FDA Panel Approves New Personalized Medicine for HIV

04/24/2007 10:07 PM |

Pfizer's New combo drug-diagnostic for HIV got through the FDA Adcomm... I still wonder what prompted the FDA to dump all the safety concerns ahead of the commitee meeting?

http://blogs.wsj.com/health/2007/04/24/pfizer-aids-drug-gets-fda-panel-support/  Read More & Comment...

Real Kryptonite Found: FDA Puts Black Box Warning on Related Products

04/24/2007 03:40 PM |

The FDA announced today that all supplements and products derived from kryptonite would have a black box warning. Dr. David Graham had pressured the agency after noting that the presence of kryptonite would pose a serious and life threatening danger to Superman, Supergirl and other survivors of the planet Krypton. Graham had been pushing Congress to expand it's drug safety program to move beyond "merely planetary surveillance activities" and into galactic exploration of pharmacovigilance matters. The FDA said in a press release " this pilot project is part of our effort to develop a global and indeed galactic risk management program." The agency had planned to establish this program in partnership with Luthor Industries and the Justice League of America but was attacked by members of Congress for being too "cozy" with special interests.  Read More & Comment...

First, do no harm ... to seniors

04/24/2007 01:46 PM |

When it comes to what this Congress is trying to do to the public health, we refuse to sit by and take a postion of, er, non-intereference.

Here's a new piece from today's edition of the Chicago Tribune:

http://www.chicagotribune.com/news/opinion/chi-0704230346apr24,0,7088012.story?coll=chi-newsopinioncommentary-hed

Hopefully some prominent Chicago officials (like Barack Obama and Rahm Emanuel) will see this and see the light. But we'll keep our expectations realistic and just hope they see it.  Read More & Comment...

New Study Finds Doctors Subconscious Altered By Drug Reps

04/24/2007 11:28 AM |

Again, I am not making this up.....

New breakthrough research demonstrates for the first time that spending 5 minutes with a drug rep alters the subconscious mind of doctors in subtle ways, causing them to prescribe drugs that no one really need or wants or even uses.

The survey of 116 visits to 97 doctors found that after a five minute "session" with a drug rep, doctors were 46 percent more likely to prescribe a drug or recommend it to their colleagues.

One of the author's of this groundbreaking study, Dr. Michael Steinman of the San Francisco Veteran's Affairs Hospital said: "The remarkable thing is how effective a very brief visit by a drug representative -- most often less than five minutes -- can be in influencing physicians' choices to use a drug for an unapproved indication,"

Besides free drug samples, salespeople often bring gifts, lunch for the doctor or office staff, new pens and coffee mugs. "The doctor feels subtly, even subconsciously, indebted to the representative," Steinman said.


The study appears in the April 24, 2007 issue of PLoS Medicine. Co-authors of the study were G. Michael Harper, MD, Mary-Margaret Chren, MD, and C. Seth Landefeld, MD, of SFVAMC and UCSF.

Steinman, Landefeld, and Chren served as unpaid expert witnesses for the plaintiff in the litigation from which the source data for the study was obtained.

What a surprise.

The study was supported by funds from the Veterans Health Administration, the National Institute on Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the John A. Hartford Foundation, and the California Tobacco-Related Disease Research Programs.

What is government money doing supporting such crap?  Read More & Comment...

FDA's Superior Attitude

04/23/2007 10:12 AM |

Download file

Here's a link to Steve Usdin's superior article on FDA's Arcoxia attitude:  Read More & Comment...

Abbott's About Face on AIDS Drug Pricing

04/23/2007 09:08 AM |

The Thai dictatorship clearly has Abbott in is sights. Working hand in glove with NGOs it clearly picked a fight over the price of its HIV drugs to distract attention over the suspension of civil liberties. It is disturbing to see Oxfam -- which boycotts Israel over so-called human rights abuses -- working with Thailand's military junta to demonize drug companies yet again and get away with it. But that is how the media and most of the world sees things. So ultimately Abbott had no choice but to cave, at least for now.

Long term, drug companies need to rethink their approach to emerging markets. Time and the wealth are on the side of innovation and property rights, not the thugs and NGOs who prop them up. They would do well to increase investment in global health policy, entrepreneurship in middle markets, and support partnerships with people interested in delivering new products throughout the world at market relevant prices.  Read More & Comment...

