Sanofi's "Strategic Use" (ie, Bribery) of "Third Parties" (ie, Physicians) to Influence the FDA

In a report titled "Sanofi's Strategic Use of Third Parties to Influence the FDA," the Senate Finance Committee said Sanofi SA "contributed more than $5 million to two medical groups and a medical researcher that encouraged U.S. regulators to delay approval" of the generic version of Levenox, a bloodthinner that had global sales exceeding $4 billion in 2009.

According a WSJ article (see "Sanofi Pays Doctors to Dis Generic Version of Lovenox"), "between 2007 and 2010, the company contributed more than $2.6 million to the Society of Hospital Medicine; more than $2.3 million to the North American Thrombosis Foundation, which studies blood clots; and more than $260,000" to Dr. Victor Tapson, thrombosis specialist and faculty member in the Pulmonary, Allergy and Critical Care Medicine division of Duke Medicine (see "Duke medical researcher named in Senate report").

Dr. Tapson and the North American Thrombosis Foundation wrote letters to the FDA that claimed generic versions of the anti-clotting medication may not be as safe as the brand-name drug. Nowhere in these letters did Tapson or the Foundation disclose financial connection to Sanofi.

In an internal email, a Sanofi public-relations representative characterized the Society of Hospital Medicine letter as a "key accomplishment."

"If we were writing the FDA now," said Larry Wellikson, society's director, "we would be very clear about our relationship with any partner, including financial support."

DUH!

Dangerous Chemistry at Home and In Your Face! A Lesson from Pfizer Think Science Now Blog

I just received notice that the following @pfizer_news tweet was recently posted to the "News Direct from Drug Industry" forum of Pharma Marketing Network Forums (see here):

pfizer_news: Dangerous chemistry at home. Read TSN Member Adam Gilbert's blog on Ned trying to unclog a sink/shower drain: http://on.pfizer.com/iKb4dQ

I decided to click on the link, which brought me to "Dangerous Chemistry at Home, Part 3 – Unclogging that Drain" posted on the Pfizer Think Science Now Blog. It's pretty hilarious. It's the latest installment of a series titled “What Will Ned Do Next?” in which the author Adam Gilbert -- a Pfizer chemist -- examines how his neighbor will "potentially hurt himself through his naïve understanding of chemistry using common household products."

"The real fun begins when Ned decides to mix these chemicals in an effort to bust up a tough clog quickly.

1. First he pours Liquid Plmr into his clogged drain: NaOH and sodium hypochlorite (an oxidant)
2. After a period of time, he pours Runo at the clog: mostly HCl
3. Finally, he pours in Drano: NaOH, sodium nitrate (NaNO3), sodium chloride (NaCl) and aluminum"

The results had me ROTFLOL!

But within minutes my laughter was over when I received one of those spam e-mails from "Cholesterol " bringing me unsolicited information under the subject line "Unclog your arteries."

Coincidence?

I think not. It may be a coincidence that the Pfizer blog post was about "unclogging" drains and the spam e-mail subject line referred to "unclogging," but -- as I have pointed out before -- it's no coincidence that pharma companies (especially Pfizer) are responsible for these spam e-mails (see "Pfizer is Responsible for 18% of My Spam Email!").

When I click on the "READ MORE" link on the e-mail, I am sent to a Web site that looks like this:

The VERY FIRST link on this screen (High-Cholesterol-Rx-Treatment.com; the administrative contact for this domain is Pfizer Inc. (NYHQ); see WHOIS entry) leads to the LIPITOR drug site. LIPITOR, of course, is a Pfizer drug.

What About Other Instances of "Dangerous Chemistry?"
Although Adam Gilbert's post is about his neighbor "Ned" and dangerous mixing of household chemical products, a similar blog post could easily be written about "Marge" and her dangerous mixing of prescription and over-the-counter drugs! IMHO, Pfizer should blog about that, so that their patients better understand that the chemistry of drugs can be dangerous also! The title of THAT blog post could be "Dangerous Chemistry in Your Face -- Unclogging That Artery."

FDA, DOJ, & Google: Conspiracy Theory, Part 2

Last week, I suggested that the FDA’s infamous 14 warning letters sent to major pharma companies regarding violative search engine ads may have been a "shot across Googles bow," intended to force Google to halt its acceptance of ads from "illegal" online pharmacies (see "How FDA, in Cahoots with DOJ, Brought Google Down").

Many people did not take my "conspiracy theory" seriously. Some pooh-poohed my suggestion that the FDA was involved. One commenter to my blog said "OMG... what a stretch...I'm sure they are laughing at you at FDA."

It turns out that the FDA WAS INVOLVED in the criminal investigation of Google by the Department of Justice (DOJ).

