Pharm Aid

Growing Problem of Prescription Drug Shortages

2011-11-20T16:37:00.001-08:00

Much has been made recently of the growing problem of prescription drug shortages. This has become yet another thing for industry adversaries to criticize. But a new report (“Drug Shortages: A Closer Look at Products, Suppliers and Volume Volatility”) from the IMS Institute for Healthcare Informatics sheds light on the topic.

The issue of prescription drug shortages is primarily, and almost exclusively, limited to injectable generic medications. Of products that have had shortage issues, over 80 percent are generic injectables. Oncology products make up 16 percent of drugs with shortages (such as Johnson & Johnson's Doxil which has a waitlist of over 2,700 people). Most of the products that have shortages are manufactured by only 1 or 2 generic manufacturers.

Early warning systems, like the one IMS is advocating, will help predict these shortages in the future. Unfortunately, this won’t actually stop the shortages. It’s unfortunate that government policies have created this situation to begin with.

TEDMED 2011

2011-11-20T14:30:00.001-08:00

A few weeks back, I had the privilege to attend TEDMED 2011. TEDMED is an event like no other – the atmosphere was so rarified. In my 35+ years in the healthcare industry, this was the single best conference I’ve ever been to.

For me, I personally enjoyed Juan Enriquez’s (of Excel Venture Management) scathing indictment of the FDA. He asked the attendees to change the counting. In addition to counting how many people the FDA saves, we also need to count the number of people the FDA kills through their delays. And the number of “FDA kills” is probably as great or greater than the number of “FDA saves.”

I was also moved by the mushroom guy – Paul Stamets (of Fungi Perfecti). He is researching how certain mushrooms from old growth forests in the Pacific Northwest can treat cancer. I had no idea this research was going on.

The presentation by Lee Stein (Prize Capital LLC and Virtual Group LLC) about his son’s sky diving accident and subsequent MRI scans revealing a possibly fatal condition was moving. The way NYU was able to work with the MRI manufacturer to push the limits of research was noteworthy.

For those who haven’t been to TEDMED, it’s tough to explain how special it is – and it is special!! I absolutely can’t wait for TEDMED 2012 in Washington, DC.

Surgeon General Regina Benjamin’s Diet

2011-11-06T12:47:00.000-08:00

At TEDMED two weeks ago, I had the opportunity to have lunch with Surgeon General Regina Benjamin. It was eye opening, to say the least. Surgeon General Benjamin was pleasant, but didn’t exactly impress. My personal feeling is that she wasn’t the most qualified person for the Surgeon General role. That said, I would like her to succeed in her mission, but am skeptical she's up to the task.

Surgeon General Benjamin encouraged the TEDMED attendees to lead a healthier life and get out there and move around. But like most things with the White House – it was a do-as-mandate-not-as-I-do. I didn’t see Regina Benjamin at any of the TEDMED exercise opportunities such as the walks or yoga or in the gym at the Hotel del Coronado.

But my lunch with Regina Benjamin was eye opening. First Lady Michelle Obama recently launched the new Food Plate (i.e., the replacement to the food pyramid). But Michelle Obama should talk to Regina Benjamin because she didn’t get the memo – Regina Benjamin’s actual food plate looked more like Michael Moore’s than the new recommendations from Michelle Obama.

Of course, this is the White House where the President smokes and exposes his two daughters to second-hand smoke.

Public Health in the United States seems to be moving in the wrong direction. We need real public health leadership. Instead, we’re getting health tips from Aunt Jemima and the Marlboro Man.

TEDMED 2011

2011-10-25T22:07:00.000-07:00

I know Pharm Aid has been quiet lately. Actually, Pharm Aid has been quiet for a lot longer than just lately. I guess I've been enjoying my retirement. I also had some medical problems and spent the latter part of the summer having surgery and recovering. But this old dog isn't going to kick the bucket just yet. And this blog isn't dead quite yet either.

I'm attending TEDMED 2011 this week in sunny San Diego! The venue (Hotel del Coronado) is beautiful and the agenda looks to be extremely robust. I'll be live blogging and Tweeting the whole conference. Be sure to follow me on Twitter: http://twitter.com/pharmaid for the latest news.

Warren Buffett Spanks J&J’s Management

2011-05-01T11:36:00.000-07:00

Warren Buffett’s Berkshire Hathaway is the fourth largest shareholder of Johnson & Johnson. You image that J&J would care about what its fourth largest thinks, but that doesn’t seem to be the case.

When J&J announced its $21.5 billion deal for the Switzerland-based med-device firm Synthes, many were surprised that J&J offered mostly equity in the deal. J&J has a huge pile of case, but they seem to be holding it in reserve for more massive payouts to CEO William Weldon. When financially well-managed companies do deals, they try to do them in the most favorable way possible. Why J&J would dilute its shares when it has the cash is baffling. And that’s Warren Buffett’s point. What’s personally good for J&J’s management isn’t good for J&J’s shareholders.

Meanwhile, on Friday, Fitch Ratings is signaling it will downgrade J&J’s credit rating due to the excessive and unnecessary debt load the company is taking on in the Synthes acquisition. Conveniently for J&J’s management, Fitch delayed its announcement until after the company’s Annual Shareholder Meeting last Thursday.

From my perspective, J&J is buying revenue to mask the damage that the company’s management has inflicted over the past few years. However, on the upside, Synthes is a strong cultural fit for J&J – Synthes has also been plagued by recalls and quality problems over the last few years.

The Link Between Pharma Data and Prescription Drug Abuse

2011-04-25T17:33:00.000-07:00

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

2011-04-23T09:24:00.000-07:00

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

2011-04-22T18:29:00.000-07:00

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

2011-04-10T17:33:00.000-07:00

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

2011-04-08T07:40:00.000-07:00

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

2011-04-07T17:25:00.000-07:00

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

2011-04-05T19:26:00.000-07:00

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.

J&J Reorganizes; More Recalls

2011-03-30T17:56:00.000-07:00

It must have been a pretty rough day at J&J headquarters today. After a day like today, it’s no wonder the State of New Jersey put up suicide prevention posters around the J&J headquarters in New Brunswick. First, the company initiated yet another recall – the second in a week. The culprit this time is more toxic Tylenol 8-Hour capsules. The 35,000 bottles had, you guessed it, the same musty, moldy smell – no doubt caused by the same pesticide 2,4,6-tribromoanisole. This batch of toxic Tylenol was also made the same Fort Washington plant that was closed down last year as all the other toxic Tylenol. It makes one ask the question – if the McNeil plant in Fort Washington was closed almost exactly one year ago, why did J&J wait to recall this batch of contaminated medication? Oh, and in addition to recalling the 35,000 bottles of toxic Tylenol, the company also decided to recall over 715,000 packages of various drugs because of sanity problems with the production equipment. On most days, yet another J&J recall would barely register a ripple with the media. However, today, it was just an appetizer to the main event. As predicted here on this very blog nearly a year ago: J&J has reorganized the McNeil Healthcare group. Instead of reporting into the existing J&J Consumer Healthcare business, it will now stand on its own. This does two things for J&J. First, William Weldon can stand up at the shareholders meeting and claim he took decisive steps to fix the problems (yeah, he created the problems in the first place and, yeah, it took him a year to pay attention, but hey – it’s J&J and they like to say they’re “slow cooking”). Of course, we’ll all smirk when it does it, but if it lets the disgraced CEO save a little face, well, the J&J Board of Directors will be all for it. Of course, back in my day we used to say, “You can paint a pile of shit and it may look different, but you and I both know what it is.” Second, this creates a number of strategic options for J&J with respect to McNeil. It gives the company the ability to bucket the financial losses into one underperforming organization (and perhaps some creative accounting), while also looking at other options – including the possible sale of the McNeil organization. McNeil is a tremendous drain on J&J right now and it remains to be seen how loyal consumers will be to Tylenol. As a company, J&J is like those cocaine addicts on the A&E show Intervention – you keep waiting for it to hit rock bottom so it can get better. But J&J keeps falling deeper and deeper into the hole. Maybe J&J needs an Intervention.

A Closer Look at J&J’s Ethicon – More Recalls

2011-03-26T09:20:00.000-07:00

The good old Merriam-Webster dictionary defines the word ethic as a set of moral principles – a theory or system of moral values; essentially a guiding philosophy. When you put the word Ethic in your company’s name, you’re making a bold statement about how you intend to do business. So, it should come as no surprise to observers of the Johnson & Johnson (J&J) corporation, that ethic can’t seem to be found at Ethicon.

Last Thursday, the company recalled nearly 400,000 wound draining products in the United States. J&J’s quality control apparatus (whatever is left of it) didn’t detect quality problems, however the company received consumer complaints of sterile packaging which had been compromised. Products covered by the recall include Ethicon’s Blake silicone drains and drain kits, Blake cardio connectors, J-Vac reservoirs, and J-Vac drain adapters.

For those keeping score, this is the third major recall for J&J’s Ethicon division in the last three months – bringing J&J’s recall count up to a number so large we’ve lost count. In the last few weeks, J&J’s Ethicon recalled 700,000 of wound sealant and also recalled over a half million sutures that were believed to be non-sterile sutures (sold mostly in Europe). With a track record like this, the FDA should be looking at Ethicon for a consent decree.

Naturally, J&J is blaming the problem on a contract manufacturer. Sure, other pharmaceutical and healthcare companies keep a close eye on their contract manufacturers and don’t have these problems. But J&J is not like other companies…and that’s a bad thing for both consumers and the industry alike.

J&J’s CEO Remains Defiant

2011-03-21T19:33:00.000-07:00

William Weldon, the disgraced CEO of Johnson & Johnson, defiantly told reporters last week that he would not retire or step down, despite the growing calls for his immediate resignation. Weldon oversaw the dismantling of J&J’s quality control infrastructure as a means to reduce costs at the company, which has directly led to the company’s worldwide quality control problems – including a record-setting number of product recalls and an FDA-mandated consent decree for J&J’s three worst-performing manufacturing facilities. Basically, William Weldon has rode J&J’s reputation down the toilet.

Unfortunately for J&J and the consumers who once-relied on its products, J&J’s Board of Directors is just as clueless Weldon. The Board gave Weldon a nice, fat pay-raise and a whopping $29 million in compensation last year to reward him for his efforts. Shareholders who put their faith in the company have been rewarded with millions in destroyed value. J&J’s stock price the day William Weldon took over the company was $63.43. J&J’s closing price today was $58.83. It’s no wonder that shareholders are justifiably pissed and have filed lawsuits against the company.

Yet Weldon remains defiant. He told journalists, “People that know me said I’ll fix this problem and, you know, I will fix it.” Forgive me for snickering. J&J wouldn’t need to have Weldon fix the mess if he didn’t create it in the first place. It’s kind of like the fireman who is also an arsonist – he sets fire to the building and then rushes in to be the hero. One thing is for certain, William Weldon is no hero.

Disclosure: I have no financial position in J&J (either long or short). And I have no J&J products in my medicine cabinet.

J&J Slapped with Consent Decree

2011-03-10T18:16:00.000-08:00

In a signal of just how wrong things have gone at J&J, the company has now been slapped with a consent decree. Today's agreement signals that the FDA lacks any faith in J&J’s management to resolve the manufacturing woes and indicates the company requires outside oversight to correct the major manufacturing abuses. In essence, J&J gets to have the FDA hovering over its every move for the next five years. Frankly, even that amount of time may be insufficient to clean up the mess at J&J.

Today’s consent decree covers the three worst Johnson & Johnson facilities operating under the McNeil Consumer Healthcare Division: Fort Washington, Pennsylvania; Lancaster, Pennsylvania and Las Piedras, Puerto Rico.

It is important to understand that this announcement covers only the McNeil Division. Other J&J facilities with gross quality problems such as the San German, Puerto Rico facility could be added to a possible future consent decree. The manufacturing problems at J&J are much broader than the McNeil division, so J&J isn’t out of the woods yet.

FDA Approves Human Genome Sciences Drug for Lupus

2011-03-10T18:07:00.000-08:00

On Thursday, the FDA approved Human Genome Sciences’ Benlysta (Belimumab) drug for the treatment of Lupus. This is the first new treatment for lupus in decades.

It is widely expected that Benlysta will be a certified blockbuster with peak-year sales of between $2.5-$3.1 billion per year.

Human Genome Sciences and its marketing partner GlaxoSmithKline anticipate the drug to be available by the end of March.

FDA Fingers Third J&J Plant for Systemic Abuses

2011-03-09T18:03:00.000-08:00

The U.S. FDA has fingered a third Johnson & Johnson manufacturing facility for gross, systemic manufacturing violations. This time, the FDA issued its indictment against the San German, Puerto Facility which manufactured J&J’s Cordis stents. The facility had repeated abuses and the company did not address the FDA’s corrective action plan.

The San German, Puerto Rico facility joins J&J facilities at Fort Washington, Pennsylvania and Las Piedras, Puerto Rico. This latest revelation adds new insights into the far reaching and systemic manufacturing deficiencies across the entire network of J&J’s companies.

HIPAA Breaches for Paper Records – Where is the Rage?

2011-03-08T18:46:00.000-08:00

Last month, Massachusetts General Hospital got slapped with a $1 million fine for potential HIPAA Privacy Rule violations. This case is interesting in that it involves paper files that an employee left on the subway. From Florida to Washington State, we’ve seen other HIPAA breaches of paper records.

This is exactly the situation I’ve discussed in the past. Where is the outrage over the privacy breach? Where are the groups that proclaim to support patient privacy rights complaining about this? If these had been electronic medical records, we’d no doubt be bombarded by warnings from these groups about the evils of technology and the end of days. But since these are paper records, there is no outrage…and no real concern over patient privacy rights.

There is always a lot of concern about patient privacy rights when you deal with electronic records. The reason is that manufactures of electronic medical records have money. It is easy to shakedown these manufacturers of EMRs and EHRs for cash so they score well on your scorecard. But, when it comes to really caring about patient privacy rights, they are nowhere to be found.

J&J Recalls Insulin Cartridges

2011-03-08T17:57:00.000-08:00

Another day, another recall for embattled drug maker Johnson & Johnson. Today, J&J’s Animas division has recalled 45,000 defective insulin cartridges which can leak and also deliver sub-therapeutic doses of the insulin.

The company has warned consumers not to use the affected lots, but it might be a good idea to speak with your physician about other options such as pumps manufactured by Roche or Medtronic.

J&J Gets Leadership Change

2011-03-07T18:28:00.000-08:00

Before we all get too excited, J&J isn't shedding the albatross that is William Weldon. Sadly, Billy-boy is still driving J&J into the ground. Rather, Johnson & Johnson announced today that the President of its embattled DePuy Orthopaedics group would be leaving the organization.

A replacement figurehead hasn't been named, but we can all be certain of two things: 1) it will be someone close to Weldon and 2) the person will have the same lack of focus on quality and patient safety as the rest of the Weldon's circle.