Disturbia: FDA's Sneak Attack on Maraviroc

04/23/2007 08:35 AM |

AP's Andrew Bridges reports today that

" Health officials repeated safety concerns about an experimental group of HIV drugs Friday, days before government advisers will recommend whether the first drug from the class merits approval.

Pfizer Inc. seeks Food and Drug Administration approval for maraviroc, potentially the first in a novel group of drugs to fight HIV, the virus that causes AIDS. Pfizer proposes marketing maraviroc as Celsentri.

Pfizer believes there is a clear unmet need for new drugs to fight HIV in patients for whom other, older drugs no longer work. Celsentri is unlike any other HIV medicines now on the market in that it targets the cells of patients and not the virus itself.

The FDA has scheduled a Tuesday meeting of outside experts to discuss Pfizer's application for approval. The FDA has asked the experts whether Celsentri, if approved, would require special labeling or if further study of the drug's safety is needed before it can be sold. FDA also asked whether the drug should be studied further in women and blacks."


Is this a strategic attempt to get the "bad news" out ahead of the Adcomm meeting or an effort to scuttle the drug in order to avoid looking bad? CCR5 inhibitors have been associated with an increased risk of liver damage and lymphoma but I don't know what that risk is relative to other drugs such as tylenol or other viruses left untreated. More worrisome perhaps: Maraviroc not only targets specific cells, but it will be marketed with a protein assay that will identify which patients that are high responders. Personalized medicine. Which means that the risk benefit profile will be higher still. I don't get this need for studying African Americans and women when you have a genetic test. Why not study Ashkenazic Jews still suffering from last night's Yankee game who live in New Jersey while your at it?

A first in class personalized medicine for a fatal disease and still the agency is screwing around with safety issues. Just how high does the bar have to be to get a drug approved?  Read More & Comment...

DTC -- Gone in 60 Seconds

04/23/2007 07:54 AM |

Lots of folks exercising their right to free speech over the issue of limiting free speech, aka: DTC advertising. The latest is the legislative attempt to give the FDA authority to ban advertising for the first two years after a drug is approved.

Here’s Senator Kennedy’s perspective:

"What we are looking at is the very rare circumstance. It would be used in the most limited kinds of circumstances, where the FDA … wants to give approval for a drug but is not sure and fears advertising will lead to massive use of the drugs.”

But FDA already negotiates such circumstances. That’s the key word, “negotiate.” And it’s not a finesse. Minus that word it’s … unconstitutional.

And there are many people, far less holy than Senator Kennedy, who see this as the first step towards banning pharmaceutical advertising altogether.

Consider what a Consumer Reports analyst said, "We don't know, and we won't know, how truly safe a drug is until it's been used in millions of people. The real testing of these drugs takes place after a pill hits the market, and that's why the advertising needs to be regulated."

Drugwonks does not believe that less information makes anything or anyone safter.

Make no mistake – this is a battle not only over the future role of the empowered health care consumer – but for the First Amendment.

Others are now saying, based on this new negative momentum, that DTC television ads will need to be more than one minute long to appropriately convey fair balance and adequate provision.

But it’s not a question of the time – it’s a question of the presentation. Can ads do a better job properly balancing risk and benefit? Most certainly. But it’s not necessarily a question of “more” as much as it is a question of “better.” And that means the FDA and industry (along with their advertising agencies) need better social science to determine how to best communicate such information to consumers.

Sounds like a good opening assignment for the agency’s new advisory committee on risk communications.

If we truly want to create a situation where our medicines are “safer” we must learn how to better communicate risk and benefit – not limit it.

Otherwise the empowered health care consumer might very well be gone in 60 seconds.  Read More & Comment...

