October 2009

I’d love to get my hands on the transcripts for this case.

Oct. 28 (Bloomberg) — A sales representative for Johnson & Johnson’s Janssen Pharmaceutica unit testified that he encouraged doctors to prescribe the antipsychotic drug Risperdal for unapproved uses.

Matthew D. Thompson, testifying today in a trial over claims by a former co-worker, said that in 2002 he pushed doctors to consider prescribing Risperdal in combination with other drugs, so-called augmentation therapy, even though government regulators hadn’t approved this use. Janssen’s training didn’t include any specific prohibitions against promoting the drug that way, he said.

“I’m not saying the company tried to hide it, but we didn’t think about augmentation in the realm of on-label or off- label at that time,” Thompson said. He said he was “probably” aware that promotion of such sales was illegal.

Source: J&J Salesman Says He Sold Drug for Unapproved Uses (Update3) – Bloomberg.com

More evidence that certain drugs can cause diabetes…

Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs.

The study, to be published Wednesday in The Journal of the American Medical Association, found that 257 young children and adolescents in New York City and on Long Island added 8 to 15 percent to their weight after taking the pills for less than 12 weeks.

Source: Rapid Weight Gain Linked to Antipsychotic Drugs – NYTimes.com


I’m not a fan of sealing verdicts, but I understand why the judge did so:

Oct. 27 (Bloomberg) — A Pfizer Inc. unit must pay an undisclosed amount of punitive damages to an Illinois woman who developed breast cancer after taking one of the drugmaker’s menopause treatments, a Philadelphia jury said yesterday.

Jurors deliberated 25 minutes before finding Pfizer’s Wyeth subsidiary was responsible for paying an award to Connie Barton. The specific amount of the award was sealed by the trial judge immediately after it was returned.

Source: Pfizer Unit’s Prempro Punitive Damages Verdict Remains Secret – Bloomberg.com

There’s another Prempro trial in the same courthouse, and the judge is worried that the jurors in that case might be swayed.  I don’t think they’d be swayed as to liability, but if they hear another dollar figure for punitive damages, it will anchor their deliberations and they’ll use that as a baseline.

The FDA will often approve a drug on the condition that its maker perform a study after the drug is on the market.  The trouble is that many pharmaceuticals ignore their obligation to run those studies:

In a report released Monday, the Government Accountability Office said that from 1992 through Nov. 20, 2008, the food and drug agency asked drug makers to complete 144 studies associated with 90 drug applications, and that drug makers had completed just two-thirds of the requested studies. Fifteen of the 52 uncompleted studies have been pending for more than five years, and several have been pending for more than eight years, the report said.

Source: Industry Years Behind on Testing Approved Drugs – NYTimes.com

How about a system of modest fines? Say, $1,000 per day after a study is say, three months late.  Some of those studies have been pending for more than eight years.  That would work out to a fine of around $3 million dollars.  In the scheme of things, it’s not a very large fine for a pharmaceutical company to pay, but (a) they would add up, and (b) the FDA could use the funds.

Please give me one good reason why it should take years for the FDA to ban researchers who commit fraud.

WASHINGTON — Delfina Hernandez helped to carry out one of the most audacious drug research frauds in American history, but because federal drug regulators sent a legal notice years late and to the wrong address, she can legally continue to conduct research.

Ms. Hernandez was a study coordinator at the Southern California Research Institute, a drug testing operation in Whittier, Calif., that federal agents raided in 1997. The institute, which was led by Dr. Robert Fiddes, helped conduct more than 170 drug studies for nearly every major drug maker in the world and routinely falsified data and patient records while doing so.

Source: Agency Finds F.D.A. Can Take Years to Ban Researchers for Fraud – NYTimes.com

Sounds like a group of well-informed students:

You’ve seen on television the shouting and angry protesting at town hall meetings across America. Most, if not all, are about the proposed healthcare reforms that are being considered in Congress.

At the University of North Carolina, the issue is a hot topic, too. And the students concerned about a particular part of the changes—one that they say will raise the costs of generic drugs—are making sure their voices are heard, the Daily Tar Heel reports. Similar demonstrations have been held at Duke University and North Carolina State University, and the report says the protests are part of a larger nationwide movement to get the attention of lawmakers.

Source: North Carolina Students Worried About the Cost of Some Healthcare Reforms – The Paper Trail (usnews.com)

It’s worth noting that many pharmaceutical companies routinely argue that lawsuits keep drugs off the market, when in fact they do everything in their power to keep generic drugs off the market. 

From the FDA:

Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.

Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.

More at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187791.htm

I just generically refer to “Mylan” when I mean any one of several Mylan companies.  The best information I’ve seen so far about which Mylan is which comes from their own in-house litigation counsel, Brian Cutherbertson.  He filed a three page affidavit on August 13th of 2009 in the case of Boles v. Mylan.  In it, he details the corporate makeup of Mylan:

5. There is no entity presently operating under the name Mylan Laboratories, Inc. In October, 2007, Mylan Laboratories Inc. officially changed its name to Mylan Inc. ("Mr').