Like all the other J&J operating companies, DePuy had been plagued by product recalls and litigation problems. The company has amassed a $280 million reserve to cover expenses associated with a recall of its artificial hips earlier this year. That amount may be insufficient when you take into account the number of class action lawsuits alleging that the J&J delayed the recall and did not act decisively on specific warnings about problems (an altogether too familiar tune when it comes to J&J).

J&J Secretely Recalls Non-Sterile Sutures in Europe

2011-03-02T19:22:00.000-08:00

Recall-plagued Johnson & Johnson quietly recalled a half-million sutures in Europe, primarily in the UK, due to significant risk of contamination from faulty packaging. J&J did not publicize the recall, which took place late last year. However, the recall came to light after the UK's MHRA posted a notice on its website earlier today.

The sutures were manufactured by J&J's Ethicon division and sold under the brand names Ethilon, Ethibond, Mersilene and Mersilk. Patients in Europe who received J&J sutures in Europe and developed an infection are urged to speak with their physicians.

J&J’s CEO Gets Whopping Bonus Despite Problems

2011-02-26T09:19:00.000-08:00

Johnson & Johnson’s CEO William Weldon received a whopping $1.98 million bonus for 2010. J&J is positioning this as a 45% cut in the bonus, while the average employees are facing significant bonus cuts and salary freezes.

Weldon’s multi-million dollar bonus seems radically excessive given his management of the company over the last few years. Outside observers had expected J&J’s Board of Directors to take a hard line and withhold Weldon’s entire bonus. Evidently, J&J’s Board is just as clueless as Weldon. Giving Weldon a massive bonus will only continue to erode employee morale and rewards the bad decisions he has made.

Ironically, on the same day that J&J announced Billy Weldon’s massive bonus, the company also recalled nearly 700,000 bottles of Sudafed 24 Hour Extended-Release packaging. Unlike previous J&J recalls, this was not because of contamination with 2,4,6-tribromoanisole (a chemical pesticide that contaminated Tylenol). Instead, the Sudafed packages were improperly labeled.

And This Week’s J&J Friday Recall Is – Sudafed

2011-02-25T19:37:00.000-08:00

In typical J&J fashion, another Friday, another recall. This time around is Sudafed 24 Hour Extended-Release tablets. The reason for the recall is improper product labeling. The recall covers nearly 700,000 packages.

Why is this not surprising?

Deborah Peel on the Eve of HIMSS

2011-02-19T13:54:00.000-08:00

Another year and another HIMSS. Last year, anti-technology activist Deborah Peel was laughed out of Atlanta. In the year since, she’s basically done nothing (see recent post). On the eve of this year’s HIMSS, I thought I’d check back in on her. She still hasn’t posted anything to her blog in over a year (last post was Dec. 31, 2009). I know I sometimes slip in updating Pharm Aid, but I’d expect Peel to have a single, original thought in 12 months. Perhaps I’ve over-estimated her need for self-promotion and narcissism.

I hope she attends HIMSS this year! No doubt she’ll be in the booth of No More Clipboard (where I caught up with her last year). Regardless of whether you agree with her or not, Deborah Peel is good, entertaining fun.

Another Week, Four More J&J Recalls

2011-02-19T13:30:00.000-08:00

In what has become a near-weekly occurrence for the embattled New Jersey-based pharmaceutical company, Johnson & Johnson announced this week that it was recalling lots of four different drugs. On February 15th, J&J recalled antipsychotic Invega (due to possible contamination and risk of infections as well as sub-potency in some formulations), which has already been linked to at least one adverse event. On February 17th, J&J recalled Dermabond (poor manufacturing; inferior color quality) and Securestrap (product and packaging sterility problems). On February 18th, J&J recalled a number of lots of RA drug Simponi (injection pens may deliver sub-potent product dose).

Previously, the company has tried to contain the PR damage to just its McNeil division and only its Fort Washington, Pennsylvania facility. However, the current batch of recalls show the manufacturing lapses stretch around the world – from Fort Washington to Switzerland and places in between – as well as impact many different J&J divisions. The problems with J&J are systemic and widespread.

J&J’s Tampon Problem

2011-02-18T20:33:00.000-08:00

As previously reported here on Pharm Aid, J&J has a feminine problem – namely o.b. tampons. o.b. tampons are missing from store shelves and the company can’t explain why. It’s a big secret.

Earlier today, I was at a grocery store in Pennsylvania and noticed that o.b. is back on Safeway store shelves. But it’s a different o.b. Or maybe it’s the same o.b. tampon, but the package is really low grade and in Spanish. It’s like what you might find at a bodega in Panama, but this is a Safeway grocery store. Where in the world is J&J importing this o.b. from?

This is not the quality you’d expect of a J&J product - back when Johnson & Johnson stood for something. But maybe it is the quality we should be expecting from the new J&J...from William Weldon's J&J.

J&J’s Phantom Tampon Recall

2011-01-23T13:46:00.000-08:00

The case of the missing o.b. tampons. That’s what consumers are calling it. But are o.b. tampons the most recent case of phantom recalls from J&J? The company has quietly pulled the product from store shelves and some wholesalers reported large bulk purchases last fall.

One thing is clear, the lack of o.b. on store shelves is a tremendous embarrassment to the already embattled J&J, and the lack of communication from the company to consumers and retail outlets is leading to speculation that the product was pulled due to adverse event reports in patients.

One thing is for certain – there’s a news story in here and we haven’t heard the last of this.

January Brings More J&J Recalls

2011-01-23T12:53:00.000-08:00

In another Friday recall, back on January 14, Johnson & Johnson recalled another 47 million units of various due to ongoing quality and contamination issues. These batches came out of the same manufacturing facility that has produced contaminated batches of Tylenol for the last several years. The January 14th recall covers J&J’s Tylenol, Benadryl, Sudafed, Sinutab and Rolaids brands that are sold in the United States and Latin America.

J&J claims that the products were produced prior to April 2010, however it emphasized that consumer health was not at risk. J&J admitted that the products were not tested.

J&J is recalling the products at the “wholesale level.” The company is encouraging consumers who may have purchased the products to continue using them. My advice to any consumers that have any J&J products on their shelves is to throw the medication out and start over.

It’s your health, and you just can’t trust it to Johnson & Johnson.

J&J Ramps Up Lobbying Efforts in Face of Manufacturing Crisis

2011-01-04T18:18:00.000-08:00

Johnson & Johnson, the embattled drug manufacturer, increased its lobbying efforts significantly over 2009. In fact, the company increased its expenditures by over 40% - from $1.7 million in third quarter 2009 to $2.4 million in third quarter 2010.

As the company has recalled dozens of products, it has faced two Congressional hearings over its actions. J&J seems to hope that increased attention to politicians will help it avoid a Consent Decree and additional future scrutiny.

Medicare Wait Times

2011-01-02T15:14:00.000-08:00

For Christmas, like all good snowbirds, we spent the holiday with family in Broward County, just north of Miami. It had been three years since I'd last been here, but it was fascinating to see the changes.

A large number of doctor's offices now publish the length of time Medicare patients need to wait before being able to see a physician. A physician in Pompano Beach proudly proclaims in advertisements, "only a 30 day wait for Medicare cardholders." As if a 30 day wait for medical care is something to be proud of.

Against this backdrop, there has been an explosion in the number of primary care retail clinics. On major streets, you can't go 10 blocks without passing one of the triage centers. If Medicare were such a great thing, you'd have to wonder why these places are sprouting like weeds and why doctors are rationing care to Medicare patients.

I'm lucky. I've done well in my life and I value my health. I don't rely on CMS and Medicare to provide for me. Yes, my private policy is expensive. But when I call up a doctor, I get right in, rather than the standard wait times for those with government healthcare. I understand it - the desire to abdicate all personal responsibility and let the government take care of me. But I'm not there yet. I want to live my life on my terms.

When I talk to the youth and their desire for "Medicare for All," they are dismayed when I say I don't want it or use it. The grass always looks greener on the other side - especially when it covers your grave. So I'll let them keep loving Medicare, I'll keep paying so I don't have to.

J&J Launches Nicorette in India

2010-12-21T18:15:00.000-08:00

To combat the high rates of smoking in India, Johnson & Johnson Ltd., has launched Nicorette gum – which will be officially available beginning December 25th.

And on December 31st (which is a Friday), I predict that J&J will recall Nicorette.

Reflections on Pharma Industry

2010-12-20T17:41:00.000-08:00

At this time of year, I usually reflect on the year. But these days, my thoughts turn back my over three decades living and breathing the pharmaceutical industry.

Over the years, our industry has changed substantially – just has every other aspect of American life as we know it. Generally, the aspect of American life that was present when I started in this industry, and is ubiquitously absent now, is trust. Doctors trusted pharma sales reps and the companies they represented. Patients trusted doctors and hospitals. The FDA trusted the drug companies to supply honest data about products, and the drug companies trusted the FDA to act toward them with fairness and competence. And almost everybody had some level of trust in the Federal government. Maybe much of this trust was misplaced, even as far back as 40 years ago, but it was very real at that time, and it influenced the way that every transaction occurred. It's gone now, and I can't see it ever coming back, at least not in this country.

All that we see today – the shoddy oversight of drug approval and manufacture; the "less than 5 minute" sample drops that constitute a sales call today in the doctor's offices; the patients scanning the Internet for information to disprove what their doctor told them; the massive hospital billing fraud that is pervasive in every hospital financial section – choose your own medical horror story with a pharma connection-- all of this came about when trust broke down between the parties that made the drugs, and sold the drugs, and dispensed the drugs, and ingested drugs to alleviate medical problems. Pharma's pathetic image today has little to do with the drug companies or their products, but it has a lot to do with our broken culture and society.

But why did trust break down and why did things change? Looking back, I think there was an exact moment when I can look back and see it. It was when pharma started DTC Television ads. It wasn’t just one ad, it was the constant barrage of AstraZeneca’s constant bombardment of “purple pill” Nexium commercials and millions of dollars Merck spent on Vioxx ads (in fact, Merck spent more advertising Vioxx on TV than Nike or Budweiser spent). Personally, I felt that DTC advertisements were a good idea. I felt, and still feel, that DTC TV advertisements are not. And the consumer backlash against those ads was both predictable and significant.

I believe that DTC television advertising changed everything, and not for the better. In terms of eroding trust, pharmaceutical DTC ads did for pharma what the constant barrage of political ads did for politicians and our government. The patients watching TV came to trust their physicians less than before (which isn’t necessarily a bad thing), as they came to see the pharma messages as their main source of medical info. Obviously, the doctors trusted pharma companies less than before, as they saw their power and exclusivity eroding away. But mainly, the pharma companies realized that marketing money spent on TV ads produced more bang for the buck than research money spent chasing new drugs (definitely a bad thing). And none of this is any new revelation to anyone who has watched the U.S. healthcare system for any length of time.

And as patients began to see ever-increasing numbers of pharmaceutical sales reps clogging the waiting rooms of their doctor’s offices, they began to question what was happening behind the scenes. These young, hot fuck-bunnies (as one doctor referred to them in legal testimony) did not create confidence in our industry.

And I don’t see the trust coming back anytime soon.

Double Standards for BestSweet and J&J

2010-12-19T12:28:00.000-08:00

Johnson & Johnson’s product recall mess is now the stuff of legend. BestSweet, a confectionary company that produced Rolaids for J&J, is less known. But there seems to be some hypocrisy in the way this is being investigated.

U.S. Representative Darrell Issa, who is looking into the J&J product contaminations and recalls, seems to be devoting more criticism of BestSweet than against J&J. Let me explain. Numerous J&J manufacturing facilities in the U.S. and Puerto Rico are racking up FDA violations like it’s a basketball game – America’s most respected drug company has received dozens on top of dozens of violations. In comparison, BestSweet’s most recent FDA inspection in October 2009 found no violations (compared to the dozens for J&J).

I have to ask why Rep. Issa is spending so much time focusing on a contract manufacturer like BestSweet in North Carolina, while the real problem is still back in New Brunswick, New Jersey. The BestSweet drama is a sideshow to the main event – a distraction. The real issue is why J&J wasn’t maintaining GMP at its own facilities and in those of its contractors (around the world).

Let’s not take our eye of the ball – there’s a cesspool on the banks of the Raritan River. And it’s time to clean it up.

J&J Marginalizes CEO William Weldon…Finally

2010-12-16T18:42:00.000-08:00

Johnson & Johnson has elevated two employees to a new “Office of the Chairman.” Alex Gorsky has been elevated to the role of Vice Chairman, Executive Committee. And Sheri McCoy has been elevated to the role of Vice Chairman, Executive Committee. Since William Weldon remains in hiding and seems completely incapable of doing anything to fix the mess he’s created, J&J thought he could use the help of Gorsky and McCoy. This is probably a solid strategy, although Weldon’s eventual departure can’t come soon enough.

Thanks to William Weldon, J&J is the worst performing company in the S&P 500. Since Weldon became CEO (and because of his leadership), J&J’s shares have dropped 1.5%. He has helped destroy millions of dollars in shareholder value.

Of course, Sheri McCoy shouldn’t get too excited about her new promotion (and she shouldn’t get too settled in her role – I might recommend that she not even unpack her boxes). J&J’s manhandling of female executives is legendary. J&J has a long history of using female executives as scapegoats. Given the dual promotions of Gorsky and McCoy, I’m guessing that Alex Gorsky will eventually replace Weldon and J&J will hang all the blame on McCoy.

My Personal Interest in J&J’s Woes

2010-12-12T09:22:00.000-08:00

I recently received a comment to one of my J&J postings that I want to address. As I’ve previously discussed, J&J has enlisted former employees who remember the “good old days” to challenge the company’s negative news. No doubt, it was one of those former employees who still, foolishly, believes in the Credo that contacted me. This J&J operative claims that I’m only writing about J&J’s ongoing woes because I’m shorting J&J’s stock and I’m trying to “create bad news for the company.” I want to address this.

First, I’m not creating anything. J&J is the one who has developed a culture of contamination and inferior quality. I did not contaminate J&J’s products with 2,4,6-tribromoanisole. I did not contaminate J&J’s products with metal shards that can cut the inside of people’s mouths. I did not create a culture at the company where short-term profits are valued over patient safety. I did not send J&J’s CEO William Weldon into hiding, where he refuses to show his face and stand for accountability. J&J did this to itself and I had nothing to do with it.

Second, as for my investments, let me say this – I have never taken a direct financial position in J&J (either long or short). When I was younger, I indirectly owned J&J shares via mutual funds. At my age now, I find the volatility and risk of equity securities to be more than I’m willing to take. I’m more concerned with the long view and leaving something to my grandkids. So no, I have no financial stake in what happens to J&J (not even the pleasant side wager with the guys over at the Legion Hall).