Virginia Tech

04/20/2007 10:43 AM |

I agree with Bob Goldberg's recent post refering to the uses of anti-psychotics and how they might have helped control the Virginia Tech killer, if they were taken, a big IF.. I also believe that universities should be able to mandate ongoing psychiatric care for someone like this - "if you don't like it, then leave the university."
which is not the say that a treating psychiatrist would have been able to intervene in time. It is not for sure that the killer would have revealed his plan beforehand. But if he had, then the treating psychiatrist would have had an obligation to admit him for acute homicidal ideation. It is also obvious that a person like this, with such a known psych history, especially with violent ideation, should not be allowed to purchase guns, and certainly computers could be used to create such a useful databank that gun stores could adhere to.
There is another issue to address - one that I have written extensively about in my book False Alarm: the Truth About the Epidemic of Fear.
Namely that it is too easy to personalize what you see in the news, too easy to attach yourself voyeuristically to a crime like Columbine or this one and feel as if it is going to happen to you.
THis kind of fear is infectious, and the killer knew this, which was one of the reasons he may have chosed a Columbine-like model.
My friend Gary Baumgarten of Paltalk, formerly of CNN radio, has written about this fear factor today in his blog and cited my book.

http://www.paltalk.com/newstalk/msiegel_041907_archive.shtml#comments  Read More & Comment...

Does Stephanie Saul Oppose A Woman's Right To Choose?

04/20/2007 09:35 AM |

She writes about a new drug designed to reduce the number of times a woman menstruates as if this were something drug companies were trying to take away from women or make them ashamed of. Why can't women choose to take control of their bodies? And incredibly THIS gets front page coverage at the NYT but not the article about the benefits of antidepressants. In fact the NYT did not assign a staff reporter to that important story. Disgusting.


http://www.nytimes.com/2007/04/20/health/20period.html?_r=1&oref=slogin  Read More & Comment...

Krugman Calls Blacks and Latinos "Idiots"

04/20/2007 09:16 AM |

Why? Because they support Medicare advantage plans that give low income and chronically ill seniors more benefits at a cost with free drugs.... (Refer to Peter's post on Mark McClellan on how this happened..)

Krugman always writes like someone who finds it helpful to grind his axe on the necks of others. This piece is no different. Read all about it in his latest meltdown....

The Plot Against Medicare

"The plot against Social Security failed: President Bush's attempt to privatize the system crashed and burned when the public realized what he was up to. But the plot against Medicare is faring better: the stealth privatization embedded in the Medicare Modernization Act, which Congress literally passed in the dead of night back in 2003, is proceeding apace.

Worse yet, the forces behind privatization not only continue to have the G.O.P. in their pocket, but they have also been finding useful idiots within the newly powerful Democratic coalition. And it's not just politicians with an eye on campaign contributions. There's no nice way to say it: the NAACP and the League of United Latin American Citizens have become patsies for the insurance industry. "  Read More & Comment...

Competence Man vs. Confidence Man

04/20/2007 07:57 AM |

"Competence Man" as dubbed by Kim Strassel, is Mark McClellan (dubbed by Drugwonks as "the hardest working man in health care"). Here's what she had to say in today's Wall Street Journal:

Competence Man

By KIMBERLEY STRASSEL

Republicans won a big victory this week, shooting down a Democratic plan for more government-run health care. The GOP victors, and free-marketeers, might send their thank-you notes to Dr. Mark McClellan.

Dr. McClellan is the 43-year-old internist who, until recently, held the thankless job of running Medicare. He was handed the further thankless task of designing and implementing Congress's tepid 2003 Medicare reform. And he's the big brain who then wrung every last ounce out of that authority to create a striking new model for Medicare competition that is today not only performing beyond expectations, but is changing the political health-care debate.

High praise, yes, but borne out by this week's GOP defeat of a bill to allow the government to fix Medicare drug prices. That was a top Democratic promise this last election, as the party sought to play off public anger over health-care costs. Liberals saw it as an important step toward their all-government, health-care nirvana. Nancy Pelosi and Harry Reid also felt this was an issue on which they could once again roll Republicans, by flashing the impoverished-senior-citizens card.

Instead, Dr. McClellan's new model came online and wowed the older class. Private companies have flocked to offer a drug benefit, giving most seniors a choice of 50 innovative plans. The competitive jockeying has slashed prices from an expected $37-a-month premium to an average $22. The cost of Medicare Part D for taxpayers was 30% below expectations its first year -- unheard of in government. And Medicare Advantage, which allows seniors to choose between private insurers, has grown to encompass nearly one in five beneficiaries.

