Latest Drugwonks' Blog
This goal, though not fleshed out in a detailed legislative proposal, is much more than a campaign slogan. That conclusion emerged from interviews with a wide range of Republican lawmakers, who said they were determined to chip away at the law if they could not dismantle it.
In these bad times, bio drugs create jobs
There are some silver linings in these dark economic clouds. Chief among them is the resilience of the American biopharmaceutical sector. Our leaders should work to build on its economic success.
Through 2008, during the worst recession in more than a generation, the biopharmaceutical sector grew by 1.4 percent. At the same time, total private-sector employment went in the opposite direction, declining 0.7 percent. Without the robust growth of biopharmaceutical companies, the recession would’ve been even worse.
America dominates biopharma. In 2007, more than 2,700 drugs were under development in the U.S. — compared to just 1,700 in the rest of the world.
From 1996 to 2006, the number of domestic jobs in the industry exploded, growing at twice the rate of job creation elsewhere in the economy. Biopharma employs almost 700,000 people and supports 3.2 million American jobs.
These are good-paying jobs, too. The average salary in the biopharmaceutical sector was $77,595 in 2008 — $32,000 more than the average private-sector job.
But the biopharmaceutical sector does more than foster economic growth — its research also saves lives.
Antiretroviral treatments have cut AIDS deaths by 70 percent. Innovative drugs are largely responsible for cutting cancer death rates in half. One Columbia University study found that between 1991 and 2004, the average American lifespan increased by nearly 2 1/2 years. The researchers attributed this staggering achievement to new drugs and better medical imaging technology.
But American dominance of this sector in the future isn’t a certainty. European and Asian companies are fighting harder and harder for a larger piece of the biopharma pie.
So how do we make sure that America remains at the top?
First, the U.S. must remain an attractive place to do business. Biopharma is a very dynamic industry. Scrappy start-ups compete head to head with some of the biggest companies in the world. Excessive taxes and an onerous regulatory environment will discourage new businesses from sprouting up, and will prompt more established actors to seek friendlier climes abroad.
Second, the U.S. must resist the temptation to forcibly limit the price of drugs. Pharmaceuticals are a high-risk, high-reward business. The average drug costs more than $1 billion to develop. For every 5,000 to 10,000 compounds that enter testing, only one will get FDA approval and make it to market.
If government price controls prevent companies from recouping the billions they pour into research and development, then investors will refuse to fund the next round of innovative research.
Finally, America’s leaders must work to improve the American educational system so that we can produce the bright young people that medical research requires.
American students rank 21st in science and 25th in math when compared to students from 30 other countries. Our lack of science and math aptitude threatens to imperil our standing as a global leader in innovation.
President Barack Obama has spoken forcefully about closing this gap, and his administration’s “Educate to Innovate” program has committed $260 million to improving math and science education. This is a good start, but more needs to be done.
In this trying economy, America’s biopharmaceutical sector provides a reason for optimism. Our leaders must make sure that the industry can continue to grow and breathe new life into the economy.
From today's edition of Reuters' "Great Debate" series:
Let cancer patients have this pill
By: Peter J. Pitts
One more day — or week, or month, or perhaps even a year. It may not seem like much time, but patients with incurable cancer know better. For Christi Turnage of Mississippi, who lives with stage IV breast cancer, it means seeing her daughter start kindergarten, celebrating her 27th wedding anniversary, and watching her sons graduate from college.
Her family and her oncologist credit her quality of life for the past two years to the drug Avastin, a biologic that combats cancer by cutting off the blood supply to tumors. But advanced breast cancer patients like Turnage have been forced to spend precious time battling something else: the possibility that federal regulators will vote today to remove approval of Avastin for their treatment.
If officials with the U.S. Food and Drug Administration are wise, they will overrule the agency’s cancer-drug advisory panel, which voted 12-to-1 last month to recommend denying a valuable clinical option to advanced breast cancer patients. According to the Department of Health and Human Services, an estimated 40,000 women die from breast cancer each year.
The panel concluded that the costly drug doesn’t eke out enough extra lifetime among breast cancer patients to justify its use and risks. This ignores all the “super responders” — the patients who reap significant benefits from Avastin. Scientists have no way of identifying these people in advance, and they could be devastated if they are denied the medicine.
“This is not a worthless drug by any means,” Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “There is almost certainly a group of women who get a big benefit.”
Indeed, the Susan G. Komen for the Cure and Ovarian Cancer National Alliance – recently sent a joint letter to the FDA urging the government to keep it as a choice best made by a woman and her doctor.
The groups also warned that if the FDA de-lists Avastin for breast cancer, it would only discourage future drug development.