Third, this individual claims that I’m just some bitter ex-J&J employee and started this blog to bash the company. I started Pharm Aid in February 2007, long before J&J’s manufacturing deficiencies came to light. I’ve written on hundreds of topics – only a small percentage of them are about J&J (although most of my writings recently are about the company that claims to be one of the most respected in the world and how it is endangering patient’s lives). And yes, I’ve even written many positive articles about J&J – when the company hasn’t been shooting itself in the foot.

To make my opinions clear – I actually like J&J, however, I think they have given a huge black eye to the entire industry. I think they not only deserve a Consent Decree, I think J&J needs one ASAP in order to protect public safety (something they company hasn’t been too concerned with over the last few years). And I think J&J’s Board of Directors needs to stand up and finally say, “We made a mistake, CEO William Weldon’s vision and actions are not in line with the Credo and he’s fired. From this day forward, J&J will no longer endanger patients.” Given how thoroughly the culture of Weldon has permeated J&J, I’m not looking for this to happen anytime soon, but it’s the next necessary step.

I keep waiting for Johnson & Johnson to surprise me – to clean up its act, to fix its chronic manufacturing woes and stop recalling products, and to start behaving ethically. I’m an old man, but I hope it happens in my lifetime. J&J has a rich history and has been a part of America for generations. I’d like to see that continue. But I don’t hold out much hope under the current regime.

Pfizer Replaces Jeff Kindler as CEO

2010-12-06T16:50:00.000-08:00

Pfizer’s CEO Jeff Kindler is hitting the road. The official story is that Kindler is leaving to “spend time with his family.” It’s a pretty typical excuse. This certainly has all the hallmarks of being ousted by the Board (especially since the company’s Board will appoint a non-executive Director in an upcoming Board meeting).

Kindler will be replaced by Ian Read, who heads the global pharmaceuticals business for Pfizer.

More Toxic Tylenol Recalls for J&J

2010-12-05T15:16:00.000-08:00

I’ve been on vacation for the last few weeks and was considering giving J&J a pass on this one. Sure, they issued their latest Tylenol right before the Thanksgiving holiday, hoping that consumers wouldn’t find out about it – its par for the course in terms of J&Js recall strategy (and is hardly the kind of ethical behavior one might expect from J&J). I’ve extensively covered all of the dozens of J&J’s recalls over the last year to the point that it seems that I’m beating up on the once-responsible drug maker. But in the end, I felt I needed to write about it. J&J is now refusing to issue press releases on their recalls. J&J is refusing to publish their recalls via the recall Twitter channel. J&J hasn’t blogged about ethics, responsibility, integrity or any of these problems in months. J&J’s strategy seems to be – ignore it and hope that consumers don’t find out about our latest Toxic Tylenol mess.

So, here’s the story – back before Thanksgiving, J&J issued yet another recall for Tylenol over “labeling concerns.” This recall comes just days after the Benadryl and Motrin recall of two weeks ago and accompanies recalls for other J&J products. J&J has now issued dozens of recalls (I’ve completely lost track of what we’re up to). It’s also important to note, that the a recent FDA inspection of the Puerto Rico plant found numerous additional serious violations (and that these violations all occurred AFTER J&J’s CEO William Weldon promised that the company had turned the corner and was focusing on product quality). While J&J management continues to scapegoat its problems on the much-maligned Fort Washington, PA plant, I’ve been arguing for over a year that J&J’s problems are systemic to nearly every J&J plant around the world. J&J has adopted a culture where quality control can (and actually should) be subverted. And senior management at the highest levels gloss over product contamination and quality problems in the interest of stock price.

J&J Conducts Silent Recall for Children’s Medicines

2010-11-22T19:31:00.000-08:00

Last week, J&J had a silent recall for another 5 million bottles of children’s Benadryl and Motrin. The last recall is called a “Silent Recall” because J&J isn’t telling people about it. In fact, the company is being pretty secretive.

According to The Wall Street Journal, no press releases were issued, as the company has done in every previous product recall. In fact, you can’t find any news about this latest recall on J&J’s website and even on its McNeilRecall Twitter page. So, just how consumers are to learn of these Silent Recalls is unclear. Maybe J&J is now relying on some form of extrasensory perception (ESP) as its communication’s strategy.

The medications were manufactured at J&J’s now-closed Fort Washington, Pennsylvania facility months ago, but the company only recently decided to act. The company claims that the recall "doesn’t affect consumers" and that the company has no evidence of patient harm.

Kudos to The Wall Street Journal’s Jonathan D. Rockoff and Dow Jones’ Peter Loftus for breaking the news of the Silent Recall!

J&J Recalls Velcade

2010-11-21T18:14:00.000-08:00

In what has become routine for Johnson & Johnson (J&J), the company issued a late-Friday recall for numerous lots of its Velcade oncology treatment. The product is co-marketed with Millennium Pharmaceuticals (U.S.) and J&J taking rest-of-world responsibilities.

The culprit for J&J this time is white particles floating in the medicine. The particles were identified as a “polyester-like material.” It makes one wonder about the integrity of the manufacturing processes over at J&J/Millennium.

It is important to note that J&J actually issued a recall for the product, vs. secretly getting the products off the market. J&J is not expecting to receive many doses back, since most of them have already been injected into unsuspecting patients. J&J spokeswoman Kellie McLaughlin was quick to add that the company is not aware of any patient injuries due to the contaminated Velcade.

Pope Considers Condoms to Protect Abused Children

2010-11-21T12:12:00.000-08:00

Over the weekend, the world was aflutter with the news that Pope Benedict XVI (formerly known as Cardinal Joseph Ratzinger) is considering the use of condoms to be morally acceptable in certain situations. One of those situations is to prevent young children from being infected with HIV when being raped by HIV-positive priests.

Such a noble gesture in the interest of public health…

J&J Plans Advertising Campaign to Restore Faith

2010-11-07T18:16:00.001-08:00

As I mentioned in a post back on May 31st (see What’s Next for J&J), Johnson & Johnson is looking to ramp up an advertising campaign to try and convince consumers its products are safe. The announcement was made by CEO William Weldon in an interview with Susan Todd of the Star-Ledger. Actually, I doubt it was an interview. The questions are so softball and sanitized that the whole thing looks to be orchestrated by J&J’s PR team (Kudos to them!).

One important note is that there is glaring factual inaccuracy in the article (partly why I believe it was submitted by J&J verbatim and Weldon was not actually interviewed by Susan Todd). J&J’s CEO makes the statement:

Q: Why did the problems at the Pennsylvania plant, which triggered the massive recalls, go unaddressed for so long?

A. It was a situation that evolved. There are a lot of issues that right now we can’t address. There are all kinds of investigations going on. That will be addressed in time. We’re endeavoring to make sure this never happens again any place. The critical thing is, this is not a problem systemic to Johnson & Johnson. We can say, clearly, that it was an isolated situation that evolved and needed to be addressed.

It sounds great, but it’s not true. The problems are systemic across J&J. It wasn’t just “the Pennsylvania plant” (meaning Fort Washington). The FDA also found problems at other J&J plants and event issued them a 483 violation in July.

After nearly two years of negative headlines, shadow recalls, deceiving government regulators and lying to consumers, J&J is claiming its problems are behind it and we’re in “the wake.” I don’t buy it. I do believe that middle management is taking the situation seriously and are trying to correct the problems. I also believe that senior management (including Weldon) are putting a lot of pressure internally to find scapegoats (including Ms. Goggins) – but that’s not trying to fix the problem. And certainly, senior management is not giving a lot lip service externally to this issue (it took multiple Congressional subpoenas to get William Weldon to show up).

I believe J&J is trying to give the appearance of fixing the problems – that’s different than actually fixing the problems.

Here’s the Star-Ledger article: Johnson & Johnson’s CEO looks ahead in wake of highly publicized drug recalls

Fallout of the Mid-Term Elections for the Healthcare Industry

2010-11-04T19:52:00.000-07:00

The mid-term elections were either a stunning rejection of President Obama’s agenda or nothing more than a minor ripple in the vast sea of Progressive Politics – depending on your perspective and political persuasion.

However, since the Republican Party has captured the House of Representatives, former Speaker of the House Nancy Pelosi has a lot of free time on her hands. Perhaps now that she’s politically irrelevant, Nancy Pelosi can finally find the time to become the spokeswoman for Allergan’s BOTOX. Since she looks like a cross between Michael Jackson and Zsa Zsa Gabor, Botox-a-Pelosi is the perfect spokeswoman for the brand and will shore up sales with the MoveOn crowd.

In other news, the Obamacare healthcare reform bill contained a provision to tax indoor tanning salons. Over the summer, a new 10% tax on indoor tanning salons took effect – much to the chagrin of the new Speaker of the House of Representatives, John Boehner and his Orangemen. Since Boehner will be more in the public eye than he has in the past, we’re looking for him to ramp up his already excessive orange appearance. Of course, the tanning tax will cost Boehner significantly, so I’d look for him to move quickly to try and repeal the tax.

No matter your political persuasion, you’ll have to agree big changes are afoot in the United States.

J&J Spokeswoman Hospitalized

2010-11-02T18:48:00.000-07:00

Johnson & Johnson recently hired on teen pop sensation Demi Lovato to be its spokeswoman for J&J’s CLEAN & CLEAR® Skincare System.

Well, J&J spokeswoman Demi Lovato is now hospitalized. According to her representatives, she’s NOT in rehab. More specifically, her representatives have said she is in a “treatment center” for “physical issues.”

One has to wonder if Demi Lovato was poisoned with the pesticide 2,4,6-tribromoanisole from using J&J products.

Struggling Through Healthcare Reform

2010-10-31T18:30:00.000-07:00

I’ve been spending the last few weeks at some hospitals talking to folks in the trenches. Much has been made of the impact of healthcare reform on patients (both the benefits and the drawbacks), pharmaceutical companies and medical device firms. Physicians have also been vocal. But until I spent time at some hospitals, I just didn’t realized how screwed our healthcare system will actually be when this law takes effect.

When Massachusetts enacted its own version of healthcare reform and universal coverage, patients came – to the emergency room. Wait times at hospitals from Springfield to Boston exploded and some patients with legitimate emergencies died as resources were drained by the newly insured. We’re not on the eve of this same thing on an unprecedented scale as millions of individuals living in the U.S. will get healthcare coverage. And come they will – most likely to the emergency room. And costs will continue to explode.

It is a tragedy that President Obama spent a year to enact healthcare reform that will neither reduce healthcare expenditures or provide better quality care. What we did do is trade better healthcare for some for lesser care for nearly all. In fact, it’s more than a tragedy – it’s criminal.

Nowhere is that more obvious than the hospital emergency rooms where I’ve spent my week. Hospitals are struggling with volumes now, they will be absolutely broken if patient volumes increase just 7-11%. At the same time, margins are thin. In the wake, we’ve already seen St. Vincent’s in New York close just days after the passage of healthcare reform. The result, patient volumes at nearby Bellevue Hospital have spike over 20%. And wait times have exploded.

For year’s we’ve seen practice after practice roll-out the “Medicare NOT Welcome Here” signs. As healthcare reform fails to stem the spiraling costs and patients find themselves getting less and less, we will come to realize that a golden opportunity for real and meaningful healthcare reform has been squandered. And chief among the failures was not to (finally) address medical malpractice.

Hospitals were nearly broken before healthcare reform, they will be broken now. And it is a tragedy that President Obama and Speaker Pelosi refused to push for real healthcare reform.

National Pharmaceutical Council Names Chief Science Officer

2010-10-19T18:28:00.000-07:00

Robert W. Dubois, MD, PhD, has been named Chief Science Officer of the National Pharmaceutical Council (NPC). Dubois will head policy for the organization, including evidence-based medicine, health economics and outcomes.

Prior to joining the NPC, Dr. Dubois was the Chief Medical Officer (CMO) for health IT giant Cerner. He received his MD from Johns Hopkins School of Medicine, a PhD in health policy from the RAND Grand School.

J&J Issues 13th Recall - More Contaminated Tylenol

2010-10-18T19:00:00.000-07:00

On Monday, Johnson & Johnson issued yet another recall for Tylenol. This marks the 13th major product recall by the company in barely a year.

On the eve of Johnson & Johnson’s quarterly earnings call, the company is recalling Tylenol for exactly the reasons as before. This latest recall covers the 50-count bottles of Tylenol 8 Hour caplets. Patients flooded J&J with adverse reports for nausea, vomiting and diarrhea after taking more Tylenol that is believed to be contaminated with pesticide 2,4,6-tribromoanisole.

Most intriguing is that the J&J has previously claimed that it stopped using the pesticide-laden wooden shipping pallets on January 15th. If that were true, this recall would seem to have been unnecessary. Once again, it seems that J&J has not been entirely forthcoming with the FDA, its investors, and most importantly, consumers.

Meanwhile, J&J seems to be soft pushing this recall. The company has not posted anything about this on its McNeil Product Recall Twitter Account or its official company blog – JNJBTW.

A Quiet Friday for J&J

2010-10-16T19:57:00.000-07:00

In what has become an almost weekly ritual, I was expecting another drug recall, management change or some other announcement of corporate malfeasance from Johnson & Johnson on Friday. It didn’t happen.

No additional poisonings of young children taking J&J products. No additional details of phantom recalls. No additional leaked documents of a company hiding questionable things from the FDA. No sacked executives (whether scapegoat or deserved). Essentially, Friday was a no-news day for J&J. Search as I might, I couldn’t find anything. (Yeah, there was that nasty quarter billion dollar fine that J&J is going to have to pay to Louisiana for misleading marketing, but that hit on Thursday. More on the Louisiana case tomorrow.)

Could it be, that J&J is FINALLY turning the corner? Or could it be that J&J just didn’t want any additional distractions before it reports quarterly earnings on Tuesday?

Pfizer Feels No Pain

2010-10-12T19:10:00.000-07:00

Pfizer is making a $3.6 billion bid to snatch up King Pharmaceuticals. Pfizer is facing the patent expiration of Lipitor and needs to replace the revenue stream. King’s portfolio of pain medications is a very tempting morsel for Pfizer.

King is in the process of developing a tamper-resistant, long-acting oxycodone. In the deal, Pfizer will also get Embeda (long-acting morphine), Skelaxin (muscle relaxant), Avinza (extended release morphine) and Flector (a trans-dermal pain medication).

What remains to be seen is the ongoing success of Pfizer’s fundamental strategy – growth by acquisition. Pfizer’s great at buying companies, but struggles with digesting the meal.

Pfizer’s Stink Problem

2010-10-12T18:46:00.000-07:00

Pfizer’s Lipitor stinks. Literally. About six lots of Lipitor have come into contact with the pesticide 2,4,6-Tribromoanisole, the same chemical that contaminated numerous J&J products…and resulted in the FDA finally uncovering the systemic manufacturing abuses.

However, Pfizer is quick to point out that it acted quickly in initiating the recall, in stark contrast to J&J who waited months, and only then tried to hide the recall via “phantom recalls.”