This success has rebutted Democratic criticisms of the drug benefit and shown up those who tar the Bush administration as incompetent. The program's success emboldened Republicans to vote for free-market health care this week. Democrats have seen flagging public support for their program of more government and fewer drugs. While Mr. Reid held his caucus together this week, some are worried about bashing a drug benefit that has an 80% senior approval rating. "Congress only wishes it had an 80% approval rating," chuckles former Democratic Sen. John Breaux, an author of the 2003 reform. "A lot of folks campaigned last year on 'We're going to fix this program,' only to be told by seniors, 'Wait a minute, it ain't broke.'"

None of this was inevitable, but goes back to the competent Dr. McClellan. President Bush came to town pushing Medicare reform, and had a shot at an historic overhaul. The GOP could offer the carrot of a new drug benefit, in return for opening the entire decrepit program to private competition. Instead, Bush and Co. became more interested in claiming credit for an $8 trillion entitlement, and settled for meager reform.

Dr. McClellan nonetheless took this pared-down opportunity and used it to show private competition can work. His success, in particular with the drug benefit, rests in two broad ideas. The first was to design a program that immediately attracted a critical mass of private players to provide price and choice competition. At the time, nobody thought that possible. Mr. Breaux remembers Congress worrying that so few private players would participate that whole areas of the country would lack private drug plans.

Dr. McClellan's solution was a program that gave companies maximum freedom to design plans, bundle drugs and turn a profit. He was a salesman, talking up the opportunities and even traveling to New York to reassure Wall Street. It worked, and by the first days of business most seniors were being courted by anywhere from 11 to 23 plan sponsors. Those numbers have only grown, creating so much competition that sponsors are eliminating deductibles, lowering premiums, offering more drugs. It's also led to smart cost-cutting and efficiencies; an estimated 60% of Medicare prescriptions are now for generics.

Dr. McClellan's other strategy -- and the flip side of the coin -- was to get seniors enrolled quickly. His team designed an Internet program that allowed seniors to punch in their information and examine the best plans. His agency reached out to local organizations -- church groups, community centers -- and enlisted their aid in explaining details. A call center at one point handled 400,000 plan questions a day. Today, some 90% of Medicare recipients are enrolled in the benefit, numbers that have further attracted private players, further spurred competition, further lowered prices. "This is how you come in under budget, increase satisfaction," says the man himself, Dr. McClellan. He adds, humbly, "Nobody should think this is perfect yet, but it's clearly accomplishing some good things."

Good things or no, the reforms are still at risk. There was a time when Democrats believed in Medicare reform, but now most prefer it as a political stick to beat President Bush. There are also liberals -- Henry Waxman, Pete Stark -- who understand this is a crucial moment in the national debate over government-versus-private health care, and will do what they can to sabotage the reforms.

Expect, therefore, more votes over Medicare's right to price-fix. If a broad bill can't pass, liberal politicians will instead target individual, high-cost drugs, arguing that since Medicare foots most of the bill for these products, it should have the right to "negotiate." The real goal will be to get any foot in the price-setting door, making it harder for private companies to craft flexible drug packages, and laying the groundwork for more price-setting down the road.

Expect, too, a push to starve the competitive programs of cash. Critics know how effective this is, having siphoned dollars out of the old Medicare Advantage program in the 1990s, causing private plans to drop out, and giving the program a bad name. Dr. McClellan's reforms, and a Republican Congress, have re-energized the program, but the key to future success is in the budget. Republicans would do well to spend more time touting the competition successes of the reform, rather than the drug giveaway.

In a perfect world, the Bush administration would never have swallowed that entitlement in the first place. In our imperfect world, it at least had the wisdom to hand the reform challenge to a guy who was able to demonstrate the merits of health-care competition, and optimistically, pave the way for broader reform down the road.

Great op-ed.

"Confidence Man" (like in FlimFlam Man") is Paul "Imus" Krugman of the New York Times. He earns this moniker because of the dishonest way he portrays the Part D benefit in today's edition of the Gray Lady, and his assertions that the NAACP and the League of United Latin American Citizens just aren't smart enough to know what's in their own best interests.  Read More & Comment...