Two years ago, the FDA fast-tracked approval of Avastin for metastatic breast cancer two years ago, and since then it has been prescribed to about 17,500 women a year with the disease. The drug, which earned FDA approval for the treatment of colon, lung, kidney and brain cancer, is the world’s best-selling cancer drug.
A clinical trial that took place from December 2001 and May 2004 found that Avastin boosted the amount of time that breast cancer patients lived without the disease spreading or worsening. The drug in combination with chemotherapy delayed tumor growth for about 11 months, which was more than five months longer than chemo alone. Follow-up studies indicated a less robust response, yet still found an average delay in tumor growth to between one and three months.
But even if Avastin does not, “on average,” extend life for breast cancer patients, that “average” is composed of patients who respond in dramatically different ways –including some like Christi Turnage who gain years.
Another is retired California art teacher Patricia Howard, who reports that infusions of Avastin every three weeks over the past two years have shrunk tumors in the lining of her lung and eliminated fluid that hampered her breathing. Now she enjoys shopping and golf, and describes her life as “beyond fabulous.”
Serving as a patient representative at the FDA’s last session, Howard recalled, “One doctor got up during the meeting and said ‘This drug gets women only to first base and we want a home run.’ I felt like jumping up and saying I don’t mind just being in the ballgame.”
If the FDA does remove approval of Avastin for breast cancer, doctors conceivably could write prescriptions for it anyway, going “off label.” But it’s likely that Medicare and private insurers would not cover the cost of what is one of the world’s most expensive drugs. Patients could continue Avastin only if they could afford $8,000 a month out of pocket.
Avastin is a better alternative than the status quo for breast cancer patients, and can be truly transformative for some. No wonder Avastin-users are desperately writing letters, circulating petitions and, like Turnage’s 19-year-old son Josh, posting videos on YouTube pleading their case.
Avastin is their last hope. The FDA should make sure it is not their lost hope.
(Reuters) - A new process to review medical products at the U.S. Food and Drug Administration in tandem with the nation's Medicare insurance program could help speed up coverage decisions, the FDA said in announcing the move on Thursday.
Under the proposal, the FDA would review and make approval decisions alongside the Centers for Medicare and Medicaid Services, which decides whether and how to pay for new medical products for its elderly and disabled patients once they are approved for the U.S. market.
To start, the agencies proposed a pilot project for devices after both FDA and CMS had time to review public comments on the proposal.
More than 45 million people are covered under the Medicare program. Private insurers often weigh CMS's coverage decisions when setting their own reimbursement policies, and a decision by Medicare to cover a new product can speed its adoption in the wider marketplace.
This litte group of elites guessed wrong. Poll and after poll shows that not is Obamacare wildly unpopular but it remains a principal reason for voters to toss out Democrats in November.
Yet, the elites still insist that the law is popular:
"A new CBS/New York Times poll has found that 49 percent of Americans oppose the health care law, compared with just 37 percent who support it.
ObamaCare booster Jonathan Cohn, while acknowledging that recent polls have been discouraging, sees some silver lining in the CBS/NYT poll. He notes that "While 40 percent of respondents said they supported repealing the Affordable Care Act, more than half changed their minds (leaving just 19 percent in favor of repeal) when pollsters mentioned that it'd mean letting insurance companies exclude people with pre-existing conditions."
What a hypocrite. As Phil Klein of the American Spectator points out:
"Yet this is the same argument that proponents of the legislation have used all along to explain poor poll results -- that it's more popular when you ask separately about its component parts. The problem is that the popular parts are linked to other less popular parts to make up the whole."
spectator.org/blog/2010/09/16/opposition-to-obamacare-rises
Moreover, Cohn and others have always insisted that you can't provide such exemptions without forcing everyone to buy into government approved plans and using price controls and rationing to control use of services. You can't have it both ways: point to support of changes people are in favor of yet insist that the entire law in its current form must be implemented. If pollsters mentioned other aspects of the bill -- as an earlier CMPI poll showed -- support evaporates.
The fact is, repealing the worst features of Obamacare and replacing it with something that gives people coverage, choice and control over health care decisions is something a vast majority of Americans favor.
pajamasmedia.com/files/2010/03/CMPIA.PJM-raw-data.pdf
Hoosier daddy?
David Graham's latest black helicopter theory about the fact that an FDA advisory committee recommended keeping Avandia on the market (with additional warnings) with editorial comments from Steve Nissen:
Silver Spring, MD - Accusations of bias among the FDA advisory committee that voted on the fate of rosiglitazone (Avandia, GlaxoSmithKline) earlier this summer have been made by two members of the FDA's Office of Surveillance and Epidemiology [1].