Pharmaceutical Growth to Rebound in 2011

2010-10-12T18:16:00.000-07:00

In its annual global pharmaceutical review, IMS Health is predicting industry growth to tick up slightly in 2011. The company is anticipating 4-5% growth for 2010 and is expecting growth to increase to 5-7% next year, or roughly $880 billion. Of course, this is a far cry from global growth rates of nearly a decade ago where the industry grew 11.8% (in 2001) and 11.5% (in 2000).

“While the overall market will appear to rebound somewhat in 2011, the underlying constraints to growth in developed markets are stronger than ever – including the impact of major patent expiries and payer mechanisms to limit drug spending,” said IMS Senior Vice President Murray Aitken. “We expect the pharmerging markets to continue their rapid expansion next year and remain strong sources of growth, and also see the potential for several significant innovative treatment options that are becoming available for patients in areas that include metastatic melanoma, multiple sclerosis and acute coronary syndrome.”

Other highlights from the IMS report:

Emerging markets (or pharmerging markets as IMS calls them) will drive the majority of the industry growth. The 17 pharmerging markets are expected to grow 15-17% to nearly $180 billion in 2011. China along will reach $50 billion (that’s an awful lot of shark fins).
The United States is still the largest global market, but growth is expected to just outpace inflation – to about $330 billion.
There will be a number of significant generic expirations in 2011 in the United States, including: Pfizer's Lipitor, BMS and Sanofi-Aventis' Plavix, Eli Lilly's Zyprexa and J&J's Levaquin. These drugs have $17 billion in annual sales.
In the United States, health plans will continue to use pre-authorizations and cost sharing provisions to drive down drug costs.

Deborah Peel and the Age of Bitterness

2010-10-10T16:09:00.000-07:00

It’s been a while since I’ve checked in Deborah Peel and her Patient Privacy Rights group. Peel has been really quiet lately – extremely quiet. She’s had a rough go of it. At HIMSS, she was basically despondent – sulking because nobody was taking her seriously. I was really concerned for her. I know Deborah Peel used to be psychiatrist – but I remember thinking at HIMSS, this woman is suffering and could really use the help.

She spent a fortune lobbying the Obama Administration for access – and got rejected. She’s given hundreds of thousands of dollars to Democratic political causes and candidates – from Emily’s List and the DNC National Committee, to Dick Durbin and Barack Obama, Deborah Peel has dropped a small fortune into buying access and clout (she's spent more money to buy access than some Americans will make in their entire lifetime). And yet Democrats continue to snub her and her agenda.

Since HIMSS, it only seems to have gotten worse. Deborah Peel hasn’t made a single posting on her blog in over nine months (her last posting is December 31, 2009). Frankly, it’s not surprising. She doesn’t have any new ideas, but I’d at least expect her to continue screaming about her old ones. But no, Deborah Peel’s despondency continues. I’m starting to feel sorry for her.

What gets me about Deborah Peel is two things: 1) She’s against all forms of technology – except when companies give her and her group money (a kind of shakedown). And 2) Deborah Peel only focuses on patient privacy when it involves technology. When was the last time you heard Deborah Peel speak about the security of paper-based medical records? Um…never. Deborah Peel can’t make any money off paper-based records, so she ignores the obvious privacy problems. Deborah Peel doesn't care about patient privacy - she cares about making money off scarring people about patient privacy.

I guess this is all on my mind because I drove by Deborah Peel’s extravagant Washington D.C. condo last week. She bought it back when she thought she was going to be a player in Washington. Those days are long gone and the condo was dark (wonder if she still lives there now that she's been rejected by everyone in Washington). Deborah Peel is starting to look like today’s version of Lorraine Day. I pity Deborah Peel.

J&J’s Procrit Gets Recalled

2010-09-26T12:31:00.000-07:00

Another day, another J&J recall.

On Friday, J&J recalled lots of Procrit because of concern that it might contain tiny glass flakes or shards. The product, manufactured by Amgen, is the latest blow to J&J. (Note, Amgen simultaneously recalled lots of its EPO Epogen). And it marks J&J’s 12th recall in as many months.

J&J Sacks Executive; Second Phantom Recall Revealed

2010-09-20T17:51:00.000-07:00

Johnson & Johnson continues to have a rough go of it.

In what is becoming a weekly ritual for the embattled drug company, late on Friday, J&J revealed that it had made Colleen Goggins its official scapegoat on the product recall situation. Or rather, J&J has announced that Colleen Goggins, the heir-apparent to take over after William Weldon retires next year, suddenly and without warning, “retired” from J&J after having been sent to Congress to testify on the matter. Nothing screams ethical integrity like hiding your CEO from accountability and then sacking your leading female executive.

However, today’s news is even more sinister. After conducting a secret covert operation to pull Motrin off the shelves instead of issuing a recall, it was revealed today that J&J considered a second secret “phantom recall” for its flagship Tylenol brand. Naturally, this was much of the focus at the original Congressional hearing. And naturally, Rep. Edolphus Towns (D-NY) still wants J&J CEO William Weldon to testify before Congress – a move that J&J and Weldon have resisted.

In a shrewd move, the company is having former employees and community leaders write articles in support of the company (the first real attempt at decent PR from J&J during this whole crisis). I don’t know Linda Stamato and the others jumping on the pro-J&J bandwagon, but I’m willing to guess that Ms. Stamato’s experience at the company many years ago has little bearing on the J&J of today. Naturally, Steamato probably remembers when J&J used to put its Credo in every room (that was pre-Weldon). And Stemato probably remembers when J&J behaved ethically (that was pre-Weldon). As companies like J &J put into their financial filings – past performance is no guarantee of future results. Nobody knows this better than the tens of thousands of patients who trusted their children’s health to J&J, only to have the company to poison their children with 2,4,6-tribromoanisole – a pesticide.

Past performance is no guarantee of future behavior. Just because a pharmaceutical company was once admired and was once ethical, does not mean that it will always be that way.

Johnson & Johnson Wrapping up Manufacturing Inquiry; Throws Party

2010-09-07T18:27:00.000-07:00

Johnson & Johnson’s embattled CEO William Weldon has proclaimed that the company’s inquiry into gross manufacturing violations is nearly completed. Of course, J&J still has a long way to go to fix those problems. The final report on the company’s problems should be finished soon – but nobody will see it. Just like the initial reports on manufacturing woes at the Fort Washington plant, the company will likely issue a sanitized statement that doesn’t actually say anything and suppress the complete report that would actually prove informative.

While Weldon was missing in action for nearly the entire crisis getting his elective surgery (read cosmetic surgery), he seems to have emerged smelling like a rose granting numerous interviews over the last few weeks. One has to ask the simple question: where the hell has he been?

There have been 11 recalls of J&J products and Weldon has been completely MIA. I’ll say it once, I’ll say it again – Is there a single J&J product on the market that consumers can believe is safe? Consumers can have no assurance in the safety of J&J’s products.

It also seems that rumors of Weldon’s demise are premature. Sure, he steered the ship into the storm. Sure, he led the organization away from its core values and abandoned the Credo. Sure, he dismantled J&J’s quality control and patient safety organization that would have caught these problems (it was a cost cutting measure). Sure, he focused more on short-term profits than the safety of J&J’s products – and the health of its patients. But J&J’s Board of Directors thinks he’s doing such a terrific job they’re going to keep him on to clean up the mess he created. It’s like asking the fox to guard the hen house. There’s something to be said for letting Weldon wallow in the shit pile he created, but not at the risk of patient safety.

Meanwhile, it seems that nothing has changed at J&J. IT’S PARTY TIME! Instead of focusing on patient safety, J&J spent a fortune having teen sensation Demi Lovato perform at a pep rally at J&J’s Skillman, NJ facility for employees. Maybe J&J got a deal on Lovato’s time – she signed up earlier this summer to hawk J&J’s CLEAN & CLEAR® Skincare System. Oh sure, it’s part of some altruistic campaign called “Join the Surge” and in partnership with some group called DoSomething.org. Naturally, it’s all very altruistic - J&J’s great that way (like suing the American Red Cross). Of course, throwing a big party with a tween singing sensation is just what J&J employees need to take their attention away from things like patient safety and ensuring the company’s products are defect free. J&J’s management should have thought about the optics of throwing a big concert for employees.

But then again, there’s a lot that J&J’s management should have been doing -- like ensuring its products are safe and effective.

FDA Finds Problems at Yet Another J&J Plant

2010-07-18T19:52:00.000-07:00

We learned over the weekend that the FDA inspected ANOTHER J&J manufacturing facility and issued it an unacceptable (Form 483). This is just another sign of systemic manufacturing problems across all of J&J’s facilities worldwide. And it should be another wake-up call to consumers on the safety of all of J&J’s products.

Meanwhile, last Thursday, J&J issued their report to the FDA on how it will plan to fix its manufacturing mess. The company had promised transparency, so I was suspecting it to post its entire plan online (like other reputable pharmaceutical companies in the past). One thing is clear – transparency and being a reputable pharmaceutical company aren’t on J&J’s mind. Instead, J&J posted a brief statement on its blog (but only after I contacted J&J’s Marc Monseau and questioned the lack of information). As you might imagine, the statement doesn’t say anything and doesn’t address how the company plans to fix the mess.

The most significant step J&J will be taking – mass layoffs. This isn’t designed to fix manufacturing problems, rather, cut costs to preserve bonuses for J&J’s management. The company will kick over 300 employees to curb in September, giving them severance packages. The company then intends to re-hire at least some of these folks in 2011 (if the FDA ever lets them resume manufacturing). In other words, J&J is transferring financial responsibility for the employees from the company to the Commonwealth of Pennsylvania for the next year. The company then anticipates hiring some of the employees back in 2011. I have to ask the question – is that the behavior of an ethical company? How does this square with the Credo (which reads: “We are responsible to our employees, the men and women who work with us throughout the world…They must have a sense of security in their jobs.”)

More background on the J&J manufacturing mess:

Why the J&J Coverage?

2010-07-18T10:47:00.000-07:00

Someone recently e-mailed me why I’m focused so much on J&J. The answer is simple – because I believe this to be THE most significant story in the pharmaceutical industry. Period.

As an industry, we have faced numerous public perception problems. J&J’s just fueling that. The one thing you could always count on was the safety of Tylenol – take two and call me in the morning.

But what happens when your Tylenol is laced with a toxic chemical that has an unknown impact on public health and the company has worked hard to cover it up?

That’s the situation we find ourselves in. J&J’s behavior hurts the entire industry.

J&J Misses Deadline for FDA Plant Fix Plant

2010-07-14T18:21:00.000-07:00

Back on May 25th, Johnson & Johnson (J&J) announced that it would present a comprehensive plan to the FDA on July 15th on how it would address its massive manufacturing woes. Today is July 15th and no plan from J&J.

However, J&J assures us that the plan is coming tomorrow – only one day late. I can’t say I’m surprised by this. Frankly, I’m not holding my breath we’ll actually see this report from J&J.

Patients Sue J&J Over Fraud

2010-07-11T20:07:00.000-07:00

Johnson & Johnson was sued last week by a group of consumers for fraud. Patients are fuming mad that J&J’s solution to the Tylenol recall is to offer coupons to consumers for more Tylenol - which isn’t actually available since the company was forced to shut down its principle manufacturing facility. J&J claims that consumers can also obtain a refund. HOWEVER, consumers have complained that when they have requested a refund, J&J has issued them with the worthless coupon instead. How irritating is that?

The usually eloquent Jim Edwards has a scathing review of the Unsolved Mysteries at J&J over at BNET. Among them, Jim Edwards wants to know why McNeil’s head Peter Luther still has his job. To that, I’d ask the question, why does William Weldon still have a job? At the rate this shaping up, I’m betting the J&J board will sack Bill Weldon, Colleen Goggins and Peter Luther before this is all done. However, they need to get themselves a little distant from the poisonings before they can clean house.

This should be an interesting week for J&J. If you recall, back on May 25th, J&J committed to the FDA that it would present the Agency with a full review of exactly how it screwed up and exactly what it would do to fix it by July 15th. This review was supposed to be conducted by an outside consultant and without any internal bias (although it is unclear if it is the same outside consultant who conducted the now famous “phantom recall.”). J&J also committed to being transparent with consumers. I think chances are good that J&J will make the July 15th deadline. However, based on its recent behavior, there’s not a chance in hell that J&J will be transparent with consumers.

I’ll be eagerly watching this week.

J&J Announces Yet Another Recall

2010-07-08T19:56:00.000-07:00

Another day, another J&J product recall. This recall covers both pediatric and adult products in the United States and about a dozen other countries on two continents. What are we up to with J&J product recalls? I think this is recall #7 or 8 major one in the last two years, at least the fourth one this year, and the second one in three weeks.

The reason for this recall? J&J says this is a “precaution” because these additional lots came in contact with the same materials that contaminated all the other J&J products. In other words, these lots should have been recalled before, but weren’t (for some reason). That seems to be a recurring theme with Johnson & Johnson.

Oh, By the Way, if you’re looking for any officially communication from J&J, forget it. J&J is pretending this isn’t happening. There’s been no word over at their official blog JNJBTW on the last several rounds of product recalls. I want to give J&J credit for actually being honest about the problem instead of hiring consultants to get the products off the shelves during the dark of night (like they have done in the past). But doing the right thing should be a minimum expectation, not the exception to the rule that it seems to be at J&J. And if you’re looking for the company to sound concerned about the safety of its products? Forget it.

I’ve said it once and I’ll say it again. We have a company that has systemically contaminated products at multiple sites in multiple countries, has ignored FDA warning letters going back to 2003 and doesn’t seem at all concerned it is poisoning people (including young children). What’s wrong with this picture?

Given the widespread nature of the manufacturing problems at J&J, we cannot assume that any J&J products are safe. These manufacturing problems are systemic across J&J and not isolated to some random manufacturing facility. For me, I question the safety of all J&J’s products. They make a lot of products, from pharmaceutical products (like Risperdal, Procrit, Levaquin, Concerta, Velcade, Aciphex, Prezista, Duragesic, etc.) to health and beauty products (like Aveeno, Listerine, etc.).

It is up to J&J to prove to us that it is an ethical company. It is up to J&J to prove that its other products are safe. The burden of proof is on J&J. We can no longer accept it on faith.

More background on the J&J manufacturing mess:

J&J’s MIA CEO Gets Another Congressional Summons

2010-06-28T19:59:00.001-07:00

It’s another sign just how much J&J is fallen – a second Congressional summons for J&J CEO William Weldon. Good old Billy Weldon bagged out last time by scheduling an elective surgery. This time around, Congress has made it known that individuals with disabilities will be accommodated. In other words, Weldon can’t get out of this a second time. So, it’ll be interesting to see if Weldon shows up on June 30, or whether J&J will continue to give the big middle finger to Congressional oversight.

