Tag Archives: FDA

Peer Pressure Crushes Silicon Valley Entrepreneur

Monkey bureaucratsAnne Wojcicki is one of those Silicon Valley entrepreneurs that started a “disruptive” company aiming to change how we view an established industry. But she’s not one of those brain–rich, resource–poor visionaries passing the hat among bored World of Warcraft players window–shopping on Kickstarter.com.

No, she and her partners, Lucy Page and Laura Arrillaga–Andreessen — respectively the wives of Internet billionaires Sergey Brin (Google), Larry Page (Google) and Marc Andreessen (Netscape) — didn’t have to do anything so common as asking for money.

Google kick–started the project, so to speak, with an initial investment of $3.9 million and soon other vulture capitalists jumped on the bandwagon. The company, 23andMe, made its debut among the one percent at the World Economic Forum in Davos, Switzerland, rubbing elbows with the likes of Bill Gates, Bill Clinton and other political or economic plutocrats.

Alexandra Wolfe writes in The Wall Street Journal, that as guests left the annual Google blowout, they were asked by “spit coaches” for a sample of their saliva. (This is one of the major differences between a redneck party and a one–percent party. At the redneck bash no permission is necessary. You just attempt to match the various pools of vomit with the contributors.)

In return for spitting in a cup the guest would receive a free DNA analysis and report. (Yet another aside: No wonder tech companies have zero concept of customer privacy, if management gives a DNA sample to a complete stranger, it’s not surprising they expect to be able to snoop freely in our secrets.)

Whereas in the past captains of industry might have indulged the little woman in a dress boutique or tea shoppe, Internet titans and their wives think bigger. Wojcicki and partners want to “drive this revolution where an individual had more of a say in health care.” Mainly by giving them a complete DNA report and analysis of individual genetic tendencies toward disease.

I don’t have a problem with any of this. It’s Google’s money and I’m not a stockholder. If the board doesn’t see a conflict of interest is funding wifey’s company, who am I to complain? Wojcicki also travels in different circles than I do and networking at the top only makes sense.

My problem is what she’s done after the product went public.

The Sultan of Spit recently made a charm offensive trip to DC and received lavish coverage in the WaPost. Wojcicki explained, “23andMe’s customers mail a test tube containing their saliva to the company, which analyzes their DNA. And for $99 they get back a report detailing any risk for more than 240 health conditions.” Time magazine was so impressed that the product was named invention of the year for 2008.

The Post writes that “celebrities gleefully tweeted their results” letting fans know if celebrity genes made it more likely for them to die of a heroin overdose in a squalid shooting gallery, suddenly change their image from that of clean teen to sex–act–simulating slut or be prone to shouting homophobic insults when surprised by a photographer.

By June of this year Wojcicki was negotiating to sell the results from an amazing 700,000 DNA samples to Edward Snowden because information wants to be free.

And then the FDA struck.

She received a “scathing letter” ordering her to cease all sales of the DNA analysis kit because it had not been approved by the Food and Drug Administration. In the letter the FDA threatened “seizure, injunction and civil money penalties.”

Why were the bureaucrats at the FDA so exercised? The Journal summary said, “The FDA contended that genetic results aren’t always accurate and can mislead consumers. Officials feared that, without the supervision of a physician, users of the service might have unnecessary elective surgery based on inconclusive genetic information.”

And even if they did, what hospital would let a walk–in start ordering medical procedures?

Alberto Gutierrez, head of the FDA’s Office of In Vitro Diagnostics, was quoted by the WaPost, as claiming “Results from questionable tests can be unnecessarily alarming, adding that some women have undergone surgery, for example, based on tests that purport to gauge the risk for ovarian cancer.”

And right here we discover why HealthCare.dud didn’t work. Federal bureaucrats are delusional. The reasoning behind the stop–and–desist order is surreal. I don’t take my car into the shop without talking to the service consultant first. Does the FDA really think there’s a danger of someone getting a DNA analysis and calling the hospital to schedule a mastectomy?

And the worry about unnecessary surgery is politically selective. If a deeply disturbed patient decides he wants a surgeon to vandalize his private parts to turn him into a woman — the definition of unnecessary, dangerous and permanently damaging surgery — the FDA, American Medical Association and American Psychiatric Association all have no problemo with that monumentally flawed decision.

