubai follies:

According to this article in the November 18th Wall Street Journal, Boeing and rival Airbus announced an astounding $150 billion worth of aircraft sales to Middle East-based airlines at the Dubai Air Show that opened the weekend before last.

So, how about some comprehensive stories about how airlines like Emirates make their purchasing decisions and negotiate discounts? The Journal reported that Emirates is “already the world’s largest international carrier by capacity” and that it bought 150 Boeing jets with a total list price of $76 billion at the air show.

More generally, what are the details behind the obvious plans for world domination by the Middle East’s airlines, and how are international air hubs like London’s Heathrow responding to what the Journal says is the Middle East states’ strategy to overtake Europe as the leading crossroad for international travel? According to the Journal, “Dubai’s existing airport is set to overtake London Heathrow as the world’s busiest international hub, and it has added a second, the new Dubai World Airport that is hosting this week’s show.”

How will the West be able to respond? And are there international trade issues related to the fact that much of the funds behind the Middle East push are coming from competition-skewing subsidies from these oil-rich governments?

Beyond that important but relatively dry stuff, I bet there’s also a fun lifestyle story here. With all that money on the line last weekend at the Dubai conclave, how about a report from the party scene?

3. Who let this drug on the market?

Lately, we’ve been bombarded by TV ads for something called AndroGel, apparently an underarm-applied drug for men that purports to boost testosterone. But it’s hard to tell what it really does because most of the ad talks about its scary side effects.

About fifty seconds of the 90-second ad  warns first of the horrible things that can happen to women or children who have any contact with the gel and then what might happen to men who use it: “worsening of enlarged prostate, possible increased risk of prostate cancer, low sperm count, swelling of ankles, feet, or body, enlarged or painful breasts, problems breathing during sleep, and blot clots in the legs.”

Earlier this month, CBS News (which clearly doesn’t worry about offending advertisers) reported on the air and on its website that “A major study published Tuesday in the Journal of the American Medical Association looked at older men, most with heart disease, in the Veterans Affairs system who had low testosterone levels. There was a 29 percent increased risk of heart attack, stroke or death in those given testosterone.”

So why is this drug allowed to be sold?

“Now I feel the way I should feel,” says one patient interviewed by CBS extolling the drug — and reflecting the new lease on life offered to men in the other 40 seconds of the AndroGel ad.

But the potential downsides are so threatening that, as a doctor interviewed by CBS puts it, “before you start treating millions of Americans with testosterone, you probably ought to think twice.” It would seem that the AndroGel ads would be a good hook for a story examining not only the process by which the Food and Drug Administration approved it for sale, but also the United States’ uncommonly loose rules when it comes allowing TV ads for drugs, even those with such dicey cost-benefit profiles.

PHOTO: United Arab Emirates’ Prime Minister and Ruler of Dubai Sheikh Mohammed bin Rashid al-Maktoum (front R) comes out of an Airbus 319 aircraft after touring it during the Dubai Airshow November 17, 2013.  REUTERS/Ahmed Jadallah 

 

Comments
3 comments so far | RSS Comments RSS

Actually, the lead Kentucky contractor didn’t do the good work on the state’s Obamacare website. Deloitte Consulting subcontracted the marketplace website to CGI, the same company working on the federal system.

Posted by 2MW747 | Report as abusive
 

speaking of loose advertising laws, something should be done about the supplement industry.

Posted by zotdoc | Report as abusive
 

Finally! They Discovered a Disease for that Cure!

According to its manufacturer, AbbVie, “AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone.” The AndroGel website offers the following ten question yes-no quiz to see whether a man “should talk to” his “doctor about Low Testosterone:”

1. Do you have a decrease in libido (sex drive)?
2. Do you have a lack of energy?
3. Do you have a decrease in strength and/or endurance?
4. Have you lost height?
5. Have you noticed a decrease in your enjoyment of life?
6. Are you sad and/or grumpy?
7. Are your erections less strong?
8. Have you noticed a recent deterioration in your ability to play sports?
9. Are you falling asleep after dinner?
10. Has there been a recent deterioration in your work performance?

The ten questions might just as well ask, “Are you getting old?” or “Are you naturally aging?” Snake oil salesmen have been selling fountain of youth elixirs since people starting getting old. Fortunately, most snake oils are only harmful to the purchaser’s wallet as many of the alleged aging cures are harmless. However, once in a while a potion does contain harmful ingredients or actual medicinal compounds which have major physiological effects. AndroGel seems to be promoted as the cure for a newly discovered disease called, “Low T.” However, its safety is in question.

On January 31, 2014, the United States Food and Drug Administration (FDA) issued a Safety Announcement regarding testosterone products. This communication stated, “At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.” While the beginning of this Safety Announcement might not seem alarming, the FDA further states, “None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.”

What is “an associated medical condition?” The manufacturers of some testosterone products would have one believe that Low T (the condition of having low testosterone levels) is an associated medical condition to the condition of having low testosterone. If you think this is strange logic, you would be correct. There are some who feel that the manufacturers of some testosterone products, realizing that they had a profitable “cure” for a disease that did not exist, simply invented a disease with ten associated symptoms (see quiz above). Recent studies have shown that certain groups of men taking testosterone will have increased risks of stroke and heart attack. Lawsuits are now being filed against the manufacturers of some testosterone products and for failing to warn consumers about the deadly harm that testosterone can cause. Without getting technical, testosterone has been shown to increase the red blood count (thickening of the blood) which can cause clotting issues leading to stroke and heart attack.

If your physician has prescribed testosterone for you, you should immediately discuss whether you truly need it and whether there are safer alternative drugs. After weighing the risks and benefits, you and your physician can determine what drug, if any, is best for you.

If you or a loved one, have taken AndroGel, and have suffered a stroke, you should immediately consult with his physician and then consult with an attorney who is experienced in handling such a matter.

- Paul

Paul J. Molinaro, M.D., J.D.
Attorney at Law, Physician

Posted by PaulMolinaroEsq | Report as abusive
 

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