From my perspective, I think there’s a 0% chance of Billyboy Weldon showing up on June 30th. However, I think there’s a better than average chance of Weldon actually showing up at some point this summer – if he manages to remain CEO.

Meanwhile, J&J has announced that it won’t be returning to manufacturing anytime soon. The company has announced that it won’t begin manufacturing at the Fort Washington facility this year – forgoing about $700 million in revenue. UBS slashed its earnings estimates for J&J through 2010 and 2011 based in part to McNeil’s woes as well as credibility concerns with J&J’s products.

J&J will not provide a timetable for returning the Fort Washington facility to normal production. The good news for J&J is that they’ve got two weeks to figure it out – final assessments are due to the FDA on July 15. Meanwhile, J&J’s McNeil unit has made token steps which include sacking some low level managers and hiring an outside firm to monitor the company. (Of course, the last time J&J hired an “outside consulting firm” it was to conduct its infamous Phantom Recall.)

J&J’s plans pertain only to the Fort Washington facility and does not address similar manufacturing failures at other J&J facilities.

And, if it couldn’t get bad enough, CNNMoney is reporting that J&J’s serious manufacturing woes date back seven years – to 2003.

J&J Expands Recall; Employees Devastated

2010-06-16T18:19:00.000-07:00

Yesterday, Johnson & Johnson (J&J) added five more products to its January 2010 recall. It’s not so much that J&J added five products to the January recall (which was recall #5), as J&J is really announcing a 6th recall. Compared to the massive McNeil Consumer Healthcare recalls of the last two years, yesterday’s J&J recall was relatively small.

What’s striking is the reason – the products, including Benadryl and Extra Strength Tylenol – were supposed to be recalled back in January as well, but the company screwed up. Or, in the words of J&J, the products were “inadvertently omitted from the initial recall.” By recall, J&J meant recall #4 (January 2010) and recall #5 (April 2010), not the original recall back at the end of 2008 – when this whole mess began. The reason for the recall is that the batches were contaminated with 2,4,6-tribromoanisole – an industrial chemical used to treat wood products (like shipping pallets).

Perhaps, most interesting, today’s products were not made at the Fort Washington plant, where the other products were manufactured. Instead, they were made at the company’s Puerto Rico facility. This is really quite troubling because it shows systematic failures in J&J’s manufacturing across the entire company. Given that the manufacturing woes are not confined to a single J&J plant, there’s no reason to believe that the problems are confined only to McNeil Consumer Healthcare products.

Meanwhile, on Tuesday, I met with a handful of acquaintances from J&J to hear their tales of woe from inside the company. I had lunch in New Brunswick and then traveled down to Plymouth Meeting, near the Fort Washington facility. As you might imagine, employees are devastated at what has happened to their company. A few of them feel like the company is being viciously attacked and unfairly portrayed in the media. However, most feel that William Weldon has led the company from the most respected into the industry to one that is almost completely distrusted. I feel bad for those decent and honest J&J employees. How sad is it to put your trust into something and build a career someplace, only to have it destroyed through executive greed?
Evidently the City of New Brunswick and the folks at New Jersey Transit are also concerned about employee morale at J&J – NJ Transit has put up suicide prevention posters in the New Brunswick train station across from J&J (pictured below).

J&J to Congress – F’ Off

2010-06-13T19:46:00.000-07:00

Johnson & Johnson – what once stood for quality and integrity now stands for inferior quality and gross lapses in judgment (and some argue, criminal activity).

Last week was a bit of a nightmare for the company that can’t seem to get out of its own way. "Epic PR disaster" doesn't even begin to explain J&J's handling of this whole situation. First, the company failed to comply with a Congressional request to turn over all documents related to its handling of the last five product recalls of its OTC products (including the “Phantom Recall”). In response to negative media attention, the company was decidedly less transparent – telling Congress and the American people to, essentially, F’ Off.

J&J likes to claim it is social responsibility and engages in ethical behavior, but its actions are strikingly otherwise. In response to the company clamming up, leaked documents show that, not only did J&J management know about the “Phantom Recall,” but was part of the planning. Oops. So the question is – did J&J scapegoat Colleen Goggins knowingly lie about J&J’s involvement when she testified before Congress? My guess is that Goggins answered the question honestly – she didn’t know about it…and that’s why J&J sent her. However, I bet Mr. William Weldon did know about and, in fact, authorized the Phantom Recall and that’s why his elective surgery was conveniently scheduled to coincide with the Congressional summons.

When FDA inspectors (namely Neisa Alonso) questioned the company on its actions, J&J deceived the agency. The agency pressed the company to conduct a full recall, something the company ultimately did after many, many, many months and countless children ingesting the contaminated products.

Meanwhile, consumers are fed up with the J&J’s coupon scheme. Parents who purchased McNeil products and gave them to their poor children are eligible for refund coupons good for the purchase of more J&J products (at whatever point in the time the company is allowed to manufacture products again). That’s good for J&J, but what if a parent doesn’t what to give their child more products from a suspect source? It’s a scary prospect for parents – giving your kids products that have consistently been manufactured poorly and contaminated for so many years. Why trust J&J again? Rightly so, parents are now suing for full cash refunds.

Meanwhile, still radio silence for J&J’s embattled CEO, William Weldon, who continues to recover from his elective surgery. J&J’s official communication channels (the blog JNJBTW, Twitter, YouTube, etc.) are all pretending nothing has happened. Once again, it seems J&J is relying on a legal strategy, rather than acting with integrity.

I’ll ask it again – What Credo?

Allscripts Snatches Up Eclipsys

2010-06-09T20:17:00.001-07:00

Health IT is where the money is at. And that’s where the deals where on Wall Street today. Allscripts has agreed to purchase Eclipsys for $1.3 billion in an all-equity deal. This is a game changer in the health IT industry where major companies like GE, McKesson, Cerner and EPIC have carved deep territories.

Allscripts office-based IT platform will be a perfect complement to Eclipsys’ hospital IT business. The company is making a major move for its share in the nearly $30 billion derby for federal stimulus dollars. Whether it will be a match made in heaven still remains to be seen.

Eclipsys shareholders will receive 1.2 shares of Allscripts common stock.

J&J tells Congress Where to Stick It

2010-06-08T19:30:00.000-07:00

One way to manage a crisis is to engage in openness, transparency and swallow your pride. Then there’s the Johnson & Johnson approach.

After appearing before Congress, legislators requested numerous documents from J&J relating to its “Phantom Recall” – buying its own drugs off the shelves using contractors, telling them to lie about the reason and not reporting product defects to the FDA.

Well, the other shoe has dropped. J&J has refused to turn over all documents requested to Congress. J&J turned over some documents, but not everything.

This doesn’t seem to be a winning strategy for Johnson & Johnson.

Meanwhile, J&J’s CEO Bill Weldon is still in hiding recovering from his “surgery” (be it a real liposuction or a convenient cover story). I’ve said it before, but if he isn’t dead, J&J needs to be parading him out in his hospital gown. Actually, J&J is probably wishing William Weldon is dead so they could bury all the problems of the last few years along with him.

Ref: Wall Street Journal

Amgen’s Prolia Scores Again

2010-06-03T19:06:00.000-07:00

Amgen scored a second approval for Prolia (denosumab) for the treatment of osteoporosis just days after its first. Last week, Prolia was approved in the European Union. Now, Prolia has received approval from the FDA.

Meanwhile, Amgen is ramping up promotion efforts in anticipation of a launch. The company is hiring and deploying nearly 1,000 additional sales reps to detail the drug.

Checking in on Peter Rost

2010-06-03T18:38:00.000-07:00

So it’s been a good long while since I last checked in on Peter Rost. Rumors of his demise were premature and I’m happy to report that the Petey is still alive and well.

Over the weekend, in Time Magazine, he opined on grand conspiracy theories where the Government and pharmaceutical companies all conspire to break the law. It’s an interesting theory and is right up there with theories that President Obama actually caused the BP oil spill. But just because it’s an interesting theory doesn’t mean it has any basis in reality.

Peter Rost has been awfully quiet since I last checked in on him – a far cry from the daily spam messages begging me to write about his book. So, for old times sake, here’s another Peter Rost Book Sales Update: Killer Drug has fallen to #1,122,636 on the Amazon bestseller list (compared to #763,413 at last check-in on October 13, 2007).

Fun times...

What’s Next for J&J?

2010-05-31T19:39:00.000-07:00

May was a bloody month for J&J. The company has been under siege for its poor manufacturing practices and the handling of its fifth recall in just under 2 years. So where does J&J go from here?

Johnson & Johnson has a first class PR mess on its hands. I said it back when J&J decided to sue the American Red Cross, but I’ll say it again – J&J needs serious PR help and if its own staff aren’t up to the task, it needs to hire someone…fast.

For J&J, shielding their CEO isn’t helping the company on the reputation front. J&J’s CEO, William Weldon, gave one media interview before going into hiding. J&J’s cover story is that he’s undergoing a pre-scheduled medical procedure (sounds like liposuction). J&J needs to get its CEO out in front of the public FAST. If he’s not dead, he needs to be doing media interviews from his hospital bed. This shouldn’t be delegated to their official scapegoat (Colleen Goggins).

The company needs to put information about the recall prominently on its website. Instead, J&J has opted to host recall information on a microsite – McNeil Product Recall. The microsite strategy is to diminish damage to the main J&J brand. Unfortunately, the company is past that point.

J&J prides itself on its use of social media – so why isn’t it using those channels to provide updates on the recall and build trust with consumers? It’s probably too late for this, but better late than never.

The company will probably need to roll out some advertisements to build trust. We’ve heard rumors that J&J is looking for famous celebrity moms for an advertising campaign called “You Can Trust Us Again.” The concept is that the celebrity mom will say she trusts her children’s health to J&J and you should too. J&J is also considering other ad concepts. J&J’s probably past the point where this will have an impact, but again, better late than never.

And, we also know the deadline – July 15th. Johnson & Johnson hasn’t taken it’s manufacturing woes seriously. It took a Congressional summons for the company to provide a blueprint to the FDA on how it was going to address this.

More background on the J&J manufacturing mess:

No Wonder Doctors and the AMA are Scared of Pharmacy Clinics

2010-05-29T20:09:00.000-07:00

So I had myself a minor (albeit embarrassing) medical issue and I didn’t want to spend hours waiting to get into my doctor. When you have Medicare, let’s face it, you’re the bottom of the barrel and doctors keep you waiting. I didn’t have that kind of time.

So I found my way over to Walgreens and its Take Care Clinic. I got there and the NP was on her lunch break for another 10 minutes and there were 2 people ahead of me. From registering to actually seeing the NP was a total of 35 minutes (at least an hour faster than if I'd gone to my doctor's office). Once I got into the consult, she spent almost 20 minutes with me. It was one of the most thorough exams I’ve had in years.

This was my first experience with a pharmacy clinic. It’s no wonder why the AMA absolutely hates these things. These clinics represent a huge challenge to physician's way of doing business. But they are decidedly pro-consumer: easy to get an appointment with quality care. My first experience at a pharmacy clinic has made me a believer.

Time to Fire Weldon?

2010-05-28T08:08:00.000-07:00

Things at Johnson & Johnson really can’t get much worse. The company was dragged before Congress yesterday to testify as to their failure to protect public health and manufacture children’s medicines that were free of contaminants. The embattled CEO, William C. Weldon, refused to testify, instead sending an underling, who will be the scapegoat for the whole unfortunate affair. Meanwhile, Mr. Weldon is recovering from his “back surgery,” which conveniently took place just days before his planned Congressional testimony (but after he received his Congressional summons).

Mr. William C. Weldon is one of the most highly compensated CEOs in the United States. In 2009, J&J paid him over $22.8 million in salary, stock and “other compensation.” Surely, Mr. Weldon has delivered exceptional value to J&J’s shareholders, right? Nope. Since being named CEO on April 25, 2002, J&J’s stock has been flat. Exactly flat. Closing price of J&J’s stock on April 29, 2002 was $63.43. Closing price of J&J’s stock on May 3, 2010 was $63.31. And J&J’s stock has continued to slide since May 3. Mr. Weldon isn’t exactly delivering shareholder value.

I don’t know Billy Boy Weldon. I’ve never met him and don’t know him from Peter Graves (the two look an awful lot alike in photos). However, I know a thing or two about leadership. He who heads the ship controls the direction. And Mr. Weldon clearly set the direction for J&J over the last decade. On Mr. Weldon’s watch, the company abandoned its famous Credo, instead, focusing on enriching the pockets of executives. On Mr. Weldon’s watch, the company decided to wage holy jihad against the American Red Cross. On Mr. Weldon’s watch, J&J has thwarted FDA oversight and shown a blatant disregard for patient safety.

There’s really only one way out of this mess for J&J and it starts with cleaning house. I don’t wish Mr. Weldon any ill will, but if J&J will ever recover, it needs ethical leadership, it needs to return to its core values (the infamous credo) and it needs to get Americans to believe in it again. A changing of the guard would go a long way to showing America that J&J is finally beginning to take this situation seriously.

Amgen’s Prolia Wins European Approval

2010-05-28T07:00:00.000-07:00

For year’s investors have wondered where the next Amgen blockbuster would come from.

Today, we have the answer. Amgen received European approval for its new osteoporosis drug Prolia (denosumab). Approval comes across all EU countries, plus Norway, Iceland and the ever-populous Liechtenstein. GlaxoSmithKline (GSK) will co-market Prolia.

The FDA will be taking up Prolia’s fate in July.

The Case of the Phantom Recall

2010-05-27T19:51:00.000-07:00

When I was a young boy, I used to read Hardy Boys novels. Most young folks today have heard of the Hardy Boys, but not actually read them, but all of the books had these overly dramatic titles. Given today’s latest revelations in the Johnson & Johnson (J&J) crisis, I figured an overly dramatic Hardy Boys title was appropriate.

So here is what we learned today. Congress summoned J&J CEO William C. Weldon to Washington to answer for his company’s actions. Unfortunately, last week, Mr. Weldon decided to undergo emergency cosmetic surgery (or was it “back surgery”) so he was unable to attend. Instead, J&J offered up their official scapegoat – Colleen Goggins, Worldwide Chairman of the Consumer Group. And she showed up this morning.

Naturally, we all have this image of J&J rapidly responding to the Tylenol crisis of 1982. J&J has spent millions cultivating that PR image. But, like the tooth fairy, it’s not the truth. Today, we got a look inside the real Johnson & Johnson. A company that, in 2008, understanding that it had a massive manufacturing problem, sent contractors out into stores to buy up all its Motrin products so it wouldn’t have to recall them (dubbed the “phantom recall”). A company that failed to notify the FDA of the problem (“what law?”) and then waited until July 2009 to actually recall the drug. This is the REAL culture at J&J, by the way.

Meanwhile, we’ve learned that the FDA is tracking over 700 active complaints on J&J products. To this point, the company has maintained that the problems were “process anomalies” and there was no risk to patients. However, we now know that at least some of the 700 complaints are being investigated for possible patient harm (investigated does not mean harm exists, but we can’t be taking J&J’s word on it anymore).