Biotech Bootcamp

04/19/2007 09:49 AM |

CMPI Board member Steve Sammut is holding a biotech bootcamp for entreprenuers at Bio 2007 in Boston on May 7. Another board member, Atlas Venture partner Bruce Booth is on one of the panels.

Disclosure: Drugwonks does not receive any compensation for this plug and was not invited to speak. In fact, we were specifically told to stay away. Ok, so there is a TRO banning us from being within 200 yards of the session.

http://www.bio2007.org/Attendees/educational_sessions/EntrepreneurshipBootCamp1.htm  Read More & Comment...

Sheila Burke: Conflicted Over What a Conflict Is

04/19/2007 09:07 AM |

Here is Sheila Burke in her NEJM article describing the IOM Drug Safety panel she chaired:

"The IOM assembled a diverse panel of experts without ostensible bias or conflict of interest, none of whom were pharmaceutical industry employees."

Here is a description of Sheila Burke chairing the Smithsonian, which oversaw the conduct of Larry Small who used millions of taxpayer dollars to redo his home and hold lavish parties:

The Smithsonian Institution last year renewed a contract giving the Chubb Group more than a half-million dollars of insurance business annually while Lawrence M. Small, then the Smithsonian secretary, and Sheila P. Burke, the deputy secretary, held highly paid seats on Chubb's board of directors.

Small received cash and stock valued at $169,675 from Chubb last year, according to proxy statements filed with the Securities and Exchange Commission. He also received options to purchase 105,943 shares.

Burke received cash and stock valued at $194,676 from Chubb and options to purchase 56,000 shares, according to the SEC. Small and Burke sit on Chubb's compensation committee. Burke is also a member of Chubb's finance committee and pension and profit-sharing committee.

Small, who resigned late last month after seven years at the helm of the Smithsonian in the wake of questions about his salary and expenses, was set to receive $915,698 from the museum complex this year. Burke received $400,000 last year. A Senate committee holds hearings on Smithsonian compensation practices today. And another Senate committee investigation has raised questions about the Chubb-Smithsonian relationship."

Earlier this year Burke told me that a Nobel Prize winner would have been excluded from her IOM panel if he or she had worked for a drug company even if that person was an expert on drug safety. But I guess having someone rebuked by NIH for claiming a link between cancer and blood pressure meds and a hired gun for trial lawyers suing drug companies in drug safety cases is ok (Bruce Psaty) and taking money from a health insurer that would benefit from fewer new drug approvals is ok too.

Can we say ethically confused and compromised.  Read More & Comment...

The Sorrow and the Pity

04/19/2007 08:32 AM |

Virginia Tech sorrow and media SSRI hysteria notwithstanding, some important new science ...

Authors of a new comprehensive analysis of antidepressants for children and teenagers say the benefits of treatment trump the small risk of increasing some patients' chances of having suicidal thoughts and behaviors.

The risk they found is lower than the one the Food and Drug Administration identified in 2004, the year the agency warned the public about the drugs' risks in children. After the warning, U.S. youth suicides increased and some mental health experts said reluctance to try antidepressants might be to blame.

The new analysis includes data from seven studies that were not part of the previous FDA analysis, including two large pediatric depression trials that were unavailable three years ago.

Researchers analyzed data on 5,310 children and teenagers from 27 studies. They found that for every 100 kids treated with antidepressants, about one additional child experienced worsening suicidal feelings above what would have happened without drug treatment. In contrast, the FDA analysis found an added risk affecting about two in 100 patients.

Here's a link to the AP story:

http://www.chron.com/disp/story.mpl/health/4729234.html  Read More & Comment...

First Avian Flu Vaccine Approved...Will Go To MSM for Review

04/19/2007 08:04 AM |

Sanofi Aventis' vaccine division received approval for the first vaccine to protect against bird flu. According to the FDA the vaccine, has been approved for use only in adults aged 18-64 who are at a greater risk of being affected by the bird flu virus. The patients will receive a 90 microgram of shot initially and then another 90 microgram after 28 days.

Given that bird flu was first detected a few years ago, the speed with which a vaccine was developed is truly a marvel. And most of the vaccine will be donated or sold at cost. But don't expect any articles on that. Rather, expect a rash of media stories on whether the vaccine is being marketed to the right people and whether the researchers conducting studies on the vaccine's effectiveness received money from SA.