Today, the Wall Street Journal reports that "as part of the criminal investigation, undercover agents for the Food and Drug Administration contacted Google posing as representatives from rogue Internet pharmacies" (my emphasis; see "Google Was Warned Repeatedly About Illegal Drug Ads").

Even if the FDA was involved, my "conspiracy theory" would not hold water UNLESS the investigation of Google preceded the issuance of FDA's warning letters at the end of March, 2009.

In my previous post, I couldn't cite specific evidence that the investigation went back prior to 2009, but now the WSj article confirms this to be true.

The period 2008-2009 saw a lot of activity related to this investigation, according to documents reviewed by the WSJ. Here are some key actions during that period reported by the WSJ:

"In July 2008, the National Center on Addiction and Substance Abuse at Columbia University (CASA) wrote to Eric Schmidt, then Google's chief executive, saying it found 'prominent displays of ads for rogue Internet pharmacies' in a Google search for controlled drugs."

In December, 2008, the National Association of Boards of Pharmacy, or NABP, a group representing state regulators in the U.S. and Canada, wrote letters to Google "warning about advertising from online drug outlets that weren't verified by a NABP screening program. The organization was 'deeply concerned that these rogue Internet sites could be a front for criminals seeking to introduce adulterated medications, counterfeit drugs, or worse, to the American market,' wrote Mary Dickson, the NABP's associate executive director. The NABP says Google didn't respond."

Google DIDN'T RESPOND?! That suggests it needed convincing. What better way to get google to respond than by sending out 14 warning letters to its BEST clients, effectively shutting down Google's legitimate drug ad revenue? (read more about this in my previous post).

"'On the basis of our analysis, I think they were turning a blind-eye,' said Bryan Liang, a California Western School of Law professor who published a 2009 report that found Google and others were profiting from online ads paid for by illegal drug sellers. 'They were making a lot of money on this.'"

"In 2009, LegitScript LLC, which monitors online drug sellers, published reports alleging that 80% and 90% of Yahoo and Microsoft's respective online drug advertisers were breaking the law."

"John Horton, who runs LegitScript, said his company also conducted in 2009 an unpublished review of Google's ads and found the same level of problems. LegitScript is now employed by Google to help identify problem sites, he said."

"PharmacyChecker [the third-party company that Google hired to verify that online pharmacy advertisers were legal] said it received a subpoena from the FDA in 2009 to produce all its communications with Google regarding pharmacy verification policies."

It is clear that the FDA and DOJ were investigating Google long before the FDA sent those March, 2009, letters.

Some of the reports and activities described above happened AFTER FDA sent the letters  (eg, the LegitScript report was published in August, 2009; see here). No doubt these reports were published due to the light the FDA letters shone on Google's drug ad policies. IMHO, the letters not only impacted Google's revenue, they also elicited further data from third-parties to bolster the DOJ's case against Google.

The End is Nigh! Judgment Day For Low Cost Generic Meds

Some people think "Judgment Day" will come tomorrow, May 21, 2011, at 2 a.m. Eastern Daylight Time at which time will begin the "rapture" where "all the graves will be opened and all of the dead bodies will come out" and only the true believers will be saved.

I don't believe in that particular fantasy, but I do believe the end is near for so-called low cost generic drugs.

Several recent signs suggest that the stars are aligned against low cost generic drugs. Here's my summary of these signs.

For quite some time we've heard about "Big Pharma’s Record Drug Shortages" (see "The nation is facing an unprecedented drug shortage" and "What’s Behind Big Pharma’s Record Drug Shortages?"). Shortages might be caused by "too many mergers and acquisitions" that have reduced the number of suppliers.

Those stories put the blame on "Big Pharma," by which they mean brand name drug manufacturers. However, lost in the copy is the FACT that "almost all the shortages are generic drugs."

The second sign was reported by Jim Edwards over at bnet in his post "4 Pharma CEOs Admit They Jack Up Drug Prices for the Hell of It."

Edwards quotes David Snow, chief executive officer at Medco Health Solutions: “As their branded drugs approach the patent cliff, there has always been the tendency to see increased pricing toward the end, just to get the last dollar out of every drug before they lose brand protection."

Yet an NPR article titled "Big Pharma's Golden Age Leads To Generics Windfall" suggests the "wave" of drugs going generic "can save consumers plenty of dough."

That would be true if generic drug companies as well as brand drug companies were not jacking up prices "for the hell of it." Actually, prices are jacked up because there is a shortage, which can be artificially produced if there is a drug industry consolidation, which there seems to be in both the generic and brand name industries.

I've heard that the price of generics has NEVER been as low as some people believe even in times where there were no shortages. Actually, the prices of some generics can be as much as 80% of the equivalent brand name drug. Why is that? I mean generic drug companies have practically NO marketing budgets, which have been blamed for high brand name drug prices by pharma critics. You'd think that without the marketing and associated overhead expenses, generic drugs would be dirt cheap!