Yes, it was a fascinating day to be an observer of pharmaceutical industry. Unfortunately, J&J’s actions reflect poorly on the entire pharmaceutical industry. Those less sophisticated may pick up on media stories and assume that all drug companies behave like J&J – they don’t. Consumers might believe that all drug companies try to hide contaminated products and wait years to address the problem – they don’t.

Back when I used to read the Hardy Boys and go to Cub Scouts, my mom used to say – don’t let one bad apple spoil the bunch. I think that’s good advice.

J&J Gets Congressional Hearing

2010-05-26T18:35:00.000-07:00

Tomorrow, Johnson & Johnson gets its day in the limelight at a Congressional hearing on the company’s ongoing manufacturing woes and most recent product recall. The company is offering up its Worldwide Chairman of the Consumer Group, Colleen Goggins, as the official scapegoat for the whole affair.

Meanwhile, over at the official blog, the company has finally offered a shell plan for what it intends to do about this whole affair. While nearly two years too late, it is a positive step for the company. I’ve been highly critical of J&J recently, but perhaps the company is finally turning a corner.

Will it be enough to avoid a consent decree with the FDA? Only time will tell.

The Rise and Fall of the Great Autism Fraud

2010-05-25T20:02:00.000-07:00

The recent history of autism and autism research has been dominated by a legend – Andrew Wakefield. The former British physician turned rogue Texas cowboy has been a lightning rod for controversy – on this everyone can agree.

We know that Andrew Wakefield pioneered the early hypothesis that the MMR vaccine caused autism. He was the author on the original Lancet study that struck fear into the hearts of millions of parents – causing tens of thousands of them to skip immunizations. His study single handedly led to the resurgence of measles.

There was just one problem – it was all a fraud. The Lancet has since fully retracted the article as a sham. Dr. Wakefield’s co-authors have apologized and accepted accountability for their actions. The methods of the paper did not have scientific rigor and it appears that much of the data was fabricated. And, earlier this week, Dr. Wakefield’s medical license in the UK has been stripped.

The loss of his medical license in the UK hasn’t been that much of a problem since Dr. Wakefield hasn’t been practicing medicine in Europe for years. Instead, he’s been practicing medicine without a license in Texas at the Thoughtful House Center for Children. In February, just days after I wrote The Great Autism Fraud, Dr. Wakefield “resigned” from Thoughtful House (resigned being a nice euphemism for sacked).

Despite the tremendous personal embarrassment of being caught fabricating scientific evidence and being exposed as the greatest medical fraud of the last 20 years, Dr. Andrew Wakefield may have the last laugh. His new book Callous Disregard: Autism and Vaccines: The Truth Behind a Tragedy hits bookstores on May 26th. While not expected to be a bestseller, it will have a devoted following among the legions of parents that will believe a modern snake oil salesman. Since Dr. Wakefield won’t be able to make money as a doctor doing tests on children, he’ll be able to make some easy cash off book sales. There’s some good news for readers of the book, they will be treated to a special forward in the book by Jenny McCarthy – the discoverer of the Cure for Autism.

The life story of Andrew Wakefield is as timeless as life itself – it’s nothing more than the rise and fall of a fraud.

J&J CEO Refuses to Testify Before Congress

2010-05-19T19:37:00.000-07:00

Johnson & Johnson’s (J&J) credibility woes continue as the company’s CEO, William Weldon, has refused to testify before Congress. He was summoned to appear at an upcoming hearing on May 27th to justify his company’s handling of five recalls over the last two years.

J&J’s excuse is that Mr. Weldon has had “back surgery.” Mr. Weldon’s “back surgery” was previously scheduled; however, he refused to postpone the surgery upon on learning of the Congressional summons last week. Despite the fact that other individuals in similar situations have prepared video testimony or even done satellite testimony, J&J appears to want to shield Mr. Weldon from accountability and responsibility. As I’ve said before, it’s a shrewd legal move from J&J, but is tanking whatever credibility the company has left.

J&J seems to be offering Colleen Goggins, Worldwide Chairman of the Consumer Group for J&J, as the scapegoat for this situation. She’ll get to handle the tough questions and then J&J will give her a package and usher her out the door.

You have to wonder how seriously J&J takes this situation that Mr. Weldon would not postpone his surgery after learning of his Congressional summons. A surgery that can be “previously scheduled” is not a medical emergency. Certainly, if Mr. Weldon cared about the children his company has exposed to contaminated products, he might have made a different decision.

J&J’s Drug Recall Checklist

2010-05-17T18:23:00.000-07:00

Nobody in America is more thankful for the BP oil spill than Johnson & Johnson CEO William Weldon. BP’s oil crisis deflects some of the popular media attention off J&J’s massive drug recall and the company’s ongoing manufacturing problems. The recall of over 40 J&J products in earlier this month is the 5th major recall of J&J products since the company was notified of significant contamination of its products back to late 2008.

So, far, J&J’s approach to the recalls have been typical for the company – slow and insufficient. But that’s J&J’s approach (they call it “Slow Cooking” – taking your sweet time).

J&J’s approach to this recall has been formulaic:

Issue a press release late on Friday and hope nobody notices (Check)
After massive media criticism, post an anemic defense of your company on your corporate blog (Check)
Give confused parents a website that doesn’t really provide any answers (Check)
Give confused parents a phone number to call with questions, where they get a pre-recorded message that reads them the press release or a representative that can’t answer any questions (Check)
Ignore media’s phone calls (Check)
Issue a passive letter from your CEO that doesn’t accept any accountability and says, “I have been assured that the chance of a serious medical event from the recalled products is remote.” (Check)
Let your CEO do a video interview on a financial website to try and restore investor confidence and thwart shareholder lawsuits (Check)

Here is what’s next for J&J:

Now that J&J has received it’s “invitation” to have Bill Weldon testify before Congress, it needs to give Weldon a personality transplant (or at least coaching). Ditch the confused and arrogant CEO who won’t accept any responsibility, and find one who has some empathy for the children and parents.
Your much-discussed “You Can Trust Us Again” advertising campaign seems insincere and misguided. J&J needs credibility, and this isn’t going to do that. Ditto for the idea of having celebrities come forward and say, “I trust McNeil products for my child.”
When your CEO Bill Weldon testifies before Congress on May 27, he better have real answers to the questions and he needs to be believable.

My expectations for Johnson & Johnson are low. They’ve known about their manufacturing problems for two years and done nothing. They’ve known about their credibility problem for several years and done nothing. I know J&J is “Slow Cooking,” but it shouldn’t take years for the company to behave responsibly. The company’s infamous credo which guided it through the infamous Tylenol Tampering of 1982 is nothing more than distant history.

When the Creed is Greed

2010-05-07T20:32:00.000-07:00

Johnson & Johnson continues to implode. The company has managed to completely fuck up decades of goodwill. In the last year, J&J has had four major product recalls – each of them has been bungled badly. Last year, the company waited over a year before notifying the FDA of manufacturing problems.

So Johnson & Johnson finds itself in the midst of yet another product recall – and they are doing their best to handle it poorly. In this latest round, J&J only took two weeks in getting the word out to parents. Just like in the past (like when J&J decided to sue the Red Cross), J&J communicated its product recalls on its official blog – J&J By The Way. Once again, J&J has demonstrated its communications strategy – communications is a “by the way” afterthought. Naturally, on the JNJBTW blog, J&J spokesman Marc Monseau has suffered through an onslaught of angry parents. And why shouldn’t parents be angry?

J&J has mismanaged its manufacturing for years (and now everyone knows it). J&J’s communications strategy continues to be…well…an afterthought. Issuing a press release late on a Friday night to ensure minimal notice is not the hallmark of an ethical company. J&J seems more concerned with getting the bottles out of the hands of parents – not to ensure that kids don’t take the medicines, but to limit the company’s future liability in lawsuits.

I feel badly for J&J. Like nearly everyone in America, J&J has been there my entire life. It’s sad to see the company descend from one of America’s most admired and most ethical, into one that has abandoned its creed in favor of greed.

J&J’s OTC Products Recalled (Again)

2010-05-02T14:48:00.000-07:00

On April 30, Johnson & Johnson announced it was recalling 43 of its OTC medications. During a recent FDA inspection, the agency found significant deficiencies in J&J’s manufacturing processes resulting in purity, potency and quality problems with a large number of J&J’s OTC products on the market.

The manufacturing deficiencies described by the FDA seem to have existed for some time. It seems possible that the problems have existed since the last J&J recall of products dating back to January (see more in A Tale of Two Recalls). This makes me wonder if J&J ever took corrective action from the last round of product recalls.

Personally, I want to congratulate Johnson & Johnson on doing a much better job of handling this situation. The last time J&J had this problem, details emerged in 2008, the company waited over a year to notify the FDA (December 2009) and then waited again until January 2010 to tell consumers. However, in this case, J&J waited only two weeks to notify consumers! This is a very positive development for J&J and I want to congratulate them on this!

Consumers can get more information at the McNeil Consumer Healthcare Product Recall Information website.

Snowbirds Flying North

2010-05-02T13:39:00.001-07:00

Like many a snowbird, Pharm Aid has flown North this week. After almost two months, Pharm Aid is back!

Thanks for your patience!

Autism Revisited

2010-03-09T19:08:00.001-08:00

I love Jenny McCarthy. Seriously. She’s a hot train wreck. She’s got a new opinion piece up on Huffington Post and its worth a read. It’s kind of like listening to the crazy guy on the street corner, but it is entertaining.

Jenny McCarthy has some pretty radical ideas about autism. She still adheres to the long-disproven belief that vaccines cause autism. OK, so McCarthy doesn’t understand science, but let’s not let a little thing like science get in the way of a good time.

In her Huffington Post article she says she doesn’t really want to talk about vaccines, she wants to talk about recovery. Yet she doesn’t talk about recovery – a pity. You see, Jenny McCarthy single-handedly discovered the cure to autism. She knows how to reverse the disease. She was able to cure her own child’s autism. Yet, selfishly, Jenny McCarthy refuses to share the cure with the tens of thousands of parents in America who also have children with autism. Why? Is she afraid that parents will learn the truth? Who’s afraid of the truth? Evidently, it’s Jenny McCarthy.

But the most intelligent thing is McCarthy’s closing line: “Who’s afraid of the truth? Usually the people it would hurt the most.” She’s right. Parents are afraid of the truth. It’s easier to blame everything on something external – vaccines, big bad drug companies and the government – rather than accept the truth: there’s not one single boogie man to blame. Autism disorders seem to have a multitude of factors: genetics, age of the parents at birth, mother’s consumption of fish during pregnancy, and mother’s substance abuse during pregnancy. It feels better to blame vaccines, drug companies and the government rather than your actions during pregnancy. However, just because it feels good, doesn’t mean it is reality.

Speaking of reality, a survey of parents found that 1 in 4 parents are convinced that vaccines cause autism (no doubt, they’re listening to Jenny McCarthy). Coincidentally, that’s the same percentage of people that believe in Big Foot, are still convinced that there are Weapons of Mass Destruction in Iraq, and that HIV was engineered by Europeans to kill off Black Africans and take over the continent.

We can continue down the road of foolishness and believe that vaccines cause autism. Or, we can stop wasting time and resources, instead focusing on those things that are actually associated with autism. Thousands of children are suffering with autism – it’s time to get them the real help they deserve and stop wasting time.

The Privacy Shakedown

2010-03-08T18:33:00.000-08:00

Last week, twenty thousand medical IT professionals invaded Atlanta for the annual HIMSS meeting. When it comes to health IT, this was ground zero.

Obama’s health IT czar in da house? Check. The gravy train of federal stimulus money? Check. Deborah Peel proclaiming the end of the world? Check.

Deborah Peel is a favorite of mine. I used to think that Deborah Peel just didn’t get it. I was wrong, Deborah Peel gets it – and has made sure that she’s profiting off it. It’s all about the money and selling fear. Her organization, Patient Privacy Rights, offers a report card on how well companies do in protecting patient privacy. Top on her list is No More Clipboards. So it is not surprising that I found Deborah Peel at the No More Clipboards booth – makes you wonder about how impartial the Patient Privacy Rights ratings actually are.

Yet something was amiss with Deborah Peel this HIMSS. Gone was the fight and the fierceness. Instead, this sad woman was left in her place. She’s given hundreds of thousands of dollars to Democratic political causes and candidates – from Emily’s List and the DNC National Committee, to Dick Durbin and Barack Obama, Deborah Peel has dropped a small fortune into buying access and clout. So, when the Democrats snubbed Peel’s privacy ideas in their health IT adoption plans, it left her to sulk in the corner. And sulk she did at HIMSS.

The thing with Deborah Peel is this – everybody has the same goal. Everyone wants to protect patient privacy. The only difference is that Deborah Peel acts like there is patient privacy only when she’s being paid – it’s the privacy shakedown. No wonder she seemed so blue at HIMSS.

Pfizer: Loose Lips Sink Ships

2010-03-01T17:06:00.000-08:00

Back in my day, we had the legacy of the American Government’s propaganda war – including the famous “Loose Lips Sink Ships” adverts. When I began my career in business, discretion was expected. Since then, many companies have paid over-priced consultants millions of dollars to develop employee training programs to teach employees the obvious – be careful what you say in public because you never know who is listening.

This is a lesson a couple of Pfizer executives failed to understand. Last Monday, I found myself heading out of Manhattan on an Amtrak train with a couple of Pfizer execs ensconced in the seats behind me and talking very loudly about certain inflammation franchise clinical trials. It doesn’t take a genius to realize you’re riding Amtrak through the Northeast Pharma Corridor and there are probably at least 4 or 5 other people within earshot who are also engaged in the pharma business – perhaps a competitor (or, even a little old blogger like me).

Having some experience in this area, I had a pretty good idea of what they were talking about. They started off talking about Crohn’s disease and their Phase 2 compound ATN-103. Naturally, my ears picked up when they started comparing the compound to existing drugs on the market and how ATN-103 was stacking up.

But perhaps the most interesting to me, was a discussion of the compound ATR-107 for Lupus. This compound was listed in the 2009 Wyeth Pipeline Report as being removed from the active project list and is not even listed in Pfizer’s 2010 Pipeline Report published just a few short weeks ago. Yet I listened to a rather lengthy discussion on the future of this compound.

I could go on and on. In an ultra-competitive industry like pharma, you’d imagine company executives would be a little more prudent and discrete in a public environment, but perhaps not.

Flu Fighting, Revisited

2010-02-19T20:41:00.000-08:00

Back on January 17, I wrote about the Department of Health and Human Services important new public health initiative – the “I’m a Flu Fighter!” application on Facebook. At the time, I was critical of HHS and especially critical of HHS Secretary Kathleen Sebelius for this initiative. However, I believe everyone has the chance to prove themselves, so I wanted to revisit this topic.