I’m wondering when the FDA is going to get around to regulating newspaper horoscopes and palm readers. Gullible consumers make all sorts of life–altering decisions based on these pseudo–sciences, to say nothing of the devastation wreaked in many families by teenage nutritionists deciding to “go vegan.”

DNA results in the mail pale in comparison.

So far I’m in Wojcicki’s corner. She wants to give consumers access to more medical information so they can make their own, informed decisions. As Wojcicki told the Journal, “For example, patients often don’t know how much a procedure at a doctor’s office costs ahead of time. “That’s why I felt we had to drive this revolution where an individual had more of a say in health care.”

Her research has shown that in India hospitals post prices lists for procedures so that patients can see what their cost options are. Rumor has it that in China organ harvesters will even price their products on a sliding scale according to the age of the replacement part.

She’s on a mission and then turf–conscious, unresponsive federal bureaucrats issue an arbitrary decision that eviscerates her business. She’s faced with months of tedious hearings, requests for documents and bureaucrat butt–kissing. And all the while she can’t sell her product. It’s all outgo and no income until the problem is solved.

Prospects for reversing the FDA edict through channels aren’t promising. The Obama administration has issued over 1,800 rules and regulations in less than three years and the WaPost reports that every single one of them are illegal since the rules violate the 1966 Congressional Review Act. Yet none of the rules have been rescinded.

This leaves Wojcicki with three options:

  1. She can file a lawsuit. This is not my favorite because it puts your fate in the hands of lawyers and judges and only serves to increase their baleful impact on modern life. I’ve never had much affection for a process that lets everyone make money from my misfortune, except me.
  2. She can try to put political and media pressure on the bureaucracy and force them to reverse the decision. If you think cockroaches scuttle for the shadows when you lift a rock and expose them to the sun, you should see a bureaucrat in the glare of publicity. For a brief time it looked like this was her intent. The WaPost coverage of her “charm offensive” and her testimony before the House Energy and Commerce Committee looked to be the beginning, but it seemed to peter out quickly.
  3. She can surrender and hope FDA bureaucrats, once they get around to finalizing their decision, leave her a business to operate.

But what Wojcicki choose to do appears to be the worst of all possible worlds. Five days after returning to California from the DC trip, she hosts a $32,400–a–person fund–raiser for the architect of her business problems: Barack Obama!

DC bureaucrats pull the plug on her business and she responds by raising money for the man and the party that support even more crippling regulation and expanding government intrusion. Why not just sign a quit–claim on your investment and give it to the Democrat National Committee?

Evidently being part of the leftist insider tech crowd is more important to Wojcicki than saving her business and striking a blow for the free market. If 23andMe goes out of business it will be bad news for employees and the other investors, but Wojcicki will be fine. Her money comes from a company that started too small for busybody federal bureaucrats to notice and by the time they did, it was too big to stifle.

That company is Google and it can afford to indulge the lifestyle leftism of its founders and support Obama and Democrats like the rest of the cool kids.

Parental Permission

age 15

age 15Last week the FDA said that 15 year olds can now purchase an abortificient type birth control over the counter. Plan B, as it’s called, is designed to be used within 72 hours of unprotected sex.  Through use of a ‘higher hormonal concentration’ it is meant to prevent implantation of an embryo and keep pregnancy from occurring.

A pharmacist, who does not have the medical history of the patient, will be the one handing over this medication. Will the child take it as prescribed? Or will she, as children often do, feel that ‘it two pills are good, six will be better? Can she just walk over to another pharmacy and get more of this medication? plan b

With all medicine there is a risk of side effects.  Who will this young girl talk to if she develops a reaction? Not her health care provider, who will be unaware of the purchase.

Difficulty breathing? Abdominal pain? These aren’t just simple reactions. What happens to the young girl who takes this medicine and then develops a life threatening problem? When, if ever, will her parents be informed of what has happened? Will the parents have to wait until reading the autopsy report of their child who died from complications of this hormone?