The fact is, "three-quarters of prescriptions these days are filled with a generic," points out NPR. "And the proportion keeps climbing." That means that generic drug companies have almost "cornered the market" (for small molecule drugs) and can charge what that market will bear (in the U.S., that is, where there are no price controls).

And soon the generic drug industry will "corner" the biologic drug market as well.

"Should the market develop according to plan," notes a WSJ article, "copies of these complex drugs [biologics] alone could make up around 50% of the expected $10 billion biosimilars market by 2016, according to data compiled by Capgemini Consulting" (see "Generics Companies Weigh In on Biological Drugs").

As biologics vie for the market to replace small-molecule pills, the situation will even be worse. As a commenter to the NPR article stated "Makers of brand-name biologics are spending big money to delay biosimilars coming onto the market, so even tho biologics like Enbrel, that goes off patent next year -- without the availability of a “biosimilar" – the cost of Enbrel will still be $1,500 a month."

The generics rapture is upon us! Save yourself!

FDA Targets Genetic Testing Services for Advertising Unapproved "Medical Devices"

FDA recently  (May 11, 2011) sent letters to two DNA testing services concerning their Direct to Consumer (DTC) advertising. The companies are Precision Quality DNA (see letter here) and Lumigenix Inc (see letter here).

Precision Quality DNA, offers a service intended to help individuals "understand the analysis of their DNA sequence while focusing on main target genes, such as BRCA1/BRCA2, to determine that individual’s main risk factors or likely response to a particular drug." FDA claims that the service "appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act."

Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:

“... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals ... [or] intended to affect the structure or any function of the body of man or other animals.”

FDA looked high and low in its files and "ha[s] been unable to identify any Food and Drug Administration (FDA) clearance or approval number for the Precision Quality DNA. We request that you provide us with the FDA clearance or approval number for the Precision Quality DNA . If you do not believe that you are required to obtain FDA clearance or approval for the Precision Quality DNA, please provide us with the basis for that determination."

Actually, Precision Quality DNA does NOT believe it requires FDA clearance and says so right on its website on a page titled "Health, Politics and Regulatory Issues" (see here). On that page, Andre Gous, Co-Founder of the company and addressee of FDA's letter, has some interesting things to say about the FDA and its authority to regulate software as a medical device, including:

"Even if you're in favor of government regulation, you're probably wondering how a 1976 FDA law could be applicable to DNA biotech -- an entire field of endeavor that was unknown to the legislature at that time. And, since that law focuses on devices, the FDA is (no surprise) also classifying more and more things, even things as ethereal as software, as a 'device.'

"If the FDA were simply deluded, that would have been bad enough already. However, the FDA didn't stop there. They mailed intimidating letters to the top 5 DNA biotech US companies, and since then they have mailed out 14 more such letters yet."

After that it's pretty much an Ayn Rand style rant; ie, government should just leave capitalists alone.

My guess is that Precision Quality DNA was not among the the "top 5 DNA biotech US companies" that previously received letters from the FDA. To paraphrase it's marketing tag line, Precision Quality DNA "Dodged the Bullet with its Name on it" from the FDA in the past, but now has to deal with that bullet. It will be interesting to see who prevails, the bullet or the target.

How FDA, in Cahoots with DOJ, Brought Google Down

FDA’s Infamous 14 Warning Letters were a Ploy to Force Google into a $500M DOJ Settlement Regarding Illegal Online Pharmacy Ads

“…something is happening here and you don't know what it is, do you, Mr. Jones?”

That’s how I’m feeling today as I try to understand what’s really behind the news about Google’s advertising policies, online pharmacies, and FDA’s 2009 warning letters to major pharmaceutical companies. If my thinking is correct, drug industry search engine ads were “collateral damage” in a war between Google and the FDA.

Yesterday, the Wall Street Journal reported that Google is “close to settling a U.S. criminal investigation into allegations it made hundreds of millions of dollars by accepting ads from online pharmacies that break U.S. laws” (see “Google Accepted Ads from Illegal Online Drug Stores”).

Not so coincidentally, a few days ago, Google disclosed that it was setting aside $500 million to potentially resolve a case with the Justice Department (DOJ) that involved "the use of Google advertising by certain advertisers."

“The investigation has examined whether Google knowingly accepted ads from online pharmacies, based in Canada and elsewhere, that violated U.S. laws,” said the WSJ article.

The FDA has long struggled to rein in American’s penchant for buying drugs from online Canadian pharmacies and this investigation of Google by DOJ is likely part of that effort. But, as I surmise below, caught up in the case may have been legitimate major pharmaceutical companies as well.

Consider FDA’s infamous 14 warning letters that the agency mysteriously sent in a single day in March, 2009, to major pharmaceutical companies about Google Rx Adwords, saying the ads were misleading because they didn't include risk information (see “FDA Warns Drug Firms Over Internet Ads”).

