The Link Between Pharma Data and Prescription Drug Abuse

Tomorrow, the United States Supreme Court will hear an important case on the freedom of information and it should be of great interest to everyone in the pharmaceutical industry. The case, Sorrell v. IMS Health, looks at free speech. At issue in the case is whether States have the right to enact special secrecy laws for physicians by banning the lawful use of information for supposedly altruistic (if often, unsubstantiated) reasons.

These laws were passed in New Hampshire, Vermont and Maine, at the urging of a group called the National Legislative Association on Prescription Drug Prices (NLARx). Just how these physician secrecy laws are supposed to drive down prescription prices has not be adequately explained by the NLARx. I guess we were just supposed to believe them on it. Since these laws were passed in 2006, the States of Maine, Vermont and New Hampshire have not made a single effort at reducing prescription drug prices via any provision of these laws.

Whatever the Supreme Court decides in the case of Sorrell v. IMS Health, NLARx Executive Director Sharon Treat and her allies have already won. Last week came the news that Sharon Treat’s home state of Maine now has the highest rate of prescription drug abuse in the country. Why? Physicians in Maine are more likely to prescribe narcotics to patients who don’t need it than any State in the USA. Thanks to Sharon Treat’s efforts, doctors have nothing to fear from people looking over their shoulder. In fact, Maine’s much lauded Prescription Management Program focuses on individual patients. It doesn’t look for patterns in prescribers. A program run by the pharmaceutical industry was shut down, again, thanks to Sharon Treat.

In fact, if you look at States with the highest drug diversion and the highest problems of prescription drug abuse, they are all States that have regulated pharmaceutical prescription data (Maine, Vermont and New Hampshire). Coincidence? Unlikely.

So, whatever the Supreme Court decides, Sharon Treat and the NLARx have already won. In 2009, after Sharon Treat was able to get her law passed in Maine, prescription drug deaths jumped to over 160 per year. In Maine, every day, a baby is born addicted to prescription drugs. Those rates have only continued to climb. Just last week, the Federal Government noted that Maine has the worst prescription drug abuse problem in the country. So, the Supreme Court can take its time – Sharon Treat and the NLARx have already won…and the bodies are piling up in Maine to prove that I’m right.

J&J Recalls Topamax Epilepsy Drug

Last week, Johnson & Johnson issued is nth (I’ve lost count, we’re well above 50 now) for the anti-epilepsy drug Topamax. As it turns out, the Topamax product has the same musty order as other products which have been contaminated with the pesticide 2,4,6-tribromoanisole (TBA).

The recall effects Topamax that was manufactured and shipped between October 19, 2010 and December 28, 2010. No word from J&J on why it waited over 4 months to initiate the recall.

No word from J&J on how this happened. Topamax is manufactured at an entirely different plant in Puerto Rico that has not previously seen manufacturing problems and is not covered by J&J’s consent decree with the FDA.

Remember the quote from the great J&J CEO William Weldon in which he said there are no systemic problems at J&J? Remember that? Help me out here – if you have the same problem at different J&J manufacturing plants, run by different J&J operating companies, under different leadership, with supposedly different quality organizations, and all of this in different countries which all yield the same result – is that not by definition a SYSTEMIC problem? Let’s review Weldon’s quote: “I think that everything has been overshadowed by one company [McNeil]” and continues by saying, “This is not a systemic problem. This is not an issue around J&J.” William Weldon is either engaging in bold face lies for the sake of his (massive) personal bonus or else he’s too stupid to understand what a systemic problem actually is. If J&J ever has a hope at recovery, it needs to dump the albatross of William Weldon.

J&J Gets Fined for Bribery

Earlier this month, J&J sunk to a new epic low. The company that once prided itself on integrity and social responsibility was fined over $70 million for bribing doctors in foreign countries (doctors who happened by employees of foreign governments).

What made this more disappointing was the lack of responsibility the company took for its actions. J&J's Corrupt Executive Officer (CEO) William Weldon tried to distance J&J from the crimes - claiming the bribes were handled by subcontractors. It was lame even by Weldon's standards.

So it certainly won’t surprise me next week if J&J's Board of Directors decide to reward Weldon for this latest problem by giving him an extra $5 million in bonus. And that's how J&J deals with ethics.

Big Pharma’s Sexy Little Secret is Autism

There’s a new “expose” out written by Jennifer Shaw making waves (or so the author would like you to think). In a move that reminded me of Peter Rost, the book’s launch was accompanied by a flurry of spam. The self-penned accolades for the book are overwhelmingly positive and there are no independent book reviews, so I have to wonder. I haven’t read it yet. If she’s following Peter Rost’s playbook, the free version on Kindle should be out within 6 months, so I’ll wait for that.