In a letter to BMJ published online September 7, 2010, Drs David Graham and Kate Gelperin point out that half the members of the July 2010 advisory panel had previously voted in favor of allowing rosiglitazone to stay on the market at an earlier FDA advisory committee in 2007. They write: "In an unprecedented move, the FDA's Center for Drug Evaluation and Research (CDER), which originally approved rosiglitazone and has defended its continued marketing, invited not only the current members of these committees [the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee] but also all members from the 2007 meeting, even though they were no longer active members of either committee. Of the 32 advisers who voted at the 2010 meeting, 16 (50%) attended the 2007 meeting, and 15 of them had voted that rosiglitazone remain on the market (one attendee was a temporary nonvoting invitee)."
Graham and Gelperin say this biased the vote at the 2010 meeting. They calculate that members voting for the first time were 4.4 times more likely to vote that rosiglitazone be withdrawn from the market than were members who had voted previously to keep it on the market. "Had these former members not been included, the vote would have been 10 out of 17 (59%) in favor of rosiglitazone withdrawal, with an additional three in favor of severely restricted distribution," they add.
Panel "loaded"?
Commenting on this for heartwire, Dr Steve Nissen (Cleveland Clinic, OH), the coauthor of the meta-analysis at the center of the rosiglitazone safety concerns, who has been leading the campaign to get rosiglitazone withdrawn, said it was obvious that the 2010 panel was "loaded."
They have rigorously defended rosiglitazone again and again, and obviously they feel they cannot be seen to have made such an error.
He added: "The outcome of FDA advisory panels is significantly influenced by who is on the panel. When I saw the roster, I knew it was going to be an uphill struggle. I was very surprised that they had invited back people who had already voted to keep the drug on the market in 2007. Once you have opined publicly, it is very difficult to turn around and admit you made a mistake." Nissen said it would have been the leadership at the CDER that decided who to invite to this panel meeting, and this is another demonstration they do not want to act against this drug. "They should have acted much earlier on, when the first negative data were reported. But they have rigorously defended rosiglitazone again and again, and obviously they feel they cannot be seen to have made such an error."
Here are my questions:
Why does BMJ feel compelled to help Graham and Nissen peddle their fearmongering? And where is the opportunity to provide an opposing (and more balanced) view?
Why are the two launching an attack on FDA's integrity now? Does it have anything to do with yet another campaign to pressure the agency to overturn the Ad Comm decision?
Does Nissen actually believe that the composition of the Ad Comm is part of a CDER coverup? That is a very serious accusation. Did St. Steven the Pure wear a wire when talking to CDER officials?
www.theheart.org/article/1121701.do
Oh, and one more question: What about the recent observational study showing no difference in heart risks between Avandia and Actos. No comment or BMJ editorial yet from Nissen or Graham, a study that, uniike Graham's did not use data dredging to squeeze out an 18 percent additional risk of heart problems associated with Avandia compared to Actos..
circoutcomes.ahajournals.org/cgi/content/short/3/5/538
Agenzia Fides, the missionary press agency of the Vatican, has spoken out against counterfeit drugs
and the approximated 700,000 people expected to die annually due to their pervasiveness.
Fake tuberculosis and malaria drugs alone are estimated to kill 700,000 people a year. A large part of these victims are African. The World Health Organization (WHO) estimates that up to 30 percent of the medicines on sale in many African countries are counterfeit and have found that nearly half of the drugs sold in Angola, Burundi, and the Congo are substandard.
In 2003, Interpol conducted a survey on the quality of drugs available in Lagos, sub-Saharan Africa's most populous city and found that 80 percent of the drugs available were fakes. In 2008, more than 80 children in Nigeria died after being given medicine for teething pain that was laced with antifreeze.
Fake medicines can be missing key ingredients, use the wrong ingredient, or have insufficient or too much of the active ingredient. In some cases, use of these medicines can increase drug resistance. When there is not enough of the active ingredient, the drug kills some of the parasites or viruses, but the pathogens that are not killed adapt. As time goes on, even if a patent was to be treated with the correct medication, he or she would not be cured.
Agenzia Fides states, “The development of germs resistant to antibiotics and other treatments is a problem that affects all humanity, not just Africans. It is therefore in the best interest of all concerned that smuggling of counterfeit drugs be fought against.”
Which brings us to the FDA and the future of medical innovation.
A few years ago I had the honor of discussing both topics with Nobel Prize Laureate Joshua Lederberg. Actually, to be accurate, I mostly listened and took notes at the feet of the great man.
When I asked him about FDA's role in 21st century medical science, Dr. Lederberg responded that the real question should be, "Is innovation even possible?"
To that end, have a look at this very interesting and challenging cover story from this week's edition of BioCentury. Titled, "Regulatory Innovation," it makes some keen observations and offers some siginificant food for thought.
Is innovation even possible? Let's hope so.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