As I always say, no good deed goes unpunished.  Read More & Comment...

High Blood Pressure? Me Too!

04/19/2007 07:57 AM |

For those of you out there (yes, that means you Marcia Angell) who think we have "too many me-too drugs," consider yesterday's FDA adcomm vote on Avalide.

FDA advisers voted 7-0 in favor of approving the drug for use in controlling high blood pressure. (Avalide was initially approved only for hypertension patients who have failed other types of treatment.)

You've heard of hypertension, right? It's one of those made-up lifestyle diseases.

If the Me-Tooers were running the show, would Avalide have been approved in the first place? After all, do we really need another drug that treats hypertension?

Indeed we do -- and now physicians have a new, valuable, and on-label weapon in their fight against a major public health enemy -- high blood pressure.  Read More & Comment...

Warning Signs of Violent Behavior: On and Off Campus

04/18/2007 05:46 PM |

From the FBI.... I might be wrong but I don't see "taking an SSRI" on the list

1. A history of violence and/or being victimized
2. Threats of violence
3. An obsessive interest in weapons
4. A tendency to be isolated
5. The inability to get along with others
6. Excessive anger
7. Job loss
8. Breakup of a relationship
9. Alcohol and drug usage
10. Intolerance of differences
11. Gang affiliation
12. Poor attachment to school
13. Exhibiting impulsive behavior
14. Making violent drawings or writings  Read More & Comment...

Shooter Had Psychiatric Treatment..Sort Of

04/18/2007 05:32 PM |

As this story unfolds drugwonks will highlight what appears to be the critical factor in this tragedy in order to stave off the j'accuse from the anti-medication mob who are quick to blame ever senseless act of adolescent violence on the use of drugs to treat mental illness. Now in this case it would appear that the killer was psychotic -- not depressed -- and had been through the entire judicial-mental health system before being allowed go "outpatient" where he completely lost contact with any systematic care.

So we will be interested to see how that squares with efforts by the mob and the media to draw a direct link between a single medication that may or may not have been in his system at the time he carried out his plot and the massacre.

The lunatic fringe, led by Scientologists and quacks peddling 'natural cures' for everything from Alzheimer's to schizophrenia, are already polluting the blogosphere with lies and half truths claiming that Cho Seung-Hui was on SSRIs.
http://vitalvotes.com/blogs/public_blog/Could-Antidepressants-Explain-the-Virginia-Tech-Massacre--10928.aspx
http://winnipeg.indymedia.org/item.php?5048S

As countless studies show, such medications will make people with tendencies towards violence, less not more so.  Read More & Comment...

Will the VA Tech Shooter Trigger Attacks on SSRIs

04/18/2007 01:48 PM |

Our colleague Ed Silverman generated a lot of controversy with his post that rumors that the VA Tech killer was on medication at some point might trigger another attack on drug companies about the alleged dangers of SSRIs.

Here's my take:

While I pin the blame on the media for over-hyping and misrepresenting the risks of SSRI's -- particularly the clinical trials involving children who have co-morbidities, misdiagnoses, etc. -- the fact is tha fear sells paper just as violence sells video games. The fact is, that as horrible as this campus shooting is, school related shootings are rare and violence on college campuses has declined because of increased security, increased counseling, etc., etc. And moreover, according to FBI crime stats, a college campus is ten times safer than than the US as a whole.

While I am on the subject, and excuse me for saying it and maybe I have a little more leeway for saying this because of my own family experience, but I am tired of the press using perpetually enraged parents who blame the death of their kid's on prescription drugs. There are thousands of children who take their own lives who who never get medication and thousands more who have pulled themselves from the abyss because of such drugs. Who are they to lecture the rest of us about the motives of drug companies and science of medicine. I am sorry for their loss but I have been through hell too. They have no monopoly on sorrow and portraying them as victims of antidepressants is inaccurate and unfair. Give it a rest!

You don't want your kids to be on anti-depressants. Fine. But stop pouring gasoline on a subject with ignorance and fear. And don't exploit a tragedy by using it to scare other parents into seeking appropriate care for their kids. As for the media, you have the facts now. Use them.  Read More & Comment...