Could that have been a “ploy” to bring Google to its knees and cave in regarding online pharmacy ads?

In other words, the FDA’s warning letters may have been a “shot across Google’s bow,” intended to force Google to halt its acceptance of ads from “illegal” online pharmacies. FDA could have been saying, “What’s more important to you? Ads from online pharmacies or ads from major pharmaceutical companies?”

FDA’s actions were a strong incentive because "sponsored link exposures to U.S. Internet users declined more than 50 percent immediately after ... FDA warning letters were issued to pharmaceutical manufacturers," according to a comScore study (see “FDA Letters Caused a Prompt, Precipitous, & Prolonged Drop in Pharma Paid Search Engine Advertising”).

It’s likely that this case goes way back because in September 2010, Google disclosed that it had filed a lawsuit against “advertisers we believe have deliberately broken our rules,” in particular involving “rogue online pharmacies” that “illegally sell drugs on the Web” (see “Google’s $500M Charge Related To Pharma Advertising Probe”).

In June 2010, I reported that Google launched a NEW Rx drug ad format that includes everything FDA requires that a drug company include in its direct-to-consumer advertising: fair balance, and direct links to side effects, precautions, dietary information, etc. (see “Finally, A Google Drug Search Ad Format That Has All FDA Could Want... But Pharma Can't Use It!”). The “ads” are really more like public service announcements. They come from National Institutes of Health (NIH) and compete with paid ads from pharmaceutical companies who cannot use the new format (see “Google's New OneBox Rx ‘Ads’ Steal Clicks from Organic Branded Rx Search Results”).

To compensate for that deficiency, Google also has come up with a new ad format for the industry (see “Is Google the New FDA?”).

All of these actions by Google could be designed to appease FDA and DOJ and regain the drug industry’s ad revenue lost as a result of FDA’s warning letters way back in 2009.

You have many contacts among the regulators
to get you facts when someone attacks your advertising
but nobody has any respect, anyway they already expect
you to all give a check to FDA and other organizations
Ah you've been with the professors and they've all liked your looks
With great lawyers you have discussed clicks and sidewikis
You've been through all of Ayn Rand’s books
You're very well read, it's well known
But something is happening here and you don't know what it is
do you, Mr. Pharma?

FDA's BadAd Program Lacks Credible Evidence

FDA's BadAd Program is "BadAss" Lately! What a difference a couple of weeks makes!

On April 25 I posted this: "FDA's Bad Ad Program is 'Phoniest Thing Ever!'," which documented that after one year, the FDA's BadAd program only resulted in one warning letter.

In the last few of days, however, the FDA has issued TWO warning letters that resulted from complaints received via the BadAd program. One (here) was dated 4/28/2011 and sent to Forest Laboratories, Inc. In that letter the FDA cited a sales representative’s statements as false or misleading because they promoted "unapproved uses for Savella, [made] unsubstantiated superiority and mechanism of action claims about the drug, and [minimized] the serious risks associated with Savella."

The other letter, dated 5/5/2011, was sent to Warner Chilcott (US) because of a video that a sales rep posted on YouTube, which was a pretty stupid thing to do. You can read about that on Phamalot.

Why the sudden increase in BadAd-inspired warning letters? Could it be that the FDA's recent webinar was effective in getting physicians to rat out pharma sales reps?

Even if the webinar was successful in generating more complaints, the FDA does not work THAT fast. In fact, the first letter I mentioned resulted from a compliant the FDA received ABOUT 8 MONTHS AGO on September 10, 2010!

Not only that, but the complaint was about ORAL statements made by a Forest sales representative on May 12, 2010, which is nearly a year ago! "On Wednesday, May 12, 2010, at approximately 1:15 p.m., a sales representative from Forest made an unsolicited sales call to a physician at his office," said FDA in the letter. Sounds like charges made by a prosecutor at a criminal trial!

Playing the role of defense lawyer, let me point out problems I have with the timeline.

First, why did the physician wait until September 10, 2010, to submit a complaint about something that happened 4 months previously? Did he/she just learn of the BadAd program in September? If so, then the only evidence the FDA has to support the complaint is the physician's affidavit that the complaint is true. THAT'S HEARSAY EVIDENCE!

Suppose the physician RECORDED the conversation with the rep? If he/she did that, then the motive must have been to make a complaint to the FDA. But why sit on it for 4 months? WE SHOULD INVESTIGATE THIS PHYSICIAN'S MOTIVES. Maybe we can discredit him/her on the stand.

But wait, there's no trial. And there's no credible evidence such as violative detail aids, brochures, etc., which the FDA usually refers to in warning letters regarding sales rep misconduct.

No wonder the FDA is not being very transparent about its BadAd program. We can get some interesting information just by reading the letters. Imagine what we can learn if more details about complaints were released.