The Left believe that kids have the right to make the grown up decision to take this medication without knowledge of or intervention by the parents. Setting aside moral arguments for or against the Plan B drug availability let’s look at what other things a 15 year old can’t do without parental permission. For example:

Can a sophomore in high school have her picture posted in the newspaper or yearbook without parental permission?

Can a junior in high school choose to participate in extracurricular activities at school, particularly sports, without parental permission?

Can a student under 18 go on a field trip, watch an ‘R-rated’ movie in school, or stay out beyond the city curfew without an okay from an adult guardian?

If a child it not allowed to take a Tylenol or use an asthma inhaler in school without parental permission, why is she allowed to buy medication with potentially dangerous side effects with only a simple consult by a pharmacy staff member, who does not know her medical history?

If a child can’t have her teeth cleaned by the dentist without parental permission, have an x-ray or receive an immunization shouldn’t the parents be involved in such other critical decisions?

As schools request the ability to hand out condoms to younger and younger children will they soon be asking to supply them with hormonal contraceptives?

Why are parents allowing themselves to be removed from the parenting process? These children, our children, do not belong to the government. Instead of being pushed out, parents need to parent.  Instead of sticking our heads in the sand and letting someone else make decisions, parents need to know what the children are doing and especially what medications they are taking.


 

When Corn Prices Rise Our Government .. Regulates Food

Corn shortage causes prices to riseWelcome to Bazaaro-world – otherwise known as the United States with a liberal Congress.

A November 18th Bloomberg article illustrates what’s happening:

China’s State Council said on its website yesterday that price caps will be used on “important daily necessities” and production materials, if necessary. U.S. soybean inventories before next year’s harvest will be 30 percent less than forecast in October, and corn reserves may drop to the lowest since 1996, the U.S. Department of Agriculture said last week.

The Chinese are worried that we aren’t producing enough Soybeans and Corn to sustain their requirements.  Surprise, we aren’t producing enough to satisfy ours either.

Some believe that China, the world’s second largest corn producer behind the U.S. is a net exporter – no longer.  The Bloomberg report continues:

China became a net importer of corn this past year for the first time in 14 years, USDA data show. The nation will buy 57 million metric tons of soybeans in the marketing year that began Oct. 1, up 13 percent from the previous year, the USDA said Nov. 9.

China no longer produces enough corn to feed its own people.  There is no fall back position. How long until we can’t feed Americans any more?  We won’t have anyone to import from, so then what?  In Obama’s words costs, “..would necessarily skyrocket”.

By itself the huge climb in corn prices is alarming.  Many grocery items that we all rely on require corn or its derivatives -corn syrup, corn flour, corn meal, etc.  But that’s not the only thing that should have your alarm bells ringing.  Just as corn, soy and cotton prices have started to climb, our government has decided to act – to regulate food.

Senate bill 510 (S. 510) is the “FDA Food Safety Modernization Act”.  This bill seeks to update the “Federal Food, Drug, and Cosmetic Act”.  If passed, it would certainly update existing law, but the changes are disconcerting.

When first read, the bill appears harmless.  It’s only when read again, with the context of the global food crisis that things stick out.  Let’s take the wording of the very first two titles (emphasis mine):

TITLE I–IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

TITLE II–IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS

Granted, the “capacity” statements seem to be around building larger government agencies and capabilities.  The question is why?  Are we expecting a sudden threat to our food supply or perhaps such a shortage that we will have to try to get corn, soy and other food stuffs from someplace else.

These first two sections certainly illustrate a known concern about our ability to produce enough food, the third .. nails it:

TITLE III–IMPROVING THE SAFETY OF IMPORTED FOOD

Digging into S. 510, the details are not comforting.  Title one contains registration section.  It forces even the smallest food producers to register with the government.  Why?  Why does the government care about someones cucumber and tomato garden if there are already plenty of cucumbers on the market.  Then again, what happens when there are no longer enough cucumbers?

There is no way to know if this is coincidence or happenstance.   Corn and Soy prices skyrocket and suddenly the Senate takes a cloture vote on legislation that is more than a year old.  This bill was introduced in March of 2009 and just sat there for 18 months.  Then food prices rise, the Chinese signal a shortage and the Senate thinks this bill needs attention.  Always the question – why?