As expected, Secretary Sebelius’ usual level of competence was brought to the task. Back when she launched the program on January 17, HHS has managed to secure 80 Facebook fans. As of this afternoon, that number had skyrocketed up to 158. All of the resources of HHS and they’ve managed to reach 158 people. That’s about one-third the number of people that the average middle school student reaches on a daily basis (Sebelius herself has 6,877 fans on her personal page). Even more embarrassing, Kathleen Sebelius herself isn’t even a fan of her own initiative! Makes you wonder how much her head is really in this one.

Let’s revisit her comments when she kicked off this program: "Friends, family and neighbors can make the difference in whether or not someone gets vaccinated against the flu. Social media has been an important tool to communicate with young people and all Americans about the importance of getting the H1N1 Flu vaccine throughout our vaccination program. This new Facebook application will help friends encourage each other to get the H1N1 flu vaccine." Why wouldn’t she be a fan of her own program? We will probably never know.

In one month, HHS has managed to do almost nothing. But I’ll give them high marks for consistency, because nothing is how they managed the H1N1 outbreak.

I’ve said it once and I’ll say it again – social media is something you do AFTER you’ve mastered the basics (like a comprehensive plan for fighting communicable disease or developing a plan for vaccine administration). Secretary Sebelius’ inaction has resulted in thousands of Americans becoming unnecessarily sick and countless unnecessary deaths.

Doctor’s Don’t Make Mistakes

2010-02-13T19:22:00.000-08:00

Contrary to all evidence, there is still an attitude out there that doctor’s are infallible and never make mistakes. Even some doctors are so self-absorbed into their world of perfection that they continue to deny all evidence that physicians make mistakes.

The New York Times recently ran an expose on medical errors associated with radiation technologies for patients with cancer. In some instances, patients are over-radiated, with sometimes lethal consequences. Sadly, the American Medical Association (AMA) and physician’s advocates rushed to claim that whatever mistakes are happening, it is not a doctor’s fault. If patients are harmed, it is the fault of technicians, nurses, hospital administrators or even the patients (yeah, blame the patient for their own medical error).

Leading the ‘doctors are perfect’ charge has been Amy Tuteur, MD – a physician, author and blogger. Tuteur is no stranger to controversy. She’s written about her role in a high profile patient death – in which she stood by and watched the patient being killed by another medical provider. Tuteur only spoke up after the fact during the eventual lawsuit. It’s a shame that she decided not to take any actions that might have saved the patient. Amy Tuteur also admits to other instances of patient harm and is quick to blame others, noting, “I’ve been involved with several maternal deaths, though never as the primary physician.” It’s always someone else’s fault…

Maybe Tuteur is telling the truth. However, her tone and attitude should strike fear into patients everywhere. In the world of these arrogant, self-important physicians, they view themselves as gods – perfect in every way. They don’t make mistakes – EVER.

How does this relate to the New York Times story on over-dosing patients with radiation? Doctors like Tuteur feel physicians are blameless in the entire continuum of care. However, physicians have a responsibility for their orders and care directives, even when those instructions are executed by nurses and technicians. Delegating the prep work for the procedure does not absolve the physician of all responsibility.

If you’re a patient, a physician’s extreme confidence can be comforting. However, it can often be fatal. Be smart, do your homework and take charge of your own care.

IMS Sale on Track

2010-02-08T18:55:00.000-08:00

The acquisition of IMS Health by TPG Capital and the CPP Investment Board passed its last final hurdle today. IMS stockholders approved the sale in a vote earlier today. Last week, IMS got the green light from European regulators for the buyout.

However, IMS may have one more unforeseen hurdle. The company is trying to float $1 billion in high-yield junk bonds to cough up enough money for its side of the transaction. However, just as IMS is trying to float the bonds, the market for junk debt is softening.

Obama’s Health Reform Desperation

2010-02-07T16:12:00.000-08:00

President Barack Obama has staked a tremendous amount of his political capital on healthcare reform. And he’s stumbled badly. First Obama left healthcare reform entirely up to his Democratic colleagues in Congress and provided no leadership. Then, he took a “my way or the highway” approach to bipartisanship – refusing to allow a malpractice overhaul into healthcare reform discussions.

Now President Obama is getting desperate. He’s finally reaching out to Republicans (while also criticizing them – so tough to see why they’d even want to come to the table). On February 25, Obama will host a healthcare summit - hopefully this will be more than just a photo op for the President. So, nearly 13 months after putting healthcare on his domestic agenda, we are beginning to see the first glimmers of leadership from President Obama. Better late than never.

It remains to be seen if Obama’s overtures to Republicans are actually genuine or if this is just political theatre. However, if Obama actually wants a healthcare reform bill that Americans actually support, he needs to put all reforms on the table – including tort reform.

The Great Autism Fraud

2010-02-02T19:54:00.000-08:00

Today, the prestigious medical journal The Lancet issued a full retraction on the infamous study by Dr. Andrew Wakefield and 13 other researchers, which claimed to show a link between the measles, mumps and rubella (MMR) vaccine and autism. This is the final nail in the death coffin of sham science and one of the greatest medical frauds of the last two decades. Of course, Wakefield’s co-authors on the paper have acknowledged that there were problems and even encouraged The Lancet to pull the plug on the study. The Lancet acknowledged that many aspects of Wakefield’s study were completely falsified. Basically, Andrew Wakefield’s study was a fraud.

In 2004, the British Government launched a formal investigation into Wakefield’s actions (as Wakefield was then a researcher in the United Kingdom). That investigation found that Wakefield didn’t obtain parental consent for his autism studies and when actual children with autism weren’t available, he drew blood samples from children who attended his kid’s birthday parties. Researchers who collaborated with Wakefield reported that he altered and forged the data on the study to support his hypothesis.

Wakefield has resorted to desperate legal strategies of suing any media outlet that has reported on his frauds, however, he usually settles out of court so he doesn’t have to actually go to trial. A trial would require a thorough evaluation of the science (or lack thereof) in Wakefield’s pseudo-research.

The British Government is continuing its investigation into Wakefield and he faces a disciplinary hearing later this year that could result in his loss of medical license. Ironically, Wakefield has fled the UK in shame. He has now taken up residence in Austin, Texas working at an alternative treatment center called Thoughtful House. According to the Texas Medical Board, Wakefield is not licensed to practice medicine in the State of Texas, despite his working at Thoughtful House.

Ironically, even the Thoughtful House has distanced itself from Andrew Wakefield’s pseudo-scientific “research.” On the Thoughtful House website, they have a Q&A and explicitly state: “Q: Have Thoughtful House researchers found any link between the MMR vaccine and autism? A: No such link has been established, but research into a possible connection is ongoing.” In other words, even Thoughtful House is dismissing Wakefield’s previous research.

Of course, the scientific facts (or lack thereof) of Wakefield’s pseudo-research and the tremendous volume of legitimate research disproving any connection between vaccines and autism will mean little to the legions of anti-immunization advocates.

Big News from Allergan

2010-02-01T19:09:00.000-08:00

This week, it is rumored that Allergan is expected to sign a major deal with Nancy Pelosi to be the new BOTOX spokeswoman. The deal is in recognition of Pelosi's willingness to be seen in public looking like a cross between Michael Jackson and Zsa Zsa Gabor.

This is a terrible move on the part of Allergan. The least they could do is team up with somebody reputable – some A-lister like Joan Rivers. Associating BOTOX with Pelosi is likely to shore up their brand with the MoveOn crowd, but this really isn’t the image they should be going after.

Meanwhile, in other Allergan news, the company announced approval from the FDA for Juvederm XC, a dermal filler that also contains the anesthetic lidocaine so patients have less discomfort. House Speaker Pelosi is dying to get her hands on this one.

Katrina Part II

2010-01-30T07:18:00.000-08:00

I just returned from the South. The situation in Florida is deteriorating fast. The Federal government is bringing in waves of Haitian immigrants into Florida hospitals for medical treatment. Wait times are up for appointments. Already over-worked nurses are being asked to do even more. Hospitals are struggling to keep up with the load. And the State of Florida is being asked to shoulder the financial burden for the U.S. Government’s response.

The tragedy in Haiti is catastrophic. And the United States has the moral duty to assist in every way possible. Unfortunately, there is a Failure of Leadership in this crisis. The Ivy League brain trust in President Obama’s Administration hasn’t made any arrangements with Florida on how to manage this. So, it is leaving the State of Florida to shoulder almost the entire financial burden of the medical relief efforts for Haiti (as well as all of the logistical considerations). It’s not right to ask a State to perform the job of the Federal Government. It wasn’t right with Hurricane Katrina. And it’s not right with the earthquake in Haiti.

There is a failure of leadership at the Federal level to handle the Haiti relief efforts. Readers of this blog know that I’m not a fan of HHS Secretary Kathleen Sebelius. Frankly, Elmo from Sesame Street could have more of an impact, but since she was a major backer of then-candidate Obama, we’re stuck with her. Sadly, the response from President Obama hasn’t been any better. He’s struggling to keep his head above water (and bring up his sagging poll numbers) with domestic initiatives, so he can’t focus on the Haiti situation. The crisis isn’t going away.

Today, the New York Times has reported that the U.S. military has stopped medical evacuations out of Haiti because Florida hospitals refuse to accept new patients. This also isn’t the answer. The U.S. needs to spread out the Haitian patients across the healthcare system to lessen the burden on individual hospitals. And, as loathe I am to admit it, the Federal Government needs to shoulder the financial burden – now. It might mean fewer lavish, tax-payer funded vacations for the Obama family to Martha’s Vineyard or Hawaii, but it is necessary. The Haitian earthquake is Obama’s Hurricane Katrina. How will he respond? This situation needs real leadership, real fast.

A Tale of Two Recalls

2010-01-17T17:05:00.000-08:00

On November 16, 2007, I wrote a blog post “If Tylenol Happened Today.” In observing Johnson & Johnson’s new corporate position of attacking the American Red Cross and suing it for trademark infringement, I noticed that Johnson & Johnson had undergone a major cultural shift from the J&J of 1982. I observed that the creedo was greedo. I speculated what would happen if a Tylenol-like problem would happen again. I never realized how right I would be.

Since that day, the Tylenol situation has happened again – and again it was J&J’s Tylenol. Many batches and lots of Tylenol (and now many, many other J&J products) contain a funky, moldy odor that has made some patients sick.

In my blog posting, I talked about J&J’s adoption of “Slow Cooking” – their new approach to communications and crisis (“Slow Cooking” is how the company itself describes its approach). In 2007, I said, “When your products are a matter of life and death, you don’t have luxury of taking your time. Communications can’t be a ‘J&J by the way’ afterthought; they need to be fully integrated into your overall strategy.”

And now we can see the implications of The New Johnson & Johnson. When the latest round of Tylenol product problems first emerged in 2008, the company waited over a YEAR to report it to the FDA – and even then the company was dismissive of patient claims of adverse events. Even then, the company did not aggressively recall the product (as they did during the Tylenol recall in 1982). A year after problems with Tylenol emerged (in December 2009), the company began recalling some products – very slowly. This is the J&J Slow Cooking approach.

This response completely validates my comments back in 2007. At that time, I wrote: “If the Tylenol tampering occurred today, we would be looking at a response that would have taken weeks or months, not days.” I was wrong. The J&J response didn’t take weeks or months – it took months and now potentially years.

Since Johnson & Johnson’s culture of integrity has failed, the FDA has weighed in and issued the company a warning letter for failing to take these problems seriously. J&J has two weeks to respond back to the FDA.

Pharma’s Response to Haiti

2010-01-17T12:40:00.000-08:00

Like most of the world, at Pharm Aid we’ve been watching the aftermath of the earthquake in Haiti. Pharm Aid has done its part in donating to the American Red Cross and Doctor’s Without Borders (both groups are on the ground in Haiti providing assistance).

But I was curious how some of the pharma companies had responded:

Amgen has donated $2 million. Merck provided an immediate donation of $350,000 in cash, plus another $200,000 in products. Eli Lilly is donating $250,000, plus another $250,000 from employees. Bristol-Myers Squibb has donated $200,000. AstraZeneca has donated $160,000.

GlaxoSmithKline (GSK), Pfizer and Abbott are providing in-kind donations of medicines, although they have not quantified those donations.

Johnson & Johnson, which sued the American Red Cross in 2007 over its logo, has made some contributions to other groups, although they have not disclosed the amounts. However, it is perhaps unsurprising to see that Johnson & Johnson did not donate to the American Red Cross. I guess there’s still some bad blood there. With the tragedy in Haiti, J&J could have worked with the American Red Cross to put that unfortunate period behind them – an opportunity squandered.

Be a Flu Fighter

2010-01-17T10:28:00.000-08:00

In the too-weird-to-be-fiction, the Department of Health and Human Services is stepping into high gear by launching a Facebook application called “I’m a Flu Fighter.” The theory is that you’re supposed to tell your friends that you are taking steps to reduce influenza transmission and getting vaccinated. That’s after you’ve picked a cool avatar for yourself.

Given HHS Secretary Kathleen Sebelius complete incompetence when it came to handling the H1N1 outbreak, I guess we can see how she’s been spending her time – Facebook. In typical Sebelius-style, she’s doing a terrific job! As of my writing this, HHS has managed to secure 80 fans. Wow! Really impressive work! One has to wonder how much money HHS spent to get the word out to those 80 people.

In the HHS press release, Secretary Sebelius says: "Friends, family and neighbors can make the difference in whether or not someone gets vaccinated against the flu. Social media has been an important tool to communicate with young people and all Americans about the importance of getting the H1N1 Flu vaccine throughout our vaccination program. This new Facebook application will help friends encourage each other to get the H1N1 flu vaccine."

You know, she’s right. However, social media is something you do AFTER you’ve mastered the basics (like a comprehensive plan for fighting flu and distributing vaccine to Americans in priority groups). So, instead of actually being a Flu Fighter, HHS Secretary Sebelius decided that she was going to pick an avatar for herself and pretend to be a flu fighter. The time for Sebelius to get engaged was months ago – before her agency completely bungled the handling of the H1N1 vaccine distribution.

HHS likes to point to the fact that 1 in 5 Americans received the H1N1 vaccine (that’s 20%) – and the majority of those received the vaccine too late. This is hardly a success story. Here’s the reality of Sebelius’ handling of H1N1: 55 million people contracted the disease with 246,000 requiring prolonged hospitalization and 11,160 dying of the disease. I hate to be critical here, but this is an absolute public health embarrassment. The Government, under Sebelius' leadership, did far too little, far too late.

America needs an HHS Secretary that can do more than play house. Perhaps she could try something novel – actually being the Secretary of HHS. I know I’m asking a lot of her, but I think Americans deserve more than the Scarecrow Governor from Kansas who goes to Washington.

Skyrocketing Prescription Prices?