But I digress. What immediately caught my eye were some of the claims the book’s author has been making on Twitter. Take this recent string on Twitter (all are dated April 9th):

1:43pm – NJ=highest rate of mandatory vaccines and the highest autism rate. Big pharma’s sexy little secret (then self-promoting link to book)

1:45pm – Is it too much to ask to make newer vaccines like Gardisil optional? Big pharma’s sexy little secret (then self-promoting book link)

1:46pm - #autism Why does NJ vaccinate more than other states? Big pharma’s sexy little secret (then self-promoting book link)

1:47pm – How many children need to die before a new vaccines gets pulled? Big pharma’s sexy little secret (then self promoting book link)

So, not only has the causal link between MMR and older vaccines been entirely disproven, but now the anti-vaccination advocates are fabricating claims against newer vaccines. It would seem Ms. Shaw is making the case that newer vaccines (specifically Gardisil) are causing autism and, because of mandatory vaccinations in NJ, Gardisil vaccinations are the reason for the New Jersey’s autism prevalence. In her defense, Jennifer is now claiming that each individual tweet is a specific topic and that none of them relate to the others. You be the judge. Are these 4 tweets in 4 minutes about the same topic or, as Ms. Shaw is now claiming, are each completely separate and totally unrelated thoughts (even though they are all about vaccines)? No doubt, Merck’s lawyers will want to look into Ms. Shaw’s remarkable allegations.

For what it’s worth, I agree with one of Ms. Shaw’s assertions – I don’t think Gardasil needs to be mandatory. However, I don’t need to make unsubstantiated claims of autism to make that point. And all of her postings rely on the now medically disproven basis of vaccines causing autism in the first place. There’s enough wrong with big pharma that we don’t need to concoct lies or fabricate falsehoods to make the point.

Autism is a serious medical issue. And kids suffering from autism need real research into the causes and solutions for their condition. We’ve beat the “vaccines cause autism” drum until it fell apart. Now we need to be looking in new directions – with real research. Making outlandish claims about the causes of autism to sell a few extra copies of a book at the expense of kids with autism is…well…let’s just say it leaves a nasty taste in my mouth.

J&J: Winning The Reputation Game

J&J pulled a Charlie Sheen this week – they are definitely winning. The Reputation Institute came out with its list of most respected companies in America. Last year, J&J was the most respected firm in America. No longer. The Toxic Tylenol Tragedy and over 50 product recalls caused the company to drop in the rankings by about 4.5 points. However, despite J&J Management’s best efforts to completely screw the company, J&J still placed third.

Kudos for this tremendous achievement need to go to J&J Communications Department! They have done an awesome job of burying the dead bodies, confusing the nation’s public and hiding the news and generally keeping a lid on this thing. They’ve kept their disgraced leader in power and helped keep the stock price from tanking any further. I’ve been critical of J&J’s Communications in the past, but this is some top-notch work!

J&J’s Cypher Stents Are Defective

Not that this is exactly surprising news, but Johnson & Johnson (J&J) announced today that the Cypher stents manufactured by its Cordis division are defective. Technically, J&J warned customers that the stents may not meet design specifications for proper functioning – essentially, they’re defective.

Like other J&J divisions, Cordis has been plagued by manufacturing woes. The company received its first warning letter in 2004, just two years after William Weldon assumed the helm at J&J. Those violations were not resolved with the FDA until 2007. Two months ago, J&J was again warned by the FDA for quality problems at its Puerto Rico plant. Such obvious manufacturing violations stand in stark contrast to recent comments from J&J’s CEO William Weldon: “I think that everything has been overshadowed by one company [McNeil]. This is not a systemic problem. This is not an issue around J&J.” All evidence to the contrary.

Johnson & Johnson’s Quality Catastrophe

That’s the headline for a recent expose on Johnson & Johnson’s manufacturing fiasco. This article should be mandatory reading for everyone in the industry.

William Weldon trots out the same excuses and tries to make the same reassurances. Weldon is quoted by BusinessWeek as saying: “I think that everything has been overshadowed by one company [McNeil]” and continues by saying, “This is not a systemic problem. This is not an issue around J&J.” It’s unclear just how William Weldon has come to such a conclusion. The recalls have spread around the world and more J&J/non-McNeil facilities have been implicated. It’s not just toxic Tylenol being recalled – it is also DuPuy, Cordis and other J&J companies. The evidence is irrefutable.