6. MI is a holding company incorporated under the laws of the Commonwealth of Pennsylvania, with its principal place of business at 1500 Corporate Drive, Canonsburg, PA 15317.

7. MI is a shareholder of companies involved in the production of quality generic and specialty pharmaceutical products.

8. MTI is a wholly owned subsidiary of MI and is a corporation organized and existing under the laws of the State of West Virginia with its principal place of business in St. Albans, Vermont.

9. On January 28,2005,M TI received approval from the federal Food and Drug Administration (" FDA") for the manufacture of the Mylan Fentanyl Transdermal System ("MFTS''). A true and correct copy of the FDA approval letter issued on January 28,2005, is attached to this Affidavit as Exhibit No. 1.

10. Pursuant to an Abbreviated New Drug Application submitted by MTI, FDA issued approval for MTI's manufacture of the MFTS concluding that the product was safe and effective when used in accordance with its approved labeling.

11. Since obtaining FDA approval on January 28, 2005, MTI has manufactured the MFTS at its production facilities in St. Albans, Vermont. Distribution of the MFTS is handled through MPI, another wholly owned subsidiary of MI. MPI is a West Virginia corporation with its principal place of business in Morgantown, West Virginia.

12. I understand that the Original Petition filed on behalf of plaintiff in this matter claims that Ms. Vail died on July 12, 2006, allegedly as a result of complications stemming from her use of the MFTS.

13. The MFTS was, at all times, developed, formulated, and manufactured by MTI. Since FDA approval of the product, MPI has been the entity responsible for the distribution and sale of the MFTS.

14. The Original Petition alleges, at paragraph 2.8, that MI, MTI, MPI, Mylan Bertek Pharmaceuticals, Inc. ("MBP"), and VDL Laboratories, Inc., are collectively " engaged in [the] business of designing, manufacturing, marketing, distributing, selling, and otherwise placing into the stream of commerce the [MFTS]." This allegation is incorrect.

15. MBP is a registered Texas corporation that is a wholly owned subsidiary of MI. However, MBP ceased all operations in June of 2005.

16. Thus, while MBP exists as a registered Texas corporation, it has no offices, employees, manufacturing facilities, warehouse, or sales staff in Texas or elsewhere. Moreover, MBP was never involved in any aspect of the design, manufacture, marketing, distribution, or sale of the MFTS.

17. Because the operations of MBP ceased in 2005, this entity absolutely was not involved in the development, manufacture, distribution, or sale of the pharmaceutical product allegedly used by Plaintiff's Decedent in 2006.

18. The final entity named in the Original Petition is VDL Laboratories, Inc. VDL Laboratories Inc. is an Illinois corporation with its principal place of business in the State of Illinois. Like MTI, UDL Laboratories, Inc. had no role or involvement in any aspect of the design, manufacture, marketing, distribution, sale, or supply of the MFTS.

If there are any typos in the above, blame my OCR software, not Mr. Cuthbertson.

Hopefully this document will help plaintiffs’ attorneys figure out which corporate entity to sue in a fentanyl lawsuit.

You tell me if this sounds competitive: Major pharmaceutical company develops new drug.  Minor pharmaceutical company wants to bring generic version on the market at a much lower price.  Major pharmaceutical company pays minor pharmaceutical company not to release the drug.  In the eyes of some pharmaceutical industries, and some Republicans, that is a competitive situation.  In the eyes of the rest of the world, it’s an unethical way for major pharmaceuticals to keep customers from having access to generic drugs.  Thankfully, we’re one step closer to those practices coming to an end.

WASHINGTON (Dow Jones)–A U.S. Senate panel on Thursday passed a bill that makes it difficult for drug companies to enter into deals that critics say delay cheaper, generic drugs from reaching the market.

The bill, which passed 12-7 mostly along party lines, would allow makers of brand-name and generic pharmaceutical drugs to enter into agreements only if they can prove such deals promote competition. It's unclear how companies would do that.

The legislation, introduced by Sen. Herb Kohl, D.Wis., has been pending in the Senate Judiciary Committee for over a month and has drawn the ire of pharmaceutical executives who say the deals do promote competition.

The legislation would presume such deals between makers of brand-name and generic drugs are illegal, a slight change from an original version of the bill that banned the agreements outright.

Source: UPDATE: Senate Panel Passes Bill Limiting Generic Drug Deals – WSJ.com

I was particularly interested in the fact that Jeff Sessions (a Republican who stridently argues to “reform” the civil justice system by making it harder for injured people to sue) was upset that this bill introduces a clear and convincing standard of evidence.  He would prefer the same standard of evidence that regular civil plaintiffs must use.  I wonder if he believes punitive damages should be proven by clear and convincing evidence?

I don’t always post FDA alerts, but when one involves possible fatalities, I do.

[Posted 10/16/2009] American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.

Source: Dexferrum (iron dextran injection) – Labeling Change