2010-01-11T16:53:00.000-08:00

The General Account Office issued a report with sensational headlines announcing “extraordinary price increases” for pharmaceuticals. Like most of the government pricing reports, the GAO looked at brand name drugs and ignored actual utilization, including the fact that many of those drugs have generic competition. The report looked back nearly a decade and found major price increases – particularly on new drugs just coming to market. Kudos to the GAO for studying the obvious and driving to meaningless conclusions.

Rather than looking at brand name only drugs, it’s important to look at the drugs in the context of how they’re actually prescribed. This would include looking at how over 60% of the drugs dispensed in the U.S. are generics – at a significantly lower price point.

Sadly, government reports love to pick on the drug industry, but don’t look at other aspects of the healthcare system. If drug prices are going up so alarmingly, then why is the percentage of pharmaceuticals still only 10% of the overall healthcare expense? If drug prices are skyrocketing, then the same must also be true of physician fees, lab tests, malpractice insurance and everything else that makes up the healthcare industry. You can’t change the numerator and keep the denominator constant and still end up with the same percentage.

In fairness, the GAO did fess up that most of the products they studied cost less than $25 per unit. The GAO also acknowledged that in more than half of the cases they looked at, the price increases were not drug companies charging more, instead, it was distributors increasing prices.

What is clear from this report and the way the conclusions were framed, is that the results were completely political.

Government Says Healthcare Reform Will Cost More

2010-01-09T19:09:00.000-08:00

A new report issued by the Obama Administration casts doubt on the Administration’s own claims. The new report from the Centers for Medicare & Medicaid Services (CMS) says that the health reform bill working its way through Congress will cost Americans more than the Government is claiming and millions of Americans will lose their employer coverage.

Worst of all, the healthcare reform bill currently pending in Congress would force many physicians, particularly those in rural areas, out of business entirely, or force them to stop seeing patients with Medicare. So, while more Americans will be “covered,” they will find it incredibly difficult to find a doctor that is going to accept them. This really shouldn’t be a news flash to anyone. Those of us old enough to Medicare have been experiencing this problem for many years as our physicians have decided they will no longer accept the Government-run insurance plan.

Instead of looking ways to truly reform healthcare (and tackle the real problems of medical malpractice and tort reform), we’re on the verge of enacting meaningless “healthcare reform” that will increase profits for trial lawyers, provide more Americans with coverage they can’t actually use and saddle future generations with trillions of dollars in debt.

FDA Approves RA Drug

2010-01-09T13:20:00.000-08:00

More than a year after asking for additional data, the FDA approved Actemra for the treatment of moderate-to-severe rheumatoid arthritis. Actemra is the great hope in Roche’s portfolio and a major driver in Roche’s total acquisition of Genentech.

Roche has every reason to be optimistic. Actemra enters an already crowded market with Johnson & Johnson’s Remicade and Abbott’s Humira have been firmly entrenched for many years and inhibit tumor necrosis favor (TNF). In 2009, J&J received approval Simponi, which is also a TNF inhibitor. However, Actemra, which uses a different mechanism of action and targets IL-6, is approved to treat patients that have failed these existing therapies.

Watch for Actemra to achieve blockbuster status.

2009 FDA Drug Approvals

2010-01-06T17:15:00.001-08:00

The results are out and pharmaceutical innovation inched up in 2009. The FDA approved 26 compounds, including 7 biotech therapies. This was up from 25 drugs, and 4 biotech therapies in 2008.

Much has been made in the popular press about the innovation draught. But there is clearly a backlog of compounds awaiting review at review at the FDA (nobody knows this more painfully than the generic drug manufacturers). At the FDA, it’s gotten to the point that PDUFA now stands for Particularly Dreadful, Under-Funded Agency. Off the top of my head, I can’t think of a single drug in 2009 where the agency met the PDUFA deadline. I’m sure there’s a positive example somewhere, I can’t think of it.

Reference: Fierce Biotech

Security of Patient Privacy

2010-01-06T14:08:00.000-08:00

This is interesting. The U.S. Department of Health and Human Services is looking for a contractor to test privacy rule under the Health Information Portability and Accountability Act (HIPAA). More specifically, the contractor will be tasked to look at de-identified patient data sets and determine if re-identification is possible.

Re-identification has not only been theorized by patient privacy advocates, but they remain convinced that it routinely happens in grassy knoll-inspired conspiracy theories. Deborah Peel and the folks over at the Patient Privacy Rights group have long used scare tactics to convince Americans that access to all of their health records was almost as easy as looking them up in a phone book. The privacy community loves to use use analogies that de-identified data is a “house built on shifting sand,” “a levee about break,” or even the 9/11 inspired “jetliner heading straight at the building you’re in” - all brilliantly vivid and totally designed to scare ignorant people.

Health systems, information brokers (such as IMS Health or SDI Health) and even the federal government all maintain de-identified information sources for health research purposes. The data is maintained as de-identified. In fact, there’s no incentive to re-identify – the research interest in is in trends over time, not what I had for breakfast (Yoplait blueberry yogurt and oatmeal – at my age, I need all the fiber I can get).

I’ve long said, the real issue here isn’t patient privacy at all. It’s money. The head of a patient privacy rights organization sat on an advisory board to a company developing personal health records. All was well, until large financial “donations” were demanded. In other words, the company was being told, we’ll come out against you unless you give us money. Back in my day, we called that a shakedown. Such is the real issue with these patient privacy rights groups. There’s an organization that issues a report card on the privacy of personal health record vendors that, you guessed it, matches up nicely to donors who contribute money (fair disclosure: this organization refuses to update their financial disclosures since 2007 – my guess is they are hiding something).

I wish HHS luck in their quest. Frankly, I look for anything that falls under HHS Secretary Kathleen Sebelius to sink like the Titantic. However, maybe she’s learned her lesson. Good luck to whoever HHS taps for this Don Quixote mission.

Ref: Washington Technology

2009 Year in Review; A Look at 2010

2009-12-30T19:34:00.000-08:00

Every year, I compile my top stories of the year and offer some predictions on where I think we're going. Last year, I set off a storm as I waded into preemption and in 2007 I called the growing focus on "sunshine laws" - those troubling relationships between doctors.

So, what happened in 2009 and what does it hold for 2010?

The War on Patients
The battle for and against healthcare screening has become nothing short of a war on patient's health. 2009 saw rationing, restrictions and "guidelines" designed to restrict access and increase the mortality of disease across a range of disease: colorectal cancer (CMS torpedoed virtual colonoscopies), breast cancer screenings in which women were cautioned to be screened much less frequently and allow their tumors to progress (courtesy of the USPSTF), the ongoing battle for healthcare parity for XY humans (recommendations against PSA prostate cancer screening for me) and recommendations screening for cervical cancer. Given the government's desire to claim victory in healthcare reform (while not enacting any actual major reforms), I'd look for the war on patients to escalate significantly in 2010 - and move beyond cancers into other diseases.

Hype and Hesitation over H1N1
H1N1. Swine flu. Words barely in anyone's vocabulary at the beginning of the year have become completely mainstream thanks to media hype and sensationalism not seen since Monica's blue dress. But within the hype was the real story - a near complete meltdown within the CDC to manage the outbreak. The CDC received top marks for public education and ongoing communications; however, the agency completely bungled the H1N1 vaccine distribution. Even now, in some states (Pennsylvania) the vaccine is almost completely unavailable even for high-risk groups.

Drug Resistance
In 2009, it seems like nearly every disease was becoming resistant to the drugs used to treat it. It was reported that H1N1 was resistant to Tamiflu and the regular flu was showing some resistance. In Africa, a new and highly dangerous strain of HIV emerged that is resistant to just about everything - even in cocktail form (prediction for 2010: just wait for this to start hitting major cities in the Western world). And antibiotic resistance for MRSA and other pathogens reached record levels.

(Lack of) Real Healthcare Reform
With all of the real stories in healthcare out there, the gorilla in the room is still the (lack of) real healthcare reform. Sure, Congress will push through a deficit-exploding multi-trillion package to expand access for the uninsured, raise taxes on the insured and restrict care for everyone. But this isn't healthcare REFORM. It's political gift wrapping - handouts to trial lawyers and others who bankrolled Obama's victory. Real healthcare reform takes time (not months) and incredible political will to tackle tough issues (that seems to be lacking in the Harry Reid Healthcare Reform Legislation). Instead of looking at how we could truly change the system, we got a potential bill that looks to prop-up inefficiencies will exploding costs. Sure, it will win politicians (both Democrats and Republicans) cheap points from their respective camps, but it won't do anything to actually fix the system. In 2010, I'd look for Harry Reid's health finance reform to pass - and I'd look for the first cracks in the facade to start appearing by December 2010 as Americans find out the truth of what they really got handed.

Looking forward to next year, here are a few other things I'm looking at:

Provenge D-Day
May 1, 2010 - The PDUFA date for Dendreon's Provenge. This story has dragged out for years. I still don't think the FDA will own up and admit to the Agency's mistakes. Approval for Provenge should have happened years ago, but in the new environment of cost-cutting/care-rationing and the embarrassment to the FDA, I look for Provenge not to be approved.

Up in Smoke
Anti-smoking advocate Dr. Thomas Frieden seems to have completely backed off on smoking prevention since he got his political appointment from the Smoker in Chief Brack Obama. Under Dr. Frieden's leadership, we saw the first increase in smoking rates in decades. I'm looking for that trend to continue in 2010.

Medicare Fraud
Healthcare reform will have two clear winners: doctors and trial lawyers. Given the massive sums of money involved, I would look for Medicare Fraud to top $250 billion next year. That's right - a quarter of a trillion dollars in Fraud - fraud that CMS doesn't seem all that anxious in stopping and the White House would prefer to ignore. It would seem to me one way to help pay for real healthcare reform would be to aggressively tackle fraud, but the Obama administration sees it otherwise.

2009 was a wild year, but 2010 will be even wilder.

San Antonio Breast

2009-12-13T15:54:00.000-08:00

It’s been an interesting weekend at the annual San Antonio Breast Cancer Symposium sponsored by the American Association for Cancer Research. The weather has been pretty good this year, thankfully it is warmer than it is back home.

Of course, the USPSTF opposition to breast cancer screening is generating a lot of informal chatter among participants, which is to be expected. The breast cancer survivors, many of them diagnosed under the age of 50, are absolutely belligerent at the idea that government is playing politics with their health.

In San Antonio, there are two major stories that I’m following. In the first, Onyx Pharmaceuticals and Bayer’s Nexavar (sorafenib) was able to resensitize hormone-sensitive breast cancers and boost the treatment with aromatase inhibitors. Since Nexavar is approved for kidney and liver cancer, this opens a new avenue for Onyx to pursue and a large trial is in the works. The addition of Nexavar allowed the aromatase inhibitors (including, AstraZeneca’s Arimidex and Pfizer’s Aromasin) to continue working and shrink tumors.

The other story I’m following at San Antonio Breast – combining Genentech’s Herceptin and GlaxoSmithKline’s Tykerb, which extends survival in women by five months vs. women who received just Tykerb. This is in women with very advanced stage breast cancer, so the benefits in early-stage tumors are likely to be more pronounced.

Of course, the problem with these pharmacological therapies is the dependency on coverage and reimbursement. Is five months of survival worth the extra money? I’d say yes, but given the recent actions of the government in rationing breast cancer diagnosis and treatment options, I’m rather pessimistic.

Pharm Aid

Growing Problem of Prescription Drug Shortages

TEDMED 2011

Surgeon General Regina Benjamin’s Diet

TEDMED 2011

Warren Buffett Spanks J&J’s Management

The Link Between Pharma Data and Prescription Drug Abuse

J&J Recalls Topamax Epilepsy Drug

J&J Gets Fined for Bribery

Big Pharma’s Sexy Little Secret is Autism

J&J: Winning The Reputation Game

J&J’s Cypher Stents Are Defective

Johnson & Johnson’s Quality Catastrophe

J&J Reorganizes; More Recalls

A Closer Look at J&J’s Ethicon – More Recalls

J&J’s CEO Remains Defiant

J&J Slapped with Consent Decree

FDA Approves Human Genome Sciences Drug for Lupus

FDA Fingers Third J&J Plant for Systemic Abuses

HIPAA Breaches for Paper Records – Where is the Rage?

J&J Recalls Insulin Cartridges

J&J Gets Leadership Change

J&J Secretely Recalls Non-Sterile Sutures in Europe

J&J’s CEO Gets Whopping Bonus Despite Problems

And This Week’s J&J Friday Recall Is – Sudafed

Deborah Peel on the Eve of HIMSS

Another Week, Four More J&J Recalls

J&J’s Tampon Problem

J&J’s Phantom Tampon Recall

January Brings More J&J Recalls

J&J Ramps Up Lobbying Efforts in Face of Manufacturing Crisis

Medicare Wait Times

Top Pharma Stories of 2010

J&J Launches Nicorette in India

Reflections on Pharma Industry

Double Standards for BestSweet and J&J

J&J Marginalizes CEO William Weldon…Finally

My Personal Interest in J&J’s Woes

Pfizer Replaces Jeff Kindler as CEO

More Toxic Tylenol Recalls for J&J

J&J Conducts Silent Recall for Children’s Medicines

J&J Recalls Velcade

Pope Considers Condoms to Protect Abused Children

J&J Plans Advertising Campaign to Restore Faith

Fallout of the Mid-Term Elections for the Healthcare Industry

J&J Spokeswoman Hospitalized

Struggling Through Healthcare Reform

National Pharmaceutical Council Names Chief Science Officer

J&J Issues 13th Recall - More Contaminated Tylenol

A Quiet Friday for J&J

Pfizer Feels No Pain

Pfizer’s Stink Problem

Pharmaceutical Growth to Rebound in 2011

Deborah Peel and the Age of Bitterness

J&J’s Procrit Gets Recalled

J&J Sacks Executive; Second Phantom Recall Revealed

Johnson & Johnson Wrapping up Manufacturing Inquiry; Throws Party

FDA Finds Problems at Yet Another J&J Plant

Why the J&J Coverage?

J&J Misses Deadline for FDA Plant Fix Plant

Patients Sue J&J Over Fraud

J&J Announces Yet Another Recall

J&J’s MIA CEO Gets Another Congressional Summons

J&J Expands Recall; Employees Devastated

J&J to Congress – F’ Off

Allscripts Snatches Up Eclipsys

J&J tells Congress Where to Stick It

Amgen’s Prolia Scores Again

Checking in on Peter Rost

What’s Next for J&J?

No Wonder Doctors and the AMA are Scared of Pharmacy Clinics

Time to Fire Weldon?

Amgen’s Prolia Wins European Approval

The Case of the Phantom Recall

J&J Gets Congressional Hearing

The Rise and Fall of the Great Autism Fraud

J&J CEO Refuses to Testify Before Congress

J&J’s Drug Recall Checklist

When the Creed is Greed

J&J’s OTC Products Recalled (Again)